Researching Cardiovascular Events With a Weekly Incretin in Diabetes (REWIND)

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT01394952
Collaborator
(none)
9,901
301
2
85
32.9
0.4

Study Details

Study Description

Brief Summary

The purpose of this trial is to assess whether dulaglutide can reduce major cardiovascular events and other serious outcomes in persons with type 2 diabetes, when added to their anti-hyperglycemic regimen.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
9901 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
The Effect of Dulaglutide on Major Cardiovascular Events in Patients With Type 2 Diabetes: Researching Cardiovascular Events With a Weekly INcretin in Diabetes (REWIND)
Actual Study Start Date :
Jul 22, 2011
Actual Primary Completion Date :
Aug 21, 2018
Actual Study Completion Date :
Aug 21, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1.5 mg Dulaglutide

Administered once weekly, subcutaneously

Drug: Dulaglutide
Administered subcutaneously
Other Names:
  • LY2189265
  • Placebo Comparator: Placebo

    Administered once weekly, subcutaneously

    Drug: Placebo
    Administered subcutaneously

    Outcome Measures

    Primary Outcome Measures

    1. Number of Participants Who Experienced an Event For Time, From Randomization to First Occurrence of Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke (a Composite Cardiovascular Outcome) [From randomization to first occurrence or death from any cause or study completion (Median Follow-Up of 5.4 Years)]

      The time from randomization to first occurrence of cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke (a composite endpoint) was evaluated using time-to-event analysis. The primary analysis model was a Cox proportional hazards regression model for the time to the first occurrence of a primary endpoint event, with treatment as a fixed effect using the intent-to-treat population. The number of participants who experienced a primary cardiovascular (CV) endpoint event is presented.

    Secondary Outcome Measures

    1. Number of Participants Who Experienced an Event for Time to First Occurrence After Randomization of Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke, Individually [From randomization to first occurrence or study completion (Median Follow-Up of 5.4 Years)]

      The time from randomization to first occurrence of cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke (individually) was evaluated using time-to-event analysis via the Cox proportional hazards regression model where response equals treatment. Death from CV causes is defined as a death resulting from an acute myocardial infarction (MI), sudden cardiac death, death due to heart failure, death due to stroke, or death due to other CV causes. The number of participants who experienced an event is presented.

    2. Number of Participants Who Experienced an Event for Time to All-cause Mortality [From randomization to study completion (Median Follow-Up of 5.4 Years)]

      The time to all-cause mortality was evaluated using time-to-event analysis via the Cox proportional hazards regression model where response equals treatment. The number of participants who experienced an event is presented.

    3. Number of Participants Who Experienced an Event for Time to First Occurrence After Randomization of the Composite Microvascular Endpoint [From randomization to first occurrence or study completion (Median Follow-Up of 5.4 Years)]

      The time from randomization to first occurrence of the composite microvascular endpoint was evaluated using time-to-event analysis via the Cox proportional hazards regression model where response equals treatment. The composite microvascular endpoint is defined as diabetic retinopathy requiring laser therapy, vitrectomy, or anti-vascular endothelial growth factor therapy (VEGF), clinical proteinuria, a greater than equal ≥ 30% decline in estimated glomerular filtration rate, or need for chronic renal replacement therapy. The number of participants who experienced the composite microvascular endpoint event is presented.

    4. Number of Participants Who Experienced An Event for Time to First Occurrence After Randomization of Heart Failure Requiring Hospitalization or an Urgent Heart Failure Clinic Visit [From randomization to first occurrence or study completion (Median Follow-Up of 5.4 Years)]

      The time to first occurrence after randomization of heart failure requiring hospitalization or an urgent heart failure clinic visit was evaluated using time-to-event analysis via the Cox proportional hazards regression model where response equals treatment. The number of participants who experienced an event is presented.

    5. Number of Participants Who Experienced an Event for Time to First Occurrence After Randomization of First Hospitalization for Unstable Angina [From randomization to first occurrence or study completion (Median Follow-Up of 5.4 Years)]

      Time to first occurrence after randomization of first hospitalization for unstable angina was evaluated using time-to-event analysis via the Cox proportional hazards regression model where response equals treatment. The number of participants who experienced an event is presented.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Type 2 diabetes with Hemoglobin A1c equal to or less than 9.5% (equal to or less than 81 mmol/mol)

    • Anti-hyperglycemic drug naive or treated with up to 2 oral hyperglycemic drugs with or without a glucagon-like peptide-1analog or basal insulin, or basal insulin alone

    • On stable antihyperglycemic regimen for at least 3 months

    • Age equal to or greater than 50 years with established clinical vascular disease, or age equal to or greater than 55 years and subclinical vascular disease or age equal to or greater than 60 years and at least 2 or more cardiovascular risk factors

    Exclusion Criteria:
    • Uncontrolled diabetes requiring immediate therapy

    • History of severe hypoglycemia in past year

    • Acute coronary or cerebrovascular event within past 2 months

    • Planned or anticipated revascularization procedure

    • History of pancreatitis, hepatic insufficiency , chronic renal failure or of C-cell thyroid disorder

    • Pregnancy or planned pregnancy during the trial period

    • Completed or withdrawn from any study investigating dulaglutide

    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. Mobile Alabama United States 36606
    2 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Pell City Alabama United States 35128
    3 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Phoenix Arizona United States 85012
    4 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Tucson Arizona United States 85723
    5 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Little Rock Arkansas United States 72205
    6 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Burlingame California United States 94010
    7 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Lakewood California United States 90712
    8 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Long Beach California United States 90822
    9 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Los Angeles California United States 90333
    10 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Northridge California United States 91325
    11 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. San Diego California United States 92161
    12 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Waterbury Connecticut United States 06708
    13 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Washington District of Columbia United States 20010
    14 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Brandon Florida United States 33511
    15 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Miami Florida United States 33125
    16 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Palm Harbor Florida United States 34684
    17 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Plant City Florida United States 33563
    18 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Port Charlotte Florida United States 33952
    19 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. West Palm Beach Florida United States 33401
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    21 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Lawrenceville Georgia United States 30046
    22 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Honolulu Hawaii United States 96814
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    25 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. New Orleans Louisiana United States 70112
    26 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Detroit Michigan United States 48202
    27 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Minneapolis Minnesota United States 55455
    28 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Columbia Missouri United States 65212
    29 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Kansas City Missouri United States 64128
    30 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Saint Louis Missouri United States 63106
    31 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Kalispell Montana United States 59901
    32 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Omaha Nebraska United States 68105
    33 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Camden New Jersey United States 08103
    34 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Fresh Meadows New York United States 11365
    35 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Rochester New York United States 14607
    36 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Westfield New York United States 14787
    37 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Morehead City North Carolina United States 28557
    38 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Columbus Ohio United States 43210
    39 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Portland Oregon United States 97239
    40 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Murrells Inlet South Carolina United States 29576
    41 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Memphis Tennessee United States 38104
    42 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Dallas Texas United States 75246
    43 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Houston Texas United States 77030
    44 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Lubbock Texas United States 79423
    45 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Salt Lake City Utah United States 84124
    46 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Burke Virginia United States 22015
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    49 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Richmond Virginia United States 23249
    50 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Salem Virginia United States 24153
    51 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Seattle Washington United States 98105
    52 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Bahia Blanca Argentina 8000
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    54 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Cipolletti Argentina 8324
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    75 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Milton Queensland Australia 4064
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    78 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Heidelberg Heights Victoria Australia 3081
    79 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Melbourne Victoria Australia 3004
    80 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Parkville Victoria Australia 3050
    81 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Nedlands Western Australia Australia 6009
    82 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Belo Horizonte Brazil 30150240
    83 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Brasilia Brazil 70390903
    84 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Campina Grande Do Sul Brazil 83430000
    85 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Campinas Brazil 13020421
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    125 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Providencia Chile 7500520
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    129 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Barranquilla Colombia 1569
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    137 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Pereira Colombia
    138 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Brno Czechia 66250
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    178 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Guri City Korea, Republic of 471-701
    179 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Gwangju Korea, Republic of 501-757
    180 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Seoul Korea, Republic of 137-701
    181 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Daugavpils Latvia LV -5417
    182 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Jelgava Latvia LV 3000
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    187 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Tukums Latvia LV-3101
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    208 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Papamoa New Zealand 3118
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    221 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Wroclaw Poland 50-127
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    225 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Alba Lulia Romania 510053
    226 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Bacau Romania 600164
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    228 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Bucharest Romania 010507
    229 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Cluj-Napoca Romania 400349
    230 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Constanta Romania 900591
    231 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Craiova Romania 200642
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    234 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Iasi Romania 700111
    235 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Maramures Romania 430123
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    237 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Pitesti Romania 110084
    238 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Ploiesti Romania 100163
    239 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Satu Mare Romania 440055
    240 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Sibiu Romania 550245
    241 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Timisoara Romania 300736
    242 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Chelyabinsk Russian Federation 454021
    243 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Moscow Russian Federation 123423
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    245 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Saint Petersburg Russian Federation 194156
    246 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Smolensk Russian Federation 214019
    247 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Volgograd Russian Federation 400138
    248 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Benoni South Africa 1500
    249 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Bloemfontein South Africa 9301
    250 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Cape Town South Africa 7925
    251 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Die Wilgers Ext 14 South Africa 0041
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    255 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Lynnwood Ridge South Africa 0040
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    259 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Somerset West South Africa 7130
    260 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Soweto South Africa 2013
    261 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Tongaat South Africa 4400
    262 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Worcester South Africa 6850
    263 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Alicante Spain 03450
    264 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Alzira Spain 46600
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    266 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Barcelona Spain 08022
    267 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Centelles Spain 08540
    268 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Lleida Spain 25198
    269 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Palma De Mallorca Spain 07198
    270 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Segovia Spain 40002
    271 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Sevilla Spain 41009
    272 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Valencia Spain 46014
    273 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Vic Spain 08500
    274 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Aneby Sweden 57893
    275 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Goteborg Sweden 41685
    276 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Härnösand Sweden 87182
    277 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Koping Sweden 73181
    278 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Ljungby Sweden 341 82
    279 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Ostersund Sweden 83183
    280 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Skelleftea Sweden 93186
    281 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Stockholm Sweden 17176
    282 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Vaxjo Sweden 35185
    283 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Vällingby Sweden 16268
    284 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Kaohsiung Hsien Taiwan 833
    285 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Sindian City Taiwan 23148
    286 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Taichung City Taiwan 404
    287 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Bath Avon United Kingdom BA2 3HT
    288 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Middlesbrough Cleveland United Kingdom TS4 3BW
    289 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Hull East Yorkshire United Kingdom HU3 2RW
    290 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Oldham Lancashire United Kingdom OL1 2JH
    291 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Belfast Northern Ireland United Kingdom BT16 0TH
    292 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Ayr Scotland United Kingdom KA6 6DX
    293 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Dundee Scotland United Kingdom DD1 9SY
    294 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Edinburgh Scotland United Kingdom EH4 2XU
    295 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Inverness Scotland United Kingdom IV2 3JH
    296 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Sheffield South Yorkshire United Kingdom S5 7AU
    297 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Swansea Wales United Kingdom SA6 6NL
    298 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Antrim United Kingdom BT412RL
    299 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Bath United Kingdom BA1 2SR
    300 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Belfast United Kingdom BT12 6BA
    301 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Londonderry United Kingdom BT47 6SB

    Sponsors and Collaborators

    • Eli Lilly and Company

    Investigators

    • Study Director: Call 1-877-CTLILLY (1-877-285-4559 or 1-317-615-4559 Mon - Fri 9 AM - 5PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Eli Lilly and Company
    ClinicalTrials.gov Identifier:
    NCT01394952
    Other Study ID Numbers:
    • 13438
    • H9X-MC-GBDJ
    First Posted:
    Jul 15, 2011
    Last Update Posted:
    Oct 8, 2019
    Last Verified:
    Sep 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Keywords provided by Eli Lilly and Company
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail Participants were randomized to either placebo or Dulaglutide. Completers included participants for whom vital status was ascertained during the study close-out period and endpoint completers.
    Arm/Group Title Placebo Dulaglutide
    Arm/Group Description Placebo was administered once weekly, subcutaneously 1.5 mg Dulaglutide was administered once weekly, subcutaneously
    Period Title: Overall Study
    STARTED 4952 4949
    Received at Least One Dose of Study Drug 4949 4943
    COMPLETED 4935 4932
    NOT COMPLETED 17 17

    Baseline Characteristics

    Arm/Group Title Placebo Dulaglutide Total
    Arm/Group Description Placebo was administered once weekly, subcutaneously 1.5 mg Dulaglutide was administered once weekly, subcutaneously Total of all reporting groups
    Overall Participants 4952 4949 9901
    Age (Count of Participants)
    <=18 years
    0
    0%
    0
    0%
    0
    0%
    Between 18 and 65 years
    2315
    46.7%
    2330
    47.1%
    4645
    46.9%
    >=65 years
    2637
    53.3%
    2619
    52.9%
    5256
    53.1%
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    66.2
    (6.5)
    66.2
    (6.5)
    66.2
    (6.5)
    Sex: Female, Male (Count of Participants)
    Female
    2283
    46.1%
    2306
    46.6%
    4589
    46.3%
    Male
    2669
    53.9%
    2643
    53.4%
    5312
    53.7%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    64
    1.3%
    60
    1.2%
    124
    1.3%
    Not Hispanic or Latino
    402
    8.1%
    400
    8.1%
    802
    8.1%
    Unknown or Not Reported
    4486
    90.6%
    4489
    90.7%
    8975
    90.6%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    543
    11%
    549
    11.1%
    1092
    11%
    Asian
    218
    4.4%
    216
    4.4%
    434
    4.4%
    Native Hawaiian or Other Pacific Islander
    22
    0.4%
    12
    0.2%
    34
    0.3%
    Black or African American
    346
    7%
    331
    6.7%
    677
    6.8%
    White
    3744
    75.6%
    3754
    75.9%
    7498
    75.7%
    More than one race
    79
    1.6%
    87
    1.8%
    166
    1.7%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    Region of Enrollment (Count of Participants)
    United States
    475
    9.6%
    468
    9.5%
    943
    9.5%
    Czechia
    107
    2.2%
    106
    2.1%
    213
    2.2%
    Russia
    50
    1%
    51
    1%
    101
    1%
    South Korea
    62
    1.3%
    60
    1.2%
    122
    1.2%
    Sweden
    117
    2.4%
    119
    2.4%
    236
    2.4%
    Latvia
    39
    0.8%
    39
    0.8%
    78
    0.8%
    Brazil
    137
    2.8%
    138
    2.8%
    275
    2.8%
    Poland
    305
    6.2%
    303
    6.1%
    608
    6.1%
    Chile
    64
    1.3%
    64
    1.3%
    128
    1.3%
    Bulgaria
    50
    1%
    51
    1%
    101
    1%
    Lithuania
    52
    1.1%
    53
    1.1%
    105
    1.1%
    Colombia
    392
    7.9%
    393
    7.9%
    785
    7.9%
    Argentina
    698
    14.1%
    697
    14.1%
    1395
    14.1%
    Romania
    544
    11%
    541
    10.9%
    1085
    11%
    Hungary
    113
    2.3%
    110
    2.2%
    223
    2.3%
    United Kingdom
    65
    1.3%
    71
    1.4%
    136
    1.4%
    Spain
    62
    1.3%
    65
    1.3%
    127
    1.3%
    New Zealand
    119
    2.4%
    115
    2.3%
    234
    2.4%
    Canada
    564
    11.4%
    564
    11.4%
    1128
    11.4%
    Taiwan
    13
    0.3%
    13
    0.3%
    26
    0.3%
    South Africa
    369
    7.5%
    372
    7.5%
    741
    7.5%
    Mexico
    219
    4.4%
    219
    4.4%
    438
    4.4%
    Australia
    44
    0.9%
    44
    0.9%
    88
    0.9%
    Germany
    292
    5.9%
    293
    5.9%
    585
    5.9%

    Outcome Measures

    1. Primary Outcome
    Title Number of Participants Who Experienced an Event For Time, From Randomization to First Occurrence of Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke (a Composite Cardiovascular Outcome)
    Description The time from randomization to first occurrence of cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke (a composite endpoint) was evaluated using time-to-event analysis. The primary analysis model was a Cox proportional hazards regression model for the time to the first occurrence of a primary endpoint event, with treatment as a fixed effect using the intent-to-treat population. The number of participants who experienced a primary cardiovascular (CV) endpoint event is presented.
    Time Frame From randomization to first occurrence or death from any cause or study completion (Median Follow-Up of 5.4 Years)

    Outcome Measure Data

    Analysis Population Description
    All randomized participants.
    Arm/Group Title Placebo Dulaglutide
    Arm/Group Description Placebo was administered once weekly, subcutaneously 1.5 mg Dulaglutide was administered once weekly, subcutaneously
    Measure Participants 4952 4949
    Count of Participants [Participants]
    663
    13.4%
    594
    12%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Dulaglutide
    Comments Primary CV endpoint
    Type of Statistical Test Superiority
    Comments Superiority was declared if the upper limit of the 2-sided 95.33% confidence interval (CI) of the hazard ratio was below 1.0 (after adjustment for the interim analysis). Once superiority was achieved for the primary endpoint, multiplicity adjustments using the graphical approach were performed for secondary efficacy endpoints in order to control the overall Type I error rate at a 2-sided alpha level of 0.0467.
    Statistical Test of Hypothesis p-Value 0.026
    Comments
    Method Regression, Cox
    Comments
    Method of Estimation Estimation Parameter Hazard Ratio (HR)
    Estimated Value 0.88
    Confidence Interval (2-Sided) 95.33%
    0.79 to 0.99
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    2. Secondary Outcome
    Title Number of Participants Who Experienced an Event for Time to First Occurrence After Randomization of Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke, Individually
    Description The time from randomization to first occurrence of cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke (individually) was evaluated using time-to-event analysis via the Cox proportional hazards regression model where response equals treatment. Death from CV causes is defined as a death resulting from an acute myocardial infarction (MI), sudden cardiac death, death due to heart failure, death due to stroke, or death due to other CV causes. The number of participants who experienced an event is presented.
    Time Frame From randomization to first occurrence or study completion (Median Follow-Up of 5.4 Years)

    Outcome Measure Data

    Analysis Population Description
    All randomized participants.
    Arm/Group Title Placebo Dulaglutide
    Arm/Group Description Placebo was administered once weekly, subcutaneously 1.5 mg Dulaglutide was administered once weekly, subcutaneously
    Measure Participants 4952 4949
    Death from CV causes
    346
    7%
    317
    6.4%
    Nonfatal MI
    212
    4.3%
    205
    4.1%
    Nonfatal stroke
    175
    3.5%
    135
    2.7%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Dulaglutide
    Comments Death from CV causes
    Type of Statistical Test Superiority
    Comments Multiplicity adjustments using the graphical approach were performed for secondary efficacy endpoints in order to control the overall Type I error rate at a 2-sided alpha level of 0.0467.
    Statistical Test of Hypothesis p-Value 0.211
    Comments
    Method Regression, Cox
    Comments
    Method of Estimation Estimation Parameter Hazard Ratio (HR)
    Estimated Value 0.91
    Confidence Interval (2-Sided) 95%
    0.78 to 1.06
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Dulaglutide
    Comments Nonfatal MI
    Type of Statistical Test Superiority
    Comments Multiplicity adjustments using the graphical approach were performed for secondary efficacy endpoints in order to control the overall Type I error rate at a 2-sided alpha level of 0.0467.
    Statistical Test of Hypothesis p-Value 0.652
    Comments
    Method Regression, Cox
    Comments
    Method of Estimation Estimation Parameter Hazard Ratio (HR)
    Estimated Value 0.96
    Confidence Interval (2-Sided) 95%
    0.79 to 1.16
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo, Dulaglutide
    Comments Nonfatal stroke
    Type of Statistical Test Superiority
    Comments Multiplicity adjustments using the graphical approach were performed for secondary efficacy endpoints in order to control the overall Type I error rate at a 2-sided alpha level of 0.0467.
    Statistical Test of Hypothesis p-Value 0.017
    Comments
    Method Regression, Cox
    Comments
    Method of Estimation Estimation Parameter Hazard Ratio (HR)
    Estimated Value 0.76
    Confidence Interval (2-Sided) 95%
    0.61 to 0.95
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    3. Secondary Outcome
    Title Number of Participants Who Experienced an Event for Time to All-cause Mortality
    Description The time to all-cause mortality was evaluated using time-to-event analysis via the Cox proportional hazards regression model where response equals treatment. The number of participants who experienced an event is presented.
    Time Frame From randomization to study completion (Median Follow-Up of 5.4 Years)

    Outcome Measure Data

    Analysis Population Description
    All randomized participants.
    Arm/Group Title Placebo Dulaglutide
    Arm/Group Description Placebo was administered once weekly, subcutaneously 1.5 mg Dulaglutide was administered once weekly, subcutaneously
    Measure Participants 4952 4949
    Count of Participants [Participants]
    592
    12%
    536
    10.8%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Dulaglutide
    Comments Time to all cause mortality
    Type of Statistical Test Superiority
    Comments Multiplicity adjustments using the graphical approach were performed for secondary efficacy endpoints in order to control the overall Type I error rate at a 2-sided alpha level of 0.0467.
    Statistical Test of Hypothesis p-Value 0.067
    Comments
    Method Regression, Cox
    Comments
    Method of Estimation Estimation Parameter Hazard Ratio (HR)
    Estimated Value 0.90
    Confidence Interval (2-Sided) 95%
    0.80 to 1.01
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    4. Secondary Outcome
    Title Number of Participants Who Experienced an Event for Time to First Occurrence After Randomization of the Composite Microvascular Endpoint
    Description The time from randomization to first occurrence of the composite microvascular endpoint was evaluated using time-to-event analysis via the Cox proportional hazards regression model where response equals treatment. The composite microvascular endpoint is defined as diabetic retinopathy requiring laser therapy, vitrectomy, or anti-vascular endothelial growth factor therapy (VEGF), clinical proteinuria, a greater than equal ≥ 30% decline in estimated glomerular filtration rate, or need for chronic renal replacement therapy. The number of participants who experienced the composite microvascular endpoint event is presented.
    Time Frame From randomization to first occurrence or study completion (Median Follow-Up of 5.4 Years)

    Outcome Measure Data

    Analysis Population Description
    All randomized participants.
    Arm/Group Title Placebo Dulaglutide
    Arm/Group Description Placebo was administered once weekly, subcutaneously 1.5 mg Dulaglutide was administered once weekly, subcutaneously
    Measure Participants 4952 4949
    Count of Participants [Participants]
    1241
    25.1%
    1099
    22.2%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Dulaglutide
    Comments microvascular endpoint
    Type of Statistical Test Superiority
    Comments Multiplicity adjustments using the graphical approach were performed for secondary efficacy endpoints in order to control the overall Type I error rate at a 2-sided alpha level of 0.0467.
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method Regression, Cox
    Comments
    Method of Estimation Estimation Parameter Hazard Ratio (HR)
    Estimated Value 0.86
    Confidence Interval (2-Sided) 95%
    0.79 to 0.93
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    5. Secondary Outcome
    Title Number of Participants Who Experienced An Event for Time to First Occurrence After Randomization of Heart Failure Requiring Hospitalization or an Urgent Heart Failure Clinic Visit
    Description The time to first occurrence after randomization of heart failure requiring hospitalization or an urgent heart failure clinic visit was evaluated using time-to-event analysis via the Cox proportional hazards regression model where response equals treatment. The number of participants who experienced an event is presented.
    Time Frame From randomization to first occurrence or study completion (Median Follow-Up of 5.4 Years)

    Outcome Measure Data

    Analysis Population Description
    All randomized participants.
    Arm/Group Title Placebo Dulaglutide
    Arm/Group Description Placebo was administered once weekly, subcutaneously 1.5 mg Dulaglutide was administered once weekly, subcutaneously
    Measure Participants 4952 4949
    Count of Participants [Participants]
    226
    4.6%
    213
    4.3%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Dulaglutide
    Comments Heart failure requiring hospitalization or an urgent heart failure clinic visit
    Type of Statistical Test Superiority
    Comments Multiplicity adjustments using the graphical approach were performed for secondary efficacy endpoints in order to control the overall Type I error rate at a 2-sided alpha level of 0.0467.
    Statistical Test of Hypothesis p-Value 0.456
    Comments
    Method Regression, Cox
    Comments
    Method of Estimation Estimation Parameter Hazard Ratio (HR)
    Estimated Value 0.93
    Confidence Interval (2-Sided) 95%
    0.77 to 1.12
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    6. Secondary Outcome
    Title Number of Participants Who Experienced an Event for Time to First Occurrence After Randomization of First Hospitalization for Unstable Angina
    Description Time to first occurrence after randomization of first hospitalization for unstable angina was evaluated using time-to-event analysis via the Cox proportional hazards regression model where response equals treatment. The number of participants who experienced an event is presented.
    Time Frame From randomization to first occurrence or study completion (Median Follow-Up of 5.4 Years)

    Outcome Measure Data

    Analysis Population Description
    All randomized participants.
    Arm/Group Title Placebo Dulaglutide
    Arm/Group Description Placebo was administered once weekly, subcutaneously 1.5 mg Dulaglutide was administered once weekly, subcutaneously
    Measure Participants 4952 4949
    Count of Participants [Participants]
    77
    1.6%
    88
    1.8%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Dulaglutide
    Comments Hospitalization for unstable angina
    Type of Statistical Test Superiority
    Comments Multiplicity adjustments using the graphical approach were performed for secondary efficacy endpoints in order to control the overall Type I error rate at a 2-sided alpha level of 0.0467.
    Statistical Test of Hypothesis p-Value 0.413
    Comments
    Method Regression, Cox
    Comments
    Method of Estimation Estimation Parameter Hazard Ratio (HR)
    Estimated Value 1.14
    Confidence Interval (2-Sided) 95%
    0.84 to 1.54
    Parameter Dispersion Type:
    Value:
    Estimation Comments

    Adverse Events

    Time Frame From Randomization to Study Completion (Up to 7 Years)
    Adverse Event Reporting Description All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
    Arm/Group Title Placebo Dulaglutide
    Arm/Group Description Placebo was administered once weekly, subcutaneously 1.5 mg Dulaglutide was administered once weekly, subcutaneously
    All Cause Mortality
    Placebo Dulaglutide
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 592/4949 (12%) 536/4943 (10.8%)
    Serious Adverse Events
    Placebo Dulaglutide
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 2044/4949 (41.3%) 1991/4943 (40.3%)
    Blood and lymphatic system disorders
    Agranulocytosis 0/4949 (0%) 0 1/4943 (0%) 1
    Anaemia 23/4949 (0.5%) 24 29/4943 (0.6%) 30
    Anaemia folate deficiency 0/4949 (0%) 0 1/4943 (0%) 1
    Anaemia macrocytic 0/4949 (0%) 0 1/4943 (0%) 1
    Anaemia of malignant disease 0/4949 (0%) 0 2/4943 (0%) 2
    Anaemia vitamin b12 deficiency 0/4949 (0%) 0 1/4943 (0%) 1
    Blood disorder 1/4949 (0%) 1 0/4943 (0%) 0
    Deficiency anaemia 0/4949 (0%) 0 1/4943 (0%) 1
    Disseminated intravascular coagulation 1/4949 (0%) 1 0/4943 (0%) 0
    Febrile neutropenia 4/4949 (0.1%) 5 2/4943 (0%) 2
    Haemolytic anaemia 1/4949 (0%) 1 0/4943 (0%) 0
    Haemorrhagic anaemia 2/4949 (0%) 2 0/4943 (0%) 0
    Histiocytosis haematophagic 0/4949 (0%) 0 1/4943 (0%) 1
    Hypochromic anaemia 0/4949 (0%) 0 2/4943 (0%) 2
    Immune thrombocytopenic purpura 0/4949 (0%) 0 1/4943 (0%) 1
    Iron deficiency anaemia 9/4949 (0.2%) 10 14/4943 (0.3%) 14
    Lymphadenopathy 1/4949 (0%) 1 0/4943 (0%) 0
    Lymphadenopathy mediastinal 1/4949 (0%) 1 1/4943 (0%) 1
    Microcytic anaemia 1/4949 (0%) 1 0/4943 (0%) 0
    Nephrogenic anaemia 1/4949 (0%) 1 1/4943 (0%) 1
    Neutropenia 0/4949 (0%) 0 1/4943 (0%) 1
    Normochromic normocytic anaemia 1/4949 (0%) 1 0/4943 (0%) 0
    Normocytic anaemia 1/4949 (0%) 1 0/4943 (0%) 0
    Pancytopenia 1/4949 (0%) 1 3/4943 (0.1%) 3
    Polycythaemia 0/4949 (0%) 0 1/4943 (0%) 1
    Splenic haemorrhage 1/4949 (0%) 1 0/4943 (0%) 0
    Splenomegaly 0/4949 (0%) 0 1/4943 (0%) 1
    Thrombocytopenia 2/4949 (0%) 2 3/4943 (0.1%) 3
    Cardiac disorders
    Acute coronary syndrome 41/4949 (0.8%) 43 43/4943 (0.9%) 44
    Acute left ventricular failure 1/4949 (0%) 1 3/4943 (0.1%) 3
    Acute myocardial infarction 53/4949 (1.1%) 59 39/4943 (0.8%) 40
    Angina pectoris 58/4949 (1.2%) 67 56/4943 (1.1%) 61
    Angina unstable 54/4949 (1.1%) 58 44/4943 (0.9%) 47
    Aortic valve disease mixed 0/4949 (0%) 0 1/4943 (0%) 1
    Aortic valve incompetence 1/4949 (0%) 1 5/4943 (0.1%) 5
    Aortic valve stenosis 6/4949 (0.1%) 7 9/4943 (0.2%) 9
    Arrhythmia 3/4949 (0.1%) 3 6/4943 (0.1%) 6
    Arteriosclerosis coronary artery 9/4949 (0.2%) 9 7/4943 (0.1%) 7
    Atrial fibrillation 62/4949 (1.3%) 79 90/4943 (1.8%) 107
    Atrial flutter 18/4949 (0.4%) 19 15/4943 (0.3%) 19
    Atrial tachycardia 0/4949 (0%) 0 2/4943 (0%) 2
    Atrial thrombosis 0/4949 (0%) 0 1/4943 (0%) 1
    Atrioventricular block 6/4949 (0.1%) 6 7/4943 (0.1%) 7
    Atrioventricular block complete 11/4949 (0.2%) 12 8/4943 (0.2%) 8
    Atrioventricular block first degree 0/4949 (0%) 0 1/4943 (0%) 1
    Atrioventricular block second degree 9/4949 (0.2%) 9 8/4943 (0.2%) 8
    Bifascicular block 1/4949 (0%) 1 0/4943 (0%) 0
    Bradyarrhythmia 3/4949 (0.1%) 3 3/4943 (0.1%) 3
    Bradycardia 10/4949 (0.2%) 10 16/4943 (0.3%) 17
    Bundle branch block left 3/4949 (0.1%) 3 0/4943 (0%) 0
    Bundle branch block right 1/4949 (0%) 1 2/4943 (0%) 2
    Cardiac arrest 14/4949 (0.3%) 15 11/4943 (0.2%) 14
    Cardiac disorder 1/4949 (0%) 1 1/4943 (0%) 1
    Cardiac failure 104/4949 (2.1%) 124 78/4943 (1.6%) 87
    Cardiac failure acute 9/4949 (0.2%) 10 8/4943 (0.2%) 11
    Cardiac failure chronic 21/4949 (0.4%) 24 14/4943 (0.3%) 15
    Cardiac failure congestive 47/4949 (0.9%) 52 38/4943 (0.8%) 42
    Cardiac tamponade 1/4949 (0%) 1 0/4943 (0%) 0
    Cardio-respiratory arrest 7/4949 (0.1%) 7 5/4943 (0.1%) 5
    Cardiogenic shock 3/4949 (0.1%) 3 5/4943 (0.1%) 5
    Cardiomyopathy 5/4949 (0.1%) 5 2/4943 (0%) 2
    Cardiomyopathy alcoholic 1/4949 (0%) 1 0/4943 (0%) 0
    Cardiopulmonary failure 1/4949 (0%) 1 2/4943 (0%) 2
    Cardiorenal syndrome 0/4949 (0%) 0 1/4943 (0%) 1
    Cardiovascular disorder 1/4949 (0%) 1 0/4943 (0%) 0
    Cardiovascular insufficiency 1/4949 (0%) 1 0/4943 (0%) 0
    Chronic left ventricular failure 1/4949 (0%) 1 0/4943 (0%) 0
    Congestive cardiomyopathy 3/4949 (0.1%) 3 7/4943 (0.1%) 7
    Cor pulmonale 1/4949 (0%) 1 0/4943 (0%) 0
    Coronary artery disease 57/4949 (1.2%) 64 57/4943 (1.2%) 63
    Coronary artery insufficiency 0/4949 (0%) 0 1/4943 (0%) 1
    Coronary artery occlusion 3/4949 (0.1%) 3 1/4943 (0%) 1
    Coronary artery perforation 1/4949 (0%) 1 1/4943 (0%) 1
    Coronary artery stenosis 4/4949 (0.1%) 4 5/4943 (0.1%) 5
    Defect conduction intraventricular 2/4949 (0%) 2 0/4943 (0%) 0
    Diastolic dysfunction 0/4949 (0%) 0 1/4943 (0%) 1
    Dressler's syndrome 0/4949 (0%) 0 1/4943 (0%) 1
    Extrasystoles 0/4949 (0%) 0 1/4943 (0%) 1
    Gastrocardiac syndrome 1/4949 (0%) 1 0/4943 (0%) 0
    Hypertensive heart disease 1/4949 (0%) 1 2/4943 (0%) 2
    Ischaemic cardiomyopathy 2/4949 (0%) 2 10/4943 (0.2%) 11
    Left ventricular dysfunction 0/4949 (0%) 0 2/4943 (0%) 2
    Left ventricular failure 8/4949 (0.2%) 8 13/4943 (0.3%) 13
    Metabolic cardiomyopathy 1/4949 (0%) 1 0/4943 (0%) 0
    Microvascular coronary artery disease 1/4949 (0%) 3 1/4943 (0%) 1
    Mitral valve disease 1/4949 (0%) 1 0/4943 (0%) 0
    Mitral valve incompetence 7/4949 (0.1%) 7 9/4943 (0.2%) 9
    Mitral valve prolapse 1/4949 (0%) 1 0/4943 (0%) 0
    Mitral valve stenosis 0/4949 (0%) 0 1/4943 (0%) 1
    Myocardial infarction 35/4949 (0.7%) 37 30/4943 (0.6%) 30
    Myocardial ischaemia 23/4949 (0.5%) 23 19/4943 (0.4%) 20
    Myocarditis 1/4949 (0%) 1 0/4943 (0%) 0
    Nodal rhythm 1/4949 (0%) 1 0/4943 (0%) 0
    Palpitations 1/4949 (0%) 1 0/4943 (0%) 0
    Pericardial effusion 2/4949 (0%) 2 2/4943 (0%) 2
    Pericarditis 6/4949 (0.1%) 6 2/4943 (0%) 3
    Prinzmetal angina 1/4949 (0%) 1 1/4943 (0%) 2
    Right ventricular dysfunction 0/4949 (0%) 0 1/4943 (0%) 1
    Right ventricular failure 2/4949 (0%) 2 1/4943 (0%) 1
    Silent myocardial infarction 1/4949 (0%) 1 2/4943 (0%) 2
    Sinoatrial block 0/4949 (0%) 0 1/4943 (0%) 1
    Sinus arrest 0/4949 (0%) 0 2/4943 (0%) 2
    Sinus bradycardia 6/4949 (0.1%) 6 2/4943 (0%) 2
    Sinus node dysfunction 9/4949 (0.2%) 9 6/4943 (0.1%) 6
    Sinus tachycardia 1/4949 (0%) 1 0/4943 (0%) 0
    Stress cardiomyopathy 2/4949 (0%) 2 0/4943 (0%) 0
    Supraventricular extrasystoles 1/4949 (0%) 1 0/4943 (0%) 0
    Supraventricular tachycardia 9/4949 (0.2%) 9 7/4943 (0.1%) 7
    Tachyarrhythmia 0/4949 (0%) 0 1/4943 (0%) 1
    Tachycardia 2/4949 (0%) 2 3/4943 (0.1%) 4
    Tachycardia induced cardiomyopathy 0/4949 (0%) 0 1/4943 (0%) 1
    Tricuspid valve incompetence 3/4949 (0.1%) 3 1/4943 (0%) 1
    Ventricular arrhythmia 1/4949 (0%) 1 1/4943 (0%) 1
    Ventricular extrasystoles 1/4949 (0%) 1 4/4943 (0.1%) 4
    Ventricular fibrillation 3/4949 (0.1%) 3 4/4943 (0.1%) 4
    Ventricular tachycardia 5/4949 (0.1%) 10 7/4943 (0.1%) 11
    Congenital, familial and genetic disorders
    Adenomatous polyposis coli 1/4949 (0%) 1 0/4943 (0%) 0
    Atrial septal defect 1/4949 (0%) 1 0/4943 (0%) 0
    Chronic granulomatous disease 0/4949 (0%) 0 1/4943 (0%) 1
    Congenital cerebrovascular anomaly 0/4949 (0%) 0 1/4943 (0%) 1
    Developmental hip dysplasia 0/4949 (0%) 0 1/4943 (0%) 1
    Exomphalos 0/4949 (0%) 0 1/4943 (0%) 1
    Gastrointestinal arteriovenous malformation 1/4949 (0%) 1 1/4943 (0%) 1
    Heart disease congenital 1/4949 (0%) 1 1/4943 (0%) 1
    Hereditary motor and sensory neuropathy 0/4949 (0%) 0 1/4943 (0%) 1
    Hydrocele 0/2667 (0%) 0 2/2640 (0.1%) 2
    Hypertrophic cardiomyopathy 1/4949 (0%) 1 0/4943 (0%) 0
    Phimosis 1/2667 (0%) 1 3/2640 (0.1%) 3
    Vascular malformation 1/4949 (0%) 1 0/4943 (0%) 0
    Ear and labyrinth disorders
    Deafness 0/4949 (0%) 0 1/4943 (0%) 1
    Deafness neurosensory 3/4949 (0.1%) 3 0/4943 (0%) 0
    Deafness unilateral 0/4949 (0%) 0 1/4943 (0%) 1
    Hypoacusis 1/4949 (0%) 1 0/4943 (0%) 0
    Sudden hearing loss 1/4949 (0%) 1 0/4943 (0%) 0
    Vertigo 6/4949 (0.1%) 6 4/4943 (0.1%) 4
    Vertigo positional 3/4949 (0.1%) 3 4/4943 (0.1%) 4
    Vestibular ataxia 0/4949 (0%) 0 1/4943 (0%) 1
    Vestibular disorder 3/4949 (0.1%) 3 1/4943 (0%) 1
    Endocrine disorders
    Acromegaly 0/4949 (0%) 0 1/4943 (0%) 1
    Adrenal insufficiency 1/4949 (0%) 1 0/4943 (0%) 0
    Adrenocortical insufficiency acute 1/4949 (0%) 1 0/4943 (0%) 0
    Autoimmune thyroiditis 0/4949 (0%) 0 1/4943 (0%) 1
    Cushing's syndrome 0/4949 (0%) 0 1/4943 (0%) 1
    Goitre 8/4949 (0.2%) 8 12/4943 (0.2%) 12
    Hyperaldosteronism 1/4949 (0%) 1 0/4943 (0%) 0
    Hyperparathyroidism 0/4949 (0%) 0 2/4943 (0%) 2
    Hyperparathyroidism primary 0/4949 (0%) 0 1/4943 (0%) 1
    Hyperparathyroidism secondary 1/4949 (0%) 1 0/4943 (0%) 0
    Hyperthyroidism 0/4949 (0%) 0 2/4943 (0%) 2
    Hypoparathyroidism secondary 0/4949 (0%) 0 1/4943 (0%) 1
    Parathyroid disorder 0/4949 (0%) 0 1/4943 (0%) 1
    Primary hyperaldosteronism 0/4949 (0%) 0 1/4943 (0%) 2
    Thyroid mass 2/4949 (0%) 2 2/4943 (0%) 2
    Thyroiditis subacute 0/4949 (0%) 0 1/4943 (0%) 1
    Toxic nodular goitre 1/4949 (0%) 1 0/4943 (0%) 0
    Eye disorders
    Amaurosis fugax 1/4949 (0%) 1 0/4943 (0%) 0
    Amblyopia 0/4949 (0%) 0 1/4943 (0%) 1
    Angle closure glaucoma 1/4949 (0%) 1 0/4943 (0%) 0
    Blepharochalasis 0/4949 (0%) 0 1/4943 (0%) 1
    Cataract 29/4949 (0.6%) 34 19/4943 (0.4%) 27
    Cataract diabetic 1/4949 (0%) 1 0/4943 (0%) 0
    Cataract nuclear 3/4949 (0.1%) 4 0/4943 (0%) 0
    Cataract subcapsular 2/4949 (0%) 2 0/4943 (0%) 0
    Dacryostenosis acquired 2/4949 (0%) 2 0/4943 (0%) 0
    Diabetic retinopathy 4/4949 (0.1%) 8 1/4943 (0%) 1
    Diplopia 1/4949 (0%) 1 0/4943 (0%) 0
    Eye haemorrhage 1/4949 (0%) 3 0/4943 (0%) 0
    Glaucoma 6/4949 (0.1%) 6 3/4943 (0.1%) 3
    Hypermetropia 1/4949 (0%) 2 0/4943 (0%) 0
    Iridodialysis 1/4949 (0%) 1 0/4943 (0%) 0
    Lens dislocation 1/4949 (0%) 1 0/4943 (0%) 0
    Macular fibrosis 0/4949 (0%) 0 2/4943 (0%) 2
    Macular hole 0/4949 (0%) 0 1/4943 (0%) 1
    Macular oedema 1/4949 (0%) 1 1/4943 (0%) 1
    Maculopathy 1/4949 (0%) 2 0/4943 (0%) 0
    Neurotrophic keratopathy 1/4949 (0%) 1 0/4943 (0%) 0
    Open angle glaucoma 2/4949 (0%) 3 0/4943 (0%) 0
    Ophthalmic vein thrombosis 1/4949 (0%) 1 0/4943 (0%) 0
    Optic ischaemic neuropathy 0/4949 (0%) 0 1/4943 (0%) 1
    Retinal artery embolism 1/4949 (0%) 1 1/4943 (0%) 1
    Retinal artery occlusion 0/4949 (0%) 0 1/4943 (0%) 1
    Retinal detachment 1/4949 (0%) 1 3/4943 (0.1%) 4
    Retinal haemorrhage 1/4949 (0%) 1 0/4943 (0%) 0
    Retinal tear 0/4949 (0%) 0 1/4943 (0%) 1
    Strabismus 0/4949 (0%) 0 1/4943 (0%) 1
    Vitreous haemorrhage 1/4949 (0%) 1 3/4943 (0.1%) 4
    Gastrointestinal disorders
    Abdominal adhesions 2/4949 (0%) 2 0/4943 (0%) 0
    Abdominal compartment syndrome 1/4949 (0%) 1 0/4943 (0%) 0
    Abdominal discomfort 0/4949 (0%) 0 1/4943 (0%) 1
    Abdominal hernia 7/4949 (0.1%) 7 7/4943 (0.1%) 7
    Abdominal hernia obstructive 1/4949 (0%) 1 1/4943 (0%) 1
    Abdominal incarcerated hernia 2/4949 (0%) 2 0/4943 (0%) 0
    Abdominal mass 0/4949 (0%) 0 1/4943 (0%) 1
    Abdominal pain 10/4949 (0.2%) 11 10/4943 (0.2%) 12
    Abdominal pain upper 5/4949 (0.1%) 5 3/4943 (0.1%) 3
    Abdominal wall haematoma 1/4949 (0%) 1 1/4943 (0%) 1
    Acute abdomen 1/4949 (0%) 1 0/4943 (0%) 0
    Anal fistula 1/4949 (0%) 1 0/4943 (0%) 0
    Anal incontinence 2/4949 (0%) 3 1/4943 (0%) 1
    Ascites 1/4949 (0%) 1 1/4943 (0%) 1
    Barrett's oesophagus 1/4949 (0%) 1 0/4943 (0%) 0
    Chronic gastritis 2/4949 (0%) 2 1/4943 (0%) 1
    Colitis 7/4949 (0.1%) 9 4/4943 (0.1%) 4
    Colitis ischaemic 3/4949 (0.1%) 3 4/4943 (0.1%) 4
    Colitis microscopic 1/4949 (0%) 1 2/4943 (0%) 2
    Colitis ulcerative 0/4949 (0%) 0 2/4943 (0%) 2
    Constipation 6/4949 (0.1%) 6 6/4943 (0.1%) 6
    Crohn's disease 1/4949 (0%) 1 0/4943 (0%) 0
    Dental cyst 0/4949 (0%) 0 1/4943 (0%) 1
    Diabetic gastroparesis 0/4949 (0%) 0 1/4943 (0%) 1
    Diaphragmatic hernia 1/4949 (0%) 1 0/4943 (0%) 0
    Diarrhoea 8/4949 (0.2%) 8 10/4943 (0.2%) 10
    Diverticular perforation 1/4949 (0%) 1 1/4943 (0%) 1
    Diverticulum 2/4949 (0%) 2 5/4943 (0.1%) 5
    Diverticulum intestinal 2/4949 (0%) 2 5/4943 (0.1%) 5
    Diverticulum intestinal haemorrhagic 3/4949 (0.1%) 3 0/4943 (0%) 0
    Duodenal ulcer 4/4949 (0.1%) 4 3/4943 (0.1%) 3
    Duodenal ulcer haemorrhage 3/4949 (0.1%) 3 3/4943 (0.1%) 3
    Duodenitis 1/4949 (0%) 1 0/4943 (0%) 0
    Dyspepsia 2/4949 (0%) 2 1/4943 (0%) 1
    Dysphagia 2/4949 (0%) 2 2/4943 (0%) 2
    Enteritis 3/4949 (0.1%) 3 0/4943 (0%) 0
    Enterovesical fistula 1/4949 (0%) 1 1/4943 (0%) 1
    Erosive duodenitis 1/4949 (0%) 1 0/4943 (0%) 0
    Faecaloma 2/4949 (0%) 3 0/4943 (0%) 0
    Fistula of small intestine 1/4949 (0%) 1 0/4943 (0%) 0
    Food poisoning 0/4949 (0%) 0 1/4943 (0%) 1
    Gallstone ileus 0/4949 (0%) 0 1/4943 (0%) 1
    Gastric dilatation 1/4949 (0%) 1 0/4943 (0%) 0
    Gastric dysplasia 0/4949 (0%) 0 1/4943 (0%) 1
    Gastric haemorrhage 0/4949 (0%) 0 1/4943 (0%) 1
    Gastric polyps 1/4949 (0%) 1 2/4943 (0%) 2
    Gastric ulcer 7/4949 (0.1%) 7 6/4943 (0.1%) 6
    Gastric ulcer haemorrhage 2/4949 (0%) 3 8/4943 (0.2%) 8
    Gastritis 17/4949 (0.3%) 17 13/4943 (0.3%) 13
    Gastritis erosive 1/4949 (0%) 1 2/4943 (0%) 2
    Gastroduodenitis 0/4949 (0%) 0 2/4943 (0%) 2
    Gastrointestinal haemorrhage 13/4949 (0.3%) 14 12/4943 (0.2%) 13
    Gastrointestinal inflammation 0/4949 (0%) 0 1/4943 (0%) 1
    Gastrointestinal motility disorder 1/4949 (0%) 1 0/4943 (0%) 0
    Gastrointestinal mucocoele 0/4949 (0%) 0 1/4943 (0%) 1
    Gastrointestinal necrosis 1/4949 (0%) 1 1/4943 (0%) 1
    Gastrointestinal polyp 0/4949 (0%) 0 1/4943 (0%) 1
    Gastrointestinal polyp haemorrhage 1/4949 (0%) 1 1/4943 (0%) 1
    Gastrointestinal ulcer 1/4949 (0%) 1 0/4943 (0%) 0
    Gastrointestinal ulcer haemorrhage 1/4949 (0%) 1 0/4943 (0%) 0
    Gastrointestinal vascular malformation haemorrhagic 0/4949 (0%) 0 1/4943 (0%) 1
    Gastrooesophageal reflux disease 6/4949 (0.1%) 6 9/4943 (0.2%) 9
    Haematemesis 1/4949 (0%) 1 0/4943 (0%) 0
    Haematochezia 1/4949 (0%) 1 0/4943 (0%) 0
    Haemorrhagic erosive gastritis 0/4949 (0%) 0 1/4943 (0%) 1
    Haemorrhoidal haemorrhage 1/4949 (0%) 1 2/4943 (0%) 2
    Haemorrhoids 2/4949 (0%) 2 5/4943 (0.1%) 5
    Haemorrhoids thrombosed 0/4949 (0%) 0 1/4943 (0%) 1
    Hernial eventration 0/4949 (0%) 0 2/4943 (0%) 2
    Heyde's syndrome 0/4949 (0%) 0 1/4943 (0%) 1
    Hiatus hernia 1/4949 (0%) 1 7/4943 (0.1%) 7
    Ileus 2/4949 (0%) 2 1/4943 (0%) 1
    Ileus paralytic 2/4949 (0%) 2 1/4943 (0%) 1
    Impaired gastric emptying 0/4949 (0%) 0 1/4943 (0%) 1
    Incarcerated inguinal hernia 2/4949 (0%) 2 0/4943 (0%) 0
    Incarcerated umbilical hernia 1/4949 (0%) 1 1/4943 (0%) 1
    Inguinal hernia 11/4949 (0.2%) 11 17/4943 (0.3%) 17
    Intestinal haemorrhage 1/4949 (0%) 1 1/4943 (0%) 2
    Intestinal ischaemia 1/4949 (0%) 1 2/4943 (0%) 2
    Intestinal mass 0/4949 (0%) 0 1/4943 (0%) 1
    Intestinal obstruction 14/4949 (0.3%) 15 9/4943 (0.2%) 9
    Intestinal perforation 0/4949 (0%) 0 1/4943 (0%) 1
    Intestinal polyp 1/4949 (0%) 1 1/4943 (0%) 1
    Intestinal stenosis 0/4949 (0%) 0 1/4943 (0%) 1
    Intra-abdominal haemorrhage 1/4949 (0%) 1 0/4943 (0%) 0
    Intussusception 0/4949 (0%) 0 2/4943 (0%) 2
    Irritable bowel syndrome 2/4949 (0%) 3 0/4943 (0%) 0
    Large intestine perforation 1/4949 (0%) 1 1/4943 (0%) 1
    Large intestine polyp 4/4949 (0.1%) 4 4/4943 (0.1%) 6
    Lower gastrointestinal haemorrhage 6/4949 (0.1%) 6 6/4943 (0.1%) 6
    Mallory-weiss syndrome 1/4949 (0%) 1 0/4943 (0%) 0
    Mechanical ileus 1/4949 (0%) 1 0/4943 (0%) 0
    Megacolon 0/4949 (0%) 0 1/4943 (0%) 1
    Melaena 3/4949 (0.1%) 3 2/4943 (0%) 2
    Mesenteric arterial occlusion 0/4949 (0%) 0 1/4943 (0%) 1
    Mesenteric artery thrombosis 2/4949 (0%) 2 0/4943 (0%) 0
    Mouth haemorrhage 1/4949 (0%) 1 0/4943 (0%) 0
    Nausea 2/4949 (0%) 2 2/4943 (0%) 2
    Necrotising oesophagitis 1/4949 (0%) 1 0/4943 (0%) 0
    Obstructive pancreatitis 2/4949 (0%) 2 0/4943 (0%) 0
    Oesophageal achalasia 1/4949 (0%) 1 0/4943 (0%) 0
    Oesophageal spasm 0/4949 (0%) 0 1/4943 (0%) 1
    Oesophageal stenosis 1/4949 (0%) 1 2/4943 (0%) 3
    Oesophageal varices haemorrhage 0/4949 (0%) 0 3/4943 (0.1%) 3
    Oesophagitis 2/4949 (0%) 2 2/4943 (0%) 2
    Palatal disorder 1/4949 (0%) 1 0/4943 (0%) 0
    Pancreatic cyst 2/4949 (0%) 2 1/4943 (0%) 1
    Pancreatic pseudocyst 1/4949 (0%) 1 0/4943 (0%) 0
    Pancreatitis 5/4949 (0.1%) 5 9/4943 (0.2%) 9
    Pancreatitis acute 8/4949 (0.2%) 10 15/4943 (0.3%) 15
    Pancreatitis chronic 0/4949 (0%) 0 1/4943 (0%) 1
    Peptic ulcer 3/4949 (0.1%) 3 2/4943 (0%) 2
    Peritoneal adhesions 0/4949 (0%) 0 1/4943 (0%) 1
    Peritoneal haematoma 1/4949 (0%) 1 0/4943 (0%) 0
    Peritoneal hernia 0/4949 (0%) 0 1/4943 (0%) 1
    Portal venous gas 0/4949 (0%) 0 1/4943 (0%) 1
    Proctitis 0/4949 (0%) 0 1/4943 (0%) 1
    Rectal haemorrhage 5/4949 (0.1%) 5 5/4943 (0.1%) 5
    Rectal polyp 0/4949 (0%) 0 2/4943 (0%) 2
    Retroperitoneal haemorrhage 1/4949 (0%) 1 0/4943 (0%) 0
    Salivary gland calculus 1/4949 (0%) 1 0/4943 (0%) 0
    Small intestinal obstruction 10/4949 (0.2%) 12 5/4943 (0.1%) 5
    Spigelian hernia 0/4949 (0%) 0 1/4943 (0%) 1
    Strangulated umbilical hernia 2/4949 (0%) 2 1/4943 (0%) 1
    Thrombosis mesenteric vessel 2/4949 (0%) 2 0/4943 (0%) 0
    Umbilical hernia 7/4949 (0.1%) 7 3/4943 (0.1%) 3
    Umbilical hernia, obstructive 2/4949 (0%) 2 0/4943 (0%) 0
    Upper gastrointestinal haemorrhage 10/4949 (0.2%) 10 7/4943 (0.1%) 7
    Varices oesophageal 1/4949 (0%) 1 1/4943 (0%) 3
    Volvulus of small bowel 1/4949 (0%) 1 1/4943 (0%) 1
    Vomiting 5/4949 (0.1%) 5 6/4943 (0.1%) 8
    General disorders
    Adverse drug reaction 0/4949 (0%) 0 3/4943 (0.1%) 3
    Asthenia 5/4949 (0.1%) 5 5/4943 (0.1%) 6
    Chest discomfort 1/4949 (0%) 1 1/4943 (0%) 1
    Chest pain 14/4949 (0.3%) 15 7/4943 (0.1%) 7
    Death 9/4949 (0.2%) 9 9/4943 (0.2%) 9
    Device intolerance 1/4949 (0%) 1 0/4943 (0%) 0
    Drug effect increased 0/4949 (0%) 0 1/4943 (0%) 1
    Drug intolerance 1/4949 (0%) 1 0/4943 (0%) 0
    Fatigue 0/4949 (0%) 0 3/4943 (0.1%) 3
    Gait disturbance 1/4949 (0%) 1 0/4943 (0%) 0
    General physical health deterioration 0/4949 (0%) 0 4/4943 (0.1%) 4
    Generalised oedema 4/4949 (0.1%) 4 2/4943 (0%) 2
    Hernia perforation 0/4949 (0%) 0 1/4943 (0%) 1
    Hyperthermia 1/4949 (0%) 1 0/4943 (0%) 0
    Impaired healing 5/4949 (0.1%) 5 4/4943 (0.1%) 4
    Inflammation 0/4949 (0%) 0 2/4943 (0%) 2
    Malaise 1/4949 (0%) 1 0/4943 (0%) 0
    Metaplasia 0/4949 (0%) 0 1/4943 (0%) 1
    Multiple organ dysfunction syndrome 4/4949 (0.1%) 4 5/4943 (0.1%) 5
    Necrosis 0/4949 (0%) 0 1/4943 (0%) 1
    Non-cardiac chest pain 37/4949 (0.7%) 44 26/4943 (0.5%) 28
    Oedema peripheral 7/4949 (0.1%) 7 4/4943 (0.1%) 4
    Pain 2/4949 (0%) 2 1/4943 (0%) 1
    Peripheral swelling 4/4949 (0.1%) 4 0/4943 (0%) 0
    Pyrexia 7/4949 (0.1%) 7 7/4943 (0.1%) 7
    Strangulated hernia 1/4949 (0%) 1 0/4943 (0%) 0
    Sudden cardiac death 2/4949 (0%) 2 0/4943 (0%) 0
    Sudden death 5/4949 (0.1%) 5 3/4943 (0.1%) 3
    Systemic inflammatory response syndrome 2/4949 (0%) 2 2/4943 (0%) 2
    Vascular stent occlusion 0/4949 (0%) 0 1/4943 (0%) 1
    Vascular stent stenosis 1/4949 (0%) 1 0/4943 (0%) 0
    Hepatobiliary disorders
    Acute hepatic failure 0/4949 (0%) 0 1/4943 (0%) 1
    Bile duct obstruction 1/4949 (0%) 1 0/4943 (0%) 0
    Bile duct stenosis 0/4949 (0%) 0 1/4943 (0%) 1
    Bile duct stone 7/4949 (0.1%) 7 8/4943 (0.2%) 8
    Biliary colic 1/4949 (0%) 1 1/4943 (0%) 1
    Biliary dyspepsia 1/4949 (0%) 1 0/4943 (0%) 0
    Cholangitis 2/4949 (0%) 2 6/4943 (0.1%) 6
    Cholangitis acute 0/4949 (0%) 0 3/4943 (0.1%) 3
    Cholangitis chronic 0/4949 (0%) 0 1/4943 (0%) 1
    Cholecystitis 15/4949 (0.3%) 15 25/4943 (0.5%) 28
    Cholecystitis acute 17/4949 (0.3%) 17 26/4943 (0.5%) 27
    Cholecystitis chronic 2/4949 (0%) 2 7/4943 (0.1%) 7
    Cholelithiasis 49/4949 (1%) 51 42/4943 (0.8%) 43
    Cholestasis 3/4949 (0.1%) 3 2/4943 (0%) 2
    Drug-induced liver injury 2/4949 (0%) 2 1/4943 (0%) 1
    Gallbladder cholesterolosis 1/4949 (0%) 1 0/4943 (0%) 0
    Gallbladder necrosis 1/4949 (0%) 1 0/4943 (0%) 0
    Gallbladder perforation 1/4949 (0%) 1 2/4943 (0%) 2
    Gallbladder polyp 0/4949 (0%) 0 1/4943 (0%) 1
    Hepatic cirrhosis 4/4949 (0.1%) 4 5/4943 (0.1%) 5
    Hepatic failure 3/4949 (0.1%) 3 1/4943 (0%) 1
    Hepatic mass 1/4949 (0%) 1 1/4943 (0%) 1
    Hepatic steatosis 1/4949 (0%) 1 0/4943 (0%) 0
    Hepatitis 1/4949 (0%) 2 0/4943 (0%) 0
    Hepatorenal syndrome 1/4949 (0%) 1 1/4943 (0%) 1
    Ischaemic hepatitis 1/4949 (0%) 1 0/4943 (0%) 0
    Jaundice 1/4949 (0%) 1 1/4943 (0%) 1
    Jaundice cholestatic 3/4949 (0.1%) 3 1/4943 (0%) 1
    Liver disorder 1/4949 (0%) 1 1/4943 (0%) 1
    Non-alcoholic fatty liver 1/4949 (0%) 1 0/4943 (0%) 0
    Non-alcoholic steatohepatitis 1/4949 (0%) 1 1/4943 (0%) 1
    Portal hypertension 1/4949 (0%) 1 1/4943 (0%) 1
    Portal vein thrombosis 0/4949 (0%) 0 1/4943 (0%) 1
    Post cholecystectomy syndrome 1/4949 (0%) 1 2/4943 (0%) 2
    Immune system disorders
    Anaphylactic reaction 2/4949 (0%) 2 0/4943 (0%) 0
    Anti-neutrophil cytoplasmic antibody positive vasculitis 1/4949 (0%) 1 0/4943 (0%) 0
    Contrast media allergy 0/4949 (0%) 0 1/4943 (0%) 1
    Drug hypersensitivity 0/4949 (0%) 0 1/4943 (0%) 1
    Hypersensitivity 1/4949 (0%) 1 0/4943 (0%) 0
    Immunodeficiency 1/4949 (0%) 1 0/4943 (0%) 0
    Sarcoidosis 1/4949 (0%) 1 0/4943 (0%) 0
    Infections and infestations
    Abdominal abscess 2/4949 (0%) 2 1/4943 (0%) 1
    Abscess 1/4949 (0%) 1 1/4943 (0%) 1
    Abscess intestinal 1/4949 (0%) 1 1/4943 (0%) 1
    Abscess limb 3/4949 (0.1%) 4 3/4943 (0.1%) 4
    Abscess neck 1/4949 (0%) 1 0/4943 (0%) 0
    Abscess oral 0/4949 (0%) 0 1/4943 (0%) 1
    Anal abscess 4/4949 (0.1%) 4 4/4943 (0.1%) 4
    Anal infection 1/4949 (0%) 1 0/4943 (0%) 0
    Aortitis salmonella 0/4949 (0%) 0 1/4943 (0%) 1
    Appendiceal abscess 0/4949 (0%) 0 1/4943 (0%) 1
    Appendicitis 2/4949 (0%) 2 6/4943 (0.1%) 6
    Appendicitis perforated 1/4949 (0%) 1 1/4943 (0%) 1
    Arthritis bacterial 4/4949 (0.1%) 4 1/4943 (0%) 1
    Arthritis infective 4/4949 (0.1%) 4 2/4943 (0%) 2
    Atypical pneumonia 0/4949 (0%) 0 1/4943 (0%) 1
    Bacteraemia 6/4949 (0.1%) 6 2/4943 (0%) 2
    Bacterial infection 1/4949 (0%) 1 0/4943 (0%) 0
    Biliary sepsis 0/4949 (0%) 0 1/4943 (0%) 1
    Brain abscess 0/4949 (0%) 0 1/4943 (0%) 1
    Breast abscess 1/4949 (0%) 1 1/4943 (0%) 1
    Breast cellulitis 1/4949 (0%) 1 0/4943 (0%) 0
    Bronchitis 12/4949 (0.2%) 12 13/4943 (0.3%) 13
    Bronchitis bacterial 1/4949 (0%) 1 1/4943 (0%) 1
    Bronchitis fungal 0/4949 (0%) 0 1/4943 (0%) 1
    Bronchitis viral 0/4949 (0%) 0 1/4943 (0%) 1
    Burn infection 0/4949 (0%) 0 1/4943 (0%) 1
    Campylobacter gastroenteritis 2/4949 (0%) 2 2/4943 (0%) 2
    Candida sepsis 1/4949 (0%) 1 1/4943 (0%) 1
    Candiduria 1/4949 (0%) 1 0/4943 (0%) 0
    Carbuncle 2/4949 (0%) 2 0/4943 (0%) 0
    Cellulitis 42/4949 (0.8%) 48 38/4943 (0.8%) 39
    Cellulitis streptococcal 0/4949 (0%) 0 1/4943 (0%) 1
    Cervicitis 0/2282 (0%) 0 1/2303 (0%) 1
    Cholecystitis infective 2/4949 (0%) 2 2/4943 (0%) 2
    Chronic hepatitis b 0/4949 (0%) 0 1/4943 (0%) 1
    Clostridium colitis 0/4949 (0%) 0 1/4943 (0%) 1
    Clostridium difficile colitis 1/4949 (0%) 1 5/4943 (0.1%) 6
    Clostridium difficile infection 3/4949 (0.1%) 3 2/4943 (0%) 2
    Corneal abscess 1/4949 (0%) 1 0/4943 (0%) 0
    Cystitis 6/4949 (0.1%) 6 3/4943 (0.1%) 3
    Cystitis escherichia 0/4949 (0%) 0 1/4943 (0%) 1
    Cytomegalovirus colitis 0/4949 (0%) 0 1/4943 (0%) 1
    Dengue fever 3/4949 (0.1%) 3 0/4943 (0%) 0
    Dengue haemorrhagic fever 0/4949 (0%) 0 1/4943 (0%) 1
    Device related infection 3/4949 (0.1%) 3 3/4943 (0.1%) 6
    Device related sepsis 0/4949 (0%) 0 1/4943 (0%) 1
    Diabetic foot infection 5/4949 (0.1%) 5 1/4943 (0%) 1
    Diabetic gangrene 3/4949 (0.1%) 3 1/4943 (0%) 2
    Diarrhoea infectious 1/4949 (0%) 1 0/4943 (0%) 0
    Diverticulitis 10/4949 (0.2%) 12 15/4943 (0.3%) 17
    Dysentery 1/4949 (0%) 1 0/4943 (0%) 0
    Echinococciasis 0/4949 (0%) 0 1/4943 (0%) 1
    Empyema 1/4949 (0%) 1 0/4943 (0%) 0
    Endocarditis 2/4949 (0%) 2 4/4943 (0.1%) 5
    Endocarditis bacterial 0/4949 (0%) 0 1/4943 (0%) 1
    Enterococcal sepsis 1/4949 (0%) 1 0/4943 (0%) 0
    Enterocolitis bacterial 0/4949 (0%) 0 1/4943 (0%) 1
    Epididymitis 0/2667 (0%) 0 4/2640 (0.2%) 4
    Erysipelas 15/4949 (0.3%) 18 11/4943 (0.2%) 12
    Escherichia bacteraemia 0/4949 (0%) 0 3/4943 (0.1%) 3
    Escherichia sepsis 2/4949 (0%) 2 0/4943 (0%) 0
    Escherichia urinary tract infection 1/4949 (0%) 1 2/4943 (0%) 2
    Extradural abscess 0/4949 (0%) 0 1/4943 (0%) 1
    Gallbladder abscess 2/4949 (0%) 2 0/4943 (0%) 0
    Gallbladder empyema 1/4949 (0%) 1 0/4943 (0%) 0
    Gangrene 11/4949 (0.2%) 11 8/4943 (0.2%) 18
    Gastroenteritis 10/4949 (0.2%) 10 21/4943 (0.4%) 22
    Gastroenteritis clostridial 1/4949 (0%) 1 2/4943 (0%) 2
    Gastroenteritis norovirus 1/4949 (0%) 1 0/4943 (0%) 0
    Gastroenteritis viral 5/4949 (0.1%) 5 2/4943 (0%) 2
    Gastrointestinal infection 0/4949 (0%) 0 1/4943 (0%) 1
    Genitourinary tract infection 1/4949 (0%) 1 0/4943 (0%) 0
    Groin abscess 0/4949 (0%) 0 1/4943 (0%) 1
    H1n1 influenza 1/4949 (0%) 1 0/4943 (0%) 0
    Haematoma infection 3/4949 (0.1%) 3 2/4943 (0%) 2
    Helicobacter gastritis 1/4949 (0%) 1 1/4943 (0%) 1
    Helicobacter infection 2/4949 (0%) 2 0/4943 (0%) 0
    Hepatitis b 0/4949 (0%) 0 1/4943 (0%) 1
    Hepatitis c 1/4949 (0%) 1 1/4943 (0%) 1
    Hepatitis e 1/4949 (0%) 2 0/4943 (0%) 0
    Hepatitis infectious mononucleosis 0/4949 (0%) 0 1/4943 (0%) 1
    Herpes zoster 5/4949 (0.1%) 5 0/4943 (0%) 0
    Herpes zoster meningoencephalitis 0/4949 (0%) 0 1/4943 (0%) 1
    Herpes zoster pharyngitis 1/4949 (0%) 1 0/4943 (0%) 0
    Hydrocele male infected 0/2667 (0%) 0 1/2640 (0%) 1
    Implant site infection 0/4949 (0%) 0 2/4943 (0%) 2
    Infected skin ulcer 3/4949 (0.1%) 3 4/4943 (0.1%) 4
    Infection 1/4949 (0%) 1 0/4943 (0%) 0
    Infectious colitis 1/4949 (0%) 1 1/4943 (0%) 1
    Infective exacerbation of chronic obstructive airways disease 6/4949 (0.1%) 8 3/4943 (0.1%) 3
    Influenza 8/4949 (0.2%) 8 5/4943 (0.1%) 5
    Injection site abscess 0/4949 (0%) 0 1/4943 (0%) 1
    Intervertebral discitis 1/4949 (0%) 2 1/4943 (0%) 1
    Intestinal sepsis 0/4949 (0%) 0 1/4943 (0%) 1
    Joint abscess 2/4949 (0%) 2 1/4943 (0%) 1
    Kidney infection 1/4949 (0%) 1 1/4943 (0%) 1
    Labyrinthitis 0/4949 (0%) 0 1/4943 (0%) 1
    Laryngitis 0/4949 (0%) 0 1/4943 (0%) 1
    Liver abscess 1/4949 (0%) 1 4/4943 (0.1%) 4
    Localised infection 8/4949 (0.2%) 8 8/4943 (0.2%) 8
    Lower respiratory tract infection 11/4949 (0.2%) 12 12/4943 (0.2%) 13
    Lower respiratory tract infection bacterial 1/4949 (0%) 1 1/4943 (0%) 1
    Lower respiratory tract infection viral 0/4949 (0%) 0 1/4943 (0%) 1
    Lung abscess 0/4949 (0%) 0 1/4943 (0%) 1
    Lung infection 1/4949 (0%) 1 3/4943 (0.1%) 3
    Lymphangitis 1/4949 (0%) 1 0/4943 (0%) 0
    Mastitis 0/4949 (0%) 0 1/4943 (0%) 1
    Mastoiditis 0/4949 (0%) 0 1/4943 (0%) 1
    Mediastinitis 1/4949 (0%) 1 1/4943 (0%) 1
    Medical device site infection 1/4949 (0%) 1 0/4943 (0%) 0
    Medical device site joint infection 0/4949 (0%) 0 1/4943 (0%) 1
    Meningitis 1/4949 (0%) 1 0/4943 (0%) 0
    Meningitis aseptic 0/4949 (0%) 0 1/4943 (0%) 1
    Myiasis 1/4949 (0%) 1 0/4943 (0%) 0
    Necrotising fasciitis 2/4949 (0%) 2 1/4943 (0%) 1
    Neutropenic sepsis 0/4949 (0%) 0 2/4943 (0%) 2
    Oesophageal candidiasis 1/4949 (0%) 1 1/4943 (0%) 1
    Orchitis 2/2667 (0.1%) 2 3/2640 (0.1%) 3
    Osteomyelitis 11/4949 (0.2%) 13 10/4943 (0.2%) 11
    Osteomyelitis acute 1/4949 (0%) 1 2/4943 (0%) 2
    Osteomyelitis chronic 0/4949 (0%) 0 2/4943 (0%) 2
    Otitis externa 0/4949 (0%) 0 1/4943 (0%) 1
    Otitis media chronic 0/4949 (0%) 0 1/4943 (0%) 1
    Pancreatic abscess 1/4949 (0%) 1 0/4943 (0%) 0
    Paronychia 0/4949 (0%) 0 2/4943 (0%) 2
    Pelvic abscess 1/4949 (0%) 1 1/4943 (0%) 1
    Pelvic infection 1/4949 (0%) 1 0/4943 (0%) 0
    Perihepatic abscess 1/4949 (0%) 1 0/4943 (0%) 0
    Perineal abscess 2/4949 (0%) 2 0/4943 (0%) 0
    Periodontitis 1/4949 (0%) 1 0/4943 (0%) 0
    Perirectal abscess 1/4949 (0%) 1 0/4943 (0%) 0
    Peritonitis 1/4949 (0%) 1 3/4943 (0.1%) 3
    Pharyngeal abscess 1/4949 (0%) 1 1/4943 (0%) 1
    Pneumonia 151/4949 (3.1%) 174 135/4943 (2.7%) 152
    Pneumonia bacterial 2/4949 (0%) 2 2/4943 (0%) 2
    Pneumonia influenzal 1/4949 (0%) 1 1/4943 (0%) 1
    Pneumonia klebsiella 1/4949 (0%) 1 0/4943 (0%) 0
    Pneumonia legionella 0/4949 (0%) 0 1/4943 (0%) 1
    Pneumonia streptococcal 2/4949 (0%) 2 1/4943 (0%) 1
    Pneumonia viral 1/4949 (0%) 1 0/4943 (0%) 0
    Post procedural infection 2/4949 (0%) 2 3/4943 (0.1%) 3
    Post procedural pneumonia 1/4949 (0%) 1 0/4943 (0%) 0
    Post procedural sepsis 1/4949 (0%) 1 2/4943 (0%) 2
    Postoperative abscess 1/4949 (0%) 1 1/4943 (0%) 1
    Postoperative wound infection 3/4949 (0.1%) 3 7/4943 (0.1%) 7
    Pseudomonal sepsis 0/4949 (0%) 0 1/4943 (0%) 1
    Pulmonary mycosis 0/4949 (0%) 0 1/4943 (0%) 1
    Pulmonary sepsis 2/4949 (0%) 2 4/4943 (0.1%) 4
    Pulmonary tuberculosis 0/4949 (0%) 0 1/4943 (0%) 1
    Pyelitis 0/4949 (0%) 0 1/4943 (0%) 1
    Pyelonephritis 15/4949 (0.3%) 15 8/4943 (0.2%) 8
    Pyelonephritis acute 8/4949 (0.2%) 8 7/4943 (0.1%) 7
    Pyelonephritis chronic 1/4949 (0%) 1 1/4943 (0%) 1
    Pyonephrosis 1/4949 (0%) 1 0/4943 (0%) 0
    Renal abscess 0/4949 (0%) 0 1/4943 (0%) 1
    Renal cyst infection 1/4949 (0%) 1 0/4943 (0%) 0
    Respiratory syncytial virus infection 0/4949 (0%) 0 1/4943 (0%) 1
    Respiratory tract infection 2/4949 (0%) 2 3/4943 (0.1%) 3
    Salmonella sepsis 0/4949 (0%) 0 1/4943 (0%) 1
    Salmonellosis 0/4949 (0%) 0 1/4943 (0%) 1
    Scrotal infection 1/2667 (0%) 1 0/2640 (0%) 0
    Sepsis 35/4949 (0.7%) 37 30/4943 (0.6%) 33
    Septic shock 22/4949 (0.4%) 24 15/4943 (0.3%) 16
    Sinusitis 0/4949 (0%) 0 1/4943 (0%) 1
    Skin graft infection 0/4949 (0%) 0 1/4943 (0%) 1
    Skin infection 2/4949 (0%) 2 1/4943 (0%) 1
    Soft tissue infection 3/4949 (0.1%) 3 0/4943 (0%) 0
    Staphylococcal bacteraemia 3/4949 (0.1%) 3 0/4943 (0%) 0
    Staphylococcal infection 1/4949 (0%) 1 2/4943 (0%) 2
    Staphylococcal mediastinitis 0/4949 (0%) 0 1/4943 (0%) 1
    Staphylococcal sepsis 1/4949 (0%) 1 0/4943 (0%) 0
    Staphylococcal skin infection 2/4949 (0%) 2 0/4943 (0%) 0
    Streptococcal bacteraemia 0/4949 (0%) 0 1/4943 (0%) 1
    Subcutaneous abscess 2/4949 (0%) 2 3/4943 (0.1%) 3
    Subdiaphragmatic abscess 0/4949 (0%) 0 1/4943 (0%) 3
    Systemic candida 1/4949 (0%) 1 0/4943 (0%) 0
    Tooth abscess 1/4949 (0%) 1 0/4943 (0%) 0
    Tracheobronchitis 1/4949 (0%) 1 1/4943 (0%) 1
    Tuberculosis 2/4949 (0%) 3 0/4943 (0%) 0
    Tuberculosis gastrointestinal 1/4949 (0%) 1 0/4943 (0%) 0
    Upper respiratory tract infection 5/4949 (0.1%) 5 2/4943 (0%) 2
    Urinary tract infection 61/4949 (1.2%) 65 64/4943 (1.3%) 78
    Urinary tract infection bacterial 0/4949 (0%) 0 2/4943 (0%) 2
    Urinary tract infection pseudomonal 2/4949 (0%) 2 0/4943 (0%) 0
    Urosepsis 19/4949 (0.4%) 20 24/4943 (0.5%) 26
    Vestibular neuronitis 3/4949 (0.1%) 3 4/4943 (0.1%) 4
    Viraemia 0/4949 (0%) 0 1/4943 (0%) 1
    Viral infection 3/4949 (0.1%) 3 0/4943 (0%) 0
    Viral myocarditis 0/4949 (0%) 0 1/4943 (0%) 1
    Wound infection 5/4949 (0.1%) 5 1/4943 (0%) 1
    Wound sepsis 3/4949 (0.1%) 3 1/4943 (0%) 1
    Injury, poisoning and procedural complications
    Accident 1/4949 (0%) 1 0/4943 (0%) 0
    Accident at work 0/4949 (0%) 0 1/4943 (0%) 1
    Accidental overdose 2/4949 (0%) 2 8/4943 (0.2%) 8
    Acetabulum fracture 1/4949 (0%) 1 0/4943 (0%) 0
    Alcohol poisoning 3/4949 (0.1%) 3 1/4943 (0%) 1
    Anaemia postoperative 1/4949 (0%) 1 0/4943 (0%) 0
    Anastomotic complication 1/4949 (0%) 1 0/4943 (0%) 0
    Anastomotic leak 0/4949 (0%) 0 2/4943 (0%) 2
    Ankle fracture 20/4949 (0.4%) 20 21/4943 (0.4%) 21
    Arterial injury 1/4949 (0%) 1 0/4943 (0%) 0
    Arteriovenous fistula occlusion 1/4949 (0%) 1 0/4943 (0%) 0
    Arthropod bite 1/4949 (0%) 1 0/4943 (0%) 0
    Back injury 0/4949 (0%) 0 1/4943 (0%) 1
    Brain contusion 1/4949 (0%) 1 0/4943 (0%) 0
    Burns second degree 1/4949 (0%) 1 1/4943 (0%) 1
    Burns third degree 1/4949 (0%) 1 0/4943 (0%) 0
    Carbon monoxide poisoning 1/4949 (0%) 1 0/4943 (0%) 0
    Cartilage injury 0/4949 (0%) 0 1/4943 (0%) 1
    Cervical vertebral fracture 1/4949 (0%) 1 4/4943 (0.1%) 4
    Chemical poisoning 0/4949 (0%) 0 1/4943 (0%) 1
    Clavicle fracture 2/4949 (0%) 2 2/4943 (0%) 2
    Concussion 2/4949 (0%) 2 4/4943 (0.1%) 4
    Contusion 3/4949 (0.1%) 3 6/4943 (0.1%) 6
    Coronary vascular graft occlusion 0/4949 (0%) 0 1/4943 (0%) 1
    Craniocerebral injury 4/4949 (0.1%) 4 7/4943 (0.1%) 7
    Craniofacial fracture 0/4949 (0%) 0 1/4943 (0%) 1
    Deep vein thrombosis postoperative 0/4949 (0%) 0 1/4943 (0%) 1
    Delayed recovery from anaesthesia 1/4949 (0%) 1 0/4943 (0%) 0
    Facial bones fracture 1/4949 (0%) 1 1/4943 (0%) 1
    Failure to anastomose 1/4949 (0%) 1 0/4943 (0%) 0
    Fall 124/4949 (2.5%) 137 110/4943 (2.2%) 123
    Femoral neck fracture 7/4949 (0.1%) 7 4/4943 (0.1%) 4
    Femur fracture 21/4949 (0.4%) 22 18/4943 (0.4%) 18
    Fibula fracture 3/4949 (0.1%) 3 5/4943 (0.1%) 5
    Foot fracture 4/4949 (0.1%) 4 3/4943 (0.1%) 3
    Forearm fracture 2/4949 (0%) 2 1/4943 (0%) 1
    Foreign body 0/4949 (0%) 0 1/4943 (0%) 1
    Foreign body aspiration 1/4949 (0%) 1 0/4943 (0%) 0
    Foreign body in gastrointestinal tract 1/4949 (0%) 1 0/4943 (0%) 0
    Gastroenteritis radiation 1/4949 (0%) 1 0/4943 (0%) 0
    Gastrointestinal injury 0/4949 (0%) 0 1/4943 (0%) 1
    Gastrointestinal stoma complication 1/4949 (0%) 1 0/4943 (0%) 0
    Graft thrombosis 1/4949 (0%) 1 1/4943 (0%) 1
    Gun shot wound 0/4949 (0%) 0 1/4943 (0%) 1
    Hand fracture 2/4949 (0%) 2 1/4943 (0%) 1
    Head injury 2/4949 (0%) 2 2/4943 (0%) 2
    Hip fracture 17/4949 (0.3%) 17 12/4943 (0.2%) 12
    Humerus fracture 20/4949 (0.4%) 20 12/4943 (0.2%) 12
    Hyphaema 1/4949 (0%) 1 0/4943 (0%) 0
    Incisional hernia 6/4949 (0.1%) 7 6/4943 (0.1%) 6
    Incisional hernia, obstructive 0/4949 (0%) 0 1/4943 (0%) 1
    Intentional overdose 1/4949 (0%) 3 0/4943 (0%) 0
    Intestinal anastomosis complication 0/4949 (0%) 0 2/4943 (0%) 4
    Jaw fracture 0/4949 (0%) 0 1/4943 (0%) 1
    Joint dislocation 4/4949 (0.1%) 6 5/4943 (0.1%) 5
    Joint injury 3/4949 (0.1%) 3 1/4943 (0%) 1
    Laceration 2/4949 (0%) 2 4/4943 (0.1%) 4
    Ligament rupture 1/4949 (0%) 1 2/4943 (0%) 2
    Ligament sprain 0/4949 (0%) 0 3/4943 (0.1%) 3
    Limb crushing injury 1/4949 (0%) 1 0/4943 (0%) 0
    Limb injury 2/4949 (0%) 2 5/4943 (0.1%) 5
    Lower limb fracture 2/4949 (0%) 2 5/4943 (0.1%) 5
    Lumbar vertebral fracture 2/4949 (0%) 2 2/4943 (0%) 2
    Lumbosacral plexus injury 0/4949 (0%) 0 1/4943 (0%) 2
    Meniscus injury 4/4949 (0.1%) 4 12/4943 (0.2%) 12
    Multiple fractures 1/4949 (0%) 1 3/4943 (0.1%) 3
    Multiple injuries 3/4949 (0.1%) 3 2/4943 (0%) 2
    Muscle rupture 1/4949 (0%) 1 0/4943 (0%) 0
    Muscle strain 2/4949 (0%) 2 1/4943 (0%) 1
    Overdose 0/4949 (0%) 0 2/4943 (0%) 2
    Patella fracture 3/4949 (0.1%) 3 1/4943 (0%) 1
    Pelvic fracture 2/4949 (0%) 2 6/4943 (0.1%) 6
    Periprosthetic fracture 0/4949 (0%) 0 2/4943 (0%) 2
    Pneumothorax traumatic 2/4949 (0%) 2 0/4943 (0%) 0
    Post concussion syndrome 2/4949 (0%) 2 0/4943 (0%) 0
    Post procedural bile leak 0/4949 (0%) 0 1/4943 (0%) 1
    Post procedural complication 3/4949 (0.1%) 3 2/4943 (0%) 2
    Post procedural discharge 0/4949 (0%) 0 1/4943 (0%) 1
    Post procedural haematoma 2/4949 (0%) 2 0/4943 (0%) 0
    Post procedural haematuria 2/4949 (0%) 2 0/4943 (0%) 0
    Post procedural haemorrhage 1/4949 (0%) 1 7/4943 (0.1%) 7
    Post procedural swelling 1/4949 (0%) 1 0/4943 (0%) 0
    Post-traumatic pain 0/4949 (0%) 0 1/4943 (0%) 1
    Postoperative adhesion 1/4949 (0%) 1 0/4943 (0%) 0
    Postoperative delirium 1/4949 (0%) 1 0/4943 (0%) 0
    Postoperative thoracic procedure complication 0/4949 (0%) 0 2/4943 (0%) 3
    Postoperative wound complication 0/4949 (0%) 0 1/4943 (0%) 1
    Procedural hypotension 0/4949 (0%) 0 1/4943 (0%) 1
    Procedural pain 2/4949 (0%) 2 0/4943 (0%) 0
    Pubis fracture 3/4949 (0.1%) 3 2/4943 (0%) 2
    Radiation pneumonitis 2/4949 (0%) 2 1/4943 (0%) 1
    Radius fracture 6/4949 (0.1%) 6 8/4943 (0.2%) 8
    Rib fracture 14/4949 (0.3%) 14 10/4943 (0.2%) 10
    Road traffic accident 9/4949 (0.2%) 10 13/4943 (0.3%) 13
    Scapula fracture 0/4949 (0%) 0 3/4943 (0.1%) 3
    Sciatic nerve injury 2/4949 (0%) 2 0/4943 (0%) 0
    Scrotal haematoma 1/2667 (0%) 1 0/2640 (0%) 0
    Skin injury 1/4949 (0%) 1 0/4943 (0%) 0
    Skull fracture 1/4949 (0%) 1 1/4943 (0%) 1
    Skull fractured base 0/4949 (0%) 0 1/4943 (0%) 1
    Soft tissue injury 1/4949 (0%) 1 0/4943 (0%) 0
    Spinal compression fracture 1/4949 (0%) 1 4/4943 (0.1%) 4
    Spinal cord injury cervical 2/4949 (0%) 2 0/4943 (0%) 0
    Spinal fracture 3/4949 (0.1%) 3 2/4943 (0%) 2
    Splenic rupture 0/4949 (0%) 0 1/4943 (0%) 1
    Stab wound 1/4949 (0%) 1 0/4943 (0%) 0
    Sternal fracture 1/4949 (0%) 1 1/4943 (0%) 1
    Stoma site haemorrhage 1/4949 (0%) 1 0/4943 (0%) 0
    Subarachnoid haemorrhage 2/4949 (0%) 2 7/4943 (0.1%) 7
    Subdural haematoma 7/4949 (0.1%) 7 7/4943 (0.1%) 8
    Subdural haemorrhage 2/4949 (0%) 2 0/4943 (0%) 0
    Suture rupture 1/4949 (0%) 1 0/4943 (0%) 0
    Tendon injury 0/4949 (0%) 0 3/4943 (0.1%) 3
    Tendon rupture 3/4949 (0.1%) 4 3/4943 (0.1%) 3
    Thermal burn 2/4949 (0%) 2 0/4943 (0%) 0
    Thoracic vertebral fracture 4/4949 (0.1%) 4 4/4943 (0.1%) 4
    Tibia fracture 8/4949 (0.2%) 8 4/4943 (0.1%) 4
    Tongue injury 0/4949 (0%) 0 1/4943 (0%) 1
    Toxicity to various agents 4/4949 (0.1%) 4 1/4943 (0%) 1
    Transfusion-related acute lung injury 1/4949 (0%) 1 0/4943 (0%) 0
    Traumatic fracture 1/4949 (0%) 1 0/4943 (0%) 0
    Traumatic haematoma 1/4949 (0%) 1 3/4943 (0.1%) 3
    Traumatic haemothorax 0/4949 (0%) 0 1/4943 (0%) 1
    Traumatic intracranial haemorrhage 2/4949 (0%) 2 2/4943 (0%) 2
    Ulna fracture 1/4949 (0%) 1 2/4943 (0%) 2
    Upper limb fracture 1/4949 (0%) 1 5/4943 (0.1%) 5
    Vascular graft occlusion 0/4949 (0%) 0 1/4943 (0%) 1
    Vascular pseudoaneurysm 3/4949 (0.1%) 3 4/4943 (0.1%) 4
    Wound 0/4949 (0%) 0 1/4943 (0%) 2
    Wound dehiscence 1/4949 (0%) 1 1/4943 (0%) 1
    Wound secretion 1/4949 (0%) 1 0/4943 (0%) 0
    Wrist fracture 5/4949 (0.1%) 5 2/4943 (0%) 2
    Investigations
    Amylase increased 0/4949 (0%) 0 1/4943 (0%) 1
    Anticoagulation drug level above therapeutic 1/4949 (0%) 1 0/4943 (0%) 0
    Blood calcitonin increased 1/4949 (0%) 1 0/4943 (0%) 0
    Blood calcium increased 1/4949 (0%) 1 0/4943 (0%) 0
    Blood creatinine increased 1/4949 (0%) 1 0/4943 (0%) 0
    Blood glucose decreased 1/4949 (0%) 1 0/4943 (0%) 0
    Blood glucose fluctuation 0/4949 (0%) 0 3/4943 (0.1%) 3
    Blood glucose increased 4/4949 (0.1%) 4 5/4943 (0.1%) 6
    Blood pressure increased 1/4949 (0%) 1 1/4943 (0%) 1
    C-reactive protein increased 1/4949 (0%) 1 0/4943 (0%) 0
    Coagulation test abnormal 1/4949 (0%) 1 0/4943 (0%) 0
    Electrocardiogram abnormal 1/4949 (0%) 1 0/4943 (0%) 0
    Gamma-glutamyltransferase increased 1/4949 (0%) 1 0/4943 (0%) 0
    Glomerular filtration rate decreased 1/4949 (0%) 1 0/4943 (0%) 0
    Glycosylated haemoglobin increased 2/4949 (0%) 2 2/4943 (0%) 2
    Haemoglobin decreased 2/4949 (0%) 2 0/4943 (0%) 0
    Hepatic enzyme increased 1/4949 (0%) 1 1/4943 (0%) 1
    Oxygen saturation decreased 1/4949 (0%) 1 1/4943 (0%) 1
    Transaminases increased 1/4949 (0%) 1 1/4943 (0%) 1
    Troponin increased 0/4949 (0%) 0 2/4943 (0%) 2
    Troponin t increased 0/4949 (0%) 0 1/4943 (0%) 1
    Urine albumin/creatinine ratio increased 0/4949 (0%) 0 1/4943 (0%) 1
    Weight decreased 4/4949 (0.1%) 4 0/4943 (0%) 0
    Metabolism and nutrition disorders
    Abnormal loss of weight 1/4949 (0%) 1 0/4943 (0%) 0
    Cachexia 1/4949 (0%) 1 0/4943 (0%) 0
    Decreased appetite 2/4949 (0%) 2 1/4943 (0%) 1
    Dehydration 14/4949 (0.3%) 15 23/4943 (0.5%) 24
    Diabetes mellitus 1/4949 (0%) 1 0/4943 (0%) 0
    Diabetes mellitus inadequate control 3/4949 (0.1%) 3 4/4943 (0.1%) 4
    Diabetic ketoacidosis 2/4949 (0%) 2 6/4943 (0.1%) 6
    Electrolyte imbalance 0/4949 (0%) 0 1/4943 (0%) 1
    Failure to thrive 1/4949 (0%) 1 0/4943 (0%) 0
    Fluid overload 1/4949 (0%) 1 2/4943 (0%) 2
    Food intolerance 1/4949 (0%) 1 0/4943 (0%) 0
    Gout 4/4949 (0.1%) 4 4/4943 (0.1%) 4
    Hypercalcaemia 2/4949 (0%) 2 1/4943 (0%) 1
    Hyperglycaemia 67/4949 (1.4%) 75 46/4943 (0.9%) 52
    Hyperglycaemic hyperosmolar nonketotic syndrome 2/4949 (0%) 2 2/4943 (0%) 2
    Hyperkalaemia 12/4949 (0.2%) 12 8/4943 (0.2%) 9
    Hyperosmolar state 1/4949 (0%) 1 1/4943 (0%) 1
    Hypocalcaemia 0/4949 (0%) 0 1/4943 (0%) 1
    Hypoglycaemia 72/4949 (1.5%) 80 62/4943 (1.3%) 69
    Hypokalaemia 5/4949 (0.1%) 5 6/4943 (0.1%) 6
    Hypomagnesaemia 0/4949 (0%) 0 2/4943 (0%) 2
    Hyponatraemia 11/4949 (0.2%) 12 8/4943 (0.2%) 8
    Iron deficiency 1/4949 (0%) 1 0/4943 (0%) 0
    Ketoacidosis 1/4949 (0%) 1 1/4943 (0%) 1
    Lactic acidosis 3/4949 (0.1%) 3 0/4943 (0%) 0
    Metabolic acidosis 3/4949 (0.1%) 3 1/4943 (0%) 1
    Obesity 5/4949 (0.1%) 5 5/4943 (0.1%) 5
    Type 2 diabetes mellitus 0/4949 (0%) 0 1/4943 (0%) 1
    Musculoskeletal and connective tissue disorders
    Arthralgia 6/4949 (0.1%) 6 9/4943 (0.2%) 9
    Arthritis 7/4949 (0.1%) 7 6/4943 (0.1%) 6
    Arthritis reactive 0/4949 (0%) 0 1/4943 (0%) 1
    Arthrofibrosis 1/4949 (0%) 1 0/4943 (0%) 0
    Arthropathy 1/4949 (0%) 1 0/4943 (0%) 0
    Articular calcification 1/4949 (0%) 1 0/4943 (0%) 0
    Back pain 9/4949 (0.2%) 10 6/4943 (0.1%) 6
    Bone lesion 1/4949 (0%) 1 1/4943 (0%) 1
    Bursitis 2/4949 (0%) 2 2/4943 (0%) 2
    Cervical spinal stenosis 2/4949 (0%) 2 5/4943 (0.1%) 5
    Chondrocalcinosis pyrophosphate 1/4949 (0%) 1 1/4943 (0%) 2
    Chondromalacia 0/4949 (0%) 0 1/4943 (0%) 2
    Chondropathy 3/4949 (0.1%) 3 0/4943 (0%) 0
    Costochondritis 1/4949 (0%) 1 0/4943 (0%) 0
    Diabetic amyotrophy 0/4949 (0%) 0 1/4943 (0%) 1
    Diabetic arthropathy 0/4949 (0%) 0 1/4943 (0%) 1
    Dupuytren's contracture 0/4949 (0%) 0 1/4943 (0%) 1
    Exostosis 0/4949 (0%) 0 1/4943 (0%) 1
    Fistula 0/4949 (0%) 0 1/4943 (0%) 1
    Foot deformity 0/4949 (0%) 0 2/4943 (0%) 2
    Fracture malunion 1/4949 (0%) 1 0/4943 (0%) 0
    Gouty arthritis 3/4949 (0.1%) 3 0/4943 (0%) 0
    Gouty tophus 1/4949 (0%) 1 0/4943 (0%) 0
    Intervertebral disc degeneration 3/4949 (0.1%) 3 0/4943 (0%) 0
    Intervertebral disc disorder 2/4949 (0%) 2 3/4943 (0.1%) 3
    Intervertebral disc protrusion 21/4949 (0.4%) 22 15/4943 (0.3%) 16
    Joint ankylosis 1/4949 (0%) 1 0/4943 (0%) 0
    Joint noise 0/4949 (0%) 0 1/4943 (0%) 1
    Joint swelling 1/4949 (0%) 1 0/4943 (0%) 0
    Lumbar spinal stenosis 11/4949 (0.2%) 14 10/4943 (0.2%) 10
    Mobility decreased 1/4949 (0%) 1 0/4943 (0%) 0
    Muscle haemorrhage 0/4949 (0%) 0 1/4943 (0%) 1
    Muscle spasms 1/4949 (0%) 1 0/4943 (0%) 0
    Muscular weakness 0/4949 (0%) 0 1/4943 (0%) 1
    Musculoskeletal chest pain 6/4949 (0.1%) 6 10/4943 (0.2%) 10
    Musculoskeletal pain 3/4949 (0.1%) 3 2/4943 (0%) 2
    Myalgia 2/4949 (0%) 2 0/4943 (0%) 0
    Neck pain 2/4949 (0%) 2 0/4943 (0%) 0
    Neuropathic arthropathy 2/4949 (0%) 2 0/4943 (0%) 0
    Osteitis deformans 0/4949 (0%) 0 1/4943 (0%) 1
    Osteoarthritis 110/4949 (2.2%) 128 136/4943 (2.8%) 155
    Osteochondrosis 0/4949 (0%) 0 4/4943 (0.1%) 4
    Osteonecrosis 3/4949 (0.1%) 3 4/4943 (0.1%) 4
    Osteopenia 0/4949 (0%) 0 1/4943 (0%) 1
    Osteoporosis 1/4949 (0%) 1 1/4943 (0%) 1
    Pain in extremity 3/4949 (0.1%) 3 2/4943 (0%) 2
    Patellofemoral pain syndrome 0/4949 (0%) 0 1/4943 (0%) 1
    Pathological fracture 0/4949 (0%) 0 2/4943 (0%) 2
    Periarthritis 1/4949 (0%) 1 3/4943 (0.1%) 3
    Plantar fascial fibromatosis 0/4949 (0%) 0 1/4943 (0%) 1
    Polymyalgia rheumatica 2/4949 (0%) 2 0/4943 (0%) 0
    Pseudarthrosis 0/4949 (0%) 0 1/4943 (0%) 1
    Rhabdomyolysis 0/4949 (0%) 0 2/4943 (0%) 2
    Rheumatic disorder 1/4949 (0%) 1 0/4943 (0%) 0
    Rheumatoid arthritis 2/4949 (0%) 2 3/4943 (0.1%) 3
    Rotator cuff syndrome 10/4949 (0.2%) 11 8/4943 (0.2%) 8
    Spinal column stenosis 7/4949 (0.1%) 7 13/4943 (0.3%) 13
    Spinal osteoarthritis 21/4949 (0.4%) 23 16/4943 (0.3%) 19
    Spinal pain 4/4949 (0.1%) 4 5/4943 (0.1%) 5
    Spondylitis 2/4949 (0%) 2 1/4943 (0%) 1
    Spondyloarthropathy 1/4949 (0%) 1 0/4943 (0%) 0
    Spondylolisthesis 3/4949 (0.1%) 3 6/4943 (0.1%) 6
    Spondylolysis 1/4949 (0%) 1 0/4943 (0%) 0
    Synovial cyst 1/4949 (0%) 1 2/4943 (0%) 2
    Synovitis 0/4949 (0%) 0 2/4943 (0%) 2
    Tendon disorder 1/4949 (0%) 1 1/4943 (0%) 1
    Tendonitis 1/4949 (0%) 1 1/4943 (0%) 1
    Tenosynovitis 0/4949 (0%) 0 1/4943 (0%) 2
    Vertebral foraminal stenosis 1/4949 (0%) 1 0/4943 (0%) 0
    Vertebral osteophyte 1/4949 (0%) 1 0/4943 (0%) 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Acute myeloid leukaemia 1/4949 (0%) 1 0/4943 (0%) 0
    Adenocarcinoma 0/4949 (0%) 0 2/4943 (0%) 2
    Adenocarcinoma gastric 10/4949 (0.2%) 11 7/4943 (0.1%) 7
    Adenocarcinoma of colon 14/4949 (0.3%) 14 17/4943 (0.3%) 17
    Adenocarcinoma of the cervix 1/2282 (0%) 1 1/2303 (0%) 1
    Adenocarcinoma pancreas 0/4949 (0%) 0 4/4943 (0.1%) 4
    Adenoma benign 1/4949 (0%) 1 0/4943 (0%) 0
    Adenosquamous cell carcinoma 0/4949 (0%) 0 1/4943 (0%) 1
    Adrenal adenoma 3/4949 (0.1%) 3 3/4943 (0.1%) 3
    Adrenal neoplasm 1/4949 (0%) 1 2/4943 (0%) 2
    Anal squamous cell carcinoma 1/4949 (0%) 1 0/4943 (0%) 0
    Anaplastic astrocytoma 1/4949 (0%) 1 0/4943 (0%) 0
    Anogenital warts 1/4949 (0%) 1 0/4943 (0%) 0
    Astrocytoma 1/4949 (0%) 2 0/4943 (0%) 0
    B-cell lymphoma 1/4949 (0%) 1 2/4943 (0%) 2
    B-cell lymphoma stage i 0/4949 (0%) 0 1/4943 (0%) 1
    B-cell lymphoma stage ii 1/4949 (0%) 1 0/4943 (0%) 0
    B-cell small lymphocytic lymphoma 0/4949 (0%) 0 2/4943 (0%) 2
    Basal cell carcinoma 11/4949 (0.2%) 11 7/4943 (0.1%) 7
    Benign gastric neoplasm 0/4949 (0%) 0 1/4943 (0%) 2
    Benign hepatic neoplasm 0/4949 (0%) 0 1/4943 (0%) 1
    Benign neoplasm of adrenal gland 0/4949 (0%) 0 1/4943 (0%) 1
    Benign neoplasm of thyroid gland 1/4949 (0%) 1 0/4943 (0%) 0
    Bile duct adenocarcinoma 1/4949 (0%) 1 0/4943 (0%) 0
    Bile duct cancer 0/4949 (0%) 0 3/4943 (0.1%) 3
    Biliary cancer metastatic 1/4949 (0%) 1 0/4943 (0%) 0
    Bladder cancer 6/4949 (0.1%) 6 5/4943 (0.1%) 5
    Bladder cancer recurrent 1/4949 (0%) 1 0/4943 (0%) 0
    Bladder neoplasm 5/4949 (0.1%) 5 1/4943 (0%) 1
    Bladder papilloma 0/4949 (0%) 0 1/4943 (0%) 1
    Bladder transitional cell carcinoma 6/4949 (0.1%) 6 3/4943 (0.1%) 3
    Bladder transitional cell carcinoma recurrent 1/4949 (0%) 1 0/4943 (0%) 0
    Bladder transitional cell carcinoma stage i 0/4949 (0%) 0 1/4943 (0%) 1
    Bone cancer 0/4949 (0%) 0 1/4943 (0%) 1
    Bone cancer metastatic 1/4949 (0%) 1 0/4943 (0%) 0
    Bone neoplasm 1/4949 (0%) 1 0/4943 (0%) 0
    Borderline ovarian tumour 0/2282 (0%) 0 1/2303 (0%) 1
    Bowen's disease 1/4949 (0%) 1 0/4943 (0%) 0
    Brain neoplasm 3/4949 (0.1%) 3 1/4943 (0%) 1
    Brain neoplasm malignant 0/4949 (0%) 0 1/4943 (0%) 1
    Breast cancer 8/4949 (0.2%) 8 11/4943 (0.2%) 11
    Breast cancer metastatic 3/4949 (0.1%) 3 2/4943 (0%) 2
    Breast cancer recurrent 1/4949 (0%) 1 0/4943 (0%) 0
    Breast cancer stage iii 1/4949 (0%) 1 1/4943 (0%) 1
    Brenner tumour 0/2282 (0%) 0 1/2303 (0%) 1
    Bronchial carcinoma 0/4949 (0%) 0 2/4943 (0%) 2
    Cancer pain 0/4949 (0%) 0 1/4943 (0%) 1
    Carcinoid tumour pulmonary 0/4949 (0%) 0 2/4943 (0%) 2
    Cardiac myxoma 0/4949 (0%) 0 1/4943 (0%) 1
    Cerebral haemangioma 0/4949 (0%) 0 1/4943 (0%) 1
    Cervix carcinoma 2/2282 (0.1%) 2 4/2303 (0.2%) 4
    Cervix carcinoma stage 0 2/2282 (0.1%) 2 0/2303 (0%) 0
    Cholangiocarcinoma 2/4949 (0%) 3 4/4943 (0.1%) 4
    Chronic lymphocytic leukaemia 1/4949 (0%) 1 4/4943 (0.1%) 4
    Chronic myeloid leukaemia 0/4949 (0%) 0 1/4943 (0%) 1
    Clear cell renal cell carcinoma 3/4949 (0.1%) 3 6/4943 (0.1%) 6
    Colon adenoma 8/4949 (0.2%) 9 5/4943 (0.1%) 5
    Colon cancer 5/4949 (0.1%) 5 6/4943 (0.1%) 6
    Colon cancer metastatic 0/4949 (0%) 0 2/4943 (0%) 2
    Colon cancer stage ii 1/4949 (0%) 1 0/4943 (0%) 0
    Colon cancer stage iv 0/4949 (0%) 0 1/4943 (0%) 1
    Colon neoplasm 3/4949 (0.1%) 3 0/4943 (0%) 0
    Colorectal adenocarcinoma 1/4949 (0%) 1 0/4943 (0%) 0
    Colorectal cancer 0/4949 (0%) 0 2/4943 (0%) 2
    Colorectal cancer metastatic 1/4949 (0%) 1 1/4943 (0%) 1
    Diffuse large b-cell lymphoma 2/4949 (0%) 2 3/4943 (0.1%) 3
    Diffuse large b-cell lymphoma stage iv 0/4949 (0%) 0 2/4943 (0%) 2
    Ductal adenocarcinoma of pancreas 1/4949 (0%) 1 1/4943 (0%) 1
    Endometrial adenocarcinoma 9/2282 (0.4%) 9 6/2303 (0.3%) 7
    Endometrial cancer 1/2282 (0%) 1 3/2303 (0.1%) 3
    Extranodal marginal zone b-cell lymphoma (malt type) 0/4949 (0%) 0 2/4943 (0%) 2
    Fibroadenoma of breast 1/4949 (0%) 1 1/4943 (0%) 1
    Fibrosarcoma 1/4949 (0%) 1 0/4943 (0%) 0
    Gallbladder cancer metastatic 1/4949 (0%) 1 0/4943 (0%) 0
    Gallbladder squamous cell carcinoma 0/4949 (0%) 0 1/4943 (0%) 1
    Gastric cancer 4/4949 (0.1%) 4 6/4943 (0.1%) 6
    Gastric neoplasm 3/4949 (0.1%) 3 1/4943 (0%) 1
    Gastrointestinal stromal cancer 1/4949 (0%) 1 0/4943 (0%) 0
    Gastrointestinal stromal tumour 0/4949 (0%) 0 1/4943 (0%) 1
    Glioblastoma 2/4949 (0%) 2 0/4943 (0%) 0
    Hepatic angiosarcoma 0/4949 (0%) 0 1/4943 (0%) 1
    Hepatic cancer 5/4949 (0.1%) 5 2/4943 (0%) 2
    Hepatic cancer metastatic 1/4949 (0%) 1 2/4943 (0%) 2
    Hepatic neoplasm 1/4949 (0%) 1 0/4943 (0%) 0
    Hepatocellular carcinoma 6/4949 (0.1%) 6 1/4943 (0%) 1
    Hodgkin's disease 1/4949 (0%) 1 0/4943 (0%) 0
    Huerthle cell carcinoma 0/4949 (0%) 0 1/4943 (0%) 1
    Intraductal proliferative breast lesion 1/4949 (0%) 1 1/4943 (0%) 1
    Invasive breast carcinoma 1/4949 (0%) 1 0/4943 (0%) 0
    Invasive ductal breast carcinoma 11/4949 (0.2%) 11 7/4943 (0.1%) 7
    Invasive lobular breast carcinoma 1/4949 (0%) 1 1/4943 (0%) 1
    Keratoacanthoma 1/4949 (0%) 1 2/4943 (0%) 2
    Large intestine benign neoplasm 0/4949 (0%) 0 1/4943 (0%) 1
    Laryngeal cancer 2/4949 (0%) 2 1/4943 (0%) 1
    Laryngeal squamous cell carcinoma 3/4949 (0.1%) 3 1/4943 (0%) 1
    Leiomyosarcoma 1/4949 (0%) 1 0/4943 (0%) 0
    Leiomyosarcoma metastatic 1/4949 (0%) 1 0/4943 (0%) 0
    Lip squamous cell carcinoma 1/4949 (0%) 1 0/4943 (0%) 0
    Lipoma 1/4949 (0%) 1 1/4943 (0%) 1
    Liposarcoma 0/4949 (0%) 0 1/4943 (0%) 1
    Liposarcoma metastatic 0/4949 (0%) 0 1/4943 (0%) 1
    Lung adenocarcinoma 8/4949 (0.2%) 8 6/4943 (0.1%) 7
    Lung adenocarcinoma stage ii 1/4949 (0%) 1 0/4943 (0%) 0
    Lung adenocarcinoma stage iii 1/4949 (0%) 1 0/4943 (0%) 0
    Lung adenocarcinoma stage iv 0/4949 (0%) 0 2/4943 (0%) 2
    Lung cancer metastatic 3/4949 (0.1%) 3 3/4943 (0.1%) 3
    Lung neoplasm 2/4949 (0%) 2 0/4943 (0%) 0
    Lung neoplasm malignant 6/4949 (0.1%) 6 9/4943 (0.2%) 9
    Lymphoma 2/4949 (0%) 2 2/4943 (0%) 3
    Malignant joint neoplasm 1/4949 (0%) 1 0/4943 (0%) 0
    Malignant melanoma 5/4949 (0.1%) 5 5/4943 (0.1%) 5
    Malignant melanoma stage iii 1/4949 (0%) 1 0/4943 (0%) 0
    Malignant neoplasm of ampulla of vater 1/4949 (0%) 1 0/4943 (0%) 0
    Malignant pleural effusion 2/4949 (0%) 2 0/4943 (0%) 0
    Mediastinum neoplasm 0/4949 (0%) 0 1/4943 (0%) 1
    Medullary thyroid cancer 0/4949 (0%) 0 1/4943 (0%) 1
    Meningeal neoplasm 1/4949 (0%) 1 0/4943 (0%) 0
    Meningioma 1/4949 (0%) 1 2/4943 (0%) 2
    Mesothelioma 0/4949 (0%) 0 1/4943 (0%) 1
    Mesothelioma malignant 1/4949 (0%) 1 0/4943 (0%) 0
    Metastases to adrenals 0/4949 (0%) 0 1/4943 (0%) 1
    Metastases to bone 1/4949 (0%) 1 0/4943 (0%) 0
    Metastases to central nervous system 2/4949 (0%) 2 1/4943 (0%) 1
    Metastases to chest wall 0/4949 (0%) 0 1/4943 (0%) 1
    Metastases to kidney 1/4949 (0%) 1 0/4943 (0%) 0
    Metastases to liver 4/4949 (0.1%) 4 7/4943 (0.1%) 7
    Metastases to lung 6/4949 (0.1%) 6 1/4943 (0%) 1
    Metastases to lymph nodes 4/4949 (0.1%) 4 1/4943 (0%) 1
    Metastases to pelvis 1/4949 (0%) 1 0/4943 (0%) 0
    Metastases to peritoneum 1/4949 (0%) 1 3/4943 (0.1%) 3
    Metastases to pleura 1/4949 (0%) 2 0/4943 (0%) 0
    Metastatic bronchial carcinoma 1/4949 (0%) 1 1/4943 (0%) 1
    Metastatic gastric cancer 0/4949 (0%) 0 2/4943 (0%) 2
    Metastatic neoplasm 5/4949 (0.1%) 5 2/4943 (0%) 2
    Metastatic renal cell carcinoma 1/4949 (0%) 1 1/4943 (0%) 1
    Myelodysplastic syndrome 0/4949 (0%) 0 3/4943 (0.1%) 3
    Nasal sinus cancer 0/4949 (0%) 0 2/4943 (0%) 2
    Neoplasm 0/4949 (0%) 0 1/4943 (0%) 1
    Neoplasm malignant 2/4949 (0%) 2 0/4943 (0%) 0
    Neoplasm prostate 0/2667 (0%) 0 3/2640 (0.1%) 3
    Neuroendocrine carcinoma 2/4949 (0%) 2 1/4943 (0%) 1
    Neuroendocrine carcinoma of the skin 1/4949 (0%) 1 0/4943 (0%) 0
    Neuroendocrine tumour 2/4949 (0%) 2 1/4943 (0%) 1
    Non-hodgkin's lymphoma 1/4949 (0%) 1 1/4943 (0%) 1
    Non-small cell lung cancer 3/4949 (0.1%) 3 0/4943 (0%) 0
    Non-small cell lung cancer metastatic 1/4949 (0%) 1 0/4943 (0%) 0
    Non-small cell lung cancer stage ii 0/4949 (0%) 0 1/4943 (0%) 1
    Non-small cell lung cancer stage iv 1/4949 (0%) 1 0/4943 (0%) 0
    Oesophageal adenocarcinoma 3/4949 (0.1%) 3 2/4943 (0%) 2
    Oesophageal carcinoma 3/4949 (0.1%) 3 3/4943 (0.1%) 3
    Oesophageal squamous cell carcinoma 0/4949 (0%) 0 1/4943 (0%) 1
    Ovarian adenoma 2/2282 (0.1%) 2 0/2303 (0%) 0
    Ovarian cancer 2/2282 (0.1%) 2 0/2303 (0%) 0
    Ovarian cancer metastatic 1/2282 (0%) 1 0/2303 (0%) 0
    Ovarian cancer stage iii 1/2282 (0%) 1 0/2303 (0%) 0
    Ovarian epithelial cancer 0/2282 (0%) 0 2/2303 (0.1%) 2
    Pancreatic carcinoma 5/4949 (0.1%) 5 8/4943 (0.2%) 8
    Pancreatic carcinoma metastatic 5/4949 (0.1%) 5 4/4943 (0.1%) 4
    Pancreatic neoplasm 0/4949 (0%) 0 2/4943 (0%) 2
    Papillary thyroid cancer 0/4949 (0%) 0 4/4943 (0.1%) 4
    Paraganglion neoplasm 0/4949 (0%) 0 1/4943 (0%) 1
    Parathyroid tumour benign 1/4949 (0%) 1 0/4943 (0%) 0
    Penile squamous cell carcinoma 1/2667 (0%) 1 0/2640 (0%) 0
    Pericardial effusion malignant 1/4949 (0%) 1 0/4943 (0%) 0
    Phaeochromocytoma 1/4949 (0%) 1 0/4943 (0%) 0
    Pituitary tumour 1/4949 (0%) 2 0/4943 (0%) 0
    Pituitary tumour benign 1/4949 (0%) 1 2/4943 (0%) 2
    Plasma cell leukaemia 1/4949 (0%) 1 0/4943 (0%) 0
    Plasma cell myeloma 2/4949 (0%) 2 5/4943 (0.1%) 6
    Prostate cancer 33/2667 (1.2%) 34 33/2640 (1.3%) 33
    Prostate cancer metastatic 4/2667 (0.1%) 4 2/2640 (0.1%) 2
    Prostate cancer recurrent 1/2667 (0%) 1 1/2640 (0%) 1
    Prostate cancer stage i 1/2667 (0%) 1 0/2640 (0%) 0
    Prostatic adenoma 3/2667 (0.1%) 3 6/2640 (0.2%) 6
    Rectal adenocarcinoma 2/4949 (0%) 2 4/4943 (0.1%) 4
    Rectal adenoma 0/4949 (0%) 0 2/4943 (0%) 2
    Rectal cancer 3/4949 (0.1%) 3 0/4943 (0%) 0
    Rectal cancer metastatic 1/4949 (0%) 1 1/4943 (0%) 1
    Rectal neoplasm 1/4949 (0%) 1 0/4943 (0%) 0
    Rectosigmoid cancer 1/4949 (0%) 1 1/4943 (0%) 1
    Renal cancer 4/4949 (0.1%) 4 5/4943 (0.1%) 5
    Renal cancer metastatic 2/4949 (0%) 2 0/4943 (0%) 0
    Renal cell carcinoma 7/4949 (0.1%) 7 4/4943 (0.1%) 4
    Renal neoplasm 3/4949 (0.1%) 3 2/4943 (0%) 2
    Renal oncocytoma 2/4949 (0%) 2 0/4943 (0%) 0
    Sarcoma 0/4949 (0%) 0 1/4943 (0%) 1
    Small cell lung cancer 3/4949 (0.1%) 3 6/4943 (0.1%) 6
    Small cell lung cancer metastatic 0/4949 (0%) 0 1/4943 (0%) 1
    Spinal meningioma benign 1/4949 (0%) 1 0/4943 (0%) 0
    Spindle cell sarcoma 1/4949 (0%) 1 0/4943 (0%) 0
    Squamous cell carcinoma 1/4949 (0%) 1 4/4943 (0.1%) 4
    Squamous cell carcinoma of lung 7/4949 (0.1%) 8 3/4943 (0.1%) 3
    Squamous cell carcinoma of skin 3/4949 (0.1%) 4 3/4943 (0.1%) 3
    Squamous cell carcinoma of the cervix 0/2282 (0%) 0 1/2303 (0%) 1
    Squamous cell carcinoma of the vagina 0/2282 (0%) 0 1/2303 (0%) 1
    Squamous cell carcinoma of the vulva 0/2282 (0%) 0 2/2303 (0.1%) 2
    Sweat gland tumour 0/4949 (0%) 0 1/4943 (0%) 2
    Throat cancer 1/4949 (0%) 1 0/4943 (0%) 0
    Thymoma 0/4949 (0%) 0 1/4943 (0%) 1
    Thyroid adenoma 1/4949 (0%) 1 1/4943 (0%) 1
    Thyroid cancer 0/4949 (0%) 0 1/4943 (0%) 1
    Tongue carcinoma stage iv 1/4949 (0%) 1 0/4943 (0%) 0
    Tongue neoplasm malignant stage unspecified 0/4949 (0%) 0 1/4943 (0%) 1
    Tonsil cancer 2/4949 (0%) 2 0/4943 (0%) 0
    Transitional cell cancer of the renal pelvis and ureter 0/4949 (0%) 0 1/4943 (0%) 1
    Transitional cell carcinoma 3/4949 (0.1%) 3 7/4943 (0.1%) 7
    Transitional cell carcinoma recurrent 0/4949 (0%) 0 1/4943 (0%) 1
    Tumour associated fever 0/4949 (0%) 0 1/4943 (0%) 1
    Tumour of ampulla of vater 0/4949 (0%) 0 1/4943 (0%) 1
    Urethral cancer 1/4949 (0%) 1 0/4943 (0%) 0
    Uterine cancer 2/2282 (0.1%) 2 4/2303 (0.2%) 4
    Uterine leiomyoma 1/2282 (0%) 1 3/2303 (0.1%) 3
    Uterine neoplasm 1/2282 (0%) 1 1/2303 (0%) 1
    Vascular neoplasm 1/4949 (0%) 1 0/4943 (0%) 0
    Nervous system disorders
    Acoustic neuritis 0/4949 (0%) 0 1/4943 (0%) 1
    Altered state of consciousness 1/4949 (0%) 1 2/4943 (0%) 2
    Amnesia 0/4949 (0%) 0 1/4943 (0%) 1
    Amputation stump pain 0/4949 (0%) 0 1/4943 (0%) 1
    Aphasia 1/4949 (0%) 1 3/4943 (0.1%) 3
    Ataxia 2/4949 (0%) 2 1/4943 (0%) 1
    Autonomic nervous system imbalance 1/4949 (0%) 1 0/4943 (0%) 0
    Balance disorder 1/4949 (0%) 1 0/4943 (0%) 0
    Basal ganglia haemorrhage 1/4949 (0%) 1 1/4943 (0%) 1
    Brain injury 1/4949 (0%) 1 1/4943 (0%) 1
    Brain stem haemorrhage 0/4949 (0%) 0 1/4943 (0%) 1
    Brain stem infarction 1/4949 (0%) 1 1/4943 (0%) 1
    Carotid arteriosclerosis 1/4949 (0%) 1 0/4943 (0%) 0
    Carotid artery occlusion 4/4949 (0.1%) 4 1/4943 (0%) 1
    Carotid artery stenosis 9/4949 (0.2%) 10 5/4943 (0.1%) 5
    Carotid sinus syndrome 1/4949 (0%) 1 0/4943 (0%) 0
    Carpal tunnel syndrome 5/4949 (0.1%) 5 1/4943 (0%) 1
    Cauda equina syndrome 1/4949 (0%) 1 0/4943 (0%) 0
    Cerebellar ataxia 0/4949 (0%) 0 1/4943 (0%) 1
    Cerebellar atrophy 1/4949 (0%) 1 0/4943 (0%) 0
    Cerebellar infarction 1/4949 (0%) 1 0/4943 (0%) 0
    Cerebral arteriosclerosis 1/4949 (0%) 1 0/4943 (0%) 0
    Cerebral atrophy 1/4949 (0%) 1 0/4943 (0%) 0
    Cerebral circulatory failure 1/4949 (0%) 1 0/4943 (0%) 0
    Cerebral haematoma 3/4949 (0.1%) 3 2/4943 (0%) 2
    Cerebral haemorrhage 2/4949 (0%) 2 2/4943 (0%) 2
    Cerebral infarction 4/4949 (0.1%) 4 5/4943 (0.1%) 5
    Cerebral ischaemia 4/4949 (0.1%) 4 5/4943 (0.1%) 5
    Cerebrovascular accident 31/4949 (0.6%) 34 24/4943 (0.5%) 25
    Cerebrovascular disorder 0/4949 (0%) 0 3/4943 (0.1%) 3
    Cerebrovascular insufficiency 3/4949 (0.1%) 3 1/4943 (0%) 1
    Cervical radiculopathy 0/4949 (0%) 0 1/4943 (0%) 1
    Cervicobrachial syndrome 1/4949 (0%) 1 0/4943 (0%) 0
    Cognitive disorder 3/4949 (0.1%) 3 2/4943 (0%) 2
    Coma 0/4949 (0%) 0 2/4943 (0%) 2
    Dementia 2/4949 (0%) 2 4/4943 (0.1%) 4
    Dementia alzheimer's type 2/4949 (0%) 2 1/4943 (0%) 1
    Demyelinating polyneuropathy 0/4949 (0%) 0 1/4943 (0%) 1
    Depressed level of consciousness 0/4949 (0%) 0 1/4943 (0%) 1
    Diabetic coma 1/4949 (0%) 1 0/4943 (0%) 0
    Diabetic hyperglycaemic coma 1/4949 (0%) 1 0/4943 (0%) 0
    Diabetic hyperosmolar coma 1/4949 (0%) 1 1/4943 (0%) 1
    Diabetic mononeuropathy 1/4949 (0%) 1 0/4943 (0%) 0
    Diabetic neuropathy 8/4949 (0.2%) 8 3/4943 (0.1%) 3
    Dizziness 2/4949 (0%) 2 9/4943 (0.2%) 9
    Dizziness postural 0/4949 (0%) 0 1/4943 (0%) 1
    Dysarthria 1/4949 (0%) 1 0/4943 (0%) 0
    Embolic stroke 0/4949 (0%) 0 1/4943 (0%) 1
    Encephalopathy 2/4949 (0%) 2 4/4943 (0.1%) 4
    Epilepsy 8/4949 (0.2%) 8 1/4943 (0%) 1
    Facial paralysis 3/4949 (0.1%) 3 5/4943 (0.1%) 5
    Frontal lobe epilepsy 0/4949 (0%) 0 1/4943 (0%) 1
    Generalised tonic-clonic seizure 1/4949 (0%) 1 1/4943 (0%) 2
    Guillain-barre syndrome 1/4949 (0%) 1 1/4943 (0%) 1
    Haemorrhage intracranial 3/4949 (0.1%) 3 3/4943 (0.1%) 3
    Haemorrhagic cerebral infarction 1/4949 (0%) 1 0/4943 (0%) 0
    Haemorrhagic stroke 2/4949 (0%) 2 4/4943 (0.1%) 4
    Headache 2/4949 (0%) 2 2/4943 (0%) 2
    Hemiparesis 5/4949 (0.1%) 5 1/4943 (0%) 1
    Hemiplegia 2/4949 (0%) 2 0/4943 (0%) 0
    Hepatic encephalopathy 0/4949 (0%) 0 1/4943 (0%) 1
    Hydrocephalus 4/4949 (0.1%) 6 1/4943 (0%) 1
    Hypertensive encephalopathy 2/4949 (0%) 2 1/4943 (0%) 1
    Hypoaesthesia 1/4949 (0%) 1 0/4943 (0%) 0
    Iiird nerve paralysis 1/4949 (0%) 1 1/4943 (0%) 1
    Intracranial aneurysm 1/4949 (0%) 1 2/4943 (0%) 3
    Intracranial haematoma 0/4949 (0%) 0 1/4943 (0%) 1
    Ischaemic cerebral infarction 1/4949 (0%) 1 0/4943 (0%) 0
    Ischaemic neuropathy 1/4949 (0%) 1 2/4943 (0%) 3
    Ischaemic stroke 18/4949 (0.4%) 22 14/4943 (0.3%) 15
    Lacunar infarction 1/4949 (0%) 1 3/4943 (0.1%) 3
    Lacunar stroke 2/4949 (0%) 2 0/4943 (0%) 0
    Language disorder 0/4949 (0%) 0 1/4943 (0%) 1
    Loss of consciousness 0/4949 (0%) 0 3/4943 (0.1%) 3
    Lumbar radiculopathy 4/4949 (0.1%) 4 2/4943 (0%) 2
    Lumbosacral radiculopathy 0/4949 (0%) 0 2/4943 (0%) 2
    Metabolic encephalopathy 1/4949 (0%) 1 5/4943 (0.1%) 5
    Migraine 0/4949 (0%) 0 2/4943 (0%) 3
    Mixed dementia 1/4949 (0%) 1 1/4943 (0%) 1
    Monoparesis 1/4949 (0%) 1 1/4943 (0%) 1
    Motor neurone disease 1/4949 (0%) 1 0/4943 (0%) 0
    Myasthenia gravis 3/4949 (0.1%) 3 0/4943 (0%) 0
    Myelopathy 2/4949 (0%) 2 2/4943 (0%) 2
    Myoclonus 0/4949 (0%) 0 1/4943 (0%) 1
    Nerve root compression 1/4949 (0%) 1 0/4943 (0%) 0
    Nervous system disorder 0/4949 (0%) 0 1/4943 (0%) 1
    Neuritis 0/4949 (0%) 0 1/4943 (0%) 1
    Neuropathy peripheral 2/4949 (0%) 2 5/4943 (0.1%) 5
    Normal pressure hydrocephalus 1/4949 (0%) 1 2/4943 (0%) 2
    Optic neuritis 1/4949 (0%) 1 0/4943 (0%) 0
    Paralysis recurrent laryngeal nerve 0/4949 (0%) 0 1/4943 (0%) 1
    Parkinson's disease 2/4949 (0%) 2 1/4943 (0%) 1
    Parkinsonism 1/4949 (0%) 1 1/4943 (0%) 1
    Partial seizures 3/4949 (0.1%) 3 2/4943 (0%) 3
    Peripheral nerve paresis 0/4949 (0%) 0 1/4943 (0%) 1
    Peripheral sensorimotor neuropathy 1/4949 (0%) 1 0/4943 (0%) 0
    Peroneal nerve palsy 2/4949 (0%) 3 1/4943 (0%) 1
    Piriformis syndrome 1/4949 (0%) 1 0/4943 (0%) 0
    Polyneuropathy 1/4949 (0%) 1 1/4943 (0%) 1
    Post herpetic neuralgia 2/4949 (0%) 2 0/4943 (0%) 0
    Presyncope 2/4949 (0%) 2 4/4943 (0.1%) 4
    Pseudobulbar palsy 1/4949 (0%) 1 0/4943 (0%) 0
    Psychomotor hyperactivity 1/4949 (0%) 1 0/4943 (0%) 0
    Quadriplegia 0/4949 (0%) 0 3/4943 (0.1%) 3
    Radiculopathy 3/4949 (0.1%) 3 1/4943 (0%) 1
    Sciatica 7/4949 (0.1%) 8 6/4943 (0.1%) 6
    Seizure 5/4949 (0.1%) 5 7/4943 (0.1%) 7
    Sensory disturbance 0/4949 (0%) 0 1/4943 (0%) 1
    Serotonin syndrome 0/4949 (0%) 0 1/4943 (0%) 1
    Spinal claudication 1/4949 (0%) 1 0/4943 (0%) 0
    Syncope 33/4949 (0.7%) 34 36/4943 (0.7%) 38
    Thrombotic stroke 0/4949 (0%) 0 1/4943 (0%) 1
    Toxic encephalopathy 1/4949 (0%) 1 0/4943 (0%) 0
    Transient global amnesia 1/4949 (0%) 1 2/4943 (0%) 2
    Transient ischaemic attack 23/4949 (0.5%) 24 22/4943 (0.4%) 25
    Tremor 1/4949 (0%) 1 0/4943 (0%) 0
    Trigeminal neuralgia 0/4949 (0%) 0 1/4943 (0%) 2
    Uraemic encephalopathy 1/4949 (0%) 1 0/4943 (0%) 0
    Vascular dementia 4/4949 (0.1%) 4 1/4943 (0%) 1
    Vascular encephalopathy 2/4949 (0%) 2 0/4943 (0%) 0
    Vascular parkinsonism 1/4949 (0%) 1 0/4943 (0%) 0
    Vertebrobasilar insufficiency 2/4949 (0%) 2 2/4943 (0%) 2
    Vith nerve paralysis 1/4949 (0%) 1 1/4943 (0%) 1
    Wernicke's encephalopathy 0/4949 (0%) 0 1/4943 (0%) 1
    Product Issues
    Device damage 0/4949 (0%) 0 1/4943 (0%) 1
    Device dislocation 4/4949 (0.1%) 4 0/4943 (0%) 0
    Device failure 4/4949 (0.1%) 4 1/4943 (0%) 1
    Device loosening 1/4949 (0%) 1 0/4943 (0%) 0
    Device malfunction 1/4949 (0%) 1 2/4943 (0%) 2
    Device occlusion 0/4949 (0%) 0 1/4943 (0%) 1
    Psychiatric disorders
    Abnormal behaviour 0/4949 (0%) 0 1/4943 (0%) 1
    Adjustment disorder 0/4949 (0%) 0 1/4943 (0%) 1
    Adjustment disorder with depressed mood 1/4949 (0%) 1 0/4943 (0%) 0
    Affective disorder 1/4949 (0%) 1 1/4943 (0%) 1
    Aggression 1/4949 (0%) 1 0/4943 (0%) 0
    Alcohol abuse 1/4949 (0%) 1 0/4943 (0%) 0
    Alcohol withdrawal syndrome 1/4949 (0%) 1 1/4943 (0%) 1
    Anxiety 2/4949 (0%) 2 1/4943 (0%) 1
    Anxiety disorder 0/4949 (0%) 0 1/4943 (0%) 1
    Bipolar disorder 1/4949 (0%) 2 1/4943 (0%) 1
    Confusional state 7/4949 (0.1%) 7 9/4943 (0.2%) 9
    Delirium 8/4949 (0.2%) 10 10/4943 (0.2%) 10
    Delusion 1/4949 (0%) 1 0/4943 (0%) 0
    Depression 7/4949 (0.1%) 8 6/4943 (0.1%) 6
    Depression suicidal 1/4949 (0%) 1 0/4943 (0%) 0
    Disorientation 2/4949 (0%) 2 0/4943 (0%) 0
    Emotional distress 1/4949 (0%) 1 0/4943 (0%) 0
    Generalised anxiety disorder 0/4949 (0%) 0 1/4943 (0%) 1
    Hypomania 1/4949 (0%) 1 0/4943 (0%) 0
    Major depression 1/4949 (0%) 1 3/4943 (0.1%) 3
    Mania 1/4949 (0%) 1 0/4943 (0%) 0
    Mental disorder 3/4949 (0.1%) 3 0/4943 (0%) 0
    Mental status changes 1/4949 (0%) 1 1/4943 (0%) 1
    Panic disorder 0/4949 (0%) 0 1/4943 (0%) 1
    Personality change due to a general medical condition 1/4949 (0%) 1 0/4943 (0%) 0
    Psychogenic seizure 0/4949 (0%) 0 1/4943 (0%) 1
    Psychotic disorder 1/4949 (0%) 1 0/4943 (0%) 0
    Restlessness 1/4949 (0%) 1 0/4943 (0%) 0
    Somatic delusion 0/4949 (0%) 0 1/4943 (0%) 1
    Somatic symptom disorder 1/4949 (0%) 1 0/4943 (0%) 0
    Suicidal ideation 1/4949 (0%) 1 1/4943 (0%) 1
    Suicide attempt 0/4949 (0%) 0 1/4943 (0%) 1
    Renal and urinary disorders
    Acute kidney injury 67/4949 (1.4%) 74 61/4943 (1.2%) 72
    Atonic urinary bladder 0/4949 (0%) 0 1/4943 (0%) 1
    Azotaemia 0/4949 (0%) 0 2/4943 (0%) 2
    Bladder dysfunction 2/4949 (0%) 2 0/4943 (0%) 0
    Bladder fibrosis 1/4949 (0%) 1 0/4943 (0%) 0
    Bladder hypertrophy 1/4949 (0%) 1 0/4943 (0%) 0
    Bladder mass 0/4949 (0%) 0 1/4943 (0%) 1
    Bladder neck obstruction 1/4949 (0%) 1 1/4943 (0%) 2
    Bladder neck sclerosis 0/4949 (0%) 0 1/4943 (0%) 1
    Bladder obstruction 1/4949 (0%) 1 0/4943 (0%) 0
    Bladder outlet obstruction 1/4949 (0%) 1 0/4943 (0%) 0
    Bladder pain 1/4949 (0%) 1 0/4943 (0%) 0
    Calculus bladder 2/4949 (0%) 2 5/4943 (0.1%) 5
    Calculus urethral 0/4949 (0%) 0 1/4943 (0%) 1
    Calculus urinary 0/4949 (0%) 0 1/4943 (0%) 1
    Chronic kidney disease 19/4949 (0.4%) 20 13/4943 (0.3%) 13
    Cystitis haemorrhagic 0/4949 (0%) 0 1/4943 (0%) 1
    Diabetic nephropathy 5/4949 (0.1%) 5 3/4943 (0.1%) 3
    Dysuria 0/4949 (0%) 0 1/4943 (0%) 1
    End stage renal disease 6/4949 (0.1%) 6 3/4943 (0.1%) 3
    Haematuria 7/4949 (0.1%) 8 2/4943 (0%) 2
    Haemorrhage urinary tract 1/4949 (0%) 1 0/4943 (0%) 0
    Hydronephrosis 4/4949 (0.1%) 4 0/4943 (0%) 0
    Hydroureter 1/4949 (0%) 1 0/4943 (0%) 0
    Hypertensive nephropathy 0/4949 (0%) 0 1/4943 (0%) 1
    Hypertonic bladder 1/4949 (0%) 1 1/4943 (0%) 1
    Kidney perforation 0/4949 (0%) 0 1/4943 (0%) 1
    Nephrolithiasis 17/4949 (0.3%) 18 18/4943 (0.4%) 19
    Nephropathy 2/4949 (0%) 2 0/4943 (0%) 0
    Pelvi-ureteric obstruction 1/4949 (0%) 1 0/4943 (0%) 0
    Proteinuria 2/4949 (0%) 2 0/4943 (0%) 0
    Renal colic 6/4949 (0.1%) 7 7/4943 (0.1%) 8
    Renal cyst 1/4949 (0%) 1 1/4943 (0%) 1
    Renal failure 17/4949 (0.3%) 17 16/4943 (0.3%) 16
    Renal haematoma 1/4949 (0%) 1 0/4943 (0%) 0
    Renal haemorrhage 1/4949 (0%) 1 1/4943 (0%) 2
    Renal impairment 6/4949 (0.1%) 6 7/4943 (0.1%) 8
    Renal infarct 1/4949 (0%) 1 0/4943 (0%) 0
    Renal mass 2/4949 (0%) 2 1/4943 (0%) 1
    Stress urinary incontinence 0/4949 (0%) 0 2/4943 (0%) 2
    Tubulointerstitial nephritis 0/4949 (0%) 0 1/4943 (0%) 1
    Ureteric dilatation 0/4949 (0%) 0 1/4943 (0%) 1
    Ureteric stenosis 1/4949 (0%) 1 0/4943 (0%) 0
    Ureterolithiasis 9/4949 (0.2%) 10 9/4943 (0.2%) 9
    Urethral caruncle 0/4949 (0%) 0 1/4943 (0%) 1
    Urethral disorder 1/4949 (0%) 1 0/4943 (0%) 0
    Urethral stenosis 4/4949 (0.1%) 4 4/4943 (0.1%) 5
    Urinary bladder polyp 0/4949 (0%) 0 1/4943 (0%) 1
    Urinary incontinence 4/4949 (0.1%) 4 1/4943 (0%) 1
    Urinary retention 9/4949 (0.2%) 9 3/4943 (0.1%) 3
    Urinary tract obstruction 1/4949 (0%) 1 0/4943 (0%) 0
    Reproductive system and breast disorders
    Acquired phimosis 1/4949 (0%) 1 0/4943 (0%) 0
    Benign prostatic hyperplasia 18/2667 (0.7%) 20 21/2640 (0.8%) 21
    Breast pain 0/4949 (0%) 0 1/4943 (0%) 1
    Cervical polyp 1/2282 (0%) 1 2/2303 (0.1%) 2
    Cystocele 4/2282 (0.2%) 5 3/2303 (0.1%) 4
    Endometrial hyperplasia 0/2282 (0%) 0 1/2303 (0%) 1
    Endometrial hypertrophy 0/2282 (0%) 0 1/2303 (0%) 1
    Endometriosis 0/2282 (0%) 0 1/2303 (0%) 1
    Erectile dysfunction 1/2667 (0%) 1 0/2640 (0%) 0
    Female genital tract fistula 0/2282 (0%) 0 2/2303 (0.1%) 3
    Fibrocystic breast disease 2/4949 (0%) 2 0/4943 (0%) 0
    Genital prolapse 2/4949 (0%) 2 3/4943 (0.1%) 3
    Gynaecomastia 0/2667 (0%) 0 2/2640 (0.1%) 3
    Metrorrhagia 0/2282 (0%) 0 2/2303 (0.1%) 2
    Ovarian cyst 1/2282 (0%) 1 6/2303 (0.3%) 6
    Pelvic fluid collection 1/4949 (0%) 1 0/4943 (0%) 0
    Pelvic prolapse 0/4949 (0%) 0 1/4943 (0%) 1
    Prostatism 2/2667 (0.1%) 2 0/2640 (0%) 0
    Prostatitis 2/2667 (0.1%) 2 4/2640 (0.2%) 4
    Prostatomegaly 1/2667 (0%) 1 0/2640 (0%) 0
    Rectocele 1/2282 (0%) 1 1/2303 (0%) 1
    Uterine disorder 0/2282 (0%) 0 1/2303 (0%) 1
    Uterine polyp 2/2282 (0.1%) 2 3/2303 (0.1%) 3
    Uterine prolapse 0/2282 (0%) 0 3/2303 (0.1%) 3
    Uterovaginal prolapse 2/2282 (0.1%) 2 2/2303 (0.1%) 2
    Vaginal haemorrhage 1/2282 (0%) 1 1/2303 (0%) 1
    Vaginal polyp 1/2282 (0%) 1 0/2303 (0%) 0
    Vaginal prolapse 0/2282 (0%) 0 2/2303 (0.1%) 2
    Respiratory, thoracic and mediastinal disorders
    Acquired diaphragmatic eventration 0/4949 (0%) 0 1/4943 (0%) 1
    Acute pulmonary oedema 2/4949 (0%) 2 4/4943 (0.1%) 5
    Acute respiratory failure 17/4949 (0.3%) 17 6/4943 (0.1%) 7
    Alveolitis allergic 1/4949 (0%) 1 0/4943 (0%) 0
    Asphyxia 1/4949 (0%) 1 1/4943 (0%) 1
    Aspiration 3/4949 (0.1%) 3 0/4943 (0%) 0
    Asthma 8/4949 (0.2%) 13 8/4943 (0.2%) 8
    Atelectasis 0/4949 (0%) 0 1/4943 (0%) 1
    Bronchial hyperreactivity 0/4949 (0%) 0 1/4943 (0%) 1
    Bronchial polyp 0/4949 (0%) 0 1/4943 (0%) 1
    Bronchitis chronic 3/4949 (0.1%) 3 1/4943 (0%) 1
    Bronchopneumopathy 1/4949 (0%) 1 0/4943 (0%) 0
    Chronic obstructive pulmonary disease 35/4949 (0.7%) 45 25/4943 (0.5%) 32
    Chronic respiratory failure 2/4949 (0%) 2 1/4943 (0%) 1
    Cough 0/4949 (0%) 0 1/4943 (0%) 1
    Dysphonia 0/4949 (0%) 0 2/4943 (0%) 2
    Dyspnoea 15/4949 (0.3%) 15 11/4943 (0.2%) 12
    Dyspnoea exertional 6/4949 (0.1%) 6 1/4943 (0%) 1
    Emphysema 1/4949 (0%) 2 0/4943 (0%) 0
    Epistaxis 5/4949 (0.1%) 5 5/4943 (0.1%) 5
    Haemoptysis 2/4949 (0%) 2 1/4943 (0%) 1
    Haemothorax 1/4949 (0%) 1 0/4943 (0%) 0
    Hypercapnia 0/4949 (0%) 0 1/4943 (0%) 1
    Hyperventilation 0/4949 (0%) 0 2/4943 (0%) 2
    Hypoxia 3/4949 (0.1%) 3 1/4943 (0%) 1
    Interstitial lung disease 7/4949 (0.1%) 7 13/4943 (0.3%) 14
    Lung disorder 2/4949 (0%) 2 1/4943 (0%) 1
    Lung infiltration 0/4949 (0%) 0 1/4943 (0%) 1
    Nasal polyps 0/4949 (0%) 0 1/4943 (0%) 1
    Nasal septum deviation 1/4949 (0%) 1 1/4943 (0%) 1
    Obstructive airways disorder 1/4949 (0%) 1 1/4943 (0%) 1
    Pharyngeal haemorrhage 1/4949 (0%) 1 0/4943 (0%) 0
    Pickwickian syndrome 1/4949 (0%) 1 0/4943 (0%) 0
    Pleural effusion 8/4949 (0.2%) 10 13/4943 (0.3%) 13
    Pleural thickening 1/4949 (0%) 1 0/4943 (0%) 0
    Pleurisy 1/4949 (0%) 1 0/4943 (0%) 0
    Pneumonia aspiration 4/4949 (0.1%) 4 2/4943 (0%) 3
    Pneumonitis 1/4949 (0%) 1 1/4943 (0%) 1
    Pneumothorax 6/4949 (0.1%) 6 4/4943 (0.1%) 4
    Pneumothorax spontaneous 1/4949 (0%) 1 1/4943 (0%) 1
    Pulmonary congestion 1/4949 (0%) 1 2/4943 (0%) 2
    Pulmonary embolism 21/4949 (0.4%) 22 22/4943 (0.4%) 23
    Pulmonary fibrosis 4/4949 (0.1%) 4 1/4943 (0%) 1
    Pulmonary hypertension 4/4949 (0.1%) 4 3/4943 (0.1%) 3
    Pulmonary mass 2/4949 (0%) 2 4/4943 (0.1%) 4
    Pulmonary oedema 20/4949 (0.4%) 20 6/4943 (0.1%) 6
    Pulmonary thrombosis 1/4949 (0%) 1 0/4943 (0%) 0
    Respiratory arrest 0/4949 (0%) 0 3/4943 (0.1%) 4
    Respiratory distress 1/4949 (0%) 1 2/4943 (0%) 2
    Respiratory failure 20/4949 (0.4%) 22 16/4943 (0.3%) 16
    Respiratory tract oedema 0/4949 (0%) 0 1/4943 (0%) 1
    Restrictive pulmonary disease 0/4949 (0%) 0 1/4943 (0%) 1
    Rhinitis hypertrophic 1/4949 (0%) 1 0/4943 (0%) 0
    Sleep apnoea syndrome 6/4949 (0.1%) 6 1/4943 (0%) 1
    Skin and subcutaneous tissue disorders
    Angioedema 3/4949 (0.1%) 3 1/4943 (0%) 1
    Decubitus ulcer 0/4949 (0%) 0 1/4943 (0%) 1
    Dermatitis allergic 2/4949 (0%) 2 0/4943 (0%) 0
    Dermatitis atopic 1/4949 (0%) 1 0/4943 (0%) 0
    Diabetic foot 19/4949 (0.4%) 24 14/4943 (0.3%) 17
    Diabetic neuropathic ulcer 0/4949 (0%) 0 1/4943 (0%) 1
    Diabetic ulcer 2/4949 (0%) 2 1/4943 (0%) 2
    Erythrodermic psoriasis 1/4949 (0%) 1 0/4943 (0%) 0
    Hypersensitivity vasculitis 2/4949 (0%) 2 0/4943 (0%) 0
    Ischaemic skin ulcer 0/4949 (0%) 0 1/4943 (0%) 1
    Neuropathic ulcer 0/4949 (0%) 0 1/4943 (0%) 2
    Pemphigoid 1/4949 (0%) 1 0/4943 (0%) 0
    Psoriasis 1/4949 (0%) 1 0/4943 (0%) 0
    Pyoderma gangrenosum 0/4949 (0%) 0 1/4943 (0%) 1
    Rash generalised 1/4949 (0%) 1 0/4943 (0%) 0
    Rash papular 0/4949 (0%) 0 1/4943 (0%) 1
    Skin disorder 1/4949 (0%) 1 0/4943 (0%) 0
    Skin lesion 0/4949 (0%) 0 1/4943 (0%) 1
    Skin ulcer 15/4949 (0.3%) 16 9/4943 (0.2%) 13
    Stasis dermatitis 0/4949 (0%) 0 1/4943 (0%) 1
    Subcutaneous emphysema 1/4949 (0%) 1 0/4943 (0%) 0
    Urticaria 1/4949 (0%) 1 0/4943 (0%) 0
    Vasculitic ulcer 0/4949 (0%) 0 1/4943 (0%) 1
    Social circumstances
    Diet noncompliance 1/4949 (0%) 1 0/4943 (0%) 0
    Organ donor 0/4949 (0%) 0 1/4943 (0%) 1
    Vascular disorders
    Angiodysplasia 0/4949 (0%) 0 1/4943 (0%) 1
    Aortic aneurysm 2/4949 (0%) 2 10/4943 (0.2%) 10
    Aortic aneurysm rupture 0/4949 (0%) 0 1/4943 (0%) 1
    Aortic arteriosclerosis 1/4949 (0%) 1 0/4943 (0%) 0
    Aortic dissection 0/4949 (0%) 0 2/4943 (0%) 2
    Aortic stenosis 16/4949 (0.3%) 17 21/4943 (0.4%) 21
    Arterial occlusive disease 3/4949 (0.1%) 4 0/4943 (0%) 0
    Arterial stenosis 0/4949 (0%) 0 1/4943 (0%) 1
    Arteriosclerosis 1/4949 (0%) 1 1/4943 (0%) 1
    Bleeding varicose vein 1/4949 (0%) 1 0/4943 (0%) 0
    Circulatory collapse 6/4949 (0.1%) 6 4/4943 (0.1%) 4
    Deep vein thrombosis 10/4949 (0.2%) 10 16/4943 (0.3%) 16
    Dry gangrene 2/4949 (0%) 2 3/4943 (0.1%) 3
    Essential hypertension 1/4949 (0%) 1 0/4943 (0%) 0
    Extremity necrosis 3/4949 (0.1%) 4 3/4943 (0.1%) 3
    Haematoma 1/4949 (0%) 1 4/4943 (0.1%) 4
    Haemodynamic instability 1/4949 (0%) 2 0/4943 (0%) 0
    Haemorrhage 0/4949 (0%) 0 1/4943 (0%) 1
    Hypertension 27/4949 (0.5%) 29 22/4943 (0.4%) 24
    Hypertensive crisis 21/4949 (0.4%) 21 14/4943 (0.3%) 14
    Hypertensive emergency 3/4949 (0.1%) 3 4/4943 (0.1%) 4
    Hypotension 7/4949 (0.1%) 7 1/4943 (0%) 1
    Hypovolaemic shock 1/4949 (0%) 1 0/4943 (0%) 0
    Iliac artery embolism 1/4949 (0%) 1 0/4943 (0%) 0
    Intermittent claudication 4/4949 (0.1%) 4 1/4943 (0%) 1
    Lymphatic fistula 1/4949 (0%) 1 0/4943 (0%) 0
    Lymphoedema 2/4949 (0%) 2 0/4943 (0%) 0
    Neurogenic shock 0/4949 (0%) 0 1/4943 (0%) 1
    Orthostatic hypotension 5/4949 (0.1%) 5 6/4943 (0.1%) 6
    Peripheral arterial occlusive disease 25/4949 (0.5%) 26 17/4943 (0.3%) 18
    Peripheral artery occlusion 4/4949 (0.1%) 4 8/4943 (0.2%) 9
    Peripheral artery stenosis 3/4949 (0.1%) 3 2/4943 (0%) 2
    Peripheral artery thrombosis 1/4949 (0%) 1 1/4943 (0%) 1
    Peripheral embolism 1/4949 (0%) 1 0/4943 (0%) 0
    Peripheral ischaemia 8/4949 (0.2%) 9 9/4943 (0.2%) 13
    Peripheral vascular disorder 7/4949 (0.1%) 8 8/4943 (0.2%) 8
    Peripheral venous disease 1/4949 (0%) 1 1/4943 (0%) 1
    Phlebitis 0/4949 (0%) 0 3/4943 (0.1%) 3
    Shock 1/4949 (0%) 1 0/4943 (0%) 0
    Shock haemorrhagic 1/4949 (0%) 1 0/4943 (0%) 0
    Subclavian artery stenosis 1/4949 (0%) 1 0/4943 (0%) 0
    Superior vena cava syndrome 0/4949 (0%) 0 1/4943 (0%) 1
    Temporal arteritis 1/4949 (0%) 1 0/4943 (0%) 0
    Thrombophlebitis 2/4949 (0%) 2 0/4943 (0%) 0
    Thrombosis 2/4949 (0%) 2 2/4943 (0%) 2
    Varicose vein 4/4949 (0.1%) 4 3/4943 (0.1%) 3
    Vena cava thrombosis 1/4949 (0%) 1 0/4943 (0%) 0
    Venous thrombosis 2/4949 (0%) 2 0/4943 (0%) 0
    Venous thrombosis limb 1/4949 (0%) 1 2/4943 (0%) 2
    Other (Not Including Serious) Adverse Events
    Placebo Dulaglutide
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 3363/4949 (68%) 3574/4943 (72.3%)
    Eye disorders
    Cataract 368/4949 (7.4%) 417 363/4943 (7.3%) 427
    Gastrointestinal disorders
    Constipation 208/4949 (4.2%) 223 361/4943 (7.3%) 409
    Diarrhoea 436/4949 (8.8%) 546 665/4943 (13.5%) 843
    Dyspepsia 147/4949 (3%) 150 291/4943 (5.9%) 331
    Nausea 269/4949 (5.4%) 310 735/4943 (14.9%) 968
    Vomiting 154/4949 (3.1%) 165 325/4943 (6.6%) 498
    Infections and infestations
    Bronchitis 421/4949 (8.5%) 554 408/4943 (8.3%) 528
    Influenza 404/4949 (8.2%) 488 369/4943 (7.5%) 435
    Nasopharyngitis 535/4949 (10.8%) 771 564/4943 (11.4%) 800
    Upper respiratory tract infection 407/4949 (8.2%) 589 368/4943 (7.4%) 533
    Urinary tract infection 517/4949 (10.4%) 749 545/4943 (11%) 795
    Metabolism and nutrition disorders
    Decreased appetite 104/4949 (2.1%) 109 325/4943 (6.6%) 379
    Hyperglycaemia 315/4949 (6.4%) 445 158/4943 (3.2%) 190
    Hypoglycaemia 354/4949 (7.2%) 1160 413/4943 (8.4%) 1477
    Musculoskeletal and connective tissue disorders
    Arthralgia 389/4949 (7.9%) 469 371/4943 (7.5%) 446
    Back pain 416/4949 (8.4%) 484 447/4943 (9%) 494
    Osteoarthritis 318/4949 (6.4%) 373 329/4943 (6.7%) 372
    Pain in extremity 245/4949 (5%) 280 260/4943 (5.3%) 296
    Nervous system disorders
    Dizziness 296/4949 (6%) 339 318/4943 (6.4%) 373
    Headache 288/4949 (5.8%) 382 324/4943 (6.6%) 414
    Renal and urinary disorders
    Microalbuminuria 259/4949 (5.2%) 263 232/4943 (4.7%) 241
    Reproductive system and breast disorders
    Benign prostatic hyperplasia 135/2667 (5.1%) 137 140/2640 (5.3%) 144
    Respiratory, thoracic and mediastinal disorders
    Cough 256/4949 (5.2%) 292 239/4943 (4.8%) 265
    Vascular disorders
    Hypertension 432/4949 (8.7%) 491 345/4943 (7%) 405

    Limitations/Caveats

    [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
    Email www.ClinicalTrials.gov@lilly.com
    Responsible Party:
    Eli Lilly and Company
    ClinicalTrials.gov Identifier:
    NCT01394952
    Other Study ID Numbers:
    • 13438
    • H9X-MC-GBDJ
    First Posted:
    Jul 15, 2011
    Last Update Posted:
    Oct 8, 2019
    Last Verified:
    Sep 1, 2019