Researching Cardiovascular Events With a Weekly Incretin in Diabetes (REWIND)
Study Details
Study Description
Brief Summary
The purpose of this trial is to assess whether dulaglutide can reduce major cardiovascular events and other serious outcomes in persons with type 2 diabetes, when added to their anti-hyperglycemic regimen.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: 1.5 mg Dulaglutide Administered once weekly, subcutaneously |
Drug: Dulaglutide
Administered subcutaneously
Other Names:
|
Placebo Comparator: Placebo Administered once weekly, subcutaneously |
Drug: Placebo
Administered subcutaneously
|
Outcome Measures
Primary Outcome Measures
- Number of Participants Who Experienced an Event For Time, From Randomization to First Occurrence of Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke (a Composite Cardiovascular Outcome) [From randomization to first occurrence or death from any cause or study completion (Median Follow-Up of 5.4 Years)]
The time from randomization to first occurrence of cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke (a composite endpoint) was evaluated using time-to-event analysis. The primary analysis model was a Cox proportional hazards regression model for the time to the first occurrence of a primary endpoint event, with treatment as a fixed effect using the intent-to-treat population. The number of participants who experienced a primary cardiovascular (CV) endpoint event is presented.
Secondary Outcome Measures
- Number of Participants Who Experienced an Event for Time to First Occurrence After Randomization of Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke, Individually [From randomization to first occurrence or study completion (Median Follow-Up of 5.4 Years)]
The time from randomization to first occurrence of cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke (individually) was evaluated using time-to-event analysis via the Cox proportional hazards regression model where response equals treatment. Death from CV causes is defined as a death resulting from an acute myocardial infarction (MI), sudden cardiac death, death due to heart failure, death due to stroke, or death due to other CV causes. The number of participants who experienced an event is presented.
- Number of Participants Who Experienced an Event for Time to All-cause Mortality [From randomization to study completion (Median Follow-Up of 5.4 Years)]
The time to all-cause mortality was evaluated using time-to-event analysis via the Cox proportional hazards regression model where response equals treatment. The number of participants who experienced an event is presented.
- Number of Participants Who Experienced an Event for Time to First Occurrence After Randomization of the Composite Microvascular Endpoint [From randomization to first occurrence or study completion (Median Follow-Up of 5.4 Years)]
The time from randomization to first occurrence of the composite microvascular endpoint was evaluated using time-to-event analysis via the Cox proportional hazards regression model where response equals treatment. The composite microvascular endpoint is defined as diabetic retinopathy requiring laser therapy, vitrectomy, or anti-vascular endothelial growth factor therapy (VEGF), clinical proteinuria, a greater than equal ≥ 30% decline in estimated glomerular filtration rate, or need for chronic renal replacement therapy. The number of participants who experienced the composite microvascular endpoint event is presented.
- Number of Participants Who Experienced An Event for Time to First Occurrence After Randomization of Heart Failure Requiring Hospitalization or an Urgent Heart Failure Clinic Visit [From randomization to first occurrence or study completion (Median Follow-Up of 5.4 Years)]
The time to first occurrence after randomization of heart failure requiring hospitalization or an urgent heart failure clinic visit was evaluated using time-to-event analysis via the Cox proportional hazards regression model where response equals treatment. The number of participants who experienced an event is presented.
- Number of Participants Who Experienced an Event for Time to First Occurrence After Randomization of First Hospitalization for Unstable Angina [From randomization to first occurrence or study completion (Median Follow-Up of 5.4 Years)]
Time to first occurrence after randomization of first hospitalization for unstable angina was evaluated using time-to-event analysis via the Cox proportional hazards regression model where response equals treatment. The number of participants who experienced an event is presented.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Type 2 diabetes with Hemoglobin A1c equal to or less than 9.5% (equal to or less than 81 mmol/mol)
-
Anti-hyperglycemic drug naive or treated with up to 2 oral hyperglycemic drugs with or without a glucagon-like peptide-1analog or basal insulin, or basal insulin alone
-
On stable antihyperglycemic regimen for at least 3 months
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Age equal to or greater than 50 years with established clinical vascular disease, or age equal to or greater than 55 years and subclinical vascular disease or age equal to or greater than 60 years and at least 2 or more cardiovascular risk factors
Exclusion Criteria:
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Uncontrolled diabetes requiring immediate therapy
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History of severe hypoglycemia in past year
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Acute coronary or cerebrovascular event within past 2 months
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Planned or anticipated revascularization procedure
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History of pancreatitis, hepatic insufficiency , chronic renal failure or of C-cell thyroid disorder
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Pregnancy or planned pregnancy during the trial period
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Completed or withdrawn from any study investigating dulaglutide
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Mobile | Alabama | United States | 36606 |
2 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Pell City | Alabama | United States | 35128 |
3 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Phoenix | Arizona | United States | 85012 |
4 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Tucson | Arizona | United States | 85723 |
5 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Little Rock | Arkansas | United States | 72205 |
6 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Burlingame | California | United States | 94010 |
7 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Lakewood | California | United States | 90712 |
8 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Long Beach | California | United States | 90822 |
9 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Los Angeles | California | United States | 90333 |
10 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Northridge | California | United States | 91325 |
11 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | San Diego | California | United States | 92161 |
12 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Waterbury | Connecticut | United States | 06708 |
13 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Washington | District of Columbia | United States | 20010 |
14 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Brandon | Florida | United States | 33511 |
15 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Miami | Florida | United States | 33125 |
16 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Palm Harbor | Florida | United States | 34684 |
17 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Plant City | Florida | United States | 33563 |
18 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Port Charlotte | Florida | United States | 33952 |
19 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | West Palm Beach | Florida | United States | 33401 |
20 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Winter Haven | Florida | United States | 33880 |
21 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Lawrenceville | Georgia | United States | 30046 |
22 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Honolulu | Hawaii | United States | 96814 |
23 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Topeka | Kansas | United States | 66606 |
24 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Lexington | Kentucky | United States | 40502 |
25 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | New Orleans | Louisiana | United States | 70112 |
26 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Detroit | Michigan | United States | 48202 |
27 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Minneapolis | Minnesota | United States | 55455 |
28 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Columbia | Missouri | United States | 65212 |
29 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Kansas City | Missouri | United States | 64128 |
30 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Saint Louis | Missouri | United States | 63106 |
31 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Kalispell | Montana | United States | 59901 |
32 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Omaha | Nebraska | United States | 68105 |
33 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Camden | New Jersey | United States | 08103 |
34 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Fresh Meadows | New York | United States | 11365 |
35 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Rochester | New York | United States | 14607 |
36 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Westfield | New York | United States | 14787 |
37 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Morehead City | North Carolina | United States | 28557 |
38 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Columbus | Ohio | United States | 43210 |
39 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Portland | Oregon | United States | 97239 |
40 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Murrells Inlet | South Carolina | United States | 29576 |
41 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Memphis | Tennessee | United States | 38104 |
42 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Dallas | Texas | United States | 75246 |
43 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Houston | Texas | United States | 77030 |
44 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Lubbock | Texas | United States | 79423 |
45 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Salt Lake City | Utah | United States | 84124 |
46 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Burke | Virginia | United States | 22015 |
47 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Charlottesville | Virginia | United States | 22903 |
48 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Norfolk | Virginia | United States | 23507 |
49 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Richmond | Virginia | United States | 23249 |
50 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Salem | Virginia | United States | 24153 |
51 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Seattle | Washington | United States | 98105 |
52 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Bahia Blanca | Argentina | 8000 | |
53 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Buenos Aires | Argentina | C1119ACN | |
54 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Cipolletti | Argentina | 8324 | |
55 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Ciudad De Parana | Argentina | E3100BBJ | |
56 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Coronel Suarez | Argentina | B7540GHD | |
57 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Corrientes | Argentina | 3400 | |
58 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Córdoba | Argentina | 5000 | |
59 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Junin | Argentina | B6000BHA | |
60 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | La Plata | Argentina | B1900AVS | |
61 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Mar Del Plata | Argentina | B7600FZN | |
62 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Merlo | Argentina | B1722COV | |
63 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Quilmes | Argentina | 1878 | |
64 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Rafaela Santa Fe | Argentina | S2300MMA | |
65 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Rosario | Argentina | 2000 | |
66 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Salta | Argentina | CP4400 | |
67 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | San Miguel De Tucuman | Argentina | T4000NIL | |
68 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | San Nicolas | Argentina | 2900 | |
69 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Santa Fe | Argentina | S2000FWO | |
70 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Venado Tuerto | Argentina | S2600 | |
71 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Villa Maria | Argentina | X5900JKA | |
72 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Zarate | Argentina | 2800 | |
73 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | St Leonards | New South Wales | Australia | 2065 |
74 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | St. Leonards | New South Wales | Australia | 2065 |
75 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Milton | Queensland | Australia | 4064 |
76 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Elizabeth Vale | South Australia | Australia | 5112 |
77 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Clayton | Victoria | Australia | 3168 |
78 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Heidelberg Heights | Victoria | Australia | 3081 |
79 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Melbourne | Victoria | Australia | 3004 |
80 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Parkville | Victoria | Australia | 3050 |
81 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Nedlands | Western Australia | Australia | 6009 |
82 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Belo Horizonte | Brazil | 30150240 | |
83 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Brasilia | Brazil | 70390903 | |
84 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Campina Grande Do Sul | Brazil | 83430000 | |
85 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Campinas | Brazil | 13020421 | |
86 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Curitiba | Brazil | 80010-030 | |
87 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Porto Alegre | Brazil | 90110-270 | |
88 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Rio De Janeiro | Brazil | 20211-340 | |
89 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Sao Jose Rio Preto | Brazil | 15090-000 | |
90 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | São Paulo | Brazil | 04025-011 | |
91 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Uberaba | Brazil | 38025-260 | |
92 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Votuporanga | Brazil | 15500-003 | |
93 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Blagoevgrad | Bulgaria | 2700 | |
94 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Plovdiv | Bulgaria | 4002 | |
95 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Sofia | Bulgaria | 1142 | |
96 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Calgary | Alberta | Canada | T3G 0B4 |
97 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Spruce Grove | Alberta | Canada | T7X 2V2 |
98 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Winnipeg | Manitoba | Canada | R2H 0R8 |
99 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Brampton | Ontario | Canada | L6S 0C9 |
100 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Burlington | Ontario | Canada | L7M 4Y1 |
101 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Cambridge | Ontario | Canada | N1R 7L6 |
102 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Etobicoke | Ontario | Canada | M9R 4E1 |
103 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Hamilton | Ontario | Canada | L8S 3Z5 |
104 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Kingston | Ontario | Canada | K7L 2V7 |
105 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | London | Ontario | Canada | N6A 4V2 |
106 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Markham | Ontario | Canada | L6B 0P9 |
107 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Oakville | Ontario | Canada | L6H 3P1 |
108 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Oshawa | Ontario | Canada | L1J 2K1 |
109 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Ottawa | Ontario | Canada | K1H 1A2 |
110 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Smiths Falls | Ontario | Canada | K7A 4W8 |
111 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Thornhill | Ontario | Canada | L4J1W3 |
112 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Toronto | Ontario | Canada | M4N 3M5 |
113 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Fleurimont | Quebec | Canada | J1H 5N4 |
114 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Gatineau | Quebec | Canada | J8Y6S9 |
115 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Granby | Quebec | Canada | J2G 8Z9 |
116 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Laval | Quebec | Canada | H7T 2P5 |
117 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Montreal | Quebec | Canada | H3A 1A1 |
118 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Quebec City | Quebec | Canada | G1N 4V3 |
119 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Sherbrooke | Quebec | Canada | J1H 4J6 |
120 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Ville De Quebec | Quebec | Canada | G1L 3L5 |
121 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Ville St-Laurent | Quebec | Canada | H4T 1Z9 |
122 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Esaskatoon | Saskatchewan | Canada | S7K 3H3 |
123 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Quebec | Canada | G1V 4G5 | |
124 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Osomo | Chile | ||
125 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Providencia | Chile | 7500520 | |
126 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Santiago | Chile | 2570017 | |
127 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Temuco | Chile | 4781173 | |
128 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Armenia | Colombia | 63001 | |
129 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Barranquilla | Colombia | 1569 | |
130 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Barrio Maridias | Colombia | ||
131 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Bogota | Colombia | 80CO | |
132 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Cartagena | Colombia | 130010 | |
133 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | El Espinal | Colombia | ||
134 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Floridablanca | Colombia | 68276 | |
135 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Manizales | Colombia | ||
136 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Medellin | Colombia | 5001 | |
137 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Pereira | Colombia | ||
138 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Brno | Czechia | 66250 | |
139 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Chomutov | Czechia | 43002 | |
140 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Havirov | Czechia | 73601 | |
141 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Jinocany | Czechia | 25225 | |
142 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Ostrava | Czechia | 70200 | |
143 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Prague | Czechia | 181 00 | |
144 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Pribram | Czechia | 261 01 | |
145 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Uherske Hradiste | Czechia | 68601 | |
146 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Valasske Klobouky | Czechia | 76601 | |
147 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Bad Oeynhausen | Germany | 32545 | |
148 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Berlin | Germany | 13158 | |
149 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Bochum | Germany | 44787 | |
150 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Burg/Spreewald | Germany | 03096 | |
151 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Dippoldiswalde | Germany | 01744 | |
152 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Dresden | Germany | 01307 | |
153 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Düsseldorf | Germany | 40210 | |
154 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Essen | Germany | 45355 | |
155 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Haag | Germany | 83527 | |
156 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Ingelheim | Germany | 55218 | |
157 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Künzing | Germany | 94550 | |
158 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Leipzig | Germany | 04107 | |
159 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Ludwigshafen | Germany | 67067 | |
160 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Mainz | Germany | 55116 | |
161 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Pirna | Germany | 01796 | |
162 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Riesa | Germany | 01587 | |
163 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Saarlouis | Germany | 66740 | |
164 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Speyer | Germany | 67346 | |
165 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Villingen-Schwenningen | Germany | 78048 | |
166 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Balatonfured | Hungary | 8230 | |
167 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Budapest | Hungary | 1125 | |
168 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Kaposvar | Hungary | 7400 | |
169 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Kecskemet | Hungary | 6000 | |
170 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Mosonmagyarovar | Hungary | 9200 | |
171 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Nyiregyhaza | Hungary | 4400 | |
172 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Szekesfehervar | Hungary | 8000 | |
173 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Szekszard | Hungary | 7100 | |
174 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Veszprem | Hungary | 8200 | |
175 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Busan | Korea, Republic of | 602-715 | |
176 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Daegu | Korea, Republic of | 705-718 | |
177 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Goyang | Korea, Republic of | 410-773 | |
178 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Guri City | Korea, Republic of | 471-701 | |
179 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Gwangju | Korea, Republic of | 501-757 | |
180 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Seoul | Korea, Republic of | 137-701 | |
181 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Daugavpils | Latvia | LV -5417 | |
182 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Jelgava | Latvia | LV 3000 | |
183 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Liepaja | Latvia | LV3401 | |
184 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Limbazi | Latvia | LV-4001 | |
185 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Ogre | Latvia | LV-5001 | |
186 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Riga | Latvia | LV-1002 | |
187 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Tukums | Latvia | LV-3101 | |
188 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Valmiera | Latvia | LV4201 | |
189 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Kaunas | Lithuania | LT50184 | |
190 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Klaipeda | Lithuania | LT94231 | |
191 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Vilniuslt | Lithuania | LT03116 | |
192 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Aguascalientes | Mexico | 20234 | |
193 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Cuernavaca | Mexico | 62250 | |
194 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Culiacan | Mexico | 80020 | |
195 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Guadalajara | Mexico | 44860 | |
196 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Mexico City | Mexico | 06090 | |
197 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Monterrey | Mexico | 64620 | |
198 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Queretaro | Mexico | 76000 | |
199 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Tijuana | Mexico | 22329 | |
200 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Tlalpan | Mexico | 14000 | |
201 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Toluca | Mexico | 50010 | |
202 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Veracruz | Mexico | 91910 | |
203 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Auckland | New Zealand | 1640 | |
204 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Beckenham, Christchurch | New Zealand | 8024 | |
205 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Christchurch | New Zealand | 8011 | |
206 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Dunedin | New Zealand | 9012 | |
207 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Hastings | New Zealand | ||
208 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Papamoa | New Zealand | 3118 | |
209 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Roslyn | New Zealand | 4414 | |
210 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Rotorua | New Zealand | 3010 | |
211 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Tauranga | New Zealand | 3112 | |
212 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Waitakere | New Zealand | 0612 | |
213 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Wellington | New Zealand | 6021 | |
214 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Westown | New Zealand | 4310 | |
215 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Bialystok | Poland | 15-435 | |
216 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Losice | Poland | 08200 | |
217 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Poznan | Poland | 61-655 | |
218 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Pulawy | Poland | 24100 | |
219 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Sobotka | Poland | 55050 | |
220 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Warsaw | Poland | 03003 | |
221 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Wroclaw | Poland | 50-127 | |
222 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Bayamon | Puerto Rico | 00960 | |
223 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Manati | Puerto Rico | 00674 | |
224 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | San Juan | Puerto Rico | 00917-3104 | |
225 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Alba Lulia | Romania | 510053 | |
226 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Bacau | Romania | 600164 | |
227 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Brasov | Romania | 500365 | |
228 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Bucharest | Romania | 010507 | |
229 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Cluj-Napoca | Romania | 400349 | |
230 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Constanta | Romania | 900591 | |
231 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Craiova | Romania | 200642 | |
232 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Deva | Romania | 330084 | |
233 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Galati | Romania | 800371 | |
234 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Iasi | Romania | 700111 | |
235 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Maramures | Romania | 430123 | |
236 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Oradea | Romania | 410169 | |
237 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Pitesti | Romania | 110084 | |
238 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Ploiesti | Romania | 100163 | |
239 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Satu Mare | Romania | 440055 | |
240 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Sibiu | Romania | 550245 | |
241 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Timisoara | Romania | 300736 | |
242 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Chelyabinsk | Russian Federation | 454021 | |
243 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Moscow | Russian Federation | 123423 | |
244 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Novosibirsk | Russian Federation | 630087 | |
245 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Saint Petersburg | Russian Federation | 194156 | |
246 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Smolensk | Russian Federation | 214019 | |
247 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Volgograd | Russian Federation | 400138 | |
248 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Benoni | South Africa | 1500 | |
249 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Bloemfontein | South Africa | 9301 | |
250 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Cape Town | South Africa | 7925 | |
251 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Die Wilgers Ext 14 | South Africa | 0041 | |
252 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Durban | South Africa | 4001 | |
253 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Grassy Park | South Africa | 7941 | |
254 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Johannesburg | South Africa | 2193 | |
255 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Lynnwood Ridge | South Africa | 0040 | |
256 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Lyttleton | South Africa | 0140 | |
257 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Parow | South Africa | 7505 | |
258 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Rondebosh | South Africa | 7700 | |
259 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Somerset West | South Africa | 7130 | |
260 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Soweto | South Africa | 2013 | |
261 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Tongaat | South Africa | 4400 | |
262 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Worcester | South Africa | 6850 | |
263 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Alicante | Spain | 03450 | |
264 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Alzira | Spain | 46600 | |
265 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Badalona | Spain | 08916 | |
266 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Barcelona | Spain | 08022 | |
267 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Centelles | Spain | 08540 | |
268 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Lleida | Spain | 25198 | |
269 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Palma De Mallorca | Spain | 07198 | |
270 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Segovia | Spain | 40002 | |
271 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Sevilla | Spain | 41009 | |
272 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Valencia | Spain | 46014 | |
273 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Vic | Spain | 08500 | |
274 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Aneby | Sweden | 57893 | |
275 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Goteborg | Sweden | 41685 | |
276 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Härnösand | Sweden | 87182 | |
277 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Koping | Sweden | 73181 | |
278 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Ljungby | Sweden | 341 82 | |
279 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Ostersund | Sweden | 83183 | |
280 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Skelleftea | Sweden | 93186 | |
281 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Stockholm | Sweden | 17176 | |
282 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Vaxjo | Sweden | 35185 | |
283 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Vällingby | Sweden | 16268 | |
284 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Kaohsiung Hsien | Taiwan | 833 | |
285 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Sindian City | Taiwan | 23148 | |
286 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Taichung City | Taiwan | 404 | |
287 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Bath | Avon | United Kingdom | BA2 3HT |
288 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Middlesbrough | Cleveland | United Kingdom | TS4 3BW |
289 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Hull | East Yorkshire | United Kingdom | HU3 2RW |
290 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Oldham | Lancashire | United Kingdom | OL1 2JH |
291 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Belfast | Northern Ireland | United Kingdom | BT16 0TH |
292 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Ayr | Scotland | United Kingdom | KA6 6DX |
293 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Dundee | Scotland | United Kingdom | DD1 9SY |
294 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Edinburgh | Scotland | United Kingdom | EH4 2XU |
295 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Inverness | Scotland | United Kingdom | IV2 3JH |
296 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Sheffield | South Yorkshire | United Kingdom | S5 7AU |
297 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Swansea | Wales | United Kingdom | SA6 6NL |
298 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Antrim | United Kingdom | BT412RL | |
299 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Bath | United Kingdom | BA1 2SR | |
300 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Belfast | United Kingdom | BT12 6BA | |
301 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Londonderry | United Kingdom | BT47 6SB |
Sponsors and Collaborators
- Eli Lilly and Company
Investigators
- Study Director: Call 1-877-CTLILLY (1-877-285-4559 or 1-317-615-4559 Mon - Fri 9 AM - 5PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company
Study Documents (Full-Text)
More Information
Publications
None provided.- 13438
- H9X-MC-GBDJ
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail | Participants were randomized to either placebo or Dulaglutide. Completers included participants for whom vital status was ascertained during the study close-out period and endpoint completers. |
Arm/Group Title | Placebo | Dulaglutide |
---|---|---|
Arm/Group Description | Placebo was administered once weekly, subcutaneously | 1.5 mg Dulaglutide was administered once weekly, subcutaneously |
Period Title: Overall Study | ||
STARTED | 4952 | 4949 |
Received at Least One Dose of Study Drug | 4949 | 4943 |
COMPLETED | 4935 | 4932 |
NOT COMPLETED | 17 | 17 |
Baseline Characteristics
Arm/Group Title | Placebo | Dulaglutide | Total |
---|---|---|---|
Arm/Group Description | Placebo was administered once weekly, subcutaneously | 1.5 mg Dulaglutide was administered once weekly, subcutaneously | Total of all reporting groups |
Overall Participants | 4952 | 4949 | 9901 |
Age (Count of Participants) | |||
<=18 years |
0
0%
|
0
0%
|
0
0%
|
Between 18 and 65 years |
2315
46.7%
|
2330
47.1%
|
4645
46.9%
|
>=65 years |
2637
53.3%
|
2619
52.9%
|
5256
53.1%
|
Age (years) [Mean (Standard Deviation) ] | |||
Mean (Standard Deviation) [years] |
66.2
(6.5)
|
66.2
(6.5)
|
66.2
(6.5)
|
Sex: Female, Male (Count of Participants) | |||
Female |
2283
46.1%
|
2306
46.6%
|
4589
46.3%
|
Male |
2669
53.9%
|
2643
53.4%
|
5312
53.7%
|
Ethnicity (NIH/OMB) (Count of Participants) | |||
Hispanic or Latino |
64
1.3%
|
60
1.2%
|
124
1.3%
|
Not Hispanic or Latino |
402
8.1%
|
400
8.1%
|
802
8.1%
|
Unknown or Not Reported |
4486
90.6%
|
4489
90.7%
|
8975
90.6%
|
Race (NIH/OMB) (Count of Participants) | |||
American Indian or Alaska Native |
543
11%
|
549
11.1%
|
1092
11%
|
Asian |
218
4.4%
|
216
4.4%
|
434
4.4%
|
Native Hawaiian or Other Pacific Islander |
22
0.4%
|
12
0.2%
|
34
0.3%
|
Black or African American |
346
7%
|
331
6.7%
|
677
6.8%
|
White |
3744
75.6%
|
3754
75.9%
|
7498
75.7%
|
More than one race |
79
1.6%
|
87
1.8%
|
166
1.7%
|
Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
Region of Enrollment (Count of Participants) | |||
United States |
475
9.6%
|
468
9.5%
|
943
9.5%
|
Czechia |
107
2.2%
|
106
2.1%
|
213
2.2%
|
Russia |
50
1%
|
51
1%
|
101
1%
|
South Korea |
62
1.3%
|
60
1.2%
|
122
1.2%
|
Sweden |
117
2.4%
|
119
2.4%
|
236
2.4%
|
Latvia |
39
0.8%
|
39
0.8%
|
78
0.8%
|
Brazil |
137
2.8%
|
138
2.8%
|
275
2.8%
|
Poland |
305
6.2%
|
303
6.1%
|
608
6.1%
|
Chile |
64
1.3%
|
64
1.3%
|
128
1.3%
|
Bulgaria |
50
1%
|
51
1%
|
101
1%
|
Lithuania |
52
1.1%
|
53
1.1%
|
105
1.1%
|
Colombia |
392
7.9%
|
393
7.9%
|
785
7.9%
|
Argentina |
698
14.1%
|
697
14.1%
|
1395
14.1%
|
Romania |
544
11%
|
541
10.9%
|
1085
11%
|
Hungary |
113
2.3%
|
110
2.2%
|
223
2.3%
|
United Kingdom |
65
1.3%
|
71
1.4%
|
136
1.4%
|
Spain |
62
1.3%
|
65
1.3%
|
127
1.3%
|
New Zealand |
119
2.4%
|
115
2.3%
|
234
2.4%
|
Canada |
564
11.4%
|
564
11.4%
|
1128
11.4%
|
Taiwan |
13
0.3%
|
13
0.3%
|
26
0.3%
|
South Africa |
369
7.5%
|
372
7.5%
|
741
7.5%
|
Mexico |
219
4.4%
|
219
4.4%
|
438
4.4%
|
Australia |
44
0.9%
|
44
0.9%
|
88
0.9%
|
Germany |
292
5.9%
|
293
5.9%
|
585
5.9%
|
Outcome Measures
Title | Number of Participants Who Experienced an Event For Time, From Randomization to First Occurrence of Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke (a Composite Cardiovascular Outcome) |
---|---|
Description | The time from randomization to first occurrence of cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke (a composite endpoint) was evaluated using time-to-event analysis. The primary analysis model was a Cox proportional hazards regression model for the time to the first occurrence of a primary endpoint event, with treatment as a fixed effect using the intent-to-treat population. The number of participants who experienced a primary cardiovascular (CV) endpoint event is presented. |
Time Frame | From randomization to first occurrence or death from any cause or study completion (Median Follow-Up of 5.4 Years) |
Outcome Measure Data
Analysis Population Description |
---|
All randomized participants. |
Arm/Group Title | Placebo | Dulaglutide |
---|---|---|
Arm/Group Description | Placebo was administered once weekly, subcutaneously | 1.5 mg Dulaglutide was administered once weekly, subcutaneously |
Measure Participants | 4952 | 4949 |
Count of Participants [Participants] |
663
13.4%
|
594
12%
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Placebo, Dulaglutide |
---|---|---|
Comments | Primary CV endpoint | |
Type of Statistical Test | Superiority | |
Comments | Superiority was declared if the upper limit of the 2-sided 95.33% confidence interval (CI) of the hazard ratio was below 1.0 (after adjustment for the interim analysis). Once superiority was achieved for the primary endpoint, multiplicity adjustments using the graphical approach were performed for secondary efficacy endpoints in order to control the overall Type I error rate at a 2-sided alpha level of 0.0467. | |
Statistical Test of Hypothesis | p-Value | 0.026 |
Comments | ||
Method | Regression, Cox | |
Comments | ||
Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
Estimated Value | 0.88 | |
Confidence Interval |
(2-Sided) 95.33% 0.79 to 0.99 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Title | Number of Participants Who Experienced an Event for Time to First Occurrence After Randomization of Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke, Individually |
---|---|
Description | The time from randomization to first occurrence of cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke (individually) was evaluated using time-to-event analysis via the Cox proportional hazards regression model where response equals treatment. Death from CV causes is defined as a death resulting from an acute myocardial infarction (MI), sudden cardiac death, death due to heart failure, death due to stroke, or death due to other CV causes. The number of participants who experienced an event is presented. |
Time Frame | From randomization to first occurrence or study completion (Median Follow-Up of 5.4 Years) |
Outcome Measure Data
Analysis Population Description |
---|
All randomized participants. |
Arm/Group Title | Placebo | Dulaglutide |
---|---|---|
Arm/Group Description | Placebo was administered once weekly, subcutaneously | 1.5 mg Dulaglutide was administered once weekly, subcutaneously |
Measure Participants | 4952 | 4949 |
Death from CV causes |
346
7%
|
317
6.4%
|
Nonfatal MI |
212
4.3%
|
205
4.1%
|
Nonfatal stroke |
175
3.5%
|
135
2.7%
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Placebo, Dulaglutide |
---|---|---|
Comments | Death from CV causes | |
Type of Statistical Test | Superiority | |
Comments | Multiplicity adjustments using the graphical approach were performed for secondary efficacy endpoints in order to control the overall Type I error rate at a 2-sided alpha level of 0.0467. | |
Statistical Test of Hypothesis | p-Value | 0.211 |
Comments | ||
Method | Regression, Cox | |
Comments | ||
Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
Estimated Value | 0.91 | |
Confidence Interval |
(2-Sided) 95% 0.78 to 1.06 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | Placebo, Dulaglutide |
---|---|---|
Comments | Nonfatal MI | |
Type of Statistical Test | Superiority | |
Comments | Multiplicity adjustments using the graphical approach were performed for secondary efficacy endpoints in order to control the overall Type I error rate at a 2-sided alpha level of 0.0467. | |
Statistical Test of Hypothesis | p-Value | 0.652 |
Comments | ||
Method | Regression, Cox | |
Comments | ||
Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
Estimated Value | 0.96 | |
Confidence Interval |
(2-Sided) 95% 0.79 to 1.16 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | Placebo, Dulaglutide |
---|---|---|
Comments | Nonfatal stroke | |
Type of Statistical Test | Superiority | |
Comments | Multiplicity adjustments using the graphical approach were performed for secondary efficacy endpoints in order to control the overall Type I error rate at a 2-sided alpha level of 0.0467. | |
Statistical Test of Hypothesis | p-Value | 0.017 |
Comments | ||
Method | Regression, Cox | |
Comments | ||
Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
Estimated Value | 0.76 | |
Confidence Interval |
(2-Sided) 95% 0.61 to 0.95 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Title | Number of Participants Who Experienced an Event for Time to All-cause Mortality |
---|---|
Description | The time to all-cause mortality was evaluated using time-to-event analysis via the Cox proportional hazards regression model where response equals treatment. The number of participants who experienced an event is presented. |
Time Frame | From randomization to study completion (Median Follow-Up of 5.4 Years) |
Outcome Measure Data
Analysis Population Description |
---|
All randomized participants. |
Arm/Group Title | Placebo | Dulaglutide |
---|---|---|
Arm/Group Description | Placebo was administered once weekly, subcutaneously | 1.5 mg Dulaglutide was administered once weekly, subcutaneously |
Measure Participants | 4952 | 4949 |
Count of Participants [Participants] |
592
12%
|
536
10.8%
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Placebo, Dulaglutide |
---|---|---|
Comments | Time to all cause mortality | |
Type of Statistical Test | Superiority | |
Comments | Multiplicity adjustments using the graphical approach were performed for secondary efficacy endpoints in order to control the overall Type I error rate at a 2-sided alpha level of 0.0467. | |
Statistical Test of Hypothesis | p-Value | 0.067 |
Comments | ||
Method | Regression, Cox | |
Comments | ||
Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
Estimated Value | 0.90 | |
Confidence Interval |
(2-Sided) 95% 0.80 to 1.01 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Title | Number of Participants Who Experienced an Event for Time to First Occurrence After Randomization of the Composite Microvascular Endpoint |
---|---|
Description | The time from randomization to first occurrence of the composite microvascular endpoint was evaluated using time-to-event analysis via the Cox proportional hazards regression model where response equals treatment. The composite microvascular endpoint is defined as diabetic retinopathy requiring laser therapy, vitrectomy, or anti-vascular endothelial growth factor therapy (VEGF), clinical proteinuria, a greater than equal ≥ 30% decline in estimated glomerular filtration rate, or need for chronic renal replacement therapy. The number of participants who experienced the composite microvascular endpoint event is presented. |
Time Frame | From randomization to first occurrence or study completion (Median Follow-Up of 5.4 Years) |
Outcome Measure Data
Analysis Population Description |
---|
All randomized participants. |
Arm/Group Title | Placebo | Dulaglutide |
---|---|---|
Arm/Group Description | Placebo was administered once weekly, subcutaneously | 1.5 mg Dulaglutide was administered once weekly, subcutaneously |
Measure Participants | 4952 | 4949 |
Count of Participants [Participants] |
1241
25.1%
|
1099
22.2%
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Placebo, Dulaglutide |
---|---|---|
Comments | microvascular endpoint | |
Type of Statistical Test | Superiority | |
Comments | Multiplicity adjustments using the graphical approach were performed for secondary efficacy endpoints in order to control the overall Type I error rate at a 2-sided alpha level of 0.0467. | |
Statistical Test of Hypothesis | p-Value | <0.001 |
Comments | ||
Method | Regression, Cox | |
Comments | ||
Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
Estimated Value | 0.86 | |
Confidence Interval |
(2-Sided) 95% 0.79 to 0.93 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Title | Number of Participants Who Experienced An Event for Time to First Occurrence After Randomization of Heart Failure Requiring Hospitalization or an Urgent Heart Failure Clinic Visit |
---|---|
Description | The time to first occurrence after randomization of heart failure requiring hospitalization or an urgent heart failure clinic visit was evaluated using time-to-event analysis via the Cox proportional hazards regression model where response equals treatment. The number of participants who experienced an event is presented. |
Time Frame | From randomization to first occurrence or study completion (Median Follow-Up of 5.4 Years) |
Outcome Measure Data
Analysis Population Description |
---|
All randomized participants. |
Arm/Group Title | Placebo | Dulaglutide |
---|---|---|
Arm/Group Description | Placebo was administered once weekly, subcutaneously | 1.5 mg Dulaglutide was administered once weekly, subcutaneously |
Measure Participants | 4952 | 4949 |
Count of Participants [Participants] |
226
4.6%
|
213
4.3%
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Placebo, Dulaglutide |
---|---|---|
Comments | Heart failure requiring hospitalization or an urgent heart failure clinic visit | |
Type of Statistical Test | Superiority | |
Comments | Multiplicity adjustments using the graphical approach were performed for secondary efficacy endpoints in order to control the overall Type I error rate at a 2-sided alpha level of 0.0467. | |
Statistical Test of Hypothesis | p-Value | 0.456 |
Comments | ||
Method | Regression, Cox | |
Comments | ||
Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
Estimated Value | 0.93 | |
Confidence Interval |
(2-Sided) 95% 0.77 to 1.12 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Title | Number of Participants Who Experienced an Event for Time to First Occurrence After Randomization of First Hospitalization for Unstable Angina |
---|---|
Description | Time to first occurrence after randomization of first hospitalization for unstable angina was evaluated using time-to-event analysis via the Cox proportional hazards regression model where response equals treatment. The number of participants who experienced an event is presented. |
Time Frame | From randomization to first occurrence or study completion (Median Follow-Up of 5.4 Years) |
Outcome Measure Data
Analysis Population Description |
---|
All randomized participants. |
Arm/Group Title | Placebo | Dulaglutide |
---|---|---|
Arm/Group Description | Placebo was administered once weekly, subcutaneously | 1.5 mg Dulaglutide was administered once weekly, subcutaneously |
Measure Participants | 4952 | 4949 |
Count of Participants [Participants] |
77
1.6%
|
88
1.8%
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Placebo, Dulaglutide |
---|---|---|
Comments | Hospitalization for unstable angina | |
Type of Statistical Test | Superiority | |
Comments | Multiplicity adjustments using the graphical approach were performed for secondary efficacy endpoints in order to control the overall Type I error rate at a 2-sided alpha level of 0.0467. | |
Statistical Test of Hypothesis | p-Value | 0.413 |
Comments | ||
Method | Regression, Cox | |
Comments | ||
Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
Estimated Value | 1.14 | |
Confidence Interval |
(2-Sided) 95% 0.84 to 1.54 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Adverse Events
Time Frame | From Randomization to Study Completion (Up to 7 Years) | |||
---|---|---|---|---|
Adverse Event Reporting Description | All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. | |||
Arm/Group Title | Placebo | Dulaglutide | ||
Arm/Group Description | Placebo was administered once weekly, subcutaneously | 1.5 mg Dulaglutide was administered once weekly, subcutaneously | ||
All Cause Mortality |
||||
Placebo | Dulaglutide | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 592/4949 (12%) | 536/4943 (10.8%) | ||
Serious Adverse Events |
||||
Placebo | Dulaglutide | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 2044/4949 (41.3%) | 1991/4943 (40.3%) | ||
Blood and lymphatic system disorders | ||||
Agranulocytosis | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Anaemia | 23/4949 (0.5%) | 24 | 29/4943 (0.6%) | 30 |
Anaemia folate deficiency | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Anaemia macrocytic | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Anaemia of malignant disease | 0/4949 (0%) | 0 | 2/4943 (0%) | 2 |
Anaemia vitamin b12 deficiency | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Blood disorder | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Deficiency anaemia | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Disseminated intravascular coagulation | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Febrile neutropenia | 4/4949 (0.1%) | 5 | 2/4943 (0%) | 2 |
Haemolytic anaemia | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Haemorrhagic anaemia | 2/4949 (0%) | 2 | 0/4943 (0%) | 0 |
Histiocytosis haematophagic | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Hypochromic anaemia | 0/4949 (0%) | 0 | 2/4943 (0%) | 2 |
Immune thrombocytopenic purpura | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Iron deficiency anaemia | 9/4949 (0.2%) | 10 | 14/4943 (0.3%) | 14 |
Lymphadenopathy | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Lymphadenopathy mediastinal | 1/4949 (0%) | 1 | 1/4943 (0%) | 1 |
Microcytic anaemia | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Nephrogenic anaemia | 1/4949 (0%) | 1 | 1/4943 (0%) | 1 |
Neutropenia | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Normochromic normocytic anaemia | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Normocytic anaemia | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Pancytopenia | 1/4949 (0%) | 1 | 3/4943 (0.1%) | 3 |
Polycythaemia | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Splenic haemorrhage | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Splenomegaly | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Thrombocytopenia | 2/4949 (0%) | 2 | 3/4943 (0.1%) | 3 |
Cardiac disorders | ||||
Acute coronary syndrome | 41/4949 (0.8%) | 43 | 43/4943 (0.9%) | 44 |
Acute left ventricular failure | 1/4949 (0%) | 1 | 3/4943 (0.1%) | 3 |
Acute myocardial infarction | 53/4949 (1.1%) | 59 | 39/4943 (0.8%) | 40 |
Angina pectoris | 58/4949 (1.2%) | 67 | 56/4943 (1.1%) | 61 |
Angina unstable | 54/4949 (1.1%) | 58 | 44/4943 (0.9%) | 47 |
Aortic valve disease mixed | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Aortic valve incompetence | 1/4949 (0%) | 1 | 5/4943 (0.1%) | 5 |
Aortic valve stenosis | 6/4949 (0.1%) | 7 | 9/4943 (0.2%) | 9 |
Arrhythmia | 3/4949 (0.1%) | 3 | 6/4943 (0.1%) | 6 |
Arteriosclerosis coronary artery | 9/4949 (0.2%) | 9 | 7/4943 (0.1%) | 7 |
Atrial fibrillation | 62/4949 (1.3%) | 79 | 90/4943 (1.8%) | 107 |
Atrial flutter | 18/4949 (0.4%) | 19 | 15/4943 (0.3%) | 19 |
Atrial tachycardia | 0/4949 (0%) | 0 | 2/4943 (0%) | 2 |
Atrial thrombosis | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Atrioventricular block | 6/4949 (0.1%) | 6 | 7/4943 (0.1%) | 7 |
Atrioventricular block complete | 11/4949 (0.2%) | 12 | 8/4943 (0.2%) | 8 |
Atrioventricular block first degree | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Atrioventricular block second degree | 9/4949 (0.2%) | 9 | 8/4943 (0.2%) | 8 |
Bifascicular block | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Bradyarrhythmia | 3/4949 (0.1%) | 3 | 3/4943 (0.1%) | 3 |
Bradycardia | 10/4949 (0.2%) | 10 | 16/4943 (0.3%) | 17 |
Bundle branch block left | 3/4949 (0.1%) | 3 | 0/4943 (0%) | 0 |
Bundle branch block right | 1/4949 (0%) | 1 | 2/4943 (0%) | 2 |
Cardiac arrest | 14/4949 (0.3%) | 15 | 11/4943 (0.2%) | 14 |
Cardiac disorder | 1/4949 (0%) | 1 | 1/4943 (0%) | 1 |
Cardiac failure | 104/4949 (2.1%) | 124 | 78/4943 (1.6%) | 87 |
Cardiac failure acute | 9/4949 (0.2%) | 10 | 8/4943 (0.2%) | 11 |
Cardiac failure chronic | 21/4949 (0.4%) | 24 | 14/4943 (0.3%) | 15 |
Cardiac failure congestive | 47/4949 (0.9%) | 52 | 38/4943 (0.8%) | 42 |
Cardiac tamponade | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Cardio-respiratory arrest | 7/4949 (0.1%) | 7 | 5/4943 (0.1%) | 5 |
Cardiogenic shock | 3/4949 (0.1%) | 3 | 5/4943 (0.1%) | 5 |
Cardiomyopathy | 5/4949 (0.1%) | 5 | 2/4943 (0%) | 2 |
Cardiomyopathy alcoholic | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Cardiopulmonary failure | 1/4949 (0%) | 1 | 2/4943 (0%) | 2 |
Cardiorenal syndrome | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Cardiovascular disorder | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Cardiovascular insufficiency | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Chronic left ventricular failure | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Congestive cardiomyopathy | 3/4949 (0.1%) | 3 | 7/4943 (0.1%) | 7 |
Cor pulmonale | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Coronary artery disease | 57/4949 (1.2%) | 64 | 57/4943 (1.2%) | 63 |
Coronary artery insufficiency | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Coronary artery occlusion | 3/4949 (0.1%) | 3 | 1/4943 (0%) | 1 |
Coronary artery perforation | 1/4949 (0%) | 1 | 1/4943 (0%) | 1 |
Coronary artery stenosis | 4/4949 (0.1%) | 4 | 5/4943 (0.1%) | 5 |
Defect conduction intraventricular | 2/4949 (0%) | 2 | 0/4943 (0%) | 0 |
Diastolic dysfunction | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Dressler's syndrome | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Extrasystoles | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Gastrocardiac syndrome | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Hypertensive heart disease | 1/4949 (0%) | 1 | 2/4943 (0%) | 2 |
Ischaemic cardiomyopathy | 2/4949 (0%) | 2 | 10/4943 (0.2%) | 11 |
Left ventricular dysfunction | 0/4949 (0%) | 0 | 2/4943 (0%) | 2 |
Left ventricular failure | 8/4949 (0.2%) | 8 | 13/4943 (0.3%) | 13 |
Metabolic cardiomyopathy | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Microvascular coronary artery disease | 1/4949 (0%) | 3 | 1/4943 (0%) | 1 |
Mitral valve disease | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Mitral valve incompetence | 7/4949 (0.1%) | 7 | 9/4943 (0.2%) | 9 |
Mitral valve prolapse | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Mitral valve stenosis | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Myocardial infarction | 35/4949 (0.7%) | 37 | 30/4943 (0.6%) | 30 |
Myocardial ischaemia | 23/4949 (0.5%) | 23 | 19/4943 (0.4%) | 20 |
Myocarditis | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Nodal rhythm | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Palpitations | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Pericardial effusion | 2/4949 (0%) | 2 | 2/4943 (0%) | 2 |
Pericarditis | 6/4949 (0.1%) | 6 | 2/4943 (0%) | 3 |
Prinzmetal angina | 1/4949 (0%) | 1 | 1/4943 (0%) | 2 |
Right ventricular dysfunction | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Right ventricular failure | 2/4949 (0%) | 2 | 1/4943 (0%) | 1 |
Silent myocardial infarction | 1/4949 (0%) | 1 | 2/4943 (0%) | 2 |
Sinoatrial block | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Sinus arrest | 0/4949 (0%) | 0 | 2/4943 (0%) | 2 |
Sinus bradycardia | 6/4949 (0.1%) | 6 | 2/4943 (0%) | 2 |
Sinus node dysfunction | 9/4949 (0.2%) | 9 | 6/4943 (0.1%) | 6 |
Sinus tachycardia | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Stress cardiomyopathy | 2/4949 (0%) | 2 | 0/4943 (0%) | 0 |
Supraventricular extrasystoles | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Supraventricular tachycardia | 9/4949 (0.2%) | 9 | 7/4943 (0.1%) | 7 |
Tachyarrhythmia | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Tachycardia | 2/4949 (0%) | 2 | 3/4943 (0.1%) | 4 |
Tachycardia induced cardiomyopathy | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Tricuspid valve incompetence | 3/4949 (0.1%) | 3 | 1/4943 (0%) | 1 |
Ventricular arrhythmia | 1/4949 (0%) | 1 | 1/4943 (0%) | 1 |
Ventricular extrasystoles | 1/4949 (0%) | 1 | 4/4943 (0.1%) | 4 |
Ventricular fibrillation | 3/4949 (0.1%) | 3 | 4/4943 (0.1%) | 4 |
Ventricular tachycardia | 5/4949 (0.1%) | 10 | 7/4943 (0.1%) | 11 |
Congenital, familial and genetic disorders | ||||
Adenomatous polyposis coli | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Atrial septal defect | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Chronic granulomatous disease | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Congenital cerebrovascular anomaly | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Developmental hip dysplasia | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Exomphalos | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Gastrointestinal arteriovenous malformation | 1/4949 (0%) | 1 | 1/4943 (0%) | 1 |
Heart disease congenital | 1/4949 (0%) | 1 | 1/4943 (0%) | 1 |
Hereditary motor and sensory neuropathy | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Hydrocele | 0/2667 (0%) | 0 | 2/2640 (0.1%) | 2 |
Hypertrophic cardiomyopathy | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Phimosis | 1/2667 (0%) | 1 | 3/2640 (0.1%) | 3 |
Vascular malformation | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Ear and labyrinth disorders | ||||
Deafness | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Deafness neurosensory | 3/4949 (0.1%) | 3 | 0/4943 (0%) | 0 |
Deafness unilateral | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Hypoacusis | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Sudden hearing loss | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Vertigo | 6/4949 (0.1%) | 6 | 4/4943 (0.1%) | 4 |
Vertigo positional | 3/4949 (0.1%) | 3 | 4/4943 (0.1%) | 4 |
Vestibular ataxia | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Vestibular disorder | 3/4949 (0.1%) | 3 | 1/4943 (0%) | 1 |
Endocrine disorders | ||||
Acromegaly | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Adrenal insufficiency | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Adrenocortical insufficiency acute | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Autoimmune thyroiditis | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Cushing's syndrome | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Goitre | 8/4949 (0.2%) | 8 | 12/4943 (0.2%) | 12 |
Hyperaldosteronism | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Hyperparathyroidism | 0/4949 (0%) | 0 | 2/4943 (0%) | 2 |
Hyperparathyroidism primary | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Hyperparathyroidism secondary | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Hyperthyroidism | 0/4949 (0%) | 0 | 2/4943 (0%) | 2 |
Hypoparathyroidism secondary | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Parathyroid disorder | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Primary hyperaldosteronism | 0/4949 (0%) | 0 | 1/4943 (0%) | 2 |
Thyroid mass | 2/4949 (0%) | 2 | 2/4943 (0%) | 2 |
Thyroiditis subacute | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Toxic nodular goitre | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Eye disorders | ||||
Amaurosis fugax | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Amblyopia | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Angle closure glaucoma | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Blepharochalasis | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Cataract | 29/4949 (0.6%) | 34 | 19/4943 (0.4%) | 27 |
Cataract diabetic | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Cataract nuclear | 3/4949 (0.1%) | 4 | 0/4943 (0%) | 0 |
Cataract subcapsular | 2/4949 (0%) | 2 | 0/4943 (0%) | 0 |
Dacryostenosis acquired | 2/4949 (0%) | 2 | 0/4943 (0%) | 0 |
Diabetic retinopathy | 4/4949 (0.1%) | 8 | 1/4943 (0%) | 1 |
Diplopia | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Eye haemorrhage | 1/4949 (0%) | 3 | 0/4943 (0%) | 0 |
Glaucoma | 6/4949 (0.1%) | 6 | 3/4943 (0.1%) | 3 |
Hypermetropia | 1/4949 (0%) | 2 | 0/4943 (0%) | 0 |
Iridodialysis | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Lens dislocation | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Macular fibrosis | 0/4949 (0%) | 0 | 2/4943 (0%) | 2 |
Macular hole | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Macular oedema | 1/4949 (0%) | 1 | 1/4943 (0%) | 1 |
Maculopathy | 1/4949 (0%) | 2 | 0/4943 (0%) | 0 |
Neurotrophic keratopathy | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Open angle glaucoma | 2/4949 (0%) | 3 | 0/4943 (0%) | 0 |
Ophthalmic vein thrombosis | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Optic ischaemic neuropathy | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Retinal artery embolism | 1/4949 (0%) | 1 | 1/4943 (0%) | 1 |
Retinal artery occlusion | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Retinal detachment | 1/4949 (0%) | 1 | 3/4943 (0.1%) | 4 |
Retinal haemorrhage | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Retinal tear | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Strabismus | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Vitreous haemorrhage | 1/4949 (0%) | 1 | 3/4943 (0.1%) | 4 |
Gastrointestinal disorders | ||||
Abdominal adhesions | 2/4949 (0%) | 2 | 0/4943 (0%) | 0 |
Abdominal compartment syndrome | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Abdominal discomfort | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Abdominal hernia | 7/4949 (0.1%) | 7 | 7/4943 (0.1%) | 7 |
Abdominal hernia obstructive | 1/4949 (0%) | 1 | 1/4943 (0%) | 1 |
Abdominal incarcerated hernia | 2/4949 (0%) | 2 | 0/4943 (0%) | 0 |
Abdominal mass | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Abdominal pain | 10/4949 (0.2%) | 11 | 10/4943 (0.2%) | 12 |
Abdominal pain upper | 5/4949 (0.1%) | 5 | 3/4943 (0.1%) | 3 |
Abdominal wall haematoma | 1/4949 (0%) | 1 | 1/4943 (0%) | 1 |
Acute abdomen | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Anal fistula | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Anal incontinence | 2/4949 (0%) | 3 | 1/4943 (0%) | 1 |
Ascites | 1/4949 (0%) | 1 | 1/4943 (0%) | 1 |
Barrett's oesophagus | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Chronic gastritis | 2/4949 (0%) | 2 | 1/4943 (0%) | 1 |
Colitis | 7/4949 (0.1%) | 9 | 4/4943 (0.1%) | 4 |
Colitis ischaemic | 3/4949 (0.1%) | 3 | 4/4943 (0.1%) | 4 |
Colitis microscopic | 1/4949 (0%) | 1 | 2/4943 (0%) | 2 |
Colitis ulcerative | 0/4949 (0%) | 0 | 2/4943 (0%) | 2 |
Constipation | 6/4949 (0.1%) | 6 | 6/4943 (0.1%) | 6 |
Crohn's disease | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Dental cyst | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Diabetic gastroparesis | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Diaphragmatic hernia | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Diarrhoea | 8/4949 (0.2%) | 8 | 10/4943 (0.2%) | 10 |
Diverticular perforation | 1/4949 (0%) | 1 | 1/4943 (0%) | 1 |
Diverticulum | 2/4949 (0%) | 2 | 5/4943 (0.1%) | 5 |
Diverticulum intestinal | 2/4949 (0%) | 2 | 5/4943 (0.1%) | 5 |
Diverticulum intestinal haemorrhagic | 3/4949 (0.1%) | 3 | 0/4943 (0%) | 0 |
Duodenal ulcer | 4/4949 (0.1%) | 4 | 3/4943 (0.1%) | 3 |
Duodenal ulcer haemorrhage | 3/4949 (0.1%) | 3 | 3/4943 (0.1%) | 3 |
Duodenitis | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Dyspepsia | 2/4949 (0%) | 2 | 1/4943 (0%) | 1 |
Dysphagia | 2/4949 (0%) | 2 | 2/4943 (0%) | 2 |
Enteritis | 3/4949 (0.1%) | 3 | 0/4943 (0%) | 0 |
Enterovesical fistula | 1/4949 (0%) | 1 | 1/4943 (0%) | 1 |
Erosive duodenitis | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Faecaloma | 2/4949 (0%) | 3 | 0/4943 (0%) | 0 |
Fistula of small intestine | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Food poisoning | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Gallstone ileus | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Gastric dilatation | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Gastric dysplasia | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Gastric haemorrhage | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Gastric polyps | 1/4949 (0%) | 1 | 2/4943 (0%) | 2 |
Gastric ulcer | 7/4949 (0.1%) | 7 | 6/4943 (0.1%) | 6 |
Gastric ulcer haemorrhage | 2/4949 (0%) | 3 | 8/4943 (0.2%) | 8 |
Gastritis | 17/4949 (0.3%) | 17 | 13/4943 (0.3%) | 13 |
Gastritis erosive | 1/4949 (0%) | 1 | 2/4943 (0%) | 2 |
Gastroduodenitis | 0/4949 (0%) | 0 | 2/4943 (0%) | 2 |
Gastrointestinal haemorrhage | 13/4949 (0.3%) | 14 | 12/4943 (0.2%) | 13 |
Gastrointestinal inflammation | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Gastrointestinal motility disorder | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Gastrointestinal mucocoele | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Gastrointestinal necrosis | 1/4949 (0%) | 1 | 1/4943 (0%) | 1 |
Gastrointestinal polyp | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Gastrointestinal polyp haemorrhage | 1/4949 (0%) | 1 | 1/4943 (0%) | 1 |
Gastrointestinal ulcer | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Gastrointestinal ulcer haemorrhage | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Gastrointestinal vascular malformation haemorrhagic | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Gastrooesophageal reflux disease | 6/4949 (0.1%) | 6 | 9/4943 (0.2%) | 9 |
Haematemesis | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Haematochezia | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Haemorrhagic erosive gastritis | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Haemorrhoidal haemorrhage | 1/4949 (0%) | 1 | 2/4943 (0%) | 2 |
Haemorrhoids | 2/4949 (0%) | 2 | 5/4943 (0.1%) | 5 |
Haemorrhoids thrombosed | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Hernial eventration | 0/4949 (0%) | 0 | 2/4943 (0%) | 2 |
Heyde's syndrome | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Hiatus hernia | 1/4949 (0%) | 1 | 7/4943 (0.1%) | 7 |
Ileus | 2/4949 (0%) | 2 | 1/4943 (0%) | 1 |
Ileus paralytic | 2/4949 (0%) | 2 | 1/4943 (0%) | 1 |
Impaired gastric emptying | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Incarcerated inguinal hernia | 2/4949 (0%) | 2 | 0/4943 (0%) | 0 |
Incarcerated umbilical hernia | 1/4949 (0%) | 1 | 1/4943 (0%) | 1 |
Inguinal hernia | 11/4949 (0.2%) | 11 | 17/4943 (0.3%) | 17 |
Intestinal haemorrhage | 1/4949 (0%) | 1 | 1/4943 (0%) | 2 |
Intestinal ischaemia | 1/4949 (0%) | 1 | 2/4943 (0%) | 2 |
Intestinal mass | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Intestinal obstruction | 14/4949 (0.3%) | 15 | 9/4943 (0.2%) | 9 |
Intestinal perforation | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Intestinal polyp | 1/4949 (0%) | 1 | 1/4943 (0%) | 1 |
Intestinal stenosis | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Intra-abdominal haemorrhage | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Intussusception | 0/4949 (0%) | 0 | 2/4943 (0%) | 2 |
Irritable bowel syndrome | 2/4949 (0%) | 3 | 0/4943 (0%) | 0 |
Large intestine perforation | 1/4949 (0%) | 1 | 1/4943 (0%) | 1 |
Large intestine polyp | 4/4949 (0.1%) | 4 | 4/4943 (0.1%) | 6 |
Lower gastrointestinal haemorrhage | 6/4949 (0.1%) | 6 | 6/4943 (0.1%) | 6 |
Mallory-weiss syndrome | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Mechanical ileus | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Megacolon | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Melaena | 3/4949 (0.1%) | 3 | 2/4943 (0%) | 2 |
Mesenteric arterial occlusion | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Mesenteric artery thrombosis | 2/4949 (0%) | 2 | 0/4943 (0%) | 0 |
Mouth haemorrhage | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Nausea | 2/4949 (0%) | 2 | 2/4943 (0%) | 2 |
Necrotising oesophagitis | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Obstructive pancreatitis | 2/4949 (0%) | 2 | 0/4943 (0%) | 0 |
Oesophageal achalasia | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Oesophageal spasm | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Oesophageal stenosis | 1/4949 (0%) | 1 | 2/4943 (0%) | 3 |
Oesophageal varices haemorrhage | 0/4949 (0%) | 0 | 3/4943 (0.1%) | 3 |
Oesophagitis | 2/4949 (0%) | 2 | 2/4943 (0%) | 2 |
Palatal disorder | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Pancreatic cyst | 2/4949 (0%) | 2 | 1/4943 (0%) | 1 |
Pancreatic pseudocyst | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Pancreatitis | 5/4949 (0.1%) | 5 | 9/4943 (0.2%) | 9 |
Pancreatitis acute | 8/4949 (0.2%) | 10 | 15/4943 (0.3%) | 15 |
Pancreatitis chronic | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Peptic ulcer | 3/4949 (0.1%) | 3 | 2/4943 (0%) | 2 |
Peritoneal adhesions | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Peritoneal haematoma | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Peritoneal hernia | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Portal venous gas | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Proctitis | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Rectal haemorrhage | 5/4949 (0.1%) | 5 | 5/4943 (0.1%) | 5 |
Rectal polyp | 0/4949 (0%) | 0 | 2/4943 (0%) | 2 |
Retroperitoneal haemorrhage | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Salivary gland calculus | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Small intestinal obstruction | 10/4949 (0.2%) | 12 | 5/4943 (0.1%) | 5 |
Spigelian hernia | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Strangulated umbilical hernia | 2/4949 (0%) | 2 | 1/4943 (0%) | 1 |
Thrombosis mesenteric vessel | 2/4949 (0%) | 2 | 0/4943 (0%) | 0 |
Umbilical hernia | 7/4949 (0.1%) | 7 | 3/4943 (0.1%) | 3 |
Umbilical hernia, obstructive | 2/4949 (0%) | 2 | 0/4943 (0%) | 0 |
Upper gastrointestinal haemorrhage | 10/4949 (0.2%) | 10 | 7/4943 (0.1%) | 7 |
Varices oesophageal | 1/4949 (0%) | 1 | 1/4943 (0%) | 3 |
Volvulus of small bowel | 1/4949 (0%) | 1 | 1/4943 (0%) | 1 |
Vomiting | 5/4949 (0.1%) | 5 | 6/4943 (0.1%) | 8 |
General disorders | ||||
Adverse drug reaction | 0/4949 (0%) | 0 | 3/4943 (0.1%) | 3 |
Asthenia | 5/4949 (0.1%) | 5 | 5/4943 (0.1%) | 6 |
Chest discomfort | 1/4949 (0%) | 1 | 1/4943 (0%) | 1 |
Chest pain | 14/4949 (0.3%) | 15 | 7/4943 (0.1%) | 7 |
Death | 9/4949 (0.2%) | 9 | 9/4943 (0.2%) | 9 |
Device intolerance | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Drug effect increased | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Drug intolerance | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Fatigue | 0/4949 (0%) | 0 | 3/4943 (0.1%) | 3 |
Gait disturbance | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
General physical health deterioration | 0/4949 (0%) | 0 | 4/4943 (0.1%) | 4 |
Generalised oedema | 4/4949 (0.1%) | 4 | 2/4943 (0%) | 2 |
Hernia perforation | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Hyperthermia | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Impaired healing | 5/4949 (0.1%) | 5 | 4/4943 (0.1%) | 4 |
Inflammation | 0/4949 (0%) | 0 | 2/4943 (0%) | 2 |
Malaise | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Metaplasia | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Multiple organ dysfunction syndrome | 4/4949 (0.1%) | 4 | 5/4943 (0.1%) | 5 |
Necrosis | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Non-cardiac chest pain | 37/4949 (0.7%) | 44 | 26/4943 (0.5%) | 28 |
Oedema peripheral | 7/4949 (0.1%) | 7 | 4/4943 (0.1%) | 4 |
Pain | 2/4949 (0%) | 2 | 1/4943 (0%) | 1 |
Peripheral swelling | 4/4949 (0.1%) | 4 | 0/4943 (0%) | 0 |
Pyrexia | 7/4949 (0.1%) | 7 | 7/4943 (0.1%) | 7 |
Strangulated hernia | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Sudden cardiac death | 2/4949 (0%) | 2 | 0/4943 (0%) | 0 |
Sudden death | 5/4949 (0.1%) | 5 | 3/4943 (0.1%) | 3 |
Systemic inflammatory response syndrome | 2/4949 (0%) | 2 | 2/4943 (0%) | 2 |
Vascular stent occlusion | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Vascular stent stenosis | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Hepatobiliary disorders | ||||
Acute hepatic failure | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Bile duct obstruction | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Bile duct stenosis | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Bile duct stone | 7/4949 (0.1%) | 7 | 8/4943 (0.2%) | 8 |
Biliary colic | 1/4949 (0%) | 1 | 1/4943 (0%) | 1 |
Biliary dyspepsia | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Cholangitis | 2/4949 (0%) | 2 | 6/4943 (0.1%) | 6 |
Cholangitis acute | 0/4949 (0%) | 0 | 3/4943 (0.1%) | 3 |
Cholangitis chronic | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Cholecystitis | 15/4949 (0.3%) | 15 | 25/4943 (0.5%) | 28 |
Cholecystitis acute | 17/4949 (0.3%) | 17 | 26/4943 (0.5%) | 27 |
Cholecystitis chronic | 2/4949 (0%) | 2 | 7/4943 (0.1%) | 7 |
Cholelithiasis | 49/4949 (1%) | 51 | 42/4943 (0.8%) | 43 |
Cholestasis | 3/4949 (0.1%) | 3 | 2/4943 (0%) | 2 |
Drug-induced liver injury | 2/4949 (0%) | 2 | 1/4943 (0%) | 1 |
Gallbladder cholesterolosis | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Gallbladder necrosis | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Gallbladder perforation | 1/4949 (0%) | 1 | 2/4943 (0%) | 2 |
Gallbladder polyp | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Hepatic cirrhosis | 4/4949 (0.1%) | 4 | 5/4943 (0.1%) | 5 |
Hepatic failure | 3/4949 (0.1%) | 3 | 1/4943 (0%) | 1 |
Hepatic mass | 1/4949 (0%) | 1 | 1/4943 (0%) | 1 |
Hepatic steatosis | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Hepatitis | 1/4949 (0%) | 2 | 0/4943 (0%) | 0 |
Hepatorenal syndrome | 1/4949 (0%) | 1 | 1/4943 (0%) | 1 |
Ischaemic hepatitis | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Jaundice | 1/4949 (0%) | 1 | 1/4943 (0%) | 1 |
Jaundice cholestatic | 3/4949 (0.1%) | 3 | 1/4943 (0%) | 1 |
Liver disorder | 1/4949 (0%) | 1 | 1/4943 (0%) | 1 |
Non-alcoholic fatty liver | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Non-alcoholic steatohepatitis | 1/4949 (0%) | 1 | 1/4943 (0%) | 1 |
Portal hypertension | 1/4949 (0%) | 1 | 1/4943 (0%) | 1 |
Portal vein thrombosis | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Post cholecystectomy syndrome | 1/4949 (0%) | 1 | 2/4943 (0%) | 2 |
Immune system disorders | ||||
Anaphylactic reaction | 2/4949 (0%) | 2 | 0/4943 (0%) | 0 |
Anti-neutrophil cytoplasmic antibody positive vasculitis | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Contrast media allergy | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Drug hypersensitivity | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Hypersensitivity | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Immunodeficiency | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Sarcoidosis | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Infections and infestations | ||||
Abdominal abscess | 2/4949 (0%) | 2 | 1/4943 (0%) | 1 |
Abscess | 1/4949 (0%) | 1 | 1/4943 (0%) | 1 |
Abscess intestinal | 1/4949 (0%) | 1 | 1/4943 (0%) | 1 |
Abscess limb | 3/4949 (0.1%) | 4 | 3/4943 (0.1%) | 4 |
Abscess neck | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Abscess oral | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Anal abscess | 4/4949 (0.1%) | 4 | 4/4943 (0.1%) | 4 |
Anal infection | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Aortitis salmonella | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Appendiceal abscess | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Appendicitis | 2/4949 (0%) | 2 | 6/4943 (0.1%) | 6 |
Appendicitis perforated | 1/4949 (0%) | 1 | 1/4943 (0%) | 1 |
Arthritis bacterial | 4/4949 (0.1%) | 4 | 1/4943 (0%) | 1 |
Arthritis infective | 4/4949 (0.1%) | 4 | 2/4943 (0%) | 2 |
Atypical pneumonia | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Bacteraemia | 6/4949 (0.1%) | 6 | 2/4943 (0%) | 2 |
Bacterial infection | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Biliary sepsis | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Brain abscess | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Breast abscess | 1/4949 (0%) | 1 | 1/4943 (0%) | 1 |
Breast cellulitis | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Bronchitis | 12/4949 (0.2%) | 12 | 13/4943 (0.3%) | 13 |
Bronchitis bacterial | 1/4949 (0%) | 1 | 1/4943 (0%) | 1 |
Bronchitis fungal | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Bronchitis viral | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Burn infection | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Campylobacter gastroenteritis | 2/4949 (0%) | 2 | 2/4943 (0%) | 2 |
Candida sepsis | 1/4949 (0%) | 1 | 1/4943 (0%) | 1 |
Candiduria | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Carbuncle | 2/4949 (0%) | 2 | 0/4943 (0%) | 0 |
Cellulitis | 42/4949 (0.8%) | 48 | 38/4943 (0.8%) | 39 |
Cellulitis streptococcal | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Cervicitis | 0/2282 (0%) | 0 | 1/2303 (0%) | 1 |
Cholecystitis infective | 2/4949 (0%) | 2 | 2/4943 (0%) | 2 |
Chronic hepatitis b | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Clostridium colitis | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Clostridium difficile colitis | 1/4949 (0%) | 1 | 5/4943 (0.1%) | 6 |
Clostridium difficile infection | 3/4949 (0.1%) | 3 | 2/4943 (0%) | 2 |
Corneal abscess | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Cystitis | 6/4949 (0.1%) | 6 | 3/4943 (0.1%) | 3 |
Cystitis escherichia | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Cytomegalovirus colitis | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Dengue fever | 3/4949 (0.1%) | 3 | 0/4943 (0%) | 0 |
Dengue haemorrhagic fever | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Device related infection | 3/4949 (0.1%) | 3 | 3/4943 (0.1%) | 6 |
Device related sepsis | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Diabetic foot infection | 5/4949 (0.1%) | 5 | 1/4943 (0%) | 1 |
Diabetic gangrene | 3/4949 (0.1%) | 3 | 1/4943 (0%) | 2 |
Diarrhoea infectious | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Diverticulitis | 10/4949 (0.2%) | 12 | 15/4943 (0.3%) | 17 |
Dysentery | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Echinococciasis | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Empyema | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Endocarditis | 2/4949 (0%) | 2 | 4/4943 (0.1%) | 5 |
Endocarditis bacterial | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Enterococcal sepsis | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Enterocolitis bacterial | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Epididymitis | 0/2667 (0%) | 0 | 4/2640 (0.2%) | 4 |
Erysipelas | 15/4949 (0.3%) | 18 | 11/4943 (0.2%) | 12 |
Escherichia bacteraemia | 0/4949 (0%) | 0 | 3/4943 (0.1%) | 3 |
Escherichia sepsis | 2/4949 (0%) | 2 | 0/4943 (0%) | 0 |
Escherichia urinary tract infection | 1/4949 (0%) | 1 | 2/4943 (0%) | 2 |
Extradural abscess | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Gallbladder abscess | 2/4949 (0%) | 2 | 0/4943 (0%) | 0 |
Gallbladder empyema | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Gangrene | 11/4949 (0.2%) | 11 | 8/4943 (0.2%) | 18 |
Gastroenteritis | 10/4949 (0.2%) | 10 | 21/4943 (0.4%) | 22 |
Gastroenteritis clostridial | 1/4949 (0%) | 1 | 2/4943 (0%) | 2 |
Gastroenteritis norovirus | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Gastroenteritis viral | 5/4949 (0.1%) | 5 | 2/4943 (0%) | 2 |
Gastrointestinal infection | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Genitourinary tract infection | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Groin abscess | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
H1n1 influenza | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Haematoma infection | 3/4949 (0.1%) | 3 | 2/4943 (0%) | 2 |
Helicobacter gastritis | 1/4949 (0%) | 1 | 1/4943 (0%) | 1 |
Helicobacter infection | 2/4949 (0%) | 2 | 0/4943 (0%) | 0 |
Hepatitis b | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Hepatitis c | 1/4949 (0%) | 1 | 1/4943 (0%) | 1 |
Hepatitis e | 1/4949 (0%) | 2 | 0/4943 (0%) | 0 |
Hepatitis infectious mononucleosis | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Herpes zoster | 5/4949 (0.1%) | 5 | 0/4943 (0%) | 0 |
Herpes zoster meningoencephalitis | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Herpes zoster pharyngitis | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Hydrocele male infected | 0/2667 (0%) | 0 | 1/2640 (0%) | 1 |
Implant site infection | 0/4949 (0%) | 0 | 2/4943 (0%) | 2 |
Infected skin ulcer | 3/4949 (0.1%) | 3 | 4/4943 (0.1%) | 4 |
Infection | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Infectious colitis | 1/4949 (0%) | 1 | 1/4943 (0%) | 1 |
Infective exacerbation of chronic obstructive airways disease | 6/4949 (0.1%) | 8 | 3/4943 (0.1%) | 3 |
Influenza | 8/4949 (0.2%) | 8 | 5/4943 (0.1%) | 5 |
Injection site abscess | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Intervertebral discitis | 1/4949 (0%) | 2 | 1/4943 (0%) | 1 |
Intestinal sepsis | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Joint abscess | 2/4949 (0%) | 2 | 1/4943 (0%) | 1 |
Kidney infection | 1/4949 (0%) | 1 | 1/4943 (0%) | 1 |
Labyrinthitis | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Laryngitis | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Liver abscess | 1/4949 (0%) | 1 | 4/4943 (0.1%) | 4 |
Localised infection | 8/4949 (0.2%) | 8 | 8/4943 (0.2%) | 8 |
Lower respiratory tract infection | 11/4949 (0.2%) | 12 | 12/4943 (0.2%) | 13 |
Lower respiratory tract infection bacterial | 1/4949 (0%) | 1 | 1/4943 (0%) | 1 |
Lower respiratory tract infection viral | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Lung abscess | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Lung infection | 1/4949 (0%) | 1 | 3/4943 (0.1%) | 3 |
Lymphangitis | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Mastitis | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Mastoiditis | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Mediastinitis | 1/4949 (0%) | 1 | 1/4943 (0%) | 1 |
Medical device site infection | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Medical device site joint infection | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Meningitis | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Meningitis aseptic | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Myiasis | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Necrotising fasciitis | 2/4949 (0%) | 2 | 1/4943 (0%) | 1 |
Neutropenic sepsis | 0/4949 (0%) | 0 | 2/4943 (0%) | 2 |
Oesophageal candidiasis | 1/4949 (0%) | 1 | 1/4943 (0%) | 1 |
Orchitis | 2/2667 (0.1%) | 2 | 3/2640 (0.1%) | 3 |
Osteomyelitis | 11/4949 (0.2%) | 13 | 10/4943 (0.2%) | 11 |
Osteomyelitis acute | 1/4949 (0%) | 1 | 2/4943 (0%) | 2 |
Osteomyelitis chronic | 0/4949 (0%) | 0 | 2/4943 (0%) | 2 |
Otitis externa | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Otitis media chronic | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Pancreatic abscess | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Paronychia | 0/4949 (0%) | 0 | 2/4943 (0%) | 2 |
Pelvic abscess | 1/4949 (0%) | 1 | 1/4943 (0%) | 1 |
Pelvic infection | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Perihepatic abscess | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Perineal abscess | 2/4949 (0%) | 2 | 0/4943 (0%) | 0 |
Periodontitis | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Perirectal abscess | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Peritonitis | 1/4949 (0%) | 1 | 3/4943 (0.1%) | 3 |
Pharyngeal abscess | 1/4949 (0%) | 1 | 1/4943 (0%) | 1 |
Pneumonia | 151/4949 (3.1%) | 174 | 135/4943 (2.7%) | 152 |
Pneumonia bacterial | 2/4949 (0%) | 2 | 2/4943 (0%) | 2 |
Pneumonia influenzal | 1/4949 (0%) | 1 | 1/4943 (0%) | 1 |
Pneumonia klebsiella | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Pneumonia legionella | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Pneumonia streptococcal | 2/4949 (0%) | 2 | 1/4943 (0%) | 1 |
Pneumonia viral | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Post procedural infection | 2/4949 (0%) | 2 | 3/4943 (0.1%) | 3 |
Post procedural pneumonia | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Post procedural sepsis | 1/4949 (0%) | 1 | 2/4943 (0%) | 2 |
Postoperative abscess | 1/4949 (0%) | 1 | 1/4943 (0%) | 1 |
Postoperative wound infection | 3/4949 (0.1%) | 3 | 7/4943 (0.1%) | 7 |
Pseudomonal sepsis | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Pulmonary mycosis | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Pulmonary sepsis | 2/4949 (0%) | 2 | 4/4943 (0.1%) | 4 |
Pulmonary tuberculosis | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Pyelitis | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Pyelonephritis | 15/4949 (0.3%) | 15 | 8/4943 (0.2%) | 8 |
Pyelonephritis acute | 8/4949 (0.2%) | 8 | 7/4943 (0.1%) | 7 |
Pyelonephritis chronic | 1/4949 (0%) | 1 | 1/4943 (0%) | 1 |
Pyonephrosis | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Renal abscess | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Renal cyst infection | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Respiratory syncytial virus infection | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Respiratory tract infection | 2/4949 (0%) | 2 | 3/4943 (0.1%) | 3 |
Salmonella sepsis | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Salmonellosis | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Scrotal infection | 1/2667 (0%) | 1 | 0/2640 (0%) | 0 |
Sepsis | 35/4949 (0.7%) | 37 | 30/4943 (0.6%) | 33 |
Septic shock | 22/4949 (0.4%) | 24 | 15/4943 (0.3%) | 16 |
Sinusitis | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Skin graft infection | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Skin infection | 2/4949 (0%) | 2 | 1/4943 (0%) | 1 |
Soft tissue infection | 3/4949 (0.1%) | 3 | 0/4943 (0%) | 0 |
Staphylococcal bacteraemia | 3/4949 (0.1%) | 3 | 0/4943 (0%) | 0 |
Staphylococcal infection | 1/4949 (0%) | 1 | 2/4943 (0%) | 2 |
Staphylococcal mediastinitis | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Staphylococcal sepsis | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Staphylococcal skin infection | 2/4949 (0%) | 2 | 0/4943 (0%) | 0 |
Streptococcal bacteraemia | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Subcutaneous abscess | 2/4949 (0%) | 2 | 3/4943 (0.1%) | 3 |
Subdiaphragmatic abscess | 0/4949 (0%) | 0 | 1/4943 (0%) | 3 |
Systemic candida | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Tooth abscess | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Tracheobronchitis | 1/4949 (0%) | 1 | 1/4943 (0%) | 1 |
Tuberculosis | 2/4949 (0%) | 3 | 0/4943 (0%) | 0 |
Tuberculosis gastrointestinal | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Upper respiratory tract infection | 5/4949 (0.1%) | 5 | 2/4943 (0%) | 2 |
Urinary tract infection | 61/4949 (1.2%) | 65 | 64/4943 (1.3%) | 78 |
Urinary tract infection bacterial | 0/4949 (0%) | 0 | 2/4943 (0%) | 2 |
Urinary tract infection pseudomonal | 2/4949 (0%) | 2 | 0/4943 (0%) | 0 |
Urosepsis | 19/4949 (0.4%) | 20 | 24/4943 (0.5%) | 26 |
Vestibular neuronitis | 3/4949 (0.1%) | 3 | 4/4943 (0.1%) | 4 |
Viraemia | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Viral infection | 3/4949 (0.1%) | 3 | 0/4943 (0%) | 0 |
Viral myocarditis | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Wound infection | 5/4949 (0.1%) | 5 | 1/4943 (0%) | 1 |
Wound sepsis | 3/4949 (0.1%) | 3 | 1/4943 (0%) | 1 |
Injury, poisoning and procedural complications | ||||
Accident | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Accident at work | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Accidental overdose | 2/4949 (0%) | 2 | 8/4943 (0.2%) | 8 |
Acetabulum fracture | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Alcohol poisoning | 3/4949 (0.1%) | 3 | 1/4943 (0%) | 1 |
Anaemia postoperative | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Anastomotic complication | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Anastomotic leak | 0/4949 (0%) | 0 | 2/4943 (0%) | 2 |
Ankle fracture | 20/4949 (0.4%) | 20 | 21/4943 (0.4%) | 21 |
Arterial injury | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Arteriovenous fistula occlusion | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Arthropod bite | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Back injury | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Brain contusion | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Burns second degree | 1/4949 (0%) | 1 | 1/4943 (0%) | 1 |
Burns third degree | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Carbon monoxide poisoning | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Cartilage injury | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Cervical vertebral fracture | 1/4949 (0%) | 1 | 4/4943 (0.1%) | 4 |
Chemical poisoning | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Clavicle fracture | 2/4949 (0%) | 2 | 2/4943 (0%) | 2 |
Concussion | 2/4949 (0%) | 2 | 4/4943 (0.1%) | 4 |
Contusion | 3/4949 (0.1%) | 3 | 6/4943 (0.1%) | 6 |
Coronary vascular graft occlusion | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Craniocerebral injury | 4/4949 (0.1%) | 4 | 7/4943 (0.1%) | 7 |
Craniofacial fracture | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Deep vein thrombosis postoperative | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Delayed recovery from anaesthesia | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Facial bones fracture | 1/4949 (0%) | 1 | 1/4943 (0%) | 1 |
Failure to anastomose | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Fall | 124/4949 (2.5%) | 137 | 110/4943 (2.2%) | 123 |
Femoral neck fracture | 7/4949 (0.1%) | 7 | 4/4943 (0.1%) | 4 |
Femur fracture | 21/4949 (0.4%) | 22 | 18/4943 (0.4%) | 18 |
Fibula fracture | 3/4949 (0.1%) | 3 | 5/4943 (0.1%) | 5 |
Foot fracture | 4/4949 (0.1%) | 4 | 3/4943 (0.1%) | 3 |
Forearm fracture | 2/4949 (0%) | 2 | 1/4943 (0%) | 1 |
Foreign body | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Foreign body aspiration | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Foreign body in gastrointestinal tract | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Gastroenteritis radiation | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Gastrointestinal injury | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Gastrointestinal stoma complication | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Graft thrombosis | 1/4949 (0%) | 1 | 1/4943 (0%) | 1 |
Gun shot wound | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Hand fracture | 2/4949 (0%) | 2 | 1/4943 (0%) | 1 |
Head injury | 2/4949 (0%) | 2 | 2/4943 (0%) | 2 |
Hip fracture | 17/4949 (0.3%) | 17 | 12/4943 (0.2%) | 12 |
Humerus fracture | 20/4949 (0.4%) | 20 | 12/4943 (0.2%) | 12 |
Hyphaema | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Incisional hernia | 6/4949 (0.1%) | 7 | 6/4943 (0.1%) | 6 |
Incisional hernia, obstructive | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Intentional overdose | 1/4949 (0%) | 3 | 0/4943 (0%) | 0 |
Intestinal anastomosis complication | 0/4949 (0%) | 0 | 2/4943 (0%) | 4 |
Jaw fracture | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Joint dislocation | 4/4949 (0.1%) | 6 | 5/4943 (0.1%) | 5 |
Joint injury | 3/4949 (0.1%) | 3 | 1/4943 (0%) | 1 |
Laceration | 2/4949 (0%) | 2 | 4/4943 (0.1%) | 4 |
Ligament rupture | 1/4949 (0%) | 1 | 2/4943 (0%) | 2 |
Ligament sprain | 0/4949 (0%) | 0 | 3/4943 (0.1%) | 3 |
Limb crushing injury | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Limb injury | 2/4949 (0%) | 2 | 5/4943 (0.1%) | 5 |
Lower limb fracture | 2/4949 (0%) | 2 | 5/4943 (0.1%) | 5 |
Lumbar vertebral fracture | 2/4949 (0%) | 2 | 2/4943 (0%) | 2 |
Lumbosacral plexus injury | 0/4949 (0%) | 0 | 1/4943 (0%) | 2 |
Meniscus injury | 4/4949 (0.1%) | 4 | 12/4943 (0.2%) | 12 |
Multiple fractures | 1/4949 (0%) | 1 | 3/4943 (0.1%) | 3 |
Multiple injuries | 3/4949 (0.1%) | 3 | 2/4943 (0%) | 2 |
Muscle rupture | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Muscle strain | 2/4949 (0%) | 2 | 1/4943 (0%) | 1 |
Overdose | 0/4949 (0%) | 0 | 2/4943 (0%) | 2 |
Patella fracture | 3/4949 (0.1%) | 3 | 1/4943 (0%) | 1 |
Pelvic fracture | 2/4949 (0%) | 2 | 6/4943 (0.1%) | 6 |
Periprosthetic fracture | 0/4949 (0%) | 0 | 2/4943 (0%) | 2 |
Pneumothorax traumatic | 2/4949 (0%) | 2 | 0/4943 (0%) | 0 |
Post concussion syndrome | 2/4949 (0%) | 2 | 0/4943 (0%) | 0 |
Post procedural bile leak | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Post procedural complication | 3/4949 (0.1%) | 3 | 2/4943 (0%) | 2 |
Post procedural discharge | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Post procedural haematoma | 2/4949 (0%) | 2 | 0/4943 (0%) | 0 |
Post procedural haematuria | 2/4949 (0%) | 2 | 0/4943 (0%) | 0 |
Post procedural haemorrhage | 1/4949 (0%) | 1 | 7/4943 (0.1%) | 7 |
Post procedural swelling | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Post-traumatic pain | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Postoperative adhesion | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Postoperative delirium | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Postoperative thoracic procedure complication | 0/4949 (0%) | 0 | 2/4943 (0%) | 3 |
Postoperative wound complication | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Procedural hypotension | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Procedural pain | 2/4949 (0%) | 2 | 0/4943 (0%) | 0 |
Pubis fracture | 3/4949 (0.1%) | 3 | 2/4943 (0%) | 2 |
Radiation pneumonitis | 2/4949 (0%) | 2 | 1/4943 (0%) | 1 |
Radius fracture | 6/4949 (0.1%) | 6 | 8/4943 (0.2%) | 8 |
Rib fracture | 14/4949 (0.3%) | 14 | 10/4943 (0.2%) | 10 |
Road traffic accident | 9/4949 (0.2%) | 10 | 13/4943 (0.3%) | 13 |
Scapula fracture | 0/4949 (0%) | 0 | 3/4943 (0.1%) | 3 |
Sciatic nerve injury | 2/4949 (0%) | 2 | 0/4943 (0%) | 0 |
Scrotal haematoma | 1/2667 (0%) | 1 | 0/2640 (0%) | 0 |
Skin injury | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Skull fracture | 1/4949 (0%) | 1 | 1/4943 (0%) | 1 |
Skull fractured base | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Soft tissue injury | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Spinal compression fracture | 1/4949 (0%) | 1 | 4/4943 (0.1%) | 4 |
Spinal cord injury cervical | 2/4949 (0%) | 2 | 0/4943 (0%) | 0 |
Spinal fracture | 3/4949 (0.1%) | 3 | 2/4943 (0%) | 2 |
Splenic rupture | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Stab wound | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Sternal fracture | 1/4949 (0%) | 1 | 1/4943 (0%) | 1 |
Stoma site haemorrhage | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Subarachnoid haemorrhage | 2/4949 (0%) | 2 | 7/4943 (0.1%) | 7 |
Subdural haematoma | 7/4949 (0.1%) | 7 | 7/4943 (0.1%) | 8 |
Subdural haemorrhage | 2/4949 (0%) | 2 | 0/4943 (0%) | 0 |
Suture rupture | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Tendon injury | 0/4949 (0%) | 0 | 3/4943 (0.1%) | 3 |
Tendon rupture | 3/4949 (0.1%) | 4 | 3/4943 (0.1%) | 3 |
Thermal burn | 2/4949 (0%) | 2 | 0/4943 (0%) | 0 |
Thoracic vertebral fracture | 4/4949 (0.1%) | 4 | 4/4943 (0.1%) | 4 |
Tibia fracture | 8/4949 (0.2%) | 8 | 4/4943 (0.1%) | 4 |
Tongue injury | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Toxicity to various agents | 4/4949 (0.1%) | 4 | 1/4943 (0%) | 1 |
Transfusion-related acute lung injury | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Traumatic fracture | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Traumatic haematoma | 1/4949 (0%) | 1 | 3/4943 (0.1%) | 3 |
Traumatic haemothorax | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Traumatic intracranial haemorrhage | 2/4949 (0%) | 2 | 2/4943 (0%) | 2 |
Ulna fracture | 1/4949 (0%) | 1 | 2/4943 (0%) | 2 |
Upper limb fracture | 1/4949 (0%) | 1 | 5/4943 (0.1%) | 5 |
Vascular graft occlusion | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Vascular pseudoaneurysm | 3/4949 (0.1%) | 3 | 4/4943 (0.1%) | 4 |
Wound | 0/4949 (0%) | 0 | 1/4943 (0%) | 2 |
Wound dehiscence | 1/4949 (0%) | 1 | 1/4943 (0%) | 1 |
Wound secretion | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Wrist fracture | 5/4949 (0.1%) | 5 | 2/4943 (0%) | 2 |
Investigations | ||||
Amylase increased | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Anticoagulation drug level above therapeutic | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Blood calcitonin increased | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Blood calcium increased | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Blood creatinine increased | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Blood glucose decreased | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Blood glucose fluctuation | 0/4949 (0%) | 0 | 3/4943 (0.1%) | 3 |
Blood glucose increased | 4/4949 (0.1%) | 4 | 5/4943 (0.1%) | 6 |
Blood pressure increased | 1/4949 (0%) | 1 | 1/4943 (0%) | 1 |
C-reactive protein increased | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Coagulation test abnormal | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Electrocardiogram abnormal | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Gamma-glutamyltransferase increased | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Glomerular filtration rate decreased | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Glycosylated haemoglobin increased | 2/4949 (0%) | 2 | 2/4943 (0%) | 2 |
Haemoglobin decreased | 2/4949 (0%) | 2 | 0/4943 (0%) | 0 |
Hepatic enzyme increased | 1/4949 (0%) | 1 | 1/4943 (0%) | 1 |
Oxygen saturation decreased | 1/4949 (0%) | 1 | 1/4943 (0%) | 1 |
Transaminases increased | 1/4949 (0%) | 1 | 1/4943 (0%) | 1 |
Troponin increased | 0/4949 (0%) | 0 | 2/4943 (0%) | 2 |
Troponin t increased | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Urine albumin/creatinine ratio increased | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Weight decreased | 4/4949 (0.1%) | 4 | 0/4943 (0%) | 0 |
Metabolism and nutrition disorders | ||||
Abnormal loss of weight | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Cachexia | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Decreased appetite | 2/4949 (0%) | 2 | 1/4943 (0%) | 1 |
Dehydration | 14/4949 (0.3%) | 15 | 23/4943 (0.5%) | 24 |
Diabetes mellitus | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Diabetes mellitus inadequate control | 3/4949 (0.1%) | 3 | 4/4943 (0.1%) | 4 |
Diabetic ketoacidosis | 2/4949 (0%) | 2 | 6/4943 (0.1%) | 6 |
Electrolyte imbalance | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Failure to thrive | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Fluid overload | 1/4949 (0%) | 1 | 2/4943 (0%) | 2 |
Food intolerance | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Gout | 4/4949 (0.1%) | 4 | 4/4943 (0.1%) | 4 |
Hypercalcaemia | 2/4949 (0%) | 2 | 1/4943 (0%) | 1 |
Hyperglycaemia | 67/4949 (1.4%) | 75 | 46/4943 (0.9%) | 52 |
Hyperglycaemic hyperosmolar nonketotic syndrome | 2/4949 (0%) | 2 | 2/4943 (0%) | 2 |
Hyperkalaemia | 12/4949 (0.2%) | 12 | 8/4943 (0.2%) | 9 |
Hyperosmolar state | 1/4949 (0%) | 1 | 1/4943 (0%) | 1 |
Hypocalcaemia | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Hypoglycaemia | 72/4949 (1.5%) | 80 | 62/4943 (1.3%) | 69 |
Hypokalaemia | 5/4949 (0.1%) | 5 | 6/4943 (0.1%) | 6 |
Hypomagnesaemia | 0/4949 (0%) | 0 | 2/4943 (0%) | 2 |
Hyponatraemia | 11/4949 (0.2%) | 12 | 8/4943 (0.2%) | 8 |
Iron deficiency | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Ketoacidosis | 1/4949 (0%) | 1 | 1/4943 (0%) | 1 |
Lactic acidosis | 3/4949 (0.1%) | 3 | 0/4943 (0%) | 0 |
Metabolic acidosis | 3/4949 (0.1%) | 3 | 1/4943 (0%) | 1 |
Obesity | 5/4949 (0.1%) | 5 | 5/4943 (0.1%) | 5 |
Type 2 diabetes mellitus | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Musculoskeletal and connective tissue disorders | ||||
Arthralgia | 6/4949 (0.1%) | 6 | 9/4943 (0.2%) | 9 |
Arthritis | 7/4949 (0.1%) | 7 | 6/4943 (0.1%) | 6 |
Arthritis reactive | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Arthrofibrosis | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Arthropathy | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Articular calcification | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Back pain | 9/4949 (0.2%) | 10 | 6/4943 (0.1%) | 6 |
Bone lesion | 1/4949 (0%) | 1 | 1/4943 (0%) | 1 |
Bursitis | 2/4949 (0%) | 2 | 2/4943 (0%) | 2 |
Cervical spinal stenosis | 2/4949 (0%) | 2 | 5/4943 (0.1%) | 5 |
Chondrocalcinosis pyrophosphate | 1/4949 (0%) | 1 | 1/4943 (0%) | 2 |
Chondromalacia | 0/4949 (0%) | 0 | 1/4943 (0%) | 2 |
Chondropathy | 3/4949 (0.1%) | 3 | 0/4943 (0%) | 0 |
Costochondritis | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Diabetic amyotrophy | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Diabetic arthropathy | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Dupuytren's contracture | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Exostosis | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Fistula | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Foot deformity | 0/4949 (0%) | 0 | 2/4943 (0%) | 2 |
Fracture malunion | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Gouty arthritis | 3/4949 (0.1%) | 3 | 0/4943 (0%) | 0 |
Gouty tophus | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Intervertebral disc degeneration | 3/4949 (0.1%) | 3 | 0/4943 (0%) | 0 |
Intervertebral disc disorder | 2/4949 (0%) | 2 | 3/4943 (0.1%) | 3 |
Intervertebral disc protrusion | 21/4949 (0.4%) | 22 | 15/4943 (0.3%) | 16 |
Joint ankylosis | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Joint noise | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Joint swelling | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Lumbar spinal stenosis | 11/4949 (0.2%) | 14 | 10/4943 (0.2%) | 10 |
Mobility decreased | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Muscle haemorrhage | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Muscle spasms | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Muscular weakness | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Musculoskeletal chest pain | 6/4949 (0.1%) | 6 | 10/4943 (0.2%) | 10 |
Musculoskeletal pain | 3/4949 (0.1%) | 3 | 2/4943 (0%) | 2 |
Myalgia | 2/4949 (0%) | 2 | 0/4943 (0%) | 0 |
Neck pain | 2/4949 (0%) | 2 | 0/4943 (0%) | 0 |
Neuropathic arthropathy | 2/4949 (0%) | 2 | 0/4943 (0%) | 0 |
Osteitis deformans | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Osteoarthritis | 110/4949 (2.2%) | 128 | 136/4943 (2.8%) | 155 |
Osteochondrosis | 0/4949 (0%) | 0 | 4/4943 (0.1%) | 4 |
Osteonecrosis | 3/4949 (0.1%) | 3 | 4/4943 (0.1%) | 4 |
Osteopenia | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Osteoporosis | 1/4949 (0%) | 1 | 1/4943 (0%) | 1 |
Pain in extremity | 3/4949 (0.1%) | 3 | 2/4943 (0%) | 2 |
Patellofemoral pain syndrome | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Pathological fracture | 0/4949 (0%) | 0 | 2/4943 (0%) | 2 |
Periarthritis | 1/4949 (0%) | 1 | 3/4943 (0.1%) | 3 |
Plantar fascial fibromatosis | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Polymyalgia rheumatica | 2/4949 (0%) | 2 | 0/4943 (0%) | 0 |
Pseudarthrosis | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Rhabdomyolysis | 0/4949 (0%) | 0 | 2/4943 (0%) | 2 |
Rheumatic disorder | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Rheumatoid arthritis | 2/4949 (0%) | 2 | 3/4943 (0.1%) | 3 |
Rotator cuff syndrome | 10/4949 (0.2%) | 11 | 8/4943 (0.2%) | 8 |
Spinal column stenosis | 7/4949 (0.1%) | 7 | 13/4943 (0.3%) | 13 |
Spinal osteoarthritis | 21/4949 (0.4%) | 23 | 16/4943 (0.3%) | 19 |
Spinal pain | 4/4949 (0.1%) | 4 | 5/4943 (0.1%) | 5 |
Spondylitis | 2/4949 (0%) | 2 | 1/4943 (0%) | 1 |
Spondyloarthropathy | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Spondylolisthesis | 3/4949 (0.1%) | 3 | 6/4943 (0.1%) | 6 |
Spondylolysis | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Synovial cyst | 1/4949 (0%) | 1 | 2/4943 (0%) | 2 |
Synovitis | 0/4949 (0%) | 0 | 2/4943 (0%) | 2 |
Tendon disorder | 1/4949 (0%) | 1 | 1/4943 (0%) | 1 |
Tendonitis | 1/4949 (0%) | 1 | 1/4943 (0%) | 1 |
Tenosynovitis | 0/4949 (0%) | 0 | 1/4943 (0%) | 2 |
Vertebral foraminal stenosis | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Vertebral osteophyte | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
Acute myeloid leukaemia | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Adenocarcinoma | 0/4949 (0%) | 0 | 2/4943 (0%) | 2 |
Adenocarcinoma gastric | 10/4949 (0.2%) | 11 | 7/4943 (0.1%) | 7 |
Adenocarcinoma of colon | 14/4949 (0.3%) | 14 | 17/4943 (0.3%) | 17 |
Adenocarcinoma of the cervix | 1/2282 (0%) | 1 | 1/2303 (0%) | 1 |
Adenocarcinoma pancreas | 0/4949 (0%) | 0 | 4/4943 (0.1%) | 4 |
Adenoma benign | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Adenosquamous cell carcinoma | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Adrenal adenoma | 3/4949 (0.1%) | 3 | 3/4943 (0.1%) | 3 |
Adrenal neoplasm | 1/4949 (0%) | 1 | 2/4943 (0%) | 2 |
Anal squamous cell carcinoma | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Anaplastic astrocytoma | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Anogenital warts | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Astrocytoma | 1/4949 (0%) | 2 | 0/4943 (0%) | 0 |
B-cell lymphoma | 1/4949 (0%) | 1 | 2/4943 (0%) | 2 |
B-cell lymphoma stage i | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
B-cell lymphoma stage ii | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
B-cell small lymphocytic lymphoma | 0/4949 (0%) | 0 | 2/4943 (0%) | 2 |
Basal cell carcinoma | 11/4949 (0.2%) | 11 | 7/4943 (0.1%) | 7 |
Benign gastric neoplasm | 0/4949 (0%) | 0 | 1/4943 (0%) | 2 |
Benign hepatic neoplasm | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Benign neoplasm of adrenal gland | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Benign neoplasm of thyroid gland | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Bile duct adenocarcinoma | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Bile duct cancer | 0/4949 (0%) | 0 | 3/4943 (0.1%) | 3 |
Biliary cancer metastatic | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Bladder cancer | 6/4949 (0.1%) | 6 | 5/4943 (0.1%) | 5 |
Bladder cancer recurrent | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Bladder neoplasm | 5/4949 (0.1%) | 5 | 1/4943 (0%) | 1 |
Bladder papilloma | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Bladder transitional cell carcinoma | 6/4949 (0.1%) | 6 | 3/4943 (0.1%) | 3 |
Bladder transitional cell carcinoma recurrent | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Bladder transitional cell carcinoma stage i | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Bone cancer | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Bone cancer metastatic | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Bone neoplasm | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Borderline ovarian tumour | 0/2282 (0%) | 0 | 1/2303 (0%) | 1 |
Bowen's disease | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Brain neoplasm | 3/4949 (0.1%) | 3 | 1/4943 (0%) | 1 |
Brain neoplasm malignant | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Breast cancer | 8/4949 (0.2%) | 8 | 11/4943 (0.2%) | 11 |
Breast cancer metastatic | 3/4949 (0.1%) | 3 | 2/4943 (0%) | 2 |
Breast cancer recurrent | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Breast cancer stage iii | 1/4949 (0%) | 1 | 1/4943 (0%) | 1 |
Brenner tumour | 0/2282 (0%) | 0 | 1/2303 (0%) | 1 |
Bronchial carcinoma | 0/4949 (0%) | 0 | 2/4943 (0%) | 2 |
Cancer pain | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Carcinoid tumour pulmonary | 0/4949 (0%) | 0 | 2/4943 (0%) | 2 |
Cardiac myxoma | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Cerebral haemangioma | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Cervix carcinoma | 2/2282 (0.1%) | 2 | 4/2303 (0.2%) | 4 |
Cervix carcinoma stage 0 | 2/2282 (0.1%) | 2 | 0/2303 (0%) | 0 |
Cholangiocarcinoma | 2/4949 (0%) | 3 | 4/4943 (0.1%) | 4 |
Chronic lymphocytic leukaemia | 1/4949 (0%) | 1 | 4/4943 (0.1%) | 4 |
Chronic myeloid leukaemia | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Clear cell renal cell carcinoma | 3/4949 (0.1%) | 3 | 6/4943 (0.1%) | 6 |
Colon adenoma | 8/4949 (0.2%) | 9 | 5/4943 (0.1%) | 5 |
Colon cancer | 5/4949 (0.1%) | 5 | 6/4943 (0.1%) | 6 |
Colon cancer metastatic | 0/4949 (0%) | 0 | 2/4943 (0%) | 2 |
Colon cancer stage ii | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Colon cancer stage iv | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Colon neoplasm | 3/4949 (0.1%) | 3 | 0/4943 (0%) | 0 |
Colorectal adenocarcinoma | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Colorectal cancer | 0/4949 (0%) | 0 | 2/4943 (0%) | 2 |
Colorectal cancer metastatic | 1/4949 (0%) | 1 | 1/4943 (0%) | 1 |
Diffuse large b-cell lymphoma | 2/4949 (0%) | 2 | 3/4943 (0.1%) | 3 |
Diffuse large b-cell lymphoma stage iv | 0/4949 (0%) | 0 | 2/4943 (0%) | 2 |
Ductal adenocarcinoma of pancreas | 1/4949 (0%) | 1 | 1/4943 (0%) | 1 |
Endometrial adenocarcinoma | 9/2282 (0.4%) | 9 | 6/2303 (0.3%) | 7 |
Endometrial cancer | 1/2282 (0%) | 1 | 3/2303 (0.1%) | 3 |
Extranodal marginal zone b-cell lymphoma (malt type) | 0/4949 (0%) | 0 | 2/4943 (0%) | 2 |
Fibroadenoma of breast | 1/4949 (0%) | 1 | 1/4943 (0%) | 1 |
Fibrosarcoma | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Gallbladder cancer metastatic | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Gallbladder squamous cell carcinoma | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Gastric cancer | 4/4949 (0.1%) | 4 | 6/4943 (0.1%) | 6 |
Gastric neoplasm | 3/4949 (0.1%) | 3 | 1/4943 (0%) | 1 |
Gastrointestinal stromal cancer | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Gastrointestinal stromal tumour | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Glioblastoma | 2/4949 (0%) | 2 | 0/4943 (0%) | 0 |
Hepatic angiosarcoma | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Hepatic cancer | 5/4949 (0.1%) | 5 | 2/4943 (0%) | 2 |
Hepatic cancer metastatic | 1/4949 (0%) | 1 | 2/4943 (0%) | 2 |
Hepatic neoplasm | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Hepatocellular carcinoma | 6/4949 (0.1%) | 6 | 1/4943 (0%) | 1 |
Hodgkin's disease | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Huerthle cell carcinoma | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Intraductal proliferative breast lesion | 1/4949 (0%) | 1 | 1/4943 (0%) | 1 |
Invasive breast carcinoma | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Invasive ductal breast carcinoma | 11/4949 (0.2%) | 11 | 7/4943 (0.1%) | 7 |
Invasive lobular breast carcinoma | 1/4949 (0%) | 1 | 1/4943 (0%) | 1 |
Keratoacanthoma | 1/4949 (0%) | 1 | 2/4943 (0%) | 2 |
Large intestine benign neoplasm | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Laryngeal cancer | 2/4949 (0%) | 2 | 1/4943 (0%) | 1 |
Laryngeal squamous cell carcinoma | 3/4949 (0.1%) | 3 | 1/4943 (0%) | 1 |
Leiomyosarcoma | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Leiomyosarcoma metastatic | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Lip squamous cell carcinoma | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Lipoma | 1/4949 (0%) | 1 | 1/4943 (0%) | 1 |
Liposarcoma | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Liposarcoma metastatic | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Lung adenocarcinoma | 8/4949 (0.2%) | 8 | 6/4943 (0.1%) | 7 |
Lung adenocarcinoma stage ii | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Lung adenocarcinoma stage iii | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Lung adenocarcinoma stage iv | 0/4949 (0%) | 0 | 2/4943 (0%) | 2 |
Lung cancer metastatic | 3/4949 (0.1%) | 3 | 3/4943 (0.1%) | 3 |
Lung neoplasm | 2/4949 (0%) | 2 | 0/4943 (0%) | 0 |
Lung neoplasm malignant | 6/4949 (0.1%) | 6 | 9/4943 (0.2%) | 9 |
Lymphoma | 2/4949 (0%) | 2 | 2/4943 (0%) | 3 |
Malignant joint neoplasm | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Malignant melanoma | 5/4949 (0.1%) | 5 | 5/4943 (0.1%) | 5 |
Malignant melanoma stage iii | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Malignant neoplasm of ampulla of vater | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Malignant pleural effusion | 2/4949 (0%) | 2 | 0/4943 (0%) | 0 |
Mediastinum neoplasm | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Medullary thyroid cancer | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Meningeal neoplasm | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Meningioma | 1/4949 (0%) | 1 | 2/4943 (0%) | 2 |
Mesothelioma | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Mesothelioma malignant | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Metastases to adrenals | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Metastases to bone | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Metastases to central nervous system | 2/4949 (0%) | 2 | 1/4943 (0%) | 1 |
Metastases to chest wall | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Metastases to kidney | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Metastases to liver | 4/4949 (0.1%) | 4 | 7/4943 (0.1%) | 7 |
Metastases to lung | 6/4949 (0.1%) | 6 | 1/4943 (0%) | 1 |
Metastases to lymph nodes | 4/4949 (0.1%) | 4 | 1/4943 (0%) | 1 |
Metastases to pelvis | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Metastases to peritoneum | 1/4949 (0%) | 1 | 3/4943 (0.1%) | 3 |
Metastases to pleura | 1/4949 (0%) | 2 | 0/4943 (0%) | 0 |
Metastatic bronchial carcinoma | 1/4949 (0%) | 1 | 1/4943 (0%) | 1 |
Metastatic gastric cancer | 0/4949 (0%) | 0 | 2/4943 (0%) | 2 |
Metastatic neoplasm | 5/4949 (0.1%) | 5 | 2/4943 (0%) | 2 |
Metastatic renal cell carcinoma | 1/4949 (0%) | 1 | 1/4943 (0%) | 1 |
Myelodysplastic syndrome | 0/4949 (0%) | 0 | 3/4943 (0.1%) | 3 |
Nasal sinus cancer | 0/4949 (0%) | 0 | 2/4943 (0%) | 2 |
Neoplasm | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Neoplasm malignant | 2/4949 (0%) | 2 | 0/4943 (0%) | 0 |
Neoplasm prostate | 0/2667 (0%) | 0 | 3/2640 (0.1%) | 3 |
Neuroendocrine carcinoma | 2/4949 (0%) | 2 | 1/4943 (0%) | 1 |
Neuroendocrine carcinoma of the skin | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Neuroendocrine tumour | 2/4949 (0%) | 2 | 1/4943 (0%) | 1 |
Non-hodgkin's lymphoma | 1/4949 (0%) | 1 | 1/4943 (0%) | 1 |
Non-small cell lung cancer | 3/4949 (0.1%) | 3 | 0/4943 (0%) | 0 |
Non-small cell lung cancer metastatic | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Non-small cell lung cancer stage ii | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Non-small cell lung cancer stage iv | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Oesophageal adenocarcinoma | 3/4949 (0.1%) | 3 | 2/4943 (0%) | 2 |
Oesophageal carcinoma | 3/4949 (0.1%) | 3 | 3/4943 (0.1%) | 3 |
Oesophageal squamous cell carcinoma | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Ovarian adenoma | 2/2282 (0.1%) | 2 | 0/2303 (0%) | 0 |
Ovarian cancer | 2/2282 (0.1%) | 2 | 0/2303 (0%) | 0 |
Ovarian cancer metastatic | 1/2282 (0%) | 1 | 0/2303 (0%) | 0 |
Ovarian cancer stage iii | 1/2282 (0%) | 1 | 0/2303 (0%) | 0 |
Ovarian epithelial cancer | 0/2282 (0%) | 0 | 2/2303 (0.1%) | 2 |
Pancreatic carcinoma | 5/4949 (0.1%) | 5 | 8/4943 (0.2%) | 8 |
Pancreatic carcinoma metastatic | 5/4949 (0.1%) | 5 | 4/4943 (0.1%) | 4 |
Pancreatic neoplasm | 0/4949 (0%) | 0 | 2/4943 (0%) | 2 |
Papillary thyroid cancer | 0/4949 (0%) | 0 | 4/4943 (0.1%) | 4 |
Paraganglion neoplasm | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Parathyroid tumour benign | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Penile squamous cell carcinoma | 1/2667 (0%) | 1 | 0/2640 (0%) | 0 |
Pericardial effusion malignant | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Phaeochromocytoma | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Pituitary tumour | 1/4949 (0%) | 2 | 0/4943 (0%) | 0 |
Pituitary tumour benign | 1/4949 (0%) | 1 | 2/4943 (0%) | 2 |
Plasma cell leukaemia | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Plasma cell myeloma | 2/4949 (0%) | 2 | 5/4943 (0.1%) | 6 |
Prostate cancer | 33/2667 (1.2%) | 34 | 33/2640 (1.3%) | 33 |
Prostate cancer metastatic | 4/2667 (0.1%) | 4 | 2/2640 (0.1%) | 2 |
Prostate cancer recurrent | 1/2667 (0%) | 1 | 1/2640 (0%) | 1 |
Prostate cancer stage i | 1/2667 (0%) | 1 | 0/2640 (0%) | 0 |
Prostatic adenoma | 3/2667 (0.1%) | 3 | 6/2640 (0.2%) | 6 |
Rectal adenocarcinoma | 2/4949 (0%) | 2 | 4/4943 (0.1%) | 4 |
Rectal adenoma | 0/4949 (0%) | 0 | 2/4943 (0%) | 2 |
Rectal cancer | 3/4949 (0.1%) | 3 | 0/4943 (0%) | 0 |
Rectal cancer metastatic | 1/4949 (0%) | 1 | 1/4943 (0%) | 1 |
Rectal neoplasm | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Rectosigmoid cancer | 1/4949 (0%) | 1 | 1/4943 (0%) | 1 |
Renal cancer | 4/4949 (0.1%) | 4 | 5/4943 (0.1%) | 5 |
Renal cancer metastatic | 2/4949 (0%) | 2 | 0/4943 (0%) | 0 |
Renal cell carcinoma | 7/4949 (0.1%) | 7 | 4/4943 (0.1%) | 4 |
Renal neoplasm | 3/4949 (0.1%) | 3 | 2/4943 (0%) | 2 |
Renal oncocytoma | 2/4949 (0%) | 2 | 0/4943 (0%) | 0 |
Sarcoma | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Small cell lung cancer | 3/4949 (0.1%) | 3 | 6/4943 (0.1%) | 6 |
Small cell lung cancer metastatic | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Spinal meningioma benign | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Spindle cell sarcoma | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Squamous cell carcinoma | 1/4949 (0%) | 1 | 4/4943 (0.1%) | 4 |
Squamous cell carcinoma of lung | 7/4949 (0.1%) | 8 | 3/4943 (0.1%) | 3 |
Squamous cell carcinoma of skin | 3/4949 (0.1%) | 4 | 3/4943 (0.1%) | 3 |
Squamous cell carcinoma of the cervix | 0/2282 (0%) | 0 | 1/2303 (0%) | 1 |
Squamous cell carcinoma of the vagina | 0/2282 (0%) | 0 | 1/2303 (0%) | 1 |
Squamous cell carcinoma of the vulva | 0/2282 (0%) | 0 | 2/2303 (0.1%) | 2 |
Sweat gland tumour | 0/4949 (0%) | 0 | 1/4943 (0%) | 2 |
Throat cancer | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Thymoma | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Thyroid adenoma | 1/4949 (0%) | 1 | 1/4943 (0%) | 1 |
Thyroid cancer | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Tongue carcinoma stage iv | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Tongue neoplasm malignant stage unspecified | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Tonsil cancer | 2/4949 (0%) | 2 | 0/4943 (0%) | 0 |
Transitional cell cancer of the renal pelvis and ureter | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Transitional cell carcinoma | 3/4949 (0.1%) | 3 | 7/4943 (0.1%) | 7 |
Transitional cell carcinoma recurrent | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Tumour associated fever | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Tumour of ampulla of vater | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Urethral cancer | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Uterine cancer | 2/2282 (0.1%) | 2 | 4/2303 (0.2%) | 4 |
Uterine leiomyoma | 1/2282 (0%) | 1 | 3/2303 (0.1%) | 3 |
Uterine neoplasm | 1/2282 (0%) | 1 | 1/2303 (0%) | 1 |
Vascular neoplasm | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Nervous system disorders | ||||
Acoustic neuritis | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Altered state of consciousness | 1/4949 (0%) | 1 | 2/4943 (0%) | 2 |
Amnesia | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Amputation stump pain | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Aphasia | 1/4949 (0%) | 1 | 3/4943 (0.1%) | 3 |
Ataxia | 2/4949 (0%) | 2 | 1/4943 (0%) | 1 |
Autonomic nervous system imbalance | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Balance disorder | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Basal ganglia haemorrhage | 1/4949 (0%) | 1 | 1/4943 (0%) | 1 |
Brain injury | 1/4949 (0%) | 1 | 1/4943 (0%) | 1 |
Brain stem haemorrhage | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Brain stem infarction | 1/4949 (0%) | 1 | 1/4943 (0%) | 1 |
Carotid arteriosclerosis | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Carotid artery occlusion | 4/4949 (0.1%) | 4 | 1/4943 (0%) | 1 |
Carotid artery stenosis | 9/4949 (0.2%) | 10 | 5/4943 (0.1%) | 5 |
Carotid sinus syndrome | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Carpal tunnel syndrome | 5/4949 (0.1%) | 5 | 1/4943 (0%) | 1 |
Cauda equina syndrome | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Cerebellar ataxia | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Cerebellar atrophy | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Cerebellar infarction | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Cerebral arteriosclerosis | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Cerebral atrophy | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Cerebral circulatory failure | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Cerebral haematoma | 3/4949 (0.1%) | 3 | 2/4943 (0%) | 2 |
Cerebral haemorrhage | 2/4949 (0%) | 2 | 2/4943 (0%) | 2 |
Cerebral infarction | 4/4949 (0.1%) | 4 | 5/4943 (0.1%) | 5 |
Cerebral ischaemia | 4/4949 (0.1%) | 4 | 5/4943 (0.1%) | 5 |
Cerebrovascular accident | 31/4949 (0.6%) | 34 | 24/4943 (0.5%) | 25 |
Cerebrovascular disorder | 0/4949 (0%) | 0 | 3/4943 (0.1%) | 3 |
Cerebrovascular insufficiency | 3/4949 (0.1%) | 3 | 1/4943 (0%) | 1 |
Cervical radiculopathy | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Cervicobrachial syndrome | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Cognitive disorder | 3/4949 (0.1%) | 3 | 2/4943 (0%) | 2 |
Coma | 0/4949 (0%) | 0 | 2/4943 (0%) | 2 |
Dementia | 2/4949 (0%) | 2 | 4/4943 (0.1%) | 4 |
Dementia alzheimer's type | 2/4949 (0%) | 2 | 1/4943 (0%) | 1 |
Demyelinating polyneuropathy | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Depressed level of consciousness | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Diabetic coma | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Diabetic hyperglycaemic coma | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Diabetic hyperosmolar coma | 1/4949 (0%) | 1 | 1/4943 (0%) | 1 |
Diabetic mononeuropathy | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Diabetic neuropathy | 8/4949 (0.2%) | 8 | 3/4943 (0.1%) | 3 |
Dizziness | 2/4949 (0%) | 2 | 9/4943 (0.2%) | 9 |
Dizziness postural | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Dysarthria | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Embolic stroke | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Encephalopathy | 2/4949 (0%) | 2 | 4/4943 (0.1%) | 4 |
Epilepsy | 8/4949 (0.2%) | 8 | 1/4943 (0%) | 1 |
Facial paralysis | 3/4949 (0.1%) | 3 | 5/4943 (0.1%) | 5 |
Frontal lobe epilepsy | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Generalised tonic-clonic seizure | 1/4949 (0%) | 1 | 1/4943 (0%) | 2 |
Guillain-barre syndrome | 1/4949 (0%) | 1 | 1/4943 (0%) | 1 |
Haemorrhage intracranial | 3/4949 (0.1%) | 3 | 3/4943 (0.1%) | 3 |
Haemorrhagic cerebral infarction | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Haemorrhagic stroke | 2/4949 (0%) | 2 | 4/4943 (0.1%) | 4 |
Headache | 2/4949 (0%) | 2 | 2/4943 (0%) | 2 |
Hemiparesis | 5/4949 (0.1%) | 5 | 1/4943 (0%) | 1 |
Hemiplegia | 2/4949 (0%) | 2 | 0/4943 (0%) | 0 |
Hepatic encephalopathy | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Hydrocephalus | 4/4949 (0.1%) | 6 | 1/4943 (0%) | 1 |
Hypertensive encephalopathy | 2/4949 (0%) | 2 | 1/4943 (0%) | 1 |
Hypoaesthesia | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Iiird nerve paralysis | 1/4949 (0%) | 1 | 1/4943 (0%) | 1 |
Intracranial aneurysm | 1/4949 (0%) | 1 | 2/4943 (0%) | 3 |
Intracranial haematoma | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Ischaemic cerebral infarction | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Ischaemic neuropathy | 1/4949 (0%) | 1 | 2/4943 (0%) | 3 |
Ischaemic stroke | 18/4949 (0.4%) | 22 | 14/4943 (0.3%) | 15 |
Lacunar infarction | 1/4949 (0%) | 1 | 3/4943 (0.1%) | 3 |
Lacunar stroke | 2/4949 (0%) | 2 | 0/4943 (0%) | 0 |
Language disorder | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Loss of consciousness | 0/4949 (0%) | 0 | 3/4943 (0.1%) | 3 |
Lumbar radiculopathy | 4/4949 (0.1%) | 4 | 2/4943 (0%) | 2 |
Lumbosacral radiculopathy | 0/4949 (0%) | 0 | 2/4943 (0%) | 2 |
Metabolic encephalopathy | 1/4949 (0%) | 1 | 5/4943 (0.1%) | 5 |
Migraine | 0/4949 (0%) | 0 | 2/4943 (0%) | 3 |
Mixed dementia | 1/4949 (0%) | 1 | 1/4943 (0%) | 1 |
Monoparesis | 1/4949 (0%) | 1 | 1/4943 (0%) | 1 |
Motor neurone disease | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Myasthenia gravis | 3/4949 (0.1%) | 3 | 0/4943 (0%) | 0 |
Myelopathy | 2/4949 (0%) | 2 | 2/4943 (0%) | 2 |
Myoclonus | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Nerve root compression | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Nervous system disorder | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Neuritis | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Neuropathy peripheral | 2/4949 (0%) | 2 | 5/4943 (0.1%) | 5 |
Normal pressure hydrocephalus | 1/4949 (0%) | 1 | 2/4943 (0%) | 2 |
Optic neuritis | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Paralysis recurrent laryngeal nerve | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Parkinson's disease | 2/4949 (0%) | 2 | 1/4943 (0%) | 1 |
Parkinsonism | 1/4949 (0%) | 1 | 1/4943 (0%) | 1 |
Partial seizures | 3/4949 (0.1%) | 3 | 2/4943 (0%) | 3 |
Peripheral nerve paresis | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Peripheral sensorimotor neuropathy | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Peroneal nerve palsy | 2/4949 (0%) | 3 | 1/4943 (0%) | 1 |
Piriformis syndrome | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Polyneuropathy | 1/4949 (0%) | 1 | 1/4943 (0%) | 1 |
Post herpetic neuralgia | 2/4949 (0%) | 2 | 0/4943 (0%) | 0 |
Presyncope | 2/4949 (0%) | 2 | 4/4943 (0.1%) | 4 |
Pseudobulbar palsy | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Psychomotor hyperactivity | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Quadriplegia | 0/4949 (0%) | 0 | 3/4943 (0.1%) | 3 |
Radiculopathy | 3/4949 (0.1%) | 3 | 1/4943 (0%) | 1 |
Sciatica | 7/4949 (0.1%) | 8 | 6/4943 (0.1%) | 6 |
Seizure | 5/4949 (0.1%) | 5 | 7/4943 (0.1%) | 7 |
Sensory disturbance | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Serotonin syndrome | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Spinal claudication | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Syncope | 33/4949 (0.7%) | 34 | 36/4943 (0.7%) | 38 |
Thrombotic stroke | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Toxic encephalopathy | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Transient global amnesia | 1/4949 (0%) | 1 | 2/4943 (0%) | 2 |
Transient ischaemic attack | 23/4949 (0.5%) | 24 | 22/4943 (0.4%) | 25 |
Tremor | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Trigeminal neuralgia | 0/4949 (0%) | 0 | 1/4943 (0%) | 2 |
Uraemic encephalopathy | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Vascular dementia | 4/4949 (0.1%) | 4 | 1/4943 (0%) | 1 |
Vascular encephalopathy | 2/4949 (0%) | 2 | 0/4943 (0%) | 0 |
Vascular parkinsonism | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Vertebrobasilar insufficiency | 2/4949 (0%) | 2 | 2/4943 (0%) | 2 |
Vith nerve paralysis | 1/4949 (0%) | 1 | 1/4943 (0%) | 1 |
Wernicke's encephalopathy | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Product Issues | ||||
Device damage | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Device dislocation | 4/4949 (0.1%) | 4 | 0/4943 (0%) | 0 |
Device failure | 4/4949 (0.1%) | 4 | 1/4943 (0%) | 1 |
Device loosening | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Device malfunction | 1/4949 (0%) | 1 | 2/4943 (0%) | 2 |
Device occlusion | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Psychiatric disorders | ||||
Abnormal behaviour | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Adjustment disorder | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Adjustment disorder with depressed mood | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Affective disorder | 1/4949 (0%) | 1 | 1/4943 (0%) | 1 |
Aggression | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Alcohol abuse | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Alcohol withdrawal syndrome | 1/4949 (0%) | 1 | 1/4943 (0%) | 1 |
Anxiety | 2/4949 (0%) | 2 | 1/4943 (0%) | 1 |
Anxiety disorder | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Bipolar disorder | 1/4949 (0%) | 2 | 1/4943 (0%) | 1 |
Confusional state | 7/4949 (0.1%) | 7 | 9/4943 (0.2%) | 9 |
Delirium | 8/4949 (0.2%) | 10 | 10/4943 (0.2%) | 10 |
Delusion | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Depression | 7/4949 (0.1%) | 8 | 6/4943 (0.1%) | 6 |
Depression suicidal | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Disorientation | 2/4949 (0%) | 2 | 0/4943 (0%) | 0 |
Emotional distress | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Generalised anxiety disorder | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Hypomania | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Major depression | 1/4949 (0%) | 1 | 3/4943 (0.1%) | 3 |
Mania | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Mental disorder | 3/4949 (0.1%) | 3 | 0/4943 (0%) | 0 |
Mental status changes | 1/4949 (0%) | 1 | 1/4943 (0%) | 1 |
Panic disorder | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Personality change due to a general medical condition | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Psychogenic seizure | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Psychotic disorder | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Restlessness | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Somatic delusion | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Somatic symptom disorder | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Suicidal ideation | 1/4949 (0%) | 1 | 1/4943 (0%) | 1 |
Suicide attempt | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Renal and urinary disorders | ||||
Acute kidney injury | 67/4949 (1.4%) | 74 | 61/4943 (1.2%) | 72 |
Atonic urinary bladder | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Azotaemia | 0/4949 (0%) | 0 | 2/4943 (0%) | 2 |
Bladder dysfunction | 2/4949 (0%) | 2 | 0/4943 (0%) | 0 |
Bladder fibrosis | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Bladder hypertrophy | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Bladder mass | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Bladder neck obstruction | 1/4949 (0%) | 1 | 1/4943 (0%) | 2 |
Bladder neck sclerosis | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Bladder obstruction | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Bladder outlet obstruction | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Bladder pain | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Calculus bladder | 2/4949 (0%) | 2 | 5/4943 (0.1%) | 5 |
Calculus urethral | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Calculus urinary | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Chronic kidney disease | 19/4949 (0.4%) | 20 | 13/4943 (0.3%) | 13 |
Cystitis haemorrhagic | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Diabetic nephropathy | 5/4949 (0.1%) | 5 | 3/4943 (0.1%) | 3 |
Dysuria | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
End stage renal disease | 6/4949 (0.1%) | 6 | 3/4943 (0.1%) | 3 |
Haematuria | 7/4949 (0.1%) | 8 | 2/4943 (0%) | 2 |
Haemorrhage urinary tract | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Hydronephrosis | 4/4949 (0.1%) | 4 | 0/4943 (0%) | 0 |
Hydroureter | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Hypertensive nephropathy | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Hypertonic bladder | 1/4949 (0%) | 1 | 1/4943 (0%) | 1 |
Kidney perforation | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Nephrolithiasis | 17/4949 (0.3%) | 18 | 18/4943 (0.4%) | 19 |
Nephropathy | 2/4949 (0%) | 2 | 0/4943 (0%) | 0 |
Pelvi-ureteric obstruction | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Proteinuria | 2/4949 (0%) | 2 | 0/4943 (0%) | 0 |
Renal colic | 6/4949 (0.1%) | 7 | 7/4943 (0.1%) | 8 |
Renal cyst | 1/4949 (0%) | 1 | 1/4943 (0%) | 1 |
Renal failure | 17/4949 (0.3%) | 17 | 16/4943 (0.3%) | 16 |
Renal haematoma | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Renal haemorrhage | 1/4949 (0%) | 1 | 1/4943 (0%) | 2 |
Renal impairment | 6/4949 (0.1%) | 6 | 7/4943 (0.1%) | 8 |
Renal infarct | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Renal mass | 2/4949 (0%) | 2 | 1/4943 (0%) | 1 |
Stress urinary incontinence | 0/4949 (0%) | 0 | 2/4943 (0%) | 2 |
Tubulointerstitial nephritis | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Ureteric dilatation | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Ureteric stenosis | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Ureterolithiasis | 9/4949 (0.2%) | 10 | 9/4943 (0.2%) | 9 |
Urethral caruncle | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Urethral disorder | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Urethral stenosis | 4/4949 (0.1%) | 4 | 4/4943 (0.1%) | 5 |
Urinary bladder polyp | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Urinary incontinence | 4/4949 (0.1%) | 4 | 1/4943 (0%) | 1 |
Urinary retention | 9/4949 (0.2%) | 9 | 3/4943 (0.1%) | 3 |
Urinary tract obstruction | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Reproductive system and breast disorders | ||||
Acquired phimosis | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Benign prostatic hyperplasia | 18/2667 (0.7%) | 20 | 21/2640 (0.8%) | 21 |
Breast pain | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Cervical polyp | 1/2282 (0%) | 1 | 2/2303 (0.1%) | 2 |
Cystocele | 4/2282 (0.2%) | 5 | 3/2303 (0.1%) | 4 |
Endometrial hyperplasia | 0/2282 (0%) | 0 | 1/2303 (0%) | 1 |
Endometrial hypertrophy | 0/2282 (0%) | 0 | 1/2303 (0%) | 1 |
Endometriosis | 0/2282 (0%) | 0 | 1/2303 (0%) | 1 |
Erectile dysfunction | 1/2667 (0%) | 1 | 0/2640 (0%) | 0 |
Female genital tract fistula | 0/2282 (0%) | 0 | 2/2303 (0.1%) | 3 |
Fibrocystic breast disease | 2/4949 (0%) | 2 | 0/4943 (0%) | 0 |
Genital prolapse | 2/4949 (0%) | 2 | 3/4943 (0.1%) | 3 |
Gynaecomastia | 0/2667 (0%) | 0 | 2/2640 (0.1%) | 3 |
Metrorrhagia | 0/2282 (0%) | 0 | 2/2303 (0.1%) | 2 |
Ovarian cyst | 1/2282 (0%) | 1 | 6/2303 (0.3%) | 6 |
Pelvic fluid collection | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Pelvic prolapse | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Prostatism | 2/2667 (0.1%) | 2 | 0/2640 (0%) | 0 |
Prostatitis | 2/2667 (0.1%) | 2 | 4/2640 (0.2%) | 4 |
Prostatomegaly | 1/2667 (0%) | 1 | 0/2640 (0%) | 0 |
Rectocele | 1/2282 (0%) | 1 | 1/2303 (0%) | 1 |
Uterine disorder | 0/2282 (0%) | 0 | 1/2303 (0%) | 1 |
Uterine polyp | 2/2282 (0.1%) | 2 | 3/2303 (0.1%) | 3 |
Uterine prolapse | 0/2282 (0%) | 0 | 3/2303 (0.1%) | 3 |
Uterovaginal prolapse | 2/2282 (0.1%) | 2 | 2/2303 (0.1%) | 2 |
Vaginal haemorrhage | 1/2282 (0%) | 1 | 1/2303 (0%) | 1 |
Vaginal polyp | 1/2282 (0%) | 1 | 0/2303 (0%) | 0 |
Vaginal prolapse | 0/2282 (0%) | 0 | 2/2303 (0.1%) | 2 |
Respiratory, thoracic and mediastinal disorders | ||||
Acquired diaphragmatic eventration | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Acute pulmonary oedema | 2/4949 (0%) | 2 | 4/4943 (0.1%) | 5 |
Acute respiratory failure | 17/4949 (0.3%) | 17 | 6/4943 (0.1%) | 7 |
Alveolitis allergic | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Asphyxia | 1/4949 (0%) | 1 | 1/4943 (0%) | 1 |
Aspiration | 3/4949 (0.1%) | 3 | 0/4943 (0%) | 0 |
Asthma | 8/4949 (0.2%) | 13 | 8/4943 (0.2%) | 8 |
Atelectasis | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Bronchial hyperreactivity | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Bronchial polyp | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Bronchitis chronic | 3/4949 (0.1%) | 3 | 1/4943 (0%) | 1 |
Bronchopneumopathy | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Chronic obstructive pulmonary disease | 35/4949 (0.7%) | 45 | 25/4943 (0.5%) | 32 |
Chronic respiratory failure | 2/4949 (0%) | 2 | 1/4943 (0%) | 1 |
Cough | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Dysphonia | 0/4949 (0%) | 0 | 2/4943 (0%) | 2 |
Dyspnoea | 15/4949 (0.3%) | 15 | 11/4943 (0.2%) | 12 |
Dyspnoea exertional | 6/4949 (0.1%) | 6 | 1/4943 (0%) | 1 |
Emphysema | 1/4949 (0%) | 2 | 0/4943 (0%) | 0 |
Epistaxis | 5/4949 (0.1%) | 5 | 5/4943 (0.1%) | 5 |
Haemoptysis | 2/4949 (0%) | 2 | 1/4943 (0%) | 1 |
Haemothorax | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Hypercapnia | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Hyperventilation | 0/4949 (0%) | 0 | 2/4943 (0%) | 2 |
Hypoxia | 3/4949 (0.1%) | 3 | 1/4943 (0%) | 1 |
Interstitial lung disease | 7/4949 (0.1%) | 7 | 13/4943 (0.3%) | 14 |
Lung disorder | 2/4949 (0%) | 2 | 1/4943 (0%) | 1 |
Lung infiltration | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Nasal polyps | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Nasal septum deviation | 1/4949 (0%) | 1 | 1/4943 (0%) | 1 |
Obstructive airways disorder | 1/4949 (0%) | 1 | 1/4943 (0%) | 1 |
Pharyngeal haemorrhage | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Pickwickian syndrome | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Pleural effusion | 8/4949 (0.2%) | 10 | 13/4943 (0.3%) | 13 |
Pleural thickening | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Pleurisy | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Pneumonia aspiration | 4/4949 (0.1%) | 4 | 2/4943 (0%) | 3 |
Pneumonitis | 1/4949 (0%) | 1 | 1/4943 (0%) | 1 |
Pneumothorax | 6/4949 (0.1%) | 6 | 4/4943 (0.1%) | 4 |
Pneumothorax spontaneous | 1/4949 (0%) | 1 | 1/4943 (0%) | 1 |
Pulmonary congestion | 1/4949 (0%) | 1 | 2/4943 (0%) | 2 |
Pulmonary embolism | 21/4949 (0.4%) | 22 | 22/4943 (0.4%) | 23 |
Pulmonary fibrosis | 4/4949 (0.1%) | 4 | 1/4943 (0%) | 1 |
Pulmonary hypertension | 4/4949 (0.1%) | 4 | 3/4943 (0.1%) | 3 |
Pulmonary mass | 2/4949 (0%) | 2 | 4/4943 (0.1%) | 4 |
Pulmonary oedema | 20/4949 (0.4%) | 20 | 6/4943 (0.1%) | 6 |
Pulmonary thrombosis | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Respiratory arrest | 0/4949 (0%) | 0 | 3/4943 (0.1%) | 4 |
Respiratory distress | 1/4949 (0%) | 1 | 2/4943 (0%) | 2 |
Respiratory failure | 20/4949 (0.4%) | 22 | 16/4943 (0.3%) | 16 |
Respiratory tract oedema | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Restrictive pulmonary disease | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Rhinitis hypertrophic | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Sleep apnoea syndrome | 6/4949 (0.1%) | 6 | 1/4943 (0%) | 1 |
Skin and subcutaneous tissue disorders | ||||
Angioedema | 3/4949 (0.1%) | 3 | 1/4943 (0%) | 1 |
Decubitus ulcer | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Dermatitis allergic | 2/4949 (0%) | 2 | 0/4943 (0%) | 0 |
Dermatitis atopic | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Diabetic foot | 19/4949 (0.4%) | 24 | 14/4943 (0.3%) | 17 |
Diabetic neuropathic ulcer | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Diabetic ulcer | 2/4949 (0%) | 2 | 1/4943 (0%) | 2 |
Erythrodermic psoriasis | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Hypersensitivity vasculitis | 2/4949 (0%) | 2 | 0/4943 (0%) | 0 |
Ischaemic skin ulcer | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Neuropathic ulcer | 0/4949 (0%) | 0 | 1/4943 (0%) | 2 |
Pemphigoid | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Psoriasis | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Pyoderma gangrenosum | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Rash generalised | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Rash papular | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Skin disorder | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Skin lesion | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Skin ulcer | 15/4949 (0.3%) | 16 | 9/4943 (0.2%) | 13 |
Stasis dermatitis | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Subcutaneous emphysema | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Urticaria | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Vasculitic ulcer | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Social circumstances | ||||
Diet noncompliance | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Organ donor | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Vascular disorders | ||||
Angiodysplasia | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Aortic aneurysm | 2/4949 (0%) | 2 | 10/4943 (0.2%) | 10 |
Aortic aneurysm rupture | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Aortic arteriosclerosis | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Aortic dissection | 0/4949 (0%) | 0 | 2/4943 (0%) | 2 |
Aortic stenosis | 16/4949 (0.3%) | 17 | 21/4943 (0.4%) | 21 |
Arterial occlusive disease | 3/4949 (0.1%) | 4 | 0/4943 (0%) | 0 |
Arterial stenosis | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Arteriosclerosis | 1/4949 (0%) | 1 | 1/4943 (0%) | 1 |
Bleeding varicose vein | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Circulatory collapse | 6/4949 (0.1%) | 6 | 4/4943 (0.1%) | 4 |
Deep vein thrombosis | 10/4949 (0.2%) | 10 | 16/4943 (0.3%) | 16 |
Dry gangrene | 2/4949 (0%) | 2 | 3/4943 (0.1%) | 3 |
Essential hypertension | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Extremity necrosis | 3/4949 (0.1%) | 4 | 3/4943 (0.1%) | 3 |
Haematoma | 1/4949 (0%) | 1 | 4/4943 (0.1%) | 4 |
Haemodynamic instability | 1/4949 (0%) | 2 | 0/4943 (0%) | 0 |
Haemorrhage | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Hypertension | 27/4949 (0.5%) | 29 | 22/4943 (0.4%) | 24 |
Hypertensive crisis | 21/4949 (0.4%) | 21 | 14/4943 (0.3%) | 14 |
Hypertensive emergency | 3/4949 (0.1%) | 3 | 4/4943 (0.1%) | 4 |
Hypotension | 7/4949 (0.1%) | 7 | 1/4943 (0%) | 1 |
Hypovolaemic shock | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Iliac artery embolism | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Intermittent claudication | 4/4949 (0.1%) | 4 | 1/4943 (0%) | 1 |
Lymphatic fistula | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Lymphoedema | 2/4949 (0%) | 2 | 0/4943 (0%) | 0 |
Neurogenic shock | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Orthostatic hypotension | 5/4949 (0.1%) | 5 | 6/4943 (0.1%) | 6 |
Peripheral arterial occlusive disease | 25/4949 (0.5%) | 26 | 17/4943 (0.3%) | 18 |
Peripheral artery occlusion | 4/4949 (0.1%) | 4 | 8/4943 (0.2%) | 9 |
Peripheral artery stenosis | 3/4949 (0.1%) | 3 | 2/4943 (0%) | 2 |
Peripheral artery thrombosis | 1/4949 (0%) | 1 | 1/4943 (0%) | 1 |
Peripheral embolism | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Peripheral ischaemia | 8/4949 (0.2%) | 9 | 9/4943 (0.2%) | 13 |
Peripheral vascular disorder | 7/4949 (0.1%) | 8 | 8/4943 (0.2%) | 8 |
Peripheral venous disease | 1/4949 (0%) | 1 | 1/4943 (0%) | 1 |
Phlebitis | 0/4949 (0%) | 0 | 3/4943 (0.1%) | 3 |
Shock | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Shock haemorrhagic | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Subclavian artery stenosis | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Superior vena cava syndrome | 0/4949 (0%) | 0 | 1/4943 (0%) | 1 |
Temporal arteritis | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Thrombophlebitis | 2/4949 (0%) | 2 | 0/4943 (0%) | 0 |
Thrombosis | 2/4949 (0%) | 2 | 2/4943 (0%) | 2 |
Varicose vein | 4/4949 (0.1%) | 4 | 3/4943 (0.1%) | 3 |
Vena cava thrombosis | 1/4949 (0%) | 1 | 0/4943 (0%) | 0 |
Venous thrombosis | 2/4949 (0%) | 2 | 0/4943 (0%) | 0 |
Venous thrombosis limb | 1/4949 (0%) | 1 | 2/4943 (0%) | 2 |
Other (Not Including Serious) Adverse Events |
||||
Placebo | Dulaglutide | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 3363/4949 (68%) | 3574/4943 (72.3%) | ||
Eye disorders | ||||
Cataract | 368/4949 (7.4%) | 417 | 363/4943 (7.3%) | 427 |
Gastrointestinal disorders | ||||
Constipation | 208/4949 (4.2%) | 223 | 361/4943 (7.3%) | 409 |
Diarrhoea | 436/4949 (8.8%) | 546 | 665/4943 (13.5%) | 843 |
Dyspepsia | 147/4949 (3%) | 150 | 291/4943 (5.9%) | 331 |
Nausea | 269/4949 (5.4%) | 310 | 735/4943 (14.9%) | 968 |
Vomiting | 154/4949 (3.1%) | 165 | 325/4943 (6.6%) | 498 |
Infections and infestations | ||||
Bronchitis | 421/4949 (8.5%) | 554 | 408/4943 (8.3%) | 528 |
Influenza | 404/4949 (8.2%) | 488 | 369/4943 (7.5%) | 435 |
Nasopharyngitis | 535/4949 (10.8%) | 771 | 564/4943 (11.4%) | 800 |
Upper respiratory tract infection | 407/4949 (8.2%) | 589 | 368/4943 (7.4%) | 533 |
Urinary tract infection | 517/4949 (10.4%) | 749 | 545/4943 (11%) | 795 |
Metabolism and nutrition disorders | ||||
Decreased appetite | 104/4949 (2.1%) | 109 | 325/4943 (6.6%) | 379 |
Hyperglycaemia | 315/4949 (6.4%) | 445 | 158/4943 (3.2%) | 190 |
Hypoglycaemia | 354/4949 (7.2%) | 1160 | 413/4943 (8.4%) | 1477 |
Musculoskeletal and connective tissue disorders | ||||
Arthralgia | 389/4949 (7.9%) | 469 | 371/4943 (7.5%) | 446 |
Back pain | 416/4949 (8.4%) | 484 | 447/4943 (9%) | 494 |
Osteoarthritis | 318/4949 (6.4%) | 373 | 329/4943 (6.7%) | 372 |
Pain in extremity | 245/4949 (5%) | 280 | 260/4943 (5.3%) | 296 |
Nervous system disorders | ||||
Dizziness | 296/4949 (6%) | 339 | 318/4943 (6.4%) | 373 |
Headache | 288/4949 (5.8%) | 382 | 324/4943 (6.6%) | 414 |
Renal and urinary disorders | ||||
Microalbuminuria | 259/4949 (5.2%) | 263 | 232/4943 (4.7%) | 241 |
Reproductive system and breast disorders | ||||
Benign prostatic hyperplasia | 135/2667 (5.1%) | 137 | 140/2640 (5.3%) | 144 |
Respiratory, thoracic and mediastinal disorders | ||||
Cough | 256/4949 (5.2%) | 292 | 239/4943 (4.8%) | 265 |
Vascular disorders | ||||
Hypertension | 432/4949 (8.7%) | 491 | 345/4943 (7%) | 405 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
Name/Title | Chief Medical Officer |
---|---|
Organization | Eli Lilly and Company |
Phone | 800-545-5979 |
www.ClinicalTrials.gov@lilly.com |
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