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Outcomes Study to Assess STatin Residual Risk Reduction With EpaNova in HiGh CV Risk PatienTs With Hypertriglyceridemia (STRENGTH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02104817
Recruitment Status : Completed
First Posted : April 4, 2014
Results First Posted : July 28, 2021
Last Update Posted : August 17, 2021
Sponsor:
Collaborators:
The Cleveland Clinic
IQVIA RDS Inc.
Information provided by (Responsible Party):
AstraZeneca

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Eligible Men or Women Considered High Risk for Atherosclerotic Cardiovascular Disease (CVD)
Interventions Drug: Epanova® (omega-3 carboxylic acids)
Drug: corn oil control
Enrollment 13078
Recruitment Details 686 study sites in 22 countries randomized subjects. The first patient was enrolled on 30 October 2014 and randomized on 11 November 2014. The last patient was randomized on 12 July 2017.
Pre-assignment Details  
Arm/Group Title Epanova Placebo
Hide Arm/Group Description Omega-3 carboxylic acid 4 x 1 gram capsule Corn oil 4 x 1 gram capsule
Period Title: Overall Study
Started 6539 6539
Completed 80 92
Not Completed 6459 6447
Reason Not Completed
Death             363             330
Lost to Follow-up             3             2
Protocol Violation             0             1
Study terminated by sponsor             5854             5901
Withdrawal by Subject             111             78
Other reasons             128             135
Arm/Group Title Epanova Placebo Total
Hide Arm/Group Description Omega-3 carboxylic acid 4 x 1 gram capsule Corn oil 4 x 1 gram capsule Total of all reporting groups
Overall Number of Baseline Participants 6539 6539 13078
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6539 participants 6539 participants 13078 participants
62.5  (8.98) 62.5  (8.98) 62.5  (8.98)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6539 participants 6539 participants 13078 participants
Female
2289
  35.0%
2279
  34.9%
4568
  34.9%
Male
4250
  65.0%
4260
  65.1%
8510
  65.1%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 6539 participants 6539 participants 13078 participants
WHITE 5341 5382 10723
BLACK OR AFRICAN AMERICAN 180 166 346
ASIAN 698 657 1355
NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER 10 11 21
AMERICAN INDIAN OR ALASKA NATIVE 114 112 226
OTHER 159 154 313
MULTIPLE 33 47 80
UNKNOWN 4 10 14
NOT REPORTED 0 0 0
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 6539 participants 6539 participants 13078 participants
Australia 58 54 112
Belgium 53 51 104
Canada 187 177 364
China 357 356 713
Czech Republic 120 108 228
Denmark 48 73 121
Estonia 57 53 110
Hungary 561 562 1123
Italy 33 34 67
Japan 166 139 305
Korea, Republic Of 68 65 133
Lithuania 170 193 363
Mexico 152 155 307
Netherlands 206 215 421
New Zealand 74 77 151
Poland 501 492 993
Russia 307 326 633
South Africa 471 490 961
Taiwan, Province Of China 28 31 59
Ukraine 1009 955 1964
United Kingdom 377 382 759
USA 1536 1551 3087
1.Primary Outcome
Title The Composite of Major Adverse Cardiovascular Events (MACE)
Hide Description MACE components include: cardiovascular (CV) death, nonfatal myocardial infarction (MI), nonfatal stroke, emergent/elective coronary revascularization, or hospitalization for unstable angina. Participants with no observed events are censored at the earliest of withdrawal of consent date and last study contact (defined as the latest of the dates of assessments contributing to an opportunity to assess as to whether the participant has had every component of the endpoint being analyzed).
Time Frame From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title Epanova Placebo
Hide Arm/Group Description:
Omega-3 carboxylic acid 4 x 1 gram capsule
Corn oil 4 x 1 gram capsule
Overall Number of Participants Analyzed 6539 6539
Measure Type: Number
Unit of Measure: Number of Participants
785 795
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Epanova, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.837
Comments The hypothesis is tested at the 5% level. A hierarchical test sequence is used to address the issue of multiple testing.
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.99
Confidence Interval (2-Sided) 95%
0.90 to 1.09
Estimation Comments [Not Specified]
2.Secondary Outcome
Title The Composite of MACE in the Subgroup of Participants With Established CV Disease(CVD) at Baseline
Hide Description MACE components include: cardiovascular (CV) death, nonfatal myocardial infarction (MI), nonfatal stroke, emergent/elective coronary revascularization, or hospitalization for unstable angina. Participants with no observed events are censored at the earliest of withdrawal of consent date and last study contact (defined as the latest of the dates of assessments contributing to an opportunity to assess as to whether the participant has had every component of the endpoint being analyzed).
Time Frame From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title Epanova Placebo
Hide Arm/Group Description:
Omega-3 carboxylic acid 4 x 1 gram capsule
Corn oil 4 x 1 gram capsule
Overall Number of Participants Analyzed 6539 6539
Measure Type: Number
Unit of Measure: Number of Participants
Overall number of participants Number Analyzed 6539 participants 6539 participants
785 795
Number of participants with established cardiovascular disease (CVD) at baseline Number Analyzed 3638 participants 3678 participants
569 610
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Epanova, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.269
Comments The hypothesis is tested at the 5% level. A hierarchical test sequence is used to address the issue of multiple testing.
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.94
Confidence Interval (2-Sided) 95%
0.84 to 1.05
Estimation Comments [Not Specified]
3.Secondary Outcome
Title The Composite of CV Events
Hide Description CV events include: cardiovascular (CV) death, non-fatal myocardial infarction (MI) and non-fatal stroke. Participants with no observed events are censored at the earliest of withdrawal of consent date and last study contact (defined as the latest of the dates of assessments contributing to an opportunity to assess as to whether the participant has had every component of the endpoint being analyzed).
Time Frame From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title Epanova Placebo
Hide Arm/Group Description:
Omega-3 carboxylic acid 4 x 1 gram capsule
Corn oil 4 x 1 gram capsule
Overall Number of Participants Analyzed 6539 6539
Measure Type: Number
Unit of Measure: Number of Participants
541 517
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Epanova, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.402
Comments The hypothesis is tested at the 5% level. A hierarchical test sequence is used to address the issue of multiple testing
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.05
Confidence Interval (2-Sided) 95%
0.93 to 1.19
Estimation Comments [Not Specified]
4.Secondary Outcome
Title The Composite of CV Events in the Subgroup of Participants With Established CV Disease (CVD) at Baseline
Hide Description CV events include: cardiovascular (CV) death, non-fatal myocardial infarction (MI) and non-fatal stroke. Participants with no observed events are censored at the earliest of withdrawal of consent date and last study contact (defined as the latest of the dates of assessments contributing to an opportunity to assess as to whether the participant has had every component of the endpoint being analyzed).
Time Frame From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title Epanova Placebo
Hide Arm/Group Description:
Omega-3 carboxylic acid 4 x 1 gram capsule
Corn oil 4 x 1 gram capsule
Overall Number of Participants Analyzed 6539 6539
Measure Type: Number
Unit of Measure: Number of Participants
Overall number of participants Number Analyzed 6539 participants 6539 participants
541 517
Number of participants with established CVD at baseline Number Analyzed 3638 participants 3678 participants
383 385
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Epanova, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.940
Comments The hypothesis is tested at the 5% level. A hierarchical test sequence is used to address the issue of multiple testing
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.01
Confidence Interval (2-Sided) 95%
0.87 to 1.16
Estimation Comments [Not Specified]
5.Secondary Outcome
Title The Composite of Coronary Events
Hide Description Coronary events include: cardiac death (including death due to acute myocardial infarction, sudden cardiac death and death due to cardiovascular procedures), non-fatal myocardial infarction (MI), emergent/elective coronary revascularization and hospitalization for unstable angina. Participants with no observed events are censored at the earliest of withdrawal of consent date and last study contact (defined as the latest of the dates of assessments contributing to an opportunity to assess as to whether the participant has had every component of the endpoint being analyzed).
Time Frame From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title Epanova Placebo
Hide Arm/Group Description:
Omega-3 carboxylic acid 4 x 1 gram capsule
Corn oil 4 x 1 gram capsule
Overall Number of Participants Analyzed 6539 6539
Measure Type: Number
Unit of Measure: Number of Participants
556 616
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Epanova, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.092
Comments The hypothesis is tested at the 5% level. A hierarchical test sequence is used to address the issue of multiple testing
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.91
Confidence Interval (2-Sided) 95%
0.81 to 1.02
Estimation Comments [Not Specified]
6.Secondary Outcome
Title The Composite of Coronary Events in the Subgroup of Participants With Established CVD at Baseline
Hide Description Coronary events include: cardiac death (including death due to acute myocardial infarction, sudden cardiac death and death due to cardiovascular procedures), non-fatal myocardial infarction (MI), emergent/elective coronary revascularization and hospitalization for unstable angina. Participants with no observed events are censored at the earliest of withdrawal of consent date and last study contact (defined as the latest of the dates of assessments contributing to an opportunity to assess as to whether the participant has had every component of the endpoint being analyzed) in the subgroup of participants with established CVD at baseline
Time Frame From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title Epanova Placebo
Hide Arm/Group Description:
Omega-3 carboxylic acid 4 x 1 gram capsule
Corn oil 4 x 1 gram capsule
Overall Number of Participants Analyzed 6539 6539
Measure Type: Number
Unit of Measure: Number of Participants
Overall number of participants Number Analyzed 6539 participants 6539 participants
556 616
Number of participants with established CVD at baseline Number Analyzed 3638 participants 3678 participants
417 493
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Epanova, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.016
Comments The hypothesis is tested at the 5% level. A hierarchical test sequence is used to address the issue of multiple testing.
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.85
Confidence Interval (2-Sided) 95%
0.75 to 0.97
Estimation Comments [Not Specified]
7.Secondary Outcome
Title CV Death
Hide Description Participants with no observed events are censored at the latest of the date of last study contact (defined as the latest of the dates of assessments contributing to an opportunity to assess as to whether the participant has had every component of the endpoint being analyzed), last date known to be alive, and date of non-cardiovascular death.
Time Frame From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Epanova Placebo
Hide Arm/Group Description:
Omega-3 carboxylic acid 4 x 1 gram capsule
Corn oil 4 x 1 gram capsule
Overall Number of Participants Analyzed 6539 6539
Measure Type: Number
Unit of Measure: Number of Participants
228 211
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Epanova, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.372
Comments The hypothesis is tested at the 5% level. A hierarchical test sequence is used to address the issue of multiple testing
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.09
Confidence Interval (2-Sided) 95%
0.90 to 1.31
Estimation Comments [Not Specified]
8.Secondary Outcome
Title CV Death in the Subgroup of Participants With Established CVD at Baseline
Hide Description Participants with no observed events are censored at the latest of the date of last study contact (defined as the latest of the dates of assessments contributing to an opportunity to assess as to whether the participant has had every component of the endpoint being analyzed), last date known to be alive, and date of non-cardiovascular death in the subgroup of participants with established CVD at baseline
Time Frame From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title Epanova Placebo
Hide Arm/Group Description:
Omega-3 carboxylic acid 4 x 1 gram capsule
Corn oil 4 x 1 gram capsule
Overall Number of Participants Analyzed 6539 6539
Measure Type: Number
Unit of Measure: Number of Participants
Overall number of participants Number Analyzed 6539 participants 6539 participants
228 211
Number of participants with established CVD at baseline Number Analyzed 3638 participants 3678 participants
152 138
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Epanova, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.336
Comments The hypothesis is tested at the 5% level. A hierarchical test sequence is used to address the issue of multiple testing.
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.12
Confidence Interval (2-Sided) 95%
0.89 to 1.41
Estimation Comments [Not Specified]
9.Secondary Outcome
Title All-cause Death
Hide Description Participants with no observed events are censored at the latest of the date of last study contact (defined as the latest of the dates of assessments contributing to an opportunity to assess as to whether the participant has had every component of the endpoint being analyzed) and last date known to be alive.
Time Frame From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title Epanova Placebo
Hide Arm/Group Description:
Omega-3 carboxylic acid 4 x 1 gram capsule
Corn oil 4 x 1 gram capsule
Overall Number of Participants Analyzed 6539 6539
Measure Type: Number
Unit of Measure: Number of Participants
373 333
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Epanova, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.112
Comments The hypothesis is tested at the 5% level. A hierarchical test sequence is used to address the issue of multiple testing.
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.13
Confidence Interval (2-Sided) 95%
0.97 to 1.31
Estimation Comments [Not Specified]
10.Secondary Outcome
Title All-cause Death in the Subgroup of Participants With Established CVD at Baseline
Hide Description Participants with no observed events are censored at the latest of the date of last study contact (defined as the latest of the dates of assessments contributing to an opportunity to assess as to whether the participant has had every component of the endpoint being analyzed) and last date known to be alive in the subgroup of participants with established CVD at baseline
Time Frame From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title Epanova Placebo
Hide Arm/Group Description:
Omega-3 carboxylic acid 4 x 1 gram capsule
Corn oil 4 x 1 gram capsule
Overall Number of Participants Analyzed 6539 6539
Measure Type: Number
Unit of Measure: Number of Participants
Overall number of participants Number Analyzed 6539 participants 6539 participants
373 333
Number of participants with established CVD at baselne Number Analyzed 3638 participants 3678 participants
234 202
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Epanova, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.091
Comments The hypothesis is tested at the 5% level. A hierarchical test sequence is used to address the issue of multiple testing.
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.18
Confidence Interval (2-Sided) 95%
0.97 to 1.42
Estimation Comments [Not Specified]
11.Other Pre-specified Outcome
Title Emergent/Elective Coronary Revascularization
Hide Description Participants with no observed events are censored at the earliest of withdrawal of consent date and last study contact (defined as the latest of the dates of assessments contributing to an opportunity to assess as to whether the participant has had every component of the endpoint being analyzed).
Time Frame From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title Epanova Placebo
Hide Arm/Group Description:
Omega-3 carboxylic acid 4 x 1 gram capsule
Corn oil 4 x 1 gram capsule
Overall Number of Participants Analyzed 6539 6539
Measure Type: Number
Unit of Measure: Number of Participants
414 441
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Epanova, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.408
Comments This endpoint was not in the testing sequence and therefore not under type I error control.
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.94
Confidence Interval (2-Sided) 95%
0.83 to 1.08
Estimation Comments [Not Specified]
12.Other Pre-specified Outcome
Title Hospitalization for Unstable Angina
Hide Description Participants with no observed events are censored at the earliest of withdrawal of consent date and last study contact (defined as the latest of the dates of assessments contributing to an opportunity to assess as to whether the participant has had every component of the endpoint being analyzed).
Time Frame From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title Epanova Placebo
Hide Arm/Group Description:
Omega-3 carboxylic acid 4 x 1 gram capsule
Corn oil 4 x 1 gram capsule
Overall Number of Participants Analyzed 6539 6539
Measure Type: Number
Unit of Measure: Number of Participants
87 104
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Epanova, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.233
Comments This endpoint was not in the testing sequence and therefore not under type I error control.
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.84
Confidence Interval (2-Sided) 95%
0.63 to 1.12
Estimation Comments [Not Specified]
13.Other Pre-specified Outcome
Title Non-fatal Myocardial Infarction
Hide Description Participants with no observed events are censored at the earliest of withdrawal of consent date and last study contact (defined as the latest of the dates of assessments contributing to an opportunity to assess as to whether the participant has had every component of the endpoint being analyzed).
Time Frame From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title Epanova Placebo
Hide Arm/Group Description:
Omega-3 carboxylic acid 4 x 1 gram capsule
Corn oil 4 x 1 gram capsule
Overall Number of Participants Analyzed 6539 6539
Measure Type: Number
Unit of Measure: Number of Participants
218 226
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Epanova, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.770
Comments This endpoint was not in the testing sequence and therefore not under type I error control.
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.97
Confidence Interval (2-Sided) 95%
0.81 to 1.17
Estimation Comments [Not Specified]
14.Other Pre-specified Outcome
Title Non-fatal Stroke
Hide Description Participants with no observed events are censored at the earliest of withdrawal of consent date and last study contact (defined as the latest of the dates of assessments contributing to an opportunity to assess as to whether the participant has had every component of the endpoint being analyzed).
Time Frame From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title Epanova Placebo
Hide Arm/Group Description:
Omega-3 carboxylic acid 4 x 1 gram capsule
Corn oil 4 x 1 gram capsule
Overall Number of Participants Analyzed 6539 6539
Measure Type: Number
Unit of Measure: Number of Participants
142 125
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Epanova, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.278
Comments This endpoint was not in the testing sequence and therefore not under type I error control.
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.14
Confidence Interval (2-Sided) 95%
0.90 to 1.45
Estimation Comments [Not Specified]
Time Frame Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Epanova Placebo
Hide Arm/Group Description Omega-3 carboxylic acid 4 x 1 gram capsule Corn oil 4 x 1 gram capsule
All-Cause Mortality
Epanova Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   373/6539 (5.70%)      333/6539 (5.09%)    
Hide Serious Adverse Events
Epanova Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2259/6532 (34.58%)      2195/6535 (33.59%)    
Blood and lymphatic system disorders     
Agranulocytosis † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Anaemia † 1  15/6532 (0.23%)  17 19/6535 (0.29%)  25
Anaemia macrocytic † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  1
Antiphospholipid syndrome † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Blood loss anaemia † 1  9/6532 (0.14%)  9 6/6535 (0.09%)  6
Coagulopathy † 1  3/6532 (0.05%)  3 0/6535 (0.00%)  0
Disseminated intravascular coagulation † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Immune thrombocytopenic purpura † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  1
Iron deficiency anaemia † 1  9/6532 (0.14%)  10 6/6535 (0.09%)  6
Leukocytosis † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Lymphadenopathy † 1  1/6532 (0.02%)  1 2/6535 (0.03%)  2
Microcytic anaemia † 1  2/6532 (0.03%)  2 1/6535 (0.02%)  1
Nephrogenic anaemia † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  1
Normocytic anaemia † 1  2/6532 (0.03%)  2 1/6535 (0.02%)  1
Pancytopenia † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  1
Polycythaemia † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Splenic infarction † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  1
Splenic thrombosis † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Splenomegaly † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Thrombocytopenia † 1  3/6532 (0.05%)  3 3/6535 (0.05%)  6
Cardiac disorders     
Acute coronary syndrome † 1  13/6532 (0.20%)  13 8/6535 (0.12%)  8
Acute left ventricular failure † 1  16/6532 (0.24%)  16 8/6535 (0.12%)  9
Acute myocardial infarction † 1  40/6532 (0.61%)  53 45/6535 (0.69%)  47
Adams-stokes syndrome † 1  0/6532 (0.00%)  0 2/6535 (0.03%)  2
Angina pectoris † 1  92/6532 (1.41%)  110 102/6535 (1.56%)  113
Angina unstable † 1  112/6532 (1.71%)  125 141/6535 (2.16%)  162
Anginal equivalent † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Aortic valve disease † 1  0/6532 (0.00%)  0 2/6535 (0.03%)  3
Aortic valve incompetence † 1  1/6532 (0.02%)  1 2/6535 (0.03%)  2
Aortic valve stenosis † 1  6/6532 (0.09%)  8 3/6535 (0.05%)  3
Arrhythmia † 1  12/6532 (0.18%)  12 5/6535 (0.08%)  5
Arteriosclerosis coronary artery † 1  19/6532 (0.29%)  23 15/6535 (0.23%)  20
Arteriospasm coronary † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  1
Atrial fibrillation † 1  150/6532 (2.30%)  188 89/6535 (1.36%)  103
Atrial flutter † 1  14/6532 (0.21%)  20 17/6535 (0.26%)  20
Atrial tachycardia † 1  2/6532 (0.03%)  3 3/6535 (0.05%)  5
Atrioventricular block † 1  2/6532 (0.03%)  2 1/6535 (0.02%)  1
Atrioventricular block complete † 1  7/6532 (0.11%)  7 7/6535 (0.11%)  7
Atrioventricular block first degree † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  1
Atrioventricular block second degree † 1  4/6532 (0.06%)  4 4/6535 (0.06%)  4
Atrioventricular dissociation † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Bradyarrhythmia † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  1
Bradycardia † 1  8/6532 (0.12%)  8 9/6535 (0.14%)  10
Cardiac aneurysm † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  1
Cardiac arrest † 1  19/6532 (0.29%)  19 11/6535 (0.17%)  11
Cardiac asthma † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  1
Cardiac discomfort † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  1
Cardiac disorder † 1  1/6532 (0.02%)  1 1/6535 (0.02%)  1
Cardiac failure † 1  90/6532 (1.38%)  117 92/6535 (1.41%)  132
Cardiac failure acute † 1  27/6532 (0.41%)  35 21/6535 (0.32%)  25
Cardiac failure chronic † 1  18/6532 (0.28%)  21 21/6535 (0.32%)  26
Cardiac failure congestive † 1  60/6532 (0.92%)  83 59/6535 (0.90%)  77
Cardiac tamponade † 1  1/6532 (0.02%)  1 1/6535 (0.02%)  1
Cardiac ventricular thrombosis † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Cardio-respiratory arrest † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Cardio-respiratory distress † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  1
Cardiogenic shock † 1  6/6532 (0.09%)  6 1/6535 (0.02%)  1
Cardiomyopathy † 1  9/6532 (0.14%)  9 2/6535 (0.03%)  2
Cardiopulmonary failure † 1  3/6532 (0.05%)  3 5/6535 (0.08%)  5
Cardiovascular deconditioning † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Cardiovascular disorder † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  1
Cardiovascular insufficiency † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  1
Congestive cardiomyopathy † 1  2/6532 (0.03%)  2 2/6535 (0.03%)  2
Coronary artery disease † 1  82/6532 (1.26%)  89 61/6535 (0.93%)  72
Coronary artery insufficiency † 1  1/6532 (0.02%)  1 1/6535 (0.02%)  1
Coronary artery occlusion † 1  3/6532 (0.05%)  3 7/6535 (0.11%)  8
Coronary artery stenosis † 1  3/6532 (0.05%)  3 8/6535 (0.12%)  8
Coronary artery thrombosis † 1  0/6532 (0.00%)  0 2/6535 (0.03%)  2
Diastolic dysfunction † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Extrasystoles † 1  1/6532 (0.02%)  1 1/6535 (0.02%)  1
Hypertensive heart disease † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Intracardiac thrombus † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Ischaemic cardiomyopathy † 1  4/6532 (0.06%)  5 10/6535 (0.15%)  11
Left ventricular dysfunction † 1  3/6532 (0.05%)  3 4/6535 (0.06%)  4
Left ventricular failure † 1  6/6532 (0.09%)  6 7/6535 (0.11%)  7
Metabolic cardiomyopathy † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  1
Mitral valve disease † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  2
Mitral valve incompetence † 1  2/6532 (0.03%)  2 4/6535 (0.06%)  4
Myocardial fibrosis † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  1
Myocardial infarction † 1  39/6532 (0.60%)  43 51/6535 (0.78%)  51
Myocardial ischaemia † 1  27/6532 (0.41%)  28 16/6535 (0.24%)  17
Myocarditis † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Nodal arrhythmia † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Nodal rhythm † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Palpitations † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  1
Paroxysmal atrioventricular block † 1  1/6532 (0.02%)  1 1/6535 (0.02%)  1
Pericardial effusion † 1  2/6532 (0.03%)  2 3/6535 (0.05%)  3
Pericarditis † 1  1/6532 (0.02%)  1 5/6535 (0.08%)  5
Pleuropericarditis † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  1
Postinfarction angina † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Pulmonary valve stenosis † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  2
Pulseless electrical activity † 1  0/6532 (0.00%)  0 4/6535 (0.06%)  5
Right ventricular failure † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  1
Silent myocardial infarction † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  1
Sinoatrial block † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  1
Sinus arrest † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Sinus bradycardia † 1  3/6532 (0.05%)  3 0/6535 (0.00%)  0
Sinus node dysfunction † 1  6/6532 (0.09%)  6 5/6535 (0.08%)  5
Sinus tachycardia † 1  0/6532 (0.00%)  0 2/6535 (0.03%)  2
Supraventricular extrasystoles † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  1
Supraventricular tachycardia † 1  6/6532 (0.09%)  6 5/6535 (0.08%)  5
Tachyarrhythmia † 1  0/6532 (0.00%)  0 2/6535 (0.03%)  2
Tachycardia † 1  0/6532 (0.00%)  0 3/6535 (0.05%)  3
Ventricular arrhythmia † 1  1/6532 (0.02%)  1 1/6535 (0.02%)  1
Ventricular dysfunction † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  1
Ventricular extrasystoles † 1  5/6532 (0.08%)  5 5/6535 (0.08%)  5
Ventricular fibrillation † 1  7/6532 (0.11%)  8 8/6535 (0.12%)  8
Ventricular tachycardia † 1  13/6532 (0.20%)  14 14/6535 (0.21%)  16
Congenital, familial and genetic disorders     
Arteriovenous malformation † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  1
Atrial septal defect † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  1
Cerebrovascular arteriovenous malformation † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  1
Familial mediterranean fever † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  1
Gastrointestinal arteriovenous malformation † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  1
Hypertrophic cardiomyopathy † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Phimosis † 1  4/6532 (0.06%)  4 1/6535 (0.02%)  1
Porokeratosis † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Pyloric stenosis † 1  1/6532 (0.02%)  2 0/6535 (0.00%)  0
Ear and labyrinth disorders     
Deafness † 1  0/6532 (0.00%)  0 2/6535 (0.03%)  2
Deafness neurosensory † 1  0/6532 (0.00%)  0 2/6535 (0.03%)  3
Deafness unilateral † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Hypoacusis † 1  1/6532 (0.02%)  1 1/6535 (0.02%)  1
Otolithiasis † 1  0/6532 (0.00%)  0 2/6535 (0.03%)  2
Sudden hearing loss † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  2
Tinnitus † 1  1/6532 (0.02%)  1 1/6535 (0.02%)  2
Vertigo † 1  12/6532 (0.18%)  13 11/6535 (0.17%)  11
Vertigo positional † 1  1/6532 (0.02%)  1 2/6535 (0.03%)  2
Vestibular disorder † 1  1/6532 (0.02%)  1 2/6535 (0.03%)  2
Endocrine disorders     
Acromegaly † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  1
Adrenal mass † 1  1/6532 (0.02%)  1 1/6535 (0.02%)  1
Goitre † 1  4/6532 (0.06%)  4 8/6535 (0.12%)  8
Hyperparathyroidism primary † 1  1/6532 (0.02%)  1 1/6535 (0.02%)  1
Hyperthyroidism † 1  2/6532 (0.03%)  2 1/6535 (0.02%)  1
Hypothyroidism † 1  0/6532 (0.00%)  0 2/6535 (0.03%)  2
Parathyroid disorder † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  1
Thyroid mass † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  1
Eye disorders     
Cataract † 1  29/6532 (0.44%)  35 20/6535 (0.31%)  24
Conjunctival erosion † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Conjunctivochalasis † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Corneal erosion † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Dacryostenosis acquired † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Diabetic retinopathy † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Diplopia † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  1
Exophthalmos † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  1
Eyelid ptosis † 1  0/6532 (0.00%)  0 2/6535 (0.03%)  2
Glaucoma † 1  4/6532 (0.06%)  5 1/6535 (0.02%)  1
Iridocyclitis † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Macular hole † 1  2/6532 (0.03%)  2 0/6535 (0.00%)  0
Maculopathy † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Open angle glaucoma † 1  2/6532 (0.03%)  2 0/6535 (0.00%)  0
Optic ischaemic neuropathy † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Retinal artery embolism † 1  2/6532 (0.03%)  2 0/6535 (0.00%)  0
Retinal artery occlusion † 1  2/6532 (0.03%)  2 1/6535 (0.02%)  1
Retinal detachment † 1  1/6532 (0.02%)  1 2/6535 (0.03%)  2
Retinal haemorrhage † 1  1/6532 (0.02%)  1 1/6535 (0.02%)  1
Retinal tear † 1  2/6532 (0.03%)  2 0/6535 (0.00%)  0
Retinal vein occlusion † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Retinopathy † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  1
Rhegmatogenous retinal detachment † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  3
Tractional retinal detachment † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  2
Vitreous detachment † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Vitreous disorder † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Vitreous haemorrhage † 1  2/6532 (0.03%)  2 1/6535 (0.02%)  1
Gastrointestinal disorders     
Abdominal adhesions † 1  1/6532 (0.02%)  1 2/6535 (0.03%)  2
Abdominal discomfort † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  1
Abdominal distension † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  1
Abdominal hernia † 1  5/6532 (0.08%)  5 5/6535 (0.08%)  5
Abdominal hernia obstructive † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  1
Abdominal incarcerated hernia † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  1
Abdominal pain † 1  8/6532 (0.12%)  9 9/6535 (0.14%)  11
Abdominal pain lower † 1  2/6532 (0.03%)  2 0/6535 (0.00%)  0
Abdominal pain upper † 1  3/6532 (0.05%)  3 3/6535 (0.05%)  3
Abdominal wall haematoma † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Alcoholic pancreatitis † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  1
Anal fistula † 1  2/6532 (0.03%)  2 0/6535 (0.00%)  0
Anal haemorrhage † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Anal stenosis † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  1
Anogenital dysplasia † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Ascites † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Barrett's oesophagus † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Chronic gastritis † 1  3/6532 (0.05%)  3 7/6535 (0.11%)  8
Coeliac artery stenosis † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Colitis † 1  7/6532 (0.11%)  7 7/6535 (0.11%)  8
Colitis ischaemic † 1  3/6532 (0.05%)  3 2/6535 (0.03%)  2
Colitis ulcerative † 1  1/6532 (0.02%)  1 3/6535 (0.05%)  4
Colonic fistula † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Constipation † 1  6/6532 (0.09%)  7 5/6535 (0.08%)  5
Crohn's disease † 1  2/6532 (0.03%)  2 0/6535 (0.00%)  0
Dental cyst † 1  2/6532 (0.03%)  2 0/6535 (0.00%)  0
Diabetic gastroparesis † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Diabetic gastropathy † 1  1/6532 (0.02%)  1 1/6535 (0.02%)  1
Diaphragmatic hernia † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Diarrhoea † 1  21/6532 (0.32%)  21 10/6535 (0.15%)  11
Dieulafoy's vascular malformation † 1  1/6532 (0.02%)  1 1/6535 (0.02%)  1
Diverticular perforation † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  1
Diverticulum † 1  3/6532 (0.05%)  3 4/6535 (0.06%)  4
Diverticulum intestinal † 1  3/6532 (0.05%)  3 0/6535 (0.00%)  0
Diverticulum intestinal haemorrhagic † 1  1/6532 (0.02%)  1 3/6535 (0.05%)  3
Duodenal perforation † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Duodenal polyp † 1  1/6532 (0.02%)  1 1/6535 (0.02%)  1
Duodenal ulcer † 1  5/6532 (0.08%)  5 3/6535 (0.05%)  3
Duodenal ulcer haemorrhage † 1  4/6532 (0.06%)  4 3/6535 (0.05%)  3
Duodenal ulcer perforation † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Duodenitis † 1  2/6532 (0.03%)  2 0/6535 (0.00%)  0
Duodenogastric reflux † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Dysbiosis † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  1
Dyspepsia † 1  2/6532 (0.03%)  2 1/6535 (0.02%)  1
Dysphagia † 1  2/6532 (0.03%)  2 1/6535 (0.02%)  1
Enteritis † 1  1/6532 (0.02%)  1 1/6535 (0.02%)  1
Enterocolitis † 1  0/6532 (0.00%)  0 2/6535 (0.03%)  2
Enterovesical fistula † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  1
Erosive duodenitis † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  1
Faecaloma † 1  0/6532 (0.00%)  0 2/6535 (0.03%)  2
Functional gastrointestinal disorder † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Gastric disorder † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  1
Gastric haemorrhage † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Gastric polyps † 1  3/6532 (0.05%)  3 2/6535 (0.03%)  2
Gastric ulcer † 1  5/6532 (0.08%)  5 1/6535 (0.02%)  1
Gastric ulcer haemorrhage † 1  4/6532 (0.06%)  4 1/6535 (0.02%)  1
Gastric ulcer perforation † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  1
Gastritis † 1  9/6532 (0.14%)  9 8/6535 (0.12%)  8
Gastritis erosive † 1  6/6532 (0.09%)  6 3/6535 (0.05%)  3
Gastritis haemorrhagic † 1  1/6532 (0.02%)  1 1/6535 (0.02%)  1
Gastroduodenal ulcer † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Gastrointestinal disorder † 1  2/6532 (0.03%)  2 0/6535 (0.00%)  0
Gastrointestinal erosion † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  1
Gastrointestinal haemorrhage † 1  24/6532 (0.37%)  31 10/6535 (0.15%)  11
Gastrointestinal inflammation † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  1
Gastrointestinal pain † 1  1/6532 (0.02%)  1 1/6535 (0.02%)  1
Gastrointestinal polyp haemorrhage † 1  1/6532 (0.02%)  1 2/6535 (0.03%)  2
Gastrointestinal ulcer haemorrhage † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  1
Gastrointestinal vascular malformation haemorrhagic † 1  1/6532 (0.02%)  1 1/6535 (0.02%)  1
Gastrooesophageal reflux disease † 1  7/6532 (0.11%)  7 7/6535 (0.11%)  7
Gingival bleeding † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Haematemesis † 1  2/6532 (0.03%)  2 1/6535 (0.02%)  1
Haematochezia † 1  4/6532 (0.06%)  4 1/6535 (0.02%)  1
Haemorrhagic erosive gastritis † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Haemorrhoidal haemorrhage † 1  2/6532 (0.03%)  2 6/6535 (0.09%)  7
Haemorrhoids † 1  5/6532 (0.08%)  5 5/6535 (0.08%)  5
Haemorrhoids thrombosed † 1  0/6532 (0.00%)  0 3/6535 (0.05%)  4
Hiatus hernia † 1  4/6532 (0.06%)  4 1/6535 (0.02%)  1
Ileus † 1  3/6532 (0.05%)  3 1/6535 (0.02%)  1
Ileus paralytic † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  1
Incarcerated inguinal hernia † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  1
Inguinal hernia † 1  18/6532 (0.28%)  19 11/6535 (0.17%)  12
Intestinal haemorrhage † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Intestinal ischaemia † 1  1/6532 (0.02%)  1 1/6535 (0.02%)  1
Intestinal mass † 1  1/6532 (0.02%)  1 1/6535 (0.02%)  1
Intestinal obstruction † 1  7/6532 (0.11%)  7 4/6535 (0.06%)  4
Intestinal perforation † 1  2/6532 (0.03%)  3 0/6535 (0.00%)  0
Intestinal polyp † 1  1/6532 (0.02%)  1 3/6535 (0.05%)  3
Intestinal pseudo-obstruction † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  1
Intra-abdominal haemorrhage † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Irritable bowel syndrome † 1  0/6532 (0.00%)  0 2/6535 (0.03%)  2
Large intestinal obstruction † 1  1/6532 (0.02%)  1 1/6535 (0.02%)  1
Large intestinal stenosis † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Large intestine perforation † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  1
Large intestine polyp † 1  14/6532 (0.21%)  15 13/6535 (0.20%)  19
Lower gastrointestinal haemorrhage † 1  1/6532 (0.02%)  1 2/6535 (0.03%)  2
Mechanical ileus † 1  0/6532 (0.00%)  0 2/6535 (0.03%)  2
Melaena † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Mesenteric artery stenosis † 1  1/6532 (0.02%)  1 1/6535 (0.02%)  1
Mesenteric haemorrhage † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  1
Mesenteric vascular insufficiency † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Mouth haemorrhage † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  1
Nausea † 1  4/6532 (0.06%)  4 3/6535 (0.05%)  3
Noninfective sialoadenitis † 1  0/6532 (0.00%)  0 2/6535 (0.03%)  2
Obstructive pancreatitis † 1  3/6532 (0.05%)  3 0/6535 (0.00%)  0
Oedematous pancreatitis † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  1
Oesophageal achalasia † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Oesophageal spasm † 1  1/6532 (0.02%)  1 2/6535 (0.03%)  2
Oesophageal stenosis † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  1
Oesophageal varices haemorrhage † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  1
Oesophagitis † 1  2/6532 (0.03%)  2 1/6535 (0.02%)  1
Pancreatic disorder † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Pancreatitis † 1  11/6532 (0.17%)  11 10/6535 (0.15%)  10
Pancreatitis acute † 1  12/6532 (0.18%)  16 11/6535 (0.17%)  11
Pancreatitis chronic † 1  0/6532 (0.00%)  0 3/6535 (0.05%)  3
Peptic ulcer † 1  0/6532 (0.00%)  0 3/6535 (0.05%)  3
Peptic ulcer haemorrhage † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  1
Pharyngo-oesophageal diverticulum † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  1
Pneumatosis intestinalis † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Rectal haemorrhage † 1  7/6532 (0.11%)  8 5/6535 (0.08%)  5
Rectal polyp † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  2
Rectal prolapse † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Reflux gastritis † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Retroperitoneal fibrosis † 1  1/6532 (0.02%)  3 0/6535 (0.00%)  0
Retroperitoneal haematoma † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Retroperitoneal haemorrhage † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Retroperitoneal mass † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Small intestinal obstruction † 1  5/6532 (0.08%)  6 9/6535 (0.14%)  12
Thrombosis mesenteric vessel † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Tongue cyst † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  1
Umbilical hernia † 1  5/6532 (0.08%)  5 2/6535 (0.03%)  2
Upper gastrointestinal haemorrhage † 1  12/6532 (0.18%)  12 3/6535 (0.05%)  3
Volvulus † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Volvulus of small bowel † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  1
Vomiting † 1  8/6532 (0.12%)  9 1/6535 (0.02%)  1
General disorders     
Adverse drug reaction † 1  1/6532 (0.02%)  1 1/6535 (0.02%)  1
Adverse event † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  1
Asthenia † 1  1/6532 (0.02%)  1 2/6535 (0.03%)  2
Cardiac death † 1  3/6532 (0.05%)  3 3/6535 (0.05%)  3
Catheter site haemorrhage † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Chest discomfort † 1  2/6532 (0.03%)  2 4/6535 (0.06%)  4
Chest pain † 1  10/6532 (0.15%)  10 23/6535 (0.35%)  23
Complication associated with device † 1  1/6532 (0.02%)  1 1/6535 (0.02%)  1
Cyst † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  1
Death † 1  57/6532 (0.87%)  57 38/6535 (0.58%)  38
Decreased activity † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  1
Device related thrombosis † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  1
Drowning † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  1
Drug intolerance † 1  1/6532 (0.02%)  1 1/6535 (0.02%)  1
Exercise tolerance decreased † 1  2/6532 (0.03%)  2 0/6535 (0.00%)  0
Fatigue † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  1
Gait disturbance † 1  1/6532 (0.02%)  1 1/6535 (0.02%)  1
General physical health deterioration † 1  2/6532 (0.03%)  2 0/6535 (0.00%)  0
Generalised oedema † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  1
Hernia † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  1
Impaired healing † 1  0/6532 (0.00%)  0 2/6535 (0.03%)  2
Implant site haematoma † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Implant site inflammation † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Inflammation † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Injection site phlebitis † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  1
Malaise † 1  0/6532 (0.00%)  0 2/6535 (0.03%)  2
Medical device site haematoma † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  1
Mucosal inflammation † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Multi-organ disorder † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Multiple organ dysfunction syndrome † 1  5/6532 (0.08%)  5 2/6535 (0.03%)  2
No adverse event † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Nodule † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  1
Non-cardiac chest pain † 1  51/6532 (0.78%)  69 51/6535 (0.78%)  53
Oedema peripheral † 1  0/6532 (0.00%)  0 3/6535 (0.05%)  4
Organ failure † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Pelvic mass † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  1
Perforation † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  1
Peripheral swelling † 1  2/6532 (0.03%)  2 3/6535 (0.05%)  3
Pyrexia † 1  3/6532 (0.05%)  3 4/6535 (0.06%)  4
Retention cyst † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Stent-graft endoleak † 1  1/6532 (0.02%)  1 1/6535 (0.02%)  1
Sudden cardiac death † 1  5/6532 (0.08%)  5 4/6535 (0.06%)  4
Sudden death † 1  4/6532 (0.06%)  4 3/6535 (0.05%)  3
Surgical failure † 1  1/6532 (0.02%)  1 1/6535 (0.02%)  1
Systemic inflammatory response syndrome † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  1
Ulcer haemorrhage † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Unevaluable event † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Vascular stent occlusion † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Vascular stent stenosis † 1  3/6532 (0.05%)  3 2/6535 (0.03%)  2
Vascular stent thrombosis † 1  1/6532 (0.02%)  1 5/6535 (0.08%)  5
Hepatobiliary disorders     
Bile duct stenosis † 1  1/6532 (0.02%)  2 0/6535 (0.00%)  0
Bile duct stone † 1  4/6532 (0.06%)  6 3/6535 (0.05%)  3
Biliary colic † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  1
Biliary tract disorder † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Cholangitis † 1  6/6532 (0.09%)  6 5/6535 (0.08%)  5
Cholangitis acute † 1  2/6532 (0.03%)  2 2/6535 (0.03%)  2
Cholecystitis † 1  13/6532 (0.20%)  13 17/6535 (0.26%)  18
Cholecystitis acute † 1  20/6532 (0.31%)  20 12/6535 (0.18%)  13
Cholecystitis chronic † 1  4/6532 (0.06%)  4 4/6535 (0.06%)  5
Cholelithiasis † 1  27/6532 (0.41%)  28 15/6535 (0.23%)  16
Chronic hepatitis † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Hepatic cirrhosis † 1  3/6532 (0.05%)  3 2/6535 (0.03%)  2
Hepatic failure † 1  0/6532 (0.00%)  0 2/6535 (0.03%)  2
Hepatic steatosis † 1  1/6532 (0.02%)  1 2/6535 (0.03%)  2
Hepatitis † 1  1/6532 (0.02%)  1 1/6535 (0.02%)  1
Hyperbilirubinaemia † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Ischaemic hepatitis † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Jaundice † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  1
Jaundice cholestatic † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  1
Liver disorder † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  1
Non-alcoholic steatohepatitis † 1  2/6532 (0.03%)  2 1/6535 (0.02%)  1
Nonalcoholic fatty liver disease † 1  2/6532 (0.03%)  2 1/6535 (0.02%)  1
Portal vein thrombosis † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  1
Post cholecystectomy syndrome † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  1
Immune system disorders     
Anaphylactic reaction † 1  1/6532 (0.02%)  1 3/6535 (0.05%)  3
Anaphylactic shock † 1  1/6532 (0.02%)  1 1/6535 (0.02%)  1
Contrast media allergy † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  1
Drug hypersensitivity † 1  2/6532 (0.03%)  2 1/6535 (0.02%)  1
Heart transplant rejection † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  2
Hypersensitivity † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  1
Kidney transplant rejection † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Sarcoidosis † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  1
Infections and infestations     
Abdominal abscess † 1  2/6532 (0.03%)  2 1/6535 (0.02%)  1
Abdominal wall abscess † 1  2/6532 (0.03%)  2 2/6535 (0.03%)  3
Abdominal wall infection † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  1
Abscess † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Abscess limb † 1  4/6532 (0.06%)  4 6/6535 (0.09%)  6
Acarodermatitis † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  1
Acquired immunodeficiency syndrome † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  1
Acute hepatitis b † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Acute sinusitis † 1  1/6532 (0.02%)  1 3/6535 (0.05%)  4
Adenovirus infection † 1  1/6532 (0.02%)  1 1/6535 (0.02%)  1
Anal abscess † 1  1/6532 (0.02%)  1 3/6535 (0.05%)  3
Appendicitis † 1  9/6532 (0.14%)  9 14/6535 (0.21%)  14
Appendicitis perforated † 1  5/6532 (0.08%)  5 1/6535 (0.02%)  1
Arthritis bacterial † 1  0/6532 (0.00%)  0 4/6535 (0.06%)  4
Arthritis infective † 1  2/6532 (0.03%)  2 1/6535 (0.02%)  1
Atypical pneumonia † 1  1/6532 (0.02%)  1 1/6535 (0.02%)  1
Bacteraemia † 1  4/6532 (0.06%)  4 4/6535 (0.06%)  4
Bacterial colitis † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  1
Bacterial infection † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Bacterial prostatitis † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  1
Beta haemolytic streptococcal infection † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Biliary sepsis † 1  1/6532 (0.02%)  1 2/6535 (0.03%)  2
Borrelia infection † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  1
Breast abscess † 1  2/6532 (0.03%)  2 1/6535 (0.02%)  1
Bronchitis † 1  10/6532 (0.15%)  11 23/6535 (0.35%)  23
Bronchitis viral † 1  1/6532 (0.02%)  1 3/6535 (0.05%)  3
Bursitis infective † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  1
Campylobacter colitis † 1  1/6532 (0.02%)  1 1/6535 (0.02%)  1
Campylobacter gastroenteritis † 1  2/6532 (0.03%)  2 0/6535 (0.00%)  0
Candida pneumonia † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Carbuncle † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Cellulitis † 1  39/6532 (0.60%)  46 46/6535 (0.70%)  52
Cellulitis of male external genital organ † 1  2/6532 (0.03%)  2 0/6535 (0.00%)  0
Cellulitis staphylococcal † 1  1/6532 (0.02%)  1 1/6535 (0.02%)  1
Chest wall abscess † 1  1/6532 (0.02%)  1 1/6535 (0.02%)  1
Cholangitis infective † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Cholecystitis infective † 1  1/6532 (0.02%)  1 3/6535 (0.05%)  4
Chronic sinusitis † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Clostridium difficile colitis † 1  2/6532 (0.03%)  2 1/6535 (0.02%)  1
Clostridium difficile infection † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Cystitis † 1  4/6532 (0.06%)  5 1/6535 (0.02%)  1
Dermatitis infected † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  1
Device related infection † 1  2/6532 (0.03%)  4 2/6535 (0.03%)  2
Diabetic foot infection † 1  1/6532 (0.02%)  1 3/6535 (0.05%)  4
Diabetic gangrene † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Diarrhoea infectious † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Diverticulitis † 1  13/6532 (0.20%)  16 9/6535 (0.14%)  12
Diverticulitis intestinal haemorrhagic † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Dysentery † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Emphysematous pyelonephritis † 1  1/6532 (0.02%)  1 1/6535 (0.02%)  1
Empyema † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  1
Endocarditis † 1  1/6532 (0.02%)  1 2/6535 (0.03%)  2
Endocarditis bacterial † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Enterococcal sepsis † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Epidemic pleurodynia † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Epididymitis † 1  1/6532 (0.02%)  2 0/6535 (0.00%)  0
Erysipelas † 1  6/6532 (0.09%)  10 6/6535 (0.09%)  7
Escherichia bacteraemia † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Escherichia infection † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  1
Escherichia pyelonephritis † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Escherichia sepsis † 1  2/6532 (0.03%)  2 0/6535 (0.00%)  0
Escherichia urinary tract infection † 1  0/6532 (0.00%)  0 2/6535 (0.03%)  2
External ear cellulitis † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Extradural abscess † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Folliculitis † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  1
Fournier's gangrene † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Fungal infection † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Gallbladder abscess † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Gallbladder empyema † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Gangrene † 1  7/6532 (0.11%)  7 9/6535 (0.14%)  11
Gastroenteritis † 1  15/6532 (0.23%)  16 20/6535 (0.31%)  20
Gastroenteritis clostridial † 1  1/6532 (0.02%)  1 1/6535 (0.02%)  1
Gastroenteritis viral † 1  4/6532 (0.06%)  5 4/6535 (0.06%)  4
Gastrointestinal infection † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  1
Gastrointestinal viral infection † 1  1/6532 (0.02%)  1 1/6535 (0.02%)  1
Genitourinary tract infection † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Graft infection † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Groin abscess † 1  3/6532 (0.05%)  3 0/6535 (0.00%)  0
Hiv infection † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Haematoma infection † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Helicobacter gastritis † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Hepatic cyst infection † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  1
Hepatitis c † 1  0/6532 (0.00%)  0 3/6535 (0.05%)  3
Herpes zoster † 1  4/6532 (0.06%)  4 4/6535 (0.06%)  4
Implant site infection † 1  0/6532 (0.00%)  0 2/6535 (0.03%)  2
Incision site cellulitis † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  1
Infected cyst † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Infected dermal cyst † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Infected skin ulcer † 1  1/6532 (0.02%)  1 1/6535 (0.02%)  1
Infection † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  1
Infectious pleural effusion † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Infective aneurysm † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  1
Infective exacerbation of chronic obstructive airways disease † 1  2/6532 (0.03%)  2 3/6535 (0.05%)  3
Infective tenosynovitis † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Influenza † 1  12/6532 (0.18%)  13 15/6535 (0.23%)  15
Intervertebral discitis † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Intestinal gangrene † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  1
Kidney infection † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  1
Klebsiella infection † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  1
Large intestine infection † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  1
Laryngitis † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  1
Liver abscess † 1  3/6532 (0.05%)  6 2/6535 (0.03%)  2
Localised infection † 1  1/6532 (0.02%)  1 5/6535 (0.08%)  9
Lower respiratory tract infection † 1  8/6532 (0.12%)  8 12/6535 (0.18%)  13
Lower respiratory tract infection bacterial † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Lyme disease † 1  2/6532 (0.03%)  2 0/6535 (0.00%)  0
Lymphangitis † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  1
Mastitis † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  1
Mediastinitis † 1  2/6532 (0.03%)  2 0/6535 (0.00%)  0
Medical device site abscess † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  1
Medical device site infection † 1  1/6532 (0.02%)  1 1/6535 (0.02%)  1
Medical device site joint infection † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Meningitis † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  1
Meningitis bacterial † 1  0/6532 (0.00%)  0 2/6535 (0.03%)  3
Meningoencephalitis herpetic † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Moraxella infection † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  1
Mycetoma mycotic † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Nasopharyngitis † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Necrotising fasciitis † 1  2/6532 (0.03%)  2 0/6535 (0.00%)  0
Oesophageal candidiasis † 1  2/6532 (0.03%)  2 1/6535 (0.02%)  1
Orchitis † 1  1/6532 (0.02%)  1 1/6535 (0.02%)  1
Osteomyelitis † 1  9/6532 (0.14%)  11 12/6535 (0.18%)  16
Osteomyelitis acute † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  1
Osteomyelitis chronic † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  1
Otitis externa † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  1
Otitis media † 1  1/6532 (0.02%)  1 1/6535 (0.02%)  1
Otitis media acute † 1  2/6532 (0.03%)  2 0/6535 (0.00%)  0
Otitis media bacterial † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  1
Otitis media chronic † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  1
Parainfluenzae virus infection † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  1
Parotitis † 1  0/6532 (0.00%)  0 2/6535 (0.03%)  2
Pelvic infection † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  1
Perineal abscess † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  1
Periodontitis † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  1
Perirectal abscess † 1  2/6532 (0.03%)  2 0/6535 (0.00%)  0
Peritonitis † 1  1/6532 (0.02%)  1 3/6535 (0.05%)  3
Peritonsillitis † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Pilonidal cyst † 1  1/6532 (0.02%)  1 1/6535 (0.02%)  1
Pneumonia † 1  113/6532 (1.73%)  130 126/6535 (1.93%)  135
Pneumonia bacterial † 1  1/6532 (0.02%)  1 2/6535 (0.03%)  2
Pneumonia haemophilus † 1  1/6532 (0.02%)  1 1/6535 (0.02%)  1
Pneumonia legionella † 1  1/6532 (0.02%)  1 1/6535 (0.02%)  1
Pneumonia pseudomonal † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  1
Pneumonia staphylococcal † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  1
Pneumonia streptococcal † 1  2/6532 (0.03%)  2 0/6535 (0.00%)  0
Pneumonia viral † 1  2/6532 (0.03%)  2 0/6535 (0.00%)  0
Post procedural cellulitis † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  1
Post procedural sepsis † 1  4/6532 (0.06%)  4 1/6535 (0.02%)  1
Postoperative abscess † 1  2/6532 (0.03%)  2 0/6535 (0.00%)  0
Postoperative wound infection † 1  8/6532 (0.12%)  8 2/6535 (0.03%)  2
Pseudomonas infection † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Psoas abscess † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Pulmonary nocardiosis † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  1
Pulmonary sepsis † 1  1/6532 (0.02%)  1 1/6535 (0.02%)  1
Pyelonephritis † 1  9/6532 (0.14%)  9 12/6535 (0.18%)  12
Pyelonephritis acute † 1  7/6532 (0.11%)  9 3/6535 (0.05%)  3
Pyelonephritis chronic † 1  5/6532 (0.08%)  5 1/6535 (0.02%)  1
Rectal abscess † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Renal abscess † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Renal cyst infection † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  1
Respiratory tract infection † 1  0/6532 (0.00%)  0 2/6535 (0.03%)  2
Respiratory tract infection viral † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  1
Rotavirus infection † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  1
Salmonellosis † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Scrotal abscess † 1  0/6532 (0.00%)  0 2/6535 (0.03%)  2
Sepsis † 1  49/6532 (0.75%)  51 43/6535 (0.66%)  47
Septic necrosis † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  1
Septic shock † 1  8/6532 (0.12%)  8 7/6535 (0.11%)  10
Sinobronchitis † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Sinusitis † 1  2/6532 (0.03%)  2 2/6535 (0.03%)  2
Skin infection † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Staphylococcal abscess † 1  0/6532 (0.00%)  0 2/6535 (0.03%)  2
Staphylococcal bacteraemia † 1  2/6532 (0.03%)  2 3/6535 (0.05%)  3
Staphylococcal infection † 1  1/6532 (0.02%)  1 3/6535 (0.05%)  3
Staphylococcal sepsis † 1  1/6532 (0.02%)  1 4/6535 (0.06%)  4
Streptococcal abscess † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Streptococcal sepsis † 1  2/6532 (0.03%)  2 0/6535 (0.00%)  0
Subcutaneous abscess † 1  0/6532 (0.00%)  0 2/6535 (0.03%)  2
Tonsillitis † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  1
Tooth abscess † 1  1/6532 (0.02%)  1 1/6535 (0.02%)  1
Tracheitis † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  1
Tracheobronchitis † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  1
Upper respiratory tract infection † 1  1/6532 (0.02%)  1 3/6535 (0.05%)  3
Urinary tract infection † 1  24/6532 (0.37%)  26 36/6535 (0.55%)  40
Urosepsis † 1  9/6532 (0.14%)  9 9/6535 (0.14%)  9
Vestibular neuronitis † 1  3/6532 (0.05%)  4 2/6535 (0.03%)  2
Viral infection † 1  1/6532 (0.02%)  1 2/6535 (0.03%)  2
Wound infection † 1  1/6532 (0.02%)  1 7/6535 (0.11%)  7
Wound infection bacterial † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Wound sepsis † 1  2/6532 (0.03%)  2 1/6535 (0.02%)  1
Injury, poisoning and procedural complications     
Abdominal injury † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  1
Accidental overdose † 1  3/6532 (0.05%)  3 1/6535 (0.02%)  1
Acetabulum fracture † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Airway complication of anaesthesia † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  1
Alcohol poisoning † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  1
Animal bite † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Ankle fracture † 1  5/6532 (0.08%)  5 9/6535 (0.14%)  10
Arterial bypass occlusion † 1  1/6532 (0.02%)  1 1/6535 (0.02%)  1
Arterial bypass stenosis † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Back injury † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  1
Bone contusion † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Brain contusion † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Burns second degree † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Carbon monoxide poisoning † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Carotid artery restenosis † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Cervical vertebral fracture † 1  2/6532 (0.03%)  2 1/6535 (0.02%)  1
Chest injury † 1  0/6532 (0.00%)  0 5/6535 (0.08%)  5
Clavicle fracture † 1  1/6532 (0.02%)  1 3/6535 (0.05%)  3
Concussion † 1  1/6532 (0.02%)  1 2/6535 (0.03%)  2
Contusion † 1  1/6532 (0.02%)  3 0/6535 (0.00%)  0
Coronary artery restenosis † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Craniocerebral injury † 1  3/6532 (0.05%)  3 2/6535 (0.03%)  2
Cystitis radiation † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Epicondylitis † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Eyelid injury † 1  1/6532 (0.02%)  1 1/6535 (0.02%)  1
Facial bones fracture † 1  1/6532 (0.02%)  1 1/6535 (0.02%)  1
Fall † 1  15/6532 (0.23%)  19 10/6535 (0.15%)  10
Femoral neck fracture † 1  9/6532 (0.14%)  9 7/6535 (0.11%)  7
Femur fracture † 1  8/6532 (0.12%)  8 9/6535 (0.14%)  9
Fibula fracture † 1  1/6532 (0.02%)  1 3/6535 (0.05%)  3
Foot fracture † 1  3/6532 (0.05%)  3 1/6535 (0.02%)  1
Forearm fracture † 1  2/6532 (0.03%)  2 0/6535 (0.00%)  0
Foreign body aspiration † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Foreign body in gastrointestinal tract † 1  0/6532 (0.00%)  0 2/6535 (0.03%)  2
Fracture displacement † 1  1/6532 (0.02%)  1 1/6535 (0.02%)  1
Frostbite † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  1
Hand fracture † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Head injury † 1  5/6532 (0.08%)  5 8/6535 (0.12%)  8
Hip fracture † 1  4/6532 (0.06%)  4 11/6535 (0.17%)  11
Humerus fracture † 1  5/6532 (0.08%)  5 6/6535 (0.09%)  6
Hyphaema † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  1
Incisional hernia † 1  5/6532 (0.08%)  5 4/6535 (0.06%)  5
Inflammation of wound † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Injury † 1  1/6532 (0.02%)  1 2/6535 (0.03%)  2
Intentional overdose † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  1
Joint dislocation † 1  0/6532 (0.00%)  0 4/6535 (0.06%)  4
Joint injury † 1  1/6532 (0.02%)  2 3/6535 (0.05%)  3
Ligament rupture † 1  2/6532 (0.03%)  2 1/6535 (0.02%)  1
Ligament sprain † 1  0/6532 (0.00%)  0 2/6535 (0.03%)  2
Limb injury † 1  2/6532 (0.03%)  2 3/6535 (0.05%)  4
Limb traumatic amputation † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Lower limb fracture † 1  3/6532 (0.05%)  4 3/6535 (0.05%)  3
Lumbar vertebral fracture † 1  2/6532 (0.03%)  2 2/6535 (0.03%)  2
Mallet finger † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Meniscus injury † 1  4/6532 (0.06%)  4 3/6535 (0.05%)  3
Multiple fractures † 1  1/6532 (0.02%)  1 3/6535 (0.05%)  3
Multiple injuries † 1  3/6532 (0.05%)  3 1/6535 (0.02%)  1
Muscle injury † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Muscle rupture † 1  2/6532 (0.03%)  2 1/6535 (0.02%)  1
Muscle strain † 1  1/6532 (0.02%)  1 1/6535 (0.02%)  1
Neck injury † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  1
Overdose † 1  1/6532 (0.02%)  1 2/6535 (0.03%)  2
Patella fracture † 1  3/6532 (0.05%)  3 0/6535 (0.00%)  0
Pelvic organ injury † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Peripheral artery restenosis † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  1
Peripheral nerve injury † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Periprosthetic fracture † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  1
Pharyngeal contusion † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  1
Poisoning † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Post concussion syndrome † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Post laminectomy syndrome † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  1
Post procedural complication † 1  2/6532 (0.03%)  2 2/6535 (0.03%)  3
Post procedural fever † 1  2/6532 (0.03%)  2 1/6535 (0.02%)  1
Post procedural haematoma † 1  1/6532 (0.02%)  1 4/6535 (0.06%)  4
Post procedural haematuria † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  1
Post procedural haemorrhage † 1  7/6532 (0.11%)  8 7/6535 (0.11%)  7
Post procedural swelling † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Postoperative delirium † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Postoperative hypotension † 1  0/6532 (0.00%)  0 1/6535 (0.02%)  1
Postoperative ileus † 1  2/6532 (0.03%)  2 2/6535 (0.03%)  5
Postoperative respiratory failure † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Postoperative thoracic procedure complication † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Procedural haemorrhage † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Procedural hypotension † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0
Procedural nausea † 1  1/6532 (0.02%)  1 0/6535 (0.00%)  0