BI 10773 (Empagliflozin) Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients (EMPA-REG OUTCOME).
Sponsor
Boehringer Ingelheim (Industry)
Overall Status
Completed
CT.gov ID
NCT01131676
Collaborator
Eli Lilly and Company (Industry)
7,064
615
3
57
11.5
0.2
Study Details
Study Description
Brief Summary
The aim of the present study is to investigate the safety of BI 10773 treatment in patients with Type 2 Diabetes Mellitus and high cardiovascular risk.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
7064 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
Primary Purpose:
Treatment
Official Title:
A Phase III, Multicentre, International, Randomised, Parallel Group, Double Blind Cardiovascular Safety Study of BI 10773 (10 mg and 25 mg Administered Orally Once Daily) Compared to Usual Care in Type 2 Diabetes Mellitus Patients With Increased Cardiovascular Risk
Study Start Date
:
Jul 1, 2010
Actual Primary Completion Date
:
Apr 1, 2015
Actual Study Completion Date
:
Apr 1, 2015
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: BI 10773 low dose BI 10773 tablets once daily |
Drug: BI 10773 low dose
BI 10773 tablets once daily
Drug: Placebo BI 10773 high dose
Placebo tablets identical to BI 10773
|
| Experimental: BI 10773 high dose BI 10773 tablets once daily |
Drug: BI 10773 high dose
BI 10773 tablets once daily
Drug: Placebo BI 10773 low dose
Placebo tablets identical to BI 10773
|
| Placebo Comparator: Placebo Placebo tablets matching BI 10773 |
Drug: Placebo BI 10773 high dose
Placebo tablets identical to BI 10773
Drug: Placebo BI 10773 low dose
Placebo tablets identical to BI 10773
|
Outcome Measures
Primary Outcome Measures
- Time to the First Occurrence of Any of the Following Adjudicated Components of the Primary Composite Endpoint (3-point MACE): CV Death (Including Fatal Stroke and Fatal MI), Non-fatal MI (Excluding Silent MI), and Non-fatal Stroke. [From randomisation to individual end of observation, up to 4.6 years]
Time to the first occurrence of any of the following adjudicated components of the primary composite endpoint (3-point major adverse cardiovascular events (MACE)): cardiovascular (CV) death (including fatal stroke and fatal myocardial infarction (MI)), non-fatal MI (excluding silent MI), and non-fatal stroke. Percentage of patients with the event are presented.
Secondary Outcome Measures
- Percentage of Participants With the Composite of All Events Adjudicated (4-point MACE): CV Death (Including Fatal Stroke and Fatal MI), Non-fatal MI (Excluding Silent MI), Non-fatal Stroke and Hospitalization for Unstable Angina Pectoris [From randomisation to individual end of observation, up to 4.6 years]
The composite of all events adjudicated (4-point MACE): cardiovascular death (including fatal stroke and fatal myocardial infarction), non-fatal myocardial infarction (excluding silent MI), non-fatal stroke and hospitalization for unstable angina pectoris.This is a key secondary endpoint of the trial. Percentage of patients with the event are presented.
- Percentage of Participants With Silent MI [From randomisation to individual end of observation, up to 4.6 years]
Silent MI; defined as presence in the ECG of: Any Q-wave in leads V2-V3 ≥0.02 seconds or QS complex in leads V2 and V3 Q-wave ≥0.03 seconds and ≥0.1 mV deep or QS complex in leads I, II, aVL, aVF, or V4-V6 in any two leads of a contiguous lead grouping (I, aVL, V6; V4-V6; II, III, and aVF) R-wave ≥0.04 seconds in V1-V2 and R/S ≥1 with a concordant positive T-wave in the absence of a conduction defect. It was also required that there had been no adjudicated and confirmed event of either acute MI, hospitalisation for unstable angina, coronary revascularisation procedures or stent thrombosis following randomisation up to and including the date of the specified ECG measurement. Percentage of patients with the event are presented.
- Percentage of Participants With Heart Failure Requiring Hospitalisation (Adjudicated) [From randomisation to individual end of observation, up to 4.6 years]
Heart failure requiring hospitalisation (adjudicated). Percentage of patients with the event are presented.
- Percentage of Participants With New Onset Albuminuria [From randomisation to individual end of observation, up to 4.6 years]
New onset albuminuria defined as urine albumin / creatinine ratio (UACR) ≥30 mg/g. Percentage of patients with the event are presented.
- Percentage of Participants With New Onset Macroalbuminuria [From randomisation to individual end of observation, up to 4.6 years]
New onset macroalbuminuria defined as UACR >300 mg/g. Percentage of patients with the event are presented.
- Percentage of Participants With the Composite Microvascular Outcome [From randomisation to individual end of observation, up to 4.6 years]
Composite microvascular outcome defined as: Initiation of retinal photocoagulation Vitreous haemorrhage Diabetes-related blindness, or New or worsening nephropathy defined as: New onset of macroalbuminuria; or Doubling of serum creatinine level accompanied by an eGFR (based on modification of diet in renal disease (MDRD) formula) ≤45 mL/min/1.73m2; or Initiation of continuous renal replacement therapy, or Death due to renal disease. Percentage of patients with the event are presented.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion criteria:
-
Diagnosis of type 2 diabetes mellitus prior to informed consent
-
Male or female patients on diet and exercise regimen who are drug naive or pre treated with any background therapy. Antidiabetic therapy has to be unchanged for 12 weeks prior to randomization.
-
Glycosylated haemoglobin (HbA1c) of >= 7.0% and <=10% for patients on background therapy or HbA1c >= 7.0% and <= 9.0% for drug naive patients
-
Age >= 18 years
-
Body Mass index <= 45 at Visit 1
-
Signed and dated informed consent
-
High cardiovascular risk
Exclusion criteria:
-
Uncontrolled hyperglycaemia with a glucose level >240 mg/dl (>13.3 mmol/L) after an overnight fast during placebo run-in and confirmed by a second measurement (not on the same day)
-
Indication of liver disease, defined by serum levels of either alanine aminotransferase (ALT), aspartate aminotransferase ALT or alkaline phosphatase above 3 x upper limit of normal (ULN) as determined at screening and/or run in.
-
Planned cardiac surgery or angioplasty within 3 months
-
Impaired renal function, defined as Glomerular Filtration Rate <30 ml/min (severe renal impairment, Modification of Diet in Renal Disease formula) during screening or run in.
-
Bariatric surgery within the past two years and other gastrointestinal surgeries that induce chronic malabsorption
-
Blood dyscrasias or any disorders causing haemolysis or unstable Red Blood Cell (e.g. malaria, babesiosis, haemolytic anemia)
-
Medical history of cancer (except for basal cell carcinoma) and/or treatment for cancer within the last 5 years
-
Contraindications to background therapy according to the local label
-
Treatment with anti-obesity drugs (e.g. sibutramine, orlistat) 3 months prior to informed consent or any other treatment at the time of screening (i.e. surgery, aggressive diet regimen, etc.) leading to unstable body weight
-
Current treatment with systemic steroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent or any other uncontrolled endocrine disorder except type 2 diabetes mellitus
-
Pre-menopausal women (last menstruation <+ 1 year prior to informed consent) who:
-
are nursing or pregnant or
-
are of child-bearing potential and are not practicing an acceptable method of birth control, or do not plan to continue using this method throughout the study and do not agree to submit to periodic pregnancy testing during participation in the trial. Acceptable methods of birth control include tubal ligation, transdermal patch, intra uterine devices/systems, oral, implantable or injectable contraceptives, sexual abstinence, double barrier method and vasectomised partner
-
Alcohol or drug abuse within the 3 months prior to informed consent that would interfere with trial participation or any ongoing condition leading to a decreased compliance to study procedures or study drug intake
-
Participation in another trial with an investigational drug within 30 days prior to informed consent
-
Any other clinical condition that would jeopardize patients safety while participating in this clinical trial
-
Acute coronary syndrome, stroke or TIA within 2 months prior to informed consent
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 1245.25.10043 Boehringer Ingelheim Investigational Site | Birmingham | Alabama | United States | |
| 2 | 1245.25.10121 Boehringer Ingelheim Investigational Site | Birmingham | Alabama | United States | |
| 3 | 1245.25.10037 Boehringer Ingelheim Investigational Site | Huntsville | Alabama | United States | |
| 4 | 1245.25.10124 Boehringer Ingelheim Investigational Site | Mobile | Alabama | United States | |
| 5 | 1245.25.10015 Boehringer Ingelheim Investigational Site | Little Rock | Alaska | United States | |
| 6 | 1245.25.10056 Boehringer Ingelheim Investigational Site | Gilbert | Arizona | United States | |
| 7 | 1245.25.10175 Boehringer Ingelheim Investigational Site | Peoria | Arizona | United States | |
| 8 | 1245.25.10072 Boehringer Ingelheim Investigational Site | Phoenix | Arizona | United States | |
| 9 | 1245.25.10048 Boehringer Ingelheim Investigational Site | Harrisburg | Arkansas | United States | |
| 10 | 1245.25.10035 Boehringer Ingelheim Investigational Site | Anaheim | California | United States | |
| 11 | 1245.25.10103 Boehringer Ingelheim Investigational Site | Encino | California | United States | |
| 12 | 1245.25.10158 Boehringer Ingelheim Investigational Site | Fresno | California | United States | |
| 13 | 1245.25.10126 Boehringer Ingelheim Investigational Site | Harbor City | California | United States | |
| 14 | 1245.25.10058 Boehringer Ingelheim Investigational Site | Huntington Park | California | United States | |
| 15 | 1245.25.10001 Boehringer Ingelheim Investigational Site | Lancaster | California | United States | |
| 16 | 1245.25.10102 Boehringer Ingelheim Investigational Site | Los Angeles | California | United States | |
| 17 | 1245.25.10047 Boehringer Ingelheim Investigational Site | Los Gatos | California | United States | |
| 18 | 1245.25.10118 Boehringer Ingelheim Investigational Site | Palm Springs | California | United States | |
| 19 | 1245.25.10061 Boehringer Ingelheim Investigational Site | Riverside | California | United States | |
| 20 | 1245.25.10040 Boehringer Ingelheim Investigational Site | San Diego | California | United States | |
| 21 | 1245.25.10055 Boehringer Ingelheim Investigational Site | San Diego | California | United States | |
| 22 | 1245.25.10193 Boehringer Ingelheim Investigational Site | San Diego | California | United States | |
| 23 | 1245.25.10027 Boehringer Ingelheim Investigational Site | Santa Rosa | California | United States | |
| 24 | 1245.25.10074 Boehringer Ingelheim Investigational Site | Stockton | California | United States | |
| 25 | 1245.25.10083 Boehringer Ingelheim Investigational Site | Valencia | California | United States | |
| 26 | 1245.25.10144 Boehringer Ingelheim Investigational Site | Colorado Springs | Colorado | United States | |
| 27 | 1245.25.10085 Boehringer Ingelheim Investigational Site | Denver | Colorado | United States | |
| 28 | 1245.25.10153 Boehringer Ingelheim Investigational Site | Denver | Colorado | United States | |
| 29 | 1245.25.10066 Boehringer Ingelheim Investigational Site | Norwalk | Connecticut | United States | |
| 30 | 1245.25.10038 Boehringer Ingelheim Investigational Site | Waterbury | Connecticut | United States | |
| 31 | 1245.25.10068 Boehringer Ingelheim Investigational Site | Washington | District of Columbia | United States | |
| 32 | 1245.25.10094 Boehringer Ingelheim Investigational Site | Bradenton | Florida | United States | |
| 33 | 1245.25.10190 Boehringer Ingelheim Investigational Site | Brooksville | Florida | United States | |
| 34 | 1245.25.10209 Boehringer Ingelheim Investigational Site | Clearwater | Florida | United States | |
| 35 | 1245.25.10212 Boehringer Ingelheim Investigational Site | Cooper City | Florida | United States | |
| 36 | 1245.25.10200 Boehringer Ingelheim Investigational Site | Delray Beach | Florida | United States | |
| 37 | 1245.25.10033 Boehringer Ingelheim Investigational Site | Ft. Lauderdale | Florida | United States | |
| 38 | 1245.25.10202 Boehringer Ingelheim Investigational Site | Hallandale Beach | Florida | United States | |
| 39 | 1245.25.10062 Boehringer Ingelheim Investigational Site | Hialeah | Florida | United States | |
| 40 | 1245.25.10063 Boehringer Ingelheim Investigational Site | Hialeah | Florida | United States | |
| 41 | 1245.25.10157 Boehringer Ingelheim Investigational Site | Hialeah | Florida | United States | |
| 42 | 1245.25.10089 Boehringer Ingelheim Investigational Site | Jacksonville | Florida | United States | |
| 43 | 1245.25.10019 Boehringer Ingelheim Investigational Site | Longwood | Florida | United States | |
| 44 | 1245.25.10168 Boehringer Ingelheim Investigational Site | Maitland | Florida | United States | |
| 45 | 1245.25.10018 Boehringer Ingelheim Investigational Site | Miami | Florida | United States | |
| 46 | 1245.25.10039 Boehringer Ingelheim Investigational Site | Miami | Florida | United States | |
| 47 | 1245.25.10184 Boehringer Ingelheim Investigational Site | Miami | Florida | United States | |
| 48 | 1245.25.10123 Boehringer Ingelheim Investigational Site | Orlando | Florida | United States | |
| 49 | 1245.25.10201 Boehringer Ingelheim Investigational Site | Orlando | Florida | United States | |
| 50 | 1245.25.10025 Boehringer Ingelheim Investigational Site | Pembroke Pines | Florida | United States | |
| 51 | 1245.25.10042 Boehringer Ingelheim Investigational Site | Pembroke Pines | Florida | United States | |
| 52 | 1245.25.10147 Boehringer Ingelheim Investigational Site | Port Charlotte | Florida | United States | |
| 53 | 1245.25.10198 Boehringer Ingelheim Investigational Site | Saint Petersburg | Florida | United States | |
| 54 | 1245.25.10203 Boehringer Ingelheim Investigational Site | Saint Petersburg | Florida | United States | |
| 55 | 1245.25.10104 Boehringer Ingelheim Investigational Site | Tampa | Florida | United States | |
| 56 | 1245.25.10178 Boehringer Ingelheim Investigational Site | Tampa | Florida | United States | |
| 57 | 1245.25.10211 Boehringer Ingelheim Investigational Site | Tampa | Florida | United States | |
| 58 | 1245.25.10023 Boehringer Ingelheim Investigational Site | Atlanta | Georgia | United States | |
| 59 | 1245.25.10174 Boehringer Ingelheim Investigational Site | Columbus | Georgia | United States | |
| 60 | 1245.25.10141 Boehringer Ingelheim Investigational Site | Riverdale | Georgia | United States | |
| 61 | 1245.25.10067 Boehringer Ingelheim Investigational Site | Roswell | Georgia | United States | |
| 62 | 1245.25.10022 Boehringer Ingelheim Investigational Site | Honolulu | Hawaii | United States | |
| 63 | 1245.25.10092 Boehringer Ingelheim Investigational Site | Boise | Idaho | United States | |
| 64 | 1245.25.10097 Boehringer Ingelheim Investigational Site | Chicago | Illinois | United States | |
| 65 | 1245.25.10116 Boehringer Ingelheim Investigational Site | Evansville | Indiana | United States | |
| 66 | 1245.25.10206 Boehringer Ingelheim Investigational Site | Valparaiso | Indiana | United States | |
| 67 | 1245.25.10021 Boehringer Ingelheim Investigational Site | Wichita | Kansas | United States | |
| 68 | 1245.25.10186 Boehringer Ingelheim Investigational Site | Lexington | Kentucky | United States | |
| 69 | 1245.25.10109 Boehringer Ingelheim Investigational Site | Louisville | Kentucky | United States | |
| 70 | 1245.25.10006 Boehringer Ingelheim Investigational Site | Madisonville | Kentucky | United States | |
| 71 | 1245.25.10005 Boehringer Ingelheim Investigational Site | Paducah | Kentucky | United States | |
| 72 | 1245.25.10020 Boehringer Ingelheim Investigational Site | New Orleans | Louisiana | United States | |
| 73 | 1245.25.10012 Boehringer Ingelheim Investigational Site | Auburn | Maine | United States | |
| 74 | 1245.25.10041 Boehringer Ingelheim Investigational Site | Baltimore | Maryland | United States | |
| 75 | 1245.25.10134 Boehringer Ingelheim Investigational Site | Hyattsville | Maryland | United States | |
| 76 | 1245.25.10210 Boehringer Ingelheim Investigational Site | Towson | Maryland | United States | |
| 77 | 1245.25.10064 Boehringer Ingelheim Investigational Site | Springfield | Massachusetts | United States | |
| 78 | 1245.25.10051 Boehringer Ingelheim Investigational Site | Watertown | Massachusetts | United States | |
| 79 | 1245.25.10071 Boehringer Ingelheim Investigational Site | Dearborn | Michigan | United States | |
| 80 | 1245.25.10013 Boehringer Ingelheim Investigational Site | Flint | Michigan | United States | |
| 81 | 1245.25.10107 Boehringer Ingelheim Investigational Site | Petoskey | Michigan | United States | |
| 82 | 1245.25.10030 Boehringer Ingelheim Investigational Site | Eagan | Minnesota | United States | |
| 83 | 1245.25.10028 Boehringer Ingelheim Investigational Site | Minneapolis | Minnesota | United States | |
| 84 | 1245.25.10176 Boehringer Ingelheim Investigational Site | Picayune | Mississippi | United States | |
| 85 | 1245.25.10011 Boehringer Ingelheim Investigational Site | Chesterfield | Missouri | United States | |
| 86 | 1245.25.10163 Boehringer Ingelheim Investigational Site | Kansas City | Missouri | United States | |
| 87 | 1245.25.10148 Boehringer Ingelheim Investigational Site | Great Falls | Montana | United States | |
| 88 | 1245.25.10191 Boehringer Ingelheim Investigational Site | Great Falls | Montana | United States | |
| 89 | 1245.25.10034 Boehringer Ingelheim Investigational Site | Omaha | Nebraska | United States | |
| 90 | 1245.25.10014 Boehringer Ingelheim Investigational Site | Flemington | New Jersey | United States | |
| 91 | 1245.25.10145 Boehringer Ingelheim Investigational Site | Albuquerque | New Mexico | United States | |
| 92 | 1245.25.10180 Boehringer Ingelheim Investigational Site | Albuquerque | New Mexico | United States | |
| 93 | 1245.25.10131 Boehringer Ingelheim Investigational Site | Binghamton | New York | United States | |
| 94 | 1245.25.10029 Boehringer Ingelheim Investigational Site | Rochester | New York | United States | |
| 95 | 1245.25.10142 Boehringer Ingelheim Investigational Site | Smithtown | New York | United States | |
| 96 | 1245.25.10096 Boehringer Ingelheim Investigational Site | Staten Island | New York | United States | |
| 97 | 1245.25.10196 Boehringer Ingelheim Investigational Site | Burlington | North Carolina | United States | |
| 98 | 1245.25.10207 Boehringer Ingelheim Investigational Site | Calabash | North Carolina | United States | |
| 99 | 1245.25.10053 Boehringer Ingelheim Investigational Site | Durham | North Carolina | United States | |
| 100 | 1245.25.10010 Boehringer Ingelheim Investigational Site | Greenville | North Carolina | United States | |
| 101 | 1245.25.10060 Boehringer Ingelheim Investigational Site | Cincinnati | Ohio | United States | |
| 102 | 1245.25.10086 Boehringer Ingelheim Investigational Site | Cincinnati | Ohio | United States | |
| 103 | 1245.25.10137 Boehringer Ingelheim Investigational Site | Dayton | Ohio | United States | |
| 104 | 1245.25.10138 Boehringer Ingelheim Investigational Site | Delaware | Ohio | United States | |
| 105 | 1245.25.10156 Boehringer Ingelheim Investigational Site | Kettering | Ohio | United States | |
| 106 | 1245.25.10091 Boehringer Ingelheim Investigational Site | Marion | Ohio | United States | |
| 107 | 1245.25.10192 Boehringer Ingelheim Investigational Site | Zanesville | Ohio | United States | |
| 108 | 1245.25.10114 Boehringer Ingelheim Investigational Site | Norman | Oklahoma | United States | |
| 109 | 1245.25.10082 Boehringer Ingelheim Investigational Site | Eugene | Oregon | United States | |
| 110 | 1245.25.10154 Boehringer Ingelheim Investigational Site | Clairton | Pennsylvania | United States | |
| 111 | 1245.25.10173 Boehringer Ingelheim Investigational Site | Clairton | Pennsylvania | United States | |
| 112 | 1245.25.10052 Boehringer Ingelheim Investigational Site | Feasterville Trevose | Pennsylvania | United States | |
| 113 | 1245.25.10069 Boehringer Ingelheim Investigational Site | Fleetwood | Pennsylvania | United States | |
| 114 | 1245.25.10172 Boehringer Ingelheim Investigational Site | Greensburg | Pennsylvania | United States | |
| 115 | 1245.25.10050 Boehringer Ingelheim Investigational Site | Indiana | Pennsylvania | United States | |
| 116 | 1245.25.10009 Boehringer Ingelheim Investigational Site | Lansdale | Pennsylvania | United States | |
| 117 | 1245.25.10214 Boehringer Ingelheim Investigational Site | Philadelphia | Pennsylvania | United States | |
| 118 | 1245.25.10149 Boehringer Ingelheim Investigational Site | Pittsburgh | Pennsylvania | United States | |
| 119 | 1245.25.10197 Boehringer Ingelheim Investigational Site | Pittsburgh | Pennsylvania | United States | |
| 120 | 1245.25.10159 Boehringer Ingelheim Investigational Site | Scottdale | Pennsylvania | United States | |
| 121 | 1245.25.10162 Boehringer Ingelheim Investigational Site | Tipton | Pennsylvania | United States | |
| 122 | 1245.25.10146 Boehringer Ingelheim Investigational Site | Uniontown | Pennsylvania | United States | |
| 123 | 1245.25.10077 Boehringer Ingelheim Investigational Site | Yardley | Pennsylvania | United States | |
| 124 | 1245.25.10070 Boehringer Ingelheim Investigational Site | Anderson | South Carolina | United States | |
| 125 | 1245.25.10044 Boehringer Ingelheim Investigational Site | Charleston | South Carolina | United States | |
| 126 | 1245.25.10002 Boehringer Ingelheim Investigational Site | Greer | South Carolina | United States | |
| 127 | 1245.25.10132 Boehringer Ingelheim Investigational Site | Hodges | South Carolina | United States | |
| 128 | 1245.25.10140 Boehringer Ingelheim Investigational Site | Mt. Pleasant | South Carolina | United States | |
| 129 | 1245.25.10065 Boehringer Ingelheim Investigational Site | Myrtle Beach | South Carolina | United States | |
| 130 | 1245.25.10127 Boehringer Ingelheim Investigational Site | Myrtle Beach | South Carolina | United States | |
| 131 | 1245.25.10170 Boehringer Ingelheim Investigational Site | North Myrtle Beach | South Carolina | United States | |
| 132 | 1245.25.10129 Boehringer Ingelheim Investigational Site | Spartanburg | South Carolina | United States | |
| 133 | 1245.25.10171 Boehringer Ingelheim Investigational Site | Union | South Carolina | United States | |
| 134 | 1245.25.10054 Boehringer Ingelheim Investigational Site | Bristol | Tennessee | United States | |
| 135 | 1245.25.10036 Boehringer Ingelheim Investigational Site | Chattanooga | Tennessee | United States | |
| 136 | 1245.25.10057 Boehringer Ingelheim Investigational Site | Chattanooga | Tennessee | United States | |
| 137 | 1245.25.10046 Boehringer Ingelheim Investigational Site | Kingsport | Tennessee | United States | |
| 138 | 1245.25.10143 Boehringer Ingelheim Investigational Site | Memphis | Tennessee | United States | |
| 139 | 1245.25.10075 Boehringer Ingelheim Investigational Site | Corpus Christi | Texas | United States | |
| 140 | 1245.25.10007 Boehringer Ingelheim Investigational Site | Dallas | Texas | United States | |
| 141 | 1245.25.10026 Boehringer Ingelheim Investigational Site | Dallas | Texas | United States | |
| 142 | 1245.25.10100 Boehringer Ingelheim Investigational Site | Dallas | Texas | United States | |
| 143 | 1245.25.10165 Boehringer Ingelheim Investigational Site | Dallas | Texas | United States | |
| 144 | 1245.25.10169 Boehringer Ingelheim Investigational Site | Fort Worth | Texas | United States | |
| 145 | 1245.25.10003 Boehringer Ingelheim Investigational Site | Houston | Texas | United States | |
| 146 | 1245.25.10125 Boehringer Ingelheim Investigational Site | Houston | Texas | United States | |
| 147 | 1245.25.10189 Boehringer Ingelheim Investigational Site | Houston | Texas | United States | |
| 148 | 1245.25.10119 Boehringer Ingelheim Investigational Site | Lubbock | Texas | United States | |
| 149 | 1245.25.10078 Boehringer Ingelheim Investigational Site | New Braunfels | Texas | United States | |
| 150 | 1245.25.10076 Boehringer Ingelheim Investigational Site | Odessa | Texas | United States | |
| 151 | 1245.25.10133 Boehringer Ingelheim Investigational Site | Pearland | Texas | United States | |
| 152 | 1245.25.10160 Boehringer Ingelheim Investigational Site | Plano | Texas | United States | |
| 153 | 1245.25.10177 Boehringer Ingelheim Investigational Site | Richardson | Texas | United States | |
| 154 | 1245.25.10049 Boehringer Ingelheim Investigational Site | San Antonio | Texas | United States | |
| 155 | 1245.25.10161 Boehringer Ingelheim Investigational Site | San Antonio | Texas | United States | |
| 156 | 1245.25.10185 Boehringer Ingelheim Investigational Site | Bountiful | Utah | United States | |
| 157 | 1245.25.10155 Boehringer Ingelheim Investigational Site | Draper | Utah | United States | |
| 158 | 1245.25.10079 Boehringer Ingelheim Investigational Site | Midvale | Utah | United States | |
| 159 | 1245.25.10080 Boehringer Ingelheim Investigational Site | Salt Lake City | Utah | United States | |
| 160 | 1245.25.10087 Boehringer Ingelheim Investigational Site | South Ogden | Utah | United States | |
| 161 | 1245.25.10218 Boehringer Ingelheim Investigational Site | Burke | Virginia | United States | |
| 162 | 1245.25.10004 Boehringer Ingelheim Investigational Site | Norfolk | Virginia | United States | |
| 163 | 1245.25.10111 Boehringer Ingelheim Investigational Site | South Chesterfield | Virginia | United States | |
| 164 | 1245.25.10115 Boehringer Ingelheim Investigational Site | Spokane | Washington | United States | |
| 165 | 1245.25.10216 Boehringer Ingelheim Investigational Site | Spokane | Washington | United States | |
| 166 | 1245.25.10017 Boehringer Ingelheim Investigational Site | Tacoma | Washington | United States | |
| 167 | 1245.25.10016 Boehringer Ingelheim Investigational Site | Walla Walla | Washington | United States | |
| 168 | 1245.25.10187 Boehringer Ingelheim Investigational Site | Charleston | West Virginia | United States | |
| 169 | 1245.25.10182 Boehringer Ingelheim Investigational Site | Morgantown | West Virginia | United States | |
| 170 | 1245.25.10098 Boehringer Ingelheim Investigational Site | Madison | Wisconsin | United States | |
| 171 | 1245.25.54012 Boehringer Ingelheim Investigational Site | Buenos Aires | Argentina | ||
| 172 | 1245.25.54001 Boehringer Ingelheim Investigational Site | Capital Federal | Argentina | ||
| 173 | 1245.25.54006 Boehringer Ingelheim Investigational Site | Capital Federal | Argentina | ||
| 174 | 1245.25.54013 Boehringer Ingelheim Investigational Site | Capital Federal | Argentina | ||
| 175 | 1245.25.54010 Boehringer Ingelheim Investigational Site | Cordoba | Argentina | ||
| 176 | 1245.25.54011 Boehringer Ingelheim Investigational Site | Cordoba | Argentina | ||
| 177 | 1245.25.54002 Boehringer Ingelheim Investigational Site | Córdoba | Argentina | ||
| 178 | 1245.25.54003 Boehringer Ingelheim Investigational Site | Córdoba | Argentina | ||
| 179 | 1245.25.54005 Boehringer Ingelheim Investigational Site | Parque Velez Sarfield | Argentina | ||
| 180 | 1245.25.54008 Boehringer Ingelheim Investigational Site | Rosario | Argentina | ||
| 181 | 1245.25.54009 Boehringer Ingelheim Investigational Site | Rosario | Argentina | ||
| 182 | 1245.25.61003 Boehringer Ingelheim Investigational Site | Herston | Queensland | Australia | |
| 183 | 1245.25.61001 Boehringer Ingelheim Investigational Site | Ashford | South Australia | Australia | |
| 184 | 1245.25.61002 Boehringer Ingelheim Investigational Site | Fullarton | South Australia | Australia | |
| 185 | 1245.25.43008 Boehringer Ingelheim Investigational Site | Feldkirch | Austria | ||
| 186 | 1245.25.43006 Boehringer Ingelheim Investigational Site | Graz | Austria | ||
| 187 | 1245.25.43016 Boehringer Ingelheim Investigational Site | Innsbruck | Austria | ||
| 188 | 1245.25.43005 Boehringer Ingelheim Investigational Site | Salzburg | Austria | ||
| 189 | 1245.25.43015 Boehringer Ingelheim Investigational Site | St. Stefan | Austria | ||
| 190 | 1245.25.43001 Boehringer Ingelheim Investigational Site | Wien | Austria | ||
| 191 | 1245.25.43007 Boehringer Ingelheim Investigational Site | Wien | Austria | ||
| 192 | 1245.25.43009 Boehringer Ingelheim Investigational Site | Wien | Austria | ||
| 193 | 1245.25.43010 Boehringer Ingelheim Investigational Site | Wien | Austria | ||
| 194 | 1245.25.43013 Boehringer Ingelheim Investigational Site | Wien | Austria | ||
| 195 | 1245.25.32010 Boehringer Ingelheim Investigational Site | Bonheiden | Belgium | ||
| 196 | 1245.25.32030 Boehringer Ingelheim Investigational Site | Brussel | Belgium | ||
| 197 | 1245.25.32008 Boehringer Ingelheim Investigational Site | Bruxelles | Belgium | ||
| 198 | 1245.25.32011 Boehringer Ingelheim Investigational Site | Bruxelles | Belgium | ||
| 199 | 1245.25.32003 Boehringer Ingelheim Investigational Site | De Pinte | Belgium | ||
| 200 | 1245.25.32002 Boehringer Ingelheim Investigational Site | Edegem | Belgium | ||
| 201 | 1245.25.32004 Boehringer Ingelheim Investigational Site | Genk | Belgium | ||
| 202 | 1245.25.32029 Boehringer Ingelheim Investigational Site | Halen | Belgium | ||
| 203 | 1245.25.32009 Boehringer Ingelheim Investigational Site | Hasselt | Belgium | ||
| 204 | 1245.25.32007 Boehringer Ingelheim Investigational Site | Huy | Belgium | ||
| 205 | 1245.25.32013 Boehringer Ingelheim Investigational Site | La Louvière | Belgium | ||
| 206 | 1245.25.32012 Boehringer Ingelheim Investigational Site | Leuven | Belgium | ||
| 207 | 1245.25.32001 Boehringer Ingelheim Investigational Site | Liège | Belgium | ||
| 208 | 1245.25.32028 Boehringer Ingelheim Investigational Site | Liège | Belgium | ||
| 209 | 1245.25.32005 Boehringer Ingelheim Investigational Site | Massemen-Wetteren | Belgium | ||
| 210 | 1245.25.32014 Boehringer Ingelheim Investigational Site | Oostham | Belgium | ||
| 211 | 1245.25.55019 Boehringer Ingelheim Investigational Site | Belo Horizonte | Brazil | ||
| 212 | 1245.25.55014 Boehringer Ingelheim Investigational Site | Belém | Brazil | ||
| 213 | 1245.25.55007 Boehringer Ingelheim Investigational Site | Boqueirão | Brazil | ||
| 214 | 1245.25.55015 Boehringer Ingelheim Investigational Site | Brasília | Brazil | ||
| 215 | 1245.25.55027 Boehringer Ingelheim Investigational Site | Campinas | Brazil | ||
| 216 | 1245.25.55028 Boehringer Ingelheim Investigational Site | Campinas | Brazil | ||
| 217 | 1245.25.55025 Boehringer Ingelheim Investigational Site | Curitiba | Brazil | ||
| 218 | 1245.25.55026 Boehringer Ingelheim Investigational Site | Fortaleza | Brazil | ||
| 219 | 1245.25.55009 Boehringer Ingelheim Investigational Site | Goiânia | Brazil | ||
| 220 | 1245.25.55002 Boehringer Ingelheim Investigational Site | Higienópolis | Brazil | ||
| 221 | 1245.25.55017 Boehringer Ingelheim Investigational Site | Marilia | Brazil | ||
| 222 | 1245.25.55022 Boehringer Ingelheim Investigational Site | Maringá | Brazil | ||
| 223 | 1245.25.55008 Boehringer Ingelheim Investigational Site | Porto Alegre | Brazil | ||
| 224 | 1245.25.55016 Boehringer Ingelheim Investigational Site | Porto Alegre | Brazil | ||
| 225 | 1245.25.55020 Boehringer Ingelheim Investigational Site | Porto Alegre | Brazil | ||
| 226 | 1245.25.55012 Boehringer Ingelheim Investigational Site | Ribeirão Preto | Brazil | ||
| 227 | 1245.25.55013 Boehringer Ingelheim Investigational Site | São José do Rio Preto | Brazil | ||
| 228 | 1245.25.55004 Boehringer Ingelheim Investigational Site | São Paulo | Brazil | ||
| 229 | 1245.25.55010 Boehringer Ingelheim Investigational Site | São Paulo | Brazil | ||
| 230 | 1245.25.55018 Boehringer Ingelheim Investigational Site | São Paulo | Brazil | ||
| 231 | 1245.25.55023 Boehringer Ingelheim Investigational Site | São Paulo | Brazil | ||
| 232 | 1245.25.55006 Boehringer Ingelheim Investigational Site | Vila Albuquerque | Brazil | ||
| 233 | 1245.25.55003 Boehringer Ingelheim Investigational Site | Vila Clementino | Brazil | ||
| 234 | 1245.25.55005 Boehringer Ingelheim Investigational Site | Vila Leopoldina | Brazil | ||
| 235 | 1245.25.55001 Boehringer Ingelheim Investigational Site | Villa Clementino | Brazil | ||
| 236 | 1245.25.20047 Boehringer Ingelheim Investigational Site | Vancouver | British Columbia | Canada | |
| 237 | 1245.25.20048 Boehringer Ingelheim Investigational Site | Winnipeg | Manitoba | Canada | |
| 238 | 1245.25.20026 Boehringer Ingelheim Investigational Site | Halifax | Nova Scotia | Canada | |
| 239 | 1245.25.20045 Boehringer Ingelheim Investigational Site | Brampton | Ontario | Canada | |
| 240 | 1245.25.20042 Boehringer Ingelheim Investigational Site | Burlington | Ontario | Canada | |
| 241 | 1245.25.20009 Boehringer Ingelheim Investigational Site | Newmarket | Ontario | Canada | |
| 242 | 1245.25.20044 Boehringer Ingelheim Investigational Site | Niagara Falls | Ontario | Canada | |
| 243 | 1245.25.20013 Boehringer Ingelheim Investigational Site | Ottawa | Ontario | Canada | |
| 244 | 1245.25.20049 Boehringer Ingelheim Investigational Site | Toronto | Ontario | Canada | |
| 245 | 1245.25.20050 Boehringer Ingelheim Investigational Site | Gatineau | Quebec | Canada | |
| 246 | 1245.25.20043 Boehringer Ingelheim Investigational Site | Longueuil | Quebec | Canada | |
| 247 | 1245.25.20046 Boehringer Ingelheim Investigational Site | Longueuil | Quebec | Canada | |
| 248 | 1245.25.20041 Boehringer Ingelheim Investigational Site | Saskatoon | Saskatchewan | Canada | |
| 249 | 1245.25.57010 Boehringer Ingelheim Investigational Site | Armenia | Colombia | ||
| 250 | 1245.25.57004 Boehringer Ingelheim Investigational Site | Barranquilla | Colombia | ||
| 251 | 1245.25.57001 Boehringer Ingelheim Investigational Site | Bogotá | Colombia | ||
| 252 | 1245.25.57003 Boehringer Ingelheim Investigational Site | Bogotá | Colombia | ||
| 253 | 1245.25.57011 Boehringer Ingelheim Investigational Site | Bogotá | Colombia | ||
| 254 | 1245.25.57006 Boehringer Ingelheim Investigational Site | Floridablanca | Colombia | ||
| 255 | 1245.25.57009 Boehringer Ingelheim Investigational Site | Medellín | Colombia | ||
| 256 | 1245.25.71005 Boehringer Ingelheim Investigational Site | Karlovac | Croatia | ||
| 257 | 1245.25.71001 Boehringer Ingelheim Investigational Site | Krapinske Toplice | Croatia | ||
| 258 | 1245.25.71006 Boehringer Ingelheim Investigational Site | Osijek | Croatia | ||
| 259 | 1245.25.71003 Boehringer Ingelheim Investigational Site | Rijeka | Croatia | ||
| 260 | 1245.25.71002 Boehringer Ingelheim Investigational Site | Zagreb | Croatia | ||
| 261 | 1245.25.71004 Boehringer Ingelheim Investigational Site | Zagreb | Croatia | ||
| 262 | 1245.25.42020 Boehringer Ingelheim Investigational Site | Brno | Czech Republic | ||
| 263 | 1245.25.42018 Boehringer Ingelheim Investigational Site | Jindrichuv Hradec | Czech Republic | ||
| 264 | 1245.25.42015 Boehringer Ingelheim Investigational Site | Praha 3 | Czech Republic | ||
| 265 | 1245.25.42019 Boehringer Ingelheim Investigational Site | Usti nad Labem | Czech Republic | ||
| 266 | 1245.25.45006 Boehringer Ingelheim Investigational Site | Frederiksberg | Denmark | ||
| 267 | 1245.25.45003 Boehringer Ingelheim Investigational Site | Gentofte | Denmark | ||
| 268 | 1245.25.45007 Boehringer Ingelheim Investigational Site | Helsingør | Denmark | ||
| 269 | 1245.25.45002 Boehringer Ingelheim Investigational Site | København NV | Denmark | ||
| 270 | 1245.25.45004 Boehringer Ingelheim Investigational Site | Randers NØ | Denmark | ||
| 271 | 1245.25.45005 Boehringer Ingelheim Investigational Site | Slagelse | Denmark | ||
| 272 | 1245.25.37003 Boehringer Ingelheim Investigational Site | Tallinn | Estonia | ||
| 273 | 1245.25.37002 Boehringer Ingelheim Investigational Site | Tallin | Estonia | ||
| 274 | 1245.25.37005 Boehringer Ingelheim Investigational Site | Tallin | Estonia | ||
| 275 | 1245.25.37001 Boehringer Ingelheim Investigational Site | Tartu | Estonia | ||
| 276 | 1245.25.37004 Boehringer Ingelheim Investigational Site | Tartu | Estonia | ||
| 277 | 1245.25.33022 Boehringer Ingelheim Investigational Site | Amiens | France | ||
| 278 | 1245.25.33033 Boehringer Ingelheim Investigational Site | Angers | France | ||
| 279 | 1245.25.33034 Boehringer Ingelheim Investigational Site | Angers | France | ||
| 280 | 1245.25.33030 Boehringer Ingelheim Investigational Site | Bourg des cptes | France | ||
| 281 | 1245.25.33023 Boehringer Ingelheim Investigational Site | Corbeil Essonnes | France | ||
| 282 | 1245.25.33024 Boehringer Ingelheim Investigational Site | Derval | France | ||
| 283 | 1245.25.33029 Boehringer Ingelheim Investigational Site | Equeurdreville Haineville | France | ||
| 284 | 1245.25.33027 Boehringer Ingelheim Investigational Site | Fleury sur Orne | France | ||
| 285 | 1245.25.33021 Boehringer Ingelheim Investigational Site | Grenoble | France | ||
| 286 | 1245.25.33003 Boehringer Ingelheim Investigational Site | La Rochelle Cedex 1 | France | ||
| 287 | 1245.25.33032 Boehringer Ingelheim Investigational Site | Le Creusot | France | ||
| 288 | 1245.25.33004 Boehringer Ingelheim Investigational Site | Narbonne Cedex | France | ||
| 289 | 1245.25.33047 Boehringer Ingelheim Investigational Site | Pessac | France | ||
| 290 | 1245.25.33046 Boehringer Ingelheim Investigational Site | Poitiers | France | ||
| 291 | 1245.25.33025 Boehringer Ingelheim Investigational Site | Saint Priez en Jarez | France | ||
| 292 | 1245.25.33035 Boehringer Ingelheim Investigational Site | Tours | France | ||
| 293 | 1245.25.99001 Boehringer Ingelheim Investigational Site | Batumi | Georgia | ||
| 294 | 1245.25.99003 Boehringer Ingelheim Investigational Site | Kutaisi | Georgia | ||
| 295 | 1245.25.99002 Boehringer Ingelheim Investigational Site | Tbilisi | Georgia | ||
| 296 | 1245.25.99004 Boehringer Ingelheim Investigational Site | Tbilisi | Georgia | ||
| 297 | 1245.25.99005 Boehringer Ingelheim Investigational Site | Tbilisi | Georgia | ||
| 298 | 1245.25.99006 Boehringer Ingelheim Investigational Site | Tbilisi | Georgia | ||
| 299 | 1245.25.99007 Boehringer Ingelheim Investigational Site | Tbilisi | Georgia | ||
| 300 | 1245.25.99008 Boehringer Ingelheim Investigational Site | Tbilisi | Georgia | ||
| 301 | 1245.25.30002 Boehringer Ingelheim Investigational Site | Athens | Greece | ||
| 302 | 1245.25.30003 Boehringer Ingelheim Investigational Site | Athens | Greece | ||
| 303 | 1245.25.30004 Boehringer Ingelheim Investigational Site | Athens | Greece | ||
| 304 | 1245.25.30007 Boehringer Ingelheim Investigational Site | Athens | Greece | ||
| 305 | 1245.25.30005 Boehringer Ingelheim Investigational Site | Larissa | Greece | ||
| 306 | 1245.25.30001 Boehringer Ingelheim Investigational Site | Nikaia | Greece | ||
| 307 | 1245.25.30006 Boehringer Ingelheim Investigational Site | Thessaloniki | Greece | ||
| 308 | 1245.25.30008 Boehringer Ingelheim Investigational Site | Thessaloniki | Greece | ||
| 309 | 1245.25.85201 Boehringer Ingelheim Investigational Site | Hong Kong | Hong Kong | ||
| 310 | 1245.25.85205 Boehringer Ingelheim Investigational Site | Hong Kong | Hong Kong | ||
| 311 | 1245.25.85207 Boehringer Ingelheim Investigational Site | Hong Kong | Hong Kong | ||
| 312 | 1245.25.85208 Boehringer Ingelheim Investigational Site | Hong Kong | Hong Kong | ||
| 313 | 1245.25.36002 Boehringer Ingelheim Investigational Site | Budapest | Hungary | ||
| 314 | 1245.25.36004 Boehringer Ingelheim Investigational Site | Budapest | Hungary | ||
| 315 | 1245.25.36008 Boehringer Ingelheim Investigational Site | Budapest | Hungary | ||
| 316 | 1245.25.36006 Boehringer Ingelheim Investigational Site | Dunaujvaros | Hungary | ||
| 317 | 1245.25.36001 Boehringer Ingelheim Investigational Site | Gyula | Hungary | ||
| 318 | 1245.25.36010 Boehringer Ingelheim Investigational Site | Kisvarda | Hungary | ||
| 319 | 1245.25.36003 Boehringer Ingelheim Investigational Site | Szekszard | Hungary | ||
| 320 | 1245.25.36011 Boehringer Ingelheim Investigational Site | Szikszo | Hungary | ||
| 321 | 1245.25.91307 Boehringer Ingelheim Investigational Site | Ahmedabad | India | ||
| 322 | 1245.25.91302 Boehringer Ingelheim Investigational Site | Bangalore | India | ||
| 323 | 1245.25.91317 Boehringer Ingelheim Investigational Site | Bangalore | India | ||
| 324 | 1245.25.91319 Boehringer Ingelheim Investigational Site | Bangalore | India | ||
| 325 | 1245.25.91320 Boehringer Ingelheim Investigational Site | Bangalore | India | ||
| 326 | 1245.25.91303 Boehringer Ingelheim Investigational Site | Chennai | India | ||
| 327 | 1245.25.91315 Boehringer Ingelheim Investigational Site | Cochin | India | ||
| 328 | 1245.25.91311 Boehringer Ingelheim Investigational Site | Hyderabad | India | ||
| 329 | 1245.25.91318 Boehringer Ingelheim Investigational Site | Indore | India | ||
| 330 | 1245.25.91305 Boehringer Ingelheim Investigational Site | Jaipur | India | ||
| 331 | 1245.25.91309 Boehringer Ingelheim Investigational Site | Jalandhar | India | ||
| 332 | 1245.25.91313 Boehringer Ingelheim Investigational Site | Nagpur | India | ||
| 333 | 1245.25.91324 Boehringer Ingelheim Investigational Site | Nagpur | India | ||
| 334 | 1245.25.91301 Boehringer Ingelheim Investigational Site | Nashik, Maharashtra | India | ||
| 335 | 1245.25.91308 Boehringer Ingelheim Investigational Site | Pune | India | ||
| 336 | 1245.25.91316 Boehringer Ingelheim Investigational Site | Secunderabad | India | ||
| 337 | 1245.25.91321 Boehringer Ingelheim Investigational Site | Varanasi | India | ||
| 338 | 1245.25.91314 Boehringer Ingelheim Investigational Site | Vijaywada | India | ||
| 339 | 1245.25.62006 Boehringer Ingelheim Investigational Site | Denpasar, Bali | Indonesia | ||
| 340 | 1245.25.62009 Boehringer Ingelheim Investigational Site | Depok | Indonesia | ||
| 341 | 1245.25.62002 Boehringer Ingelheim Investigational Site | Jakarta | Indonesia | ||
| 342 | 1245.25.62008 Boehringer Ingelheim Investigational Site | Jakarta | Indonesia | ||
| 343 | 1245.25.62010 Boehringer Ingelheim Investigational Site | Jakarta | Indonesia | ||
| 344 | 1245.25.62004 Boehringer Ingelheim Investigational Site | Malang | Indonesia | ||
| 345 | 1245.25.62003 Boehringer Ingelheim Investigational Site | Surabaya | Indonesia | ||
| 346 | 1245.25.62001 Boehringer Ingelheim Investigational Site | Yogyakarta | Indonesia | ||
| 347 | 1245.25.97003 Boehringer Ingelheim Investigational Site | Afula | Israel | ||
| 348 | 1245.25.97006 Boehringer Ingelheim Investigational Site | Hadera | Israel | ||
| 349 | 1245.25.97008 Boehringer Ingelheim Investigational Site | Haifa | Israel | ||
| 350 | 1245.25.97009 Boehringer Ingelheim Investigational Site | Holon | Israel | ||
| 351 | 1245.25.97005 Boehringer Ingelheim Investigational Site | Nahariya | Israel | ||
| 352 | 1245.25.97001 Boehringer Ingelheim Investigational Site | Safed | Israel | ||
| 353 | 1245.25.97002 Boehringer Ingelheim Investigational Site | Zerifin | Israel | ||
| 354 | 1245.25.39007 Boehringer Ingelheim Investigational Site | Bologna | Italy | ||
| 355 | 1245.25.39002 Boehringer Ingelheim Investigational Site | Campobasso | Italy | ||
| 356 | 1245.25.39008 Boehringer Ingelheim Investigational Site | Catanzaro | Italy | ||
| 357 | 1245.25.39010 Boehringer Ingelheim Investigational Site | Chieti | Italy | ||
| 358 | 1245.25.39024 Boehringer Ingelheim Investigational Site | Ferrara | Italy | ||
| 359 | 1245.25.39009 Boehringer Ingelheim Investigational Site | Firenze | Italy | ||
| 360 | 1245.25.39005 Boehringer Ingelheim Investigational Site | Foggia | Italy | ||
| 361 | 1245.25.39004 Boehringer Ingelheim Investigational Site | Napoli | Italy | ||
| 362 | 1245.25.39006 Boehringer Ingelheim Investigational Site | Padova | Italy | ||
| 363 | 1245.25.39001 Boehringer Ingelheim Investigational Site | Pisa | Italy | ||
| 364 | 1245.25.39003 Boehringer Ingelheim Investigational Site | Roma | Italy | ||
| 365 | 1245.25.39011 Boehringer Ingelheim Investigational Site | Roma | Italy | ||
| 366 | 1245.25.39012 Boehringer Ingelheim Investigational Site | Roma | Italy | ||
| 367 | 1245.25.39014 Boehringer Ingelheim Investigational Site | Roma | Italy | ||
| 368 | 1245.25.39013 Boehringer Ingelheim Investigational Site | Venezia | Italy | ||
| 369 | 1245.25.81008 Boehringer Ingelheim Investigational Site | Chuo-ku, tokyo | Japan | ||
| 370 | 1245.25.81010 Boehringer Ingelheim Investigational Site | Gifushi, Gifu | Japan | ||
| 371 | 1245.25.81002 Boehringer Ingelheim Investigational Site | Hanyushi, Saitama | Japan | ||
| 372 | 1245.25.81013 Boehringer Ingelheim Investigational Site | Kamigyo-ku, Kyotoshi, Kyoto | Japan | ||
| 373 | 1245.25.81003 Boehringer Ingelheim Investigational Site | Kishiwadashi. Osaka | Japan | ||
| 374 | 1245.25.81012 Boehringer Ingelheim Investigational Site | Kita-ku, Nagoyashi, Aichi | Japan | ||
| 375 | 1245.25.81014 Boehringer Ingelheim Investigational Site | Kumamoto-shi, Kumamoto | Japan | ||
| 376 | 1245.25.81001 Boehringer Ingelheim Investigational Site | Matsudoshi, Chiba | Japan | ||
| 377 | 1245.25.81006 Boehringer Ingelheim Investigational Site | Mitoshi, Ibaraki | Japan | ||
| 378 | 1245.25.81005 Boehringer Ingelheim Investigational Site | Nishi-ku, Sapporoshi, Hokkaido | Japan | ||
| 379 | 1245.25.81007 Boehringer Ingelheim Investigational Site | Nodashi, Chiba | Japan | ||
| 380 | 1245.25.81004 Boehringer Ingelheim Investigational Site | Shimajiri-gun,Okinawa | Japan | ||
| 381 | 1245.25.81009 Boehringer Ingelheim Investigational Site | Toyamashi, Toyama | Japan | ||
| 382 | 1245.25.81015 Boehringer Ingelheim Investigational Site | Toyoakeshi, Aichi | Japan | ||
| 383 | 1245.25.82030 Boehringer Ingelheim Investigational Site | Busan | Korea, Republic of | ||
| 384 | 1245.25.82018 Boehringer Ingelheim Investigational Site | Daegu | Korea, Republic of | ||
| 385 | 1245.25.82021 Boehringer Ingelheim Investigational Site | Daejeon | Korea, Republic of | ||
| 386 | 1245.25.82031 Boehringer Ingelheim Investigational Site | Daejoen | Korea, Republic of | ||
| 387 | 1245.25.82027 Boehringer Ingelheim Investigational Site | Goyang | Korea, Republic of | ||
| 388 | 1245.25.82022 Boehringer Ingelheim Investigational Site | Gwangju | Korea, Republic of | ||
| 389 | 1245.25.82029 Boehringer Ingelheim Investigational Site | Incheon | Korea, Republic of | ||
| 390 | 1245.25.82017 Boehringer Ingelheim Investigational Site | Pusan | Korea, Republic of | ||
| 391 | 1245.25.82015 Boehringer Ingelheim Investigational Site | Seoul | Korea, Republic of | ||
| 392 | 1245.25.82016 Boehringer Ingelheim Investigational Site | Seoul | Korea, Republic of | ||
| 393 | 1245.25.82019 Boehringer Ingelheim Investigational Site | Seoul | Korea, Republic of | ||
| 394 | 1245.25.82020 Boehringer Ingelheim Investigational Site | Seoul | Korea, Republic of | ||
| 395 | 1245.25.82023 Boehringer Ingelheim Investigational Site | Seoul | Korea, Republic of | ||
| 396 | 1245.25.82024 Boehringer Ingelheim Investigational Site | Seoul | Korea, Republic of | ||
| 397 | 1245.25.82025 Boehringer Ingelheim Investigational Site | Seoul | Korea, Republic of | ||
| 398 | 1245.25.82026 Boehringer Ingelheim Investigational Site | Suwon | Korea, Republic of | ||
| 399 | 1245.25.82028 Boehringer Ingelheim Investigational Site | Wonju | Korea, Republic of | ||
| 400 | 1245.25.60019 Boehringer Ingelheim Investigational Site | Johor Bahru | Malaysia | ||
| 401 | 1245.25.60020 Boehringer Ingelheim Investigational Site | Kedah | Malaysia | ||
| 402 | 1245.25.60013 Boehringer Ingelheim Investigational Site | Kelantan | Malaysia | ||
| 403 | 1245.25.60015 Boehringer Ingelheim Investigational Site | Kota Kinabalu | Malaysia | ||
| 404 | 1245.25.60012 Boehringer Ingelheim Investigational Site | Kuala Lumpur | Malaysia | ||
| 405 | 1245.25.60017 Boehringer Ingelheim Investigational Site | Kuala Lumpur | Malaysia | ||
| 406 | 1245.25.60004 Boehringer Ingelheim Investigational Site | Pahang | Malaysia | ||
| 407 | 1245.25.60018 Boehringer Ingelheim Investigational Site | Selangor Darul Ehsan | Malaysia | ||
| 408 | 1245.25.60016 Boehringer Ingelheim Investigational Site | Selangor | Malaysia | ||
| 409 | 1245.25.60021 Boehringer Ingelheim Investigational Site | Selangor | Malaysia | ||
| 410 | 1245.25.52009 Boehringer Ingelheim Investigational Site | Colonia Americana | Mexico | ||
| 411 | 1245.25.52007 Boehringer Ingelheim Investigational Site | Distrito Federal | Mexico | ||
| 412 | 1245.25.52013 Boehringer Ingelheim Investigational Site | Ladron de Guevara | Mexico | ||
| 413 | 1245.25.52010 Boehringer Ingelheim Investigational Site | Los Robles | Mexico | ||
| 414 | 1245.25.52001 Boehringer Ingelheim Investigational Site | Monterrey | Mexico | ||
| 415 | 1245.25.52011 Boehringer Ingelheim Investigational Site | Reforma Social | Mexico | ||
| 416 | 1245.25.52012 Boehringer Ingelheim Investigational Site | San Lucas tepetlcalco | Mexico | ||
| 417 | 1245.25.31015 Boehringer Ingelheim Investigational Site | Amersfoort | Netherlands | ||
| 418 | 1245.25.31013 Boehringer Ingelheim Investigational Site | Apeldoorn | Netherlands | ||
| 419 | 1245.25.31036 Boehringer Ingelheim Investigational Site | Baarle - Nassau | Netherlands | ||
| 420 | 1245.25.31032 Boehringer Ingelheim Investigational Site | Delft | Netherlands | ||
| 421 | 1245.25.31026 Boehringer Ingelheim Investigational Site | Den Helder | Netherlands | ||
| 422 | 1245.25.31012 Boehringer Ingelheim Investigational Site | Geleen | Netherlands | ||
| 423 | 1245.25.31017 Boehringer Ingelheim Investigational Site | Hardenberg | Netherlands | ||
| 424 | 1245.25.31035 Boehringer Ingelheim Investigational Site | Heerlen | Netherlands | ||
| 425 | 1245.25.31011 Boehringer Ingelheim Investigational Site | Hoogeveen | Netherlands | ||
| 426 | 1245.25.31029 Boehringer Ingelheim Investigational Site | Hoogezand | Netherlands | ||
| 427 | 1245.25.31023 Boehringer Ingelheim Investigational Site | Hoogwoud | Netherlands | ||
| 428 | 1245.25.31009 Boehringer Ingelheim Investigational Site | Maastricht | Netherlands | ||
| 429 | 1245.25.31031 Boehringer Ingelheim Investigational Site | Meppel | Netherlands | ||
| 430 | 1245.25.31024 Boehringer Ingelheim Investigational Site | Nijverdal | Netherlands | ||
| 431 | 1245.25.31014 Boehringer Ingelheim Investigational Site | Rotterdam | Netherlands | ||
| 432 | 1245.25.31033 Boehringer Ingelheim Investigational Site | Rotterdam | Netherlands | ||
| 433 | 1245.25.31030 Boehringer Ingelheim Investigational Site | Schiedam | Netherlands | ||
| 434 | 1245.25.31002 Boehringer Ingelheim Investigational Site | Utrecht | Netherlands | ||
| 435 | 1245.25.31028 Boehringer Ingelheim Investigational Site | Wildervank | Netherlands | ||
| 436 | 1245.25.31034 Boehringer Ingelheim Investigational Site | Zutphen | Netherlands | ||
| 437 | 1245.25.64004 Boehringer Ingelheim Investigational Site | Christchurch | New Zealand | ||
| 438 | 1245.25.64001 Boehringer Ingelheim Investigational Site | Grafton / Auckland | New Zealand | ||
| 439 | 1245.25.64003 Boehringer Ingelheim Investigational Site | Wellington | New Zealand | ||
| 440 | 1245.25.47002 Boehringer Ingelheim Investigational Site | Fornebu | Norway | ||
| 441 | 1245.25.47004 Boehringer Ingelheim Investigational Site | Gjøvik | Norway | ||
| 442 | 1245.25.47009 Boehringer Ingelheim Investigational Site | Kløfta | Norway | ||
| 443 | 1245.25.47008 Boehringer Ingelheim Investigational Site | Kongsvinger | Norway | ||
| 444 | 1245.25.47001 Boehringer Ingelheim Investigational Site | Oslo | Norway | ||
| 445 | 1245.25.47006 Boehringer Ingelheim Investigational Site | Oslo | Norway | ||
| 446 | 1245.25.47007 Boehringer Ingelheim Investigational Site | Trondheim | Norway | ||
| 447 | 1245.25.47005 Boehringer Ingelheim Investigational Site | Tynset | Norway | ||
| 448 | 1245.25.51001 Boehringer Ingelheim Investigational Site | Arequipa | Peru | ||
| 449 | 1245.25.51008 Boehringer Ingelheim Investigational Site | Arequipa | Peru | ||
| 450 | 1245.25.51002 Boehringer Ingelheim Investigational Site | Bellavista | Peru | ||
| 451 | 1245.25.51004 Boehringer Ingelheim Investigational Site | El Agustino | Peru | ||
| 452 | 1245.25.51006 Boehringer Ingelheim Investigational Site | Ica | Peru | ||
| 453 | 1245.25.51003 Boehringer Ingelheim Investigational Site | Jesus Maria | Peru | ||
| 454 | 1245.25.51007 Boehringer Ingelheim Investigational Site | Lima | Peru | ||
| 455 | 1245.25.51009 Boehringer Ingelheim Investigational Site | Lima | Peru | ||
| 456 | 1245.25.51010 Boehringer Ingelheim Investigational Site | Lima | Peru | ||
| 457 | 1245.25.51011 Boehringer Ingelheim Investigational Site | Lima | Peru | ||
| 458 | 1245.25.51005 Boehringer Ingelheim Investigational Site | Miraflores | Peru | ||
| 459 | 1245.25.63016 Boehringer Ingelheim Investigational Site | Cavite City | Philippines | ||
| 460 | 1245.25.63002 Boehringer Ingelheim Investigational Site | Cebu | Philippines | ||
| 461 | 1245.25.63003 Boehringer Ingelheim Investigational Site | Davao | Philippines | ||
| 462 | 1245.25.63020 Boehringer Ingelheim Investigational Site | Jaro Iloilo City | Philippines | ||
| 463 | 1245.25.63001 Boehringer Ingelheim Investigational Site | Manila | Philippines | ||
| 464 | 1245.25.63004 Boehringer Ingelheim Investigational Site | Manila | Philippines | ||
| 465 | 1245.25.63018 Boehringer Ingelheim Investigational Site | Manila | Philippines | ||
| 466 | 1245.25.63009 Boehringer Ingelheim Investigational Site | Marikina City | Philippines | ||
| 467 | 1245.25.63021 Boehringer Ingelheim Investigational Site | Marikina City | Philippines | ||
| 468 | 1245.25.63019 Boehringer Ingelheim Investigational Site | Tarlac | Philippines | ||
| 469 | 1245.25.48013 Boehringer Ingelheim Investigational Site | Gdansk | Poland | ||
| 470 | 1245.25.48004 Boehringer Ingelheim Investigational Site | Lodz | Poland | ||
| 471 | 1245.25.48009 Boehringer Ingelheim Investigational Site | Lodz | Poland | ||
| 472 | 1245.25.48010 Boehringer Ingelheim Investigational Site | Lodz | Poland | ||
| 473 | 1245.25.48001 Boehringer Ingelheim Investigational Site | Lublin | Poland | ||
| 474 | 1245.25.48014 Boehringer Ingelheim Investigational Site | Oswiecim | Poland | ||
| 475 | 1245.25.48002 Boehringer Ingelheim Investigational Site | Poznan | Poland | ||
| 476 | 1245.25.48008 Boehringer Ingelheim Investigational Site | Pulawy | Poland | ||
| 477 | 1245.25.48007 Boehringer Ingelheim Investigational Site | Ruda Slaska | Poland | ||
| 478 | 1245.25.48005 Boehringer Ingelheim Investigational Site | Torun | Poland | ||
| 479 | 1245.25.48011 Boehringer Ingelheim Investigational Site | Torun | Poland | ||
| 480 | 1245.25.35006 Boehringer Ingelheim Investigational Site | Amadora | Portugal | ||
| 481 | 1245.25.35004 Boehringer Ingelheim Investigational Site | Coimbra | Portugal | ||
| 482 | 1245.25.35018 Boehringer Ingelheim Investigational Site | Faro | Portugal | ||
| 483 | 1245.25.35021 Boehringer Ingelheim Investigational Site | Funchal | Portugal | ||
| 484 | 1245.25.35008 Boehringer Ingelheim Investigational Site | Leiria | Portugal | ||
| 485 | 1245.25.35001 Boehringer Ingelheim Investigational Site | Lisboa | Portugal | ||
| 486 | 1245.25.35002 Boehringer Ingelheim Investigational Site | Lisboa | Portugal | ||
| 487 | 1245.25.35015 Boehringer Ingelheim Investigational Site | Lisboa | Portugal | ||
| 488 | 1245.25.35017 Boehringer Ingelheim Investigational Site | Lisboa | Portugal | ||
| 489 | 1245.25.35011 Boehringer Ingelheim Investigational Site | Porto | Portugal | ||
| 490 | 1245.25.35005 Boehringer Ingelheim Investigational Site | Santiago do Cacém | Portugal | ||
| 491 | 1245.25.35020 Boehringer Ingelheim Investigational Site | Torres Novas | Portugal | ||
| 492 | 1245.25.35014 Boehringer Ingelheim Investigational Site | Viana do Castelo | Portugal | ||
| 493 | 1245.25.35019 Boehringer Ingelheim Investigational Site | Vila Nova de Gaia | Portugal | ||
| 494 | 1245.25.40008 Boehringer Ingelheim Investigational Site | Alba Iulia | Romania | ||
| 495 | 1245.25.40011 Boehringer Ingelheim Investigational Site | Baia Mare Maramures | Romania | ||
| 496 | 1245.25.40003 Boehringer Ingelheim Investigational Site | Bucharest | Romania | ||
| 497 | 1245.25.40007 Boehringer Ingelheim Investigational Site | Bucharest | Romania | ||
| 498 | 1245.25.40005 Boehringer Ingelheim Investigational Site | Constanta | Romania | ||
| 499 | 1245.25.40002 Boehringer Ingelheim Investigational Site | Craiova | Romania | ||
| 500 | 1245.25.40006 Boehringer Ingelheim Investigational Site | Craiova | Romania | ||
| 501 | 1245.25.40009 Boehringer Ingelheim Investigational Site | Oradea | Romania | ||
| 502 | 1245.25.40010 Boehringer Ingelheim Investigational Site | Targu-Mures | Romania | ||
| 503 | 1245.25.70019 Boehringer Ingelheim Investigational Site | Barnaul | Russian Federation | ||
| 504 | 1245.25.70015 Boehringer Ingelheim Investigational Site | Kemerovo | Russian Federation | ||
| 505 | 1245.25.70020 Boehringer Ingelheim Investigational Site | Kemerovo | Russian Federation | ||
| 506 | 1245.25.70003 Boehringer Ingelheim Investigational Site | Moscow | Russian Federation | ||
| 507 | 1245.25.70009 Boehringer Ingelheim Investigational Site | Moscow | Russian Federation | ||
| 508 | 1245.25.70011 Boehringer Ingelheim Investigational Site | Moscow | Russian Federation | ||
| 509 | 1245.25.70016 Boehringer Ingelheim Investigational Site | Moscow | Russian Federation | ||
| 510 | 1245.25.70021 Boehringer Ingelheim Investigational Site | Moscow | Russian Federation | ||
| 511 | 1245.25.70022 Boehringer Ingelheim Investigational Site | Moscow | Russian Federation | ||
| 512 | 1245.25.70014 Boehringer Ingelheim Investigational Site | Novosibirsk | Russian Federation | ||
| 513 | 1245.25.70018 Boehringer Ingelheim Investigational Site | Novosibirsk | Russian Federation | ||
| 514 | 1245.25.70024 Boehringer Ingelheim Investigational Site | Novosibirsk | Russian Federation | ||
| 515 | 1245.25.70028 Boehringer Ingelheim Investigational Site | Novosibirsk | Russian Federation | ||
| 516 | 1245.25.70005 Boehringer Ingelheim Investigational Site | Saint Petersburg | Russian Federation | ||
| 517 | 1245.25.70025 Boehringer Ingelheim Investigational Site | Saint Petersburg | Russian Federation | ||
| 518 | 1245.25.70026 Boehringer Ingelheim Investigational Site | Saint Petersburg | Russian Federation | ||
| 519 | 1245.25.70027 Boehringer Ingelheim Investigational Site | Saint Petersburg | Russian Federation | ||
| 520 | 1245.25.70001 Boehringer Ingelheim Investigational Site | St. Petersburg | Russian Federation | ||
| 521 | 1245.25.70004 Boehringer Ingelheim Investigational Site | St. Petersburg | Russian Federation | ||
| 522 | 1245.25.70006 Boehringer Ingelheim Investigational Site | St. Petersburg | Russian Federation | ||
| 523 | 1245.25.70013 Boehringer Ingelheim Investigational Site | St. Petersburg | Russian Federation | ||
| 524 | 1245.25.70017 Boehringer Ingelheim Investigational Site | St. Petersburg | Russian Federation | ||
| 525 | 1245.25.70023 Boehringer Ingelheim Investigational Site | St. Petersburg | Russian Federation | ||
| 526 | 1245.25.70002 Boehringer Ingelheim Investigational Site | Vsevolozhsk | Russian Federation | ||
| 527 | 1245.25.70029 Boehringer Ingelheim Investigational Site | Yaroslavl | Russian Federation | ||
| 528 | 1245.25.65001 Boehringer Ingelheim Investigational Site | Singapore | Singapore | ||
| 529 | 1245.25.65003 Boehringer Ingelheim Investigational Site | Singapore | Singapore | ||
| 530 | 1245.25.65004 Boehringer Ingelheim Investigational Site | Singapore | Singapore | ||
| 531 | 1245.25.76007 Boehringer Ingelheim Investigational Site | Alberton | South Africa | ||
| 532 | 1245.25.76002 Boehringer Ingelheim Investigational Site | Bellville | South Africa | ||
| 533 | 1245.25.76009 Boehringer Ingelheim Investigational Site | Bloemfontein | South Africa | ||
| 534 | 1245.25.76014 Boehringer Ingelheim Investigational Site | Cape Town | South Africa | ||
| 535 | 1245.25.76020 Boehringer Ingelheim Investigational Site | Cape Town | South Africa | ||
| 536 | 1245.25.76022 Boehringer Ingelheim Investigational Site | Chatsworth Unit 10 | South Africa | ||
| 537 | 1245.25.76013 Boehringer Ingelheim Investigational Site | Durban | South Africa | ||
| 538 | 1245.25.76016 Boehringer Ingelheim Investigational Site | Durban | South Africa | ||
| 539 | 1245.25.76019 Boehringer Ingelheim Investigational Site | Durban | South Africa | ||
| 540 | 1245.25.76003 Boehringer Ingelheim Investigational Site | Goodwood | South Africa | ||
| 541 | 1245.25.76001 Boehringer Ingelheim Investigational Site | Houghton | South Africa | ||
| 542 | 1245.25.76021 Boehringer Ingelheim Investigational Site | Kempton Park | South Africa | ||
| 543 | 1245.25.76017 Boehringer Ingelheim Investigational Site | Krugersdorp | South Africa | ||
| 544 | 1245.25.76004 Boehringer Ingelheim Investigational Site | Newtown | South Africa | ||
| 545 | 1245.25.76006 Boehringer Ingelheim Investigational Site | Paarl | South Africa | ||
| 546 | 1245.25.76005 Boehringer Ingelheim Investigational Site | Parow | South Africa | ||
| 547 | 1245.25.76018 Boehringer Ingelheim Investigational Site | Port Elizabeth | South Africa | ||
| 548 | 1245.25.76015 Boehringer Ingelheim Investigational Site | Somerset West | South Africa | ||
| 549 | 1245.25.76012 Boehringer Ingelheim Investigational Site | Sydenham | South Africa | ||
| 550 | 1245.25.76008 Boehringer Ingelheim Investigational Site | Tongaat | South Africa | ||
| 551 | 1245.25.76023 Boehringer Ingelheim Investigational Site | Worcester | South Africa | ||
| 552 | 1245.25.34025 Boehringer Ingelheim Investigational Site | Alcorcon (Madrid) | Spain | ||
| 553 | 1245.25.34048 Boehringer Ingelheim Investigational Site | Alicante | Spain | ||
| 554 | 1245.25.34050 Boehringer Ingelheim Investigational Site | Alzira | Spain | ||
| 555 | 1245.25.34039 Boehringer Ingelheim Investigational Site | Avila | Spain | ||
| 556 | 1245.25.34040 Boehringer Ingelheim Investigational Site | Badía del Vallès - Barcelona | Spain | ||
| 557 | 1245.25.34029 Boehringer Ingelheim Investigational Site | Barcelona | Spain | ||
| 558 | 1245.25.34030 Boehringer Ingelheim Investigational Site | Barcelona | Spain | ||
| 559 | 1245.25.34049 Boehringer Ingelheim Investigational Site | Barcelona | Spain | ||
| 560 | 1245.25.34031 Boehringer Ingelheim Investigational Site | Granada | Spain | ||
| 561 | 1245.25.34024 Boehringer Ingelheim Investigational Site | Leganes (Madrid) | Spain | ||
| 562 | 1245.25.34013 Boehringer Ingelheim Investigational Site | Madrid | Spain | ||
| 563 | 1245.25.34023 Boehringer Ingelheim Investigational Site | Madrid | Spain | ||
| 564 | 1245.25.34026 Boehringer Ingelheim Investigational Site | Madrid | Spain | ||
| 565 | 1245.25.34028 Boehringer Ingelheim Investigational Site | Madrid | Spain | ||
| 566 | 1245.25.34033 Boehringer Ingelheim Investigational Site | Madrid | Spain | ||
| 567 | 1245.25.34036 Boehringer Ingelheim Investigational Site | Madrid | Spain | ||
| 568 | 1245.25.34038 Boehringer Ingelheim Investigational Site | Madrid | Spain | ||
| 569 | 1245.25.34022 Boehringer Ingelheim Investigational Site | Mahadahonda (Madrid) | Spain | ||
| 570 | 1245.25.34047 Boehringer Ingelheim Investigational Site | Palma de Mallorca | Spain | ||
| 571 | 1245.25.34034 Boehringer Ingelheim Investigational Site | Sabadell (Barcelona) | Spain | ||
| 572 | 1245.25.34027 Boehringer Ingelheim Investigational Site | Salamanca | Spain | ||
| 573 | 1245.25.34037 Boehringer Ingelheim Investigational Site | Santa Cruz de Tenerife | Spain | ||
| 574 | 1245.25.34046 Boehringer Ingelheim Investigational Site | Segovia | Spain | ||
| 575 | 1245.25.94002 Boehringer Ingelheim Investigational Site | Colombo | Sri Lanka | ||
| 576 | 1245.25.94005 Boehringer Ingelheim Investigational Site | Kalubowila | Sri Lanka | ||
| 577 | 1245.25.94004 Boehringer Ingelheim Investigational Site | Kandy | Sri Lanka | ||
| 578 | 1245.25.94006 Boehringer Ingelheim Investigational Site | Kandy | Sri Lanka | ||
| 579 | 1245.25.94001 Boehringer Ingelheim Investigational Site | Nugegoda | Sri Lanka | ||
| 580 | 1245.25.94003 Boehringer Ingelheim Investigational Site | Ragama | Sri Lanka | ||
| 581 | 1245.25.88022 Boehringer Ingelheim Investigational Site | Hualien | Taiwan | ||
| 582 | 1245.25.88010 Boehringer Ingelheim Investigational Site | Kaohsiung | Taiwan | ||
| 583 | 1245.25.88019 Boehringer Ingelheim Investigational Site | Kaohsiung | Taiwan | ||
| 584 | 1245.25.88009 Boehringer Ingelheim Investigational Site | Taichung | Taiwan | ||
| 585 | 1245.25.88020 Boehringer Ingelheim Investigational Site | Taichung | Taiwan | ||
| 586 | 1245.25.88018 Boehringer Ingelheim Investigational Site | Tainan | Taiwan | ||
| 587 | 1245.25.88015 Boehringer Ingelheim Investigational Site | Taipei | Taiwan | ||
| 588 | 1245.25.88016 Boehringer Ingelheim Investigational Site | Taipei | Taiwan | ||
| 589 | 1245.25.88023 Boehringer Ingelheim Investigational Site | Tamsui, Taipei county | Taiwan | ||
| 590 | 1245.25.88017 Boehringer Ingelheim Investigational Site | Taoyuan | Taiwan | ||
| 591 | 1245.25.66006 Boehringer Ingelheim Investigational Site | Bangkok | Thailand | ||
| 592 | 1245.25.66007 Boehringer Ingelheim Investigational Site | Bangkok | Thailand | ||
| 593 | 1245.25.66009 Boehringer Ingelheim Investigational Site | Chiang Mai | Thailand | ||
| 594 | 1245.25.66004 Boehringer Ingelheim Investigational Site | Muang District | Thailand | ||
| 595 | 1245.25.66010 Boehringer Ingelheim Investigational Site | Nakhonratchasima | Thailand | ||
| 596 | 1245.25.66011 Boehringer Ingelheim Investigational Site | Pathum Tani | Thailand | ||
| 597 | 1245.25.75009 Boehringer Ingelheim Investigational Site | Kharkiv | Ukraine | ||
| 598 | 1245.25.75011 Boehringer Ingelheim Investigational Site | Kharkiv | Ukraine | ||
| 599 | 1245.25.75001 Boehringer Ingelheim Investigational Site | Kharkov | Ukraine | ||
| 600 | 1245.25.75008 Boehringer Ingelheim Investigational Site | Kharkov | Ukraine | ||
| 601 | 1245.25.75007 Boehringer Ingelheim Investigational Site | Kiev | Ukraine | ||
| 602 | 1245.25.75012 Boehringer Ingelheim Investigational Site | Kiev | Ukraine | ||
| 603 | 1245.25.75010 Boehringer Ingelheim Investigational Site | Odessa | Ukraine | ||
| 604 | 1245.25.44045 Boehringer Ingelheim Investigational Site | Airdrie | United Kingdom | ||
| 605 | 1245.25.44020 Boehringer Ingelheim Investigational Site | Ashford | United Kingdom | ||
| 606 | 1245.25.44013 Boehringer Ingelheim Investigational Site | Blackpool | United Kingdom | ||
| 607 | 1245.25.44014 Boehringer Ingelheim Investigational Site | Bolton | United Kingdom | ||
| 608 | 1245.25.44021 Boehringer Ingelheim Investigational Site | Bradford on Avon | United Kingdom | ||
| 609 | 1245.25.44002 Boehringer Ingelheim Investigational Site | Dumfries | United Kingdom | ||
| 610 | 1245.25.44009 Boehringer Ingelheim Investigational Site | Dundee | United Kingdom | ||
| 611 | 1245.25.44005 Boehringer Ingelheim Investigational Site | Edinburgh | United Kingdom | ||
| 612 | 1245.25.44004 Boehringer Ingelheim Investigational Site | Fowey | United Kingdom | ||
| 613 | 1245.25.44001 Boehringer Ingelheim Investigational Site | Frome | United Kingdom | ||
| 614 | 1245.25.44003 Boehringer Ingelheim Investigational Site | Inverness | United Kingdom | ||
| 615 | 1245.25.44044 Boehringer Ingelheim Investigational Site | Wishaw | United Kingdom |
Sponsors and Collaborators
- Boehringer Ingelheim
- Eli Lilly and Company
Investigators
- Study Chair: Boehringer Ingelheim, Boehringer Ingelheim
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01131676
Other Study ID Numbers:
- 1245.25
- 2009-016178-33
First Posted:
May 27, 2010
Last Update Posted:
May 16, 2016
Last Verified:
Apr 1, 2016
Study Results
Participant Flow
| Recruitment Details | Patients randomised to treatments in 1:1:1 ratio. |
|---|---|
| Pre-assignment Detail | Randomisation stratified by:BMI at randomisation(<30/≥30 kg/m2),HbA1c at screening (<8.5%/ ≥8.5%);geographical region(North America including Australia and New Zealand,Latin America,Europe,Africa,Asia);renal function at screening (normal:eGFR ≥90 mL/min, mild impairment:60 mL/min ≤ eGFR ≤89 mL/min, moderate impairment:30 mL/min ≤ eGFR≤59 mL/min). |
| Arm/Group Title | Placebo | Empagliflozin 10 mg | Empagliflozin 25 mg |
|---|---|---|---|
| Arm/Group Description | Oral administration of Placebo matching empagliflozin 10 mg or 25 mg (1 tablet once daily) | Oral administration of Empagliflozin 10 mg (BI 10773) film coated tablets (1 tablet once daily) | Oral administration of Empagliflozin 25 mg (BI 10773) film coated tablets (1 tablet once daily) |
| Period Title: Discontinuation From Treatment | |||
| STARTED | 2337 | 2347 | 2344 |
| COMPLETED | 1650 | 1790 | 1800 |
| NOT COMPLETED | 687 | 557 | 544 |
| Period Title: Discontinuation From Treatment | |||
| STARTED | 2333 | 2345 | 2342 |
| Final Vital Status (VS) Available | 2316 | 2324 | 2327 |
| COMPLETED | 2266 | 2264 | 2279 |
| NOT COMPLETED | 67 | 81 | 63 |
Baseline Characteristics
| Arm/Group Title | Placebo | Empagliflozin 10 mg | Empagliflozin 25 mg | Total |
|---|---|---|---|---|
| Arm/Group Description | Oral administration of Placebo matching empagliflozin 10 mg or 25 mg (1 tablet once daily) | Oral administration of Empagliflozin 10 mg (BI 10773) film coated tablets (1 tablet once daily) | Oral administration of Empagliflozin 25 mg (BI 10773) film coated tablets (1 tablet once daily) | Total of all reporting groups |
| Overall Participants | 2333 | 2345 | 2342 | 7020 |
| Age (years) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [years] |
63.2
(8.8)
|
63.0
(8.6)
|
63.2
(8.6)
|
63.1
(8.6)
|
| Sex: Female, Male (Count of Participants) | ||||
| Female |
653
28%
|
692
29.5%
|
659
28.1%
|
2004
28.5%
|
| Male |
1680
72%
|
1653
70.5%
|
1683
71.9%
|
5016
71.5%
|
Outcome Measures
| Title | Time to the First Occurrence of Any of the Following Adjudicated Components of the Primary Composite Endpoint (3-point MACE): CV Death (Including Fatal Stroke and Fatal MI), Non-fatal MI (Excluding Silent MI), and Non-fatal Stroke. |
|---|---|
| Description | Time to the first occurrence of any of the following adjudicated components of the primary composite endpoint (3-point major adverse cardiovascular events (MACE)): cardiovascular (CV) death (including fatal stroke and fatal myocardial infarction (MI)), non-fatal MI (excluding silent MI), and non-fatal stroke. Percentage of patients with the event are presented. |
| Time Frame | From randomisation to individual end of observation, up to 4.6 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| TS |
| Arm/Group Title | Placebo | Empagliflozin 10 mg | Empagliflozin 25 mg | All Empagliflozin |
|---|---|---|---|---|
| Arm/Group Description | Oral administration of Placebo matching empagliflozin 10 mg or 25 mg (1 tablet once daily) | Oral administration of Empagliflozin 10 mg (BI 10773) film coated tablets (1 tablet once daily) | Oral administration of Empagliflozin 25 mg (BI 10773) film coated tablets (1 tablet once daily) | Patients who received either 10 mg or 25 mg of empagliflozin were pooled into a common empagliflozin treatment group |
| Measure Participants | 2333 | 2345 | 2342 | 4687 |
| Number [percentage of participants] |
12.1
0.5%
|
10.4
0.4%
|
10.5
0.4%
|
10.5
0.1%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, All Empagliflozin |
|---|---|---|
| Comments | Primary objective was to establish the non-inferiority of All empagliflozin relative to placebo for time to first 3-point MACE. A 4-step hierarchical testing strategy was followed for the non-inferiority test of the primary endpoint and then the key secondary endpoint, each at a margin of 1.3, followed by test of superiority of primary and key secondary endpoints. | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | The non-inferiority margin was chosen as 1.3 based on Food and Drug Administration (FDA) Guidance for Industry - Diabetes Mellitus - Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes | |
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | One-sided test with alpha = 0.0249 | |
| Method | Cox proportional hazards model | |
| Comments | Cox proportional hazards model with factors for treatment, age, gender, categorised BMI, HbA1c, eGFR and geographical region. | |
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.86 | |
| Confidence Interval |
(2-Sided) 95.02% 0.74 to 0.99 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | All Empagliflozin divided by Placebo | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, All Empagliflozin |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0382 |
| Comments | Two-sided test with alpha=0.0498 | |
| Method | Cox proportional hazards model | |
| Comments | Cox proportional hazards model with factors for treatment, age, gender, categorised BMI, HbA1c, eGFR and geographical region. | |
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.86 | |
| Confidence Interval |
(2-Sided) 95.02% 0.74 to 0.99 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | All Empagliflozin divided by Placebo | |
| Title | Percentage of Participants With the Composite of All Events Adjudicated (4-point MACE): CV Death (Including Fatal Stroke and Fatal MI), Non-fatal MI (Excluding Silent MI), Non-fatal Stroke and Hospitalization for Unstable Angina Pectoris |
|---|---|
| Description | The composite of all events adjudicated (4-point MACE): cardiovascular death (including fatal stroke and fatal myocardial infarction), non-fatal myocardial infarction (excluding silent MI), non-fatal stroke and hospitalization for unstable angina pectoris.This is a key secondary endpoint of the trial. Percentage of patients with the event are presented. |
| Time Frame | From randomisation to individual end of observation, up to 4.6 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| TS |
| Arm/Group Title | Placebo | Empagliflozin 10 mg | Empagliflozin 25 mg | All Empagliflozin |
|---|---|---|---|---|
| Arm/Group Description | Oral administration of Placebo matching empagliflozin 10 mg or 25 mg (1 tablet once daily) | Oral administration of Empagliflozin 10 mg (BI 10773) film coated tablets (1 tablet once daily) | Oral administration of Empagliflozin 25 mg (BI 10773) film coated tablets (1 tablet once daily) | Patients who received either 10 mg or 25 mg of empagliflozin were pooled into a common empagliflozin treatment group |
| Measure Participants | 2333 | 2345 | 2342 | 4687 |
| Number [percentage of participants] |
14.3
0.6%
|
12.8
0.5%
|
12.8
0.5%
|
12.8
0.2%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, All Empagliflozin |
|---|---|---|
| Comments | A 4-step hierarchical testing strategy was followed for the non-inferiority test of the primary endpoint and then the key secondary endpoint, each at a margin of 1.3, followed by test of superiority of primary and key secondary endpoints. | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | The non-inferiority margin was chosen as 1.3 based on Food and Drug Administration (FDA) Guidance for Industry - Diabetes Mellitus - Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes | |
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | One-sided test with alpha = 0.0249 | |
| Method | Cox proportional hazards model | |
| Comments | Cox proportional hazards model with factors for treatment, age, gender, categorised BMI, HbA1c, eGFR and geographical region. | |
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.89 | |
| Confidence Interval |
(2-Sided) 95.02% 0.78 to 1.01 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | All Empagliflozin divided by Placebo | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, All Empagliflozin |
|---|---|---|
| Comments | A 4-step hierarchical testing strategy was followed for the non-inferiority test of the primary endpoint and then the key secondary endpoint, each at a margin of 1.3, followed by test of superiority of primary and key secondary endpoints. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0795 |
| Comments | Two-sided test with alpha=0.0498 | |
| Method | Cox proportional hazards model | |
| Comments | Cox proportional hazards model with factors for treatment, age, gender, categorised BMI, HbA1c, eGFR and geographical region. | |
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.89 | |
| Confidence Interval |
(2-Sided) 95.02% 0.78 to 1.01 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | All Empagliflozin divided by Placebo | |
| Title | Percentage of Participants With Silent MI |
|---|---|
| Description | Silent MI; defined as presence in the ECG of: Any Q-wave in leads V2-V3 ≥0.02 seconds or QS complex in leads V2 and V3 Q-wave ≥0.03 seconds and ≥0.1 mV deep or QS complex in leads I, II, aVL, aVF, or V4-V6 in any two leads of a contiguous lead grouping (I, aVL, V6; V4-V6; II, III, and aVF) R-wave ≥0.04 seconds in V1-V2 and R/S ≥1 with a concordant positive T-wave in the absence of a conduction defect. It was also required that there had been no adjudicated and confirmed event of either acute MI, hospitalisation for unstable angina, coronary revascularisation procedures or stent thrombosis following randomisation up to and including the date of the specified ECG measurement. Percentage of patients with the event are presented. |
| Time Frame | From randomisation to individual end of observation, up to 4.6 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| TS (evaluable cases) |
| Arm/Group Title | Placebo | Empagliflozin 10 mg | Empagliflozin 25 mg | All Empagliflozin |
|---|---|---|---|---|
| Arm/Group Description | Oral administration of Placebo matching empagliflozin 10 mg or 25 mg (1 tablet once daily) | Oral administration of Empagliflozin 10 mg (BI 10773) film coated tablets (1 tablet once daily) | Oral administration of Empagliflozin 25 mg (BI 10773) film coated tablets (1 tablet once daily) | Patients who received either 10 mg or 25 mg of empagliflozin were pooled into a common empagliflozin treatment group |
| Measure Participants | 1211 | 1174 | 1204 | 2378 |
| Number [percentage of participants] |
1.2
0.1%
|
1.6
0.1%
|
1.6
0.1%
|
1.6
0%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, All Empagliflozin |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.4172 |
| Comments | Two-sided test with alpha = 0.05. | |
| Method | Cox proportional hazards model | |
| Comments | Cox proportional hazards model with factors for treatment, age, gender, categorised BMI, HbA1c, eGFR and geographical region. | |
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 1.28 | |
| Confidence Interval |
(2-Sided) 95% 0.70 to 2.33 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | All Empagliflozin divided by Placebo | |
| Title | Percentage of Participants With Heart Failure Requiring Hospitalisation (Adjudicated) |
|---|---|
| Description | Heart failure requiring hospitalisation (adjudicated). Percentage of patients with the event are presented. |
| Time Frame | From randomisation to individual end of observation, up to 4.6 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| TS |
| Arm/Group Title | Placebo | Empagliflozin 10 mg | Empagliflozin 25 mg | All Empagliflozin |
|---|---|---|---|---|
| Arm/Group Description | Oral administration of Placebo matching empagliflozin 10 mg or 25 mg (1 tablet once daily) | Oral administration of Empagliflozin 10 mg (BI 10773) film coated tablets (1 tablet once daily) | Oral administration of Empagliflozin 25 mg (BI 10773) film coated tablets (1 tablet once daily) | Patients who received either 10 mg or 25 mg of empagliflozin were pooled into a common empagliflozin treatment group |
| Measure Participants | 2333 | 2345 | 2342 | 4687 |
| Number [percentage of participants] |
4.1
0.2%
|
2.6
0.1%
|
2.8
0.1%
|
2.7
0%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, All Empagliflozin |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0017 |
| Comments | Two-sided test with alpha = 0.05. | |
| Method | Cox proportional hazards model | |
| Comments | Cox proportional hazards model with factors for treatment, age, gender, categorised BMI, HbA1c, eGFR and geographical region. | |
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.65 | |
| Confidence Interval |
(2-Sided) 95% 0.50 to 0.85 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | All Empagliflozin divided by Placebo | |
| Title | Percentage of Participants With New Onset Albuminuria |
|---|---|
| Description | New onset albuminuria defined as urine albumin / creatinine ratio (UACR) ≥30 mg/g. Percentage of patients with the event are presented. |
| Time Frame | From randomisation to individual end of observation, up to 4.6 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| TS (evaluable cases) |
| Arm/Group Title | Placebo | Empagliflozin 10 mg | Empagliflozin 25 mg | All Empagliflozin |
|---|---|---|---|---|
| Arm/Group Description | Oral administration of Placebo matching empagliflozin 10 mg or 25 mg (1 tablet once daily) | Oral administration of Empagliflozin 10 mg (BI 10773) film coated tablets (1 tablet once daily) | Oral administration of Empagliflozin 25 mg (BI 10773) film coated tablets (1 tablet once daily) | Patients who received either 10 mg or 25 mg of empagliflozin were pooled into a common empagliflozin treatment group |
| Measure Participants | 1374 | 1403 | 1376 | 2779 |
| Number [percentage of participants] |
51.2
2.2%
|
51.5
2.2%
|
51.5
2.2%
|
51.5
0.7%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, All Empagliflozin |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.2547 |
| Comments | Two-sided test with alpha = 0.05. | |
| Method | Cox proportional hazards model | |
| Comments | Cox proportional hazards model with factors for treatment, age, gender, categorised BMI, HbA1c, eGFR and geographical region. | |
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.95 | |
| Confidence Interval |
(2-Sided) 95% 0.87 to 1.04 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | All Empagliflozin divided by Placebo | |
| Title | Percentage of Participants With New Onset Macroalbuminuria |
|---|---|
| Description | New onset macroalbuminuria defined as UACR >300 mg/g. Percentage of patients with the event are presented. |
| Time Frame | From randomisation to individual end of observation, up to 4.6 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| TS (evaluable cases) |
| Arm/Group Title | Placebo | Empagliflozin 10 mg | Empagliflozin 25 mg | All Empagliflozin |
|---|---|---|---|---|
| Arm/Group Description | Oral administration of Placebo matching empagliflozin 10 mg or 25 mg (1 tablet once daily) | Oral administration of Empagliflozin 10 mg (BI 10773) film coated tablets (1 tablet once daily) | Oral administration of Empagliflozin 25 mg (BI 10773) film coated tablets (1 tablet once daily) | Patients who received either 10 mg or 25 mg of empagliflozin were pooled into a common empagliflozin treatment group |
| Measure Participants | 2033 | 2037 | 2054 | 4091 |
| Number [percentage of participants] |
16.2
0.7%
|
10.9
0.5%
|
11.5
0.5%
|
11.2
0.2%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, All Empagliflozin |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | Two-sided test with alpha = 0.05. | |
| Method | Cox proportional hazards model | |
| Comments | Cox proportional hazards model with factors for treatment, age, gender, categorised BMI, HbA1c, eGFR and geographical region. | |
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.62 | |
| Confidence Interval |
(2-Sided) 95% 0.54 to 0.72 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | All Empagliflozin divided by Placebo | |
| Title | Percentage of Participants With the Composite Microvascular Outcome |
|---|---|
| Description | Composite microvascular outcome defined as: Initiation of retinal photocoagulation Vitreous haemorrhage Diabetes-related blindness, or New or worsening nephropathy defined as: New onset of macroalbuminuria; or Doubling of serum creatinine level accompanied by an eGFR (based on modification of diet in renal disease (MDRD) formula) ≤45 mL/min/1.73m2; or Initiation of continuous renal replacement therapy, or Death due to renal disease. Percentage of patients with the event are presented. |
| Time Frame | From randomisation to individual end of observation, up to 4.6 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| TS (evaluable cases) |
| Arm/Group Title | Placebo | Empagliflozin 10 mg | Empagliflozin 25 mg | All Empagliflozin |
|---|---|---|---|---|
| Arm/Group Description | Oral administration of Placebo matching empagliflozin 10 mg or 25 mg (1 tablet once daily) | Oral administration of Empagliflozin 10 mg (BI 10773) film coated tablets (1 tablet once daily) | Oral administration of Empagliflozin 25 mg (BI 10773) film coated tablets (1 tablet once daily) | Patients who received either 10 mg or 25 mg of empagliflozin were pooled into a common empagliflozin treatment group |
| Measure Participants | 2068 | 2057 | 2075 | 4132 |
| Number [percentage of participants] |
20.5
0.9%
|
13.9
0.6%
|
14.1
0.6%
|
14.0
0.2%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, All Empagliflozin |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | Two-sided test with alpha = 0.05. | |
| Method | Cox proportional hazards model | |
| Comments | Cox proportional hazards model with factors for treatment, age, gender, categorised BMI, HbA1c, eGFR and geographical region. | |
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.62 | |
| Confidence Interval |
(2-Sided) 95% 0.54 to 0.70 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | All Empagliflozin divided by Placebo | |
Adverse Events
| Time Frame | All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years | |||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||
| Arm/Group Title | Placebo | Empagliflozin 10 mg | Empagliflozin 25 mg | |||
| Arm/Group Description | Oral administration of Placebo matching empagliflozin 10 mg or 25 mg (1 tablet once daily) | Oral administration of Empagliflozin 10 mg (BI 10773) film coated tablets (1 tablet once daily) | Oral administration of Empagliflozin 25 mg (BI 10773) film coated tablets (1 tablet once daily) | |||
All Cause Mortality |
||||||
| Placebo | Empagliflozin 10 mg | Empagliflozin 25 mg | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | |||
Serious Adverse Events |
||||||
| Placebo | Empagliflozin 10 mg | Empagliflozin 25 mg | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 988/2333 (42.3%) | 876/2345 (37.4%) | 913/2342 (39%) | |||
| Blood and lymphatic system disorders | ||||||
| Anaemia | 12/2333 (0.5%) | 8/2345 (0.3%) | 7/2342 (0.3%) | |||
| Coagulopathy | 1/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Febrile neutropenia | 0/2333 (0%) | 1/2345 (0%) | 1/2342 (0%) | |||
| Haemorrhagic anaemia | 0/2333 (0%) | 0/2345 (0%) | 2/2342 (0.1%) | |||
| Hypereosinophilic syndrome | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Hypochromic anaemia | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Hypocoagulable state | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Iron deficiency anaemia | 2/2333 (0.1%) | 1/2345 (0%) | 4/2342 (0.2%) | |||
| Microcytic anaemia | 0/2333 (0%) | 2/2345 (0.1%) | 0/2342 (0%) | |||
| Neutropenia | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Normochromic normocytic anaemia | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Thrombocytopenia | 1/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Cardiac disorders | ||||||
| Acute coronary syndrome | 10/2333 (0.4%) | 10/2345 (0.4%) | 14/2342 (0.6%) | |||
| Acute myocardial infarction | 42/2333 (1.8%) | 32/2345 (1.4%) | 48/2342 (2%) | |||
| Angina pectoris | 32/2333 (1.4%) | 36/2345 (1.5%) | 42/2342 (1.8%) | |||
| Angina unstable | 87/2333 (3.7%) | 82/2345 (3.5%) | 73/2342 (3.1%) | |||
| Aortic valve disease | 0/2333 (0%) | 0/2345 (0%) | 2/2342 (0.1%) | |||
| Aortic valve stenosis | 1/2333 (0%) | 0/2345 (0%) | 2/2342 (0.1%) | |||
| Arrhythmia | 2/2333 (0.1%) | 5/2345 (0.2%) | 1/2342 (0%) | |||
| Arteriosclerosis coronary artery | 1/2333 (0%) | 1/2345 (0%) | 6/2342 (0.3%) | |||
| Atrial fibrillation | 14/2333 (0.6%) | 25/2345 (1.1%) | 12/2342 (0.5%) | |||
| Atrial flutter | 5/2333 (0.2%) | 7/2345 (0.3%) | 4/2342 (0.2%) | |||
| Atrial tachycardia | 1/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Atrial thrombosis | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Atrioventricular block | 3/2333 (0.1%) | 2/2345 (0.1%) | 1/2342 (0%) | |||
| Atrioventricular block complete | 2/2333 (0.1%) | 2/2345 (0.1%) | 3/2342 (0.1%) | |||
| Atrioventricular block first degree | 1/2333 (0%) | 1/2345 (0%) | 1/2342 (0%) | |||
| Atrioventricular block second degree | 1/2333 (0%) | 2/2345 (0.1%) | 1/2342 (0%) | |||
| Bradyarrhythmia | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Bradycardia | 11/2333 (0.5%) | 2/2345 (0.1%) | 4/2342 (0.2%) | |||
| Bundle branch block bilateral | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Bundle branch block right | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Cardiac arrest | 12/2333 (0.5%) | 6/2345 (0.3%) | 5/2342 (0.2%) | |||
| Cardiac asthma | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Cardiac disorder | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Cardiac failure | 55/2333 (2.4%) | 42/2345 (1.8%) | 24/2342 (1%) | |||
| Cardiac failure acute | 9/2333 (0.4%) | 4/2345 (0.2%) | 2/2342 (0.1%) | |||
| Cardiac failure chronic | 0/2333 (0%) | 4/2345 (0.2%) | 2/2342 (0.1%) | |||
| Cardiac failure congestive | 45/2333 (1.9%) | 30/2345 (1.3%) | 35/2342 (1.5%) | |||
| Cardiac failure high output | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Cardio-respiratory arrest | 6/2333 (0.3%) | 5/2345 (0.2%) | 2/2342 (0.1%) | |||
| Cardiogenic shock | 2/2333 (0.1%) | 2/2345 (0.1%) | 2/2342 (0.1%) | |||
| Cardiomyopathy | 2/2333 (0.1%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Cardiopulmonary failure | 2/2333 (0.1%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Cardiorenal syndrome | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Cardiovascular disorder | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Cardiovascular insufficiency | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Congestive cardiomyopathy | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Coronary artery disease | 46/2333 (2%) | 21/2345 (0.9%) | 29/2342 (1.2%) | |||
| Coronary artery insufficiency | 1/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Coronary artery occlusion | 6/2333 (0.3%) | 3/2345 (0.1%) | 7/2342 (0.3%) | |||
| Coronary artery stenosis | 5/2333 (0.2%) | 5/2345 (0.2%) | 5/2342 (0.2%) | |||
| Cyanosis | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Diastolic dysfunction | 2/2333 (0.1%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Hypertensive cardiomyopathy | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Hypertensive heart disease | 1/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Intracardiac thrombus | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Ischaemic cardiomyopathy | 1/2333 (0%) | 0/2345 (0%) | 4/2342 (0.2%) | |||
| Left atrial dilatation | 0/2333 (0%) | 1/2345 (0%) | 1/2342 (0%) | |||
| Left ventricular dysfunction | 1/2333 (0%) | 0/2345 (0%) | 2/2342 (0.1%) | |||
| Left ventricular failure | 2/2333 (0.1%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Microvascular coronary artery disease | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Mitral valve incompetence | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Myocardial infarction | 47/2333 (2%) | 50/2345 (2.1%) | 44/2342 (1.9%) | |||
| Myocardial ischaemia | 15/2333 (0.6%) | 5/2345 (0.2%) | 7/2342 (0.3%) | |||
| Myocarditis | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Nodal arrhythmia | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Palpitations | 0/2333 (0%) | 2/2345 (0.1%) | 1/2342 (0%) | |||
| Papillary muscle disorder | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Pericardial cyst | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Pericardial effusion | 2/2333 (0.1%) | 2/2345 (0.1%) | 0/2342 (0%) | |||
| Pericarditis | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Postinfarction angina | 1/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Right ventricular failure | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Silent myocardial infarction | 1/2333 (0%) | 3/2345 (0.1%) | 3/2342 (0.1%) | |||
| Sinus arrhythmia | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Sinus bradycardia | 1/2333 (0%) | 1/2345 (0%) | 2/2342 (0.1%) | |||
| Sinus node dysfunction | 6/2333 (0.3%) | 5/2345 (0.2%) | 3/2342 (0.1%) | |||
| Supraventricular tachycardia | 4/2333 (0.2%) | 5/2345 (0.2%) | 1/2342 (0%) | |||
| Systolic dysfunction | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Tachycardia | 5/2333 (0.2%) | 3/2345 (0.1%) | 0/2342 (0%) | |||
| Tachycardia paroxysmal | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Trifascicular block | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Ventricular arrhythmia | 2/2333 (0.1%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Ventricular extrasystoles | 1/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Ventricular fibrillation | 2/2333 (0.1%) | 1/2345 (0%) | 2/2342 (0.1%) | |||
| Ventricular tachycardia | 8/2333 (0.3%) | 2/2345 (0.1%) | 5/2342 (0.2%) | |||
| Congenital, familial and genetic disorders | ||||||
| Atrial septal defect | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Congenital anomalies of ear ossicles | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Hydrocele | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Phimosis | 1/2333 (0%) | 1/2345 (0%) | 2/2342 (0.1%) | |||
| Pyloric stenosis | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Ear and labyrinth disorders | ||||||
| Cerumen impaction | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Deafness | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Deafness unilateral | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Sudden hearing loss | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Tinnitus | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Tympanic membrane perforation | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Vertigo | 7/2333 (0.3%) | 2/2345 (0.1%) | 9/2342 (0.4%) | |||
| Vertigo positional | 6/2333 (0.3%) | 0/2345 (0%) | 2/2342 (0.1%) | |||
| Endocrine disorders | ||||||
| Basedow's disease | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Goitre | 1/2333 (0%) | 0/2345 (0%) | 2/2342 (0.1%) | |||
| Hyperparathyroidism | 0/2333 (0%) | 1/2345 (0%) | 2/2342 (0.1%) | |||
| Hyperparathyroidism primary | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Hyperthyroidism | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Eye disorders | ||||||
| Amaurosis | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Blindness | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Blindness unilateral | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Cataract | 9/2333 (0.4%) | 13/2345 (0.6%) | 11/2342 (0.5%) | |||
| Cataract cortical | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Corneal degeneration | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Diabetic retinopathy | 4/2333 (0.2%) | 1/2345 (0%) | 2/2342 (0.1%) | |||
| Exfoliation syndrome | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Glaucoma | 1/2333 (0%) | 3/2345 (0.1%) | 2/2342 (0.1%) | |||
| Keratopathy | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Macular fibrosis | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Macular oedema | 2/2333 (0.1%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Papilloedema | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Retinal artery occlusion | 0/2333 (0%) | 1/2345 (0%) | 2/2342 (0.1%) | |||
| Retinal detachment | 0/2333 (0%) | 4/2345 (0.2%) | 2/2342 (0.1%) | |||
| Retinal haemorrhage | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Retinal tear | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Retinopathy | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Retinoschisis | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Visual acuity reduced | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Vitreous haemorrhage | 4/2333 (0.2%) | 1/2345 (0%) | 3/2342 (0.1%) | |||
| Vitreous opacities | 0/2333 (0%) | 3/2345 (0.1%) | 0/2342 (0%) | |||
| Gastrointestinal disorders | ||||||
| Abdominal hernia | 0/2333 (0%) | 2/2345 (0.1%) | 2/2342 (0.1%) | |||
| Abdominal hernia obstructive | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Abdominal pain | 5/2333 (0.2%) | 5/2345 (0.2%) | 2/2342 (0.1%) | |||
| Abdominal pain lower | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Abdominal pain upper | 0/2333 (0%) | 3/2345 (0.1%) | 2/2342 (0.1%) | |||
| Anal fissure | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Anal fistula | 0/2333 (0%) | 2/2345 (0.1%) | 0/2342 (0%) | |||
| Ascites | 0/2333 (0%) | 2/2345 (0.1%) | 0/2342 (0%) | |||
| Bezoar | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Chronic gastritis | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Colitis | 0/2333 (0%) | 2/2345 (0.1%) | 3/2342 (0.1%) | |||
| Colitis ischaemic | 1/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Colon dysplasia | 1/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Constipation | 4/2333 (0.2%) | 2/2345 (0.1%) | 2/2342 (0.1%) | |||
| Crohn's disease | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Dental caries | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Diabetic gastroparesis | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Diabetic gastropathy | 1/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Diarrhoea | 6/2333 (0.3%) | 6/2345 (0.3%) | 4/2342 (0.2%) | |||
| Diverticulum | 2/2333 (0.1%) | 1/2345 (0%) | 1/2342 (0%) | |||
| Diverticulum intestinal | 0/2333 (0%) | 3/2345 (0.1%) | 1/2342 (0%) | |||
| Duodenal perforation | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Duodenal ulcer | 2/2333 (0.1%) | 2/2345 (0.1%) | 0/2342 (0%) | |||
| Duodenal ulcer haemorrhage | 1/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Duodenal ulcer perforation | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Duodenitis | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Dyspepsia | 1/2333 (0%) | 1/2345 (0%) | 1/2342 (0%) | |||
| Dysphagia | 2/2333 (0.1%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Enteritis | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Enterocolitis | 1/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Epigastric discomfort | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Erosive duodenitis | 1/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Faecaloma | 2/2333 (0.1%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Food poisoning | 1/2333 (0%) | 0/2345 (0%) | 2/2342 (0.1%) | |||
| Gastric haemorrhage | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Gastric perforation | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Gastric polyps | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Gastric ulcer | 3/2333 (0.1%) | 1/2345 (0%) | 2/2342 (0.1%) | |||
| Gastric ulcer haemorrhage | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Gastric ulcer perforation | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Gastritis | 2/2333 (0.1%) | 2/2345 (0.1%) | 7/2342 (0.3%) | |||
| Gastritis erosive | 1/2333 (0%) | 1/2345 (0%) | 1/2342 (0%) | |||
| Gastritis haemorrhagic | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Gastroduodenal ulcer | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Gastroduodenitis | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Gastrointestinal angiodysplasia | 1/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Gastrointestinal disorder | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Gastrointestinal haemorrhage | 9/2333 (0.4%) | 4/2345 (0.2%) | 4/2342 (0.2%) | |||
| Gastrointestinal inflammation | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Gastrooesophageal reflux disease | 5/2333 (0.2%) | 7/2345 (0.3%) | 3/2342 (0.1%) | |||
| Gingival bleeding | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Haematemesis | 0/2333 (0%) | 2/2345 (0.1%) | 0/2342 (0%) | |||
| Haematochezia | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Haemorrhoidal haemorrhage | 1/2333 (0%) | 1/2345 (0%) | 1/2342 (0%) | |||
| Haemorrhoids | 3/2333 (0.1%) | 2/2345 (0.1%) | 1/2342 (0%) | |||
| Haemorrhoids thrombosed | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Hiatus hernia | 1/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Ileus | 0/2333 (0%) | 1/2345 (0%) | 1/2342 (0%) | |||
| Ileus paralytic | 3/2333 (0.1%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Impaired gastric emptying | 0/2333 (0%) | 0/2345 (0%) | 3/2342 (0.1%) | |||
| Incarcerated umbilical hernia | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Inguinal hernia | 3/2333 (0.1%) | 5/2345 (0.2%) | 4/2342 (0.2%) | |||
| Inguinal hernia strangulated | 0/2333 (0%) | 1/2345 (0%) | 1/2342 (0%) | |||
| Intestinal haemorrhage | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Intestinal ischaemia | 2/2333 (0.1%) | 2/2345 (0.1%) | 0/2342 (0%) | |||
| Intestinal obstruction | 5/2333 (0.2%) | 1/2345 (0%) | 3/2342 (0.1%) | |||
| Intestinal perforation | 2/2333 (0.1%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Irritable bowel syndrome | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Large intestinal ulcer | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Large intestine perforation | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Large intestine polyp | 0/2333 (0%) | 5/2345 (0.2%) | 0/2342 (0%) | |||
| Localised intraabdominal fluid collection | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Lumbar hernia | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Mallory-Weiss syndrome | 1/2333 (0%) | 1/2345 (0%) | 1/2342 (0%) | |||
| Melaena | 0/2333 (0%) | 1/2345 (0%) | 1/2342 (0%) | |||
| Mesenteric vein thrombosis | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Nausea | 2/2333 (0.1%) | 4/2345 (0.2%) | 2/2342 (0.1%) | |||
| Oesophageal stenosis | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Oesophagitis | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Pancreatitis | 4/2333 (0.2%) | 3/2345 (0.1%) | 3/2342 (0.1%) | |||
| Pancreatitis acute | 3/2333 (0.1%) | 1/2345 (0%) | 3/2342 (0.1%) | |||
| Pancreatitis chronic | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Pancreatitis relapsing | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Peptic ulcer | 0/2333 (0%) | 2/2345 (0.1%) | 0/2342 (0%) | |||
| Peptic ulcer haemorrhage | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Peptic ulcer perforation | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Peritoneal haemorrhage | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Rectal haemorrhage | 1/2333 (0%) | 2/2345 (0.1%) | 2/2342 (0.1%) | |||
| Small intestinal obstruction | 1/2333 (0%) | 3/2345 (0.1%) | 2/2342 (0.1%) | |||
| Small intestinal perforation | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Stomatitis | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Stress ulcer | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Subileus | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Thrombosis mesenteric vessel | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Umbilical hernia | 2/2333 (0.1%) | 3/2345 (0.1%) | 0/2342 (0%) | |||
| Upper gastrointestinal haemorrhage | 3/2333 (0.1%) | 2/2345 (0.1%) | 5/2342 (0.2%) | |||
| Varices oesophageal | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Volvulus | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Vomiting | 2/2333 (0.1%) | 3/2345 (0.1%) | 4/2342 (0.2%) | |||
| General disorders | ||||||
| Adverse drug reaction | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Asthenia | 0/2333 (0%) | 2/2345 (0.1%) | 1/2342 (0%) | |||
| Cardiac death | 3/2333 (0.1%) | 4/2345 (0.2%) | 2/2342 (0.1%) | |||
| Chest discomfort | 4/2333 (0.2%) | 2/2345 (0.1%) | 3/2342 (0.1%) | |||
| Chest pain | 28/2333 (1.2%) | 32/2345 (1.4%) | 33/2342 (1.4%) | |||
| Chills | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Death | 12/2333 (0.5%) | 10/2345 (0.4%) | 5/2342 (0.2%) | |||
| Device defective | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Device deposit issue | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Device difficult to use | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Device malfunction | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Device occlusion | 0/2333 (0%) | 0/2345 (0%) | 2/2342 (0.1%) | |||
| Drowning | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Drug ineffective | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Dysplasia | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Extravasation | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Fatigue | 1/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Feeling abnormal | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Gait disturbance | 1/2333 (0%) | 1/2345 (0%) | 1/2342 (0%) | |||
| General physical health deterioration | 2/2333 (0.1%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Generalised oedema | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Granuloma | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Hernia | 2/2333 (0.1%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Impaired healing | 0/2333 (0%) | 1/2345 (0%) | 1/2342 (0%) | |||
| Implant site necrosis | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Malaise | 1/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Multi-organ failure | 3/2333 (0.1%) | 2/2345 (0.1%) | 0/2342 (0%) | |||
| Necrobiosis | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Non-cardiac chest pain | 6/2333 (0.3%) | 5/2345 (0.2%) | 15/2342 (0.6%) | |||
| Oedema peripheral | 5/2333 (0.2%) | 1/2345 (0%) | 1/2342 (0%) | |||
| Oversensing | 2/2333 (0.1%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Pacemaker generated arrhythmia | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Pain | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Perforated ulcer | 1/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Peripheral swelling | 2/2333 (0.1%) | 1/2345 (0%) | 1/2342 (0%) | |||
| Polyp | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Pyrexia | 5/2333 (0.2%) | 7/2345 (0.3%) | 2/2342 (0.1%) | |||
| Stent malfunction | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Strangulated hernia | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Sudden cardiac death | 2/2333 (0.1%) | 2/2345 (0.1%) | 2/2342 (0.1%) | |||
| Sudden death | 6/2333 (0.3%) | 8/2345 (0.3%) | 5/2342 (0.2%) | |||
| Systemic inflammatory response syndrome | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Ulcer | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Hepatobiliary disorders | ||||||
| Bile duct obstruction | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Bile duct stone | 0/2333 (0%) | 4/2345 (0.2%) | 2/2342 (0.1%) | |||
| Cholangitis | 1/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Cholecystitis | 4/2333 (0.2%) | 4/2345 (0.2%) | 5/2342 (0.2%) | |||
| Cholecystitis acute | 4/2333 (0.2%) | 7/2345 (0.3%) | 6/2342 (0.3%) | |||
| Cholecystitis chronic | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Cholelithiasis | 7/2333 (0.3%) | 9/2345 (0.4%) | 12/2342 (0.5%) | |||
| Cholestasis | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Gallbladder disorder | 1/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Hepatic cirrhosis | 2/2333 (0.1%) | 2/2345 (0.1%) | 2/2342 (0.1%) | |||
| Hepatic failure | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Hepatic function abnormal | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Hepatic steatosis | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Ischaemic hepatitis | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Jaundice cholestatic | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Non-alcoholic steatohepatitis | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Portal hypertension | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Post cholecystectomy syndrome | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Sphincter of Oddi dysfunction | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Immune system disorders | ||||||
| Anaphylactic reaction | 0/2333 (0%) | 1/2345 (0%) | 1/2342 (0%) | |||
| Anaphylactic shock | 0/2333 (0%) | 1/2345 (0%) | 1/2342 (0%) | |||
| Contrast media allergy | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Food allergy | 1/2333 (0%) | 0/2345 (0%) | 2/2342 (0.1%) | |||
| Hypersensitivity | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Iodine allergy | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Infections and infestations | ||||||
| Abdominal abscess | 0/2333 (0%) | 2/2345 (0.1%) | 0/2342 (0%) | |||
| Abdominal wall abscess | 0/2333 (0%) | 2/2345 (0.1%) | 1/2342 (0%) | |||
| Abscess | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Abscess limb | 3/2333 (0.1%) | 6/2345 (0.3%) | 2/2342 (0.1%) | |||
| Abscess of eyelid | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Acute sinusitis | 0/2333 (0%) | 0/2345 (0%) | 2/2342 (0.1%) | |||
| Amoebiasis | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Amoebic dysentery | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Anal abscess | 1/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Appendicitis | 3/2333 (0.1%) | 5/2345 (0.2%) | 3/2342 (0.1%) | |||
| Appendicitis perforated | 0/2333 (0%) | 0/2345 (0%) | 2/2342 (0.1%) | |||
| Arteriosclerotic gangrene | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Arthritis bacterial | 1/2333 (0%) | 1/2345 (0%) | 2/2342 (0.1%) | |||
| Atypical pneumonia | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Bacteraemia | 2/2333 (0.1%) | 0/2345 (0%) | 3/2342 (0.1%) | |||
| Bacterial sepsis | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Biliary tract infection | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Bone abscess | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Bronchiolitis | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Bronchitis | 10/2333 (0.4%) | 5/2345 (0.2%) | 5/2342 (0.2%) | |||
| Bronchitis viral | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Bronchopneumonia | 3/2333 (0.1%) | 1/2345 (0%) | 3/2342 (0.1%) | |||
| Catheter site infection | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Cellulitis | 20/2333 (0.9%) | 11/2345 (0.5%) | 17/2342 (0.7%) | |||
| Cellulitis gangrenous | 0/2333 (0%) | 2/2345 (0.1%) | 0/2342 (0%) | |||
| Cellulitis of male external genital organ | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Cellulitis staphylococcal | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Cholecystitis infective | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Chronic sinusitis | 0/2333 (0%) | 0/2345 (0%) | 3/2342 (0.1%) | |||
| Clostridium difficile colitis | 1/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Cutaneous larva migrans | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Cystitis | 2/2333 (0.1%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Cystitis bacterial | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Dengue fever | 1/2333 (0%) | 2/2345 (0.1%) | 1/2342 (0%) | |||
| Device related infection | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Device related sepsis | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Diabetic foot infection | 6/2333 (0.3%) | 5/2345 (0.2%) | 7/2342 (0.3%) | |||
| Diabetic gangrene | 3/2333 (0.1%) | 1/2345 (0%) | 2/2342 (0.1%) | |||
| Diverticulitis | 3/2333 (0.1%) | 3/2345 (0.1%) | 0/2342 (0%) | |||
| Ear infection | 1/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Eczema infected | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Empyema | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Endocarditis | 1/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Endophthalmitis | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Enterocolitis infectious | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Enterocolitis viral | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Epididymitis | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Erysipelas | 9/2333 (0.4%) | 8/2345 (0.3%) | 5/2342 (0.2%) | |||
| Escherichia sepsis | 2/2333 (0.1%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Escherichia urinary tract infection | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Febrile infection | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Furuncle | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Gallbladder empyema | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Gangrene | 8/2333 (0.3%) | 10/2345 (0.4%) | 6/2342 (0.3%) | |||
| Gastroenteritis | 15/2333 (0.6%) | 18/2345 (0.8%) | 15/2342 (0.6%) | |||
| Gastroenteritis salmonella | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Gastroenteritis viral | 0/2333 (0%) | 1/2345 (0%) | 1/2342 (0%) | |||
| Gastrointestinal infection | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Gastrointestinal protozoal infection | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Giardiasis | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| H1N1 influenza | 0/2333 (0%) | 1/2345 (0%) | 2/2342 (0.1%) | |||
| Incision site infection | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Infected skin ulcer | 4/2333 (0.2%) | 2/2345 (0.1%) | 3/2342 (0.1%) | |||
| Infectious colitis | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Infectious pleural effusion | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Influenza | 2/2333 (0.1%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Infusion site infection | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Inguinal hernia gangrenous | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Intestinal fistula infection | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Intestinal tuberculosis | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Kidney infection | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Klebsiella infection | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Labyrinthitis | 1/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Liver abscess | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Lobar pneumonia | 3/2333 (0.1%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Localised infection | 5/2333 (0.2%) | 2/2345 (0.1%) | 4/2342 (0.2%) | |||
| Lower respiratory tract infection | 4/2333 (0.2%) | 8/2345 (0.3%) | 2/2342 (0.1%) | |||
| Lower respiratory tract infection bacterial | 2/2333 (0.1%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Lung infection | 0/2333 (0%) | 2/2345 (0.1%) | 0/2342 (0%) | |||
| Lyme disease | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Mediastinitis | 2/2333 (0.1%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Meningitis | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Meningitis bacterial | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Meningitis streptococcal | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Meningitis tuberculous | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Muscle abscess | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Myelitis | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Nasal abscess | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Oesophageal candidiasis | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Osteomyelitis | 5/2333 (0.2%) | 5/2345 (0.2%) | 9/2342 (0.4%) | |||
| Osteomyelitis acute | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Osteomyelitis bacterial | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Osteomyelitis chronic | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Otitis externa | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Otitis media | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Periodontitis | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Peritonitis | 1/2333 (0%) | 2/2345 (0.1%) | 3/2342 (0.1%) | |||
| Peritonsillar abscess | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Pertussis | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Pharyngotonsillitis | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Pneumonia | 53/2333 (2.3%) | 41/2345 (1.7%) | 38/2342 (1.6%) | |||
| Pneumonia bacterial | 1/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Pneumonia fungal | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Pneumonia haemophilus | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Pneumonia influenzal | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Pneumonia pneumococcal | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Post procedural infection | 2/2333 (0.1%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Post procedural sepsis | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Postoperative wound infection | 1/2333 (0%) | 1/2345 (0%) | 2/2342 (0.1%) | |||
| Prostatic abscess | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Pseudomonal sepsis | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Psoas abscess | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Pulmonary mycosis | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Pulmonary tuberculosis | 2/2333 (0.1%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Pyelonephritis | 2/2333 (0.1%) | 0/2345 (0%) | 5/2342 (0.2%) | |||
| Pyelonephritis acute | 6/2333 (0.3%) | 4/2345 (0.2%) | 1/2342 (0%) | |||
| Pyelonephritis chronic | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Respiratory tract infection | 7/2333 (0.3%) | 0/2345 (0%) | 2/2342 (0.1%) | |||
| Rhinitis | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Rotavirus infection | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Salmonellosis | 2/2333 (0.1%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Scrotal abscess | 0/2333 (0%) | 1/2345 (0%) | 1/2342 (0%) | |||
| Sepsis | 5/2333 (0.2%) | 7/2345 (0.3%) | 6/2342 (0.3%) | |||
| Septic encephalopathy | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Septic shock | 8/2333 (0.3%) | 2/2345 (0.1%) | 5/2342 (0.2%) | |||
| Sinusitis | 1/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Skin infection | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Staphylococcal infection | 0/2333 (0%) | 2/2345 (0.1%) | 0/2342 (0%) | |||
| Staphylococcal sepsis | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Staphylococcal skin infection | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Subcutaneous abscess | 1/2333 (0%) | 0/2345 (0%) | 2/2342 (0.1%) | |||
| Tonsillitis | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Tracheobronchitis | 1/2333 (0%) | 2/2345 (0.1%) | 0/2342 (0%) | |||
| Tuberculosis | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Tuberculous pleurisy | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Upper respiratory tract infection | 2/2333 (0.1%) | 1/2345 (0%) | 2/2342 (0.1%) | |||
| Urinary tract infection | 16/2333 (0.7%) | 13/2345 (0.6%) | 16/2342 (0.7%) | |||
| Urinary tract infection fungal | 0/2333 (0%) | 0/2345 (0%) | 3/2342 (0.1%) | |||
| Urinary tract infection pseudomonal | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Urosepsis | 3/2333 (0.1%) | 6/2345 (0.3%) | 11/2342 (0.5%) | |||
| Vaginal cellulitis | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Varicella | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Vestibular neuronitis | 2/2333 (0.1%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Viral infection | 0/2333 (0%) | 2/2345 (0.1%) | 5/2342 (0.2%) | |||
| Wound infection | 3/2333 (0.1%) | 4/2345 (0.2%) | 3/2342 (0.1%) | |||
| Wound sepsis | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Injury, poisoning and procedural complications | ||||||
| Accident at work | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Acetabulum fracture | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Anaemia postoperative | 2/2333 (0.1%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Animal bite | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Ankle fracture | 2/2333 (0.1%) | 4/2345 (0.2%) | 2/2342 (0.1%) | |||
| Avulsion fracture | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Back injury | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Brain contusion | 1/2333 (0%) | 1/2345 (0%) | 1/2342 (0%) | |||
| Cardiac procedure complication | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Chemical poisoning | 1/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Chest injury | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Clavicle fracture | 1/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Concussion | 0/2333 (0%) | 2/2345 (0.1%) | 2/2342 (0.1%) | |||
| Contusion | 4/2333 (0.2%) | 2/2345 (0.1%) | 2/2342 (0.1%) | |||
| Coronary artery restenosis | 4/2333 (0.2%) | 4/2345 (0.2%) | 2/2342 (0.1%) | |||
| Craniocerebral injury | 0/2333 (0%) | 0/2345 (0%) | 2/2342 (0.1%) | |||
| Deep vein thrombosis postoperative | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Facial bones fracture | 2/2333 (0.1%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Fall | 16/2333 (0.7%) | 9/2345 (0.4%) | 16/2342 (0.7%) | |||
| Femoral neck fracture | 1/2333 (0%) | 1/2345 (0%) | 2/2342 (0.1%) | |||
| Femur fracture | 3/2333 (0.1%) | 0/2345 (0%) | 2/2342 (0.1%) | |||
| Fibula fracture | 2/2333 (0.1%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Foot fracture | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Fracture displacement | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Gastrointestinal anastomotic complication | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Graft thrombosis | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Gun shot wound | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Hand fracture | 1/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Head injury | 2/2333 (0.1%) | 1/2345 (0%) | 1/2342 (0%) | |||
| Hip fracture | 2/2333 (0.1%) | 1/2345 (0%) | 7/2342 (0.3%) | |||
| Humerus fracture | 0/2333 (0%) | 2/2345 (0.1%) | 3/2342 (0.1%) | |||
| Incisional hernia | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Injury | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Intentional overdose | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Intestinal anastomosis complication | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Joint dislocation | 0/2333 (0%) | 2/2345 (0.1%) | 0/2342 (0%) | |||
| Joint injury | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Kidney rupture | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Laceration | 1/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Ligament rupture | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Ligament sprain | 2/2333 (0.1%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Limb injury | 1/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Lower limb fracture | 2/2333 (0.1%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Meniscus injury | 3/2333 (0.1%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Multiple fractures | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Multiple injuries | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Muscle injury | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Open fracture | 1/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Overdose | 1/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Pelvic fracture | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Periorbital contusion | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Peripheral artery restenosis | 1/2333 (0%) | 2/2345 (0.1%) | 0/2342 (0%) | |||
| Periprosthetic fracture | 1/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Perirenal haematoma | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Post laminectomy syndrome | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Post procedural discomfort | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Post procedural haematuria | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Post procedural haemorrhage | 0/2333 (0%) | 3/2345 (0.1%) | 0/2342 (0%) | |||
| Postoperative ileus | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Pubis fracture | 1/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Radius fracture | 1/2333 (0%) | 3/2345 (0.1%) | 0/2342 (0%) | |||
| Rib fracture | 6/2333 (0.3%) | 4/2345 (0.2%) | 4/2342 (0.2%) | |||
| Road traffic accident | 6/2333 (0.3%) | 6/2345 (0.3%) | 9/2342 (0.4%) | |||
| Scar | 0/2333 (0%) | 1/2345 (0%) | 1/2342 (0%) | |||
| Seroma | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Skin abrasion | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Spinal column injury | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Spinal compression fracture | 1/2333 (0%) | 0/2345 (0%) | 3/2342 (0.1%) | |||
| Spinal fracture | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Splenic rupture | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Stab wound | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Subdural haematoma | 2/2333 (0.1%) | 2/2345 (0.1%) | 1/2342 (0%) | |||
| Subdural haemorrhage | 2/2333 (0.1%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Tendon injury | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Tendon rupture | 1/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Thoracic vertebral fracture | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Tibia fracture | 7/2333 (0.3%) | 0/2345 (0%) | 2/2342 (0.1%) | |||
| Tongue injury | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Toxicity to various agents | 2/2333 (0.1%) | 2/2345 (0.1%) | 0/2342 (0%) | |||
| Traumatic haematoma | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Traumatic haemorrhage | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Traumatic intracranial haemorrhage | 2/2333 (0.1%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Traumatic liver injury | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Traumatic renal injury | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Ulna fracture | 0/2333 (0%) | 1/2345 (0%) | 1/2342 (0%) | |||
| Upper limb fracture | 0/2333 (0%) | 0/2345 (0%) | 2/2342 (0.1%) | |||
| Vascular graft occlusion | 2/2333 (0.1%) | 1/2345 (0%) | 3/2342 (0.1%) | |||
| Vascular graft thrombosis | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Vascular pseudoaneurysm | 0/2333 (0%) | 0/2345 (0%) | 2/2342 (0.1%) | |||
| Wound | 2/2333 (0.1%) | 3/2345 (0.1%) | 1/2342 (0%) | |||
| Wound dehiscence | 0/2333 (0%) | 1/2345 (0%) | 1/2342 (0%) | |||
| Wrist fracture | 0/2333 (0%) | 1/2345 (0%) | 1/2342 (0%) | |||
| Investigations | ||||||
| Alanine aminotransferase increased | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Angiogram | 1/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Angiogram normal | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Anticoagulation drug level above therapeutic | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Arteriogram coronary | 2/2333 (0.1%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Aspartate aminotransferase increased | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Biopsy lung | 1/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Blood calcium decreased | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Blood creatine phosphokinase MB increased | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Blood creatine phosphokinase increased | 0/2333 (0%) | 2/2345 (0.1%) | 0/2342 (0%) | |||
| Blood creatinine increased | 2/2333 (0.1%) | 1/2345 (0%) | 2/2342 (0.1%) | |||
| Blood glucose fluctuation | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Blood lactate dehydrogenase increased | 1/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Blood magnesium decreased | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Blood potassium increased | 2/2333 (0.1%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Blood pressure increased | 2/2333 (0.1%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Blood pressure orthostatic decreased | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Blood urea increased | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| C-reactive protein increased | 0/2333 (0%) | 2/2345 (0.1%) | 0/2342 (0%) | |||
| Cardiac murmur | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Cardiac stress test abnormal | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Catheterisation cardiac | 1/2333 (0%) | 2/2345 (0.1%) | 0/2342 (0%) | |||
| Ejection fraction decreased | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Electrocardiogram T wave inversion | 0/2333 (0%) | 1/2345 (0%) | 1/2342 (0%) | |||
| Haemoglobin decreased | 2/2333 (0.1%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Heart rate irregular | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Hepatic enzyme increased | 1/2333 (0%) | 3/2345 (0.1%) | 0/2342 (0%) | |||
| Lipase increased | 2/2333 (0.1%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Liver function test abnormal | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Oxygen consumption increased | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Physical examination | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Prostatic specific antigen increased | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Scan myocardial perfusion abnormal | 2/2333 (0.1%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Smear cervix abnormal | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Transaminases increased | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Troponin I increased | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Troponin increased | 1/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Weight decreased | 0/2333 (0%) | 0/2345 (0%) | 2/2342 (0.1%) | |||
| White blood cell count increased | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Metabolism and nutrition disorders | ||||||
| Decreased appetite | 0/2333 (0%) | 1/2345 (0%) | 1/2342 (0%) | |||
| Dehydration | 5/2333 (0.2%) | 5/2345 (0.2%) | 5/2342 (0.2%) | |||
| Diabetes mellitus | 6/2333 (0.3%) | 3/2345 (0.1%) | 2/2342 (0.1%) | |||
| Diabetes mellitus inadequate control | 6/2333 (0.3%) | 8/2345 (0.3%) | 3/2342 (0.1%) | |||
| Diabetic complication | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Diabetic ketoacidosis | 0/2333 (0%) | 3/2345 (0.1%) | 1/2342 (0%) | |||
| Diabetic metabolic decompensation | 1/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Fluid overload | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Gout | 0/2333 (0%) | 0/2345 (0%) | 2/2342 (0.1%) | |||
| Hyperglycaemia | 14/2333 (0.6%) | 5/2345 (0.2%) | 3/2342 (0.1%) | |||
| Hyperkalaemia | 5/2333 (0.2%) | 2/2345 (0.1%) | 3/2342 (0.1%) | |||
| Hypernatraemia | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Hypervolaemia | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Hypoglycaemia | 17/2333 (0.7%) | 10/2345 (0.4%) | 9/2342 (0.4%) | |||
| Hypokalaemia | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Hypomagnesaemia | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Hyponatraemia | 1/2333 (0%) | 2/2345 (0.1%) | 2/2342 (0.1%) | |||
| Hypovolaemia | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Insulin resistance | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Lactic acidosis | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Lipomatosis | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Metabolic acidosis | 1/2333 (0%) | 0/2345 (0%) | 2/2342 (0.1%) | |||
| Obesity | 3/2333 (0.1%) | 2/2345 (0.1%) | 1/2342 (0%) | |||
| Type 2 diabetes mellitus | 2/2333 (0.1%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Musculoskeletal and connective tissue disorders | ||||||
| Arthralgia | 4/2333 (0.2%) | 1/2345 (0%) | 5/2342 (0.2%) | |||
| Arthritis | 1/2333 (0%) | 2/2345 (0.1%) | 1/2342 (0%) | |||
| Back pain | 9/2333 (0.4%) | 3/2345 (0.1%) | 8/2342 (0.3%) | |||
| Bone fistula | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Bursitis | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Cervical spinal stenosis | 1/2333 (0%) | 1/2345 (0%) | 2/2342 (0.1%) | |||
| Costochondritis | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Dactylitis | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Dupuytren's contracture | 1/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Fistula | 0/2333 (0%) | 1/2345 (0%) | 1/2342 (0%) | |||
| Flank pain | 1/2333 (0%) | 1/2345 (0%) | 2/2342 (0.1%) | |||
| Foot deformity | 2/2333 (0.1%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Fracture delayed union | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Fracture nonunion | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Gouty arthritis | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Gouty tophus | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Intervertebral disc compression | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Intervertebral disc degeneration | 0/2333 (0%) | 1/2345 (0%) | 1/2342 (0%) | |||
| Intervertebral disc disorder | 1/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Intervertebral disc protrusion | 10/2333 (0.4%) | 4/2345 (0.2%) | 6/2342 (0.3%) | |||
| Lower extremity mass | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Lumbar spinal stenosis | 2/2333 (0.1%) | 1/2345 (0%) | 3/2342 (0.1%) | |||
| Muscle tightness | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Muscle twitching | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Muscular weakness | 2/2333 (0.1%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Musculoskeletal chest pain | 2/2333 (0.1%) | 0/2345 (0%) | 2/2342 (0.1%) | |||
| Musculoskeletal disorder | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Musculoskeletal pain | 3/2333 (0.1%) | 2/2345 (0.1%) | 3/2342 (0.1%) | |||
| Myalgia | 3/2333 (0.1%) | 2/2345 (0.1%) | 1/2342 (0%) | |||
| Myofascial pain syndrome | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Myositis | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Neck pain | 0/2333 (0%) | 2/2345 (0.1%) | 0/2342 (0%) | |||
| Neuropathic arthropathy | 1/2333 (0%) | 2/2345 (0.1%) | 0/2342 (0%) | |||
| Osteitis | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Osteitis deformans | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Osteoarthritis | 15/2333 (0.6%) | 15/2345 (0.6%) | 17/2342 (0.7%) | |||
| Osteomalacia | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Osteonecrosis | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Osteoporosis | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Osteoporotic fracture | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Pain in extremity | 4/2333 (0.2%) | 3/2345 (0.1%) | 6/2342 (0.3%) | |||
| Pathological fracture | 1/2333 (0%) | 1/2345 (0%) | 1/2342 (0%) | |||
| Periarthritis | 0/2333 (0%) | 0/2345 (0%) | 3/2342 (0.1%) | |||
| Rhabdomyolysis | 2/2333 (0.1%) | 1/2345 (0%) | 5/2342 (0.2%) | |||
| Rotator cuff syndrome | 1/2333 (0%) | 6/2345 (0.3%) | 1/2342 (0%) | |||
| Spinal column stenosis | 6/2333 (0.3%) | 2/2345 (0.1%) | 1/2342 (0%) | |||
| Spinal osteoarthritis | 3/2333 (0.1%) | 1/2345 (0%) | 2/2342 (0.1%) | |||
| Spinal pain | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Spondylitis | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Spondylolisthesis | 0/2333 (0%) | 1/2345 (0%) | 1/2342 (0%) | |||
| Synovitis | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Tendonitis | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Tenosynovitis stenosans | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Trigger finger | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||
| Acoustic neuroma | 0/2333 (0%) | 3/2345 (0.1%) | 0/2342 (0%) | |||
| Acute lymphocytic leukaemia | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Acute myeloid leukaemia | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Adenocarcinoma | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Adenocarcinoma gastric | 2/2333 (0.1%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Adenocarcinoma of colon | 2/2333 (0.1%) | 2/2345 (0.1%) | 2/2342 (0.1%) | |||
| Adenocarcinoma pancreas | 2/2333 (0.1%) | 3/2345 (0.1%) | 3/2342 (0.1%) | |||
| Adenoma benign | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Anogenital warts | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| B-cell lymphoma | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Basal cell carcinoma | 16/2333 (0.7%) | 15/2345 (0.6%) | 12/2342 (0.5%) | |||
| Basosquamous carcinoma | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Benign hepatic neoplasm | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Benign laryngeal neoplasm | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Benign lung neoplasm | 2/2333 (0.1%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Benign neoplasm of adrenal gland | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Benign neoplasm of bladder | 1/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Benign neoplasm of prostate | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Benign neoplasm of thyroid gland | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Benign pancreatic neoplasm | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Benign respiratory tract neoplasm | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Benign uterine neoplasm | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Bile duct cancer | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Bladder cancer | 0/2333 (0%) | 1/2345 (0%) | 5/2342 (0.2%) | |||
| Bladder cancer recurrent | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Bladder transitional cell carcinoma | 0/2333 (0%) | 1/2345 (0%) | 1/2342 (0%) | |||
| Bone cancer | 1/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Bone giant cell tumour benign | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Bowen's disease | 0/2333 (0%) | 1/2345 (0%) | 2/2342 (0.1%) | |||
| Brain neoplasm | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Breast cancer | 2/2333 (0.1%) | 2/2345 (0.1%) | 2/2342 (0.1%) | |||
| Bronchial carcinoma | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Cardiac myxoma | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Cervix carcinoma | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Cholesteatoma | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Chronic lymphocytic leukaemia | 0/2333 (0%) | 3/2345 (0.1%) | 0/2342 (0%) | |||
| Clear cell renal cell carcinoma | 3/2333 (0.1%) | 2/2345 (0.1%) | 1/2342 (0%) | |||
| Colon adenoma | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Colon cancer | 2/2333 (0.1%) | 5/2345 (0.2%) | 1/2342 (0%) | |||
| Colon cancer metastatic | 1/2333 (0%) | 0/2345 (0%) | 3/2342 (0.1%) | |||
| Colon neoplasm | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Colorectal adenocarcinoma | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Colorectal cancer | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Endometrial cancer | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Fibroadenoma of breast | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Fibrosarcoma | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Follicular thyroid cancer | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Gastric cancer | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Gastrointestinal stromal tumour | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Genital neoplasm malignant female | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Haemangioma of bone | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Haemangioma of liver | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Hepatic neoplasm | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Hepatocellular carcinoma | 1/2333 (0%) | 3/2345 (0.1%) | 1/2342 (0%) | |||
| Hodgkin's disease stage I | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Intraductal proliferative breast lesion | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Invasive ductal breast carcinoma | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Keratoacanthoma | 0/2333 (0%) | 2/2345 (0.1%) | 1/2342 (0%) | |||
| Large cell lung cancer | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Laryngeal cancer | 0/2333 (0%) | 0/2345 (0%) | 2/2342 (0.1%) | |||
| Laryngeal squamous cell carcinoma | 0/2333 (0%) | 0/2345 (0%) | 2/2342 (0.1%) | |||
| Lipoma | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Lung adenocarcinoma | 2/2333 (0.1%) | 5/2345 (0.2%) | 3/2342 (0.1%) | |||
| Lung cancer metastatic | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Lung carcinoma cell type unspecified stage III | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Lung neoplasm malignant | 3/2333 (0.1%) | 1/2345 (0%) | 7/2342 (0.3%) | |||
| Lung squamous cell carcinoma stage III | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Lymphocytic lymphoma | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Lymphoma | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Lymphoproliferative disorder | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Malignant melanoma | 1/2333 (0%) | 3/2345 (0.1%) | 3/2342 (0.1%) | |||
| Malignant melanoma in situ | 0/2333 (0%) | 1/2345 (0%) | 1/2342 (0%) | |||
| Malignant neoplasm of unknown primary site | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Malignant neoplasm progression | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Meningioma | 0/2333 (0%) | 2/2345 (0.1%) | 0/2342 (0%) | |||
| Metastases to bone | 0/2333 (0%) | 2/2345 (0.1%) | 0/2342 (0%) | |||
| Metastases to liver | 3/2333 (0.1%) | 5/2345 (0.2%) | 5/2342 (0.2%) | |||
| Metastases to lung | 1/2333 (0%) | 2/2345 (0.1%) | 2/2342 (0.1%) | |||
| Metastases to lymph nodes | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Metastases to neck | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Metastases to peritoneum | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Metastases to pleura | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Metastasis | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Metastatic malignant melanoma | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Metastatic renal cell carcinoma | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Myelodysplastic syndrome | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Nasopharyngeal cancer | 0/2333 (0%) | 1/2345 (0%) | 2/2342 (0.1%) | |||
| Neuroendocrine carcinoma | 1/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Neuroendocrine carcinoma of the skin | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Non-Hodgkin's lymphoma | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Non-Hodgkin's lymphoma stage IV | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Oesophageal adenocarcinoma | 1/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Oesophageal carcinoma | 2/2333 (0.1%) | 0/2345 (0%) | 0/2342 (0%) | |||
| POEMS syndrome | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Pancreatic carcinoma | 0/2333 (0%) | 2/2345 (0.1%) | 2/2342 (0.1%) | |||
| Papillary serous endometrial carcinoma | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Papillary thyroid cancer | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Parathyroid tumour benign | 1/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Penile squamous cell carcinoma | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Pituitary tumour benign | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Plasma cell myeloma | 1/2333 (0%) | 2/2345 (0.1%) | 1/2342 (0%) | |||
| Prostate cancer | 9/2333 (0.4%) | 11/2345 (0.5%) | 9/2342 (0.4%) | |||
| Prostate cancer recurrent | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Prostatic adenoma | 0/2333 (0%) | 2/2345 (0.1%) | 0/2342 (0%) | |||
| Rectal adenocarcinoma | 0/2333 (0%) | 4/2345 (0.2%) | 3/2342 (0.1%) | |||
| Rectal cancer | 0/2333 (0%) | 3/2345 (0.1%) | 0/2342 (0%) | |||
| Renal cancer | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Renal cancer metastatic | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Renal cell carcinoma | 1/2333 (0%) | 2/2345 (0.1%) | 1/2342 (0%) | |||
| Renal cell carcinoma stage I | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Renal cell carcinoma stage II | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Salivary gland adenoma | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Salivary gland neoplasm | 1/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Sarcoma | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Skin cancer | 1/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Small cell carcinoma | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Small cell lung cancer | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Splenic marginal zone lymphoma | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Squamous cell carcinoma | 3/2333 (0.1%) | 6/2345 (0.3%) | 3/2342 (0.1%) | |||
| Squamous cell carcinoma of lung | 1/2333 (0%) | 3/2345 (0.1%) | 0/2342 (0%) | |||
| Squamous cell carcinoma of skin | 7/2333 (0.3%) | 4/2345 (0.2%) | 3/2342 (0.1%) | |||
| Squamous cell carcinoma of the oral cavity | 1/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Thyroid neoplasm | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Tongue neoplasm malignant stage unspecified | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Transitional cell carcinoma | 3/2333 (0.1%) | 1/2345 (0%) | 1/2342 (0%) | |||
| Tumour haemorrhage | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Uterine cancer | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Uterine leiomyoma | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Nervous system disorders | ||||||
| Altered state of consciousness | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Amnesia | 1/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Aphasia | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Autonomic neuropathy | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Balance disorder | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Brain oedema | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Brain stem haemorrhage | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Brain stem infarction | 0/2333 (0%) | 1/2345 (0%) | 2/2342 (0.1%) | |||
| Brain stem ischaemia | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Brain stem stroke | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Carotid arteriosclerosis | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Carotid artery disease | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Carotid artery occlusion | 1/2333 (0%) | 0/2345 (0%) | 4/2342 (0.2%) | |||
| Carotid artery stenosis | 10/2333 (0.4%) | 7/2345 (0.3%) | 12/2342 (0.5%) | |||
| Carotid artery thrombosis | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Carpal tunnel syndrome | 3/2333 (0.1%) | 1/2345 (0%) | 1/2342 (0%) | |||
| Central nervous system inflammation | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Cerebellar infarction | 1/2333 (0%) | 2/2345 (0.1%) | 2/2342 (0.1%) | |||
| Cerebral arteriosclerosis | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Cerebral artery occlusion | 1/2333 (0%) | 1/2345 (0%) | 1/2342 (0%) | |||
| Cerebral artery stenosis | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Cerebral ataxia | 1/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Cerebral infarction | 7/2333 (0.3%) | 7/2345 (0.3%) | 11/2342 (0.5%) | |||
| Cerebral ischaemia | 1/2333 (0%) | 3/2345 (0.1%) | 1/2342 (0%) | |||
| Cerebrovascular accident | 31/2333 (1.3%) | 46/2345 (2%) | 37/2342 (1.6%) | |||
| Cerebrovascular disorder | 2/2333 (0.1%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Cerebrovascular insufficiency | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Cervical cord compression | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Cervical myelopathy | 1/2333 (0%) | 0/2345 (0%) | 2/2342 (0.1%) | |||
| Cervical radiculopathy | 2/2333 (0.1%) | 1/2345 (0%) | 1/2342 (0%) | |||
| Cognitive disorder | 0/2333 (0%) | 0/2345 (0%) | 2/2342 (0.1%) | |||
| Complex partial seizures | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Coordination abnormal | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Dementia Alzheimer's type | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Diabetic neuropathy | 2/2333 (0.1%) | 2/2345 (0.1%) | 1/2342 (0%) | |||
| Dizziness | 5/2333 (0.2%) | 8/2345 (0.3%) | 5/2342 (0.2%) | |||
| Dysarthria | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Embolic cerebral infarction | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Embolic stroke | 3/2333 (0.1%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Encephalopathy | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Epilepsy | 0/2333 (0%) | 2/2345 (0.1%) | 2/2342 (0.1%) | |||
| Generalised tonic-clonic seizure | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Guillain-Barre syndrome | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Haemorrhage intracranial | 2/2333 (0.1%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Haemorrhagic cerebral infarction | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Haemorrhagic stroke | 4/2333 (0.2%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Headache | 2/2333 (0.1%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Hemiparesis | 0/2333 (0%) | 0/2345 (0%) | 2/2342 (0.1%) | |||
| Hemiplegia | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Hydrocephalus | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Hypercapnic coma | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Hyperkinesia | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Hypertensive encephalopathy | 2/2333 (0.1%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Hypoaesthesia | 1/2333 (0%) | 1/2345 (0%) | 1/2342 (0%) | |||
| Hypoglycaemic coma | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Hypotonia | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| IIIrd nerve paralysis | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Intercostal neuralgia | 1/2333 (0%) | 0/2345 (0%) | 2/2342 (0.1%) | |||
| Ischaemic cerebral infarction | 1/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Ischaemic stroke | 22/2333 (0.9%) | 18/2345 (0.8%) | 20/2342 (0.9%) | |||
| Lacunar infarction | 2/2333 (0.1%) | 1/2345 (0%) | 2/2342 (0.1%) | |||
| Leukoencephalopathy | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Loss of consciousness | 2/2333 (0.1%) | 0/2345 (0%) | 2/2342 (0.1%) | |||
| Lumbar radiculopathy | 1/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Metabolic encephalopathy | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Migraine | 1/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Mononeuritis | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Monoplegia | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Muscle spasticity | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Myelitis transverse | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Myelopathy | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Myoclonus | 0/2333 (0%) | 1/2345 (0%) | 1/2342 (0%) | |||
| Nerve root compression | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Neuroleptic malignant syndrome | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Neuropathy peripheral | 2/2333 (0.1%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Paraesthesia | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Paraparesis | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Paraplegia | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Parkinson's disease | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Partial seizures | 2/2333 (0.1%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Peripheral motor neuropathy | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Peroneal nerve palsy | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Petit mal epilepsy | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Piriformis syndrome | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Presyncope | 0/2333 (0%) | 1/2345 (0%) | 1/2342 (0%) | |||
| Radiculopathy | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Sciatica | 1/2333 (0%) | 2/2345 (0.1%) | 1/2342 (0%) | |||
| Seizure | 4/2333 (0.2%) | 7/2345 (0.3%) | 5/2342 (0.2%) | |||
| Sensory disturbance | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Spinal cord compression | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Spinal epidural haematoma | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Spondylitic myelopathy | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Subarachnoid haemorrhage | 3/2333 (0.1%) | 3/2345 (0.1%) | 2/2342 (0.1%) | |||
| Subdural hygroma | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Syncope | 8/2333 (0.3%) | 9/2345 (0.4%) | 18/2342 (0.8%) | |||
| Thalamic infarction | 1/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Thrombotic cerebral infarction | 1/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Thrombotic stroke | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Transient ischaemic attack | 23/2333 (1%) | 23/2345 (1%) | 30/2342 (1.3%) | |||
| VIIth nerve paralysis | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Vascular encephalopathy | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Vertebral artery dissection | 0/2333 (0%) | 1/2345 (0%) | 1/2342 (0%) | |||
| Vertebral artery stenosis | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Vertebrobasilar insufficiency | 3/2333 (0.1%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Vocal cord paresis | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Psychiatric disorders | ||||||
| Anxiety | 4/2333 (0.2%) | 1/2345 (0%) | 1/2342 (0%) | |||
| Completed suicide | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Confusional state | 2/2333 (0.1%) | 3/2345 (0.1%) | 0/2342 (0%) | |||
| Delirium | 0/2333 (0%) | 2/2345 (0.1%) | 1/2342 (0%) | |||
| Depression | 5/2333 (0.2%) | 1/2345 (0%) | 1/2342 (0%) | |||
| Hallucination | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Insomnia | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Major depression | 0/2333 (0%) | 1/2345 (0%) | 1/2342 (0%) | |||
| Mental status changes | 4/2333 (0.2%) | 1/2345 (0%) | 1/2342 (0%) | |||
| Rapid eye movements sleep abnormal | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Substance abuse | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Suicidal ideation | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Suicide attempt | 1/2333 (0%) | 1/2345 (0%) | 1/2342 (0%) | |||
| Renal and urinary disorders | ||||||
| Acute kidney injury | 32/2333 (1.4%) | 26/2345 (1.1%) | 19/2342 (0.8%) | |||
| Acute prerenal failure | 2/2333 (0.1%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Albuminuria | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Anuria | 1/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Bladder neck sclerosis | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Bladder outlet obstruction | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Calculus bladder | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Calculus ureteric | 4/2333 (0.2%) | 1/2345 (0%) | 2/2342 (0.1%) | |||
| Calculus urinary | 2/2333 (0.1%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Chronic kidney disease | 3/2333 (0.1%) | 2/2345 (0.1%) | 4/2342 (0.2%) | |||
| Cystitis glandularis | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Cystitis haemorrhagic | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Diabetic nephropathy | 2/2333 (0.1%) | 2/2345 (0.1%) | 2/2342 (0.1%) | |||
| Dysuria | 1/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Haematuria | 4/2333 (0.2%) | 2/2345 (0.1%) | 1/2342 (0%) | |||
| Hydronephrosis | 2/2333 (0.1%) | 2/2345 (0.1%) | 0/2342 (0%) | |||
| Hypertensive nephropathy | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Lower urinary tract symptoms | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Microalbuminuria | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Nephritis | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Nephrolithiasis | 3/2333 (0.1%) | 3/2345 (0.1%) | 7/2342 (0.3%) | |||
| Nephropathy | 1/2333 (0%) | 1/2345 (0%) | 1/2342 (0%) | |||
| Nephrotic syndrome | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Obstructive uropathy | 0/2333 (0%) | 1/2345 (0%) | 1/2342 (0%) | |||
| Oliguria | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Polyuria | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Renal artery arteriosclerosis | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Renal artery stenosis | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Renal colic | 1/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Renal cyst | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Renal failure | 10/2333 (0.4%) | 2/2345 (0.1%) | 4/2342 (0.2%) | |||
| Renal impairment | 2/2333 (0.1%) | 2/2345 (0.1%) | 4/2342 (0.2%) | |||
| Renal infarct | 0/2333 (0%) | 2/2345 (0.1%) | 0/2342 (0%) | |||
| Renal tubular necrosis | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Stress urinary incontinence | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Tubulointerstitial nephritis | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Ureteric obstruction | 0/2333 (0%) | 0/2345 (0%) | 2/2342 (0.1%) | |||
| Urethral stenosis | 2/2333 (0.1%) | 4/2345 (0.2%) | 0/2342 (0%) | |||
| Urinary bladder haemorrhage | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Urinary bladder polyp | 2/2333 (0.1%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Urinary incontinence | 2/2333 (0.1%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Urinary retention | 3/2333 (0.1%) | 4/2345 (0.2%) | 5/2342 (0.2%) | |||
| Urinary tract obstruction | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Reproductive system and breast disorders | ||||||
| Benign prostatic hyperplasia | 6/2333 (0.3%) | 8/2345 (0.3%) | 10/2342 (0.4%) | |||
| Cystocele | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Endometrial hyperplasia | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Fibrocystic breast disease | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Genital prolapse | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Gynaecomastia | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Menorrhagia | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Ovarian cyst | 0/2333 (0%) | 1/2345 (0%) | 1/2342 (0%) | |||
| Prostatic obstruction | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Prostatism | 0/2333 (0%) | 0/2345 (0%) | 2/2342 (0.1%) | |||
| Prostatitis | 2/2333 (0.1%) | 2/2345 (0.1%) | 2/2342 (0.1%) | |||
| Uterine polyp | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Uterine prolapse | 0/2333 (0%) | 1/2345 (0%) | 1/2342 (0%) | |||
| Uterovaginal prolapse | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Vaginal prolapse | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Respiratory, thoracic and mediastinal disorders | ||||||
| Acute pulmonary oedema | 5/2333 (0.2%) | 7/2345 (0.3%) | 1/2342 (0%) | |||
| Acute respiratory distress syndrome | 2/2333 (0.1%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Acute respiratory failure | 4/2333 (0.2%) | 5/2345 (0.2%) | 3/2342 (0.1%) | |||
| Allergic sinusitis | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Asthma | 6/2333 (0.3%) | 4/2345 (0.2%) | 2/2342 (0.1%) | |||
| Atelectasis | 0/2333 (0%) | 0/2345 (0%) | 3/2342 (0.1%) | |||
| Bronchial disorder | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Bronchial secretion retention | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Bronchiectasis | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Bronchitis chronic | 0/2333 (0%) | 2/2345 (0.1%) | 1/2342 (0%) | |||
| Bronchospasm | 2/2333 (0.1%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Chronic obstructive pulmonary disease | 11/2333 (0.5%) | 6/2345 (0.3%) | 10/2342 (0.4%) | |||
| Dyspnoea | 14/2333 (0.6%) | 6/2345 (0.3%) | 9/2342 (0.4%) | |||
| Dyspnoea exertional | 2/2333 (0.1%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Emphysema | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Epistaxis | 1/2333 (0%) | 3/2345 (0.1%) | 2/2342 (0.1%) | |||
| Haemoptysis | 4/2333 (0.2%) | 1/2345 (0%) | 1/2342 (0%) | |||
| Haemothorax | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Hydrothorax | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Hypoxia | 1/2333 (0%) | 2/2345 (0.1%) | 1/2342 (0%) | |||
| Idiopathic pulmonary fibrosis | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Interstitial lung disease | 0/2333 (0%) | 0/2345 (0%) | 2/2342 (0.1%) | |||
| Laryngeal oedema | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Lung disorder | 1/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Lung infiltration | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Mediastinal haematoma | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Nasal polyps | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Obstructive airways disorder | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Paranasal cyst | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Pleural effusion | 4/2333 (0.2%) | 1/2345 (0%) | 4/2342 (0.2%) | |||
| Pleural fibrosis | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Pleurisy | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Pleuritic pain | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Pneumonia aspiration | 2/2333 (0.1%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Pneumonitis | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Pneumothorax | 1/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Pulmonary arterial hypertension | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Pulmonary congestion | 0/2333 (0%) | 0/2345 (0%) | 2/2342 (0.1%) | |||
| Pulmonary embolism | 4/2333 (0.2%) | 0/2345 (0%) | 6/2342 (0.3%) | |||
| Pulmonary fibrosis | 0/2333 (0%) | 1/2345 (0%) | 1/2342 (0%) | |||
| Pulmonary hypertension | 5/2333 (0.2%) | 1/2345 (0%) | 2/2342 (0.1%) | |||
| Pulmonary mass | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Pulmonary oedema | 5/2333 (0.2%) | 2/2345 (0.1%) | 1/2342 (0%) | |||
| Pulmonary thrombosis | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Pulmonary toxicity | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Respiratory arrest | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Respiratory distress | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Respiratory failure | 9/2333 (0.4%) | 2/2345 (0.1%) | 4/2342 (0.2%) | |||
| Sinus disorder | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Sleep apnoea syndrome | 4/2333 (0.2%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Status asthmaticus | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Upper airway obstruction | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Vocal cord polyp | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Vocal cord thickening | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Skin and subcutaneous tissue disorders | ||||||
| Angioedema | 1/2333 (0%) | 0/2345 (0%) | 3/2342 (0.1%) | |||
| Cold sweat | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Dermal cyst | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Dermatitis contact | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Diabetic bullosis | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Diabetic foot | 12/2333 (0.5%) | 10/2345 (0.4%) | 11/2342 (0.5%) | |||
| Eczema | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Erythema | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Erythrodermic psoriasis | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Ingrowing nail | 1/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Leukoplakia | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Neuropathic ulcer | 1/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Pemphigus | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Skin fibrosis | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Skin necrosis | 1/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Skin ulcer | 10/2333 (0.4%) | 6/2345 (0.3%) | 11/2342 (0.5%) | |||
| Skin ulcer haemorrhage | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Urticaria | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Social circumstances | ||||||
| Physical assault | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Surgical and medical procedures | ||||||
| Angioplasty | 1/2333 (0%) | 1/2345 (0%) | 1/2342 (0%) | |||
| Coronary angioplasty | 3/2333 (0.1%) | 0/2345 (0%) | 2/2342 (0.1%) | |||
| Coronary arterial stent insertion | 1/2333 (0%) | 2/2345 (0.1%) | 1/2342 (0%) | |||
| Coronary artery bypass | 4/2333 (0.2%) | 3/2345 (0.1%) | 4/2342 (0.2%) | |||
| Coronary revascularisation | 5/2333 (0.2%) | 2/2345 (0.1%) | 4/2342 (0.2%) | |||
| Fracture treatment | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Percutaneous coronary intervention | 0/2333 (0%) | 2/2345 (0.1%) | 3/2342 (0.1%) | |||
| Prophylaxis | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Stent placement | 0/2333 (0%) | 2/2345 (0.1%) | 1/2342 (0%) | |||
| Vascular disorders | ||||||
| Accelerated hypertension | 0/2333 (0%) | 1/2345 (0%) | 1/2342 (0%) | |||
| Aneurysm | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Angiopathy | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Aortic aneurysm | 1/2333 (0%) | 3/2345 (0.1%) | 4/2342 (0.2%) | |||
| Aortic arteriosclerosis | 1/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Aortic dissection | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Aortic stenosis | 4/2333 (0.2%) | 2/2345 (0.1%) | 3/2342 (0.1%) | |||
| Arterial disorder | 4/2333 (0.2%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Arterial haemorrhage | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Arterial occlusive disease | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Arterial stenosis | 3/2333 (0.1%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Arteriosclerosis | 2/2333 (0.1%) | 1/2345 (0%) | 1/2342 (0%) | |||
| Arteriovenous fistula | 1/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Arteritis | 0/2333 (0%) | 0/2345 (0%) | 3/2342 (0.1%) | |||
| Deep vein thrombosis | 5/2333 (0.2%) | 3/2345 (0.1%) | 10/2342 (0.4%) | |||
| Diabetic microangiopathy | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Embolism | 1/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Embolism arterial | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Extremity necrosis | 5/2333 (0.2%) | 4/2345 (0.2%) | 8/2342 (0.3%) | |||
| Femoral artery embolism | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Femoral artery occlusion | 1/2333 (0%) | 3/2345 (0.1%) | 5/2342 (0.2%) | |||
| Haematoma | 0/2333 (0%) | 1/2345 (0%) | 2/2342 (0.1%) | |||
| Haemorrhage | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Hypertension | 10/2333 (0.4%) | 4/2345 (0.2%) | 7/2342 (0.3%) | |||
| Hypertensive crisis | 8/2333 (0.3%) | 3/2345 (0.1%) | 4/2342 (0.2%) | |||
| Hypertensive emergency | 2/2333 (0.1%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Hypotension | 9/2333 (0.4%) | 5/2345 (0.2%) | 4/2342 (0.2%) | |||
| Hypovolaemic shock | 2/2333 (0.1%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Iliac artery occlusion | 1/2333 (0%) | 0/2345 (0%) | 2/2342 (0.1%) | |||
| Infarction | 1/2333 (0%) | 0/2345 (0%) | 2/2342 (0.1%) | |||
| Intermittent claudication | 2/2333 (0.1%) | 4/2345 (0.2%) | 5/2342 (0.2%) | |||
| Ischaemia | 2/2333 (0.1%) | 1/2345 (0%) | 2/2342 (0.1%) | |||
| Leriche syndrome | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Malignant hypertension | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Orthostatic hypotension | 2/2333 (0.1%) | 3/2345 (0.1%) | 1/2342 (0%) | |||
| Peripheral arterial occlusive disease | 23/2333 (1%) | 28/2345 (1.2%) | 30/2342 (1.3%) | |||
| Peripheral artery aneurysm | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Peripheral artery stenosis | 6/2333 (0.3%) | 3/2345 (0.1%) | 9/2342 (0.4%) | |||
| Peripheral artery thrombosis | 0/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Peripheral coldness | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Peripheral embolism | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Peripheral ischaemia | 9/2333 (0.4%) | 4/2345 (0.2%) | 11/2342 (0.5%) | |||
| Peripheral vascular disorder | 8/2333 (0.3%) | 3/2345 (0.1%) | 6/2342 (0.3%) | |||
| Peripheral venous disease | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Subclavian artery stenosis | 0/2333 (0%) | 1/2345 (0%) | 1/2342 (0%) | |||
| Thrombophlebitis | 2/2333 (0.1%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Thrombophlebitis superficial | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Thrombosis | 2/2333 (0.1%) | 2/2345 (0.1%) | 2/2342 (0.1%) | |||
| Varicose ulceration | 1/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Varicose vein | 2/2333 (0.1%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Vascular calcification | 1/2333 (0%) | 1/2345 (0%) | 0/2342 (0%) | |||
| Vascular insufficiency | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
| Venous occlusion | 1/2333 (0%) | 0/2345 (0%) | 0/2342 (0%) | |||
| Venous thrombosis | 0/2333 (0%) | 1/2345 (0%) | 1/2342 (0%) | |||
| Venous thrombosis limb | 0/2333 (0%) | 0/2345 (0%) | 1/2342 (0%) | |||
Other (Not Including Serious) Adverse Events |
||||||
| Placebo | Empagliflozin 10 mg | Empagliflozin 25 mg | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1690/2333 (72.4%) | 1556/2345 (66.4%) | 1551/2342 (66.2%) | |||
| Gastrointestinal disorders | ||||||
| Constipation | 109/2333 (4.7%) | 91/2345 (3.9%) | 119/2342 (5.1%) | |||
| Diarrhoea | 171/2333 (7.3%) | 145/2345 (6.2%) | 144/2342 (6.1%) | |||
| General disorders | ||||||
| Oedema peripheral | 155/2333 (6.6%) | 84/2345 (3.6%) | 75/2342 (3.2%) | |||
| Infections and infestations | ||||||
| Bronchitis | 164/2333 (7%) | 129/2345 (5.5%) | 117/2342 (5%) | |||
| Influenza | 165/2333 (7.1%) | 134/2345 (5.7%) | 149/2342 (6.4%) | |||
| Nasopharyngitis | 217/2333 (9.3%) | 210/2345 (9%) | 220/2342 (9.4%) | |||
| Upper respiratory tract infection | 199/2333 (8.5%) | 191/2345 (8.1%) | 175/2342 (7.5%) | |||
| Urinary tract infection | 344/2333 (14.7%) | 339/2345 (14.5%) | 337/2342 (14.4%) | |||
| Metabolism and nutrition disorders | ||||||
| Hyperglycaemia | 423/2333 (18.1%) | 217/2345 (9.3%) | 202/2342 (8.6%) | |||
| Hypoglycaemia | 685/2333 (29.4%) | 694/2345 (29.6%) | 673/2342 (28.7%) | |||
| Musculoskeletal and connective tissue disorders | ||||||
| Arthralgia | 130/2333 (5.6%) | 107/2345 (4.6%) | 148/2342 (6.3%) | |||
| Back pain | 148/2333 (6.3%) | 149/2345 (6.4%) | 166/2342 (7.1%) | |||
| Pain in extremity | 133/2333 (5.7%) | 114/2345 (4.9%) | 101/2342 (4.3%) | |||
| Nervous system disorders | ||||||
| Dizziness | 151/2333 (6.5%) | 170/2345 (7.2%) | 173/2342 (7.4%) | |||
| Headache | 123/2333 (5.3%) | 100/2345 (4.3%) | 124/2342 (5.3%) | |||
| Respiratory, thoracic and mediastinal disorders | ||||||
| Cough | 146/2333 (6.3%) | 119/2345 (5.1%) | 108/2342 (4.6%) | |||
| Vascular disorders | ||||||
| Hypertension | 210/2333 (9%) | 154/2345 (6.6%) | 176/2342 (7.5%) | |||
Limitations/Caveats
2 sets of duplicates(4 patients(pts)) were counted only once.652 sites were initiated and 611 enrolled.One site transferred all pts to other sites.27 pts randomised and 13 pts screened were excluded from analyses due to serious non-compliance
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights
Results Point of Contact
| Name/Title | Boehringer Ingelheim Call Center |
|---|---|
| Organization | Boehringer Ingelheim |
| Phone | 800-243-0127 ext +1 |
| clintriage.rdg@boehringer-ingelheim.com |
Responsible Party:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01131676
Other Study ID Numbers:
- 1245.25
- 2009-016178-33
First Posted:
May 27, 2010
Last Update Posted:
May 16, 2016
Last Verified:
Apr 1, 2016