ACCELERATE: A Study of Evacetrapib in High-Risk Vascular Disease
Sponsor
Eli Lilly and Company (Industry)
Overall Status
Terminated
CT.gov ID
NCT01687998
Collaborator
The Cleveland Clinic (Other)
12,092
444
2
45
27.2
0.6
Study Details
Study Description
Brief Summary
The purpose of the ACCELERATE study is to evaluate the efficacy and safety of evacetrapib in participants with high-risk vascular disease (HRVD).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
12092 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Assessment of Clinical Effects of Cholesteryl Ester Transfer Protein Inhibition With Evacetrapib in Patients at a High-Risk for Vascular Outcomes
Study Start Date
:
Oct 1, 2012
Actual Primary Completion Date
:
Mar 1, 2016
Actual Study Completion Date
:
Jul 1, 2016
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Evacetrapib Evacetrapib 130 mg tablet, administered orally once daily for up to 4 years. Participants will also receive standard of care for high-risk vascular disease (HRVD). |
Drug: Evacetrapib
Administered Orally
Other Names:
|
| Placebo Comparator: Placebo Placebo, tablet administered orally once daily for up to 4 years. Participants will also receive standard of care for HRVD. |
Drug: Placebo
Administered Orally
|
Outcome Measures
Primary Outcome Measures
- Number of Participants With Composite Primary Endpoint of Cardiovascular (CV) Death, Myocardial Infarction (MI), Stroke, Coronary Revascularization, or Hospitalization for Unstable Angina (UA) [Baseline to Study Completion (Up to 4 years)]
For component endpoints, the number of participants includes those experiencing fatal events and account for all occurrences regardless of whether or not another component event occurred previously.
Secondary Outcome Measures
- Mean Percent Change From Baseline to 3 Months in Low-Density (LDL-C) and High-Density Lipoprotein Cholesterol (HDL-C) Levels [Baseline, 3 Months]
- Number of Participants With Composite Endpoint of All-Cause Mortality, MI, Stroke, Coronary Revascularization, or Hospitalization for UA [Baseline through End of Study (Up to 4 years)]
For component endpoints, the number of participants includes those experiencing fatal events and account for all occurrences regardless of whether or not another component event occurred previously.
- Number of Participants With Composite Endpoint of CV Death, MI, or Coronary Revascularization [Baseline through End of Study (Up to 4 years)]
For component endpoints, the number of participants includes those experiencing fatal events and account for all occurrences regardless of whether or not another component event occurred previously.
- Number of Participants With Composite Endpoint of CV Death, MI, Stroke, or Hospitalization for UA [Baseline through End of Study (Up to 4 years)]
For component endpoints, the number of participants includes those experiencing fatal events and account for all occurrences regardless of whether or not another component event occurred previously.
- Number of Participants With Triple Composite Endpoint of CV Death, MI, or Stroke [Baseline through End of Study (Up to 4 years)]
For component endpoints, the number of participants includes those experiencing fatal events and account for all occurrences regardless of whether or not another component event occurred previously.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Diagnosis of high risk vascular disease (HRVD) (that is, meet at least one of the disease diagnostic criteria of: 1)History of acute coronary syndrome (ACS) (that is, ≥30 days through 365 days after discharge for ACS) 2)cerebrovascular atherosclerotic disease 3)peripheral arterial disease 4)diabetes mellitus with documented coronary artery disease and are clinically stable (as judged by the responsible physician).
-
Must be treated with a statin for at least 30 days prior to screening. If not treated with a statin must have documented statin intolerance, or contraindication to statin
-
Have a screening high-density lipoprotein cholesterol (HDL-C) ≤80 milligram per deciliter (mg/dL) (≤2.1 millimole per liter [mmol/L])
-
Have screening triglycerides (TG) ≤400 mg/dL (≤4.5 mmol/L)
-
Meet 1 of the following criteria:
-
screening low-density lipoprotein cholesterol (LDL-C) no more than 10 mg/dL (0.3 mmol/L) above the target chosen by the investigator (either LDL-C <100 mg/dL [<2.6 mmol/L] or LDL-C <70 mg/dL [<1.8 mmol/L]), OR
-
if LDL-C is greater than target, the participant must be on maximum tolerated statin dose (for at least 30 days), have documented statin intolerance, or contraindication to statin
Exclusion Criteria:
-
Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational product or non-approved use of a drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
-
Have previously completed or withdrawn from this study, or withdrawn from any other study investigating evacetrapib
-
Female participants who are known to be pregnant or breastfeeding
-
Women of child-bearing potential only, who test positive for pregnancy between screening and randomization, or who do not agree to use a reliable method of birth control during the study
-
History of transient ischemic attack (TIA) or ischemic stroke <30 days and ACS <30 days
-
Any reading of systolic blood pressure ≥180 millimeter of mercury (mm Hg) or diastolic blood pressure ≥110 mm Hg at screening or randomization
-
History of hemorrhagic stroke or intracranial hemorrhage
-
New York Heart Association class III or IV congestive heart failure
-
Serum creatinine >2.2 mg/dL (>194.5 micromole per liter [μmol/L]) at screening
-
Clinically active liver disease. Participants are not excluded due to Gilbert's Syndrome or a history of cholelithiasis/cholecystectomy
-
History of malignancy within the preceding 3 years prior to screening
-
Known malabsorption syndrome with the exception of lactose intolerance
-
Participants with a known history of primary or secondary hyperaldosteronism
-
Participants with a history of intolerance/hypersensitivity to cholesterol ester transfer protein (CETP) inhibitors
-
Any clinically significant medical condition that according to the investigator could interfere with participation in the study
-
Participants whose life expectancy is anticipated to be less than 4 years
-
Unable or unwilling to comply with study requirements, or deemed by the investigator to be unfit for the study
-
Have a history of drug, alcohol, or substance abuse within the past 6 months, as assessed by the investigator
-
Concurrent or anticipated need for treatment with niacin >250 mg/day or for chronic administration of drugs on the exclusion list
-
Previous exposure to the CETP inhibitors dalcetrapib or evacetrapib within the last 3 months or anacetrapib within the last 12 months
-
Any planned coronary angiography or coronary revascularization procedure. If angiography or revascularization is planned, participants may be screened and enrolled after all such planned procedures are completed.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 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. | Birmingham | Alabama | United States | 35233 |
| 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. | Huntsville | Alabama | United States | 35801 |
| 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. | Mobile | Alabama | United States | 36608 |
| 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. | Cottonwood | Arizona | United States | 86326 |
| 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. | Glendale | Arizona | United States | 85306 |
| 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. | Tucson | Arizona | United States | 85724 |
| 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. | Fort Smith | Arkansas | United States | 72901 |
| 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. | Little Rock | Arkansas | United States | 72205 |
| 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. | Escondido | California | United States | 92029 |
| 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. | Fresno | California | United States | 93710 |
| 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. | Lomita | California | United States | 90717 |
| 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. | Long Beach | California | United States | 90822 |
| 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. | Mission Viejo | California | United States | 92691 |
| 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. | Santa Rosa | California | United States | 95405 |
| 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. | Stockton | California | United States | 95204 |
| 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. | Thousand Oaks | California | United States | 91360 |
| 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. | Torrance | California | United States | 90509 |
| 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. | Colorado Springs | Colorado | United States | 80909 |
| 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. | Golden | Colorado | United States | 80401 |
| 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. | Bridgeport | Connecticut | United States | 06606 |
| 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. | Waterbury | Connecticut | United States | 06708 |
| 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. | Aventura | Florida | United States | 33180 |
| 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. | Boynton Beach | Florida | United States | 33472 |
| 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. | Brandon | Florida | United States | 33511 |
| 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. | Clearwater | Florida | United States | 33756 |
| 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. | Fleming Island | Florida | United States | 32003 |
| 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. | Gainesville | Florida | United States | 32605 |
| 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. | Inverness | Florida | United States | 34452 |
| 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. | Jacksonville Beach | Florida | United States | FL |
| 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. | Jacksonville | Florida | United States | 32258 |
| 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. | Jupiter | Florida | United States | 33458 |
| 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. | Lakeland | Florida | United States | 33805 |
| 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. | Largo | Florida | United States | 33777 |
| 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. | Margate | Florida | United States | 33063 |
| 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. | Melbourne | Florida | United States | 32901 |
| 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. | Miami Beach | Florida | United States | 33140 |
| 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. | Miami | Florida | United States | 33135 |
| 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. | Naples | Florida | United States | 34102 |
| 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. | Ocala | Florida | United States | 34471 |
| 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. | Orlando | Florida | United States | 32803 |
| 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. | Panama City | Florida | United States | 32401 |
| 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. | Pembroke Pines | Florida | United States | 33026 |
| 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. | Pensacola | Florida | United States | 32501 |
| 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. | Ponte Vedra | Florida | United States | 32081 |
| 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. | Port Charlotte | Florida | United States | 33952 |
| 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. | Safety Harbor | Florida | United States | 34695 |
| 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. | Tallahassee | Florida | United States | 32308 |
| 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. | Wellington | Florida | United States | 33449 |
| 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. | Covington | Georgia | United States | 30014 |
| 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. | Cumming | Georgia | United States | 30041 |
| 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. | Tucker | Georgia | United States | 30084 |
| 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. | Arlington Heights | Illinois | United States | 60005 |
| 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. | Aurora | Illinois | United States | 60504 |
| 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. | Bannockburn | Illinois | United States | 60015 |
| 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. | Jerseyville | Illinois | United States | 62052 |
| 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. | Rock Island | Illinois | United States | 61201 |
| 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. | Anderson | Indiana | United States | 46011 |
| 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. | Brownsburg | Indiana | United States | 46112 |
| 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. | Elkhart | Indiana | United States | 46514 |
| 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. | Fort Wayne | Indiana | United States | 46845 |
| 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. | Hammond | Indiana | United States | 46320 |
| 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. | Indianapolis | Indiana | United States | 46290 |
| 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. | Waterloo | Iowa | United States | 50702 |
| 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. | Hutchinson | Kansas | United States | 67502 |
| 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. | Overland Park | Kansas | United States | 66209 |
| 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. | Lexington | Kentucky | United States | 40536 |
| 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. | Louisville | Kentucky | United States | 40207 |
| 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. | Baton Rouge | Louisiana | United States | 70808 |
| 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. | Covington | Louisiana | United States | 70433 |
| 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. | Lake Charles | Louisiana | United States | 70601 |
| 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. | Auburn | Maine | United States | 04210 |
| 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. | Bangor | Maine | United States | 04401 |
| 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. | Baltimore | Maryland | United States | 21237 |
| 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. | Columbia | Maryland | United States | 21044 |
| 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. | Lutherville | Maryland | United States | 21093 |
| 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. | Salisbury | Maryland | United States | 21804 |
| 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. | Haverhill | Massachusetts | United States | 01830 |
| 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. | Hyannis | Massachusetts | United States | 02601 |
| 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. | Natick | Massachusetts | United States | 01760 |
| 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. | Springfield | Massachusetts | United States | 01199 |
| 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. | Cadillac | Michigan | United States | 49601 |
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| 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. | Elizabeth City | North Carolina | United States | 27909 |
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| 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. | Hickory | North Carolina | United States | 28602 |
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| 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. | Wilmington | North Carolina | United States | 28401 |
| 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. | Beachwood | Ohio | United States | 44122 |
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| 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. | Toledo | Ohio | United States | 43606 |
| 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. | Zanesville | Ohio | United States | 43701 |
| 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. | Oklahoma City | Oklahoma | United States | 73135 |
| 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. | Tulsa | Oklahoma | United States | 74136 |
| 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. | Portland | Oregon | United States | 97225 |
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| 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. | Philadelphia | Pennsylvania | United States | 19152 |
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| 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. | Rapid City | South Dakota | United States | 57701 |
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| 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. | Tullahoma | Tennessee | United States | 37388 |
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| 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. | San Antonio | Texas | United States | 78217 |
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| 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. | Bountiful | Utah | United States | 84010 |
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| 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. | Salt Lake City | Utah | United States | 84124 |
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| 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. | Falls Church | Virginia | United States | 22042 |
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| 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. | Roanoke | Virginia | United States | 24014 |
| 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. | Bellevue | Washington | United States | 98004 |
| 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. | Tacoma | Washington | United States | 98405 |
| 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. | Huntington | West Virginia | United States | 25701 |
| 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. | Green Bay | Wisconsin | United States | 54303 |
| 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. | Madison | Wisconsin | United States | 53792 |
| 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. | Milwaukee | Wisconsin | United States | 53295 |
| 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. | Oregon | Wisconsin | United States | 53575 |
| 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. | Belgrano | Argentina | C1428DCO | |
| 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. | Buenos Aires | Argentina | CBA 1425 | |
| 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. | Coronel Suarez | Argentina | B7540GHD | |
| 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. | Córdoba | Argentina | 5006 | |
| 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. | San Luis | Argentina | D5702JRS | |
| 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. | San Miguel De Tucuman | Argentina | T4000NIL | |
| 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. | Camperdown | New South Wales | Australia | 2050 |
| 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. | Wollongong | New South Wales | Australia | 2522 |
| 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. | Herston | Queensland | Australia | 4029 |
| 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. | Milton | Queensland | Australia | 4064 |
| 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. | Southport | Queensland | Australia | 4215 |
| 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. | Woodville | South Australia | Australia | 5011 |
| 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. | Launceston | Tasmania | Australia | 7250 |
| 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. | Box Hill | Victoria | Australia | 3128 |
| 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. | Geelong | Victoria | Australia | 3220 |
| 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. | Heidelberg | Victoria | Australia | 3084 |
| 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. | Melbourne | Victoria | Australia | 3162 |
| 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. | Windsor | Victoria | Australia | 3183 |
| 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. | Feldkirch | Austria | 6807 | |
| 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. | Graz | Austria | 8036 | |
| 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. | Innsbruck | Austria | 6020 | |
| 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. | Vienna | Austria | 1140 | |
| 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. | Antwerpen | Belgium | 2060 | |
| 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. | Brussels | Belgium | 01200 | |
| 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. | Huy | Belgium | 4500 | |
| 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. | Merksem | Belgium | 2170 | |
| 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. | Tienen | Belgium | 3300 | |
| 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. | Fortaleza | Brazil | 60430-370 | |
| 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. | Rio De Janeiro | Brazil | 22271-100 | |
| 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. | São Paulo | Brazil | 05403-000 | |
| 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. | Gabrovo | Bulgaria | 5300 | |
| 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. | Pazardzhik | Bulgaria | 4400 | |
| 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. | Pleven | Bulgaria | 5800 | |
| 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. | Plovdiv | Bulgaria | 4000 | |
| 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. | Smolyan | Bulgaria | 4700 | |
| 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. | Sofia | Bulgaria | 1527 | |
| 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. | Kelowna | British Columbia | Canada | V1Y 1V6 |
| 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. | Mount Pearl | Newfoundland and Labrador | Canada | A1N 2C3 |
| 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. | Cambridge | Ontario | Canada | N1R 6V6 |
| 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. | Hamilton | Ontario | Canada | L8L 2X2 |
| 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. | Mississauga | Ontario | Canada | L5B 2P7 |
| 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. | Oshawa | Ontario | Canada | L1J 2J9 |
| 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. | Sarnia | Ontario | Canada | N7T 6K9 |
| 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. | Sudbury | Ontario | Canada | P3E 2N8 |
| 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. | Thunder Bay | Ontario | Canada | P7B 7C7 |
| 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. | Toronto | Ontario | Canada | M5C 2T2 |
| 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. | Brossard | Quebec | Canada | J4X 1S4 |
| 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. | Chicoutimi | Quebec | Canada | G7H 5H6 |
| 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. | Gatineau | Quebec | Canada | J8Y6S9 |
| 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. | Greenfield Park | Quebec | Canada | J4V 2G8 |
| 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. | Joilette | Quebec | Canada | J6E 6J2 |
| 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. | Longueuil | Quebec | Canada | J4M 2X1 |
| 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. | Montreal | Quebec | Canada | H1T 1C8 |
| 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. | Saint-Georges | Quebec | Canada | G5Y 4T8 |
| 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. | Sainte-Foy | Quebec | Canada | G1V 4G5 |
| 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. | St-Jerome | Quebec | Canada | J7Z 5T3 |
| 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. | St-Lambert | Quebec | Canada | J4P 2H4 |
| 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. | Beijing | China | 100034 | |
| 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. | Changsha | China | 410005 | |
| 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. | Guang Zhou | China | 510515 | |
| 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. | Harbin | China | 150001 | |
| 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. | Shanghai | China | 200032 | |
| 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. | Shenyang | China | 110004 | |
| 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. | Cesky Krumlov | Czechia | 381 01 | |
| 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. | Hodonin | Czechia | 69501 | |
| 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. | Marianske Lazne | Czechia | 35301 | |
| 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. | Pardubice | Czechia | 53002 | |
| 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. | Pisek | Czechia | 39701 | |
| 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. | Prague | Czechia | 13000 | |
| 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. | Pribram | Czechia | 26101 | |
| 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. | Teplice | Czechia | 41501 | |
| 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. | Aalborg | Denmark | 9000 | |
| 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. | Ballerup | Denmark | 2750 | |
| 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. | Copenhagen | Denmark | 2300 | |
| 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. | Kobenhavn | Denmark | 2400 | |
| 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. | Vejle | Denmark | 7100 | |
| 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. | Tallinn | Estonia | 10128 | |
| 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. | Viljandi | Estonia | 71024 | |
| 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. | Bordeaux | France | 33000 | |
| 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. | Dijon | France | 21000 | |
| 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. | Le Coudray | France | 28630 | |
| 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. | Paris | France | 75651 | |
| 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. | Pessac | France | 33600 | |
| 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. | Strasbourg | France | 67091 | |
| 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. | Toulouse | France | 31059 | |
| 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. | Altenburg | Germany | 04600 | |
| 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. | Bad Krozingen | Germany | 79189 | |
| 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. | Berlin | Germany | 13347 | |
| 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. | Bielefeld | Germany | 33604 | |
| 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. | Dortmund | Germany | 44137 | |
| 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. | Dresden | Germany | 01067 | |
| 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. | Frankfurt | Germany | 65929 | |
| 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. | Heidelberg | Germany | 69120 | |
| 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. | Kassel | Germany | 34121 | |
| 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. | Mainz | Germany | 55131 | |
| 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. | Mönchengladbach | Germany | 41063 | |
| 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. | Stuttgart | Germany | 70376 | |
| 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. | Tübingen | Germany | D-72076 | |
| 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. | Warendorf | Germany | 48231 | |
| 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. | Wiesbaden | Germany | 65199 | |
| 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. | Central | Hong Kong | ||
| 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. | Hong Kong | Hong Kong | ||
| 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. | Shatin | Hong Kong | ||
| 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. | Bekescsaba | Hungary | 5600 | |
| 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. | Budapest | Hungary | 1096 | |
| 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. | Debrecen | Hungary | 4025 | |
| 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. | Esztergom | Hungary | 2500 | |
| 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. | Hodmezovasarhely | Hungary | 6800 | |
| 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. | Kalocsa | Hungary | H-6300 | |
| 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. | Komarom | Hungary | 2921 | |
| 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. | Oroshaza | Hungary | 5901 | |
| 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. | Szekszard | Hungary | 7100 | |
| 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. | Zalaegerszeg | Hungary | 8900 | |
| 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. | Haifa | Israel | 31096 | |
| 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. | Jerusalem | Israel | 91004 | |
| 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. | Nazareth | Israel | 16100 | |
| 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. | Rehovot | Israel | 76100 | |
| 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. | Safed | Israel | 13110 | |
| 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. | Tel Hashomer | Israel | 52621 | |
| 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. | Tel-Aviv | Israel | 64239 | |
| 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. | Bologna | Italy | 40138 | |
| 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. | Castelfranco Veneto | Italy | 31033 | |
| 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. | Chieti Scalo | Italy | 66013 | |
| 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. | Milano | Italy | 20138 | |
| 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. | Napoli | Italy | 80131 | |
| 302 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Novara | Italy | 28100 | |
| 303 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Parma | Italy | 43100 | |
| 304 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Piacenza | Italy | 29100 | |
| 305 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | San Daniele Del Friuli | Italy | 33038 | |
| 306 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Sessa Aurunca | Italy | 81037 | |
| 307 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Aichi | Japan | 470-1192 | |
| 308 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Chiba | Japan | 270-2251 | |
| 309 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Ehime | Japan | 798-8510 | |
| 310 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Fukuoka | Japan | 830-8543 | |
| 311 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Gunma | Japan | 377-0061 | |
| 312 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Hyogo | Japan | 665-0022 | |
| 313 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Ibaraki | Japan | 311-3193 | |
| 314 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Ishikawa | Japan | 920-8641 | |
| 315 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Kanagawa | Japan | 232-0024 | |
| 316 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Kumamoto | Japan | 860-8556 | |
| 317 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Kyoto | Japan | 661-0042 | |
| 318 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Okinawa | Japan | 901-0493 | |
| 319 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Osaka | Japan | 581-0011 | |
| 320 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Saitama | Japan | 351-0102 | |
| 321 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Shizuoka | Japan | 411-8611 | |
| 322 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Tokushima | Japan | 770-8539 | |
| 323 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Tokyo | Japan | 152-8902 | |
| 324 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Yamaguchi | Japan | 740-8510 | |
| 325 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Anyang | Korea, Republic of | 431-070 | |
| 326 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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 | 614-735 | |
| 327 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Chungbuk | Korea, Republic of | 361-711 | |
| 328 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Daejeon | Korea, Republic of | 301-721 | |
| 329 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Gangwon-Do | Korea, Republic of | 200-722 | |
| 330 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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 | |
| 331 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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 | 510-757 | |
| 332 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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 | |
| 333 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Kaunas | Lithuania | LT-50009 | |
| 334 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Klaipeda | Lithuania | LT-92288 | |
| 335 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Vilnius | Lithuania | LT-10323 | |
| 336 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Aguascalientes | Mexico | 20230 | |
| 337 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Chihuahua | Mexico | 31238 | |
| 338 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Cul Sinaloa | Mexico | 80020 | |
| 339 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Guadalajara | Mexico | 44130 | |
| 340 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Huixquilucan | Mexico | 52763 | |
| 341 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Mexico City | Mexico | 11850 | |
| 342 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Queretaro | Mexico | 76000 | |
| 343 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | San Luis Potosi | Mexico | 78216 | |
| 344 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Tampico | Mexico | 89000 | |
| 345 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Tijuana | Mexico | 22500 | |
| 346 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Amersfoort | Netherlands | 3818 ES | |
| 347 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Amsterdam | Netherlands | 1105 AZ | |
| 348 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Beverwijk | Netherlands | 1942 LE | |
| 349 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Delft | Netherlands | 2625 AD | |
| 350 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Den Helder | Netherlands | 1782 GZ | |
| 351 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Deventer | Netherlands | 7416 SE | |
| 352 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Drachten | Netherlands | 9202 NN | |
| 353 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Heerlen | Netherlands | 6401CX | |
| 354 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Hilversum | Netherlands | 1213 XZ | |
| 355 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Hoogeveen | Netherlands | 7909AA | |
| 356 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Hoorn | Netherlands | 1625 HV | |
| 357 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Leiden | Netherlands | 2333 | |
| 358 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | S-Hertogenbosch | Netherlands | 5223 GV | |
| 359 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Tilburg | Netherlands | 5042 AD | |
| 360 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Venlo | Netherlands | 5912 BL | |
| 361 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Waalwijk | Netherlands | 5141 BM | |
| 362 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Zaandam | Netherlands | 1502 DV | |
| 363 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Zwijndrecht | Netherlands | 3331 LZ | |
| 364 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Addington | New Zealand | 8011 | |
| 365 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Grafton | New Zealand | 1023 | |
| 366 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Hamilton West | New Zealand | 3204 | |
| 367 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Newtown | New Zealand | 6021 | |
| 368 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Tauranga | New Zealand | 3140 | |
| 369 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Westlake | New Zealand | 0620 | |
| 370 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Bydgoszcz | Poland | 85-863 | |
| 371 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Gdansk | Poland | 80-126 | |
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| 378 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Skierniewice | Poland | 96-100 | |
| 379 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Sobotka | Poland | 55050 | |
| 380 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Warsaw | Poland | 04-730 | |
| 381 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Wroclaw | Poland | 51-112 | |
| 382 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Ponce | Puerto Rico | 00717-1322 | |
| 383 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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 | 00909 | |
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| 385 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Braila | Romania | 810249 | |
| 386 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Bucharest | Romania | 022328 | |
| 387 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Buzau | Romania | 120203 | |
| 388 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Focsani | Romania | 620034 | |
| 389 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Oradea | Romania | 410169 | |
| 390 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Arkhangelsk | Russian Federation | 163045 | |
| 391 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Kemerovo | Russian Federation | 650002 | |
| 392 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Moscow | Russian Federation | 111020 | |
| 393 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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 | 196105 | |
| 394 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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 | |
| 395 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Tomsk | Russian Federation | 196105 | |
| 396 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Yaroslavl | Russian Federation | 150002 | |
| 397 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Bardejov | Slovakia | 08501 | |
| 398 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Bratislava | Slovakia | 85101 | |
| 399 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Kralovsky Chlmec | Slovakia | 07701 | |
| 400 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Nitra | Slovakia | 949 01 | |
| 401 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Presov | Slovakia | 080 01 | |
| 402 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Zilina | Slovakia | 010 01 | |
| 403 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Alberton | South Africa | 1449 | |
| 404 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Bellville | South Africa | 7530 | |
| 405 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Bloemfontein | South Africa | 9300 | |
| 406 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Goodwood | South Africa | 7460 | |
| 407 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Johannesburg | South Africa | 1460 | |
| 408 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Kuilsriver | South Africa | 7580 | |
| 409 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Newlands West | South Africa | 4035 | |
| 410 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Parktown West | South Africa | 2193 | |
| 411 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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 | |
| 412 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Ciudad Real | Spain | 13005 | |
| 413 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Cordoba | Spain | 14004 | |
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| 417 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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 | |
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| 419 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Lund | Sweden | 22221 | |
| 420 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Malmö | Sweden | 20502 | |
| 421 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Stockholm | Sweden | 11157 | |
| 422 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Östersund | Sweden | 83183 | |
| 423 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Lugano | Switzerland | CH-6900 | |
| 424 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Zürich | Switzerland | CH-8091 | |
| 425 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Kaohsiung City | Taiwan | 83301 | |
| 426 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Kaohsiung | Taiwan | 807 | |
| 427 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Kuei Shan Hsiang | Taiwan | 33305 | |
| 428 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Taichung City | Taiwan | 40201 | |
| 429 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Taichung | Taiwan | 40705 | |
| 430 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Taipei | Taiwan | 111 | |
| 431 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Ankara | Turkey | 06520 | |
| 432 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Konya | Turkey | 42250 | |
| 433 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Kyiv | Ukraine | 2091 | |
| 434 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Lutsk | Ukraine | 43024 | |
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| 437 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Welwyn Garden City | Hertfordshire | United Kingdom | AL7 4HQ |
| 438 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Barnet | Herts | United Kingdom | EN5 3DJ |
| 439 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Stevenage | Herts | United Kingdom | SG4 7NH |
| 440 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Tooting | London | United Kingdom | SW17 ORE |
| 441 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Wellingborough | Northants | United Kingdom | NN8 4RW |
| 442 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Dudley | West Midlands | United Kingdom | DY1 2HQ |
| 443 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Bath | United Kingdom | BA2 4BY | |
| 444 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Frome | United Kingdom | BA11 1EZ |
Sponsors and Collaborators
- Eli Lilly and Company
- The Cleveland Clinic
Investigators
- Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01687998
Other Study ID Numbers:
- 11949
- I1V-MC-EIAN
First Posted:
Sep 19, 2012
Last Update Posted:
Oct 8, 2019
Last Verified:
Sep 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | Non-Completers: Participants "Known to be Alive at Study End" is a subset of those who did not withdraw consent and later found to be alive from public sources. "Lost to follow-up" is a subset of those who did not withdraw consent for whom study end vital status could not be ascertained. |
| Arm/Group Title | Evacetrapib | Placebo |
|---|---|---|
| Arm/Group Description | Evacetrapib 130 milligram (mg) tablet, administered orally once daily for up to 4 years. Participants will also receive standard of care for high-risk vascular disease (HRVD). | Placebo, tablet administered orally once daily for up to 4 years. Participants will also receive standard of care for HRVD. |
| Period Title: Overall Study | ||
| STARTED | 6038 | 6054 |
| Received at Least One Dose of Study Drug | 6036 | 6052 |
| COMPLETED | 5926 | 5934 |
| NOT COMPLETED | 112 | 120 |
Baseline Characteristics
| Arm/Group Title | Evacetrapib | Placebo | Total |
|---|---|---|---|
| Arm/Group Description | Evacetrapib 130 mg tablet, administered orally once daily for up to 4 years. Participants received standard of care for HRVD. | Placebo, tablet administered orally once daily for up to 4 years. Participants received standard of care for HRVD. | Total of all reporting groups |
| Overall Participants | 6038 | 6054 | 12092 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
64.791
(9.3849)
|
64.994
(9.4591)
|
64.892
(9.4223)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
1390
23%
|
1394
23%
|
2784
23%
|
| Male |
4648
77%
|
4660
77%
|
9308
77%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||
| Hispanic or Latino |
500
8.3%
|
522
8.6%
|
1022
8.5%
|
| Not Hispanic or Latino |
5394
89.3%
|
5386
89%
|
10780
89.1%
|
| Unknown or Not Reported |
144
2.4%
|
146
2.4%
|
290
2.4%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
243
4%
|
226
3.7%
|
469
3.9%
|
| Asian |
650
10.8%
|
640
10.6%
|
1290
10.7%
|
| Native Hawaiian or Other Pacific Islander |
6
0.1%
|
5
0.1%
|
11
0.1%
|
| Black or African American |
141
2.3%
|
153
2.5%
|
294
2.4%
|
| White |
4933
81.7%
|
4971
82.1%
|
9904
81.9%
|
| More than one race |
35
0.6%
|
26
0.4%
|
61
0.5%
|
| Unknown or Not Reported |
30
0.5%
|
33
0.5%
|
63
0.5%
|
| Region of Enrollment (Count of Participants) | |||
| Russia |
85
1.4%
|
82
1.4%
|
167
1.4%
|
| Hong Kong |
24
0.4%
|
28
0.5%
|
52
0.4%
|
| United States |
2235
37%
|
2240
37%
|
4475
37%
|
| Netherlands |
171
2.8%
|
169
2.8%
|
340
2.8%
|
| Austria |
34
0.6%
|
34
0.6%
|
68
0.6%
|
| Sweden |
33
0.5%
|
33
0.5%
|
66
0.5%
|
| China |
224
3.7%
|
221
3.7%
|
445
3.7%
|
| South Korea |
87
1.4%
|
94
1.6%
|
181
1.5%
|
| Poland |
243
4%
|
240
4%
|
483
4%
|
| Brazil |
54
0.9%
|
56
0.9%
|
110
0.9%
|
| Slovakia |
116
1.9%
|
117
1.9%
|
233
1.9%
|
| France |
45
0.7%
|
52
0.9%
|
97
0.8%
|
| Bulgaria |
113
1.9%
|
118
1.9%
|
231
1.9%
|
| Lithuania |
13
0.2%
|
15
0.2%
|
28
0.2%
|
| Argentina |
89
1.5%
|
91
1.5%
|
180
1.5%
|
| Romania |
64
1.1%
|
66
1.1%
|
130
1.1%
|
| Hungary |
118
2%
|
115
1.9%
|
233
1.9%
|
| Japan |
205
3.4%
|
202
3.3%
|
407
3.4%
|
| Ukraine |
67
1.1%
|
66
1.1%
|
133
1.1%
|
| United Kingdom |
58
1%
|
58
1%
|
116
1%
|
| Switzerland |
15
0.2%
|
14
0.2%
|
29
0.2%
|
| Spain |
65
1.1%
|
66
1.1%
|
131
1.1%
|
| New Zealand |
63
1%
|
64
1.1%
|
127
1.1%
|
| Canada |
626
10.4%
|
619
10.2%
|
1245
10.3%
|
| Czechia |
187
3.1%
|
185
3.1%
|
372
3.1%
|
| Turkey |
1
0%
|
2
0%
|
3
0%
|
| Belgium |
42
0.7%
|
42
0.7%
|
84
0.7%
|
| Taiwan |
52
0.9%
|
53
0.9%
|
105
0.9%
|
| Denmark |
95
1.6%
|
100
1.7%
|
195
1.6%
|
| Italy |
43
0.7%
|
40
0.7%
|
83
0.7%
|
| Mexico |
235
3.9%
|
231
3.8%
|
466
3.9%
|
| South Africa |
77
1.3%
|
76
1.3%
|
153
1.3%
|
| Israel |
72
1.2%
|
74
1.2%
|
146
1.2%
|
| Australia |
159
2.6%
|
160
2.6%
|
319
2.6%
|
| Germany |
198
3.3%
|
202
3.3%
|
400
3.3%
|
| Estonia |
30
0.5%
|
29
0.5%
|
59
0.5%
|
Outcome Measures
| Title | Number of Participants With Composite Primary Endpoint of Cardiovascular (CV) Death, Myocardial Infarction (MI), Stroke, Coronary Revascularization, or Hospitalization for Unstable Angina (UA) |
|---|---|
| Description | For component endpoints, the number of participants includes those experiencing fatal events and account for all occurrences regardless of whether or not another component event occurred previously. |
| Time Frame | Baseline to Study Completion (Up to 4 years) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All randomized participants. |
| Arm/Group Title | Evacetrapib | Placebo |
|---|---|---|
| Arm/Group Description | Evacetrapib 130 mg tablet, administered orally once daily for up to 4 years. Participants received standard of care for HRVD. | Placebo, tablet administered orally once daily for up to 4 years. Participants received standard of care for HRVD. |
| Measure Participants | 6038 | 6054 |
| Count of Participants [Participants] |
779
12.9%
|
776
12.8%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Evacetrapib, Placebo |
|---|---|---|
| Comments | Primary Endpoint: Time to First Occurrence of the Composite Primary Endpoint of Cardiovascular (CV) Death, Myocardial Infarction (MI), Stroke, Coronary Revascularization, or Hospitalization for Unstable Angina (UA) | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.9054 |
| Comments | ||
| Method | Regression, Cox | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 1.006 | |
| Confidence Interval |
(2-Sided) 95% 0.911 to 1.111 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Mean Percent Change From Baseline to 3 Months in Low-Density (LDL-C) and High-Density Lipoprotein Cholesterol (HDL-C) Levels |
|---|---|
| Description | |
| Time Frame | Baseline, 3 Months |
Outcome Measure Data
| Analysis Population Description |
|---|
| All randomized participants with evaluable LDL-C and HDL-C levels. |
| Arm/Group Title | Evacetrapib | Placebo |
|---|---|---|
| Arm/Group Description | Evacetrapib 130 mg tablet, administered orally once daily for up to 4 years. Participants received standard of care for HRVD. | Placebo, tablet administered orally once daily for up to 4 years. Participants received standard of care for HRVD. |
| Measure Participants | 6038 | 6054 |
| LDL-C |
-31.12
(27.583)
|
5.99
(29.007)
|
| HDL-C |
133.18
(57.204)
|
1.63
(17.455)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Evacetrapib, Placebo |
|---|---|---|
| Comments | LDL-C | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -37.11 | |
| Confidence Interval |
(2-Sided) 95% -38.15 to -36.08 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Evacetrapib, Placebo |
|---|---|---|
| Comments | HDL-C | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 131.55 | |
| Confidence Interval |
(2-Sided) 95% 130.01 to 133.09 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Number of Participants With Composite Endpoint of All-Cause Mortality, MI, Stroke, Coronary Revascularization, or Hospitalization for UA |
|---|---|
| Description | For component endpoints, the number of participants includes those experiencing fatal events and account for all occurrences regardless of whether or not another component event occurred previously. |
| Time Frame | Baseline through End of Study (Up to 4 years) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All randomized participants. |
| Arm/Group Title | Evacetrapib | Placebo |
|---|---|---|
| Arm/Group Description | Evacetrapib 130 mg tablet, administered orally once daily for up to 4 years. Participants received standard of care for HRVD. | Placebo, tablet administered orally once daily for up to 4 years. Participants received standard of care for HRVD. |
| Measure Participants | 6038 | 6054 |
| Count of Participants [Participants] |
857
14.2%
|
867
14.3%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Evacetrapib, Placebo |
|---|---|---|
| Comments | Time to First Occurrence of the Composite Endpoint of All-Cause Mortality, MI, Stroke, Coronary Revascularization, or Hospitalization for UA | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.8463 |
| Comments | ||
| Method | Regression, Cox | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.991 | |
| Confidence Interval |
(2-Sided) 95% 0.901 to 1.089 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Number of Participants With Composite Endpoint of CV Death, MI, or Coronary Revascularization |
|---|---|
| Description | For component endpoints, the number of participants includes those experiencing fatal events and account for all occurrences regardless of whether or not another component event occurred previously. |
| Time Frame | Baseline through End of Study (Up to 4 years) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All randomized participants. |
| Arm/Group Title | Evacetrapib | Placebo |
|---|---|---|
| Arm/Group Description | Evacetrapib 130 mg tablet, administered orally once daily for up to 4 years. Participants received standard of care for HRVD. | Placebo, tablet administered orally once daily for up to 4 years. Participants received standard of care for HRVD. |
| Measure Participants | 6038 | 6054 |
| Count of Participants [Participants] |
690
11.4%
|
691
11.4%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Evacetrapib, Placebo |
|---|---|---|
| Comments | Time to First Occurrence of the Composite Endpoint of CV Death, MI, or Coronary Revascularization | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.9874 |
| Comments | ||
| Method | Regression, Cox | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 1.001 | |
| Confidence Interval |
(2-Sided) 95% 0.901 to 1.112 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Number of Participants With Composite Endpoint of CV Death, MI, Stroke, or Hospitalization for UA |
|---|---|
| Description | For component endpoints, the number of participants includes those experiencing fatal events and account for all occurrences regardless of whether or not another component event occurred previously. |
| Time Frame | Baseline through End of Study (Up to 4 years) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All randomized participants. |
| Arm/Group Title | Evacetrapib | Placebo |
|---|---|---|
| Arm/Group Description | Evacetrapib 130 mg tablet, administered orally once daily for up to 4 years. Participants received standard of care for HRVD. | Placebo, tablet administered orally once daily for up to 4 years. Participants received standard of care for HRVD. |
| Measure Participants | 6038 | 6054 |
| Count of Participants [Participants] |
571
9.5%
|
570
9.4%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Evacetrapib, Placebo |
|---|---|---|
| Comments | Time to First Occurrence of the Composite Endpoint of CV Death, MI, Stroke, or Hospitalization for UA | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.9574 |
| Comments | ||
| Method | Regression, Cox | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 1.003 | |
| Confidence Interval |
(2-Sided) 95% 0.893 to 1.127 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Number of Participants With Triple Composite Endpoint of CV Death, MI, or Stroke |
|---|---|
| Description | For component endpoints, the number of participants includes those experiencing fatal events and account for all occurrences regardless of whether or not another component event occurred previously. |
| Time Frame | Baseline through End of Study (Up to 4 years) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All randomized participants. |
| Arm/Group Title | Evacetrapib | Placebo |
|---|---|---|
| Arm/Group Description | Evacetrapib 130 mg tablet, administered orally once daily for up to 4 years. Participants received standard of care for HRVD. | Placebo, tablet administered orally once daily for up to 4 years. Participants received standard of care for HRVD. |
| Measure Participants | 6038 | 6054 |
| Count of Participants [Participants] |
437
7.2%
|
453
7.5%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Evacetrapib, Placebo |
|---|---|---|
| Comments | Time to First Occurrence of Triple Composite Endpoint of CV Death, MI, or Stroke | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.5917 |
| Comments | ||
| Method | Regression, Cox | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.965 | |
| Confidence Interval |
(2-Sided) 95% 0.846 to 1.100 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Adverse Events
| Time Frame | ||||
|---|---|---|---|---|
| Adverse Event Reporting Description | All randomized participants who received at least one dose of study drug. 4 participants were randomized but never took drug and were not in the safety population. 2 females were assigned to evacetrapib and 2 males were assigned to placebo. | |||
| Arm/Group Title | Evacetrapib | Placebo | ||
| Arm/Group Description | Evacetrapib 130 mg tablet, administered orally once daily for up to 4 years. Participants received standard of care for HRVD. | Placebo, tablet administered orally once daily for up to 4 years. Participants received standard of care for HRVD. | ||
All Cause Mortality |
||||
| Evacetrapib | Placebo | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Evacetrapib | Placebo | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 2306/6036 (38.2%) | 2341/6052 (38.7%) | ||
| Blood and lymphatic system disorders | ||||
| Anaemia | 30/6036 (0.5%) | 31 | 38/6052 (0.6%) | 46 |
| Aplastic anaemia | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Coagulopathy | 0/6036 (0%) | 0 | 2/6052 (0%) | 2 |
| Cytopenia | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Disseminated intravascular coagulation | 1/6036 (0%) | 1 | 3/6052 (0%) | 3 |
| Febrile neutropenia | 3/6036 (0%) | 4 | 0/6052 (0%) | 0 |
| Haemorrhagic anaemia | 1/6036 (0%) | 1 | 5/6052 (0.1%) | 6 |
| Heparin-induced thrombocytopenia | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Immune thrombocytopenic purpura | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Iron deficiency anaemia | 2/6036 (0%) | 2 | 5/6052 (0.1%) | 5 |
| Leukocytosis | 0/6036 (0%) | 0 | 4/6052 (0.1%) | 4 |
| Lymphadenitis | 2/6036 (0%) | 2 | 1/6052 (0%) | 1 |
| Lymphadenopathy | 1/6036 (0%) | 1 | 1/6052 (0%) | 1 |
| Lymphadenopathy mediastinal | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Microcytic anaemia | 3/6036 (0%) | 3 | 2/6052 (0%) | 2 |
| Normochromic normocytic anaemia | 0/6036 (0%) | 0 | 2/6052 (0%) | 2 |
| Pancytopenia | 2/6036 (0%) | 2 | 2/6052 (0%) | 2 |
| Pernicious anaemia | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Splenic infarction | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Spontaneous haemorrhage | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Thrombocytopenia | 0/6036 (0%) | 0 | 3/6052 (0%) | 3 |
| Cardiac disorders | ||||
| Acute coronary syndrome | 9/6036 (0.1%) | 9 | 4/6052 (0.1%) | 4 |
| Acute myocardial infarction | 146/6036 (2.4%) | 168 | 137/6052 (2.3%) | 149 |
| Adams-stokes syndrome | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Angina pectoris | 102/6036 (1.7%) | 113 | 98/6052 (1.6%) | 103 |
| Angina unstable | 298/6036 (4.9%) | 389 | 289/6052 (4.8%) | 363 |
| Aortic valve disease | 4/6036 (0.1%) | 4 | 1/6052 (0%) | 1 |
| Aortic valve incompetence | 0/6036 (0%) | 0 | 2/6052 (0%) | 2 |
| Aortic valve sclerosis | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Aortic valve stenosis | 7/6036 (0.1%) | 7 | 6/6052 (0.1%) | 8 |
| Arrhythmia | 5/6036 (0.1%) | 5 | 3/6052 (0%) | 3 |
| Arteriosclerosis coronary artery | 2/6036 (0%) | 3 | 1/6052 (0%) | 1 |
| Arteriospasm coronary | 1/6036 (0%) | 1 | 1/6052 (0%) | 2 |
| Atrial fibrillation | 86/6036 (1.4%) | 109 | 78/6052 (1.3%) | 94 |
| Atrial flutter | 25/6036 (0.4%) | 27 | 16/6052 (0.3%) | 18 |
| Atrial tachycardia | 0/6036 (0%) | 0 | 2/6052 (0%) | 2 |
| Atrial thrombosis | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Atrioventricular block | 5/6036 (0.1%) | 5 | 3/6052 (0%) | 3 |
| Atrioventricular block complete | 8/6036 (0.1%) | 8 | 6/6052 (0.1%) | 6 |
| Atrioventricular block second degree | 6/6036 (0.1%) | 6 | 1/6052 (0%) | 1 |
| Bradyarrhythmia | 0/6036 (0%) | 0 | 5/6052 (0.1%) | 5 |
| Bradycardia | 8/6036 (0.1%) | 8 | 11/6052 (0.2%) | 11 |
| Cardiac arrest | 17/6036 (0.3%) | 18 | 30/6052 (0.5%) | 32 |
| Cardiac discomfort | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Cardiac failure | 67/6036 (1.1%) | 79 | 63/6052 (1%) | 78 |
| Cardiac failure acute | 11/6036 (0.2%) | 13 | 9/6052 (0.1%) | 9 |
| Cardiac failure chronic | 7/6036 (0.1%) | 7 | 10/6052 (0.2%) | 12 |
| Cardiac failure congestive | 95/6036 (1.6%) | 134 | 103/6052 (1.7%) | 138 |
| Cardiac tamponade | 2/6036 (0%) | 2 | 1/6052 (0%) | 1 |
| Cardio-respiratory arrest | 5/6036 (0.1%) | 5 | 6/6052 (0.1%) | 7 |
| Cardiogenic shock | 8/6036 (0.1%) | 8 | 7/6052 (0.1%) | 7 |
| Cardiomyopathy | 1/6036 (0%) | 1 | 5/6052 (0.1%) | 5 |
| Cardiopulmonary failure | 3/6036 (0%) | 3 | 0/6052 (0%) | 0 |
| Cardiorenal syndrome | 2/6036 (0%) | 2 | 1/6052 (0%) | 1 |
| Cardiovascular insufficiency | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Chronotropic incompetence | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Conduction disorder | 4/6036 (0.1%) | 4 | 1/6052 (0%) | 1 |
| Congestive cardiomyopathy | 1/6036 (0%) | 1 | 2/6052 (0%) | 2 |
| Coronary artery disease | 37/6036 (0.6%) | 40 | 44/6052 (0.7%) | 45 |
| Coronary artery dissection | 2/6036 (0%) | 2 | 0/6052 (0%) | 0 |
| Coronary artery occlusion | 3/6036 (0%) | 3 | 6/6052 (0.1%) | 6 |
| Coronary artery stenosis | 7/6036 (0.1%) | 7 | 6/6052 (0.1%) | 7 |
| Diastolic dysfunction | 2/6036 (0%) | 2 | 1/6052 (0%) | 1 |
| Dressler's syndrome | 1/6036 (0%) | 1 | 2/6052 (0%) | 2 |
| Extrasystoles | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Hypertensive heart disease | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Intracardiac thrombus | 1/6036 (0%) | 1 | 1/6052 (0%) | 1 |
| Ischaemic cardiomyopathy | 7/6036 (0.1%) | 7 | 10/6052 (0.2%) | 11 |
| Left ventricular dysfunction | 5/6036 (0.1%) | 6 | 3/6052 (0%) | 4 |
| Left ventricular failure | 0/6036 (0%) | 0 | 4/6052 (0.1%) | 4 |
| Microvascular coronary artery disease | 0/6036 (0%) | 0 | 2/6052 (0%) | 2 |
| Mitral valve incompetence | 3/6036 (0%) | 4 | 4/6052 (0.1%) | 6 |
| Mitral valve stenosis | 1/6036 (0%) | 1 | 1/6052 (0%) | 1 |
| Myocardial infarction | 82/6036 (1.4%) | 88 | 100/6052 (1.7%) | 107 |
| Myocardial ischaemia | 15/6036 (0.2%) | 16 | 9/6052 (0.1%) | 9 |
| Myocardial rupture | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Nodal rhythm | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Palpitations | 6/6036 (0.1%) | 6 | 2/6052 (0%) | 2 |
| Pericardial effusion | 1/6036 (0%) | 1 | 2/6052 (0%) | 2 |
| Pericardial haemorrhage | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Pericarditis | 5/6036 (0.1%) | 5 | 2/6052 (0%) | 2 |
| Postinfarction angina | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Prinzmetal angina | 0/6036 (0%) | 0 | 2/6052 (0%) | 2 |
| Right ventricular failure | 3/6036 (0%) | 3 | 2/6052 (0%) | 2 |
| Sinus arrest | 2/6036 (0%) | 2 | 1/6052 (0%) | 1 |
| Sinus bradycardia | 0/6036 (0%) | 0 | 3/6052 (0%) | 3 |
| Sinus node dysfunction | 12/6036 (0.2%) | 12 | 9/6052 (0.1%) | 9 |
| Sinus tachycardia | 2/6036 (0%) | 2 | 0/6052 (0%) | 0 |
| Stress cardiomyopathy | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Supraventricular tachycardia | 3/6036 (0%) | 3 | 6/6052 (0.1%) | 6 |
| Systolic dysfunction | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Tachyarrhythmia | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Tachycardia | 1/6036 (0%) | 1 | 1/6052 (0%) | 1 |
| Ventricle rupture | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Ventricular arrhythmia | 4/6036 (0.1%) | 4 | 2/6052 (0%) | 2 |
| Ventricular extrasystoles | 1/6036 (0%) | 1 | 4/6052 (0.1%) | 4 |
| Ventricular fibrillation | 7/6036 (0.1%) | 7 | 10/6052 (0.2%) | 10 |
| Ventricular hypokinesia | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Ventricular tachyarrhythmia | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Ventricular tachycardia | 16/6036 (0.3%) | 21 | 24/6052 (0.4%) | 24 |
| Wolff-parkinson-white syndrome | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Congenital, familial and genetic disorders | ||||
| Arteriovenous malformation | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Atrial septal defect | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Dermoid cyst | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Hydrocele | 0/6036 (0%) | 0 | 2/4658 (0%) | 2 |
| Hypertrophic cardiomyopathy | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Leukodystrophy | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Phimosis | 0/6036 (0%) | 0 | 1/4658 (0%) | 1 |
| Ear and labyrinth disorders | ||||
| Conductive deafness | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Deafness neurosensory | 1/6036 (0%) | 1 | 1/6052 (0%) | 1 |
| Ear pain | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Eustachian tube dysfunction | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Meniere's disease | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Otosclerosis | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Tinnitus | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Vertigo | 7/6036 (0.1%) | 7 | 15/6052 (0.2%) | 15 |
| Vertigo positional | 5/6036 (0.1%) | 5 | 2/6052 (0%) | 2 |
| Endocrine disorders | ||||
| Autoimmune thyroiditis | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Goitre | 1/6036 (0%) | 1 | 3/6052 (0%) | 3 |
| Hyperparathyroidism | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Hyperparathyroidism primary | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Eye disorders | ||||
| Age-related macular degeneration | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Cataract | 15/6036 (0.2%) | 19 | 14/6052 (0.2%) | 14 |
| Cataract nuclear | 2/6036 (0%) | 2 | 2/6052 (0%) | 3 |
| Conjunctival haemorrhage | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Diabetic retinopathy | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Diplopia | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Ectropion | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Entropion | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Eye haemorrhage | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Eye pain | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Eyelid ptosis | 3/6036 (0%) | 3 | 1/6052 (0%) | 1 |
| Glaucoma | 3/6036 (0%) | 3 | 2/6052 (0%) | 3 |
| Idiopathic orbital inflammation | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Iridocyclitis | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Iritis | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Keratitis | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Keratopathy | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Lens dislocation | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Macular fibrosis | 1/6036 (0%) | 1 | 1/6052 (0%) | 1 |
| Open angle glaucoma | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Optic atrophy | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Optic ischaemic neuropathy | 0/6036 (0%) | 0 | 2/6052 (0%) | 2 |
| Optic neuropathy | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Retinal artery occlusion | 1/6036 (0%) | 1 | 1/6052 (0%) | 1 |
| Retinal detachment | 2/6036 (0%) | 2 | 2/6052 (0%) | 2 |
| Retinal haemorrhage | 1/6036 (0%) | 1 | 1/6052 (0%) | 1 |
| Retinopathy | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Visual acuity reduced | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Visual impairment | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Vitreous haemorrhage | 1/6036 (0%) | 1 | 1/6052 (0%) | 1 |
| Gastrointestinal disorders | ||||
| Abdominal adhesions | 1/6036 (0%) | 1 | 1/6052 (0%) | 1 |
| Abdominal compartment syndrome | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Abdominal distension | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Abdominal hernia | 2/6036 (0%) | 2 | 3/6052 (0%) | 3 |
| Abdominal mass | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Abdominal pain | 18/6036 (0.3%) | 20 | 8/6052 (0.1%) | 8 |
| Abdominal pain upper | 5/6036 (0.1%) | 5 | 7/6052 (0.1%) | 7 |
| Abdominal strangulated hernia | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Abdominal wall cyst | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Abdominal wall haematoma | 1/6036 (0%) | 1 | 1/6052 (0%) | 1 |
| Alcoholic pancreatitis | 0/6036 (0%) | 0 | 2/6052 (0%) | 4 |
| Anal haemorrhage | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Ascites | 0/6036 (0%) | 0 | 2/6052 (0%) | 2 |
| Chronic gastritis | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Coeliac artery stenosis | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Colitis | 5/6036 (0.1%) | 5 | 9/6052 (0.1%) | 9 |
| Colitis ischaemic | 4/6036 (0.1%) | 4 | 6/6052 (0.1%) | 7 |
| Colitis microscopic | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Colitis ulcerative | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Colonic fistula | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Constipation | 5/6036 (0.1%) | 5 | 8/6052 (0.1%) | 8 |
| Crohn's disease | 1/6036 (0%) | 2 | 0/6052 (0%) | 0 |
| Diarrhoea | 6/6036 (0.1%) | 7 | 4/6052 (0.1%) | 4 |
| Dieulafoy's vascular malformation | 0/6036 (0%) | 0 | 2/6052 (0%) | 2 |
| Diverticular perforation | 1/6036 (0%) | 1 | 1/6052 (0%) | 1 |
| Diverticulum | 1/6036 (0%) | 1 | 1/6052 (0%) | 1 |
| Diverticulum intestinal | 2/6036 (0%) | 2 | 0/6052 (0%) | 0 |
| Diverticulum intestinal haemorrhagic | 5/6036 (0.1%) | 5 | 2/6052 (0%) | 2 |
| Duodenal stenosis | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Duodenal ulcer | 3/6036 (0%) | 3 | 3/6052 (0%) | 3 |
| Duodenal ulcer haemorrhage | 0/6036 (0%) | 0 | 3/6052 (0%) | 3 |
| Duodenal ulcer perforation | 0/6036 (0%) | 0 | 3/6052 (0%) | 3 |
| Duodenitis | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Dyspepsia | 0/6036 (0%) | 0 | 2/6052 (0%) | 2 |
| Dysphagia | 0/6036 (0%) | 0 | 2/6052 (0%) | 2 |
| Enteritis | 2/6036 (0%) | 2 | 1/6052 (0%) | 1 |
| Enterocolitis | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Enterovesical fistula | 1/6036 (0%) | 1 | 1/6052 (0%) | 1 |
| Erosive oesophagitis | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Faecal incontinence | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Faecaloma | 0/6036 (0%) | 0 | 4/6052 (0.1%) | 4 |
| Femoral hernia | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Food poisoning | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Gastric cyst | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Gastric disorder | 1/6036 (0%) | 1 | 1/6052 (0%) | 1 |
| Gastric haemorrhage | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Gastric polyps | 2/6036 (0%) | 2 | 0/6052 (0%) | 0 |
| Gastric ulcer | 6/6036 (0.1%) | 6 | 7/6052 (0.1%) | 7 |
| Gastric ulcer haemorrhage | 1/6036 (0%) | 1 | 2/6052 (0%) | 2 |
| Gastric ulcer perforation | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Gastritis | 10/6036 (0.2%) | 10 | 10/6052 (0.2%) | 10 |
| Gastritis alcoholic | 0/6036 (0%) | 0 | 1/6052 (0%) | 3 |
| Gastritis erosive | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Gastritis haemorrhagic | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Gastrointestinal angiodysplasia | 1/6036 (0%) | 1 | 2/6052 (0%) | 2 |
| Gastrointestinal angiodysplasia haemorrhagic | 0/6036 (0%) | 0 | 3/6052 (0%) | 3 |
| Gastrointestinal disorder | 1/6036 (0%) | 2 | 0/6052 (0%) | 0 |
| Gastrointestinal haemorrhage | 32/6036 (0.5%) | 32 | 26/6052 (0.4%) | 32 |
| Gastrointestinal inflammation | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Gastrointestinal ulcer haemorrhage | 1/6036 (0%) | 1 | 1/6052 (0%) | 1 |
| Gastrooesophageal reflux disease | 13/6036 (0.2%) | 13 | 11/6052 (0.2%) | 11 |
| Gingival bleeding | 0/6036 (0%) | 0 | 1/6052 (0%) | 2 |
| Glossitis | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Haematemesis | 3/6036 (0%) | 3 | 1/6052 (0%) | 1 |
| Haematochezia | 3/6036 (0%) | 3 | 1/6052 (0%) | 1 |
| Haemorrhoidal haemorrhage | 2/6036 (0%) | 2 | 1/6052 (0%) | 1 |
| Haemorrhoids | 4/6036 (0.1%) | 4 | 2/6052 (0%) | 2 |
| Heyde's syndrome | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Hiatus hernia | 4/6036 (0.1%) | 4 | 2/6052 (0%) | 2 |
| Ileus | 5/6036 (0.1%) | 5 | 5/6052 (0.1%) | 5 |
| Impaired gastric emptying | 2/6036 (0%) | 3 | 1/6052 (0%) | 1 |
| Inguinal hernia | 15/6036 (0.2%) | 15 | 13/6052 (0.2%) | 14 |
| Intestinal haemorrhage | 1/6036 (0%) | 1 | 1/6052 (0%) | 1 |
| Intestinal infarction | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Intestinal ischaemia | 5/6036 (0.1%) | 6 | 1/6052 (0%) | 1 |
| Intestinal obstruction | 2/6036 (0%) | 2 | 6/6052 (0.1%) | 6 |
| Intestinal perforation | 2/6036 (0%) | 2 | 3/6052 (0%) | 3 |
| Intestinal prolapse | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Intra-abdominal haematoma | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Intra-abdominal haemorrhage | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Irritable bowel syndrome | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Jejunal perforation | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Large intestinal haemorrhage | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Large intestinal obstruction | 1/6036 (0%) | 1 | 1/6052 (0%) | 1 |
| Large intestinal stenosis | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Large intestine perforation | 2/6036 (0%) | 2 | 2/6052 (0%) | 2 |
| Large intestine polyp | 6/6036 (0.1%) | 7 | 11/6052 (0.2%) | 12 |
| Localised intraabdominal fluid collection | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Lower gastrointestinal haemorrhage | 6/6036 (0.1%) | 6 | 4/6052 (0.1%) | 4 |
| Mallory-weiss syndrome | 0/6036 (0%) | 0 | 2/6052 (0%) | 2 |
| Melaena | 3/6036 (0%) | 3 | 3/6052 (0%) | 3 |
| Mesenteric vascular insufficiency | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Mouth haemorrhage | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Nausea | 8/6036 (0.1%) | 8 | 6/6052 (0.1%) | 6 |
| Odynophagia | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Oedematous pancreatitis | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Oesophageal achalasia | 2/6036 (0%) | 3 | 0/6052 (0%) | 0 |
| Oesophageal oedema | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Oesophageal spasm | 0/6036 (0%) | 0 | 2/6052 (0%) | 2 |
| Oesophageal stenosis | 1/6036 (0%) | 1 | 1/6052 (0%) | 1 |
| Oesophageal ulcer | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Oesophagitis | 0/6036 (0%) | 0 | 2/6052 (0%) | 2 |
| Pancreatic mass | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Pancreatic pseudocyst | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Pancreatitis | 12/6036 (0.2%) | 13 | 10/6052 (0.2%) | 11 |
| Pancreatitis acute | 10/6036 (0.2%) | 10 | 6/6052 (0.1%) | 6 |
| Pancreatitis chronic | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Pancreatitis haemorrhagic | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Pancreatitis necrotising | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Peptic ulcer | 1/6036 (0%) | 1 | 2/6052 (0%) | 2 |
| Peptic ulcer haemorrhage | 2/6036 (0%) | 2 | 0/6052 (0%) | 0 |
| Peritoneal adhesions | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Pneumoperitoneum | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Rectal haemorrhage | 2/6036 (0%) | 2 | 1/6052 (0%) | 1 |
| Rectal polyp | 1/6036 (0%) | 1 | 2/6052 (0%) | 2 |
| Rectal ulcer haemorrhage | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Retroperitoneal effusion | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Retroperitoneal haematoma | 2/6036 (0%) | 2 | 0/6052 (0%) | 0 |
| Retroperitoneal haemorrhage | 1/6036 (0%) | 1 | 2/6052 (0%) | 3 |
| Salivary gland mass | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Small intestinal obstruction | 11/6036 (0.2%) | 12 | 10/6052 (0.2%) | 11 |
| Small intestinal perforation | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Subileus | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Swollen tongue | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Tongue haemorrhage | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Tongue oedema | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Umbilical hernia | 3/6036 (0%) | 3 | 6/6052 (0.1%) | 6 |
| Upper gastrointestinal haemorrhage | 11/6036 (0.2%) | 12 | 10/6052 (0.2%) | 10 |
| Volvulus | 1/6036 (0%) | 1 | 1/6052 (0%) | 1 |
| Vomiting | 9/6036 (0.1%) | 12 | 7/6052 (0.1%) | 7 |
| General disorders | ||||
| Adverse drug reaction | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Asthenia | 5/6036 (0.1%) | 5 | 9/6052 (0.1%) | 9 |
| Cardiac death | 0/6036 (0%) | 0 | 5/6052 (0.1%) | 5 |
| Chest discomfort | 7/6036 (0.1%) | 7 | 12/6052 (0.2%) | 13 |
| Chest pain | 37/6036 (0.6%) | 38 | 34/6052 (0.6%) | 42 |
| Death | 20/6036 (0.3%) | 20 | 14/6052 (0.2%) | 14 |
| Device breakage | 0/6036 (0%) | 0 | 2/6052 (0%) | 2 |
| Device dislocation | 4/6036 (0.1%) | 5 | 1/6052 (0%) | 1 |
| Device end of service | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Device failure | 2/6036 (0%) | 2 | 2/6052 (0%) | 2 |
| Device inappropriate shock delivery | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Device malfunction | 1/6036 (0%) | 1 | 6/6052 (0.1%) | 6 |
| Device material issue | 1/6036 (0%) | 1 | 1/6052 (0%) | 1 |
| Device occlusion | 2/6036 (0%) | 2 | 0/6052 (0%) | 0 |
| Drowning | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Drug withdrawal syndrome | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Exercise tolerance decreased | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Gait disturbance | 2/6036 (0%) | 2 | 1/6052 (0%) | 1 |
| General physical health deterioration | 2/6036 (0%) | 2 | 1/6052 (0%) | 1 |
| Generalised oedema | 3/6036 (0%) | 3 | 0/6052 (0%) | 0 |
| Granuloma | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Hyperthermia | 0/6036 (0%) | 0 | 2/6052 (0%) | 2 |
| Hypertrophy | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Hypothermia | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Impaired healing | 2/6036 (0%) | 2 | 3/6052 (0%) | 3 |
| Implant site haematoma | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Incarcerated hernia | 1/6036 (0%) | 1 | 3/6052 (0%) | 4 |
| Ischaemic ulcer | 0/6036 (0%) | 0 | 2/6052 (0%) | 2 |
| Lead dislodgement | 0/6036 (0%) | 0 | 2/6052 (0%) | 2 |
| Multi-organ failure | 4/6036 (0.1%) | 4 | 6/6052 (0.1%) | 6 |
| Necrobiosis | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Necrosis | 2/6036 (0%) | 2 | 0/6052 (0%) | 0 |
| Non-cardiac chest pain | 107/6036 (1.8%) | 123 | 108/6052 (1.8%) | 118 |
| Oedema | 1/6036 (0%) | 3 | 0/6052 (0%) | 0 |
| Oedema peripheral | 0/6036 (0%) | 0 | 3/6052 (0%) | 3 |
| Pain | 2/6036 (0%) | 2 | 0/6052 (0%) | 0 |
| Pelvic mass | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Peripheral swelling | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Precancerous mucosal lesion | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Pyrexia | 3/6036 (0%) | 3 | 4/6052 (0.1%) | 4 |
| Stent-graft endoleak | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Sudden cardiac death | 16/6036 (0.3%) | 16 | 15/6052 (0.2%) | 15 |
| Sudden death | 2/6036 (0%) | 2 | 1/6052 (0%) | 1 |
| Systemic inflammatory response syndrome | 4/6036 (0.1%) | 4 | 0/6052 (0%) | 0 |
| Thrombosis in device | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Ulcer haemorrhage | 1/6036 (0%) | 1 | 2/6052 (0%) | 2 |
| Vascular stent occlusion | 1/6036 (0%) | 1 | 2/6052 (0%) | 2 |
| Vascular stent restenosis | 6/6036 (0.1%) | 6 | 5/6052 (0.1%) | 6 |
| Vascular stent stenosis | 1/6036 (0%) | 1 | 1/6052 (0%) | 1 |
| Vascular stent thrombosis | 0/6036 (0%) | 0 | 2/6052 (0%) | 2 |
| Vessel puncture site haematoma | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Hepatobiliary disorders | ||||
| Autoimmune hepatitis | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Bile duct obstruction | 1/6036 (0%) | 1 | 1/6052 (0%) | 1 |
| Bile duct stenosis | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Bile duct stone | 5/6036 (0.1%) | 6 | 10/6052 (0.2%) | 11 |
| Biliary colic | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Biliary tract disorder | 1/6036 (0%) | 1 | 2/6052 (0%) | 2 |
| Cholangitis | 1/6036 (0%) | 1 | 4/6052 (0.1%) | 4 |
| Cholangitis acute | 1/6036 (0%) | 1 | 2/6052 (0%) | 2 |
| Cholecystitis | 19/6036 (0.3%) | 20 | 16/6052 (0.3%) | 16 |
| Cholecystitis acute | 12/6036 (0.2%) | 12 | 15/6052 (0.2%) | 16 |
| Cholecystitis chronic | 4/6036 (0.1%) | 4 | 1/6052 (0%) | 1 |
| Cholelithiasis | 23/6036 (0.4%) | 23 | 22/6052 (0.4%) | 23 |
| Cholestasis | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Gallbladder disorder | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Hepatic cirrhosis | 2/6036 (0%) | 2 | 3/6052 (0%) | 3 |
| Hepatic lesion | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Hepatic steatosis | 0/6036 (0%) | 0 | 2/6052 (0%) | 2 |
| Hepatitis alcoholic | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Hepatomegaly | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Hydrocholecystis | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Ischaemic hepatitis | 0/6036 (0%) | 0 | 2/6052 (0%) | 2 |
| Jaundice | 0/6036 (0%) | 0 | 3/6052 (0%) | 3 |
| Jaundice cholestatic | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Jaundice extrahepatic obstructive | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Liver disorder | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Liver injury | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Portal vein thrombosis | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Immune system disorders | ||||
| Anaphylactic reaction | 1/6036 (0%) | 1 | 1/6052 (0%) | 1 |
| Anaphylactic shock | 1/6036 (0%) | 1 | 1/6052 (0%) | 1 |
| Drug hypersensitivity | 1/6036 (0%) | 1 | 1/6052 (0%) | 1 |
| Hypersensitivity | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Infections and infestations | ||||
| Abdominal abscess | 3/6036 (0%) | 3 | 5/6052 (0.1%) | 5 |
| Abdominal infection | 2/6036 (0%) | 2 | 0/6052 (0%) | 0 |
| Abdominal sepsis | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Abdominal wall abscess | 1/6036 (0%) | 1 | 1/6052 (0%) | 1 |
| Abdominal wall infection | 1/6036 (0%) | 2 | 0/6052 (0%) | 0 |
| Abscess | 1/6036 (0%) | 1 | 2/6052 (0%) | 2 |
| Abscess limb | 3/6036 (0%) | 3 | 4/6052 (0.1%) | 4 |
| Abscess neck | 1/6036 (0%) | 1 | 1/6052 (0%) | 1 |
| Abscess of salivary gland | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Abscess oral | 1/6036 (0%) | 1 | 1/6052 (0%) | 1 |
| Acute sinusitis | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Anal abscess | 1/6036 (0%) | 1 | 1/6052 (0%) | 1 |
| Appendicitis | 9/6036 (0.1%) | 9 | 5/6052 (0.1%) | 5 |
| Appendicitis perforated | 1/6036 (0%) | 1 | 2/6052 (0%) | 2 |
| Arteriosclerotic gangrene | 1/6036 (0%) | 2 | 0/6052 (0%) | 0 |
| Arteritis infective | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Arthritis bacterial | 1/6036 (0%) | 1 | 1/6052 (0%) | 1 |
| Atypical pneumonia | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Bacteraemia | 6/6036 (0.1%) | 7 | 5/6052 (0.1%) | 6 |
| Bacterial infection | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Bacterial sepsis | 3/6036 (0%) | 3 | 2/6052 (0%) | 2 |
| Biliary sepsis | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Biliary tract infection | 2/6036 (0%) | 2 | 0/6052 (0%) | 0 |
| Breast cellulitis | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Bronchitis | 25/6036 (0.4%) | 25 | 18/6052 (0.3%) | 18 |
| Bronchitis viral | 1/6036 (0%) | 1 | 1/6052 (0%) | 1 |
| Bursitis infective | 1/6036 (0%) | 1 | 3/6052 (0%) | 3 |
| Cellulitis | 41/6036 (0.7%) | 48 | 42/6052 (0.7%) | 45 |
| Cellulitis staphylococcal | 1/6036 (0%) | 1 | 2/6052 (0%) | 2 |
| Cholangitis infective | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Cholecystitis infective | 5/6036 (0.1%) | 5 | 3/6052 (0%) | 3 |
| Chronic sinusitis | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Clostridium difficile colitis | 1/6036 (0%) | 1 | 8/6052 (0.1%) | 10 |
| Clostridium difficile infection | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Clostridium difficile sepsis | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Colonic abscess | 1/6036 (0%) | 1 | 1/6052 (0%) | 1 |
| Cystitis | 6/6036 (0.1%) | 6 | 2/6052 (0%) | 2 |
| Device related infection | 1/6036 (0%) | 1 | 2/6052 (0%) | 2 |
| Diabetic foot infection | 1/6036 (0%) | 1 | 1/6052 (0%) | 1 |
| Diabetic gangrene | 2/6036 (0%) | 2 | 0/6052 (0%) | 0 |
| Diverticulitis | 13/6036 (0.2%) | 13 | 5/6052 (0.1%) | 5 |
| Endocarditis | 2/6036 (0%) | 4 | 1/6052 (0%) | 2 |
| Endocarditis bacterial | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Endocarditis enterococcal | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Endophthalmitis | 2/6036 (0%) | 2 | 0/6052 (0%) | 0 |
| Enterobacter infection | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Enterococcal bacteraemia | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Enterococcal infection | 0/6036 (0%) | 0 | 2/6052 (0%) | 2 |
| Enterococcal sepsis | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Epididymitis | 1/4648 (0%) | 1 | 1/4658 (0%) | 1 |
| Erysipelas | 6/6036 (0.1%) | 8 | 5/6052 (0.1%) | 5 |
| Escherichia bacteraemia | 2/6036 (0%) | 2 | 0/6052 (0%) | 0 |
| Escherichia infection | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Escherichia pyelonephritis | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Escherichia sepsis | 0/6036 (0%) | 0 | 2/6052 (0%) | 2 |
| Escherichia urinary tract infection | 1/6036 (0%) | 1 | 2/6052 (0%) | 2 |
| Extradural abscess | 1/6036 (0%) | 1 | 1/6052 (0%) | 1 |
| Febrile infection | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Folliculitis | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Gallbladder abscess | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Gallbladder empyema | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Gangrene | 7/6036 (0.1%) | 7 | 11/6052 (0.2%) | 14 |
| Gastritis viral | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Gastroenteritis | 16/6036 (0.3%) | 19 | 16/6052 (0.3%) | 16 |
| Gastroenteritis norovirus | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Gastroenteritis viral | 8/6036 (0.1%) | 8 | 3/6052 (0%) | 3 |
| Giardiasis | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Graft infection | 2/6036 (0%) | 2 | 1/6052 (0%) | 1 |
| Groin abscess | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| H1n1 influenza | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Haematoma infection | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Hepatitis c | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Hepatitis viral | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Herpes zoster | 2/6036 (0%) | 2 | 2/6052 (0%) | 2 |
| Implant site cellulitis | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Implant site infection | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Incision site infection | 2/6036 (0%) | 2 | 0/6052 (0%) | 0 |
| Infected bite | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Infected fistula | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Infected seroma | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Infected skin ulcer | 4/6036 (0.1%) | 4 | 1/6052 (0%) | 1 |
| Infection | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Infectious colitis | 1/6036 (0%) | 1 | 1/6052 (0%) | 1 |
| Infectious pleural effusion | 0/6036 (0%) | 0 | 2/6052 (0%) | 2 |
| Infective exacerbation of chronic obstructive airways disease | 1/6036 (0%) | 1 | 3/6052 (0%) | 4 |
| Influenza | 11/6036 (0.2%) | 11 | 9/6052 (0.1%) | 9 |
| Infusion site cellulitis | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Infusion site infection | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Intervertebral discitis | 2/6036 (0%) | 2 | 0/6052 (0%) | 0 |
| Keratitis bacterial | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Klebsiella sepsis | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Liver abscess | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Localised infection | 2/6036 (0%) | 2 | 4/6052 (0.1%) | 5 |
| Lower respiratory tract infection | 2/6036 (0%) | 3 | 7/6052 (0.1%) | 7 |
| Lung abscess | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Lung infection | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Mastoiditis | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Mediastinitis | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Myelitis | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Nail bed infection | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Necrotising fasciitis | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Oesophageal candidiasis | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Orbital infection | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Osteomyelitis | 13/6036 (0.2%) | 15 | 5/6052 (0.1%) | 6 |
| Osteomyelitis acute | 1/6036 (0%) | 1 | 1/6052 (0%) | 1 |
| Osteomyelitis bacterial | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Osteomyelitis chronic | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Parainfluenzae virus infection | 1/6036 (0%) | 1 | 1/6052 (0%) | 1 |
| Parotitis | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Parvovirus infection | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Pelvic abscess | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Penile abscess | 1/4648 (0%) | 1 | 0/6052 (0%) | 0 |
| Perihepatic abscess | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Periodontitis | 1/6036 (0%) | 1 | 1/6052 (0%) | 1 |
| Perirectal abscess | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Peritonitis | 3/6036 (0%) | 3 | 1/6052 (0%) | 1 |
| Peritonitis bacterial | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Peritonsillar abscess | 0/6036 (0%) | 0 | 2/6052 (0%) | 2 |
| Pharyngitis | 0/6036 (0%) | 0 | 2/6052 (0%) | 2 |
| Pilonidal cyst | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Pneumonia | 115/6036 (1.9%) | 128 | 112/6052 (1.9%) | 122 |
| Pneumonia bacterial | 2/6036 (0%) | 2 | 6/6052 (0.1%) | 6 |
| Pneumonia chlamydial | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Pneumonia fungal | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Pneumonia influenzal | 2/6036 (0%) | 3 | 0/6052 (0%) | 0 |
| Pneumonia legionella | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Pneumonia parainfluenzae viral | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Pneumonia pneumococcal | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Pneumonia staphylococcal | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Pneumonia streptococcal | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Pneumonia viral | 1/6036 (0%) | 1 | 1/6052 (0%) | 1 |
| Post procedural cellulitis | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Post procedural infection | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Post procedural sepsis | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Postoperative abscess | 0/6036 (0%) | 0 | 2/6052 (0%) | 2 |
| Postoperative wound infection | 4/6036 (0.1%) | 4 | 6/6052 (0.1%) | 6 |
| Pulmonary sepsis | 0/6036 (0%) | 0 | 2/6052 (0%) | 2 |
| Pulmonary tuberculosis | 1/6036 (0%) | 1 | 2/6052 (0%) | 2 |
| Pyelonephritis | 7/6036 (0.1%) | 7 | 4/6052 (0.1%) | 4 |
| Pyelonephritis acute | 2/6036 (0%) | 2 | 1/6052 (0%) | 1 |
| Pyelonephritis chronic | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Respiratory syncytial virus infection | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Respiratory tract infection | 2/6036 (0%) | 2 | 3/6052 (0%) | 4 |
| Respiratory tract infection viral | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Rhinovirus infection | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Salmonellosis | 2/6036 (0%) | 2 | 0/6052 (0%) | 0 |
| Sepsis | 44/6036 (0.7%) | 49 | 28/6052 (0.5%) | 32 |
| Septic shock | 10/6036 (0.2%) | 10 | 7/6052 (0.1%) | 7 |
| Sialoadenitis | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Sinusitis | 2/6036 (0%) | 2 | 2/6052 (0%) | 2 |
| Sinusitis fungal | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Skin candida | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Soft tissue infection | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Spinal cord abscess | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Staphylococcal bacteraemia | 1/6036 (0%) | 1 | 3/6052 (0%) | 3 |
| Staphylococcal infection | 6/6036 (0.1%) | 6 | 1/6052 (0%) | 1 |
| Staphylococcal mediastinitis | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Staphylococcal sepsis | 0/6036 (0%) | 0 | 2/6052 (0%) | 2 |
| Streptococcal bacteraemia | 2/6036 (0%) | 2 | 3/6052 (0%) | 3 |
| Streptococcal sepsis | 2/6036 (0%) | 2 | 1/6052 (0%) | 1 |
| Subcutaneous abscess | 1/6036 (0%) | 1 | 1/6052 (0%) | 2 |
| Tooth infection | 1/6036 (0%) | 1 | 1/6052 (0%) | 1 |
| Tracheobronchitis | 3/6036 (0%) | 3 | 1/6052 (0%) | 1 |
| Upper respiratory tract infection | 3/6036 (0%) | 3 | 2/6052 (0%) | 2 |
| Urinary tract infection | 19/6036 (0.3%) | 22 | 32/6052 (0.5%) | 36 |
| Urinary tract infection bacterial | 2/6036 (0%) | 2 | 1/6052 (0%) | 1 |
| Urinary tract infection pseudomonal | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Urosepsis | 16/6036 (0.3%) | 17 | 14/6052 (0.2%) | 14 |
| Vestibular neuronitis | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Viral infection | 0/6036 (0%) | 0 | 3/6052 (0%) | 3 |
| Viral labyrinthitis | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Wound abscess | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Wound infection | 4/6036 (0.1%) | 4 | 7/6052 (0.1%) | 8 |
| Wound infection bacterial | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Wound infection staphylococcal | 2/6036 (0%) | 2 | 1/6052 (0%) | 1 |
| Injury, poisoning and procedural complications | ||||
| Abdominal wound dehiscence | 1/6036 (0%) | 1 | 1/6052 (0%) | 1 |
| Accident | 2/6036 (0%) | 2 | 1/6052 (0%) | 1 |
| Accidental exposure to product | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Accidental overdose | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Acetabulum fracture | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Alcohol poisoning | 1/6036 (0%) | 1 | 3/6052 (0%) | 3 |
| Anaemia postoperative | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Anal injury | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Anastomotic stenosis | 1/6036 (0%) | 1 | 1/6052 (0%) | 1 |
| Anastomotic ulcer haemorrhage | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Ankle fracture | 9/6036 (0.1%) | 9 | 5/6052 (0.1%) | 5 |
| Back injury | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Brain contusion | 1/6036 (0%) | 1 | 1/6052 (0%) | 1 |
| Cartilage injury | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Cervical vertebral fracture | 2/6036 (0%) | 2 | 3/6052 (0%) | 3 |
| Chemical burn of skin | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Chemical injury | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Chest injury | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Clavicle fracture | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Colon injury | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Compression fracture | 1/6036 (0%) | 1 | 1/6052 (0%) | 1 |
| Concussion | 4/6036 (0.1%) | 4 | 1/6052 (0%) | 1 |
| Contrast media reaction | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Contusion | 4/6036 (0.1%) | 4 | 4/6052 (0.1%) | 4 |
| Coronary artery restenosis | 0/6036 (0%) | 0 | 2/6052 (0%) | 2 |
| Craniocerebral injury | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Crush injury | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Cystitis radiation | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Extradural haematoma | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Eye injury | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Facial bones fracture | 3/6036 (0%) | 3 | 1/6052 (0%) | 1 |
| Fall | 39/6036 (0.6%) | 40 | 50/6052 (0.8%) | 53 |
| Femoral neck fracture | 2/6036 (0%) | 2 | 6/6052 (0.1%) | 6 |
| Femur fracture | 6/6036 (0.1%) | 6 | 6/6052 (0.1%) | 6 |
| Fibula fracture | 2/6036 (0%) | 2 | 2/6052 (0%) | 2 |
| Foot fracture | 2/6036 (0%) | 2 | 2/6052 (0%) | 2 |
| Foreign body | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Fracture | 1/6036 (0%) | 2 | 0/6052 (0%) | 0 |
| Fractured sacrum | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Gastrointestinal anastomotic complication | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Gastrointestinal injury | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Gastrointestinal stoma complication | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Graft thrombosis | 2/6036 (0%) | 3 | 3/6052 (0%) | 3 |
| Gun shot wound | 1/6036 (0%) | 1 | 1/6052 (0%) | 1 |
| Hand fracture | 1/6036 (0%) | 1 | 2/6052 (0%) | 2 |
| Head injury | 6/6036 (0.1%) | 6 | 3/6052 (0%) | 3 |
| Heat illness | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Hip fracture | 6/6036 (0.1%) | 6 | 7/6052 (0.1%) | 7 |
| Humerus fracture | 3/6036 (0%) | 3 | 4/6052 (0.1%) | 4 |
| Incisional hernia | 4/6036 (0.1%) | 4 | 2/6052 (0%) | 2 |
| Injury | 2/6036 (0%) | 2 | 1/6052 (0%) | 1 |
| Intentional overdose | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Jaw fracture | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Joint dislocation | 5/6036 (0.1%) | 6 | 2/6052 (0%) | 2 |
| Joint injury | 2/6036 (0%) | 2 | 3/6052 (0%) | 3 |
| Laceration | 2/6036 (0%) | 2 | 2/6052 (0%) | 2 |
| Ligament injury | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Ligament sprain | 2/6036 (0%) | 3 | 0/6052 (0%) | 0 |
| Limb traumatic amputation | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Lower limb fracture | 4/6036 (0.1%) | 6 | 2/6052 (0%) | 2 |
| Lumbar vertebral fracture | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Meniscus injury | 2/6036 (0%) | 2 | 4/6052 (0.1%) | 4 |
| Multiple fractures | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Multiple injuries | 0/6036 (0%) | 0 | 3/6052 (0%) | 4 |
| Muscle contusion | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Muscle injury | 1/6036 (0%) | 1 | 1/6052 (0%) | 1 |
| Muscle rupture | 0/6036 (0%) | 0 | 2/6052 (0%) | 2 |
| Nerve root injury lumbar | 2/6036 (0%) | 2 | 0/6052 (0%) | 0 |
| Overdose | 1/6036 (0%) | 1 | 1/6052 (0%) | 1 |
| Patella fracture | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Pelvic fracture | 1/6036 (0%) | 1 | 2/6052 (0%) | 2 |
| Peripheral arterial reocclusion | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Peripheral artery restenosis | 2/6036 (0%) | 2 | 1/6052 (0%) | 1 |
| Periprosthetic fracture | 1/6036 (0%) | 1 | 2/6052 (0%) | 2 |
| Poisoning | 0/6036 (0%) | 0 | 2/6052 (0%) | 2 |
| Post concussion syndrome | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Post laminectomy syndrome | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Post procedural bile leak | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Post procedural complication | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Post procedural haematoma | 2/6036 (0%) | 2 | 1/6052 (0%) | 1 |
| Post procedural haemorrhage | 4/6036 (0.1%) | 4 | 4/6052 (0.1%) | 4 |
| Post procedural myocardial infarction | 5/6036 (0.1%) | 6 | 3/6052 (0%) | 3 |
| Post procedural stroke | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Postoperative fever | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Postoperative ileus | 2/6036 (0%) | 2 | 1/6052 (0%) | 1 |
| Postoperative respiratory failure | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Postoperative thoracic procedure complication | 1/6036 (0%) | 1 | 2/6052 (0%) | 3 |
| Postoperative wound complication | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Procedural haemorrhage | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Procedural hypotension | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Pubis fracture | 1/6036 (0%) | 1 | 1/6052 (0%) | 1 |
| Pulmonary contusion | 1/6036 (0%) | 1 | 2/6052 (0%) | 2 |
| Radius fracture | 2/6036 (0%) | 2 | 1/6052 (0%) | 1 |
| Rib fracture | 5/6036 (0.1%) | 5 | 8/6052 (0.1%) | 8 |
| Road traffic accident | 15/6036 (0.2%) | 15 | 15/6052 (0.2%) | 15 |
| Seroma | 1/6036 (0%) | 1 | 2/6052 (0%) | 2 |
| Skull fracture | 1/6036 (0%) | 1 | 3/6052 (0%) | 3 |
| Soft tissue injury | 2/6036 (0%) | 2 | 0/6052 (0%) | 0 |
| Spinal compression fracture | 3/6036 (0%) | 3 | 5/6052 (0.1%) | 5 |
| Spinal cord injury | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Spinal cord injury cervical | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Spinal fracture | 2/6036 (0%) | 2 | 2/6052 (0%) | 2 |
| Splenic rupture | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Sternal fracture | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Stoma site haemorrhage | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Subdural haematoma | 7/6036 (0.1%) | 7 | 7/6052 (0.1%) | 7 |
| Subdural haemorrhage | 2/6036 (0%) | 2 | 4/6052 (0.1%) | 4 |
| Tendon injury | 2/6036 (0%) | 2 | 0/6052 (0%) | 0 |
| Tendon rupture | 8/6036 (0.1%) | 9 | 7/6052 (0.1%) | 7 |
| Thermal burn | 2/6036 (0%) | 2 | 0/6052 (0%) | 0 |
| Thoracic vertebral fracture | 1/6036 (0%) | 1 | 1/6052 (0%) | 1 |
| Tibia fracture | 5/6036 (0.1%) | 5 | 4/6052 (0.1%) | 4 |
| Tooth fracture | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Toxicity to various agents | 3/6036 (0%) | 3 | 4/6052 (0.1%) | 4 |
| Traumatic amputation | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Traumatic fracture | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Traumatic haematoma | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Traumatic intracranial haemorrhage | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Traumatic liver injury | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Ulna fracture | 1/6036 (0%) | 1 | 1/6052 (0%) | 1 |
| Upper limb fracture | 2/6036 (0%) | 2 | 2/6052 (0%) | 2 |
| Vascular graft occlusion | 7/6036 (0.1%) | 7 | 7/6052 (0.1%) | 7 |
| Vascular graft thrombosis | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Vascular pseudoaneurysm | 3/6036 (0%) | 3 | 2/6052 (0%) | 3 |
| Vascular pseudoaneurysm ruptured | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Wound | 0/6036 (0%) | 0 | 3/6052 (0%) | 3 |
| Wound complication | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Wound dehiscence | 1/6036 (0%) | 1 | 1/6052 (0%) | 1 |
| Wound haemorrhage | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Wrist fracture | 1/6036 (0%) | 1 | 3/6052 (0%) | 3 |
| Investigations | ||||
| Alanine aminotransferase increased | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Angiogram | 7/6036 (0.1%) | 7 | 7/6052 (0.1%) | 7 |
| Anticoagulation drug level above therapeutic | 2/6036 (0%) | 2 | 0/6052 (0%) | 0 |
| Arteriogram | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Arteriogram coronary | 16/6036 (0.3%) | 16 | 17/6052 (0.3%) | 17 |
| Arteriogram renal | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Aspartate aminotransferase increased | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Biopsy brain | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Blood creatine phosphokinase increased | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Blood creatinine increased | 1/6036 (0%) | 1 | 2/6052 (0%) | 2 |
| Blood glucose decreased | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Blood glucose increased | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Blood osmolarity decreased | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Blood pressure increased | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Cardiac function test | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Cardiac stress test abnormal | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Cardiovascular evaluation | 1/6036 (0%) | 1 | 1/6052 (0%) | 1 |
| Cardiovascular examination | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Carotid bruit | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Catheterisation cardiac | 10/6036 (0.2%) | 11 | 14/6052 (0.2%) | 15 |
| Clostridium test positive | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Colonoscopy | 1/6036 (0%) | 1 | 1/6052 (0%) | 1 |
| Computerised tomogram | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Computerised tomogram thorax | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Diagnostic procedure | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Ejection fraction decreased | 5/6036 (0.1%) | 5 | 4/6052 (0.1%) | 4 |
| Electrocardiogram abnormal | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Electrocardiogram qt prolonged | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Endoscopy gastrointestinal | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Gamma-glutamyltransferase increased | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Haemoglobin decreased | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Heart rate irregular | 1/6036 (0%) | 1 | 1/6052 (0%) | 1 |
| Hepatic enzyme increased | 1/6036 (0%) | 1 | 1/6052 (0%) | 1 |
| International normalised ratio decreased | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| International normalised ratio increased | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Investigation | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Liver function test abnormal | 2/6036 (0%) | 2 | 0/6052 (0%) | 0 |
| Myocardial necrosis marker increased | 2/6036 (0%) | 2 | 1/6052 (0%) | 1 |
| Oesophagogastroduodenoscopy | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Peripheral arteriogram | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Prostatic specific antigen increased | 2/4648 (0%) | 2 | 0/6052 (0%) | 0 |
| Transaminases increased | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Troponin increased | 2/6036 (0%) | 2 | 2/6052 (0%) | 2 |
| Ureteroscopy | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Vitamin b12 decreased | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Weight decreased | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Metabolism and nutrition disorders | ||||
| Decreased appetite | 1/6036 (0%) | 1 | 1/6052 (0%) | 1 |
| Dehydration | 15/6036 (0.2%) | 15 | 26/6052 (0.4%) | 28 |
| Diabetes mellitus | 11/6036 (0.2%) | 11 | 20/6052 (0.3%) | 22 |
| Diabetes mellitus inadequate control | 8/6036 (0.1%) | 9 | 14/6052 (0.2%) | 15 |
| Diabetic ketoacidosis | 3/6036 (0%) | 3 | 1/6052 (0%) | 1 |
| Diabetic metabolic decompensation | 2/6036 (0%) | 3 | 0/6052 (0%) | 0 |
| Electrolyte imbalance | 1/6036 (0%) | 1 | 2/6052 (0%) | 4 |
| Failure to thrive | 1/6036 (0%) | 1 | 2/6052 (0%) | 2 |
| Fluid overload | 2/6036 (0%) | 2 | 2/6052 (0%) | 2 |
| Gout | 4/6036 (0.1%) | 4 | 6/6052 (0.1%) | 6 |
| Hypercalcaemia | 2/6036 (0%) | 2 | 1/6052 (0%) | 1 |
| Hyperglycaemia | 13/6036 (0.2%) | 13 | 10/6052 (0.2%) | 11 |
| Hyperkalaemia | 9/6036 (0.1%) | 9 | 9/6052 (0.1%) | 10 |
| Hyperosmolar hyperglycaemic state | 2/6036 (0%) | 2 | 0/6052 (0%) | 0 |
| Hypoglycaemia | 17/6036 (0.3%) | 17 | 18/6052 (0.3%) | 18 |
| Hypokalaemia | 4/6036 (0.1%) | 4 | 7/6052 (0.1%) | 7 |
| Hypomagnesaemia | 2/6036 (0%) | 2 | 0/6052 (0%) | 0 |
| Hyponatraemia | 6/6036 (0.1%) | 7 | 9/6052 (0.1%) | 9 |
| Hypovolaemia | 0/6036 (0%) | 0 | 2/6052 (0%) | 2 |
| Ketoacidosis | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Lactic acidosis | 1/6036 (0%) | 1 | 1/6052 (0%) | 1 |
| Malnutrition | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Metabolic acidosis | 2/6036 (0%) | 2 | 1/6052 (0%) | 1 |
| Obesity | 5/6036 (0.1%) | 5 | 5/6052 (0.1%) | 5 |
| Type 2 diabetes mellitus | 6/6036 (0.1%) | 6 | 6/6052 (0.1%) | 6 |
| Vitamin b12 deficiency | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Musculoskeletal and connective tissue disorders | ||||
| Ankylosing spondylitis | 2/6036 (0%) | 2 | 0/6052 (0%) | 0 |
| Arthralgia | 7/6036 (0.1%) | 8 | 17/6052 (0.3%) | 19 |
| Arthritis | 9/6036 (0.1%) | 10 | 7/6052 (0.1%) | 7 |
| Arthropathy | 2/6036 (0%) | 2 | 0/6052 (0%) | 0 |
| Back pain | 15/6036 (0.2%) | 15 | 14/6052 (0.2%) | 14 |
| Bone pain | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Bursitis | 1/6036 (0%) | 1 | 1/6052 (0%) | 1 |
| Cervical spinal stenosis | 1/6036 (0%) | 1 | 1/6052 (0%) | 1 |
| Chondrocalcinosis pyrophosphate | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Compartment syndrome | 0/6036 (0%) | 0 | 2/6052 (0%) | 2 |
| Costochondritis | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Dupuytren's contracture | 1/6036 (0%) | 1 | 1/6052 (0%) | 1 |
| Facet joint syndrome | 0/6036 (0%) | 0 | 2/6052 (0%) | 2 |
| Fibromyalgia | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Foot deformity | 4/6036 (0.1%) | 4 | 3/6052 (0%) | 4 |
| Gouty arthritis | 1/6036 (0%) | 1 | 1/6052 (0%) | 1 |
| Groin pain | 0/6036 (0%) | 0 | 1/6052 (0%) | 2 |
| Haemarthrosis | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Intervertebral disc degeneration | 7/6036 (0.1%) | 8 | 6/6052 (0.1%) | 6 |
| Intervertebral disc disorder | 6/6036 (0.1%) | 6 | 2/6052 (0%) | 2 |
| Intervertebral disc protrusion | 6/6036 (0.1%) | 6 | 14/6052 (0.2%) | 15 |
| Joint instability | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Joint swelling | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Kyphosis | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Ligament laxity | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Lumbar spinal stenosis | 13/6036 (0.2%) | 13 | 23/6052 (0.4%) | 24 |
| Mobility decreased | 1/6036 (0%) | 1 | 1/6052 (0%) | 1 |
| Muscle haemorrhage | 1/6036 (0%) | 1 | 4/6052 (0.1%) | 4 |
| Muscle spasms | 2/6036 (0%) | 2 | 1/6052 (0%) | 1 |
| Muscular weakness | 4/6036 (0.1%) | 4 | 4/6052 (0.1%) | 4 |
| Musculoskeletal chest pain | 17/6036 (0.3%) | 18 | 15/6052 (0.2%) | 15 |
| Musculoskeletal discomfort | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Musculoskeletal pain | 5/6036 (0.1%) | 6 | 0/6052 (0%) | 0 |
| Musculoskeletal stiffness | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Myalgia | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Neck pain | 2/6036 (0%) | 2 | 4/6052 (0.1%) | 4 |
| Neuropathic arthropathy | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Osteitis | 1/6036 (0%) | 2 | 2/6052 (0%) | 2 |
| Osteoarthritis | 70/6036 (1.2%) | 76 | 66/6052 (1.1%) | 75 |
| Osteochondrosis | 0/6036 (0%) | 0 | 2/6052 (0%) | 2 |
| Osteonecrosis | 0/6036 (0%) | 0 | 2/6052 (0%) | 2 |
| Pain in extremity | 7/6036 (0.1%) | 7 | 2/6052 (0%) | 2 |
| Pain in jaw | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Polymyalgia rheumatica | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Pseudarthrosis | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Rhabdomyolysis | 6/6036 (0.1%) | 6 | 3/6052 (0%) | 3 |
| Rheumatoid arthritis | 1/6036 (0%) | 2 | 1/6052 (0%) | 1 |
| Rotator cuff syndrome | 8/6036 (0.1%) | 8 | 3/6052 (0%) | 3 |
| Scoliosis | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Spinal column stenosis | 6/6036 (0.1%) | 6 | 10/6052 (0.2%) | 10 |
| Spinal osteoarthritis | 5/6036 (0.1%) | 5 | 8/6052 (0.1%) | 9 |
| Spinal pain | 5/6036 (0.1%) | 5 | 3/6052 (0%) | 3 |
| Spondylolisthesis | 4/6036 (0.1%) | 4 | 2/6052 (0%) | 2 |
| Synovial cyst | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Synovitis | 2/6036 (0%) | 3 | 0/6052 (0%) | 0 |
| Tendon disorder | 2/6036 (0%) | 2 | 1/6052 (0%) | 1 |
| Tendonitis | 2/6036 (0%) | 2 | 0/6052 (0%) | 0 |
| Trigger finger | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Vertebral foraminal stenosis | 1/6036 (0%) | 1 | 1/6052 (0%) | 1 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| Acute myeloid leukaemia | 1/6036 (0%) | 1 | 1/6052 (0%) | 1 |
| Adenocarcinoma | 2/6036 (0%) | 2 | 0/6052 (0%) | 0 |
| Adenocarcinoma gastric | 2/6036 (0%) | 2 | 1/6052 (0%) | 1 |
| Adenocarcinoma of colon | 3/6036 (0%) | 3 | 5/6052 (0.1%) | 5 |
| Adenocarcinoma pancreas | 1/6036 (0%) | 1 | 2/6052 (0%) | 2 |
| Adenosquamous cell lung cancer | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Anal squamous cell carcinoma | 0/6036 (0%) | 0 | 2/6052 (0%) | 2 |
| Anaplastic astrocytoma | 1/6036 (0%) | 2 | 0/6052 (0%) | 0 |
| B-cell lymphoma | 2/6036 (0%) | 2 | 1/6052 (0%) | 1 |
| B-cell lymphoma stage iv | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Basal cell carcinoma | 17/6036 (0.3%) | 17 | 13/6052 (0.2%) | 16 |
| Basosquamous carcinoma | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Benign gastric neoplasm | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Benign neoplasm of adrenal gland | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Benign neoplasm of spinal cord | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Benign neoplasm of thyroid gland | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Benign renal neoplasm | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Bladder cancer | 8/6036 (0.1%) | 8 | 3/6052 (0%) | 3 |
| Bladder cancer recurrent | 1/6036 (0%) | 1 | 2/6052 (0%) | 2 |
| Bladder neoplasm | 1/6036 (0%) | 1 | 1/6052 (0%) | 1 |
| Bladder transitional cell carcinoma | 4/6036 (0.1%) | 4 | 5/6052 (0.1%) | 7 |
| Borderline mucinous tumour of ovary | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Bowen's disease | 1/6036 (0%) | 3 | 0/6052 (0%) | 0 |
| Breast cancer | 6/6036 (0.1%) | 6 | 4/6052 (0.1%) | 4 |
| Breast cancer metastatic | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Bronchial carcinoma | 2/6036 (0%) | 2 | 2/6052 (0%) | 3 |
| Bronchial neoplasm | 0/6036 (0%) | 0 | 1/6052 (0%) | 3 |
| Burkitt's lymphoma | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Buschke-lowenstein's tumour | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Carcinoid tumour | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Carcinoid tumour of the gastrointestinal tract | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Cervix carcinoma stage 0 | 1/1388 (0.1%) | 1 | 0/6052 (0%) | 0 |
| Cholangiocarcinoma | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Chronic lymphocytic leukaemia | 0/6036 (0%) | 0 | 4/6052 (0.1%) | 4 |
| Chronic lymphocytic leukaemia stage 0 | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Chronic myeloid leukaemia | 2/6036 (0%) | 2 | 0/6052 (0%) | 0 |
| Colon adenoma | 5/6036 (0.1%) | 5 | 2/6052 (0%) | 2 |
| Colon cancer | 4/6036 (0.1%) | 4 | 7/6052 (0.1%) | 7 |
| Colon cancer metastatic | 1/6036 (0%) | 1 | 2/6052 (0%) | 2 |
| Colon cancer stage 0 | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Colon cancer stage iii | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Colon cancer stage iv | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Colorectal cancer | 2/6036 (0%) | 3 | 0/6052 (0%) | 0 |
| Colorectal cancer metastatic | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Colorectal cancer stage iv | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Desmoplastic melanoma | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Diffuse large b-cell lymphoma | 2/6036 (0%) | 2 | 2/6052 (0%) | 2 |
| Diffuse large b-cell lymphoma recurrent | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Diffuse large b-cell lymphoma stage ii | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Diffuse large b-cell lymphoma stage iii | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Endometrial adenocarcinoma | 1/6036 (0%) | 1 | 1/6052 (0%) | 1 |
| Ewing's sarcoma metastatic | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Fallopian tube cancer | 0/6036 (0%) | 0 | 1/1394 (0.1%) | 1 |
| Fibrous histiocytoma | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Gallbladder adenocarcinoma | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Gastric adenoma | 1/6036 (0%) | 1 | 1/6052 (0%) | 1 |
| Gastric cancer | 4/6036 (0.1%) | 5 | 6/6052 (0.1%) | 7 |
| Gastrointestinal cancer metastatic | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Gastrointestinal stromal tumour | 1/6036 (0%) | 1 | 2/6052 (0%) | 2 |
| Gastrointestinal tract adenoma | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Gastrooesophageal cancer | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Gingival cancer | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Glioblastoma | 2/6036 (0%) | 3 | 3/6052 (0%) | 4 |
| Haemangioma of liver | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Hepatic cancer | 0/6036 (0%) | 0 | 3/6052 (0%) | 3 |
| Hepatic cancer metastatic | 2/6036 (0%) | 2 | 1/6052 (0%) | 2 |
| Hepatocellular carcinoma | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Hodgkin's disease | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Hodgkin's disease stage iv | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Intestinal adenocarcinoma | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Invasive breast carcinoma | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Invasive ductal breast carcinoma | 2/6036 (0%) | 2 | 4/6052 (0.1%) | 4 |
| Invasive lobular breast carcinoma | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Kaposi's sarcoma | 1/6036 (0%) | 1 | 1/6052 (0%) | 1 |
| Keratinising squamous cell carcinoma of nasopharynx | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Keratoacanthoma | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Large intestine benign neoplasm | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Laryngeal cancer | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Laryngeal neoplasm | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Laryngeal squamous cell carcinoma | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Lip squamous cell carcinoma | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Lipoma | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Lung adenocarcinoma | 7/6036 (0.1%) | 7 | 7/6052 (0.1%) | 8 |
| Lung adenocarcinoma stage i | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Lung adenocarcinoma stage ii | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Lung adenocarcinoma stage iii | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Lung cancer metastatic | 2/6036 (0%) | 2 | 2/6052 (0%) | 2 |
| Lung carcinoma cell type unspecified recurrent | 1/6036 (0%) | 1 | 1/6052 (0%) | 1 |
| Lung carcinoma cell type unspecified stage ii | 2/6036 (0%) | 2 | 0/6052 (0%) | 0 |
| Lung carcinoma cell type unspecified stage iii | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Lung carcinoma cell type unspecified stage iv | 0/6036 (0%) | 0 | 2/6052 (0%) | 2 |
| Lung neoplasm | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Lung neoplasm malignant | 14/6036 (0.2%) | 15 | 13/6052 (0.2%) | 13 |
| Lung squamous cell carcinoma metastatic | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Lung squamous cell carcinoma stage i | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Lung squamous cell carcinoma stage iii | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Lymphocytic lymphoma | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Lymphoma | 2/6036 (0%) | 2 | 3/6052 (0%) | 3 |
| Malignant fibrous histiocytoma | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Malignant melanoma | 5/6036 (0.1%) | 5 | 6/6052 (0.1%) | 8 |
| Malignant melanoma in situ | 1/6036 (0%) | 1 | 1/6052 (0%) | 1 |
| Malignant neoplasm of unknown primary site | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Malignant neoplasm progression | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Malignant pleural effusion | 0/6036 (0%) | 0 | 2/6052 (0%) | 2 |
| Mediastinum neoplasm | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Meningioma | 2/6036 (0%) | 2 | 0/6052 (0%) | 0 |
| Meningioma malignant | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Metastases to bone | 2/6036 (0%) | 2 | 0/6052 (0%) | 0 |
| Metastases to central nervous system | 2/6036 (0%) | 2 | 2/6052 (0%) | 2 |
| Metastases to liver | 0/6036 (0%) | 0 | 3/6052 (0%) | 5 |
| Metastases to lung | 0/6036 (0%) | 0 | 3/6052 (0%) | 3 |
| Metastases to lymph nodes | 1/6036 (0%) | 2 | 0/6052 (0%) | 0 |
| Metastases to salivary gland | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Metastatic malignant melanoma | 1/6036 (0%) | 1 | 2/6052 (0%) | 2 |
| Metastatic squamous cell carcinoma | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Myelodysplastic syndrome | 2/6036 (0%) | 2 | 1/6052 (0%) | 1 |
| Myxofibrosarcoma | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Nasal sinus cancer | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Nasopharyngeal cancer | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Neoplasm progression | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Neoplasm prostate | 0/6036 (0%) | 0 | 1/4658 (0%) | 1 |
| Neoplasm skin | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Neuroendocrine carcinoma metastatic | 2/6036 (0%) | 2 | 0/6052 (0%) | 0 |
| Neuroendocrine tumour | 1/6036 (0%) | 1 | 1/6052 (0%) | 1 |
| Non-hodgkin's lymphoma | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Non-small cell lung cancer | 2/6036 (0%) | 2 | 1/6052 (0%) | 1 |
| Non-small cell lung cancer metastatic | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Non-small cell lung cancer stage iii | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Non-small cell lung cancer stage iiia | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Non-small cell lung cancer stage iv | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Oesophageal adenocarcinoma | 3/6036 (0%) | 3 | 0/6052 (0%) | 0 |
| Oesophageal adenocarcinoma metastatic | 1/6036 (0%) | 2 | 1/6052 (0%) | 1 |
| Oesophageal adenocarcinoma stage 0 | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Oesophageal carcinoma | 2/6036 (0%) | 2 | 1/6052 (0%) | 1 |
| Oral cavity cancer metastatic | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Oropharyngeal cancer | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Oropharyngeal squamous cell carcinoma | 1/6036 (0%) | 2 | 0/6052 (0%) | 0 |
| Pancreatic carcinoma | 3/6036 (0%) | 3 | 7/6052 (0.1%) | 8 |
| Pancreatic carcinoma metastatic | 1/6036 (0%) | 1 | 2/6052 (0%) | 2 |
| Pancreatic neoplasm | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Pancreatic neuroendocrine tumour | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Papillary cystadenoma lymphomatosum | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Papillary thyroid cancer | 2/6036 (0%) | 2 | 0/6052 (0%) | 0 |
| Parathyroid tumour benign | 2/6036 (0%) | 2 | 0/6052 (0%) | 0 |
| Phaeochromocytoma | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Pituitary tumour | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Plasma cell myeloma | 2/6036 (0%) | 2 | 2/6052 (0%) | 2 |
| Polycythaemia vera | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Prostate cancer | 26/4648 (0.6%) | 26 | 28/4658 (0.6%) | 28 |
| Prostate cancer metastatic | 0/6036 (0%) | 0 | 1/4658 (0%) | 1 |
| Prostate cancer recurrent | 3/4648 (0.1%) | 3 | 0/6052 (0%) | 0 |
| Prostate cancer stage ii | 2/4648 (0%) | 2 | 1/4658 (0%) | 1 |
| Prostate cancer stage iv | 0/6036 (0%) | 0 | 1/4658 (0%) | 1 |
| Prostatic adenoma | 1/4648 (0%) | 1 | 0/6052 (0%) | 0 |
| Rectal adenocarcinoma | 1/6036 (0%) | 1 | 3/6052 (0%) | 3 |
| Rectal cancer | 1/6036 (0%) | 1 | 1/6052 (0%) | 1 |
| Rectal cancer metastatic | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Rectal cancer stage 0 | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Renal cancer | 2/6036 (0%) | 2 | 1/6052 (0%) | 1 |
| Renal cancer recurrent | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Renal cell carcinoma | 5/6036 (0.1%) | 5 | 2/6052 (0%) | 2 |
| Sinonasal papilloma | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Skin cancer | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Small cell lung cancer | 2/6036 (0%) | 2 | 1/6052 (0%) | 1 |
| Small cell lung cancer metastatic | 0/6036 (0%) | 0 | 2/6052 (0%) | 2 |
| Spinal cord neoplasm | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Squamous cell carcinoma | 6/6036 (0.1%) | 7 | 1/6052 (0%) | 1 |
| Squamous cell carcinoma of lung | 3/6036 (0%) | 3 | 3/6052 (0%) | 3 |
| Squamous cell carcinoma of skin | 5/6036 (0.1%) | 8 | 3/6052 (0%) | 3 |
| Squamous cell carcinoma of the oral cavity | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Squamous cell carcinoma of the tongue | 2/6036 (0%) | 2 | 1/6052 (0%) | 1 |
| Squamous cell carcinoma of the vulva | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| T-cell lymphoma | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Testicular neoplasm | 1/4648 (0%) | 1 | 0/6052 (0%) | 0 |
| Testicular seminoma (pure) | 0/6036 (0%) | 0 | 1/4658 (0%) | 1 |
| Throat cancer | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Thymoma malignant | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Thyroid cancer | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Thyroid neoplasm | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Tongue carcinoma stage iv | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Tongue neoplasm malignant stage unspecified | 0/6036 (0%) | 0 | 2/6052 (0%) | 2 |
| Tonsil cancer | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Tonsil cancer metastatic | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Transitional cell carcinoma | 2/6036 (0%) | 2 | 4/6052 (0.1%) | 4 |
| Transitional cell carcinoma recurrent | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Ureteric cancer | 2/6036 (0%) | 2 | 1/6052 (0%) | 1 |
| Uterine cancer | 0/6036 (0%) | 0 | 1/1394 (0.1%) | 1 |
| Uterine leiomyoma | 1/1388 (0.1%) | 1 | 0/6052 (0%) | 0 |
| Uterine neoplasm | 0/6036 (0%) | 0 | 1/1394 (0.1%) | 1 |
| Nervous system disorders | ||||
| Acute disseminated encephalomyelitis | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Amyotrophic lateral sclerosis | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Aphasia | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Ataxia | 1/6036 (0%) | 1 | 1/6052 (0%) | 1 |
| Autonomic nervous system imbalance | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Brain injury | 1/6036 (0%) | 1 | 2/6052 (0%) | 2 |
| Brain mass | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Brain stem stroke | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Carotid arteriosclerosis | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Carotid artery disease | 1/6036 (0%) | 1 | 4/6052 (0.1%) | 4 |
| Carotid artery occlusion | 1/6036 (0%) | 1 | 1/6052 (0%) | 1 |
| Carotid artery stenosis | 21/6036 (0.3%) | 21 | 39/6052 (0.6%) | 42 |
| Carotid sinus syndrome | 2/6036 (0%) | 2 | 0/6052 (0%) | 0 |
| Carpal tunnel syndrome | 2/6036 (0%) | 2 | 2/6052 (0%) | 2 |
| Cerebellar ischaemia | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Cerebellar syndrome | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Cerebral arteriosclerosis | 2/6036 (0%) | 2 | 1/6052 (0%) | 1 |
| Cerebral artery occlusion | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Cerebral haemorrhage | 3/6036 (0%) | 3 | 3/6052 (0%) | 3 |
| Cerebral infarction | 5/6036 (0.1%) | 5 | 4/6052 (0.1%) | 4 |
| Cerebral ischaemia | 1/6036 (0%) | 1 | 3/6052 (0%) | 4 |
| Cerebrovascular accident | 61/6036 (1%) | 63 | 62/6052 (1%) | 65 |
| Cerebrovascular insufficiency | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Cervical myelopathy | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Cervical radiculopathy | 1/6036 (0%) | 1 | 3/6052 (0%) | 3 |
| Cognitive disorder | 1/6036 (0%) | 1 | 2/6052 (0%) | 2 |
| Complex partial seizures | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Complex regional pain syndrome | 0/6036 (0%) | 0 | 1/6052 (0%) | 2 |
| Dementia | 3/6036 (0%) | 4 | 3/6052 (0%) | 3 |
| Dementia alzheimer's type | 3/6036 (0%) | 3 | 1/6052 (0%) | 1 |
| Diabetic neuropathy | 6/6036 (0.1%) | 9 | 2/6052 (0%) | 2 |
| Dizziness | 6/6036 (0.1%) | 6 | 6/6052 (0.1%) | 7 |
| Embolic cerebral infarction | 2/6036 (0%) | 2 | 0/6052 (0%) | 0 |
| Embolic stroke | 1/6036 (0%) | 1 | 1/6052 (0%) | 1 |
| Encephalopathy | 4/6036 (0.1%) | 4 | 4/6052 (0.1%) | 5 |
| Epilepsy | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Essential tremor | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Guillain-barre syndrome | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Haemorrhage intracranial | 1/6036 (0%) | 1 | 1/6052 (0%) | 1 |
| Haemorrhagic stroke | 3/6036 (0%) | 3 | 5/6052 (0.1%) | 5 |
| Haemorrhagic transformation stroke | 0/6036 (0%) | 0 | 2/6052 (0%) | 2 |
| Headache | 7/6036 (0.1%) | 7 | 2/6052 (0%) | 2 |
| Hemiparesis | 3/6036 (0%) | 3 | 0/6052 (0%) | 0 |
| Hypoaesthesia | 0/6036 (0%) | 0 | 2/6052 (0%) | 2 |
| Hypoglycaemic coma | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Hypoxic-ischaemic encephalopathy | 1/6036 (0%) | 1 | 2/6052 (0%) | 2 |
| Intraventricular haemorrhage | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Ischaemic stroke | 25/6036 (0.4%) | 25 | 18/6052 (0.3%) | 19 |
| Lacunar infarction | 2/6036 (0%) | 2 | 2/6052 (0%) | 2 |
| Loss of consciousness | 1/6036 (0%) | 1 | 2/6052 (0%) | 2 |
| Lumbar radiculopathy | 3/6036 (0%) | 3 | 2/6052 (0%) | 2 |
| Lumbosacral radiculopathy | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Metabolic encephalopathy | 3/6036 (0%) | 3 | 5/6052 (0.1%) | 5 |
| Migraine | 5/6036 (0.1%) | 5 | 0/6052 (0%) | 0 |
| Moyamoya disease | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Myasthenia gravis | 0/6036 (0%) | 0 | 1/6052 (0%) | 2 |
| Myelitis transverse | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Myoclonus | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Nerve compression | 1/6036 (0%) | 1 | 1/6052 (0%) | 1 |
| Nerve root compression | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Nervous system disorder | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Neuralgia | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Neuropathy peripheral | 1/6036 (0%) | 1 | 1/6052 (0%) | 1 |
| Normal pressure hydrocephalus | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Paraesthesia | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Parkinson's disease | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Partial seizures | 0/6036 (0%) | 0 | 3/6052 (0%) | 3 |
| Peroneal nerve palsy | 1/6036 (0%) | 1 | 1/6052 (0%) | 1 |
| Polyneuropathy | 0/6036 (0%) | 0 | 2/6052 (0%) | 2 |
| Post herpetic neuralgia | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Postictal paralysis | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Presyncope | 8/6036 (0.1%) | 9 | 9/6052 (0.1%) | 9 |
| Quadriparesis | 1/6036 (0%) | 1 | 1/6052 (0%) | 1 |
| Quadriplegia | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Radicular syndrome | 0/6036 (0%) | 0 | 2/6052 (0%) | 2 |
| Radiculopathy | 2/6036 (0%) | 2 | 2/6052 (0%) | 8 |
| Restless legs syndrome | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Sciatica | 6/6036 (0.1%) | 6 | 4/6052 (0.1%) | 4 |
| Seizure | 7/6036 (0.1%) | 7 | 6/6052 (0.1%) | 6 |
| Spinal claudication | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Spinal cord compression | 1/6036 (0%) | 1 | 1/6052 (0%) | 1 |
| Spinal cord infarction | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Spinal cord oedema | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Status epilepticus | 1/6036 (0%) | 1 | 1/6052 (0%) | 1 |
| Subarachnoid haemorrhage | 4/6036 (0.1%) | 4 | 4/6052 (0.1%) | 4 |
| Syncope | 46/6036 (0.8%) | 48 | 52/6052 (0.9%) | 54 |
| Thalamus haemorrhage | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Thrombotic stroke | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Toxic encephalopathy | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Transient global amnesia | 0/6036 (0%) | 0 | 2/6052 (0%) | 2 |
| Transient ischaemic attack | 37/6036 (0.6%) | 44 | 39/6052 (0.6%) | 42 |
| Tremor | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Trigeminal neuralgia | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Uraemic encephalopathy | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Vascular dementia | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Vascular encephalopathy | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Vasogenic cerebral oedema | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Vertebral artery stenosis | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Vertebrobasilar insufficiency | 2/6036 (0%) | 2 | 1/6052 (0%) | 1 |
| Vertigo cns origin | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Viith nerve paralysis | 2/6036 (0%) | 2 | 3/6052 (0%) | 3 |
| Vith nerve paralysis | 1/6036 (0%) | 1 | 1/6052 (0%) | 1 |
| Vith nerve paresis | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Pregnancy, puerperium and perinatal conditions | ||||
| Abortion spontaneous | 0/6036 (0%) | 0 | 1/1394 (0.1%) | 1 |
| Pregnancy | 0/6036 (0%) | 0 | 1/1394 (0.1%) | 1 |
| Psychiatric disorders | ||||
| Abnormal behaviour | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Acute psychosis | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Acute stress disorder | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Adjustment disorder | 1/6036 (0%) | 1 | 1/6052 (0%) | 1 |
| Adjustment disorder with anxiety | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Adjustment disorder with depressed mood | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Adjustment disorder with mixed disturbance of emotion and conduct | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Aggression | 1/6036 (0%) | 1 | 1/6052 (0%) | 1 |
| Alcohol abuse | 2/6036 (0%) | 2 | 4/6052 (0.1%) | 4 |
| Alcohol withdrawal syndrome | 1/6036 (0%) | 1 | 1/6052 (0%) | 1 |
| Alcoholism | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Anxiety | 3/6036 (0%) | 3 | 2/6052 (0%) | 3 |
| Anxiety disorder | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Completed suicide | 2/6036 (0%) | 2 | 1/6052 (0%) | 1 |
| Confusional state | 3/6036 (0%) | 3 | 5/6052 (0.1%) | 5 |
| Delirium | 2/6036 (0%) | 2 | 3/6052 (0%) | 3 |
| Delirium tremens | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Depression | 4/6036 (0.1%) | 4 | 2/6052 (0%) | 2 |
| Depression suicidal | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Generalised anxiety disorder | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Hallucination | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Hypomania | 0/6036 (0%) | 0 | 1/6052 (0%) | 2 |
| Major depression | 2/6036 (0%) | 3 | 1/6052 (0%) | 1 |
| Mental disorder | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Mental status changes | 3/6036 (0%) | 3 | 13/6052 (0.2%) | 15 |
| Panic attack | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Post-traumatic stress disorder | 1/6036 (0%) | 3 | 0/6052 (0%) | 0 |
| Psychogenic seizure | 1/6036 (0%) | 1 | 1/6052 (0%) | 1 |
| Psychotic disorder | 1/6036 (0%) | 1 | 2/6052 (0%) | 2 |
| Suicidal ideation | 1/6036 (0%) | 1 | 1/6052 (0%) | 1 |
| Suicide attempt | 1/6036 (0%) | 1 | 1/6052 (0%) | 1 |
| Renal and urinary disorders | ||||
| Acute kidney injury | 48/6036 (0.8%) | 58 | 67/6052 (1.1%) | 81 |
| Acute prerenal failure | 0/6036 (0%) | 0 | 2/6052 (0%) | 2 |
| Azotaemia | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Bladder outlet obstruction | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Bladder prolapse | 0/6036 (0%) | 0 | 2/6052 (0%) | 2 |
| Calculus ureteric | 7/6036 (0.1%) | 7 | 9/6052 (0.1%) | 9 |
| Calculus urinary | 0/6036 (0%) | 0 | 2/6052 (0%) | 2 |
| Chronic kidney disease | 9/6036 (0.1%) | 10 | 10/6052 (0.2%) | 11 |
| Cystitis haemorrhagic | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Cystitis ulcerative | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Diabetic nephropathy | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Dysuria | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Glomerulonephritis | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Glomerulosclerosis | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Haematuria | 11/6036 (0.2%) | 14 | 4/6052 (0.1%) | 4 |
| Hydronephrosis | 1/6036 (0%) | 1 | 5/6052 (0.1%) | 5 |
| Hypotonic urinary bladder | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Nephrolithiasis | 19/6036 (0.3%) | 20 | 10/6052 (0.2%) | 12 |
| Nephropathy | 2/6036 (0%) | 2 | 0/6052 (0%) | 0 |
| Nephrosclerosis | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Nephrotic syndrome | 0/6036 (0%) | 0 | 2/6052 (0%) | 2 |
| Obstructive uropathy | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Pelvi-ureteric obstruction | 0/6036 (0%) | 0 | 1/6052 (0%) | 2 |
| Prerenal failure | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Renal artery stenosis | 3/6036 (0%) | 3 | 5/6052 (0.1%) | 5 |
| Renal colic | 2/6036 (0%) | 2 | 2/6052 (0%) | 2 |
| Renal cyst | 1/6036 (0%) | 1 | 1/6052 (0%) | 1 |
| Renal failure | 14/6036 (0.2%) | 16 | 11/6052 (0.2%) | 11 |
| Renal haematoma | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Renal impairment | 3/6036 (0%) | 3 | 2/6052 (0%) | 2 |
| Renal infarct | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Renal injury | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Renal tubular necrosis | 1/6036 (0%) | 1 | 2/6052 (0%) | 2 |
| Renal vein thrombosis | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Stress urinary incontinence | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Tubulointerstitial nephritis | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Ureteral disorder | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Urethral haemorrhage | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Urethral stenosis | 2/6036 (0%) | 2 | 3/6052 (0%) | 3 |
| Urinary bladder haemorrhage | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Urinary incontinence | 4/6036 (0.1%) | 4 | 1/6052 (0%) | 1 |
| Urinary retention | 2/6036 (0%) | 2 | 9/6052 (0.1%) | 9 |
| Urinary tract obstruction | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Reproductive system and breast disorders | ||||
| Amastia | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Benign prostatic hyperplasia | 10/4648 (0.2%) | 10 | 12/4658 (0.3%) | 12 |
| Cervical polyp | 0/6036 (0%) | 0 | 1/1394 (0.1%) | 1 |
| Cystocele | 1/1388 (0.1%) | 1 | 0/6052 (0%) | 0 |
| Dysmenorrhoea | 0/6036 (0%) | 0 | 1/1394 (0.1%) | 1 |
| Menometrorrhagia | 0/6036 (0%) | 0 | 1/1394 (0.1%) | 1 |
| Ovarian cyst | 2/1388 (0.1%) | 2 | 1/1394 (0.1%) | 1 |
| Penile necrosis | 0/6036 (0%) | 0 | 1/4658 (0%) | 1 |
| Peyronie's disease | 1/4648 (0%) | 1 | 0/6052 (0%) | 0 |
| Prostatitis | 4/4648 (0.1%) | 5 | 2/4658 (0%) | 2 |
| Rectocele | 0/6036 (0%) | 0 | 1/1394 (0.1%) | 1 |
| Testicular disorder | 1/4648 (0%) | 1 | 0/6052 (0%) | 0 |
| Uterine polyp | 1/1388 (0.1%) | 1 | 0/6052 (0%) | 0 |
| Uterine prolapse | 2/1388 (0.1%) | 2 | 2/1394 (0.1%) | 2 |
| Respiratory, thoracic and mediastinal disorders | ||||
| Acute pulmonary oedema | 8/6036 (0.1%) | 10 | 5/6052 (0.1%) | 5 |
| Acute respiratory distress syndrome | 1/6036 (0%) | 1 | 2/6052 (0%) | 2 |
| Acute respiratory failure | 14/6036 (0.2%) | 16 | 20/6052 (0.3%) | 20 |
| Alveolitis | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Asphyxia | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Aspiration | 0/6036 (0%) | 0 | 2/6052 (0%) | 2 |
| Asthma | 8/6036 (0.1%) | 9 | 5/6052 (0.1%) | 7 |
| Atelectasis | 0/6036 (0%) | 0 | 2/6052 (0%) | 2 |
| Bronchiectasis | 2/6036 (0%) | 2 | 0/6052 (0%) | 0 |
| Bronchitis chronic | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Bronchospasm | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Chronic obstructive pulmonary disease | 43/6036 (0.7%) | 55 | 47/6052 (0.8%) | 55 |
| Chylothorax | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Cough | 0/6036 (0%) | 0 | 2/6052 (0%) | 2 |
| Dyspnoea | 26/6036 (0.4%) | 29 | 23/6052 (0.4%) | 23 |
| Dyspnoea exertional | 6/6036 (0.1%) | 6 | 10/6052 (0.2%) | 10 |
| Emphysema | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Epistaxis | 6/6036 (0.1%) | 6 | 6/6052 (0.1%) | 6 |
| Haemoptysis | 1/6036 (0%) | 1 | 7/6052 (0.1%) | 11 |
| Haemothorax | 0/6036 (0%) | 0 | 2/6052 (0%) | 2 |
| Hiccups | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Hydrothorax | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Hypercapnia | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Hypoxia | 7/6036 (0.1%) | 7 | 4/6052 (0.1%) | 4 |
| Idiopathic pulmonary fibrosis | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Interstitial lung disease | 4/6036 (0.1%) | 4 | 1/6052 (0%) | 1 |
| Lung consolidation | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Lung infiltration | 1/6036 (0%) | 1 | 2/6052 (0%) | 2 |
| Mediastinal haemorrhage | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Nasal septum deviation | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Organising pneumonia | 2/6036 (0%) | 2 | 1/6052 (0%) | 1 |
| Pickwickian syndrome | 1/6036 (0%) | 1 | 1/6052 (0%) | 1 |
| Pleural effusion | 8/6036 (0.1%) | 8 | 12/6052 (0.2%) | 13 |
| Pleurisy | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Pleuritic pain | 2/6036 (0%) | 2 | 2/6052 (0%) | 2 |
| Pneumomediastinum | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Pneumonia aspiration | 7/6036 (0.1%) | 8 | 8/6052 (0.1%) | 11 |
| Pneumonitis | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Pneumothorax | 2/6036 (0%) | 3 | 3/6052 (0%) | 3 |
| Pneumothorax spontaneous | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Pulmonary alveolar haemorrhage | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Pulmonary arterial hypertension | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Pulmonary congestion | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Pulmonary embolism | 21/6036 (0.3%) | 22 | 20/6052 (0.3%) | 20 |
| Pulmonary fibrosis | 4/6036 (0.1%) | 4 | 4/6052 (0.1%) | 5 |
| Pulmonary hypertension | 2/6036 (0%) | 2 | 2/6052 (0%) | 2 |
| Pulmonary infarction | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Pulmonary mass | 4/6036 (0.1%) | 4 | 5/6052 (0.1%) | 5 |
| Pulmonary oedema | 8/6036 (0.1%) | 8 | 8/6052 (0.1%) | 8 |
| Respiratory arrest | 2/6036 (0%) | 2 | 2/6052 (0%) | 2 |
| Respiratory distress | 2/6036 (0%) | 2 | 3/6052 (0%) | 3 |
| Respiratory failure | 17/6036 (0.3%) | 17 | 16/6052 (0.3%) | 17 |
| Sleep apnoea syndrome | 3/6036 (0%) | 3 | 3/6052 (0%) | 3 |
| Tracheomalacia | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Skin and subcutaneous tissue disorders | ||||
| Angioedema | 2/6036 (0%) | 2 | 2/6052 (0%) | 2 |
| Decubitus ulcer | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Dermal cyst | 0/6036 (0%) | 0 | 2/6052 (0%) | 2 |
| Dermatomyositis | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Diabetic foot | 10/6036 (0.2%) | 11 | 3/6052 (0%) | 4 |
| Diabetic neuropathic ulcer | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Erythema multiforme | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Henoch-schonlein purpura | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Hyperhidrosis | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Hyperkeratosis | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Hypersensitivity vasculitis | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Psoriasis | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Rash | 1/6036 (0%) | 1 | 2/6052 (0%) | 2 |
| Skin lesion | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Skin ulcer | 9/6036 (0.1%) | 9 | 5/6052 (0.1%) | 6 |
| Urticaria | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Vasculitic rash | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Surgical and medical procedures | ||||
| Abdominal hernia repair | 1/6036 (0%) | 1 | 2/6052 (0%) | 2 |
| Adrenalectomy | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Amputation | 0/6036 (0%) | 0 | 1/6052 (0%) | 2 |
| Analgesic therapy | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Aneurysm repair | 1/6036 (0%) | 1 | 1/6052 (0%) | 1 |
| Angioplasty | 12/6036 (0.2%) | 12 | 8/6052 (0.1%) | 9 |
| Ankle arthroplasty | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Aortic aneurysm repair | 4/6036 (0.1%) | 4 | 1/6052 (0%) | 1 |
| Aortic bypass | 1/6036 (0%) | 1 | 1/6052 (0%) | 1 |
| Aortic valve repair | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Aortic valve replacement | 4/6036 (0.1%) | 4 | 1/6052 (0%) | 1 |
| Arterial stent insertion | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Atherectomy | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Atrial septal defect repair | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Autonomic nerve operation | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Bladder neck suspension | 1/1388 (0.1%) | 1 | 0/6052 (0%) | 0 |
| Bone operation | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Bronchial lesion excision | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Cancer surgery | 1/6036 (0%) | 1 | 1/6052 (0%) | 1 |
| Cardiac ablation | 3/6036 (0%) | 5 | 6/6052 (0.1%) | 6 |
| Cardiac pacemaker battery replacement | 1/6036 (0%) | 1 | 3/6052 (0%) | 3 |
| Cardiac pacemaker insertion | 6/6036 (0.1%) | 6 | 3/6052 (0%) | 4 |
| Cardiac pacemaker replacement | 1/6036 (0%) | 1 | 1/6052 (0%) | 1 |
| Cardiac rehabilitation therapy | 1/6036 (0%) | 1 | 3/6052 (0%) | 4 |
| Cardiac resynchronisation therapy | 0/6036 (0%) | 0 | 2/6052 (0%) | 2 |
| Cardioversion | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Carotid angioplasty | 1/6036 (0%) | 1 | 1/6052 (0%) | 1 |
| Carotid endarterectomy | 3/6036 (0%) | 3 | 6/6052 (0.1%) | 6 |
| Carotid revascularisation | 1/6036 (0%) | 1 | 2/6052 (0%) | 2 |
| Carpal tunnel decompression | 1/6036 (0%) | 1 | 1/6052 (0%) | 1 |
| Cataract operation | 3/6036 (0%) | 4 | 4/6052 (0.1%) | 5 |
| Catheter placement | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Cholecystectomy | 2/6036 (0%) | 2 | 5/6052 (0.1%) | 5 |
| Colectomy | 4/6036 (0.1%) | 4 | 1/6052 (0%) | 1 |
| Colostomy closure | 2/6036 (0%) | 2 | 1/6052 (0%) | 1 |
| Coronary angioplasty | 13/6036 (0.2%) | 16 | 21/6052 (0.3%) | 23 |
| Coronary arterial stent insertion | 11/6036 (0.2%) | 11 | 12/6052 (0.2%) | 13 |
| Coronary artery bypass | 54/6036 (0.9%) | 54 | 59/6052 (1%) | 59 |
| Coronary revascularisation | 82/6036 (1.4%) | 92 | 79/6052 (1.3%) | 89 |
| Cox-maze procedure | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Debridement | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Diaphragmatic operation | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Elective surgery | 1/6036 (0%) | 2 | 0/6052 (0%) | 0 |
| Endarterectomy | 2/6036 (0%) | 2 | 2/6052 (0%) | 2 |
| Endovenous ablation | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Explorative laparotomy | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Exploratory operation | 1/6036 (0%) | 1 | 1/6052 (0%) | 1 |
| Eye operation | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Foot amputation | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Gastrectomy | 1/6036 (0%) | 1 | 2/6052 (0%) | 2 |
| Gastric bypass | 2/6036 (0%) | 2 | 1/6052 (0%) | 1 |
| Gastrointestinal endoscopic therapy | 0/6036 (0%) | 0 | 2/6052 (0%) | 2 |
| Haematoma evacuation | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Heart valve replacement | 0/6036 (0%) | 0 | 2/6052 (0%) | 2 |
| Hernia repair | 1/6036 (0%) | 1 | 3/6052 (0%) | 3 |
| High frequency ablation | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Hip arthroplasty | 11/6036 (0.2%) | 12 | 7/6052 (0.1%) | 7 |
| Hip surgery | 1/6036 (0%) | 1 | 1/6052 (0%) | 1 |
| Hospitalisation | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Hysterectomy | 1/1388 (0.1%) | 1 | 1/1394 (0.1%) | 1 |
| Implantable defibrillator insertion | 11/6036 (0.2%) | 11 | 13/6052 (0.2%) | 13 |
| Implantable defibrillator replacement | 1/6036 (0%) | 1 | 1/6052 (0%) | 1 |
| Incisional drainage | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Incisional hernia repair | 2/6036 (0%) | 2 | 0/6052 (0%) | 0 |
| Inguinal hernia repair | 1/6036 (0%) | 1 | 5/6052 (0.1%) | 5 |
| Intervertebral disc operation | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Intraocular lens implant | 2/6036 (0%) | 3 | 1/6052 (0%) | 1 |
| Joint arthroplasty | 3/6036 (0%) | 3 | 1/6052 (0%) | 1 |
| Knee arthroplasty | 12/6036 (0.2%) | 14 | 12/6052 (0.2%) | 12 |
| Knee operation | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Leg amputation | 5/6036 (0.1%) | 6 | 3/6052 (0%) | 3 |
| Lens extraction | 1/6036 (0%) | 2 | 1/6052 (0%) | 1 |
| Lipoma excision | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Mastectomy | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Medical device change | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Medical device removal | 3/6036 (0%) | 3 | 0/6052 (0%) | 0 |
| Mitral valve replacement | 2/6036 (0%) | 2 | 0/6052 (0%) | 0 |
| Nephrectomy | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Open reduction of fracture | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Osteosynthesis | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Osteotomy | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Pancreatectomy | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Pancreaticoduodenectomy | 0/6036 (0%) | 0 | 2/6052 (0%) | 2 |
| Penile repair | 0/6036 (0%) | 0 | 1/4658 (0%) | 1 |
| Percutaneous coronary intervention | 192/6036 (3.2%) | 217 | 182/6052 (3%) | 214 |
| Peripheral artery angioplasty | 3/6036 (0%) | 5 | 4/6052 (0.1%) | 5 |
| Peripheral artery bypass | 5/6036 (0.1%) | 5 | 6/6052 (0.1%) | 6 |
| Peripheral artery stent insertion | 0/6036 (0%) | 0 | 2/6052 (0%) | 3 |
| Peripheral endarterectomy | 3/6036 (0%) | 3 | 6/6052 (0.1%) | 6 |
| Peripheral nerve transposition | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Peripheral revascularisation | 2/6036 (0%) | 2 | 2/6052 (0%) | 2 |
| Prostate ablation | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Prostatectomy | 0/6036 (0%) | 0 | 2/4658 (0%) | 2 |
| Radioactive iodine therapy | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Rectal prolapse repair | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Renal artery angioplasty | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Renal sympathetic nerve ablation | 0/6036 (0%) | 0 | 2/6052 (0%) | 2 |
| Resection of rectum | 1/6036 (0%) | 1 | 1/6052 (0%) | 1 |
| Resuscitation | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Retinopexy | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Rotator cuff repair | 1/6036 (0%) | 1 | 1/6052 (0%) | 1 |
| Shoulder arthroplasty | 2/6036 (0%) | 2 | 0/6052 (0%) | 0 |
| Shoulder operation | 1/6036 (0%) | 1 | 1/6052 (0%) | 1 |
| Skin neoplasm excision | 1/6036 (0%) | 2 | 1/6052 (0%) | 1 |
| Spinal decompression | 1/6036 (0%) | 1 | 1/6052 (0%) | 1 |
| Spinal fusion surgery | 5/6036 (0.1%) | 5 | 1/6052 (0%) | 1 |
| Spinal laminectomy | 4/6036 (0.1%) | 4 | 3/6052 (0%) | 3 |
| Spinal operation | 1/6036 (0%) | 1 | 1/6052 (0%) | 1 |
| Stent placement | 3/6036 (0%) | 3 | 2/6052 (0%) | 2 |
| Sympathectomy | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Tenotomy | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Therapeutic embolisation | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Therapy cessation | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Thrombectomy | 3/6036 (0%) | 3 | 1/6052 (0%) | 1 |
| Thrombosis prophylaxis | 1/6036 (0%) | 1 | 1/6052 (0%) | 1 |
| Thyroidectomy | 3/6036 (0%) | 3 | 0/6052 (0%) | 0 |
| Toe amputation | 1/6036 (0%) | 1 | 4/6052 (0.1%) | 4 |
| Tongue operation | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Transmyocardial revascularisation | 2/6036 (0%) | 2 | 0/6052 (0%) | 0 |
| Transurethral bladder resection | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Transurethral prostatectomy | 2/4648 (0%) | 2 | 1/4658 (0%) | 1 |
| Tricuspid valve repair | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Tumour excision | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Ureteral stent insertion | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Ureteral stent removal | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Vaginal prolapse repair | 1/1388 (0.1%) | 1 | 0/6052 (0%) | 0 |
| Valvuloplasty cardiac | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Vascular graft | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Venous stent insertion | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Ventricular assist device insertion | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Vitrectomy | 0/6036 (0%) | 0 | 2/6052 (0%) | 2 |
| Wound drainage | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Vascular disorders | ||||
| Accelerated hypertension | 2/6036 (0%) | 2 | 1/6052 (0%) | 1 |
| Aneurysm | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Aortic aneurysm | 18/6036 (0.3%) | 18 | 14/6052 (0.2%) | 14 |
| Aortic aneurysm rupture | 3/6036 (0%) | 3 | 1/6052 (0%) | 1 |
| Aortic dissection | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Aortic elongation | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Aortic occlusion | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Aortic rupture | 0/6036 (0%) | 0 | 2/6052 (0%) | 2 |
| Aortic stenosis | 18/6036 (0.3%) | 18 | 17/6052 (0.3%) | 19 |
| Aortitis | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Arterial disorder | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Arterial haemorrhage | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Arterial insufficiency | 1/6036 (0%) | 1 | 1/6052 (0%) | 1 |
| Arterial occlusive disease | 3/6036 (0%) | 4 | 1/6052 (0%) | 1 |
| Arterial perforation | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Arterial stenosis | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Arterial thrombosis | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Arteriosclerosis | 1/6036 (0%) | 1 | 3/6052 (0%) | 3 |
| Artery dissection | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Axillary vein thrombosis | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Blood pressure inadequately controlled | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Brachiocephalic artery stenosis | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Circulatory collapse | 1/6036 (0%) | 1 | 3/6052 (0%) | 3 |
| Deep vein thrombosis | 11/6036 (0.2%) | 12 | 16/6052 (0.3%) | 16 |
| Dry gangrene | 0/6036 (0%) | 0 | 2/6052 (0%) | 3 |
| Embolism arterial | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Extremity necrosis | 1/6036 (0%) | 1 | 1/6052 (0%) | 1 |
| Femoral artery aneurysm | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Femoral artery occlusion | 7/6036 (0.1%) | 8 | 7/6052 (0.1%) | 7 |
| Femoral artery perforation | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Haematoma | 7/6036 (0.1%) | 7 | 3/6052 (0%) | 3 |
| Haemorrhage | 0/6036 (0%) | 0 | 3/6052 (0%) | 3 |
| Hypertension | 21/6036 (0.3%) | 23 | 18/6052 (0.3%) | 19 |
| Hypertensive crisis | 9/6036 (0.1%) | 9 | 14/6052 (0.2%) | 16 |
| Hypertensive emergency | 3/6036 (0%) | 3 | 0/6052 (0%) | 0 |
| Hypotension | 11/6036 (0.2%) | 12 | 17/6052 (0.3%) | 18 |
| Hypovolaemic shock | 2/6036 (0%) | 2 | 1/6052 (0%) | 1 |
| Iliac artery occlusion | 2/6036 (0%) | 2 | 3/6052 (0%) | 3 |
| Iliac artery rupture | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Intermittent claudication | 7/6036 (0.1%) | 7 | 16/6052 (0.3%) | 20 |
| Jugular vein thrombosis | 0/6036 (0%) | 0 | 2/6052 (0%) | 2 |
| Lymphatic fistula | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Lymphorrhoea | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Malignant hypertension | 4/6036 (0.1%) | 4 | 1/6052 (0%) | 1 |
| Orthostatic hypotension | 11/6036 (0.2%) | 11 | 4/6052 (0.1%) | 4 |
| Peripheral arterial occlusive disease | 52/6036 (0.9%) | 66 | 50/6052 (0.8%) | 66 |
| Peripheral artery aneurysm | 2/6036 (0%) | 2 | 2/6052 (0%) | 2 |
| Peripheral artery stenosis | 19/6036 (0.3%) | 21 | 10/6052 (0.2%) | 10 |
| Peripheral artery thrombosis | 1/6036 (0%) | 1 | 6/6052 (0.1%) | 7 |
| Peripheral embolism | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Peripheral ischaemia | 12/6036 (0.2%) | 14 | 20/6052 (0.3%) | 25 |
| Peripheral vascular disorder | 21/6036 (0.3%) | 25 | 10/6052 (0.2%) | 11 |
| Shock | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Shock haemorrhagic | 1/6036 (0%) | 1 | 1/6052 (0%) | 1 |
| Subclavian artery occlusion | 0/6036 (0%) | 0 | 2/6052 (0%) | 2 |
| Subclavian artery stenosis | 2/6036 (0%) | 3 | 4/6052 (0.1%) | 4 |
| Subclavian artery thrombosis | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Temporal arteritis | 2/6036 (0%) | 2 | 0/6052 (0%) | 0 |
| Thrombophlebitis | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Thrombophlebitis superficial | 2/6036 (0%) | 2 | 0/6052 (0%) | 0 |
| Thrombosis | 1/6036 (0%) | 1 | 1/6052 (0%) | 1 |
| Varicose vein | 2/6036 (0%) | 2 | 2/6052 (0%) | 2 |
| Vascular occlusion | 2/6036 (0%) | 2 | 0/6052 (0%) | 0 |
| Vasculitis | 0/6036 (0%) | 0 | 1/6052 (0%) | 1 |
| Vena cava thrombosis | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
| Venous thrombosis | 2/6036 (0%) | 2 | 0/6052 (0%) | 0 |
| Venous thrombosis limb | 1/6036 (0%) | 1 | 0/6052 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||
| Evacetrapib | Placebo | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 2659/6036 (44.1%) | 2529/6052 (41.8%) | ||
| Gastrointestinal disorders | ||||
| Diarrhoea | 472/6036 (7.8%) | 568 | 414/6052 (6.8%) | 484 |
| Infections and infestations | ||||
| Bronchitis | 363/6036 (6%) | 456 | 375/6052 (6.2%) | 443 |
| Nasopharyngitis | 452/6036 (7.5%) | 603 | 465/6052 (7.7%) | 602 |
| Upper respiratory tract infection | 327/6036 (5.4%) | 397 | 327/6052 (5.4%) | 410 |
| Musculoskeletal and connective tissue disorders | ||||
| Arthralgia | 375/6036 (6.2%) | 426 | 370/6052 (6.1%) | 425 |
| Back pain | 399/6036 (6.6%) | 442 | 379/6052 (6.3%) | 412 |
| Pain in extremity | 339/6036 (5.6%) | 412 | 329/6052 (5.4%) | 388 |
| Nervous system disorders | ||||
| Dizziness | 389/6036 (6.4%) | 435 | 352/6052 (5.8%) | 407 |
| Respiratory, thoracic and mediastinal disorders | ||||
| Cough | 327/6036 (5.4%) | 367 | 279/6052 (4.6%) | 304 |
| Dyspnoea | 305/6036 (5.1%) | 339 | 307/6052 (5.1%) | 341 |
| Vascular disorders | ||||
| Hypertension | 453/6036 (7.5%) | 508 | 403/6052 (6.7%) | 466 |
Limitations/Caveats
[Not Specified]
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 |
| ClinicalTrials.gov@lilly.com |
Responsible Party:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01687998
Other Study ID Numbers:
- 11949
- I1V-MC-EIAN
First Posted:
Sep 19, 2012
Last Update Posted:
Oct 8, 2019
Last Verified:
Sep 1, 2019