Randomized Evaluation of Long Term Anticoagulant Therapy (RE-LY) With Dabigatran Etexilate
Sponsor
Boehringer Ingelheim (Industry)
Overall Status
Completed
CT.gov ID
NCT00262600
Collaborator
Population Health Research Institute (Other), Uppsala University (Other)
18,113
984
3
18.4
Study Details
Study Description
Brief Summary
The primary objective of this trial is to demonstrate the efficacy and safety of dabigatran etexilate in patients with non-valvular atrial fibrillation for the prevention of stroke and systemic embolism.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
18113 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Primary Purpose:
Prevention
Official Title:
Randomized Evaluation of Long Term Anticoagulant Therapy (RE-LY) Comparing the Efficacy and Safety of Two Blinded Doses of Dabigatran Etexilate With Open Label Warfarin for the Prevention of Stroke and Systemic Embolism in Patients With Non-valvular Atrial Fibrillation: Prospective, Multi-centre, Parallel-group, Non-inferiority Trial (RE-LY Study)
Actual Study Start Date
:
Dec 1, 2005
Actual Primary Completion Date
:
Apr 1, 2009
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Dabigatran dose 2 twice a day |
Drug: Dabigatran dose 2
twice a day
|
| Active Comparator: Warfarin once a day |
Drug: warfarin
once a day
|
| Active Comparator: Dabigatran dose 1 twice a day |
Drug: Dabigatran dose 1
twice daily
|
Outcome Measures
Primary Outcome Measures
- Yearly Event Rate for Composite Endpoint of Stroke/SEE [36 months]
Time to first occurrence of stroke or systemic embolic event. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum(date of study termination - date of randomization + 1) of all randomized subjects / 365.25
Secondary Outcome Measures
- Yearly Event Rate for Composite Endpoint of Stroke/SEE/All Cause Death [36 months]
Time to first occurrence of stroke, SEE or all cause death. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum(date of study termination - date of randomization + 1) of all randomized subjects / 365.25
- Yearly Event Rate: Composite of Stroke/SEE/PE/MI/Vascular Death [36 months]
Time to first occurrence of stroke, systemic embolic event, pulmonary embolism, myocardial infarction including silent myocardial infarction or vascular death. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum(date of study termination - date of randomization + 1) of all randomized subjects / 365.25
- Bleeding Events (Major and Minor) [36 months]
Yearly event rate of bleeds. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum(date of study termination - date of randomization + 1) of all randomized subjects / 365.25 Major bleeds are adjudicated, whereas minor bleeds are investigator reported.
- Clinical Relevant Abnormalities for Intracerebral Hemorrhage and Other Intracranial Hemorrhage (ICH) [36 months]
Patients with clinical relevant abnormalities for intracerebral hemorrhage, other intracranial hemorrhage (ICH)
- Abnormal Liver Function Test [36 months]
Number of subjects with abnormal liver function test (LFT), i.e., ALT/AST>3xULN and total bilirubin > 2 x ULN
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion criteria Patients with non-valvular atrial fibrillation (AF), at moderate to high risk of stroke, or systemic embolism with at least one additional risk factor (i.e. previous ischemic stroke, TIA, or systemic embolism, left ventricular dysfunction, age >=75 years, age >=65 with either diabetes mellitus, history of coronary artery disease or hypertension)
Exclusion criteria
-
Prosthetic heart valves requiring anticoagulation per se, or hemodynamically relevant valve disease that is expected to require surgical intervention during the course of the study
-
Severe, disabling stroke within the previous 6 months, or any stroke within the previous 14 days
-
Conditions associated with an increased risk of bleeding
-
Contraindication to warfarin treatment
-
Reversible causes of atrial fibrillation (e.g., cardiac surgery, pulmonary embolism, untreated hyperthyroidism).
-
Plan to perform a pulmonary vein ablation or surgery for cure of the AF
-
Severe renal impairment (estimated creatinine clearance <=30 mL/min)
-
Active infective endocarditis
-
Active liver disease
-
Women who are pregnant, lactating, or of childbearing potential who refuse to use a medically acceptable form of contraception throughout the study
-
Anaemia (haemoglobin <100g/L) or thrombocytopenia (platelet count <100 x 109/L)
-
Patients who have developed transaminase elevations upon exposure to ximelagatran
-
Patients who have received an investigational drug in the past 30 days or are participating in another drug study
-
Patients considered unreliable by the investigator concerning the requirements for follow-up during the study and/or compliance with study drug administration, has a life expectancy less than the expected duration of the trial due to concomitant disease, or has any condition which in the opinion of the investigator, would not allow safe participation in the study (e.g., drug addiction, alcohol abuse)
-
Any known hypersensitivity to galactose if the warfarin used contains galactose.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 1160.26.0009 Boehringer Ingelheim Investigational Site | Birmingham | Alabama | United States | |
| 2 | 1160.26.0046 Boehringer Ingelheim Investigational Site | Birmingham | Alabama | United States | |
| 3 | 1160.26.0057 Boehringer Ingelheim Investigational Site | Birmingham | Alabama | United States | |
| 4 | 1160.26.0211 Boehringer Ingelheim Investigational Site | Birmingham | Alabama | United States | |
| 5 | 1160.26.0206 Boehringer Ingelheim Investigational Site | Huntsville | Alabama | United States | |
| 6 | 1160.26.0115 Boehringer Ingelheim Investigational Site | Mobile | Alabama | United States | |
| 7 | 1160.26.0104 Boehringer Ingelheim Investigational Site | Lake Havasu City | Arizona | United States | |
| 8 | 1160.26.0304 Boehringer Ingelheim Investigational Site | Peoria | Arizona | United States | |
| 9 | 1160.26.0185 Boehringer Ingelheim Investigational Site | Tucson | Arizona | United States | |
| 10 | 1160.26.0305 Boehringer Ingelheim Investigational Site | Tucson | Arizona | United States | |
| 11 | 1160.26.0038 Boehringer Ingelheim Investigational Site | Hot Springs | Arkansas | United States | |
| 12 | 1160.26.0302 Boehringer Ingelheim Investigational Site | Jonesboro | Arkansas | United States | |
| 13 | 1160.26.0121 Boehringer Ingelheim Investigational Site | Little Rock | Arkansas | United States | |
| 14 | 1160.26.0191 Boehringer Ingelheim Investigational Site | Little Rock | Arkansas | United States | |
| 15 | 1160.26.0204 Boehringer Ingelheim Investigational Site | Little Rock | Arkansas | United States | |
| 16 | 1160.26.0213 Boehringer Ingelheim Investigational Site | Little Rock | Arkansas | United States | |
| 17 | 1160.26.0455 Boehringer Ingelheim Investigational Site | Little Rock | Arkansas | United States | |
| 18 | 1160.26.0388 Boehringer Ingelheim Investigational Site | Anaheim | California | United States | |
| 19 | 1160.26.0441 Boehringer Ingelheim Investigational Site | Carmichael | California | United States | |
| 20 | 1160.26.0145 Boehringer Ingelheim Investigational Site | French Camp | California | United States | |
| 21 | 1160.26.0333 Boehringer Ingelheim Investigational Site | Fullerton | California | United States | |
| 22 | 1160.26.0384 Boehringer Ingelheim Investigational Site | La Jolla | California | United States | |
| 23 | 1160.26.0091 Boehringer Ingelheim Investigational Site | La Mesa | California | United States | |
| 24 | 1160.26.0246 Boehringer Ingelheim Investigational Site | Lancaster | California | United States | |
| 25 | 1160.26.0345 Boehringer Ingelheim Investigational Site | Larkspur | California | United States | |
| 26 | 1160.26.0217 Boehringer Ingelheim Investigational Site | Loma Linda | California | United States | |
| 27 | 1160.26.0059 Boehringer Ingelheim Investigational Site | Los Angeles | California | United States | |
| 28 | 1160.26.0088 Boehringer Ingelheim Investigational Site | Los Angeles | California | United States | |
| 29 | 1160.26.0337 Boehringer Ingelheim Investigational Site | Los Angeles | California | United States | |
| 30 | 1160.26.0326 Boehringer Ingelheim Investigational Site | Mather | California | United States | |
| 31 | 1160.26.0070 Boehringer Ingelheim Investigational Site | Merced | California | United States | |
| 32 | 1160.26.0349 Boehringer Ingelheim Investigational Site | Oakland | California | United States | |
| 33 | 1160.26.0016 Boehringer Ingelheim Investigational Site | Oceanside | California | United States | |
| 34 | 1160.26.0087 Boehringer Ingelheim Investigational Site | Palm Springs | California | United States | |
| 35 | 1160.26.0459 Boehringer Ingelheim Investigational Site | Pasadena | California | United States | |
| 36 | 1160.26.0216 Boehringer Ingelheim Investigational Site | Redondo Beach | California | United States | |
| 37 | 1160.26.0135 Boehringer Ingelheim Investigational Site | Riverside | California | United States | |
| 38 | 1160.26.0162 Boehringer Ingelheim Investigational Site | Sacramento | California | United States | |
| 39 | 1160.26.0300 Boehringer Ingelheim Investigational Site | Sacramento | California | United States | |
| 40 | 1160.26.0371 Boehringer Ingelheim Investigational Site | Sacramento | California | United States | |
| 41 | 1160.26.0116 Boehringer Ingelheim Investigational Site | San Diego | California | United States | |
| 42 | 1160.26.0148 Boehringer Ingelheim Investigational Site | San Diego | California | United States | |
| 43 | 1160.26.0270 Boehringer Ingelheim Investigational Site | San Diego | California | United States | |
| 44 | 1160.26.0284 Boehringer Ingelheim Investigational Site | San Diego | California | United States | |
| 45 | 1160.26.0351 Boehringer Ingelheim Investigational Site | Santa Ana | California | United States | |
| 46 | 1160.26.0043 Boehringer Ingelheim Investigational Site | Santa Rosa | California | United States | |
| 47 | 1160.26.0462 Boehringer Ingelheim Investigational Site | Sylmar | California | United States | |
| 48 | 1160.26.0276 Boehringer Ingelheim Investigational Site | Torrance | California | United States | |
| 49 | 1160.26.0379 Boehringer Ingelheim Investigational Site | Walnut Creek | California | United States | |
| 50 | 1160.26.0419 Boehringer Ingelheim Investigational Site | Aurora | Colorado | United States | |
| 51 | 1160.26.0321 Boehringer Ingelheim Investigational Site | Colorado Springs | Colorado | United States | |
| 52 | 1160.26.0449 Boehringer Ingelheim Investigational Site | Colorado Springs | Colorado | United States | |
| 53 | 1160.26.0360 Boehringer Ingelheim Investigational Site | Denver | Colorado | United States | |
| 54 | 1160.26.0413 Boehringer Ingelheim Investigational Site | Denver | Colorado | United States | |
| 55 | 1160.26.0362 Boehringer Ingelheim Investigational Site | Fort Collins | Colorado | United States | |
| 56 | 1160.26.0399 Boehringer Ingelheim Investigational Site | Greeley | Colorado | United States | |
| 57 | 1160.26.0058 Boehringer Ingelheim Investigational Site | Bridgeport | Connecticut | United States | |
| 58 | 1160.26.0241 Boehringer Ingelheim Investigational Site | Bridgeport | Connecticut | United States | |
| 59 | 1160.26.0278 Boehringer Ingelheim Investigational Site | Bridgeport | Connecticut | United States | |
| 60 | 1160.26.0085 Boehringer Ingelheim Investigational Site | Fairfield | Connecticut | United States | |
| 61 | 1160.26.0482 Boehringer Ingelheim Investigational Site | Guilford | Connecticut | United States | |
| 62 | 1160.26.0366 Boehringer Ingelheim Investigational Site | Newark | Delaware | United States | |
| 63 | 1160.26.0343 Boehringer Ingelheim Investigational Site | Washington | District of Columbia | United States | |
| 64 | 1160.26.0022 Boehringer Ingelheim Investigational Site | Atlantis | Florida | United States | |
| 65 | 1160.26.0382 Boehringer Ingelheim Investigational Site | Boynton Beach | Florida | United States | |
| 66 | 1160.26.0056 Boehringer Ingelheim Investigational Site | Brandon | Florida | United States | |
| 67 | 1160.26.0105 Boehringer Ingelheim Investigational Site | Clearwater | Florida | United States | |
| 68 | 1160.26.0296 Boehringer Ingelheim Investigational Site | Clearwater | Florida | United States | |
| 69 | 1160.26.0429 Boehringer Ingelheim Investigational Site | Clearwater | Florida | United States | |
| 70 | 1160.26.0376 Boehringer Ingelheim Investigational Site | Daytona Beach | Florida | United States | |
| 71 | 1160.26.0411 Boehringer Ingelheim Investigational Site | Deerfield Beach | Florida | United States | |
| 72 | 1160.26.0074 Boehringer Ingelheim Investigational Site | Fort Myers | Florida | United States | |
| 73 | 1160.26.0239 Boehringer Ingelheim Investigational Site | Gainesville | Florida | United States | |
| 74 | 1160.26.0260 Boehringer Ingelheim Investigational Site | Hollywood | Florida | United States | |
| 75 | 1160.26.0265 Boehringer Ingelheim Investigational Site | Hollywood | Florida | United States | |
| 76 | 1160.26.0100 Boehringer Ingelheim Investigational Site | Inverness | Florida | United States | |
| 77 | 1160.26.0209 Boehringer Ingelheim Investigational Site | Jacksonville Beach | Florida | United States | |
| 78 | 1160.26.0033 Boehringer Ingelheim Investigational Site | Jacksonville | Florida | United States | |
| 79 | 1160.26.0089 Boehringer Ingelheim Investigational Site | Jacksonville | Florida | United States | |
| 80 | 1160.26.0232 Boehringer Ingelheim Investigational Site | Jacksonville | Florida | United States | |
| 81 | 1160.26.0240 Boehringer Ingelheim Investigational Site | Jacksonville | Florida | United States | |
| 82 | 1160.26.0427 Boehringer Ingelheim Investigational Site | Jacksonville | Florida | United States | |
| 83 | 1160.26.0464 Boehringer Ingelheim Investigational Site | Jacksonville | Florida | United States | |
| 84 | 1160.26.0012 Boehringer Ingelheim Investigational Site | Lakeland | Florida | United States | |
| 85 | 1160.26.0259 Boehringer Ingelheim Investigational Site | Melbourne | Florida | United States | |
| 86 | 1160.26.0358 Boehringer Ingelheim Investigational Site | Melbourne | Florida | United States | |
| 87 | 1160.26.0034 Boehringer Ingelheim Investigational Site | Miami | Florida | United States | |
| 88 | 1160.26.0199 Boehringer Ingelheim Investigational Site | Miami | Florida | United States | |
| 89 | 1160.26.0227 Boehringer Ingelheim Investigational Site | Orlando | Florida | United States | |
| 90 | 1160.26.0095 Boehringer Ingelheim Investigational Site | Ormond Beach | Florida | United States | |
| 91 | 1160.26.0037 Boehringer Ingelheim Investigational Site | Pensacola | Florida | United States | |
| 92 | 1160.26.0076 Boehringer Ingelheim Investigational Site | Pensacola | Florida | United States | |
| 93 | 1160.26.0081 Boehringer Ingelheim Investigational Site | Pensacola | Florida | United States | |
| 94 | 1160.26.0111 Boehringer Ingelheim Investigational Site | Pensacola | Florida | United States | |
| 95 | 1160.26.0137 Boehringer Ingelheim Investigational Site | Port Charlotte | Florida | United States | |
| 96 | 1160.26.0389 Boehringer Ingelheim Investigational Site | Port Charlotte | Florida | United States | |
| 97 | 1160.26.0417 Boehringer Ingelheim Investigational Site | Port Charlotte | Florida | United States | |
| 98 | 1160.26.0332 Boehringer Ingelheim Investigational Site | Rockledge | Florida | United States | |
| 99 | 1160.26.0226 Boehringer Ingelheim Investigational Site | Safety Harbor | Florida | United States | |
| 100 | 1160.26.0015 Boehringer Ingelheim Investigational Site | Saint Petersburg | Florida | United States | |
| 101 | 1160.26.0339 Boehringer Ingelheim Investigational Site | Saint Petersburg | Florida | United States | |
| 102 | 1160.26.0031 Boehringer Ingelheim Investigational Site | Sarasota | Florida | United States | |
| 103 | 1160.26.0385 Boehringer Ingelheim Investigational Site | Sarasota | Florida | United States | |
| 104 | 1160.26.0010 Boehringer Ingelheim Investigational Site | Stuart | Florida | United States | |
| 105 | 1160.26.0327 Boehringer Ingelheim Investigational Site | Tamarac | Florida | United States | |
| 106 | 1160.26.0271 Boehringer Ingelheim Investigational Site | Tampa | Florida | United States | |
| 107 | 1160.26.0328 Boehringer Ingelheim Investigational Site | Tampa | Florida | United States | |
| 108 | 1160.26.0381 Boehringer Ingelheim Investigational Site | Tampa | Florida | United States | |
| 109 | 1160.26.0019 Boehringer Ingelheim Investigational Site | Vero Beach | Florida | United States | |
| 110 | 1160.26.0159 Boehringer Ingelheim Investigational Site | Atlanta | Georgia | United States | |
| 111 | 1160.26.0283 Boehringer Ingelheim Investigational Site | Atlanta | Georgia | United States | |
| 112 | 1160.26.0338 Boehringer Ingelheim Investigational Site | Atlanta | Georgia | United States | |
| 113 | 1160.26.0021 Boehringer Ingelheim Investigational Site | Augusta | Georgia | United States | |
| 114 | 1160.26.0319 Boehringer Ingelheim Investigational Site | Augusta | Georgia | United States | |
| 115 | 1160.26.0092 Boehringer Ingelheim Investigational Site | Blue Ridge | Georgia | United States | |
| 116 | 1160.26.0161 Boehringer Ingelheim Investigational Site | Conyers | Georgia | United States | |
| 117 | 1160.26.0026 Boehringer Ingelheim Investigational Site | Coeur d'Alene | Idaho | United States | |
| 118 | 1160.26.0218 Boehringer Ingelheim Investigational Site | Berwyn | Illinois | United States | |
| 119 | 1160.26.0184 Boehringer Ingelheim Investigational Site | Chicago | Illinois | United States | |
| 120 | 1160.26.0233 Boehringer Ingelheim Investigational Site | Chicago | Illinois | United States | |
| 121 | 1160.26.0324 Boehringer Ingelheim Investigational Site | Chicago | Illinois | United States | |
| 122 | 1160.26.0457 Boehringer Ingelheim Investigational Site | Chicago | Illinois | United States | |
| 123 | 1160.26.0237 Boehringer Ingelheim Investigational Site | Evanston | Illinois | United States | |
| 124 | 1160.26.0236 Boehringer Ingelheim Investigational Site | Glenview | Illinois | United States | |
| 125 | 1160.26.0396 Boehringer Ingelheim Investigational Site | Hines | Illinois | United States | |
| 126 | 1160.26.0438 Boehringer Ingelheim Investigational Site | Maywood | Illinois | United States | |
| 127 | 1160.26.0331 Boehringer Ingelheim Investigational Site | Melrose Park | Illinois | United States | |
| 128 | 1160.26.0364 Boehringer Ingelheim Investigational Site | Normal | Illinois | United States | |
| 129 | 1160.26.0109 Boehringer Ingelheim Investigational Site | North Chicago | Illinois | United States | |
| 130 | 1160.26.0152 Boehringer Ingelheim Investigational Site | Oak Lawn | Illinois | United States | |
| 131 | 1160.26.0198 Boehringer Ingelheim Investigational Site | Rockford | Illinois | United States | |
| 132 | 1160.26.0433 Boehringer Ingelheim Investigational Site | Winfield | Illinois | United States | |
| 133 | 1160.26.0041 Boehringer Ingelheim Investigational Site | Evansville | Indiana | United States | |
| 134 | 1160.26.0377 Boehringer Ingelheim Investigational Site | Fort Wayne | Indiana | United States | |
| 135 | 1160.26.0288 Boehringer Ingelheim Investigational Site | Indianapolis | Indiana | United States | |
| 136 | 1160.26.0352 Boehringer Ingelheim Investigational Site | Indianapolis | Indiana | United States | |
| 137 | 1160.26.0436 Boehringer Ingelheim Investigational Site | Indianapolis | Indiana | United States | |
| 138 | 1160.26.0028 Boehringer Ingelheim Investigational Site | Jeffersonville | Indiana | United States | |
| 139 | 1160.26.0235 Boehringer Ingelheim Investigational Site | South Bend | Indiana | United States | |
| 140 | 1160.26.0268 Boehringer Ingelheim Investigational Site | Dubuque | Iowa | United States | |
| 141 | 1160.26.0001 Boehringer Ingelheim Investigational Site | West Des Moines | Iowa | United States | |
| 142 | 1160.26.0189 Boehringer Ingelheim Investigational Site | West Des Moines | Iowa | United States | |
| 143 | 1160.26.0357 Boehringer Ingelheim Investigational Site | West Des Moines | Iowa | United States | |
| 144 | 1160.26.0354 Boehringer Ingelheim Investigational Site | Wichita | Kansas | United States | |
| 145 | 1160.26.0077 Boehringer Ingelheim Investigational Site | Bowling Green | Kentucky | United States | |
| 146 | 1160.26.0138 Boehringer Ingelheim Investigational Site | Crestview Hills | Kentucky | United States | |
| 147 | 1160.26.0422 Boehringer Ingelheim Investigational Site | Lexington | Kentucky | United States | |
| 148 | 1160.26.0178 Boehringer Ingelheim Investigational Site | Louisville | Kentucky | United States | |
| 149 | 1160.26.0397 Boehringer Ingelheim Investigational Site | Louisville | Kentucky | United States | |
| 150 | 1160.26.0310 Boehringer Ingelheim Investigational Site | Owensboro | Kentucky | United States | |
| 151 | 1160.26.0011 Boehringer Ingelheim Investigational Site | Baton Rouge | Louisiana | United States | |
| 152 | 1160.26.0144 Boehringer Ingelheim Investigational Site | Baton Rouge | Louisiana | United States | |
| 153 | 1160.26.0404 Boehringer Ingelheim Investigational Site | Baton Rouge | Louisiana | United States | |
| 154 | 1160.26.0093 Boehringer Ingelheim Investigational Site | Covington | Louisiana | United States | |
| 155 | 1160.26.0340 Boehringer Ingelheim Investigational Site | Lacombe | Louisiana | United States | |
| 156 | 1160.26.0018 Boehringer Ingelheim Investigational Site | Lafayette | Louisiana | United States | |
| 157 | 1160.26.0391 Boehringer Ingelheim Investigational Site | Lafayette | Louisiana | United States | |
| 158 | 1160.26.0252 Boehringer Ingelheim Investigational Site | Morgan City | Louisiana | United States | |
| 159 | 1160.26.0132 Boehringer Ingelheim Investigational Site | New Iberia | Louisiana | United States | |
| 160 | 1160.26.0299 Tulane University School Of Medicine | New Orleans | Louisiana | United States | |
| 161 | 1160.26.0048 Boehringer Ingelheim Investigational Site | Shreveport | Louisiana | United States | |
| 162 | 1160.26.0096 Boehringer Ingelheim Investigational Site | Auburn | Maine | United States | |
| 163 | 1160.26.0068 Boehringer Ingelheim Investigational Site | Scarborough | Maine | United States | |
| 164 | 1160.26.0114 Boehringer Ingelheim Investigational Site | Annapolis | Maryland | United States | |
| 165 | 1160.26.0164 Boehringer Ingelheim Investigational Site | Annapolis | Maryland | United States | |
| 166 | 1160.26.0023 Boehringer Ingelheim Investigational Site | Baltimore | Maryland | United States | |
| 167 | 1160.26.0047 Boehringer Ingelheim Investigational Site | Baltimore | Maryland | United States | |
| 168 | 1160.26.0079 Boehringer Ingelheim Investigational Site | Baltimore | Maryland | United States | |
| 169 | 1160.26.0186 Boehringer Ingelheim Investigational Site | Baltimore | Maryland | United States | |
| 170 | 1160.26.0194 Boehringer Ingelheim Investigational Site | Baltimore | Maryland | United States | |
| 171 | 1160.26.0255 Boehringer Ingelheim Investigational Site | Bel Air | Maryland | United States | |
| 172 | 1160.26.0398 Boehringer Ingelheim Investigational Site | Columbia | Maryland | United States | |
| 173 | 1160.26.0177 Boehringer Ingelheim Investigational Site | Rockville | Maryland | United States | |
| 174 | 1160.26.0073 Boehringer Ingelheim Investigational Site | Salisbury | Maryland | United States | |
| 175 | 1160.26.0207 Boehringer Ingelheim Investigational Site | Salisbury | Maryland | United States | |
| 176 | 1160.26.0196 Boehringer Ingelheim Investigational Site | Takoma Park | Maryland | United States | |
| 177 | 1160.26.0187 Boehringer Ingelheim Investigational Site | Towson | Maryland | United States | |
| 178 | 1160.26.0052 Boehringer Ingelheim Investigational Site | Westminster | Maryland | United States | |
| 179 | 1160.26.0042 Boehringer Ingelheim Investigational Site | Ayer | Massachusetts | United States | |
| 180 | 1160.26.0401 Boehringer Ingelheim Investigational Site | Boston | Massachusetts | United States | |
| 181 | 1160.26.0160 Boehringer Ingelheim Investigational Site | East Bridgewater | Massachusetts | United States | |
| 182 | 1160.26.0443 Boehringer Ingelheim Investigational Site | Haverhill | Massachusetts | United States | |
| 183 | 1160.26.0452 Boehringer Ingelheim Investigational Site | Haverhill | Massachusetts | United States | |
| 184 | 1160.26.0029 Boehringer Ingelheim Investigational Site | Natick | Massachusetts | United States | |
| 185 | 1160.26.0446 Boehringer Ingelheim Investigational Site | Newtown | Massachusetts | United States | |
| 186 | 1160.26.0003 Boehringer Ingelheim Investigational Site | North Dartmouth | Massachusetts | United States | |
| 187 | 1160.26.0470 Boehringer Ingelheim Investigational Site | Northborough | Massachusetts | United States | |
| 188 | 1160.26.0308 Boehringer Ingelheim Investigational Site | Worcester | Massachusetts | United States | |
| 189 | 1160.26.0141 Boehringer Ingelheim Investigational Site | Bloomfield Hills | Michigan | United States | |
| 190 | 1160.26.0225 Boehringer Ingelheim Investigational Site | Detroit | Michigan | United States | |
| 191 | 1160.26.0154 Boehringer Ingelheim Investigational Site | Grand Blanc | Michigan | United States | |
| 192 | 1160.26.0030 Boehringer Ingelheim Investigational Site | Grand Rapids | Michigan | United States | |
| 193 | 1160.26.0171 Boehringer Ingelheim Investigational Site | Kalamazoo | Michigan | United States | |
| 194 | 1160.26.0205 Boehringer Ingelheim Investigational Site | Lapeer | Michigan | United States | |
| 195 | 1160.26.0279 Boehringer Ingelheim Investigational Site | Muskegon | Michigan | United States | |
| 196 | 1160.26.0445 Boehringer Ingelheim Investigational Site | Petoskey | Michigan | United States | |
| 197 | 1160.26.0274 Boehringer Ingelheim Investigational Site | Rochester Hills | Michigan | United States | |
| 198 | 1160.26.0165 Boehringer Ingelheim Investigational Site | Saginaw | Michigan | United States | |
| 199 | 1160.26.0020 Boehringer Ingelheim Investigational Site | Troy | Michigan | United States | |
| 200 | 1160.26.0188 Boehringer Ingelheim Investigational Site | Ypsilanti | Michigan | United States | |
| 201 | 1160.26.0131 Boehringer Ingelheim Investigational Site | Minneapolis | Minnesota | United States | |
| 202 | 1160.26.0421 Boehringer Ingelheim Investigational Site | Minneapolis | Minnesota | United States | |
| 203 | 1160.26.0202 Boehringer Ingelheim Investigational Site | Robbinsdale | Minnesota | United States | |
| 204 | 1160.26.0101 Boehringer Ingelheim Investigational Site | Saint Paul | Minnesota | United States | |
| 205 | 1160.26.0086 Boehringer Ingelheim Investigational Site | Gulfport | Mississippi | United States | |
| 206 | 1160.26.0119 Boehringer Ingelheim Investigational Site | Tupelo | Mississippi | United States | |
| 207 | 1160.26.0055 Boehringer Ingelheim Investigational Site | Columbia | Missouri | United States | |
| 208 | 1160.26.0172 Boehringer Ingelheim Investigational Site | Columbia | Missouri | United States | |
| 209 | 1160.26.0257 Boehringer Ingelheim Investigational Site | Kansas City | Missouri | United States | |
| 210 | 1160.26.0266 Boehringer Ingelheim Investigational Site | Kansas City | Missouri | United States | |
| 211 | 1160.26.0336 Boehringer Ingelheim Investigational Site | Saint Charles | Missouri | United States | |
| 212 | 1160.26.0249 Boehringer Ingelheim Investigational Site | Saint Louis | Missouri | United States | |
| 213 | 1160.26.0027 Boehringer Ingelheim Investigational Site | Kalispell | Montana | United States | |
| 214 | 1160.26.0128 Boehringer Ingelheim Investigational Site | Alliance | Nebraska | United States | |
| 215 | 1160.26.0110 Boehringer Ingelheim Investigational Site | Omaha | Nebraska | United States | |
| 216 | 1160.26.0355 Boehringer Ingelheim Investigational Site | Papillion | Nebraska | United States | |
| 217 | 1160.26.0346 Boehringer Ingelheim Investigational Site | Henderson | Nevada | United States | |
| 218 | 1160.26.0066 Boehringer Ingelheim Investigational Site | Las Vegas | Nevada | United States | |
| 219 | 1160.26.0174 Boehringer Ingelheim Investigational Site | Las Vegas | Nevada | United States | |
| 220 | 1160.26.0430 Boehringer Ingelheim Investigational Site | Las Vegas | Nevada | United States | |
| 221 | 1160.26.0190 Boehringer Ingelheim Investigational Site | Lebanon | New Hampshire | United States | |
| 222 | 1160.26.0142 Boehringer Ingelheim Investigational Site | Browns Mills | New Jersey | United States | |
| 223 | 1160.26.0125 Boehringer Ingelheim Investigational Site | Cherry Hill | New Jersey | United States | |
| 224 | 1160.26.0432 Boehringer Ingelheim Investigational Site | Elmer | New Jersey | United States | |
| 225 | 1160.26.0448 Boehringer Ingelheim Investigational Site | Englewood | New Jersey | United States | |
| 226 | 1160.26.0248 Boehringer Ingelheim Investigational Site | Flemington | New Jersey | United States | |
| 227 | 1160.26.0244 Boehringer Ingelheim Investigational Site | Haddon Heights | New Jersey | United States | |
| 228 | 1160.26.0243 Boehringer Ingelheim Investigational Site | New Brunswick | New Jersey | United States | |
| 229 | 1160.26.0478 Boehringer Ingelheim Investigational Site | Oakland | New Jersey | United States | |
| 230 | 1160.26.0392 Boehringer Ingelheim Investigational Site | Ocean City | New Jersey | United States | |
| 231 | 1160.26.0472 Boehringer Ingelheim Investigational Site | Paterson | New Jersey | United States | |
| 232 | 1160.26.0221 Boehringer Ingelheim Investigational Site | Voorhees | New Jersey | United States | |
| 233 | 1160.26.0254 Boehringer Ingelheim Investigational Site | Westwood | New Jersey | United States | |
| 234 | 1160.26.0127 Boehringer Ingelheim Investigational Site | Albuquerque | New Mexico | United States | |
| 235 | 1160.26.0423 Boehringer Ingelheim Investigational Site | Albuquerque | New Mexico | United States | |
| 236 | 1160.26.0476 Boehringer Ingelheim Investigational Site | Albany | New York | United States | |
| 237 | 1160.26.0113 Boehringer Ingelheim Investigational Site | Bronx | New York | United States | |
| 238 | 1160.26.0281 Boehringer Ingelheim Investigational Site | Bronx | New York | United States | |
| 239 | 1160.26.0063 Boehringer Ingelheim Investigational Site | Buffalo | New York | United States | |
| 240 | 1160.26.0044 Boehringer Ingelheim Investigational Site | Cortlandt Manor | New York | United States | |
| 241 | 1160.26.0373 Boehringer Ingelheim Investigational Site | Flushing | New York | United States | |
| 242 | 1160.26.0045 Boehringer Ingelheim Investigational Site | Garden City | New York | United States | |
| 243 | 1160.26.0251 Boehringer Ingelheim Investigational Site | Kingston | New York | United States | |
| 244 | 1160.26.0229 Boehringer Ingelheim Investigational Site | Mineola | New York | United States | |
| 245 | 1160.26.0451 Boehringer Ingelheim Investigational Site | Mineola | New York | United States | |
| 246 | 1160.26.0090 Boehringer Ingelheim Investigational Site | New Hyde Park | New York | United States | |
| 247 | 1160.26.0183 Boehringer Ingelheim Investigational Site | New Rochelle | New York | United States | |
| 248 | 1160.26.0316 Boehringer Ingelheim Investigational Site | New York | New York | United States | |
| 249 | 1160.26.0146 Boehringer Ingelheim Investigational Site | North Massapequa | New York | United States | |
| 250 | 1160.26.0210 Boehringer Ingelheim Investigational Site | Northport | New York | United States | |
| 251 | 1160.26.0075 Boehringer Ingelheim Investigational Site | Poughkeepsie | New York | United States | |
| 252 | 1160.26.0197 Boehringer Ingelheim Investigational Site | Rochester | New York | United States | |
| 253 | 1160.26.0320 Boehringer Ingelheim Investigational Site | Rochester | New York | United States | |
| 254 | 1160.26.0064 Boehringer Ingelheim Investigational Site | Scarsdale | New York | United States | |
| 255 | 1160.26.0414 Boehringer Ingelheim Investigational Site | Troy | New York | United States | |
| 256 | 1160.26.0356 Boehringer Ingelheim Investigational Site | Watertown | New York | United States | |
| 257 | 1160.26.0039 Boehringer Ingelheim Investigational Site | Williamsville | New York | United States | |
| 258 | 1160.26.0353 Boehringer Ingelheim Investigational Site | Asheville | North Carolina | United States | |
| 259 | 1160.26.0080 Boehringer Ingelheim Investigational Site | Charlotte | North Carolina | United States | |
| 260 | 1160.26.0412 Boehringer Ingelheim Investigational Site | Charlotte | North Carolina | United States | |
| 261 | 1160.26.0350 Boehringer Ingelheim Investigational Site | Gastonia | North Carolina | United States | |
| 262 | 1160.26.0322 Boehringer Ingelheim Investigational Site | Greensboro | North Carolina | United States | |
| 263 | 1160.26.0173 Boehringer Ingelheim Investigational Site | High Point | North Carolina | United States | |
| 264 | 1160.26.0108 Boehringer Ingelheim Investigational Site | Lexington | North Carolina | United States | |
| 265 | 1160.26.0006 Boehringer Ingelheim Investigational Site | Pinehurst | North Carolina | United States | |
| 266 | 1160.26.0002 Boehringer Ingelheim Investigational Site | Statesville | North Carolina | United States | |
| 267 | 1160.26.0069 Boehringer Ingelheim Investigational Site | Statesville | North Carolina | United States | |
| 268 | 1160.26.0372 Boehringer Ingelheim Investigational Site | Wilmington | North Carolina | United States | |
| 269 | 1160.26.0094 Boehringer Ingelheim Investigational Site | Winston-Salem | North Carolina | United States | |
| 270 | 1160.26.0425 Boehringer Ingelheim Investigational Site | Winston-Salem | North Carolina | United States | |
| 271 | 1160.26.0102 Boehringer Ingelheim Investigational Site | Grand Forks | North Dakota | United States | |
| 272 | 1160.26.0222 Boehringer Ingelheim Investigational Site | Jamestown | North Dakota | United States | |
| 273 | 1160.26.0203 Boehringer Ingelheim Investigational Site | Akron | Ohio | United States | |
| 274 | 1160.26.0434 Boehringer Ingelheim Investigational Site | Canal Fulton | Ohio | United States | |
| 275 | 1160.26.0083 Boehringer Ingelheim Investigational Site | Cincinnati | Ohio | United States | |
| 276 | 1160.26.0402 Boehringer Ingelheim Investigational Site | Cincinnati | Ohio | United States | |
| 277 | 1160.26.0426 Boehringer Ingelheim Investigational Site | Cincinnati | Ohio | United States | |
| 278 | 1160.26.0479 Boehringer Ingelheim Investigational Site | Cincinnati | Ohio | United States | |
| 279 | 1160.26.0263 Boehringer Ingelheim Investigational Site | Cleveland | Ohio | United States | |
| 280 | 1160.26.0480 Boehringer Ingelheim Investigational Site | Cleveland | Ohio | United States | |
| 281 | 1160.26.0267 Boehringer Ingelheim Investigational Site | Columbus | Ohio | United States | |
| 282 | 1160.26.0035 Boehringer Ingelheim Investigational Site | Dayton | Ohio | United States | |
| 283 | 1160.26.0150 Boehringer Ingelheim Investigational Site | Fairview Park | Ohio | United States | |
| 284 | 1160.26.0201 Boehringer Ingelheim Investigational Site | Kettering | Ohio | United States | |
| 285 | 1160.26.0223 Boehringer Ingelheim Investigational Site | Lorain | Ohio | United States | |
| 286 | 1160.26.0214 Boehringer Ingelheim Investigational Site | Lyndhurst | Ohio | United States | |
| 287 | 1160.26.0275 Boehringer Ingelheim Investigational Site | Sandusky | Ohio | United States | |
| 288 | 1160.26.0103 Boehringer Ingelheim Investigational Site | Westlake | Ohio | United States | |
| 289 | 1160.26.0155 Boehringer Ingelheim Investigational Site | Bartlesville | Oklahoma | United States | |
| 290 | 1160.26.0435 Boehringer Ingelheim Investigational Site | Tulsa | Oklahoma | United States | |
| 291 | 1160.26.0139 Boehringer Ingelheim Investigational Site | Corvallis | Oregon | United States | |
| 292 | 1160.26.0325 Boehringer Ingelheim Investigational Site | Eugene | Oregon | United States | |
| 293 | 1160.26.0078 Boehringer Ingelheim Investigational Site | Hillsboro | Oregon | United States | |
| 294 | 1160.26.0245 Boehringer Ingelheim Investigational Site | Portland | Oregon | United States | |
| 295 | 1160.26.0133 Boehringer Ingelheim Investigational Site | Springfield | Oregon | United States | |
| 296 | 1160.26.0301 Boehringer Ingelheim Investigational Site | Allentown | Pennsylvania | United States | |
| 297 | 1160.26.0454 Boehringer Ingelheim Investigational Site | Altoona | Pennsylvania | United States | |
| 298 | 1160.26.0295 Boehringer Ingelheim Investigational Site | Camp Hill | Pennsylvania | United States | |
| 299 | 1160.26.0294 Boehringer Ingelheim Investigational Site | Hershey | Pennsylvania | United States | |
| 300 | 1160.26.0369 Boehringer Ingelheim Investigational Site | Jenkintown | Pennsylvania | United States | |
| 301 | 1160.26.0303 Boehringer Ingelheim Investigational Site | Jersey Shore | Pennsylvania | United States | |
| 302 | 1160.26.0431 Boehringer Ingelheim Investigational Site | Lancaster | Pennsylvania | United States | |
| 303 | 1160.26.0168 Boehringer Ingelheim Investigational Site | Langhorne | Pennsylvania | United States | |
| 304 | 1160.26.0293 Boehringer Ingelheim Investigational Site | Meadowbrook | Pennsylvania | United States | |
| 305 | 1160.26.0025 Boehringer Ingelheim Investigational Site | Newton | Pennsylvania | United States | |
| 306 | 1160.26.0394 Boehringer Ingelheim Investigational Site | Norristown | Pennsylvania | United States | |
| 307 | 1160.26.0158 Boehringer Ingelheim Investigational Site | Philadelphia | Pennsylvania | United States | |
| 308 | 1160.26.0181 Boehringer Ingelheim Investigational Site | Philadelphia | Pennsylvania | United States | |
| 309 | 1160.26.0416 Boehringer Ingelheim Investigational Site | Philadelphia | Pennsylvania | United States | |
| 310 | 1160.26.0344 Boehringer Ingelheim Investigational Site | Pittsburgh | Pennsylvania | United States | |
| 311 | 1160.26.0466 Boehringer Ingelheim Investigational Site | Pittsburgh | Pennsylvania | United States | |
| 312 | 1160.26.0208 Boehringer Ingelheim Investigational Site | Sellersville | Pennsylvania | United States | |
| 313 | 1160.26.0465 Boehringer Ingelheim Investigational Site | Uniontown | Pennsylvania | United States | |
| 314 | 1160.26.0400 Boehringer Ingelheim Investigational Site | Upland | Pennsylvania | United States | |
| 315 | 1160.26.0032 Boehringer Ingelheim Investigational Site | Wynnewood | Pennsylvania | United States | |
| 316 | 1160.26.0067 Boehringer Ingelheim Investigational Site | Wyomissing | Pennsylvania | United States | |
| 317 | 1160.26.0212 Boehringer Ingelheim Investigational Site | Pawtucket | Rhode Island | United States | |
| 318 | 1160.26.0007 Boehringer Ingelheim Investigational Site | Beaufort | South Carolina | United States | |
| 319 | 1160.26.0383 Boehringer Ingelheim Investigational Site | Charleston | South Carolina | United States | |
| 320 | 1160.26.0313 Boehringer Ingelheim Investigational Site | Greenville | South Carolina | United States | |
| 321 | 1160.26.0450 Boehringer Ingelheim Investigational Site | Mount Pleasant | South Carolina | United States | |
| 322 | 1160.26.0166 Boehringer Ingelheim Investigational Site | Spartanburg | South Carolina | United States | |
| 323 | 1160.26.0008 Boehringer Ingelheim Investigational Site | Summerville | South Carolina | United States | |
| 324 | 1160.26.0468 Boehringer Ingelheim Investigational Site | West Columbia | South Carolina | United States | |
| 325 | 1160.26.0348 Boehringer Ingelheim Investigational Site | Rapid City | South Dakota | United States | |
| 326 | 1160.26.0084 Boehringer Ingelheim Investigational Site | Chattanooga | Tennessee | United States | |
| 327 | 1160.26.0062 Boehringer Ingelheim Investigational Site | Germantown | Tennessee | United States | |
| 328 | 1160.26.0370 Boehringer Ingelheim Investigational Site | Johnson City | Tennessee | United States | |
| 329 | 1160.26.0323 Boehringer Ingelheim Investigational Site | Nashville | Tennessee | United States | |
| 330 | 1160.26.0395 Boehringer Ingelheim Investigational Site | Nashville | Tennessee | United States | |
| 331 | 1160.26.0474 Boehringer Ingelheim Investigational Site | Oak Ridge | Tennessee | United States | |
| 332 | 1160.26.0129 Boehringer Ingelheim Investigational Site | Austin | Texas | United States | |
| 333 | 1160.26.0410 Boehringer Ingelheim Investigational Site | Austin | Texas | United States | |
| 334 | 1160.26.0156 Boehringer Ingelheim Investigational Site | Dallas | Texas | United States | |
| 335 | 1160.26.0315 Boehringer Ingelheim Investigational Site | Fort Worth | Texas | United States | |
| 336 | 1160.26.0444 Boehringer Ingelheim Investigational Site | Fort Worth | Texas | United States | |
| 337 | 1160.26.0447 Boehringer Ingelheim Investigational Site | Houston | Texas | United States | |
| 338 | 1160.26.0483 Boehringer Ingelheim Investigational Site | Killeen | Texas | United States | |
| 339 | 1160.26.0335 Boehringer Ingelheim Investigational Site | Lubbock | Texas | United States | |
| 340 | 1160.26.0230 Boehringer Ingelheim Investigational Site | McKinney | Texas | United States | |
| 341 | 1160.26.0467 Boehringer Ingelheim Investigational Site | Plano | Texas | United States | |
| 342 | 1160.26.0013 Boehringer Ingelheim Investigational Site | San Antonio | Texas | United States | |
| 343 | 1160.26.0269 Boehringer Ingelheim Investigational Site | San Antonio | Texas | United States | |
| 344 | 1160.26.0307 Boehringer Ingelheim Investigational Site | San Antonio | Texas | United States | |
| 345 | 1160.26.0285 Boehringer Ingelheim Investigational Site | San Marcos | Texas | United States | |
| 346 | 1160.26.0215 Boehringer Ingelheim Investigational Site | Tyler | Texas | United States | |
| 347 | 1160.26.0367 Boehringer Ingelheim Investigational Site | Tyler | Texas | United States | |
| 348 | 1160.26.0195 Boehringer Ingelheim Investigational Site | Arlington | Virginia | United States | |
| 349 | 1160.26.0453 Boehringer Ingelheim Investigational Site | Charlottesville | Virginia | United States | |
| 350 | 1160.26.0053 Boehringer Ingelheim Investigational Site | Chesapeake | Virginia | United States | |
| 351 | 1160.26.0098 Boehringer Ingelheim Investigational Site | Danville | Virginia | United States | |
| 352 | 1160.26.0386 Boehringer Ingelheim Investigational Site | Falls Church | Virginia | United States | |
| 353 | 1160.26.0428 Boehringer Ingelheim Investigational Site | Fredericksburg | Virginia | United States | |
| 354 | 1160.26.0311 Boehringer Ingelheim Investigational Site | Harrisonburg | Virginia | United States | |
| 355 | 1160.26.0292 Boehringer Ingelheim Investigational Site | Newport News | Virginia | United States | |
| 356 | 1160.26.0224 Boehringer Ingelheim Investigational Site | Norfolk | Virginia | United States | |
| 357 | 1160.26.0220 Boehringer Ingelheim Investigational Site | Salem | Virginia | United States | |
| 358 | 1160.26.0317 Boehringer Ingelheim Investigational Site | Winchester | Virginia | United States | |
| 359 | 1160.26.0287 Boehringer Ingelheim Investigational Site | Bellevue | Washington | United States | |
| 360 | 1160.26.0050 Boehringer Ingelheim Investigational Site | Bellingham | Washington | United States | |
| 361 | 1160.26.0040 Boehringer Ingelheim Investigational Site | Burien | Washington | United States | |
| 362 | 1160.26.0298 Boehringer Ingelheim Investigational Site | Olympia | Washington | United States | |
| 363 | 1160.26.0250 Boehringer Ingelheim Investigational Site | Spokane | Washington | United States | |
| 364 | 1160.26.0256 Boehringer Ingelheim Investigational Site | Tacoma | Washington | United States | |
| 365 | 1160.26.0024 Boehringer Ingelheim Investigational Site | Wenatchee | Washington | United States | |
| 366 | 1160.26.0193 Boehringer Ingelheim Investigational Site | Charleston | West Virginia | United States | |
| 367 | 1160.26.0169 Boehringer Ingelheim Investigational Site | Clarksburg | West Virginia | United States | |
| 368 | 1160.26.0365 Boehringer Ingelheim Investigational Site | Huntington | West Virginia | United States | |
| 369 | 1160.26.0072 Boehringer Ingelheim Investigational Site | Elkhorn | Wisconsin | United States | |
| 370 | 1160.26.0234 Boehringer Ingelheim Investigational Site | Green Bay | Wisconsin | United States | |
| 371 | 1160.26.0099 Boehringer Ingelheim Investigational Site | Madison | Wisconsin | United States | |
| 372 | 1160.26.0242 Boehringer Ingelheim Investigational Site | Madison | Wisconsin | United States | |
| 373 | 1160.26.0359 Boehringer Ingelheim Investigational Site | Marshfield | Wisconsin | United States | |
| 374 | 1160.26.0461 Boehringer Ingelheim Investigational Site | Milwaukee | Wisconsin | United States | |
| 375 | 1160.26.0523 Boehringer Ingelheim Investigational Site | BahÃa Blanca | Argentina | ||
| 376 | 1160.26.0524 Boehringer Ingelheim Investigational Site | Capital Federal | Argentina | ||
| 377 | 1160.26.0533 Boehringer Ingelheim Investigational Site | Capital Federal | Argentina | ||
| 378 | 1160.26.0526 Boehringer Ingelheim Investigational Site | Cipolletti | Argentina | ||
| 379 | 1160.26.0529 Boehringer Ingelheim Investigational Site | Coronel Suárez | Argentina | ||
| 380 | 1160.26.0531 Boehringer Ingelheim Investigational Site | Córdoba | Argentina | ||
| 381 | 1160.26.0530 Boehringer Ingelheim Investigational Site | La Plata | Argentina | ||
| 382 | 1160.26.0527 Boehringer Ingelheim Investigational Site | Mar del Plata | Argentina | ||
| 383 | 1160.26.0532 Boehringer Ingelheim Investigational Site | Mar del Plata | Argentina | ||
| 384 | 1160.26.0525 Boehringer Ingelheim Investigational Site | Quilmes | Argentina | ||
| 385 | 1160.26.0521 Boehringer Ingelheim Investigational Site | Rosario | Argentina | ||
| 386 | 1160.26.0528 Boehringer Ingelheim Investigational Site | Salta | Argentina | ||
| 387 | 1160.26.0522 Boehringer Ingelheim Investigational Site | Santa Fe | Argentina | ||
| 388 | 1160.26.0508 Boehringer Ingelheim Investigational Site | Coffs Harbour | New South Wales | Australia | |
| 389 | 1160.26.0510 Boehringer Ingelheim Investigational Site | Gosford | New South Wales | Australia | |
| 390 | 1160.26.0505 Boehringer Ingelheim Investigational Site | Herston | Queensland | Australia | |
| 391 | 1160.26.0506 Boehringer Ingelheim Investigational Site | Milton | Queensland | Australia | |
| 392 | 1160.26.0509 Boehringer Ingelheim Investigational Site | Ashford | South Australia | Australia | |
| 393 | 1160.26.0507 Boehringer Ingelheim Investigational Site | Launceston | Tasmania | Australia | |
| 394 | 1160.26.0504 Boehringer Ingelheim Investigational Site | Box Hill | Victoria | Australia | |
| 395 | 1160.26.0501 Boehringer Ingelheim Investigational Site | Geelong | Victoria | Australia | |
| 396 | 1160.26.0502 Boehringer Ingelheim Investigational Site | Parkville | Victoria | Australia | |
| 397 | 1160.26.0503 Boehringer Ingelheim Investigational Site | Prahran | Victoria | Australia | |
| 398 | 1160.26.0543 Boehringer Ingelheim Investigational Site | Graz | Austria | ||
| 399 | 1160.26.0549 Boehringer Ingelheim Investigational Site | Linz | Austria | ||
| 400 | 1160.26.0546 Boehringer Ingelheim Investigational Site | Wels | Austria | ||
| 401 | 1160.26.0541 Boehringer Ingelheim Investigational Site | Wien | Austria | ||
| 402 | 1160.26.0542 Boehringer Ingelheim Investigational Site | Wien | Austria | ||
| 403 | 1160.26.0544 Boehringer Ingelheim Investigational Site | Wien | Austria | ||
| 404 | 1160.26.0545 Boehringer Ingelheim Investigational Site | Wien | Austria | ||
| 405 | 1160.26.0547 Boehringer Ingelheim Investigational Site | Wien | Austria | ||
| 406 | 1160.26.0548 Boehringer Ingelheim Investigational Site | Wien | Austria | ||
| 407 | 1160.26.0550 Boehringer Ingelheim Investigational Site | Wr. Neustadt | Austria | ||
| 408 | 1160.26.0564 Boehringer Ingelheim Investigational Site | Aalst | Belgium | ||
| 409 | 1160.26.0573 Boehringer Ingelheim Investigational Site | Antwerpen | Belgium | ||
| 410 | 1160.26.0575 Boehringer Ingelheim Investigational Site | Antwerpen | Belgium | ||
| 411 | 1160.26.0572 Boehringer Ingelheim Investigational Site | Brasschaat | Belgium | ||
| 412 | 1160.26.0577 Boehringer Ingelheim Investigational Site | Brugge | Belgium | ||
| 413 | 1160.26.0571 Boehringer Ingelheim Investigational Site | Brussels | Belgium | ||
| 414 | 1160.26.0581 Boehringer Ingelheim Investigational Site | Bruxelles | Belgium | ||
| 415 | 1160.26.0585 Boehringer Ingelheim Investigational Site | Bruxelles | Belgium | ||
| 416 | 1160.26.0586 Boehringer Ingelheim Investigational Site | Bruxelles | Belgium | ||
| 417 | 1160.26.0563 Boehringer Ingelheim Investigational Site | Edegem | Belgium | ||
| 418 | 1160.26.0578 Boehringer Ingelheim Investigational Site | Genk | Belgium | ||
| 419 | 1160.26.0587 Boehringer Ingelheim Investigational Site | Genk | Belgium | ||
| 420 | 1160.26.0574 Boehringer Ingelheim Investigational Site | Gent | Belgium | ||
| 421 | 1160.26.0588 Boehringer Ingelheim Investigational Site | Gilly | Belgium | ||
| 422 | 1160.26.0580 Boehringer Ingelheim Investigational Site | Haine-St.-Paul | Belgium | ||
| 423 | 1160.26.0568 Boehringer Ingelheim Investigational Site | Hasselt | Belgium | ||
| 424 | 1160.26.0569 Boehringer Ingelheim Investigational Site | Kortrijk | Belgium | ||
| 425 | 1160.26.0561 Boehringer Ingelheim Investigational Site | Leuven | Belgium | ||
| 426 | 1160.26.0579 Boehringer Ingelheim Investigational Site | Liège | Belgium | ||
| 427 | 1160.26.0583 Boehringer Ingelheim Investigational Site | Liège | Belgium | ||
| 428 | 1160.26.0589 Boehringer Ingelheim Investigational Site | Mol | Belgium | ||
| 429 | 1160.26.0567 Boehringer Ingelheim Investigational Site | Oostende | Belgium | ||
| 430 | 1160.26.0570 Boehringer Ingelheim Investigational Site | Roeselare | Belgium | ||
| 431 | 1160.26.0566 Boehringer Ingelheim Investigational Site | Tienen | Belgium | ||
| 432 | 1160.26.0562 Boehringer Ingelheim Investigational Site | Turnhout | Belgium | ||
| 433 | 1160.26.550648 Boehringer Ingelheim Investigational Site | Belo Horizonte | Brazil | ||
| 434 | 1160.26.550654 Boehringer Ingelheim Investigational Site | Blumenau | Brazil | ||
| 435 | 1160.26.550644 Boehringer Ingelheim Investigational Site | Campinas | Brazil | ||
| 436 | 1160.26.550650 Boehringer Ingelheim Investigational Site | Curitiba | Brazil | ||
| 437 | 1160.26.550651 Boehringer Ingelheim Investigational Site | Curitiba | Brazil | ||
| 438 | 1160.26.550653 Boehringer Ingelheim Investigational Site | Curitiba | Brazil | ||
| 439 | 1160.26.550652 Boehringer Ingelheim Investigational Site | Goiania | Brazil | ||
| 440 | 1160.26.550645 Boehringer Ingelheim Investigational Site | MarÃlia | Brazil | ||
| 441 | 1160.26.550646 Boehringer Ingelheim Investigational Site | São José do Rio Preto | Brazil | ||
| 442 | 1160.26.550647 Boehringer Ingelheim Investigational Site | São José do Rio Preto | Brazil | ||
| 443 | 1160.26.550641 Boehringer Ingelheim Investigational Site | São Paulo | Brazil | ||
| 444 | 1160.26.550642 Boehringer Ingelheim Investigational Site | São Paulo | Brazil | ||
| 445 | 1160.26.550643 Boehringer Ingelheim Investigational Site | São Paulo | Brazil | ||
| 446 | 1160.26.550649 Boehringer Ingelheim Investigational Site | Uberaba | Brazil | ||
| 447 | 1160.26.0620 Boehringer Ingelheim Investigational Site | Pleven | Bulgaria | ||
| 448 | 1160.26.0611 Boehringer Ingelheim Investigational Site | Sofia | Bulgaria | ||
| 449 | 1160.26.0612 Boehringer Ingelheim Investigational Site | Sofia | Bulgaria | ||
| 450 | 1160.26.0613 Boehringer Ingelheim Investigational Site | Sofia | Bulgaria | ||
| 451 | 1160.26.0614 Boehringer Ingelheim Investigational Site | Sofia | Bulgaria | ||
| 452 | 1160.26.0615 Boehringer Ingelheim Investigational Site | Sofia | Bulgaria | ||
| 453 | 1160.26.0616 Boehringer Ingelheim Investigational Site | Sofia | Bulgaria | ||
| 454 | 1160.26.0617 Boehringer Ingelheim Investigational Site | Sofia | Bulgaria | ||
| 455 | 1160.26.0618 Boehringer Ingelheim Investigational Site | Sofia | Bulgaria | ||
| 456 | 1160.26.0622 Boehringer Ingelheim Investigational Site | Sofia | Bulgaria | ||
| 457 | 1160.26.0623 Boehringer Ingelheim Investigational Site | Sofia | Bulgaria | ||
| 458 | 1160.26.0624 Boehringer Ingelheim Investigational Site | Sofia | Bulgaria | ||
| 459 | 1160.26.0625 Boehringer Ingelheim Investigational Site | Sofia | Bulgaria | ||
| 460 | 1160.26.0626 Boehringer Ingelheim Investigational Site | Stara Zagora | Bulgaria | ||
| 461 | 1160.26.0621 Boehringer Ingelheim Investigational Site | Varna | Bulgaria | ||
| 462 | 1160.26.0694 Boehringer Ingelheim Investigational Site | Calgary | Alberta | Canada | |
| 463 | 1160.26.0696 Boehringer Ingelheim Investigational Site | Calgary | Alberta | Canada | |
| 464 | 1160.26.0680 Boehringer Ingelheim Investigational Site | Coquitlam | British Columbia | Canada | |
| 465 | 1160.26.0712 Boehringer Ingelheim Investigational Site | Coquitlam | British Columbia | Canada | |
| 466 | 1160.26.0706 Boehringer Ingelheim Investigational Site | Kelowna | British Columbia | Canada | |
| 467 | 1160.26.0725 Boehringer Ingelheim Investigational Site | Nanaimo | British Columbia | Canada | |
| 468 | 1160.26.0691 Boehringer Ingelheim Investigational Site | New Westminster | British Columbia | Canada | |
| 469 | 1160.26.0714 Boehringer Ingelheim Investigational Site | Victoria | British Columbia | Canada | |
| 470 | 1160.26.0701 Boehringer Ingelheim Investigational Site | Portage la Prairie | Manitoba | Canada | |
| 471 | 1160.26.0698 Boehringer Ingelheim Investigational Site | Winnipeg | Manitoba | Canada | |
| 472 | 1160.26.0707 Boehringer Ingelheim Investigational Site | Bay Roberts | Newfoundland and Labrador | Canada | |
| 473 | 1160.26.0676 Boehringer Ingelheim Investigational Site | Antigonish | Nova Scotia | Canada | |
| 474 | 1160.26.0703 Boehringer Ingelheim Investigational Site | Halifax | Nova Scotia | Canada | |
| 475 | 1160.26.0679 Boehringer Ingelheim Investigational Site | Ajax | Ontario | Canada | |
| 476 | 1160.26.0677 Boehringer Ingelheim Investigational Site | Brampton | Ontario | Canada | |
| 477 | 1160.26.0674 Boehringer Ingelheim Investigational Site | Burlington | Ontario | Canada | |
| 478 | 1160.26.0702 Boehringer Ingelheim Investigational Site | Cambridge | Ontario | Canada | |
| 479 | 1160.26.0720 Boehringer Ingelheim Investigational Site | Cambridge | Ontario | Canada | |
| 480 | 1160.26.0671 Clinical Research & Diagnostic Solutions Inc. | Etobicoke | Ontario | Canada | |
| 481 | 1160.26.0692 Boehringer Ingelheim Investigational Site | Grimsby | Ontario | Canada | |
| 482 | 1160.26.0685 Boehringer Ingelheim Investigational Site | Hamilton | Ontario | Canada | |
| 483 | 1160.26.0697 Boehringer Ingelheim Investigational Site | Hamilton | Ontario | Canada | |
| 484 | 1160.26.0710 Boehringer Ingelheim Investigational Site | Hamilton | Ontario | Canada | |
| 485 | 1160.26.0719 Boehringer Ingelheim Investigational Site | Hamilton | Ontario | Canada | |
| 486 | 1160.26.0721 Boehringer Ingelheim Investigational Site | Hamilton | Ontario | Canada | |
| 487 | 1160.26.0689 Boehringer Ingelheim Investigational Site | Kitchener | Ontario | Canada | |
| 488 | 1160.26.0695 Boehringer Ingelheim Investigational Site | Mississauga | Ontario | Canada | |
| 489 | 1160.26.0708 Boehringer Ingelheim Investigational Site | Mississauga | Ontario | Canada | |
| 490 | 1160.26.0724 Boehringer Ingelheim Investigational Site | Mississauga | Ontario | Canada | |
| 491 | 1160.26.0688 Boehringer Ingelheim Investigational Site | Newmarket | Ontario | Canada | |
| 492 | 1160.26.0672 Boehringer Ingelheim Investigational Site | Oshawa | Ontario | Canada | |
| 493 | 1160.26.0687 Boehringer Ingelheim Investigational Site | Ottawa | Ontario | Canada | |
| 494 | 1160.26.0723 Boehringer Ingelheim Investigational Site | Scarborough | Ontario | Canada | |
| 495 | 1160.26.0715 Boehringer Ingelheim Investigational Site | Sudbury | Ontario | Canada | |
| 496 | 1160.26.0690 Boehringer Ingelheim Investigational Site | Thunder Bay | Ontario | Canada | |
| 497 | 1160.26.0684 Boehringer Ingelheim Investigational Site | Toronto | Ontario | Canada | |
| 498 | 1160.26.0718 Boehringer Ingelheim Investigational Site | Toronto | Ontario | Canada | |
| 499 | 1160.26.0711 Boehringer Ingelheim Investigational Site | Waterloo | Ontario | Canada | |
| 500 | 1160.26.0686 Boehringer Ingelheim Investigational Site | Windsor | Ontario | Canada | |
| 501 | 1160.26.0693 Boehringer Ingelheim Investigational Site | Longueuil | Quebec | Canada | |
| 502 | 1160.26.0681 Boehringer Ingelheim Investigational Site | Montreal | Quebec | Canada | |
| 503 | 1160.26.0683 Boehringer Ingelheim Investigational Site | Montreal | Quebec | Canada | |
| 504 | 1160.26.0705 Boehringer Ingelheim Investigational Site | Montreal | Quebec | Canada | |
| 505 | 1160.26.0709 Boehringer Ingelheim Investigational Site | Montreal | Quebec | Canada | |
| 506 | 1160.26.0716 Boehringer Ingelheim Investigational Site | Montreal | Quebec | Canada | |
| 507 | 1160.26.0717 Boehringer Ingelheim Investigational Site | Quebec City | Quebec | Canada | |
| 508 | 1160.26.0713 Boehringer Ingelheim Investigational Site | Saint George-de-Beauce | Quebec | Canada | |
| 509 | 1160.26.0704 Boehringer Ingelheim Investigational Site | Saint Jerome | Quebec | Canada | |
| 510 | 1160.26.0699 Boehringer Ingelheim Investigational Site | St. Charles-Borromee | Quebec | Canada | |
| 511 | 1160.26.0675 Boehringer Ingelheim Investigational Site | St. Hyacinthe | Quebec | Canada | |
| 512 | 1160.26.0700 Boehringer Ingelheim Investigational Site | Ste-Foy | Quebec | Canada | |
| 513 | 1160.26.0682 Boehringer Ingelheim Investigational Site | Terrebonne (Lachenaie) | Quebec | Canada | |
| 514 | 1160.26.0673 Boehringer Ingelheim Investigational Site | Saskatoon | Saskatchewan | Canada | |
| 515 | 1160.26.0678 Boehringer Ingelheim Investigational Site | Saskatoon | Saskatchewan | Canada | |
| 516 | 1160.26.0771 Boehringer Ingelheim Investigational Site | Beijing | China | ||
| 517 | 1160.26.0772 Boehringer Ingelheim Investigational Site | Beijing | China | ||
| 518 | 1160.26.0773 Boehringer Ingelheim Investigational Site | Beijing | China | ||
| 519 | 1160.26.0774 Boehringer Ingelheim Investigational Site | Beijing | China | ||
| 520 | 1160.26.0775 Boehringer Ingelheim Investigational Site | Beijing | China | ||
| 521 | 1160.26.0783 Boehringer Ingelheim Investigational Site | Beijing | China | ||
| 522 | 1160.26.0784 Boehringer Ingelheim Investigational Site | Hangzhou | China | ||
| 523 | 1160.26.0776 Boehringer Ingelheim Investigational Site | Harbin | China | ||
| 524 | 1160.26.0778 Boehringer Ingelheim Investigational Site | QingDao | China | ||
| 525 | 1160.26.0781 Boehringer Ingelheim Investigational Site | Shanghai | China | ||
| 526 | 1160.26.0782 Boehringer Ingelheim Investigational Site | Shanghai | China | ||
| 527 | 1160.26.0777 Boehringer Ingelheim Investigational Site | Shenyang | China | ||
| 528 | 1160.26.0780 Boehringer Ingelheim Investigational Site | Shijiazhuang | China | ||
| 529 | 1160.26.0801 Boehringer Ingelheim Investigational Site | Bogotá | Colombia | ||
| 530 | 1160.26.0802 Boehringer Ingelheim Investigational Site | Bogotá | Colombia | ||
| 531 | 1160.26.0803 Boehringer Ingelheim Investigational Site | Bogotá | Colombia | ||
| 532 | 1160.26.0815 Boehringer Ingelheim Investigational Site | Brno | Czechia | ||
| 533 | 1160.26.0816 Boehringer Ingelheim Investigational Site | Brno | Czechia | ||
| 534 | 1160.26.0820 Boehringer Ingelheim Investigational Site | Ostrava 1 | Czechia | ||
| 535 | 1160.26.0818 Boehringer Ingelheim Investigational Site | Pardubice | Czechia | ||
| 536 | 1160.26.0814 Boehringer Ingelheim Investigational Site | Plzen-Bory | Czechia | ||
| 537 | 1160.26.0813 Boehringer Ingelheim Investigational Site | Pragha 9 | Czechia | ||
| 538 | 1160.26.0811 Boehringer Ingelheim Investigational Site | Prague 5 | Czechia | ||
| 539 | 1160.26.0812 Boehringer Ingelheim Investigational Site | Praha 6 | Czechia | ||
| 540 | 1160.26.0817 Boehringer Ingelheim Investigational Site | Pribram | Czechia | ||
| 541 | 1160.26.0819 Boehringer Ingelheim Investigational Site | Usti nad Orlici | Czechia | ||
| 542 | 1160.26.0837 Boehringer Ingelheim Investigational Site | Aalborg | Denmark | ||
| 543 | 1160.26.0835 Boehringer Ingelheim Investigational Site | Aarhus C | Denmark | ||
| 544 | 1160.26.0838 Boehringer Ingelheim Investigational Site | Frederikssund | Denmark | ||
| 545 | 1160.26.0833 Boehringer Ingelheim Investigational Site | Helsingør | Denmark | ||
| 546 | 1160.26.0834 Boehringer Ingelheim Investigational Site | Herlev | Denmark | ||
| 547 | 1160.26.0841 Boehringer Ingelheim Investigational Site | Horsens | Denmark | ||
| 548 | 1160.26.0832 Boehringer Ingelheim Investigational Site | Hvidovre | Denmark | ||
| 549 | 1160.26.0840 Boehringer Ingelheim Investigational Site | Køge | Denmark | ||
| 550 | 1160.26.0831 Boehringer Ingelheim Investigational Site | Odense | Denmark | ||
| 551 | 1160.26.0839 Boehringer Ingelheim Investigational Site | Roskilde | Denmark | ||
| 552 | 1160.26.0836 Boehringer Ingelheim Investigational Site | Svendborg | Denmark | ||
| 553 | 1160.26.0856 Boehringer Ingelheim Investigational Site | Espoo | Finland | ||
| 554 | 1160.26.0851 Boehringer Ingelheim Investigational Site | HUS | Finland | ||
| 555 | 1160.26.0859 Boehringer Ingelheim Investigational Site | Jyväskylä | Finland | ||
| 556 | 1160.26.0855 Boehringer Ingelheim Investigational Site | Kuopio | Finland | ||
| 557 | 1160.26.0857 Boehringer Ingelheim Investigational Site | Lappeenranta | Finland | ||
| 558 | 1160.26.0854 Boehringer Ingelheim Investigational Site | OYS | Finland | ||
| 559 | 1160.26.0858 Boehringer Ingelheim Investigational Site | Pori | Finland | ||
| 560 | 1160.26.0852 Boehringer Ingelheim Investigational Site | Tampere | Finland | ||
| 561 | 1160.26.0853 Boehringer Ingelheim Investigational Site | Turku | Finland | ||
| 562 | 1160.26.0875A Boehringer Ingelheim Investigational Site | ABBEVILLE cedex | France | ||
| 563 | 1160.26.0882A Boehringer Ingelheim Investigational Site | Angers | France | ||
| 564 | 1160.26.0882B Boehringer Ingelheim Investigational Site | Angers | France | ||
| 565 | 1160.26.0882C Boehringer Ingelheim Investigational Site | Angers | France | ||
| 566 | 1160.26.0882D Boehringer Ingelheim Investigational Site | Angers | France | ||
| 567 | 1160.26.0882E Boehringer Ingelheim Investigational Site | Angers | France | ||
| 568 | 1160.26.0882G Boehringer Ingelheim Investigational Site | Angers | France | ||
| 569 | 1160.26.0882H Boehringer Ingelheim Investigational Site | Angers | France | ||
| 570 | 1160.26.0882I Boehringer Ingelheim Investigational Site | Angers | France | ||
| 571 | 1160.26.0882K Boehringer Ingelheim Investigational Site | Angers | France | ||
| 572 | 1160.26.0882L Boehringer Ingelheim Investigational Site | Angers | France | ||
| 573 | 1160.26.0884A Boehringer Ingelheim Investigational Site | Angers | France | ||
| 574 | 1160.26.0887A Boehringer Ingelheim Investigational Site | Cholet | France | ||
| 575 | 1160.26.0889A Boehringer Ingelheim Investigational Site | Gap | France | ||
| 576 | 1160.26.0888A Boehringer Ingelheim Investigational Site | Grenoble | France | ||
| 577 | 1160.26.0879A Boehringer Ingelheim Investigational Site | Joue les Tours | France | ||
| 578 | 1160.26.0879B Boehringer Ingelheim Investigational Site | Joue les Tours | France | ||
| 579 | 1160.26.0879C Boehringer Ingelheim Investigational Site | Joue les Tours | France | ||
| 580 | 1160.26.0879E Boehringer Ingelheim Investigational Site | Joue les Tours | France | ||
| 581 | 1160.26.0879F Boehringer Ingelheim Investigational Site | Joue les Tours | France | ||
| 582 | 1160.26.0879G Boehringer Ingelheim Investigational Site | Joue les Tours | France | ||
| 583 | 1160.26.0879H Boehringer Ingelheim Investigational Site | Joue les Tours | France | ||
| 584 | 1160.26.0879S Boehringer Ingelheim Investigational Site | Joue les Tours | France | ||
| 585 | 1160.26.0880A Boehringer Ingelheim Investigational Site | Joue les Tours | France | ||
| 586 | 1160.26.0880F Boehringer Ingelheim Investigational Site | Joue les Tours | France | ||
| 587 | 1160.26.0880G Boehringer Ingelheim Investigational Site | Joue les Tours | France | ||
| 588 | 1160.26.0880J Boehringer Ingelheim Investigational Site | Joue les Tours | France | ||
| 589 | 1160.26.0881A Boehringer Ingelheim Investigational Site | Joue les Tours | France | ||
| 590 | 1160.26.0881D Boehringer Ingelheim Investigational Site | Joue les Tours | France | ||
| 591 | 1160.26.0880B Boehringer Ingelheim Investigational Site | Joué les Tours | France | ||
| 592 | 1160.26.0880C Boehringer Ingelheim Investigational Site | Joué les Tours | France | ||
| 593 | 1160.26.0880D Boehringer Ingelheim Investigational Site | Joué les Tours | France | ||
| 594 | 1160.26.0880E Boehringer Ingelheim Investigational Site | Joué les Tours | France | ||
| 595 | 1160.26.0874A Boehringer Ingelheim Investigational Site | Langres | France | ||
| 596 | 1160.26.0874B Boehringer Ingelheim Investigational Site | Langres | France | ||
| 597 | 1160.26.0871A Boehringer Ingelheim Investigational Site | Paris | France | ||
| 598 | 1160.26.0873A Boehringer Ingelheim Investigational Site | TOULOUSE cedex | France | ||
| 599 | 1160.26.0886A Boehringer Ingelheim Investigational Site | Tourcoing | France | ||
| 600 | 1160.26.0872A Boehringer Ingelheim Investigational Site | VALENCIENNES cedex | France | ||
| 601 | 1160.26.0872C Boehringer Ingelheim Investigational Site | Valenciennes cedex | France | ||
| 602 | 1160.26.0872B Boehringer Ingelheim Investigational Site | Valenciennes | France | ||
| 603 | 1160.26.0932 Boehringer Ingelheim Investigational Site | Berlin | Germany | ||
| 604 | 1160.26.0948 Boehringer Ingelheim Investigational Site | Berlin | Germany | ||
| 605 | 1160.26.0962 Boehringer Ingelheim Investigational Site | Berlin | Germany | ||
| 606 | 1160.26.0940 Boehringer Ingelheim Investigational Site | Bochum | Germany | ||
| 607 | 1160.26.0936 Boehringer Ingelheim Investigational Site | Coburg | Germany | ||
| 608 | 1160.26.0968 Boehringer Ingelheim Investigational Site | Dachau | Germany | ||
| 609 | 1160.26.0972 Boehringer Ingelheim Investigational Site | Dortmund | Germany | ||
| 610 | 1160.26.0957 Boehringer Ingelheim Investigational Site | Duisburg | Germany | ||
| 611 | 1160.26.0971 Boehringer Ingelheim Investigational Site | Erlangen | Germany | ||
| 612 | 1160.26.0965 Boehringer Ingelheim Investigational Site | Eschweiler | Germany | ||
| 613 | 1160.26.0934 Boehringer Ingelheim Investigational Site | Essen | Germany | ||
| 614 | 1160.26.0931 Boehringer Ingelheim Investigational Site | Frankfurt/Main | Germany | ||
| 615 | 1160.26.0943 Boehringer Ingelheim Investigational Site | Heidelberg | Germany | ||
| 616 | 1160.26.0955 Boehringer Ingelheim Investigational Site | Kassel | Germany | ||
| 617 | 1160.26.0963 Boehringer Ingelheim Investigational Site | Köln | Germany | ||
| 618 | 1160.26.0946 Boehringer Ingelheim Investigational Site | Lahr | Germany | ||
| 619 | 1160.26.0944 Boehringer Ingelheim Investigational Site | Limburg | Germany | ||
| 620 | 1160.26.0951 Boehringer Ingelheim Investigational Site | Mainz | Germany | ||
| 621 | 1160.26.0933 Boehringer Ingelheim Investigational Site | Mannheim | Germany | ||
| 622 | 1160.26.0945 Boehringer Ingelheim Investigational Site | Mannheim | Germany | ||
| 623 | 1160.26.0970 Boehringer Ingelheim Investigational Site | Mannheim | Germany | ||
| 624 | 1160.26.0947 Boehringer Ingelheim Investigational Site | München | Germany | ||
| 625 | 1160.26.0952 Boehringer Ingelheim Investigational Site | München | Germany | ||
| 626 | 1160.26.0941 Boehringer Ingelheim Investigational Site | Papenburg | Germany | ||
| 627 | 1160.26.0959 Boehringer Ingelheim Investigational Site | Suhl | Germany | ||
| 628 | 1160.26.0937 Boehringer Ingelheim Investigational Site | Witten | Germany | ||
| 629 | 1160.26.0966 Boehringer Ingelheim Investigational Site | Wuppertal | Germany | ||
| 630 | 1160.26.0908 University Hospital of Alexandroupolis | Alexandroupolis | Greece | ||
| 631 | 1160.26.0901 General Hospital "Alexandra", Therapeutic Clinic UOA | Athens | Greece | ||
| 632 | 1160.26.0906 General Hospital ";Evangelismos" | Athens | Greece | ||
| 633 | 1160.26.0907 "Pammakaristos" Hospital of Athens | Athens | Greece | ||
| 634 | 1160.26.0915 "Hippokratio" Hospital of Athens | Athens | Greece | ||
| 635 | 1160.26.0914 2nd IKA Hospital, Thessaloniki | Kalamaria-Thessaloniki | Greece | ||
| 636 | 1160.26.0904 General Hospital of Larissa | Larissa | Greece | ||
| 637 | 1160.26.0913 University Hospital of Larissa | Larissa | Greece | ||
| 638 | 1160.26.0912 General Hospital of Leivadia | Leivadia | Greece | ||
| 639 | 1160.26.0902 General Hospital " Papageorgiou" | Thessaloniki | Greece | ||
| 640 | 1160.26.0910 General Hospital of Thiva | Thiva | Greece | ||
| 641 | 1160.26.0903 General Hospital of Trikala | Trikala | Greece | ||
| 642 | 1160.26.0905 Boehringer Ingelheim Investigational Site | Voula - Athens | Greece | ||
| 643 | 1160.26.1001 Boehringer Ingelheim Investigational Site | Hong Kong | Hong Kong | ||
| 644 | 1160.26.1002 Boehringer Ingelheim Investigational Site | Hong Kong | Hong Kong | ||
| 645 | 1160.26.1003 Boehringer Ingelheim Investigational Site | Kowloon | Hong Kong | ||
| 646 | 1160.26.1004 Boehringer Ingelheim Investigational Site | Kowloon | Hong Kong | ||
| 647 | 1160.26.1011 Boehringer Ingelheim Investigational Site | Budapest | Hungary | ||
| 648 | 1160.26.1012 Boehringer Ingelheim Investigational Site | Budapest | Hungary | ||
| 649 | 1160.26.1013 Boehringer Ingelheim Investigational Site | Budapest | Hungary | ||
| 650 | 1160.26.1014 Boehringer Ingelheim Investigational Site | Budapest | Hungary | ||
| 651 | 1160.26.1015 Boehringer Ingelheim Investigational Site | Budapest | Hungary | ||
| 652 | 1160.26.1016 Boehringer Ingelheim Investigational Site | Budapest | Hungary | ||
| 653 | 1160.26.1020 Boehringer Ingelheim Investigational Site | Gyongyos | Hungary | ||
| 654 | 1160.26.1017 Boehringer Ingelheim Investigational Site | Komarom | Hungary | ||
| 655 | 1160.26.1018 Boehringer Ingelheim Investigational Site | Pecs | Hungary | ||
| 656 | 1160.26.1019 Boehringer Ingelheim Investigational Site | Veszprem | Hungary | ||
| 657 | 1160.26.1056 Boehringer Ingelheim Investigational Site | Ahmedabad | India | ||
| 658 | 1160.26.1057 Boehringer Ingelheim Investigational Site | Ahmedabad | India | ||
| 659 | 1160.26.1064 Boehringer Ingelheim Investigational Site | Bangalore | India | ||
| 660 | 1160.26.1065 Boehringer Ingelheim Investigational Site | Bangalore | India | ||
| 661 | 1160.26.1071 Boehringer Ingelheim Investigational Site | Bikaner | India | ||
| 662 | 1160.26.1066 Boehringer Ingelheim Investigational Site | Chennai | India | ||
| 663 | 1160.26.1069 Boehringer Ingelheim Investigational Site | Coimbatore | India | ||
| 664 | 1160.26.1062 Boehringer Ingelheim Investigational Site | Hyderabad | India | ||
| 665 | 1160.26.1058 Boehringer Ingelheim Investigational Site | Indore | India | ||
| 666 | 1160.26.1053 Boehringer Ingelheim Investigational Site | Jaipur | India | ||
| 667 | 1160.26.1073 Boehringer Ingelheim Investigational Site | Jaipur | India | ||
| 668 | 1160.26.1067 Boehringer Ingelheim Investigational Site | Kerala | India | ||
| 669 | 1160.26.1068 Boehringer Ingelheim Investigational Site | Kottayam | India | ||
| 670 | 1160.26.1055 Boehringer Ingelheim Investigational Site | Lucknow | India | ||
| 671 | 1160.26.1051 Boehringer Ingelheim Investigational Site | Ludhiana | India | ||
| 672 | 1160.26.1060 Boehringer Ingelheim Investigational Site | Mumbai | India | ||
| 673 | 1160.26.1072 Boehringer Ingelheim Investigational Site | Mysore | India | ||
| 674 | 1160.26.1059 Boehringer Ingelheim Investigational Site | Nagpur | India | ||
| 675 | 1160.26.1052 Boehringer Ingelheim Investigational Site | New Delhi | India | ||
| 676 | 1160.26.1070 Boehringer Ingelheim Investigational Site | Pune | India | ||
| 677 | 1160.26.1110 Boehringer Ingelheim Investigational Site | Afula | Israel | ||
| 678 | 1160.26.1121 Boehringer Ingelheim Investigational Site | Afula | Israel | ||
| 679 | 1160.26.1111 Boehringer Ingelheim Investigational Site | Ashkelon | Israel | ||
| 680 | 1160.26.1102 Boehringer Ingelheim Investigational Site | Be´er Scheva | Israel | ||
| 681 | 1160.26.1117 Boehringer Ingelheim Investigational Site | Givatayim | Israel | ||
| 682 | 1160.26.1112 Boehringer Ingelheim Investigational Site | Hadera | Israel | ||
| 683 | 1160.26.1091 Boehringer Ingelheim Investigational Site | Haifa | Israel | ||
| 684 | 1160.26.1113 Boehringer Ingelheim Investigational Site | Haifa | Israel | ||
| 685 | 1160.26.1114 Boehringer Ingelheim Investigational Site | Haifa | Israel | ||
| 686 | 1160.26.1116 Boehringer Ingelheim Investigational Site | Haifa | Israel | ||
| 687 | 1160.26.1118 Boehringer Ingelheim Investigational Site | Haifa | Israel | ||
| 688 | 1160.26.1105 Boehringer Ingelheim Investigational Site | Holon | Israel | ||
| 689 | 1160.26.1097 Boehringer Ingelheim Investigational Site | Jerusalem | Israel | ||
| 690 | 1160.26.1101 Boehringer Ingelheim Investigational Site | Jerusalem | Israel | ||
| 691 | 1160.26.1104 Boehringer Ingelheim Investigational Site | Jerusalem | Israel | ||
| 692 | 1160.26.1106 Boehringer Ingelheim Investigational Site | Jerusalem | Israel | ||
| 693 | 1160.26.1119 Boehringer Ingelheim Investigational Site | Kfar Saba | Israel | ||
| 694 | 1160.26.1115 Boehringer Ingelheim Investigational Site | Nazareth | Israel | ||
| 695 | 1160.26.1096 Boehringer Ingelheim Investigational Site | Petah Tikva | Israel | ||
| 696 | 1160.26.1093 Boehringer Ingelheim Investigational Site | Ramat Gan | Israel | ||
| 697 | 1160.26.1094 Boehringer Ingelheim Investigational Site | Ramat Gan | Israel | ||
| 698 | 1160.26.1095 Boehringer Ingelheim Investigational Site | Ramat Gan | Israel | ||
| 699 | 1160.26.1100 Boehringer Ingelheim Investigational Site | Rehovot | Israel | ||
| 700 | 1160.26.1103 Boehringer Ingelheim Investigational Site | Safed | Israel | ||
| 701 | 1160.26.1092 Boehringer Ingelheim Investigational Site | Tel Hashomer | Israel | ||
| 702 | 1160.26.1098 Boehringer Ingelheim Investigational Site | Tel Hashomer | Israel | ||
| 703 | 1160.26.1107 Boehringer Ingelheim Investigational Site | Tel-Aviv | Israel | ||
| 704 | 1160.26.1108 Boehringer Ingelheim Investigational Site | Tel-Aviv | Israel | ||
| 705 | 1160.26.1109 Boehringer Ingelheim Investigational Site | Tel-Aviv | Israel | ||
| 706 | 1160.26.1120 Boehringer Ingelheim Investigational Site | Tel-Aviv | Israel | ||
| 707 | 1160.26.1122 Boehringer Ingelheim Investigational Site | Tel-Aviv | Israel | ||
| 708 | 1160.26.1099 Boehringer Ingelheim Investigational Site | Zerifin | Israel | ||
| 709 | 1160.26.1169 Boehringer Ingelheim Investigational Site | Arezzo | Italy | ||
| 710 | 1160.26.1172 Boehringer Ingelheim Investigational Site | Ascoli Piceno | Italy | ||
| 711 | 1160.26.1180 Boehringer Ingelheim Investigational Site | Bentivoglio (BO) | Italy | ||
| 712 | 1160.26.1161 Boehringer Ingelheim Investigational Site | Bologna | Italy | ||
| 713 | 1160.26.1163 Boehringer Ingelheim Investigational Site | Castelnuovo Garfagnana | Italy | ||
| 714 | 1160.26.1178 Boehringer Ingelheim Investigational Site | Chieti | Italy | ||
| 715 | 1160.26.1171 Boehringer Ingelheim Investigational Site | Colleferro | Italy | ||
| 716 | 1160.26.1174 Boehringer Ingelheim Investigational Site | Cremona | Italy | ||
| 717 | 1160.26.1167 Boehringer Ingelheim Investigational Site | Eboli | Italy | ||
| 718 | 1160.26.1168 Boehringer Ingelheim Investigational Site | Isernia | Italy | ||
| 719 | 1160.26.1162 Boehringer Ingelheim Investigational Site | Legnago | Italy | ||
| 720 | 1160.26.1177 Boehringer Ingelheim Investigational Site | Mantova | Italy | ||
| 721 | 1160.26.1165 Boehringer Ingelheim Investigational Site | Perugia SAN Sisto | Italy | ||
| 722 | 1160.26.1175 Boehringer Ingelheim Investigational Site | Roma | Italy | ||
| 723 | 1160.26.1181 Boehringer Ingelheim Investigational Site | San Bonifacio | Italy | ||
| 724 | 1160.26.1173 Boehringer Ingelheim Investigational Site | San Daniele Del Friuli | Italy | ||
| 725 | 1160.26.1170 Boehringer Ingelheim Investigational Site | Sassari | Italy | ||
| 726 | 1160.26.1176 Boehringer Ingelheim Investigational Site | Sassari | Italy | ||
| 727 | 1160.26.1204 Boehringer Ingelheim Investigational Site | Abeno-ku, Osaka, Osaka | Japan | ||
| 728 | 1160.26.1209 Boehringer Ingelheim Investigational Site | Aki-gun, Hiroshima | Japan | ||
| 729 | 1160.26.1193 Boehringer Ingelheim Investigational Site | Aoba-ku, Sendai, Miyagi | Japan | ||
| 730 | 1160.26.1211 Boehringer Ingelheim Investigational Site | Chuo-ku, Fukuoka, Fukuoka | Japan | ||
| 731 | 1160.26.1225 Boehringer Ingelheim Investigational Site | Chuo-ku, Fukuoka, Fukuoka | Japan | ||
| 732 | 1160.26.1221 Boehringer Ingelheim Investigational Site | Chuo-ku, Kobe, Hyogo | Japan | ||
| 733 | 1160.26.1219 Boehringer Ingelheim Investigational Site | Chuo-ku, Osaka, Osaka | Japan | ||
| 734 | 1160.26.1229 Boehringer Ingelheim Investigational Site | Fujioka-shi , Gunma-ken | Japan | ||
| 735 | 1160.26.1232 Boehringer Ingelheim Investigational Site | Fukushima-shi,Fukushima-ken | Japan | ||
| 736 | 1160.26.1228 Boehringer Ingelheim Investigational Site | Higashimatsushimashi, Miyagi-ken | Japan | ||
| 737 | 1160.26.1208 Boehringer Ingelheim Investigational Site | Himeji, Hyogo | Japan | ||
| 738 | 1160.26.1214 Boehringer Ingelheim Investigational Site | Iida, Nagano | Japan | ||
| 739 | 1160.26.1240 Boehringer Ingelheim Investigational Site | Isesaki-shi,Gunma | Japan | ||
| 740 | 1160.26.1224 Boehringer Ingelheim Investigational Site | Iwakuni, Yamaguchi | Japan | ||
| 741 | 1160.26.1194 Boehringer Ingelheim Investigational Site | Izumi-ku, Sendai, Miyagi | Japan | ||
| 742 | 1160.26.1241 Boehringer Ingelheim Investigational Site | Kamigyo-ku, Kyoto | Japan | ||
| 743 | 1160.26.1220 Boehringer Ingelheim Investigational Site | Kawachinagano, Osaka | Japan | ||
| 744 | 1160.26.1203 Boehringer Ingelheim Investigational Site | Kita-ku, Osaka, Osaka | Japan | ||
| 745 | 1160.26.1207 Boehringer Ingelheim Investigational Site | Kita-ku, Sakai, Osaka | Japan | ||
| 746 | 1160.26.1231 Boehringer Ingelheim Investigational Site | Komatsu-shi,Ishikawa -ken | Japan | ||
| 747 | 1160.26.1233 Boehringer Ingelheim Investigational Site | Kyoto-shi,Kyoto | Japan | ||
| 748 | 1160.26.1242 Boehringer Ingelheim Investigational Site | Matsumoto, Nagano | Japan | ||
| 749 | 1160.26.1210 Boehringer Ingelheim Investigational Site | Minami-ku, Fukuoka, Fukuoka | Japan | ||
| 750 | 1160.26.1218 Boehringer Ingelheim Investigational Site | Minato, Tokyo | Japan | ||
| 751 | 1160.26.1200 Boehringer Ingelheim Investigational Site | Minato-ku, Nagoya, Aichi | Japan | ||
| 752 | 1160.26.1201 Boehringer Ingelheim Investigational Site | Minato-ku, Nagoya, Aichi | Japan | ||
| 753 | 1160.26.1216 Boehringer Ingelheim Investigational Site | Narashino, Chiba | Japan | ||
| 754 | 1160.26.1237 Boehringer Ingelheim Investigational Site | Nishinomiya-shi,Hyogo | Japan | ||
| 755 | 1160.26.1223 Boehringer Ingelheim Investigational Site | Okayama, Okayama | Japan | ||
| 756 | 1160.26.1197 Boehringer Ingelheim Investigational Site | Oota, Tokyo | Japan | ||
| 757 | 1160.26.1212 Boehringer Ingelheim Investigational Site | Otaru, Hokkaido | Japan | ||
| 758 | 1160.26.1230 Boehringer Ingelheim Investigational Site | Sagamihara, Kanagawa-ken | Japan | ||
| 759 | 1160.26.1238 Boehringer Ingelheim Investigational Site | Sapporo-shi,Hokkai-do | Japan | ||
| 760 | 1160.26.1217 Boehringer Ingelheim Investigational Site | Shibuya, Tokyo | Japan | ||
| 761 | 1160.26.1196 Boehringer Ingelheim Investigational Site | Shinjuku, Tokyo | Japan | ||
| 762 | 1160.26.1191 Boehringer Ingelheim Investigational Site | Shiroishi-ku, Sapporo, Hokkaido | Japan | ||
| 763 | 1160.26.1192 Boehringer Ingelheim Investigational Site | Shiroishi-ku, Sapporo, Hokkaido | Japan | ||
| 764 | 1160.26.1206 Boehringer Ingelheim Investigational Site | Suita, Osaka | Japan | ||
| 765 | 1160.26.1235 Boehringer Ingelheim Investigational Site | Suita-shi, Osaka | Japan | ||
| 766 | 1160.26.1236 Boehringer Ingelheim Investigational Site | Suita-shi, Osaka | Japan | ||
| 767 | 1160.26.1205 Boehringer Ingelheim Investigational Site | Sumiyoshi-ku, Osaka, Osaka | Japan | ||
| 768 | 1160.26.1234 Boehringer Ingelheim Investigational Site | Takatsuki-shi,Osaka | Japan | ||
| 769 | 1160.26.1215 Boehringer Ingelheim Investigational Site | Tokorozawa, Saitama | Japan | ||
| 770 | 1160.26.1198 Boehringer Ingelheim Investigational Site | Totsuka-ku, Yokohama, Kanagawa | Japan | ||
| 771 | 1160.26.1195 Boehringer Ingelheim Investigational Site | Tsuchiura, Ibaragi | Japan | ||
| 772 | 1160.26.1199 Boehringer Ingelheim Investigational Site | Ueda, Nagano | Japan | ||
| 773 | 1160.26.1222 Boehringer Ingelheim Investigational Site | Wakayama, Wakayama | Japan | ||
| 774 | 1160.26.1227 Boehringer Ingelheim Investigational Site | Yanagawa, Fukuoka | Japan | ||
| 775 | 1160.26.1243 Boehringer Ingelheim Investigational Site | Yao, Osaka | Japan | ||
| 776 | 1160.26.1585 Boehringer Ingelheim Investigational Site | Busan | Korea, Republic of | ||
| 777 | 1160.26.1586 Boehringer Ingelheim Investigational Site | Chungchungnam-Do | Korea, Republic of | ||
| 778 | 1160.26.1584 Boehringer Ingelheim Investigational Site | Daegu | Korea, Republic of | ||
| 779 | 1160.26.1591 Boehringer Ingelheim Investigational Site | Daegu | Korea, Republic of | ||
| 780 | 1160.26.1590 Boehringer Ingelheim Investigational Site | Gwangju | Korea, Republic of | ||
| 781 | 1160.26.1581 Boehringer Ingelheim Investigational Site | Incheon | Korea, Republic of | ||
| 782 | 1160.26.1582 Boehringer Ingelheim Investigational Site | Seoul | Korea, Republic of | ||
| 783 | 1160.26.1583 Boehringer Ingelheim Investigational Site | Seoul | Korea, Republic of | ||
| 784 | 1160.26.1588 Boehringer Ingelheim Investigational Site | Seoul | Korea, Republic of | ||
| 785 | 1160.26.1589 Boehringer Ingelheim Investigational Site | Seoul | Korea, Republic of | ||
| 786 | 1160.26.1592 Boehringer Ingelheim Investigational Site | Seoul | Korea, Republic of | ||
| 787 | 1160.26.1593 Boehringer Ingelheim Investigational Site | Seoul | Korea, Republic of | ||
| 788 | 1160.26.1297 Boehringer Ingelheim Investigational Site | Kajang,Selangor | Malaysia | ||
| 789 | 1160.26.1291 Boehringer Ingelheim Investigational Site | Kuala Lumpur | Malaysia | ||
| 790 | 1160.26.1292 Boehringer Ingelheim Investigational Site | Kuala Lumpur | Malaysia | ||
| 791 | 1160.26.1294 Boehringer Ingelheim Investigational Site | Kuala Lumpur | Malaysia | ||
| 792 | 1160.26.1293 Boehringer Ingelheim Investigational Site | Kuching | Malaysia | ||
| 793 | 1160.26.1295 Boehringer Ingelheim Investigational Site | Penang | Malaysia | ||
| 794 | 1160.26.1296 Boehringer Ingelheim Investigational Site | Penang | Malaysia | ||
| 795 | 1160.26.1318 Hospital General "Dr. Santiago Ramón y Cajal | Durango | Mexico | ||
| 796 | 1160.26.1311 Hospital Mexico-Americano | Guadalajara | Mexico | ||
| 797 | 1160.26.1317 hOSPITAL bERNARDETTE | Guadalajara | Mexico | ||
| 798 | 1160.26.1312 Hospital de Jesus | Mexico | Mexico | ||
| 799 | 1160.26.1319 Instituto Nacional de Cardiologia | Mexico | Mexico | ||
| 800 | 1160.26.1314 Hospital 1o. de Octubre | México | Mexico | ||
| 801 | 1160.26.1313 Hosp. Angeles Centro Medico del Potosi | San Luis Potosà | Mexico | ||
| 802 | 1160.26.1322 Hospital Central "Dr. Ignacio Morones Prieto" | San Luis Potosà | Mexico | ||
| 803 | 1160.26.1344 Boehringer Ingelheim Investigational Site | Almelo | Netherlands | ||
| 804 | 1160.26.1331 Boehringer Ingelheim Investigational Site | Amsterdam | Netherlands | ||
| 805 | 1160.26.1336 Boehringer Ingelheim Investigational Site | Apeldoorn | Netherlands | ||
| 806 | 1160.26.1332 Boehringer Ingelheim Investigational Site | Breda | Netherlands | ||
| 807 | 1160.26.1337 Boehringer Ingelheim Investigational Site | Den Bosch | Netherlands | ||
| 808 | 1160.26.1349 Boehringer Ingelheim Investigational Site | Den Helder | Netherlands | ||
| 809 | 1160.26.1345 Boehringer Ingelheim Investigational Site | Deventer | Netherlands | ||
| 810 | 1160.26.1360 Boehringer Ingelheim Investigational Site | Dirksland | Netherlands | ||
| 811 | 1160.26.1348 Boehringer Ingelheim Investigational Site | Dordrecht | Netherlands | ||
| 812 | 1160.26.1340 Boehringer Ingelheim Investigational Site | Ede | Netherlands | ||
| 813 | 1160.26.1358 Boehringer Ingelheim Investigational Site | Eindhoven | Netherlands | ||
| 814 | 1160.26.1338 Boehringer Ingelheim Investigational Site | Enschede | Netherlands | ||
| 815 | 1160.26.1343 Boehringer Ingelheim Investigational Site | Goes | Netherlands | ||
| 816 | 1160.26.1347 Boehringer Ingelheim Investigational Site | Gorinchem | Netherlands | ||
| 817 | 1160.26.1333 Boehringer Ingelheim Investigational Site | Groningen | Netherlands | ||
| 818 | 1160.26.1355 Boehringer Ingelheim Investigational Site | Groningen | Netherlands | ||
| 819 | 1160.26.1361 Boehringer Ingelheim Investigational Site | Heerlen | Netherlands | ||
| 820 | 1160.26.1339 Boehringer Ingelheim Investigational Site | Hengelo | Netherlands | ||
| 821 | 1160.26.1346 Boehringer Ingelheim Investigational Site | Hilversum | Netherlands | ||
| 822 | 1160.26.1356 Boehringer Ingelheim Investigational Site | Hoorn | Netherlands | ||
| 823 | 1160.26.1359 Boehringer Ingelheim Investigational Site | Maastricht | Netherlands | ||
| 824 | 1160.26.1341 Boehringer Ingelheim Investigational Site | Meppel | Netherlands | ||
| 825 | 1160.26.1354 Boehringer Ingelheim Investigational Site | Rotterdam | Netherlands | ||
| 826 | 1160.26.1351 Boehringer Ingelheim Investigational Site | Sneek | Netherlands | ||
| 827 | 1160.26.1334 Boehringer Ingelheim Investigational Site | Spiijkenisse | Netherlands | ||
| 828 | 1160.26.1335 Boehringer Ingelheim Investigational Site | Terneuzen | Netherlands | ||
| 829 | 1160.26.1353 Boehringer Ingelheim Investigational Site | Tiel | Netherlands | ||
| 830 | 1160.26.1352 Boehringer Ingelheim Investigational Site | Tilburg | Netherlands | ||
| 831 | 1160.26.1350 Boehringer Ingelheim Investigational Site | Veldhoven | Netherlands | ||
| 832 | 1160.26.1342 Boehringer Ingelheim Investigational Site | Velp | Netherlands | ||
| 833 | 1160.26.1357 Boehringer Ingelheim Investigational Site | Venlo | Netherlands | ||
| 834 | 1160.26.1396 Boehringer Ingelheim Investigational Site | Gjøvik | Norway | ||
| 835 | 1160.26.1393 Boehringer Ingelheim Investigational Site | Moss | Norway | ||
| 836 | 1160.26.1395 Boehringer Ingelheim Investigational Site | Nordbyhagen | Norway | ||
| 837 | 1160.26.1391 Boehringer Ingelheim Investigational Site | Oslo | Norway | ||
| 838 | 1160.26.1392 Boehringer Ingelheim Investigational Site | Oslo | Norway | ||
| 839 | 1160.26.1397 Boehringer Ingelheim Investigational Site | Oslo | Norway | ||
| 840 | 1160.26.1394 Boehringer Ingelheim Investigational Site | RUD | Norway | ||
| 841 | 1160.26.1415 Hospital Alberto Sabogal | Bella Vista | Peru | ||
| 842 | 1160.26.1411 Clinica San Felipe | Jesús MarÃa | Peru | ||
| 843 | 1160.26.1412 ClÃnica Anglo Americana | San Isidro | Peru | ||
| 844 | 1160.26.1413 Hospital Cayetano Heredia | San MartÃn de Porres | Peru | ||
| 845 | 1160.26.1414 ClÃnica Vesalio | Urbanización Sto Tomas De San Borja | Peru | ||
| 846 | 1160.26.1421 Philippine General Hospital | Manila | Philippines | ||
| 847 | 1160.26.1422 Manila Doctors Hospital | Manila | Philippines | ||
| 848 | 1160.26.1424 The Medical City | Pasig City | Philippines | ||
| 849 | 1160.26.1423 Philippine Heart Center | Quezon City | Philippines | ||
| 850 | 1160.26.1425 St Lukes Medical Center | Quezon City | Philippines | ||
| 851 | 1160.26.1437 Boehringer Ingelheim Investigational Site | Gdynia Redlowo | Poland | ||
| 852 | 1160.26.1436 Boehringer Ingelheim Investigational Site | Gdynia | Poland | ||
| 853 | 1160.26.1438 Boehringer Ingelheim Investigational Site | Gdynia | Poland | ||
| 854 | 1160.26.1435 Boehringer Ingelheim Investigational Site | Katowice | Poland | ||
| 855 | 1160.26.1439 Boehringer Ingelheim Investigational Site | Krakow | Poland | ||
| 856 | 1160.26.1440 Boehringer Ingelheim Investigational Site | Krakow | Poland | ||
| 857 | 1160.26.1433 Boehringer Ingelheim Investigational Site | Pulawy | Poland | ||
| 858 | 1160.26.1431 Boehringer Ingelheim Investigational Site | Warsaw | Poland | ||
| 859 | 1160.26.1432 Boehringer Ingelheim Investigational Site | Warsaw | Poland | ||
| 860 | 1160.26.1434 Boehringer Ingelheim Investigational Site | Zabrze | Poland | ||
| 861 | 1160.26.1456 Boehringer Ingelheim Investigational Site | Amadora | Portugal | ||
| 862 | 1160.26.1451 Boehringer Ingelheim Investigational Site | Carnaxide | Portugal | ||
| 863 | 1160.26.1454 Boehringer Ingelheim Investigational Site | Coimbra | Portugal | ||
| 864 | 1160.26.1459 Boehringer Ingelheim Investigational Site | Coimbra | Portugal | ||
| 865 | 1160.26.1457 Boehringer Ingelheim Investigational Site | Covilhã | Portugal | ||
| 866 | 1160.26.1453 Boehringer Ingelheim Investigational Site | Lisboa | Portugal | ||
| 867 | 1160.26.1458 Boehringer Ingelheim Investigational Site | Lisboa | Portugal | ||
| 868 | 1160.26.1455 Boehringer Ingelheim Investigational Site | Porto | Portugal | ||
| 869 | 1160.26.1452 Boehringer Ingelheim Investigational Site | Setúbal | Portugal | ||
| 870 | 1160.26.1471 Boehringer Ingelheim Investigational Site | Bucharest | Romania | ||
| 871 | 1160.26.1472 Boehringer Ingelheim Investigational Site | Bucharest | Romania | ||
| 872 | 1160.26.1478 Boehringer Ingelheim Investigational Site | Cluj Napoca | Romania | ||
| 873 | 1160.26.1501 Boehringer Ingelheim Investigational Site | Moscow | Russian Federation | ||
| 874 | 1160.26.1502 Boehringer Ingelheim Investigational Site | Moscow | Russian Federation | ||
| 875 | 1160.26.1503 Boehringer Ingelheim Investigational Site | Moscow | Russian Federation | ||
| 876 | 1160.26.1504 Boehringer Ingelheim Investigational Site | Moscow | Russian Federation | ||
| 877 | 1160.26.1505 Boehringer Ingelheim Investigational Site | Moscow | Russian Federation | ||
| 878 | 1160.26.1506 Boehringer Ingelheim Investigational Site | Moscow | Russian Federation | ||
| 879 | 1160.26.1507 Boehringer Ingelheim Investigational Site | Moscow | Russian Federation | ||
| 880 | 1160.26.1508 Boehringer Ingelheim Investigational Site | Moscow | Russian Federation | ||
| 881 | 1160.26.1509 Boehringer Ingelheim Investigational Site | Moscow | Russian Federation | ||
| 882 | 1160.26.1510 Boehringer Ingelheim Investigational Site | Moscow | Russian Federation | ||
| 883 | 1160.26.1511 Boehringer Ingelheim Investigational Site | Moscow | Russian Federation | ||
| 884 | 1160.26.1512 Boehringer Ingelheim Investigational Site | St. Petersburg | Russian Federation | ||
| 885 | 1160.26.1513 Boehringer Ingelheim Investigational Site | St. Petersburg | Russian Federation | ||
| 886 | 1160.26.1514 Boehringer Ingelheim Investigational Site | St. Petersburg | Russian Federation | ||
| 887 | 1160.26.1515 Boehringer Ingelheim Investigational Site | St. Petersburg | Russian Federation | ||
| 888 | 1160.26.1531 Boehringer Ingelheim Investigational Site | Singapore | Singapore | ||
| 889 | 1160.26.1532 Boehringer Ingelheim Investigational Site | Singapore | Singapore | ||
| 890 | 1160.26.1548 Boehringer Ingelheim Investigational Site | Banska Bystrica | Slovakia | ||
| 891 | 1160.26.1541 Boehringer Ingelheim Investigational Site | Bratislava | Slovakia | ||
| 892 | 1160.26.1542 Boehringer Ingelheim Investigational Site | Bratislava | Slovakia | ||
| 893 | 1160.26.1543 Boehringer Ingelheim Investigational Site | Bratislava | Slovakia | ||
| 894 | 1160.26.1544 Boehringer Ingelheim Investigational Site | Bratislava | Slovakia | ||
| 895 | 1160.26.1545 Boehringer Ingelheim Investigational Site | Bratislava | Slovakia | ||
| 896 | 1160.26.1546 Boehringer Ingelheim Investigational Site | Bratislava | Slovakia | ||
| 897 | 1160.26.1549 Boehringer Ingelheim Investigational Site | Kosice | Slovakia | ||
| 898 | 1160.26.1550 Boehringer Ingelheim Investigational Site | Kosice | Slovakia | ||
| 899 | 1160.26.1547 Boehringer Ingelheim Investigational Site | Zilina | Slovakia | ||
| 900 | 1160.26.1562 Boehringer Ingelheim Investigational Site | Bloemfontein | South Africa | ||
| 901 | 1160.26.1569 Boehringer Ingelheim Investigational Site | Boksburg | South Africa | ||
| 902 | 1160.26.1561 Boehringer Ingelheim Investigational Site | Cape Town | South Africa | ||
| 903 | 1160.26.1564 Boehringer Ingelheim Investigational Site | Johannesburg | South Africa | ||
| 904 | 1160.26.1567 Boehringer Ingelheim Investigational Site | Johannesburg | South Africa | ||
| 905 | 1160.26.1568 Boehringer Ingelheim Investigational Site | Johannesburg | South Africa | ||
| 906 | 1160.26.1566 Boehringer Ingelheim Investigational Site | Pretoria | South Africa | ||
| 907 | 1160.26.1563 Boehringer Ingelheim Investigational Site | Randburg | South Africa | ||
| 908 | 1160.26.1565 Boehringer Ingelheim Investigational Site | Somerset West | South Africa | ||
| 909 | 1160.26.1601 Boehringer Ingelheim Investigational Site | Barcelona | Spain | ||
| 910 | 1160.26.1606 Boehringer Ingelheim Investigational Site | Cadiz | Spain | ||
| 911 | 1160.26.1607 Boehringer Ingelheim Investigational Site | Fuenlabrada (Madrid) | Spain | ||
| 912 | 1160.26.1604 Boehringer Ingelheim Investigational Site | Leganés, Madrid | Spain | ||
| 913 | 1160.26.1609 Boehringer Ingelheim Investigational Site | Madrid-San Lorenzo Del Escorial | Spain | ||
| 914 | 1160.26.1603 Boehringer Ingelheim Investigational Site | Madrid | Spain | ||
| 915 | 1160.26.1608 Boehringer Ingelheim Investigational Site | Madrid | Spain | ||
| 916 | 1160.26.1605 Boehringer Ingelheim Investigational Site | Móstoles (Madrid) | Spain | ||
| 917 | 1160.26.1602 Boehringer Ingelheim Investigational Site | Sabadell | Spain | ||
| 918 | 1160.26.1633 Sahlgrenska Sjukhuset | Göteboerg | Sweden | ||
| 919 | 1160.26.1629 AVK-mott, Spec.M1, Länssjukhuset Ryhov | Jönköping | Sweden | ||
| 920 | 1160.26.1631 Universitetssjukhuset i Linköping | Linköping | Sweden | ||
| 921 | 1160.26.1627 Hjärtmott. ING 35, Malmö Universitetssjukhus MAS | Malmö | Sweden | ||
| 922 | 1160.26.1625 Hjärtmott./Medicinkliniken, Vrinnevisjukhuset | Norrköping | Sweden | ||
| 923 | 1160.26.1628 Rådhusg. 29, Lars Mörlids Läkarmottagning | Nässjö | Sweden | ||
| 924 | 1160.26.1626 Hjärtkärllaboratoriet, Danderyds Sjukhus AB | Stockholm | Sweden | ||
| 925 | 1160.26.1632 Capio S:t Görans Sjukhus | Stockholm | Sweden | ||
| 926 | 1160.26.1634 Södersjukhuset | Stockholm | Sweden | ||
| 927 | 1160.26.1624 Klin. forskningscentrum, Norrlands Universitetssjukhus | Umeå | Sweden | ||
| 928 | 1160.26.1621 Kardiologiska kliniken, Akademiska Sjukhuset | Uppsala | Sweden | ||
| 929 | 1160.26.1635 UCR/Uppsala | Uppsala | Sweden | ||
| 930 | 1160.26.1622 Hjärtmottagningen, Centrallasarettet | Västerås | Sweden | ||
| 931 | 1160.26.1623 Kardiologiska kliniken, Universitetssjukhuset | Örebro | Sweden | ||
| 932 | 1160.26.1652 Boehringer Ingelheim Investigational Site | Basel | Switzerland | ||
| 933 | 1160.26.1655 Boehringer Ingelheim Investigational Site | Bellinzona | Switzerland | ||
| 934 | 1160.26.1651 Boehringer Ingelheim Investigational Site | Bern | Switzerland | ||
| 935 | 1160.26.1654 Boehringer Ingelheim Investigational Site | Lugano | Switzerland | ||
| 936 | 1160.26.1680 Boehringer Ingelheim Investigational Site | Changhua County | Taiwan | ||
| 937 | 1160.26.1683 Boehringer Ingelheim Investigational Site | Hualien | Taiwan | ||
| 938 | 1160.26.1682 Boehringer Ingelheim Investigational Site | Kaohsiung | Taiwan | ||
| 939 | 1160.26.1679 China Medical University Hospital | Taichung | Taiwan | ||
| 940 | 1160.26.1681 Boehringer Ingelheim Investigational Site | Tainan | Taiwan | ||
| 941 | 1160.26.1671 Boehringer Ingelheim Investigational Site | Taipei | Taiwan | ||
| 942 | 1160.26.1672 Boehringer Ingelheim Investigational Site | Taipei | Taiwan | ||
| 943 | 1160.26.1673 Boehringer Ingelheim Investigational Site | Taipei | Taiwan | ||
| 944 | 1160.26.1674 Boehringer Ingelheim Investigational Site | Taipei | Taiwan | ||
| 945 | 1160.26.1675 Boehringer Ingelheim Investigational Site | Taipei | Taiwan | ||
| 946 | 1160.26.1676 Boehringer Ingelheim Investigational Site | Taipei | Taiwan | ||
| 947 | 1160.26.1677 Boehringer Ingelheim Investigational Site | Taipei | Taiwan | ||
| 948 | 1160.26.1678 Boehringer Ingelheim Investigational Site | Taoyuan | Taiwan | ||
| 949 | 1160.26.1701 Boehringer Ingelheim Investigational Site | Bangkok | Thailand | ||
| 950 | 1160.26.1702 Boehringer Ingelheim Investigational Site | Bangkok | Thailand | ||
| 951 | 1160.26.1703 Boehringer Ingelheim Investigational Site | Chiangmai | Thailand | ||
| 952 | 1160.26.1704 Boehringer Ingelheim Investigational Site | Khon Kaen | Thailand | ||
| 953 | 1160.26.1705 Boehringer Ingelheim Investigational Site | Muang Nakhonratchasima | Thailand | ||
| 954 | 1160.26.1715 Boehringer Ingelheim Investigational Site | Adana | Turkey | ||
| 955 | 1160.26.1711 Boehringer Ingelheim Investigational Site | Ankara | Turkey | ||
| 956 | 1160.26.1713 Gazi Universitesi Tip Fakultesi Kardiyoloji Abd | Ankara | Turkey | ||
| 957 | 1160.26.1714 Dokuz Eylul Universitesi Tip Fakultesi | Izmir | Turkey | ||
| 958 | 1160.26.1727 Boehringer Ingelheim Investigational Site | Dnyepropetrovsk | Ukraine | ||
| 959 | 1160.26.1726 Boehringer Ingelheim Investigational Site | Kharkiv | Ukraine | ||
| 960 | 1160.26.1724 Boehringer Ingelheim Investigational Site | Kharkov | Ukraine | ||
| 961 | 1160.26.1725 Boehringer Ingelheim Investigational Site | Kharkov | Ukraine | ||
| 962 | 1160.26.1721 Boehringer Ingelheim Investigational Site | Kiev | Ukraine | ||
| 963 | 1160.26.1722 Boehringer Ingelheim Investigational Site | Kiev | Ukraine | ||
| 964 | 1160.26.1723 Boehringer Ingelheim Investigational Site | Kiev | Ukraine | ||
| 965 | 1160.26.1728 Boehringer Ingelheim Investigational Site | Kiev | Ukraine | ||
| 966 | 1160.26.1730 Boehringer Ingelheim Investigational Site | Kiev | Ukraine | ||
| 967 | 1160.26.1731 Boehringer Ingelheim Investigational Site | Kiev | Ukraine | ||
| 968 | 1160.26.1729 Boehringer Ingelheim Investigational Site | Lvov | Ukraine | ||
| 969 | 1160.26.1744 Boehringer Ingelheim Investigational Site | Birmingham | United Kingdom | ||
| 970 | 1160.26.1746 Boehringer Ingelheim Investigational Site | Chertsey | United Kingdom | ||
| 971 | 1160.26.1747 Boehringer Ingelheim Investigational Site | Glasgow | United Kingdom | ||
| 972 | 1160.26.1750 Boehringer Ingelheim Investigational Site | Harrow | United Kingdom | ||
| 973 | 1160.26.1753 Boehringer Ingelheim Investigational Site | Hull | United Kingdom | ||
| 974 | 1160.26.1755 Boehringer Ingelheim Investigational Site | Kirkcaldy, Fife | United Kingdom | ||
| 975 | 1160.26.1749 Boehringer Ingelheim Investigational Site | Londonderry | United Kingdom | ||
| 976 | 1160.26.1741 Boehringer Ingelheim Investigational Site | London | United Kingdom | ||
| 977 | 1160.26.1756 Boehringer Ingelheim Investigational Site | London | United Kingdom | ||
| 978 | 1160.26.1742 Boehringer Ingelheim Investigational Site | Newcastle upon Tyne | United Kingdom | ||
| 979 | 1160.26.1751 Boehringer Ingelheim Investigational Site | Newport | United Kingdom | ||
| 980 | 1160.26.1752 Boehringer Ingelheim Investigational Site | Northampton | United Kingdom | ||
| 981 | 1160.26.1745 Boehringer Ingelheim Investigational Site | Portadown, County Atrim | United Kingdom | ||
| 982 | 1160.26.1743 Boehringer Ingelheim Investigational Site | Romford, Essex | United Kingdom | ||
| 983 | 1160.26.1754 Boehringer Ingelheim Investigational Site | Stoke-On-Trent | United Kingdom | ||
| 984 | 1160.26.1748 Boehringer Ingelheim Investigational Site | York | United Kingdom |
Sponsors and Collaborators
- Boehringer Ingelheim
- Population Health Research Institute
- Uppsala University
Investigators
- Study Chair: Boehringer Ingelheim, Boehringer Ingelheim
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00262600
Other Study ID Numbers:
- 1160.26
- 2005-003894-26
First Posted:
Dec 7, 2005
Last Update Posted:
Apr 17, 2019
Last Verified:
Apr 1, 2014
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Dabigatran 110 mg | Dabigatran 150 mg | Warfarin |
|---|---|---|---|
| Arm/Group Description | 110 mg twice daily, total daily dose 220 mg | 150 mg twice daily, total daily dose 300 mg | Target International Normalized Ratio (INR) of 2.0 to 3.0 |
| Period Title: Overall Study | |||
| STARTED | 6015 | 6076 | 6022 |
| COMPLETED | 5780 | 5824 | 5756 |
| NOT COMPLETED | 235 | 252 | 266 |
Baseline Characteristics
| Arm/Group Title | Dabigatran 110 mg | Dabigatran 150 mg | Warfarin | Total |
|---|---|---|---|---|
| Arm/Group Description | 110 mg twice daily, total daily dose 220 mg | 150 mg twice daily, total daily dose 300 mg | Target International Normalized Ratio (INR) of 2.0 to 3.0 | Total of all reporting groups |
| Overall Participants | 6015 | 6076 | 6022 | 18113 |
| Age (years) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [years] |
71.4
(8.6)
|
71.5
(8.8)
|
71.6
(8.6)
|
71.5
(8.7)
|
| Age, Customized (Number) [Number] | ||||
| <65 |
998
16.6%
|
1030
17%
|
953
15.8%
|
2981
16.5%
|
| 65<= and <75 |
2668
44.4%
|
2580
42.5%
|
2646
43.9%
|
7894
43.6%
|
| >=75 |
2349
39.1%
|
2466
40.6%
|
2423
40.2%
|
7238
40%
|
| Sex/Gender, Customized (participants) [Number] | ||||
| Male |
3865
64.3%
|
3840
63.2%
|
3809
63.3%
|
11514
63.6%
|
| Female |
2149
35.7%
|
2236
36.8%
|
2213
36.7%
|
6598
36.4%
|
| Missing |
1
0%
|
0
0%
|
0
0%
|
1
0%
|
| Ethnicity (NIH/OMB) (Count of Participants) | ||||
| Not Hispanic or Latino |
5593
93%
|
5660
93.2%
|
5615
93.2%
|
16868
93.1%
|
| Hispanic or Latino |
421
7%
|
416
6.8%
|
407
6.8%
|
1244
6.9%
|
| Unknown or Not Reported |
1
0%
|
0
0%
|
0
0%
|
1
0%
|
| Race/Ethnicity, Customized (participants) [Number] | ||||
| White |
4208
70%
|
4268
70.2%
|
4203
69.8%
|
12679
70%
|
| Black |
52
0.9%
|
57
0.9%
|
67
1.1%
|
176
1%
|
| Asian |
955
15.9%
|
965
15.9%
|
955
15.9%
|
2875
15.9%
|
| Other |
799
13.3%
|
786
12.9%
|
797
13.2%
|
2382
13.2%
|
| Missing |
1
0%
|
0
0%
|
0
0%
|
1
0%
|
| Region of Enrollment (participants) [Number] | ||||
| USA, Canada |
2166
36%
|
2200
36.2%
|
2167
36%
|
6533
36.1%
|
| Central Europe |
707
11.8%
|
706
11.6%
|
706
11.7%
|
2119
11.7%
|
| Western Europe |
1544
25.7%
|
1555
25.6%
|
1552
25.8%
|
4651
25.7%
|
| Latin America |
320
5.3%
|
320
5.3%
|
316
5.2%
|
956
5.3%
|
| Asia |
923
15.3%
|
933
15.4%
|
926
15.4%
|
2782
15.4%
|
| Other |
355
5.9%
|
362
6%
|
355
5.9%
|
1072
5.9%
|
| Smoking history (participants) [Number] | ||||
| Non-smoker |
2941
48.9%
|
2993
49.3%
|
3006
49.9%
|
8940
49.4%
|
| Smoker |
440
7.3%
|
447
7.4%
|
448
7.4%
|
1335
7.4%
|
| Ex-smoker |
2633
43.8%
|
2636
43.4%
|
2567
42.6%
|
7836
43.3%
|
| Missing |
1
0%
|
0
0%
|
1
0%
|
2
0%
|
| Regular Alcohol Consumption (participants) [Number] | ||||
| No |
4017
66.8%
|
4077
67.1%
|
4040
67.1%
|
12134
67%
|
| Yes |
1996
33.2%
|
1999
32.9%
|
1981
32.9%
|
5976
33%
|
| Missing |
2
0%
|
0
0%
|
1
0%
|
3
0%
|
Outcome Measures
| Title | Yearly Event Rate for Composite Endpoint of Stroke/SEE |
|---|---|
| Description | Time to first occurrence of stroke or systemic embolic event. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum(date of study termination - date of randomization + 1) of all randomized subjects / 365.25 |
| Time Frame | 36 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Randomized set - The randomized set includes all randomized subjects in the treatment groups to which they were randomized, regardless of whether the subjects took randomized study medication or not. |
| Arm/Group Title | Dabigatran 110 mg | Dabigatran 150 mg | Warfarin |
|---|---|---|---|
| Arm/Group Description | 110 mg twice daily, total daily dose 220 mg | 150 mg twice daily, total daily dose 300 mg | Target International Normalized Ratio (INR) of 2.0 to 3.0 |
| Measure Participants | 6015 | 6076 | 6022 |
| Number [yearly event rate (percentage)] |
1.54
|
1.11
|
1.71
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Dabigatran 110 mg, Warfarin |
|---|---|---|
| Comments | Non-inferiority comparison of dabigatran 110 mg to warfarin | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | Comparisons between treatment groups were performed using a Cox regression analysis with treatment in the model. | |
| Statistical Test of Hypothesis | p-Value | <.0001 |
| Comments | p-value for protocol specified margin of 1.46 | |
| Method | Regression, Cox | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Cox Proportional Hazard |
| Estimated Value | 0.90 | |
| Confidence Interval |
() 95% 0.74 to 1.10 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Dabigatran 150 mg, Warfarin |
|---|---|---|
| Comments | Non-inferiority comparison of dabigatran 150 mg to warfarin | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | Comparisons between treatment groups were performed using a Cox regression analysis with treatment in the model. | |
| Statistical Test of Hypothesis | p-Value | <.0001 |
| Comments | p-value for protocol specified margin of 1.46 | |
| Method | Regression, Cox | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Cox Proportional Hazard |
| Estimated Value | 0.65 | |
| Confidence Interval |
() 95% 0.52 to 0.81 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Yearly Event Rate for Composite Endpoint of Stroke/SEE/All Cause Death |
|---|---|
| Description | Time to first occurrence of stroke, SEE or all cause death. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum(date of study termination - date of randomization + 1) of all randomized subjects / 365.25 |
| Time Frame | 36 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Randomized set - The randomized set includes all randomized subjects in the treatment groups to which they were randomized, regardless of whether the subjects took randomized study medication or not. |
| Arm/Group Title | Dabigatran 110 mg | Dabigatran 150 mg | Warfarin |
|---|---|---|---|
| Arm/Group Description | 110 mg twice daily, total daily dose 220 mg | 150 mg twice daily, total daily dose 300 mg | Target International Normalized Ratio (INR) of 2.0 to 3.0 |
| Measure Participants | 6015 | 6076 | 6022 |
| Number [yearly event rate (percentage)] |
4.85
|
4.32
|
5.20
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Dabigatran 110 mg, Warfarin |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.2206 |
| Comments | p-value is for superiority testing | |
| Method | Regression, Cox | |
| Comments | Comparisons between treatment groups were performed using a Cox regression analysis with treatment in the model. | |
| Method of Estimation | Estimation Parameter | Cox Proportional Hazard |
| Estimated Value | 0.93 | |
| Confidence Interval |
() 95% 0.83 to 1.04 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Dabigatran 150 mg, Warfarin |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0015 |
| Comments | p-value is for superiority testing | |
| Method | Regression, Cox | |
| Comments | Comparisons between treatment groups were performed using a Cox regression analysis with treatment in the model. | |
| Method of Estimation | Estimation Parameter | Cox Proportional Hazard |
| Estimated Value | 0.83 | |
| Confidence Interval |
() 95% 0.74 to 0.93 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Yearly Event Rate: Composite of Stroke/SEE/PE/MI/Vascular Death |
|---|---|
| Description | Time to first occurrence of stroke, systemic embolic event, pulmonary embolism, myocardial infarction including silent myocardial infarction or vascular death. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum(date of study termination - date of randomization + 1) of all randomized subjects / 365.25 |
| Time Frame | 36 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Randomized set - The randomized set includes all randomized subjects in the treatment groups to which they were randomized, regardless of whether the subjects took randomized study medication or not. |
| Arm/Group Title | Dabigatran 110 mg | Dabigatran 150 mg | Warfarin |
|---|---|---|---|
| Arm/Group Description | 110 mg twice daily, total daily dose 220 mg | 150 mg twice daily, total daily dose 300 mg | Target International Normalized Ratio (INR) of 2.0 to 3.0 |
| Measure Participants | 6015 | 6076 | 6022 |
| Number [yearly event rate (percentage)] |
4.26
|
3.68
|
4.35
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Dabigatran 110 mg, Warfarin |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.7508 |
| Comments | p-value is for superiority testing | |
| Method | Regression, Cox | |
| Comments | Comparisons between treatment groups were performed using a Cox regression analysis with treatment in the model. | |
| Method of Estimation | Estimation Parameter | Cox Proportional Hazard |
| Estimated Value | 0.98 | |
| Confidence Interval |
() 95% 0.87 to 1.11 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Dabigatran 150 mg, Warfarin |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0093 |
| Comments | p-value is for superiority testing | |
| Method | Regression, Cox | |
| Comments | Comparisons between treatment groups were performed using a Cox regression analysis with treatment in the model. | |
| Method of Estimation | Estimation Parameter | Cox Proportional Hazard |
| Estimated Value | 0.84 | |
| Confidence Interval |
() 95% 0.74 to 0.96 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Bleeding Events (Major and Minor) |
|---|---|
| Description | Yearly event rate of bleeds. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum(date of study termination - date of randomization + 1) of all randomized subjects / 365.25 Major bleeds are adjudicated, whereas minor bleeds are investigator reported. |
| Time Frame | 36 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Randomized set - The randomized set includes all randomized subjects in the treatment groups to which they were randomized, regardless of whether the subjects took randomized study medication or not. |
| Arm/Group Title | Dabigatran 110 mg | Dabigatran 150 mg | Warfarin |
|---|---|---|---|
| Arm/Group Description | 110 mg twice daily, total daily dose 220 mg | 150 mg twice daily, total daily dose 300 mg | Target International Normalized Ratio (INR) of 2.0 to 3.0 |
| Measure Participants | 6015 | 6076 | 6022 |
| Major bleeds |
2.99
|
3.55
|
3.81
|
| Minor bleeds |
13.16
|
14.85
|
16.37
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Dabigatran 110 mg, Warfarin |
|---|---|---|
| Comments | Analysis is for adjudicated major bleeds | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0026 |
| Comments | p-value is for superiority testing | |
| Method | Regression, Cox | |
| Comments | Comparisons between treatment groups were performed using Cox regression analysis with treatment in the model. | |
| Method of Estimation | Estimation Parameter | Cox Proportional Hazard |
| Estimated Value | 0.80 | |
| Confidence Interval |
() 95% 0.70 to 0.93 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Dabigatran 150 mg, Warfarin |
|---|---|---|
| Comments | Analysis is for adjudicated major bleeds | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.3146 |
| Comments | p-value is for superiority testing | |
| Method | Regression, Cox | |
| Comments | Comparisons between treatment groups were performed using Cox regression analysis with treatment in the model. | |
| Method of Estimation | Estimation Parameter | Cox Proportional Hazard |
| Estimated Value | 0.93 | |
| Confidence Interval |
() 95% 0.81 to 1.07 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Clinical Relevant Abnormalities for Intracerebral Hemorrhage and Other Intracranial Hemorrhage (ICH) |
|---|---|
| Description | Patients with clinical relevant abnormalities for intracerebral hemorrhage, other intracranial hemorrhage (ICH) |
| Time Frame | 36 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Randomized set - The randomized set includes all randomized subjects in the treatment groups to which they were randomized, regardless of whether the subjects took randomized study medication or not. |
| Arm/Group Title | Dabigatran 110 mg | Dabigatran 150 mg | Warfarin |
|---|---|---|---|
| Arm/Group Description | 110 mg twice daily, total daily dose 220 mg | 150 mg twice daily, total daily dose 300 mg | Target International Normalized Ratio (INR) of 2.0 to 3.0 |
| Measure Participants | 5983 | 6059 | 5998 |
| intracerebral hemorrhage |
0.12
|
0.10
|
0.38
|
| intracranial hemorrhage (ICH) |
0.23
|
0.32
|
0.76
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Dabigatran 110 mg, Warfarin |
|---|---|---|
| Comments | Analysis of ICH | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | p-value is for superiority testing | |
| Method | Regression, Cox | |
| Comments | Comparisons between treatment groups were performed using Cox regression analysis with treatment in the model. | |
| Method of Estimation | Estimation Parameter | Cox Proportional Hazard |
| Estimated Value | 0.30 | |
| Confidence Interval |
() 95% 0.19 to 0.45 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Dabigatran 150 mg, Warfarin |
|---|---|---|
| Comments | Analysis of ICH | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | p-value is for superiority testing | |
| Method | Regression, Cox | |
| Comments | Comparisons between treatment groups were performed using Cox regression analysis with treatment in the model. | |
| Method of Estimation | Estimation Parameter | Cox Proportional Hazard |
| Estimated Value | 0.41 | |
| Confidence Interval |
() 95% 0.28 to 0.60 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Abnormal Liver Function Test |
|---|---|
| Description | Number of subjects with abnormal liver function test (LFT), i.e., ALT/AST>3xULN and total bilirubin > 2 x ULN |
| Time Frame | 36 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety set - all subjects who were randomized and received at least 1 dose of study drug |
| Arm/Group Title | Dabigatran 110 mg | Dabigatran 150 mg | Warfarin |
|---|---|---|---|
| Arm/Group Description | 110 mg twice daily, total daily dose 220 mg | 150 mg twice daily, total daily dose 300 mg | Target International Normalized Ratio (INR) of 2.0 to 3.0 |
| Measure Participants | 5983 | 6059 | 5998 |
| Number [participants] |
11
0.2%
|
14
0.2%
|
21
0.3%
|
Adverse Events
| Time Frame | 36 months | |||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | Number of participants at risk represents the number of participants who received study medication. The following number of subjects did not take any study drug after randomization: 32 assigned to Dabigatran 110 mg; 17 assigned to Dabigatran 150 mg; and 24 assigned to Warfarin. | |||||
| Arm/Group Title | Dabigatran 110 mg | Dabigatran 150 mg | Warfarin | |||
| Arm/Group Description | 110 mg twice daily, total daily dose 220 mg | 150 mg twice daily, total daily dose 300 mg | Target International Normalized Ratio (INR) of 2.0 to 3.0 | |||
All Cause Mortality |
||||||
| Dabigatran 110 mg | Dabigatran 150 mg | Warfarin | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | |||
Serious Adverse Events |
||||||
| Dabigatran 110 mg | Dabigatran 150 mg | Warfarin | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1263/5983 (21.1%) | 1289/6059 (21.3%) | 1357/5998 (22.6%) | |||
| Blood and lymphatic system disorders | ||||||
| Anaemia | 34/5983 (0.6%) | 47/6059 (0.8%) | 33/5998 (0.6%) | |||
| Coagulopathy | 4/5983 (0.1%) | 3/6059 (0%) | 12/5998 (0.2%) | |||
| Disseminated intravascular coagulation | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Febrile neutropenia | 1/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Haemolysis | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Haemorrhagic anaemia | 6/5983 (0.1%) | 5/6059 (0.1%) | 10/5998 (0.2%) | |||
| Heparin-induced thrombocytopenia | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Hypereosinophilic syndrome | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Hypocoagulable state | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Iron deficiency anaemia | 7/5983 (0.1%) | 1/6059 (0%) | 3/5998 (0.1%) | |||
| Leukocytosis | 2/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Leukopenia | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Lymphadenopathy | 2/5983 (0%) | 2/6059 (0%) | 3/5998 (0.1%) | |||
| Lymphadenopathy mediastinal | 2/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Lymphatic disorder | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Microcytic anaemia | 2/5983 (0%) | 2/6059 (0%) | 2/5998 (0%) | |||
| Neutropenia | 1/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Normochromic normocytic anaemia | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Pancytopenia | 3/5983 (0.1%) | 3/6059 (0%) | 1/5998 (0%) | |||
| Sideroblastic anaemia | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Splenic haemorrhage | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Splenomegaly | 2/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Spontaneous haematoma | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Thrombocytopenia | 5/5983 (0.1%) | 6/6059 (0.1%) | 3/5998 (0.1%) | |||
| Cardiac disorders | ||||||
| Acute coronary syndrome | 5/5983 (0.1%) | 8/6059 (0.1%) | 4/5998 (0.1%) | |||
| Acute left ventricular failure | 1/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Acute myocardial infarction | 1/5983 (0%) | 0/6059 (0%) | 4/5998 (0.1%) | |||
| Angina pectoris | 29/5983 (0.5%) | 30/6059 (0.5%) | 22/5998 (0.4%) | |||
| Angina unstable | 7/5983 (0.1%) | 13/6059 (0.2%) | 5/5998 (0.1%) | |||
| Aortic valve calcification | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Aortic valve disease | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Aortic valve incompetence | 2/5983 (0%) | 0/6059 (0%) | 3/5998 (0.1%) | |||
| Aortic valve sclerosis | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Aortic valve stenosis | 4/5983 (0.1%) | 2/6059 (0%) | 1/5998 (0%) | |||
| Arrhythmia | 6/5983 (0.1%) | 1/6059 (0%) | 4/5998 (0.1%) | |||
| Arrhythmia supraventricular | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Arteriosclerosis coronary artery | 0/5983 (0%) | 3/6059 (0%) | 0/5998 (0%) | |||
| Atrial fibrillation | 64/5983 (1.1%) | 55/6059 (0.9%) | 74/5998 (1.2%) | |||
| Atrial flutter | 5/5983 (0.1%) | 10/6059 (0.2%) | 5/5998 (0.1%) | |||
| Atrial thrombosis | 7/5983 (0.1%) | 5/6059 (0.1%) | 1/5998 (0%) | |||
| Atrioventricular block | 2/5983 (0%) | 2/6059 (0%) | 2/5998 (0%) | |||
| Atrioventricular block complete | 2/5983 (0%) | 4/6059 (0.1%) | 5/5998 (0.1%) | |||
| Atrioventricular block first degree | 3/5983 (0.1%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Atrioventricular block second degree | 2/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Bradyarrhythmia | 0/5983 (0%) | 2/6059 (0%) | 0/5998 (0%) | |||
| Bradycardia | 20/5983 (0.3%) | 21/6059 (0.3%) | 20/5998 (0.3%) | |||
| Cardiac arrest | 8/5983 (0.1%) | 5/6059 (0.1%) | 5/5998 (0.1%) | |||
| Cardiac asthma | 0/5983 (0%) | 0/6059 (0%) | 2/5998 (0%) | |||
| Cardiac failure | 51/5983 (0.9%) | 62/6059 (1%) | 65/5998 (1.1%) | |||
| Cardiac failure acute | 5/5983 (0.1%) | 1/6059 (0%) | 7/5998 (0.1%) | |||
| Cardiac failure chronic | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Cardiac failure congestive | 83/5983 (1.4%) | 58/6059 (1%) | 73/5998 (1.2%) | |||
| Cardiac perforation | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Cardio-respiratory arrest | 1/5983 (0%) | 2/6059 (0%) | 2/5998 (0%) | |||
| Cardiogenic shock | 4/5983 (0.1%) | 1/6059 (0%) | 6/5998 (0.1%) | |||
| Cardiomegaly | 1/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Cardiomyopathy | 2/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Conduction disorder | 1/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Congestive cardiomyopathy | 2/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Cor pulmonale | 2/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Coronary artery disease | 9/5983 (0.2%) | 10/6059 (0.2%) | 11/5998 (0.2%) | |||
| Coronary artery occlusion | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Coronary artery perforation | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Coronary artery stenosis | 2/5983 (0%) | 0/6059 (0%) | 2/5998 (0%) | |||
| Coronary artery thrombosis | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Electromechanical dissociation | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Intracardiac thrombus | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Ischaemic cardiomyopathy | 0/5983 (0%) | 1/6059 (0%) | 2/5998 (0%) | |||
| Left ventricular dysfunction | 2/5983 (0%) | 0/6059 (0%) | 2/5998 (0%) | |||
| Left ventricular failure | 1/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Mitral valve incompetence | 6/5983 (0.1%) | 4/6059 (0.1%) | 10/5998 (0.2%) | |||
| Mitral valve prolapse | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Mitral valve stenosis | 1/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Myocardial infarction | 1/5983 (0%) | 2/6059 (0%) | 0/5998 (0%) | |||
| Myocardial ischaemia | 3/5983 (0.1%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Nodal arrhythmia | 0/5983 (0%) | 2/6059 (0%) | 1/5998 (0%) | |||
| Nodal rhythm | 1/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Palpitations | 7/5983 (0.1%) | 2/6059 (0%) | 5/5998 (0.1%) | |||
| Pericardial effusion | 4/5983 (0.1%) | 4/6059 (0.1%) | 5/5998 (0.1%) | |||
| Pericardial haemorrhage | 1/5983 (0%) | 3/6059 (0%) | 3/5998 (0.1%) | |||
| Pericarditis | 1/5983 (0%) | 1/6059 (0%) | 2/5998 (0%) | |||
| Pericarditis constrictive | 0/5983 (0%) | 0/6059 (0%) | 3/5998 (0.1%) | |||
| Prinzmetal angina | 0/5983 (0%) | 1/6059 (0%) | 1/5998 (0%) | |||
| Restrictive cardiomyopathy | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Right ventricular failure | 0/5983 (0%) | 1/6059 (0%) | 2/5998 (0%) | |||
| Sick sinus syndrome | 8/5983 (0.1%) | 3/6059 (0%) | 8/5998 (0.1%) | |||
| Sinoatrial block | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Sinus arrest | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Sinus arrhythmia | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Sinus bradycardia | 2/5983 (0%) | 1/6059 (0%) | 1/5998 (0%) | |||
| Stress cardiomyopathy | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Supraventricular tachycardia | 1/5983 (0%) | 1/6059 (0%) | 1/5998 (0%) | |||
| Tachyarrhythmia | 0/5983 (0%) | 2/6059 (0%) | 0/5998 (0%) | |||
| Tachycardia | 1/5983 (0%) | 0/6059 (0%) | 5/5998 (0.1%) | |||
| Torsade de pointes | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Tricuspid valve incompetence | 2/5983 (0%) | 1/6059 (0%) | 5/5998 (0.1%) | |||
| Ventricular arrhythmia | 5/5983 (0.1%) | 5/6059 (0.1%) | 3/5998 (0.1%) | |||
| Ventricular extrasystoles | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Ventricular fibrillation | 2/5983 (0%) | 3/6059 (0%) | 1/5998 (0%) | |||
| Ventricular hypokinesia | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Ventricular tachyarrhythmia | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Ventricular tachycardia | 6/5983 (0.1%) | 3/6059 (0%) | 10/5998 (0.2%) | |||
| Congenital, familial and genetic disorders | ||||||
| Atrial septal defect | 1/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Cerebral palsy | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Congenital arterial malformation | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Diverticulitis Meckel's | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Exomphalos | 0/5983 (0%) | 2/6059 (0%) | 0/5998 (0%) | |||
| Gastrointestinal angiodysplasia | 2/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Gastrointestinal angiodysplasia haemorrhagic | 1/5983 (0%) | 2/6059 (0%) | 0/5998 (0%) | |||
| Gastrointestinal arteriovenous malformation | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Hydrocele | 1/5983 (0%) | 2/6059 (0%) | 1/5998 (0%) | |||
| Ventricular septal defect | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Ear and labyrinth disorders | ||||||
| Deafness | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Deafness unilateral | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| External ear pain | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Hearing impaired | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Meniere's disease | 0/5983 (0%) | 0/6059 (0%) | 2/5998 (0%) | |||
| Vertigo | 5/5983 (0.1%) | 6/6059 (0.1%) | 14/5998 (0.2%) | |||
| Vertigo positional | 3/5983 (0.1%) | 2/6059 (0%) | 1/5998 (0%) | |||
| Vestibular disorder | 1/5983 (0%) | 2/6059 (0%) | 0/5998 (0%) | |||
| Endocrine disorders | ||||||
| Addison's disease | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Adrenal insufficiency | 3/5983 (0.1%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Goitre | 0/5983 (0%) | 5/6059 (0.1%) | 2/5998 (0%) | |||
| Hyperparathyroidism | 0/5983 (0%) | 3/6059 (0%) | 0/5998 (0%) | |||
| Hyperthyroidism | 2/5983 (0%) | 3/6059 (0%) | 2/5998 (0%) | |||
| Hypothyroidism | 2/5983 (0%) | 1/6059 (0%) | 1/5998 (0%) | |||
| Inappropriate antidiuretic hormone secretion | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Thyroid mass | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Thyrotoxic crisis | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Eye disorders | ||||||
| Amaurosis fugax | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Blindness transient | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Cataract | 7/5983 (0.1%) | 6/6059 (0.1%) | 11/5998 (0.2%) | |||
| Conjunctival discolouration | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Conjunctival haemorrhage | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Dacryostenosis acquired | 1/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Diabetic retinopathy | 2/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Diplopia | 0/5983 (0%) | 0/6059 (0%) | 2/5998 (0%) | |||
| Dry eye | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Eye haemorrhage | 4/5983 (0.1%) | 3/6059 (0%) | 6/5998 (0.1%) | |||
| Glaucoma | 2/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Hyphaema | 2/5983 (0%) | 2/6059 (0%) | 0/5998 (0%) | |||
| Hypotony of eye | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Keratitis | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Macular degeneration | 3/5983 (0.1%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Necrotising retinitis | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Optic neuropathy | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Pseudophakia | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Retinal detachment | 3/5983 (0.1%) | 1/6059 (0%) | 3/5998 (0.1%) | |||
| Retinal haemorrhage | 3/5983 (0.1%) | 1/6059 (0%) | 1/5998 (0%) | |||
| Retinal tear | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Retinitis | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Uveitis | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Vision blurred | 0/5983 (0%) | 1/6059 (0%) | 1/5998 (0%) | |||
| Visual acuity reduced | 2/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Visual impairment | 1/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Vitreous haemorrhage | 1/5983 (0%) | 3/6059 (0%) | 0/5998 (0%) | |||
| Gastrointestinal disorders | ||||||
| Abdominal discomfort | 0/5983 (0%) | 1/6059 (0%) | 1/5998 (0%) | |||
| Abdominal distension | 0/5983 (0%) | 1/6059 (0%) | 1/5998 (0%) | |||
| Abdominal hernia | 3/5983 (0.1%) | 3/6059 (0%) | 3/5998 (0.1%) | |||
| Abdominal mass | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Abdominal pain | 11/5983 (0.2%) | 8/6059 (0.1%) | 17/5998 (0.3%) | |||
| Abdominal pain lower | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Abdominal pain upper | 4/5983 (0.1%) | 5/6059 (0.1%) | 4/5998 (0.1%) | |||
| Abdominal tenderness | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Acute abdomen | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Alcoholic pancreatitis | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Anal fissure | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Anal polyp | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Appendiceal mucocoele | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Ascites | 3/5983 (0.1%) | 3/6059 (0%) | 3/5998 (0.1%) | |||
| Coeliac disease | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Colitis | 2/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Colitis ischaemic | 3/5983 (0.1%) | 2/6059 (0%) | 0/5998 (0%) | |||
| Colitis ulcerative | 0/5983 (0%) | 1/6059 (0%) | 1/5998 (0%) | |||
| Colonic obstruction | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Colonic polyp | 1/5983 (0%) | 2/6059 (0%) | 5/5998 (0.1%) | |||
| Colonic stenosis | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Constipation | 2/5983 (0%) | 1/6059 (0%) | 4/5998 (0.1%) | |||
| Crohn's disease | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Diarrhoea | 8/5983 (0.1%) | 7/6059 (0.1%) | 20/5998 (0.3%) | |||
| Diarrhoea haemorrhagic | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Diverticular perforation | 1/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Diverticulitis intestinal haemorrhagic | 0/5983 (0%) | 1/6059 (0%) | 1/5998 (0%) | |||
| Diverticulum | 1/5983 (0%) | 2/6059 (0%) | 3/5998 (0.1%) | |||
| Diverticulum intestinal haemorrhagic | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Duodenal ulcer | 3/5983 (0.1%) | 4/6059 (0.1%) | 5/5998 (0.1%) | |||
| Duodenal ulcer haemorrhage | 2/5983 (0%) | 2/6059 (0%) | 2/5998 (0%) | |||
| Duodenal ulcer perforation | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Duodenitis | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Duodenitis haemorrhagic | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Dyskinesia oesophageal | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Dyspepsia | 6/5983 (0.1%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Dysphagia | 4/5983 (0.1%) | 3/6059 (0%) | 2/5998 (0%) | |||
| Enteritis | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Enterocele | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Enterocolitis | 0/5983 (0%) | 1/6059 (0%) | 1/5998 (0%) | |||
| Enterovesical fistula | 1/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Erosive oesophagitis | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Faecaloma | 1/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Faeces discoloured | 0/5983 (0%) | 2/6059 (0%) | 1/5998 (0%) | |||
| Gastric disorder | 1/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Gastric haemorrhage | 0/5983 (0%) | 2/6059 (0%) | 1/5998 (0%) | |||
| Gastric perforation | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Gastric polyps | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Gastric stenosis | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Gastric ulcer | 5/5983 (0.1%) | 5/6059 (0.1%) | 4/5998 (0.1%) | |||
| Gastric ulcer haemorrhage | 3/5983 (0.1%) | 5/6059 (0.1%) | 5/5998 (0.1%) | |||
| Gastric ulcer perforation | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Gastritis | 6/5983 (0.1%) | 6/6059 (0.1%) | 6/5998 (0.1%) | |||
| Gastritis erosive | 5/5983 (0.1%) | 4/6059 (0.1%) | 1/5998 (0%) | |||
| Gastritis haemorrhagic | 2/5983 (0%) | 3/6059 (0%) | 2/5998 (0%) | |||
| Gastrointestinal disorder | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Gastrointestinal dysplasia | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Gastrointestinal haemorrhage | 38/5983 (0.6%) | 55/6059 (0.9%) | 41/5998 (0.7%) | |||
| Gastrointestinal inflammation | 0/5983 (0%) | 1/6059 (0%) | 1/5998 (0%) | |||
| Gastrointestinal obstruction | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Gastrointestinal perforation | 1/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Gastrointestinal ulcer | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Gastrooesophageal reflux disease | 5/5983 (0.1%) | 4/6059 (0.1%) | 2/5998 (0%) | |||
| Gingival bleeding | 0/5983 (0%) | 3/6059 (0%) | 3/5998 (0.1%) | |||
| Haematemesis | 2/5983 (0%) | 5/6059 (0.1%) | 2/5998 (0%) | |||
| Haematochezia | 5/5983 (0.1%) | 2/6059 (0%) | 3/5998 (0.1%) | |||
| Haemorrhagic erosive gastritis | 2/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Haemorrhoidal haemorrhage | 2/5983 (0%) | 3/6059 (0%) | 0/5998 (0%) | |||
| Haemorrhoids | 1/5983 (0%) | 3/6059 (0%) | 1/5998 (0%) | |||
| Hernial eventration | 1/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Hiatus hernia | 1/5983 (0%) | 1/6059 (0%) | 1/5998 (0%) | |||
| Hiatus hernia, obstructive | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Ileus | 8/5983 (0.1%) | 1/6059 (0%) | 2/5998 (0%) | |||
| Ileus paralytic | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Impaired gastric emptying | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Inguinal hernia | 15/5983 (0.3%) | 16/6059 (0.3%) | 12/5998 (0.2%) | |||
| Inguinal hernia, obstructive | 1/5983 (0%) | 0/6059 (0%) | 2/5998 (0%) | |||
| Intestinal fistula | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Intestinal haemorrhage | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Intestinal infarction | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Intestinal ischaemia | 1/5983 (0%) | 2/6059 (0%) | 0/5998 (0%) | |||
| Intestinal mass | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Intestinal obstruction | 4/5983 (0.1%) | 2/6059 (0%) | 4/5998 (0.1%) | |||
| Intestinal perforation | 0/5983 (0%) | 0/6059 (0%) | 2/5998 (0%) | |||
| Intra-abdominal haematoma | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Intra-abdominal haemorrhage | 1/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Intussusception | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Large intestinal haemorrhage | 2/5983 (0%) | 2/6059 (0%) | 0/5998 (0%) | |||
| Large intestinal obstruction | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Large intestine perforation | 2/5983 (0%) | 1/6059 (0%) | 2/5998 (0%) | |||
| Lower gastrointestinal haemorrhage | 8/5983 (0.1%) | 12/6059 (0.2%) | 3/5998 (0.1%) | |||
| Malabsorption | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Mallory-Weiss syndrome | 2/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Melaena | 7/5983 (0.1%) | 10/6059 (0.2%) | 6/5998 (0.1%) | |||
| Melanosis coli | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Mouth haemorrhage | 0/5983 (0%) | 0/6059 (0%) | 2/5998 (0%) | |||
| Mouth ulceration | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Nausea | 11/5983 (0.2%) | 7/6059 (0.1%) | 9/5998 (0.2%) | |||
| Odynophagia | 0/5983 (0%) | 1/6059 (0%) | 1/5998 (0%) | |||
| Oesophageal mass | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Oesophageal perforation | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Oesophageal spasm | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Oesophageal stenosis | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Oesophageal ulcer | 1/5983 (0%) | 1/6059 (0%) | 1/5998 (0%) | |||
| Oesophageal ulcer haemorrhage | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Oesophagitis | 2/5983 (0%) | 2/6059 (0%) | 1/5998 (0%) | |||
| Oral discomfort | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Pancreatic cyst | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Pancreatic insufficiency | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Pancreatic mass | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Pancreatitis | 1/5983 (0%) | 4/6059 (0.1%) | 8/5998 (0.1%) | |||
| Pancreatitis acute | 3/5983 (0.1%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Pancreatitis chronic | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Paraesthesia oral | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Peptic ulcer | 1/5983 (0%) | 1/6059 (0%) | 1/5998 (0%) | |||
| Periodontal disease | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Periodontitis | 2/5983 (0%) | 0/6059 (0%) | 2/5998 (0%) | |||
| Peritoneal cyst | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Peritoneal haemorrhage | 0/5983 (0%) | 2/6059 (0%) | 1/5998 (0%) | |||
| Peritonitis | 1/5983 (0%) | 0/6059 (0%) | 3/5998 (0.1%) | |||
| Pharyngoesophageal diverticulum | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Pneumoperitoneum | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Presbyoesophagus | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Proctitis | 1/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Rectal haemorrhage | 15/5983 (0.3%) | 13/6059 (0.2%) | 9/5998 (0.2%) | |||
| Rectal lesion | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Rectal prolapse | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Rectal ulcer | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Retroperitoneal haematoma | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Retroperitoneal haemorrhage | 0/5983 (0%) | 1/6059 (0%) | 1/5998 (0%) | |||
| Salivary gland cyst | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Small intestinal haemorrhage | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Small intestinal obstruction | 4/5983 (0.1%) | 4/6059 (0.1%) | 2/5998 (0%) | |||
| Stress ulcer | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Subileus | 1/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Umbilical hernia | 0/5983 (0%) | 1/6059 (0%) | 3/5998 (0.1%) | |||
| Upper gastrointestinal haemorrhage | 8/5983 (0.1%) | 13/6059 (0.2%) | 12/5998 (0.2%) | |||
| Volvulus | 0/5983 (0%) | 0/6059 (0%) | 2/5998 (0%) | |||
| Vomiting | 17/5983 (0.3%) | 6/6059 (0.1%) | 9/5998 (0.2%) | |||
| General disorders | ||||||
| Adhesion | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Adverse drug reaction | 1/5983 (0%) | 0/6059 (0%) | 3/5998 (0.1%) | |||
| Asthenia | 12/5983 (0.2%) | 10/6059 (0.2%) | 15/5998 (0.3%) | |||
| Chest discomfort | 3/5983 (0.1%) | 4/6059 (0.1%) | 2/5998 (0%) | |||
| Chest pain | 29/5983 (0.5%) | 45/6059 (0.7%) | 46/5998 (0.8%) | |||
| Chills | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Condition aggravated | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Cyst | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Death | 4/5983 (0.1%) | 4/6059 (0.1%) | 0/5998 (0%) | |||
| Discomfort | 1/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Drug withdrawal syndrome | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Fatigue | 3/5983 (0.1%) | 6/6059 (0.1%) | 12/5998 (0.2%) | |||
| Feeling abnormal | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Gait disturbance | 0/5983 (0%) | 3/6059 (0%) | 2/5998 (0%) | |||
| General physical health deterioration | 1/5983 (0%) | 3/6059 (0%) | 5/5998 (0.1%) | |||
| Generalised oedema | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Hernia | 2/5983 (0%) | 2/6059 (0%) | 2/5998 (0%) | |||
| Hernia obstructive | 1/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Hyperthermia | 2/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Hypothermia | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Impaired healing | 1/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Implant site inflammation | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Inflammation | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Injection site haemorrhage | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Ischaemic ulcer | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Malaise | 1/5983 (0%) | 2/6059 (0%) | 0/5998 (0%) | |||
| Mass | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Mechanical complication of implant | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Mucosal inflammation | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Multi-organ failure | 5/5983 (0.1%) | 3/6059 (0%) | 6/5998 (0.1%) | |||
| Necrosis | 0/5983 (0%) | 2/6059 (0%) | 0/5998 (0%) | |||
| Non-cardiac chest pain | 2/5983 (0%) | 3/6059 (0%) | 5/5998 (0.1%) | |||
| Oedema | 2/5983 (0%) | 1/6059 (0%) | 3/5998 (0.1%) | |||
| Oedema peripheral | 10/5983 (0.2%) | 3/6059 (0%) | 13/5998 (0.2%) | |||
| Pain | 1/5983 (0%) | 2/6059 (0%) | 6/5998 (0.1%) | |||
| Pelvic mass | 1/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Polyp | 1/5983 (0%) | 1/6059 (0%) | 2/5998 (0%) | |||
| Pyrexia | 11/5983 (0.2%) | 13/6059 (0.2%) | 14/5998 (0.2%) | |||
| Sudden cardiac death | 2/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Systemic inflammatory response syndrome | 1/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Ulcer | 0/5983 (0%) | 1/6059 (0%) | 2/5998 (0%) | |||
| Hepatobiliary disorders | ||||||
| Bile duct obstruction | 0/5983 (0%) | 0/6059 (0%) | 2/5998 (0%) | |||
| Bile duct stone | 0/5983 (0%) | 2/6059 (0%) | 0/5998 (0%) | |||
| Biliary colic | 1/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Biliary dilatation | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Cholangitis | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Cholangitis acute | 1/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Cholecystitis | 8/5983 (0.1%) | 8/6059 (0.1%) | 9/5998 (0.2%) | |||
| Cholecystitis acute | 4/5983 (0.1%) | 3/6059 (0%) | 2/5998 (0%) | |||
| Cholecystitis chronic | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Cholelithiasis | 7/5983 (0.1%) | 3/6059 (0%) | 7/5998 (0.1%) | |||
| Cholestasis | 0/5983 (0%) | 2/6059 (0%) | 1/5998 (0%) | |||
| Cytolytic hepatitis | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Gallbladder disorder | 0/5983 (0%) | 2/6059 (0%) | 0/5998 (0%) | |||
| Hepatic cirrhosis | 2/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Hepatic failure | 1/5983 (0%) | 0/6059 (0%) | 3/5998 (0.1%) | |||
| Hepatic function abnormal | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Hepatic lesion | 1/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Hepatic steatosis | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Hepatitis | 2/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Hepatotoxicity | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Hyperbilirubinaemia | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Jaundice | 0/5983 (0%) | 3/6059 (0%) | 2/5998 (0%) | |||
| Jaundice cholestatic | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Liver disorder | 0/5983 (0%) | 2/6059 (0%) | 0/5998 (0%) | |||
| Immune system disorders | ||||||
| Amyloidosis | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Anaphylactic reaction | 0/5983 (0%) | 1/6059 (0%) | 1/5998 (0%) | |||
| Anaphylactic shock | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Drug hypersensitivity | 0/5983 (0%) | 1/6059 (0%) | 1/5998 (0%) | |||
| Hypersensitivity | 1/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Primary amyloidosis | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Infections and infestations | ||||||
| Abdominal abscess | 1/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Abdominal wall abscess | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Abscess | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Abscess intestinal | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Abscess limb | 3/5983 (0.1%) | 2/6059 (0%) | 4/5998 (0.1%) | |||
| Acute sinusitis | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Acute tonsillitis | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Alpha haemolytic streptococcal infection | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Anal abscess | 4/5983 (0.1%) | 2/6059 (0%) | 2/5998 (0%) | |||
| Appendiceal abscess | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Appendicitis | 5/5983 (0.1%) | 11/6059 (0.2%) | 7/5998 (0.1%) | |||
| Appendicitis perforated | 1/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Arthritis bacterial | 2/5983 (0%) | 2/6059 (0%) | 2/5998 (0%) | |||
| Arthritis infective | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Bacteraemia | 4/5983 (0.1%) | 2/6059 (0%) | 2/5998 (0%) | |||
| Bacterial sepsis | 3/5983 (0.1%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Biliary tract infection | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Bronchiectasis | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Bronchitis | 11/5983 (0.2%) | 13/6059 (0.2%) | 11/5998 (0.2%) | |||
| Bronchitis bacterial | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Bronchopneumonia | 1/5983 (0%) | 2/6059 (0%) | 3/5998 (0.1%) | |||
| Bursitis infective | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Carbuncle | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Catheter sepsis | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Cellulitis | 21/5983 (0.4%) | 23/6059 (0.4%) | 20/5998 (0.3%) | |||
| Cellulitis of male external genital organ | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Cellulitis staphylococcal | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Cervicitis | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Cholecystitis infective | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Chronic sinusitis | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Clostridial infection | 2/5983 (0%) | 1/6059 (0%) | 1/5998 (0%) | |||
| Clostridium difficile colitis | 3/5983 (0.1%) | 1/6059 (0%) | 1/5998 (0%) | |||
| Creutzfeldt-Jakob disease | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Cystitis | 2/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Dengue fever | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Device related infection | 2/5983 (0%) | 3/6059 (0%) | 4/5998 (0.1%) | |||
| Diabetic gangrene | 0/5983 (0%) | 2/6059 (0%) | 1/5998 (0%) | |||
| Diarrhoea infectious | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Disseminated tuberculosis | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Diverticulitis | 5/5983 (0.1%) | 5/6059 (0.1%) | 12/5998 (0.2%) | |||
| Empyema | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Endocarditis | 3/5983 (0.1%) | 3/6059 (0%) | 1/5998 (0%) | |||
| Endocarditis bacterial | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Endophthalmitis | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Enterococcal bacteraemia | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Enterococcal sepsis | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Epiglottitis | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Erysipelas | 4/5983 (0.1%) | 7/6059 (0.1%) | 3/5998 (0.1%) | |||
| Escherichia bacteraemia | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Escherichia sepsis | 3/5983 (0.1%) | 0/6059 (0%) | 2/5998 (0%) | |||
| Eye infection viral | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Gangrene | 3/5983 (0.1%) | 4/6059 (0.1%) | 3/5998 (0.1%) | |||
| Gastroenteritis | 11/5983 (0.2%) | 13/6059 (0.2%) | 8/5998 (0.1%) | |||
| Gastroenteritis norovirus | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Gastroenteritis salmonella | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Gastroenteritis viral | 3/5983 (0.1%) | 3/6059 (0%) | 1/5998 (0%) | |||
| Gastrointestinal infection | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Groin abscess | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Haematoma infection | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Helicobacter infection | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Helminthic infection | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Herpes zoster | 2/5983 (0%) | 5/6059 (0.1%) | 1/5998 (0%) | |||
| Herpes zoster ophthalmic | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Histoplasmosis | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Implant site cellulitis | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Implant site infection | 1/5983 (0%) | 3/6059 (0%) | 2/5998 (0%) | |||
| Incision site cellulitis | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Incision site infection | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Infected cyst | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Infected skin ulcer | 2/5983 (0%) | 1/6059 (0%) | 1/5998 (0%) | |||
| Infection | 0/5983 (0%) | 3/6059 (0%) | 3/5998 (0.1%) | |||
| Influenza | 2/5983 (0%) | 1/6059 (0%) | 2/5998 (0%) | |||
| Infusion site infection | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Intervertebral discitis | 3/5983 (0.1%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Intestinal gangrene | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Jejunal gangrene | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Keratitis herpetic | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Liver abscess | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Lobar pneumonia | 6/5983 (0.1%) | 3/6059 (0%) | 5/5998 (0.1%) | |||
| Localised infection | 3/5983 (0.1%) | 4/6059 (0.1%) | 3/5998 (0.1%) | |||
| Lower respiratory tract infection | 3/5983 (0.1%) | 1/6059 (0%) | 3/5998 (0.1%) | |||
| Lung infection | 2/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Mastoiditis | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Mediastinitis | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Meningitis bacterial | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Meningitis viral | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Necrotising fasciitis | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Oesophageal candidiasis | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Osteomyelitis | 4/5983 (0.1%) | 8/6059 (0.1%) | 2/5998 (0%) | |||
| Osteomyelitis acute | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Osteomyelitis chronic | 0/5983 (0%) | 0/6059 (0%) | 2/5998 (0%) | |||
| Osteomyelitis salmonella | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Otitis media | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Parotitis | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Pelvic abscess | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Pelvic infection | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Peridiverticular abscess | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Periorbital abscess | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Perirectal abscess | 0/5983 (0%) | 2/6059 (0%) | 1/5998 (0%) | |||
| Peritoneal infection | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Peritonsillar abscess | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Pharyngeal abscess | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Pharyngitis | 0/5983 (0%) | 0/6059 (0%) | 3/5998 (0.1%) | |||
| Pharyngitis streptococcal | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Pneumocystis jiroveci pneumonia | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Pneumonia | 74/5983 (1.2%) | 70/6059 (1.2%) | 62/5998 (1%) | |||
| Pneumonia bacterial | 0/5983 (0%) | 1/6059 (0%) | 2/5998 (0%) | |||
| Pneumonia primary atypical | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Pneumonia streptococcal | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Pneumonia viral | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Post procedural infection | 0/5983 (0%) | 2/6059 (0%) | 1/5998 (0%) | |||
| Postoperative abscess | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Postoperative wound infection | 5/5983 (0.1%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Proteus infection | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Psoas abscess | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Pulmonary sepsis | 1/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Pulmonary tuberculosis | 1/5983 (0%) | 2/6059 (0%) | 0/5998 (0%) | |||
| Pyelonephritis | 5/5983 (0.1%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Pyelonephritis acute | 3/5983 (0.1%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Pyonephrosis | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Pyothorax | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Respiratory tract infection | 2/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Salmonella bacteraemia | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Scrotal abscess | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Sepsis | 19/5983 (0.3%) | 17/6059 (0.3%) | 19/5998 (0.3%) | |||
| Sepsis syndrome | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Septic shock | 10/5983 (0.2%) | 6/6059 (0.1%) | 3/5998 (0.1%) | |||
| Sinusitis | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Skin infection | 0/5983 (0%) | 1/6059 (0%) | 2/5998 (0%) | |||
| Staphylococcal bacteraemia | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Staphylococcal infection | 2/5983 (0%) | 5/6059 (0.1%) | 3/5998 (0.1%) | |||
| Staphylococcal sepsis | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Staphylococcal skin infection | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Streptococcal bacteraemia | 1/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Streptococcal sepsis | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Subacute endocarditis | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Subcutaneous abscess | 1/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Superinfection | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Tinea pedis | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Tonsillitis | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Tooth abscess | 0/5983 (0%) | 0/6059 (0%) | 2/5998 (0%) | |||
| Toxoplasmosis | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Tracheobronchitis | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Tuberculosis | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Upper respiratory tract infection | 3/5983 (0.1%) | 3/6059 (0%) | 6/5998 (0.1%) | |||
| Urinary tract infection | 18/5983 (0.3%) | 13/6059 (0.2%) | 21/5998 (0.4%) | |||
| Urinary tract infection bacterial | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Urosepsis | 10/5983 (0.2%) | 4/6059 (0.1%) | 4/5998 (0.1%) | |||
| Vestibular neuronitis | 0/5983 (0%) | 0/6059 (0%) | 2/5998 (0%) | |||
| Viral infection | 0/5983 (0%) | 3/6059 (0%) | 3/5998 (0.1%) | |||
| Viral upper respiratory tract infection | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| West Nile viral infection | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Wound infection | 0/5983 (0%) | 4/6059 (0.1%) | 1/5998 (0%) | |||
| Wound infection staphylococcal | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Injury, poisoning and procedural complications | ||||||
| Accidental exposure | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Accidental overdose | 1/5983 (0%) | 1/6059 (0%) | 5/5998 (0.1%) | |||
| Adrenal haematoma | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Agitation postoperative | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Alcohol poisoning | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Anaemia postoperative | 1/5983 (0%) | 1/6059 (0%) | 1/5998 (0%) | |||
| Anastomotic complication | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Ankle fracture | 2/5983 (0%) | 1/6059 (0%) | 1/5998 (0%) | |||
| Arthropod bite | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Back injury | 1/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Bladder injury | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Brain contusion | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Brain herniation | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Burns third degree | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Cardiac pacemaker malfunction | 2/5983 (0%) | 2/6059 (0%) | 2/5998 (0%) | |||
| Cartilage injury | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Cataract operation complication | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Cervical vertebral fracture | 1/5983 (0%) | 1/6059 (0%) | 1/5998 (0%) | |||
| Clavicle fracture | 0/5983 (0%) | 2/6059 (0%) | 0/5998 (0%) | |||
| Collapse of lung | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Complication of device insertion | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Compression fracture | 2/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Concussion | 3/5983 (0.1%) | 5/6059 (0.1%) | 2/5998 (0%) | |||
| Confusion postoperative | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Contusion | 4/5983 (0.1%) | 1/6059 (0%) | 4/5998 (0.1%) | |||
| Device breakage | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Device dislocation | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Device electrical finding | 1/5983 (0%) | 2/6059 (0%) | 0/5998 (0%) | |||
| Device failure | 0/5983 (0%) | 2/6059 (0%) | 4/5998 (0.1%) | |||
| Device lead damage | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Drug administration error | 0/5983 (0%) | 2/6059 (0%) | 1/5998 (0%) | |||
| Drug toxicity | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Excoriation | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Eye injury | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Face injury | 0/5983 (0%) | 0/6059 (0%) | 2/5998 (0%) | |||
| Facial bones fracture | 1/5983 (0%) | 1/6059 (0%) | 2/5998 (0%) | |||
| Failure to capture | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Fall | 22/5983 (0.4%) | 29/6059 (0.5%) | 43/5998 (0.7%) | |||
| Femoral neck fracture | 1/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Femur fracture | 4/5983 (0.1%) | 8/6059 (0.1%) | 6/5998 (0.1%) | |||
| Fibula fracture | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Flail chest | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Foot fracture | 0/5983 (0%) | 0/6059 (0%) | 2/5998 (0%) | |||
| Forearm fracture | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Fracture | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Gastroenteritis radiation | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Graft complication | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Hand fracture | 1/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Head injury | 4/5983 (0.1%) | 3/6059 (0%) | 6/5998 (0.1%) | |||
| Heart injury | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Heat exhaustion | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Hip fracture | 8/5983 (0.1%) | 8/6059 (0.1%) | 3/5998 (0.1%) | |||
| Humerus fracture | 2/5983 (0%) | 1/6059 (0%) | 2/5998 (0%) | |||
| Iatrogenic injury | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Implantable defibrillator malfunction | 1/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| In-stent coronary artery restenosis | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Incision site haematoma | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Incisional hernia | 0/5983 (0%) | 1/6059 (0%) | 1/5998 (0%) | |||
| Injury | 2/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Joint dislocation | 1/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Joint injury | 2/5983 (0%) | 1/6059 (0%) | 2/5998 (0%) | |||
| Joint sprain | 0/5983 (0%) | 1/6059 (0%) | 1/5998 (0%) | |||
| Laceration | 0/5983 (0%) | 1/6059 (0%) | 1/5998 (0%) | |||
| Laryngeal injury | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Limb crushing injury | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Limb injury | 2/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Lower limb fracture | 1/5983 (0%) | 0/6059 (0%) | 3/5998 (0.1%) | |||
| Lumbar vertebral fracture | 1/5983 (0%) | 3/6059 (0%) | 0/5998 (0%) | |||
| Lung injury | 1/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Meniscus lesion | 3/5983 (0.1%) | 3/6059 (0%) | 0/5998 (0%) | |||
| Multiple drug overdose | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Multiple fractures | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Multiple injuries | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Muscle injury | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Muscle rupture | 0/5983 (0%) | 2/6059 (0%) | 2/5998 (0%) | |||
| Muscle strain | 0/5983 (0%) | 1/6059 (0%) | 1/5998 (0%) | |||
| Narcotic intoxication | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Nerve root injury | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Operative haemorrhage | 0/5983 (0%) | 3/6059 (0%) | 1/5998 (0%) | |||
| Overdose | 1/5983 (0%) | 1/6059 (0%) | 8/5998 (0.1%) | |||
| Pacemaker complication | 2/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Pancreatic injury | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Patella fracture | 1/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Pelvic fracture | 1/5983 (0%) | 1/6059 (0%) | 1/5998 (0%) | |||
| Pocket erosion | 1/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Post concussion syndrome | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Post procedural fistula | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Post procedural haematoma | 1/5983 (0%) | 2/6059 (0%) | 0/5998 (0%) | |||
| Post procedural haematuria | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Post procedural haemorrhage | 2/5983 (0%) | 5/6059 (0.1%) | 3/5998 (0.1%) | |||
| Postoperative ileus | 0/5983 (0%) | 1/6059 (0%) | 1/5998 (0%) | |||
| Postoperative thoracic procedure complication | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Procedural complication | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Procedural pain | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Pubic rami fracture | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Radius fracture | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Renal injury | 1/5983 (0%) | 0/6059 (0%) | 2/5998 (0%) | |||
| Respiratory fume inhalation disorder | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Retinal scar | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Rib fracture | 5/5983 (0.1%) | 6/6059 (0.1%) | 5/5998 (0.1%) | |||
| Road traffic accident | 3/5983 (0.1%) | 5/6059 (0.1%) | 4/5998 (0.1%) | |||
| Scapula fracture | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Scrotal haematoma | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Seroma | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Skin laceration | 3/5983 (0.1%) | 8/6059 (0.1%) | 1/5998 (0%) | |||
| Skull fracture | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Soft tissue injury | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Spinal compression fracture | 3/5983 (0.1%) | 1/6059 (0%) | 2/5998 (0%) | |||
| Spinal fracture | 1/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Splenic haematoma | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Splenic injury | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Splenic rupture | 1/5983 (0%) | 4/6059 (0.1%) | 1/5998 (0%) | |||
| Sternal fracture | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Subcutaneous haematoma | 0/5983 (0%) | 3/6059 (0%) | 2/5998 (0%) | |||
| Subdural haematoma | 5/5983 (0.1%) | 11/6059 (0.2%) | 20/5998 (0.3%) | |||
| Subdural haemorrhage | 1/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Tendon rupture | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Therapeutic agent toxicity | 6/5983 (0.1%) | 5/6059 (0.1%) | 9/5998 (0.2%) | |||
| Thermal burn | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Thoracic vertebral fracture | 2/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Thrombosis in device | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Tibia fracture | 1/5983 (0%) | 2/6059 (0%) | 0/5998 (0%) | |||
| Transfusion reaction | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Transurethral resection syndrome | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Traumatic brain injury | 1/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Traumatic haematoma | 1/5983 (0%) | 0/6059 (0%) | 2/5998 (0%) | |||
| Traumatic haemorrhage | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Traumatic intracranial haemorrhage | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Underdose | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Upper limb fracture | 2/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Vaccination complication | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Vascular bypass dysfunction | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Vascular pseudoaneurysm | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Ventriculoperitoneal shunt malfunction | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Vertebral injury | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Wound | 2/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Wound complication | 1/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Wound dehiscence | 1/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Wrist fracture | 2/5983 (0%) | 1/6059 (0%) | 1/5998 (0%) | |||
| Investigations | ||||||
| Alanine aminotransferase increased | 1/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Anticoagulation drug level above therapeutic | 0/5983 (0%) | 0/6059 (0%) | 2/5998 (0%) | |||
| Arteriogram coronary | 1/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Aspartate aminotransferase increased | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Biopsy | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Biopsy breast | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Biopsy endometrium | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Biopsy lung | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Biopsy prostate | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Blood albumin decreased | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Blood calcium decreased | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Blood creatinine increased | 0/5983 (0%) | 5/6059 (0.1%) | 0/5998 (0%) | |||
| Blood glucose increased | 1/5983 (0%) | 0/6059 (0%) | 2/5998 (0%) | |||
| Blood osmolarity decreased | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Blood potassium increased | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Blood pressure decreased | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Blood pressure increased | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Blood urea increased | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Blood uric acid increased | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Blood urine present | 1/5983 (0%) | 0/6059 (0%) | 3/5998 (0.1%) | |||
| Brain natriuretic peptide increased | 2/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Carbohydrate antigen 125 increased | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Cardiac electrophysiologic study | 1/5983 (0%) | 2/6059 (0%) | 1/5998 (0%) | |||
| Cardiac stress test | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Cardiac stress test abnormal | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Catheterisation cardiac | 1/5983 (0%) | 0/6059 (0%) | 5/5998 (0.1%) | |||
| Chest X-ray abnormal | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Coagulation factor increased | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Coagulation test abnormal | 0/5983 (0%) | 1/6059 (0%) | 1/5998 (0%) | |||
| Coagulation time prolonged | 0/5983 (0%) | 0/6059 (0%) | 3/5998 (0.1%) | |||
| Colonoscopy | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Colonoscopy abnormal | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Creatinine renal clearance decreased | 0/5983 (0%) | 3/6059 (0%) | 0/5998 (0%) | |||
| Echocardiogram abnormal | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Electroencephalogram abnormal | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Glycosylated haemoglobin increased | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Haematocrit decreased | 1/5983 (0%) | 3/6059 (0%) | 4/5998 (0.1%) | |||
| Haemoglobin decreased | 7/5983 (0.1%) | 12/6059 (0.2%) | 10/5998 (0.2%) | |||
| Heart rate increased | 1/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Hepatic enzyme increased | 0/5983 (0%) | 4/6059 (0.1%) | 2/5998 (0%) | |||
| International normalised ratio increased | 0/5983 (0%) | 1/6059 (0%) | 19/5998 (0.3%) | |||
| Intraocular pressure increased | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Liver function test abnormal | 5/5983 (0.1%) | 8/6059 (0.1%) | 5/5998 (0.1%) | |||
| Lymphocyte count increased | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Megakaryocytes decreased | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Occult blood positive | 1/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Oesophagogastroduodenoscopy | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Platelet count decreased | 0/5983 (0%) | 2/6059 (0%) | 0/5998 (0%) | |||
| Precancerous cells present | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Prostatic specific antigen | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Prostatic specific antigen increased | 1/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Prothrombin time prolonged | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Sinus rhythm | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Troponin increased | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Tumour marker increased | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Urine output decreased | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Venous pressure jugular increased | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Weight decreased | 6/5983 (0.1%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Weight increased | 1/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| White blood cell count increased | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Metabolism and nutrition disorders | ||||||
| Anorexia | 3/5983 (0.1%) | 0/6059 (0%) | 2/5998 (0%) | |||
| Cachexia | 1/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Decreased appetite | 0/5983 (0%) | 3/6059 (0%) | 0/5998 (0%) | |||
| Dehydration | 15/5983 (0.3%) | 22/6059 (0.4%) | 31/5998 (0.5%) | |||
| Diabetes mellitus | 5/5983 (0.1%) | 6/6059 (0.1%) | 7/5998 (0.1%) | |||
| Diabetes mellitus inadequate control | 4/5983 (0.1%) | 5/6059 (0.1%) | 3/5998 (0.1%) | |||
| Diabetic foot | 4/5983 (0.1%) | 3/6059 (0%) | 2/5998 (0%) | |||
| Diabetic ketoacidosis | 0/5983 (0%) | 2/6059 (0%) | 1/5998 (0%) | |||
| Electrolyte imbalance | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Failure to thrive | 0/5983 (0%) | 2/6059 (0%) | 2/5998 (0%) | |||
| Fluid overload | 1/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Gout | 3/5983 (0.1%) | 3/6059 (0%) | 7/5998 (0.1%) | |||
| Hypercalcaemia | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Hyperglycaemia | 6/5983 (0.1%) | 7/6059 (0.1%) | 3/5998 (0.1%) | |||
| Hyperkalaemia | 18/5983 (0.3%) | 4/6059 (0.1%) | 12/5998 (0.2%) | |||
| Hypernatraemia | 1/5983 (0%) | 0/6059 (0%) | 2/5998 (0%) | |||
| Hypoalbuminaemia | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Hypocalcaemia | 1/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Hypochloraemia | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Hypoglycaemia | 10/5983 (0.2%) | 11/6059 (0.2%) | 12/5998 (0.2%) | |||
| Hypokalaemia | 3/5983 (0.1%) | 5/6059 (0.1%) | 10/5998 (0.2%) | |||
| Hypomagnesaemia | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Hyponatraemia | 9/5983 (0.2%) | 9/6059 (0.1%) | 10/5998 (0.2%) | |||
| Hypovolaemia | 0/5983 (0%) | 2/6059 (0%) | 0/5998 (0%) | |||
| Ketoacidosis | 0/5983 (0%) | 0/6059 (0%) | 2/5998 (0%) | |||
| Ketosis | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Malnutrition | 1/5983 (0%) | 1/6059 (0%) | 1/5998 (0%) | |||
| Metabolic acidosis | 1/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Metabolic disorder | 1/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Obesity | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Starvation | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Tetany | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Type 2 diabetes mellitus | 0/5983 (0%) | 1/6059 (0%) | 4/5998 (0.1%) | |||
| Musculoskeletal and connective tissue disorders | ||||||
| Arthralgia | 2/5983 (0%) | 7/6059 (0.1%) | 11/5998 (0.2%) | |||
| Arthritis | 2/5983 (0%) | 3/6059 (0%) | 3/5998 (0.1%) | |||
| Arthritis reactive | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Arthropathy | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Articular disc disorder | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Back pain | 14/5983 (0.2%) | 17/6059 (0.3%) | 9/5998 (0.2%) | |||
| Bursitis | 2/5983 (0%) | 2/6059 (0%) | 5/5998 (0.1%) | |||
| Cervical spinal stenosis | 1/5983 (0%) | 1/6059 (0%) | 2/5998 (0%) | |||
| Compartment syndrome | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Diabetic amyotrophy | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Dupuytren's contracture | 1/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Fasciitis | 1/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Fistula | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Flank pain | 0/5983 (0%) | 1/6059 (0%) | 2/5998 (0%) | |||
| Foot deformity | 2/5983 (0%) | 1/6059 (0%) | 1/5998 (0%) | |||
| Gouty arthritis | 2/5983 (0%) | 2/6059 (0%) | 1/5998 (0%) | |||
| Groin pain | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Haemarthrosis | 3/5983 (0.1%) | 1/6059 (0%) | 3/5998 (0.1%) | |||
| Intervertebral disc degeneration | 2/5983 (0%) | 2/6059 (0%) | 1/5998 (0%) | |||
| Intervertebral disc protrusion | 5/5983 (0.1%) | 1/6059 (0%) | 3/5998 (0.1%) | |||
| Jaw cyst | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Joint effusion | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Joint range of motion decreased | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Joint swelling | 1/5983 (0%) | 1/6059 (0%) | 1/5998 (0%) | |||
| Loose body in joint | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Lumbar spinal stenosis | 9/5983 (0.2%) | 4/6059 (0.1%) | 4/5998 (0.1%) | |||
| Monarthritis | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Muscle haemorrhage | 1/5983 (0%) | 0/6059 (0%) | 2/5998 (0%) | |||
| Muscle spasms | 0/5983 (0%) | 1/6059 (0%) | 1/5998 (0%) | |||
| Muscle tightness | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Muscular weakness | 3/5983 (0.1%) | 3/6059 (0%) | 4/5998 (0.1%) | |||
| Musculoskeletal chest pain | 1/5983 (0%) | 2/6059 (0%) | 0/5998 (0%) | |||
| Musculoskeletal pain | 3/5983 (0.1%) | 2/6059 (0%) | 3/5998 (0.1%) | |||
| Myalgia | 0/5983 (0%) | 2/6059 (0%) | 1/5998 (0%) | |||
| Myopathy | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Myositis | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Neck pain | 0/5983 (0%) | 1/6059 (0%) | 2/5998 (0%) | |||
| Nodule on extremity | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Osteoarthritis | 22/5983 (0.4%) | 13/6059 (0.2%) | 21/5998 (0.4%) | |||
| Osteoporosis | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Pain in extremity | 4/5983 (0.1%) | 4/6059 (0.1%) | 5/5998 (0.1%) | |||
| Pain in jaw | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Pathological fracture | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Periarthritis | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Polymyalgia rheumatica | 2/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Pseudarthrosis | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Rhabdomyolysis | 0/5983 (0%) | 1/6059 (0%) | 1/5998 (0%) | |||
| Rheumatoid arthritis | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Rotator cuff syndrome | 4/5983 (0.1%) | 5/6059 (0.1%) | 2/5998 (0%) | |||
| Sacroiliitis | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Scoliosis | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Shoulder deformity | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Spinal column stenosis | 3/5983 (0.1%) | 3/6059 (0%) | 2/5998 (0%) | |||
| Spinal osteoarthritis | 2/5983 (0%) | 0/6059 (0%) | 2/5998 (0%) | |||
| Spondylolisthesis | 3/5983 (0.1%) | 1/6059 (0%) | 3/5998 (0.1%) | |||
| Synovial cyst | 1/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Tendonitis | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Vertebral column mass | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||
| Abdominal neoplasm | 2/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Acoustic neuroma | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Acute myeloid leukaemia | 1/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Adenocarcinoma | 2/5983 (0%) | 3/6059 (0%) | 2/5998 (0%) | |||
| Adenocarcinoma pancreas | 1/5983 (0%) | 1/6059 (0%) | 2/5998 (0%) | |||
| Anal cancer | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| B-cell lymphoma | 3/5983 (0.1%) | 1/6059 (0%) | 2/5998 (0%) | |||
| B-cell small lymphocytic lymphoma | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Basal cell carcinoma | 3/5983 (0.1%) | 1/6059 (0%) | 1/5998 (0%) | |||
| Benign bone neoplasm | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Benign neoplasm of bladder | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Bile duct cancer | 0/5983 (0%) | 4/6059 (0.1%) | 1/5998 (0%) | |||
| Bladder cancer | 8/5983 (0.1%) | 13/6059 (0.2%) | 14/5998 (0.2%) | |||
| Bladder cancer recurrent | 1/5983 (0%) | 2/6059 (0%) | 0/5998 (0%) | |||
| Bladder cancer stage III | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Bladder neoplasm | 1/5983 (0%) | 4/6059 (0.1%) | 3/5998 (0.1%) | |||
| Bladder papilloma | 0/5983 (0%) | 0/6059 (0%) | 2/5998 (0%) | |||
| Bladder transitional cell carcinoma | 1/5983 (0%) | 4/6059 (0.1%) | 1/5998 (0%) | |||
| Bladder transitional cell carcinoma recurrent | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Bone cancer metastatic | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Bone neoplasm malignant | 1/5983 (0%) | 1/6059 (0%) | 1/5998 (0%) | |||
| Bowen's disease | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Brain cancer metastatic | 1/5983 (0%) | 0/6059 (0%) | 3/5998 (0.1%) | |||
| Brain neoplasm | 2/5983 (0%) | 1/6059 (0%) | 1/5998 (0%) | |||
| Brain neoplasm malignant | 2/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Breast cancer | 13/5983 (0.2%) | 17/6059 (0.3%) | 10/5998 (0.2%) | |||
| Breast cancer female | 0/5983 (0%) | 1/6059 (0%) | 1/5998 (0%) | |||
| Breast cancer in situ | 0/5983 (0%) | 2/6059 (0%) | 0/5998 (0%) | |||
| Breast cancer metastatic | 1/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Breast cancer recurrent | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Breast cancer stage IV | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Breast neoplasm | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Bronchial carcinoma | 0/5983 (0%) | 2/6059 (0%) | 3/5998 (0.1%) | |||
| Cardiac fibroma | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Cardiac neoplasm malignant | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Cardiac neoplasm unspecified | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Central nervous system leukaemia | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Choroid melanoma | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Chronic lymphocytic leukaemia | 2/5983 (0%) | 2/6059 (0%) | 2/5998 (0%) | |||
| Chronic myeloid leukaemia | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Colon adenoma | 0/5983 (0%) | 0/6059 (0%) | 2/5998 (0%) | |||
| Colon cancer | 19/5983 (0.3%) | 17/6059 (0.3%) | 8/5998 (0.1%) | |||
| Colon cancer metastatic | 1/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Colon cancer stage 0 | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Colon cancer stage I | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Colon cancer stage IV | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Colon neoplasm | 1/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Colorectal cancer | 3/5983 (0.1%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Colorectal cancer metastatic | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Endometrial cancer | 3/5983 (0.1%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Ependymoma | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Gallbladder cancer metastatic | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Gallbladder cancer non-resectable | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Gastric adenoma | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Gastric cancer | 1/5983 (0%) | 1/6059 (0%) | 2/5998 (0%) | |||
| Gastric cancer stage II | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Gastric neoplasm | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Gastrointestinal cancer metastatic | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Gastrointestinal carcinoma | 1/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Gastrointestinal neoplasm | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Gastrointestinal stromal tumour | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Gastrointestinal tract adenoma | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Gastrooesophageal cancer | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Glioblastoma | 1/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Glioblastoma multiforme | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Haemangioma | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Head and neck cancer | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Hepatic cancer metastatic | 0/5983 (0%) | 2/6059 (0%) | 2/5998 (0%) | |||
| Hepatic neoplasm malignant | 0/5983 (0%) | 3/6059 (0%) | 3/5998 (0.1%) | |||
| Hodgkin's disease | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Hypopharyngeal cancer | 1/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Inflammatory carcinoma of the breast | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Inflammatory myofibroblastic tumour | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Intestinal adenocarcinoma | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Keratoacanthoma | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Langerhans' cell granulomatosis | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Large cell carcinoma of the respiratory tract stage unspecified | 1/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Laryngeal cancer | 4/5983 (0.1%) | 1/6059 (0%) | 2/5998 (0%) | |||
| Laryngeal cancer recurrent | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Laryngeal cancer stage 0 | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Laryngeal neoplasm | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Leiomyosarcoma | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Leiomyosarcoma recurrent | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Leukaemia | 1/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Leukaemia monocytic | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Lip and/or oral cavity cancer | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Lipoma | 1/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Liposarcoma | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Lung adenocarcinoma | 3/5983 (0.1%) | 2/6059 (0%) | 0/5998 (0%) | |||
| Lung cancer metastatic | 3/5983 (0.1%) | 1/6059 (0%) | 3/5998 (0.1%) | |||
| Lung carcinoma cell type unspecified stage II | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Lung carcinoma cell type unspecified stage III | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Lung neoplasm | 2/5983 (0%) | 2/6059 (0%) | 0/5998 (0%) | |||
| Lung neoplasm malignant | 20/5983 (0.3%) | 8/6059 (0.1%) | 14/5998 (0.2%) | |||
| Lung squamous cell carcinoma stage IV | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Lung squamous cell carcinoma stage unspecified | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Lymphocytic lymphoma | 0/5983 (0%) | 1/6059 (0%) | 1/5998 (0%) | |||
| Lymphoma | 3/5983 (0.1%) | 1/6059 (0%) | 2/5998 (0%) | |||
| Malignant melanoma | 8/5983 (0.1%) | 4/6059 (0.1%) | 2/5998 (0%) | |||
| Malignant melanoma stage III | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Malignant neoplasm of renal pelvis | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Malignant palate neoplasm | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Malignant peritoneal neoplasm | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Mantle cell lymphoma recurrent | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Meningioma | 2/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Meningioma benign | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Metastases to bone | 5/5983 (0.1%) | 1/6059 (0%) | 3/5998 (0.1%) | |||
| Metastases to central nervous system | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Metastases to eye | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Metastases to kidney | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Metastases to liver | 4/5983 (0.1%) | 5/6059 (0.1%) | 3/5998 (0.1%) | |||
| Metastases to lung | 2/5983 (0%) | 2/6059 (0%) | 4/5998 (0.1%) | |||
| Metastases to lymph nodes | 2/5983 (0%) | 2/6059 (0%) | 1/5998 (0%) | |||
| Metastases to pleura | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Metastases to spine | 1/5983 (0%) | 1/6059 (0%) | 1/5998 (0%) | |||
| Metastases to spleen | 1/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Metastases to the mediastinum | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Metastasis | 1/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Metastatic carcinoid tumour | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Metastatic gastric cancer | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Metastatic malignant melanoma | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Metastatic neoplasm | 2/5983 (0%) | 2/6059 (0%) | 4/5998 (0.1%) | |||
| Metastatic renal cell carcinoma | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Metastatic squamous cell carcinoma | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Multiple myeloma | 1/5983 (0%) | 4/6059 (0.1%) | 3/5998 (0.1%) | |||
| Myelodysplastic syndrome | 2/5983 (0%) | 0/6059 (0%) | 2/5998 (0%) | |||
| Neoplasm | 1/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Neoplasm malignant | 2/5983 (0%) | 3/6059 (0%) | 4/5998 (0.1%) | |||
| Neoplasm prostate | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Neuroendocrine carcinoma of the skin | 1/5983 (0%) | 1/6059 (0%) | 1/5998 (0%) | |||
| Neuroendocrine tumour | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Non-Hodgkin's lymphoma | 1/5983 (0%) | 1/6059 (0%) | 2/5998 (0%) | |||
| Non-Hodgkin's lymphoma recurrent | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Non-small cell lung cancer | 0/5983 (0%) | 4/6059 (0.1%) | 3/5998 (0.1%) | |||
| Non-small cell lung cancer metastatic | 1/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Oesophageal adenocarcinoma | 1/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Oesophageal carcinoma | 5/5983 (0.1%) | 4/6059 (0.1%) | 3/5998 (0.1%) | |||
| Oesophageal neoplasm | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Oncologic complication | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Oropharyngeal cancer stage unspecified | 0/5983 (0%) | 2/6059 (0%) | 0/5998 (0%) | |||
| Osteoma | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Ovarian adenoma | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Ovarian cancer | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Ovarian neoplasm | 0/5983 (0%) | 1/6059 (0%) | 1/5998 (0%) | |||
| Pancreatic carcinoma | 2/5983 (0%) | 1/6059 (0%) | 7/5998 (0.1%) | |||
| Pancreatic carcinoma metastatic | 1/5983 (0%) | 2/6059 (0%) | 0/5998 (0%) | |||
| Paraneoplastic syndrome | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Parathyroid tumour benign | 1/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Penis carcinoma | 1/5983 (0%) | 1/6059 (0%) | 1/5998 (0%) | |||
| Peritoneal neoplasm | 1/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Phaeochromocytoma | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Plasmacytoma | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Prostate cancer | 25/5983 (0.4%) | 32/6059 (0.5%) | 29/5998 (0.5%) | |||
| Prostate cancer metastatic | 2/5983 (0%) | 2/6059 (0%) | 2/5998 (0%) | |||
| Prostate cancer recurrent | 1/5983 (0%) | 0/6059 (0%) | 2/5998 (0%) | |||
| Prostatic adenoma | 1/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Rectal cancer | 3/5983 (0.1%) | 1/6059 (0%) | 2/5998 (0%) | |||
| Rectal neoplasm | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Rectosigmoid cancer | 1/5983 (0%) | 2/6059 (0%) | 0/5998 (0%) | |||
| Renal cancer | 0/5983 (0%) | 2/6059 (0%) | 5/5998 (0.1%) | |||
| Renal cell carcinoma | 4/5983 (0.1%) | 3/6059 (0%) | 4/5998 (0.1%) | |||
| Renal neoplasm | 1/5983 (0%) | 1/6059 (0%) | 2/5998 (0%) | |||
| Salivary gland neoplasm | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Sarcoma | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Seborrhoeic keratosis | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Skin cancer | 2/5983 (0%) | 2/6059 (0%) | 4/5998 (0.1%) | |||
| Small cell carcinoma | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Small cell lung cancer metastatic | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Small cell lung cancer stage unspecified | 1/5983 (0%) | 1/6059 (0%) | 2/5998 (0%) | |||
| Small intestine carcinoma | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Squamous cell carcinoma | 10/5983 (0.2%) | 15/6059 (0.2%) | 10/5998 (0.2%) | |||
| Squamous cell carcinoma of skin | 6/5983 (0.1%) | 8/6059 (0.1%) | 2/5998 (0%) | |||
| Superficial spreading melanoma stage unspecified | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| T-cell lymphoma | 0/5983 (0%) | 2/6059 (0%) | 0/5998 (0%) | |||
| Testicular cancer metastatic | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Throat cancer | 1/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Thyroid cancer | 1/5983 (0%) | 2/6059 (0%) | 0/5998 (0%) | |||
| Thyroid neoplasm | 0/5983 (0%) | 2/6059 (0%) | 0/5998 (0%) | |||
| Tongue neoplasm malignant stage unspecified | 1/5983 (0%) | 1/6059 (0%) | 2/5998 (0%) | |||
| Tonsil cancer | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Transitional cell carcinoma | 1/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Tumour flare | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Tumour invasion | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Urethral cancer | 0/5983 (0%) | 2/6059 (0%) | 1/5998 (0%) | |||
| Urethral papilloma | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Urinary bladder adenoma | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Uterine cancer | 0/5983 (0%) | 2/6059 (0%) | 2/5998 (0%) | |||
| Uterine leiomyoma | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Nervous system disorders | ||||||
| Altered state of consciousness | 0/5983 (0%) | 1/6059 (0%) | 3/5998 (0.1%) | |||
| Amnesia | 0/5983 (0%) | 1/6059 (0%) | 2/5998 (0%) | |||
| Amyotrophic lateral sclerosis | 1/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Anoxic encephalopathy | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Aphasia | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Ataxia | 1/5983 (0%) | 0/6059 (0%) | 2/5998 (0%) | |||
| Balance disorder | 0/5983 (0%) | 1/6059 (0%) | 1/5998 (0%) | |||
| Basilar artery occlusion | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Burning sensation | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Carotid arteriosclerosis | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Carotid artery disease | 1/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Carotid artery stenosis | 3/5983 (0.1%) | 7/6059 (0.1%) | 5/5998 (0.1%) | |||
| Carotid artery thrombosis | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Carpal tunnel syndrome | 1/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Cerebellar haemorrhage | 0/5983 (0%) | 1/6059 (0%) | 1/5998 (0%) | |||
| Cerebellar infarction | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Cerebral atrophy | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Cerebral circulatory failure | 1/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Cerebral haematoma | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Cerebral haemorrhage | 2/5983 (0%) | 2/6059 (0%) | 13/5998 (0.2%) | |||
| Cerebral hypoperfusion | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Cerebral infarction | 3/5983 (0.1%) | 3/6059 (0%) | 2/5998 (0%) | |||
| Cerebral ischaemia | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Cerebrovascular accident | 7/5983 (0.1%) | 1/6059 (0%) | 5/5998 (0.1%) | |||
| Cerebrovascular disorder | 0/5983 (0%) | 1/6059 (0%) | 1/5998 (0%) | |||
| Cerebrovascular insufficiency | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Cervical myelopathy | 0/5983 (0%) | 2/6059 (0%) | 0/5998 (0%) | |||
| Cervicobrachial syndrome | 0/5983 (0%) | 1/6059 (0%) | 1/5998 (0%) | |||
| Cognitive disorder | 2/5983 (0%) | 2/6059 (0%) | 0/5998 (0%) | |||
| Coma | 1/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Complex partial seizures | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Convulsion | 2/5983 (0%) | 3/6059 (0%) | 3/5998 (0.1%) | |||
| Dementia | 1/5983 (0%) | 2/6059 (0%) | 0/5998 (0%) | |||
| Dementia Alzheimer's type | 1/5983 (0%) | 2/6059 (0%) | 0/5998 (0%) | |||
| Depressed level of consciousness | 2/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Dizziness | 15/5983 (0.3%) | 18/6059 (0.3%) | 18/5998 (0.3%) | |||
| Dysarthria | 0/5983 (0%) | 3/6059 (0%) | 2/5998 (0%) | |||
| Embolic stroke | 1/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Encephalitis | 2/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Encephalopathy | 4/5983 (0.1%) | 3/6059 (0%) | 6/5998 (0.1%) | |||
| Epilepsy | 2/5983 (0%) | 3/6059 (0%) | 0/5998 (0%) | |||
| Facial palsy | 1/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Frontotemporal dementia | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Global amnesia | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Grand mal convulsion | 1/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Guillain-Barre syndrome | 0/5983 (0%) | 2/6059 (0%) | 0/5998 (0%) | |||
| Haemorrhage intracranial | 2/5983 (0%) | 1/6059 (0%) | 5/5998 (0.1%) | |||
| Haemorrhagic stroke | 1/5983 (0%) | 2/6059 (0%) | 9/5998 (0.2%) | |||
| Headache | 1/5983 (0%) | 4/6059 (0.1%) | 3/5998 (0.1%) | |||
| Hemiparesis | 2/5983 (0%) | 1/6059 (0%) | 3/5998 (0.1%) | |||
| Hepatic encephalopathy | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Hydrocephalus | 1/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Hyperaesthesia | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Hypoaesthesia | 1/5983 (0%) | 3/6059 (0%) | 1/5998 (0%) | |||
| Hypoglycaemic coma | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Hypoxic encephalopathy | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Intracranial aneurysm | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Ischaemic stroke | 2/5983 (0%) | 2/6059 (0%) | 1/5998 (0%) | |||
| Lacunar infarction | 2/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Lethargy | 1/5983 (0%) | 2/6059 (0%) | 0/5998 (0%) | |||
| Loss of consciousness | 3/5983 (0.1%) | 4/6059 (0.1%) | 0/5998 (0%) | |||
| Memory impairment | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Metabolic encephalopathy | 1/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Monoparesis | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Myoclonus | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Narcolepsy | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Nerve compression | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Neuralgia | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Neuritis | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Neurological decompensation | 1/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Neuropathy peripheral | 2/5983 (0%) | 1/6059 (0%) | 1/5998 (0%) | |||
| Normal pressure hydrocephalus | 2/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Paraesthesia | 2/5983 (0%) | 1/6059 (0%) | 1/5998 (0%) | |||
| Paralysis | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Parkinson's disease | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Parkinsonism | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Peripheral paralysis | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Post herpetic neuralgia | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Post-traumatic headache | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Posterior interosseous syndrome | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Presyncope | 3/5983 (0.1%) | 7/6059 (0.1%) | 5/5998 (0.1%) | |||
| Pseudoparalysis | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Radial nerve palsy | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Radicular syndrome | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Restless legs syndrome | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Sciatica | 1/5983 (0%) | 1/6059 (0%) | 1/5998 (0%) | |||
| Somnolence | 1/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Speech disorder | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Spinal claudication | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Spinal cord compression | 0/5983 (0%) | 1/6059 (0%) | 1/5998 (0%) | |||
| Subarachnoid haemorrhage | 1/5983 (0%) | 1/6059 (0%) | 2/5998 (0%) | |||
| Subdural hygroma | 0/5983 (0%) | 2/6059 (0%) | 0/5998 (0%) | |||
| Syncope | 33/5983 (0.6%) | 31/6059 (0.5%) | 34/5998 (0.6%) | |||
| Tension headache | 0/5983 (0%) | 2/6059 (0%) | 0/5998 (0%) | |||
| Toxic encephalopathy | 1/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Transient ischaemic attack | 1/5983 (0%) | 2/6059 (0%) | 3/5998 (0.1%) | |||
| Tremor | 2/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Unresponsive to stimuli | 1/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Vascular dementia | 1/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Vascular encephalopathy | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Visual field defect | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Wernicke's encephalopathy | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Psychiatric disorders | ||||||
| Adjustment disorder | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Agitation | 0/5983 (0%) | 1/6059 (0%) | 1/5998 (0%) | |||
| Alcohol abuse | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Alcohol withdrawal syndrome | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Alcoholism | 0/5983 (0%) | 0/6059 (0%) | 2/5998 (0%) | |||
| Anxiety | 2/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Apathy | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Bereavement reaction | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Completed suicide | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Confusional state | 7/5983 (0.1%) | 8/6059 (0.1%) | 10/5998 (0.2%) | |||
| Delirium | 1/5983 (0%) | 2/6059 (0%) | 4/5998 (0.1%) | |||
| Delusion | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Delusional disorder, unspecified type | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Depression | 6/5983 (0.1%) | 8/6059 (0.1%) | 6/5998 (0.1%) | |||
| Drug abuse | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Hallucination | 0/5983 (0%) | 2/6059 (0%) | 1/5998 (0%) | |||
| Hallucination, auditory | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Major depression | 0/5983 (0%) | 1/6059 (0%) | 1/5998 (0%) | |||
| Mania | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Mental status changes | 4/5983 (0.1%) | 9/6059 (0.1%) | 6/5998 (0.1%) | |||
| Panic attack | 1/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Post-traumatic stress disorder | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Psychotic disorder | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Sleep disorder | 1/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Somatisation disorder | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Somatoform disorder | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Suicidal ideation | 1/5983 (0%) | 2/6059 (0%) | 0/5998 (0%) | |||
| Suicide attempt | 1/5983 (0%) | 1/6059 (0%) | 1/5998 (0%) | |||
| Withdrawal syndrome | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Renal and urinary disorders | ||||||
| Acute prerenal failure | 2/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Azotaemia | 0/5983 (0%) | 1/6059 (0%) | 1/5998 (0%) | |||
| Bladder mass | 0/5983 (0%) | 2/6059 (0%) | 1/5998 (0%) | |||
| Bladder neck obstruction | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Bladder obstruction | 1/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Bladder prolapse | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Bladder tamponade | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Calculus bladder | 2/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Calculus ureteric | 4/5983 (0.1%) | 1/6059 (0%) | 3/5998 (0.1%) | |||
| Calculus urinary | 1/5983 (0%) | 1/6059 (0%) | 1/5998 (0%) | |||
| Cystitis haemorrhagic | 0/5983 (0%) | 1/6059 (0%) | 1/5998 (0%) | |||
| Diabetic nephropathy | 0/5983 (0%) | 0/6059 (0%) | 2/5998 (0%) | |||
| Dysuria | 1/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Haematuria | 16/5983 (0.3%) | 14/6059 (0.2%) | 15/5998 (0.3%) | |||
| Haemorrhage urinary tract | 0/5983 (0%) | 3/6059 (0%) | 2/5998 (0%) | |||
| Hydronephrosis | 3/5983 (0.1%) | 0/6059 (0%) | 2/5998 (0%) | |||
| Nephritis | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Nephrolithiasis | 5/5983 (0.1%) | 3/6059 (0%) | 8/5998 (0.1%) | |||
| Nephropathy | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Nephrosclerosis | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Nephrotic syndrome | 1/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Obstructive uropathy | 2/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Pelvi-ureteric obstruction | 0/5983 (0%) | 2/6059 (0%) | 0/5998 (0%) | |||
| Renal artery stenosis | 1/5983 (0%) | 1/6059 (0%) | 2/5998 (0%) | |||
| Renal colic | 0/5983 (0%) | 0/6059 (0%) | 2/5998 (0%) | |||
| Renal cyst | 0/5983 (0%) | 1/6059 (0%) | 1/5998 (0%) | |||
| Renal disorder | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Renal failure | 15/5983 (0.3%) | 19/6059 (0.3%) | 27/5998 (0.5%) | |||
| Renal failure acute | 42/5983 (0.7%) | 38/6059 (0.6%) | 35/5998 (0.6%) | |||
| Renal failure chronic | 1/5983 (0%) | 0/6059 (0%) | 2/5998 (0%) | |||
| Renal impairment | 3/5983 (0.1%) | 5/6059 (0.1%) | 2/5998 (0%) | |||
| Renal mass | 3/5983 (0.1%) | 3/6059 (0%) | 4/5998 (0.1%) | |||
| Renal pain | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Renal tubular necrosis | 3/5983 (0.1%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Stress urinary incontinence | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Tubulointerstitial nephritis | 2/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Urethral haemorrhage | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Urethral obstruction | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Urethral stenosis | 4/5983 (0.1%) | 1/6059 (0%) | 1/5998 (0%) | |||
| Urinary bladder haemorrhage | 1/5983 (0%) | 1/6059 (0%) | 1/5998 (0%) | |||
| Urinary bladder polyp | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Urinary retention | 6/5983 (0.1%) | 4/6059 (0.1%) | 6/5998 (0.1%) | |||
| Urinary tract obstruction | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Reproductive system and breast disorders | ||||||
| Benign prostatic hyperplasia | 7/5983 (0.1%) | 5/6059 (0.1%) | 5/5998 (0.1%) | |||
| Breast mass | 0/5983 (0%) | 2/6059 (0%) | 2/5998 (0%) | |||
| Colpocele | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Cystocele | 0/5983 (0%) | 1/6059 (0%) | 1/5998 (0%) | |||
| Endometrial hyperplasia | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Epididymitis | 1/5983 (0%) | 0/6059 (0%) | 2/5998 (0%) | |||
| Gynaecomastia | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Ovarian cyst | 2/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Ovarian mass | 1/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Pelvic haematoma | 0/5983 (0%) | 0/6059 (0%) | 2/5998 (0%) | |||
| Postmenopausal haemorrhage | 1/5983 (0%) | 0/6059 (0%) | 3/5998 (0.1%) | |||
| Prostatic disorder | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Prostatic obstruction | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Prostatism | 1/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Prostatitis | 3/5983 (0.1%) | 3/6059 (0%) | 2/5998 (0%) | |||
| Prostatomegaly | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Rectocele | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Scrotal haematocoele | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Uterine enlargement | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Uterine prolapse | 1/5983 (0%) | 1/6059 (0%) | 2/5998 (0%) | |||
| Vaginal disorder | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Vaginal haemorrhage | 1/5983 (0%) | 2/6059 (0%) | 1/5998 (0%) | |||
| Vaginal polyp | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Vaginal prolapse | 2/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Respiratory, thoracic and mediastinal disorders | ||||||
| Acute interstitial pneumonitis | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Acute pulmonary oedema | 2/5983 (0%) | 6/6059 (0.1%) | 8/5998 (0.1%) | |||
| Acute respiratory distress syndrome | 1/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Acute respiratory failure | 2/5983 (0%) | 4/6059 (0.1%) | 3/5998 (0.1%) | |||
| Allergic cough | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Alveolitis allergic | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Asthma | 7/5983 (0.1%) | 2/6059 (0%) | 2/5998 (0%) | |||
| Atelectasis | 0/5983 (0%) | 1/6059 (0%) | 1/5998 (0%) | |||
| Bronchial secretion retention | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Bronchitis chronic | 1/5983 (0%) | 1/6059 (0%) | 3/5998 (0.1%) | |||
| Bronchospasm | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Chronic obstructive pulmonary disease | 24/5983 (0.4%) | 14/6059 (0.2%) | 20/5998 (0.3%) | |||
| Chronic respiratory failure | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Cough | 2/5983 (0%) | 2/6059 (0%) | 3/5998 (0.1%) | |||
| Diaphragmatic rupture | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Dyspnoea | 38/5983 (0.6%) | 43/6059 (0.7%) | 45/5998 (0.8%) | |||
| Dyspnoea exertional | 2/5983 (0%) | 2/6059 (0%) | 4/5998 (0.1%) | |||
| Emphysema | 1/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Eosinophilic pneumonia acute | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Epistaxis | 6/5983 (0.1%) | 10/6059 (0.2%) | 17/5998 (0.3%) | |||
| Haemoptysis | 5/5983 (0.1%) | 7/6059 (0.1%) | 9/5998 (0.2%) | |||
| Haemothorax | 3/5983 (0.1%) | 3/6059 (0%) | 2/5998 (0%) | |||
| Hiccups | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Hydropneumothorax | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Hydrothorax | 1/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Hypercapnia | 0/5983 (0%) | 1/6059 (0%) | 1/5998 (0%) | |||
| Hyperventilation | 0/5983 (0%) | 0/6059 (0%) | 2/5998 (0%) | |||
| Hypoventilation | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Hypoxia | 3/5983 (0.1%) | 1/6059 (0%) | 4/5998 (0.1%) | |||
| Idiopathic pulmonary fibrosis | 0/5983 (0%) | 2/6059 (0%) | 0/5998 (0%) | |||
| Interstitial lung disease | 0/5983 (0%) | 2/6059 (0%) | 0/5998 (0%) | |||
| Lung disorder | 4/5983 (0.1%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Lung infiltration | 0/5983 (0%) | 1/6059 (0%) | 3/5998 (0.1%) | |||
| Mediastinal mass | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Nasal congestion | 1/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Nasal septum deviation | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Nasal turbinate hypertrophy | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Nocturnal dyspnoea | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Oropharyngeal pain | 1/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Orthopnoea | 0/5983 (0%) | 1/6059 (0%) | 1/5998 (0%) | |||
| Pharyngeal mass | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Pickwickian syndrome | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Pleural effusion | 22/5983 (0.4%) | 17/6059 (0.3%) | 21/5998 (0.4%) | |||
| Pleurisy | 3/5983 (0.1%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Pleuritic pain | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Pneumomediastinum | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Pneumonia aspiration | 3/5983 (0.1%) | 1/6059 (0%) | 4/5998 (0.1%) | |||
| Pneumonitis | 0/5983 (0%) | 1/6059 (0%) | 2/5998 (0%) | |||
| Pneumothorax | 8/5983 (0.1%) | 3/6059 (0%) | 5/5998 (0.1%) | |||
| Postnasal drip | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Productive cough | 2/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Pulmonary alveolar haemorrhage | 1/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Pulmonary arterial hypertension | 0/5983 (0%) | 1/6059 (0%) | 1/5998 (0%) | |||
| Pulmonary congestion | 2/5983 (0%) | 0/6059 (0%) | 2/5998 (0%) | |||
| Pulmonary embolism | 1/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Pulmonary fibrosis | 3/5983 (0.1%) | 3/6059 (0%) | 2/5998 (0%) | |||
| Pulmonary haemorrhage | 0/5983 (0%) | 0/6059 (0%) | 2/5998 (0%) | |||
| Pulmonary hypertension | 3/5983 (0.1%) | 3/6059 (0%) | 2/5998 (0%) | |||
| Pulmonary mass | 1/5983 (0%) | 4/6059 (0.1%) | 4/5998 (0.1%) | |||
| Pulmonary oedema | 7/5983 (0.1%) | 7/6059 (0.1%) | 9/5998 (0.2%) | |||
| Pulmonary toxicity | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Respiratory acidosis | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Respiratory arrest | 2/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Respiratory disorder | 1/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Respiratory distress | 4/5983 (0.1%) | 3/6059 (0%) | 4/5998 (0.1%) | |||
| Respiratory failure | 9/5983 (0.2%) | 15/6059 (0.2%) | 15/5998 (0.3%) | |||
| Restrictive pulmonary disease | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Sinus disorder | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Sleep apnoea syndrome | 3/5983 (0.1%) | 2/6059 (0%) | 3/5998 (0.1%) | |||
| Status asthmaticus | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Tachypnoea | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Upper respiratory tract inflammation | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Wegener's granulomatosis | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Wheezing | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Skin and subcutaneous tissue disorders | ||||||
| Angioedema | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Blister | 1/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Campbell de Morgan spots | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Decubitus ulcer | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Dermatitis | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Dermatitis allergic | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Dermatitis contact | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Diabetic bullosis | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Diabetic ulcer | 1/5983 (0%) | 1/6059 (0%) | 1/5998 (0%) | |||
| Drug eruption | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Dry gangrene | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Ecchymosis | 0/5983 (0%) | 1/6059 (0%) | 2/5998 (0%) | |||
| Eczema | 1/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Eczema nummular | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Erythema | 1/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Erythema multiforme | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Haemorrhage subcutaneous | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Henoch-Schonlein purpura | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Hyperhidrosis | 0/5983 (0%) | 2/6059 (0%) | 2/5998 (0%) | |||
| Leukocytoclastic vasculitis | 1/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Pemphigoid | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Pemphigus | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Petechiae | 0/5983 (0%) | 0/6059 (0%) | 2/5998 (0%) | |||
| Photosensitivity allergic reaction | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Photosensitivity reaction | 1/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Pruritus | 0/5983 (0%) | 0/6059 (0%) | 2/5998 (0%) | |||
| Pruritus generalised | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Psoriasis | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Rash | 1/5983 (0%) | 3/6059 (0%) | 3/5998 (0.1%) | |||
| Rash erythematous | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Rash generalised | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Rash maculo-papular | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Skin ulcer | 6/5983 (0.1%) | 4/6059 (0.1%) | 6/5998 (0.1%) | |||
| Subcutaneous emphysema | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Swelling face | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Urticaria | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Social circumstances | ||||||
| Joint prosthesis user | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Refusal of treatment by patient | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Walking disability | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Surgical and medical procedures | ||||||
| Alcohol rehabilitation | 1/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Aortic aneurysm repair | 2/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Aortic valve repair | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Aortic valve replacement | 0/5983 (0%) | 0/6059 (0%) | 2/5998 (0%) | |||
| Arthrodesis | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Artificial urinary sphincter implant | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Bladder neoplasm surgery | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Bladder operation | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Cardiac ablation | 1/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Cardiac operation | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Cardiac pacemaker battery replacement | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Cardiac pacemaker insertion | 9/5983 (0.2%) | 7/6059 (0.1%) | 10/5998 (0.2%) | |||
| Cardiac pacemaker replacement | 0/5983 (0%) | 3/6059 (0%) | 1/5998 (0%) | |||
| Cardiac pacemaker revision | 0/5983 (0%) | 1/6059 (0%) | 1/5998 (0%) | |||
| Cardioversion | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Cataract operation | 2/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Chemotherapy | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Cholecystectomy | 0/5983 (0%) | 1/6059 (0%) | 2/5998 (0%) | |||
| Colon operation | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Contraceptive diaphragm | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Coronary angioplasty | 1/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Coronary artery bypass | 0/5983 (0%) | 2/6059 (0%) | 2/5998 (0%) | |||
| Craniotomy | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Debridement | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Dupuytren's contracture operation | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Endarterectomy | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Eventration procedure | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Explorative laparotomy | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Eye operation | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Gamma radiation therapy to prostate | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Gastrointestinal tube insertion | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Heart valve operation | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Hepatectomy | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Hernia repair | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| High frequency ablation | 2/5983 (0%) | 2/6059 (0%) | 1/5998 (0%) | |||
| Hip arthroplasty | 2/5983 (0%) | 3/6059 (0%) | 5/5998 (0.1%) | |||
| Hospitalisation | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Hysterectomy | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Hysterosalpingo-oophorectomy | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Implantable defibrillator insertion | 2/5983 (0%) | 1/6059 (0%) | 3/5998 (0.1%) | |||
| Incisional hernia repair | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Inguinal hernia repair | 1/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Internal fixation of fracture | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Knee arthroplasty | 0/5983 (0%) | 1/6059 (0%) | 1/5998 (0%) | |||
| Laparoscopic surgery | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Malignant tumour excision | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Mass excision | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Mastectomy | 1/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Medical device implantation | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Medical device removal | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Mitral valve repair | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Mitral valve replacement | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Nerve block | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Open reduction of fracture | 1/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Osteosynthesis | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Patellectomy | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Pleurodesis | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Polymedication | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Prostatic operation | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Radiotherapy | 1/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Resuscitation | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Shoulder arthroplasty | 1/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Skin neoplasm excision | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Small intestinal resection | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Spinal laminectomy | 0/5983 (0%) | 2/6059 (0%) | 1/5998 (0%) | |||
| Stent placement | 1/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Sternotomy | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Surgery | 2/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Tendon operation | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Thoracotomy | 3/5983 (0.1%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Thyroidectomy | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Toe amputation | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Transfusion | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Transurethral prostatectomy | 0/5983 (0%) | 0/6059 (0%) | 2/5998 (0%) | |||
| Umbilical hernia repair | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Uterine dilation and curettage | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Wound drainage | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Vascular disorders | ||||||
| Accelerated hypertension | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Aneurysm | 1/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Angiodysplasia | 0/5983 (0%) | 2/6059 (0%) | 0/5998 (0%) | |||
| Aortic aneurysm | 8/5983 (0.1%) | 8/6059 (0.1%) | 9/5998 (0.2%) | |||
| Aortic aneurysm rupture | 1/5983 (0%) | 1/6059 (0%) | 1/5998 (0%) | |||
| Aortic calcification | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Aortic dissection | 3/5983 (0.1%) | 1/6059 (0%) | 1/5998 (0%) | |||
| Aortic occlusion | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Aortic rupture | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Aortic stenosis | 11/5983 (0.2%) | 5/6059 (0.1%) | 8/5998 (0.1%) | |||
| Aortic thrombosis | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Arterial occlusive disease | 2/5983 (0%) | 1/6059 (0%) | 2/5998 (0%) | |||
| Arterial stenosis limb | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Arterial thrombosis limb | 3/5983 (0.1%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Arteriosclerosis | 2/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Arteriosclerosis obliterans | 3/5983 (0.1%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Bleeding varicose vein | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Circulatory collapse | 2/5983 (0%) | 2/6059 (0%) | 2/5998 (0%) | |||
| Deep vein thrombosis | 7/5983 (0.1%) | 4/6059 (0.1%) | 4/5998 (0.1%) | |||
| Embolism | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Exsanguination | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Extremity necrosis | 1/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Femoral arterial stenosis | 1/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Femoral artery occlusion | 1/5983 (0%) | 1/6059 (0%) | 1/5998 (0%) | |||
| Haematoma | 4/5983 (0.1%) | 7/6059 (0.1%) | 13/5998 (0.2%) | |||
| Haemorrhage | 7/5983 (0.1%) | 9/6059 (0.1%) | 8/5998 (0.1%) | |||
| Hypertension | 16/5983 (0.3%) | 10/6059 (0.2%) | 10/5998 (0.2%) | |||
| Hypertensive crisis | 1/5983 (0%) | 1/6059 (0%) | 3/5998 (0.1%) | |||
| Hypertensive emergency | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Hypotension | 17/5983 (0.3%) | 9/6059 (0.1%) | 14/5998 (0.2%) | |||
| Hypovolaemic shock | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Iliac artery occlusion | 0/5983 (0%) | 2/6059 (0%) | 0/5998 (0%) | |||
| Iliac artery stenosis | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Intermittent claudication | 3/5983 (0.1%) | 2/6059 (0%) | 2/5998 (0%) | |||
| Ischaemia | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Jugular vein distension | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Leriche syndrome | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Lymphangiectasia | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Orthostatic hypotension | 4/5983 (0.1%) | 4/6059 (0.1%) | 3/5998 (0.1%) | |||
| Peripheral arterial occlusive disease | 4/5983 (0.1%) | 3/6059 (0%) | 4/5998 (0.1%) | |||
| Peripheral artery aneurysm | 0/5983 (0%) | 2/6059 (0%) | 2/5998 (0%) | |||
| Peripheral embolism | 1/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Peripheral ischaemia | 2/5983 (0%) | 6/6059 (0.1%) | 2/5998 (0%) | |||
| Peripheral vascular disorder | 5/5983 (0.1%) | 6/6059 (0.1%) | 1/5998 (0%) | |||
| Phlebitis | 1/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Phlebitis deep | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Shock haemorrhagic | 0/5983 (0%) | 2/6059 (0%) | 0/5998 (0%) | |||
| Subclavian artery thrombosis | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Subclavian vein thrombosis | 0/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Temporal arteritis | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Thrombophlebitis | 2/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Thrombosis | 2/5983 (0%) | 2/6059 (0%) | 2/5998 (0%) | |||
| Varicose vein | 2/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Varicose vein ruptured | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Vascular insufficiency | 1/5983 (0%) | 1/6059 (0%) | 0/5998 (0%) | |||
| Vascular occlusion | 1/5983 (0%) | 0/6059 (0%) | 0/5998 (0%) | |||
| Vasculitis | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Venous haemorrhage | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Venous insufficiency | 0/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Venous thrombosis | 1/5983 (0%) | 0/6059 (0%) | 2/5998 (0%) | |||
| Venous thrombosis limb | 2/5983 (0%) | 0/6059 (0%) | 1/5998 (0%) | |||
| Wound haemorrhage | 0/5983 (0%) | 2/6059 (0%) | 2/5998 (0%) | |||
Other (Not Including Serious) Adverse Events |
||||||
| Dabigatran 110 mg | Dabigatran 150 mg | Warfarin | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 2286/5983 (38.2%) | 2273/6059 (37.5%) | 2118/5998 (35.3%) | |||
| Gastrointestinal disorders | ||||||
| Diarrhoea | 347/5983 (5.8%) | 360/6059 (5.9%) | 308/5998 (5.1%) | |||
| Dyspepsia | 362/5983 (6.1%) | 344/6059 (5.7%) | 83/5998 (1.4%) | |||
| General disorders | ||||||
| Chest pain | 258/5983 (4.3%) | 310/6059 (5.1%) | 296/5998 (4.9%) | |||
| Fatigue | 367/5983 (6.1%) | 361/6059 (6%) | 341/5998 (5.7%) | |||
| Oedema peripheral | 436/5983 (7.3%) | 439/6059 (7.2%) | 440/5998 (7.3%) | |||
| Infections and infestations | ||||||
| Nasopharyngitis | 315/5983 (5.3%) | 309/6059 (5.1%) | 327/5998 (5.5%) | |||
| Musculoskeletal and connective tissue disorders | ||||||
| Back pain | 281/5983 (4.7%) | 272/6059 (4.5%) | 322/5998 (5.4%) | |||
| Arthralgia | 246/5983 (4.1%) | 306/6059 (5.1%) | 318/5998 (5.3%) | |||
| Nervous system disorders | ||||||
| Dizziness | 442/5983 (7.4%) | 440/6059 (7.3%) | 536/5998 (8.9%) | |||
| Respiratory, thoracic and mediastinal disorders | ||||||
| Cough | 318/5983 (5.3%) | 308/6059 (5.1%) | 343/5998 (5.7%) | |||
| Dyspnoea | 460/5983 (7.7%) | 483/6059 (8%) | 506/5998 (8.4%) | |||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
Results Point of Contact
| Name/Title | Boehringer Ingelheim Call Center |
|---|---|
| Organization | Boehringer Ingelheim Pharmaceuticals |
| Phone | 1-800-243-0127 |
| clintriage.rdg@boehringer-ingelheim.com |
Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00262600
Other Study ID Numbers:
- 1160.26
- 2005-003894-26
First Posted:
Dec 7, 2005
Last Update Posted:
Apr 17, 2019
Last Verified:
Apr 1, 2014