Comparison of Tiotropium in the HandiHaler Versus the Respimat in Chronic Obstructive Pulmonary Disease
Sponsor
Boehringer Ingelheim (Industry)
Overall Status
Completed
CT.gov ID
NCT01126437
Collaborator
(none)
17,183
1191
3
36
14.4
0.4
Study Details
Study Description
Brief Summary
Direct comparison studies of the tiotropium HandiHaler® 18 µg and Respimat® 5 µg formulations have been limited to 4-week crossover studies. Therefore, prospective data from a trial of adequate size and duration is required to establish that compared to tiotropium HandiHaler®, tiotropium Respimat® will have (a) similar effects on safety and (b) similar or superior effects on exacerbations.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
17183 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
Primary Purpose:
Treatment
Official Title:
A Randomized, Active-controlled, Double-blind, Double-dummy, Parallel Group Design, Multi-center Trial to Compare the Efficacy and Safety of 2.5 µg and 5 µg Tiotropium Inhalation Solution Delivered by the Respimat Inhaler With Tiotropium Inhalation Capsules 18 µg Delivered by the HandiHaler (TIOSPIR)
Study Start Date
:
May 1, 2010
Actual Primary Completion Date
:
May 1, 2013
Actual Study Completion Date
:
May 1, 2013
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: tiotropium 2.5 mcg and placebo Patients receive one of the active tiotropium arms daily |
Drug: tiotropium 1.25 mcg (2 actuations/day)
soft mist inhaler 2 actuations=2 puffs/day
|
| Active Comparator: tiotropium 18 mcg and placebo Patients receive one of the active tiotropium arms daily |
Drug: tiotropium 18 mcg
HandiHaler
|
| Experimental: tiotropium 5 mcg and placebo Patients receive one of the active tiotropium arms daily |
Drug: tiotropium 2.5 mcg (2 actuations/day)
soft mist inhaler (2 actuations=2 puffs/day)
|
Outcome Measures
Primary Outcome Measures
- Time to All-Cause Mortality [Up to 3 years]
Number of patients with all-cause mortality
- Time to First COPD Exacerbation [Up to 3 years]
Defined as "a complex of lower respiratory events/symptoms (increase of new onset) related to the underlying COPD, with duration of three days or more, requiring a change in treatment" where a "complex of lower respiratory event/symptoms" was defined as having at least two of the following: shortness of breath, sputum production (volume), occurrence of purulent sputum, cough, wheezing, chest tightness and where "a required change in treatment" includes the following:Prescription of antibiotics and/or systemic steroids, and/or a newly prescribed maintenance respiratory medication (i.e., bronchodilators including theophyllines). "Onset of exacerbation" was defined by the onset of first recorded symptom. The "end of exacerbation" was decided by the investigator based on clinical judgement. Exacerbations were classified as follows: Mild:a new prescription of maintenance bronchodilator only Moderate:antibiotics or systemic steroids without hospitalization Severe:hospitalization.
Secondary Outcome Measures
- Trough FEV1 Over 120 Weeks (in a Substudy of 1370 Patients) [Up to 3 years]
Trough forced expiratory volume in one second (FEV1) over 120 weeks (in a substudy of 1370 patients)
- Number of COPD Exacerbations [Up to 3 years]
The number of COPD exacerbations. COPD exacerbation defined as "a complex of lower respiratory events/symptoms (increase of new onset) related to the underlying COPD, with duration of three days or more, requiring a change in treatment" where a "complex of lower respiratory event/symptoms" was defined as having at least two of the following: shortness of breath, sputum production (volume), occurrence of purulent sputum, cough, wheezing, chest tightness and where "a required change in treatment" includes the following:Prescription of antibiotics and/or systemic steroids, and/or a newly prescribed maintenance respiratory medication (i.e., bronchodilators including theophyllines).
- Time to First Hospitalization Associated With COPD Exacerbation [Up to 3 years]
The results presented below are for the patients with hospitalizations due to COPD exacerbations.
- Number of Hospitalizations Associated With COPD Exacerbation [Up to 3 years]
Total number of hospitalizations associated with COPD exacerbation.
- Time to First Moderate to Severe COPD Exacerbation [Up to 3 years]
COPD exacerbation defined as "a complex of lower respiratory events/symptoms (increase of new onset) related to the underlying COPD, with duration of three days or more, requiring a change in treatment" where a "complex of lower respiratory event/symptoms" was defined as having at least two of the following: shortness of breath, sputum production (volume), occurrence of purulent sputum, cough, wheezing, chest tightness and where "a required change in treatment" includes the following:Prescription of antibiotics and/or systemic steroids, and/or a newly prescribed maintenance respiratory medication (i.e., bronchodilators including theophyllines). Exacerbations classified as follows: Mild:a new prescription of maintenance bronchodilator only Moderate:antibiotics or systemic steroids without hospitalization Severe:hospitalization. Results presented below are number of patients with moderate to severe exacerbations.
- Time to Onset of First Major Adverse Cardiovascular Event (MACE) [Up to 3 years]
Time to onset of first major adverse cardiovascular event (MACE). MACE was defined as: Fatal event in the system organ classes of cardiac and vascular disorders, Preferred terms: sudden death, cardiac death, sudden cardiac death, Outcome events of myocardial infarction (serious and non-serious), Outcome events of stroke (serious and non-serious) and Outcome events of TIA (serious and non-serious). The results presented below are for the number of patients with MACE.
- Time to Death From Major Adverse Cardiovascular Event (MACE) [Up to 3 years]
The results presented below are number of patients with death from MACE.
Eligibility Criteria
Criteria
Ages Eligible for Study:
40 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion criteria:
-
All patients must sign an informed consent consistent with International Conference on Harmonization Good Clinical Practice (ICH-GCP) guidelines prior to participation in the trial, which includes medication washout and restrictions.
-
Male or female patients 40 years of age or older.
-
Patients must be current or ex-smokers with a smoking history of ≥10 pack-years. (Patients who have never smoked cigarettes must be excluded)
-
All patients must have a diagnosis of COPD (P06-12085), and must meet the following criteria: Relatively stable airway obstruction with a post-bronchodilator FEV1 ≤ 70% of predicted normal and post-bronchodilator FEV1 / FVC ≤70%.
Pulmonary function tests (PFTs) were conducted after the inhalation of 400 μg salbutamol / albuterol (preferred), however testing with either 200 μg salbutamol/albuterol or a combination of salbutamol / albuterol with ipratropium bromide (2 to 4 actuations) was acceptable. Other short-acting beta agonists, such as terbutaline, may have been used for the testing. The medication used for the testing was documented. Further, historical data from measurements within the past 6 months either at the site or at a referral site may have been used (see Section 6.2.1 of the CTP, located in Appendix 16.1.1). Subjects were not to have been randomized to the study without the availability of spirometry data at the actual study site.
Eligibility for PFT sub-study: For subjects participating in the spirometry sub-study, historical data may not have been used for inclusion. These subjects must have qualified in the clinic at Visit 1 after performing a baseline measurement. These subjects performed a pre-dose PFT which was followed by the administration of 400 μg salbutamol / albuterol only (no other short-acting beta agonist was allowed), followed by a post-dose PFT for qualification.
- Able to inhale from the HandiHaler® and the Respimat® devices.
Exclusion criteria:
-
Significant diseases other than COPD. A significant disease is defined as a disease or condition which, in the opinion of the investigator, may put the patient at risk because of participation in the study or may influence the patients ability to participate in the study.
-
Patients with a recent history (i.e., six months or less) of myocardial infarction.
-
Patients with any unstable or life-threatening cardiac arrhythmia requiring intervention or change in drug therapy during the last year.
-
Hospitalisation for cardiac failure (New York Heart Association (NYHA) Class III or
- during the past year.
-
Known active tuberculosis.
-
Patients with a history of asthma, cystic fibrosis, clinically evident bronchiectasis, interstitial lung disease, or pulmonary thromboembolic disease.
-
History of thoracotomy with pulmonary resection. Subjects with a history of thoracotomy for other reasons were to have been evaluated per exclusion criterion 1.
-
Subject was planning to undergo lung transplant or lung volume reduction surgery (LVRS).
-
Malignancy for which the subject had undergone resection, radiation, chemotherapy or biological treatments within the last 5 years. Subjects with treated basal cell carcinoma were allowed.
-
Known respiratory infection or exacerbation of COPD in the 4 weeks prior to randomization.
-
Known hypersensitivity to anticholinergic drugs, lactose, benzalkonium chloride (BAC), ethylenediaminetetraacetic acid (EDTA), or any other components of the HandiHaler® or Respimat® inhalation solution delivery system.
-
Known moderate to severe renal impairment (as judged by the investigator).
-
Known narrow angle glaucoma.
-
Known significant symptomatic prostatic hyperplasia or bladder-neck obstruction. Subjects whose symptoms were controlled on treatment may have been included.
-
Use of systemic corticosteroid medication at unstable doses (i.e., less than 6 weeks on stable dose) or at doses in excess of the equivalent of 10 mg prednisolone per day.
-
Pregnant or nursing women or women of childbearing potential not using a medically approved means of contraception for at least 3 months prior to and for the duration of the trial.
-
Significant alcohol or drug abuse within the past 12 months.
-
Subjects requiring the use of supplemental oxygen therapy for > 12 hours per day.
-
Subjects who had completed a pulmonary rehabilitation program in the 6 weeks prior to the screening visit or subjects who were currently in a pulmonary rehabilitation program that was not maintained throughout the duration of the study.
-
Subjects who had taken an investigational drug within 30 days prior to the Screening Visit.
-
Previous participation (receipt of randomized treatment) in this study.
-
Subjects who were currently participating in an interventional study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 205.452.01107 Boehringer Ingelheim Investigational Site | Athens | Alabama | United States | |
| 2 | 205.452.01023 Boehringer Ingelheim Investigational Site | Birmingham | Alabama | United States | |
| 3 | 205.452.01035 Boehringer Ingelheim Investigational Site | Birmingham | Alabama | United States | |
| 4 | 205.452.01052 Boehringer Ingelheim Investigational Site | Birmingham | Alabama | United States | |
| 5 | 205.452.01219 Boehringer Ingelheim Investigational Site | Birmingham | Alabama | United States | |
| 6 | 205.452.01227 Boehringer Ingelheim Investigational Site | Birmingham | Alabama | United States | |
| 7 | 205.452.01280 Boehringer Ingelheim Investigational Site | Birmingham | Alabama | United States | |
| 8 | 205.452.01198 Boehringer Ingelheim Investigational Site | Florence | Alabama | United States | |
| 9 | 205.452.01244 Boehringer Ingelheim Investigational Site | Mobile | Alabama | United States | |
| 10 | 205.452.01041 Boehringer Ingelheim Investigational Site | Montgomery | Alabama | United States | |
| 11 | 205.452.01070 Boehringer Ingelheim Investigational Site | Anchorage | Alaska | United States | |
| 12 | 205.452.01218 Boehringer Ingelheim Investigational Site | Chandler | Arizona | United States | |
| 13 | 205.452.01175 Boehringer Ingelheim Investigational Site | Mesa | Arizona | United States | |
| 14 | 205.452.01200 Boehringer Ingelheim Investigational Site | Mesa | Arizona | United States | |
| 15 | 205.452.01317 Boehringer Ingelheim Investigational Site | Mesa | Arizona | United States | |
| 16 | 205.452.01350 Boehringer Ingelheim Investigational Site | Pheonix | Arizona | United States | |
| 17 | 205.452.01254 Boehringer Ingelheim Investigational Site | Phoenix | Arizona | United States | |
| 18 | 205.452.01283 Boehringer Ingelheim Investigational Site | Phoenix | Arizona | United States | |
| 19 | 205.452.01315 Boehringer Ingelheim Investigational Site | Tempe | Arizona | United States | |
| 20 | 205.452.01158 Boehringer Ingelheim Investigational Site | Tucson | Arizona | United States | |
| 21 | 205.452.01161 Boehringer Ingelheim Investigational Site | Tucson | Arizona | United States | |
| 22 | 205.452.01302 Boehringer Ingelheim Investigational Site | Anaheim | California | United States | |
| 23 | 205.452.01038 Boehringer Ingelheim Investigational Site | Encinitas | California | United States | |
| 24 | 205.452.01313 Boehringer Ingelheim Investigational Site | Fountain Valley | California | United States | |
| 25 | 205.452.01375 Boehringer Ingelheim Investigational Site | Fountain Valley | California | United States | |
| 26 | 205.452.01074 Boehringer Ingelheim Investigational Site | Fullerton | California | United States | |
| 27 | 205.452.01345 Boehringer Ingelheim Investigational Site | Lancaster | California | United States | |
| 28 | 205.452.01171 Boehringer Ingelheim Investigational Site | Lincoln | California | United States | |
| 29 | 205.452.01339 Boehringer Ingelheim Investigational Site | Lomita | California | United States | |
| 30 | 205.452.01298 Boehringer Ingelheim Investigational Site | Los Angeles | California | United States | |
| 31 | 205.452.01356 Boehringer Ingelheim Investigational Site | Los Angeles | California | United States | |
| 32 | 205.452.01148 Boehringer Ingelheim Investigational Site | Orange | California | United States | |
| 33 | 205.452.01111 Boehringer Ingelheim Investigational Site | Palm Springs | California | United States | |
| 34 | 205.452.01147 Boehringer Ingelheim Investigational Site | Paramount | California | United States | |
| 35 | 205.452.01071 Boehringer Ingelheim Investigational Site | Poway | California | United States | |
| 36 | 205.452.01089 Boehringer Ingelheim Investigational Site | Rancho Cucamonga | California | United States | |
| 37 | 205.452.01097 Boehringer Ingelheim Investigational Site | Redlands | California | United States | |
| 38 | 205.452.01078 Boehringer Ingelheim Investigational Site | San Diego | California | United States | |
| 39 | 205.452.01176 Boehringer Ingelheim Investigational Site | San Diego | California | United States | |
| 40 | 205.452.01346 Boehringer Ingelheim Investigational Site | San Diego | California | United States | |
| 41 | 205.452.01306 Boehringer Ingelheim Investigational Site | San Jose | California | United States | |
| 42 | 205.452.01297 Boehringer Ingelheim Investigational Site | Santa Barbara | California | United States | |
| 43 | 205.452.01362 Boehringer Ingelheim Investigational Site | Tustin | California | United States | |
| 44 | 205.452.01225 Boehringer Ingelheim Investigational Site | Victorville | California | United States | |
| 45 | 205.452.01224 Boehringer Ingelheim Investigational Site | Walnut Creek | California | United States | |
| 46 | 205.452.01236 Boehringer Ingelheim Investigational Site | Wildomar | California | United States | |
| 47 | 205.452.01049 Boehringer Ingelheim Investigational Site | Colorado Springs | Colorado | United States | |
| 48 | 205.452.01245 Boehringer Ingelheim Investigational Site | Colorado Springs | Colorado | United States | |
| 49 | 205.452.01351 Boehringer Ingelheim Investigational Site | Denver | Colorado | United States | |
| 50 | 205.452.01018 Boehringer Ingelheim Investigational Site | Fort Collins | Colorado | United States | |
| 51 | 205.452.01005 Boehringer Ingelheim Investigational Site | Wheat Ridge | Colorado | United States | |
| 52 | 205.452.01024 Boehringer Ingelheim Investigational Site | Wheat Ridge | Colorado | United States | |
| 53 | 205.452.01199 Boehringer Ingelheim Investigational Site | Danbury | Connecticut | United States | |
| 54 | 205.452.01054 Boehringer Ingelheim Investigational Site | Hartford | Connecticut | United States | |
| 55 | 205.452.01072 Boehringer Ingelheim Investigational Site | Norwalk | Connecticut | United States | |
| 56 | 205.452.01040 Boehringer Ingelheim Investigational Site | Stamford | Connecticut | United States | |
| 57 | 205.452.01109 Boehringer Ingelheim Investigational Site | Waterbury | Connecticut | United States | |
| 58 | 205.452.01308 Boehringer Ingelheim Investigational Site | Newark | Delaware | United States | |
| 59 | 205.452.01011 Boehringer Ingelheim Investigational Site | Clearwater | Florida | United States | |
| 60 | 205.452.01209 Boehringer Ingelheim Investigational Site | Hialeah | Florida | United States | |
| 61 | 205.452.01360 Boehringer Ingelheim Investigational Site | Homestead | Florida | United States | |
| 62 | 205.452.01241 Boehringer Ingelheim Investigational Site | Jacksonville | Florida | United States | |
| 63 | 205.452.01337 Boehringer Ingelheim Investigational Site | Jacksonville | Florida | United States | |
| 64 | 205.452.01343 Boehringer Ingelheim Investigational Site | Jacksonville | Florida | United States | |
| 65 | 205.452.01184 Boehringer Ingelheim Investigational Site | Jupiter | Florida | United States | |
| 66 | 205.452.01138 Boehringer Ingelheim Investigational Site | Miami | Florida | United States | |
| 67 | 205.452.01246 Boehringer Ingelheim Investigational Site | Miami | Florida | United States | |
| 68 | 205.452.01321 Boehringer Ingelheim Investigational Site | Miami | Florida | United States | |
| 69 | 205.452.01290 Boehringer Ingelheim Investigational Site | New Port Richey | Florida | United States | |
| 70 | 205.452.01203 Boehringer Ingelheim Investigational Site | Ocala | Florida | United States | |
| 71 | 205.452.01174 Boehringer Ingelheim Investigational Site | Orlando | Florida | United States | |
| 72 | 205.452.01135 Boehringer Ingelheim Investigational Site | Ormond Beach | Florida | United States | |
| 73 | 205.452.01173 Boehringer Ingelheim Investigational Site | Oviedo | Florida | United States | |
| 74 | 205.452.01195 Boehringer Ingelheim Investigational Site | Panama City | Florida | United States | |
| 75 | 205.452.01197 Boehringer Ingelheim Investigational Site | Panama City | Florida | United States | |
| 76 | 205.452.01239 Boehringer Ingelheim Investigational Site | Pembroke Pines | Florida | United States | |
| 77 | 205.452.01247 Boehringer Ingelheim Investigational Site | Pembroke Pines | Florida | United States | |
| 78 | 205.452.01286 Boehringer Ingelheim Investigational Site | Pembroke Pines | Florida | United States | |
| 79 | 205.452.01240 Boehringer Ingelheim Investigational Site | Pensacola | Florida | United States | |
| 80 | 205.452.01260 Boehringer Ingelheim Investigational Site | Ponte Vedra | Florida | United States | |
| 81 | 205.452.01092 Boehringer Ingelheim Investigational Site | Rockledge | Florida | United States | |
| 82 | 205.452.01251 Boehringer Ingelheim Investigational Site | Sarasota | Florida | United States | |
| 83 | 205.452.01133 Boehringer Ingelheim Investigational Site | St. Petersburg | Florida | United States | |
| 84 | 205.452.01136 Boehringer Ingelheim Investigational Site | St. Petersburg | Florida | United States | |
| 85 | 205.452.01207 Boehringer Ingelheim Investigational Site | St. Petersburg | Florida | United States | |
| 86 | 205.452.01134 Boehringer Ingelheim Investigational Site | Tamarac | Florida | United States | |
| 87 | 205.452.01231 Boehringer Ingelheim Investigational Site | Tamarac | Florida | United States | |
| 88 | 205.452.01025 Boehringer Ingelheim Investigational Site | Tampa | Florida | United States | |
| 89 | 205.452.01250 Boehringer Ingelheim Investigational Site | Tampa | Florida | United States | |
| 90 | 205.452.01060 Boehringer Ingelheim Investigational Site | Winter Park | Florida | United States | |
| 91 | 205.452.01130 Boehringer Ingelheim Investigational Site | Atlanta | Georgia | United States | |
| 92 | 205.452.01047 Boehringer Ingelheim Investigational Site | Austell | Georgia | United States | |
| 93 | 205.452.01255 Boehringer Ingelheim Investigational Site | Columbus | Georgia | United States | |
| 94 | 205.452.01012 Boehringer Ingelheim Investigational Site | Conyers | Georgia | United States | |
| 95 | 205.452.01299 Boehringer Ingelheim Investigational Site | Gainesville | Georgia | United States | |
| 96 | 205.452.01288 Boehringer Ingelheim Investigational Site | Lawrenceville | Georgia | United States | |
| 97 | 205.452.01090 Boehringer Ingelheim Investigational Site | Snellville | Georgia | United States | |
| 98 | 205.452.01100 Boehringer Ingelheim Investigational Site | Honolulu | Hawaii | United States | |
| 99 | 205.452.01165 Boehringer Ingelheim Investigational Site | Boise | Idaho | United States | |
| 100 | 205.452.01059 Boehringer Ingelheim Investigational Site | Coeur d'Alene | Idaho | United States | |
| 101 | 205.452.01062 Boehringer Ingelheim Investigational Site | Eagle | Idaho | United States | |
| 102 | 205.452.01166 Boehringer Ingelheim Investigational Site | Hayden Lake | Idaho | United States | |
| 103 | 205.452.01275 Boehringer Ingelheim Investigational Site | Meridian | Idaho | United States | |
| 104 | 205.452.01330 Boehringer Ingelheim Investigational Site | Arlington Heights | Illinois | United States | |
| 105 | 205.452.01248 Boehringer Ingelheim Investigational Site | Belleville | Illinois | United States | |
| 106 | 205.452.01278 Boehringer Ingelheim Investigational Site | Chicago | Illinois | United States | |
| 107 | 205.452.01371 Boehringer Ingelheim Investigational Site | Downer Grove | Illinois | United States | |
| 108 | 205.452.01235 Boehringer Ingelheim Investigational Site | Lombard | Illinois | United States | |
| 109 | 205.452.01180 Boehringer Ingelheim Investigational Site | O'Fallon | Illinois | United States | |
| 110 | 205.452.01268 Boehringer Ingelheim Investigational Site | Oak Park | Illinois | United States | |
| 111 | 205.452.01359 Boehringer Ingelheim Investigational Site | Quincy | Illinois | United States | |
| 112 | 205.452.01347 Boehringer Ingelheim Investigational Site | Brownsburg | Indiana | United States | |
| 113 | 205.452.01153 Boehringer Ingelheim Investigational Site | Evansville | Indiana | United States | |
| 114 | 205.452.01301 Boehringer Ingelheim Investigational Site | Fishers | Indiana | United States | |
| 115 | 205.452.01141 Boehringer Ingelheim Investigational Site | Franklin | Indiana | United States | |
| 116 | 205.452.01137 Boehringer Ingelheim Investigational Site | Lafayette | Indiana | United States | |
| 117 | 205.452.01263 Boehringer Ingelheim Investigational Site | Muncie | Indiana | United States | |
| 118 | 205.452.01284 Boehringer Ingelheim Investigational Site | Council Bluffs | Iowa | United States | |
| 119 | 205.452.01021 Boehringer Ingelheim Investigational Site | Dubuque | Iowa | United States | |
| 120 | 205.452.01305 Boehringer Ingelheim Investigational Site | Lansing | Kansas | United States | |
| 121 | 205.452.01304 Boehringer Ingelheim Investigational Site | Olathe | Kansas | United States | |
| 122 | 205.452.01125 Boehringer Ingelheim Investigational Site | Overland Park | Kansas | United States | |
| 123 | 205.452.01068 Boehringer Ingelheim Investigational Site | Topeka | Kansas | United States | |
| 124 | 205.452.01063 Boehringer Ingelheim Investigational Site | Bowling Green | Kentucky | United States | |
| 125 | 205.452.01206 Boehringer Ingelheim Investigational Site | Fort Mitchell | Kentucky | United States | |
| 126 | 205.452.01289 Boehringer Ingelheim Investigational Site | Louisville | Kentucky | United States | |
| 127 | 205.452.01152 Boehringer Ingelheim Investigational Site | Paducah | Kentucky | United States | |
| 128 | 205.452.01015 Boehringer Ingelheim Investigational Site | Lafayette | Louisiana | United States | |
| 129 | 205.452.01091 Boehringer Ingelheim Investigational Site | Shreveport | Louisiana | United States | |
| 130 | 205.452.01329 Boehringer Ingelheim Investigational Site | Shreveport | Louisiana | United States | |
| 131 | 205.452.01364 Boehringer Ingelheim Investigational Site | Auburn | Maine | United States | |
| 132 | 205.452.01169 Boehringer Ingelheim Investigational Site | Bangor | Maine | United States | |
| 133 | 205.452.01022 Boehringer Ingelheim Investigational Site | Biddeford | Maine | United States | |
| 134 | 205.452.01053 Boehringer Ingelheim Investigational Site | Baltimore | Maryland | United States | |
| 135 | 205.452.01190 Boehringer Ingelheim Investigational Site | Elkridge | Maryland | United States | |
| 136 | 205.452.01336 Boehringer Ingelheim Investigational Site | Hollywood | Maryland | United States | |
| 137 | 205.452.01238 Boehringer Ingelheim Investigational Site | Towson | Maryland | United States | |
| 138 | 205.452.01243 Boehringer Ingelheim Investigational Site | Towson | Maryland | United States | |
| 139 | 205.452.01366 Boehringer Ingelheim Investigational Site | Fall River | Massachusetts | United States | |
| 140 | 205.452.01269 Boehringer Ingelheim Investigational Site | Haverhill | Massachusetts | United States | |
| 141 | 205.452.01208 Boehringer Ingelheim Investigational Site | New Bedford | Massachusetts | United States | |
| 142 | 205.452.01170 Boehringer Ingelheim Investigational Site | Worcester | Massachusetts | United States | |
| 143 | 205.452.01270 Boehringer Ingelheim Investigational Site | Ann Arbor | Michigan | United States | |
| 144 | 205.452.01349 Boehringer Ingelheim Investigational Site | Benzonia | Michigan | United States | |
| 145 | 205.452.01365 Boehringer Ingelheim Investigational Site | Chelsea | Michigan | United States | |
| 146 | 205.452.01149 Boehringer Ingelheim Investigational Site | Chesterfield | Michigan | United States | |
| 147 | 205.452.01146 Boehringer Ingelheim Investigational Site | Detroit | Michigan | United States | |
| 148 | 205.452.01139 Boehringer Ingelheim Investigational Site | Interlochen | Michigan | United States | |
| 149 | 205.452.01080 Boehringer Ingelheim Investigational Site | Kalamazoo | Michigan | United States | |
| 150 | 205.452.01310 Boehringer Ingelheim Investigational Site | Stevensville | Michigan | United States | |
| 151 | 205.452.01122 Boehringer Ingelheim Investigational Site | Traverse City | Michigan | United States | |
| 152 | 205.452.01081 Boehringer Ingelheim Investigational Site | Troy | Michigan | United States | |
| 153 | 205.452.01221 Boehringer Ingelheim Investigational Site | Troy | Michigan | United States | |
| 154 | 205.452.01205 Boehringer Ingelheim Investigational Site | Chaska | Minnesota | United States | |
| 155 | 205.452.01211 Boehringer Ingelheim Investigational Site | Edina | Minnesota | United States | |
| 156 | 205.452.01104 Boehringer Ingelheim Investigational Site | Fridley | Minnesota | United States | |
| 157 | 205.452.01113 Boehringer Ingelheim Investigational Site | Minneapolis | Minnesota | United States | |
| 158 | 205.452.01042 Boehringer Ingelheim Investigational Site | Rochester | Minnesota | United States | |
| 159 | 205.452.01019 Boehringer Ingelheim Investigational Site | Olive Branch | Mississippi | United States | |
| 160 | 205.452.01014 Boehringer Ingelheim Investigational Site | Chesterfield | Missouri | United States | |
| 161 | 205.452.01129 Boehringer Ingelheim Investigational Site | St. Charles | Missouri | United States | |
| 162 | 205.452.01110 Boehringer Ingelheim Investigational Site | St. Louis | Missouri | United States | |
| 163 | 205.452.01179 Boehringer Ingelheim Investigational Site | West Plains | Missouri | United States | |
| 164 | 205.452.01226 Boehringer Ingelheim Investigational Site | Billings | Montana | United States | |
| 165 | 205.452.01076 Boehringer Ingelheim Investigational Site | Butte | Montana | United States | |
| 166 | 205.452.01196 Boehringer Ingelheim Investigational Site | Missoula | Montana | United States | |
| 167 | 205.452.01150 Boehringer Ingelheim Investigational Site | Bellevue | Nebraska | United States | |
| 168 | 205.452.01187 Boehringer Ingelheim Investigational Site | Fremont | Nebraska | United States | |
| 169 | 205.452.01155 Boehringer Ingelheim Investigational Site | Omaha | Nebraska | United States | |
| 170 | 205.452.01073 Boehringer Ingelheim Investigational Site | Henderson | Nevada | United States | |
| 171 | 205.452.01031 Boehringer Ingelheim Investigational Site | Las Vegas | Nevada | United States | |
| 172 | 205.452.01261 Boehringer Ingelheim Investigational Site | Las Vegas | Nevada | United States | |
| 173 | 205.452.01026 Boehringer Ingelheim Investigational Site | Lebanon | New Hampshire | United States | |
| 174 | 205.452.01369 Boehringer Ingelheim Investigational Site | Newington | New Hampshire | United States | |
| 175 | 205.452.01296 Boehringer Ingelheim Investigational Site | Ocean | New Jersey | United States | |
| 176 | 205.452.01046 Boehringer Ingelheim Investigational Site | Toms River | New Jersey | United States | |
| 177 | 205.452.01061 Boehringer Ingelheim Investigational Site | Albuquerque | New Mexico | United States | |
| 178 | 205.452.01167 Boehringer Ingelheim Investigational Site | Albuquerque | New Mexico | United States | |
| 179 | 205.452.01159 Boehringer Ingelheim Investigational Site | Bayside | New York | United States | |
| 180 | 205.452.01163 Boehringer Ingelheim Investigational Site | Bronxville | New York | United States | |
| 181 | 205.452.01194 Boehringer Ingelheim Investigational Site | Cooperstown | New York | United States | |
| 182 | 205.452.01131 Boehringer Ingelheim Investigational Site | Elmira | New York | United States | |
| 183 | 205.452.01142 Boehringer Ingelheim Investigational Site | Endwell | New York | United States | |
| 184 | 205.452.01192 Boehringer Ingelheim Investigational Site | Glens Falls | New York | United States | |
| 185 | 205.452.01279 Boehringer Ingelheim Investigational Site | Great Neck | New York | United States | |
| 186 | 205.452.01328 Boehringer Ingelheim Investigational Site | Honeoye Falls | New York | United States | |
| 187 | 205.452.01118 Boehringer Ingelheim Investigational Site | New Windsor | New York | United States | |
| 188 | 205.452.01127 Boehringer Ingelheim Investigational Site | New York | New York | United States | |
| 189 | 205.452.01058 Boehringer Ingelheim Investigational Site | Rochester | New York | United States | |
| 190 | 205.452.01085 Boehringer Ingelheim Investigational Site | Syracuse | New York | United States | |
| 191 | 205.452.01293 Boehringer Ingelheim Investigational Site | Syracuse | New York | United States | |
| 192 | 205.452.01151 Boehringer Ingelheim Investigational Site | Vestal | New York | United States | |
| 193 | 205.452.01188 Boehringer Ingelheim Investigational Site | Westfield | New York | United States | |
| 194 | 205.452.01271 Boehringer Ingelheim Investigational Site | Asheville | North Carolina | United States | |
| 195 | 205.452.01101 Boehringer Ingelheim Investigational Site | Burlington | North Carolina | United States | |
| 196 | 205.452.01264 Boehringer Ingelheim Investigational Site | Calabash | North Carolina | United States | |
| 197 | 205.452.01168 Boehringer Ingelheim Investigational Site | Charlotte | North Carolina | United States | |
| 198 | 205.452.01108 Boehringer Ingelheim Investigational Site | Elizabeth City | North Carolina | United States | |
| 199 | 205.452.01033 Boehringer Ingelheim Investigational Site | Greensboro | North Carolina | United States | |
| 200 | 205.452.01172 Boehringer Ingelheim Investigational Site | Greensboro | North Carolina | United States | |
| 201 | 205.452.01098 Boehringer Ingelheim Investigational Site | Hickory | North Carolina | United States | |
| 202 | 205.452.01115 Boehringer Ingelheim Investigational Site | Hickory | North Carolina | United States | |
| 203 | 205.452.01128 Boehringer Ingelheim Investigational Site | Raleigh | North Carolina | United States | |
| 204 | 205.452.01352 Boehringer Ingelheim Investigational Site | Rocky Mount | North Carolina | United States | |
| 205 | 205.452.01348 Boehringer Ingelheim Investigational Site | Salisbury | North Carolina | United States | |
| 206 | 205.452.01032 Boehringer Ingelheim Investigational Site | Statesville | North Carolina | United States | |
| 207 | 205.452.01276 Boehringer Ingelheim Investigational Site | Tabor City | North Carolina | United States | |
| 208 | 205.452.01157 Boehringer Ingelheim Investigational Site | Wilmington | North Carolina | United States | |
| 209 | 205.452.01363 Boehringer Ingelheim Investigational Site | Winston Salem | North Carolina | United States | |
| 210 | 205.452.01193 Boehringer Ingelheim Investigational Site | Canal Fulton | Ohio | United States | |
| 211 | 205.452.01374 Boehringer Ingelheim Investigational Site | Centerville | Ohio | United States | |
| 212 | 205.452.01006 Boehringer Ingelheim Investigational Site | Cincinnati | Ohio | United States | |
| 213 | 205.452.01373 Boehringer Ingelheim Investigational Site | Cincinnati | Ohio | United States | |
| 214 | 205.452.01314 Boehringer Ingelheim Investigational Site | Cleveland | Ohio | United States | |
| 215 | 205.452.01210 Boehringer Ingelheim Investigational Site | Columbus | Ohio | United States | |
| 216 | 205.452.01232 Boehringer Ingelheim Investigational Site | Columbus | Ohio | United States | |
| 217 | 205.452.01309 Boehringer Ingelheim Investigational Site | Dayton | Ohio | United States | |
| 218 | 205.452.01140 Boehringer Ingelheim Investigational Site | Delaware | Ohio | United States | |
| 219 | 205.452.01084 Boehringer Ingelheim Investigational Site | Sylvania | Ohio | United States | |
| 220 | 205.452.01287 Boehringer Ingelheim Investigational Site | Toledo | Ohio | United States | |
| 221 | 205.452.01010 Boehringer Ingelheim Investigational Site | Oklahoma City | Oklahoma | United States | |
| 222 | 205.452.01094 Boehringer Ingelheim Investigational Site | Oklahoma City | Oklahoma | United States | |
| 223 | 205.452.01029 Boehringer Ingelheim Investigational Site | Tulsa | Oklahoma | United States | |
| 224 | 205.452.01043 Boehringer Ingelheim Investigational Site | Tulsa | Oklahoma | United States | |
| 225 | 205.452.01266 Boehringer Ingelheim Investigational Site | Ashland | Oregon | United States | |
| 226 | 205.452.01083 Boehringer Ingelheim Investigational Site | Bend | Oregon | United States | |
| 227 | 205.452.01189 Boehringer Ingelheim Investigational Site | Corvallis | Oregon | United States | |
| 228 | 205.452.01341 Boehringer Ingelheim Investigational Site | Springfield | Oregon | United States | |
| 229 | 205.452.01002 Boehringer Ingelheim Investigational Site | Altoona | Pennsylvania | United States | |
| 230 | 205.452.01354 Boehringer Ingelheim Investigational Site | Beaver | Pennsylvania | United States | |
| 231 | 205.452.01143 Boehringer Ingelheim Investigational Site | Carnegie | Pennsylvania | United States | |
| 232 | 205.452.01320 Boehringer Ingelheim Investigational Site | Downingtown | Pennsylvania | United States | |
| 233 | 205.452.01323 Boehringer Ingelheim Investigational Site | Erie | Pennsylvania | United States | |
| 234 | 205.452.01257 Boehringer Ingelheim Investigational Site | Jefferson Hills | Pennsylvania | United States | |
| 235 | 205.452.01332 Boehringer Ingelheim Investigational Site | Langhorne | Pennsylvania | United States | |
| 236 | 205.452.01075 Boehringer Ingelheim Investigational Site | Norristown | Pennsylvania | United States | |
| 237 | 205.452.01087 Boehringer Ingelheim Investigational Site | Philadelphia | Pennsylvania | United States | |
| 238 | 205.452.01144 Boehringer Ingelheim Investigational Site | Philadelphia | Pennsylvania | United States | |
| 239 | 205.452.01003 Boehringer Ingelheim Investigational Site | Pittsburgh | Pennsylvania | United States | |
| 240 | 205.452.01361 Boehringer Ingelheim Investigational Site | Pittsburgh | Pennsylvania | United States | |
| 241 | 205.452.01036 Boehringer Ingelheim Investigational Site | Pleasant Hills | Pennsylvania | United States | |
| 242 | 205.452.01106 Boehringer Ingelheim Investigational Site | Uniontown | Pennsylvania | United States | |
| 243 | 205.452.01156 Boehringer Ingelheim Investigational Site | Uniontown | Pennsylvania | United States | |
| 244 | 205.452.01204 Boehringer Ingelheim Investigational Site | Warminster | Pennsylvania | United States | |
| 245 | 205.452.01338 Boehringer Ingelheim Investigational Site | Wyomissing | Pennsylvania | United States | |
| 246 | 205.452.01267 Boehringer Ingelheim Investigational Site | Cranston | Rhode Island | United States | |
| 247 | 205.452.01214 Boehringer Ingelheim Investigational Site | Johnston | Rhode Island | United States | |
| 248 | 205.452.01340 Boehringer Ingelheim Investigational Site | Anderson | South Carolina | United States | |
| 249 | 205.452.01066 Boehringer Ingelheim Investigational Site | Charleston | South Carolina | United States | |
| 250 | 205.452.01217 Boehringer Ingelheim Investigational Site | Columbia | South Carolina | United States | |
| 251 | 205.452.01303 Boehringer Ingelheim Investigational Site | Easley | South Carolina | United States | |
| 252 | 205.452.01259 Boehringer Ingelheim Investigational Site | Florence | South Carolina | United States | |
| 253 | 205.452.01013 Boehringer Ingelheim Investigational Site | Gaffney | South Carolina | United States | |
| 254 | 205.452.01077 Boehringer Ingelheim Investigational Site | Greenville | South Carolina | United States | |
| 255 | 205.452.01093 Boehringer Ingelheim Investigational Site | Greer | South Carolina | United States | |
| 256 | 205.452.01295 Boehringer Ingelheim Investigational Site | Hodges | South Carolina | United States | |
| 257 | 205.452.01335 Boehringer Ingelheim Investigational Site | Myrtle Beach | South Carolina | United States | |
| 258 | 205.452.01056 Boehringer Ingelheim Investigational Site | Rock Hill | South Carolina | United States | |
| 259 | 205.452.01294 Boehringer Ingelheim Investigational Site | Spartanburg | South Carolina | United States | |
| 260 | 205.452.01004 Boehringer Ingelheim Investigational Site | Rapid City | South Dakota | United States | |
| 261 | 205.452.01126 Boehringer Ingelheim Investigational Site | Brentwood | Tennessee | United States | |
| 262 | 205.452.01220 Boehringer Ingelheim Investigational Site | Chattanooga | Tennessee | United States | |
| 263 | 205.452.01324 Boehringer Ingelheim Investigational Site | Chattanooga | Tennessee | United States | |
| 264 | 205.452.01342 Boehringer Ingelheim Investigational Site | Kingsport | Tennessee | United States | |
| 265 | 205.452.01096 Boehringer Ingelheim Investigational Site | Arlington | Texas | United States | |
| 266 | 205.452.01050 Boehringer Ingelheim Investigational Site | Corsicana | Texas | United States | |
| 267 | 205.452.01233 Boehringer Ingelheim Investigational Site | Dallas | Texas | United States | |
| 268 | 205.452.01334 Boehringer Ingelheim Investigational Site | Dallas | Texas | United States | |
| 269 | 205.452.01057 Boehringer Ingelheim Investigational Site | Fort Worth | Texas | United States | |
| 270 | 205.452.01181 Boehringer Ingelheim Investigational Site | Fort Worth | Texas | United States | |
| 271 | 205.452.01272 Boehringer Ingelheim Investigational Site | Fort Worth | Texas | United States | |
| 272 | 205.452.01082 Boehringer Ingelheim Investigational Site | Houston | Texas | United States | |
| 273 | 205.452.01105 Boehringer Ingelheim Investigational Site | Houston | Texas | United States | |
| 274 | 205.452.01178 Boehringer Ingelheim Investigational Site | Houston | Texas | United States | |
| 275 | 205.452.01212 Boehringer Ingelheim Investigational Site | Houston | Texas | United States | |
| 276 | 205.452.01274 Boehringer Ingelheim Investigational Site | Longview | Texas | United States | |
| 277 | 205.452.01116 Boehringer Ingelheim Investigational Site | McKinney | Texas | United States | |
| 278 | 205.452.01262 Boehringer Ingelheim Investigational Site | Richardson | Texas | United States | |
| 279 | 205.452.01055 Boehringer Ingelheim Investigational Site | San Antonio | Texas | United States | |
| 280 | 205.452.01182 Boehringer Ingelheim Investigational Site | San Antonio | Texas | United States | |
| 281 | 205.452.01186 Boehringer Ingelheim Investigational Site | San Antonio | Texas | United States | |
| 282 | 205.452.01353 Boehringer Ingelheim Investigational Site | San Antonio | Texas | United States | |
| 283 | 205.452.01215 Boehringer Ingelheim Investigational Site | Sugar Land | Texas | United States | |
| 284 | 205.452.01223 Boehringer Ingelheim Investigational Site | Midvale | Utah | United States | |
| 285 | 205.452.01001 Boehringer Ingelheim Investigational Site | Salt Lake City | Utah | United States | |
| 286 | 205.452.01079 Boehringer Ingelheim Investigational Site | Abingdon | Virginia | United States | |
| 287 | 205.452.01234 Boehringer Ingelheim Investigational Site | Alexandria | Virginia | United States | |
| 288 | 205.452.01065 Boehringer Ingelheim Investigational Site | Danville | Virginia | United States | |
| 289 | 205.452.01285 Boehringer Ingelheim Investigational Site | Danville | Virginia | United States | |
| 290 | 205.452.01045 Boehringer Ingelheim Investigational Site | Ettrick | Virginia | United States | |
| 291 | 205.452.01030 Boehringer Ingelheim Investigational Site | Lynchburg | Virginia | United States | |
| 292 | 205.452.01016 Boehringer Ingelheim Investigational Site | Richmond | Virginia | United States | |
| 293 | 205.452.01039 Boehringer Ingelheim Investigational Site | Richmond | Virginia | United States | |
| 294 | 205.452.01044 Boehringer Ingelheim Investigational Site | Richmond | Virginia | United States | |
| 295 | 205.452.01300 Boehringer Ingelheim Investigational Site | Richmond | Virginia | United States | |
| 296 | 205.452.01099 Boehringer Ingelheim Investigational Site | Selah | Washington | United States | |
| 297 | 205.452.01008 Boehringer Ingelheim Investigational Site | Spokane | Washington | United States | |
| 298 | 205.452.01069 Boehringer Ingelheim Investigational Site | Spokane | Washington | United States | |
| 299 | 205.452.01145 Boehringer Ingelheim Investigational Site | Spokane | Washington | United States | |
| 300 | 205.452.01185 Boehringer Ingelheim Investigational Site | Tacoma | Washington | United States | |
| 301 | 205.452.01007 Boehringer Ingelheim Investigational Site | Wenatchee | Washington | United States | |
| 302 | 205.452.01201 Boehringer Ingelheim Investigational Site | Oregon | Wisconsin | United States | |
| 303 | 205.452.01344 Boehringer Ingelheim Investigational Site | West Allis | Wisconsin | United States | |
| 304 | 205.452.54003 Boehringer Ingelheim Investigational Site | Capital Federal | Argentina | ||
| 305 | 205.452.54011 Boehringer Ingelheim Investigational Site | Capital Federal | Argentina | ||
| 306 | 205.452.54013 Boehringer Ingelheim Investigational Site | Capital Federal | Argentina | ||
| 307 | 205.452.54027 Boehringer Ingelheim Investigational Site | Capital Federal | Argentina | ||
| 308 | 205.452.54029 Boehringer Ingelheim Investigational Site | Capital Federal | Argentina | ||
| 309 | 205.452.54031 Boehringer Ingelheim Investigational Site | Capital Federal | Argentina | ||
| 310 | 205.452.54025 Boehringer Ingelheim Investigational Site | Florencio Varela | Argentina | ||
| 311 | 205.452.54007 Boehringer Ingelheim Investigational Site | Mar del Plata | Argentina | ||
| 312 | 205.452.54015 Boehringer Ingelheim Investigational Site | Mar del Plata | Argentina | ||
| 313 | 205.452.54001 Boehringer Ingelheim Investigational Site | Mendoza | Argentina | ||
| 314 | 205.452.54019 Boehringer Ingelheim Investigational Site | Monte Grande | Argentina | ||
| 315 | 205.452.54005 Boehringer Ingelheim Investigational Site | Quilmes | Argentina | ||
| 316 | 205.452.54009 Boehringer Ingelheim Investigational Site | Rosario | Argentina | ||
| 317 | 205.452.54021 Boehringer Ingelheim Investigational Site | Rosario | Argentina | ||
| 318 | 205.452.54017 Boehringer Ingelheim Investigational Site | San Miguel de Tucumán | Argentina | ||
| 319 | 205.452.54023 Boehringer Ingelheim Investigational Site | San Miguel de Tucumán | Argentina | ||
| 320 | 205.452.61006 Boehringer Ingelheim Investigational Site | Adelaide | South Australia | Australia | |
| 321 | 205.452.61002 Boehringer Ingelheim Investigational Site | Woodville | South Australia | Australia | |
| 322 | 205.452.61004 Boehringer Ingelheim Investigational Site | Box Hill | Victoria | Australia | |
| 323 | 205.452.61003 Boehringer Ingelheim Investigational Site | Footscray | Victoria | Australia | |
| 324 | 205.452.61001 Boehringer Ingelheim Investigational Site | Frankston | Victoria | Australia | |
| 325 | 205.452.61005 Boehringer Ingelheim Investigational Site | Nedlands | Western Australia | Australia | |
| 326 | 205.452.43002 Boehringer Ingelheim Investigational Site | Feldbach | Austria | ||
| 327 | 205.452.43003 Boehringer Ingelheim Investigational Site | Hallein | Austria | ||
| 328 | 205.452.43005 Boehringer Ingelheim Investigational Site | Thalheim bei Wels | Austria | ||
| 329 | 205.452.32009 Boehringer Ingelheim Investigational Site | Godinne | Belgium | ||
| 330 | 205.452.32007 Boehringer Ingelheim Investigational Site | Gozée | Belgium | ||
| 331 | 205.452.32002 Boehringer Ingelheim Investigational Site | Halen | Belgium | ||
| 332 | 205.452.32001 Boehringer Ingelheim Investigational Site | Leuven | Belgium | ||
| 333 | 205.452.32006 Boehringer Ingelheim Investigational Site | Linkebeek | Belgium | ||
| 334 | 205.452.32005 Boehringer Ingelheim Investigational Site | Merksem | Belgium | ||
| 335 | 205.452.32008 Boehringer Ingelheim Investigational Site | Natoye | Belgium | ||
| 336 | 205.452.32003 Boehringer Ingelheim Investigational Site | Tessenderlo | Belgium | ||
| 337 | 205.452.32004 Boehringer Ingelheim Investigational Site | Zichem | Belgium | ||
| 338 | 205.452.55005 Boehringer Ingelheim Investigational Site | Florianópolis | Brazil | ||
| 339 | 205.452.55010 Boehringer Ingelheim Investigational Site | Passo Fundo - RS | Brazil | ||
| 340 | 205.452.55001 Boehringer Ingelheim Investigational Site | Porto Alegre | Brazil | ||
| 341 | 205.452.55002 Boehringer Ingelheim Investigational Site | Porto Alegre | Brazil | ||
| 342 | 205.452.55003 Boehringer Ingelheim Investigational Site | Recife | Brazil | ||
| 343 | 205.452.55004 Boehringer Ingelheim Investigational Site | Rio de Janeiro | Brazil | ||
| 344 | 205.452.55011 Boehringer Ingelheim Investigational Site | Río de Janeiro | Brazil | ||
| 345 | 205.452.55008 Boehringer Ingelheim Investigational Site | Sao Pablo | Brazil | ||
| 346 | 205.452.55009 Boehringer Ingelheim Investigational Site | Sao Paulo | Brazil | ||
| 347 | 205.452.55006 Boehringer Ingelheim Investigational Site | São Paulo | Brazil | ||
| 348 | 205.452.55007 Boehringer Ingelheim Investigational Site | São Paulo | Brazil | ||
| 349 | 205.452.35909 Boehringer Ingelheim Investigational Site | Plovdiv | Bulgaria | ||
| 350 | 205.452.35910 Boehringer Ingelheim Investigational Site | Plovdiv | Bulgaria | ||
| 351 | 205.452.35901 Boehringer Ingelheim Investigational Site | Sofia | Bulgaria | ||
| 352 | 205.452.35902 Boehringer Ingelheim Investigational Site | Sofia | Bulgaria | ||
| 353 | 205.452.35903 Boehringer Ingelheim Investigational Site | Sofia | Bulgaria | ||
| 354 | 205.452.35904 Boehringer Ingelheim Investigational Site | Sofia | Bulgaria | ||
| 355 | 205.452.35905 Boehringer Ingelheim Investigational Site | Sofia | Bulgaria | ||
| 356 | 205.452.35908 Boehringer Ingelheim Investigational Site | Sofia | Bulgaria | ||
| 357 | 205.452.35914 Boehringer Ingelheim Investigational Site | Sofia | Bulgaria | ||
| 358 | 205.452.35915 Boehringer Ingelheim Investigational Site | Sofia | Bulgaria | ||
| 359 | 205.452.35912 Boehringer Ingelheim Investigational Site | Stara Zagora | Bulgaria | ||
| 360 | 205.452.35906 Boehringer Ingelheim Investigational Site | Veliko Turnovo | Bulgaria | ||
| 361 | 205.452.11015 Boehringer Ingelheim Investigational Site | Calgary | Alberta | Canada | |
| 362 | 205.452.11032 Boehringer Ingelheim Investigational Site | Calgary | Alberta | Canada | |
| 363 | 205.452.11028 Boehringer Ingelheim Investigational Site | Edmonton | Alberta | Canada | |
| 364 | 205.452.11037 Boehringer Ingelheim Investigational Site | Edmonton | Alberta | Canada | |
| 365 | 205.452.11045 Boehringer Ingelheim Investigational Site | Edmonton | Alberta | Canada | |
| 366 | 205.452.11047 Boehringer Ingelheim Investigational Site | Edmonton | Alberta | Canada | |
| 367 | 205.452.11002 Boehringer Ingelheim Investigational Site | Spruce Grove | Alberta | Canada | |
| 368 | 205.452.11048 Boehringer Ingelheim Investigational Site | Kelowna | British Columbia | Canada | |
| 369 | 205.452.11051 Boehringer Ingelheim Investigational Site | Maple Ridge | British Columbia | Canada | |
| 370 | 205.452.11014 Boehringer Ingelheim Investigational Site | Vancouver | British Columbia | Canada | |
| 371 | 205.452.11016 Boehringer Ingelheim Investigational Site | Vancouver | British Columbia | Canada | |
| 372 | 205.452.11025 Boehringer Ingelheim Investigational Site | Winnipeg | Manitoba | Canada | |
| 373 | 205.452.11033 Boehringer Ingelheim Investigational Site | Moncton | New Brunswick | Canada | |
| 374 | 205.452.11010 Boehringer Ingelheim Investigational Site | Saint John | New Brunswick | Canada | |
| 375 | 205.452.11044 Boehringer Ingelheim Investigational Site | Grand Falls-Windsor | Newfoundland and Labrador | Canada | |
| 376 | 205.452.11053 Boehringer Ingelheim Investigational Site | Mount Pearl | Newfoundland and Labrador | Canada | |
| 377 | 205.452.11017 Boehringer Ingelheim Investigational Site | St. John's | Newfoundland and Labrador | Canada | |
| 378 | 205.452.11021 Boehringer Ingelheim Investigational Site | St. John's | Newfoundland and Labrador | Canada | |
| 379 | 205.452.11030 Boehringer Ingelheim Investigational Site | Burlington | Ontario | Canada | |
| 380 | 205.452.11042 Boehringer Ingelheim Investigational Site | Corunna | Ontario | Canada | |
| 381 | 205.452.11049 Boehringer Ingelheim Investigational Site | Courtice | Ontario | Canada | |
| 382 | 205.452.11004 Boehringer Ingelheim Investigational Site | Downsview | Ontario | Canada | |
| 383 | 205.452.11009 Boehringer Ingelheim Investigational Site | Hamilton | Ontario | Canada | |
| 384 | 205.452.11029 Boehringer Ingelheim Investigational Site | Hamilton | Ontario | Canada | |
| 385 | 205.452.11050 Boehringer Ingelheim Investigational Site | Hamilton | Ontario | Canada | |
| 386 | 205.452.11040 Boehringer Ingelheim Investigational Site | Kingston | Ontario | Canada | |
| 387 | 205.452.11035 Boehringer Ingelheim Investigational Site | London | Ontario | Canada | |
| 388 | 205.452.11001 Boehringer Ingelheim Investigational Site | Mississauga | Ontario | Canada | |
| 389 | 205.452.11054 Boehringer Ingelheim Investigational Site | Mississauga | Ontario | Canada | |
| 390 | 205.452.11022 Boehringer Ingelheim Investigational Site | Newmarket | Ontario | Canada | |
| 391 | 205.452.11024 Boehringer Ingelheim Investigational Site | Ottawa | Ontario | Canada | |
| 392 | 205.452.11027 Boehringer Ingelheim Investigational Site | Richmond Hill | Ontario | Canada | |
| 393 | 205.452.11041 Boehringer Ingelheim Investigational Site | Sarnia | Ontario | Canada | |
| 394 | 205.452.11019 Boehringer Ingelheim Investigational Site | Toronto | Ontario | Canada | |
| 395 | 205.452.11034 Boehringer Ingelheim Investigational Site | Toronto | Ontario | Canada | |
| 396 | 205.452.11052 Boehringer Ingelheim Investigational Site | Toronto | Ontario | Canada | |
| 397 | 205.452.11012 Boehringer Ingelheim Investigational Site | Windsor | Ontario | Canada | |
| 398 | 205.452.11007 Boehringer Ingelheim Investigational Site | Greenfield Park | Quebec | Canada | |
| 399 | 205.452.11005 Boehringer Ingelheim Investigational Site | La Malbaie | Quebec | Canada | |
| 400 | 205.452.11006 Boehringer Ingelheim Investigational Site | Longueuil | Quebec | Canada | |
| 401 | 205.452.11043 Boehringer Ingelheim Investigational Site | Montreal | Quebec | Canada | |
| 402 | 205.452.11013 Boehringer Ingelheim Investigational Site | Point Claire | Quebec | Canada | |
| 403 | 205.452.11018 Boehringer Ingelheim Investigational Site | Sherbrooke | Quebec | Canada | |
| 404 | 205.452.11020 Boehringer Ingelheim Investigational Site | St. Lambert | Quebec | Canada | |
| 405 | 205.452.11026 Boehringer Ingelheim Investigational Site | Trois-Rivieres | Quebec | Canada | |
| 406 | 205.452.11003 Boehringer Ingelheim Investigational Site | Saskatoon | Saskatchewan | Canada | |
| 407 | 205.452.11011 Boehringer Ingelheim Investigational Site | Saskatoon | Saskatchewan | Canada | |
| 408 | 205.452.11036 Boehringer Ingelheim Investigational Site | Saskatoon | Saskatchewan | Canada | |
| 409 | 205.452.11039 Boehringer Ingelheim Investigational Site | Saskatoon | Saskatchewan | Canada | |
| 410 | 205.452.11031 Boehringer Ingelheim Investigational Site | Quebec | Canada | ||
| 411 | 205.452.86009 Boehringer Ingelheim Investigational Site | Beijing | China | ||
| 412 | 205.452.86010 Boehringer Ingelheim Investigational Site | Beijing | China | ||
| 413 | 205.452.86011 Boehringer Ingelheim Investigational Site | Beijing | China | ||
| 414 | 205.452.86012 Boehringer Ingelheim Investigational Site | Beijing | China | ||
| 415 | 205.452.86038 Boehringer Ingelheim Investigational Site | Beijing | China | ||
| 416 | 205.452.86026 Boehringer Ingelheim Investigational Site | Changchun | China | ||
| 417 | 205.452.86024 Boehringer Ingelheim Investigational Site | Changsha | China | ||
| 418 | 205.452.86025 Boehringer Ingelheim Investigational Site | Changsha | China | ||
| 419 | 205.452.86021 Boehringer Ingelheim Investigational Site | Chengdu | China | ||
| 420 | 205.452.86032 Boehringer Ingelheim Investigational Site | Chengdu | China | ||
| 421 | 205.452.86034 Boehringer Ingelheim Investigational Site | Chongqing | China | ||
| 422 | 205.452.86035 Boehringer Ingelheim Investigational Site | Chongqing | China | ||
| 423 | 205.452.86036 Boehringer Ingelheim Investigational Site | Chongqing | China | ||
| 424 | 205.452.86020 Boehringer Ingelheim Investigational Site | Foshan | China | ||
| 425 | 205.452.86001 Boehringer Ingelheim Investigational Site | Guangzhou | China | ||
| 426 | 205.452.86004 Boehringer Ingelheim Investigational Site | Guangzhou | China | ||
| 427 | 205.452.86005 Boehringer Ingelheim Investigational Site | Guangzhou | China | ||
| 428 | 205.452.86019 Boehringer Ingelheim Investigational Site | Guangzhou | China | ||
| 429 | 205.452.86028 Boehringer Ingelheim Investigational Site | Guangzhou | China | ||
| 430 | 205.452.86030 Boehringer Ingelheim Investigational Site | Haikou | China | ||
| 431 | 205.452.86007 Boehringer Ingelheim Investigational Site | Hangzhou | China | ||
| 432 | 205.452.86008 Boehringer Ingelheim Investigational Site | Hangzhou | China | ||
| 433 | 205.452.86029 Boehringer Ingelheim Investigational Site | Nan Ning | China | ||
| 434 | 205.452.86037 Boehringer Ingelheim Investigational Site | Nanchang | China | ||
| 435 | 205.452.86022 Boehringer Ingelheim Investigational Site | Nanjing | China | ||
| 436 | 205.452.86027 Boehringer Ingelheim Investigational Site | Qingdao | China | ||
| 437 | 205.452.86002 Boehringer Ingelheim Investigational Site | Shanghai | China | ||
| 438 | 205.452.86003 Boehringer Ingelheim Investigational Site | Shanghai | China | ||
| 439 | 205.452.86018 Boehringer Ingelheim Investigational Site | Shanghai | China | ||
| 440 | 205.452.86014 Boehringer Ingelheim Investigational Site | Shenyang | China | ||
| 441 | 205.452.86015 Boehringer Ingelheim Investigational Site | Shenyang | China | ||
| 442 | 205.452.86006 Boehringer Ingelheim Investigational Site | Suzhou | China | ||
| 443 | 205.452.86033 Boehringer Ingelheim Investigational Site | Tianjin | China | ||
| 444 | 205.452.86031 Boehringer Ingelheim Investigational Site | Wuhan | China | ||
| 445 | 205.452.86016 Boehringer Ingelheim Investigational Site | Xi'An | China | ||
| 446 | 205.452.86017 Boehringer Ingelheim Investigational Site | Xi'An | China | ||
| 447 | 205.452.57002 Boehringer Ingelheim Investigational Site | Bogotá | Colombia | ||
| 448 | 205.452.57004 Boehringer Ingelheim Investigational Site | Bogotá | Colombia | ||
| 449 | 205.452.57005 Boehringer Ingelheim Investigational Site | Bogotá | Colombia | ||
| 450 | 205.452.57006 Boehringer Ingelheim Investigational Site | Bogotá | Colombia | ||
| 451 | 205.452.57001 Boehringer Ingelheim Investigational Site | Medellín | Colombia | ||
| 452 | 205.452.38512 Boehringer Ingelheim Investigational Site | Cakovec | Croatia | ||
| 453 | 205.452.38508 Boehringer Ingelheim Investigational Site | Dubrovnik | Croatia | ||
| 454 | 205.452.38510 Boehringer Ingelheim Investigational Site | Osijek | Croatia | ||
| 455 | 205.452.38501 Boehringer Ingelheim Investigational Site | Rijeka | Croatia | ||
| 456 | 205.452.38506 Boehringer Ingelheim Investigational Site | Sisak | Croatia | ||
| 457 | 205.452.38502 Boehringer Ingelheim Investigational Site | Split | Croatia | ||
| 458 | 205.452.38503 Boehringer Ingelheim Investigational Site | Split | Croatia | ||
| 459 | 205.452.38504 Boehringer Ingelheim Investigational Site | Zagreb | Croatia | ||
| 460 | 205.452.38505 Boehringer Ingelheim Investigational Site | Zagreb | Croatia | ||
| 461 | 205.452.38507 Boehringer Ingelheim Investigational Site | Zagreb | Croatia | ||
| 462 | 205.452.38509 Boehringer Ingelheim Investigational Site | Zagreb | Croatia | ||
| 463 | 205.452.38511 Boehringer Ingelheim Investigational Site | Zagreb | Croatia | ||
| 464 | 205.452.45002 Boehringer Ingelheim Investigational Site | Aalborg | Denmark | ||
| 465 | 205.452.45003 Boehringer Ingelheim Investigational Site | Aarhus C | Denmark | ||
| 466 | 205.452.45006 Boehringer Ingelheim Investigational Site | Birkerød | Denmark | ||
| 467 | 205.452.45013 Boehringer Ingelheim Investigational Site | Kolding | Denmark | ||
| 468 | 205.452.45001 Boehringer Ingelheim Investigational Site | København NV | Denmark | ||
| 469 | 205.452.45005 Boehringer Ingelheim Investigational Site | København S | Denmark | ||
| 470 | 205.452.45012 Boehringer Ingelheim Investigational Site | Odense C | Denmark | ||
| 471 | 205.452.45016 Boehringer Ingelheim Investigational Site | Roskilde | Denmark | ||
| 472 | 205.452.45009 Boehringer Ingelheim Investigational Site | Rødovre | Denmark | ||
| 473 | 205.452.45010 Boehringer Ingelheim Investigational Site | Rødovre | Denmark | ||
| 474 | 205.452.45004 Boehringer Ingelheim Investigational Site | Silkeborg | Denmark | ||
| 475 | 205.452.45014 Boehringer Ingelheim Investigational Site | Skive | Denmark | ||
| 476 | 205.452.45011 Boehringer Ingelheim Investigational Site | Sønderborg | Denmark | ||
| 477 | 205.452.45015 Boehringer Ingelheim Investigational Site | Viby | Denmark | ||
| 478 | 205.452.45007 Boehringer Ingelheim Investigational Site | Værløse | Denmark | ||
| 479 | 205.452.35801 Boehringer Ingelheim Investigational Site | Helsinki | Finland | ||
| 480 | 205.452.35804 Boehringer Ingelheim Investigational Site | Lahti | Finland | ||
| 481 | 205.452.35808 Boehringer Ingelheim Investigational Site | Pori | Finland | ||
| 482 | 205.452.35805 Boehringer Ingelheim Investigational Site | Porvoo | Finland | ||
| 483 | 205.452.35806 Boehringer Ingelheim Investigational Site | Tammisaari | Finland | ||
| 484 | 205.452.35802 Boehringer Ingelheim Investigational Site | Tampere | Finland | ||
| 485 | 205.452.35803 Boehringer Ingelheim Investigational Site | Turku | Finland | ||
| 486 | 205.452.33087 Boehringer Ingelheim Investigational Site | Albens | France | ||
| 487 | 205.452.33028 Boehringer Ingelheim Investigational Site | Angers | France | ||
| 488 | 205.452.33055 Boehringer Ingelheim Investigational Site | Angers | France | ||
| 489 | 205.452.33142 Boehringer Ingelheim Investigational Site | Angers | France | ||
| 490 | 205.452.33159 Boehringer Ingelheim Investigational Site | Angers | France | ||
| 491 | 205.452.33030 Boehringer Ingelheim Investigational Site | Anzin | France | ||
| 492 | 205.452.33158 Boehringer Ingelheim Investigational Site | Arras | France | ||
| 493 | 205.452.33084 Boehringer Ingelheim Investigational Site | Avrillé | France | ||
| 494 | 205.452.33128 Boehringer Ingelheim Investigational Site | Becon les Granits | France | ||
| 495 | 205.452.33029 Boehringer Ingelheim Investigational Site | Bersée | France | ||
| 496 | 205.452.33018 Boehringer Ingelheim Investigational Site | Beziers | France | ||
| 497 | 205.452.33053 Boehringer Ingelheim Investigational Site | Bischheim | France | ||
| 498 | 205.452.33024 Boehringer Ingelheim Investigational Site | Blois | France | ||
| 499 | 205.452.33043 Boehringer Ingelheim Investigational Site | Bort les Orgues | France | ||
| 500 | 205.452.33091 Boehringer Ingelheim Investigational Site | Bourg des cptes | France | ||
| 501 | 205.452.33123 Boehringer Ingelheim Investigational Site | Briollay | France | ||
| 502 | 205.452.33063 Boehringer Ingelheim Investigational Site | Broglie | France | ||
| 503 | 205.452.33074 Boehringer Ingelheim Investigational Site | Bruay La Buissiere | France | ||
| 504 | 205.452.33010 Boehringer Ingelheim Investigational Site | Cannes Cedex | France | ||
| 505 | 205.452.33118 Boehringer Ingelheim Investigational Site | Cannes | France | ||
| 506 | 205.452.33009 Boehringer Ingelheim Investigational Site | Chamalières | France | ||
| 507 | 205.452.33073 Boehringer Ingelheim Investigational Site | Chambery | France | ||
| 508 | 205.452.33059 Boehringer Ingelheim Investigational Site | Chateau Renault | France | ||
| 509 | 205.452.33089 Boehringer Ingelheim Investigational Site | Colombey les Belles | France | ||
| 510 | 205.452.33099 Boehringer Ingelheim Investigational Site | Cournonterral | France | ||
| 511 | 205.452.33127 Boehringer Ingelheim Investigational Site | Cournonterral | France | ||
| 512 | 205.452.33162 Boehringer Ingelheim Investigational Site | Croix | France | ||
| 513 | 205.452.33105 Boehringer Ingelheim Investigational Site | Dinard | France | ||
| 514 | 205.452.33110 Boehringer Ingelheim Investigational Site | Donges | France | ||
| 515 | 205.452.33094 Boehringer Ingelheim Investigational Site | Gambsheim | France | ||
| 516 | 205.452.33046 Boehringer Ingelheim Investigational Site | Grenoble | France | ||
| 517 | 205.452.33096 Boehringer Ingelheim Investigational Site | Hautmont | France | ||
| 518 | 205.452.33090 Boehringer Ingelheim Investigational Site | Hinx | France | ||
| 519 | 205.452.33145 Boehringer Ingelheim Investigational Site | Jarny | France | ||
| 520 | 205.452.33154 Boehringer Ingelheim Investigational Site | La Bouëxière | France | ||
| 521 | 205.452.33065 Boehringer Ingelheim Investigational Site | La Chapelle sur Erdre | France | ||
| 522 | 205.452.33102 Boehringer Ingelheim Investigational Site | La Montagne | France | ||
| 523 | 205.452.33100 Boehringer Ingelheim Investigational Site | La Riche | France | ||
| 524 | 205.452.33058 Boehringer Ingelheim Investigational Site | Lambersart | France | ||
| 525 | 205.452.33098 Boehringer Ingelheim Investigational Site | Lambersart | France | ||
| 526 | 205.452.33103 Boehringer Ingelheim Investigational Site | Levallois Perret | France | ||
| 527 | 205.452.33164 Boehringer Ingelheim Investigational Site | Louvigne De bais | France | ||
| 528 | 205.452.33111 Boehringer Ingelheim Investigational Site | Luynes | France | ||
| 529 | 205.452.33136 Boehringer Ingelheim Investigational Site | Marcq en Baroeul | France | ||
| 530 | 205.452.33115 Boehringer Ingelheim Investigational Site | Mondelange | France | ||
| 531 | 205.452.33088 Boehringer Ingelheim Investigational Site | Mont de Marsan | France | ||
| 532 | 205.452.33138 Boehringer Ingelheim Investigational Site | Mont de Marsan | France | ||
| 533 | 205.452.33005 Boehringer Ingelheim Investigational Site | Montigny les Metz | France | ||
| 534 | 205.452.33163 Boehringer Ingelheim Investigational Site | Mundolsheim | France | ||
| 535 | 205.452.33109 Boehringer Ingelheim Investigational Site | Murs Erigne | France | ||
| 536 | 205.452.33031 Boehringer Ingelheim Investigational Site | Nantes | France | ||
| 537 | 205.452.33003 Boehringer Ingelheim Investigational Site | Nice | France | ||
| 538 | 205.452.33108 Boehringer Ingelheim Investigational Site | Oignies | France | ||
| 539 | 205.452.33014 Boehringer Ingelheim Investigational Site | Ollioules | France | ||
| 540 | 205.452.33157 Boehringer Ingelheim Investigational Site | Orthez | France | ||
| 541 | 205.452.33112 Boehringer Ingelheim Investigational Site | Parcay les Pins | France | ||
| 542 | 205.452.33001 Boehringer Ingelheim Investigational Site | Paris | France | ||
| 543 | 205.452.33051 Boehringer Ingelheim Investigational Site | Paris | France | ||
| 544 | 205.452.33082 Boehringer Ingelheim Investigational Site | Paris | France | ||
| 545 | 205.452.33165 Boehringer Ingelheim Investigational Site | Paris | France | ||
| 546 | 205.452.33130 Boehringer Ingelheim Investigational Site | Pont à Mousson | France | ||
| 547 | 205.452.33122 Boehringer Ingelheim Investigational Site | Quarouble | France | ||
| 548 | 205.452.33006 Boehringer Ingelheim Investigational Site | Reims | France | ||
| 549 | 205.452.33153 Boehringer Ingelheim Investigational Site | Rosiers d'Egletons | France | ||
| 550 | 205.452.33161 Boehringer Ingelheim Investigational Site | Rugles | France | ||
| 551 | 205.452.33126 Boehringer Ingelheim Investigational Site | Saint Alban Leysse | France | ||
| 552 | 205.452.33140 Boehringer Ingelheim Investigational Site | Saint Aulaire | France | ||
| 553 | 205.452.33052 Boehringer Ingelheim Investigational Site | Saint Avertin | France | ||
| 554 | 205.452.33011 Boehringer Ingelheim Investigational Site | Saint Léger des Bois | France | ||
| 555 | 205.452.33002 Boehringer Ingelheim Investigational Site | Saintes | France | ||
| 556 | 205.452.33148 Boehringer Ingelheim Investigational Site | Salies de Bearn | France | ||
| 557 | 205.452.33026 Boehringer Ingelheim Investigational Site | Savonnières | France | ||
| 558 | 205.452.33067 Boehringer Ingelheim Investigational Site | Segre | France | ||
| 559 | 205.452.33040 Boehringer Ingelheim Investigational Site | Serres Casset | France | ||
| 560 | 205.452.33012 Boehringer Ingelheim Investigational Site | Six Four les Plages | France | ||
| 561 | 205.452.33160 Boehringer Ingelheim Investigational Site | St Jouan des Guerets | France | ||
| 562 | 205.452.33079 Boehringer Ingelheim Investigational Site | St Sebastien sur Loire | France | ||
| 563 | 205.452.33007 Boehringer Ingelheim Investigational Site | Strasbourg | France | ||
| 564 | 205.452.33033 Boehringer Ingelheim Investigational Site | Strasbourg | France | ||
| 565 | 205.452.33097 Boehringer Ingelheim Investigational Site | Strasbourg | France | ||
| 566 | 205.452.33101 Boehringer Ingelheim Investigational Site | Strasbourg | France | ||
| 567 | 205.452.33107 Boehringer Ingelheim Investigational Site | Thouars | France | ||
| 568 | 205.452.33116 Boehringer Ingelheim Investigational Site | Tinténiac | France | ||
| 569 | 205.452.33013 Boehringer Ingelheim Investigational Site | Toulon | France | ||
| 570 | 205.452.33054 Boehringer Ingelheim Investigational Site | Tours | France | ||
| 571 | 205.452.33064 Boehringer Ingelheim Investigational Site | Tours | France | ||
| 572 | 205.452.33092 Boehringer Ingelheim Investigational Site | Tours | France | ||
| 573 | 205.452.33124 Boehringer Ingelheim Investigational Site | Tours | France | ||
| 574 | 205.452.33066 Boehringer Ingelheim Investigational Site | Vendôme | France | ||
| 575 | 205.452.33137 Boehringer Ingelheim Investigational Site | Vernoil | France | ||
| 576 | 205.452.33032 Boehringer Ingelheim Investigational Site | Vieux Condé | France | ||
| 577 | 205.452.33151 Boehringer Ingelheim Investigational Site | Vihiers | France | ||
| 578 | 205.452.33077 Boehringer Ingelheim Investigational Site | Villey St Etienne | France | ||
| 579 | 205.452.33135 Boehringer Ingelheim Investigational Site | Wattrelos | France | ||
| 580 | 205.452.99501 Boehringer Ingelheim Investigational Site | Tbilisi | Georgia | ||
| 581 | 205.452.99502 Boehringer Ingelheim Investigational Site | Tbilisi | Georgia | ||
| 582 | 205.452.99503 Boehringer Ingelheim Investigational Site | Tbilisi | Georgia | ||
| 583 | 205.452.99504 Boehringer Ingelheim Investigational Site | Tbilisi | Georgia | ||
| 584 | 205.452.99505 Boehringer Ingelheim Investigational Site | Tbilisi | Georgia | ||
| 585 | 205.452.99506 Boehringer Ingelheim Investigational Site | Tbilisi | Georgia | ||
| 586 | 205.452.99507 Boehringer Ingelheim Investigational Site | Tbilisi | Georgia | ||
| 587 | 205.452.49096 Boehringer Ingelheim Investigational Site | Aschaffenburg | Germany | ||
| 588 | 205.452.49130 Boehringer Ingelheim Investigational Site | Augsburg | Germany | ||
| 589 | 205.452.49161 Boehringer Ingelheim Investigational Site | Augsburg | Germany | ||
| 590 | 205.452.49001 Boehringer Ingelheim Investigational Site | Backnang | Germany | ||
| 591 | 205.452.49173 Boehringer Ingelheim Investigational Site | Bad Kissingen | Germany | ||
| 592 | 205.452.49134 Boehringer Ingelheim Investigational Site | Bad Lippspringe | Germany | ||
| 593 | 205.452.49082 Boehringer Ingelheim Investigational Site | Bad Neustadt | Germany | ||
| 594 | 205.452.49058 Boehringer Ingelheim Investigational Site | Bad Wörishofen | Germany | ||
| 595 | 205.452.49145 Boehringer Ingelheim Investigational Site | Bamberg | Germany | ||
| 596 | 205.452.49072 Boehringer Ingelheim Investigational Site | Bensheim | Germany | ||
| 597 | 205.452.49048 Boehringer Ingelheim Investigational Site | Bergisch Gladbach | Germany | ||
| 598 | 205.452.49006 Boehringer Ingelheim Investigational Site | Berlin | Germany | ||
| 599 | 205.452.49016 Boehringer Ingelheim Investigational Site | Berlin | Germany | ||
| 600 | 205.452.49028 Boehringer Ingelheim Investigational Site | Berlin | Germany | ||
| 601 | 205.452.49031 Boehringer Ingelheim Investigational Site | Berlin | Germany | ||
| 602 | 205.452.49054 Boehringer Ingelheim Investigational Site | Berlin | Germany | ||
| 603 | 205.452.49064 Boehringer Ingelheim Investigational Site | Berlin | Germany | ||
| 604 | 205.452.49066 Boehringer Ingelheim Investigational Site | Berlin | Germany | ||
| 605 | 205.452.49068 Boehringer Ingelheim Investigational Site | Berlin | Germany | ||
| 606 | 205.452.49102 Boehringer Ingelheim Investigational Site | Berlin | Germany | ||
| 607 | 205.452.49135 Boehringer Ingelheim Investigational Site | Berlin | Germany | ||
| 608 | 205.452.49138 Boehringer Ingelheim Investigational Site | Berlin | Germany | ||
| 609 | 205.452.49157 Boehringer Ingelheim Investigational Site | Berlin | Germany | ||
| 610 | 205.452.49167 Boehringer Ingelheim Investigational Site | Berlin | Germany | ||
| 611 | 205.452.49175 Boehringer Ingelheim Investigational Site | Berlin | Germany | ||
| 612 | 205.452.49180 Boehringer Ingelheim Investigational Site | Berlin | Germany | ||
| 613 | 205.452.49037 Boehringer Ingelheim Investigational Site | Bonn | Germany | ||
| 614 | 205.452.49118 Boehringer Ingelheim Investigational Site | Bonn | Germany | ||
| 615 | 205.452.49083 Boehringer Ingelheim Investigational Site | Brake | Germany | ||
| 616 | 205.452.49040 Boehringer Ingelheim Investigational Site | Bruchsal | Germany | ||
| 617 | 205.452.49089 Boehringer Ingelheim Investigational Site | Celle | Germany | ||
| 618 | 205.452.49143 Boehringer Ingelheim Investigational Site | Cottbus | Germany | ||
| 619 | 205.452.49119 Boehringer Ingelheim Investigational Site | Deggendorf | Germany | ||
| 620 | 205.452.49151 Boehringer Ingelheim Investigational Site | Dillingen | Germany | ||
| 621 | 205.452.49117 Boehringer Ingelheim Investigational Site | Donaueschingen | Germany | ||
| 622 | 205.452.49015 Boehringer Ingelheim Investigational Site | Dortmund | Germany | ||
| 623 | 205.452.49008 Boehringer Ingelheim Investigational Site | Düren | Germany | ||
| 624 | 205.452.49098 Boehringer Ingelheim Investigational Site | Emden | Germany | ||
| 625 | 205.452.49003 Boehringer Ingelheim Investigational Site | Engelskirchen | Germany | ||
| 626 | 205.452.49024 Boehringer Ingelheim Investigational Site | Ense | Germany | ||
| 627 | 205.452.49168 Boehringer Ingelheim Investigational Site | Essen | Germany | ||
| 628 | 205.452.49104 Boehringer Ingelheim Investigational Site | Forchheim | Germany | ||
| 629 | 205.452.49070 Boehringer Ingelheim Investigational Site | Frankfurt | Germany | ||
| 630 | 205.452.49147 Boehringer Ingelheim Investigational Site | Frankfurt | Germany | ||
| 631 | 205.452.49137 Boehringer Ingelheim Investigational Site | Fulda | Germany | ||
| 632 | 205.452.49133 Boehringer Ingelheim Investigational Site | Föhren | Germany | ||
| 633 | 205.452.49107 Boehringer Ingelheim Investigational Site | Gelnhausen | Germany | ||
| 634 | 205.452.49032 Boehringer Ingelheim Investigational Site | Gütersloh | Germany | ||
| 635 | 205.452.49026 Boehringer Ingelheim Investigational Site | Hagen | Germany | ||
| 636 | 205.452.49041 Boehringer Ingelheim Investigational Site | Hagen | Germany | ||
| 637 | 205.452.49044 Boehringer Ingelheim Investigational Site | Hamburg | Germany | ||
| 638 | 205.452.49061 Boehringer Ingelheim Investigational Site | Hamburg | Germany | ||
| 639 | 205.452.49080 Boehringer Ingelheim Investigational Site | Hamburg | Germany | ||
| 640 | 205.452.49038 Boehringer Ingelheim Investigational Site | Hannover | Germany | ||
| 641 | 205.452.49052 Boehringer Ingelheim Investigational Site | Hannover | Germany | ||
| 642 | 205.452.49094 Boehringer Ingelheim Investigational Site | Hannover | Germany | ||
| 643 | 205.452.49181 Boehringer Ingelheim Investigational Site | Heidelberg | Germany | ||
| 644 | 205.452.49116 Boehringer Ingelheim Investigational Site | Heilbronn | Germany | ||
| 645 | 205.452.49022 Boehringer Ingelheim Investigational Site | Hemmingen | Germany | ||
| 646 | 205.452.49007 Boehringer Ingelheim Investigational Site | Höchstädt | Germany | ||
| 647 | 205.452.49136 Boehringer Ingelheim Investigational Site | Ingelheim | Germany | ||
| 648 | 205.452.49159 Boehringer Ingelheim Investigational Site | Karlsruhe | Germany | ||
| 649 | 205.452.49027 Boehringer Ingelheim Investigational Site | Kassel | Germany | ||
| 650 | 205.452.49105 Boehringer Ingelheim Investigational Site | Kaufbeuren | Germany | ||
| 651 | 205.452.49101 Boehringer Ingelheim Investigational Site | Koblenz | Germany | ||
| 652 | 205.452.49047 Boehringer Ingelheim Investigational Site | Käbschütztal-Krögis | Germany | ||
| 653 | 205.452.49146 Boehringer Ingelheim Investigational Site | Köln | Germany | ||
| 654 | 205.452.49114 Boehringer Ingelheim Investigational Site | Landsberg am Lech | Germany | ||
| 655 | 205.452.49169 Boehringer Ingelheim Investigational Site | Langen | Germany | ||
| 656 | 205.452.49017 Boehringer Ingelheim Investigational Site | Leipzig | Germany | ||
| 657 | 205.452.49035 Boehringer Ingelheim Investigational Site | Leipzig | Germany | ||
| 658 | 205.452.49113 Boehringer Ingelheim Investigational Site | Leipzig | Germany | ||
| 659 | 205.452.49139 Boehringer Ingelheim Investigational Site | Leipzig | Germany | ||
| 660 | 205.452.49172 Boehringer Ingelheim Investigational Site | Leipzig | Germany | ||
| 661 | 205.452.49110 Boehringer Ingelheim Investigational Site | Leonberg | Germany | ||
| 662 | 205.452.49088 Boehringer Ingelheim Investigational Site | Mannheim | Germany | ||
| 663 | 205.452.49108 Boehringer Ingelheim Investigational Site | Marburg | Germany | ||
| 664 | 205.452.49122 Boehringer Ingelheim Investigational Site | Marburg | Germany | ||
| 665 | 205.452.49055 Boehringer Ingelheim Investigational Site | Minden | Germany | ||
| 666 | 205.452.49025 Boehringer Ingelheim Investigational Site | München | Germany | ||
| 667 | 205.452.49131 Boehringer Ingelheim Investigational Site | München | Germany | ||
| 668 | 205.452.49023 Boehringer Ingelheim Investigational Site | Neumünster | Germany | ||
| 669 | 205.452.49132 Boehringer Ingelheim Investigational Site | Neuruppin | Germany | ||
| 670 | 205.452.49045 Boehringer Ingelheim Investigational Site | Neuwied | Germany | ||
| 671 | 205.452.49062 Boehringer Ingelheim Investigational Site | Oranienburg | Germany | ||
| 672 | 205.452.49124 Boehringer Ingelheim Investigational Site | Oschersleben | Germany | ||
| 673 | 205.452.49019 Boehringer Ingelheim Investigational Site | Paderborn | Germany | ||
| 674 | 205.452.49053 Boehringer Ingelheim Investigational Site | Potsdam | Germany | ||
| 675 | 205.452.49076 Boehringer Ingelheim Investigational Site | Potsdam | Germany | ||
| 676 | 205.452.49049 Boehringer Ingelheim Investigational Site | Radebeul | Germany | ||
| 677 | 205.452.49056 Boehringer Ingelheim Investigational Site | Rathenow | Germany | ||
| 678 | 205.452.49009 Boehringer Ingelheim Investigational Site | Raubach | Germany | ||
| 679 | 205.452.49002 Boehringer Ingelheim Investigational Site | Rehau | Germany | ||
| 680 | 205.452.49142 Boehringer Ingelheim Investigational Site | Reinfeld | Germany | ||
| 681 | 205.452.49030 Boehringer Ingelheim Investigational Site | Rhaunen | Germany | ||
| 682 | 205.452.49184 Boehringer Ingelheim Investigational Site | Rheine | Germany | ||
| 683 | 205.452.49077 Boehringer Ingelheim Investigational Site | Rodgau-Dudenhofen | Germany | ||
| 684 | 205.452.49021 Boehringer Ingelheim Investigational Site | Rüsselsheim | Germany | ||
| 685 | 205.452.49091 Boehringer Ingelheim Investigational Site | Rüsselsheim | Germany | ||
| 686 | 205.452.49042 Boehringer Ingelheim Investigational Site | Saarlouis | Germany | ||
| 687 | 205.452.49034 Boehringer Ingelheim Investigational Site | Schwetzingen | Germany | ||
| 688 | 205.452.49013 Boehringer Ingelheim Investigational Site | Solingen | Germany | ||
| 689 | 205.452.49057 Boehringer Ingelheim Investigational Site | Solingen | Germany | ||
| 690 | 205.452.49078 Boehringer Ingelheim Investigational Site | Tübingen | Germany | ||
| 691 | 205.452.49099 Boehringer Ingelheim Investigational Site | Ulm | Germany | ||
| 692 | 205.452.49043 Boehringer Ingelheim Investigational Site | Wallerfing | Germany | ||
| 693 | 205.452.49067 Boehringer Ingelheim Investigational Site | Wardenburg | Germany | ||
| 694 | 205.452.49165 Boehringer Ingelheim Investigational Site | Warendorf | Germany | ||
| 695 | 205.452.49051 Boehringer Ingelheim Investigational Site | Weinheim | Germany | ||
| 696 | 205.452.49127 Boehringer Ingelheim Investigational Site | Weyhe | Germany | ||
| 697 | 205.452.49092 Boehringer Ingelheim Investigational Site | Wiesloch | Germany | ||
| 698 | 205.452.49018 Boehringer Ingelheim Investigational Site | Witten | Germany | ||
| 699 | 205.452.49029 Boehringer Ingelheim Investigational Site | Witten | Germany | ||
| 700 | 205.452.49095 Boehringer Ingelheim Investigational Site | Wolfsburg | Germany | ||
| 701 | 205.452.49060 Boehringer Ingelheim Investigational Site | Zerbst | Germany | ||
| 702 | 205.452.30002 Boehringer Ingelheim Investigational Site | Athens | Greece | ||
| 703 | 205.452.30003 Boehringer Ingelheim Investigational Site | Athens | Greece | ||
| 704 | 205.452.30008 Boehringer Ingelheim Investigational Site | Athens | Greece | ||
| 705 | 205.452.30001 Boehringer Ingelheim Investigational Site | Heraklion | Greece | ||
| 706 | 205.452.30007 Boehringer Ingelheim Investigational Site | Kalamaria | Greece | ||
| 707 | 205.452.30010 Boehringer Ingelheim Investigational Site | Kavala | Greece | ||
| 708 | 205.452.30012 Boehringer Ingelheim Investigational Site | Lamia | Greece | ||
| 709 | 205.452.30005 Boehringer Ingelheim Investigational Site | Nafplio | Greece | ||
| 710 | 205.452.30011 Boehringer Ingelheim Investigational Site | Rethymno | Greece | ||
| 711 | 205.452.30006 Boehringer Ingelheim Investigational Site | Serres | Greece | ||
| 712 | 205.452.30004 Boehringer Ingelheim Investigational Site | Thessaloniki | Greece | ||
| 713 | 205.452.30009 Boehringer Ingelheim Investigational Site | Thessaloniki | Greece | ||
| 714 | 205.452.50205 Boehringer Ingelheim Investigational Site | Guatemala | Guatemala | ||
| 715 | 205.452.50206 Boehringer Ingelheim Investigational Site | Guatemala | Guatemala | ||
| 716 | 205.452.50203 Boehringer Ingelheim Investigational Site | Nivel 12 | Guatemala | ||
| 717 | 205.452.50201 Boehringer Ingelheim Investigational Site | Nivel Guatemala | Guatemala | ||
| 718 | 205.452.50202 Boehringer Ingelheim Investigational Site | Nivel Guatemala | Guatemala | ||
| 719 | 205.452.50204 Boehringer Ingelheim Investigational Site | Nivel Guatemala | Guatemala | ||
| 720 | 205.452.50207 Boehringer Ingelheim Investigational Site | Quetzaltenango | Guatemala | ||
| 721 | 205.452.36005 Boehringer Ingelheim Investigational Site | Baja | Hungary | ||
| 722 | 205.452.36004 Boehringer Ingelheim Investigational Site | Budapest | Hungary | ||
| 723 | 205.452.36016 Boehringer Ingelheim Investigational Site | Budapest | Hungary | ||
| 724 | 205.452.36030 Boehringer Ingelheim Investigational Site | Budapest | Hungary | ||
| 725 | 205.452.36007 Boehringer Ingelheim Investigational Site | Debrecen | Hungary | ||
| 726 | 205.452.36013 Boehringer Ingelheim Investigational Site | Debrecen | Hungary | ||
| 727 | 205.452.36015 Boehringer Ingelheim Investigational Site | Debrecen | Hungary | ||
| 728 | 205.452.36029 Boehringer Ingelheim Investigational Site | Deszk | Hungary | ||
| 729 | 205.452.36026 Boehringer Ingelheim Investigational Site | Dombovar | Hungary | ||
| 730 | 205.452.36003 Boehringer Ingelheim Investigational Site | Erd | Hungary | ||
| 731 | 205.452.36008 Boehringer Ingelheim Investigational Site | Farkasgyepü | Hungary | ||
| 732 | 205.452.36020 Boehringer Ingelheim Investigational Site | Györ | Hungary | ||
| 733 | 205.452.36012 Boehringer Ingelheim Investigational Site | Hajduböszörmeny | Hungary | ||
| 734 | 205.452.36023 Boehringer Ingelheim Investigational Site | Hodmezovasarhely | Hungary | ||
| 735 | 205.452.36010 Boehringer Ingelheim Investigational Site | Kaposvar | Hungary | ||
| 736 | 205.452.36018 Boehringer Ingelheim Investigational Site | Kapuvar | Hungary | ||
| 737 | 205.452.36002 Boehringer Ingelheim Investigational Site | Kecskemet | Hungary | ||
| 738 | 205.452.36001 Boehringer Ingelheim Investigational Site | Makó | Hungary | ||
| 739 | 205.452.36006 Boehringer Ingelheim Investigational Site | Mohacs | Hungary | ||
| 740 | 205.452.36022 Boehringer Ingelheim Investigational Site | Mosonmagyarovar | Hungary | ||
| 741 | 205.452.36027 Boehringer Ingelheim Investigational Site | Nagykanizsa | Hungary | ||
| 742 | 205.452.36014 Boehringer Ingelheim Investigational Site | Nyiregyhaza | Hungary | ||
| 743 | 205.452.36009 Boehringer Ingelheim Investigational Site | Pecs | Hungary | ||
| 744 | 205.452.36011 Boehringer Ingelheim Investigational Site | Pecs | Hungary | ||
| 745 | 205.452.36028 Boehringer Ingelheim Investigational Site | Siófok | Hungary | ||
| 746 | 205.452.36021 Boehringer Ingelheim Investigational Site | Szarvas | Hungary | ||
| 747 | 205.452.36017 Boehringer Ingelheim Investigational Site | Szeged | Hungary | ||
| 748 | 205.452.36024 Boehringer Ingelheim Investigational Site | Tatabanya | Hungary | ||
| 749 | 205.452.36019 Boehringer Ingelheim Investigational Site | Törökbálint | Hungary | ||
| 750 | 205.452.36025 Boehringer Ingelheim Investigational Site | Törökbálint | Hungary | ||
| 751 | 205.452.91017 Boehringer Ingelheim Investigational Site | Ahmedabad | India | ||
| 752 | 205.452.91018 Boehringer Ingelheim Investigational Site | Chennai | India | ||
| 753 | 205.452.91001 Boehringer Ingelheim Investigational Site | Coimbatore | India | ||
| 754 | 205.452.91002 Boehringer Ingelheim Investigational Site | Coimbatore | India | ||
| 755 | 205.452.91014 Boehringer Ingelheim Investigational Site | Dadar(East) | India | ||
| 756 | 205.452.91005 Boehringer Ingelheim Investigational Site | Hyderabad | India | ||
| 757 | 205.452.91009 Boehringer Ingelheim Investigational Site | Hyderabad | India | ||
| 758 | 205.452.91004 Boehringer Ingelheim Investigational Site | Jaipur | India | ||
| 759 | 205.452.91007 Boehringer Ingelheim Investigational Site | Jaipur | India | ||
| 760 | 205.452.91015 Boehringer Ingelheim Investigational Site | Jaipur | India | ||
| 761 | 205.452.91016 Boehringer Ingelheim Investigational Site | Jaipur | India | ||
| 762 | 205.452.91008 Boehringer Ingelheim Investigational Site | Karnataka | India | ||
| 763 | 205.452.91006 Boehringer Ingelheim Investigational Site | Maharashtra | India | ||
| 764 | 205.452.91003 Boehringer Ingelheim Investigational Site | Maharastra | India | ||
| 765 | 205.452.91011 Boehringer Ingelheim Investigational Site | Punjab | India | ||
| 766 | 205.452.35307 Boehringer Ingelheim Investigational Site | Co. Cork | Ireland | ||
| 767 | 205.452.35306 Boehringer Ingelheim Investigational Site | Co. Tipperary | Ireland | ||
| 768 | 205.452.35305 Boehringer Ingelheim Investigational Site | Co. Wexford | Ireland | ||
| 769 | 205.452.35301 Boehringer Ingelheim Investigational Site | Dublin 24 | Ireland | ||
| 770 | 205.452.35302 Boehringer Ingelheim Investigational Site | Dublin | Ireland | ||
| 771 | 205.452.35303 Boehringer Ingelheim Investigational Site | Limerick | Ireland | ||
| 772 | 205.452.35308 Boehringer Ingelheim Investigational Site | Limerick | Ireland | ||
| 773 | 205.452.35304 Boehringer Ingelheim Investigational Site | Offaly | Ireland | ||
| 774 | 205.452.97207 Boehringer Ingelheim Investigational Site | Ashkelon | Israel | ||
| 775 | 205.452.97204 Boehringer Ingelheim Investigational Site | Beer Sheva | Israel | ||
| 776 | 205.452.97208 Boehringer Ingelheim Investigational Site | Haifa | Israel | ||
| 777 | 205.452.97202 Boehringer Ingelheim Investigational Site | Jerusalem | Israel | ||
| 778 | 205.452.97206 Boehringer Ingelheim Investigational Site | Kfar Saba | Israel | ||
| 779 | 205.452.97203 Boehringer Ingelheim Investigational Site | Petach Tikva | Israel | ||
| 780 | 205.452.97201 Boehringer Ingelheim Investigational Site | Rehovot | Israel | ||
| 781 | 205.452.97205 Boehringer Ingelheim Investigational Site | Tel-Aviv | Israel | ||
| 782 | 205.452.39003 Boehringer Ingelheim Investigational Site | Arenzano (ge) | Italy | ||
| 783 | 205.452.39019 Boehringer Ingelheim Investigational Site | Ascoli Piceno | Italy | ||
| 784 | 205.452.39016 Boehringer Ingelheim Investigational Site | Avellino | Italy | ||
| 785 | 205.452.39007 Boehringer Ingelheim Investigational Site | Benevento | Italy | ||
| 786 | 205.452.39024 Boehringer Ingelheim Investigational Site | Brescia | Italy | ||
| 787 | 205.452.39029 Boehringer Ingelheim Investigational Site | Busto Arsizio (va) | Italy | ||
| 788 | 205.452.39011 Boehringer Ingelheim Investigational Site | Cagliari | Italy | ||
| 789 | 205.452.39013 Boehringer Ingelheim Investigational Site | Cagliari | Italy | ||
| 790 | 205.452.39020 Boehringer Ingelheim Investigational Site | Cagliari | Italy | ||
| 791 | 205.452.39015 Boehringer Ingelheim Investigational Site | Catanzaro | Italy | ||
| 792 | 205.452.39006 Boehringer Ingelheim Investigational Site | Chieti Scalo | Italy | ||
| 793 | 205.452.39001 Boehringer Ingelheim Investigational Site | Firenze | Italy | ||
| 794 | 205.452.39021 Boehringer Ingelheim Investigational Site | Monza | Italy | ||
| 795 | 205.452.39014 Boehringer Ingelheim Investigational Site | Napoli | Italy | ||
| 796 | 205.452.39012 Boehringer Ingelheim Investigational Site | Orbassano (to) | Italy | ||
| 797 | 205.452.39026 Boehringer Ingelheim Investigational Site | Orbassano (to) | Italy | ||
| 798 | 205.452.39010 Boehringer Ingelheim Investigational Site | Palermo | Italy | ||
| 799 | 205.452.39005 Boehringer Ingelheim Investigational Site | Parma | Italy | ||
| 800 | 205.452.39009 Boehringer Ingelheim Investigational Site | Perugia | Italy | ||
| 801 | 205.452.39002 Boehringer Ingelheim Investigational Site | Prato | Italy | ||
| 802 | 205.452.39030 Boehringer Ingelheim Investigational Site | Reggio Emilia | Italy | ||
| 803 | 205.452.39004 Boehringer Ingelheim Investigational Site | Roma | Italy | ||
| 804 | 205.452.39017 Boehringer Ingelheim Investigational Site | Roma | Italy | ||
| 805 | 205.452.39027 Boehringer Ingelheim Investigational Site | Roma | Italy | ||
| 806 | 205.452.39023 Boehringer Ingelheim Investigational Site | Treviso | Italy | ||
| 807 | 205.452.82008 Boehringer Ingelheim Investigational Site | Bucheon | Korea, Republic of | ||
| 808 | 205.452.82002 Boehringer Ingelheim Investigational Site | Busan | Korea, Republic of | ||
| 809 | 205.452.82012 Boehringer Ingelheim Investigational Site | Busan | Korea, Republic of | ||
| 810 | 205.452.82010 Boehringer Ingelheim Investigational Site | Daegu | Korea, Republic of | ||
| 811 | 205.452.82016 Boehringer Ingelheim Investigational Site | Daejoen | Korea, Republic of | ||
| 812 | 205.452.82009 Boehringer Ingelheim Investigational Site | Gangwon-Do | Korea, Republic of | ||
| 813 | 205.452.82017 Boehringer Ingelheim Investigational Site | Goyang | Korea, Republic of | ||
| 814 | 205.452.82004 Boehringer Ingelheim Investigational Site | Gwangju | Korea, Republic of | ||
| 815 | 205.452.82005 Boehringer Ingelheim Investigational Site | Incheon | Korea, Republic of | ||
| 816 | 205.452.82020 Boehringer Ingelheim Investigational Site | Jeonju | Korea, Republic of | ||
| 817 | 205.452.82001 Boehringer Ingelheim Investigational Site | Seoul | Korea, Republic of | ||
| 818 | 205.452.82003 Boehringer Ingelheim Investigational Site | Seoul | Korea, Republic of | ||
| 819 | 205.452.82006 Boehringer Ingelheim Investigational Site | Seoul | Korea, Republic of | ||
| 820 | 205.452.82007 Boehringer Ingelheim Investigational Site | Seoul | Korea, Republic of | ||
| 821 | 205.452.82011 Boehringer Ingelheim Investigational Site | Seoul | Korea, Republic of | ||
| 822 | 205.452.82013 Boehringer Ingelheim Investigational Site | Seoul | Korea, Republic of | ||
| 823 | 205.452.82014 Boehringer Ingelheim Investigational Site | Seoul | Korea, Republic of | ||
| 824 | 205.452.82015 Boehringer Ingelheim Investigational Site | Seoul | Korea, Republic of | ||
| 825 | 205.452.82018 Boehringer Ingelheim Investigational Site | Seoul | Korea, Republic of | ||
| 826 | 205.452.82019 Boehringer Ingelheim Investigational Site | Uijeongbu | Korea, Republic of | ||
| 827 | 205.452.37106 Boehringer Ingelheim Investigational Site | Daugavpils | Latvia | ||
| 828 | 205.452.37107 Boehringer Ingelheim Investigational Site | Daugavpils | Latvia | ||
| 829 | 205.452.37108 Boehringer Ingelheim Investigational Site | Daugavpils | Latvia | ||
| 830 | 205.452.37102 Boehringer Ingelheim Investigational Site | Kraslava | Latvia | ||
| 831 | 205.452.37104 Boehringer Ingelheim Investigational Site | Riga | Latvia | ||
| 832 | 205.452.37105 Boehringer Ingelheim Investigational Site | Riga | Latvia | ||
| 833 | 205.452.37109 Boehringer Ingelheim Investigational Site | Riga | Latvia | ||
| 834 | 205.452.37110 Boehringer Ingelheim Investigational Site | Riga | Latvia | ||
| 835 | 205.452.37101 Boehringer Ingelheim Investigational Site | Talsi | Latvia | ||
| 836 | 205.452.37103 Boehringer Ingelheim Investigational Site | Valmiera | Latvia | ||
| 837 | 205.452.37003 Boehringer Ingelheim Investigational Site | Alytus | Lithuania | ||
| 838 | 205.452.37001 Boehringer Ingelheim Investigational Site | Kaunas | Lithuania | ||
| 839 | 205.452.37002 Boehringer Ingelheim Investigational Site | Kaunas | Lithuania | ||
| 840 | 205.452.37005 Boehringer Ingelheim Investigational Site | Klaipeda | Lithuania | ||
| 841 | 205.452.37007 Boehringer Ingelheim Investigational Site | Siauliai | Lithuania | ||
| 842 | 205.452.37011 Boehringer Ingelheim Investigational Site | Utena | Lithuania | ||
| 843 | 205.452.37004 Boehringer Ingelheim Investigational Site | Vilnius | Lithuania | ||
| 844 | 205.452.37008 Boehringer Ingelheim Investigational Site | Vilnius | Lithuania | ||
| 845 | 205.452.37010 Boehringer Ingelheim Investigational Site | Vilnius | Lithuania | ||
| 846 | 205.452.60006 Boehringer Ingelheim Investigational Site | Johor Bahru | Malaysia | ||
| 847 | 205.452.60001 Boehringer Ingelheim Investigational Site | Kuala Lumpur | Malaysia | ||
| 848 | 205.452.60002 Boehringer Ingelheim Investigational Site | Kuala Lumpur | Malaysia | ||
| 849 | 205.452.60004 Boehringer Ingelheim Investigational Site | Kuala Lumpur | Malaysia | ||
| 850 | 205.452.60008 Boehringer Ingelheim Investigational Site | Pahang | Malaysia | ||
| 851 | 205.452.60005 Boehringer Ingelheim Investigational Site | Sarawak | Malaysia | ||
| 852 | 205.452.60009 Boehringer Ingelheim Investigational Site | Selangor | Malaysia | ||
| 853 | 205.452.60007 Boehringer Ingelheim Investigational Site | Terengganu | Malaysia | ||
| 854 | 205.452.52004 Boehringer Ingelheim Investigational Site | Aguascalientes | Mexico | ||
| 855 | 205.452.52007 Boehringer Ingelheim Investigational Site | Distrito Federal | Mexico | ||
| 856 | 205.452.52005 Boehringer Ingelheim Investigational Site | Guadalajara | Mexico | ||
| 857 | 205.452.52002 Boehringer Ingelheim Investigational Site | Monte Rey | Mexico | ||
| 858 | 205.452.52001 Boehringer Ingelheim Investigational Site | México | Mexico | ||
| 859 | 205.452.52003 Boehringer Ingelheim Investigational Site | Zona Río | Mexico | ||
| 860 | 205.452.31001 Boehringer Ingelheim Investigational Site | Almere | Netherlands | ||
| 861 | 205.452.31008 Boehringer Ingelheim Investigational Site | Andijk | Netherlands | ||
| 862 | 205.452.31012 Boehringer Ingelheim Investigational Site | Beek En Donk | Netherlands | ||
| 863 | 205.452.31002 Boehringer Ingelheim Investigational Site | Beek | Netherlands | ||
| 864 | 205.452.31003 Boehringer Ingelheim Investigational Site | Ermelo | Netherlands | ||
| 865 | 205.452.31010 Boehringer Ingelheim Investigational Site | Hoogwoud | Netherlands | ||
| 866 | 205.452.31011 Boehringer Ingelheim Investigational Site | Nijverdal | Netherlands | ||
| 867 | 205.452.31007 Boehringer Ingelheim Investigational Site | Oude Pekela | Netherlands | ||
| 868 | 205.452.31005 Boehringer Ingelheim Investigational Site | Roelofarendsveen | Netherlands | ||
| 869 | 205.452.64004 Boehringer Ingelheim Investigational Site | Christchurch | New Zealand | ||
| 870 | 205.452.64003 Boehringer Ingelheim Investigational Site | Dunedin | New Zealand | ||
| 871 | 205.452.64002 Boehringer Ingelheim Investigational Site | Newtown Wellington NZ | New Zealand | ||
| 872 | 205.452.64001 Boehringer Ingelheim Investigational Site | Tauranga | New Zealand | ||
| 873 | 205.452.47008 Boehringer Ingelheim Investigational Site | Drammen | Norway | ||
| 874 | 205.452.47009 Boehringer Ingelheim Investigational Site | Fredrikstad | Norway | ||
| 875 | 205.452.47001 Boehringer Ingelheim Investigational Site | Hønefoss | Norway | ||
| 876 | 205.452.47010 Boehringer Ingelheim Investigational Site | Kløfta | Norway | ||
| 877 | 205.452.47007 Boehringer Ingelheim Investigational Site | Kolbjørnsvik | Norway | ||
| 878 | 205.452.47005 Boehringer Ingelheim Investigational Site | Løvenstad | Norway | ||
| 879 | 205.452.47002 Boehringer Ingelheim Investigational Site | Oslo | Norway | ||
| 880 | 205.452.47003 Boehringer Ingelheim Investigational Site | Oslo | Norway | ||
| 881 | 205.452.47011 Boehringer Ingelheim Investigational Site | Oslo | Norway | ||
| 882 | 205.452.47012 Boehringer Ingelheim Investigational Site | Sandvika | Norway | ||
| 883 | 205.452.47004 Boehringer Ingelheim Investigational Site | Svelvik | Norway | ||
| 884 | 205.452.47006 Boehringer Ingelheim Investigational Site | Trollåsen | Norway | ||
| 885 | 205.452.50703 Boehringer Ingelheim Investigational Site | Carrasquilla | Panama | ||
| 886 | 205.452.50701 Boehringer Ingelheim Investigational Site | Marbella | Panama | ||
| 887 | 205.452.50702 Boehringer Ingelheim Investigational Site | Marbella | Panama | ||
| 888 | 205.452.51002 Boehringer Ingelheim Investigational Site | Bellavista | Peru | ||
| 889 | 205.452.51003 Boehringer Ingelheim Investigational Site | Cusco | Peru | ||
| 890 | 205.452.51004 Boehringer Ingelheim Investigational Site | Jesús Maria | Peru | ||
| 891 | 205.452.51007 Boehringer Ingelheim Investigational Site | Jesús María | Peru | ||
| 892 | 205.452.51005 Boehringer Ingelheim Investigational Site | Lima | Peru | ||
| 893 | 205.452.51001 Boehringer Ingelheim Investigational Site | San Isidro | Peru | ||
| 894 | 205.452.51006 Boehringer Ingelheim Investigational Site | San Martin de Porres | Peru | ||
| 895 | 205.452.63004 Boehringer Ingelheim Investigational Site | Cavite City | Philippines | ||
| 896 | 205.452.63002 Boehringer Ingelheim Investigational Site | Davao City | Philippines | ||
| 897 | 205.452.63003 Boehringer Ingelheim Investigational Site | Iloilo City | Philippines | ||
| 898 | 205.452.63006 Boehringer Ingelheim Investigational Site | Iloilo City | Philippines | ||
| 899 | 205.452.63001 Boehringer Ingelheim Investigational Site | Manila | Philippines | ||
| 900 | 205.452.63008 Boehringer Ingelheim Investigational Site | Manila | Philippines | ||
| 901 | 205.452.63005 Boehringer Ingelheim Investigational Site | Quezon City | Philippines | ||
| 902 | 205.452.63007 Boehringer Ingelheim Investigational Site | Quezon City | Philippines | ||
| 903 | 205.452.48031 Boehringer Ingelheim Investigational Site | Babice | Poland | ||
| 904 | 205.452.48003 Boehringer Ingelheim Investigational Site | Bialystok | Poland | ||
| 905 | 205.452.48011 Boehringer Ingelheim Investigational Site | Bialystok | Poland | ||
| 906 | 205.452.48014 Boehringer Ingelheim Investigational Site | Bydgoszcz | Poland | ||
| 907 | 205.452.48008 Boehringer Ingelheim Investigational Site | Checiny | Poland | ||
| 908 | 205.452.48016 Boehringer Ingelheim Investigational Site | Gdansk | Poland | ||
| 909 | 205.452.48019 Boehringer Ingelheim Investigational Site | Gdynia | Poland | ||
| 910 | 205.452.48037 Boehringer Ingelheim Investigational Site | Gorzow Wlkp | Poland | ||
| 911 | 205.452.48015 Boehringer Ingelheim Investigational Site | Ilawa | Poland | ||
| 912 | 205.452.48033 Boehringer Ingelheim Investigational Site | Katowice | Poland | ||
| 913 | 205.452.48039 Boehringer Ingelheim Investigational Site | Katowice | Poland | ||
| 914 | 205.452.48044 Boehringer Ingelheim Investigational Site | Katowice | Poland | ||
| 915 | 205.452.48009 Boehringer Ingelheim Investigational Site | Krakow | Poland | ||
| 916 | 205.452.48021 Boehringer Ingelheim Investigational Site | Krakow | Poland | ||
| 917 | 205.452.48029 Boehringer Ingelheim Investigational Site | Krakow | Poland | ||
| 918 | 205.452.48030 Boehringer Ingelheim Investigational Site | Krakow | Poland | ||
| 919 | 205.452.48048 Boehringer Ingelheim Investigational Site | Krakow | Poland | ||
| 920 | 205.452.48043 Boehringer Ingelheim Investigational Site | Libiaz | Poland | ||
| 921 | 205.452.48002 Boehringer Ingelheim Investigational Site | Lodz | Poland | ||
| 922 | 205.452.48051 Boehringer Ingelheim Investigational Site | Lodz | Poland | ||
| 923 | 205.452.48056 Boehringer Ingelheim Investigational Site | Lodz | Poland | ||
| 924 | 205.452.48059 Boehringer Ingelheim Investigational Site | Lodz | Poland | ||
| 925 | 205.452.48018 Boehringer Ingelheim Investigational Site | Olsztyn | Poland | ||
| 926 | 205.452.48025 Boehringer Ingelheim Investigational Site | Ostrow Wielkopolska | Poland | ||
| 927 | 205.452.48012 Boehringer Ingelheim Investigational Site | Piaseczno | Poland | ||
| 928 | 205.452.48040 Boehringer Ingelheim Investigational Site | Piaseczno | Poland | ||
| 929 | 205.452.48026 Boehringer Ingelheim Investigational Site | Poznan | Poland | ||
| 930 | 205.452.48027 Boehringer Ingelheim Investigational Site | Poznan | Poland | ||
| 931 | 205.452.48058 Boehringer Ingelheim Investigational Site | Poznan | Poland | ||
| 932 | 205.452.48060 Boehringer Ingelheim Investigational Site | Rokietnica | Poland | ||
| 933 | 205.452.48001 Boehringer Ingelheim Investigational Site | Skierniewice | Poland | ||
| 934 | 205.452.48032 Boehringer Ingelheim Investigational Site | Slawkow | Poland | ||
| 935 | 205.452.48036 Boehringer Ingelheim Investigational Site | Szczecin | Poland | ||
| 936 | 205.452.48045 Boehringer Ingelheim Investigational Site | Tarnow | Poland | ||
| 937 | 205.452.48057 Boehringer Ingelheim Investigational Site | Tczew | Poland | ||
| 938 | 205.452.48004 Boehringer Ingelheim Investigational Site | Torun | Poland | ||
| 939 | 205.452.48007 Boehringer Ingelheim Investigational Site | Tranow | Poland | ||
| 940 | 205.452.48053 Boehringer Ingelheim Investigational Site | Turek | Poland | ||
| 941 | 205.452.48034 Boehringer Ingelheim Investigational Site | Warsaw | Poland | ||
| 942 | 205.452.48042 Boehringer Ingelheim Investigational Site | Warszawa | Poland | ||
| 943 | 205.452.48049 Boehringer Ingelheim Investigational Site | Warszawa | Poland | ||
| 944 | 205.452.48017 Boehringer Ingelheim Investigational Site | Wolomin | Poland | ||
| 945 | 205.452.48006 Boehringer Ingelheim Investigational Site | Wroclaw | Poland | ||
| 946 | 205.452.48028 Boehringer Ingelheim Investigational Site | Wroclaw | Poland | ||
| 947 | 205.452.48035 Boehringer Ingelheim Investigational Site | Wroclaw | Poland | ||
| 948 | 205.452.48038 Boehringer Ingelheim Investigational Site | Wroclaw | Poland | ||
| 949 | 205.452.48022 Boehringer Ingelheim Investigational Site | Zakopane | Poland | ||
| 950 | 205.452.35103 Boehringer Ingelheim Investigational Site | Amadora | Portugal | ||
| 951 | 205.452.35102 Boehringer Ingelheim Investigational Site | Coimbra | Portugal | ||
| 952 | 205.452.35107 Boehringer Ingelheim Investigational Site | Lisboa | Portugal | ||
| 953 | 205.452.35108 Boehringer Ingelheim Investigational Site | Lisboa | Portugal | ||
| 954 | 205.452.35101 Boehringer Ingelheim Investigational Site | Matosinhos | Portugal | ||
| 955 | 205.452.35105 Boehringer Ingelheim Investigational Site | Penafiel | Portugal | ||
| 956 | 205.452.35106 Boehringer Ingelheim Investigational Site | Vila Nova de Gaia | Portugal | ||
| 957 | 205.452.35104 Boehringer Ingelheim Investigational Site | Viseu | Portugal | ||
| 958 | 205.452.01177 Boehringer Ingelheim Investigational Site | Ponce | Puerto Rico | ||
| 959 | 205.452.01162 Boehringer Ingelheim Investigational Site | San Juan | Puerto Rico | ||
| 960 | 205.452.40008 Boehringer Ingelheim Investigational Site | Brasov | Romania | ||
| 961 | 205.452.40012 Boehringer Ingelheim Investigational Site | Brasov | Romania | ||
| 962 | 205.452.40001 Boehringer Ingelheim Investigational Site | Bucharest | Romania | ||
| 963 | 205.452.40003 Boehringer Ingelheim Investigational Site | Bucharest | Romania | ||
| 964 | 205.452.40004 Boehringer Ingelheim Investigational Site | Bucharest | Romania | ||
| 965 | 205.452.40007 Boehringer Ingelheim Investigational Site | Bucharest | Romania | ||
| 966 | 205.452.40009 Boehringer Ingelheim Investigational Site | Bucharest | Romania | ||
| 967 | 205.452.40013 Boehringer Ingelheim Investigational Site | Bucharest | Romania | ||
| 968 | 205.452.40002 Boehringer Ingelheim Investigational Site | Bucuresti | Romania | ||
| 969 | 205.452.40011 Boehringer Ingelheim Investigational Site | Constanta | Romania | ||
| 970 | 205.452.40006 Boehringer Ingelheim Investigational Site | Craiova | Romania | ||
| 971 | 205.452.07030 Boehringer Ingelheim Investigational Site | Arkhangelsk | Russian Federation | ||
| 972 | 205.452.07049 Boehringer Ingelheim Investigational Site | Barnaul | Russian Federation | ||
| 973 | 205.452.07054 Boehringer Ingelheim Investigational Site | Barnaul | Russian Federation | ||
| 974 | 205.452.07053 Boehringer Ingelheim Investigational Site | Chelyabinsk | Russian Federation | ||
| 975 | 205.452.07031 Boehringer Ingelheim Investigational Site | Ekaterinburg | Russian Federation | ||
| 976 | 205.452.07038 Boehringer Ingelheim Investigational Site | Gatchina (Leningradskaya oblast) | Russian Federation | ||
| 977 | 205.452.07036 Boehringer Ingelheim Investigational Site | Irkutsk | Russian Federation | ||
| 978 | 205.452.07001 Boehringer Ingelheim Investigational Site | Ivanovo | Russian Federation | ||
| 979 | 205.452.07023 Boehringer Ingelheim Investigational Site | Kaliningrad | Russian Federation | ||
| 980 | 205.452.07003 Boehringer Ingelheim Investigational Site | Kazan | Russian Federation | ||
| 981 | 205.452.07005 Boehringer Ingelheim Investigational Site | Kazan | Russian Federation | ||
| 982 | 205.452.07007 Boehringer Ingelheim Investigational Site | Kazan | Russian Federation | ||
| 983 | 205.452.07048 Boehringer Ingelheim Investigational Site | Kemerovo | Russian Federation | ||
| 984 | 205.452.07060 Boehringer Ingelheim Investigational Site | Kemerovo | Russian Federation | ||
| 985 | 205.452.07059 Boehringer Ingelheim Investigational Site | Kirov | Russian Federation | ||
| 986 | 205.452.07009 Boehringer Ingelheim Investigational Site | Krasnodar | Russian Federation | ||
| 987 | 205.452.07010 Boehringer Ingelheim Investigational Site | Krasnodar | Russian Federation | ||
| 988 | 205.452.07013 Boehringer Ingelheim Investigational Site | Moscow | Russian Federation | ||
| 989 | 205.452.07020 Boehringer Ingelheim Investigational Site | Moscow | Russian Federation | ||
| 990 | 205.452.07021 Boehringer Ingelheim Investigational Site | Moscow | Russian Federation | ||
| 991 | 205.452.07026 Boehringer Ingelheim Investigational Site | Moscow | Russian Federation | ||
| 992 | 205.452.07027 Boehringer Ingelheim Investigational Site | Moscow | Russian Federation | ||
| 993 | 205.452.07028 Boehringer Ingelheim Investigational Site | Moscow | Russian Federation | ||
| 994 | 205.452.07029 Boehringer Ingelheim Investigational Site | Moscow | Russian Federation | ||
| 995 | 205.452.07043 Boehringer Ingelheim Investigational Site | Moscow | Russian Federation | ||
| 996 | 205.452.07045 Boehringer Ingelheim Investigational Site | Moscow | Russian Federation | ||
| 997 | 205.452.07004 Boehringer Ingelheim Investigational Site | Murmansk | Russian Federation | ||
| 998 | 205.452.07055 Boehringer Ingelheim Investigational Site | Nizhniy Novgorod | Russian Federation | ||
| 999 | 205.452.07051 Boehringer Ingelheim Investigational Site | Nizhny Novgorod | Russian Federation | ||
| 1000 | 205.452.07037 Boehringer Ingelheim Investigational Site | Novosibirsk | Russian Federation | ||
| 1001 | 205.452.07040 Boehringer Ingelheim Investigational Site | Novosibirsk | Russian Federation | ||
| 1002 | 205.452.07042 Boehringer Ingelheim Investigational Site | Novosibirsk | Russian Federation | ||
| 1003 | 205.452.07041 Boehringer Ingelheim Investigational Site | Penza | Russian Federation | ||
| 1004 | 205.452.07050 Boehringer Ingelheim Investigational Site | Pskov | Russian Federation | ||
| 1005 | 205.452.07015 Boehringer Ingelheim Investigational Site | Rostov-na-Donu | Russian Federation | ||
| 1006 | 205.452.07016 Boehringer Ingelheim Investigational Site | Rostov-on-Don | Russian Federation | ||
| 1007 | 205.452.07039 Boehringer Ingelheim Investigational Site | Ryazan | Russian Federation | ||
| 1008 | 205.452.07034 Boehringer Ingelheim Investigational Site | Samara | Russian Federation | ||
| 1009 | 205.452.07047 Boehringer Ingelheim Investigational Site | Saratov | Russian Federation | ||
| 1010 | 205.452.07002 Boehringer Ingelheim Investigational Site | St. Petersburg | Russian Federation | ||
| 1011 | 205.452.07006 Boehringer Ingelheim Investigational Site | St. Petersburg | Russian Federation | ||
| 1012 | 205.452.07011 Boehringer Ingelheim Investigational Site | St. Petersburg | Russian Federation | ||
| 1013 | 205.452.07014 Boehringer Ingelheim Investigational Site | St. Petersburg | Russian Federation | ||
| 1014 | 205.452.07017 Boehringer Ingelheim Investigational Site | St. Petersburg | Russian Federation | ||
| 1015 | 205.452.07018 Boehringer Ingelheim Investigational Site | St. Petersburg | Russian Federation | ||
| 1016 | 205.452.07022 Boehringer Ingelheim Investigational Site | St. Petersburg | Russian Federation | ||
| 1017 | 205.452.07024 Boehringer Ingelheim Investigational Site | St. Petersburg | Russian Federation | ||
| 1018 | 205.452.07025 Boehringer Ingelheim Investigational Site | St. Petersburg | Russian Federation | ||
| 1019 | 205.452.07033 Boehringer Ingelheim Investigational Site | St. Petersburg | Russian Federation | ||
| 1020 | 205.452.07046 Boehringer Ingelheim Investigational Site | St. Petersburg | Russian Federation | ||
| 1021 | 205.452.07052 Boehringer Ingelheim Investigational Site | St. Petersburg | Russian Federation | ||
| 1022 | 205.452.07032 Boehringer Ingelheim Investigational Site | Tomsk | Russian Federation | ||
| 1023 | 205.452.07035 Boehringer Ingelheim Investigational Site | Tomsk | Russian Federation | ||
| 1024 | 205.452.07057 Boehringer Ingelheim Investigational Site | Tomsk | Russian Federation | ||
| 1025 | 205.452.07019 Boehringer Ingelheim Investigational Site | Velikiy Novgorod | Russian Federation | ||
| 1026 | 205.452.07044 Boehringer Ingelheim Investigational Site | Yaroslavl | Russian Federation | ||
| 1027 | 205.452.38103 Boehringer Ingelheim Investigational Site | Belgrade | Serbia | ||
| 1028 | 205.452.38104 Boehringer Ingelheim Investigational Site | Belgrade | Serbia | ||
| 1029 | 205.452.38106 Boehringer Ingelheim Investigational Site | Belgrade | Serbia | ||
| 1030 | 205.452.38107 Boehringer Ingelheim Investigational Site | Belgrade | Serbia | ||
| 1031 | 205.452.38102 Boehringer Ingelheim Investigational Site | Kragujevac | Serbia | ||
| 1032 | 205.452.38105 Boehringer Ingelheim Investigational Site | Nis | Serbia | ||
| 1033 | 205.452.38101 Boehringer Ingelheim Investigational Site | Sremska Kamenica | Serbia | ||
| 1034 | 205.452.42103 Boehringer Ingelheim Investigational Site | Bardejov | Slovakia | ||
| 1035 | 205.452.42107 Boehringer Ingelheim Investigational Site | Bratislava | Slovakia | ||
| 1036 | 205.452.42102 Boehringer Ingelheim Investigational Site | Humenne | Slovakia | ||
| 1037 | 205.452.42105 Boehringer Ingelheim Investigational Site | Kosice | Slovakia | ||
| 1038 | 205.452.42111 Boehringer Ingelheim Investigational Site | Kosice | Slovakia | ||
| 1039 | 205.452.42113 Boehringer Ingelheim Investigational Site | Kosice | Slovakia | ||
| 1040 | 205.452.42108 Boehringer Ingelheim Investigational Site | Levice | Slovakia | ||
| 1041 | 205.452.42109 Boehringer Ingelheim Investigational Site | Martin | Slovakia | ||
| 1042 | 205.452.42112 Boehringer Ingelheim Investigational Site | Poprad | Slovakia | ||
| 1043 | 205.452.42101 Boehringer Ingelheim Investigational Site | Presov | Slovakia | ||
| 1044 | 205.452.42104 Boehringer Ingelheim Investigational Site | Rimavska Sobota | Slovakia | ||
| 1045 | 205.452.42106 Boehringer Ingelheim Investigational Site | Spisska Nova Ves | Slovakia | ||
| 1046 | 205.452.42110 Boehringer Ingelheim Investigational Site | Sturovo | Slovakia | ||
| 1047 | 205.452.27013 Boehringer Ingelheim Investigational Site | Amanzimtoti | South Africa | ||
| 1048 | 205.452.27002 Boehringer Ingelheim Investigational Site | Bellville | South Africa | ||
| 1049 | 205.452.27010 Boehringer Ingelheim Investigational Site | Bloemfontein | South Africa | ||
| 1050 | 205.452.27001 Boehringer Ingelheim Investigational Site | Cape Town | South Africa | ||
| 1051 | 205.452.27004 Boehringer Ingelheim Investigational Site | Cape Town | South Africa | ||
| 1052 | 205.452.27008 Boehringer Ingelheim Investigational Site | Cape Town | South Africa | ||
| 1053 | 205.452.27011 Boehringer Ingelheim Investigational Site | Cape Town | South Africa | ||
| 1054 | 205.452.27012 Boehringer Ingelheim Investigational Site | Cape Town | South Africa | ||
| 1055 | 205.452.27006 Boehringer Ingelheim Investigational Site | Centurion | South Africa | ||
| 1056 | 205.452.27003 Boehringer Ingelheim Investigational Site | Durban | South Africa | ||
| 1057 | 205.452.27014 Boehringer Ingelheim Investigational Site | Johannesburg | South Africa | ||
| 1058 | 205.452.27005 Boehringer Ingelheim Investigational Site | Pretoria | South Africa | ||
| 1059 | 205.452.27009 Boehringer Ingelheim Investigational Site | Pretoria | South Africa | ||
| 1060 | 205.452.27007 Boehringer Ingelheim Investigational Site | Somerset West | South Africa | ||
| 1061 | 205.452.34018 Boehringer Ingelheim Investigational Site | Badajoz | Spain | ||
| 1062 | 205.452.34021 Boehringer Ingelheim Investigational Site | Badalona (Barcelona) | Spain | ||
| 1063 | 205.452.34010 Boehringer Ingelheim Investigational Site | Barcelona | Spain | ||
| 1064 | 205.452.34025 Boehringer Ingelheim Investigational Site | Barcelona | Spain | ||
| 1065 | 205.452.34027 Boehringer Ingelheim Investigational Site | Centelles | Spain | ||
| 1066 | 205.452.34015 Boehringer Ingelheim Investigational Site | Cáceres | Spain | ||
| 1067 | 205.452.34016 Boehringer Ingelheim Investigational Site | Elda | Spain | ||
| 1068 | 205.452.34008 Boehringer Ingelheim Investigational Site | Hospitalet de Llobregat | Spain | ||
| 1069 | 205.452.34026 Boehringer Ingelheim Investigational Site | Lugo | Spain | ||
| 1070 | 205.452.34011 Boehringer Ingelheim Investigational Site | Madrid | Spain | ||
| 1071 | 205.452.34019 Boehringer Ingelheim Investigational Site | Madrid | Spain | ||
| 1072 | 205.452.34020 Boehringer Ingelheim Investigational Site | Málaga | Spain | ||
| 1073 | 205.452.34002 Boehringer Ingelheim Investigational Site | Mérida | Spain | ||
| 1074 | 205.452.34017 Boehringer Ingelheim Investigational Site | Plasencia | Spain | ||
| 1075 | 205.452.34001 Boehringer Ingelheim Investigational Site | Pozuelo de Alarcón | Spain | ||
| 1076 | 205.452.34024 Boehringer Ingelheim Investigational Site | San Juan de Alicante | Spain | ||
| 1077 | 205.452.34003 Boehringer Ingelheim Investigational Site | Santander | Spain | ||
| 1078 | 205.452.34005 Boehringer Ingelheim Investigational Site | Terrassa (Barcelona) | Spain | ||
| 1079 | 205.452.34007 Boehringer Ingelheim Investigational Site | Torrevieja | Spain | ||
| 1080 | 205.452.34012 Boehringer Ingelheim Investigational Site | Valencia | Spain | ||
| 1081 | 205.452.34013 Boehringer Ingelheim Investigational Site | Valladolid | Spain | ||
| 1082 | 205.452.34009 Boehringer Ingelheim Investigational Site | Vic (Barcelona) | Spain | ||
| 1083 | 205.452.34023 Boehringer Ingelheim Investigational Site | Vilanova i la Geltrú | Spain | ||
| 1084 | 205.452.34004 Boehringer Ingelheim Investigational Site | Zaragoza | Spain | ||
| 1085 | 205.452.46005 Boehringer Ingelheim Investigational Site | Brämhult | Sweden | ||
| 1086 | 205.452.46014 Boehringer Ingelheim Investigational Site | Eksjö | Sweden | ||
| 1087 | 205.452.46012 Boehringer Ingelheim Investigational Site | Gullspång | Sweden | ||
| 1088 | 205.452.46013 Boehringer Ingelheim Investigational Site | Göteborg | Sweden | ||
| 1089 | 205.452.46001 Boehringer Ingelheim Investigational Site | Höllviken | Sweden | ||
| 1090 | 205.452.46008 Boehringer Ingelheim Investigational Site | Järfälla | Sweden | ||
| 1091 | 205.452.46009 Boehringer Ingelheim Investigational Site | Kil | Sweden | ||
| 1092 | 205.452.46007 Boehringer Ingelheim Investigational Site | Lidingö | Sweden | ||
| 1093 | 205.452.46003 Boehringer Ingelheim Investigational Site | Luleå | Sweden | ||
| 1094 | 205.452.46010 Boehringer Ingelheim Investigational Site | Sigtuna | Sweden | ||
| 1095 | 205.452.46002 Boehringer Ingelheim Investigational Site | Solna | Sweden | ||
| 1096 | 205.452.46011 Boehringer Ingelheim Investigational Site | Uddevalla | Sweden | ||
| 1097 | 205.452.46006 Boehringer Ingelheim Investigational Site | Örebro | Sweden | ||
| 1098 | 205.452.41003 Boehringer Ingelheim Investigational Site | Ascona | Switzerland | ||
| 1099 | 205.452.41004 Boehringer Ingelheim Investigational Site | Basel | Switzerland | ||
| 1100 | 205.452.41016 Boehringer Ingelheim Investigational Site | Bern | Switzerland | ||
| 1101 | 205.452.41012 Boehringer Ingelheim Investigational Site | Glarus | Switzerland | ||
| 1102 | 205.452.41001 Boehringer Ingelheim Investigational Site | Gossau | Switzerland | ||
| 1103 | 205.452.41015 Boehringer Ingelheim Investigational Site | Liestal | Switzerland | ||
| 1104 | 205.452.41010 Boehringer Ingelheim Investigational Site | Locarno | Switzerland | ||
| 1105 | 205.452.41011 Boehringer Ingelheim Investigational Site | Lugano | Switzerland | ||
| 1106 | 205.452.41007 Boehringer Ingelheim Investigational Site | Spiez | Switzerland | ||
| 1107 | 205.452.41002 Boehringer Ingelheim Investigational Site | St. Gallen | Switzerland | ||
| 1108 | 205.452.41009 Boehringer Ingelheim Investigational Site | St. Gallen | Switzerland | ||
| 1109 | 205.452.41013 Boehringer Ingelheim Investigational Site | Zürich | Switzerland | ||
| 1110 | 205.452.41014 Boehringer Ingelheim Investigational Site | Zürich | Switzerland | ||
| 1111 | 205.452.88607 Boehringer Ingelheim Investigational Site | Changhua | Taiwan | ||
| 1112 | 205.452.88614 Boehringer Ingelheim Investigational Site | Chia-Yi | Taiwan | ||
| 1113 | 205.452.88608 Boehringer Ingelheim Investigational Site | Kaohsiung City | Taiwan | ||
| 1114 | 205.452.88609 Boehringer Ingelheim Investigational Site | Kaohsiung City | Taiwan | ||
| 1115 | 205.452.88611 Boehringer Ingelheim Investigational Site | Kaohsiung | Taiwan | ||
| 1116 | 205.452.88604 Boehringer Ingelheim Investigational Site | New Taipei | Taiwan | ||
| 1117 | 205.452.88605 Boehringer Ingelheim Investigational Site | Taichung | Taiwan | ||
| 1118 | 205.452.88606 Boehringer Ingelheim Investigational Site | Taichung | Taiwan | ||
| 1119 | 205.452.88612 Boehringer Ingelheim Investigational Site | Taichung | Taiwan | ||
| 1120 | 205.452.88610 Boehringer Ingelheim Investigational Site | Tainan | Taiwan | ||
| 1121 | 205.452.88602 Boehringer Ingelheim Investigational Site | Taipei | Taiwan | ||
| 1122 | 205.452.88603 Boehringer Ingelheim Investigational Site | Taipei | Taiwan | ||
| 1123 | 205.452.88613 Boehringer Ingelheim Investigational Site | Taipei | Taiwan | ||
| 1124 | 205.452.88601 Boehringer Ingelheim Investigational Site | Taoyuan County | Taiwan | ||
| 1125 | 205.452.66004 Boehringer Ingelheim Investigational Site | Chiang Mai | Thailand | ||
| 1126 | 205.452.66003 Boehringer Ingelheim Investigational Site | Hatyai, Songkhla | Thailand | ||
| 1127 | 205.452.66002 Boehringer Ingelheim Investigational Site | Khon Kaen | Thailand | ||
| 1128 | 205.452.66005 Boehringer Ingelheim Investigational Site | Muang, Phitsanulok | Thailand | ||
| 1129 | 205.452.66001 Boehringer Ingelheim Investigational Site | Nonthaburi | Thailand | ||
| 1130 | 205.452.21603 Boehringer Ingelheim Investigational Site | Ariana | Tunisia | ||
| 1131 | 205.452.21605 Boehringer Ingelheim Investigational Site | Ariana | Tunisia | ||
| 1132 | 205.452.21606 Boehringer Ingelheim Investigational Site | Ariana | Tunisia | ||
| 1133 | 205.452.21607 Boehringer Ingelheim Investigational Site | Ariana | Tunisia | ||
| 1134 | 205.452.21610 Boehringer Ingelheim Investigational Site | Mahdia | Tunisia | ||
| 1135 | 205.452.21609 Boehringer Ingelheim Investigational Site | Monastir | Tunisia | ||
| 1136 | 205.452.21608 Boehringer Ingelheim Investigational Site | Nabeul | Tunisia | ||
| 1137 | 205.452.21601 Boehringer Ingelheim Investigational Site | Tunis | Tunisia | ||
| 1138 | 205.452.21602 Boehringer Ingelheim Investigational Site | Tunis | Tunisia | ||
| 1139 | 205.452.21604 Boehringer Ingelheim Investigational Site | Tunis | Tunisia | ||
| 1140 | 205.452.90001 Boehringer Ingelheim Investigational Site | Adana | Turkey | ||
| 1141 | 205.452.90008 Boehringer Ingelheim Investigational Site | Ankara | Turkey | ||
| 1142 | 205.452.90013 Boehringer Ingelheim Investigational Site | Ankara | Turkey | ||
| 1143 | 205.452.90005 Boehringer Ingelheim Investigational Site | Antalya | Turkey | ||
| 1144 | 205.452.90018 Boehringer Ingelheim Investigational Site | Aydin | Turkey | ||
| 1145 | 205.452.90003 Boehringer Ingelheim Investigational Site | Bolu | Turkey | ||
| 1146 | 205.452.90006 Boehringer Ingelheim Investigational Site | Edirne | Turkey | ||
| 1147 | 205.452.90010 Boehringer Ingelheim Investigational Site | Erzurum | Turkey | ||
| 1148 | 205.452.90019 Boehringer Ingelheim Investigational Site | Hatay | Turkey | ||
| 1149 | 205.452.90017 Boehringer Ingelheim Investigational Site | Istanbul | Turkey | ||
| 1150 | 205.452.90020 Boehringer Ingelheim Investigational Site | Istanbul | Turkey | ||
| 1151 | 205.452.90021 Boehringer Ingelheim Investigational Site | Istanbul | Turkey | ||
| 1152 | 205.452.90015 Boehringer Ingelheim Investigational Site | Izmir | Turkey | ||
| 1153 | 205.452.90016 Boehringer Ingelheim Investigational Site | Izmir | Turkey | ||
| 1154 | 205.452.90022 Boehringer Ingelheim Investigational Site | Izmir | Turkey | ||
| 1155 | 205.452.90007 Boehringer Ingelheim Investigational Site | Malatya | Turkey | ||
| 1156 | 205.452.38028 Boehringer Ingelheim Investigational Site | Crimea | Ukraine | ||
| 1157 | 205.452.38024 Boehringer Ingelheim Investigational Site | Dnipropetrovks | Ukraine | ||
| 1158 | 205.452.38022 Boehringer Ingelheim Investigational Site | Dnipropetrovsk | Ukraine | ||
| 1159 | 205.452.38034 Boehringer Ingelheim Investigational Site | Dnyepropyetrovsk | Ukraine | ||
| 1160 | 205.452.38002 Boehringer Ingelheim Investigational Site | Donetsk | Ukraine | ||
| 1161 | 205.452.38020 Boehringer Ingelheim Investigational Site | Donetsk | Ukraine | ||
| 1162 | 205.452.38011 Boehringer Ingelheim Investigational Site | Ivano-Frankivsk | Ukraine | ||
| 1163 | 205.452.38005 Boehringer Ingelheim Investigational Site | Kharkiv | Ukraine | ||
| 1164 | 205.452.38001 Boehringer Ingelheim Investigational Site | Kharkov | Ukraine | ||
| 1165 | 205.452.38004 Boehringer Ingelheim Investigational Site | Kharkov | Ukraine | ||
| 1166 | 205.452.38006 Boehringer Ingelheim Investigational Site | Kharkov | Ukraine | ||
| 1167 | 205.452.38008 Boehringer Ingelheim Investigational Site | Kharkov | Ukraine | ||
| 1168 | 205.452.38018 Boehringer Ingelheim Investigational Site | Kharkov | Ukraine | ||
| 1169 | 205.452.38003 Boehringer Ingelheim Investigational Site | Kiev | Ukraine | ||
| 1170 | 205.452.38010 Boehringer Ingelheim Investigational Site | Kiev | Ukraine | ||
| 1171 | 205.452.38012 Boehringer Ingelheim Investigational Site | Kiev | Ukraine | ||
| 1172 | 205.452.38013 Boehringer Ingelheim Investigational Site | Kiev | Ukraine | ||
| 1173 | 205.452.38015 Boehringer Ingelheim Investigational Site | Kiev | Ukraine | ||
| 1174 | 205.452.38032 Boehringer Ingelheim Investigational Site | Kiev | Ukraine | ||
| 1175 | 205.452.38026 Boehringer Ingelheim Investigational Site | Nikolayev | Ukraine | ||
| 1176 | 205.452.38023 Boehringer Ingelheim Investigational Site | Odesa | Ukraine | ||
| 1177 | 205.452.38027 Boehringer Ingelheim Investigational Site | Odessa | Ukraine | ||
| 1178 | 205.452.38031 Boehringer Ingelheim Investigational Site | Odessa | Ukraine | ||
| 1179 | 205.452.38017 Boehringer Ingelheim Investigational Site | Simferopol | Ukraine | ||
| 1180 | 205.452.38019 Boehringer Ingelheim Investigational Site | Vinnytsya | Ukraine | ||
| 1181 | 205.452.38030 Boehringer Ingelheim Investigational Site | Zaporizhzhya | Ukraine | ||
| 1182 | 205.452.44010 Boehringer Ingelheim Investigational Site | Atherstone | United Kingdom | ||
| 1183 | 205.452.44008 Boehringer Ingelheim Investigational Site | Burbage | United Kingdom | ||
| 1184 | 205.452.44004 Boehringer Ingelheim Investigational Site | Chertsey | United Kingdom | ||
| 1185 | 205.452.44002 Boehringer Ingelheim Investigational Site | Chesterfield | United Kingdom | ||
| 1186 | 205.452.44003 Boehringer Ingelheim Investigational Site | Coventry | United Kingdom | ||
| 1187 | 205.452.44001 Boehringer Ingelheim Investigational Site | Exeter | United Kingdom | ||
| 1188 | 205.452.44007 Boehringer Ingelheim Investigational Site | Fowey | United Kingdom | ||
| 1189 | 205.452.44005 Boehringer Ingelheim Investigational Site | Frome | United Kingdom | ||
| 1190 | 205.452.44011 Boehringer Ingelheim Investigational Site | Leamington Spa | United Kingdom | ||
| 1191 | 205.452.44006 Boehringer Ingelheim Investigational Site | St Just, Penzance | United Kingdom |
Sponsors and Collaborators
- Boehringer Ingelheim
Investigators
- Study Chair: Boehringer Ingelheim, Boehringer Ingelheim
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01126437
Other Study ID Numbers:
- 205.452
- 2009-015713-51
First Posted:
May 19, 2010
Last Update Posted:
Jun 20, 2014
Last Verified:
May 1, 2014
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | This table summarizes study treatment disposition and reasons for discontinuation of study medication. Deaths that caused discontinuation from trial medications are included in AEs. Lost to follow-up indicates status at time of discontinuation of trial medication. Vital status was ascertained for 99.7% of patients. |
| Arm/Group Title | Tiotropium 2.5 mcg and Placebo | Tiotropium 5 mcg and Placebo | Tiotropium 18 mcg and Placebo |
|---|---|---|---|
| Arm/Group Description | Patients receive one of the active tiotropium arms daily tiotropium 1.25 mcg (2 actuations/day): soft mist inhaler 2 actuations=2 puffs/day | Patients receive one of the active tiotropium arms daily tiotropium 2.5 mcg (2 actuations/day): soft mist inhaler (2 actuations=2 puffs/day) | Patients receive one of the active tiotropium arms daily tiotropium 18 mcg: HandiHaler |
| Period Title: Overall Study | |||
| STARTED | 5741 | 5729 | 5713 |
| COMPLETED | 4400 | 4399 | 4400 |
| NOT COMPLETED | 1341 | 1330 | 1313 |
Baseline Characteristics
| Arm/Group Title | Tiotropium 2.5 mcg and Placebo | Tiotropium 5 mcg and Placebo | Tiotropium 18 mcg and Placebo | Total |
|---|---|---|---|---|
| Arm/Group Description | Patients receive one of the active tiotropium arms daily tiotropium 1.25 mcg (2 actuations/day): soft mist inhaler 2 actuations=2 puffs/day | Patients receive one of the active tiotropium arms daily tiotropium 2.5 mcg (2 actuations/day): soft mist inhaler (2 actuations=2 puffs/day) | Patients receive one of the active tiotropium arms daily tiotropium 18 mcg: HandiHaler | Total of all reporting groups |
| Overall Participants | 5724 | 5705 | 5687 | 17116 |
| Age (years) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [years] |
65.1
(9.1)
|
64.9
(9.1)
|
65.0
(9.0)
|
65.0
(9.1)
|
| Sex: Female, Male (Count of Participants) | ||||
| Female |
1656
28.9%
|
1571
27.5%
|
1652
29%
|
4879
28.5%
|
| Male |
4068
71.1%
|
4134
72.5%
|
4035
71%
|
12237
71.5%
|
Outcome Measures
| Title | Time to All-Cause Mortality |
|---|---|
| Description | Number of patients with all-cause mortality |
| Time Frame | Up to 3 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| Death analysis set (DAS) including vital status follow-up: This analysis set included all randomized subjects excluding only subjects who were documented as not treated. |
| Arm/Group Title | Tiotropium 2.5 mcg and Placebo | Tiotropium 5 mcg and Placebo | Tiotropium 18 mcg and Placebo |
|---|---|---|---|
| Arm/Group Description | Patients receive one of the active tiotropium arms daily tiotropium 1.25 mcg (2 actuations/day): soft mist inhaler 2 actuations=2 puffs/day | Patients receive one of the active tiotropium arms daily tiotropium 2.5 mcg (2 actuations/day): soft mist inhaler (2 actuations=2 puffs/day) | Patients receive one of the active tiotropium arms daily tiotropium 18 mcg: HandiHaler |
| Measure Participants | 5730 | 5711 | 5694 |
| Number [Number of deaths] |
440
(7.7)
|
423
(7.4)
|
439
(7.7)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Tiotropium 5 mcg and Placebo, Tiotropium 18 mcg and Placebo |
|---|---|---|
| Comments | H0: Hazard Ratio for Respimat/HandiHaler >= 1.25 Ha: Hazard Ratio for Respimat/HandiHaler < 1.25 | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | Three tests were conducted in hierarchical order. Non-inferiority of time to death from any cause was tested on the two Respimat doses: Tio R 5 vs. Tio HH18, then if non-inferiority was achieved Tio R 2.5 vs Tio HH18. If successful, a test of superiority of Tio R5 over Tio HH18 for time to first COPD exacerbation was conducted. The non-inferiority delta for time to death was 1.25. Non-inferiority tests were performed at one-sided α=0.025 level. Superiority test was performed at two sided α=0.05. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.957 | |
| Confidence Interval |
(2-Sided) 95% 0.837 to 1.094 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Tiotropium 2.5 mcg and Placebo, Tiotropium 18 mcg and Placebo |
|---|---|---|
| Comments | H0: Hazard Ratio for Respimat/HandiHaler >= 1.25 Ha: Hazard Ratio for Respimat/HandiHaler < 1.25 | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | Three tests were conducted in hierarchical order. Non-inferiority of time to death from any cause was tested on the two Respimat doses: Tio R 5 vs. Tio HH18, then if non-inferiority was achieved Tio R 2.5 vs Tio HH18. If successful, a test of superiority of Tio R5 over Tio HH18 for time to first COPD exacerbation was conducted. The non-inferiority delta for time to death was 1.25. Non-inferiority tests were performed at one-sided α=0.025 level. Superiority test was performed at two sided α=0.05. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.996 | |
| Confidence Interval |
(2-Sided) 95% 0.872 to 1.136 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Time to First COPD Exacerbation |
|---|---|
| Description | Defined as "a complex of lower respiratory events/symptoms (increase of new onset) related to the underlying COPD, with duration of three days or more, requiring a change in treatment" where a "complex of lower respiratory event/symptoms" was defined as having at least two of the following: shortness of breath, sputum production (volume), occurrence of purulent sputum, cough, wheezing, chest tightness and where "a required change in treatment" includes the following:Prescription of antibiotics and/or systemic steroids, and/or a newly prescribed maintenance respiratory medication (i.e., bronchodilators including theophyllines). "Onset of exacerbation" was defined by the onset of first recorded symptom. The "end of exacerbation" was decided by the investigator based on clinical judgement. Exacerbations were classified as follows: Mild:a new prescription of maintenance bronchodilator only Moderate:antibiotics or systemic steroids without hospitalization Severe:hospitalization. |
| Time Frame | Up to 3 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| Treated set (TS, on-treatment only) |
| Arm/Group Title | Tiotropium 2.5 mcg and Placebo | Tiotropium 5 mcg and Placebo | Tiotropium 18 mcg and Placebo |
|---|---|---|---|
| Arm/Group Description | Patients receive one of the active tiotropium arms daily tiotropium 1.25 mcg (2 actuations/day): soft mist inhaler 2 actuations=2 puffs/day | Patients receive one of the active tiotropium arms daily tiotropium 2.5 mcg (2 actuations/day): soft mist inhaler (2 actuations=2 puffs/day) | Patients receive one of the active tiotropium arms daily tiotropium 18 mcg: HandiHaler |
| Measure Participants | 5724 | 5705 | 5687 |
| Median (95% Confidence Interval) [days to event] |
707
|
756
|
719
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Tiotropium 5 mcg and Placebo, Tiotropium 18 mcg and Placebo |
|---|---|---|
| Comments | H0: Hazard Ratio for Respimat/HandiHaler = 1 Ha: Hazard Ratio for Respimat/HandiHaler ≠ 1 at alpha = 0.05 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.4194 |
| Comments | ||
| Method | Regression, Cox | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.978 | |
| Confidence Interval |
(2-Sided) 95% 0.928 to 1.032 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Tiotropium 2.5 mcg and Placebo, Tiotropium 18 mcg and Placebo |
|---|---|---|
| Comments | H0: Hazard Ratio for Respimat/HandiHaler = 1 Ha: Hazard Ratio for Respimat/HandiHaler ≠ 1 at alpha = 0.05 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.5593 |
| Comments | ||
| Method | Regression, Cox | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 1.016 | |
| Confidence Interval |
(2-Sided) 95% 0.964 to 1.070 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Tiotropium 2.5 mcg and Placebo, Tiotropium 5 mcg and Placebo |
|---|---|---|
| Comments | H0: Hazard Ratio for Respimat/HandiHaler = 1 Ha: Hazard Ratio for Respimat/HandiHaler ≠ 1 at alpha = 0.05 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1639 |
| Comments | ||
| Method | Regression, Cox | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 1.038 | |
| Confidence Interval |
(2-Sided) 95% 0.985 to 1.094 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Trough FEV1 Over 120 Weeks (in a Substudy of 1370 Patients) |
|---|---|
| Description | Trough forced expiratory volume in one second (FEV1) over 120 weeks (in a substudy of 1370 patients) |
| Time Frame | Up to 3 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| SSS - PFT - Sub-study set (pulmonary function testing). This analysis set included all subjects in the TS who signed informed consent to participate in the spirometry sub-study and had at least baseline and one on-treatment trough FEV1. |
| Arm/Group Title | Tiotropium 2.5 mcg and Placebo | Tiotropium 5 mcg and Placebo | Tiotropium 18 mcg and Placebo |
|---|---|---|---|
| Arm/Group Description | Patients receive one of the active tiotropium arms daily tiotropium 1.25 mcg (2 actuations/day): soft mist inhaler 2 actuations=2 puffs/day | Patients receive one of the active tiotropium arms daily tiotropium 2.5 mcg (2 actuations/day): soft mist inhaler (2 actuations=2 puffs/day) | Patients receive one of the active tiotropium arms daily tiotropium 18 mcg: HandiHaler |
| Measure Participants | 464 | 461 | 445 |
| Least Squares Mean (Standard Error) [Liter] |
1.258
(0.012)
|
1.285
(0.012)
|
1.295
(0.012)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Tiotropium 5 mcg and Placebo, Tiotropium 18 mcg and Placebo |
|---|---|---|
| Comments | FEV1 was analyzed through Week 120 using REML-based repeated measures. H0: Adjusted mean difference for Respimat/HandiHaler ≥ 50ml Ha: Adjusted mean difference for Respimat/HandiHaler < 50 ml | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | The first test performed was to test the main effect for treatment in the mixed model repeated measures (MMRM) model, specifically the 95% CI for the contrast between Tio R 5ug and Tio HH 18ug was compared to the non-inferiority delta of 50 mL. If that test was successful, the second test in the hierarchy was to test the main effect for treatment in the MMRM model, specifically the 95% CI for the contrast between Tio R 2.5 ug and Tio HH 18 ug was compared to the non-inferiority delta of 50 mL. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Adjusted mean difference |
| Estimated Value | -.010 | |
| Confidence Interval |
(2-Sided) 95% -.038 to 0.018 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.014 |
|
| Estimation Comments | Model included the fixed, categorical effects of treatment, investigative site, visit, and treatment-by-visit interaction, and continuous, fixed covariates of baseline and baseline-by-visit interaction, and a random term of patient. | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Tiotropium 2.5 mcg and Placebo, Tiotropium 18 mcg and Placebo |
|---|---|---|
| Comments | FEV1 was analyzed through Week 120 using REML-based repeated measures. H0: Adjusted mean difference for Respimat/HandiHaler ≥ 50ml Ha: Adjusted mean difference for Respimat/HandiHaler < 50 ml | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | The first test performed was to test the main effect for treatment in the mixed model repeated measures (MMRM) model, specifically the 95% CI for the contrast between Tio R 5ug and Tio HH 18ug was compared to the non-inferiority delta of 50 mL. If that test was successful, the second test in the hierarchy was to test the main effect for treatment in the MMRM model, specifically the 95% CI for the contrast between Tio R 2.5 ug and Tio HH 18 ug was compared to the non-inferiority delta of 50 mL. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Adjusted mean difference |
| Estimated Value | -.037 | |
| Confidence Interval |
(2-Sided) 95% -.065 to -.009 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.014 |
|
| Estimation Comments | Model included the fixed, categorical effects of treatment, investigative site, visit, and treatment-by-visit interaction, and continuous, fixed covariates of baseline and baseline-by-visit interaction, and a random term of patient. | |
| Title | Number of COPD Exacerbations |
|---|---|
| Description | The number of COPD exacerbations. COPD exacerbation defined as "a complex of lower respiratory events/symptoms (increase of new onset) related to the underlying COPD, with duration of three days or more, requiring a change in treatment" where a "complex of lower respiratory event/symptoms" was defined as having at least two of the following: shortness of breath, sputum production (volume), occurrence of purulent sputum, cough, wheezing, chest tightness and where "a required change in treatment" includes the following:Prescription of antibiotics and/or systemic steroids, and/or a newly prescribed maintenance respiratory medication (i.e., bronchodilators including theophyllines). |
| Time Frame | Up to 3 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| Treated Set - on treatment only |
| Arm/Group Title | Tiotropium 2.5 mcg and Placebo | Tiotropium 5 mcg and Placebo | Tiotropium 18 mcg and Placebo |
|---|---|---|---|
| Arm/Group Description | Patients receive one of the active tiotropium arms daily tiotropium 1.25 mcg (2 actuations/day): soft mist inhaler 2 actuations=2 puffs/day | Patients receive one of the active tiotropium arms daily tiotropium 2.5 mcg (2 actuations/day): soft mist inhaler (2 actuations=2 puffs/day) | Patients receive one of the active tiotropium arms daily tiotropium 18 mcg: HandiHaler |
| Measure Participants | 5724 | 5705 | 5687 |
| Number [number of COPD exacerbations] |
6565
|
6425
|
6504
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Tiotropium 2.5 mcg and Placebo, Tiotropium 18 mcg and Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.8330 |
| Comments | ||
| Method | Negative binomial regression | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Rate ratio of events |
| Estimated Value | 1.01 | |
| Confidence Interval |
(2-Sided) 95% 0.95 to 1.06 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.03 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Tiotropium 5 mcg and Placebo, Tiotropium 18 mcg and Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.8047 |
| Comments | ||
| Method | Negative binomial regression | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Rate ratio of events |
| Estimated Value | 0.99 | |
| Confidence Interval |
(2-Sided) 95% 0.94 to 1.05 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.03 |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Tiotropium 2.5 mcg and Placebo, Tiotropium 5 mcg and Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.6468 |
| Comments | ||
| Method | Negative binomial regression | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Rate ratio of events |
| Estimated Value | 1.01 | |
| Confidence Interval |
(2-Sided) 95% 0.96 to 1.07 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.03 |
|
| Estimation Comments | ||
| Title | Time to First Hospitalization Associated With COPD Exacerbation |
|---|---|
| Description | The results presented below are for the patients with hospitalizations due to COPD exacerbations. |
| Time Frame | Up to 3 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| treated set - on-treatment only |
| Arm/Group Title | Tiotropium 2.5 mcg and Placebo | Tiotropium 5 mcg and Placebo | Tiotropium 18 mcg and Placebo |
|---|---|---|---|
| Arm/Group Description | Patients receive one of the active tiotropium arms daily tiotropium 1.25 mcg (2 actuations/day): soft mist inhaler 2 actuations=2 puffs/day | Patients receive one of the active tiotropium arms daily tiotropium 2.5 mcg (2 actuations/day): soft mist inhaler (2 actuations=2 puffs/day) | Patients receive one of the active tiotropium arms daily tiotropium 18 mcg: HandiHaler |
| Measure Participants | 5724 | 5705 | 5687 |
| Number [Number of patients with event] |
869
|
826
|
811
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Tiotropium 2.5 mcg and Placebo, Tiotropium 18 mcg and Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1762 |
| Comments | ||
| Method | Regression, Cox | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 1.068 | |
| Confidence Interval |
(2-Sided) 95% 0.971 to 1.176 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Tiotropium 5 mcg and Placebo, Tiotropium 18 mcg and Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.6384 |
| Comments | ||
| Method | Regression, Cox | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 1.024 | |
| Confidence Interval |
(2-Sided) 95% 0.929 to 1.128 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Tiotropium 2.5 mcg and Placebo, Tiotropium 5 mcg and Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.3784 |
| Comments | ||
| Method | Regression, Cox | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 1.044 | |
| Confidence Interval |
(2-Sided) 95% 0.949 to 1.148 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Number of Hospitalizations Associated With COPD Exacerbation |
|---|---|
| Description | Total number of hospitalizations associated with COPD exacerbation. |
| Time Frame | Up to 3 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| treated set - on treatment only |
| Arm/Group Title | Tiotropium 2.5 mcg and Placebo | Tiotropium 5 mcg and Placebo | Tiotropium 18 mcg and Placebo |
|---|---|---|---|
| Arm/Group Description | Patients receive one of the active tiotropium arms daily tiotropium 1.25 mcg (2 actuations/day): soft mist inhaler 2 actuations=2 puffs/day | Patients receive one of the active tiotropium arms daily tiotropium 2.5 mcg (2 actuations/day): soft mist inhaler (2 actuations=2 puffs/day) | Patients receive one of the active tiotropium arms daily tiotropium 18 mcg: HandiHaler |
| Measure Participants | 5724 | 5705 | 5687 |
| Number [number of hospitalizations] |
1316
|
1284
|
1216
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Tiotropium 2.5 mcg and Placebo, Tiotropium 18 mcg and Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1255 |
| Comments | p-value from negative binomial regression. | |
| Method | Negative binomial regression | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Rate ratio of events |
| Estimated Value | 1.09 | |
| Confidence Interval |
(2-Sided) 95% 0.98 to 1.22 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.06 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Tiotropium 5 mcg and Placebo, Tiotropium 18 mcg and Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.3441 |
| Comments | p-value from negative binomial regression. | |
| Method | Negative binomial regression | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Rate ratio of events |
| Estimated Value | 1.06 | |
| Confidence Interval |
(2-Sided) 95% 0.94 to 1.18 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.06 |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Tiotropium 2.5 mcg and Placebo, Tiotropium 5 mcg and Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.5573 |
| Comments | p-value from negative binomial regression. | |
| Method | Negative binomial regression | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Rate ratio of events |
| Estimated Value | 1.03 | |
| Confidence Interval |
(2-Sided) 95% 0.92 to 1.16 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.06 |
|
| Estimation Comments | ||
| Title | Time to First Moderate to Severe COPD Exacerbation |
|---|---|
| Description | COPD exacerbation defined as "a complex of lower respiratory events/symptoms (increase of new onset) related to the underlying COPD, with duration of three days or more, requiring a change in treatment" where a "complex of lower respiratory event/symptoms" was defined as having at least two of the following: shortness of breath, sputum production (volume), occurrence of purulent sputum, cough, wheezing, chest tightness and where "a required change in treatment" includes the following:Prescription of antibiotics and/or systemic steroids, and/or a newly prescribed maintenance respiratory medication (i.e., bronchodilators including theophyllines). Exacerbations classified as follows: Mild:a new prescription of maintenance bronchodilator only Moderate:antibiotics or systemic steroids without hospitalization Severe:hospitalization. Results presented below are number of patients with moderate to severe exacerbations. |
| Time Frame | Up to 3 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| treated set - on treatment only |
| Arm/Group Title | Tiotropium 2.5 mcg and Placebo | Tiotropium 5 mcg and Placebo | Tiotropium 18 mcg and Placebo |
|---|---|---|---|
| Arm/Group Description | Patients receive one of the active tiotropium arms daily tiotropium 1.25 mcg (2 actuations/day): soft mist inhaler 2 actuations=2 puffs/day | Patients receive one of the active tiotropium arms daily tiotropium 2.5 mcg (2 actuations/day): soft mist inhaler (2 actuations=2 puffs/day) | Patients receive one of the active tiotropium arms daily tiotropium 18 mcg: HandiHaler |
| Measure Participants | 5724 | 5705 | 5687 |
| Number [number of patients with event] |
2769
|
2694
|
2732
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Tiotropium 2.5 mcg and Placebo, Tiotropium 18 mcg and Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.6823 |
| Comments | ||
| Method | Regression, Cox | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 1.011 | |
| Confidence Interval |
(2-Sided) 95% 0.959 to 1.066 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Tiotropium 5 mcg and Placebo, Tiotropium 18 mcg and Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.5377 |
| Comments | ||
| Method | Regression, Cox | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.983 | |
| Confidence Interval |
(2-Sided) 95% 0.932 to 1.037 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Tiotropium 2.5 mcg and Placebo, Tiotropium 5 mcg and Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.3048 |
| Comments | ||
| Method | Regression, Cox | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 1.028 | |
| Confidence Interval |
(2-Sided) 95% 0.975 to 1.084 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Time to Onset of First Major Adverse Cardiovascular Event (MACE) |
|---|---|
| Description | Time to onset of first major adverse cardiovascular event (MACE). MACE was defined as: Fatal event in the system organ classes of cardiac and vascular disorders, Preferred terms: sudden death, cardiac death, sudden cardiac death, Outcome events of myocardial infarction (serious and non-serious), Outcome events of stroke (serious and non-serious) and Outcome events of TIA (serious and non-serious). The results presented below are for the number of patients with MACE. |
| Time Frame | Up to 3 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| Treated set - on treatment only |
| Arm/Group Title | Tiotropium 2.5 mcg and Placebo | Tiotropium 5 mcg and Placebo | Tiotropium 18 mcg and Placebo |
|---|---|---|---|
| Arm/Group Description | Patients receive one of the active tiotropium arms daily tiotropium 1.25 mcg (2 actuations/day): soft mist inhaler 2 actuations=2 puffs/day | Patients receive one of the active tiotropium arms daily tiotropium 2.5 mcg (2 actuations/day): soft mist inhaler (2 actuations=2 puffs/day) | Patients receive one of the active tiotropium arms daily tiotropium 18 mcg: HandiHaler |
| Measure Participants | 5724 | 5705 | 5687 |
| Number [number of patients with MACE] |
224
|
222
|
202
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Tiotropium 2.5 mcg and Placebo, Tiotropium 18 mcg and Placebo |
|---|---|---|
| Comments | Causes of death from MACE were determined by adjudication. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.3043 |
| Comments | ||
| Method | Regression, Cox | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 1.105 | |
| Confidence Interval |
(2-Sided) 95% 0.913 to 1.336 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Tiotropium 5 mcg and Placebo, Tiotropium 18 mcg and Placebo |
|---|---|---|
| Comments | Causes of death from MACE were determined by adjudication. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.3263 |
| Comments | ||
| Method | Regression, Cox | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 1.100 | |
| Confidence Interval |
(2-Sided) 95% 0.909 to 1.331 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Tiotropium 2.5 mcg and Placebo, Tiotropium 5 mcg and Placebo |
|---|---|---|
| Comments | Causes of death from MACE were determined by adjudication. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.9644 |
| Comments | ||
| Method | Regression, Cox | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 1.004 | |
| Confidence Interval |
(2-Sided) 95% 0.834 to 1.209 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Time to Death From Major Adverse Cardiovascular Event (MACE) |
|---|---|
| Description | The results presented below are number of patients with death from MACE. |
| Time Frame | Up to 3 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| TS including vital status follow-up, DAS |
| Arm/Group Title | Tiotropium 2.5 mcg and Placebo | Tiotropium 5 mcg and Placebo | Tiotropium 18 mcg and Placebo |
|---|---|---|---|
| Arm/Group Description | Patients receive one of the active tiotropium arms daily tiotropium 1.25 mcg (2 actuations/day): soft mist inhaler 2 actuations=2 puffs/day | Patients receive one of the active tiotropium arms daily tiotropium 2.5 mcg (2 actuations/day): soft mist inhaler (2 actuations=2 puffs/day) | Patients receive one of the active tiotropium arms daily tiotropium 18 mcg: HandiHaler |
| Measure Participants | 5730 | 5711 | 5694 |
| Number [Number of deaths from MACE] |
119
|
113
|
101
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Tiotropium 2.5 mcg and Placebo, Tiotropium 18 mcg and Placebo |
|---|---|---|
| Comments | Time to death from MACE was analyzed using the full study duration including vital status follow-up. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.2439 |
| Comments | ||
| Method | Regression, Cox | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 1.171 | |
| Confidence Interval |
(2-Sided) 95% 0.898 to 1.526 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Tiotropium 5 mcg and Placebo, Tiotropium 18 mcg and Placebo |
|---|---|---|
| Comments | Time to death from MACE was analyzed using the full study duration including vital status follow-up. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.4413 |
| Comments | ||
| Method | Regression, Cox | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 1.111 | |
| Confidence Interval |
(2-Sided) 95% 0.850 to 1.453 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Tiotropium 2.5 mcg and Placebo, Tiotropium 5 mcg and Placebo |
|---|---|---|
| Comments | Time to death from MACE was analyzed using the full study duration including vital status follow-up. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.6910 |
| Comments | ||
| Method | Regression, Cox | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 1.054 | |
| Confidence Interval |
(2-Sided) 95% 0.814 to 1.363 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Adverse Events
| Time Frame | From the first drug intake up to 30 days after administration | |||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial. | |||||
| Arm/Group Title | Tiotropium 2.5 mcg and Placebo | Tiotropium 5 mcg and Placebo | Tiotropium 18 mcg and Placebo | |||
| Arm/Group Description | Patients receive one of the active tiotropium arms daily tiotropium 1.25 mcg (2 actuations/day): soft mist inhaler 2 actuations=2 puffs/day | Patients receive one of the active tiotropium arms daily tiotropium 2.5 mcg (2 actuations/day): soft mist inhaler (2 actuations=2 puffs/day) | Patients receive one of the active tiotropium arms daily Tiotropium 18 mcg: HandiHaler | |||
All Cause Mortality |
||||||
| Tiotropium 2.5 mcg and Placebo | Tiotropium 5 mcg and Placebo | Tiotropium 18 mcg and Placebo | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | |||
Serious Adverse Events |
||||||
| Tiotropium 2.5 mcg and Placebo | Tiotropium 5 mcg and Placebo | Tiotropium 18 mcg and Placebo | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1932/5724 (33.8%) | 1876/5705 (32.9%) | 1928/5687 (33.9%) | |||
| Blood and lymphatic system disorders | ||||||
| Anaemia | 10/5724 (0.2%) | 10/5705 (0.2%) | 13/5687 (0.2%) | |||
| Coagulopathy | 0/5724 (0%) | 0/5705 (0%) | 3/5687 (0.1%) | |||
| Disseminated intravascular coagulation | 1/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Febrile neutropenia | 1/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Haemorrhagic anaemia | 0/5724 (0%) | 0/5705 (0%) | 4/5687 (0.1%) | |||
| Hypercoagulation | 1/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Iron deficiency anaemia | 2/5724 (0%) | 0/5705 (0%) | 2/5687 (0%) | |||
| Leukocytosis | 3/5724 (0.1%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Lymphadenitis | 0/5724 (0%) | 1/5705 (0%) | 1/5687 (0%) | |||
| Lymphadenopathy | 0/5724 (0%) | 1/5705 (0%) | 1/5687 (0%) | |||
| Lymphadenopathy mediastinal | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Microcytic anaemia | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Pancytopenia | 2/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Pernicious anaemia | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Polycythaemia | 0/5724 (0%) | 1/5705 (0%) | 1/5687 (0%) | |||
| Splenomegaly | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Thrombocytopenia | 0/5724 (0%) | 0/5705 (0%) | 2/5687 (0%) | |||
| Thrombocytosis | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Cardiac disorders | ||||||
| Acute coronary syndrome | 4/5724 (0.1%) | 3/5705 (0.1%) | 9/5687 (0.2%) | |||
| Acute myocardial infarction | 21/5724 (0.4%) | 21/5705 (0.4%) | 13/5687 (0.2%) | |||
| Adams-Stokes syndrome | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Angina pectoris | 20/5724 (0.3%) | 28/5705 (0.5%) | 22/5687 (0.4%) | |||
| Angina unstable | 10/5724 (0.2%) | 19/5705 (0.3%) | 10/5687 (0.2%) | |||
| Aortic valve disease | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Aortic valve disease mixed | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Aortic valve incompetence | 0/5724 (0%) | 1/5705 (0%) | 3/5687 (0.1%) | |||
| Aortic valve stenosis | 2/5724 (0%) | 3/5705 (0.1%) | 3/5687 (0.1%) | |||
| Arrhythmia | 5/5724 (0.1%) | 8/5705 (0.1%) | 7/5687 (0.1%) | |||
| Arrhythmia supraventricular | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Arteriosclerosis coronary artery | 2/5724 (0%) | 2/5705 (0%) | 0/5687 (0%) | |||
| Atrial fibrillation | 41/5724 (0.7%) | 37/5705 (0.6%) | 32/5687 (0.6%) | |||
| Atrial flutter | 10/5724 (0.2%) | 6/5705 (0.1%) | 4/5687 (0.1%) | |||
| Atrial tachycardia | 2/5724 (0%) | 0/5705 (0%) | 3/5687 (0.1%) | |||
| Atrioventricular block | 3/5724 (0.1%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Atrioventricular block complete | 2/5724 (0%) | 1/5705 (0%) | 2/5687 (0%) | |||
| Atrioventricular block second degree | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Bradycardia | 4/5724 (0.1%) | 2/5705 (0%) | 2/5687 (0%) | |||
| Bundle branch block left | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Bundle branch block right | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Cardiac arrest | 12/5724 (0.2%) | 7/5705 (0.1%) | 9/5687 (0.2%) | |||
| Cardiac asthma | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Cardiac disorder | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Cardiac failure | 30/5724 (0.5%) | 23/5705 (0.4%) | 24/5687 (0.4%) | |||
| Cardiac failure acute | 4/5724 (0.1%) | 4/5705 (0.1%) | 6/5687 (0.1%) | |||
| Cardiac failure chronic | 2/5724 (0%) | 2/5705 (0%) | 3/5687 (0.1%) | |||
| Cardiac failure congestive | 26/5724 (0.5%) | 22/5705 (0.4%) | 29/5687 (0.5%) | |||
| Cardiac valve disease | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Cardio-respiratory arrest | 9/5724 (0.2%) | 5/5705 (0.1%) | 8/5687 (0.1%) | |||
| Cardiomegaly | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Cardiomyopathy | 3/5724 (0.1%) | 4/5705 (0.1%) | 3/5687 (0.1%) | |||
| Cardiomyopathy alcoholic | 1/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Cardiopulmonary failure | 9/5724 (0.2%) | 11/5705 (0.2%) | 9/5687 (0.2%) | |||
| Cardiovascular disorder | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Congestive cardiomyopathy | 1/5724 (0%) | 3/5705 (0.1%) | 1/5687 (0%) | |||
| Cor pulmonale | 4/5724 (0.1%) | 4/5705 (0.1%) | 6/5687 (0.1%) | |||
| Cor pulmonale acute | 1/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Cor pulmonale chronic | 3/5724 (0.1%) | 2/5705 (0%) | 4/5687 (0.1%) | |||
| Coronary artery disease | 18/5724 (0.3%) | 25/5705 (0.4%) | 23/5687 (0.4%) | |||
| Coronary artery insufficiency | 2/5724 (0%) | 1/5705 (0%) | 1/5687 (0%) | |||
| Coronary artery occlusion | 2/5724 (0%) | 2/5705 (0%) | 2/5687 (0%) | |||
| Coronary artery stenosis | 6/5724 (0.1%) | 2/5705 (0%) | 3/5687 (0.1%) | |||
| Diastolic dysfunction | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Hypertensive heart disease | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Ischaemic cardiomyopathy | 1/5724 (0%) | 1/5705 (0%) | 4/5687 (0.1%) | |||
| Left ventricular dysfunction | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Left ventricular failure | 2/5724 (0%) | 2/5705 (0%) | 1/5687 (0%) | |||
| Mitral valve incompetence | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Myocardial infarction | 53/5724 (0.9%) | 45/5705 (0.8%) | 39/5687 (0.7%) | |||
| Myocardial ischaemia | 7/5724 (0.1%) | 7/5705 (0.1%) | 11/5687 (0.2%) | |||
| Palpitations | 1/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Pericardial effusion | 2/5724 (0%) | 1/5705 (0%) | 2/5687 (0%) | |||
| Pericarditis | 1/5724 (0%) | 1/5705 (0%) | 2/5687 (0%) | |||
| Postinfarction angina | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Prinzmetal angina | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Right ventricular failure | 2/5724 (0%) | 2/5705 (0%) | 1/5687 (0%) | |||
| Sick sinus syndrome | 0/5724 (0%) | 2/5705 (0%) | 1/5687 (0%) | |||
| Silent myocardial infarction | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Sinus bradycardia | 1/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Stress cardiomyopathy | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Supraventricular extrasystoles | 0/5724 (0%) | 1/5705 (0%) | 1/5687 (0%) | |||
| Supraventricular tachycardia | 1/5724 (0%) | 3/5705 (0.1%) | 6/5687 (0.1%) | |||
| Tachyarrhythmia | 0/5724 (0%) | 2/5705 (0%) | 1/5687 (0%) | |||
| Tachycardia | 3/5724 (0.1%) | 2/5705 (0%) | 2/5687 (0%) | |||
| Ventricular arrhythmia | 0/5724 (0%) | 2/5705 (0%) | 0/5687 (0%) | |||
| Ventricular dysfunction | 1/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Ventricular extrasystoles | 1/5724 (0%) | 1/5705 (0%) | 1/5687 (0%) | |||
| Ventricular fibrillation | 3/5724 (0.1%) | 2/5705 (0%) | 1/5687 (0%) | |||
| Ventricular tachycardia | 1/5724 (0%) | 2/5705 (0%) | 3/5687 (0.1%) | |||
| Congenital, familial and genetic disorders | ||||||
| Alpha-1 anti-trypsin deficiency | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Congenital absence of bile ducts | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Hamartoma | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Hydrocele | 0/5724 (0%) | 2/5705 (0%) | 0/5687 (0%) | |||
| Ear and labyrinth disorders | ||||||
| Deafness | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Hypoacusis | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Vertigo | 6/5724 (0.1%) | 1/5705 (0%) | 2/5687 (0%) | |||
| Endocrine disorders | ||||||
| Adrenal mass | 1/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Goitre | 1/5724 (0%) | 2/5705 (0%) | 1/5687 (0%) | |||
| Hyperthyroidism | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Hypothyroidism | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Inappropriate antidiuretic hormone secretion | 2/5724 (0%) | 0/5705 (0%) | 2/5687 (0%) | |||
| Thyroid mass | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Eye disorders | ||||||
| Amaurosis | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Amaurosis fugax | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Cataract | 13/5724 (0.2%) | 10/5705 (0.2%) | 14/5687 (0.2%) | |||
| Cataract subcapsular | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Eyelid ptosis | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Glaucoma | 0/5724 (0%) | 1/5705 (0%) | 1/5687 (0%) | |||
| Lens dislocation | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Macular degeneration | 1/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Open angle glaucoma | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Retinal detachment | 0/5724 (0%) | 3/5705 (0.1%) | 2/5687 (0%) | |||
| Retinal haemorrhage | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Retinal infarction | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Strabismus | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Ulcerative keratitis | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Vitreous haemorrhage | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Gastrointestinal disorders | ||||||
| Abdominal adhesions | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Abdominal distension | 2/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Abdominal hernia | 1/5724 (0%) | 3/5705 (0.1%) | 3/5687 (0.1%) | |||
| Abdominal hernia obstructive | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Abdominal pain | 4/5724 (0.1%) | 13/5705 (0.2%) | 4/5687 (0.1%) | |||
| Abdominal pain upper | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Abdominal wall haematoma | 2/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Acute abdomen | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Anal fistula | 1/5724 (0%) | 0/5705 (0%) | 2/5687 (0%) | |||
| Barrett's oesophagus | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Colitis | 4/5724 (0.1%) | 0/5705 (0%) | 2/5687 (0%) | |||
| Colitis ischaemic | 1/5724 (0%) | 2/5705 (0%) | 2/5687 (0%) | |||
| Colitis ulcerative | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Colonic fistula | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Colonic stenosis | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Constipation | 3/5724 (0.1%) | 3/5705 (0.1%) | 4/5687 (0.1%) | |||
| Crohn's disease | 3/5724 (0.1%) | 2/5705 (0%) | 0/5687 (0%) | |||
| Dental caries | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Diarrhoea | 7/5724 (0.1%) | 4/5705 (0.1%) | 7/5687 (0.1%) | |||
| Diverticular perforation | 1/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Diverticulum | 2/5724 (0%) | 1/5705 (0%) | 2/5687 (0%) | |||
| Diverticulum intestinal | 1/5724 (0%) | 0/5705 (0%) | 2/5687 (0%) | |||
| Diverticulum intestinal haemorrhagic | 1/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Duodenal scarring | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Duodenal stenosis | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Duodenal ulcer | 6/5724 (0.1%) | 2/5705 (0%) | 2/5687 (0%) | |||
| Duodenal ulcer haemorrhage | 2/5724 (0%) | 2/5705 (0%) | 3/5687 (0.1%) | |||
| Duodenal ulcer perforation | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Duodenitis | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Duodenogastric reflux | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Dyspepsia | 1/5724 (0%) | 1/5705 (0%) | 1/5687 (0%) | |||
| Dysphagia | 2/5724 (0%) | 3/5705 (0.1%) | 2/5687 (0%) | |||
| Enteritis | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Enterocolitis | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Enterocutaneous fistula | 1/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Epiploic appendagitis | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Faecaloma | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Femoral hernia | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Food poisoning | 1/5724 (0%) | 3/5705 (0.1%) | 0/5687 (0%) | |||
| Gastric haemorrhage | 2/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Gastric polyps | 0/5724 (0%) | 1/5705 (0%) | 1/5687 (0%) | |||
| Gastric ulcer | 4/5724 (0.1%) | 1/5705 (0%) | 4/5687 (0.1%) | |||
| Gastric ulcer haemorrhage | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Gastritis | 7/5724 (0.1%) | 6/5705 (0.1%) | 4/5687 (0.1%) | |||
| Gastritis atrophic | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Gastritis erosive | 0/5724 (0%) | 3/5705 (0.1%) | 1/5687 (0%) | |||
| Gastritis haemorrhagic | 2/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Gastroduodenal ulcer | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Gastroduodenitis | 2/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Gastrointestinal angiodysplasia | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Gastrointestinal haemorrhage | 11/5724 (0.2%) | 12/5705 (0.2%) | 8/5687 (0.1%) | |||
| Gastrointestinal inflammation | 1/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Gastrointestinal necrosis | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Gastrooesophageal reflux disease | 7/5724 (0.1%) | 3/5705 (0.1%) | 3/5687 (0.1%) | |||
| Gastrooesophagitis | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Haematemesis | 1/5724 (0%) | 2/5705 (0%) | 0/5687 (0%) | |||
| Haematochezia | 1/5724 (0%) | 3/5705 (0.1%) | 0/5687 (0%) | |||
| Haemorrhoidal haemorrhage | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Haemorrhoids | 3/5724 (0.1%) | 0/5705 (0%) | 3/5687 (0.1%) | |||
| Hiatus hernia | 2/5724 (0%) | 2/5705 (0%) | 3/5687 (0.1%) | |||
| Ileus | 2/5724 (0%) | 3/5705 (0.1%) | 8/5687 (0.1%) | |||
| Ileus paralytic | 2/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Impaired gastric emptying | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Inguinal hernia | 10/5724 (0.2%) | 16/5705 (0.3%) | 15/5687 (0.3%) | |||
| Inguinal hernia, obstructive | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Intestinal haemorrhage | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Intestinal ischaemia | 0/5724 (0%) | 3/5705 (0.1%) | 0/5687 (0%) | |||
| Intestinal mass | 0/5724 (0%) | 2/5705 (0%) | 0/5687 (0%) | |||
| Intestinal obstruction | 9/5724 (0.2%) | 6/5705 (0.1%) | 7/5687 (0.1%) | |||
| Intestinal perforation | 1/5724 (0%) | 1/5705 (0%) | 1/5687 (0%) | |||
| Intestinal polyp | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Irritable bowel syndrome | 1/5724 (0%) | 1/5705 (0%) | 1/5687 (0%) | |||
| Jejunal ulcer | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Large intestinal obstruction | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Large intestine perforation | 1/5724 (0%) | 1/5705 (0%) | 1/5687 (0%) | |||
| Large intestine polyp | 3/5724 (0.1%) | 0/5705 (0%) | 2/5687 (0%) | |||
| Lower gastrointestinal haemorrhage | 0/5724 (0%) | 1/5705 (0%) | 1/5687 (0%) | |||
| Lumbar hernia | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Malabsorption | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Mallory-Weiss syndrome | 0/5724 (0%) | 1/5705 (0%) | 1/5687 (0%) | |||
| Mechanical ileus | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Megacolon | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Melaena | 3/5724 (0.1%) | 2/5705 (0%) | 3/5687 (0.1%) | |||
| Mesenteric artery thrombosis | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Mouth haemorrhage | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Mouth ulceration | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Nausea | 2/5724 (0%) | 2/5705 (0%) | 6/5687 (0.1%) | |||
| Obstruction gastric | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Oesophageal food impaction | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Oesophageal perforation | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Oesophageal stenosis | 1/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Oesophageal ulcer | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Oesophagitis | 0/5724 (0%) | 2/5705 (0%) | 1/5687 (0%) | |||
| Oesophagitis ulcerative | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Pancreatic cyst | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Pancreatitis | 9/5724 (0.2%) | 3/5705 (0.1%) | 4/5687 (0.1%) | |||
| Pancreatitis acute | 5/5724 (0.1%) | 3/5705 (0.1%) | 4/5687 (0.1%) | |||
| Pancreatitis chronic | 4/5724 (0.1%) | 1/5705 (0%) | 1/5687 (0%) | |||
| Pancreatitis necrotising | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Pancreatolithiasis | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Papilla of Vater stenosis | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Parotid gland enlargement | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Peptic ulcer | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Peptic ulcer haemorrhage | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Peptic ulcer perforation | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Pharyngo-oesophageal diverticulum | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Proctalgia | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Proctocolitis | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Rectal haemorrhage | 1/5724 (0%) | 5/5705 (0.1%) | 2/5687 (0%) | |||
| Rectal prolapse | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Reflux gastritis | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Retching | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Retroperitoneal haemorrhage | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Retroperitoneal mass | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Small intestinal obstruction | 6/5724 (0.1%) | 7/5705 (0.1%) | 4/5687 (0.1%) | |||
| Stomatitis | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Subileus | 0/5724 (0%) | 2/5705 (0%) | 1/5687 (0%) | |||
| Umbilical hernia | 5/5724 (0.1%) | 1/5705 (0%) | 2/5687 (0%) | |||
| Umbilical hernia, obstructive | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Upper gastrointestinal haemorrhage | 5/5724 (0.1%) | 3/5705 (0.1%) | 3/5687 (0.1%) | |||
| Volvulus | 0/5724 (0%) | 1/5705 (0%) | 1/5687 (0%) | |||
| Vomiting | 4/5724 (0.1%) | 3/5705 (0.1%) | 3/5687 (0.1%) | |||
| General disorders | ||||||
| Adverse drug reaction | 2/5724 (0%) | 1/5705 (0%) | 3/5687 (0.1%) | |||
| Asthenia | 8/5724 (0.1%) | 3/5705 (0.1%) | 3/5687 (0.1%) | |||
| Cardiac death | 1/5724 (0%) | 0/5705 (0%) | 2/5687 (0%) | |||
| Chest discomfort | 1/5724 (0%) | 3/5705 (0.1%) | 3/5687 (0.1%) | |||
| Chest pain | 4/5724 (0.1%) | 8/5705 (0.1%) | 6/5687 (0.1%) | |||
| Condition aggravated | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Cyst | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Death | 28/5724 (0.5%) | 21/5705 (0.4%) | 13/5687 (0.2%) | |||
| Device dislocation | 0/5724 (0%) | 2/5705 (0%) | 0/5687 (0%) | |||
| Device failure | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Device lead damage | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Device malfunction | 0/5724 (0%) | 0/5705 (0%) | 2/5687 (0%) | |||
| Device occlusion | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Drowning | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Drug withdrawal syndrome | 1/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Effusion | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Exercise tolerance decreased | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Fibrosis | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| General physical health deterioration | 1/5724 (0%) | 2/5705 (0%) | 1/5687 (0%) | |||
| Hernia | 3/5724 (0.1%) | 3/5705 (0.1%) | 4/5687 (0.1%) | |||
| Hernia obstructive | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Hyperthermia | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Impaired healing | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Implant site calcification | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Implant site inflammation | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Malaise | 1/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Mass | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Multi-organ disorder | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Multi-organ failure | 2/5724 (0%) | 3/5705 (0.1%) | 7/5687 (0.1%) | |||
| Necrosis | 2/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Non-cardiac chest pain | 19/5724 (0.3%) | 23/5705 (0.4%) | 22/5687 (0.4%) | |||
| Oedema | 0/5724 (0%) | 1/5705 (0%) | 2/5687 (0%) | |||
| Oedema peripheral | 2/5724 (0%) | 0/5705 (0%) | 5/5687 (0.1%) | |||
| Polyp | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Pyrexia | 1/5724 (0%) | 3/5705 (0.1%) | 5/5687 (0.1%) | |||
| Spinal pain | 0/5724 (0%) | 0/5705 (0%) | 2/5687 (0%) | |||
| Sudden cardiac death | 3/5724 (0.1%) | 9/5705 (0.2%) | 6/5687 (0.1%) | |||
| Sudden death | 27/5724 (0.5%) | 13/5705 (0.2%) | 18/5687 (0.3%) | |||
| Systemic inflammatory response syndrome | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Ulcer haemorrhage | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Vessel puncture site haemorrhage | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Hepatobiliary disorders | ||||||
| Alcoholic liver disease | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Bile duct obstruction | 3/5724 (0.1%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Bile duct stone | 3/5724 (0.1%) | 2/5705 (0%) | 0/5687 (0%) | |||
| Biliary colic | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Biliary cyst | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Biliary dyskinesia | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Cholangitis | 2/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Cholecystitis | 11/5724 (0.2%) | 7/5705 (0.1%) | 6/5687 (0.1%) | |||
| Cholecystitis acute | 10/5724 (0.2%) | 2/5705 (0%) | 10/5687 (0.2%) | |||
| Cholecystitis chronic | 1/5724 (0%) | 1/5705 (0%) | 1/5687 (0%) | |||
| Cholelithiasis | 12/5724 (0.2%) | 12/5705 (0.2%) | 4/5687 (0.1%) | |||
| Gallbladder perforation | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Hepatic cirrhosis | 1/5724 (0%) | 0/5705 (0%) | 2/5687 (0%) | |||
| Hepatic congestion | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Hepatic failure | 2/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Hepatic ischaemia | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Hepatic mass | 0/5724 (0%) | 2/5705 (0%) | 0/5687 (0%) | |||
| Hepatitis | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Hepatitis acute | 2/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Hepatorenal syndrome | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Liver disorder | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Non-alcoholic steatohepatitis | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Immune system disorders | ||||||
| Amyloidosis | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Anaphylactic reaction | 2/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Anaphylactic shock | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Autoimmune disorder | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Drug hypersensitivity | 0/5724 (0%) | 1/5705 (0%) | 1/5687 (0%) | |||
| Food allergy | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Hypersensitivity | 2/5724 (0%) | 2/5705 (0%) | 1/5687 (0%) | |||
| Infections and infestations | ||||||
| Abdominal abscess | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Abdominal sepsis | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Abscess | 0/5724 (0%) | 2/5705 (0%) | 0/5687 (0%) | |||
| Abscess intestinal | 1/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Abscess limb | 0/5724 (0%) | 1/5705 (0%) | 3/5687 (0.1%) | |||
| Abscess neck | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Acinetobacter infection | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Acute sinusitis | 0/5724 (0%) | 0/5705 (0%) | 2/5687 (0%) | |||
| Amoebic dysentery | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Anal abscess | 1/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Anal infection | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Appendiceal abscess | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Appendicitis | 7/5724 (0.1%) | 6/5705 (0.1%) | 7/5687 (0.1%) | |||
| Appendicitis perforated | 3/5724 (0.1%) | 2/5705 (0%) | 2/5687 (0%) | |||
| Arthritis bacterial | 2/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Arthritis infective | 2/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Atypical mycobacterial infection | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Atypical pneumonia | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Bacteraemia | 1/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Bacterial infection | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Bacterial toxaemia | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Bronchitis | 16/5724 (0.3%) | 9/5705 (0.2%) | 11/5687 (0.2%) | |||
| Bronchitis bacterial | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Bronchopneumonia | 4/5724 (0.1%) | 3/5705 (0.1%) | 4/5687 (0.1%) | |||
| Bursitis infective | 0/5724 (0%) | 2/5705 (0%) | 0/5687 (0%) | |||
| Campylobacter gastroenteritis | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Campylobacter infection | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Cellulitis | 6/5724 (0.1%) | 14/5705 (0.2%) | 14/5687 (0.2%) | |||
| Cellulitis of male external genital organ | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Cholecystitis infective | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Chronic hepatitis C | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Chronic sinusitis | 0/5724 (0%) | 1/5705 (0%) | 3/5687 (0.1%) | |||
| Clostridium colitis | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Clostridium difficile colitis | 2/5724 (0%) | 3/5705 (0.1%) | 2/5687 (0%) | |||
| Clostridium difficile infection | 3/5724 (0.1%) | 2/5705 (0%) | 0/5687 (0%) | |||
| Colon gangrene | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Cystitis | 2/5724 (0%) | 3/5705 (0.1%) | 4/5687 (0.1%) | |||
| Dengue fever | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Device related infection | 1/5724 (0%) | 1/5705 (0%) | 1/5687 (0%) | |||
| Diarrhoea infectious | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Diverticulitis | 9/5724 (0.2%) | 6/5705 (0.1%) | 6/5687 (0.1%) | |||
| Ear infection | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Eczema infected | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Empyema | 0/5724 (0%) | 1/5705 (0%) | 3/5687 (0.1%) | |||
| Endocarditis | 0/5724 (0%) | 3/5705 (0.1%) | 3/5687 (0.1%) | |||
| Endophthalmitis | 1/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Enterobacter pneumonia | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Enterococcal sepsis | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Enterocolitis infectious | 0/5724 (0%) | 1/5705 (0%) | 1/5687 (0%) | |||
| Enterocolitis viral | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Erysipelas | 2/5724 (0%) | 2/5705 (0%) | 3/5687 (0.1%) | |||
| Eye infection | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Febrile infection | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Fungal infection | 2/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Gallbladder empyema | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Gangrene | 0/5724 (0%) | 2/5705 (0%) | 1/5687 (0%) | |||
| Gastritis viral | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Gastroenteritis | 11/5724 (0.2%) | 5/5705 (0.1%) | 8/5687 (0.1%) | |||
| Gastroenteritis bacterial | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Gastroenteritis clostridial | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Gastroenteritis norovirus | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Gastroenteritis salmonella | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Gastroenteritis viral | 2/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Groin abscess | 2/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Groin infection | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| H1N1 influenza | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Haematoma infection | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Helicobacter gastritis | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Helicobacter infection | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Hepatic cyst infection | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Hepatitis B | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Hepatitis C | 2/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Hepatitis viral | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Herpes virus infection | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Herpes zoster | 3/5724 (0.1%) | 2/5705 (0%) | 2/5687 (0%) | |||
| Herpes zoster ophthalmic | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Herpes zoster oticus | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Implant site infection | 1/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Incision site infection | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Infection | 1/5724 (0%) | 2/5705 (0%) | 4/5687 (0.1%) | |||
| Infectious pleural effusion | 1/5724 (0%) | 2/5705 (0%) | 0/5687 (0%) | |||
| Infective exacerbation of chronic obstructive airways disease | 16/5724 (0.3%) | 8/5705 (0.1%) | 8/5687 (0.1%) | |||
| Influenza | 4/5724 (0.1%) | 6/5705 (0.1%) | 2/5687 (0%) | |||
| Intervertebral discitis | 2/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Kidney infection | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Klebsiella infection | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Klebsiella sepsis | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Labyrinthitis | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Laryngitis | 0/5724 (0%) | 1/5705 (0%) | 1/5687 (0%) | |||
| Liver abscess | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Lobar pneumonia | 16/5724 (0.3%) | 15/5705 (0.3%) | 12/5687 (0.2%) | |||
| Localised infection | 2/5724 (0%) | 2/5705 (0%) | 2/5687 (0%) | |||
| Lower respiratory tract infection | 1/5724 (0%) | 0/5705 (0%) | 2/5687 (0%) | |||
| Lung abscess | 2/5724 (0%) | 2/5705 (0%) | 2/5687 (0%) | |||
| Lung infection | 0/5724 (0%) | 1/5705 (0%) | 3/5687 (0.1%) | |||
| Lyme disease | 0/5724 (0%) | 1/5705 (0%) | 2/5687 (0%) | |||
| Mastitis | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Measles | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Neutropenic sepsis | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Nosocomial infection | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Oesophageal candidiasis | 2/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Orchitis | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Osteomyelitis | 3/5724 (0.1%) | 1/5705 (0%) | 1/5687 (0%) | |||
| Otitis media | 0/5724 (0%) | 1/5705 (0%) | 1/5687 (0%) | |||
| Pelvic abscess | 0/5724 (0%) | 0/5705 (0%) | 2/5687 (0%) | |||
| Perineal abscess | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Peritonitis | 4/5724 (0.1%) | 2/5705 (0%) | 1/5687 (0%) | |||
| Pertussis | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Pharyngitis | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Pneumocystis jiroveci infection | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Pneumonia | 339/5724 (5.9%) | 344/5705 (6%) | 340/5687 (6%) | |||
| Pneumonia bacterial | 4/5724 (0.1%) | 1/5705 (0%) | 1/5687 (0%) | |||
| Pneumonia influenzal | 2/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Pneumonia legionella | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Pneumonia necrotising | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Pneumonia pneumococcal | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Pneumonia pseudomonas aeruginosa | 1/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Pneumonia staphylococcal | 1/5724 (0%) | 1/5705 (0%) | 2/5687 (0%) | |||
| Pneumonia streptococcal | 0/5724 (0%) | 1/5705 (0%) | 1/5687 (0%) | |||
| Pneumonia viral | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Postoperative abscess | 0/5724 (0%) | 0/5705 (0%) | 2/5687 (0%) | |||
| Postoperative wound infection | 0/5724 (0%) | 1/5705 (0%) | 3/5687 (0.1%) | |||
| Pseudomembranous colitis | 0/5724 (0%) | 2/5705 (0%) | 0/5687 (0%) | |||
| Pseudomonas bronchitis | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Psoas abscess | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Pulmonary tuberculoma | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Pulmonary tuberculosis | 0/5724 (0%) | 1/5705 (0%) | 5/5687 (0.1%) | |||
| Purulence | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Pyelonephritis | 6/5724 (0.1%) | 6/5705 (0.1%) | 2/5687 (0%) | |||
| Pyelonephritis acute | 0/5724 (0%) | 1/5705 (0%) | 1/5687 (0%) | |||
| Pyelonephritis chronic | 1/5724 (0%) | 1/5705 (0%) | 2/5687 (0%) | |||
| Pyoderma | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Pyonephrosis | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Rectal abscess | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Respiratory tract infection | 3/5724 (0.1%) | 7/5705 (0.1%) | 3/5687 (0.1%) | |||
| Scrotal abscess | 1/5724 (0%) | 2/5705 (0%) | 0/5687 (0%) | |||
| Sepsis | 18/5724 (0.3%) | 22/5705 (0.4%) | 16/5687 (0.3%) | |||
| Sepsis syndrome | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Septic shock | 6/5724 (0.1%) | 6/5705 (0.1%) | 12/5687 (0.2%) | |||
| Serratia infection | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Sialoadenitis | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Sinusitis | 3/5724 (0.1%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Skin infection | 1/5724 (0%) | 1/5705 (0%) | 1/5687 (0%) | |||
| Soft tissue infection | 1/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Staphylococcal infection | 1/5724 (0%) | 0/5705 (0%) | 2/5687 (0%) | |||
| Staphylococcal sepsis | 0/5724 (0%) | 2/5705 (0%) | 0/5687 (0%) | |||
| Streptococcal sepsis | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Subcutaneous abscess | 1/5724 (0%) | 1/5705 (0%) | 2/5687 (0%) | |||
| Tracheobronchitis | 0/5724 (0%) | 1/5705 (0%) | 1/5687 (0%) | |||
| Tuberculosis | 2/5724 (0%) | 3/5705 (0.1%) | 2/5687 (0%) | |||
| Upper respiratory tract infection | 4/5724 (0.1%) | 5/5705 (0.1%) | 3/5687 (0.1%) | |||
| Urethral abscess | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Urinary tract infection | 9/5724 (0.2%) | 22/5705 (0.4%) | 6/5687 (0.1%) | |||
| Urinary tract infection bacterial | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Urinary tract infection staphylococcal | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Urosepsis | 7/5724 (0.1%) | 2/5705 (0%) | 4/5687 (0.1%) | |||
| Vestibular neuronitis | 1/5724 (0%) | 1/5705 (0%) | 1/5687 (0%) | |||
| Viral diarrhoea | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Viral infection | 1/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Wound infection | 2/5724 (0%) | 3/5705 (0.1%) | 3/5687 (0.1%) | |||
| Injury, poisoning and procedural complications | ||||||
| Abdominal wound dehiscence | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Accident | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Accidental overdose | 0/5724 (0%) | 1/5705 (0%) | 1/5687 (0%) | |||
| Alcohol poisoning | 1/5724 (0%) | 1/5705 (0%) | 1/5687 (0%) | |||
| Anaemia postoperative | 1/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Anastomotic leak | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Animal bite | 0/5724 (0%) | 0/5705 (0%) | 2/5687 (0%) | |||
| Ankle fracture | 2/5724 (0%) | 1/5705 (0%) | 1/5687 (0%) | |||
| Arterial restenosis | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Arthropod sting | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Bone contusion | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Burns second degree | 1/5724 (0%) | 1/5705 (0%) | 1/5687 (0%) | |||
| Cataract operation complication | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Cervical vertebral fracture | 0/5724 (0%) | 2/5705 (0%) | 1/5687 (0%) | |||
| Chemical poisoning | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Clavicle fracture | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Comminuted fracture | 1/5724 (0%) | 1/5705 (0%) | 1/5687 (0%) | |||
| Concussion | 1/5724 (0%) | 1/5705 (0%) | 2/5687 (0%) | |||
| Contusion | 3/5724 (0.1%) | 1/5705 (0%) | 4/5687 (0.1%) | |||
| Craniocerebral injury | 3/5724 (0.1%) | 1/5705 (0%) | 1/5687 (0%) | |||
| Endotracheal intubation complication | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Excoriation | 1/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Face injury | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Facial bones fracture | 0/5724 (0%) | 3/5705 (0.1%) | 2/5687 (0%) | |||
| Fall | 8/5724 (0.1%) | 19/5705 (0.3%) | 4/5687 (0.1%) | |||
| Femoral neck fracture | 1/5724 (0%) | 3/5705 (0.1%) | 5/5687 (0.1%) | |||
| Femur fracture | 5/5724 (0.1%) | 5/5705 (0.1%) | 4/5687 (0.1%) | |||
| Fibula fracture | 3/5724 (0.1%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Foot fracture | 1/5724 (0%) | 3/5705 (0.1%) | 1/5687 (0%) | |||
| Foreign body | 3/5724 (0.1%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Fracture | 1/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Fractured coccyx | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Fractured sacrum | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Hand fracture | 2/5724 (0%) | 0/5705 (0%) | 2/5687 (0%) | |||
| Head injury | 1/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Hip fracture | 11/5724 (0.2%) | 5/5705 (0.1%) | 11/5687 (0.2%) | |||
| Humerus fracture | 1/5724 (0%) | 4/5705 (0.1%) | 1/5687 (0%) | |||
| Incisional hernia | 3/5724 (0.1%) | 2/5705 (0%) | 1/5687 (0%) | |||
| Incisional hernia, obstructive | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Injury | 0/5724 (0%) | 1/5705 (0%) | 1/5687 (0%) | |||
| Injury corneal | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Intentional overdose | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Joint dislocation | 3/5724 (0.1%) | 2/5705 (0%) | 1/5687 (0%) | |||
| Joint injury | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Laceration | 1/5724 (0%) | 0/5705 (0%) | 2/5687 (0%) | |||
| Ligament sprain | 0/5724 (0%) | 1/5705 (0%) | 1/5687 (0%) | |||
| Limb crushing injury | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Limb injury | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Lower limb fracture | 2/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Lumbar vertebral fracture | 5/5724 (0.1%) | 0/5705 (0%) | 2/5687 (0%) | |||
| Meniscus injury | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Multiple fractures | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Multiple injuries | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Muscle strain | 0/5724 (0%) | 2/5705 (0%) | 1/5687 (0%) | |||
| Open fracture | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Overdose | 2/5724 (0%) | 3/5705 (0.1%) | 0/5687 (0%) | |||
| Patella fracture | 1/5724 (0%) | 1/5705 (0%) | 1/5687 (0%) | |||
| Pelvic fracture | 2/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Pneumoconiosis | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Pneumonitis chemical | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Post lumbar puncture syndrome | 0/5724 (0%) | 2/5705 (0%) | 0/5687 (0%) | |||
| Post procedural complication | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Post procedural contusion | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Post procedural haematuria | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Post procedural haemorrhage | 0/5724 (0%) | 0/5705 (0%) | 2/5687 (0%) | |||
| Post procedural myocardial infarction | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Postoperative ileus | 1/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Procedural hypotension | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Procedural pain | 1/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Radius fracture | 4/5724 (0.1%) | 2/5705 (0%) | 0/5687 (0%) | |||
| Rib fracture | 10/5724 (0.2%) | 9/5705 (0.2%) | 5/5687 (0.1%) | |||
| Road traffic accident | 2/5724 (0%) | 3/5705 (0.1%) | 5/5687 (0.1%) | |||
| Scar | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Skin graft failure | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Skin injury | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Skull fracture | 2/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Spinal column injury | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Spinal compression fracture | 4/5724 (0.1%) | 2/5705 (0%) | 4/5687 (0.1%) | |||
| Spinal cord injury cervical | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Spinal fracture | 6/5724 (0.1%) | 1/5705 (0%) | 2/5687 (0%) | |||
| Splenic rupture | 0/5724 (0%) | 2/5705 (0%) | 1/5687 (0%) | |||
| Splinter | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Subdural haematoma | 2/5724 (0%) | 2/5705 (0%) | 5/5687 (0.1%) | |||
| Subdural haemorrhage | 0/5724 (0%) | 1/5705 (0%) | 1/5687 (0%) | |||
| Tendon rupture | 1/5724 (0%) | 3/5705 (0.1%) | 0/5687 (0%) | |||
| Thermal burn | 0/5724 (0%) | 2/5705 (0%) | 0/5687 (0%) | |||
| Thoracic vertebral fracture | 2/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Tibia fracture | 5/5724 (0.1%) | 2/5705 (0%) | 0/5687 (0%) | |||
| Toxicity to various agents | 2/5724 (0%) | 2/5705 (0%) | 4/5687 (0.1%) | |||
| Traumatic lung injury | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Ulna fracture | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Upper limb fracture | 6/5724 (0.1%) | 3/5705 (0.1%) | 0/5687 (0%) | |||
| Urethral injury | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Vascular graft occlusion | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Vascular pseudoaneurysm | 2/5724 (0%) | 0/5705 (0%) | 2/5687 (0%) | |||
| Wound | 1/5724 (0%) | 1/5705 (0%) | 2/5687 (0%) | |||
| Wound dehiscence | 0/5724 (0%) | 2/5705 (0%) | 0/5687 (0%) | |||
| Wound secretion | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Wrist fracture | 2/5724 (0%) | 1/5705 (0%) | 4/5687 (0.1%) | |||
| Investigations | ||||||
| Angiogram | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Arteriogram coronary normal | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Arthroscopy | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Biopsy lung | 1/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Biopsy vocal cord normal | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Blood creatinine increased | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Blood pressure increased | 1/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Catheterisation cardiac | 2/5724 (0%) | 1/5705 (0%) | 2/5687 (0%) | |||
| Chest X-ray abnormal | 1/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Fibrin D dimer increased | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Full blood count decreased | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| International normalised ratio abnormal | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| International normalised ratio increased | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Investigation | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Laparoscopy | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Oxygen saturation decreased | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Prostatic specific antigen increased | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Troponin I increased | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Weight decreased | 4/5724 (0.1%) | 3/5705 (0.1%) | 0/5687 (0%) | |||
| Metabolism and nutrition disorders | ||||||
| Decreased appetite | 0/5724 (0%) | 2/5705 (0%) | 1/5687 (0%) | |||
| Dehydration | 8/5724 (0.1%) | 8/5705 (0.1%) | 5/5687 (0.1%) | |||
| Diabetes mellitus | 2/5724 (0%) | 4/5705 (0.1%) | 1/5687 (0%) | |||
| Diabetes mellitus inadequate control | 1/5724 (0%) | 1/5705 (0%) | 2/5687 (0%) | |||
| Diabetes with hyperosmolarity | 0/5724 (0%) | 2/5705 (0%) | 0/5687 (0%) | |||
| Diabetic ketoacidosis | 1/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Electrolyte imbalance | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Failure to thrive | 0/5724 (0%) | 0/5705 (0%) | 4/5687 (0.1%) | |||
| Feeding disorder | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Glucose tolerance impaired | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Gout | 1/5724 (0%) | 1/5705 (0%) | 1/5687 (0%) | |||
| Hyperglycaemia | 3/5724 (0.1%) | 4/5705 (0.1%) | 0/5687 (0%) | |||
| Hyperkalaemia | 1/5724 (0%) | 2/5705 (0%) | 2/5687 (0%) | |||
| Hypoglycaemia | 2/5724 (0%) | 3/5705 (0.1%) | 2/5687 (0%) | |||
| Hypokalaemia | 2/5724 (0%) | 2/5705 (0%) | 1/5687 (0%) | |||
| Hyponatraemia | 8/5724 (0.1%) | 4/5705 (0.1%) | 5/5687 (0.1%) | |||
| Hypophagia | 1/5724 (0%) | 0/5705 (0%) | 2/5687 (0%) | |||
| Hypovolaemia | 2/5724 (0%) | 2/5705 (0%) | 1/5687 (0%) | |||
| Lactic acidosis | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Malnutrition | 1/5724 (0%) | 1/5705 (0%) | 1/5687 (0%) | |||
| Metabolic acidosis | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Obesity | 0/5724 (0%) | 2/5705 (0%) | 1/5687 (0%) | |||
| Type 1 diabetes mellitus | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Type 2 diabetes mellitus | 0/5724 (0%) | 1/5705 (0%) | 1/5687 (0%) | |||
| Musculoskeletal and connective tissue disorders | ||||||
| Arthralgia | 6/5724 (0.1%) | 1/5705 (0%) | 5/5687 (0.1%) | |||
| Arthritis | 5/5724 (0.1%) | 8/5705 (0.1%) | 2/5687 (0%) | |||
| Back pain | 11/5724 (0.2%) | 3/5705 (0.1%) | 6/5687 (0.1%) | |||
| Bone infarction | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Bursa disorder | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Bursitis | 0/5724 (0%) | 1/5705 (0%) | 2/5687 (0%) | |||
| Cervical spinal stenosis | 1/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Chondritis | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Costochondritis | 0/5724 (0%) | 0/5705 (0%) | 2/5687 (0%) | |||
| Diastasis recti abdominis | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Dupuytren's contracture | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Facet joint syndrome | 1/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Fibromyalgia | 0/5724 (0%) | 2/5705 (0%) | 0/5687 (0%) | |||
| Fistula | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Foot deformity | 0/5724 (0%) | 0/5705 (0%) | 2/5687 (0%) | |||
| Fracture malunion | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Fracture nonunion | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Haemarthrosis | 0/5724 (0%) | 0/5705 (0%) | 2/5687 (0%) | |||
| Intervertebral disc degeneration | 2/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Intervertebral disc disorder | 1/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Intervertebral disc protrusion | 10/5724 (0.2%) | 6/5705 (0.1%) | 10/5687 (0.2%) | |||
| Joint ankylosis | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Joint swelling | 1/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Knee deformity | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Kyphosis | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Lumbar spinal stenosis | 1/5724 (0%) | 4/5705 (0.1%) | 1/5687 (0%) | |||
| Mixed connective tissue disease | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Muscle spasms | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Muscular weakness | 3/5724 (0.1%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Musculoskeletal chest pain | 0/5724 (0%) | 1/5705 (0%) | 2/5687 (0%) | |||
| Musculoskeletal pain | 1/5724 (0%) | 4/5705 (0.1%) | 2/5687 (0%) | |||
| Myalgia | 1/5724 (0%) | 1/5705 (0%) | 2/5687 (0%) | |||
| Myopathy | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Neck pain | 1/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Osteoarthritis | 10/5724 (0.2%) | 12/5705 (0.2%) | 23/5687 (0.4%) | |||
| Osteochondrosis | 1/5724 (0%) | 1/5705 (0%) | 1/5687 (0%) | |||
| Osteonecrosis | 3/5724 (0.1%) | 2/5705 (0%) | 2/5687 (0%) | |||
| Osteoporosis | 2/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Osteoporotic fracture | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Pain in extremity | 1/5724 (0%) | 1/5705 (0%) | 1/5687 (0%) | |||
| Pain in jaw | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Periarthritis | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Polyarthritis | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Polymyalgia rheumatica | 0/5724 (0%) | 1/5705 (0%) | 1/5687 (0%) | |||
| Rhabdomyolysis | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Rheumatoid arthritis | 2/5724 (0%) | 2/5705 (0%) | 1/5687 (0%) | |||
| Rotator cuff syndrome | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Spinal column stenosis | 6/5724 (0.1%) | 1/5705 (0%) | 2/5687 (0%) | |||
| Spinal disorder | 0/5724 (0%) | 1/5705 (0%) | 1/5687 (0%) | |||
| Spinal osteoarthritis | 4/5724 (0.1%) | 4/5705 (0.1%) | 6/5687 (0.1%) | |||
| Spondyloarthropathy | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Spondylolisthesis | 0/5724 (0%) | 1/5705 (0%) | 3/5687 (0.1%) | |||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||
| Acoustic neuroma | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Acral lentiginous melanoma | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Acute leukaemia | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Acute myeloid leukaemia | 0/5724 (0%) | 0/5705 (0%) | 3/5687 (0.1%) | |||
| Adenocarcinoma | 1/5724 (0%) | 2/5705 (0%) | 2/5687 (0%) | |||
| Adenocarcinoma gastric | 2/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Adenocarcinoma of colon | 3/5724 (0.1%) | 2/5705 (0%) | 0/5687 (0%) | |||
| Adenocarcinoma pancreas | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Adenoma benign | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Anal cancer | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Angiosarcoma | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Anogenital warts | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| B-cell lymphoma | 1/5724 (0%) | 0/5705 (0%) | 3/5687 (0.1%) | |||
| B-cell unclassifiable lymphoma low grade | 0/5724 (0%) | 1/5705 (0%) | 1/5687 (0%) | |||
| Basal cell carcinoma | 17/5724 (0.3%) | 26/5705 (0.5%) | 15/5687 (0.3%) | |||
| Benign breast neoplasm | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Benign neoplasm of adrenal gland | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Benign neoplasm of bladder | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Benign neoplasm of urethra | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Benign ovarian tumour | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Benign salivary gland neoplasm | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Bile duct cancer | 1/5724 (0%) | 1/5705 (0%) | 1/5687 (0%) | |||
| Bladder adenocarcinoma stage unspecified | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Bladder cancer | 13/5724 (0.2%) | 10/5705 (0.2%) | 4/5687 (0.1%) | |||
| Bladder cancer recurrent | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Bladder cancer stage 0, with cancer in situ | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Bladder neoplasm | 5/5724 (0.1%) | 1/5705 (0%) | 4/5687 (0.1%) | |||
| Bladder transitional cell carcinoma | 0/5724 (0%) | 2/5705 (0%) | 0/5687 (0%) | |||
| Bone cancer | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Bone neoplasm | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Bowen's disease | 0/5724 (0%) | 1/5705 (0%) | 1/5687 (0%) | |||
| Brain cancer metastatic | 1/5724 (0%) | 1/5705 (0%) | 1/5687 (0%) | |||
| Brain neoplasm | 1/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Brain neoplasm malignant | 0/5724 (0%) | 2/5705 (0%) | 0/5687 (0%) | |||
| Breast cancer | 8/5724 (0.1%) | 8/5705 (0.1%) | 4/5687 (0.1%) | |||
| Breast cancer metastatic | 1/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Breast cancer stage I | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Breast cancer stage II | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Breast neoplasm | 1/5724 (0%) | 2/5705 (0%) | 0/5687 (0%) | |||
| Bronchial carcinoma | 8/5724 (0.1%) | 7/5705 (0.1%) | 4/5687 (0.1%) | |||
| Bronchial neoplasm | 0/5724 (0%) | 0/5705 (0%) | 2/5687 (0%) | |||
| Carcinoid tumour pulmonary | 0/5724 (0%) | 2/5705 (0%) | 1/5687 (0%) | |||
| Cardiac myxoma | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Cervix carcinoma | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Cholangiocarcinoma | 0/5724 (0%) | 4/5705 (0.1%) | 1/5687 (0%) | |||
| Chronic lymphocytic leukaemia | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Chronic myeloid leukaemia | 0/5724 (0%) | 0/5705 (0%) | 2/5687 (0%) | |||
| Colon adenoma | 1/5724 (0%) | 3/5705 (0.1%) | 0/5687 (0%) | |||
| Colon cancer | 13/5724 (0.2%) | 4/5705 (0.1%) | 10/5687 (0.2%) | |||
| Colon cancer metastatic | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Colon neoplasm | 1/5724 (0%) | 2/5705 (0%) | 0/5687 (0%) | |||
| Colorectal cancer | 1/5724 (0%) | 1/5705 (0%) | 1/5687 (0%) | |||
| Gastric adenoma | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Gastric cancer | 6/5724 (0.1%) | 3/5705 (0.1%) | 4/5687 (0.1%) | |||
| Gastric neoplasm | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Gastrointestinal cancer metastatic | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Gastrointestinal carcinoma | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Gastrointestinal neoplasm | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Gastrointestinal tract adenoma | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Glioblastoma | 0/5724 (0%) | 1/5705 (0%) | 1/5687 (0%) | |||
| Glioblastoma multiforme | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Glioma | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Hepatic cancer | 3/5724 (0.1%) | 4/5705 (0.1%) | 1/5687 (0%) | |||
| Hepatic cancer metastatic | 2/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Hepatic neoplasm | 1/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Hodgkin's disease | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Intraductal proliferative breast lesion | 2/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Invasive ductal breast carcinoma | 1/5724 (0%) | 1/5705 (0%) | 1/5687 (0%) | |||
| Invasive lobular breast carcinoma | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Large cell lung cancer stage IV | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Large intestine benign neoplasm | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Laryngeal cancer | 1/5724 (0%) | 1/5705 (0%) | 2/5687 (0%) | |||
| Laryngeal neoplasm | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Laryngeal squamous cell carcinoma | 3/5724 (0.1%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Leukaemia | 3/5724 (0.1%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Lip squamous cell carcinoma | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Lipoma | 1/5724 (0%) | 2/5705 (0%) | 0/5687 (0%) | |||
| Lung adenocarcinoma | 10/5724 (0.2%) | 9/5705 (0.2%) | 6/5687 (0.1%) | |||
| Lung adenocarcinoma metastatic | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Lung adenocarcinoma stage IV | 1/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Lung cancer metastatic | 3/5724 (0.1%) | 7/5705 (0.1%) | 9/5687 (0.2%) | |||
| Lung carcinoma cell type unspecified recurrent | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Lung carcinoma cell type unspecified stage I | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Lung carcinoma cell type unspecified stage IV | 4/5724 (0.1%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Lung neoplasm | 6/5724 (0.1%) | 7/5705 (0.1%) | 5/5687 (0.1%) | |||
| Lung neoplasm malignant | 52/5724 (0.9%) | 60/5705 (1.1%) | 48/5687 (0.8%) | |||
| Lung squamous cell carcinoma stage III | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Lung squamous cell carcinoma stage IV | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Lymphoma | 1/5724 (0%) | 0/5705 (0%) | 2/5687 (0%) | |||
| Malignant melanoma | 2/5724 (0%) | 3/5705 (0.1%) | 4/5687 (0.1%) | |||
| Malignant melanoma in situ | 1/5724 (0%) | 1/5705 (0%) | 1/5687 (0%) | |||
| Malignant neoplasm of ampulla of Vater | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Malignant neoplasm of unknown primary site | 0/5724 (0%) | 2/5705 (0%) | 0/5687 (0%) | |||
| Malignant palate neoplasm | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Malignant pleural effusion | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Malignant splenic neoplasm | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Mediastinum neoplasm | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Melanocytic naevus | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Meningioma | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Mesothelioma | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Metastases to adrenals | 1/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Metastases to bone | 3/5724 (0.1%) | 1/5705 (0%) | 3/5687 (0.1%) | |||
| Metastases to central nervous system | 9/5724 (0.2%) | 0/5705 (0%) | 2/5687 (0%) | |||
| Metastases to kidney | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Metastases to liver | 6/5724 (0.1%) | 3/5705 (0.1%) | 3/5687 (0.1%) | |||
| Metastases to lung | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Metastases to lymph nodes | 1/5724 (0%) | 2/5705 (0%) | 0/5687 (0%) | |||
| Metastases to muscle | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Metastases to peritoneum | 0/5724 (0%) | 0/5705 (0%) | 2/5687 (0%) | |||
| Metastases to retroperitoneum | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Metastases to spine | 2/5724 (0%) | 1/5705 (0%) | 1/5687 (0%) | |||
| Metastases to spleen | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Metastatic bronchial carcinoma | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Metastatic gastric cancer | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Metastatic neoplasm | 0/5724 (0%) | 1/5705 (0%) | 1/5687 (0%) | |||
| Monoclonal gammopathy | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Myelodysplastic syndrome | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Nasal cavity cancer | 0/5724 (0%) | 0/5705 (0%) | 2/5687 (0%) | |||
| Nasal neoplasm | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Nasopharyngeal cancer | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Nasopharyngeal cancer stage II | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Nasopharyngeal neoplasm benign | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Neoplasm | 1/5724 (0%) | 1/5705 (0%) | 1/5687 (0%) | |||
| Neoplasm malignant | 0/5724 (0%) | 3/5705 (0.1%) | 1/5687 (0%) | |||
| Neoplasm prostate | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Neuroendocrine carcinoma | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Neuroendocrine carcinoma of the skin | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Non-Hodgkin's lymphoma | 2/5724 (0%) | 2/5705 (0%) | 1/5687 (0%) | |||
| Non-small cell lung cancer | 6/5724 (0.1%) | 5/5705 (0.1%) | 5/5687 (0.1%) | |||
| Non-small cell lung cancer metastatic | 1/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Non-small cell lung cancer stage I | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Non-small cell lung cancer stage II | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Oesophageal adenocarcinoma | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Oesophageal carcinoma | 1/5724 (0%) | 1/5705 (0%) | 2/5687 (0%) | |||
| Oesophageal neoplasm | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Oral neoplasm | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Oropharyngeal cancer | 1/5724 (0%) | 0/5705 (0%) | 2/5687 (0%) | |||
| Oropharyngeal neoplasm | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Ovarian cancer | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Pancreatic carcinoma | 6/5724 (0.1%) | 6/5705 (0.1%) | 7/5687 (0.1%) | |||
| Pancreatic neoplasm | 0/5724 (0%) | 1/5705 (0%) | 1/5687 (0%) | |||
| Pharyngeal cancer | 0/5724 (0%) | 0/5705 (0%) | 2/5687 (0%) | |||
| Pituitary tumour benign | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Plasma cell myeloma | 1/5724 (0%) | 1/5705 (0%) | 3/5687 (0.1%) | |||
| Pleural mesothelioma | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Pleural neoplasm | 0/5724 (0%) | 1/5705 (0%) | 1/5687 (0%) | |||
| Prostate cancer | 17/5724 (0.3%) | 17/5705 (0.3%) | 14/5687 (0.2%) | |||
| Prostate cancer metastatic | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Prostate cancer stage II | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Prostatic adenoma | 1/5724 (0%) | 2/5705 (0%) | 1/5687 (0%) | |||
| Rectal adenocarcinoma | 0/5724 (0%) | 2/5705 (0%) | 2/5687 (0%) | |||
| Rectal cancer | 4/5724 (0.1%) | 0/5705 (0%) | 3/5687 (0.1%) | |||
| Rectal neoplasm | 2/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Renal cancer | 1/5724 (0%) | 0/5705 (0%) | 2/5687 (0%) | |||
| Renal cell carcinoma | 0/5724 (0%) | 4/5705 (0.1%) | 0/5687 (0%) | |||
| Renal neoplasm | 3/5724 (0.1%) | 2/5705 (0%) | 1/5687 (0%) | |||
| Salivary gland cancer | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Salivary gland neoplasm | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Signet-ring cell carcinoma | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Skin cancer | 2/5724 (0%) | 2/5705 (0%) | 1/5687 (0%) | |||
| Small cell carcinoma | 1/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Small cell lung cancer | 3/5724 (0.1%) | 5/5705 (0.1%) | 4/5687 (0.1%) | |||
| Small cell lung cancer metastatic | 0/5724 (0%) | 1/5705 (0%) | 2/5687 (0%) | |||
| Small intestine carcinoma | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Splenic marginal zone lymphoma | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Squamous cell carcinoma | 9/5724 (0.2%) | 12/5705 (0.2%) | 19/5687 (0.3%) | |||
| Squamous cell carcinoma of lung | 6/5724 (0.1%) | 6/5705 (0.1%) | 6/5687 (0.1%) | |||
| Squamous cell carcinoma of pharynx | 3/5724 (0.1%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Squamous cell carcinoma of skin | 2/5724 (0%) | 3/5705 (0.1%) | 2/5687 (0%) | |||
| Squamous cell carcinoma of the hypopharynx | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Squamous cell carcinoma of the oral cavity | 1/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Squamous cell carcinoma of the tongue | 1/5724 (0%) | 0/5705 (0%) | 2/5687 (0%) | |||
| Throat cancer | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Thymoma | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Thyroid cancer | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Thyroid neoplasm | 0/5724 (0%) | 1/5705 (0%) | 2/5687 (0%) | |||
| Tongue neoplasm malignant stage unspecified | 1/5724 (0%) | 1/5705 (0%) | 1/5687 (0%) | |||
| Transitional cell carcinoma | 4/5724 (0.1%) | 5/5705 (0.1%) | 1/5687 (0%) | |||
| Tumour necrosis | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Urinary tract carcinoma in situ | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Uterine leiomyoma | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Vaginal cancer | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Vascular neoplasm | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Vocal cord neoplasm | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Vulval cancer | 1/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Nervous system disorders | ||||||
| Altered state of consciousness | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Aphasia | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Brain hypoxia | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Brain injury | 0/5724 (0%) | 1/5705 (0%) | 3/5687 (0.1%) | |||
| Brain oedema | 1/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Brain stem infarction | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Carotid artery stenosis | 4/5724 (0.1%) | 8/5705 (0.1%) | 7/5687 (0.1%) | |||
| Carpal tunnel syndrome | 0/5724 (0%) | 0/5705 (0%) | 2/5687 (0%) | |||
| Cauda equina syndrome | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Cerebellar ataxia | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Cerebral arteriosclerosis | 1/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Cerebral artery embolism | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Cerebral haemorrhage | 4/5724 (0.1%) | 4/5705 (0.1%) | 2/5687 (0%) | |||
| Cerebral infarction | 2/5724 (0%) | 2/5705 (0%) | 2/5687 (0%) | |||
| Cerebral ischaemia | 2/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Cerebral thrombosis | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Cerebrosclerosis | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Cerebrovascular accident | 35/5724 (0.6%) | 38/5705 (0.7%) | 35/5687 (0.6%) | |||
| Cerebrovascular insufficiency | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Cervical myelopathy | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Coma | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Complicated migraine | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Convulsion | 3/5724 (0.1%) | 2/5705 (0%) | 5/5687 (0.1%) | |||
| Dementia | 1/5724 (0%) | 4/5705 (0.1%) | 1/5687 (0%) | |||
| Dementia Alzheimer's type | 2/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Demyelinating polyneuropathy | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Diabetic neuropathy | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Dizziness | 6/5724 (0.1%) | 5/5705 (0.1%) | 3/5687 (0.1%) | |||
| Dysarthria | 1/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Embolic stroke | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Encephalitis | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Encephalopathy | 1/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Epilepsy | 2/5724 (0%) | 4/5705 (0.1%) | 3/5687 (0.1%) | |||
| Facial spasm | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Grand mal convulsion | 0/5724 (0%) | 1/5705 (0%) | 1/5687 (0%) | |||
| Guillain-Barre syndrome | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Haemorrhage intracranial | 0/5724 (0%) | 1/5705 (0%) | 1/5687 (0%) | |||
| Haemorrhagic stroke | 1/5724 (0%) | 3/5705 (0.1%) | 0/5687 (0%) | |||
| Headache | 2/5724 (0%) | 3/5705 (0.1%) | 3/5687 (0.1%) | |||
| Hemiplegia | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Hepatic encephalopathy | 1/5724 (0%) | 1/5705 (0%) | 1/5687 (0%) | |||
| Hydrocephalus | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Hypertensive encephalopathy | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Hypertonia | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Hypoaesthesia | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Hypoglycaemic coma | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Hypoxic-ischaemic encephalopathy | 2/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Intercostal neuralgia | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Intracranial aneurysm | 3/5724 (0.1%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Intracranial haematoma | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Ischaemic stroke | 5/5724 (0.1%) | 3/5705 (0.1%) | 7/5687 (0.1%) | |||
| Lacunar infarction | 1/5724 (0%) | 1/5705 (0%) | 1/5687 (0%) | |||
| Loss of consciousness | 0/5724 (0%) | 1/5705 (0%) | 1/5687 (0%) | |||
| Metabolic encephalopathy | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Migraine | 2/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Motor dysfunction | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Myelopathy | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Myoclonus | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Nervous system disorder | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Paraesthesia | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Parkinson's disease | 1/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Peripheral nerve lesion | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Polyneuropathy | 0/5724 (0%) | 2/5705 (0%) | 0/5687 (0%) | |||
| Post herpetic neuralgia | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Presyncope | 1/5724 (0%) | 0/5705 (0%) | 2/5687 (0%) | |||
| Quadriplegia | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Radial nerve palsy | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Ruptured cerebral aneurysm | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Sciatica | 3/5724 (0.1%) | 2/5705 (0%) | 2/5687 (0%) | |||
| Spinal cord compression | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Spinal cord infarction | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Spinal cord ischaemia | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Status epilepticus | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Subarachnoid haemorrhage | 3/5724 (0.1%) | 0/5705 (0%) | 2/5687 (0%) | |||
| Syncope | 14/5724 (0.2%) | 17/5705 (0.3%) | 15/5687 (0.3%) | |||
| Tension headache | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Tongue biting | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Tonic convulsion | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Toxic encephalopathy | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Transient ischaemic attack | 18/5724 (0.3%) | 23/5705 (0.4%) | 14/5687 (0.2%) | |||
| Tremor | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Trigeminal neuralgia | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Ulnar tunnel syndrome | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| VIIth nerve paralysis | 1/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Vascular dementia | 1/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Vascular encephalopathy | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Vocal cord paralysis | 0/5724 (0%) | 1/5705 (0%) | 1/5687 (0%) | |||
| Psychiatric disorders | ||||||
| Alcohol abuse | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Alcohol withdrawal syndrome | 0/5724 (0%) | 1/5705 (0%) | 1/5687 (0%) | |||
| Alcoholic psychosis | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Alcoholism | 2/5724 (0%) | 3/5705 (0.1%) | 0/5687 (0%) | |||
| Anxiety | 2/5724 (0%) | 5/5705 (0.1%) | 2/5687 (0%) | |||
| Anxiety disorder | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Completed suicide | 0/5724 (0%) | 2/5705 (0%) | 2/5687 (0%) | |||
| Confusional state | 1/5724 (0%) | 0/5705 (0%) | 3/5687 (0.1%) | |||
| Delirium | 3/5724 (0.1%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Depressed mood | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Depression | 7/5724 (0.1%) | 7/5705 (0.1%) | 5/5687 (0.1%) | |||
| Disorientation | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Drug abuse | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Hallucination | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Major depression | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Mania | 0/5724 (0%) | 2/5705 (0%) | 0/5687 (0%) | |||
| Mental disorder | 1/5724 (0%) | 2/5705 (0%) | 0/5687 (0%) | |||
| Mental disorder due to a general medical condition | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Mental status changes | 2/5724 (0%) | 2/5705 (0%) | 2/5687 (0%) | |||
| Psychotic disorder | 1/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Stress | 1/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Substance abuse | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Suicide attempt | 0/5724 (0%) | 2/5705 (0%) | 2/5687 (0%) | |||
| Renal and urinary disorders | ||||||
| Acute prerenal failure | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Azotaemia | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Bladder cyst | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Bladder neck obstruction | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Bladder outlet obstruction | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Bladder perforation | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Bladder prolapse | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Calculus bladder | 1/5724 (0%) | 3/5705 (0.1%) | 0/5687 (0%) | |||
| Calculus urethral | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Calculus urinary | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Cystitis haemorrhagic | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Dysuria | 1/5724 (0%) | 0/5705 (0%) | 4/5687 (0.1%) | |||
| Glomerulonephritis | 0/5724 (0%) | 0/5705 (0%) | 2/5687 (0%) | |||
| Haematuria | 3/5724 (0.1%) | 9/5705 (0.2%) | 4/5687 (0.1%) | |||
| Hydronephrosis | 0/5724 (0%) | 3/5705 (0.1%) | 0/5687 (0%) | |||
| Ketonuria | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Nephritis | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Nephrolithiasis | 4/5724 (0.1%) | 8/5705 (0.1%) | 4/5687 (0.1%) | |||
| Nephropathy | 0/5724 (0%) | 2/5705 (0%) | 0/5687 (0%) | |||
| Nephrotic syndrome | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Obstructive uropathy | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Oliguria | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Postrenal failure | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Renal artery stenosis | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Renal colic | 0/5724 (0%) | 1/5705 (0%) | 3/5687 (0.1%) | |||
| Renal failure | 9/5724 (0.2%) | 8/5705 (0.1%) | 5/5687 (0.1%) | |||
| Renal failure acute | 17/5724 (0.3%) | 14/5705 (0.2%) | 24/5687 (0.4%) | |||
| Renal failure chronic | 2/5724 (0%) | 2/5705 (0%) | 2/5687 (0%) | |||
| Renal impairment | 2/5724 (0%) | 1/5705 (0%) | 1/5687 (0%) | |||
| Renal infarct | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Stress urinary incontinence | 0/5724 (0%) | 0/5705 (0%) | 2/5687 (0%) | |||
| Urethral stenosis | 0/5724 (0%) | 2/5705 (0%) | 0/5687 (0%) | |||
| Urinary bladder haemorrhage | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Urinary bladder polyp | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Urinary incontinence | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Urinary retention | 5/5724 (0.1%) | 9/5705 (0.2%) | 9/5687 (0.2%) | |||
| Urinary tract obstruction | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Reproductive system and breast disorders | ||||||
| Acquired phimosis | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Benign prostatic hyperplasia | 8/5724 (0.1%) | 14/5705 (0.2%) | 4/5687 (0.1%) | |||
| Breast mass | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Cervical dysplasia | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Cystocele | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Epididymitis | 2/5724 (0%) | 1/5705 (0%) | 2/5687 (0%) | |||
| Ovarian mass | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Pelvic pain | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Postmenopausal haemorrhage | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Prostatic dysplasia | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Prostatic obstruction | 1/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Prostatitis | 5/5724 (0.1%) | 2/5705 (0%) | 1/5687 (0%) | |||
| Rectocele | 1/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Spermatic cord inflammation | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Uterine prolapse | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Respiratory, thoracic and mediastinal disorders | ||||||
| Acute pulmonary oedema | 1/5724 (0%) | 1/5705 (0%) | 1/5687 (0%) | |||
| Acute respiratory distress syndrome | 1/5724 (0%) | 1/5705 (0%) | 1/5687 (0%) | |||
| Acute respiratory failure | 30/5724 (0.5%) | 32/5705 (0.6%) | 28/5687 (0.5%) | |||
| Asphyxia | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Asthma | 2/5724 (0%) | 0/5705 (0%) | 2/5687 (0%) | |||
| Atelectasis | 0/5724 (0%) | 1/5705 (0%) | 1/5687 (0%) | |||
| Bronchitis chronic | 1/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Bronchopleural fistula | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Bronchopneumopathy | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Bronchospasm | 2/5724 (0%) | 4/5705 (0.1%) | 7/5687 (0.1%) | |||
| Bullous lung disease | 0/5724 (0%) | 3/5705 (0.1%) | 0/5687 (0%) | |||
| Chronic obstructive pulmonary disease | 895/5724 (15.6%) | 868/5705 (15.2%) | 851/5687 (15%) | |||
| Chronic respiratory failure | 2/5724 (0%) | 1/5705 (0%) | 5/5687 (0.1%) | |||
| Cough | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Dyspnoea | 24/5724 (0.4%) | 17/5705 (0.3%) | 21/5687 (0.4%) | |||
| Dyspnoea exertional | 1/5724 (0%) | 2/5705 (0%) | 0/5687 (0%) | |||
| Dyspnoea paroxysmal nocturnal | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Emphysema | 2/5724 (0%) | 2/5705 (0%) | 0/5687 (0%) | |||
| Epiglottic cyst | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Epistaxis | 6/5724 (0.1%) | 1/5705 (0%) | 4/5687 (0.1%) | |||
| Haemoptysis | 10/5724 (0.2%) | 8/5705 (0.1%) | 13/5687 (0.2%) | |||
| Haemothorax | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Hydropneumothorax | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Hydrothorax | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Hypercapnia | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Hypoventilation | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Hypoxia | 3/5724 (0.1%) | 8/5705 (0.1%) | 8/5687 (0.1%) | |||
| Interstitial lung disease | 1/5724 (0%) | 1/5705 (0%) | 1/5687 (0%) | |||
| Laryngeal cyst | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Laryngeal disorder | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Laryngeal leukoplakia | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Laryngeal stenosis | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Lung cyst | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Lung disorder | 2/5724 (0%) | 3/5705 (0.1%) | 3/5687 (0.1%) | |||
| Lung infiltration | 2/5724 (0%) | 2/5705 (0%) | 0/5687 (0%) | |||
| Mediastinal mass | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Nasal congestion | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Nasal polyps | 1/5724 (0%) | 1/5705 (0%) | 1/5687 (0%) | |||
| Nasal ulcer | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Obstructive airways disorder | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Organising pneumonia | 1/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Pharyngeal mass | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Pharyngeal polyp | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Pharyngeal ulceration | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Pleural calcification | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Pleural effusion | 6/5724 (0.1%) | 8/5705 (0.1%) | 10/5687 (0.2%) | |||
| Pleural fibrosis | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Pleural fistula | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Pleurisy | 2/5724 (0%) | 5/5705 (0.1%) | 1/5687 (0%) | |||
| Pleuritic pain | 2/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Pneumonia aspiration | 7/5724 (0.1%) | 3/5705 (0.1%) | 4/5687 (0.1%) | |||
| Pneumonitis | 1/5724 (0%) | 0/5705 (0%) | 3/5687 (0.1%) | |||
| Pneumothorax | 25/5724 (0.4%) | 25/5705 (0.4%) | 21/5687 (0.4%) | |||
| Pulmonary cavitation | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Pulmonary embolism | 28/5724 (0.5%) | 28/5705 (0.5%) | 24/5687 (0.4%) | |||
| Pulmonary fibrosis | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Pulmonary haemorrhage | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Pulmonary hypertension | 3/5724 (0.1%) | 2/5705 (0%) | 1/5687 (0%) | |||
| Pulmonary infarction | 0/5724 (0%) | 1/5705 (0%) | 1/5687 (0%) | |||
| Pulmonary mass | 5/5724 (0.1%) | 4/5705 (0.1%) | 10/5687 (0.2%) | |||
| Pulmonary oedema | 2/5724 (0%) | 2/5705 (0%) | 4/5687 (0.1%) | |||
| Pulmonary thrombosis | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Pulmonary venous thrombosis | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Respiratory acidosis | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Respiratory arrest | 0/5724 (0%) | 2/5705 (0%) | 2/5687 (0%) | |||
| Respiratory disorder | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Respiratory distress | 7/5724 (0.1%) | 1/5705 (0%) | 1/5687 (0%) | |||
| Respiratory failure | 42/5724 (0.7%) | 40/5705 (0.7%) | 35/5687 (0.6%) | |||
| Sinus polyp | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Sleep apnoea syndrome | 3/5724 (0.1%) | 2/5705 (0%) | 0/5687 (0%) | |||
| Vocal cord cyst | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Vocal cord polyp | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Vocal cord thickening | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Skin and subcutaneous tissue disorders | ||||||
| Angioedema | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Blister | 0/5724 (0%) | 1/5705 (0%) | 1/5687 (0%) | |||
| Decubitus ulcer | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Dermatitis | 2/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Dermatitis contact | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Dermatitis exfoliative | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Diabetic foot | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Eczema | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Erythema nodosum | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Henoch-Schonlein purpura | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Peau d'orange | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Pyoderma gangrenosum | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Rash | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Skin discolouration | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Skin disorder | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Skin lesion | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Skin ulcer | 1/5724 (0%) | 1/5705 (0%) | 1/5687 (0%) | |||
| Stasis dermatitis | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Subcutaneous emphysema | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Urticaria | 0/5724 (0%) | 1/5705 (0%) | 1/5687 (0%) | |||
| Social circumstances | ||||||
| Abstains from alcohol | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Cardiac assistance device user | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Surgical and medical procedures | ||||||
| Angioplasty | 0/5724 (0%) | 0/5705 (0%) | 2/5687 (0%) | |||
| Aortic valve repair | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Aortic valve replacement | 1/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Appendicectomy | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Arterial repair | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Arterial stent insertion | 1/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Bladder neoplasm surgery | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Bladder operation | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Bone graft | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Bone operation | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Cardiac ablation | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Cardiac pacemaker insertion | 1/5724 (0%) | 1/5705 (0%) | 2/5687 (0%) | |||
| Cardiac pacemaker removal | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Cardiac pacemaker replacement | 1/5724 (0%) | 2/5705 (0%) | 1/5687 (0%) | |||
| Central venous catheterisation | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Cholecystectomy | 5/5724 (0.1%) | 5/5705 (0.1%) | 1/5687 (0%) | |||
| Cholecystostomy | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Colon operation | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Colostomy | 1/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Coronary arterial stent insertion | 2/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Coronary artery bypass | 1/5724 (0%) | 2/5705 (0%) | 2/5687 (0%) | |||
| Coronary endarterectomy | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Coronary revascularisation | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Dental implantation | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Ear operation | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Elective surgery | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Endobronchial valve implantation | 1/5724 (0%) | 1/5705 (0%) | 1/5687 (0%) | |||
| Frontal sinus operation | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Gallbladder operation | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Gastroenterostomy | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Haemorrhoid operation | 0/5724 (0%) | 2/5705 (0%) | 0/5687 (0%) | |||
| Heart valve operation | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Heart valve replacement | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Hip arthroplasty | 1/5724 (0%) | 2/5705 (0%) | 4/5687 (0.1%) | |||
| Hip surgery | 0/5724 (0%) | 2/5705 (0%) | 0/5687 (0%) | |||
| Hospitalisation | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Hysterectomy | 2/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Hysterosalpingo-oophorectomy | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Implantable defibrillator insertion | 0/5724 (0%) | 2/5705 (0%) | 1/5687 (0%) | |||
| Implantable defibrillator replacement | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Inguinal hernia repair | 2/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Intervertebral disc operation | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Knee arthroplasty | 3/5724 (0.1%) | 6/5705 (0.1%) | 4/5687 (0.1%) | |||
| Large intestine anastomosis | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Leg amputation | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Limb operation | 1/5724 (0%) | 2/5705 (0%) | 0/5687 (0%) | |||
| Lung transplant | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Lung volume reduction surgery | 1/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Mechanical ventilation | 1/5724 (0%) | 1/5705 (0%) | 1/5687 (0%) | |||
| Medical device change | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Medical device removal | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Nasal septal operation | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Obesity surgery | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Partial lung resection | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Peripheral artery bypass | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Polypectomy | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Prophylaxis | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Prostatectomy | 2/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Prostatic operation | 0/5724 (0%) | 3/5705 (0.1%) | 0/5687 (0%) | |||
| Prosthesis implantation | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Pulmonary valve replacement | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Rehabilitation therapy | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Respiratory therapy | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Rotator cuff repair | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Salpingo-oophorectomy | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Shoulder arthroplasty | 2/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Shoulder operation | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Skin operation | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Spinal fusion surgery | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Spinal laminectomy | 0/5724 (0%) | 2/5705 (0%) | 1/5687 (0%) | |||
| Spinal operation | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Stem cell transplant | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Stent placement | 0/5724 (0%) | 0/5705 (0%) | 2/5687 (0%) | |||
| Surgery | 0/5724 (0%) | 1/5705 (0%) | 1/5687 (0%) | |||
| Thyroidectomy | 0/5724 (0%) | 2/5705 (0%) | 0/5687 (0%) | |||
| Transurethral bladder resection | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Transurethral prostatectomy | 2/5724 (0%) | 1/5705 (0%) | 2/5687 (0%) | |||
| Urethral operation | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Urethrotomy | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Vaginoplasty | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Vascular graft | 1/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Vascular stent insertion | 0/5724 (0%) | 1/5705 (0%) | 1/5687 (0%) | |||
| Vascular disorders | ||||||
| Accelerated hypertension | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Aneurysm | 0/5724 (0%) | 4/5705 (0.1%) | 0/5687 (0%) | |||
| Aneurysm ruptured | 2/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Aortic aneurysm | 8/5724 (0.1%) | 15/5705 (0.3%) | 12/5687 (0.2%) | |||
| Aortic aneurysm rupture | 2/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Aortic dissection | 1/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Aortic occlusion | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Aortic rupture | 2/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Aortic stenosis | 2/5724 (0%) | 4/5705 (0.1%) | 1/5687 (0%) | |||
| Arterial disorder | 1/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Arterial haemorrhage | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Arterial occlusive disease | 2/5724 (0%) | 3/5705 (0.1%) | 2/5687 (0%) | |||
| Arterial stenosis | 0/5724 (0%) | 2/5705 (0%) | 0/5687 (0%) | |||
| Arterial thrombosis | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Arteriosclerosis | 5/5724 (0.1%) | 6/5705 (0.1%) | 4/5687 (0.1%) | |||
| Arteritis | 0/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Bleeding varicose vein | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Circulatory collapse | 4/5724 (0.1%) | 2/5705 (0%) | 1/5687 (0%) | |||
| Deep vein thrombosis | 5/5724 (0.1%) | 11/5705 (0.2%) | 6/5687 (0.1%) | |||
| Embolism | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Extremity necrosis | 1/5724 (0%) | 1/5705 (0%) | 1/5687 (0%) | |||
| Femoral artery occlusion | 1/5724 (0%) | 2/5705 (0%) | 1/5687 (0%) | |||
| Haematoma | 0/5724 (0%) | 1/5705 (0%) | 4/5687 (0.1%) | |||
| Haemorrhage | 2/5724 (0%) | 0/5705 (0%) | 2/5687 (0%) | |||
| Hypertension | 8/5724 (0.1%) | 8/5705 (0.1%) | 12/5687 (0.2%) | |||
| Hypertensive crisis | 4/5724 (0.1%) | 2/5705 (0%) | 1/5687 (0%) | |||
| Hypotension | 0/5724 (0%) | 6/5705 (0.1%) | 9/5687 (0.2%) | |||
| Hypovolaemic shock | 1/5724 (0%) | 0/5705 (0%) | 2/5687 (0%) | |||
| Iliac artery occlusion | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Intermittent claudication | 4/5724 (0.1%) | 2/5705 (0%) | 3/5687 (0.1%) | |||
| Jugular vein thrombosis | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Leriche syndrome | 0/5724 (0%) | 1/5705 (0%) | 1/5687 (0%) | |||
| Lymphoedema | 0/5724 (0%) | 0/5705 (0%) | 4/5687 (0.1%) | |||
| Orthostatic hypotension | 1/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Peripheral arterial occlusive disease | 7/5724 (0.1%) | 8/5705 (0.1%) | 10/5687 (0.2%) | |||
| Peripheral artery aneurysm | 0/5724 (0%) | 2/5705 (0%) | 0/5687 (0%) | |||
| Peripheral artery stenosis | 4/5724 (0.1%) | 3/5705 (0.1%) | 0/5687 (0%) | |||
| Peripheral artery thrombosis | 0/5724 (0%) | 2/5705 (0%) | 1/5687 (0%) | |||
| Peripheral ischaemia | 4/5724 (0.1%) | 5/5705 (0.1%) | 3/5687 (0.1%) | |||
| Peripheral vascular disorder | 4/5724 (0.1%) | 2/5705 (0%) | 1/5687 (0%) | |||
| Post thrombotic syndrome | 1/5724 (0%) | 1/5705 (0%) | 0/5687 (0%) | |||
| Shock | 2/5724 (0%) | 1/5705 (0%) | 1/5687 (0%) | |||
| Shock haemorrhagic | 2/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Steal syndrome | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Subclavian artery stenosis | 0/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Subclavian vein thrombosis | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Thrombophlebitis | 1/5724 (0%) | 0/5705 (0%) | 1/5687 (0%) | |||
| Thrombosis | 4/5724 (0.1%) | 0/5705 (0%) | 3/5687 (0.1%) | |||
| Varicose vein | 2/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Vascular occlusion | 2/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Vasculitis | 0/5724 (0%) | 0/5705 (0%) | 2/5687 (0%) | |||
| Vasodilatation | 0/5724 (0%) | 1/5705 (0%) | 1/5687 (0%) | |||
| Venous insufficiency | 1/5724 (0%) | 0/5705 (0%) | 0/5687 (0%) | |||
| Venous thrombosis limb | 2/5724 (0%) | 1/5705 (0%) | 2/5687 (0%) | |||
Other (Not Including Serious) Adverse Events |
||||||
| Tiotropium 2.5 mcg and Placebo | Tiotropium 5 mcg and Placebo | Tiotropium 18 mcg and Placebo | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1932/5724 (33.8%) | 1876/5705 (32.9%) | 1928/5687 (33.9%) | |||
| Respiratory, thoracic and mediastinal disorders | ||||||
| Chronic obstructive pulmonary disease | 1932/5724 (33.8%) | 1876/5705 (32.9%) | 1928/5687 (33.9%) | |||
Limitations/Caveats
Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
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:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01126437
Other Study ID Numbers:
- 205.452
- 2009-015713-51
First Posted:
May 19, 2010
Last Update Posted:
Jun 20, 2014
Last Verified:
May 1, 2014