Effectiveness and Safety of Ramipril Alone Compared With Telmisartan Alone and in Combination With Ramipril in Patients at High Risk for Cardiovascular Events. Patients Intolerant to Ramipril Were Entered in TRANSCEND, Telmisartan Compared to Placebo.
Sponsor
Boehringer Ingelheim (Industry)
Overall Status
Completed
CT.gov ID
NCT00153101
Collaborator
(none)
31,546
732
43.1
Study Details
Study Description
Brief Summary
The Ongoing Telmisartan Alone and in combination wiht Ramipril Global Endpoint trial (ONTARGET): The primary objectives are to determine if (a) telmisartan 80mg daily and ramipril 10mg daily combination therapy is more effective in reducing the composite endpoint of Cardiovascular Death (CV) death, Myocardial infarction (MI), stroke or hospitalization for Congestive Heart Failure (CHF) compared with ramipril 10mg alone; and (b) telmisartan 80mg daily is at least as effective as (i.e. not less effective than) ramipril 10mg daily, on this endpoint.
Telmisartan Randomised Assessment Study in Angiotension converting Enzyme inhibitor intolerant subjects with Cardiovascular Disease. (TRANSCEND): The primary objective of the study is to determine if treatment with telmisartan 80mg daily is superior to placebo reducing the composite endpoint of Cardiovascular Death (CV), Myocardial Infarction ( MI)I, stroke or hospitalization for Congestive Heart Failure (CHF) in patients who are intolerant to Angiotension Converting Enzyme inhibitors.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
31546 participants
Intervention Model:
Parallel Assignment
Primary Purpose:
Prevention
Official Title:
ONTARGET ONgoing Telmisartan Alone and in Combination With Ramipril Global Endpoint Trial A Large, Simple Randomized Trial of an Angiotensin II Receptor Antagonist (Telmisartan) and an ACE-Inhibitor (Ramipril) in Patients at High Risk for Cardiovascular Events and TRANSCEND Telmisartan Randomized AssessmeNt Study in aCE iNtolerant Subjects With Cardiovascular Disease. A Parallel Study Comparing the Effects of Telmisartan With Placebo and Outcomes in Patients at High Risk for Cardiovascular Events and Intolerant to ACE-I.
Study Start Date
:
Nov 1, 2001
Actual Primary Completion Date
:
Jun 1, 2008
Outcome Measures
Primary Outcome Measures
- ONTARGET. Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke and Hospitalization for Congestive Heart Failure [56 months]
The Ongoing Telmisartan Alone and combination with Ramipril global Endpoint trial (ONTARGET). Time to first event analysis of the following defined endpoints, Cardiovascular Death, Non-fatal myocardial infarction, non-fatal stroke and hospitalization for congestive heart failure.
- ONTARGET. 3-fold Composite Endpoint of Doubling of Serum Creatinine, Progression to End Stage Renal Disease (ESRD) and All-cause Mortality in Diabetic Nephropathy Patients [56 months]
ESRD is defined by initiation of dialysis, need for renal transplantation, or eGFR <15 mL/min/1.73 m². Diabetic nephropathy patients are diabetic patients with macro-albuminuria assessed as a Urinary Albumin Creatinine Ratio (UACR) ≥300 mg/g Crea at baseline. These renal outcomes were not adjudicated (apart from death).
- TRANSCEND. Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke and Hospitalization for Congestive Heart Failure [56 months]
Telmisartan Randomized Assessment Study in Angiotension Converting Enzyme inhibitor intolerant subjects with cardiovascular disease (TRANSCEND). Time to first event analysis of the following defined endpoints, Cardiovascular Death, Non-fatal myocardial infarction, non-fatal stroke and hospitalization for congestive heart failure.
Secondary Outcome Measures
- ONTARGET. Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction and Non-fatal Stroke [56 months]
The Ongoing Telmisartan Alone and combination with Ramipril global Endpoint trial (ONTARGET). Time to first event analysis of the following defined endpoints, non-fatal myocardial infarction or non-fatal stroke
- ONTARGET. Cardiovascular Death [56 months]
The Ongoing Telmisartan Alone and combination with Ramipril global Endpoint trial (ONTARGET). Time to the first event analysis of the endpoint cardiovascular death.
- ONTARGET. Non-fatal Myocardial Infarction [56 months]
The Ongoing Telmisartan Alone and combination with Ramipril global Endpoint trial (ONTARGET). Time to the first event analysis of the endpoint non-fatal myocardial infarction.
- ONTARGET. Non-fatal Stroke [56 months]
The Ongoing Telmisartan Alone and combination with Ramipril global Endpoint trial (ONTARGET). Time to first event analysis of the endpoint non-fatal stroke.
- ONTARGET. Hospitalization for Congestive Heart Failure [56 months]
The Ongoing Telmisartan Alone and combination with Ramipril global Endpoint trial (ONTARGET). Time to the first event analysis of the endpoint hospitalization for congestive heart failure.
- ONTARGET. Doubling of Serum Creatinine in Diabetic Nephropathy Patients [56 months]
Diabetic nephropathy patients are diabetic patients with macro-albuminuria assessed as a Urinary Albumin Creatinine Ratio (UACR) ≥300 mg/g Crea at baseline.
- ONTARGET. Progression to End Stage Renal Disease (ESRD) in Diabetic Nephropathy Patients [56 months]
ESRD is defined by initiation of dialysis, need for renal transplantation, or eGFR <15 mL/min/1.73 m². Diabetic nephropathy patients are diabetic patients with macro-albuminuria assessed as a Urinary Albumin Creatinine Ratio (UACR) ≥300 mg/g Crea at baseline.
- ONTARGET. All-cause Mortality in Diabetic Nephropathy Patients [56 months]
Diabetic nephropathy patients are diabetic patients with macro-albuminuria assessed as a Urinary Albumin Creatinine Ratio (UACR) ≥300 mg/g Crea at baseline.
- ONTARGET. Doubling of Serum Creatinine [56 months]
ONTARGET. Nephropathy subcategory: doubling of serum creatinine
- ONTARGET. Progression to ESRD [56 months]
ONTARGET. Nephropathy subcategory: Progression to ESRD. Progression to ESRD is defined as initiation of dialysis, need for renal transplantation, or eGFR <15 mL/min/1.73 m².
- ONTARGET. New Microalbuminuria [56 months]
ONTARGET. Nephropathy subcategory: New microalbuminuria. New microalbuminuria is defined as Urinary Albumin Creatinine Ratio ≥30 mg/g Crea in patients with a Urinary Albumin Creatinine Ratio <30 mg/g Crea at baseline.
- ONTARGET. New Macroalbuminuria [56 months]
ONTARGET. Nephropathy subcategory: New macroalbuminuria. New macroalbuminuria is defined as Urinary Albumin Creatinine Ratio ≥300 mg/g Crea in patients with a Urinary Albumin Creatinine Ratio <300 mg/g Crea at baseline.
- ONTARGET. Combined Endpoint of Doubling of Serum Creatinine, Progression to ESRD, New Microalbuminuria, or New Macroalbuminuria [56 months]
ONTARGET. Nephropathy subcategory: Combined endpoint of doubling of serum creatinine, progression to ESRD, new microalbuminuria, or new macroalbuminuria
- ONTARGET. Normalisation From Micro- or Macroalbuminuria to Normoalbuminuria [56 months]
ONTARGET. Nephropathy subcategory: Normalisation from micro- or macroalbuminuria to normoalbuminuria. Normalisation from micro- or macroalbuminuria to normoalbuminuria is defined as UACR <30 mg/g Crea in patients with a UACR ≥30 mg/g Crea at baseline.
- ONTARGET. Newly Diagnosed Congestive Heart Failure [56 months]
The Ongoing Telmisartan Alone and combination with Ramipril global Endpoint trial (ONTARGET). Time to the first event analysis of the endpoint Newly diagnosed Congestive Heart failure.
- ONTARGET. Cardiovascular Revascularization Procedure [56 months]
The Ongoing Telmisartan Alone and combination with Ramipril global Endpoint trial (ONTARGET).
- ONTARGET. Newly Diagnosed Diabetes [56 months]
The Ongoing Telmisartan Alone and combination with Ramipril global Endpoint trial (ONTARGET). Time to the first event analysis of the endpoint Newly diagnosed Diabetes. Only calculated for those patients without diabetes at baseline.
- ONTARGET. Cognitive Decline [56 months]
The Ongoing Telmisartan Alone and combination with Ramipril global Endpoint trial (ONTARGET). Time to first event analysis of the endpoint cognitive decline i.e. Comparison of the Mini mental state Evaluation (MMSE) of patients at baseline with that at the 2years and end of trial. A decrease in MMSE from baseline represents a cognitive decline. This outcome measure is only available for those patients who had MMSE at baseline.
- ONTARGET. New Onset of Atrial Fibrillation [56 months]
The Ongoing Telmisartan Alone and combination with Ramipril global Endpoint trial (ONTARGET). Time to first event analysis of endpoint new onset of atrial fibrillation.
- TRANSCEND. Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction and Non-fatal Stroke [56 months]
Telmisartan Randomized Assessment Study in Angiotension Converting Enzyme inhibitor intolerant subjects with cardiovascular disease (TRANSCEND). Time to first event analysis of the following defined endpoints, Cardiovascular Death, Non-fatal myocardial infarction, non-fatal stroke and hospitalization for congestive heart failure.
- TRANSCEND. Cardiovascular Death [56 months]
Telmisartan Randomized Assessment Study in Angiotension Converting Enzyme inhibitor intolerant subjects with cardiovascular disease (TRANSCEND). Time to the first event analysis of the endpoint cardiovascular death.
- TRANSCEND. Non-fatal Myocardial Infarction [56 months]
Telmisartan Randomized Assessment Study in Angiotension Converting Enzyme inhibitor intolerant subjects with cardiovascular disease (TRANSCEND). Time to the first event analysis of the endpoint non-fatal myocardial infarction.
- TRANSCEND. Non-fatal Stroke [56 months]
Telmisartan Randomized Assessment Study in Angiotension Converting Enzyme inhibitor intolerant subjects with cardiovascular disease (TRANSCEND).
- TRANSCEND. Hospitalization for Congestive Heart Failure [56 months]
Telmisartan Randomized Assessment Study in Angiotension Converting Enzyme inhibitor intolerant subjects with cardiovascular disease (TRANSCEND).
- TRANSCEND. Doubling of Serum Creatinine [56 months]
TRANSCEND. Nephropathy subcategory: doubling of serum creatinine
- TRANSCEND. Progression to ESRD [56 months]
TRANSCEND. Nephropathy subcategory: Progression to ESRD. Progression to ESRD is defined as initiation of dialysis, need for renal transplantation, or eGFR <15 mL/min/1.73m²
- TRANSCEND. New Microalbuminuria [56 months]
TRANSCEND. Nephropathy subcategory: New microalbuminuria. New microalbuminuria is defined as UACR ≥30 mg/g creatinine [Crea] in patients with a UACR <30 mg/g Crea at baseline
- TRANSCEND. New Macroalbuminuria [56 months]
TRANSCEND. Nephropathy subcategory: New macroalbuminuria. New macroalbuminuria is defined as UACR ≥300 mg/g creatinine [Crea] in patients with a UACR <300 mg/g Crea at baseline
- TRANSCEND. Combined Endpoint of Doubling Serum Creatinine, Progression to ESRD, New Microalbuminuria or New Macroalbuminuria [56 months]
TRANSCEND. Nephropathy subcategory: Combined endpoint of doubling serum creatinine, progression to ESRD, new microalbuminuria or new macroalbuminuria
- TRANSCEND. Normalisation From Micro- or Macroalbuminuria to Normoalbuminuria [56 months]
TRANSCEND. Nephropathy subcategory: Normalisation from micro- or macroalbuminuria to normoalbuminuria. Normalisation from micro- or macroalbuminuria to normoalbuminuria is defined as UACR <30 mg/g Crea in patients with a UACR ≥30 mg/g Crea at baseline.
- TRANSCEND. New Onset of Atrial Fibrillation [56 months]
Telmisartan Randomized Assessment Study in Angiotension Converting Enzyme inhibitor intolerant subjects with cardiovascular disease (TRANSCEND).
- TRANSCEND. Cognitive Decline [56 months]
Telmisartan Randomized Assessment Study in Angiotension Converting Enzyme inhibitor intolerant subjects with cardiovascular disease (TRANSCEND). Time to first event analysis of the endpoint cognitive decline i.e. Comparison of the Mini mental state Evaluation (MMSE) of patients at baseline with that at the 2years and end of trial. A decrease in MMSE from baseline represents a cognitive decline. This outcome measure is only available for those patients who had MMSE at baseline.
- TRANSCEND. Newly Diagnosed Diabetes [56 months]
Telmisartan Randomized Assessment Study in Angiotension Converting Enzyme inhibitor intolerant subjects with cardiovascular disease (TRANSCEND). Time to the first event analysis of the endpoint Newly diagnosed Diabetes. Only calculated for those patients without diabetes at baseline.
- TRANSCEND. Cardiovascular Revascularization Procedure [56 months]
Telmisartan Randomized Assessment Study in Angiotension Converting Enzyme inhibitor intolerant subjects with cardiovascular disease (TRANSCEND).
- TRANSCEND. Newly Diagnosed Congestive Heart Failure [56 months]
Telmisartan Randomized Assessment Study in Angiotension Converting Enzyme inhibitor intolerant subjects with cardiovascular disease (TRANSCEND).
Eligibility Criteria
Criteria
Ages Eligible for Study:
55 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
Coronary Artery Disease: Previous Myocardial infarction(> 2 days prior to informed consent), or stable or previous unstable angina (> 30 days prior to informed consent) with documented multivessel coronary artery disease or a positive stress test, or multivessel Percutaneous Transluminal Coronary Angioplasty (> 30 days prior to informed consent), or previous multivessel Coronary Artery Bypass Grafting without angina (if surgery performed > 4 years prior to informed consent) or with recurrent angina after surgery.
Other High Risk:
-
Peripheral Arterial Disease: Previous limb bypass surgery or angioplasty or amputation, intermittent claudication on history with ankle/arm Blood Pressure ratio < 0.8 on at least one side, or significant stenosis by angiography or non-invasive testing
-
Previous stroke
-
Transient ischemic Attack > 7 days and < 1 year prior to informed consent
-
Diabetes Mellitus (types I or II): with evidence of end-organ damage (retinopathy, Left ventricular hypertrophy, micro or macro albuminuria), or any evidence of previous cardiac or vascular disease.
No definite and specific indication or contraindication for any of the study treatments. Written informed consent.
Exclusion Criteria:
A. Medication use:
-
Inability to discontinue Angiotension Converting Enzyme (ACE) inhibitors or Angiotension 2 receptor antagonists (AIIAs).
-
Patients with known hypersensitivity or intolerance to Angiotension 2 receptor antagonists (AIIAs) or Angiotension Converting Enzyme (ACE)inhibitors.
NOTE: Patients with known intolerance to Angiotension Converting Enzyme inhibitor intolerance ( ACE-I) can be enrolled in the TRANSCEND study.
B. Cardiovascular disease:
-
Symptomatic congestive heart failure.
-
Hemodynamically significant primary valvular or outflow tract obstruction (e.g. aortic or mitral valve stenosis, asymmetric septal hypertrophy, malfunctioning prosthetic valve).
-
Constrictive pericarditis.
-
Complex congenital heart disease.
-
Syncopal episodes of unknown etiology < 3 months before informed consent.
-
Planned cardiac surgery or angioplasty within three months.
-
Uncontrolled hypertension on treatment (i.e.Blood pressure ( BP) > 160/100).
-
Heart transplant recipient.
-
Strokes due to subarachnoid hemorrhage
C. Other conditions:
-
Significant renal disease defined as:
-
Renal artery stenosis;
-
Creatinine clearance < 0.6 ml/min or serum creatinine > 265 umol/L (> 3.0 mg/dL);
-
Hyperkalemia: potassium > 5.5 mmol/L.
-
Proteinuria* (for TRANSCEND only).
-
Hepatic dysfunction as defined by the following laboratory parameters: Serum Glutamate Pyruvate Transaminase( SGPT) Alaninaminotransferase (ALT) or Serum Glutamic Oxaloacetic Transaminase (SGOT) Aspartate aminotransferase (AST) > than 4 times upper limit of normal or additional criteria for hepatic impairment the upper limit of normal range, total Bilirubin > 20 umol/L, biliary obstructive disorders.
-
Uncorrected volume depletion or sodium depletion.
-
Primary aldosteronism.
-
Hereditary fructose intolerance.
-
Any other major non-cardiac illness expected to reduce life expectancy or interfere with study participation.
-
Patient is simultaneously taking another experimental drug.
-
Patient with significant disability that precludes regular attendance at clinic for follow-up.
-
Patient has sufficient disability or other incapacity that precludes regular attendance at clinic for follow-up.
-
Unable or unwilling to provide written informed consent.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 502.373.0256 Boehringer Ingelheim Investigational Site | Athens | Alabama | United States | |
| 2 | 502.373.0251 Boehringer Ingelheim Investigational Site | Birmingham | Alabama | United States | |
| 3 | 502.373.0182 Boehringer Ingelheim Investigational Site | Phoenix | Arizona | United States | |
| 4 | 502.373.0188 Boehringer Ingelheim Investigational Site | Phoenix | Arizona | United States | |
| 5 | 502.373.0189 Boehringer Ingelheim Investigational Site | Tucson | Arizona | United States | |
| 6 | 502.373.0177 Boehringer Ingelheim Investigational Site | Tuscon | Arizona | United States | |
| 7 | 502.373.0209 Boehringer Ingelheim Investigational Site | Bentonville | Arkansas | United States | |
| 8 | 502.373.0173 Boehringer Ingelheim Investigational Site | Concord | California | United States | |
| 9 | 502.373.0266 Boehringer Ingelheim Investigational Site | Harbor City | California | United States | |
| 10 | 502.373.0283 Boehringer Ingelheim Investigational Site | Loma Linda | California | United States | |
| 11 | 502.373.0180 Boehringer Ingelheim Investigational Site | Los Angeles | California | United States | |
| 12 | 502.373.0175 Boehringer Ingelheim Investigational Site | Sacramento | California | United States | |
| 13 | 502.373.0165 Boehringer Ingelheim Investigational Site | San Diego | California | United States | |
| 14 | 502.373.0228 Boehringer Ingelheim Investigational Site | San Leandro | California | United States | |
| 15 | 502.373.0205 Boehringer Ingelheim Investigational Site | Sylmar | California | United States | |
| 16 | 502.373.0277 Boehringer Ingelheim Investigational Site | West Hills | California | United States | |
| 17 | 502.373.0226 Boehringer Ingelheim Investigational Site | Bridgeport | Connecticut | United States | |
| 18 | 502.373.0174 Boehringer Ingelheim Investigational Site | Farmington | Connecticut | United States | |
| 19 | 502.373.0258 Boehringer Ingelheim Investigational Site | Washington | District of Columbia | United States | |
| 20 | 502.373.0179 Boehringer Ingelheim Investigational Site | Gainesville | Florida | United States | |
| 21 | 502.373.0183 Boehringer Ingelheim Investigational Site | Palm Harbor | Florida | United States | |
| 22 | 502.373.0240 Boehringer Ingelheim Investigational Site | Panama City | Florida | United States | |
| 23 | 502.373.0171 Boehringer Ingelheim Investigational Site | Tampa | Florida | United States | |
| 24 | 502.373.0282 Boehringer Ingelheim Investigational Site | Vero Beach | Florida | United States | |
| 25 | 502.373.0214 Boehringer Ingelheim Investigational Site | Weston | Florida | United States | |
| 26 | 502.373.0161 Boehringer Ingelheim Investigational Site | Augusta | Georgia | United States | |
| 27 | 502.373.0193 Boehringer Ingelheim Investigational Site | Augusta | Georgia | United States | |
| 28 | 502.373.0201 Boehringer Ingelheim Investigational Site | Augusta | Georgia | United States | |
| 29 | 502.373.0223 Boehringer Ingelheim Investigational Site | Conyers | Georgia | United States | |
| 30 | 502.373.0268 Boehringer Ingelheim Investigational Site | Sandersville | Georgia | United States | |
| 31 | 502.373.0245 Boehringer Ingelheim Investigational Site | Savannah | Georgia | United States | |
| 32 | 502.373.0199 Boehringer Ingelheim Investigational Site | Tucker | Georgia | United States | |
| 33 | 502.373.0162 Boehringer Ingelheim Investigational Site | Valdosta | Georgia | United States | |
| 34 | 502.373.0203 Boehringer Ingelheim Investigational Site | Pocatello | Idaho | United States | |
| 35 | 502.373.0244 Boehringer Ingelheim Investigational Site | Burbank | Illinois | United States | |
| 36 | 502.373.0272 Boehringer Ingelheim Investigational Site | Chicago | Illinois | United States | |
| 37 | 502.373.0217 Boehringer Ingelheim Investigational Site | Olympia Fields | Illinois | United States | |
| 38 | 502.373.0270 Boehringer Ingelheim Investigational Site | Des Moines | Iowa | United States | |
| 39 | 502.373.0167 Boehringer Ingelheim Investigational Site | Monroe | Louisiana | United States | |
| 40 | 502.373.0158 Boehringer Ingelheim Investigational Site | Shreveport | Louisiana | United States | |
| 41 | 502.373.0247 Boehringer Ingelheim Investigational Site | Baltimore | Maryland | United States | |
| 42 | 502.373.0284 Boehringer Ingelheim Investigational Site | Boston | Massachusetts | United States | |
| 43 | 502.373.0229 Boehringer Ingelheim Investigational Site | Springfield | Massachusetts | United States | |
| 44 | 502.373.0237 Boehringer Ingelheim Investigational Site | Wyandotte | Michigan | United States | |
| 45 | 502.373.0208 Boehringer Ingelheim Investigational Site | Minneapolis | Minnesota | United States | |
| 46 | 502.373.0232 Boehringer Ingelheim Investigational Site | Minneapolis | Minnesota | United States | |
| 47 | 502.373.0231 Boehringer Ingelheim Investigational Site | St. Paul | Minnesota | United States | |
| 48 | 502.373.0181 Boehringer Ingelheim Investigational Site | Biloxi | Mississippi | United States | |
| 49 | 502.373.0185 Boehringer Ingelheim Investigational Site | Cleveland | Mississippi | United States | |
| 50 | 502.373.0254 Boehringer Ingelheim Investigational Site | Jackson | Mississippi | United States | |
| 51 | 502.373.0195 Boehringer Ingelheim Investigational Site | Kansas City | Missouri | United States | |
| 52 | 502.373.0207 Boehringer Ingelheim Investigational Site | St. Louis | Missouri | United States | |
| 53 | 502.373.0239 Boehringer Ingelheim Investigational Site | St. Louis | Missouri | United States | |
| 54 | 502.373.0279 Boehringer Ingelheim Investigational Site | Omaha | Nebraska | United States | |
| 55 | 502.373.0169 Boehringer Ingelheim Investigational Site | North Las Vegas | Nevada | United States | |
| 56 | 502.373.0157 Boehringer Ingelheim Investigational Site | Camden | New Jersey | United States | |
| 57 | 502.373.0202 Boehringer Ingelheim Investigational Site | East Orange | New Jersey | United States | |
| 58 | 502.373.0191 Boehringer Ingelheim Investigational Site | Newark | New Jersey | United States | |
| 59 | 502.373.0271 Boehringer Ingelheim Investigational Site | Westwood | New Jersey | United States | |
| 60 | 502.373.0150 Boehringer Ingelheim Investigational Site | Bronx | New York | United States | |
| 61 | 502.373.0213 Boehringer Ingelheim Investigational Site | Brooklyn | New York | United States | |
| 62 | 502.373.0230 Boehringer Ingelheim Investigational Site | Buffalo | New York | United States | |
| 63 | 502.373.0288 Boehringer Ingelheim Investigational Site | Kingston | New York | United States | |
| 64 | 502.373.0238 Boehringer Ingelheim Investigational Site | New York | New York | United States | |
| 65 | 502.373.0252 Boehringer Ingelheim Investigational Site | New York | New York | United States | |
| 66 | 502.373.0286 Boehringer Ingelheim Investigational Site | New York | New York | United States | |
| 67 | 502.373.0166 Boehringer Ingelheim Investigational Site | Northport | New York | United States | |
| 68 | 502.373.0156 Boehringer Ingelheim Investigational Site | Rochester | New York | United States | |
| 69 | 502.373.0264 Boehringer Ingelheim Investigational Site | Rochester | New York | United States | |
| 70 | 502.373.0227 Boehringer Ingelheim Investigational Site | Scarsdale | New York | United States | |
| 71 | 502.373.0163 Boehringer Ingelheim Investigational Site | Westfield | New York | United States | |
| 72 | 502.373.0241 Boehringer Ingelheim Investigational Site | Williamsville | New York | United States | |
| 73 | 502.373.0273 Boehringer Ingelheim Investigational Site | Durham | North Carolina | United States | |
| 74 | 502.373.0261 Boehringer Ingelheim Investigational Site | Winston Salem | North Carolina | United States | |
| 75 | 502.373.0222 Boehringer Ingelheim Investigational Site | Fargo | North Dakota | United States | |
| 76 | 502.373.0155 Boehringer Ingelheim Investigational Site | Cincinnati | Ohio | United States | |
| 77 | 502.373.0164 Boehringer Ingelheim Investigational Site | Cleveland | Ohio | United States | |
| 78 | 502.373.0168 Boehringer Ingelheim Investigational Site | Dayton | Ohio | United States | |
| 79 | 502.373.0159 Boehringer Ingelheim Investigational Site | Mansfield | Ohio | United States | |
| 80 | 502.373.0178 Boehringer Ingelheim Investigational Site | Oklahoma City | Ohio | United States | |
| 81 | 502.373.0259 Boehringer Ingelheim Investigational Site | Guthrie | Oklahoma | United States | |
| 82 | 502.373.0154 Boehringer Ingelheim Investigational Site | Oklahoma City | Oklahoma | United States | |
| 83 | 502.373.0152 Boehringer Ingelheim Investigational Site | Tulsa | Oklahoma | United States | |
| 84 | 502.373.0243 Boehringer Ingelheim Investigational Site | Portland | Oregon | United States | |
| 85 | 502.373.0265 Boehringer Ingelheim Investigational Site | Erie | Pennsylvania | United States | |
| 86 | 502.373.0153 Boehringer Ingelheim Investigational Site | Philadelphia | Pennsylvania | United States | |
| 87 | 502.373.0274 Boehringer Ingelheim Investigational Site | Sellersville | Pennsylvania | United States | |
| 88 | 502.373.0184 Boehringer Ingelheim Investigational Site | Charleston | South Carolina | United States | |
| 89 | 502.373.0248 Boehringer Ingelheim Investigational Site | Columbia | South Carolina | United States | |
| 90 | 502.373.0172 Boehringer Ingelheim Investigational Site | Dallas | Texas | United States | |
| 91 | 502.373.0187 Boehringer Ingelheim Investigational Site | Dallas | Texas | United States | |
| 92 | 502.373.0219 Boehringer Ingelheim Investigational Site | Dallas | Texas | United States | |
| 93 | 502.373.0275 Boehringer Ingelheim Investigational Site | Dallas | Texas | United States | |
| 94 | 502.373.0221 Boehringer Ingelheim Investigational Site | Fort Worth | Texas | United States | |
| 95 | 502.373.0206 Boehringer Ingelheim Investigational Site | Houston | Texas | United States | |
| 96 | 502.373.0234 Boehringer Ingelheim Investigational Site | Houston | Texas | United States | |
| 97 | 502.373.0280 Boehringer Ingelheim Investigational Site | Houston | Texas | United States | |
| 98 | 502.373.0249 Boehringer Ingelheim Investigational Site | Burke | Virginia | United States | |
| 99 | 502.373.0281 Boehringer Ingelheim Investigational Site | Seattle | Washington | United States | |
| 100 | 502.373.0212 Boehringer Ingelheim Investigational Site | Milwaukee | Wisconsin | United States | |
| 101 | 502.373.350 Boehringer Ingelheim Investigational Site | Capital Federal | Argentina | ||
| 102 | 502.373.351 Boehringer Ingelheim Investigational Site | Capital Federal | Argentina | ||
| 103 | 502.373.352 Boehringer Ingelheim Investigational Site | Capital Federal | Argentina | ||
| 104 | 502.373.353 Boehringer Ingelheim Investigational Site | Capital Federal | Argentina | ||
| 105 | 502.373.354 Boehringer Ingelheim Investigational Site | Capital Federal | Argentina | ||
| 106 | 502.373.355 Boehringer Ingelheim Investigational Site | Capital Federal | Argentina | ||
| 107 | 502.373.356 Boehringer Ingelheim Investigational Site | Capital Federal | Argentina | ||
| 108 | 502.373.378 Boehringer Ingelheim Investigational Site | Capital Federal | Argentina | ||
| 109 | 502.373.362 Boehringer Ingelheim Investigational Site | Corones Suárez | Argentina | ||
| 110 | 502.373.357 Boehringer Ingelheim Investigational Site | Córdoba | Argentina | ||
| 111 | 502.373.358 Boehringer Ingelheim Investigational Site | Córdoba | Argentina | ||
| 112 | 502.373.360 Boehringer Ingelheim Investigational Site | Córdoba | Argentina | ||
| 113 | 502.373.361 Boehringer Ingelheim Investigational Site | Córdoba | Argentina | ||
| 114 | 502.373.377 Boehringer Ingelheim Investigational Site | Córdoba | Argentina | ||
| 115 | 502.373.364 Boehringer Ingelheim Investigational Site | La Plata | Argentina | ||
| 116 | 502.373.365 Boehringer Ingelheim Investigational Site | Mar del Plata | Argentina | ||
| 117 | 502.373.366 Boehringer Ingelheim Investigational Site | Mendoza | Argentina | ||
| 118 | 502.373.376 Boehringer Ingelheim Investigational Site | Mendoza | Argentina | ||
| 119 | 502.373.367 Boehringer Ingelheim Investigational Site | Rosario | Argentina | ||
| 120 | 502.373.369 Boehringer Ingelheim Investigational Site | Salta | Argentina | ||
| 121 | 502.373.375 Boehringer Ingelheim Investigational Site | Santa Fe | Argentina | ||
| 122 | 502.373.371 Boehringer Ingelheim Investigational Site | Tucumán | Argentina | ||
| 123 | 502.373.373 Boehringer Ingelheim Investigational Site | Tucumán | Argentina | ||
| 124 | 502.373.374 Boehringer Ingelheim Investigational Site | Zárate | Argentina | ||
| 125 | 502.373.0534 The Canberra Hospital | Woden | Australian Capital Territory | Australia | |
| 126 | 502.373.0536 Royal Prince Alfred Hospital | Camperdown | New South Wales | Australia | |
| 127 | 502.373.0544 Coffs Harbour Cardiovascular Clinic | Coffs Harbour | New South Wales | Australia | |
| 128 | 502.373.0538 Concord Repatriation General Hospital | Concord | New South Wales | Australia | |
| 129 | 502.373.0539 Central Coast Neuroscience Research | Gosford | New South Wales | Australia | |
| 130 | 502.373.0556 Gosford Hospital | Gosford | New South Wales | Australia | |
| 131 | 502.373.0542 St. George Hospital | Kogarah | New South Wales | Australia | |
| 132 | 502.373.0552 St George Private Hospital | Kogarah | New South Wales | Australia | |
| 133 | 502.373.0559 St George Hospital - Dept of Clinical Pharmacology | Kogarah | New South Wales | Australia | |
| 134 | 502.373.0528 John Hunter Hospital | Newcastle | New South Wales | Australia | |
| 135 | 502.373.0535 The Prince of Wales Hospital | Randwick | New South Wales | Australia | |
| 136 | 502.373.0533 Royal North Shore Hospital | St Leonards | New South Wales | Australia | |
| 137 | 502.373.0549 Illawarra Regional Hospital | Wollongong | New South Wales | Australia | |
| 138 | 502.373.0523 The Prince Charles Hospital | Chermside | Queensland | Australia | |
| 139 | 502.373.0524 Royal Brisbane Hospital | Herston | Queensland | Australia | |
| 140 | 502.373.0526 Peninsula Clinical Research Centre | Kippa-Ring | Queensland | Australia | |
| 141 | 502.373.0540 Gold Coast Hospital | Southport | Queensland | Australia | |
| 142 | 502.373.0521 Princess Alexandra Hospital | Woolloongabba | Queensland | Australia | |
| 143 | 502.373.0546 Flinders Medical Centre | Bedford Park | South Australia | Australia | |
| 144 | 502.373.0550 Repatriation General Hospital | Daw Park | South Australia | Australia | |
| 145 | 502.373.0551 Port Lincoln "The Investigator" Clinic | Port Lincoln | South Australia | Australia | |
| 146 | 502.373.0529 Launceston General Hospital | Launceston | Tasmania | Australia | |
| 147 | 502.373.0531 Box Hill Hospital | Box Hill | Victoria | Australia | |
| 148 | 502.373.0548 The Northern Hospital | Epping | Victoria | Australia | |
| 149 | 502.373.0522 The Geelong Hospital | Geelong | Victoria | Australia | |
| 150 | 502.373.0520 Royal Melbourne Hospital | Parkville | Victoria | Australia | |
| 151 | 502.373.0525 The Alfred Hospital | Prahran | Victoria | Australia | |
| 152 | 502.373.0532 Baker Medical Research Centre | Prahran | Victoria | Australia | |
| 153 | 502.373.0557 Maroondah Hospital | Ringwood East | Victoria | Australia | |
| 154 | 502.373.0537 Austin & Repatriation Medical Centre | West Heidelberg | Victoria | Australia | |
| 155 | 502.373.0547 Fremantle Hospital | Fremantle | Western Australia | Australia | |
| 156 | 502.373.0530 Sir Charles Gairdner Hospital | Nedlands | Western Australia | Australia | |
| 157 | 502.373.0545 Royal Perth Hospital | Perth | Western Australia | Australia | |
| 158 | 502.373.1128 Boehringer Ingelheim Investigational Site | Graz | Austria | ||
| 159 | 502.373.1125 Boehringer Ingelheim Investigational Site | Wels | Austria | ||
| 160 | 502.373.1126 Boehringer Ingelheim Investigational Site | Wien | Austria | ||
| 161 | 502.373.1127 Boehringer Ingelheim Investigational Site | Wien | Austria | ||
| 162 | 502.373.1129 Boehringer Ingelheim Investigational Site | Wien | Austria | ||
| 163 | 502.373.1004 Boehringer Ingelheim Investigational Site | Aalst | Belgium | ||
| 164 | 502.373.1015 Boehringer Ingelheim Investigational Site | Anderlecht | Belgium | ||
| 165 | 502.373.1005 Boehringer Ingelheim Investigational Site | Antwerpen | Belgium | ||
| 166 | 502.373.1022 Boehringer Ingelheim Investigational Site | Bornem | Belgium | ||
| 167 | 502.373.1021 Boehringer Ingelheim Investigational Site | Brasschaat | Belgium | ||
| 168 | 502.373.1003 Boehringer Ingelheim Investigational Site | Brugge | Belgium | ||
| 169 | 502.373.1017 Boehringer Ingelheim Investigational Site | Charleroi | Belgium | ||
| 170 | 502.373.1009 Boehringer Ingelheim Investigational Site | Genk | Belgium | ||
| 171 | 502.373.1018 Boehringer Ingelheim Investigational Site | Godinne | Belgium | ||
| 172 | 502.373.1011 Boehringer Ingelheim Investigational Site | Haine-Saint-Paul | Belgium | ||
| 173 | 502.373.1019 Boehringer Ingelheim Investigational Site | Haine-Saint-Paul | Belgium | ||
| 174 | 502.373.1007 Boehringer Ingelheim Investigational Site | Hasselt | Belgium | ||
| 175 | 502.373.1000 Boehringer Ingelheim Investigational Site | Leuven | Belgium | ||
| 176 | 502.373.1020 Boehringer Ingelheim Investigational Site | Mechelen | Belgium | ||
| 177 | 502.373.1006 Boehringer Ingelheim Investigational Site | Mol | Belgium | ||
| 178 | 502.373.1028 Boehringer Ingelheim Investigational Site | Roeselare | Belgium | ||
| 179 | 502.373.1014 Boehringer Ingelheim Investigational Site | Seraing | Belgium | ||
| 180 | 502.373.1002 Boehringer Ingelheim Investigational Site | Turnhout | Belgium | ||
| 181 | 502.373.1010 Boehringer Ingelheim Investigational Site | Turnhout | Belgium | ||
| 182 | 502.373.1025 Boehringer Ingelheim Investigational Site | Woluwé-Saint-Lambert | Belgium | ||
| 183 | 502.373.405 Boehringer Ingelheim Investigational Site | Belo Horizonte | Brazil | ||
| 184 | 502.373.412 Boehringer Ingelheim Investigational Site | Belo Horizonte | Brazil | ||
| 185 | 502.373.426 Boehringer Ingelheim Investigational Site | Belo Horizonte | Brazil | ||
| 186 | 502.373.418 Boehringer Ingelheim Investigational Site | Botucatu - | Brazil | ||
| 187 | 502.373.407 Boehringer Ingelheim Investigational Site | Campinas | Brazil | ||
| 188 | 502.373.419 Boehringer Ingelheim Investigational Site | Campinas | Brazil | ||
| 189 | 502.373.425 Boehringer Ingelheim Investigational Site | Cerqueira César - São Paulo | Brazil | ||
| 190 | 502.373.406 Boehringer Ingelheim Investigational Site | Curitiba | Brazil | ||
| 191 | 502.373.411 Boehringer Ingelheim Investigational Site | Goiania | Brazil | ||
| 192 | 502.373.403 Boehringer Ingelheim Investigational Site | Marília | Brazil | ||
| 193 | 502.373.400 Boehringer Ingelheim Investigational Site | Pelotas | Brazil | ||
| 194 | 502.373.415 Boehringer Ingelheim Investigational Site | Porto Alegre - Rs | Brazil | ||
| 195 | 502.373.416 Boehringer Ingelheim Investigational Site | Porto Alegre | Brazil | ||
| 196 | 502.373.417 Boehringer Ingelheim Investigational Site | Porto Alegre | Brazil | ||
| 197 | 502.373.420 Boehringer Ingelheim Investigational Site | Ribeirao Preto | Brazil | ||
| 198 | 502.373.413 Boehringer Ingelheim Investigational Site | Rio de Janeiro - Rj | Brazil | ||
| 199 | 502.373.414 Boehringer Ingelheim Investigational Site | Rio de Janeiro | Brazil | ||
| 200 | 502.373.409 Boehringer Ingelheim Investigational Site | Salvador | Brazil | ||
| 201 | 502.373.410 Boehringer Ingelheim Investigational Site | Salvador | Brazil | ||
| 202 | 502.373.404 Boehringer Ingelheim Investigational Site | Santa Catalina | Brazil | ||
| 203 | 502.373.421 Boehringer Ingelheim Investigational Site | Sao Jose do Rio Preto | Brazil | ||
| 204 | 502.373.422 Boehringer Ingelheim Investigational Site | Sao Paulo | Brazil | ||
| 205 | 502.373.402 Boehringer Ingelheim Investigational Site | São Paulo | Brazil | ||
| 206 | 502.373.408 Boehringer Ingelheim Investigational Site | São Paulo | Brazil | ||
| 207 | 502.373.424 Boehringer Ingelheim Investigational Site | São Paulo | Brazil | ||
| 208 | 502.373.423 Boehringer Ingelheim Investigational Site | Vila Clementino, São Paulo | Brazil | ||
| 209 | 502.373.0001 C849 Division of Cardiology, Foothills Medical Centre | Calgary | Alberta | Canada | |
| 210 | 502.373.0071 Peter Lougheed Centre | Calgary | Alberta | Canada | |
| 211 | 502.373.0020 CHA/University Hospital | Edmonton | Alberta | Canada | |
| 212 | 502.373.0073 Alder Medical Centre | Campbell river | British Columbia | Canada | |
| 213 | 502.373.0062 Gain Medical Centre | Coquitlam | British Columbia | Canada | |
| 214 | 502.373.0046 Interior Clinical Research Consultants Ltd | Kelowna | British Columbia | Canada | |
| 215 | 502.373.0038 New West Cardiac Research | New Westminster | British Columbia | Canada | |
| 216 | 502.373.0048 Suite 100 | North Vancouver | British Columbia | Canada | |
| 217 | 502.373.0002 Penticton Regional Hospital | Penticton | British Columbia | Canada | |
| 218 | 502.373.0009 Vancouver Hospital | Vancouver | British Columbia | Canada | |
| 219 | 502.373.0003 Discovery Clinical Services Ltd | Victoria | British Columbia | Canada | |
| 220 | 502.373.0050 St. Pierre Medical Clinic | St. Pierre | Manitoba | Canada | |
| 221 | 502.373.0077 Health Science Centre Diabetes Research Group | Winnipeg | Manitoba | Canada | |
| 222 | 502.373.0005 Dr. Jeffrey Hiscock | ST John's | Newfoundland and Labrador | Canada | |
| 223 | 502.373.0006 The General Hospital | St. John's | Newfoundland and Labrador | Canada | |
| 224 | 502.373.0056 Antigonish Clinical Trials | Antigonish | Nova Scotia | Canada | |
| 225 | 502.373.0045 Queen Elizabeth II HSC | Halifax | Nova Scotia | Canada | |
| 226 | 502.373.0031 Brampton Research Associates | Brampton | Ontario | Canada | |
| 227 | 502.373.0011 St. Joseph's Hospital Cardiac Research | Hamilton | Ontario | Canada | |
| 228 | 502.373.0034 HGH McMaster Clinic | Hamilton | Ontario | Canada | |
| 229 | 502.373.0035 Hamilton Medical Research | Hamilton | Ontario | Canada | |
| 230 | 502.373.0064 Chedoke Hospital | Hamilton | Ontario | Canada | |
| 231 | 502.373.0082 3U4, McMaster University Medical Centre | Hamilton | Ontario | Canada | |
| 232 | 502.373.0085 HGH McMaster Clinic | Hamilton | Ontario | Canada | |
| 233 | 502.373.0024 London HSC - University Hospital | London | Ontario | Canada | |
| 234 | 502.373.0044 Mississauga Clinical Research Centre | Mississauga | Ontario | Canada | |
| 235 | 502.373.0043 Fraser Clinical Trial Inc | New Westminster | Ontario | Canada | |
| 236 | 502.373.0032 New Market Cardiology Research Grp | Newmarket | Ontario | Canada | |
| 237 | 502.373.0037 Niagara Falls Medical Centre | Niagara Falls | Ontario | Canada | |
| 238 | 502.373.0054 Orleans Medical-Dental Centre | Orleans | Ontario | Canada | |
| 239 | 502.373.0058 Medical Sciences Building | Oshawa | Ontario | Canada | |
| 240 | 502.373.0063 Paradigm Clinical Trials | Oshawa | Ontario | Canada | |
| 241 | 502.373.0029 Riverside Professional Building | Ottawa | Ontario | Canada | |
| 242 | 502.373.0051 Merivale Cardiovascular Consultants | Ottawa | Ontario | Canada | |
| 243 | 502.373.0040 Etobicok Cardiology | Rexdale | Ontario | Canada | |
| 244 | 502.373.0023 Group Health Centre - Clinical Trials | Sault Ste Marie | Ontario | Canada | |
| 245 | 502.373.0039 Scarborough Cardiology Research | Scarborough | Ontario | Canada | |
| 246 | 502.373.0007 Sudbury Cardiac Research | Sudbury | Ontario | Canada | |
| 247 | 502.373.0061 CLIKS Medical Research Corp | Thunder Bay | Ontario | Canada | |
| 248 | 502.373.0042 Sunnybrook & Woman's College Health Science Centre | Toronto | Ontario | Canada | |
| 249 | 502.373.0083 St. Michael's Hospital | Toronto | Ontario | Canada | |
| 250 | 502.373.0052 Dr. Bruce Lubelsky | Willowdale | Ontario | Canada | |
| 251 | 502.373.0008 Windsor Health Clinic | Windsor | Ontario | Canada | |
| 252 | 502.373.0081 Centre de recherche clinique, CUSE 3001 | Fleurimont | Quebec | Canada | |
| 253 | 502.373.0076 Centre Hospitalier de Vallees de l'Outaouais Gatineau | Gatineau | Quebec | Canada | |
| 254 | 502.373.0057 Centre De Recherche Clinique | Laval | Quebec | Canada | |
| 255 | 502.373.0033 Clinique de Cardiologie de Levis | Levis | Quebec | Canada | |
| 256 | 502.373.0010 Recherche Invascor | Longueuil | Quebec | Canada | |
| 257 | 502.373.0013 Suite 170 | Longueuil | Quebec | Canada | |
| 258 | 502.373.0014 Via Car Recherche Clinique Inc | Longueuil | Quebec | Canada | |
| 259 | 502.373.0015 C/O Peter Carmichael | Longueuil | Quebec | Canada | |
| 260 | 502.373.0016 Suite 170 | Longueuil | Quebec | Canada | |
| 261 | 502.373.0017 Suite 170 | Longueuil | Quebec | Canada | |
| 262 | 502.373.0086 Via Car Recherche Clinique Inc | Longueuil | Quebec | Canada | |
| 263 | 502.373.0018 Montreal Heart Institute | Montreal | Quebec | Canada | |
| 264 | 502.373.0021 Medi - recherche Inc. | Montreal | Quebec | Canada | |
| 265 | 502.373.0022 CHUM - Hotel Dieu | Montreal | Quebec | Canada | |
| 266 | 502.373.0025 Hopital Maisonneuve Rosemont | Montreal | Quebec | Canada | |
| 267 | 502.373.0079 Jewish General Hospital | Montreal | Quebec | Canada | |
| 268 | 502.373.0027 Ctr Hospitalier Beauce Etchemin | St George de Beauce | Quebec | Canada | |
| 269 | 502.373.0012 Hopital Laval - Institute Cardiologie de Quebec | Ste-Foy | Quebec | Canada | |
| 270 | 502.373.0026 Centre hospitalier Pierre-Le Gardeur | Terrebonne | Quebec | Canada | |
| 271 | 502.373.0072 Chra | Thetford Mines | Quebec | Canada | |
| 272 | 502.373.0053 Mount Royal Clinic | Saskatoon | Saskatchewan | Canada | |
| 273 | 502.373.0055 Specialists - Internal Medicine | Saskatoon | Saskatchewan | Canada | |
| 274 | 502.373.0066 SDRI - University of Saskatchewan | Saskatoon | Saskatchewan | Canada | |
| 275 | 502.373.0067 SDRI - University of Saskatchewan | Saskatoon | Saskatchewan | Canada | |
| 276 | 502.373.0068 SDRI - University of Saskatchewan | Saskatoon | Saskatchewan | Canada | |
| 277 | 502.373.0070 SDRI - University of Saskatchewan | Saskatoon | Saskatchewan | Canada | |
| 278 | 502.373.0030 Portage Clinical Studies | Manitoba | Canada | ||
| 279 | 502.373.0028 Hop. Du St. Sacrement | Quebec | Canada | ||
| 280 | 502.373.0041 Recherches Clinicar Inc. | Quebec | Canada | ||
| 281 | 502.373.0080 Polyclinique vasculaire Centre hospitalier universitaire de | Quebec | Canada | ||
| 282 | 502.373.0084 CHA-Hopital de l'Efant-Jesus | Quebec | Canada | ||
| 283 | 502.373.0601 Boehringer Ingelheim Investigational Site | Beijing | China | ||
| 284 | 502.373.0602 Boehringer Ingelheim Investigational Site | Beijing | China | ||
| 285 | 502.373.0603 Boehringer Ingelheim Investigational Site | Beijing | China | ||
| 286 | 502.373.0604 Boehringer Ingelheim Investigational Site | Beijing | China | ||
| 287 | 502.373.0605 Boehringer Ingelheim Investigational Site | Beijing | China | ||
| 288 | 502.373.0606 Boehringer Ingelheim Investigational Site | Beijing | China | ||
| 289 | 502.373.0607 Boehringer Ingelheim Investigational Site | Beijing | China | ||
| 290 | 502.373.0621 Boehringer Ingelheim Investigational Site | Beijing | China | ||
| 291 | 502.373.0622 Boehringer Ingelheim Investigational Site | Beijing | China | ||
| 292 | 502.373.0623 Boehringer Ingelheim Investigational Site | Beijing | China | ||
| 293 | 502.373.0626 Boehringer Ingelheim Investigational Site | Beijing | China | ||
| 294 | 502.373.0616 Boehringer Ingelheim Investigational Site | Changsha | China | ||
| 295 | 502.373.0613 Boehringer Ingelheim Investigational Site | Chengdu | China | ||
| 296 | 502.373.0625 Boehringer Ingelheim Investigational Site | Chengdu | China | ||
| 297 | 502.373.0620 Boehringer Ingelheim Investigational Site | Guangzhou | China | ||
| 298 | 502.373.0612 Boehringer Ingelheim Investigational Site | Harbin | China | ||
| 299 | 502.373.0634 Boehringer Ingelheim Investigational Site | HeBei Province | China | ||
| 300 | 502.373.0624 Boehringer Ingelheim Investigational Site | Henan Province | China | ||
| 301 | 502.373.0627 Boehringer Ingelheim Investigational Site | Hubei Province | China | ||
| 302 | 502.373.0614 Boehringer Ingelheim Investigational Site | Nanjing | China | ||
| 303 | 502.373.0629 Boehringer Ingelheim Investigational Site | QingDao | China | ||
| 304 | 502.373.0632 Boehringer Ingelheim Investigational Site | ShanDong Province | China | ||
| 305 | 502.373.0633 Boehringer Ingelheim Investigational Site | ShanDong Province | China | ||
| 306 | 502.373.0617 Boehringer Ingelheim Investigational Site | Shanghai | China | ||
| 307 | 502.373.0618 Boehringer Ingelheim Investigational Site | Shanghai | China | ||
| 308 | 502.373.0619 Boehringer Ingelheim Investigational Site | Shanghai | China | ||
| 309 | 502.373.0628 Boehringer Ingelheim Investigational Site | Shen Yang | China | ||
| 310 | 502.373.0611 Boehringer Ingelheim Investigational Site | Shijiazhuang | China | ||
| 311 | 502.373.0615 Boehringer Ingelheim Investigational Site | Tianjin | China | ||
| 312 | 502.373.0631 Boehringer Ingelheim Investigational Site | Tianjin | China | ||
| 313 | 502.373.0630 Boehringer Ingelheim Investigational Site | Weizikeng | China | ||
| 314 | 502.373.0608 Boehringer Ingelheim Investigational Site | Wuhan | China | ||
| 315 | 502.373.0610 Boehringer Ingelheim Investigational Site | Zhenzhou | China | ||
| 316 | 502.373.1053 Boehringer Ingelheim Investigational Site | Brno | Czech Republic | ||
| 317 | 502.373.1060 Boehringer Ingelheim Investigational Site | Havirov | Czech Republic | ||
| 318 | 502.373.1055 Boehringer Ingelheim Investigational Site | Kladno | Czech Republic | ||
| 319 | 502.373.1059 Boehringer Ingelheim Investigational Site | Mlada Boleslav | Czech Republic | ||
| 320 | 502.373.1061 Boehringer Ingelheim Investigational Site | Plzen | Czech Republic | ||
| 321 | 502.373.1051 Boehringer Ingelheim Investigational Site | Prague 5 | Czech Republic | ||
| 322 | 502.373.1057 Boehringer Ingelheim Investigational Site | Prague | Czech Republic | ||
| 323 | 502.373.1062 Boehringer Ingelheim Investigational Site | Praha 2 | Czech Republic | ||
| 324 | 502.373.1056 Boehringer Ingelheim Investigational Site | Pribram 1 | Czech Republic | ||
| 325 | 502.373.1058 Boehringer Ingelheim Investigational Site | Usti nad Orlici | Czech Republic | ||
| 326 | 502.373.1450 Boehringer Ingelheim Investigational Site | Aalborg | Denmark | ||
| 327 | 502.373.1453 Boehringer Ingelheim Investigational Site | Aarhus C | Denmark | ||
| 328 | 502.373.1459 Boehringer Ingelheim Investigational Site | Frederiksberg C | Denmark | ||
| 329 | 502.373.1455 Boehringer Ingelheim Investigational Site | Frederiksberg | Denmark | ||
| 330 | 502.373.1460 Boehringer Ingelheim Investigational Site | Helsingoer | Denmark | ||
| 331 | 502.373.1458 Boehringer Ingelheim Investigational Site | Hilleroed | Denmark | ||
| 332 | 502.373.1451 Boehringer Ingelheim Investigational Site | Holbaek | Denmark | ||
| 333 | 502.373.1452 Boehringer Ingelheim Investigational Site | Hvidovre | Denmark | ||
| 334 | 502.373.1461 Boehringer Ingelheim Investigational Site | Kjellerup | Denmark | ||
| 335 | 502.373.1456 Boehringer Ingelheim Investigational Site | Randers | Denmark | ||
| 336 | 502.373.1457 Boehringer Ingelheim Investigational Site | Slagelse | Denmark | ||
| 337 | 502.373.1454 Boehringer Ingelheim Investigational Site | Svendborg | Denmark | ||
| 338 | 502.373.1470 Boehringer Ingelheim Investigational Site | Helsinki | Finland | ||
| 339 | 502.373.1473 Boehringer Ingelheim Investigational Site | Helsinki | Finland | ||
| 340 | 502.373.1486 Boehringer Ingelheim Investigational Site | Hämeenlinna | Finland | ||
| 341 | 502.373.1479 Boehringer Ingelheim Investigational Site | Jyväskylä | Finland | ||
| 342 | 502.373.1488 Boehringer Ingelheim Investigational Site | Kuopio | Finland | ||
| 343 | 502.373.1481 Boehringer Ingelheim Investigational Site | Kuusankoski | Finland | ||
| 344 | 502.373.1487 Boehringer Ingelheim Investigational Site | Liperi | Finland | ||
| 345 | 502.373.1475 Boehringer Ingelheim Investigational Site | Oulun kaupunki | Finland | ||
| 346 | 502.373.1471 Boehringer Ingelheim Investigational Site | Turku | Finland | ||
| 347 | 502.373.1485 Boehringer Ingelheim Investigational Site | Vantaa | Finland | ||
| 348 | 502.373.1093 Cabinet Médical | Albens | France | ||
| 349 | 502.373.1090 Cabinet Médical | Beziers | France | ||
| 350 | 502.373.1075 Cabinet Médical | Bourges | France | ||
| 351 | 502.373.1091 Cabinet Médical | Broglie | France | ||
| 352 | 502.373.1097 Cabinet Médical | Castelnaudary | France | ||
| 353 | 502.373.1089 Cabinet Médical | Gemenos | France | ||
| 354 | 502.373.1099 Cabinet Médical | Husseren Wesserlin | France | ||
| 355 | 502.373.1094 Cabinet Médical | Hyeres | France | ||
| 356 | 502.373.1078 Cabinet Médical des Tanneurs | L'Aigle | France | ||
| 357 | 502.373.1096 Cabinet Médical | La Rochelle | France | ||
| 358 | 502.373.1081 Cabinet Médical | Le Pradet | France | ||
| 359 | 502.373.1083 Cabinet Médical | Murs Erigne | France | ||
| 360 | 502.373.1084 Cabinet Médical | Nantes | France | ||
| 361 | 502.373.1086 Cabinet Médical | Nantes | France | ||
| 362 | 502.373.1080 Cabinet Médical | Niort | France | ||
| 363 | 502.373.1095 Cabinet Médical | Ortez | France | ||
| 364 | 502.373.1079 Cabinet Médical | Paris | France | ||
| 365 | 502.373.1088 Cabinet Médical | Rennes | France | ||
| 366 | 502.373.1098 Cabinet Médical | Rosiers d'Egletons | France | ||
| 367 | 502.373.1085 Cabinet Médical | Saint Julien des Landes | France | ||
| 368 | 502.373.1076 Cabinet Médical La Grande Ramée | Saint Martin dHyeres | France | ||
| 369 | 502.373.1092 Cabinet Médical de St Pierre | Saint Pierre de Chandieu | France | ||
| 370 | 502.373.1077 Cabinet Médical | Saint Romain sur Cher | France | ||
| 371 | 502.373.1087 Cabinet Médical | Strasbourg | France | ||
| 372 | 502.373.1082 Cabinet Médical | Tours | France | ||
| 373 | 502.373.1164 Boehringer Ingelheim Investigational Site | Bad Lausick | Germany | ||
| 374 | 502.373.1166 Boehringer Ingelheim Investigational Site | Bad Lauterberg | Germany | ||
| 375 | 502.373.1138 Boehringer Ingelheim Investigational Site | Bad Mergentheim | Germany | ||
| 376 | 502.373.1156 Boehringer Ingelheim Investigational Site | Berlin | Germany | ||
| 377 | 502.373.1160 Boehringer Ingelheim Investigational Site | Berlin | Germany | ||
| 378 | 502.373.1161 Boehringer Ingelheim Investigational Site | Berlin | Germany | ||
| 379 | 502.373.1144 Boehringer Ingelheim Investigational Site | Bielefeld | Germany | ||
| 380 | 502.373.1152 Boehringer Ingelheim Investigational Site | Dessau | Germany | ||
| 381 | 502.373.1139 Boehringer Ingelheim Investigational Site | Dortmund | Germany | ||
| 382 | 502.373.1159 Boehringer Ingelheim Investigational Site | Dortmund | Germany | ||
| 383 | 502.373.1136 Boehringer Ingelheim Investigational Site | Dresden | Germany | ||
| 384 | 502.373.1145 Boehringer Ingelheim Investigational Site | Eberswalde | Germany | ||
| 385 | 502.373.1155 Boehringer Ingelheim Investigational Site | Erlangen | Germany | ||
| 386 | 502.373.1157 Boehringer Ingelheim Investigational Site | Essen | Germany | ||
| 387 | 502.373.1153 Boehringer Ingelheim Investigational Site | Haag | Germany | ||
| 388 | 502.373.1148 Boehringer Ingelheim Investigational Site | Hamburg | Germany | ||
| 389 | 502.373.1132 Boehringer Ingelheim Investigational Site | Heidelberg | Germany | ||
| 390 | 502.373.1131 Boehringer Ingelheim Investigational Site | Homburg/Saar | Germany | ||
| 391 | 502.373.1147 Boehringer Ingelheim Investigational Site | Karlsburg | Germany | ||
| 392 | 502.373.1154 Boehringer Ingelheim Investigational Site | Kelkheim | Germany | ||
| 393 | 502.373.1137 Boehringer Ingelheim Investigational Site | Köln | Germany | ||
| 394 | 502.373.1142 Boehringer Ingelheim Investigational Site | Künzing | Germany | ||
| 395 | 502.373.1165 Boehringer Ingelheim Investigational Site | Lübeck | Germany | ||
| 396 | 502.373.1134 Boehringer Ingelheim Investigational Site | Mainz | Germany | ||
| 397 | 502.373.1133 Boehringer Ingelheim Investigational Site | Melsungen | Germany | ||
| 398 | 502.373.1146 Boehringer Ingelheim Investigational Site | München | Germany | ||
| 399 | 502.373.1149 Boehringer Ingelheim Investigational Site | Offenbach am Main | Germany | ||
| 400 | 502.373.1162 Boehringer Ingelheim Investigational Site | Riesa | Germany | ||
| 401 | 502.373.1140 Boehringer Ingelheim Investigational Site | Rostock | Germany | ||
| 402 | 502.373.1150 Boehringer Ingelheim Investigational Site | Sindelfingen | Germany | ||
| 403 | 502.373.1163 Boehringer Ingelheim Investigational Site | Starnberg | Germany | ||
| 404 | 502.373.1158 Boehringer Ingelheim Investigational Site | Stuttgart | Germany | ||
| 405 | 502.373.1167 Boehringer Ingelheim Investigational Site | Timmendorfer Strand | Germany | ||
| 406 | 502.373.1135 Boehringer Ingelheim Investigational Site | Wiesbaden | Germany | ||
| 407 | 502.373.1141 Boehringer Ingelheim Investigational Site | Witten | Germany | ||
| 408 | 502.373.1200 Boehringer Ingelheim Investigational Site | Athens | Greece | ||
| 409 | 502.373.1203 Boehringer Ingelheim Investigational Site | Athens | Greece | ||
| 410 | 502.373.1206 Boehringer Ingelheim Investigational Site | Athens | Greece | ||
| 411 | 502.373.1207 Boehringer Ingelheim Investigational Site | Athens | Greece | ||
| 412 | 502.373.1208 Boehringer Ingelheim Investigational Site | Athens | Greece | ||
| 413 | 502.373.1214 Boehringer Ingelheim Investigational Site | Athens | Greece | ||
| 414 | 502.373.1209 Boehringer Ingelheim Investigational Site | Elefsina | Greece | ||
| 415 | 502.373.1211 Boehringer Ingelheim Investigational Site | Goudi/ Athens | Greece | ||
| 416 | 502.373.1201 Boehringer Ingelheim Investigational Site | Ioannina | Greece | ||
| 417 | 502.373.1210 Boehringer Ingelheim Investigational Site | Kavala,greece | Greece | ||
| 418 | 502.373.1224 Boehringer Ingelheim Investigational Site | Korinthos | Greece | ||
| 419 | 502.373.1202 Boehringer Ingelheim Investigational Site | Melissia, Athens | Greece | ||
| 420 | 502.373.1205 Boehringer Ingelheim Investigational Site | Thessaloniki | Greece | ||
| 421 | 502.373.1213 Boehringer Ingelheim Investigational Site | Thessaloniki | Greece | ||
| 422 | 502.373.1204 Boehringer Ingelheim Investigational Site | Veria | Greece | ||
| 423 | 502.373.0676 Boehringer Ingelheim Investigational Site | Hong Kong | Hong Kong | ||
| 424 | 502.373.0677 Boehringer Ingelheim Investigational Site | Hong Kong | Hong Kong | ||
| 425 | 502.373.0680 Boehringer Ingelheim Investigational Site | Hong Kong | Hong Kong | ||
| 426 | 502.373.0681 Boehringer Ingelheim Investigational Site | Hong Kong | Hong Kong | ||
| 427 | 502.373.0685 Boehringer Ingelheim Investigational Site | Hong Kong | Hong Kong | ||
| 428 | 502.373.1227 Boehringer Ingelheim Investigational Site | Budapest | Hungary | ||
| 429 | 502.373.1230 Boehringer Ingelheim Investigational Site | Budapest | Hungary | ||
| 430 | 502.373.1231 Boehringer Ingelheim Investigational Site | Budapest | Hungary | ||
| 431 | 502.373.1232 Boehringer Ingelheim Investigational Site | Budapest | Hungary | ||
| 432 | 502.373.1233 Boehringer Ingelheim Investigational Site | Budapest | Hungary | ||
| 433 | 502.373.1235 Boehringer Ingelheim Investigational Site | Budapest | Hungary | ||
| 434 | 502.373.1237 Boehringer Ingelheim Investigational Site | Budapest | Hungary | ||
| 435 | 502.373.1239 Boehringer Ingelheim Investigational Site | Budapest | Hungary | ||
| 436 | 502.373.1242 Boehringer Ingelheim Investigational Site | Budapest | Hungary | ||
| 437 | 502.373.1244 Boehringer Ingelheim Investigational Site | Budapest | Hungary | ||
| 438 | 502.373.1236 Boehringer Ingelheim Investigational Site | Debrecen | Hungary | ||
| 439 | 502.373.1240 Boehringer Ingelheim Investigational Site | Debrecen | Hungary | ||
| 440 | 502.373.1228 Boehringer Ingelheim Investigational Site | Kecskemet | Hungary | ||
| 441 | 502.373.1241 Boehringer Ingelheim Investigational Site | Nyiregyhaza | Hungary | ||
| 442 | 502.373.1226 Boehringer Ingelheim Investigational Site | Pecs | Hungary | ||
| 443 | 502.373.1229 Boehringer Ingelheim Investigational Site | Siofok | Hungary | ||
| 444 | 502.373.1238 Boehringer Ingelheim Investigational Site | Szeged | Hungary | ||
| 445 | 502.373.1225 Boehringer Ingelheim Investigational Site | Szekesfehervar | Hungary | ||
| 446 | 502.373.1234 Boehringer Ingelheim Investigational Site | Tatabanya | Hungary | ||
| 447 | 502.373.1243 Boehringer Ingelheim Investigational Site | Veszprem | Hungary | ||
| 448 | 502.373.1717 Adelaide & Meath Hospitals | Dublin 24 | Ireland | ||
| 449 | 502.373.1714 Dept. of Clinical Pharmacology | Dublin 8 | Ireland | ||
| 450 | 502.373.1719 Pulmonary Function Laboratory | Dublin 9 | Ireland | ||
| 451 | 502.373.1720 Mallow General Hospital | Mallow | Ireland | ||
| 452 | 502.373.1257 Ospedale "Mazzoni" | Ascoli Piceno | Italy | ||
| 453 | 502.373.1259 Ospedale di Bentivoglio | Bentivoglio (BO) | Italy | ||
| 454 | 502.373.1255 Ospedale "S. Orsola Malpighi" | Bologna | Italy | ||
| 455 | 502.373.1278 Ospedale Bellaria | Bologna | Italy | ||
| 456 | 502.373.1275 A.O. Spedali Civili di Brescia -Univ. degli studi di Brescia | Brescia | Italy | ||
| 457 | 502.373.1261 Ospedale Civile di Casarano | Casarano (LE) | Italy | ||
| 458 | 502.373.1252 Azienda Ospedaliera di Caserta | Caserta | Italy | ||
| 459 | 502.373.1254 Ospedale di Città della Pieve | Città della Pieve (PG) | Italy | ||
| 460 | 502.373.1262 Arcispedale "S. Anna" | Ferrara | Italy | ||
| 461 | 502.373.1250 Ospedale Civile "S. Polo" | Monfalcone (go) | Italy | ||
| 462 | 502.373.1266 Azienda Universitaria Policlinico "Federico II" | Napoli | Italy | ||
| 463 | 502.373.1267 Azienda Universitaria Policlinico II | Napoli | Italy | ||
| 464 | 502.373.1269 Università Federico II | Napoli | Italy | ||
| 465 | 502.373.1279 Asl Na 1 | Napoli | Italy | ||
| 466 | 502.373.1264 Presidio Ospedaliero "Villa Sofia" | Palermo | Italy | ||
| 467 | 502.373.1265 IRCCS - Policlinico S. Matteo | Pavia | Italy | ||
| 468 | 502.373.1251 Policlinico Monteluce | Perugia | Italy | ||
| 469 | 502.373.1258 Ospedale "R. Silvestrini" | Perugia | Italy | ||
| 470 | 502.373.1274 Ospedale "R. Silvestrini" | Perugia | Italy | ||
| 471 | 502.373.1253 Istituto di Ricovero a Carattere Scientifico Neuromed- IRCCS | Pozzilli (IS) | Italy | ||
| 472 | 502.373.1263 Policlinico Umberto I | Roma | Italy | ||
| 473 | 502.373.1268 Ospedale "S. Spirito" | Roma | Italy | ||
| 474 | 502.373.1270 Policlinico di Tor Vergata | Roma | Italy | ||
| 475 | 502.373.1273 A.O. "S. Camillo de Lellis" | Roma | Italy | ||
| 476 | 502.373.1260 Ospedale "N. Melli" | S. Pietro Vernotico (BR) | Italy | ||
| 477 | 502.373.1256 Ospedale Civile SS. Annunziata - USL 1 | Sassari | Italy | ||
| 478 | 502.373.1277 A.S.O. "S. Giovanni Battista" | Torino | Italy | ||
| 479 | 502.373.1272 Ospedale di Circolo di Varese | Varese | Italy | ||
| 480 | 502.373.1271 Ospedale Civile | Venezia | Italy | ||
| 481 | 502.373.1276 Ospedale Belcolle | Viterbo | Italy | ||
| 482 | 502.373.0763 Boehringer Ingelheim Investigational Site | Incheon | Korea, Republic of | ||
| 483 | 502.373.0764 Boehringer Ingelheim Investigational Site | Kwang-ju | Korea, Republic of | ||
| 484 | 502.373.0755 Boehringer Ingelheim Investigational Site | Pusan | Korea, Republic of | ||
| 485 | 502.373.0750 Boehringer Ingelheim Investigational Site | Seoul | Korea, Republic of | ||
| 486 | 502.373.0753 Boehringer Ingelheim Investigational Site | Seoul | Korea, Republic of | ||
| 487 | 502.373.0756 Boehringer Ingelheim Investigational Site | Seoul | Korea, Republic of | ||
| 488 | 502.373.0757 Boehringer Ingelheim Investigational Site | Seoul | Korea, Republic of | ||
| 489 | 502.373.0760 Boehringer Ingelheim Investigational Site | Seoul | Korea, Republic of | ||
| 490 | 502.373.0761 Boehringer Ingelheim Investigational Site | Seoul | Korea, Republic of | ||
| 491 | 502.373.0754 Boehringer Ingelheim Investigational Site | Taegu | Korea, Republic of | ||
| 492 | 502.373.0736 Boehringer Ingelheim Investigational Site | Johor Baharu | Malaysia | ||
| 493 | 502.373.2707 Boehringer Ingelheim Investigational Site | Kelantan Darul Naim | Malaysia | ||
| 494 | 502.373.0739 Boehringer Ingelheim Investigational Site | Kelantan | Malaysia | ||
| 495 | 502.373.0732 Boehringer Ingelheim Investigational Site | Kuala Lumpur | Malaysia | ||
| 496 | 502.373.0734 Boehringer Ingelheim Investigational Site | Kuala Lumpur | Malaysia | ||
| 497 | 502.373.0733 Boehringer Ingelheim Investigational Site | Penang | Malaysia | ||
| 498 | 502.373.0731 Boehringer Ingelheim Investigational Site | Putrajaya | Malaysia | ||
| 499 | 502.373.60001 Boehringer Ingelheim Investigational Site | Selangor | Malaysia | ||
| 500 | 502.373.0450 Boehringer Ingelheim Investigational Site | Guadalajara | Mexico | ||
| 501 | 502.373.0451 Boehringer Ingelheim Investigational Site | Guadalajara | Mexico | ||
| 502 | 502.373.0452 Boehringer Ingelheim Investigational Site | Guadalajara | Mexico | ||
| 503 | 502.373.0459 Boehringer Ingelheim Investigational Site | Guadalajara | Mexico | ||
| 504 | 502.373.0460 Boehringer Ingelheim Investigational Site | Guadalajara | Mexico | ||
| 505 | 502.373.0461 Boehringer Ingelheim Investigational Site | Guadalajara | Mexico | ||
| 506 | 502.373.0470 Boehringer Ingelheim Investigational Site | Guadalajara | Mexico | ||
| 507 | 502.373.0457 Boehringer Ingelheim Investigational Site | Mexico | Mexico | ||
| 508 | 502.373.0458 Boehringer Ingelheim Investigational Site | Mexico | Mexico | ||
| 509 | 502.373.0454 Boehringer Ingelheim Investigational Site | Monterrey | Mexico | ||
| 510 | 502.373.0453 Boehringer Ingelheim Investigational Site | Zapopan | Mexico | ||
| 511 | 502.373.0456 Boehringer Ingelheim Investigational Site | Zapopan | Mexico | ||
| 512 | 502.373.1309 Boehringer Ingelheim Investigational Site | Amsterdam | Netherlands | ||
| 513 | 502.373.1305 Boehringer Ingelheim Investigational Site | Beverwijk | Netherlands | ||
| 514 | 502.373.1313 Boehringer Ingelheim Investigational Site | Den Bosch | Netherlands | ||
| 515 | 502.373.1312 Boehringer Ingelheim Investigational Site | Den Haag | Netherlands | ||
| 516 | 502.373.1302 Boehringer Ingelheim Investigational Site | Doetinchem | Netherlands | ||
| 517 | 502.373.1304 Boehringer Ingelheim Investigational Site | Drachten | Netherlands | ||
| 518 | 502.373.1301 Boehringer Ingelheim Investigational Site | Eindhoven | Netherlands | ||
| 519 | 502.373.1318 Boehringer Ingelheim Investigational Site | Ermelo | Netherlands | ||
| 520 | 502.373.1320 Boehringer Ingelheim Investigational Site | Ewijk | Netherlands | ||
| 521 | 502.373.1310 Boehringer Ingelheim Investigational Site | Hengelo | Netherlands | ||
| 522 | 502.373.1303 Boehringer Ingelheim Investigational Site | Hoorn | Netherlands | ||
| 523 | 502.373.1322 Boehringer Ingelheim Investigational Site | Huizen | Netherlands | ||
| 524 | 502.373.1300 Boehringer Ingelheim Investigational Site | Lichtenvoorde | Netherlands | ||
| 525 | 502.373.1323 Boehringer Ingelheim Investigational Site | Losser | Netherlands | ||
| 526 | 502.373.1307 Boehringer Ingelheim Investigational Site | Nieuwegein | Netherlands | ||
| 527 | 502.373.1317 Boehringer Ingelheim Investigational Site | Rijswijk | Netherlands | ||
| 528 | 502.373.1319 Boehringer Ingelheim Investigational Site | Roelofarendsveen | Netherlands | ||
| 529 | 502.373.1308 Boehringer Ingelheim Investigational Site | Rotterdam | Netherlands | ||
| 530 | 502.373.1321 Boehringer Ingelheim Investigational Site | Spijkenisse | Netherlands | ||
| 531 | 502.373.1311 Boehringer Ingelheim Investigational Site | Stadskanaal | Netherlands | ||
| 532 | 502.373.1314 Boehringer Ingelheim Investigational Site | Tilburg | Netherlands | ||
| 533 | 502.373.1316 Boehringer Ingelheim Investigational Site | Utrecht | Netherlands | ||
| 534 | 502.373.1315 Boehringer Ingelheim Investigational Site | Velp | Netherlands | ||
| 535 | 502.373.0502 Boehringer Ingelheim Investigational Site | Auckland 3 | New Zealand | ||
| 536 | 502.373.0500 Boehringer Ingelheim Investigational Site | Auckland | New Zealand | ||
| 537 | 502.373.0507 Boehringer Ingelheim Investigational Site | Christchurch | New Zealand | ||
| 538 | 502.373.0504 Boehringer Ingelheim Investigational Site | Hamiton | New Zealand | ||
| 539 | 502.373.0506 Boehringer Ingelheim Investigational Site | Hasting | New Zealand | ||
| 540 | 502.373.0501 Middlemore Hospital | Otahuhu Auckland | New Zealand | ||
| 541 | 502.373.0503 Boehringer Ingelheim Investigational Site | Takapuna Auckland | New Zealand | ||
| 542 | 502.373.0505 Tauranga Study Centre | Tauranga | New Zealand | ||
| 543 | 502.373.20003 Boehringer Ingelheim Investigational Site | Fevik | Norway | ||
| 544 | 502.373.20004 Fana Hjertesenter | Nesttun | Norway | ||
| 545 | 502.373.20001 Stavanger Universitetssykehus | Stavanger | Norway | ||
| 546 | 502.373.20002 Tvedestrand Legesenter | Tvedestrand | Norway | ||
| 547 | 502.373.20005 Sykehuset i Vestfold, Avd. Tønsberg | Tønsberg | Norway | ||
| 548 | 502.373.0702 De La Salle University Medical Center | Cavite | Philippines | ||
| 549 | 502.373.0700 Philippine General Hospital | Manila | Philippines | ||
| 550 | 502.373.0701 Manila Doctors Hospital, Room 3 Annex | Manila | Philippines | ||
| 551 | 502.373.0705 The Medical City | Pasig City | Philippines | ||
| 552 | 502.373.0703 Philippine Heart Center | Quezon City | Philippines | ||
| 553 | 502.373.0704 National Kidney & Transplant Institute, Room 821 | Quezon City | Philippines | ||
| 554 | 502.373.1354 Boehringer Ingelheim Investigational Site | Bydgoszcz | Poland | ||
| 555 | 502.373.1366 Boehringer Ingelheim Investigational Site | Czestochowa | Poland | ||
| 556 | 502.373.1365 Boehringer Ingelheim Investigational Site | Gdynia Redlowo | Poland | ||
| 557 | 502.373.1368 Boehringer Ingelheim Investigational Site | Gdynia | Poland | ||
| 558 | 502.373.1359 Boehringer Ingelheim Investigational Site | Grojec | Poland | ||
| 559 | 502.373.1369 Boehringer Ingelheim Investigational Site | Grudziadz | Poland | ||
| 560 | 502.373.1375 Boehringer Ingelheim Investigational Site | Inowroclaw | Poland | ||
| 561 | 502.373.1360 Boehringer Ingelheim Investigational Site | Jaroslawiec | Poland | ||
| 562 | 502.373.1372 Boehringer Ingelheim Investigational Site | Katowice | Poland | ||
| 563 | 502.373.1376 Boehringer Ingelheim Investigational Site | Katowice | Poland | ||
| 564 | 502.373.1361 Boehringer Ingelheim Investigational Site | Kielce | Poland | ||
| 565 | 502.373.1358 Boehringer Ingelheim Investigational Site | Lodz | Poland | ||
| 566 | 502.373.1364 Boehringer Ingelheim Investigational Site | Lubartow | Poland | ||
| 567 | 502.373.1374 Boehringer Ingelheim Investigational Site | Lubin | Poland | ||
| 568 | 502.373.1367 Boehringer Ingelheim Investigational Site | Nowy Sacz | Poland | ||
| 569 | 502.373.1356 Boehringer Ingelheim Investigational Site | Piotrkow Trybunalski | Poland | ||
| 570 | 502.373.1370 Boehringer Ingelheim Investigational Site | Poznan | Poland | ||
| 571 | 502.373.1357 Boehringer Ingelheim Investigational Site | Ruda Slaska | Poland | ||
| 572 | 502.373.1352 Boehringer Ingelheim Investigational Site | Skierniewice | Poland | ||
| 573 | 502.373.1362 Boehringer Ingelheim Investigational Site | Tarnow | Poland | ||
| 574 | 502.373.1355 Boehringer Ingelheim Investigational Site | Tomaszow Mazowiecki | Poland | ||
| 575 | 502.373.1353 Boehringer Ingelheim Investigational Site | Torun | Poland | ||
| 576 | 502.373.1351 Boehringer Ingelheim Investigational Site | Warsaw | Poland | ||
| 577 | 502.373.1363 Boehringer Ingelheim Investigational Site | Warsaw | Poland | ||
| 578 | 502.373.1373 Boehringer Ingelheim Investigational Site | Wegrow | Poland | ||
| 579 | 502.373.1402 Hospital Garcia de Orta | Almada | Portugal | ||
| 580 | 502.373.1400 Hospital Fernando Fonseca | Amadora | Portugal | ||
| 581 | 502.373.1411 Hospital de Santa Cruz | Carnaxide | Portugal | 2799-523 | |
| 582 | 502.373.1408 Hospitais da Universidade de Coimbra | Coimbra | Portugal | ||
| 583 | 502.373.1406 Hospital Distrital de Faro Geral | Faro | Portugal | ||
| 584 | 502.373.1403 Hospital de Santa Marta | Lisboa | Portugal | ||
| 585 | 502.373.1409 Hospital de Santa Maria | Lisboa | Portugal | ||
| 586 | 502.373.1401 Unidade Local de Saúde de Matosinhos | Matosinhos | Portugal | ||
| 587 | 502.373.1410 Hospital de Santo António | Porto | Portugal | ||
| 588 | 502.373.1407 Centro Hospitalar vila Nova de Gaia | Vila Nova de Gaia | Portugal | ||
| 589 | 502.373.0215 Boehringer Ingelheim Investigational Site | Caguas | Puerto Rico | ||
| 590 | 502.373.0267 Boehringer Ingelheim Investigational Site | Las Lomas | Puerto Rico | ||
| 591 | 502.373.0190 Boehringer Ingelheim Investigational Site | Manati | Puerto Rico | ||
| 592 | 502.373.0198 Boehringer Ingelheim Investigational Site | Orocovis | Puerto Rico | ||
| 593 | 502.373.0262 Boehringer Ingelheim Investigational Site | Rio Piedras | Puerto Rico | ||
| 594 | 502.373.1425 Boehringer Ingelheim Investigational Site | Moscow | Russian Federation | ||
| 595 | 502.373.1426 Boehringer Ingelheim Investigational Site | Moscow | Russian Federation | ||
| 596 | 502.373.1427 Boehringer Ingelheim Investigational Site | Moscow | Russian Federation | ||
| 597 | 502.373.1428 Boehringer Ingelheim Investigational Site | Moscow | Russian Federation | ||
| 598 | 502.373.1429 Boehringer Ingelheim Investigational Site | Moscow | Russian Federation | ||
| 599 | 502.373.1430 Boehringer Ingelheim Investigational Site | Moscow | Russian Federation | ||
| 600 | 502.373.1433 Boehringer Ingelheim Investigational Site | Moscow | Russian Federation | ||
| 601 | 502.373.1431 Boehringer Ingelheim Investigational Site | St. Petersburg | Russian Federation | ||
| 602 | 502.373.1432 Boehringer Ingelheim Investigational Site | St. Petersburg | Russian Federation | ||
| 603 | 502.373.2706 Boehringer Ingelheim Investigational Site | Kuala Lumpur | Singapore | ||
| 604 | 502.373.0725 Boehringer Ingelheim Investigational Site | Singapore | Singapore | ||
| 605 | 502.373.0726 Boehringer Ingelheim Investigational Site | Singapore | Singapore | ||
| 606 | 502.373.1535 Boehringer Ingelheim Investigational Site | Bratislava | Slovakia | ||
| 607 | 502.373.1529 Boehringer Ingelheim Investigational Site | Kosice | Slovakia | ||
| 608 | 502.373.1540 Boehringer Ingelheim Investigational Site | Kosice | Slovakia | ||
| 609 | 502.373.1538 Boehringer Ingelheim Investigational Site | Nitra | Slovakia | ||
| 610 | 502.373.1545 Boehringer Ingelheim Investigational Site | Rimavska Sobota | Slovakia | ||
| 611 | 502.373.1553 Boehringer Ingelheim Investigational Site | Bellville | South Africa | ||
| 612 | 502.373.1552 Boehringer Ingelheim Investigational Site | Bloemfontein | South Africa | ||
| 613 | 502.373.1550 Boehringer Ingelheim Investigational Site | Cape Town | South Africa | ||
| 614 | 502.373.1561 Boehringer Ingelheim Investigational Site | Cape Town | South Africa | ||
| 615 | 502.373.1554 Boehringer Ingelheim Investigational Site | Congella | South Africa | ||
| 616 | 502.373.1551 Boehringer Ingelheim Investigational Site | Durban | South Africa | ||
| 617 | 502.373.1560 Boehringer Ingelheim Investigational Site | Fiachrdtpark, Bloemfontein | South Africa | ||
| 618 | 502.373.1563 Boehringer Ingelheim Investigational Site | George East | South Africa | ||
| 619 | 502.373.1555 Boehringer Ingelheim Investigational Site | Park Town West | South Africa | ||
| 620 | 502.373.1559 Boehringer Ingelheim Investigational Site | Port Elizabeth | South Africa | ||
| 621 | 502.373.1562 Boehringer Ingelheim Investigational Site | Port Elizabeth | South Africa | ||
| 622 | 502.373.1558 Boehringer Ingelheim Investigational Site | Soweto | South Africa | ||
| 623 | 502.373.1557 Boehringer Ingelheim Investigational Site | Sunninghill | South Africa | ||
| 624 | 502.373.1564 Boehringer Ingelheim Investigational Site | Sunninghill | South Africa | ||
| 625 | 502.373.1556 Boehringer Ingelheim Investigational Site | Vanderbijlpark | South Africa | ||
| 626 | 502.373.1582 Boehringer Ingelheim Investigational Site | Alcorcón (Madrid) | Spain | ||
| 627 | 502.373.1601 Boehringer Ingelheim Investigational Site | Alicante | Spain | ||
| 628 | 502.373.1586 Boehringer Ingelheim Investigational Site | Barcelona | Spain | ||
| 629 | 502.373.1590 Boehringer Ingelheim Investigational Site | Barcelona | Spain | ||
| 630 | 502.373.1597 Boehringer Ingelheim Investigational Site | Barcelona | Spain | ||
| 631 | 502.373.1599 Boehringer Ingelheim Investigational Site | Barcelona | Spain | ||
| 632 | 502.373.1595 Boehringer Ingelheim Investigational Site | Burjasot (Valencia) | Spain | ||
| 633 | 502.373.1584 Boehringer Ingelheim Investigational Site | Granada | Spain | ||
| 634 | 502.373.1585 Boehringer Ingelheim Investigational Site | Granada | Spain | ||
| 635 | 502.373.1576 Boehringer Ingelheim Investigational Site | Madrid | Spain | ||
| 636 | 502.373.1578 Boehringer Ingelheim Investigational Site | Madrid | Spain | ||
| 637 | 502.373.1580 Boehringer Ingelheim Investigational Site | Madrid | Spain | ||
| 638 | 502.373.1589 Boehringer Ingelheim Investigational Site | Madrid | Spain | ||
| 639 | 502.373.1592 Boehringer Ingelheim Investigational Site | Madrid | Spain | ||
| 640 | 502.373.1594 Boehringer Ingelheim Investigational Site | Murcia | Spain | ||
| 641 | 502.373.1577 Boehringer Ingelheim Investigational Site | Málaga | Spain | ||
| 642 | 502.373.1596 Boehringer Ingelheim Investigational Site | Málaga | Spain | ||
| 643 | 502.373.1579 Boehringer Ingelheim Investigational Site | Santiago de Compostela | Spain | ||
| 644 | 502.373.1593 Boehringer Ingelheim Investigational Site | Santiago de Compostela | Spain | ||
| 645 | 502.373.1598 Boehringer Ingelheim Investigational Site | Santiago de Compostela | Spain | ||
| 646 | 502.373.1583 Boehringer Ingelheim Investigational Site | Sevilla | Spain | ||
| 647 | 502.373.1575 Boehringer Ingelheim Investigational Site | Valencia | Spain | ||
| 648 | 502.373.1591 Boehringer Ingelheim Investigational Site | Valencia | Spain | ||
| 649 | 502.373.1504 Capio Lundby sjukhus | Göteborg | Sweden | ||
| 650 | 502.373.1509 Hjärtsektionen / Med.kliniken | Göteborg | Sweden | ||
| 651 | 502.373.1514 Hjärt/Kärlforskn.enheten | Göteborg | Sweden | ||
| 652 | 502.373.1501 Hjaertmottagningen | Helsingborg | Sweden | ||
| 653 | 502.373.1505 Jakobsbergs sjukhus | Järfälla | Sweden | ||
| 654 | 502.373.1502 Borgmästargaardens Läkarmottagning | Malmoe | Sweden | ||
| 655 | 502.373.1506 Hjärtmottagningen | Malmö | Sweden | ||
| 656 | 502.373.1507 Kardiologiska kliniken | Malmö | Sweden | ||
| 657 | 502.373.1508 Kolgahuset Läkargrupp | Malmö | Sweden | ||
| 658 | 502.373.1511 Sjuntorps Vaardcentral | Sjuntorp | Sweden | ||
| 659 | 502.373.1503 Källtorps Vaardcentral | Trollhättan | Sweden | ||
| 660 | 502.373.1512 Vännäs Vaardcentral | Vännäs | Sweden | ||
| 661 | 502.373.1625 Boehringer Ingelheim Investigational Site | Basel | Switzerland | ||
| 662 | 502.373.1632 Boehringer Ingelheim Investigational Site | Bellinzona | Switzerland | ||
| 663 | 502.373.1634 Boehringer Ingelheim Investigational Site | Bern | Switzerland | ||
| 664 | 502.373.1627 Boehringer Ingelheim Investigational Site | Biel/Bienne | Switzerland | ||
| 665 | 502.373.1631 Boehringer Ingelheim Investigational Site | Chur | Switzerland | ||
| 666 | 502.373.1633 Boehringer Ingelheim Investigational Site | Kreuzlingen | Switzerland | ||
| 667 | 502.373.1639 Boehringer Ingelheim Investigational Site | Lausanne | Switzerland | ||
| 668 | 502.373.1629 Boehringer Ingelheim Investigational Site | Lugano | Switzerland | ||
| 669 | 502.373.1628 Boehringer Ingelheim Investigational Site | St. Gallen | Switzerland | ||
| 670 | 502.373.1637 Boehringer Ingelheim Investigational Site | Zürich | Switzerland | ||
| 671 | 502.373.0780 Boehringer Ingelheim Investigational Site | Changhua | Taiwan | ||
| 672 | 502.373.0779 Boehringer Ingelheim Investigational Site | Chia-Yi | Taiwan | ||
| 673 | 502.373.0783 Boehringer Ingelheim Investigational Site | Hualien | Taiwan | ||
| 674 | 502.373.0776 Boehringer Ingelheim Investigational Site | Kaohsiung | Taiwan | ||
| 675 | 502.373.0778 Boehringer Ingelheim Investigational Site | Kaohsiung | Taiwan | ||
| 676 | 502.373.0775 Boehringer Ingelheim Investigational Site | Tainan | Taiwan | ||
| 677 | 502.373.0777 Boehringer Ingelheim Investigational Site | Tainan | Taiwan | ||
| 678 | 502.373.0781 Boehringer Ingelheim Investigational Site | Taipei | Taiwan | ||
| 679 | 502.373.0782 Boehringer Ingelheim Investigational Site | Taipei | Taiwan | ||
| 680 | 502.373.0801 Boehringer Ingelheim Investigational Site | Bangkok | Thailand | ||
| 681 | 502.373.0802 Boehringer Ingelheim Investigational Site | Bangkok | Thailand | ||
| 682 | 502.373.0804 Boehringer Ingelheim Investigational Site | Bangkok | Thailand | ||
| 683 | 502.373.0805 Boehringer Ingelheim Investigational Site | Bangkok | Thailand | ||
| 684 | 502.373.0806 Boehringer Ingelheim Investigational Site | Bangkok | Thailand | ||
| 685 | 502.373.0808 Boehringer Ingelheim Investigational Site | Bangkok | Thailand | ||
| 686 | 502.373.0803 Boehringer Ingelheim Investigational Site | Khon Kaen | Thailand | ||
| 687 | 502.373.0807 Boehringer Ingelheim Investigational Site | Nonthaburi | Thailand | ||
| 688 | 502.373.1651 Cukurova Universitesi Tip Fakultesi | Adana | Turkey | ||
| 689 | 502.373.1652 Cukurova Universitesi Tip Fakultesi | Adana | Turkey | ||
| 690 | 502.373.1653 Ankara Hastanesi Endokrinoloji Bölümü | Ankara | Turkey | ||
| 691 | 502.373.1656 Baskent Universitesi Tip Fakultesi | Ankara | Turkey | ||
| 692 | 502.373.1659 Ankara Universitesi Tip Fakultesi | Ankara | Turkey | ||
| 693 | 502.373.1654 Göztepe SSK Egitim ve Arastirma Hastanesi | Istanbul | Turkey | ||
| 694 | 502.373.1655 Cerrahpasa Universitesi Tip Fakultesi | Istanbul | Turkey | ||
| 695 | 502.373.1657 Haseki Hastanesi | Istanbul | Turkey | ||
| 696 | 502.373.1658 Ege Universitesi Tip Fakultesi | Izmir | Turkey | ||
| 697 | 502.373.1650 Erciyes Universitesi Tip Fakultesi Kardiyoloji Anabilim Dali | Kayseri | Turkey | ||
| 698 | 502.373.1730 Boehringer Ingelheim Investigational Site | Dnyepropetrovsk | Ukraine | ||
| 699 | 502.373.1731 Boehringer Ingelheim Investigational Site | Dnyepropetrovsk | Ukraine | ||
| 700 | 502.373.1728 Boehringer Ingelheim Investigational Site | Kharkov | Ukraine | ||
| 701 | 502.373.1732 Boehringer Ingelheim Investigational Site | Kharkov | Ukraine | ||
| 702 | 502.373.1733 Boehringer Ingelheim Investigational Site | Kharkov | Ukraine | ||
| 703 | 502.373.1725 Boehringer Ingelheim Investigational Site | Kiev | Ukraine | ||
| 704 | 502.373.1726 Boehringer Ingelheim Investigational Site | Kiev | Ukraine | ||
| 705 | 502.373.1727 Boehringer Ingelheim Investigational Site | Kiev | Ukraine | ||
| 706 | 502.373.1729 Boehringer Ingelheim Investigational Site | Kiev | Ukraine | ||
| 707 | 502.373.1734 Boehringer Ingelheim Investigational Site | Kiev | Ukraine | ||
| 708 | 502.373.1680 Boehringer Ingelheim Investigational Site | Abu Dhabi | United Arab Emirates | ||
| 709 | 502.373.1675 Boehringer Ingelheim Investigational Site | Dubai | United Arab Emirates | ||
| 710 | 502.373.1679 Boehringer Ingelheim Investigational Site | Dubai | United Arab Emirates | ||
| 711 | 502.373.1677 Boehringer Ingelheim Investigational Site | Sharjah | United Arab Emirates | ||
| 712 | 502.373.1698 Boehringer Ingelheim Investigational Site | Aberdeen | United Kingdom | ||
| 713 | 502.373.1706 Boehringer Ingelheim Investigational Site | Bathampton | United Kingdom | ||
| 714 | 502.373.1690 Boehringer Ingelheim Investigational Site | Belfast | United Kingdom | ||
| 715 | 502.373.1694 Boehringer Ingelheim Investigational Site | Birmingham | United Kingdom | ||
| 716 | 502.373.1707 Boehringer Ingelheim Investigational Site | Brighton | United Kingdom | ||
| 717 | 502.373.1703 Boehringer Ingelheim Investigational Site | Cardiff | United Kingdom | ||
| 718 | 502.373.1709 Boehringer Ingelheim Investigational Site | Chichester | United Kingdom | ||
| 719 | 502.373.1701 Boehringer Ingelheim Investigational Site | Derby | United Kingdom | ||
| 720 | 502.373.1705 Boehringer Ingelheim Investigational Site | Gateshead | United Kingdom | ||
| 721 | 502.373.1710 Boehringer Ingelheim Investigational Site | Glasgow | United Kingdom | ||
| 722 | 502.373.1700 Boehringer Ingelheim Investigational Site | Kirkcaldy, Fife | United Kingdom | ||
| 723 | 502.373.1691 Boehringer Ingelheim Investigational Site | Leeds | United Kingdom | ||
| 724 | 502.373.1699 Boehringer Ingelheim Investigational Site | Leicester | United Kingdom | ||
| 725 | 502.373.1702 Boehringer Ingelheim Investigational Site | Lincoln | United Kingdom | ||
| 726 | 502.373.1697 Boehringer Ingelheim Investigational Site | Liverpool | United Kingdom | ||
| 727 | 502.373.1695 Boehringer Ingelheim Investigational Site | London | United Kingdom | ||
| 728 | 502.373.1693 Boehringer Ingelheim Investigational Site | Manchester | United Kingdom | ||
| 729 | 502.373.1708 Boehringer Ingelheim Investigational Site | Portadown, County Atrim | United Kingdom | ||
| 730 | 502.373.1692 Boehringer Ingelheim Investigational Site | Rugby | United Kingdom | ||
| 731 | 502.373.1696 Boehringer Ingelheim Investigational Site | Sheffield | United Kingdom | ||
| 732 | 502.373.1704 Boehringer Ingelheim Investigational Site | Stirling | United Kingdom |
Sponsors and Collaborators
- Boehringer Ingelheim
Investigators
- Study Chair: Boehringer Ingelheim, Boehringer Ingelheim
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00153101
Other Study ID Numbers:
- 502.373
- NCT00034931
First Posted:
Sep 12, 2005
Last Update Posted:
May 20, 2014
Last Verified:
May 1, 2014
Study Results
Participant Flow
| Recruitment Details | At the randomization visit, patients who have adhered to the medication regimen (consumed > 75% of ramipril + telmisartan during run-in phase) and were Angiotensin Converting Enzyme (ACE) tolerant were randomized into the main study (ONTARGET). ACE intolerant patients were randomized into the parallel trial (TRANSCEND). |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Telmisartan/Ramipril (ONTARGET) | Telmisartan (ONTARGET) | Ramipril (ONTARGET) | Telmisartan (TRANSCEND) | Placebo (TRANSCEND) |
|---|---|---|---|---|---|
| Arm/Group Description | Telmisartan 80mg tablet / Ramipril 10mg tablet. One tablet of each administered once daily in the morning. | Telmisartan 80mg tablet /Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning. | Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning. | Telmisartan 80mg tablet, one tablet administered once daily in the morning. | Telmisartan 80mg placebo tablet, one tablet administered once daily in the morning. |
| Period Title: Overall Study | |||||
| STARTED | 8502 | 8542 | 8576 | 2954 | 2972 |
| COMPLETED | 8485 | 8524 | 8561 | 2946 | 2962 |
| NOT COMPLETED | 17 | 18 | 15 | 8 | 10 |
Baseline Characteristics
| Arm/Group Title | Telmisartan/Ramipril (ONTARGET) | Telmisartan (ONTARGET) | Ramipril (ONTARGET) | Telmisartan (TRANSCEND) | Placebo (TRANSCEND) | Total |
|---|---|---|---|---|---|---|
| Arm/Group Description | Telmisartan 80mg tablet / Ramipril 10mg tablet. One tablet of each administered once daily in the morning. | Telmisartan 80mg tablet /Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning. | Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning. | Telmisartan 80mg tablet, one tablet administered once daily in the morning. | Telmisartan 80mg placebo tablet, one tablet administered once daily in the morning. | Total of all reporting groups |
| Overall Participants | 8502 | 8542 | 8576 | 2954 | 2972 | 31546 |
| Age (years) [Mean (Standard Deviation) ] | ||||||
| Mean (Standard Deviation) [years] |
66.4
(7.3)
|
66.4
(7.1)
|
66.4
(7.2)
|
66.9
(7.3)
|
66.9
(7.4)
|
66.5
(7.2)
|
| Sex: Female, Male (Count of Participants) | ||||||
| Female |
2250
26.5%
|
2250
26.3%
|
2331
27.2%
|
1280
43.3%
|
1267
42.6%
|
9378
29.7%
|
| Male |
6252
73.5%
|
6292
73.7%
|
6245
72.8%
|
1674
56.7%
|
1705
57.4%
|
22168
70.3%
|
Outcome Measures
| Title | ONTARGET. Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke and Hospitalization for Congestive Heart Failure |
|---|---|
| Description | The Ongoing Telmisartan Alone and combination with Ramipril global Endpoint trial (ONTARGET). Time to first event analysis of the following defined endpoints, Cardiovascular Death, Non-fatal myocardial infarction, non-fatal stroke and hospitalization for congestive heart failure. |
| Time Frame | 56 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS of the ONTARGET trial |
| Arm/Group Title | Telmisartan/Ramipril (ONTARGET) | Telmisartan (ONTARGET) | Ramipril (ONTARGET) |
|---|---|---|---|
| Arm/Group Description | Telmisartan 80mg tablet / Ramipril 10mg tablet. One tablet of each administered once daily in the morning. | Telmisartan 80mg tablet / Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning. | Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning. |
| Measure Participants | 8502 | 8542 | 8576 |
| Number [participants] |
1386
16.3%
|
1423
16.7%
|
1412
16.5%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Telmisartan/Ramipril (ONTARGET), Ramipril (ONTARGET) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.8462 |
| Comments | ||
| Method | Regression, Cox | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.99 | |
| Confidence Interval |
() 95% 0.92 to 1.07 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Telmisartan (ONTARGET), Ramipril (ONTARGET) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | Non-inferiority margin was 1.13 | |
| Statistical Test of Hypothesis | p-Value | 0.0019 |
| Comments | ||
| Method | Regression, Cox | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 1.01 | |
| Confidence Interval |
() 97.5% 0.93 to 1.10 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | ONTARGET. Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction and Non-fatal Stroke |
|---|---|
| Description | The Ongoing Telmisartan Alone and combination with Ramipril global Endpoint trial (ONTARGET). Time to first event analysis of the following defined endpoints, non-fatal myocardial infarction or non-fatal stroke |
| Time Frame | 56 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS of the ONTARGET trial |
| Arm/Group Title | Telmisartan/Ramipril (ONTARGET) | Telmisartan (ONTARGET) | Ramipril (ONTARGET) |
|---|---|---|---|
| Arm/Group Description | Telmisartan 80mg tablet / Ramipril 10mg tablet. One tablet of each administered once daily in the morning. | Telmisartan 80mg tablet / Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning. | Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning. |
| Measure Participants | 8502 | 8542 | 8576 |
| Number [participants] |
1200
14.1%
|
1190
13.9%
|
1210
14.1%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Telmisartan/Ramipril (ONTARGET), Ramipril (ONTARGET) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.9086 |
| Comments | ||
| Method | Regression, Cox | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 1.00 | |
| Confidence Interval |
() 95% 0.93 to 1.09 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Telmisartan (ONTARGET), Ramipril (ONTARGET) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | Non-inferiority margin was 1.13 | |
| Statistical Test of Hypothesis | p-Value | 0.0004 |
| Comments | ||
| Method | Regression, Cox | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.99 | |
| Confidence Interval |
() 97.5% 0.90 to 1.08 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | ONTARGET. Cardiovascular Death |
|---|---|
| Description | The Ongoing Telmisartan Alone and combination with Ramipril global Endpoint trial (ONTARGET). Time to the first event analysis of the endpoint cardiovascular death. |
| Time Frame | 56 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS of the ONTARGET trial |
| Arm/Group Title | Telmisartan/Ramipril (ONTARGET) | Telmisartan (ONTARGET) | Ramipril (ONTARGET) |
|---|---|---|---|
| Arm/Group Description | Telmisartan 80mg tablet /Ramipril 10mg tablet. One tablet of each administered once daily in the morning. | Telmisartan 80mg tablet /Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning. | Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning. |
| Measure Participants | 8502 | 8542 | 8576 |
| Number [participants] |
620
7.3%
|
598
7%
|
603
7%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Telmisartan/Ramipril (ONTARGET), Ramipril (ONTARGET) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.4535 |
| Comments | ||
| Method | Regression, Cox | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 1.04 | |
| Confidence Interval |
() 95% 0.93 to 1.17 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Telmisartan (ONTARGET), Ramipril (ONTARGET) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.9421 |
| Comments | ||
| Method | Regression, Cox | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 1.00 | |
| Confidence Interval |
() 95% 0.89 to 1.12 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | ONTARGET. Non-fatal Myocardial Infarction |
|---|---|
| Description | The Ongoing Telmisartan Alone and combination with Ramipril global Endpoint trial (ONTARGET). Time to the first event analysis of the endpoint non-fatal myocardial infarction. |
| Time Frame | 56 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS of the ONTARGET trial |
| Arm/Group Title | Telmisartan/Ramipril (ONTARGET) | Telmisartan (ONTARGET) | Ramipril (ONTARGET) |
|---|---|---|---|
| Arm/Group Description | Telmisartan 80mg tablet /Ramipril 10mg tablet. One tablet of each administered once daily in the morning. | Telmisartan 80mg tablet /Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning. | Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning. |
| Measure Participants | 8502 | 8542 | 8576 |
| Number [participants] |
424
5%
|
431
5%
|
400
4.7%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Telmisartan/Ramipril (ONTARGET), Ramipril (ONTARGET) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.2909 |
| Comments | ||
| Method | Regression, Cox | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 1.08 | |
| Confidence Interval |
() 95% 0.94 to 1.23 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Telmisartan (ONTARGET), Ramipril (ONTARGET) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.2534 |
| Comments | ||
| Method | Regression, Cox | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 1.08 | |
| Confidence Interval |
() 95% 0.94 to 1.24 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | ONTARGET. Non-fatal Stroke |
|---|---|
| Description | The Ongoing Telmisartan Alone and combination with Ramipril global Endpoint trial (ONTARGET). Time to first event analysis of the endpoint non-fatal stroke. |
| Time Frame | 56 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS of the ONTARGET trial |
| Arm/Group Title | Telmisartan/Ramipril (ONTARGET) | Telmisartan (ONTARGET) | Ramipril (ONTARGET) |
|---|---|---|---|
| Arm/Group Description | Telmisartan 80mg tablet /Ramipril 10mg tablet. One tablet of each administered once daily in the morning. | Telmisartan 80mg tablet /Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning. | Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning. |
| Measure Participants | 8502 | 8542 | 8576 |
| Number [participants] |
364
4.3%
|
364
4.3%
|
402
4.7%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Telmisartan/Ramipril (ONTARGET), Ramipril (ONTARGET) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.2248 |
| Comments | ||
| Method | Regression, Cox | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.92 | |
| Confidence Interval |
() 95% 0.79 to 1.06 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Telmisartan (ONTARGET), Ramipril (ONTARGET) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1829 |
| Comments | ||
| Method | Regression, Cox | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.91 | |
| Confidence Interval |
() 95% 0.79 to 1.05 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | ONTARGET. Hospitalization for Congestive Heart Failure |
|---|---|
| Description | The Ongoing Telmisartan Alone and combination with Ramipril global Endpoint trial (ONTARGET). Time to the first event analysis of the endpoint hospitalization for congestive heart failure. |
| Time Frame | 56 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS of the ONTARGET trial |
| Arm/Group Title | Telmisartan/Ramipril (ONTARGET) | Telmisartan (ONTARGET) | Ramipril (ONTARGET) |
|---|---|---|---|
| Arm/Group Description | Telmisartan 80mg tablet /Ramipril 10mg tablet. One tablet of each administered once daily in the morning. | Telmisartan 80mg tablet /Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning. | Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning. |
| Measure Participants | 8502 | 8542 | 8576 |
| Number [participants] |
332
3.9%
|
394
4.6%
|
354
4.1%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Telmisartan/Ramipril (ONTARGET), Ramipril (ONTARGET) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.4984 |
| Comments | ||
| Method | Regression, Cox | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.95 | |
| Confidence Interval |
() 95% 0.82 to 1.10 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Telmisartan (ONTARGET), Ramipril (ONTARGET) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1203 |
| Comments | ||
| Method | Regression, Cox | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 1.12 | |
| Confidence Interval |
() 95% 0.97 to 1.29 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | ONTARGET. Doubling of Serum Creatinine in Diabetic Nephropathy Patients |
|---|---|
| Description | Diabetic nephropathy patients are diabetic patients with macro-albuminuria assessed as a Urinary Albumin Creatinine Ratio (UACR) ≥300 mg/g Crea at baseline. |
| Time Frame | 56 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS [DN] of the ONTARGET trial |
| Arm/Group Title | Telmisartan/Ramipril (ONTARGET) | Telmisartan (ONTARGET) | Ramipril (ONTARGET) |
|---|---|---|---|
| Arm/Group Description | Telmisartan 80mg tablet / Ramipril 10mg tablet. One tablet of each administered once daily in the morning. | Telmisartan 80mg tablet / Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning. | Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning. |
| Measure Participants | 248 | 288 | 238 |
| Number [participants] |
30
0.4%
|
24
0.3%
|
23
0.3%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Telmisartan/Ramipril (ONTARGET), Ramipril (ONTARGET) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.4221 |
| Comments | ||
| Method | Regression, Cox | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 1.25 | |
| Confidence Interval |
(2-Sided) 95% 0.73 to 2.15 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Telmisartan (ONTARGET), Ramipril (ONTARGET) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.7305 |
| Comments | ||
| Method | Regression, Cox | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.90 | |
| Confidence Interval |
() 95% 0.51 to 1.60 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | ONTARGET. Progression to End Stage Renal Disease (ESRD) in Diabetic Nephropathy Patients |
|---|---|
| Description | ESRD is defined by initiation of dialysis, need for renal transplantation, or eGFR <15 mL/min/1.73 m². Diabetic nephropathy patients are diabetic patients with macro-albuminuria assessed as a Urinary Albumin Creatinine Ratio (UACR) ≥300 mg/g Crea at baseline. |
| Time Frame | 56 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS [DN] of the ONTARGET trial |
| Arm/Group Title | Telmisartan/Ramipril (ONTARGET) | Telmisartan (ONTARGET) | Ramipril (ONTARGET) |
|---|---|---|---|
| Arm/Group Description | Telmisartan 80mg tablet / Ramipril 10mg tablet. One tablet of each administered once daily in the morning. | Telmisartan 80mg tablet / Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning. | Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning. |
| Measure Participants | 248 | 288 | 238 |
| Number [participants] |
30
0.4%
|
24
0.3%
|
32
0.4%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Telmisartan/Ramipril (ONTARGET), Ramipril (ONTARGET) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.6248 |
| Comments | ||
| Method | Regression, Cox | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.88 | |
| Confidence Interval |
() 95% 0.54 to 1.45 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Telmisartan (ONTARGET), Ramipril (ONTARGET) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0751 |
| Comments | ||
| Method | Regression, Cox | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.62 | |
| Confidence Interval |
(2-Sided) 95% 0.36 to 1.05 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | ONTARGET. All-cause Mortality in Diabetic Nephropathy Patients |
|---|---|
| Description | Diabetic nephropathy patients are diabetic patients with macro-albuminuria assessed as a Urinary Albumin Creatinine Ratio (UACR) ≥300 mg/g Crea at baseline. |
| Time Frame | 56 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS [DN] of the ONTARGET trial |
| Arm/Group Title | Telmisartan/Ramipril (ONTARGET) | Telmisartan (ONTARGET) | Ramipril (ONTARGET) |
|---|---|---|---|
| Arm/Group Description | Telmisartan 80mg tablet / Ramipril 10mg tablet. One tablet of each administered once daily in the morning. | Telmisartan 80mg tablet / Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning. | Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning. |
| Measure Participants | 248 | 288 | 238 |
| Number [participants] |
75
0.9%
|
92
1.1%
|
83
1%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Telmisartan/Ramipril (ONTARGET), Ramipril (ONTARGET) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.3682 |
| Comments | ||
| Method | Regression, Cox | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.87 | |
| Confidence Interval |
() 95% 0.63 to 1.18 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Telmisartan (ONTARGET), Ramipril (ONTARGET) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.6014 |
| Comments | ||
| Method | Regression, Cox | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.92 | |
| Confidence Interval |
() 95% 0.69 to 1.24 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | ONTARGET. Doubling of Serum Creatinine |
|---|---|
| Description | ONTARGET. Nephropathy subcategory: doubling of serum creatinine |
| Time Frame | 56 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS of the ONTARGET trial |
| Arm/Group Title | Telmisartan/Ramipril (ONTARGET) | Telmisartan (ONTARGET) | Ramipril (ONTARGET) |
|---|---|---|---|
| Arm/Group Description | Telmisartan 80mg tablet / Ramipril 10mg tablet. One tablet of each administered once daily in the morning. | Telmisartan 80mg tablet / Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning. | Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning. |
| Measure Participants | 8483 | 8525 | 8557 |
| Number [participants] |
167
2%
|
160
1.9%
|
149
1.7%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Telmisartan/Ramipril (ONTARGET), Ramipril (ONTARGET) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.2550 |
| Comments | ||
| Method | Regression, Cox | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 1.14 | |
| Confidence Interval |
() 95% 0.91 to 1.42 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Telmisartan (ONTARGET), Ramipril (ONTARGET) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.5297 |
| Comments | ||
| Method | Regression, Cox | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 1.07 | |
| Confidence Interval |
() 95% 0.86 to 1.34 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | ONTARGET. Progression to ESRD |
|---|---|
| Description | ONTARGET. Nephropathy subcategory: Progression to ESRD. Progression to ESRD is defined as initiation of dialysis, need for renal transplantation, or eGFR <15 mL/min/1.73 m². |
| Time Frame | 56 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS of the ONTARGET trial |
| Arm/Group Title | Telmisartan/Ramipril (ONTARGET) | Telmisartan (ONTARGET) | Ramipril (ONTARGET) |
|---|---|---|---|
| Arm/Group Description | Telmisartan 80mg tablet / Ramipril 10mg tablet. One tablet of each administered once daily in the morning. | Telmisartan 80mg tablet / Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning. | Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning. |
| Measure Participants | 8502 | 8542 | 8576 |
| Number [participants] |
79
0.9%
|
67
0.8%
|
71
0.8%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Telmisartan/Ramipril (ONTARGET), Ramipril (ONTARGET) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.4593 |
| Comments | ||
| Method | Regression, Cox | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 1.13 | |
| Confidence Interval |
() 95% 0.82 to 1.56 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Telmisartan (ONTARGET), Ramipril (ONTARGET) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.7468 |
| Comments | ||
| Method | Regression, Cox | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.95 | |
| Confidence Interval |
() 95% 0.68 to 1.32 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | ONTARGET. 3-fold Composite Endpoint of Doubling of Serum Creatinine, Progression to End Stage Renal Disease (ESRD) and All-cause Mortality in Diabetic Nephropathy Patients |
|---|---|
| Description | ESRD is defined by initiation of dialysis, need for renal transplantation, or eGFR <15 mL/min/1.73 m². Diabetic nephropathy patients are diabetic patients with macro-albuminuria assessed as a Urinary Albumin Creatinine Ratio (UACR) ≥300 mg/g Crea at baseline. These renal outcomes were not adjudicated (apart from death). |
| Time Frame | 56 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Subset of the Full Analysis Set (FAS [DN]) consisting of all randomised patients with diabetic nephropathy (UACR ≥300 mg/g Crea) of the ONTARGET trial. |
| Arm/Group Title | Telmisartan/Ramipril (ONTARGET) | Telmisartan (ONTARGET) | Ramipril (ONTARGET) |
|---|---|---|---|
| Arm/Group Description | Telmisartan 80mg tablet / Ramipril 10mg tablet. One tablet of each administered once daily in the morning. | Telmisartan 80mg tablet / Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning. | Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning. |
| Measure Participants | 248 | 288 | 238 |
| Number [participants] |
108
1.3%
|
119
1.4%
|
112
1.3%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Telmisartan/Ramipril (ONTARGET), Ramipril (ONTARGET) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.5461 |
| Comments | ||
| Method | Regression, Cox | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.92 | |
| Confidence Interval |
(2-Sided) 95% 0.71 to 1.20 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Telmisartan (ONTARGET), Ramipril (ONTARGET) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.3436 |
| Comments | ||
| Method | Regression, Cox | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.88 | |
| Confidence Interval |
() 95% 0.68 to 1.14 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | ONTARGET. New Microalbuminuria |
|---|---|
| Description | ONTARGET. Nephropathy subcategory: New microalbuminuria. New microalbuminuria is defined as Urinary Albumin Creatinine Ratio ≥30 mg/g Crea in patients with a Urinary Albumin Creatinine Ratio <30 mg/g Crea at baseline. |
| Time Frame | 56 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS of the ONTARGET trial |
| Arm/Group Title | Telmisartan/Ramipril (ONTARGET) | Telmisartan (ONTARGET) | Ramipril (ONTARGET) |
|---|---|---|---|
| Arm/Group Description | Telmisartan 80mg tablet / Ramipril 10mg tablet. One tablet of each administered once daily in the morning. | Telmisartan 80mg tablet / Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning. | Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning. |
| Measure Participants | 6446 | 6456 | 6532 |
| Number [participants] |
763
9%
|
799
9.4%
|
869
10.1%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Telmisartan/Ramipril (ONTARGET), Ramipril (ONTARGET) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0133 |
| Comments | ||
| Method | Regression, Cox | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.88 | |
| Confidence Interval |
() 95% 0.80 to 0.97 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Telmisartan (ONTARGET), Ramipril (ONTARGET) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1251 |
| Comments | ||
| Method | Regression, Cox | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.93 | |
| Confidence Interval |
() 95% 0.84 to 1.02 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | ONTARGET. New Macroalbuminuria |
|---|---|
| Description | ONTARGET. Nephropathy subcategory: New macroalbuminuria. New macroalbuminuria is defined as Urinary Albumin Creatinine Ratio ≥300 mg/g Crea in patients with a Urinary Albumin Creatinine Ratio <300 mg/g Crea at baseline. |
| Time Frame | 56 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS of the ONTARGET trial |
| Arm/Group Title | Telmisartan/Ramipril (ONTARGET) | Telmisartan (ONTARGET) | Ramipril (ONTARGET) |
|---|---|---|---|
| Arm/Group Description | Telmisartan 80mg tablet / Ramipril 10mg tablet. One tablet of each administered once daily in the morning. | Telmisartan 80mg tablet / Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning. | Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning. |
| Measure Participants | 7486 | 7465 | 7552 |
| Number [participants] |
205
2.4%
|
229
2.7%
|
257
3%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Telmisartan/Ramipril (ONTARGET), Ramipril (ONTARGET) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0213 |
| Comments | ||
| Method | Regression, Cox | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.81 | |
| Confidence Interval |
() 95% 0.67 to 0.97 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Telmisartan (ONTARGET), Ramipril (ONTARGET) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.2396 |
| Comments | ||
| Method | Regression, Cox | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.90 | |
| Confidence Interval |
() 95% 0.75 to 1.07 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | ONTARGET. Combined Endpoint of Doubling of Serum Creatinine, Progression to ESRD, New Microalbuminuria, or New Macroalbuminuria |
|---|---|
| Description | ONTARGET. Nephropathy subcategory: Combined endpoint of doubling of serum creatinine, progression to ESRD, new microalbuminuria, or new macroalbuminuria |
| Time Frame | 56 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS of the ONTARGET trial |
| Arm/Group Title | Telmisartan/Ramipril (ONTARGET) | Telmisartan (ONTARGET) | Ramipril (ONTARGET) |
|---|---|---|---|
| Arm/Group Description | Telmisartan 80mg tablet / Ramipril 10mg tablet. One tablet of each administered once daily in the morning. | Telmisartan 80mg tablet / Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning. | Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning. |
| Measure Participants | 8502 | 8542 | 8576 |
| Number [participants] |
1067
12.5%
|
1101
12.9%
|
1190
13.9%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Telmisartan/Ramipril (ONTARGET), Ramipril (ONTARGET) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0111 |
| Comments | ||
| Method | Regression, Cox | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.90 | |
| Confidence Interval |
() 95% 0.83 to 0.98 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Telmisartan (ONTARGET), Ramipril (ONTARGET) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0606 |
| Comments | ||
| Method | Regression, Cox | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.92 | |
| Confidence Interval |
() 95% 0.85 to 1.00 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | ONTARGET. Normalisation From Micro- or Macroalbuminuria to Normoalbuminuria |
|---|---|
| Description | ONTARGET. Nephropathy subcategory: Normalisation from micro- or macroalbuminuria to normoalbuminuria. Normalisation from micro- or macroalbuminuria to normoalbuminuria is defined as UACR <30 mg/g Crea in patients with a UACR ≥30 mg/g Crea at baseline. |
| Time Frame | 56 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS of the ONTARGET trial |
| Arm/Group Title | Telmisartan/Ramipril (ONTARGET) | Telmisartan (ONTARGET) | Ramipril (ONTARGET) |
|---|---|---|---|
| Arm/Group Description | Telmisartan 80mg tablet / Ramipril 10mg tablet. One tablet of each administered once daily in the morning. | Telmisartan 80mg tablet / Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning. | Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning. |
| Measure Participants | 1337 | 1361 | 1314 |
| Number [participants] |
508
6%
|
483
5.7%
|
448
5.2%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Telmisartan/Ramipril (ONTARGET), Ramipril (ONTARGET) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0082 |
| Comments | ||
| Method | Regression, Cox | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 1.19 | |
| Confidence Interval |
() 95% 1.05 to 1.35 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Telmisartan (ONTARGET), Ramipril (ONTARGET) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.2164 |
| Comments | ||
| Method | Regression, Cox | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 1.08 | |
| Confidence Interval |
() 95% 0.95 to 1.23 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | ONTARGET. Newly Diagnosed Congestive Heart Failure |
|---|---|
| Description | The Ongoing Telmisartan Alone and combination with Ramipril global Endpoint trial (ONTARGET). Time to the first event analysis of the endpoint Newly diagnosed Congestive Heart failure. |
| Time Frame | 56 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS of the ONTARGET trial |
| Arm/Group Title | Telmisartan/Ramipril (ONTARGET) | Telmisartan (ONTARGET) | Ramipril (ONTARGET) |
|---|---|---|---|
| Arm/Group Description | Telmisartan 80mg tablet /Ramipril 10mg tablet. One tablet of each administered once daily in the morning. | Telmisartan 80mg tablet /Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning. | Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning. |
| Measure Participants | 8502 | 8542 | 8576 |
| Number [participants] |
469
5.5%
|
529
6.2%
|
503
5.9%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Telmisartan/Ramipril (ONTARGET), Ramipril (ONTARGET) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.3732 |
| Comments | ||
| Method | Regression, Cox | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.94 | |
| Confidence Interval |
() 95% 0.83 to 1.07 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Telmisartan (ONTARGET), Ramipril (ONTARGET) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.3633 |
| Comments | ||
| Method | Regression, Cox | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 1.06 | |
| Confidence Interval |
() 95% 0.94 to 1.20 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | ONTARGET. Cardiovascular Revascularization Procedure |
|---|---|
| Description | The Ongoing Telmisartan Alone and combination with Ramipril global Endpoint trial (ONTARGET). |
| Time Frame | 56 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS of the ONTARGET trial |
| Arm/Group Title | Telmisartan/Ramipril (ONTARGET) | Telmisartan (ONTARGET) | Ramipril (ONTARGET) |
|---|---|---|---|
| Arm/Group Description | Telmisartan 80mg tablet /Ramipril 10mg tablet. One tablet of each administered once daily in the morning. | Telmisartan 80mg tablet /Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning. | Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning. |
| Measure Participants | 8502 | 8542 | 8576 |
| Number [participants] |
1303
15.3%
|
1290
15.1%
|
1269
14.8%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Telmisartan/Ramipril (ONTARGET), Ramipril (ONTARGET) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.2713 |
| Comments | ||
| Method | Regression, Cox | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 1.04 | |
| Confidence Interval |
() 95% 0.97 to 1.13 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Telmisartan (ONTARGET), Ramipril (ONTARGET) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.5150 |
| Comments | ||
| Method | Regression, Cox | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 1.03 | |
| Confidence Interval |
() 95% 0.95 to 1.11 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | ONTARGET. Newly Diagnosed Diabetes |
|---|---|
| Description | The Ongoing Telmisartan Alone and combination with Ramipril global Endpoint trial (ONTARGET). Time to the first event analysis of the endpoint Newly diagnosed Diabetes. Only calculated for those patients without diabetes at baseline. |
| Time Frame | 56 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Only patients of the ONTARGET trial treated with Telmisartan 80mg/ramipril 10mg or Telmisartan 80mg/Ramipril 10mg placebo or Ramipril 10mg/ telmisartan 80mg placebo daily for 56 months without baseline diabetes. |
| Arm/Group Title | Telmisartan/Ramipril (ONTARGET) | Telmisartan (ONTARGET) | Ramipril (ONTARGET) |
|---|---|---|---|
| Arm/Group Description | Telmisartan 80mg tablet /Ramipril 10mg tablet. One tablet of each administered once daily in the morning. | Telmisartan 80mg tablet /Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning. | Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning. |
| Measure Participants | 5037 | 4992 | 5123 |
| Number [participants] |
224
2.6%
|
277
3.2%
|
249
2.9%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Telmisartan/Ramipril (ONTARGET), Ramipril (ONTARGET) |
|---|---|---|
| Comments | for subjects without diabetes at baseline | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.3485 |
| Comments | ||
| Method | Regression, Cox | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.92 | |
| Confidence Interval |
() 95% 0.77 to 1.10 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Telmisartan (ONTARGET), Ramipril (ONTARGET) |
|---|---|---|
| Comments | for subjects without diabetes at baseline | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1235 |
| Comments | ||
| Method | Regression, Cox | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 1.14 | |
| Confidence Interval |
() 95% 0.96 to 1.36 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | ONTARGET. Cognitive Decline |
|---|---|
| Description | The Ongoing Telmisartan Alone and combination with Ramipril global Endpoint trial (ONTARGET). Time to first event analysis of the endpoint cognitive decline i.e. Comparison of the Mini mental state Evaluation (MMSE) of patients at baseline with that at the 2years and end of trial. A decrease in MMSE from baseline represents a cognitive decline. This outcome measure is only available for those patients who had MMSE at baseline. |
| Time Frame | 56 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Only patients of the ONTARGET trial treated with Telmisartan 80mg/ramipril 10mg or Telmisartan 80mg/Ramipril 10mg placebo or Ramipril 10mg/ telmisartan 80mg placebo daily for 56 months with Mini mental state evaluation (MMSE) at baseline. |
| Arm/Group Title | Telmisartan/Ramipril (ONTARGET) | Telmisartan (ONTARGET) | Ramipril (ONTARGET) |
|---|---|---|---|
| Arm/Group Description | Telmisartan 80mg tablet /Ramipril 10mg tablet. One tablet of each administered once daily in the morning. | Telmisartan 80mg tablet /Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning. | Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning. |
| Measure Participants | 7461 | 7566 | 7602 |
| Number [participants] |
561
6.6%
|
600
7%
|
577
6.7%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Telmisartan/Ramipril (ONTARGET), Ramipril (ONTARGET) |
|---|---|---|
| Comments | for subjects with available Mini Mental State Examination (MMSE) at baseline | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.8690 |
| Comments | ||
| Method | Chi-squared | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Risk Ratio (RR) |
| Estimated Value | 0.99 | |
| Confidence Interval |
() 95% 0.89 to 1.11 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Telmisartan (ONTARGET), Ramipril (ONTARGET) |
|---|---|---|
| Comments | for subjects with available Mini Mental State Examination (MMSE) at baseline | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.4337 |
| Comments | ||
| Method | Chi-squared | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Risk Ratio (RR) |
| Estimated Value | 1.04 | |
| Confidence Interval |
() 95% 0.94 to 1.17 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | ONTARGET. New Onset of Atrial Fibrillation |
|---|---|
| Description | The Ongoing Telmisartan Alone and combination with Ramipril global Endpoint trial (ONTARGET). Time to first event analysis of endpoint new onset of atrial fibrillation. |
| Time Frame | 56 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Only patients of the ONTARGET trial treated with Telmisartan 80mg/ramipril 10mg or Telmisartan 80mg/Ramipril 10mg placebo or Ramipril 10mg/ telmisartan 80mg placebo daily for 56 months without atrial fibrillation at baseline. |
| Arm/Group Title | Telmisartan/Ramipril (ONTARGET) | Telmisartan (ONTARGET) | Ramipril (ONTARGET) |
|---|---|---|---|
| Arm/Group Description | Telmisartan 80mg tablet /Ramipril 10mg tablet. One tablet of each administered once daily in the morning. | Telmisartan 80mg tablet /Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning. | Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning. |
| Measure Participants | 8218 | 8259 | 8296 |
| Number [participants] |
542
6.4%
|
560
6.6%
|
586
6.8%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Telmisartan/Ramipril (ONTARGET), Ramipril (ONTARGET) |
|---|---|---|
| Comments | for subjects without atrial fibrillation at baseline | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.2666 |
| Comments | ||
| Method | Regression, Cox | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.94 | |
| Confidence Interval |
() 95% 0.83 to 1.05 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Telmisartan (ONTARGET), Ramipril (ONTARGET) |
|---|---|---|
| Comments | for subjects without atrial fibrillation at baseline | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.4784 |
| Comments | ||
| Method | Regression, Cox | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.96 | |
| Confidence Interval |
() 95% 0.85 to 1.08 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | TRANSCEND. Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction and Non-fatal Stroke |
|---|---|
| Description | Telmisartan Randomized Assessment Study in Angiotension Converting Enzyme inhibitor intolerant subjects with cardiovascular disease (TRANSCEND). Time to first event analysis of the following defined endpoints, Cardiovascular Death, Non-fatal myocardial infarction, non-fatal stroke and hospitalization for congestive heart failure. |
| Time Frame | 56 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS of the TRANSCEND trial |
| Arm/Group Title | Telmisartan (TRANSCEND) | Placebo (TRANSCEND) |
|---|---|---|
| Arm/Group Description | Telmisartan 80mg tablet, one tablet administered once daily in the morning. | Telmisartan 80mg placebo tablet, one tablet administered once daily in the morning. |
| Measure Participants | 2954 | 2972 |
| Number [participants] |
384
4.5%
|
440
5.2%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Telmisartan/Ramipril (ONTARGET), Telmisartan (ONTARGET) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0483 |
| Comments | ||
| Method | Regression, Cox | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.87 | |
| Confidence Interval |
() 95% 0.76 to 1.00 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | TRANSCEND. Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke and Hospitalization for Congestive Heart Failure |
|---|---|
| Description | Telmisartan Randomized Assessment Study in Angiotension Converting Enzyme inhibitor intolerant subjects with cardiovascular disease (TRANSCEND). Time to first event analysis of the following defined endpoints, Cardiovascular Death, Non-fatal myocardial infarction, non-fatal stroke and hospitalization for congestive heart failure. |
| Time Frame | 56 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS of the TRANSCEND trial |
| Arm/Group Title | Telmisartan (TRANSCEND) | Placebo (TRANSCEND) |
|---|---|---|
| Arm/Group Description | Telmisartan 80mg tablet, one tablet administered once daily in the morning. | Telmisartan 80mg placebo tablet, one tablet administered once daily in the morning. |
| Measure Participants | 2954 | 2972 |
| Number [participants] |
465
5.5%
|
504
5.9%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Telmisartan/Ramipril (ONTARGET), Telmisartan (ONTARGET) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.2192 |
| Comments | ||
| Method | Regression, Cox | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.92 | |
| Confidence Interval |
() 95% 0.81 to 1.05 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | TRANSCEND. Cardiovascular Death |
|---|---|
| Description | Telmisartan Randomized Assessment Study in Angiotension Converting Enzyme inhibitor intolerant subjects with cardiovascular disease (TRANSCEND). Time to the first event analysis of the endpoint cardiovascular death. |
| Time Frame | 56 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS of the TRANSCEND trial |
| Arm/Group Title | Telmisartan (TRANSCEND) | Placebo (TRANSCEND) |
|---|---|---|
| Arm/Group Description | Telmisartan 80mg tablet, one tablet administered once daily in the morning. | Telmisartan 80mg placebo tablet, one tablet administered once daily in the morning. |
| Measure Participants | 2954 | 2972 |
| Number [participants] |
227
2.7%
|
223
2.6%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Telmisartan/Ramipril (ONTARGET), Telmisartan (ONTARGET) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.7764 |
| Comments | ||
| Method | Regression, Cox | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 1.03 | |
| Confidence Interval |
() 95% 0.85 to 1.24 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | TRANSCEND. Non-fatal Myocardial Infarction |
|---|---|
| Description | Telmisartan Randomized Assessment Study in Angiotension Converting Enzyme inhibitor intolerant subjects with cardiovascular disease (TRANSCEND). Time to the first event analysis of the endpoint non-fatal myocardial infarction. |
| Time Frame | 56 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS of the TRANSCEND trial |
| Arm/Group Title | Telmisartan (TRANSCEND) | Placebo (TRANSCEND) |
|---|---|---|
| Arm/Group Description | Telmisartan 80mg tablet, one tablet administered once daily in the morning. | Telmisartan 80mg placebo tablet, one tablet administered once daily in the morning. |
| Measure Participants | 2954 | 2972 |
| Number [participants] |
114
1.3%
|
145
1.7%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Telmisartan/Ramipril (ONTARGET), Telmisartan (ONTARGET) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0574 |
| Comments | ||
| Method | Regression, Cox | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.79 | |
| Confidence Interval |
() 95% 0.62 to 1.01 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | TRANSCEND. Non-fatal Stroke |
|---|---|
| Description | Telmisartan Randomized Assessment Study in Angiotension Converting Enzyme inhibitor intolerant subjects with cardiovascular disease (TRANSCEND). |
| Time Frame | 56 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS of the TRANSCEND trial |
| Arm/Group Title | Telmisartan (TRANSCEND) | Placebo (TRANSCEND) |
|---|---|---|
| Arm/Group Description | Telmisartan 80mg tablet, one tablet administered once daily in the morning. | Telmisartan 80mg placebo tablet, one tablet administered once daily in the morning. |
| Measure Participants | 2954 | 2972 |
| Number [participants] |
112
1.3%
|
136
1.6%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Telmisartan/Ramipril (ONTARGET), Telmisartan (ONTARGET) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1365 |
| Comments | ||
| Method | Regression, Cox | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.83 | |
| Confidence Interval |
() 95% 0.64 to 1.06 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | TRANSCEND. Hospitalization for Congestive Heart Failure |
|---|---|
| Description | Telmisartan Randomized Assessment Study in Angiotension Converting Enzyme inhibitor intolerant subjects with cardiovascular disease (TRANSCEND). |
| Time Frame | 56 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS of the TRANSCEND trial |
| Arm/Group Title | Telmisartan (TRANSCEND) | Placebo (TRANSCEND) |
|---|---|---|
| Arm/Group Description | Telmisartan 80mg tablet, one tablet administered once daily in the morning. | Telmisartan 80mg placebo tablet, one tablet administered once daily in the morning. |
| Measure Participants | 2954 | 2972 |
| Number [participants] |
134
1.6%
|
129
1.5%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Telmisartan/Ramipril (ONTARGET), Telmisartan (ONTARGET) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.6940 |
| Comments | ||
| Method | Regression, Cox | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 1.05 | |
| Confidence Interval |
() 95% 0.82 to 1.34 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | TRANSCEND. Doubling of Serum Creatinine |
|---|---|
| Description | TRANSCEND. Nephropathy subcategory: doubling of serum creatinine |
| Time Frame | 56 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS of the TRANSCEND trial |
| Arm/Group Title | Telmisartan (TRANSCEND) | Placebo (TRANSCEND) |
|---|---|---|
| Arm/Group Description | Telmisartan 80mg tablet, one tablet administered once daily in the morning. | Telmisartan 80mg placebo tablet, one tablet administered once daily in the morning. |
| Measure Participants | 2950 | 2965 |
| Number [participants] |
62
0.7%
|
40
0.5%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Telmisartan/Ramipril (ONTARGET), Telmisartan (ONTARGET) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0245 |
| Comments | ||
| Method | Regression, Cox | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 1.58 | |
| Confidence Interval |
() 95% 1.06 to 2.35 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | TRANSCEND. Progression to ESRD |
|---|---|
| Description | TRANSCEND. Nephropathy subcategory: Progression to ESRD. Progression to ESRD is defined as initiation of dialysis, need for renal transplantation, or eGFR <15 mL/min/1.73m² |
| Time Frame | 56 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS of the TRANSCEND trial |
| Arm/Group Title | Telmisartan (TRANSCEND) | Placebo (TRANSCEND) |
|---|---|---|
| Arm/Group Description | Telmisartan 80mg tablet, one tablet administered once daily in the morning. | Telmisartan 80mg placebo tablet, one tablet administered once daily in the morning. |
| Measure Participants | 2954 | 2972 |
| Number [participants] |
11
0.1%
|
14
0.2%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Telmisartan/Ramipril (ONTARGET), Telmisartan (ONTARGET) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.5798 |
| Comments | ||
| Method | Regression, Cox | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.80 | |
| Confidence Interval |
() 95% 0.36 to 1.76 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | TRANSCEND. New Microalbuminuria |
|---|---|
| Description | TRANSCEND. Nephropathy subcategory: New microalbuminuria. New microalbuminuria is defined as UACR ≥30 mg/g creatinine [Crea] in patients with a UACR <30 mg/g Crea at baseline |
| Time Frame | 56 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS of the TRANSCEND trial |
| Arm/Group Title | Telmisartan (TRANSCEND) | Placebo (TRANSCEND) |
|---|---|---|
| Arm/Group Description | Telmisartan 80mg tablet, one tablet administered once daily in the morning. | Telmisartan 80mg placebo tablet, one tablet administered once daily in the morning. |
| Measure Participants | 2372 | 2403 |
| Number [participants] |
276
3.2%
|
363
4.2%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Telmisartan/Ramipril (ONTARGET), Telmisartan (ONTARGET) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0006 |
| Comments | ||
| Method | Regression, Cox | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.76 | |
| Confidence Interval |
() 95% 0.65 to 0.89 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | TRANSCEND. New Macroalbuminuria |
|---|---|
| Description | TRANSCEND. Nephropathy subcategory: New macroalbuminuria. New macroalbuminuria is defined as UACR ≥300 mg/g creatinine [Crea] in patients with a UACR <300 mg/g Crea at baseline |
| Time Frame | 56 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS of the TRANSCEND trial |
| Arm/Group Title | Telmisartan (TRANSCEND) | Placebo (TRANSCEND) |
|---|---|---|
| Arm/Group Description | Telmisartan 80mg tablet, one tablet administered once daily in the morning. | Telmisartan 80mg placebo tablet, one tablet administered once daily in the morning. |
| Measure Participants | 2658 | 2676 |
| Number [participants] |
66
0.8%
|
101
1.2%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Telmisartan/Ramipril (ONTARGET), Telmisartan (ONTARGET) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0085 |
| Comments | ||
| Method | Regression, Cox | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.66 | |
| Confidence Interval |
() 95% 0.48 to 0.90 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | TRANSCEND. Combined Endpoint of Doubling Serum Creatinine, Progression to ESRD, New Microalbuminuria or New Macroalbuminuria |
|---|---|
| Description | TRANSCEND. Nephropathy subcategory: Combined endpoint of doubling serum creatinine, progression to ESRD, new microalbuminuria or new macroalbuminuria |
| Time Frame | 56 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS of the TRANSCEND trial |
| Arm/Group Title | Telmisartan (TRANSCEND) | Placebo (TRANSCEND) |
|---|---|---|
| Arm/Group Description | Telmisartan 80mg tablet, one tablet administered once daily in the morning. | Telmisartan 80mg placebo tablet, one tablet administered once daily in the morning. |
| Measure Participants | 2954 | 2972 |
| Number [participants] |
357
4.2%
|
448
5.2%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Telmisartan/Ramipril (ONTARGET), Telmisartan (ONTARGET) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0015 |
| Comments | ||
| Method | Regression, Cox | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.80 | |
| Confidence Interval |
() 95% 0.69 to 0.92 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | TRANSCEND. Normalisation From Micro- or Macroalbuminuria to Normoalbuminuria |
|---|---|
| Description | TRANSCEND. Nephropathy subcategory: Normalisation from micro- or macroalbuminuria to normoalbuminuria. Normalisation from micro- or macroalbuminuria to normoalbuminuria is defined as UACR <30 mg/g Crea in patients with a UACR ≥30 mg/g Crea at baseline. |
| Time Frame | 56 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS of the TRANSCEND trial |
| Arm/Group Title | Telmisartan (TRANSCEND) | Placebo (TRANSCEND) |
|---|---|---|
| Arm/Group Description | Telmisartan 80mg tablet, one tablet administered once daily in the morning. | Telmisartan 80mg placebo tablet, one tablet administered once daily in the morning. |
| Measure Participants | 319 | 318 |
| Number [participants] |
135
1.6%
|
110
1.3%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Telmisartan/Ramipril (ONTARGET), Telmisartan (ONTARGET) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0101 |
| Comments | ||
| Method | Regression, Cox | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 1.39 | |
| Confidence Interval |
() 95% 1.08 to 1.79 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | TRANSCEND. New Onset of Atrial Fibrillation |
|---|---|
| Description | Telmisartan Randomized Assessment Study in Angiotension Converting Enzyme inhibitor intolerant subjects with cardiovascular disease (TRANSCEND). |
| Time Frame | 56 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS of the TRANSCEND trial |
| Arm/Group Title | Telmisartan (TRANSCEND) | Placebo (TRANSCEND) |
|---|---|---|
| Arm/Group Description | Telmisartan 80mg tablet, one tablet administered once daily in the morning. | Telmisartan 80mg placebo tablet, one tablet administered once daily in the morning. |
| Measure Participants | 2851 | 2870 |
| Number [participants] |
181
2.1%
|
182
2.1%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Telmisartan/Ramipril (ONTARGET), Telmisartan (ONTARGET) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.9563 |
| Comments | ||
| Method | Regression, Cox | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 1.01 | |
| Confidence Interval |
() 95% 0.82 to 1.24 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | TRANSCEND. Cognitive Decline |
|---|---|
| Description | Telmisartan Randomized Assessment Study in Angiotension Converting Enzyme inhibitor intolerant subjects with cardiovascular disease (TRANSCEND). Time to first event analysis of the endpoint cognitive decline i.e. Comparison of the Mini mental state Evaluation (MMSE) of patients at baseline with that at the 2years and end of trial. A decrease in MMSE from baseline represents a cognitive decline. This outcome measure is only available for those patients who had MMSE at baseline. |
| Time Frame | 56 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Only patients of the TRANSCEND trial treated with Telmisartan 80mg or telmisartan 80mg placebo daily for 56 months with Mini mental state evaluation (MMSE) at baseline. |
| Arm/Group Title | Telmisartan (TRANSCEND) | Placebo (TRANSCEND) |
|---|---|---|
| Arm/Group Description | Telmisartan 80mg tablet, one tablet administered once daily in the morning. | Telmisartan 80mg placebo tablet, one tablet administered once daily in the morning. |
| Measure Participants | 2642 | 2589 |
| Number [participants] |
230
2.7%
|
192
2.2%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Telmisartan/Ramipril (ONTARGET), Telmisartan (ONTARGET) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0868 |
| Comments | ||
| Method | Chi-squared | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Risk Ratio (RR) |
| Estimated Value | 1.17 | |
| Confidence Interval |
() 95% 0.98 to 1.41 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | TRANSCEND. Newly Diagnosed Diabetes |
|---|---|
| Description | Telmisartan Randomized Assessment Study in Angiotension Converting Enzyme inhibitor intolerant subjects with cardiovascular disease (TRANSCEND). Time to the first event analysis of the endpoint Newly diagnosed Diabetes. Only calculated for those patients without diabetes at baseline. |
| Time Frame | 56 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Only for patients of TRANSCEND trial treated with Telmisartan 80mg or Telmisartan 80mg placebo daily for 56 months without diabetes at baseline. |
| Arm/Group Title | Telmisartan (TRANSCEND) | Placebo (TRANSCEND) |
|---|---|---|
| Arm/Group Description | Telmisartan 80mg tablet, one tablet administered once daily in the morning. | Telmisartan 80mg placebo tablet, one tablet administered once daily in the morning. |
| Measure Participants | 1710 | 1751 |
| Number [participants] |
124
1.5%
|
165
1.9%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Telmisartan/Ramipril (ONTARGET), Telmisartan (ONTARGET) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0172 |
| Comments | ||
| Method | Regression, Cox | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.75 | |
| Confidence Interval |
() 95% 0.60 to 0.95 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | TRANSCEND. Cardiovascular Revascularization Procedure |
|---|---|
| Description | Telmisartan Randomized Assessment Study in Angiotension Converting Enzyme inhibitor intolerant subjects with cardiovascular disease (TRANSCEND). |
| Time Frame | 56 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS of the TRANSCEND trial |
| Arm/Group Title | Telmisartan (TRANSCEND) | Placebo (TRANSCEND) |
|---|---|---|
| Arm/Group Description | Telmisartan 80mg tablet, one tablet administered once daily in the morning. | Telmisartan 80mg placebo tablet, one tablet administered once daily in the morning. |
| Measure Participants | 2954 | 2972 |
| Number [participants] |
351
4.1%
|
390
4.6%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Telmisartan/Ramipril (ONTARGET), Telmisartan (ONTARGET) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1431 |
| Comments | ||
| Method | Regression, Cox | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.90 | |
| Confidence Interval |
() 95% 0.78 to 1.04 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | TRANSCEND. Newly Diagnosed Congestive Heart Failure |
|---|---|
| Description | Telmisartan Randomized Assessment Study in Angiotension Converting Enzyme inhibitor intolerant subjects with cardiovascular disease (TRANSCEND). |
| Time Frame | 56 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS of the TRANSCEND trial |
| Arm/Group Title | Telmisartan (TRANSCEND) | Placebo (TRANSCEND) |
|---|---|---|
| Arm/Group Description | Telmisartan 80mg tablet, one tablet administered once daily in the morning. | Telmisartan 80mg placebo tablet, one tablet administered once daily in the morning. |
| Measure Participants | 2949 | 2965 |
| Number [participants] |
187
2.2%
|
191
2.2%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Telmisartan/Ramipril (ONTARGET), Telmisartan (ONTARGET) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.8974 |
| Comments | ||
| Method | Regression, Cox | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.99 | |
| Confidence Interval |
() 95% 0.81 to 1.21 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Adverse Events
| Time Frame | Up to 6 Years | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | In the ONTARGET part, the time frame is up to 5.5 years and in the TRANSCEND part up to 6 years | |||||||||
| Arm/Group Title | Telmisartan/Ramipril (ONTARGET) | Telmisartan (ONTARGET) | Ramipril (ONTARGET) | Telmisartan (TRANSCEND) | Placebo (TRANSCEND) | |||||
| Arm/Group Description | Telmisartan 80mg tablet / Ramipril 10mg tablet. One tablet of each administered once daily in the morning. | Telmisartan 80mg tablet /Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning. | Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning. | Telmisartan 80mg tablet, one tablet administered once daily in the morning. | Telmisartan 80mg placebo tablet, one tablet administered once daily in the morning. | |||||
All Cause Mortality |
||||||||||
| Telmisartan/Ramipril (ONTARGET) | Telmisartan (ONTARGET) | Ramipril (ONTARGET) | Telmisartan (TRANSCEND) | Placebo (TRANSCEND) | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | |||||
Serious Adverse Events |
||||||||||
| Telmisartan/Ramipril (ONTARGET) | Telmisartan (ONTARGET) | Ramipril (ONTARGET) | Telmisartan (TRANSCEND) | Placebo (TRANSCEND) | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 5268/8502 (62%) | 5506/8542 (64.5%) | 5375/8576 (62.7%) | 1781/2954 (60.3%) | 1830/2972 (61.6%) | |||||
| Blood and lymphatic system disorders | ||||||||||
| Agranulocytosis | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Anaemia | 125/8502 (1.5%) | 156/8542 (1.8%) | 131/8576 (1.5%) | 43/2954 (1.5%) | 36/2972 (1.2%) | |||||
| Anaemia haemolytic autoimmune | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Anaemia macrocytic | 2/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Anaemia of chronic disease | 3/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Anaemia vitamin B12 deficiency | 2/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Aplastic anaemia | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Autoimmune thrombocytopenia | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Coagulopathy | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Disseminated intravascular coagulation | 1/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Febrile bone marrow aplasia | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Febrile neutropenia | 4/8502 (0%) | 1/8542 (0%) | 2/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Haemolysis | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Haemolytic anaemia | 0/8502 (0%) | 0/8542 (0%) | 2/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Haemorrhagic anaemia | 1/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Haemorrhagic diathesis | 3/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Haemorrhagic disorder | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Hyperglobulinaemia | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Hypersplenism | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Hypochromic anaemia | 2/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Idiopathic thrombocytopenic purpura | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Iron deficiency anaemia | 2/8502 (0%) | 6/8542 (0.1%) | 8/8576 (0.1%) | 2/2954 (0.1%) | 2/2972 (0.1%) | |||||
| Leukocytosis | 2/8502 (0%) | 1/8542 (0%) | 4/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Leukopenia | 3/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Lymphadenopathy | 3/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Lymphadenopathy mediastinal | 2/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Microcytic anaemia | 2/8502 (0%) | 3/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Nephrogenic anaemia | 0/8502 (0%) | 2/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Neutropenia | 3/8502 (0%) | 0/8542 (0%) | 3/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Normochromic normocytic anaemia | 4/8502 (0%) | 3/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Pancytopenia | 8/8502 (0.1%) | 1/8542 (0%) | 2/8576 (0%) | 1/2954 (0%) | 1/2972 (0%) | |||||
| Pernicious anaemia | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Polycythaemia | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Red blood cell abnormality | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Spleen disorder | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Splenic vein thrombosis | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Thrombocytopenia | 7/8502 (0.1%) | 4/8542 (0%) | 3/8576 (0%) | 3/2954 (0.1%) | 1/2972 (0%) | |||||
| Thrombocytopenic purpura | 0/8502 (0%) | 0/8542 (0%) | 3/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Cardiac disorders | ||||||||||
| AV dissociation | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Acute coronary syndrome | 6/8502 (0.1%) | 11/8542 (0.1%) | 7/8576 (0.1%) | 1/2954 (0%) | 3/2972 (0.1%) | |||||
| Acute left ventricular failure | 0/8502 (0%) | 4/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Acute myocardial infarction | 2/8502 (0%) | 1/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Adams-Stokes syndrome | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Angina pectoris | 1206/8502 (14.2%) | 1296/8542 (15.2%) | 1244/8576 (14.5%) | 418/2954 (14.2%) | 455/2972 (15.3%) | |||||
| Angina unstable | 7/8502 (0.1%) | 15/8542 (0.2%) | 12/8576 (0.1%) | 0/2954 (0%) | 5/2972 (0.2%) | |||||
| Aortic valve disease | 0/8502 (0%) | 0/8542 (0%) | 2/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Aortic valve incompetence | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Aortic valve stenosis | 0/8502 (0%) | 2/8542 (0%) | 5/8576 (0.1%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Arrhythmia | 1/8502 (0%) | 3/8542 (0%) | 7/8576 (0.1%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Arrhythmia supraventricular | 38/8502 (0.4%) | 41/8542 (0.5%) | 41/8576 (0.5%) | 19/2954 (0.6%) | 15/2972 (0.5%) | |||||
| Arteriosclerosis coronary artery | 2/8502 (0%) | 2/8542 (0%) | 2/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Arteriospasm coronary | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Atrial fibrillation | 449/8502 (5.3%) | 499/8542 (5.8%) | 509/8576 (5.9%) | 146/2954 (4.9%) | 149/2972 (5%) | |||||
| Atrial flutter | 2/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Atrial thrombosis | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Atrioventricular block | 6/8502 (0.1%) | 4/8542 (0%) | 7/8576 (0.1%) | 3/2954 (0.1%) | 2/2972 (0.1%) | |||||
| Atrioventricular block complete | 18/8502 (0.2%) | 18/8542 (0.2%) | 11/8576 (0.1%) | 3/2954 (0.1%) | 2/2972 (0.1%) | |||||
| Atrioventricular block first degree | 3/8502 (0%) | 0/8542 (0%) | 2/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Atrioventricular block second degree | 4/8502 (0%) | 6/8542 (0.1%) | 4/8576 (0%) | 1/2954 (0%) | 2/2972 (0.1%) | |||||
| Bifascicular block | 0/8502 (0%) | 1/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Bradyarrhythmia | 5/8502 (0.1%) | 2/8542 (0%) | 2/8576 (0%) | 2/2954 (0.1%) | 1/2972 (0%) | |||||
| Bradycardia | 30/8502 (0.4%) | 30/8542 (0.4%) | 32/8576 (0.4%) | 8/2954 (0.3%) | 10/2972 (0.3%) | |||||
| Bundle branch block bilateral | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Bundle branch block left | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Bundle branch block right | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Cardiac aneurysm | 2/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Cardiac arrest | 35/8502 (0.4%) | 37/8542 (0.4%) | 37/8576 (0.4%) | 12/2954 (0.4%) | 9/2972 (0.3%) | |||||
| Cardiac disorder | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Cardiac failure | 11/8502 (0.1%) | 6/8542 (0.1%) | 7/8576 (0.1%) | 2/2954 (0.1%) | 5/2972 (0.2%) | |||||
| Cardiac failure acute | 47/8502 (0.6%) | 27/8542 (0.3%) | 52/8576 (0.6%) | 26/2954 (0.9%) | 15/2972 (0.5%) | |||||
| Cardiac failure chronic | 0/8502 (0%) | 2/8542 (0%) | 1/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Cardiac failure congestive | 400/8502 (4.7%) | 484/8542 (5.7%) | 465/8576 (5.4%) | 174/2954 (5.9%) | 172/2972 (5.8%) | |||||
| Cardiac pseudoaneurysm | 0/8502 (0%) | 2/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Cardiac tamponade | 0/8502 (0%) | 4/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Cardiac valve disease | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Cardiac valve sclerosis | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Cardio-respiratory arrest | 8/8502 (0.1%) | 7/8542 (0.1%) | 2/8576 (0%) | 1/2954 (0%) | 3/2972 (0.1%) | |||||
| Cardiogenic shock | 7/8502 (0.1%) | 6/8542 (0.1%) | 9/8576 (0.1%) | 2/2954 (0.1%) | 0/2972 (0%) | |||||
| Cardiomegaly | 0/8502 (0%) | 1/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Cardiomyopathy | 1/8502 (0%) | 1/8542 (0%) | 1/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Cardiopulmonary failure | 1/8502 (0%) | 2/8542 (0%) | 2/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Cardiovascular disorder | 2/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Congestive cardiomyopathy | 1/8502 (0%) | 1/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Cor pulmonale | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Coronary artery dilatation | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Coronary artery disease | 12/8502 (0.1%) | 15/8542 (0.2%) | 9/8576 (0.1%) | 5/2954 (0.2%) | 2/2972 (0.1%) | |||||
| Coronary artery occlusion | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Diabetic cardiomyopathy | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Electromechanical dissociation | 0/8502 (0%) | 1/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Extrasystoles | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Heart valve incompetence | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Hypertensive heart disease | 0/8502 (0%) | 3/8542 (0%) | 2/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Intracardiac thrombus | 0/8502 (0%) | 1/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Ischaemic cardiomyopathy | 2/8502 (0%) | 0/8542 (0%) | 2/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Left ventricular dysfunction | 2/8502 (0%) | 4/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 2/2972 (0.1%) | |||||
| Left ventricular failure | 0/8502 (0%) | 1/8542 (0%) | 3/8576 (0%) | 0/2954 (0%) | 3/2972 (0.1%) | |||||
| Low cardiac output syndrome | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Mitral valve incompetence | 3/8502 (0%) | 1/8542 (0%) | 2/8576 (0%) | 0/2954 (0%) | 2/2972 (0.1%) | |||||
| Myocardial infarction | 456/8502 (5.4%) | 480/8542 (5.6%) | 457/8576 (5.3%) | 138/2954 (4.7%) | 161/2972 (5.4%) | |||||
| Myocardial ischaemia | 11/8502 (0.1%) | 9/8542 (0.1%) | 11/8576 (0.1%) | 4/2954 (0.1%) | 4/2972 (0.1%) | |||||
| Myocarditis | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Nodal arrhythmia | 0/8502 (0%) | 3/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Nodal rhythm | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Pacemaker generated arrhythmia | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Palpitations | 7/8502 (0.1%) | 13/8542 (0.2%) | 5/8576 (0.1%) | 2/2954 (0.1%) | 1/2972 (0%) | |||||
| Pericardial effusion | 1/8502 (0%) | 2/8542 (0%) | 3/8576 (0%) | 1/2954 (0%) | 1/2972 (0%) | |||||
| Pericardial haemorrhage | 0/8502 (0%) | 1/8542 (0%) | 2/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Pericarditis | 0/8502 (0%) | 4/8542 (0%) | 4/8576 (0%) | 3/2954 (0.1%) | 1/2972 (0%) | |||||
| Prinzmetal angina | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Right ventricular failure | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Sick sinus syndrome | 11/8502 (0.1%) | 9/8542 (0.1%) | 12/8576 (0.1%) | 4/2954 (0.1%) | 1/2972 (0%) | |||||
| Sinus arrest | 1/8502 (0%) | 2/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Sinus arrhythmia | 0/8502 (0%) | 1/8542 (0%) | 2/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Sinus bradycardia | 6/8502 (0.1%) | 6/8542 (0.1%) | 5/8576 (0.1%) | 5/2954 (0.2%) | 0/2972 (0%) | |||||
| Sinus tachycardia | 0/8502 (0%) | 1/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Supraventricular extrasystoles | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Supraventricular tachycardia | 1/8502 (0%) | 2/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Tachyarrhythmia | 0/8502 (0%) | 1/8542 (0%) | 2/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Tachycardia | 6/8502 (0.1%) | 1/8542 (0%) | 3/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Trifascicular block | 1/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Ventricular arrhythmia | 62/8502 (0.7%) | 75/8542 (0.9%) | 64/8576 (0.7%) | 18/2954 (0.6%) | 24/2972 (0.8%) | |||||
| Ventricular dysfunction | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Ventricular extrasystoles | 1/8502 (0%) | 1/8542 (0%) | 1/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Ventricular fibrillation | 3/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Ventricular remodeling | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Ventricular tachyarrhythmia | 19/8502 (0.2%) | 19/8542 (0.2%) | 15/8576 (0.2%) | 6/2954 (0.2%) | 1/2972 (0%) | |||||
| Ventricular tachycardia | 7/8502 (0.1%) | 5/8542 (0.1%) | 2/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Wandering pacemaker | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Wolff-Parkinson-White syndrome | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Congenital, familial and genetic disorders | ||||||||||
| Alagille syndrome | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Arteriovenous malformation | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Atrial septal defect | 2/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Congenital cystic kidney disease | 3/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Dolichocolon | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Fragile X syndrome | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Gastrointestinal angiodysplasia | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Gastrointestinal angiodysplasia haemorrhagic | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Gastrointestinal malformation | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Hydrocele | 3/8502 (0%) | 5/8542 (0.1%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Kidney malformation | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Limb reduction defect | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Meningomyelocele | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Neural tube defect | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Oculopharyngeal dystrophy | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Osteogenesis imperfecta | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Phimosis | 0/8502 (0%) | 3/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Pyloric stenosis | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Sickle cell anaemia | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Spondylolisthesis | 0/8502 (0%) | 0/8542 (0%) | 3/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Transposition of the great vessels | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Turner's syndrome | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Ventricular septal defect | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Ear and labyrinth disorders | ||||||||||
| Acute vestibular syndrome | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 2/2954 (0.1%) | 0/2972 (0%) | |||||
| Deafness | 0/8502 (0%) | 1/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Deafness neurosensory | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Ear disorder | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Ear pain | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Hearing impaired | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Meniere's disease | 0/8502 (0%) | 1/8542 (0%) | 2/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Middle ear disorder | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Middle ear inflammation | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Otorrhoea | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Sudden hearing loss | 1/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Tinnitus | 1/8502 (0%) | 1/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Vertigo | 28/8502 (0.3%) | 18/8542 (0.2%) | 30/8576 (0.3%) | 13/2954 (0.4%) | 18/2972 (0.6%) | |||||
| Vertigo labyrinthine | 0/8502 (0%) | 1/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Vertigo positional | 2/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 2/2954 (0.1%) | 1/2972 (0%) | |||||
| Vestibular ataxia | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Vestibular disorder | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Vestibular neuronitis | 3/8502 (0%) | 3/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Endocrine disorders | ||||||||||
| Addison's disease | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Adrenal insufficiency | 3/8502 (0%) | 1/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Adrenal mass | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Adrenocortical insufficiency acute | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Antidiuretic hormone abnormality | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Endocrine disorder | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Goitre | 2/8502 (0%) | 1/8542 (0%) | 4/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Hyperthyroidism | 6/8502 (0.1%) | 5/8542 (0.1%) | 9/8576 (0.1%) | 1/2954 (0%) | 1/2972 (0%) | |||||
| Hypopituitarism | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Hypothyroidism | 4/8502 (0%) | 7/8542 (0.1%) | 4/8576 (0%) | 2/2954 (0.1%) | 0/2972 (0%) | |||||
| Secondary adrenocortical insufficiency | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Thyroid cyst | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Thyroid mass | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Thyroiditis | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Eye disorders | ||||||||||
| Amaurosis fugax | 0/8502 (0%) | 1/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Blindness | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Cataract | 12/8502 (0.1%) | 10/8542 (0.1%) | 15/8576 (0.2%) | 4/2954 (0.1%) | 1/2972 (0%) | |||||
| Cataract diabetic | 0/8502 (0%) | 0/8542 (0%) | 2/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Choroidal haemorrhage | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Corneal infiltrates | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Diabetic retinal oedema | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Diabetic retinopathy | 3/8502 (0%) | 3/8542 (0%) | 5/8576 (0.1%) | 2/2954 (0.1%) | 3/2972 (0.1%) | |||||
| Diplopia | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Endocrine ophthalmopathy | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Extraocular muscle paresis | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Eye degenerative disorder | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Eye disorder | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Eye haemorrhage | 3/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Eyelid ptosis | 0/8502 (0%) | 1/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Glaucoma | 3/8502 (0%) | 12/8542 (0.1%) | 6/8576 (0.1%) | 3/2954 (0.1%) | 2/2972 (0.1%) | |||||
| Lacrimation increased | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Macular degeneration | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Maculopathy | 1/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Miosis | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Open angle glaucoma | 0/8502 (0%) | 1/8542 (0%) | 2/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Optic ischaemic neuropathy | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Optic neuropathy | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Pseudophakia | 0/8502 (0%) | 0/8542 (0%) | 2/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Pterygium | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Retinal artery embolism | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Retinal artery occlusion | 0/8502 (0%) | 1/8542 (0%) | 2/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Retinal artery thrombosis | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Retinal degeneration | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Retinal detachment | 6/8502 (0.1%) | 8/8542 (0.1%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Retinal disorder | 1/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Retinal infarction | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Retinal ischaemia | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Retinal neovascularisation | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Retinal vascular disorder | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Retinal vascular thrombosis | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Retinal vein occlusion | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Retinal vein thrombosis | 1/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Retinopathy | 4/8502 (0%) | 6/8542 (0.1%) | 4/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Retinopathy hypertensive | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Retinopathy proliferative | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Swollen tear duct | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Ulcerative keratitis | 0/8502 (0%) | 1/8542 (0%) | 1/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Vision blurred | 1/8502 (0%) | 1/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Visual disturbance | 2/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Vitreous detachment | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Vitreous haemorrhage | 1/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Vitreous opacities | 0/8502 (0%) | 0/8542 (0%) | 2/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Gastrointestinal disorders | ||||||||||
| Abdominal adhesions | 2/8502 (0%) | 1/8542 (0%) | 2/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Abdominal discomfort | 1/8502 (0%) | 1/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Abdominal hernia | 3/8502 (0%) | 4/8542 (0%) | 5/8576 (0.1%) | 1/2954 (0%) | 2/2972 (0.1%) | |||||
| Abdominal mass | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Abdominal pain | 43/8502 (0.5%) | 23/8542 (0.3%) | 39/8576 (0.5%) | 4/2954 (0.1%) | 10/2972 (0.3%) | |||||
| Abdominal pain lower | 2/8502 (0%) | 3/8542 (0%) | 1/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Abdominal pain upper | 17/8502 (0.2%) | 22/8542 (0.3%) | 15/8576 (0.2%) | 8/2954 (0.3%) | 2/2972 (0.1%) | |||||
| Acute abdomen | 2/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Alcoholic pancreatitis | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Anal dilatation | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Anal fissure | 3/8502 (0%) | 2/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Anal fistula | 2/8502 (0%) | 2/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Anal haemorrhage | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Anal polyp | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Anal ulcer | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Aphthous stomatitis | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Appendicitis perforated | 2/8502 (0%) | 3/8542 (0%) | 2/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Ascites | 3/8502 (0%) | 3/8542 (0%) | 3/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Barrett's oesophagus | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Change of bowel habit | 0/8502 (0%) | 1/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Cheilitis | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Chronic gastrointestinal bleeding | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Coeliac disease | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Colitis | 8/8502 (0.1%) | 6/8542 (0.1%) | 7/8576 (0.1%) | 1/2954 (0%) | 1/2972 (0%) | |||||
| Colitis ischaemic | 4/8502 (0%) | 2/8542 (0%) | 12/8576 (0.1%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Colitis ulcerative | 3/8502 (0%) | 2/8542 (0%) | 0/8576 (0%) | 2/2954 (0.1%) | 0/2972 (0%) | |||||
| Colonic obstruction | 0/8502 (0%) | 0/8542 (0%) | 2/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Colonic polyp | 4/8502 (0%) | 6/8542 (0.1%) | 5/8576 (0.1%) | 2/2954 (0.1%) | 3/2972 (0.1%) | |||||
| Colonic pseudo-obstruction | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Colonic stenosis | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Constipation | 15/8502 (0.2%) | 10/8542 (0.1%) | 19/8576 (0.2%) | 2/2954 (0.1%) | 6/2972 (0.2%) | |||||
| Crohn's disease | 1/8502 (0%) | 1/8542 (0%) | 2/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Diabetic gastropathy | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Diarrhoea | 45/8502 (0.5%) | 39/8542 (0.5%) | 32/8576 (0.4%) | 12/2954 (0.4%) | 3/2972 (0.1%) | |||||
| Diarrhoea haemorrhagic | 2/8502 (0%) | 1/8542 (0%) | 2/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Diverticular perforation | 1/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Diverticulitis intestinal haemorrhagic | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Diverticulum | 4/8502 (0%) | 7/8542 (0.1%) | 7/8576 (0.1%) | 5/2954 (0.2%) | 2/2972 (0.1%) | |||||
| Diverticulum intestinal | 2/8502 (0%) | 3/8542 (0%) | 4/8576 (0%) | 5/2954 (0.2%) | 3/2972 (0.1%) | |||||
| Diverticulum intestinal haemorrhagic | 1/8502 (0%) | 2/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Diverticulum oesophageal | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Duodenal fistula | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Duodenal obstruction | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Duodenal perforation | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Duodenal ulcer | 15/8502 (0.2%) | 13/8542 (0.2%) | 11/8576 (0.1%) | 5/2954 (0.2%) | 3/2972 (0.1%) | |||||
| Duodenal ulcer haemorrhage | 6/8502 (0.1%) | 4/8542 (0%) | 3/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Duodenal ulcer perforation | 1/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Duodenitis | 0/8502 (0%) | 8/8542 (0.1%) | 1/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Duodenogastric reflux | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Dyspepsia | 7/8502 (0.1%) | 8/8542 (0.1%) | 5/8576 (0.1%) | 5/2954 (0.2%) | 1/2972 (0%) | |||||
| Dysphagia | 7/8502 (0.1%) | 5/8542 (0.1%) | 9/8576 (0.1%) | 1/2954 (0%) | 1/2972 (0%) | |||||
| Enteritis | 2/8502 (0%) | 2/8542 (0%) | 3/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Enterocele | 0/8502 (0%) | 2/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Enterocolitis | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Enterocolitis haemorrhagic | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Enterocolonic fistula | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Enterocutaneous fistula | 2/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Enterovesical fistula | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Epigastric discomfort | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Erosive oesophagitis | 2/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Faecaloma | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Femoral hernia | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Food poisoning | 4/8502 (0%) | 2/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Gastric antral vascular ectasia | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Gastric disorder | 1/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 1/2954 (0%) | 1/2972 (0%) | |||||
| Gastric haemorrhage | 5/8502 (0.1%) | 8/8542 (0.1%) | 5/8576 (0.1%) | 2/2954 (0.1%) | 3/2972 (0.1%) | |||||
| Gastric hypermotility | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Gastric perforation | 2/8502 (0%) | 1/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Gastric polyps | 0/8502 (0%) | 2/8542 (0%) | 2/8576 (0%) | 2/2954 (0.1%) | 1/2972 (0%) | |||||
| Gastric ulcer | 24/8502 (0.3%) | 26/8542 (0.3%) | 23/8576 (0.3%) | 6/2954 (0.2%) | 5/2972 (0.2%) | |||||
| Gastric ulcer haemorrhage | 5/8502 (0.1%) | 10/8542 (0.1%) | 8/8576 (0.1%) | 7/2954 (0.2%) | 3/2972 (0.1%) | |||||
| Gastric ulcer perforation | 1/8502 (0%) | 0/8542 (0%) | 2/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Gastritis | 25/8502 (0.3%) | 31/8542 (0.4%) | 28/8576 (0.3%) | 7/2954 (0.2%) | 15/2972 (0.5%) | |||||
| Gastritis erosive | 4/8502 (0%) | 6/8542 (0.1%) | 2/8576 (0%) | 3/2954 (0.1%) | 1/2972 (0%) | |||||
| Gastritis haemorrhagic | 1/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Gastroduodenitis | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 2/2954 (0.1%) | 1/2972 (0%) | |||||
| Gastrointestinal disorder | 0/8502 (0%) | 1/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Gastrointestinal fistula | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Gastrointestinal haemorrhage | 56/8502 (0.7%) | 59/8542 (0.7%) | 50/8576 (0.6%) | 19/2954 (0.6%) | 11/2972 (0.4%) | |||||
| Gastrointestinal inflammation | 0/8502 (0%) | 4/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Gastrointestinal ischaemia | 1/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Gastrointestinal mucosal disorder | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Gastrointestinal necrosis | 0/8502 (0%) | 2/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Gastrointestinal obstruction | 4/8502 (0%) | 3/8542 (0%) | 3/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Gastrointestinal oedema | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Gastrointestinal pain | 0/8502 (0%) | 3/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Gastrointestinal perforation | 1/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Gastrointestinal stenosis | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Gastrointestinal ulcer | 1/8502 (0%) | 3/8542 (0%) | 3/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Gastrointestinal ulcer haemorrhage | 2/8502 (0%) | 3/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Gastrooesophageal reflux disease | 18/8502 (0.2%) | 9/8542 (0.1%) | 10/8576 (0.1%) | 4/2954 (0.1%) | 2/2972 (0.1%) | |||||
| Gastroptosis | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Gingivitis | 3/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Haematemesis | 8/8502 (0.1%) | 8/8542 (0.1%) | 8/8576 (0.1%) | 2/2954 (0.1%) | 2/2972 (0.1%) | |||||
| Haematochezia | 3/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Haemorrhoidal haemorrhage | 1/8502 (0%) | 1/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 2/2972 (0.1%) | |||||
| Haemorrhoids | 7/8502 (0.1%) | 9/8542 (0.1%) | 5/8576 (0.1%) | 7/2954 (0.2%) | 6/2972 (0.2%) | |||||
| Hiatus hernia | 8/8502 (0.1%) | 6/8542 (0.1%) | 3/8576 (0%) | 3/2954 (0.1%) | 3/2972 (0.1%) | |||||
| Hiatus hernia, obstructive | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Ileus | 4/8502 (0%) | 7/8542 (0.1%) | 4/8576 (0%) | 2/2954 (0.1%) | 7/2972 (0.2%) | |||||
| Ileus paralytic | 2/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Impaired gastric emptying | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Inflammatory bowel disease | 1/8502 (0%) | 2/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 1/2972 (0%) | |||||
| Inguinal hernia | 21/8502 (0.2%) | 34/8542 (0.4%) | 26/8576 (0.3%) | 2/2954 (0.1%) | 9/2972 (0.3%) | |||||
| Inguinal hernia, obstructive | 1/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Intestinal angina | 1/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Intestinal functional disorder | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Intestinal haemorrhage | 1/8502 (0%) | 2/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Intestinal infarction | 0/8502 (0%) | 1/8542 (0%) | 2/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Intestinal ischaemia | 2/8502 (0%) | 3/8542 (0%) | 3/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Intestinal obstruction | 13/8502 (0.2%) | 14/8542 (0.2%) | 11/8576 (0.1%) | 3/2954 (0.1%) | 3/2972 (0.1%) | |||||
| Intestinal perforation | 1/8502 (0%) | 3/8542 (0%) | 2/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Intra-abdominal haematoma | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Irritable bowel syndrome | 2/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 1/2954 (0%) | 1/2972 (0%) | |||||
| Jejunitis | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Large intestinal haemorrhage | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Large intestinal obstruction | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 1/2972 (0%) | |||||
| Large intestinal ulcer | 1/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Large intestine perforation | 3/8502 (0%) | 2/8542 (0%) | 2/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Lip oedema | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Lower gastrointestinal haemorrhage | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Lumbar hernia | 0/8502 (0%) | 2/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Mallory-Weiss syndrome | 2/8502 (0%) | 3/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Melaena | 8/8502 (0.1%) | 4/8542 (0%) | 11/8576 (0.1%) | 2/2954 (0.1%) | 2/2972 (0.1%) | |||||
| Mesenteric artery embolism | 2/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Mesenteric artery stenosis | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Mesenteric artery thrombosis | 1/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Mesenteric occlusion | 1/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Mesenteric vein thrombosis | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Mouth cyst | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Mouth haemorrhage | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Nausea | 19/8502 (0.2%) | 24/8542 (0.3%) | 20/8576 (0.2%) | 6/2954 (0.2%) | 7/2972 (0.2%) | |||||
| Necrotising colitis | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Obstruction gastric | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Odynophagia | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Oesophageal achalasia | 1/8502 (0%) | 1/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Oesophageal dilatation | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Oesophageal disorder | 0/8502 (0%) | 3/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Oesophageal dysplasia | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Oesophageal haemorrhage | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Oesophageal obstruction | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Oesophageal perforation | 1/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Oesophageal polyp | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Oesophageal rupture | 3/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Oesophageal stenosis | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Oesophageal ulcer | 1/8502 (0%) | 2/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Oesophageal ulcer haemorrhage | 2/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Oesophageal varices haemorrhage | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Oesophagitis | 5/8502 (0.1%) | 16/8542 (0.2%) | 6/8576 (0.1%) | 3/2954 (0.1%) | 1/2972 (0%) | |||||
| Oesophagitis haemorrhagic | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Oesophagitis ulcerative | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Pancreatic mass | 3/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Pancreatitis | 17/8502 (0.2%) | 20/8542 (0.2%) | 13/8576 (0.2%) | 3/2954 (0.1%) | 2/2972 (0.1%) | |||||
| Pancreatitis acute | 8/8502 (0.1%) | 11/8542 (0.1%) | 7/8576 (0.1%) | 4/2954 (0.1%) | 5/2972 (0.2%) | |||||
| Pancreatitis chronic | 2/8502 (0%) | 3/8542 (0%) | 5/8576 (0.1%) | 2/2954 (0.1%) | 4/2972 (0.1%) | |||||
| Pancreatitis necrotising | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Pancreatolithiasis | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Paraesthesia oral | 1/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Peptic ulcer | 9/8502 (0.1%) | 5/8542 (0.1%) | 10/8576 (0.1%) | 3/2954 (0.1%) | 4/2972 (0.1%) | |||||
| Peptic ulcer haemorrhage | 2/8502 (0%) | 3/8542 (0%) | 2/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Peptic ulcer perforation | 1/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Periproctitis | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Peritoneal adhesions | 1/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Peritoneal effusion | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Peritoneal haemorrhage | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Peritonitis | 4/8502 (0%) | 2/8542 (0%) | 5/8576 (0.1%) | 2/2954 (0.1%) | 2/2972 (0.1%) | |||||
| Pharyngoesophageal diverticulum | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Proctitis | 1/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Proctocolitis | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Rectal haemorrhage | 19/8502 (0.2%) | 10/8542 (0.1%) | 9/8576 (0.1%) | 3/2954 (0.1%) | 8/2972 (0.3%) | |||||
| Rectal obstruction | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Rectal polyp | 1/8502 (0%) | 1/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Rectal prolapse | 1/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Reflux gastritis | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Reflux oesophagitis | 3/8502 (0%) | 2/8542 (0%) | 2/8576 (0%) | 1/2954 (0%) | 4/2972 (0.1%) | |||||
| Retroperitoneal haematoma | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Retroperitoneal haemorrhage | 2/8502 (0%) | 1/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Salivary gland calculus | 0/8502 (0%) | 1/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Salivary gland enlargement | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Salivary hypersecretion | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Small intestinal haemorrhage | 1/8502 (0%) | 1/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Small intestinal obstruction | 11/8502 (0.1%) | 12/8542 (0.1%) | 5/8576 (0.1%) | 0/2954 (0%) | 3/2972 (0.1%) | |||||
| Small intestinal stenosis | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Small intestinal ulcer haemorrhage | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Stomatitis | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Subileus | 4/8502 (0%) | 1/8542 (0%) | 2/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Swollen tongue | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Toothache | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Umbilical hernia | 2/8502 (0%) | 4/8542 (0%) | 7/8576 (0.1%) | 2/2954 (0.1%) | 1/2972 (0%) | |||||
| Upper gastrointestinal haemorrhage | 16/8502 (0.2%) | 19/8542 (0.2%) | 16/8576 (0.2%) | 8/2954 (0.3%) | 6/2972 (0.2%) | |||||
| Uraemic gastropathy | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Varices oesophageal | 1/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Volvulus | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Vomiting | 27/8502 (0.3%) | 28/8542 (0.3%) | 29/8576 (0.3%) | 6/2954 (0.2%) | 6/2972 (0.2%) | |||||
| General disorders | ||||||||||
| Abasia | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Accidental death | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Adverse drug reaction | 2/8502 (0%) | 1/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Application site bleeding | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Asthenia | 17/8502 (0.2%) | 15/8542 (0.2%) | 20/8576 (0.2%) | 7/2954 (0.2%) | 4/2972 (0.1%) | |||||
| Cardiac death | 1/8502 (0%) | 2/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Chest discomfort | 7/8502 (0.1%) | 4/8542 (0%) | 11/8576 (0.1%) | 3/2954 (0.1%) | 3/2972 (0.1%) | |||||
| Chest pain | 117/8502 (1.4%) | 96/8542 (1.1%) | 103/8576 (1.2%) | 38/2954 (1.3%) | 26/2972 (0.9%) | |||||
| Chills | 2/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Chronic fatigue syndrome | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Death | 31/8502 (0.4%) | 32/8542 (0.4%) | 31/8576 (0.4%) | 11/2954 (0.4%) | 8/2972 (0.3%) | |||||
| Discomfort | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Drowning | 1/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 1/2972 (0%) | |||||
| Drug interaction | 0/8502 (0%) | 3/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Drug intolerance | 2/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Electrocution | 0/8502 (0%) | 0/8542 (0%) | 2/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Exercise tolerance decreased | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Face oedema | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Fatigue | 9/8502 (0.1%) | 3/8542 (0%) | 8/8576 (0.1%) | 1/2954 (0%) | 1/2972 (0%) | |||||
| Gait deviation | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Gait disturbance | 4/8502 (0%) | 2/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| General physical health deterioration | 6/8502 (0.1%) | 6/8542 (0.1%) | 1/8576 (0%) | 3/2954 (0.1%) | 1/2972 (0%) | |||||
| Generalised oedema | 1/8502 (0%) | 0/8542 (0%) | 2/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Granuloma | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Hernia | 4/8502 (0%) | 11/8542 (0.1%) | 4/8576 (0%) | 0/2954 (0%) | 2/2972 (0.1%) | |||||
| Hernia obstructive | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Hyperthermia | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Hypothermia | 2/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Impaired healing | 0/8502 (0%) | 2/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Implant site effusion | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Inflammation | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Ischaemic ulcer | 1/8502 (0%) | 1/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Loss of control of legs | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Malaise | 6/8502 (0.1%) | 9/8542 (0.1%) | 2/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Mass | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Microlithiasis | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Mucosal inflammation | 0/8502 (0%) | 3/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Multi-organ failure | 9/8502 (0.1%) | 8/8542 (0.1%) | 11/8576 (0.1%) | 3/2954 (0.1%) | 3/2972 (0.1%) | |||||
| Necrosis | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Non-cardiac chest pain | 29/8502 (0.3%) | 33/8542 (0.4%) | 29/8576 (0.3%) | 13/2954 (0.4%) | 12/2972 (0.4%) | |||||
| Oedema | 1/8502 (0%) | 2/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Oedema peripheral | 4/8502 (0%) | 9/8542 (0.1%) | 8/8576 (0.1%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Orthostatic intolerance | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Pain | 4/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 1/2972 (0%) | |||||
| Pre-existing disease | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Pyrexia | 30/8502 (0.4%) | 21/8542 (0.2%) | 23/8576 (0.3%) | 4/2954 (0.1%) | 2/2972 (0.1%) | |||||
| Secretion discharge | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Submandibular mass | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Sudden cardiac death | 134/8502 (1.6%) | 155/8542 (1.8%) | 141/8576 (1.6%) | 69/2954 (2.3%) | 68/2972 (2.3%) | |||||
| Sudden death | 11/8502 (0.1%) | 14/8542 (0.2%) | 12/8576 (0.1%) | 2/2954 (0.1%) | 3/2972 (0.1%) | |||||
| Systemic inflammatory response syndrome | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Ulcer | 1/8502 (0%) | 1/8542 (0%) | 3/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Ulcer haemorrhage | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Hepatobiliary disorders | ||||||||||
| Acute hepatic failure | 2/8502 (0%) | 3/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Alcoholic liver disease | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Autoimmune hepatitis | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Bile duct obstruction | 0/8502 (0%) | 1/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Bile duct stenosis | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 2/2972 (0.1%) | |||||
| Bile duct stone | 0/8502 (0%) | 2/8542 (0%) | 5/8576 (0.1%) | 1/2954 (0%) | 3/2972 (0.1%) | |||||
| Biliary colic | 2/8502 (0%) | 3/8542 (0%) | 3/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Biliary dilatation | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Biliary dyskinesia | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Biliary ischaemia | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Biliary tract disorder | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Cholangitis | 9/8502 (0.1%) | 2/8542 (0%) | 5/8576 (0.1%) | 3/2954 (0.1%) | 1/2972 (0%) | |||||
| Cholangitis acute | 2/8502 (0%) | 1/8542 (0%) | 2/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Cholecystitis | 20/8502 (0.2%) | 26/8542 (0.3%) | 41/8576 (0.5%) | 12/2954 (0.4%) | 9/2972 (0.3%) | |||||
| Cholecystitis acute | 11/8502 (0.1%) | 18/8542 (0.2%) | 12/8576 (0.1%) | 3/2954 (0.1%) | 5/2972 (0.2%) | |||||
| Cholecystitis chronic | 3/8502 (0%) | 3/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 2/2972 (0.1%) | |||||
| Cholelithiasis | 28/8502 (0.3%) | 32/8542 (0.4%) | 21/8576 (0.2%) | 13/2954 (0.4%) | 9/2972 (0.3%) | |||||
| Cholelithiasis obstructive | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Cholestasis | 1/8502 (0%) | 1/8542 (0%) | 4/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Chronic hepatitis | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Cirrhosis alcoholic | 1/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Gallbladder disorder | 3/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Gallbladder necrosis | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Gallbladder perforation | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Hepatic cirrhosis | 7/8502 (0.1%) | 6/8542 (0.1%) | 3/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Hepatic cyst | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Hepatic failure | 2/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 1/2972 (0%) | |||||
| Hepatic function abnormal | 1/8502 (0%) | 2/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Hepatic lesion | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Hepatic necrosis | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Hepatic vein thrombosis | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Hepatitis | 7/8502 (0.1%) | 3/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Hepatitis acute | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Hepatitis toxic | 0/8502 (0%) | 1/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Hepatocellular injury | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Hepatomegaly | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Hepatorenal syndrome | 1/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Hepatotoxicity | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Hydrocholecystis | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Hyperbilirubinaemia | 0/8502 (0%) | 1/8542 (0%) | 1/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Jaundice | 3/8502 (0%) | 5/8542 (0.1%) | 5/8576 (0.1%) | 2/2954 (0.1%) | 1/2972 (0%) | |||||
| Jaundice cholestatic | 2/8502 (0%) | 4/8542 (0%) | 1/8576 (0%) | 2/2954 (0.1%) | 1/2972 (0%) | |||||
| Liver disorder | 1/8502 (0%) | 2/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 3/2972 (0.1%) | |||||
| Portal hypertension | 1/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Portal vein phlebitis | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Portal vein thrombosis | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Post cholecystectomy syndrome | 0/8502 (0%) | 1/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Immune system disorders | ||||||||||
| Allergic oedema | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Allergy to arthropod sting | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Anaphylactic reaction | 1/8502 (0%) | 2/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Anaphylactic shock | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Anaphylactoid shock | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Drug hypersensitivity | 0/8502 (0%) | 0/8542 (0%) | 3/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Food allergy | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Hypersensitivity | 1/8502 (0%) | 2/8542 (0%) | 4/8576 (0%) | 1/2954 (0%) | 1/2972 (0%) | |||||
| Immunodeficiency | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Insulin autoimmune syndrome | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Pancreas transplant rejection | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Sarcoidosis | 1/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Infections and infestations | ||||||||||
| Abdominal abscess | 3/8502 (0%) | 2/8542 (0%) | 1/8576 (0%) | 1/2954 (0%) | 2/2972 (0.1%) | |||||
| Abdominal infection | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Abdominal sepsis | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Abscess | 1/8502 (0%) | 2/8542 (0%) | 2/8576 (0%) | 2/2954 (0.1%) | 0/2972 (0%) | |||||
| Abscess intestinal | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Abscess limb | 1/8502 (0%) | 1/8542 (0%) | 3/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Acquired immunodeficiency syndrome | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Acute sinusitis | 0/8502 (0%) | 1/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Adenoviral upper respiratory infection | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Anal abscess | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Anogenital warts | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Anorectal infection | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Appendiceal abscess | 2/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Appendicitis | 14/8502 (0.2%) | 8/8542 (0.1%) | 11/8576 (0.1%) | 4/2954 (0.1%) | 4/2972 (0.1%) | |||||
| Application site infection | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Arteriosclerotic gangrene | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Arthritis bacterial | 3/8502 (0%) | 1/8542 (0%) | 5/8576 (0.1%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Arthritis infective | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Aspergilloma | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Bacteraemia | 3/8502 (0%) | 3/8542 (0%) | 2/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Bacterial food poisoning | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Bacterial infection | 0/8502 (0%) | 1/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Bacterial sepsis | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Bacteriuria | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Biliary sepsis | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Biliary tract infection | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Bone tuberculosis | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Breast abscess | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Bronchiectasis | 2/8502 (0%) | 1/8542 (0%) | 2/8576 (0%) | 2/2954 (0.1%) | 0/2972 (0%) | |||||
| Bronchitis | 37/8502 (0.4%) | 30/8542 (0.4%) | 35/8576 (0.4%) | 16/2954 (0.5%) | 12/2972 (0.4%) | |||||
| Bronchitis viral | 1/8502 (0%) | 1/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Bronchopneumonia | 26/8502 (0.3%) | 25/8542 (0.3%) | 21/8576 (0.2%) | 6/2954 (0.2%) | 8/2972 (0.3%) | |||||
| Bursitis infective | 0/8502 (0%) | 0/8542 (0%) | 2/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Campylobacter intestinal infection | 1/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Candida sepsis | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Candidiasis | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Carbuncle | 1/8502 (0%) | 1/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Catheter related infection | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Cavernous sinus thrombosis | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Cellulitis | 26/8502 (0.3%) | 29/8542 (0.3%) | 39/8576 (0.5%) | 12/2954 (0.4%) | 14/2972 (0.5%) | |||||
| Cellulitis of male external genital organ | 1/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Cellulitis orbital | 1/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Central nervous system infection | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Cholecystitis infective | 4/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Chronic sinusitis | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Citrobacter infection | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Clostridial infection | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Clostridium difficile colitis | 3/8502 (0%) | 1/8542 (0%) | 4/8576 (0%) | 1/2954 (0%) | 2/2972 (0.1%) | |||||
| Creutzfeldt-Jakob disease | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Cystitis | 5/8502 (0.1%) | 7/8542 (0.1%) | 10/8576 (0.1%) | 5/2954 (0.2%) | 4/2972 (0.1%) | |||||
| Dengue fever | 1/8502 (0%) | 1/8542 (0%) | 1/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Device related infection | 0/8502 (0%) | 0/8542 (0%) | 2/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Diarrhoea infectious | 2/8502 (0%) | 2/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Diverticulitis | 18/8502 (0.2%) | 16/8542 (0.2%) | 22/8576 (0.3%) | 5/2954 (0.2%) | 6/2972 (0.2%) | |||||
| Ear infection | 5/8502 (0.1%) | 4/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Empyema | 3/8502 (0%) | 1/8542 (0%) | 5/8576 (0.1%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Encephalitis viral | 1/8502 (0%) | 2/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Endocarditis | 3/8502 (0%) | 0/8542 (0%) | 2/8576 (0%) | 2/2954 (0.1%) | 1/2972 (0%) | |||||
| Endocarditis bacterial | 0/8502 (0%) | 1/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Enteritis infectious | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Enterobacter pneumonia | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Enterococcal bacteraemia | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Enterococcal infection | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Enterocolitis infectious | 0/8502 (0%) | 2/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Epiglottitis | 1/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Erysipelas | 9/8502 (0.1%) | 13/8542 (0.2%) | 10/8576 (0.1%) | 3/2954 (0.1%) | 3/2972 (0.1%) | |||||
| Escherichia bacteraemia | 1/8502 (0%) | 2/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Escherichia sepsis | 1/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Escherichia urinary tract infection | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| External ear cellulitis | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Extradural abscess | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Eye infection | 1/8502 (0%) | 1/8542 (0%) | 2/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Febrile infection | 1/8502 (0%) | 0/8542 (0%) | 2/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Fungal infection | 1/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Furuncle | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Gallbladder abscess | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Gallbladder empyema | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Gangrene | 0/8502 (0%) | 1/8542 (0%) | 2/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Gastric infection | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Gastritis viral | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Gastroenteritis | 46/8502 (0.5%) | 33/8542 (0.4%) | 32/8576 (0.4%) | 8/2954 (0.3%) | 11/2972 (0.4%) | |||||
| Gastroenteritis salmonella | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Gastroenteritis staphylococcal | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Gastroenteritis viral | 3/8502 (0%) | 2/8542 (0%) | 3/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Gastrointestinal infection | 2/8502 (0%) | 4/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Genital infection female | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Genitourinary tract infection | 1/8502 (0%) | 1/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Graft infection | 1/8502 (0%) | 1/8542 (0%) | 1/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Groin abscess | 0/8502 (0%) | 2/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Groin infection | 0/8502 (0%) | 1/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Helicobacter gastritis | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Helicobacter infection | 0/8502 (0%) | 2/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Hepatic infection | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Hepatitis A | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Hepatitis B | 1/8502 (0%) | 2/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Hepatitis C | 0/8502 (0%) | 2/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 1/2972 (0%) | |||||
| Herpes simplex | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Herpes virus infection | 0/8502 (0%) | 1/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Herpes zoster | 5/8502 (0.1%) | 8/8542 (0.1%) | 10/8576 (0.1%) | 6/2954 (0.2%) | 0/2972 (0%) | |||||
| Herpes zoster disseminated | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Herpes zoster infection neurological | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Herpes zoster oticus | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Histoplasmosis | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Incision site abscess | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Incision site infection | 0/8502 (0%) | 1/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Incisional hernia gangrenous | 2/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Infected cyst | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Infected lymphocele | 0/8502 (0%) | 2/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Infected sebaceous cyst | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Infection | 10/8502 (0.1%) | 18/8542 (0.2%) | 23/8576 (0.3%) | 2/2954 (0.1%) | 3/2972 (0.1%) | |||||
| Infective exacerbation of chronic obstructive airways disease | 1/8502 (0%) | 2/8542 (0%) | 2/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Influenza | 4/8502 (0%) | 5/8542 (0.1%) | 3/8576 (0%) | 0/2954 (0%) | 3/2972 (0.1%) | |||||
| Injection site abscess | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Injection site infection | 1/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Intervertebral discitis | 1/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 1/2972 (0%) | |||||
| Intestinal fistula infection | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Intestinal gangrene | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Kidney infection | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Klebsiella infection | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Klebsiella sepsis | 1/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Labyrinthitis | 2/8502 (0%) | 3/8542 (0%) | 2/8576 (0%) | 3/2954 (0.1%) | 1/2972 (0%) | |||||
| Laryngitis | 1/8502 (0%) | 0/8542 (0%) | 2/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Leptospirosis | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Liver abscess | 3/8502 (0%) | 1/8542 (0%) | 4/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Lobar pneumonia | 9/8502 (0.1%) | 11/8542 (0.1%) | 14/8576 (0.2%) | 2/2954 (0.1%) | 5/2972 (0.2%) | |||||
| Localised infection | 3/8502 (0%) | 3/8542 (0%) | 7/8576 (0.1%) | 3/2954 (0.1%) | 2/2972 (0.1%) | |||||
| Lower respiratory tract infection | 22/8502 (0.3%) | 26/8542 (0.3%) | 23/8576 (0.3%) | 10/2954 (0.3%) | 8/2972 (0.3%) | |||||
| Lung abscess | 1/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Lung infection | 2/8502 (0%) | 3/8542 (0%) | 5/8576 (0.1%) | 1/2954 (0%) | 3/2972 (0.1%) | |||||
| Lung infection pseudomonal | 1/8502 (0%) | 1/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Lymphangitis | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Mastitis | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Mediastinitis | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Meningitis | 3/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Meningoencephalitis herpetic | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Mycotic corneal ulcer | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Myringitis | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Nasopharyngitis | 2/8502 (0%) | 2/8542 (0%) | 6/8576 (0.1%) | 2/2954 (0.1%) | 0/2972 (0%) | |||||
| Necrotising fasciitis | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Neurosyphilis | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Neutropenic sepsis | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Nocardiosis | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Nosocomial infection | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Orchitis | 1/8502 (0%) | 3/8542 (0%) | 2/8576 (0%) | 1/2954 (0%) | 2/2972 (0.1%) | |||||
| Osteomyelitis | 2/8502 (0%) | 2/8542 (0%) | 6/8576 (0.1%) | 1/2954 (0%) | 1/2972 (0%) | |||||
| Osteomyelitis acute | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Osteomyelitis chronic | 0/8502 (0%) | 0/8542 (0%) | 3/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Otitis externa | 1/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Otitis media | 1/8502 (0%) | 1/8542 (0%) | 2/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Otitis media acute | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Otitis media chronic | 0/8502 (0%) | 2/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Pancreas infection | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Parainfluenzae virus infection | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Paronychia | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Pelvic abscess | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Perianal abscess | 5/8502 (0.1%) | 4/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Peridiverticular abscess | 0/8502 (0%) | 1/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Perineal abscess | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Perirectal abscess | 0/8502 (0%) | 0/8542 (0%) | 2/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Peritoneal abscess | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Peritoneal infection | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Peritonsillar abscess | 1/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Pharyngitis | 1/8502 (0%) | 1/8542 (0%) | 2/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Pilonidal cyst | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Pleural infection | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Pneumococcal sepsis | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Pneumonia | 272/8502 (3.2%) | 310/8542 (3.6%) | 278/8576 (3.2%) | 99/2954 (3.4%) | 97/2972 (3.3%) | |||||
| Pneumonia haemophilus | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Pneumonia legionella | 0/8502 (0%) | 3/8542 (0%) | 2/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Pneumonia parainfluenzae viral | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Pneumonia primary atypical | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Pneumonia staphylococcal | 1/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Pneumonia streptococcal | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Pneumonia viral | 1/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Post procedural cellulitis | 0/8502 (0%) | 2/8542 (0%) | 2/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Post procedural infection | 4/8502 (0%) | 4/8542 (0%) | 7/8576 (0.1%) | 0/2954 (0%) | 3/2972 (0.1%) | |||||
| Postoperative abscess | 0/8502 (0%) | 0/8542 (0%) | 2/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Postoperative wound infection | 4/8502 (0%) | 7/8542 (0.1%) | 12/8576 (0.1%) | 2/2954 (0.1%) | 2/2972 (0.1%) | |||||
| Prostate infection | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Prostatic abscess | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Pseudomembranous colitis | 0/8502 (0%) | 0/8542 (0%) | 2/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Pseudomonal sepsis | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Pulmonary mycosis | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Pulmonary sepsis | 1/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Pulmonary tuberculosis | 3/8502 (0%) | 3/8542 (0%) | 6/8576 (0.1%) | 2/2954 (0.1%) | 2/2972 (0.1%) | |||||
| Purulence | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Pyelonephritis | 15/8502 (0.2%) | 15/8542 (0.2%) | 10/8576 (0.1%) | 8/2954 (0.3%) | 6/2972 (0.2%) | |||||
| Pyelonephritis acute | 2/8502 (0%) | 2/8542 (0%) | 2/8576 (0%) | 3/2954 (0.1%) | 0/2972 (0%) | |||||
| Pyelonephritis chronic | 4/8502 (0%) | 1/8542 (0%) | 7/8576 (0.1%) | 3/2954 (0.1%) | 3/2972 (0.1%) | |||||
| Pyothorax | 0/8502 (0%) | 0/8542 (0%) | 2/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Rectal abscess | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Renal abscess | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Respiratory tract infection | 14/8502 (0.2%) | 15/8542 (0.2%) | 15/8576 (0.2%) | 11/2954 (0.4%) | 6/2972 (0.2%) | |||||
| Respiratory tract infection viral | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Retroperitoneal abscess | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Rhinitis | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Salmonellosis | 0/8502 (0%) | 2/8542 (0%) | 2/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Scrotal abscess | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Scrub typhus | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Sepsis | 49/8502 (0.6%) | 43/8542 (0.5%) | 32/8576 (0.4%) | 14/2954 (0.5%) | 9/2972 (0.3%) | |||||
| Septic shock | 7/8502 (0.1%) | 14/8542 (0.2%) | 16/8576 (0.2%) | 7/2954 (0.2%) | 3/2972 (0.1%) | |||||
| Sinusitis | 1/8502 (0%) | 2/8542 (0%) | 7/8576 (0.1%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Skin infection | 2/8502 (0%) | 2/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Small intestine gangrene | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Staphylococcal bacteraemia | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Staphylococcal infection | 0/8502 (0%) | 2/8542 (0%) | 1/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Staphylococcal sepsis | 2/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Streptococcal sepsis | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Subcutaneous abscess | 1/8502 (0%) | 0/8542 (0%) | 4/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Subdiaphragmatic abscess | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Syphilitic endocarditis of heart valve | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Tick-borne fever | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Tonsillitis | 0/8502 (0%) | 2/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Tooth abscess | 0/8502 (0%) | 2/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Toxoplasmosis | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Tracheitis | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 2/2954 (0.1%) | 0/2972 (0%) | |||||
| Tracheobronchitis | 1/8502 (0%) | 1/8542 (0%) | 3/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Tuberculosis | 4/8502 (0%) | 2/8542 (0%) | 2/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Tuberculous pleurisy | 0/8502 (0%) | 2/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Upper respiratory tract infection | 4/8502 (0%) | 10/8542 (0.1%) | 11/8576 (0.1%) | 6/2954 (0.2%) | 4/2972 (0.1%) | |||||
| Urethral carbuncle | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Urethritis | 1/8502 (0%) | 2/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Urinary tract infection | 73/8502 (0.9%) | 71/8542 (0.8%) | 79/8576 (0.9%) | 31/2954 (1%) | 26/2972 (0.9%) | |||||
| Urinary tract infection enterococcal | 1/8502 (0%) | 1/8542 (0%) | 1/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Urogenital infection bacterial | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Urosepsis | 14/8502 (0.2%) | 11/8542 (0.1%) | 7/8576 (0.1%) | 3/2954 (0.1%) | 4/2972 (0.1%) | |||||
| Vaginal abscess | 1/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Vaginal infection | 0/8502 (0%) | 0/8542 (0%) | 2/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Varicella | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Viral infection | 4/8502 (0%) | 2/8542 (0%) | 3/8576 (0%) | 2/2954 (0.1%) | 3/2972 (0.1%) | |||||
| Viral upper respiratory tract infection | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 2/2954 (0.1%) | 1/2972 (0%) | |||||
| Wound abscess | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Wound infection | 2/8502 (0%) | 6/8542 (0.1%) | 5/8576 (0.1%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Wound infection staphylococcal | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Injury, poisoning and procedural complications | ||||||||||
| Abdominal injury | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Accident | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Accident at home | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Accident at work | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Accidental needle stick | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Accidental overdose | 1/8502 (0%) | 2/8542 (0%) | 3/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Acetabulum fracture | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Alcohol poisoning | 2/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Anaemia postoperative | 2/8502 (0%) | 2/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Anaesthetic complication | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Animal bite | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Ankle fracture | 10/8502 (0.1%) | 16/8542 (0.2%) | 12/8576 (0.1%) | 1/2954 (0%) | 4/2972 (0.1%) | |||||
| Arterial injury | 1/8502 (0%) | 1/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Arthropod bite | 1/8502 (0%) | 0/8542 (0%) | 2/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Asbestosis | 0/8502 (0%) | 1/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Back injury | 1/8502 (0%) | 1/8542 (0%) | 3/8576 (0%) | 1/2954 (0%) | 1/2972 (0%) | |||||
| Blast injury | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Brain contusion | 5/8502 (0.1%) | 2/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Burn of internal organs | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Burns first degree | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Burns second degree | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Carbon monoxide poisoning | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Cardiac pacemaker malfunction | 2/8502 (0%) | 1/8542 (0%) | 2/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Cardiac valve replacement complication | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Cervical vertebral fracture | 3/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Chest injury | 0/8502 (0%) | 1/8542 (0%) | 3/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Clavicle fracture | 3/8502 (0%) | 4/8542 (0%) | 3/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Collapse of lung | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Compression fracture | 1/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Concussion | 4/8502 (0%) | 1/8542 (0%) | 3/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Confusion postoperative | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Contrast media reaction | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Contusion | 3/8502 (0%) | 9/8542 (0.1%) | 5/8576 (0.1%) | 2/2954 (0.1%) | 2/2972 (0.1%) | |||||
| Corneal abrasion | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Cranial nerve injury | 0/8502 (0%) | 2/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 1/2972 (0%) | |||||
| Device breakage | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Device dislocation | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Device electrical finding | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Device migration | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Device occlusion | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Dislocation of joint prosthesis | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Dislocation of vertebra | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Drug toxicity | 3/8502 (0%) | 3/8542 (0%) | 3/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Electric shock | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Epicondylitis | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Excoriation | 0/8502 (0%) | 1/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Eye injury | 0/8502 (0%) | 1/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Eye penetration | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Face injury | 3/8502 (0%) | 2/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Facial bones fracture | 3/8502 (0%) | 8/8542 (0.1%) | 2/8576 (0%) | 3/2954 (0.1%) | 2/2972 (0.1%) | |||||
| Fall | 97/8502 (1.1%) | 99/8542 (1.2%) | 98/8576 (1.1%) | 38/2954 (1.3%) | 37/2972 (1.2%) | |||||
| Femoral neck fracture | 5/8502 (0.1%) | 3/8542 (0%) | 4/8576 (0%) | 1/2954 (0%) | 1/2972 (0%) | |||||
| Femur fracture | 17/8502 (0.2%) | 14/8542 (0.2%) | 15/8576 (0.2%) | 6/2954 (0.2%) | 5/2972 (0.2%) | |||||
| Fibula fracture | 5/8502 (0.1%) | 4/8542 (0%) | 2/8576 (0%) | 4/2954 (0.1%) | 1/2972 (0%) | |||||
| Foot fracture | 3/8502 (0%) | 6/8542 (0.1%) | 5/8576 (0.1%) | 1/2954 (0%) | 2/2972 (0.1%) | |||||
| Forearm fracture | 1/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Foreign body trauma | 1/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Fracture | 1/8502 (0%) | 3/8542 (0%) | 4/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Fractured ischium | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Fractured sacrum | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Gastrointestinal stoma complication | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Graft haemorrhage | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Graft thrombosis | 2/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Hand fracture | 4/8502 (0%) | 6/8542 (0.1%) | 4/8576 (0%) | 2/2954 (0.1%) | 3/2972 (0.1%) | |||||
| Head injury | 11/8502 (0.1%) | 9/8542 (0.1%) | 6/8576 (0.1%) | 7/2954 (0.2%) | 6/2972 (0.2%) | |||||
| Heat exhaustion | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Hepatic rupture | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Hip fracture | 55/8502 (0.6%) | 47/8542 (0.6%) | 43/8576 (0.5%) | 21/2954 (0.7%) | 18/2972 (0.6%) | |||||
| Humerus fracture | 14/8502 (0.2%) | 11/8542 (0.1%) | 8/8576 (0.1%) | 2/2954 (0.1%) | 3/2972 (0.1%) | |||||
| Iliotibial band syndrome | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Implantable defibrillator malfunction | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Incision site pain | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Incisional hernia | 0/8502 (0%) | 1/8542 (0%) | 2/8576 (0%) | 1/2954 (0%) | 2/2972 (0.1%) | |||||
| Injury | 0/8502 (0%) | 2/8542 (0%) | 2/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Intervertebral disc injury | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Jaw fracture | 1/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Joint dislocation | 6/8502 (0.1%) | 10/8542 (0.1%) | 4/8576 (0%) | 1/2954 (0%) | 3/2972 (0.1%) | |||||
| Joint injury | 1/8502 (0%) | 7/8542 (0.1%) | 10/8576 (0.1%) | 3/2954 (0.1%) | 2/2972 (0.1%) | |||||
| Joint sprain | 0/8502 (0%) | 2/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 1/2972 (0%) | |||||
| Ligament rupture | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Limb crushing injury | 2/8502 (0%) | 1/8542 (0%) | 2/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Limb injury | 2/8502 (0%) | 1/8542 (0%) | 3/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Limb traumatic amputation | 0/8502 (0%) | 2/8542 (0%) | 1/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Lower limb fracture | 12/8502 (0.1%) | 4/8542 (0%) | 6/8576 (0.1%) | 5/2954 (0.2%) | 3/2972 (0.1%) | |||||
| Lumbar vertebral fracture | 2/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Lung injury | 1/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Medical device complication | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Meniscus lesion | 2/8502 (0%) | 3/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Mountain sickness acute | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Multiple injuries | 2/8502 (0%) | 1/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Muscle injury | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Muscle rupture | 1/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Muscle strain | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Neck injury | 2/8502 (0%) | 0/8542 (0%) | 2/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Nerve injury | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Open wound | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Overdose | 1/8502 (0%) | 5/8542 (0.1%) | 2/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Pacemaker complication | 0/8502 (0%) | 1/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Patella fracture | 5/8502 (0.1%) | 3/8542 (0%) | 4/8576 (0%) | 0/2954 (0%) | 3/2972 (0.1%) | |||||
| Pelvic fracture | 5/8502 (0.1%) | 6/8542 (0.1%) | 8/8576 (0.1%) | 0/2954 (0%) | 3/2972 (0.1%) | |||||
| Pelvic organ injury | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Penetrating abdominal trauma | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Periorbital haematoma | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Perirenal haematoma | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Pneumoconiosis | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Post procedural complication | 2/8502 (0%) | 4/8542 (0%) | 2/8576 (0%) | 1/2954 (0%) | 2/2972 (0.1%) | |||||
| Post procedural diarrhoea | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Post procedural fistula | 2/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Post procedural haematoma | 2/8502 (0%) | 2/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 2/2972 (0.1%) | |||||
| Post procedural haemorrhage | 4/8502 (0%) | 2/8542 (0%) | 3/8576 (0%) | 1/2954 (0%) | 1/2972 (0%) | |||||
| Postoperative fever | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Postoperative hernia | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Postoperative ileus | 0/8502 (0%) | 2/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Postoperative renal failure | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 1/2972 (0%) | |||||
| Postoperative thoracic procedure complication | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Postoperative wound complication | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Postpericardiotomy syndrome | 2/8502 (0%) | 2/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Procedural headache | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Procedural hypertension | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Procedural hypotension | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Procedural pain | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 1/2972 (0%) | |||||
| Pubic rami fracture | 1/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Radiation injury | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Radiation pneumonitis | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Radius fracture | 5/8502 (0.1%) | 4/8542 (0%) | 2/8576 (0%) | 0/2954 (0%) | 2/2972 (0.1%) | |||||
| Reocclusion | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Respiratory fume inhalation disorder | 1/8502 (0%) | 0/8542 (0%) | 3/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Rib fracture | 18/8502 (0.2%) | 19/8542 (0.2%) | 16/8576 (0.2%) | 2/2954 (0.1%) | 4/2972 (0.1%) | |||||
| Road traffic accident | 23/8502 (0.3%) | 11/8542 (0.1%) | 18/8576 (0.2%) | 5/2954 (0.2%) | 6/2972 (0.2%) | |||||
| Scapula fracture | 2/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Sciatic nerve injury | 1/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Shunt occlusion | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Silicosis | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Skeletal injury | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Skin laceration | 3/8502 (0%) | 8/8542 (0.1%) | 4/8576 (0%) | 2/2954 (0.1%) | 1/2972 (0%) | |||||
| Skull fracture | 5/8502 (0.1%) | 3/8542 (0%) | 5/8576 (0.1%) | 3/2954 (0.1%) | 0/2972 (0%) | |||||
| Skull fractured base | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Soft tissue injury | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Spinal compression fracture | 1/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Spinal cord injury | 2/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Spinal fracture | 19/8502 (0.2%) | 17/8542 (0.2%) | 23/8576 (0.3%) | 5/2954 (0.2%) | 4/2972 (0.1%) | |||||
| Splenic haematoma | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Splenic rupture | 0/8502 (0%) | 0/8542 (0%) | 3/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Spondylopathy traumatic | 0/8502 (0%) | 1/8542 (0%) | 2/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Stent occlusion | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Sternal fracture | 0/8502 (0%) | 1/8542 (0%) | 1/8576 (0%) | 2/2954 (0.1%) | 0/2972 (0%) | |||||
| Sternal injury | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Subcutaneous haematoma | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Subdural haematoma | 8/8502 (0.1%) | 9/8542 (0.1%) | 11/8576 (0.1%) | 3/2954 (0.1%) | 2/2972 (0.1%) | |||||
| Subdural haemorrhage | 1/8502 (0%) | 0/8542 (0%) | 3/8576 (0%) | 3/2954 (0.1%) | 0/2972 (0%) | |||||
| Tendon injury | 2/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 2/2954 (0.1%) | 0/2972 (0%) | |||||
| Tendon rupture | 2/8502 (0%) | 3/8542 (0%) | 2/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Therapeutic agent toxicity | 2/8502 (0%) | 3/8542 (0%) | 4/8576 (0%) | 3/2954 (0.1%) | 0/2972 (0%) | |||||
| Thermal burn | 1/8502 (0%) | 3/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 3/2972 (0.1%) | |||||
| Thoracic vertebral fracture | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Tibia fracture | 6/8502 (0.1%) | 6/8542 (0.1%) | 2/8576 (0%) | 2/2954 (0.1%) | 5/2972 (0.2%) | |||||
| Traumatic amputation | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Traumatic anuria | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Traumatic brain injury | 2/8502 (0%) | 0/8542 (0%) | 4/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Ulna fracture | 2/8502 (0%) | 1/8542 (0%) | 2/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Upper limb fracture | 12/8502 (0.1%) | 8/8542 (0.1%) | 14/8576 (0.2%) | 7/2954 (0.2%) | 5/2972 (0.2%) | |||||
| Urethral stricture postoperative | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Urinary bladder rupture | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Urinary retention postoperative | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Urinary tract injury | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Vascular graft complication | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Vascular graft occlusion | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Vertebral injury | 1/8502 (0%) | 1/8542 (0%) | 2/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Whiplash injury | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Wound | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Wound dehiscence | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Wrist fracture | 9/8502 (0.1%) | 3/8542 (0%) | 7/8576 (0.1%) | 1/2954 (0%) | 2/2972 (0.1%) | |||||
| Investigations | ||||||||||
| Acid base balance abnormal | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Amphetamines positive | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Angiogram | 85/8502 (1%) | 79/8542 (0.9%) | 72/8576 (0.8%) | 35/2954 (1.2%) | 22/2972 (0.7%) | |||||
| Angiogram cerebral | 1/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Angiogram peripheral | 7/8502 (0.1%) | 6/8542 (0.1%) | 6/8576 (0.1%) | 0/2954 (0%) | 2/2972 (0.1%) | |||||
| Anticoagulation drug level above therapeutic | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Aortogram | 1/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Arteriogram | 2/8502 (0%) | 4/8542 (0%) | 3/8576 (0%) | 0/2954 (0%) | 2/2972 (0.1%) | |||||
| Arteriogram carotid | 3/8502 (0%) | 3/8542 (0%) | 8/8576 (0.1%) | 3/2954 (0.1%) | 1/2972 (0%) | |||||
| Arteriogram coronary | 64/8502 (0.8%) | 68/8542 (0.8%) | 55/8576 (0.6%) | 18/2954 (0.6%) | 26/2972 (0.9%) | |||||
| Arteriogram coronary abnormal | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Arteriogram renal | 3/8502 (0%) | 2/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Arthroscopy | 6/8502 (0.1%) | 13/8542 (0.2%) | 12/8576 (0.1%) | 6/2954 (0.2%) | 3/2972 (0.1%) | |||||
| Aspiration bronchial | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Barium enema | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Barium meal normal | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Biopsy | 4/8502 (0%) | 4/8542 (0%) | 3/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Biopsy artery | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Biopsy bladder | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Biopsy brain | 0/8502 (0%) | 1/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Biopsy breast | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Biopsy cervix | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Biopsy kidney | 1/8502 (0%) | 2/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Biopsy larynx | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Biopsy liver | 0/8502 (0%) | 0/8542 (0%) | 3/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Biopsy lung | 3/8502 (0%) | 3/8542 (0%) | 2/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Biopsy lymph gland | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Biopsy muscle | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Biopsy oesophagus | 2/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Biopsy pleura | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Biopsy prostate | 5/8502 (0.1%) | 2/8542 (0%) | 5/8576 (0.1%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Biopsy site unspecified normal | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Biopsy spinal cord | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Biopsy tongue | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Biopsy trachea | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Biopsy uterus | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 2/2954 (0.1%) | 0/2972 (0%) | |||||
| Biopsy vulva | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Blood alcohol increased | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Blood calcium decreased | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Blood calcium increased | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Blood cholesterol increased | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Blood creatine increased | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Blood creatine phosphokinase MB normal | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Blood creatinine abnormal | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Blood creatinine increased | 43/8502 (0.5%) | 29/8542 (0.3%) | 30/8576 (0.3%) | 9/2954 (0.3%) | 3/2972 (0.1%) | |||||
| Blood culture positive | 1/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Blood glucose fluctuation | 1/8502 (0%) | 0/8542 (0%) | 2/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Blood glucose increased | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Blood immunoglobulin G increased | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Blood magnesium decreased | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Blood osmolarity decreased | 1/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Blood phosphorus | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Blood potassium abnormal | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Blood potassium decreased | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Blood potassium increased | 3/8502 (0%) | 1/8542 (0%) | 2/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Blood pressure abnormal | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Blood pressure decreased | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Blood pressure increased | 1/8502 (0%) | 2/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Blood pressure orthostatic | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Blood pressure orthostatic abnormal | 0/8502 (0%) | 0/8542 (0%) | 2/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Blood sodium abnormal | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Blood sodium decreased | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Blood sodium increased | 1/8502 (0%) | 1/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Blood urea | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Blood urea abnormal | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Blood urea increased | 7/8502 (0.1%) | 1/8542 (0%) | 5/8576 (0.1%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Blood uric acid increased | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Blood urine | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Blood urine present | 0/8502 (0%) | 1/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Borrelia burgdorferi serology positive | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Bronchoscopy | 3/8502 (0%) | 0/8542 (0%) | 2/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Cardiac electrophysiologic study | 0/8502 (0%) | 8/8542 (0.1%) | 0/8576 (0%) | 2/2954 (0.1%) | 1/2972 (0%) | |||||
| Cardiac enzymes increased | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Cardiac function test | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Cardiac output decreased | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Cardiac pacemaker evaluation | 1/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Cardiac stress test | 2/8502 (0%) | 1/8542 (0%) | 2/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Cardiac stress test abnormal | 3/8502 (0%) | 1/8542 (0%) | 1/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Cardiovascular evaluation | 19/8502 (0.2%) | 21/8542 (0.2%) | 20/8576 (0.2%) | 4/2954 (0.1%) | 8/2972 (0.3%) | |||||
| Cardiovascular function test | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Chest X-ray abnormal | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Cholangiogram | 0/8502 (0%) | 0/8542 (0%) | 3/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Coagulation test abnormal | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Coagulation time prolonged | 2/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Coagulation time shortened | 1/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Colonoscopy | 18/8502 (0.2%) | 14/8542 (0.2%) | 6/8576 (0.1%) | 3/2954 (0.1%) | 6/2972 (0.2%) | |||||
| Colonoscopy abnormal | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Colonoscopy normal | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Computerised tomogram | 2/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Computerised tomogram abdomen | 1/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Computerised tomogram abnormal | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Computerised tomogram thorax | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Creatinine renal clearance decreased | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Cyst aspiration | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Cystogram | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Cystoscopy | 4/8502 (0%) | 13/8542 (0.2%) | 12/8576 (0.1%) | 1/2954 (0%) | 2/2972 (0.1%) | |||||
| Cystoscopy abnormal | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Dermatologic examination | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Diagnostic procedure | 1/8502 (0%) | 7/8542 (0.1%) | 10/8576 (0.1%) | 2/2954 (0.1%) | 3/2972 (0.1%) | |||||
| Drug level decreased | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Ear, nose and throat examination | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Echocardiogram | 1/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Electrocardiogram ST segment depression | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Electrocardiogram ST-T change | 0/8502 (0%) | 1/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Electrocardiogram T wave inversion | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Electrocardiogram ambulatory | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Electrocardiogram change | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Electrocardiogram normal | 1/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Electroneuromyography | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Endocrine test | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Endoscopic retrograde cholangiopancreatography | 5/8502 (0.1%) | 1/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 1/2972 (0%) | |||||
| Endoscopy | 2/8502 (0%) | 4/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Endoscopy gastrointestinal | 0/8502 (0%) | 1/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Endoscopy upper gastrointestinal tract | 4/8502 (0%) | 5/8542 (0.1%) | 1/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Fibrin D dimer increased | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Flexible sigmoidoscopy | 1/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Functional residual capacity decreased | 0/8502 (0%) | 2/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Glomerular filtration rate decreased | 1/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Gynaecological examination | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| HIV test positive | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Haemoglobin decreased | 1/8502 (0%) | 4/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Heart rate abnormal | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Heart rate decreased | 0/8502 (0%) | 1/8542 (0%) | 2/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Heart rate increased | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Heart rate irregular | 2/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Hysteroscopy | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 1/2972 (0%) | |||||
| International normalised ratio | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 2/2972 (0.1%) | |||||
| International normalised ratio decreased | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| International normalised ratio increased | 3/8502 (0%) | 3/8542 (0%) | 3/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Investigation | 3/8502 (0%) | 4/8542 (0%) | 2/8576 (0%) | 0/2954 (0%) | 2/2972 (0.1%) | |||||
| Laparoscopy | 1/8502 (0%) | 0/8542 (0%) | 2/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Laryngoscopy | 1/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Liver function test abnormal | 2/8502 (0%) | 1/8542 (0%) | 2/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Mean arterial pressure | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Mediastinoscopy | 0/8502 (0%) | 1/8542 (0%) | 3/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Medical observation | 9/8502 (0.1%) | 14/8542 (0.2%) | 9/8576 (0.1%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Medication residue | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Muscle relaxant drug level above therapeutic | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Neurological examination | 0/8502 (0%) | 1/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Nuclear magnetic resonance imaging | 2/8502 (0%) | 0/8542 (0%) | 2/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Occult blood | 2/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Occult blood positive | 0/8502 (0%) | 2/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Oesophagogastroduodenoscopy | 2/8502 (0%) | 2/8542 (0%) | 2/8576 (0%) | 1/2954 (0%) | 2/2972 (0.1%) | |||||
| Orthopedic examination | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Pain assessment | 1/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Platelet count decreased | 1/8502 (0%) | 1/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Platelet count increased | 1/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Prostate examination | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Prothrombin level decreased | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Prothrombin time shortened | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Psychiatric evaluation | 1/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Pulmonary function challenge test abnormal | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Pyelogram retrograde | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Pyelogram retrograde normal | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Sigmoidoscopy | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Sleep study | 2/8502 (0%) | 3/8542 (0%) | 3/8576 (0%) | 0/2954 (0%) | 2/2972 (0.1%) | |||||
| Spinal X-ray | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Stress echocardiogram | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Transplant evaluation | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Troponin T increased | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Ultrasound Doppler | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Ultrasound scan | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Ureteroscopy | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Urethroscopy | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Urodynamics measurement | 0/8502 (0%) | 1/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Urogram | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Urological examination | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Vascular test | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 2/2954 (0.1%) | 0/2972 (0%) | |||||
| Weight decreased | 9/8502 (0.1%) | 6/8542 (0.1%) | 5/8576 (0.1%) | 2/2954 (0.1%) | 0/2972 (0%) | |||||
| Weight increased | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| White blood cell count decreased | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| X-ray | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| X-ray limb | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Metabolism and nutrition disorders | ||||||||||
| Acidosis | 1/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Anorexia | 3/8502 (0%) | 8/8542 (0.1%) | 3/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Decreased appetite | 1/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Dehydration | 57/8502 (0.7%) | 32/8542 (0.4%) | 37/8576 (0.4%) | 6/2954 (0.2%) | 6/2972 (0.2%) | |||||
| Diabetes mellitus | 304/8502 (3.6%) | 394/8542 (4.6%) | 361/8576 (4.2%) | 195/2954 (6.6%) | 239/2972 (8%) | |||||
| Diabetes mellitus inadequate control | 5/8502 (0.1%) | 2/8542 (0%) | 2/8576 (0%) | 1/2954 (0%) | 3/2972 (0.1%) | |||||
| Diabetic complication | 1/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Diabetic foot | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Diabetic ketoacidosis | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Diet refusal | 1/8502 (0%) | 2/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Dyslipidaemia | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Electrolyte imbalance | 1/8502 (0%) | 3/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Failure to thrive | 0/8502 (0%) | 6/8542 (0.1%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Fluid imbalance | 0/8502 (0%) | 2/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Fluid overload | 4/8502 (0%) | 0/8542 (0%) | 4/8576 (0%) | 1/2954 (0%) | 1/2972 (0%) | |||||
| Fluid retention | 1/8502 (0%) | 2/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Gout | 14/8502 (0.2%) | 7/8542 (0.1%) | 7/8576 (0.1%) | 2/2954 (0.1%) | 2/2972 (0.1%) | |||||
| Hypercalcaemia | 2/8502 (0%) | 1/8542 (0%) | 2/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Hyperglycaemia | 122/8502 (1.4%) | 133/8542 (1.6%) | 132/8576 (1.5%) | 40/2954 (1.4%) | 47/2972 (1.6%) | |||||
| Hyperkalaemia | 45/8502 (0.5%) | 23/8542 (0.3%) | 28/8576 (0.3%) | 7/2954 (0.2%) | 3/2972 (0.1%) | |||||
| Hyperlipidaemia | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Hypermagnesaemia | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Hypernatraemia | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Hyperphagia | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Hyperphosphataemia | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Hypocalcaemia | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Hypoglycaemia | 59/8502 (0.7%) | 51/8542 (0.6%) | 55/8576 (0.6%) | 19/2954 (0.6%) | 8/2972 (0.3%) | |||||
| Hypokalaemia | 5/8502 (0.1%) | 5/8542 (0.1%) | 5/8576 (0.1%) | 4/2954 (0.1%) | 0/2972 (0%) | |||||
| Hypomagnesaemia | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Hyponatraemia | 21/8502 (0.2%) | 8/8542 (0.1%) | 20/8576 (0.2%) | 6/2954 (0.2%) | 5/2972 (0.2%) | |||||
| Hypoproteinaemia | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Hypovolaemia | 4/8502 (0%) | 2/8542 (0%) | 3/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Increased insulin requirement | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Iron deficiency | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Ketoacidosis | 9/8502 (0.1%) | 6/8542 (0.1%) | 7/8576 (0.1%) | 1/2954 (0%) | 4/2972 (0.1%) | |||||
| Lactic acidosis | 2/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Lipomatosis | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Magnesium deficiency | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Malnutrition | 1/8502 (0%) | 2/8542 (0%) | 2/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Marasmus | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Metabolic acidosis | 4/8502 (0%) | 2/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Metabolic disorder | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Metabolic syndrome | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Neuroglycopenia | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Obesity | 1/8502 (0%) | 1/8542 (0%) | 1/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Podagra | 1/8502 (0%) | 1/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Salt intoxication | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Shock hypoglycaemic | 0/8502 (0%) | 1/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Type 1 diabetes mellitus | 1/8502 (0%) | 1/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Type 2 diabetes mellitus | 1/8502 (0%) | 1/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Vitamin B12 deficiency | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Musculoskeletal and connective tissue disorders | ||||||||||
| Arthralgia | 4/8502 (0%) | 6/8542 (0.1%) | 7/8576 (0.1%) | 4/2954 (0.1%) | 1/2972 (0%) | |||||
| Arthritis | 5/8502 (0.1%) | 10/8542 (0.1%) | 5/8576 (0.1%) | 2/2954 (0.1%) | 2/2972 (0.1%) | |||||
| Arthritis allergic | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Arthrofibrosis | 1/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Arthropathy | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Back pain | 21/8502 (0.2%) | 28/8542 (0.3%) | 34/8576 (0.4%) | 7/2954 (0.2%) | 7/2972 (0.2%) | |||||
| Bone disorder | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Bursitis | 3/8502 (0%) | 5/8542 (0.1%) | 4/8576 (0%) | 1/2954 (0%) | 1/2972 (0%) | |||||
| Cervical spinal stenosis | 0/8502 (0%) | 4/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Chondritis | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Chondrocalcinosis | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Chondrocalcinosis pyrophosphate | 0/8502 (0%) | 1/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Chondropathy | 0/8502 (0%) | 0/8542 (0%) | 2/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Costochondritis | 3/8502 (0%) | 2/8542 (0%) | 1/8576 (0%) | 1/2954 (0%) | 1/2972 (0%) | |||||
| Dupuytren's contracture | 1/8502 (0%) | 3/8542 (0%) | 1/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Exostosis | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Fasciitis | 0/8502 (0%) | 1/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Fibromyalgia | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 2/2972 (0.1%) | |||||
| Fistula | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Flank pain | 1/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Foot deformity | 2/8502 (0%) | 4/8542 (0%) | 3/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Gouty arthritis | 4/8502 (0%) | 6/8542 (0.1%) | 2/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Gouty tophus | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Groin pain | 1/8502 (0%) | 0/8542 (0%) | 2/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Haemarthrosis | 0/8502 (0%) | 2/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Intervertebral disc compression | 0/8502 (0%) | 0/8542 (0%) | 2/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Intervertebral disc degeneration | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Intervertebral disc disorder | 1/8502 (0%) | 2/8542 (0%) | 4/8576 (0%) | 0/2954 (0%) | 2/2972 (0.1%) | |||||
| Intervertebral disc displacement | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Intervertebral disc protrusion | 12/8502 (0.1%) | 9/8542 (0.1%) | 6/8576 (0.1%) | 1/2954 (0%) | 3/2972 (0.1%) | |||||
| Joint ankylosis | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Joint effusion | 1/8502 (0%) | 3/8542 (0%) | 1/8576 (0%) | 2/2954 (0.1%) | 0/2972 (0%) | |||||
| Joint swelling | 1/8502 (0%) | 2/8542 (0%) | 3/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Juvenile arthritis | 0/8502 (0%) | 2/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Kyphoscoliosis | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Limb discomfort | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Lumbar spinal stenosis | 1/8502 (0%) | 7/8542 (0.1%) | 11/8576 (0.1%) | 1/2954 (0%) | 4/2972 (0.1%) | |||||
| Mixed connective tissue disease | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Mobility decreased | 3/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 2/2954 (0.1%) | 0/2972 (0%) | |||||
| Muscle contracture | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Muscle haemorrhage | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Muscle spasms | 1/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Muscular weakness | 5/8502 (0.1%) | 5/8542 (0.1%) | 4/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Musculoskeletal chest pain | 15/8502 (0.2%) | 13/8542 (0.2%) | 9/8576 (0.1%) | 2/2954 (0.1%) | 3/2972 (0.1%) | |||||
| Musculoskeletal discomfort | 2/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Musculoskeletal pain | 6/8502 (0.1%) | 8/8542 (0.1%) | 9/8576 (0.1%) | 3/2954 (0.1%) | 4/2972 (0.1%) | |||||
| Musculoskeletal stiffness | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Myalgia | 3/8502 (0%) | 2/8542 (0%) | 4/8576 (0%) | 1/2954 (0%) | 1/2972 (0%) | |||||
| Myalgia intercostal | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Myopathy | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Myopathy steroid | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Myositis | 1/8502 (0%) | 1/8542 (0%) | 2/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Neck pain | 1/8502 (0%) | 4/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Osteitis | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Osteitis deformans | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Osteoarthritis | 22/8502 (0.3%) | 40/8542 (0.5%) | 25/8576 (0.3%) | 16/2954 (0.5%) | 10/2972 (0.3%) | |||||
| Osteoarthropathy | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Osteochondrosis | 5/8502 (0.1%) | 3/8542 (0%) | 4/8576 (0%) | 1/2954 (0%) | 3/2972 (0.1%) | |||||
| Osteolysis | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Osteonecrosis | 1/8502 (0%) | 1/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Osteoporosis | 2/8502 (0%) | 1/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Osteoporotic fracture | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 1/2954 (0%) | 1/2972 (0%) | |||||
| Osteosclerosis | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Osteosis | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Pain in extremity | 7/8502 (0.1%) | 4/8542 (0%) | 12/8576 (0.1%) | 0/2954 (0%) | 3/2972 (0.1%) | |||||
| Pain in jaw | 2/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 1/2972 (0%) | |||||
| Pathological fracture | 0/8502 (0%) | 0/8542 (0%) | 3/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Periarthritis | 0/8502 (0%) | 1/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Periostitis | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Polyarthritis | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 2/2954 (0.1%) | 1/2972 (0%) | |||||
| Polymyalgia rheumatica | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 2/2954 (0.1%) | 1/2972 (0%) | |||||
| Pseudarthrosis | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Psoriatic arthropathy | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Rhabdomyolysis | 6/8502 (0.1%) | 1/8542 (0%) | 5/8576 (0.1%) | 0/2954 (0%) | 2/2972 (0.1%) | |||||
| Rheumatoid arthritis | 1/8502 (0%) | 0/8542 (0%) | 4/8576 (0%) | 2/2954 (0.1%) | 2/2972 (0.1%) | |||||
| Rotator cuff syndrome | 5/8502 (0.1%) | 4/8542 (0%) | 5/8576 (0.1%) | 1/2954 (0%) | 1/2972 (0%) | |||||
| Senile ankylosing vertebral hyperostosis | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Sensation of heaviness | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Sjogren's syndrome | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Spinal column stenosis | 4/8502 (0%) | 9/8542 (0.1%) | 7/8576 (0.1%) | 2/2954 (0.1%) | 4/2972 (0.1%) | |||||
| Spinal osteoarthritis | 12/8502 (0.1%) | 9/8542 (0.1%) | 10/8576 (0.1%) | 8/2954 (0.3%) | 4/2972 (0.1%) | |||||
| Spondylitis | 1/8502 (0%) | 2/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Synovitis | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 2/2972 (0.1%) | |||||
| Systemic lupus erythematosus | 1/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Tendon disorder | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Tendonitis | 0/8502 (0%) | 0/8542 (0%) | 2/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||||
| Abdominal neoplasm | 4/8502 (0%) | 2/8542 (0%) | 2/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Acoustic neuroma | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Acute leukaemia | 1/8502 (0%) | 1/8542 (0%) | 2/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Acute lymphocytic leukaemia | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Acute myeloid leukaemia | 7/8502 (0.1%) | 5/8542 (0.1%) | 2/8576 (0%) | 1/2954 (0%) | 1/2972 (0%) | |||||
| Adenocarcinoma | 5/8502 (0.1%) | 3/8542 (0%) | 2/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Adenocarcinoma of the cervix | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Adenocarcinoma pancreas | 1/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Adenoma benign | 1/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Adrenal adenoma | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Adrenal carcinoma | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Anaplastic thyroid cancer | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Angiocentric lymphoma | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| B-cell lymphoma | 2/8502 (0%) | 1/8542 (0%) | 2/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Basal cell carcinoma | 58/8502 (0.7%) | 53/8542 (0.6%) | 52/8576 (0.6%) | 7/2954 (0.2%) | 9/2972 (0.3%) | |||||
| Basosquamous carcinoma | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Benign neoplasm | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Benign neoplasm of prostate | 1/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Benign neoplasm of skin | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Benign ovarian tumour | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Benign pancreatic neoplasm | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Benign salivary gland neoplasm | 0/8502 (0%) | 2/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Bile duct cancer | 5/8502 (0.1%) | 4/8542 (0%) | 1/8576 (0%) | 2/2954 (0.1%) | 1/2972 (0%) | |||||
| Biliary neoplasm | 0/8502 (0%) | 1/8542 (0%) | 2/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Bladder cancer | 36/8502 (0.4%) | 47/8542 (0.6%) | 38/8576 (0.4%) | 12/2954 (0.4%) | 13/2972 (0.4%) | |||||
| Bladder cancer recurrent | 1/8502 (0%) | 0/8542 (0%) | 3/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Bladder neoplasm | 1/8502 (0%) | 0/8542 (0%) | 3/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Bladder papilloma | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Bladder transitional cell carcinoma | 0/8502 (0%) | 2/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Bone cancer metastatic | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Bone neoplasm malignant | 3/8502 (0%) | 4/8542 (0%) | 7/8576 (0.1%) | 1/2954 (0%) | 3/2972 (0.1%) | |||||
| Bowen's disease | 2/8502 (0%) | 0/8542 (0%) | 4/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Brain cancer metastatic | 1/8502 (0%) | 0/8542 (0%) | 3/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Brain neoplasm | 12/8502 (0.1%) | 10/8542 (0.1%) | 21/8576 (0.2%) | 2/2954 (0.1%) | 4/2972 (0.1%) | |||||
| Breast cancer | 37/8502 (0.4%) | 30/8542 (0.4%) | 36/8576 (0.4%) | 19/2954 (0.6%) | 16/2972 (0.5%) | |||||
| Breast cancer metastatic | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Bronchial carcinoma | 0/8502 (0%) | 1/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Bronchial neoplasm | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Burkitt's lymphoma | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Carcinoid tumour of the gastrointestinal tract | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Carcinoid tumour of the stomach | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Carcinoma in situ of eye | 1/8502 (0%) | 2/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Central nervous system lymphoma | 2/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Cerebral neuroblastoma | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Cervix carcinoma | 4/8502 (0%) | 2/8542 (0%) | 5/8576 (0.1%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Cervix neoplasm | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Cholesteatoma | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Chronic leukaemia | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Chronic lymphocytic leukaemia | 4/8502 (0%) | 4/8542 (0%) | 5/8576 (0.1%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Chronic myeloid leukaemia | 1/8502 (0%) | 2/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Colon adenoma | 0/8502 (0%) | 2/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Colon cancer | 78/8502 (0.9%) | 80/8542 (0.9%) | 68/8576 (0.8%) | 21/2954 (0.7%) | 28/2972 (0.9%) | |||||
| Colon cancer metastatic | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Colon neoplasm | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Cranial nerve neoplasm benign | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Diffuse large B-cell lymphoma | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Dysplastic naevus syndrome | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Ear neoplasm | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Endometrial cancer | 2/8502 (0%) | 3/8542 (0%) | 1/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Endometrial cancer metastatic | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Epithelioid sarcoma metastatic | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Essential thrombocythaemia | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Fallopian tube cancer | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Fibrosarcoma | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Follicle centre lymphoma, follicular grade I, II, III | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Gallbladder cancer | 6/8502 (0.1%) | 3/8542 (0%) | 3/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Ganglioneuroma | 1/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Gastric cancer | 14/8502 (0.2%) | 17/8542 (0.2%) | 18/8576 (0.2%) | 7/2954 (0.2%) | 6/2972 (0.2%) | |||||
| Gastrointestinal carcinoma | 0/8502 (0%) | 2/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Gastrointestinal stromal tumour | 0/8502 (0%) | 2/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Gastrointestinal tract adenoma | 0/8502 (0%) | 1/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Gastrooesophageal cancer | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Genitourinary tract neoplasm | 3/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Gum neoplasm malignant stage unspecified | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Haemangioma of liver | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Head and neck cancer | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 1/2972 (0%) | |||||
| Hepatic neoplasm | 1/8502 (0%) | 0/8542 (0%) | 4/8576 (0%) | 2/2954 (0.1%) | 1/2972 (0%) | |||||
| Hepatic neoplasm malignant | 20/8502 (0.2%) | 25/8542 (0.3%) | 24/8576 (0.3%) | 7/2954 (0.2%) | 4/2972 (0.1%) | |||||
| Hepatic neoplasm malignant recurrent | 0/8502 (0%) | 1/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Hepatobiliary neoplasm | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Histiocytosis haematophagic | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Hodgkin's disease | 3/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Hypopharyngeal cancer | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Intestinal adenocarcinoma | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Intraocular melanoma | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Kaposi's sarcoma | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Keratoacanthoma | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Laryngeal cancer | 5/8502 (0.1%) | 8/8542 (0.1%) | 8/8576 (0.1%) | 3/2954 (0.1%) | 2/2972 (0.1%) | |||||
| Laryngeal neoplasm | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Leiomyosarcoma | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 1/2972 (0%) | |||||
| Leukaemia | 12/8502 (0.1%) | 8/8542 (0.1%) | 8/8576 (0.1%) | 1/2954 (0%) | 3/2972 (0.1%) | |||||
| Lip and/or oral cavity cancer | 2/8502 (0%) | 2/8542 (0%) | 2/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Lip neoplasm malignant stage unspecified | 3/8502 (0%) | 4/8542 (0%) | 2/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Liposarcoma | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Lung adenocarcinoma | 1/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Lung neoplasm | 1/8502 (0%) | 2/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Lung neoplasm malignant | 110/8502 (1.3%) | 102/8542 (1.2%) | 109/8576 (1.3%) | 30/2954 (1%) | 23/2972 (0.8%) | |||||
| Lymphocytic leukaemia | 1/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Lymphoma | 15/8502 (0.2%) | 14/8542 (0.2%) | 14/8576 (0.2%) | 6/2954 (0.2%) | 2/2972 (0.1%) | |||||
| Malignant melanoma | 19/8502 (0.2%) | 19/8542 (0.2%) | 17/8576 (0.2%) | 2/2954 (0.1%) | 4/2972 (0.1%) | |||||
| Malignant melanoma in situ | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Malignant mesenchymoma | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Malignant neoplasm of ampulla of Vater | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Malignant neoplasm of eyelid | 0/8502 (0%) | 3/8542 (0%) | 2/8576 (0%) | 1/2954 (0%) | 1/2972 (0%) | |||||
| Malignant neoplasm of pleura | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Malignant neoplasm of spinal cord | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Malignant neoplasm of thorax | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Malignant peritoneal neoplasm | 0/8502 (0%) | 2/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Malignant pleural effusion | 0/8502 (0%) | 0/8542 (0%) | 2/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Malignant urinary tract neoplasm | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Mantle cell lymphoma | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Mediastinum neoplasm | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Meningioma | 3/8502 (0%) | 2/8542 (0%) | 3/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Meningioma benign | 1/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Mesothelioma | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Metastases to abdominal cavity | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Metastases to adrenals | 2/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Metastases to bladder | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Metastases to bone | 7/8502 (0.1%) | 5/8542 (0.1%) | 6/8576 (0.1%) | 0/2954 (0%) | 2/2972 (0.1%) | |||||
| Metastases to breast | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Metastases to central nervous system | 6/8502 (0.1%) | 6/8542 (0.1%) | 4/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Metastases to chest wall | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Metastases to kidney | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Metastases to large intestine | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Metastases to liver | 7/8502 (0.1%) | 8/8542 (0.1%) | 4/8576 (0%) | 2/2954 (0.1%) | 0/2972 (0%) | |||||
| Metastases to lung | 2/8502 (0%) | 7/8542 (0.1%) | 3/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Metastases to lymph nodes | 3/8502 (0%) | 2/8542 (0%) | 2/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Metastases to neck | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Metastases to ovary | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Metastases to pancreas | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Metastases to peritoneum | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Metastases to pharynx | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Metastases to pleura | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Metastases to soft tissue | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Metastases to spine | 1/8502 (0%) | 1/8542 (0%) | 2/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Metastases to spleen | 1/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Metastasis | 2/8502 (0%) | 3/8542 (0%) | 2/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Metastatic malignant melanoma | 0/8502 (0%) | 2/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Metastatic neoplasm | 6/8502 (0.1%) | 0/8542 (0%) | 4/8576 (0%) | 2/2954 (0.1%) | 0/2972 (0%) | |||||
| Metastatic pain | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Metastatic squamous cell carcinoma | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Mixed hepatocellular cholangiocarcinoma | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Multiple myeloma | 4/8502 (0%) | 7/8542 (0.1%) | 2/8576 (0%) | 3/2954 (0.1%) | 0/2972 (0%) | |||||
| Myelodysplastic syndrome | 5/8502 (0.1%) | 0/8542 (0%) | 3/8576 (0%) | 0/2954 (0%) | 3/2972 (0.1%) | |||||
| Myelofibrosis | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Myeloid leukaemia | 1/8502 (0%) | 1/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Myeloproliferative disorder | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Nasal cavity cancer | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Nasal neoplasm | 1/8502 (0%) | 3/8542 (0%) | 3/8576 (0%) | 1/2954 (0%) | 1/2972 (0%) | |||||
| Nasal sinus cancer | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Nasopharyngeal cancer | 0/8502 (0%) | 1/8542 (0%) | 3/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Neoplasm | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Neoplasm malignant | 10/8502 (0.1%) | 7/8542 (0.1%) | 8/8576 (0.1%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Neoplasm of appendix | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 1/2972 (0%) | |||||
| Neoplasm of thymus | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Neurilemmoma | 1/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Neuroendocrine carcinoma of the skin | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Non-Hodgkin's lymphoma | 6/8502 (0.1%) | 8/8542 (0.1%) | 6/8576 (0.1%) | 2/2954 (0.1%) | 2/2972 (0.1%) | |||||
| Non-Hodgkin's lymphoma recurrent | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Oesophageal cancer metastatic | 3/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Oesophageal carcinoma | 19/8502 (0.2%) | 10/8542 (0.1%) | 6/8576 (0.1%) | 0/2954 (0%) | 2/2972 (0.1%) | |||||
| Oesophageal neoplasm | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Omentum neoplasm | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Oral cavity cancer metastatic | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Oral neoplasm benign | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Oropharyngeal cancer stage III | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Oropharyngeal cancer stage unspecified | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Osteochondroma | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Ovarian adenoma | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Ovarian cancer | 2/8502 (0%) | 4/8542 (0%) | 8/8576 (0.1%) | 4/2954 (0.1%) | 2/2972 (0.1%) | |||||
| Ovarian cancer metastatic | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Ovarian epithelial cancer | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Ovarian neoplasm | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Pancreatic carcinoma | 18/8502 (0.2%) | 18/8542 (0.2%) | 20/8576 (0.2%) | 6/2954 (0.2%) | 5/2972 (0.2%) | |||||
| Papilloma | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Parathyroid tumour benign | 1/8502 (0%) | 2/8542 (0%) | 2/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Pelvic neoplasm | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Penile neoplasm | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Penis carcinoma | 1/8502 (0%) | 1/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Peritoneal neoplasm | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Pharyngeal cancer stage unspecified | 1/8502 (0%) | 3/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Pituitary tumour | 1/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Pituitary tumour benign | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Plasmacytoma | 1/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Pleural mesothelioma | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Pleural neoplasm | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Polycythaemia vera | 0/8502 (0%) | 2/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Prostate cancer | 132/8502 (1.6%) | 136/8542 (1.6%) | 119/8576 (1.4%) | 34/2954 (1.2%) | 24/2972 (0.8%) | |||||
| Prostate cancer metastatic | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Prostatic adenoma | 2/8502 (0%) | 3/8542 (0%) | 3/8576 (0%) | 1/2954 (0%) | 1/2972 (0%) | |||||
| Pseudomyxoma peritonei | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Rectal cancer | 3/8502 (0%) | 6/8542 (0.1%) | 10/8576 (0.1%) | 1/2954 (0%) | 1/2972 (0%) | |||||
| Rectosigmoid cancer | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Renal adenoma | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Renal cancer | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 7/2954 (0.2%) | 4/2972 (0.1%) | |||||
| Renal cell carcinoma | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Renal cell carcinoma stage unspecified | 19/8502 (0.2%) | 19/8542 (0.2%) | 17/8576 (0.2%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Renal oncocytoma | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Retroperitoneal cancer | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Retroperitoneal neoplasm | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Salivary gland cancer | 0/8502 (0%) | 7/8542 (0.1%) | 3/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Salivary gland neoplasm | 1/8502 (0%) | 1/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Sarcoma | 0/8502 (0%) | 1/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Skin cancer | 92/8502 (1.1%) | 100/8542 (1.2%) | 102/8576 (1.2%) | 22/2954 (0.7%) | 19/2972 (0.6%) | |||||
| Skin cancer metastatic | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Skin papilloma | 2/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Small cell carcinoma | 0/8502 (0%) | 2/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Small cell lung cancer stage unspecified | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Small intestine carcinoma | 1/8502 (0%) | 2/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Spinal cord neoplasm | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Squamous cell carcinoma | 9/8502 (0.1%) | 12/8542 (0.1%) | 15/8576 (0.2%) | 3/2954 (0.1%) | 0/2972 (0%) | |||||
| Squamous cell carcinoma of skin | 5/8502 (0.1%) | 0/8542 (0%) | 3/8576 (0%) | 1/2954 (0%) | 1/2972 (0%) | |||||
| Squamous cell carcinoma of the cervix | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Tendon neoplasm | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Testis cancer | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Throat cancer | 0/8502 (0%) | 3/8542 (0%) | 3/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Thymoma | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Thyroid adenoma | 1/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Thyroid cancer | 1/8502 (0%) | 2/8542 (0%) | 2/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Thyroid neoplasm | 2/8502 (0%) | 3/8542 (0%) | 4/8576 (0%) | 2/2954 (0.1%) | 1/2972 (0%) | |||||
| Tongue cancer metastatic | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Tongue neoplasm | 4/8502 (0%) | 4/8542 (0%) | 2/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Tongue neoplasm malignant stage unspecified | 3/8502 (0%) | 1/8542 (0%) | 3/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Tonsil cancer | 0/8502 (0%) | 2/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Transitional cell carcinoma | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Ureteric cancer | 4/8502 (0%) | 1/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Urethral cancer | 0/8502 (0%) | 3/8542 (0%) | 2/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Urethral cancer recurrent | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Urinary tract neoplasm | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Uterine cancer | 8/8502 (0.1%) | 8/8542 (0.1%) | 3/8576 (0%) | 3/2954 (0.1%) | 2/2972 (0.1%) | |||||
| Uterine leiomyoma | 0/8502 (0%) | 0/8542 (0%) | 2/8576 (0%) | 0/2954 (0%) | 3/2972 (0.1%) | |||||
| Vocal cord neoplasm | 2/8502 (0%) | 2/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Vulval cancer | 1/8502 (0%) | 2/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Nervous system disorders | ||||||||||
| Amnesia | 1/8502 (0%) | 2/8542 (0%) | 1/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Amyotrophic lateral sclerosis | 1/8502 (0%) | 3/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Anaesthesia | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Anoxic encephalopathy | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Aphasia | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Ataxia | 2/8502 (0%) | 3/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 1/2972 (0%) | |||||
| Autonomic nervous system imbalance | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Balance disorder | 2/8502 (0%) | 1/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Benign intracranial hypertension | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Brain injury | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Brain mass | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Brain oedema | 0/8502 (0%) | 2/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Brain stem infarction | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Brain stem ischaemia | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Burning sensation | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Carotid artery disease | 1/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Carotid artery occlusion | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Carotid artery stenosis | 4/8502 (0%) | 1/8542 (0%) | 4/8576 (0%) | 1/2954 (0%) | 1/2972 (0%) | |||||
| Carotid sinus syndrome | 2/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Carpal tunnel syndrome | 2/8502 (0%) | 6/8542 (0.1%) | 0/8576 (0%) | 1/2954 (0%) | 1/2972 (0%) | |||||
| Cauda equina syndrome | 0/8502 (0%) | 0/8542 (0%) | 2/8576 (0%) | 1/2954 (0%) | 1/2972 (0%) | |||||
| Cerebral arteriosclerosis | 0/8502 (0%) | 2/8542 (0%) | 0/8576 (0%) | 2/2954 (0.1%) | 0/2972 (0%) | |||||
| Cerebral artery embolism | 0/8502 (0%) | 1/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Cerebral artery occlusion | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Cerebral circulatory failure | 0/8502 (0%) | 0/8542 (0%) | 2/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Cerebral haematoma | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Cerebral haemorrhage | 32/8502 (0.4%) | 34/8542 (0.4%) | 44/8576 (0.5%) | 8/2954 (0.3%) | 16/2972 (0.5%) | |||||
| Cerebral hypoperfusion | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Cerebral infarction | 254/8502 (3%) | 259/8542 (3%) | 271/8576 (3.2%) | 82/2954 (2.8%) | 93/2972 (3.1%) | |||||
| Cerebral ischaemia | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Cerebrovascular accident | 144/8502 (1.7%) | 141/8542 (1.7%) | 162/8576 (1.9%) | 51/2954 (1.7%) | 53/2972 (1.8%) | |||||
| Cerebrovascular disorder | 1/8502 (0%) | 2/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Cerebrovascular insufficiency | 1/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Cervical myelopathy | 1/8502 (0%) | 2/8542 (0%) | 0/8576 (0%) | 2/2954 (0.1%) | 0/2972 (0%) | |||||
| Cervical root pain | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Cervicobrachial syndrome | 1/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Chronic inflammatory demyelinating polyradiculoneuropathy | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Cognitive disorder | 0/8502 (0%) | 1/8542 (0%) | 2/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Coma | 1/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Complex partial seizures | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Convulsion | 15/8502 (0.2%) | 15/8542 (0.2%) | 9/8576 (0.1%) | 6/2954 (0.2%) | 5/2972 (0.2%) | |||||
| Dementia | 16/8502 (0.2%) | 6/8542 (0.1%) | 16/8576 (0.2%) | 4/2954 (0.1%) | 1/2972 (0%) | |||||
| Dementia Alzheimer's type | 6/8502 (0.1%) | 2/8542 (0%) | 2/8576 (0%) | 0/2954 (0%) | 2/2972 (0.1%) | |||||
| Dementia of the Alzheimer's type, with delirium | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Diabetic hyperosmolar coma | 2/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Diabetic neuropathy | 4/8502 (0%) | 1/8542 (0%) | 3/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Dizziness | 44/8502 (0.5%) | 51/8542 (0.6%) | 40/8576 (0.5%) | 11/2954 (0.4%) | 10/2972 (0.3%) | |||||
| Dizziness exertional | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Dizziness postural | 1/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Drop attacks | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Dysarthria | 1/8502 (0%) | 1/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Dysphasia | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Encephalitis | 1/8502 (0%) | 0/8542 (0%) | 2/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Encephalopathy | 5/8502 (0.1%) | 6/8542 (0.1%) | 9/8576 (0.1%) | 1/2954 (0%) | 5/2972 (0.2%) | |||||
| Epilepsy | 6/8502 (0.1%) | 8/8542 (0.1%) | 10/8576 (0.1%) | 5/2954 (0.2%) | 3/2972 (0.1%) | |||||
| Extrapyramidal disorder | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Facial palsy | 1/8502 (0%) | 4/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Facial paresis | 2/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 1/2972 (0%) | |||||
| Global amnesia | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Grand mal convulsion | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Guillain-Barre syndrome | 1/8502 (0%) | 1/8542 (0%) | 3/8576 (0%) | 0/2954 (0%) | 2/2972 (0.1%) | |||||
| Haemorrhage intracranial | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Headache | 4/8502 (0%) | 16/8542 (0.2%) | 5/8576 (0.1%) | 3/2954 (0.1%) | 8/2972 (0.3%) | |||||
| Hemiparesis | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Hemiplegia | 1/8502 (0%) | 2/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Hepatic encephalopathy | 2/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 1/2972 (0%) | |||||
| Hydrocephalus | 2/8502 (0%) | 1/8542 (0%) | 1/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Hyperpathia | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Hypersomnia | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Hypertensive encephalopathy | 2/8502 (0%) | 2/8542 (0%) | 1/8576 (0%) | 1/2954 (0%) | 4/2972 (0.1%) | |||||
| Hypertonia | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Hypoaesthesia | 1/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Hypokinesia | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Hypotonia | 4/8502 (0%) | 2/8542 (0%) | 2/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Hypotonic-hyporesponsive episode | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Hypoxic encephalopathy | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| IIIrd nerve paralysis | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Intercostal neuralgia | 0/8502 (0%) | 1/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Intracranial aneurysm | 2/8502 (0%) | 0/8542 (0%) | 2/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Intracranial venous sinus thrombosis | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Intraventricular haemorrhage | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Ischaemic neuropathy | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Lacunar infarction | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Lethargy | 1/8502 (0%) | 1/8542 (0%) | 3/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Loss of consciousness | 4/8502 (0%) | 6/8542 (0.1%) | 3/8576 (0%) | 1/2954 (0%) | 2/2972 (0.1%) | |||||
| Lumbar radiculopathy | 2/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Memory impairment | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Mental impairment | 2/8502 (0%) | 2/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Metabolic encephalopathy | 0/8502 (0%) | 0/8542 (0%) | 2/8576 (0%) | 1/2954 (0%) | 1/2972 (0%) | |||||
| Migraine | 1/8502 (0%) | 2/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Motor neurone disease | 0/8502 (0%) | 2/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Multiple sclerosis | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Myasthenia gravis | 1/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Myasthenic syndrome | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Myelitis | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Myelopathy | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Nerve compression | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Nervous system disorder | 1/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Neuralgia | 1/8502 (0%) | 0/8542 (0%) | 2/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Neuritis | 0/8502 (0%) | 0/8542 (0%) | 2/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Neurodegenerative disorder | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Neurological symptom | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Neuropathy | 4/8502 (0%) | 3/8542 (0%) | 3/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Neuropathy peripheral | 1/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 2/2954 (0.1%) | 2/2972 (0.1%) | |||||
| Normal pressure hydrocephalus | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Optic neuritis | 1/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Paraesthesia | 3/8502 (0%) | 1/8542 (0%) | 2/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Paraparesis | 0/8502 (0%) | 2/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Paresis | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Parkinson's disease | 5/8502 (0.1%) | 6/8542 (0.1%) | 0/8576 (0%) | 1/2954 (0%) | 1/2972 (0%) | |||||
| Parkinsonism | 2/8502 (0%) | 1/8542 (0%) | 4/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Partial seizures | 0/8502 (0%) | 1/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Peripheral paralysis | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Peripheral sensory neuropathy | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Peroneal nerve palsy | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Polyneuropathy | 3/8502 (0%) | 0/8542 (0%) | 3/8576 (0%) | 2/2954 (0.1%) | 1/2972 (0%) | |||||
| Post herpetic neuralgia | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Post-traumatic epilepsy | 0/8502 (0%) | 0/8542 (0%) | 2/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Postictal state | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Presyncope | 16/8502 (0.2%) | 14/8542 (0.2%) | 13/8576 (0.2%) | 2/2954 (0.1%) | 4/2972 (0.1%) | |||||
| Pseudobulbar palsy | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Radicular pain | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Radicular syndrome | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Radiculitis | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Radiculitis lumbosacral | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Radiculopathy | 0/8502 (0%) | 0/8542 (0%) | 3/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Ruptured cerebral aneurysm | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Sciatica | 11/8502 (0.1%) | 6/8542 (0.1%) | 7/8576 (0.1%) | 1/2954 (0%) | 2/2972 (0.1%) | |||||
| Somnolence | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Speech disorder | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Spinal claudication | 0/8502 (0%) | 0/8542 (0%) | 2/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Spinal cord compression | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Spinal cord ischaemia | 0/8502 (0%) | 1/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Spinal epidural haemorrhage | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Spondylitic myelopathy | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Status epilepticus | 0/8502 (0%) | 2/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Subarachnoid haemorrhage | 6/8502 (0.1%) | 10/8542 (0.1%) | 7/8576 (0.1%) | 0/2954 (0%) | 2/2972 (0.1%) | |||||
| Supranuclear palsy | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Syncope | 112/8502 (1.3%) | 133/8542 (1.6%) | 127/8576 (1.5%) | 31/2954 (1%) | 19/2972 (0.6%) | |||||
| Syncope vasovagal | 14/8502 (0.2%) | 13/8542 (0.2%) | 13/8576 (0.2%) | 2/2954 (0.1%) | 0/2972 (0%) | |||||
| Tension headache | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Tonic convulsion | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Toxic encephalopathy | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Transient ischaemic attack | 192/8502 (2.3%) | 183/8542 (2.1%) | 199/8576 (2.3%) | 57/2954 (1.9%) | 60/2972 (2%) | |||||
| Tremor | 0/8502 (0%) | 2/8542 (0%) | 2/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Trigeminal neuralgia | 1/8502 (0%) | 1/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Vascular dementia | 1/8502 (0%) | 1/8542 (0%) | 3/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Vascular encephalopathy | 1/8502 (0%) | 3/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 1/2972 (0%) | |||||
| Vascular headache | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Vertebral artery stenosis | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Vertebrobasilar insufficiency | 3/8502 (0%) | 6/8542 (0.1%) | 3/8576 (0%) | 1/2954 (0%) | 5/2972 (0.2%) | |||||
| Vertigo CNS origin | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Wernicke's encephalopathy | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Pregnancy, puerperium and perinatal conditions | ||||||||||
| Perineal haematoma | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Psychiatric disorders | ||||||||||
| Abnormal behaviour | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Acute psychosis | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Agitation | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Alcohol abuse | 2/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Alcohol withdrawal syndrome | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Alcoholism | 0/8502 (0%) | 1/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Anxiety | 9/8502 (0.1%) | 5/8542 (0.1%) | 4/8576 (0%) | 4/2954 (0.1%) | 0/2972 (0%) | |||||
| Anxiety disorder | 1/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Bipolar disorder | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Cardiac neurosis | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Catatonia | 2/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Completed suicide | 5/8502 (0.1%) | 5/8542 (0.1%) | 3/8576 (0%) | 4/2954 (0.1%) | 0/2972 (0%) | |||||
| Conduct disorder | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Confusional state | 14/8502 (0.2%) | 11/8542 (0.1%) | 5/8576 (0.1%) | 3/2954 (0.1%) | 4/2972 (0.1%) | |||||
| Conversion disorder | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Delirium | 4/8502 (0%) | 1/8542 (0%) | 3/8576 (0%) | 1/2954 (0%) | 1/2972 (0%) | |||||
| Delirium tremens | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Delusional disorder, persecutory type | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Depression | 20/8502 (0.2%) | 20/8542 (0.2%) | 13/8576 (0.2%) | 4/2954 (0.1%) | 1/2972 (0%) | |||||
| Depression suicidal | 1/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Disorientation | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Drug abuse | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Dysphoria | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Emotional distress | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Hallucination | 1/8502 (0%) | 1/8542 (0%) | 3/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Hallucination, auditory | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Initial insomnia | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Insomnia | 1/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Major depression | 2/8502 (0%) | 2/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 2/2972 (0.1%) | |||||
| Mental disorder | 1/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Mental status changes | 7/8502 (0.1%) | 9/8542 (0.1%) | 8/8576 (0.1%) | 2/2954 (0.1%) | 3/2972 (0.1%) | |||||
| Narcissistic personality disorder | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Nervousness | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Neurosis | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Panic attack | 3/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Personality change due to a general medical condition | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Phobia | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Post-traumatic stress disorder | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Psychosomatic disease | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Psychotic disorder | 3/8502 (0%) | 0/8542 (0%) | 2/8576 (0%) | 1/2954 (0%) | 1/2972 (0%) | |||||
| Psychotic disorder due to a general medical condition | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Schizophrenia, paranoid type | 1/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Stress | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Substance abuse | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Suicidal ideation | 0/8502 (0%) | 0/8542 (0%) | 2/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Suicide attempt | 1/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Renal and urinary disorders | ||||||||||
| Acute prerenal failure | 6/8502 (0.1%) | 6/8542 (0.1%) | 2/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Anuria | 2/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Azotaemia | 3/8502 (0%) | 4/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 2/2972 (0.1%) | |||||
| Bladder cyst | 0/8502 (0%) | 1/8542 (0%) | 1/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Bladder dilatation | 0/8502 (0%) | 1/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Bladder disorder | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Bladder mass | 1/8502 (0%) | 2/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Bladder neck obstruction | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Bladder neck sclerosis | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Bladder obstruction | 2/8502 (0%) | 1/8542 (0%) | 2/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Bladder stenosis | 2/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Calculus bladder | 4/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Calculus ureteric | 4/8502 (0%) | 3/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Calculus urethral | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Calculus urinary | 7/8502 (0.1%) | 5/8542 (0.1%) | 6/8576 (0.1%) | 3/2954 (0.1%) | 3/2972 (0.1%) | |||||
| Cystitis haemorrhagic | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Cystitis noninfective | 1/8502 (0%) | 1/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Diabetic end stage renal disease | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Diabetic nephropathy | 192/8502 (2.3%) | 181/8542 (2.1%) | 180/8576 (2.1%) | 57/2954 (1.9%) | 61/2972 (2.1%) | |||||
| Dysuria | 1/8502 (0%) | 6/8542 (0.1%) | 2/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Enuresis | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Glomerulonephritis | 2/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Glomerulonephritis chronic | 1/8502 (0%) | 1/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Glomerulonephritis membranous | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Glomerulonephritis proliferative | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Glomerulosclerosis | 3/8502 (0%) | 4/8542 (0%) | 5/8576 (0.1%) | 2/2954 (0.1%) | 0/2972 (0%) | |||||
| Haematuria | 19/8502 (0.2%) | 18/8542 (0.2%) | 24/8576 (0.3%) | 3/2954 (0.1%) | 4/2972 (0.1%) | |||||
| Hydronephrosis | 2/8502 (0%) | 3/8542 (0%) | 3/8576 (0%) | 2/2954 (0.1%) | 1/2972 (0%) | |||||
| Hypertensive nephropathy | 15/8502 (0.2%) | 8/8542 (0.1%) | 14/8576 (0.2%) | 8/2954 (0.3%) | 1/2972 (0%) | |||||
| Hypertonic bladder | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Incontinence | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Kidney fibrosis | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Microalbuminuria | 1/8502 (0%) | 2/8542 (0%) | 3/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Nephritis | 1/8502 (0%) | 0/8542 (0%) | 2/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Nephritis interstitial | 1/8502 (0%) | 1/8542 (0%) | 1/8576 (0%) | 2/2954 (0.1%) | 1/2972 (0%) | |||||
| Nephroangiosclerosis | 3/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Nephrolithiasis | 19/8502 (0.2%) | 18/8542 (0.2%) | 22/8576 (0.3%) | 7/2954 (0.2%) | 4/2972 (0.1%) | |||||
| Nephropathy | 4/8502 (0%) | 3/8542 (0%) | 5/8576 (0.1%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Nephropathy toxic | 3/8502 (0%) | 6/8542 (0.1%) | 2/8576 (0%) | 1/2954 (0%) | 2/2972 (0.1%) | |||||
| Nephrosclerosis | 6/8502 (0.1%) | 3/8542 (0%) | 5/8576 (0.1%) | 5/2954 (0.2%) | 1/2972 (0%) | |||||
| Nephrotic syndrome | 2/8502 (0%) | 5/8542 (0.1%) | 1/8576 (0%) | 0/2954 (0%) | 2/2972 (0.1%) | |||||
| Neurogenic bladder | 1/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Obstructive uropathy | 1/8502 (0%) | 3/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Oliguria | 1/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Pelvi-ureteric obstruction | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Pollakiuria | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Polyuria | 0/8502 (0%) | 1/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Proteinuria | 2/8502 (0%) | 1/8542 (0%) | 5/8576 (0.1%) | 2/2954 (0.1%) | 2/2972 (0.1%) | |||||
| Renal aneurysm | 1/8502 (0%) | 1/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Renal artery arteriosclerosis | 2/8502 (0%) | 1/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Renal artery occlusion | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Renal artery stenosis | 9/8502 (0.1%) | 6/8542 (0.1%) | 3/8576 (0%) | 1/2954 (0%) | 6/2972 (0.2%) | |||||
| Renal atrophy | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Renal colic | 5/8502 (0.1%) | 4/8542 (0%) | 5/8576 (0.1%) | 3/2954 (0.1%) | 1/2972 (0%) | |||||
| Renal cyst | 4/8502 (0%) | 2/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 2/2972 (0.1%) | |||||
| Renal disorder | 3/8502 (0%) | 1/8542 (0%) | 2/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Renal embolism | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Renal failure | 140/8502 (1.6%) | 115/8542 (1.3%) | 107/8576 (1.2%) | 23/2954 (0.8%) | 19/2972 (0.6%) | |||||
| Renal failure acute | 61/8502 (0.7%) | 36/8542 (0.4%) | 29/8576 (0.3%) | 7/2954 (0.2%) | 11/2972 (0.4%) | |||||
| Renal failure chronic | 25/8502 (0.3%) | 11/8542 (0.1%) | 10/8576 (0.1%) | 5/2954 (0.2%) | 6/2972 (0.2%) | |||||
| Renal impairment | 20/8502 (0.2%) | 18/8542 (0.2%) | 13/8576 (0.2%) | 8/2954 (0.3%) | 3/2972 (0.1%) | |||||
| Renal infarct | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Renal ischaemia | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 2/2954 (0.1%) | 0/2972 (0%) | |||||
| Renal mass | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Renal tubular acidosis | 0/8502 (0%) | 2/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Renal tubular necrosis | 0/8502 (0%) | 2/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Renal vessel disorder | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Residual urine | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Stag horn calculus | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Stress urinary incontinence | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Urate nephropathy | 2/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Ureteral disorder | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Ureteric dilatation | 1/8502 (0%) | 2/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Ureteric obstruction | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Ureteric stenosis | 1/8502 (0%) | 2/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Urethral dilatation | 1/8502 (0%) | 3/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Urethral obstruction | 0/8502 (0%) | 1/8542 (0%) | 2/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Urethral stenosis | 5/8502 (0.1%) | 4/8542 (0%) | 2/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Urinary bladder haemorrhage | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Urinary bladder polyp | 2/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Urinary incontinence | 2/8502 (0%) | 1/8542 (0%) | 2/8576 (0%) | 1/2954 (0%) | 1/2972 (0%) | |||||
| Urinary retention | 12/8502 (0.1%) | 17/8542 (0.2%) | 25/8576 (0.3%) | 3/2954 (0.1%) | 4/2972 (0.1%) | |||||
| Urinary tract disorder | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Urinary tract inflammation | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Urinary tract obstruction | 3/8502 (0%) | 0/8542 (0%) | 3/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Urinoma | 1/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Urogenital fistula | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Urogenital haemorrhage | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Vesical fistula | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Vesicoureteric reflux | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Reproductive system and breast disorders | ||||||||||
| Balanitis | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Benign prostatic hyperplasia | 25/8502 (0.3%) | 30/8542 (0.4%) | 25/8576 (0.3%) | 3/2954 (0.1%) | 6/2972 (0.2%) | |||||
| Breast cyst | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Breast dysplasia | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Breast haematoma | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Breast inflammation | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Breast pain | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Calculus prostatic | 0/8502 (0%) | 1/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Colpocele | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Cystocele | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Endometrial hyperplasia | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Endometriosis | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Epididymal cyst | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Epididymitis | 1/8502 (0%) | 1/8542 (0%) | 2/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Erectile dysfunction | 2/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Female genital tract fistula | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Fibrocystic breast disease | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Genital prolapse | 3/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Gynaecomastia | 2/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Metrorrhagia | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Oedema genital | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Orchitis noninfective | 1/8502 (0%) | 0/8542 (0%) | 4/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Organic erectile dysfunction | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Ovarian cyst | 1/8502 (0%) | 2/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 2/2972 (0.1%) | |||||
| Pelvic pain | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Peyronie's disease | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Postmenopausal haemorrhage | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 1/2972 (0%) | |||||
| Prostatic atrophy | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Prostatic disorder | 0/8502 (0%) | 1/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Prostatic obstruction | 1/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Prostatism | 1/8502 (0%) | 0/8542 (0%) | 3/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Prostatitis | 3/8502 (0%) | 6/8542 (0.1%) | 1/8576 (0%) | 4/2954 (0.1%) | 1/2972 (0%) | |||||
| Prostatomegaly | 5/8502 (0.1%) | 2/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Scrotal oedema | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Testicular mass | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Testicular swelling | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Testicular torsion | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Urogenital prolapse | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Uterine cervical erosion | 1/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Uterine cyst | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Uterine disorder | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Uterine fistula | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Uterine haemorrhage | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Uterine polyp | 0/8502 (0%) | 2/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Uterine prolapse | 2/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Uterovaginal prolapse | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Vaginal inflammation | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Vaginal lesion | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Vaginal prolapse | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Vulval ulceration | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||
| Acute pulmonary oedema | 6/8502 (0.1%) | 9/8542 (0.1%) | 12/8576 (0.1%) | 2/2954 (0.1%) | 3/2972 (0.1%) | |||||
| Acute respiratory distress syndrome | 0/8502 (0%) | 1/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 2/2972 (0.1%) | |||||
| Acute respiratory failure | 6/8502 (0.1%) | 5/8542 (0.1%) | 5/8576 (0.1%) | 1/2954 (0%) | 2/2972 (0.1%) | |||||
| Allergic respiratory disease | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Alveolitis fibrosing | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Anoxia | 0/8502 (0%) | 1/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Apnoea | 1/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Asphyxia | 1/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Aspiration | 0/8502 (0%) | 0/8542 (0%) | 3/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Asthma | 23/8502 (0.3%) | 17/8542 (0.2%) | 22/8576 (0.3%) | 11/2954 (0.4%) | 12/2972 (0.4%) | |||||
| Asthmatic crisis | 1/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Bronchial hyperreactivity | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Bronchial polyp | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Bronchitis chronic | 7/8502 (0.1%) | 7/8542 (0.1%) | 7/8576 (0.1%) | 8/2954 (0.3%) | 7/2972 (0.2%) | |||||
| Broncholithiasis | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Bronchopneumopathy | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Bronchopulmonary disease | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Bronchospasm | 3/8502 (0%) | 0/8542 (0%) | 2/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Chronic obstructive pulmonary disease | 52/8502 (0.6%) | 61/8542 (0.7%) | 66/8576 (0.8%) | 16/2954 (0.5%) | 24/2972 (0.8%) | |||||
| Chronic respiratory disease | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Chronic respiratory failure | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Cough | 12/8502 (0.1%) | 6/8542 (0.1%) | 11/8576 (0.1%) | 1/2954 (0%) | 4/2972 (0.1%) | |||||
| Diaphragmatic paralysis | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Dysphonia | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Dyspnoea | 50/8502 (0.6%) | 51/8542 (0.6%) | 52/8576 (0.6%) | 12/2954 (0.4%) | 10/2972 (0.3%) | |||||
| Dyspnoea exertional | 1/8502 (0%) | 2/8542 (0%) | 4/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Emphysema | 1/8502 (0%) | 3/8542 (0%) | 3/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Epistaxis | 16/8502 (0.2%) | 10/8542 (0.1%) | 12/8576 (0.1%) | 5/2954 (0.2%) | 3/2972 (0.1%) | |||||
| Haemoptysis | 7/8502 (0.1%) | 9/8542 (0.1%) | 8/8576 (0.1%) | 3/2954 (0.1%) | 7/2972 (0.2%) | |||||
| Haemothorax | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Hydropneumothorax | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Hyperventilation | 2/8502 (0%) | 2/8542 (0%) | 3/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Hypoxia | 5/8502 (0.1%) | 4/8542 (0%) | 4/8576 (0%) | 1/2954 (0%) | 1/2972 (0%) | |||||
| Idiopathic pulmonary fibrosis | 2/8502 (0%) | 1/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Interstitial lung disease | 3/8502 (0%) | 2/8542 (0%) | 3/8576 (0%) | 2/2954 (0.1%) | 0/2972 (0%) | |||||
| Laryngitis allergic | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Lung consolidation | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Lung disorder | 2/8502 (0%) | 3/8542 (0%) | 7/8576 (0.1%) | 3/2954 (0.1%) | 2/2972 (0.1%) | |||||
| Lung infiltration | 0/8502 (0%) | 1/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Mediastinal cyst | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Mediastinal mass | 1/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Nasal congestion | 2/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Nasal cyst | 1/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Nasal polyps | 1/8502 (0%) | 2/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Nasal septum deviation | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Nocturnal dyspnoea | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Obstructive airways disorder | 1/8502 (0%) | 1/8542 (0%) | 2/8576 (0%) | 0/2954 (0%) | 2/2972 (0.1%) | |||||
| Orthopnoea | 0/8502 (0%) | 1/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Pharyngolaryngeal pain | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Pleural effusion | 14/8502 (0.2%) | 15/8542 (0.2%) | 19/8576 (0.2%) | 3/2954 (0.1%) | 3/2972 (0.1%) | |||||
| Pleural haemorrhage | 0/8502 (0%) | 0/8542 (0%) | 2/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Pleurisy | 2/8502 (0%) | 5/8542 (0.1%) | 6/8576 (0.1%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Pleuritic pain | 2/8502 (0%) | 1/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Pneumonia aspiration | 6/8502 (0.1%) | 7/8542 (0.1%) | 4/8576 (0%) | 2/2954 (0.1%) | 3/2972 (0.1%) | |||||
| Pneumonitis | 2/8502 (0%) | 3/8542 (0%) | 2/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Pneumothorax | 5/8502 (0.1%) | 3/8542 (0%) | 4/8576 (0%) | 3/2954 (0.1%) | 0/2972 (0%) | |||||
| Pneumothorax spontaneous tension | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Productive cough | 0/8502 (0%) | 1/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Pulmonary alveolar haemorrhage | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Pulmonary congestion | 2/8502 (0%) | 0/8542 (0%) | 2/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Pulmonary embolism | 41/8502 (0.5%) | 50/8542 (0.6%) | 35/8576 (0.4%) | 14/2954 (0.5%) | 14/2972 (0.5%) | |||||
| Pulmonary fibrosis | 6/8502 (0.1%) | 5/8542 (0.1%) | 8/8576 (0.1%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Pulmonary haemorrhage | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Pulmonary hypertension | 2/8502 (0%) | 4/8542 (0%) | 2/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Pulmonary mass | 2/8502 (0%) | 2/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Pulmonary oedema | 6/8502 (0.1%) | 9/8542 (0.1%) | 12/8576 (0.1%) | 6/2954 (0.2%) | 1/2972 (0%) | |||||
| Pulmonary sarcoidosis | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Pulmonary venous thrombosis | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Respiratory acidosis | 0/8502 (0%) | 1/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Respiratory arrest | 2/8502 (0%) | 1/8542 (0%) | 2/8576 (0%) | 2/2954 (0.1%) | 1/2972 (0%) | |||||
| Respiratory depression | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Respiratory disorder | 0/8502 (0%) | 2/8542 (0%) | 0/8576 (0%) | 2/2954 (0.1%) | 0/2972 (0%) | |||||
| Respiratory distress | 0/8502 (0%) | 2/8542 (0%) | 3/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Respiratory failure | 23/8502 (0.3%) | 24/8542 (0.3%) | 33/8576 (0.4%) | 5/2954 (0.2%) | 7/2972 (0.2%) | |||||
| Sinus disorder | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Sleep apnoea syndrome | 10/8502 (0.1%) | 14/8542 (0.2%) | 15/8576 (0.2%) | 1/2954 (0%) | 8/2972 (0.3%) | |||||
| Snoring | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Sputum retention | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Tachypnoea | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Vocal cord disorder | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Vocal cord polyp | 1/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Wegener's granulomatosis | 1/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Wheezing | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Skin and subcutaneous tissue disorders | ||||||||||
| Actinic keratosis | 2/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Acute febrile neutrophilic dermatosis | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Angioedema | 8/8502 (0.1%) | 5/8542 (0.1%) | 16/8576 (0.2%) | 1/2954 (0%) | 1/2972 (0%) | |||||
| Cold sweat | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Cutaneous amyloidosis | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Decubitus ulcer | 3/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 2/2954 (0.1%) | 0/2972 (0%) | |||||
| Dermal cyst | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Dermatitis | 0/8502 (0%) | 1/8542 (0%) | 2/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Dermatitis allergic | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Dermatitis bullous | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Diabetic ulcer | 108/8502 (1.3%) | 121/8542 (1.4%) | 114/8576 (1.3%) | 18/2954 (0.6%) | 19/2972 (0.6%) | |||||
| Drug eruption | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Drug rash with eosinophilia and systemic symptoms | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Eczema | 0/8502 (0%) | 0/8542 (0%) | 2/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Erythema | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Erythema multiforme | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Erythema nodosum | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Henoch-Schonlein purpura | 1/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Hyperhidrosis | 0/8502 (0%) | 2/8542 (0%) | 2/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Hyperkeratosis | 2/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Hypoaesthesia facial | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Lichen planus | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Neurodermatitis | 2/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Parapsoriasis | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Pemphigoid | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Pemphigus | 2/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Petechiae | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Pruritus | 0/8502 (0%) | 1/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Psoriasis | 1/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Purpura | 0/8502 (0%) | 1/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Rash | 3/8502 (0%) | 3/8542 (0%) | 1/8576 (0%) | 2/2954 (0.1%) | 0/2972 (0%) | |||||
| Scar | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Skin burning sensation | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Skin lesion | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Skin necrosis | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Skin reaction | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Skin ulcer | 285/8502 (3.4%) | 314/8542 (3.7%) | 321/8576 (3.7%) | 74/2954 (2.5%) | 59/2972 (2%) | |||||
| Stasis dermatitis | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Stevens-Johnson syndrome | 1/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Toxic skin eruption | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Urticaria | 3/8502 (0%) | 0/8542 (0%) | 2/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Social circumstances | ||||||||||
| Alcohol use | 0/8502 (0%) | 1/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Cardiac assistance device user | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Cardiac valve prosthesis user | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Death of relative | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Exercise adequate | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Hearing disability | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Homicide | 1/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Joint prosthesis user | 1/8502 (0%) | 1/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Limb prosthesis user | 1/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Living in residential institution | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Overwork | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Physical assault | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Refusal of treatment by patient | 0/8502 (0%) | 1/8542 (0%) | 1/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Respite care | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Sexual relationship change | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Social stay hospitalisation | 9/8502 (0.1%) | 6/8542 (0.1%) | 3/8576 (0%) | 1/2954 (0%) | 4/2972 (0.1%) | |||||
| Treatment noncompliance | 2/8502 (0%) | 2/8542 (0%) | 2/8576 (0%) | 3/2954 (0.1%) | 1/2972 (0%) | |||||
| Victim of crime | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Walking disability | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Surgical and medical procedures | ||||||||||
| Abdominal cavity drainage | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Abdominal hernia repair | 4/8502 (0%) | 5/8542 (0.1%) | 2/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Abdominal operation | 0/8502 (0%) | 1/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Abdominoplasty | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Abscess drainage | 1/8502 (0%) | 3/8542 (0%) | 4/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Adenoidectomy | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Adhesiolysis | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Alcohol rehabilitation | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Amputation | 34/8502 (0.4%) | 47/8542 (0.6%) | 39/8576 (0.5%) | 6/2954 (0.2%) | 6/2972 (0.2%) | |||||
| Amputation of penis | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Amputation revision | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Anal fissure excision | 2/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Anal fistula excision | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Anal lesion excision | 1/8502 (0%) | 1/8542 (0%) | 2/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Anal sphincterotomy | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Analgesic intervention supportive therapy | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Analgesic therapy | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Angioplasty | 346/8502 (4.1%) | 333/8542 (3.9%) | 317/8576 (3.7%) | 71/2954 (2.4%) | 68/2972 (2.3%) | |||||
| Ankle arthroplasty | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Ankle operation | 0/8502 (0%) | 1/8542 (0%) | 2/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Ankle reconstruction | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Antibiotic prophylaxis | 1/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Anticoagulant therapy | 3/8502 (0%) | 1/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Aortic aneurysm repair | 18/8502 (0.2%) | 17/8542 (0.2%) | 14/8576 (0.2%) | 1/2954 (0%) | 1/2972 (0%) | |||||
| Aortic bypass | 4/8502 (0%) | 3/8542 (0%) | 3/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Aortic surgery | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 2/2972 (0.1%) | |||||
| Aortic valve repair | 4/8502 (0%) | 2/8542 (0%) | 7/8576 (0.1%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Aortic valve replacement | 17/8502 (0.2%) | 30/8542 (0.4%) | 24/8576 (0.3%) | 6/2954 (0.2%) | 13/2972 (0.4%) | |||||
| Appendicectomy | 6/8502 (0.1%) | 5/8542 (0.1%) | 11/8576 (0.1%) | 1/2954 (0%) | 2/2972 (0.1%) | |||||
| Arterial aneurysm repair | 1/8502 (0%) | 1/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Arterial bypass operation | 6/8502 (0.1%) | 3/8542 (0%) | 4/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Arterial stent insertion | 3/8502 (0%) | 2/8542 (0%) | 5/8576 (0.1%) | 1/2954 (0%) | 1/2972 (0%) | |||||
| Arteriovenous fistula operation | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Arteriovenous graft | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Arteriovenous shunt operation | 1/8502 (0%) | 0/8542 (0%) | 3/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Arthrodesis | 0/8502 (0%) | 4/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Arthroscopic surgery | 1/8502 (0%) | 2/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Artificial urinary sphincter implant | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Atrial septal defect repair | 0/8502 (0%) | 1/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Balneotherapy | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Benign tumour excision | 2/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Bilateral orchidectomy | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Bile duct T-tube removal | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Biliary tract operation | 3/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Bladder catheterisation | 1/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Bladder lesion excision | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Bladder neck resection | 1/8502 (0%) | 2/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Bladder neoplasm surgery | 1/8502 (0%) | 2/8542 (0%) | 2/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Bladder operation | 1/8502 (0%) | 4/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Bladder polypectomy | 0/8502 (0%) | 3/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Bladder repair | 1/8502 (0%) | 4/8542 (0%) | 1/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Bladder sphincterectomy | 1/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Blood pressure management | 1/8502 (0%) | 1/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Bone debridement | 1/8502 (0%) | 1/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Bone operation | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Brachytherapy | 2/8502 (0%) | 1/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Brachytherapy to prostate | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Brachytherapy to uterus | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Brain operation | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Breast operation | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Bunion operation | 3/8502 (0%) | 4/8542 (0%) | 3/8576 (0%) | 1/2954 (0%) | 3/2972 (0.1%) | |||||
| Burn debridement | 0/8502 (0%) | 0/8542 (0%) | 2/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Bursa removal | 0/8502 (0%) | 2/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Cardiac ablation | 2/8502 (0%) | 7/8542 (0.1%) | 2/8576 (0%) | 1/2954 (0%) | 1/2972 (0%) | |||||
| Cardiac aneurysm repair | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Cardiac pacemaker battery replacement | 4/8502 (0%) | 6/8542 (0.1%) | 4/8576 (0%) | 0/2954 (0%) | 2/2972 (0.1%) | |||||
| Cardiac pacemaker insertion | 56/8502 (0.7%) | 62/8542 (0.7%) | 69/8576 (0.8%) | 13/2954 (0.4%) | 20/2972 (0.7%) | |||||
| Cardiac pacemaker removal | 1/8502 (0%) | 1/8542 (0%) | 3/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Cardiac pacemaker replacement | 10/8502 (0.1%) | 9/8542 (0.1%) | 8/8576 (0.1%) | 2/2954 (0.1%) | 4/2972 (0.1%) | |||||
| Cardiac pacemaker revision | 0/8502 (0%) | 1/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Cardiac rehabilitation therapy | 10/8502 (0.1%) | 14/8542 (0.2%) | 14/8576 (0.2%) | 3/2954 (0.1%) | 1/2972 (0%) | |||||
| Cardiac resynchronisation therapy | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Cardiovascular event prophylaxis | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 4/2972 (0.1%) | |||||
| Cardioversion | 2/8502 (0%) | 4/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 1/2972 (0%) | |||||
| Carotid endarterectomy | 72/8502 (0.8%) | 84/8542 (1%) | 62/8576 (0.7%) | 16/2954 (0.5%) | 16/2972 (0.5%) | |||||
| Carpal tunnel decompression | 2/8502 (0%) | 5/8542 (0.1%) | 3/8576 (0%) | 0/2954 (0%) | 2/2972 (0.1%) | |||||
| Cataract operation | 522/8502 (6.1%) | 565/8542 (6.6%) | 575/8576 (6.7%) | 145/2954 (4.9%) | 158/2972 (5.3%) | |||||
| Catheter removal | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Catheterisation cardiac | 23/8502 (0.3%) | 22/8542 (0.3%) | 20/8576 (0.2%) | 7/2954 (0.2%) | 4/2972 (0.1%) | |||||
| Cerebral decompression | 1/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Cervical polypectomy | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Cervix operation | 2/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Chemotherapy | 7/8502 (0.1%) | 10/8542 (0.1%) | 5/8576 (0.1%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Chest tube insertion | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Cholecystectomy | 49/8502 (0.6%) | 62/8542 (0.7%) | 80/8576 (0.9%) | 22/2954 (0.7%) | 17/2972 (0.6%) | |||||
| Cholecystostomy | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Choledocholithotomy | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Choledochostomy | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Choledochotomy | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Cholelithotomy | 0/8502 (0%) | 1/8542 (0%) | 5/8576 (0.1%) | 1/2954 (0%) | 1/2972 (0%) | |||||
| Chondroplasty | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Circumcision | 0/8502 (0%) | 0/8542 (0%) | 2/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Colectomy | 6/8502 (0.1%) | 11/8542 (0.1%) | 8/8576 (0.1%) | 1/2954 (0%) | 2/2972 (0.1%) | |||||
| Colectomy total | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Colon operation | 0/8502 (0%) | 3/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Colon polypectomy | 4/8502 (0%) | 1/8542 (0%) | 1/8576 (0%) | 1/2954 (0%) | 2/2972 (0.1%) | |||||
| Colostomy | 4/8502 (0%) | 5/8542 (0.1%) | 3/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Colostomy closure | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Colporrhaphy | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Colposuspension | 1/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Corneal operation | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Corneal transplant | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Coronary angioplasty | 606/8502 (7.1%) | 645/8542 (7.6%) | 617/8576 (7.2%) | 198/2954 (6.7%) | 211/2972 (7.1%) | |||||
| Coronary arterial stent insertion | 0/8502 (0%) | 2/8542 (0%) | 3/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Coronary artery bypass | 240/8502 (2.8%) | 260/8542 (3%) | 271/8576 (3.2%) | 79/2954 (2.7%) | 83/2972 (2.8%) | |||||
| Coronary revascularisation | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Cox-Maze procedure | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Cranial nerve operation | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Craniotomy | 0/8502 (0%) | 2/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Cyst drainage | 0/8502 (0%) | 0/8542 (0%) | 2/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Cyst removal | 0/8502 (0%) | 2/8542 (0%) | 5/8576 (0.1%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Cystocele repair | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 1/2972 (0%) | |||||
| Cystopexy | 1/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 1/2954 (0%) | 1/2972 (0%) | |||||
| Cystoprostatectomy | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Cystostomy | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Dacryocystorhinostomy | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 1/2972 (0%) | |||||
| Debridement | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Dental implantation | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Dental operation | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Detoxification | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Diabetes mellitus management | 9/8502 (0.1%) | 12/8542 (0.1%) | 8/8576 (0.1%) | 6/2954 (0.2%) | 7/2972 (0.2%) | |||||
| Dialysis | 42/8502 (0.5%) | 31/8542 (0.4%) | 29/8576 (0.3%) | 6/2954 (0.2%) | 8/2972 (0.3%) | |||||
| Diathermy | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Drug therapy | 1/8502 (0%) | 2/8542 (0%) | 4/8576 (0%) | 1/2954 (0%) | 2/2972 (0.1%) | |||||
| Drug therapy changed | 0/8502 (0%) | 1/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Duodenal sphincterotomy | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Duodenectomy | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Dupuytren's contracture operation | 3/8502 (0%) | 4/8542 (0%) | 2/8576 (0%) | 0/2954 (0%) | 2/2972 (0.1%) | |||||
| Ear operation | 4/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Elective surgery | 0/8502 (0%) | 0/8542 (0%) | 2/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Electron radiation therapy to prostate | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Empyema drainage | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Endarterectomy | 5/8502 (0.1%) | 2/8542 (0%) | 3/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Endarterectomy of aorta | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Endometrial ablation | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Epididymal cyst removal | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Epididymal operation | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Ethmoid sinus surgery | 2/8502 (0%) | 0/8542 (0%) | 2/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Eventration procedure | 1/8502 (0%) | 4/8542 (0%) | 1/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Excision of palatal lesion | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Explorative laparotomy | 0/8502 (0%) | 2/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Exploratory operation | 1/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Eye laser surgery | 2/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Eye operation | 2/8502 (0%) | 8/8542 (0.1%) | 3/8576 (0%) | 2/2954 (0.1%) | 3/2972 (0.1%) | |||||
| Eyelid operation | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Face lift | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Fasciectomy | 1/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Fasciotomy | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Femoral hernia repair | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Finger amputation | 2/8502 (0%) | 1/8542 (0%) | 2/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Fistula repair | 0/8502 (0%) | 1/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Fluid intake restriction | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Foot amputation | 1/8502 (0%) | 4/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Foot operation | 1/8502 (0%) | 2/8542 (0%) | 5/8576 (0.1%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Fracture debridement | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Fracture reduction | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Frontal sinus operation | 1/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Gallbladder operation | 2/8502 (0%) | 2/8542 (0%) | 9/8576 (0.1%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Gastrectomy | 0/8502 (0%) | 3/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 2/2972 (0.1%) | |||||
| Gastric banding | 1/8502 (0%) | 2/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Gastric bypass | 1/8502 (0%) | 2/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Gastric operation | 2/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Gastric polypectomy | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Gastro-jejunostomy | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Gastrointestinal tube insertion | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Gastrostomy | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Gastrostomy tube insertion | 1/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| General anaesthesia | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Genitourinary operation | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Gingival operation | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Glaucoma surgery | 0/8502 (0%) | 2/8542 (0%) | 3/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Haematoma evacuation | 2/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Haemorrhoid operation | 8/8502 (0.1%) | 5/8542 (0.1%) | 8/8576 (0.1%) | 2/2954 (0.1%) | 5/2972 (0.2%) | |||||
| Heart valve operation | 0/8502 (0%) | 1/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Heel nodule excision | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Heparin neutralisation therapy | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Hepatectomy | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Hepaticojejunostomy | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Hernia hiatus repair | 0/8502 (0%) | 1/8542 (0%) | 2/8576 (0%) | 1/2954 (0%) | 1/2972 (0%) | |||||
| Hernia repair | 23/8502 (0.3%) | 27/8542 (0.3%) | 23/8576 (0.3%) | 2/2954 (0.1%) | 6/2972 (0.2%) | |||||
| High frequency ablation | 1/8502 (0%) | 1/8542 (0%) | 4/8576 (0%) | 2/2954 (0.1%) | 4/2972 (0.1%) | |||||
| Hip arthroplasty | 59/8502 (0.7%) | 91/8542 (1.1%) | 62/8576 (0.7%) | 17/2954 (0.6%) | 21/2972 (0.7%) | |||||
| Hip surgery | 7/8502 (0.1%) | 8/8542 (0.1%) | 11/8576 (0.1%) | 3/2954 (0.1%) | 3/2972 (0.1%) | |||||
| Hospitalisation | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 2/2954 (0.1%) | 2/2972 (0.1%) | |||||
| Hydrocele excision | 0/8502 (0%) | 7/8542 (0.1%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Hydrocele repair | 0/8502 (0%) | 1/8542 (0%) | 2/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Hypotensive anaesthesia procedure | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Hysterectomy | 9/8502 (0.1%) | 8/8542 (0.1%) | 5/8576 (0.1%) | 4/2954 (0.1%) | 4/2972 (0.1%) | |||||
| Hysterosalpingo-oophorectomy | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Ileectomy | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Ileostomy | 1/8502 (0%) | 2/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Ileostomy closure | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Implantable defibrillator insertion | 13/8502 (0.2%) | 25/8542 (0.3%) | 12/8576 (0.1%) | 1/2954 (0%) | 3/2972 (0.1%) | |||||
| Implantable defibrillator replacement | 4/8502 (0%) | 1/8542 (0%) | 2/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Incisional drainage | 0/8502 (0%) | 0/8542 (0%) | 2/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Incisional hernia repair | 2/8502 (0%) | 6/8542 (0.1%) | 5/8576 (0.1%) | 1/2954 (0%) | 1/2972 (0%) | |||||
| Indwelling catheter management | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Inguinal hernia repair | 48/8502 (0.6%) | 54/8542 (0.6%) | 40/8576 (0.5%) | 14/2954 (0.5%) | 15/2972 (0.5%) | |||||
| Internal fixation of fracture | 1/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Intervertebral disc operation | 14/8502 (0.2%) | 10/8542 (0.1%) | 11/8576 (0.1%) | 1/2954 (0%) | 3/2972 (0.1%) | |||||
| Intestinal adhesion lysis | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Intestinal anastomosis | 0/8502 (0%) | 2/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 1/2972 (0%) | |||||
| Intestinal fistula repair | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Intestinal operation | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Intestinal polypectomy | 0/8502 (0%) | 1/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Intestinal resection | 1/8502 (0%) | 2/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Intestinal stent insertion | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Intestinal stoma | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Intraocular lens extraction | 1/8502 (0%) | 4/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Intraocular lens implant | 0/8502 (0%) | 2/8542 (0%) | 4/8576 (0%) | 0/2954 (0%) | 2/2972 (0.1%) | |||||
| Isotope therapy to thyroid | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Joint arthroplasty | 5/8502 (0.1%) | 4/8542 (0%) | 4/8576 (0%) | 2/2954 (0.1%) | 0/2972 (0%) | |||||
| Joint injection | 1/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Joint irrigation | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Joint manipulation | 0/8502 (0%) | 1/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Joint reconstruction | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Joint resurfacing surgery | 1/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Joint surgery | 1/8502 (0%) | 2/8542 (0%) | 2/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Keratoplasty | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Kidney anastomosis | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Knee arthroplasty | 73/8502 (0.9%) | 97/8542 (1.1%) | 80/8576 (0.9%) | 28/2954 (0.9%) | 30/2972 (1%) | |||||
| Knee meniscectomy | 1/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 2/2954 (0.1%) | 1/2972 (0%) | |||||
| Knee operation | 11/8502 (0.1%) | 13/8542 (0.2%) | 12/8576 (0.1%) | 5/2954 (0.2%) | 4/2972 (0.1%) | |||||
| Laparoscopic surgery | 3/8502 (0%) | 1/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Laparotomy | 2/8502 (0%) | 2/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Large intestine anastomosis | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Laryngeal operation | 1/8502 (0%) | 1/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Laryngectomy | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Laser therapy | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Leg amputation | 5/8502 (0.1%) | 7/8542 (0.1%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Lesion excision | 2/8502 (0%) | 0/8542 (0%) | 2/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Ligament operation | 0/8502 (0%) | 1/8542 (0%) | 1/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Limb operation | 2/8502 (0%) | 3/8542 (0%) | 2/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Lip lesion excision | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Lip operation | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Lipoma excision | 2/8502 (0%) | 1/8542 (0%) | 2/8576 (0%) | 2/2954 (0.1%) | 0/2972 (0%) | |||||
| Liposuction | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Liver operation | 1/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Lung cyst removal | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Lung lobectomy | 1/8502 (0%) | 2/8542 (0%) | 2/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Lung operation | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Lymphadenectomy | 2/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Malignant tumour excision | 0/8502 (0%) | 3/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Mandibulectomy | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Mass excision | 1/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Mastectomy | 2/8502 (0%) | 4/8542 (0%) | 1/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Maxillary antrum operation | 0/8502 (0%) | 1/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Mediastinal operation | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Medical device implantation | 0/8502 (0%) | 0/8542 (0%) | 2/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Medical device removal | 4/8502 (0%) | 2/8542 (0%) | 3/8576 (0%) | 1/2954 (0%) | 2/2972 (0.1%) | |||||
| Medical diet | 2/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Meningioma surgery | 1/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Meniscus operation | 1/8502 (0%) | 2/8542 (0%) | 6/8576 (0.1%) | 0/2954 (0%) | 2/2972 (0.1%) | |||||
| Mitral valve repair | 4/8502 (0%) | 0/8542 (0%) | 7/8576 (0.1%) | 0/2954 (0%) | 2/2972 (0.1%) | |||||
| Mitral valve replacement | 7/8502 (0.1%) | 5/8542 (0.1%) | 8/8576 (0.1%) | 3/2954 (0.1%) | 1/2972 (0%) | |||||
| Modified radical mastectomy | 0/8502 (0%) | 0/8542 (0%) | 2/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Myringoplasty | 1/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Nail operation | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Nasal cyst removal | 0/8502 (0%) | 1/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Nasal operation | 1/8502 (0%) | 4/8542 (0%) | 2/8576 (0%) | 0/2954 (0%) | 2/2972 (0.1%) | |||||
| Nasal polypectomy | 2/8502 (0%) | 2/8542 (0%) | 1/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Nasal septal operation | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Neck exploration | 1/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Nephrectomy | 3/8502 (0%) | 3/8542 (0%) | 2/8576 (0%) | 2/2954 (0.1%) | 0/2972 (0%) | |||||
| Nephrostomy | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Nephroureterectomy | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Nerve block | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Nervous system surgery | 0/8502 (0%) | 1/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Neurectomy | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Neurolysis | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Oesophageal dilation procedure | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Oesophageal operation | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Oesophagogastric fundoplasty | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Oophorectomy bilateral | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Open reduction of fracture | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Orchidectomy | 0/8502 (0%) | 2/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Orthopedic procedure | 6/8502 (0.1%) | 1/8542 (0%) | 7/8576 (0.1%) | 0/2954 (0%) | 2/2972 (0.1%) | |||||
| Ossicular operation | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Ostectomy | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Osteomyelitis drainage | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Osteosynthesis | 0/8502 (0%) | 1/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Osteotomy | 2/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Otorhinolaryngological surgery | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Ovarian operation | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Packed red blood cell transfusion | 0/8502 (0%) | 3/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Pain management | 1/8502 (0%) | 3/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Palliative care | 2/8502 (0%) | 2/8542 (0%) | 2/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Pancreatic operation | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Pancreaticoduodenectomy | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Pancreaticosplenectomy | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Papilloma excision | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Parathyroid gland operation | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Parathyroidectomy | 4/8502 (0%) | 3/8542 (0%) | 2/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Parotidectomy | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Pelvic exploration | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Penile prosthesis insertion | 1/8502 (0%) | 2/8542 (0%) | 3/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Percutaneous coronary intervention | 3/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Perineoplasty | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Peripheral artery angioplasty | 2/8502 (0%) | 2/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Peripheral nerve decompression | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Peripheral nerve operation | 1/8502 (0%) | 1/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Peripheral revascularisation | 1/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Peritoneal dialysis | 2/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Peritoneal lavage | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Phlebectomy | 1/8502 (0%) | 2/8542 (0%) | 2/8576 (0%) | 2/2954 (0.1%) | 3/2972 (0.1%) | |||||
| Physiotherapy | 1/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Pilonidal sinus repair | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Plastic surgery | 1/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Polypectomy | 2/8502 (0%) | 2/8542 (0%) | 3/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Postoperative analgesia | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Postoperative care | 0/8502 (0%) | 1/8542 (0%) | 4/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Preoperative care | 0/8502 (0%) | 4/8542 (0%) | 2/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Prolapse repair | 0/8502 (0%) | 1/8542 (0%) | 1/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Prophylaxis | 9/8502 (0.1%) | 10/8542 (0.1%) | 7/8576 (0.1%) | 2/2954 (0.1%) | 0/2972 (0%) | |||||
| Prophylaxis against gastrointestinal ulcer | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Prophylaxis of nausea and vomiting | 1/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Prostatectomy | 20/8502 (0.2%) | 23/8542 (0.3%) | 21/8576 (0.2%) | 9/2954 (0.3%) | 5/2972 (0.2%) | |||||
| Prostatic operation | 2/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Prosthesis implantation | 2/8502 (0%) | 2/8542 (0%) | 3/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Pyelolithotomy | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Radical mastectomy | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Radical prostatectomy | 1/8502 (0%) | 3/8542 (0%) | 5/8576 (0.1%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Radiculotomy | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Radioactive iodine therapy | 1/8502 (0%) | 0/8542 (0%) | 3/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Radiotherapy | 0/8502 (0%) | 2/8542 (0%) | 3/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Radiotherapy to liver | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Radiotherapy to prostate | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Rectal lesion excision | 1/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Rectal polypectomy | 1/8502 (0%) | 3/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Rectal prolapse repair | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 1/2972 (0%) | |||||
| Rectocele repair | 0/8502 (0%) | 4/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Rehabilitation therapy | 27/8502 (0.3%) | 22/8542 (0.3%) | 34/8576 (0.4%) | 9/2954 (0.3%) | 9/2972 (0.3%) | |||||
| Removal of foreign body | 1/8502 (0%) | 1/8542 (0%) | 1/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Removal of foreign body from throat | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Removal of internal fixation | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Renal artery stent placement | 2/8502 (0%) | 0/8542 (0%) | 2/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Renal cyst excision | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Renal stone removal | 2/8502 (0%) | 4/8542 (0%) | 2/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Renal surgery | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Renal tumour excision | 1/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Resection of rectum | 3/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Resuscitation | 2/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Retinal laser coagulation | 181/8502 (2.1%) | 189/8542 (2.2%) | 201/8576 (2.3%) | 39/2954 (1.3%) | 36/2972 (1.2%) | |||||
| Retinal operation | 4/8502 (0%) | 3/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Revision of internal fixation | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Rhinoplasty | 1/8502 (0%) | 1/8542 (0%) | 3/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Rib excision | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Rotator cuff repair | 5/8502 (0.1%) | 7/8542 (0.1%) | 13/8576 (0.2%) | 2/2954 (0.1%) | 1/2972 (0%) | |||||
| Routine health maintenance | 1/8502 (0%) | 4/8542 (0%) | 2/8576 (0%) | 1/2954 (0%) | 1/2972 (0%) | |||||
| Salpingo-oophorectomy bilateral | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Sebaceous cyst excision | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Septoplasty | 2/8502 (0%) | 0/8542 (0%) | 2/8576 (0%) | 1/2954 (0%) | 1/2972 (0%) | |||||
| Shoulder arthroplasty | 4/8502 (0%) | 8/8542 (0.1%) | 9/8576 (0.1%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Shoulder operation | 3/8502 (0%) | 7/8542 (0.1%) | 5/8576 (0.1%) | 2/2954 (0.1%) | 3/2972 (0.1%) | |||||
| Sigmoidectomy | 3/8502 (0%) | 0/8542 (0%) | 3/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Sinus operation | 3/8502 (0%) | 0/8542 (0%) | 2/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Skin cyst excision | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Skin graft | 0/8502 (0%) | 0/8542 (0%) | 4/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Skin implant | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Skin lesion excision | 0/8502 (0%) | 3/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Skin neoplasm excision | 0/8502 (0%) | 1/8542 (0%) | 3/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Small intestinal resection | 2/8502 (0%) | 1/8542 (0%) | 2/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Speech rehabilitation | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Sphenoid sinus operation | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Spinal cord operation | 1/8502 (0%) | 0/8542 (0%) | 5/8576 (0.1%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Spinal decompression | 6/8502 (0.1%) | 9/8542 (0.1%) | 5/8576 (0.1%) | 0/2954 (0%) | 2/2972 (0.1%) | |||||
| Spinal deformity correction | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Spinal fusion surgery | 5/8502 (0.1%) | 4/8542 (0%) | 8/8576 (0.1%) | 3/2954 (0.1%) | 2/2972 (0.1%) | |||||
| Spinal laminectomy | 16/8502 (0.2%) | 12/8542 (0.1%) | 16/8576 (0.2%) | 3/2954 (0.1%) | 10/2972 (0.3%) | |||||
| Spinal operation | 3/8502 (0%) | 2/8542 (0%) | 5/8576 (0.1%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Spinal rod removal | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Splenectomy | 1/8502 (0%) | 2/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Stapedectomy | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Stem cell transplant | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Stent placement | 9/8502 (0.1%) | 7/8542 (0.1%) | 4/8576 (0%) | 2/2954 (0.1%) | 1/2972 (0%) | |||||
| Sternal wiring | 0/8502 (0%) | 2/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Steroid therapy | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Strangulated hernia repair | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Subdural haematoma evacuation | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Suprapubic catheter insertion | 2/8502 (0%) | 0/8542 (0%) | 2/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Surgery | 10/8502 (0.1%) | 8/8542 (0.1%) | 7/8576 (0.1%) | 1/2954 (0%) | 2/2972 (0.1%) | |||||
| Suture removal | 1/8502 (0%) | 2/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Sympathectomy | 8/8502 (0.1%) | 3/8542 (0%) | 2/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Synovectomy | 0/8502 (0%) | 1/8542 (0%) | 2/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Tendon operation | 4/8502 (0%) | 2/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Tendon sheath lesion excision | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Tenotomy | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Testicular operation | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Therapeutic embolisation | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Therapeutic procedure | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Therapy cessation | 2/8502 (0%) | 9/8542 (0.1%) | 1/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Therapy regimen changed | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Thoracic cavity drainage | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Thoracotomy | 3/8502 (0%) | 1/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Thrombectomy | 2/8502 (0%) | 2/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Thromboembolectomy | 1/8502 (0%) | 1/8542 (0%) | 3/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Thrombolysis | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Thyroglossal cyst excision | 1/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Thyroid operation | 1/8502 (0%) | 2/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Thyroidectomy | 6/8502 (0.1%) | 8/8542 (0.1%) | 8/8576 (0.1%) | 6/2954 (0.2%) | 2/2972 (0.1%) | |||||
| Toe amputation | 7/8502 (0.1%) | 14/8542 (0.2%) | 7/8576 (0.1%) | 3/2954 (0.1%) | 0/2972 (0%) | |||||
| Toe operation | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Tonsillectomy | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Tooth extraction | 2/8502 (0%) | 2/8542 (0%) | 3/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Trabeculectomy | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Tracheal fistula repair | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Transfusion | 4/8502 (0%) | 1/8542 (0%) | 4/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Transurethral bladder resection | 1/8502 (0%) | 3/8542 (0%) | 2/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Transurethral prostatectomy | 47/8502 (0.6%) | 55/8542 (0.6%) | 52/8576 (0.6%) | 10/2954 (0.3%) | 8/2972 (0.3%) | |||||
| Tricuspid valve repair | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Tubal ligation | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Tumour excision | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Turbinectomy | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Umbilical hernia repair | 5/8502 (0.1%) | 10/8542 (0.1%) | 4/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Ureteral stent insertion | 1/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Ureterectomy | 1/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Ureteric calculus removal | 0/8502 (0%) | 1/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Ureterocelectomy | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Ureterolithotomy | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Urethral dilation procedure | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Urethral operation | 1/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Urethral repair | 1/8502 (0%) | 1/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Urethral stent insertion | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Urethrotomy | 2/8502 (0%) | 1/8542 (0%) | 3/8576 (0%) | 0/2954 (0%) | 2/2972 (0.1%) | |||||
| Urinary bladder excision | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Urogenital fistula repair | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Uterine dilation and curettage | 2/8502 (0%) | 2/8542 (0%) | 1/8576 (0%) | 1/2954 (0%) | 2/2972 (0.1%) | |||||
| Uterine prolapse repair | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Vaginal operation | 2/8502 (0%) | 1/8542 (0%) | 2/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Vaginoperineorrhaphy | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Vaginoplasty | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Varicocele repair | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Varicose vein operation | 4/8502 (0%) | 2/8542 (0%) | 5/8576 (0.1%) | 2/2954 (0.1%) | 1/2972 (0%) | |||||
| Vascular graft | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Vasectomy | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Vasodilation procedure | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Venous ligation | 1/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Venous operation | 0/8502 (0%) | 1/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Ventricular assist device insertion | 0/8502 (0%) | 2/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Vertebroplasty | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 2/2954 (0.1%) | 0/2972 (0%) | |||||
| Vitrectomy | 0/8502 (0%) | 5/8542 (0.1%) | 4/8576 (0%) | 3/2954 (0.1%) | 1/2972 (0%) | |||||
| Wedge resection toenail | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Weight loss diet | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Wound debridement | 3/8502 (0%) | 1/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Wrist surgery | 1/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Vascular disorders | ||||||||||
| Accelerated hypertension | 0/8502 (0%) | 3/8542 (0%) | 5/8576 (0.1%) | 1/2954 (0%) | 2/2972 (0.1%) | |||||
| Aneurysm | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Aneurysm ruptured | 1/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Angiopathy | 1/8502 (0%) | 4/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Aortic aneurysm | 18/8502 (0.2%) | 23/8542 (0.3%) | 20/8576 (0.2%) | 6/2954 (0.2%) | 5/2972 (0.2%) | |||||
| Aortic aneurysm rupture | 5/8502 (0.1%) | 8/8542 (0.1%) | 9/8576 (0.1%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Aortic arteriosclerosis | 0/8502 (0%) | 2/8542 (0%) | 2/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Aortic dilatation | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Aortic dissection | 1/8502 (0%) | 1/8542 (0%) | 3/8576 (0%) | 3/2954 (0.1%) | 0/2972 (0%) | |||||
| Aortic embolus | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Aortic necrosis | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Aortic stenosis | 3/8502 (0%) | 2/8542 (0%) | 2/8576 (0%) | 1/2954 (0%) | 2/2972 (0.1%) | |||||
| Aortic thrombosis | 0/8502 (0%) | 1/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Arterial disorder | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Arterial haemorrhage | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Arterial insufficiency | 0/8502 (0%) | 0/8542 (0%) | 2/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Arterial occlusive disease | 3/8502 (0%) | 3/8542 (0%) | 2/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Arterial stenosis | 1/8502 (0%) | 2/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Arterial stenosis limb | 1/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Arterial thrombosis | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Arterial thrombosis limb | 0/8502 (0%) | 0/8542 (0%) | 2/8576 (0%) | 2/2954 (0.1%) | 0/2972 (0%) | |||||
| Arteriosclerosis | 5/8502 (0.1%) | 8/8542 (0.1%) | 11/8576 (0.1%) | 4/2954 (0.1%) | 2/2972 (0.1%) | |||||
| Arteriosclerosis obliterans | 1/8502 (0%) | 4/8542 (0%) | 2/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Arteritis | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Axillary vein thrombosis | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Blood pressure fluctuation | 1/8502 (0%) | 2/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Blood pressure inadequately controlled | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Cardiovascular insufficiency | 1/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Circulatory collapse | 5/8502 (0.1%) | 5/8542 (0.1%) | 1/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Deep vein thrombosis | 22/8502 (0.3%) | 27/8542 (0.3%) | 25/8576 (0.3%) | 4/2954 (0.1%) | 3/2972 (0.1%) | |||||
| Diabetic macroangiopathy | 0/8502 (0%) | 2/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Diabetic microangiopathy | 0/8502 (0%) | 3/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Embolism | 7/8502 (0.1%) | 1/8542 (0%) | 8/8576 (0.1%) | 1/2954 (0%) | 2/2972 (0.1%) | |||||
| Essential hypertension | 0/8502 (0%) | 0/8542 (0%) | 2/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Extremity necrosis | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Femoral arterial stenosis | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Femoral artery aneurysm | 0/8502 (0%) | 1/8542 (0%) | 2/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Femoral artery occlusion | 0/8502 (0%) | 1/8542 (0%) | 2/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Haematoma | 2/8502 (0%) | 5/8542 (0.1%) | 1/8576 (0%) | 5/2954 (0.2%) | 1/2972 (0%) | |||||
| Haemodynamic instability | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Haemorrhage | 11/8502 (0.1%) | 7/8542 (0.1%) | 4/8576 (0%) | 5/2954 (0.2%) | 3/2972 (0.1%) | |||||
| Hypertension | 97/8502 (1.1%) | 84/8542 (1%) | 94/8576 (1.1%) | 33/2954 (1.1%) | 42/2972 (1.4%) | |||||
| Hypertensive crisis | 8/8502 (0.1%) | 8/8542 (0.1%) | 17/8576 (0.2%) | 4/2954 (0.1%) | 8/2972 (0.3%) | |||||
| Hypertensive emergency | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Hypotension | 83/8502 (1%) | 57/8542 (0.7%) | 55/8576 (0.6%) | 15/2954 (0.5%) | 13/2972 (0.4%) | |||||
| Hypovolaemic shock | 1/8502 (0%) | 6/8542 (0.1%) | 1/8576 (0%) | 1/2954 (0%) | 1/2972 (0%) | |||||
| Iliac artery embolism | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Iliac artery occlusion | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Iliac artery stenosis | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Intermittent claudication | 689/8502 (8.1%) | 686/8542 (8%) | 657/8576 (7.7%) | 198/2954 (6.7%) | 168/2972 (5.7%) | |||||
| Ischaemia | 5/8502 (0.1%) | 4/8542 (0%) | 7/8576 (0.1%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Ischaemic limb pain | 1/8502 (0%) | 1/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Labile blood pressure | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Leriche syndrome | 1/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Lymphoedema | 2/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Lymphostasis | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Malignant hypertension | 0/8502 (0%) | 1/8542 (0%) | 2/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Microangiopathy | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Necrosis ischaemic | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Neurogenic shock | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Orthostatic hypotension | 19/8502 (0.2%) | 13/8542 (0.2%) | 16/8576 (0.2%) | 2/2954 (0.1%) | 1/2972 (0%) | |||||
| Peripheral arterial occlusive disease | 9/8502 (0.1%) | 5/8542 (0.1%) | 7/8576 (0.1%) | 2/2954 (0.1%) | 0/2972 (0%) | |||||
| Peripheral artery aneurysm | 0/8502 (0%) | 2/8542 (0%) | 3/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Peripheral embolism | 2/8502 (0%) | 2/8542 (0%) | 1/8576 (0%) | 3/2954 (0.1%) | 1/2972 (0%) | |||||
| Peripheral ischaemia | 0/8502 (0%) | 3/8542 (0%) | 5/8576 (0.1%) | 2/2954 (0.1%) | 3/2972 (0.1%) | |||||
| Peripheral vascular disorder | 2/8502 (0%) | 2/8542 (0%) | 4/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Phlebitis | 1/8502 (0%) | 3/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Phlebitis superficial | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 1/2972 (0%) | |||||
| Poor peripheral circulation | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Raynaud's phenomenon | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Secondary hypertension | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Shock | 3/8502 (0%) | 1/8542 (0%) | 3/8576 (0%) | 2/2954 (0.1%) | 2/2972 (0.1%) | |||||
| Shock haemorrhagic | 2/8502 (0%) | 1/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Subclavian steal syndrome | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Temporal arteritis | 0/8502 (0%) | 1/8542 (0%) | 2/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Thrombophlebitis | 4/8502 (0%) | 3/8542 (0%) | 7/8576 (0.1%) | 2/2954 (0.1%) | 2/2972 (0.1%) | |||||
| Thrombophlebitis superficial | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
| Thrombosis | 5/8502 (0.1%) | 1/8542 (0%) | 2/8576 (0%) | 1/2954 (0%) | 0/2972 (0%) | |||||
| Varicose ulceration | 0/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Varicose vein | 0/8502 (0%) | 1/8542 (0%) | 2/8576 (0%) | 0/2954 (0%) | 4/2972 (0.1%) | |||||
| Vascular pseudoaneurysm | 0/8502 (0%) | 1/8542 (0%) | 3/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Vascular shunt | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Vascular stenosis | 1/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Vasculitis | 0/8502 (0%) | 2/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Vasculitis necrotising | 0/8502 (0%) | 0/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Vasodilatation | 0/8502 (0%) | 1/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Vena cava thrombosis | 1/8502 (0%) | 1/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
| Venous stasis | 1/8502 (0%) | 1/8542 (0%) | 1/8576 (0%) | 1/2954 (0%) | 2/2972 (0.1%) | |||||
| Venous thrombosis | 4/8502 (0%) | 1/8542 (0%) | 5/8576 (0.1%) | 2/2954 (0.1%) | 0/2972 (0%) | |||||
| Venous thrombosis limb | 1/8502 (0%) | 2/8542 (0%) | 1/8576 (0%) | 0/2954 (0%) | 1/2972 (0%) | |||||
Other (Not Including Serious) Adverse Events |
||||||||||
| Telmisartan/Ramipril (ONTARGET) | Telmisartan (ONTARGET) | Ramipril (ONTARGET) | Telmisartan (TRANSCEND) | Placebo (TRANSCEND) | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/8502 (0%) | 0/8542 (0%) | 0/8576 (0%) | 0/2954 (0%) | 0/2972 (0%) | |||||
Limitations/Caveats
Only non-serious Adverse Events (AE) which lead to discontinuation of study medication were assessed and collected; the frequency was under 5%. Non-serious AEs per se were not assessed or collected.
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
Results Point of Contact
| Name/Title | Boehringer Ingelheim Call Center |
|---|---|
| Organization | Boehringer Ingelheim Pharmaceuticals |
| Phone | 1-800-243-0127 |
| clintriage.rdg@boehringer-ingelheim.com |
Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00153101
Other Study ID Numbers:
- 502.373
- NCT00034931
First Posted:
Sep 12, 2005
Last Update Posted:
May 20, 2014
Last Verified:
May 1, 2014