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The Stabilization of Atherosclerotic Plaque by Initiation of Darapladib Therapy Trial (STABILITY)

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ClinicalTrials.gov Identifier: NCT00799903
Recruitment Status : Completed
First Posted : December 1, 2008
Results First Posted : August 10, 2017
Last Update Posted : August 10, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Atherosclerosis
Interventions Drug: Darapladib
Drug: Placebo
Enrollment 15828
Recruitment Details The study consisted of a Screening Phase of up to 8 weeks duration, a Treatment Phase, an End-of-Treatment (EOT) visit, and a Follow-up visit scheduled for 35 +/- 7 days after last study drug intake. The median treatment duration was anticipated to be 2.75 years.
Pre-assignment Details During the Screening Phase of the study, participants presenting with chronic Coronary Heart Disease (CHD) were randomized within 8 weeks. In addition to chronic CHD, participants were required to have at least one additional predictor of cardiovascular risk specified in the protocol.
Arm/Group Title Placebo Darapladib
Hide Arm/Group Description Participants were randomized to receive matching placebo once daily. Participants were randomized to receive darapladib 160 milligram (mg) enteric-coated tablets once daily.
Period Title: Overall Study
Started 7904 7924
Completed 7631 7646
Not Completed 273 278
Reason Not Completed
Investigator Site Closed             25             23
Withdrawal by Subject             179             175
Lost to Follow-up             69             80
Arm/Group Title Placebo Darapladib Total
Hide Arm/Group Description Participants were randomized to receive matching placebo once daily. Participants were randomized to receive darapladib 160 milligram (mg) enteric-coated tablets once daily. Total of all reporting groups
Overall Number of Baseline Participants 7904 7924 15828
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 7904 participants 7924 participants 15828 participants
64.3  (9.39) 64.5  (9.31) 64.4  (9.35)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7904 participants 7924 participants 15828 participants
Female
1506
  19.1%
1461
  18.4%
2967
  18.7%
Male
6398
  80.9%
6463
  81.6%
12861
  81.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7904 participants 7924 participants 15828 participants
American Indian or Alaska Native
108
   1.4%
106
   1.3%
214
   1.4%
Asian
1366
  17.3%
1351
  17.0%
2717
  17.2%
Native Hawaiian or Other Pacific Islander
11
   0.1%
4
   0.1%
15
   0.1%
Black or African American
191
   2.4%
175
   2.2%
366
   2.3%
White
6177
  78.2%
6233
  78.7%
12410
  78.4%
More than one race
51
   0.6%
55
   0.7%
106
   0.7%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Number of Participants With First Occurrence of Any Component of the Composite of Major Adverse Cardiovascular Events (Cardiovascular [CV] Death, Non-fatal Myocardial Infarction [MI] or Non-fatal Stroke) During the Time Period for Follow-up of CV Events
Hide Description CV death=death due to a CV cause, which included but was not limited to deaths resulting from stroke, arrhythmia, sudden death (witnessed/unwitnessed), MI, heart failure, pulmonary embolism, peripheral arterial disease, or complications of a CV procedure. Deaths not clearly attributable to non-CV causes are considered to be CV deaths. Acute MI=evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia. Prior MI diagnosed post-randomization (e.g., silent MI)=the development of new pathological Q waves with/without symptoms OR imaging evidence of a region of loss of viable myocardium that is thinned and fails to contract, in the absence of a non-ischemic cause (pre-event imaging data required for verification of new abnormality), OR pathological findings of a healed/healing MI. Stroke=presence of a new focal neurologic deficit thought to be of vascular origin, with signs/symptoms lasting >24 hours or results in death (in <24 hours).
Time Frame From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 4.25 years/average of 3.51 years)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All-randomized Intent-to-treat (ITT) population comprised of all randomized participants.
Arm/Group Title Placebo Darapladib
Hide Arm/Group Description:
Participants were randomized to receive matching placebo once daily.
Participants were randomized to receive darapladib 160 milligram (mg) enteric-coated tablets once daily.
Overall Number of Participants Analyzed 7904 7924
Measure Type: Count of Participants
Unit of Measure: Participants
819
  10.4%
769
   9.7%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Darapladib
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.199
Comments Hazard ratio and p-value are estimated using a Cox proportional hazard regression model with treatment as the only covariate. A hazard ratio < 1 indicates a lower risk with this treatment compared to Placebo.
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.94
Confidence Interval (2-Sided) 95.1%
0.85 to 1.03
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Number of Participants With First Occurrence of Any Event in the Composite of Major Coronary Events (Coronary Heart Disease [CHD] Death, Non-fatal MI, or Urgent Coronary Revascularization [CR] for MI) During the Time Period for Follow-up (FU) of CV Events
Hide Description CHD death=occurrence of a fatal MI, death caused by documented cardiac arrest, death resulting from heart failure in a participant with known CHD, death from other forms of acute/chronic CHD, unwitnessed death of unknown origin, or sudden death. Acute MI=evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia. Prior MI diagnosed post-randomization (e.g.,silent MI)=the development of new pathological Q waves with/without symptoms OR imaging evidence of a region of loss of viable myocardium that is thinned and fails to contract, in the absence of a non-ischemic cause (pre-event imaging data required for verification of new abnormality), OR pathological findings of a healed/healing MI. Urgent CR for MI=ischemic discomfort at rest that prompted CR (percutaneous coronary intervention [PCI: any attempt at CR even if not successful] or coronary artery bypass graft) during the same hospitalization or resulted in hospital transfer for the purpose of CR.
Time Frame From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 4.25 years/average of 3.51 years)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All Randomized (ITT) Population
Arm/Group Title Placebo Darapladib
Hide Arm/Group Description:
Participants were randomized to receive matching placebo once daily.
Participants were randomized to receive darapladib 160 milligram (mg) enteric-coated tablets once daily.
Overall Number of Participants Analyzed 7904 7924
Measure Type: Count of Participants
Unit of Measure: Participants
814
  10.3%
737
   9.3%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Darapladib
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.045
Comments Hazard ratio and p-value are estimated using a Cox proportional hazard regression model with treatment as the only covariate. A hazard ratio < 1 indicates a lower risk with this treatment compared to Placebo.
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.90
Confidence Interval (2-Sided) 95%
0.82 to 1.00
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Number of Participants With First Occurrence of Any Event in the Composite of Total Coronary Events (CHD Death, Non-fatal MI, Hospitalization for Unstable Angina, or Any Coronary Revascularization Procedure) During Time Period for FU of CV Events
Hide Description CHD death, acute MI, and prior MI are defined in the previous secondary endpoint (major coronary events). Hospitalization for unstable angina=one of the following, but not fulfilling the criteria for MI: ischemic discomfort at rest associated with electrocardiogram (ECG) changes leading to hospitalization; ischemic discomfort at rest regardless of ECG changes leading to hospitalization and revascularization during the same admission; ischemic discomfort at rest in hospital associated with ECG changes; ischemic discomfort at rest in hospital without ECG changes resulting in revascularization during the same admission. NOTE: The event was not considered to be unstable angina if, after invasive/non-invasive testing or other diagnostic testing, the discomfort is found not to be caused by myocardial ischemia.
Time Frame From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 4.25 years/average of 3.51 years)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All Randomized (ITT) Population
Arm/Group Title Placebo Darapladib
Hide Arm/Group Description:
Participants were randomized to receive matching placebo once daily.
Participants were randomized to receive darapladib 160 milligram (mg) enteric-coated tablets once daily.
Overall Number of Participants Analyzed 7904 7924
Measure Type: Count of Participants
Unit of Measure: Participants
1269
  16.1%
1159
  14.6%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Darapladib
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.019
Comments Hazard ratio and p-value are estimated using a Cox proportional hazard regression model with treatment as the only covariate. A hazard ratio < 1 indicates a lower risk with this treatment compared to Placebo.
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.91
Confidence Interval (2-Sided) 95%
0.84 to 0.98
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Number of Participants With CV Death During the Time Period for Follow-up of CV Events
Hide Description CV death is defined as a death due to a CV cause, which included but was not limited to deaths resulting from stroke, arrhythmia, sudden death (witnessed/unwitnessed), MI, heart failure, pulmonary embolism, peripheral arterial disease, or complications of a CV procedure. Deaths not clearly attributable to non-CV causes are considered to be CV deaths.
Time Frame From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 4.25 years/average of 3.51 years)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All Randomized (ITT) Population
Arm/Group Title Placebo Darapladib
Hide Arm/Group Description:
Participants were randomized to receive matching placebo once daily.
Participants were randomized to receive darapladib 160 milligram (mg) enteric-coated tablets once daily.
Overall Number of Participants Analyzed 7904 7924
Measure Type: Count of Participants
Unit of Measure: Participants
373
   4.7%
359
   4.5%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Darapladib
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.594
Comments Hazard ratio and p-value are estimated using a Cox proportional hazard regression model with treatment as the only covariate. A hazard ratio < 1 indicates a lower risk with this treatment compared to Placebo.
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.96
Confidence Interval (2-Sided) 95%
0.83 to 1.11
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Number of Participants With First Occurrence of MI (Fatal/Non-fatal) During the Time Period for Follow-up of CV Events
Hide Description Acute MI is defined as evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia. Prior MI diagnosed post-randomization (e.g., silent MI)=the development of new pathological Q waves with/without symptoms OR imaging evidence of a region of loss of viable myocardium that is thinned and fails to contract, in the absence of a non-ischemic cause (pre-event imaging data required for verification of new abnormality), OR pathological findings of a healed/healing MI.
Time Frame From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 4.25 years/average of 3.51 years)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All Randomized (ITT) Population
Arm/Group Title Placebo Darapladib
Hide Arm/Group Description:
Participants were randomized to receive matching placebo once daily.
Participants were randomized to receive darapladib 160 milligram (mg) enteric-coated tablets once daily.
Overall Number of Participants Analyzed 7904 7924
Measure Type: Count of Participants
Unit of Measure: Participants
405
   5.1%
361
   4.6%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Darapladib
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.108
Comments Hazard ratio and p-value are estimated using a Cox proportional hazard regression model with treatment as the only covariate. A hazard ratio < 1 indicates a lower risk with this treatment compared to Placebo.
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.89
Confidence Interval (2-Sided) 95%
0.77 to 1.03
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Number of Participants With First Occurrence of Stroke (Fatal/Non-fatal) During the Time Period for Follow-up of CV Events
Hide Description Stroke is defined as the presence of a new focal neurologic deficit thought to be of vascular origin, with signs/symptoms lasting >24 hours or results in death (in <24 hours).
Time Frame From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 4.25 years/average of 3.51 years)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All Randomized (ITT) Population
Arm/Group Title Placebo Darapladib
Hide Arm/Group Description:
Participants were randomized to receive matching placebo once daily.
Participants were randomized to receive darapladib 160 milligram (mg) enteric-coated tablets once daily.
Overall Number of Participants Analyzed 7904 7924
Measure Type: Count of Participants
Unit of Measure: Participants
152
   1.9%
154
   1.9%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Darapladib
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.920
Comments Hazard ratio and p-value are estimated using a Cox proportional hazard regression model with treatment as the only covariate. A hazard ratio < 1 indicates a lower risk with this treatment compared to Placebo.
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.01
Confidence Interval (2-Sided) 95%
0.81 to 1.27
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Number of Participants With First Occurrence of Any Component of the Composite of All-cause Mortality, Non-fatal MI, or Non-fatal Stroke During the Time Period for Follow-up of CV Events
Hide Description Acute MI is defined as evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia. Prior MI diagnosed post-randomization (e.g., silent MI)=the development of new pathological Q waves with/without symptoms OR imaging evidence of a region of loss of viable myocardium that is thinned and fails to contract, in the absence of a non-ischemic cause (pre-event imaging data required for verification of new abnormality), OR pathological findings of a healed/healing MI. Stroke=presence of a new focal neurologic deficit thought to be of vascular origin, with signs/symptoms lasting >24 hours or results in death (in <24 hours).
Time Frame From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 4.25 years/average of 3.51 years)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All Randomized (ITT) Population
Arm/Group Title Placebo Darapladib
Hide Arm/Group Description:
Participants were randomized to receive matching placebo once daily.
Participants were randomized to receive darapladib 160 milligram (mg) enteric-coated tablets once daily.
Overall Number of Participants Analyzed 7904 7924
Measure Type: Count of Participants
Unit of Measure: Participants
962
  12.2%
926
  11.7%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Darapladib
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.397
Comments Hazard ratio and p-value are estimated using a Cox proportional hazard regression model with treatment as the only covariate. A hazard ratio < 1 indicates a lower risk with this treatment compared to Placebo.
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.96
Confidence Interval (2-Sided) 95%
0.88 to 1.05
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Number of Participants With All-cause Mortality During the Time Period for Vital Status
Hide Description The number of participants with all-cause mortality was assessed.
Time Frame From randomization until death or study completion (up to 4.49 years/average of 3.65 years)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All Randomized (ITT) Population
Arm/Group Title Placebo Darapladib
Hide Arm/Group Description:
Participants were randomized to receive matching placebo once daily.
Participants were randomized to receive darapladib 160 milligram (mg) enteric-coated tablets once daily.
Overall Number of Participants Analyzed 7904 7924
Measure Type: Count of Participants
Unit of Measure: Participants
577
   7.3%
582
   7.3%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Darapladib
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.870
Comments Hazard ratio and p-value are estimated using a Cox proportional hazard regression model with treatment as the only covariate. A hazard ratio < 1 indicates a lower risk with this treatment compared to Placebo.
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.01
Confidence Interval (2-Sided) 95%
0.90 to 1.13
Estimation Comments [Not Specified]
Time Frame Start=Randomization; Stop=Longer of 35 days after last dose of IP or follow-up (FU) visit. “SAEs assessed as related to IP, study participation, or a GSK concomitant medication” and cancer/GI polyps/neoplasms were recorded up to/including any FU contact.
Adverse Event Reporting Description SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product. Post-randomization AEs have an onset date that is on or after the randomization date.
 
Arm/Group Title Placebo Darapladib
Hide Arm/Group Description Participants were randomized to receive matching placebo once daily. Participants were randomized to receive darapladib 160 milligram (mg) enteric-coated tablets once daily.
All-Cause Mortality
Placebo Darapladib
Affected / at Risk (%) Affected / at Risk (%)
Total   577/7904 (7.30%)   582/7924 (7.34%) 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Darapladib
Affected / at Risk (%) Affected / at Risk (%)
Total   3448/7890 (43.70%)   3369/7912 (42.58%) 
Blood and lymphatic system disorders     
Anaemia  1  52/7890 (0.66%)  42/7912 (0.53%) 
Iron deficiency anaemia  1  8/7890 (0.10%)  6/7912 (0.08%) 
Thrombocytopenia  1  7/7890 (0.09%)  5/7912 (0.06%) 
Disseminated intravascular coagulation  1  3/7890 (0.04%)  3/7912 (0.04%) 
Haemorrhagic anaemia  1  1/7890 (0.01%)  5/7912 (0.06%) 
Coagulopathy  1  3/7890 (0.04%)  0/7912 (0.00%) 
Febrile neutropenia  1  2/7890 (0.03%)  1/7912 (0.01%) 
Hypochromic anaemia  1  3/7890 (0.04%)  0/7912 (0.00%) 
Lymphadenopathy  1  1/7890 (0.01%)  1/7912 (0.01%) 
Microcytic anaemia  1  2/7890 (0.03%)  0/7912 (0.00%) 
Anaemia macrocytic  1  0/7890 (0.00%)  1/7912 (0.01%) 
Anaemia megaloblastic  1  0/7890 (0.00%)  1/7912 (0.01%) 
Anaemia of chronic disease  1  1/7890 (0.01%)  0/7912 (0.00%) 
Bone marrow failure  1  0/7890 (0.00%)  1/7912 (0.01%) 
Bone marrow ischaemia  1  1/7890 (0.01%)  0/7912 (0.00%) 
Haemolytic anaemia  1  0/7890 (0.00%)  1/7912 (0.01%) 
Hyperprothrombinaemia  1  1/7890 (0.01%)  0/7912 (0.00%) 
Idiopathic thrombocytopenic purpura  1  0/7890 (0.00%)  1/7912 (0.01%) 
Jaundice acholuric  1  1/7890 (0.01%)  0/7912 (0.00%) 
Pancytopenia  1  0/7890 (0.00%)  1/7912 (0.01%) 
Polycythaemia  1  1/7890 (0.01%)  0/7912 (0.00%) 
Spontaneous haematoma  1  1/7890 (0.01%)  0/7912 (0.00%) 
Cardiac disorders     
Angina unstable  1  489/7890 (6.20%)  472/7912 (5.97%) 
Acute myocardial infarction  1  359/7890 (4.55%)  303/7912 (3.83%) 
Angina pectoris  1  271/7890 (3.43%)  248/7912 (3.13%) 
Coronary artery disease  1  177/7890 (2.24%)  168/7912 (2.12%) 
Cardiac failure  1  178/7890 (2.26%)  155/7912 (1.96%) 
Cardiac failure congestive  1  135/7890 (1.71%)  125/7912 (1.58%) 
Atrial fibrillation  1  135/7890 (1.71%)  123/7912 (1.55%) 
Coronary artery stenosis  1  59/7890 (0.75%)  56/7912 (0.71%) 
Myocardial infarction  1  54/7890 (0.68%)  56/7912 (0.71%) 
Myocardial ischaemia  1  41/7890 (0.52%)  47/7912 (0.59%) 
Ventricular tachycardia  1  42/7890 (0.53%)  37/7912 (0.47%) 
Atrial flutter  1  27/7890 (0.34%)  27/7912 (0.34%) 
Cardiac arrest  1  26/7890 (0.33%)  28/7912 (0.35%) 
Bradycardia  1  19/7890 (0.24%)  24/7912 (0.30%) 
Ventricular fibrillation  1  19/7890 (0.24%)  22/7912 (0.28%) 
Sick sinus syndrome  1  24/7890 (0.30%)  15/7912 (0.19%) 
Cardiac failure chronic  1  19/7890 (0.24%)  17/7912 (0.21%) 
Coronary artery occlusion  1  17/7890 (0.22%)  19/7912 (0.24%) 
Acute coronary syndrome  1  17/7890 (0.22%)  17/7912 (0.21%) 
Cardio-respiratory arrest  1  15/7890 (0.19%)  15/7912 (0.19%) 
Cardiogenic shock  1  11/7890 (0.14%)  16/7912 (0.20%) 
Cardiac failure acute  1  16/7890 (0.20%)  10/7912 (0.13%) 
Ischaemic cardiomyopathy  1  14/7890 (0.18%)  11/7912 (0.14%) 
Supraventricular tachycardia  1  8/7890 (0.10%)  14/7912 (0.18%) 
Left ventricular dysfunction  1  8/7890 (0.10%)  13/7912 (0.16%) 
Arteriosclerosis coronary artery  1  15/7890 (0.19%)  5/7912 (0.06%) 
Mitral valve incompetence  1  9/7890 (0.11%)  10/7912 (0.13%) 
Left ventricular failure  1  6/7890 (0.08%)  12/7912 (0.15%) 
Aortic valve stenosis  1  10/7890 (0.13%)  7/7912 (0.09%) 
Atrioventricular block complete  1  12/7890 (0.15%)  5/7912 (0.06%) 
Ventricular extrasystoles  1  9/7890 (0.11%)  8/7912 (0.10%) 
Arrhythmia  1  8/7890 (0.10%)  7/7912 (0.09%) 
Atrioventricular block second degree  1  7/7890 (0.09%)  8/7912 (0.10%) 
Atrioventricular block  1  9/7890 (0.11%)  5/7912 (0.06%) 
Palpitations  1  9/7890 (0.11%)  5/7912 (0.06%) 
Cardiac discomfort  1  6/7890 (0.08%)  5/7912 (0.06%) 
Pericardial effusion  1  6/7890 (0.08%)  5/7912 (0.06%) 
Cardiovascular disorder  1  6/7890 (0.08%)  4/7912 (0.05%) 
Cardiopulmonary failure  1  2/7890 (0.03%)  6/7912 (0.08%) 
Cardiomyopathy  1  4/7890 (0.05%)  3/7912 (0.04%) 
Tachycardia  1  4/7890 (0.05%)  3/7912 (0.04%) 
Atrial tachycardia  1  1/7890 (0.01%)  5/7912 (0.06%) 
Arrhythmia supraventricular  1  4/7890 (0.05%)  1/7912 (0.01%) 
Cardiac disorder  1  3/7890 (0.04%)  2/7912 (0.03%) 
Cardiovascular insufficiency  1  4/7890 (0.05%)  1/7912 (0.01%) 
Congestive cardiomyopathy  1  4/7890 (0.05%)  1/7912 (0.01%) 
Sinus bradycardia  1  1/7890 (0.01%)  4/7912 (0.05%) 
Ventricular arrhythmia  1  1/7890 (0.01%)  4/7912 (0.05%) 
Bundle branch block left  1  2/7890 (0.03%)  2/7912 (0.03%) 
Cardiac asthma  1  1/7890 (0.01%)  3/7912 (0.04%) 
Right ventricular failure  1  3/7890 (0.04%)  1/7912 (0.01%) 
Acute left ventricular failure  1  3/7890 (0.04%)  0/7912 (0.00%) 
Aortic valve incompetence  1  1/7890 (0.01%)  2/7912 (0.03%) 
Arteriospasm coronary  1  2/7890 (0.03%)  1/7912 (0.01%) 
Cardiac aneurysm  1  1/7890 (0.01%)  2/7912 (0.03%) 
Cardiac tamponade  1  2/7890 (0.03%)  1/7912 (0.01%) 
Coronary artery insufficiency  1  1/7890 (0.01%)  2/7912 (0.03%) 
Myocardial fibrosis  1  2/7890 (0.03%)  1/7912 (0.01%) 
Bradyarrhythmia  1  2/7890 (0.03%)  0/7912 (0.00%) 
Diastolic dysfunction  1  1/7890 (0.01%)  1/7912 (0.01%) 
Nodal arrhythmia  1  1/7890 (0.01%)  1/7912 (0.01%) 
Pericarditis  1  1/7890 (0.01%)  1/7912 (0.01%) 
Postinfarction angina  1  2/7890 (0.03%)  0/7912 (0.00%) 
Prinzmetal angina  1  1/7890 (0.01%)  1/7912 (0.01%) 
Pulseless electrical activity  1  2/7890 (0.03%)  0/7912 (0.00%) 
Silent myocardial infarction  1  0/7890 (0.00%)  2/7912 (0.03%) 
Sinus arrest  1  1/7890 (0.01%)  1/7912 (0.01%) 
Sinus arrhythmia  1  0/7890 (0.00%)  2/7912 (0.03%) 
Stress cardiomyopathy  1  1/7890 (0.01%)  1/7912 (0.01%) 
Supraventricular extrasystoles  1  2/7890 (0.03%)  0/7912 (0.00%) 
Tricuspid valve disease  1  0/7890 (0.00%)  2/7912 (0.03%) 
Aortic valve disease  1  1/7890 (0.01%)  0/7912 (0.00%) 
Aortic valve disease mixed  1  1/7890 (0.01%)  0/7912 (0.00%) 
Atrial thrombosis  1  1/7890 (0.01%)  0/7912 (0.00%) 
Atrioventricular block first degree  1  0/7890 (0.00%)  1/7912 (0.01%) 
Atrioventricular dissociation  1  0/7890 (0.00%)  1/7912 (0.01%) 
Bifascicular block  1  1/7890 (0.01%)  0/7912 (0.00%) 
Bundle branch block right  1  1/7890 (0.01%)  0/7912 (0.00%) 
Cardiac valve disease  1  1/7890 (0.01%)  0/7912 (0.00%) 
Cardiovascular deconditioning  1  1/7890 (0.01%)  0/7912 (0.00%) 
Chronic left ventricular failure  1  1/7890 (0.01%)  0/7912 (0.00%) 
Chronotropic incompetence  1  1/7890 (0.01%)  0/7912 (0.00%) 
Conduction disorder  1  1/7890 (0.01%)  0/7912 (0.00%) 
Cor pulmonale chronic  1  1/7890 (0.01%)  0/7912 (0.00%) 
Extrasystoles  1  1/7890 (0.01%)  0/7912 (0.00%) 
Hypertensive cardiomyopathy  1  1/7890 (0.01%)  0/7912 (0.00%) 
Hypertensive heart disease  1  1/7890 (0.01%)  0/7912 (0.00%) 
Intracardiac thrombus  1  0/7890 (0.00%)  1/7912 (0.01%) 
Left ventricular hypertrophy  1  0/7890 (0.00%)  1/7912 (0.01%) 
Mitral valve disease  1  1/7890 (0.01%)  0/7912 (0.00%) 
Mitral valve stenosis  1  1/7890 (0.01%)  0/7912 (0.00%) 
Myocarditis  1  1/7890 (0.01%)  0/7912 (0.00%) 
Pericardial haemorrhage  1  0/7890 (0.00%)  1/7912 (0.01%) 
Pericarditis constrictive  1  0/7890 (0.00%)  1/7912 (0.01%) 
Sinoatrial block  1  1/7890 (0.01%)  0/7912 (0.00%) 
Sinus tachycardia  1  0/7890 (0.00%)  1/7912 (0.01%) 
Supraventricular tachyarrhythmia  1  1/7890 (0.01%)  0/7912 (0.00%) 
Systolic dysfunction  1  1/7890 (0.01%)  0/7912 (0.00%) 
Torsade de pointes  1  1/7890 (0.01%)  0/7912 (0.00%) 
Trifascicular block  1  0/7890 (0.00%)  1/7912 (0.01%) 
Ventricular dyssynchrony  1  1/7890 (0.01%)  0/7912 (0.00%) 
Ventricular tachyarrhythmia  1  1/7890 (0.01%)  0/7912 (0.00%) 
Congenital, familial and genetic disorders     
Hydrocele  1  5/7890 (0.06%)  6/7912 (0.08%) 
Atrial septal defect  1  0/7890 (0.00%)  2/7912 (0.03%) 
Hypertrophic cardiomyopathy  1  0/7890 (0.00%)  2/7912 (0.03%) 
Arteriovenous malformation  1  0/7890 (0.00%)  1/7912 (0.01%) 
Congenital coronary artery malformation  1  0/7890 (0.00%)  1/7912 (0.01%) 
Spinal vessel congenital anomaly  1  0/7890 (0.00%)  1/7912 (0.01%) 
Syringomyelia  1  1/7890 (0.01%)  0/7912 (0.00%) 
Ear and labyrinth disorders     
Vertigo  1  6/7890 (0.08%)  14/7912 (0.18%) 
Vestibular disorder  1  4/7890 (0.05%)  2/7912 (0.03%) 
Vertigo positional  1  3/7890 (0.04%)  1/7912 (0.01%) 
Vertigo labyrinthine  1  1/7890 (0.01%)  2/7912 (0.03%) 
Deafness  1  0/7890 (0.00%)  2/7912 (0.03%) 
Sudden hearing loss  1  1/7890 (0.01%)  1/7912 (0.01%) 
Otosclerosis  1  1/7890 (0.01%)  0/7912 (0.00%) 
Ototoxicity  1  0/7890 (0.00%)  1/7912 (0.01%) 
Tinnitus  1  0/7890 (0.00%)  1/7912 (0.01%) 
Endocrine disorders     
Hyperthyroidism  1  4/7890 (0.05%)  4/7912 (0.05%) 
Goitre  1  2/7890 (0.03%)  3/7912 (0.04%) 
Adrenal disorder  1  0/7890 (0.00%)  1/7912 (0.01%) 
Adrenal insufficiency  1  0/7890 (0.00%)  1/7912 (0.01%) 
Hyperparathyroidism  1  0/7890 (0.00%)  1/7912 (0.01%) 
Hyperparathyroidism primary  1  0/7890 (0.00%)  1/7912 (0.01%) 
Hypothyroidism  1  1/7890 (0.01%)  0/7912 (0.00%) 
Thyroid cyst  1  1/7890 (0.01%)  0/7912 (0.00%) 
Thyroid disorder  1  0/7890 (0.00%)  1/7912 (0.01%) 
Toxic nodular goitre  1  1/7890 (0.01%)  0/7912 (0.00%) 
Eye disorders     
Cataract  1  16/7890 (0.20%)  16/7912 (0.20%) 
Retinal detachment  1  3/7890 (0.04%)  3/7912 (0.04%) 
Amaurosis fugax  1  3/7890 (0.04%)  1/7912 (0.01%) 
Vitreous haemorrhage  1  2/7890 (0.03%)  2/7912 (0.03%) 
Diabetic retinopathy  1  0/7890 (0.00%)  3/7912 (0.04%) 
Diplopia  1  1/7890 (0.01%)  2/7912 (0.03%) 
Glaucoma  1  1/7890 (0.01%)  2/7912 (0.03%) 
Blindness  1  1/7890 (0.01%)  1/7912 (0.01%) 
Ocular vascular disorder  1  1/7890 (0.01%)  1/7912 (0.01%) 
Retinal artery occlusion  1  0/7890 (0.00%)  2/7912 (0.03%) 
Retinal ischaemia  1  0/7890 (0.00%)  2/7912 (0.03%) 
Retinal tear  1  2/7890 (0.03%)  0/7912 (0.00%) 
Retinal vein occlusion  1  1/7890 (0.01%)  1/7912 (0.01%) 
Vision blurred  1  1/7890 (0.01%)  1/7912 (0.01%) 
Blindness unilateral  1  0/7890 (0.00%)  1/7912 (0.01%) 
Conjunctivitis  1  0/7890 (0.00%)  1/7912 (0.01%) 
Dacryostenosis acquired  1  0/7890 (0.00%)  1/7912 (0.01%) 
Diabetic eye disease  1  1/7890 (0.01%)  0/7912 (0.00%) 
Eye disorder  1  1/7890 (0.01%)  0/7912 (0.00%) 
Eye haemorrhage  1  1/7890 (0.01%)  0/7912 (0.00%) 
Eye pain  1  1/7890 (0.01%)  0/7912 (0.00%) 
Eyelid ptosis  1  0/7890 (0.00%)  1/7912 (0.01%) 
Ocular retrobulbar haemorrhag  1  1/7890 (0.01%)  0/7912 (0.00%) 
Ophthalmoplegia  1  1/7890 (0.01%)  0/7912 (0.00%) 
Optic ischaemic neuropathy  1  1/7890 (0.01%)  0/7912 (0.00%) 
Pterygium  1  1/7890 (0.01%)  0/7912 (0.00%) 
Retinal artery thrombosis  1  1/7890 (0.01%)  0/7912 (0.00%) 
Retinal degeneration  1  0/7890 (0.00%)  1/7912 (0.01%) 
Retinal haemorrhage  1  0/7890 (0.00%)  1/7912 (0.01%) 
Retinal vascular thrombosis  1  1/7890 (0.01%)  0/7912 (0.00%) 
Retinopathy  1  1/7890 (0.01%)  0/7912 (0.00%) 
Ulcerative keratitis  1  0/7890 (0.00%)  1/7912 (0.01%) 
Visual acuity reduced  1  1/7890 (0.01%)  0/7912 (0.00%) 
Gastrointestinal disorders     
Inguinal hernia  1  48/7890 (0.61%)  31/7912 (0.39%) 
Gastrointestinal haemorrhage  1  26/7890 (0.33%)  30/7912 (0.38%) 
Diarrhoea  1  21/7890 (0.27%)  23/7912 (0.29%) 
Abdominal pain  1  25/7890 (0.32%)  12/7912 (0.15%) 
Large intestine polyp  1  16/7890 (0.20%)  21/7912 (0.27%) 
Upper gastrointestinal haemorrhage  1  16/7890 (0.20%)  18/7912 (0.23%) 
Gastrooesophageal reflux disease  1  18/7890 (0.23%)  14/7912 (0.18%) 
Gastritis  1  18/7890 (0.23%)  12/7912 (0.15%) 
Pancreatitis  1  15/7890 (0.19%)  15/7912 (0.19%) 
Gastric ulcer  1  7/7890 (0.09%)  17/7912 (0.21%) 
Nausea  1  12/7890 (0.15%)  11/7912 (0.14%) 
Rectal haemorrhage  1  9/7890 (0.11%)  13/7912 (0.16%) 
Small intestinal obstruction  1  9/7890 (0.11%)  11/7912 (0.14%) 
Colitis  1  12/7890 (0.15%)  7/7912 (0.09%) 
Pancreatitis acute  1  12/7890 (0.15%)  7/7912 (0.09%) 
Vomiting  1  12/7890 (0.15%)  7/7912 (0.09%) 
Abdominal pain upper  1  7/7890 (0.09%)  11/7912 (0.14%) 
Constipation  1  5/7890 (0.06%)  11/7912 (0.14%) 
Intestinal obstruction  1  7/7890 (0.09%)  9/7912 (0.11%) 
Lower gastrointestinal haemorrhage  1  10/7890 (0.13%)  4/7912 (0.05%) 
Ileus  1  7/7890 (0.09%)  6/7912 (0.08%) 
Umbilical hernia  1  7/7890 (0.09%)  6/7912 (0.08%) 
Diverticulum intestinal  1  5/7890 (0.06%)  7/7912 (0.09%) 
Duodenal ulcer haemorrhage  1  7/7890 (0.09%)  5/7912 (0.06%) 
Abdominal hernia  1  5/7890 (0.06%)  6/7912 (0.08%) 
Colitis ischaemic  1  5/7890 (0.06%)  6/7912 (0.08%) 
Duodenal ulcer  1  6/7890 (0.08%)  5/7912 (0.06%) 
Gastric ulcer haemorrhage  1  6/7890 (0.08%)  5/7912 (0.06%) 
Haemorrhoids  1  8/7890 (0.10%)  2/7912 (0.03%) 
Gastric haemorrhage  1  3/7890 (0.04%)  6/7912 (0.08%) 
Gastritis erosive  1  7/7890 (0.09%)  2/7912 (0.03%) 
Intestinal ischaemia  1  5/7890 (0.06%)  4/7912 (0.05%) 
Ascites  1  5/7890 (0.06%)  3/7912 (0.04%) 
Dyspepsia  1  4/7890 (0.05%)  4/7912 (0.05%) 
Dysphagia  1  4/7890 (0.05%)  4/7912 (0.05%) 
Melaena  1  3/7890 (0.04%)  5/7912 (0.06%) 
Diverticulum  1  3/7890 (0.04%)  3/7912 (0.04%) 
Oesophagitis  1  1/7890 (0.01%)  5/7912 (0.06%) 
Pancreatitis chronic  1  4/7890 (0.05%)  2/7912 (0.03%) 
Diverticulum intestinal haemorrhagic  1  4/7890 (0.05%)  1/7912 (0.01%) 
Duodenitis  1  1/7890 (0.01%)  4/7912 (0.05%) 
Gastritis haemorrhagic  1  3/7890 (0.04%)  2/7912 (0.03%) 
Anal fistula  1  3/7890 (0.04%)  1/7912 (0.01%) 
Enterovesical fistula  1  2/7890 (0.03%)  2/7912 (0.03%) 
Haematemesis  1  2/7890 (0.03%)  2/7912 (0.03%) 
Mallory-Weiss syndrome  1  4/7890 (0.05%)  0/7912 (0.00%) 
Oesophageal ulcer  1  1/7890 (0.01%)  3/7912 (0.04%) 
Peptic ulcer  1  1/7890 (0.01%)  3/7912 (0.04%) 
Colitis ulcerative  1  1/7890 (0.01%)  2/7912 (0.03%) 
Diverticulitis intestinal haemorrhagic  1  1/7890 (0.01%)  2/7912 (0.03%) 
Gastric polyps  1  2/7890 (0.03%)  1/7912 (0.01%) 
Haematochezia  1  1/7890 (0.01%)  2/7912 (0.03%) 
Hiatus hernia  1  1/7890 (0.01%)  2/7912 (0.03%) 
Inguinal hernia, obstructive  1  2/7890 (0.03%)  1/7912 (0.01%) 
Intestinal haemorrhage  1  1/7890 (0.01%)  2/7912 (0.03%) 
Intestinal perforation  1  1/7890 (0.01%)  2/7912 (0.03%) 
Large intestine perforation  1  2/7890 (0.03%)  1/7912 (0.01%) 
Peptic ulcer haemorrhage  1  2/7890 (0.03%)  1/7912 (0.01%) 
Umbilical hernia, obstructive  1  2/7890 (0.03%)  1/7912 (0.01%) 
Abdominal distension  1  0/7890 (0.00%)  2/7912 (0.03%) 
Abdominal strangulated hernia  1  2/7890 (0.03%)  0/7912 (0.00%) 
Abdominal wall haematoma  1  0/7890 (0.00%)  2/7912 (0.03%) 
Crohn's disease  1  1/7890 (0.01%)  1/7912 (0.01%) 
Diaphragmatic hernia  1  0/7890 (0.00%)  2/7912 (0.03%) 
Diverticular perforation  1  0/7890 (0.00%)  2/7912 (0.03%) 
Duodenal ulcer perforation  1  2/7890 (0.03%)  0/7912 (0.00%) 
Enteritis  1  1/7890 (0.01%)  1/7912 (0.01%) 
Enterocolitis  1  1/7890 (0.01%)  1/7912 (0.01%) 
Erosive duodenitis  1  1/7890 (0.01%)  1/7912 (0.01%) 
Faecal incontinence  1  1/7890 (0.01%)  1/7912 (0.01%) 
Gastritis atrophic  1  1/7890 (0.01%)  1/7912 (0.01%) 
Gastrointestinal necrosis  1  1/7890 (0.01%)  1/7912 (0.01%) 
Gastrointestinal angidysplasia  1  2/7890 (0.03%)  0/7912 (0.00%) 
Haemorrhoidal haemorrhage  1  0/7890 (0.00%)  2/7912 (0.03%) 
Ileus paralytic  1  0/7890 (0.00%)  2/7912 (0.03%) 
Large intestinal ulcer  1  0/7890 (0.00%)  2/7912 (0.03%) 
Oesophageal varices haemorrhage  1  1/7890 (0.01%)  1/7912 (0.01%) 
Proctitis  1  1/7890 (0.01%)  1/7912 (0.01%) 
Rectal polyp  1  1/7890 (0.01%)  1/7912 (0.01%) 
Rectal prolapse  1  2/7890 (0.03%)  0/7912 (0.00%) 
Stomach mass  1  1/7890 (0.01%)  1/7912 (0.01%) 
Volvulus  1  0/7890 (0.00%)  2/7912 (0.03%) 
Abdominal adhesions  1  1/7890 (0.01%)  0/7912 (0.00%) 
Abdominal hernia obstructive  1  1/7890 (0.01%)  0/7912 (0.00%) 
Abdominal wall mass  1  1/7890 (0.01%)  0/7912 (0.00%) 
Acute abdomen  1  1/7890 (0.01%)  0/7912 (0.00%) 
Alcoholic pancreatitis  1  0/7890 (0.00%)  1/7912 (0.01%) 
Anal fissure  1  0/7890 (0.00%)  1/7912 (0.01%) 
Anorectal disorder  1  0/7890 (0.00%)  1/7912 (0.01%) 
Appendix disorder  1  0/7890 (0.00%)  1/7912 (0.01%) 
Buccal polyp  1  0/7890 (0.00%)  1/7912 (0.01%) 
Colonic stenosis  1  1/7890 (0.01%)  0/7912 (0.00%) 
Dental caries  1  1/7890 (0.01%)  0/7912 (0.00%) 
Diabetic gastroparesis  1  0/7890 (0.00%)  1/7912 (0.01%) 
Diarrhoea haemorrhagic  1  1/7890 (0.01%)  0/7912 (0.00%) 
Dieulafoy's vascular malformation  1  0/7890 (0.00%)  1/7912 (0.01%) 
Duodenal polyp  1  1/7890 (0.01%)  0/7912 (0.00%) 
Duodenal vascular ectasia  1  1/7890 (0.01%)  0/7912 (0.00%) 
Epigastric discomfort  1  0/7890 (0.00%)  1/7912 (0.01%) 
Erosive oesophagitis  1  0/7890 (0.00%)  1/7912 (0.01%) 
Faeces discoloured  1  0/7890 (0.00%)  1/7912 (0.01%) 
Femoral hernia, obstructive  1  1/7890 (0.01%)  0/7912 (0.00%) 
Frequent bowel movements  1  1/7890 (0.01%)  0/7912 (0.00%) 
Gallstone ileus  1  0/7890 (0.00%)  1/7912 (0.01%) 
Gastric dysplasia  1  0/7890 (0.00%)  1/7912 (0.01%) 
Gastroduodenal ulcer  1  1/7890 (0.01%)  0/7912 (0.00%) 
Gastroduodenitis  1  1/7890 (0.01%)  0/7912 (0.00%) 
Gastrointestinal erosion  1  1/7890 (0.01%)  0/7912 (0.00%) 
Gastrointestinal ischaemia  1  1/7890 (0.01%)  0/7912 (0.00%) 
Gastrointestinal motility disorder  1  1/7890 (0.01%)  0/7912 (0.00%) 
Gastrointestinal pain  1  1/7890 (0.01%)  0/7912 (0.00%) 
Gastrointestinal ulcer haemorrhage  1  1/7890 (0.01%)  0/7912 (0.00%) 
Gastrointestinal angiodysplasia haemorrhagic  1  1/7890 (0.01%)  0/7912 (0.00%) 
Gastrooesophagitis  1  1/7890 (0.01%)  0/7912 (0.00%) 
Haemorrhagic erosive gastritis  1  1/7890 (0.01%)  0/7912 (0.00%) 
Hypoaesthesia oral  1  1/7890 (0.01%)  0/7912 (0.00%) 
Ileal ulcer  1  1/7890 (0.01%)  0/7912 (0.00%) 
Ileitis  1  1/7890 (0.01%)  1/7912 (0.01%) 
Internal hernia  1  1/7890 (0.01%)  0/7912 (0.00%) 
Intestinal infarction  1  0/7890 (0.00%)  1/7912 (0.01%) 
Intestinal polyp  1  1/7890 (0.01%)  0/7912 (0.00%) 
Large intestinal ulcer  1  0/7890 (0.00%)  1/7912 (0.01%) 
Lip haematoma  1  1/7890 (0.01%)  0/7912 (0.00%) 
Lumbar hernia  1  0/7890 (0.00%)  1/7912 (0.01%) 
Mesenteric artery stenosis  1  0/7890 (0.00%)  1/7912 (0.01%) 
Mesenteric occlusion  1  0/7890 (0.00%)  1/7912 (0.01%) 
Mesenteric panniculitis  1  0/7890 (0.00%)  1/7912 (0.01%) 
Mouth cyst  1  0/7890 (0.00%)  1/7912 (0.01%) 
Oedema mouth  1  0/7890 (0.00%)  1/7912 (0.01%) 
Oedematous pancreatitis  1  0/7890 (0.00%)  1/7912 (0.01%) 
Oesophageal dysplasia  1  0/7890 (0.00%)  1/7912 (0.01%) 
Oesophageal perforation  1  1/7890 (0.01%)  0/7912 (0.00%) 
Oesophageal ulcer haemorrhage  1  1/7890 (0.01%)  0/7912 (0.00%) 
Oesophageal varices haemorrhage  1  1/7890 (0.01%)  0/7912 (0.00%) 
Oral pain  1  1/7890 (0.01%)  0/7912 (0.00%) 
Pancreatic calcification  1  0/7890 (0.00%)  1/7912 (0.01%) 
Pancreatic disorder  1  1/7890 (0.01%)  0/7912 (0.00%) 
Pancreatitis haemorrhagic  1  0/7890 (0.00%)  1/7912 (0.01%) 
Pancreatitis necrotising  1  0/7890 (0.00%)  1/7912 (0.01%) 
Papilla of  1  1/7890 (0.01%)  0/7912 (0.00%) 
Paraesthesia oral  1  1/7890 (0.01%)  0/7912 (0.00%) 
Peptic ulcer perforation  1  0/7890 (0.00%)  1/7912 (0.01%) 
Pneumatosis intestinalis  1  1/7890 (0.01%)  0/7912 (0.00%) 
Poor dental condition  1  0/7890 (0.00%)  1/7912 (0.01%) 
Proctalgia  1  1/7890 (0.01%)  0/7912 (0.00%) 
Proctitis ulcerative  1  1/7890 (0.01%)  0/7912 (0.00%) 
Reflux gastritis  1  0/7890 (0.00%)  1/7912 (0.01%) 
Retroperitoneal haematoma  1  0/7890 (0.00%)  1/7912 (0.01%) 
Retroperitoneal haemorrhage  1  0/7890 (0.00%)  1/7912 (0.01%) 
Small intestinal perforation  1  1/7890 (0.01%)  0/7912 (0.00%) 
Spigelian hernia  1  1/7890 (0.01%)  0/7912 (0.00%) 
Subileus  1  0/7890 (0.00%)  1/7912 (0.01%) 
Tooth disorder  1  0/7890 (0.00%)  1/7912 (0.01%) 
Toothache  1  1/7890 (0.01%)  0/7912 (0.00%) 
General disorders     
Non-cardiac chest pain  1  196/7890 (2.48%)  191/7912 (2.41%) 
Death  1  73/7890 (0.93%)  56/7912 (0.71%) 
Sudden death  1  56/7890 (0.71%)  57/7912 (0.72%) 
Sudden cardiac death  1  22/7890 (0.28%)  24/7912 (0.30%) 
Chest pain  1  18/7890 (0.23%)  11/7912 (0.14%) 
Asthenia  1  15/7890 (0.19%)  11/7912 (0.14%) 
Pyrexia  1  12/7890 (0.15%)  12/7912 (0.15%) 
Device occlusion  1  11/7890 (0.14%)  12/7912 (0.15%) 
Fatigue  1  9/7890 (0.11%)  8/7912 (0.10%) 
Chest discomfort  1  7/7890 (0.09%)  9/7912 (0.11%) 
Oedema peripheral  1  6/7890 (0.08%)  8/7912 (0.10%) 
Multi-organ failure  1  6/7890 (0.08%)  6/7912 (0.08%) 
Device malfunction  1  5/7890 (0.06%)  4/7912 (0.05%) 
Hernia  1  5/7890 (0.06%)  3/7912 (0.04%) 
Malaise  1  2/7890 (0.03%)  3/7912 (0.04%) 
Medical device complication  1  4/7890 (0.05%)  1/7912 (0.01%) 
Device dislocation  1  1/7890 (0.01%)  3/7912 (0.04%) 
Adverse drug reaction  1  2/7890 (0.03%)  1/7912 (0.01%) 
Gait disturbance  1  0/7890 (0.00%)  3/7912 (0.04%) 
Thrombosis in device  1  1/7890 (0.01%)  2/7912 (0.03%) 
General physical health deterioration  1  2/7890 (0.03%)  0/7912 (0.00%) 
Ill-defined disorder  1  1/7890 (0.01%)  1/7912 (0.01%) 
Medical device pain  1  2/7890 (0.03%)  0/7912 (0.00%) 
Pain  1  1/7890 (0.01%)  1/7912 (0.01%) 
Spinal pain  1  1/7890 (0.01%)  1/7912 (0.01%) 
Ulcer haemorrhage  1  2/7890 (0.03%)  0/7912 (0.00%) 
Axillary pain  1  1/7890 (0.01%)  0/7912 (0.00%) 
Cardiac complication associated with device  1  0/7890 (0.00%)  1/7912 (0.01%) 
Chills  1  1/7890 (0.01%)  0/7912 (0.00%) 
Device battery issue  1  1/7890 (0.01%)  0/7912 (0.00%) 
Device lead damage  1  0/7890 (0.00%)  1/7912 (0.01%) 
Device lead issue  1  1/7890 (0.01%)  0/7912 (0.00%) 
Device power source issue  1  1/7890 (0.01%)  0/7912 (0.00%) 
Drowning  1  1/7890 (0.01%)  0/7912 (0.00%) 
Drug intolerance  1  1/7890 (0.01%)  0/7912 (0.00%) 
Exercise tolerance decreased  1  0/7890 (0.00%)  1/7912 (0.01%) 
Face oedema  1  1/7890 (0.01%)  0/7912 (0.00%) 
Fat necrosis  1  1/7890 (0.01%)  0/7912 (0.00%) 
Generalised oedema  1  0/7890 (0.00%)  1/7912 (0.01%) 
Hypothermia  1  1/7890 (0.01%)  0/7912 (0.00%) 
Impaired healing  1  0/7890 (0.00%)  1/7912 (0.01%) 
Implant site thrombosis  1  0/7890 (0.00%)  1/7912 (0.01%) 
Inflammation  1  0/7890 (0.00%)  1/7912 (0.01%) 
Influenza like illness  1  1/7890 (0.01%)  0/7912 (0.00%) 
Ischaemic ulcer  1  1/7890 (0.01%)  0/7912 (0.00%) 
Lipogranuloma  1  1/7890 (0.01%)  0/7912 (0.00%) 
Medical device site reaction  1  1/7890 (0.01%)  0/7912 (0.00%) 
Multi-organ disorder  1  1/7890 (0.01%)  0/7912 (0.00%) 
Nodule  1  0/7890 (0.00%)  1/7912 (0.01%) 
Polyp  1  0/7890 (0.00%)  1/7912 (0.01%) 
Puncture site haemorrhage  1  0/7890 (0.00%)  1/7912 (0.01%) 
Stent embolisation  1  1/7890 (0.01%)  0/7912 (0.00%) 
Systemic inflammatory response syndrome  1  1/7890 (0.01%)  0/7912 (0.00%) 
Vestibulitis  1  0/7890 (0.00%)  1/7912 (0.01%) 
Hepatobiliary disorders     
Cholelithiasis  1  28/7890 (0.35%)  30/7912 (0.38%) 
Cholecystitis acute  1  24/7890 (0.30%)  19/7912 (0.24%) 
Cholecystitis chronic  1  7/7890 (0.09%)  5/7912 (0.06%) 
Bile duct stone  1  3/7890 (0.04%)  6/7912 (0.08%) 
Hepatic function abnormal  1  2/7890 (0.03%)  5/7912 (0.06%) 
Cholangitis  1  3/7890 (0.04%)  3/7912 (0.04%) 
Jaundice cholestatic  1  3/7890 (0.04%)  3/7912 (0.04%) 
Biliary colic  1  1/7890 (0.01%)  3/7912 (0.04%) 
Hepatic steatosis  1  3/7890 (0.04%)  1/7912 (0.01%) 
Hepatic cirrhosis  1  0/7890 (0.00%)  3/7912 (0.04%) 
Hepatic failure  1  1/7890 (0.01%)  2/7912 (0.03%) 
Acute hepatic failure  1  1/7890 (0.01%)  1/7912 (0.01%) 
Cholangitis acute  1  2/7890 (0.03%)  0/7912 (0.00%) 
Cholelithiasis obstructive  1  2/7890 (0.03%)  0/7912 (0.00%) 
Cholestasish  1  1/7890 (0.01%)  1/7912 (0.01%) 
Gallbladder disorder  1  1/7890 (0.01%)  1/7912 (0.01%) 
Hepatitis  1  0/7890 (0.00%)  2/7912 (0.03%) 
Hepatitis alcoholic  1  2/7890 (0.03%)  0/7912 (0.00%) 
Hepatocellular injury  1  2/7890 (0.03%)  0/7912 (0.00%) 
Hepatotoxicity  1  2/7890 (0.03%)  0/7912 (0.00%) 
Ischaemic hepatitis  1  2/7890 (0.03%)  0/7912 (0.00%) 
Jaundice  1  1/7890 (0.01%)  1/7912 (0.01%) 
Portal hypertension  1  2/7890 (0.03%)  0/7912 (0.00%) 
Alcoholic liver disease  1  1/7890 (0.01%)  0/7912 (0.00%) 
Bile duct obstruction  1  1/7890 (0.01%)  0/7912 (0.00%) 
Bile duct stenosis  1  1/7890 (0.01%)  0/7912 (0.00%) 
Biliary fistula  1  1/7890 (0.01%)  0/7912 (0.00%) 
Drug-induced liver injury  1  1/7890 (0.01%)  0/7912 (0.00%) 
Gallbladder pain  1  1/7890 (0.01%)  0/7912 (0.00%) 
Gallbladder perforation  1  1/7890 (0.01%)  0/7912 (0.00%) 
Hepatic cyst  1  1/7890 (0.01%)  0/7912 (0.00%) 
Hepatic haemorrhage  1  0/7890 (0.00%)  1/7912 (0.01%) 
Hepatic mass  1  0/7890 (0.00%)  1/7912 (0.01%) 
Hepatitis acute  1  1/7890 (0.01%)  0/7912 (0.00%) 
Hepatitis toxic  1  0/7890 (0.00%)  1/7912 (0.01%) 
Hepatorenal failure  1  0/7890 (0.00%)  1/7912 (0.01%) 
Hydrocholecystis  1  0/7890 (0.00%)  1/7912 (0.01%) 
Hyperbilirubinaemia  1  0/7890 (0.00%)  1/7912 (0.01%) 
Liver injury  1  0/7890 (0.00%)  3/7912 (0.04%) 
Pneumobilia  1  0/7890 (0.00%)  1/7912 (0.01%) 
Immune system disorders     
Anaphylactic reaction  1  1/7890 (0.01%)  4/7912 (0.05%) 
Allergy to arthropod sting  1  3/7890 (0.04%)  1/7912 (0.01%) 
Hypersensitivity  1  2/7890 (0.03%)  2/7912 (0.03%) 
Allergy to arthropod bite  1  1/7890 (0.01%)  1/7912 (0.01%) 
Allergic oedema  1  0/7890 (0.00%)  1/7912 (0.01%) 
Food allergy  1  0/7890 (0.00%)  1/7912 (0.01%) 
Infections and infestations     
Pneumonia  1  160/7890 (2.03%)  139/7912 (1.76%) 
Cellulitis  1  46/7890 (0.58%)  38/7912 (0.48%) 
Urinary tract infection  1  36/7890 (0.46%)  43/7912 (0.54%) 
Gastroenteritis  1  29/7890 (0.37%)  31/7912 (0.39%) 
Sepsis  1  23/7890 (0.29%)  35/7912 (0.44%) 
Bronchitis  1  18/7890 (0.23%)  24/7912 (0.30%) 
Appendicitis  1  19/7890 (0.24%)  15/7912 (0.19%) 
Septic shock  1  25/7890 (0.32%)  9/7912 (0.11%) 
Urosepsis  1  15/7890 (0.19%)  14/7912 (0.18%) 
Diverticulitis  1  11/7890 (0.14%)  15/7912 (0.19%) 
Lobar pneumonia  1  17/7890 (0.22%)  9/7912 (0.11%) 
Erysipelas  1  14/7890 (0.18%)  8/7912 (0.10%) 
Bronchopneumonia  1  7/7890 (0.09%)  12/7912 (0.15%) 
Localised infection  1  9/7890 (0.11%)  9/7912 (0.11%) 
Lower respiratory tract infection  1  10/7890 (0.13%)  8/7912 (0.10%) 
Pyelonephritis  1  6/7890 (0.08%)  12/7912 (0.15%) 
Osteomyelitis  1  7/7890 (0.09%)  10/7912 (0.13%) 
Respiratory tract infection  1  7/7890 (0.09%)  8/7912 (0.10%) 
Device related infection  1  8/7890 (0.10%)  6/7912 (0.08%) 
Influenza  1  7/7890 (0.09%)  7/7912 (0.09%) 
Lung infection  1  8/7890 (0.10%)  5/7912 (0.06%) 
Staphylococcal infection  1  6/7890 (0.08%)  6/7912 (0.08%) 
Gastroenteritis viral  1  5/7890 (0.06%)  5/7912 (0.06%) 
Herpes zoster  1  5/7890 (0.06%)  5/7912 (0.06%) 
Peritonitis  1  7/7890 (0.09%)  3/7912 (0.04%) 
Wound infection  1  6/7890 (0.08%)  3/7912 (0.04%) 
Infection  1  4/7890 (0.05%)  4/7912 (0.05%) 
Postoperative wound infection  1  3/7890 (0.04%)  5/7912 (0.06%) 
Gangrene  1  4/7890 (0.05%)  3/7912 (0.04%) 
Post procedural infection  1  1/7890 (0.01%)  6/7912 (0.08%) 
Upper respiratory tract infection  1  3/7890 (0.04%)  4/7912 (0.05%) 
Appendicitis perforated  1  3/7890 (0.04%)  3/7912 (0.04%) 
Bacteraemia  1  1/7890 (0.01%)  5/7912 (0.06%) 
Infective exacerbation of chronic obstructive airways disease  1  3/7890 (0.04%)  3/7912 (0.04%) 
Viral infection  1  2/7890 (0.03%)  4/7912 (0.05%) 
Abscess  1  5/7890 (0.06%)  0/7912 (0.00%) 
Arthritis infective  1  2/7890 (0.03%)  3/7912 (0.04%) 
Cholecystitis infective  1  1/7890 (0.01%)  4/7912 (0.05%) 
Clostridium difficile infection  1  3/7890 (0.04%)  2/7912 (0.03%) 
Pulmonary tuberculosis  1  3/7890 (0.04%)  2/7912 (0.03%) 
Pyelonephritis acute  1  1/7890 (0.01%)  4/7912 (0.05%) 
Anal abscess  1  1/7890 (0.01%)  3/7912 (0.04%) 
Arthritis bacterial  1  1/7890 (0.01%)  3/7912 (0.04%) 
Clostridium difficile colitis  1  2/7890 (0.03%)  2/7912 (0.03%) 
Cystitis  1  2/7890 (0.03%)  2/7912 (0.03%) 
Diabetic gangrene  1  2/7890 (0.03%)  2/7912 (0.03%) 
Endocarditis  1  0/7890 (0.00%)  4/7912 (0.05%) 
Enterocolitis infectious  1  1/7890 (0.01%)  3/7912 (0.04%) 
Escherichia bacteraemia  1  3/7890 (0.04%)  1/7912 (0.01%) 
Escherichia sepsis  1  0/7890 (0.00%)  4/7912 (0.05%) 
Orchitis  1  2/7890 (0.03%)  2/7912 (0.03%) 
Pneumonia bacterial  1  0/7890 (0.00%)  4/7912 (0.05%) 
Postoperative abscess  1  0/7890 (0.00%)  4/7912 (0.05%) 
Skin infection  1  2/7890 (0.03%)  2/7912 (0.03%) 
Abdominal wall abscess  1  0/7890 (0.00%)  3/7912 (0.04%) 
Abscess limb  1  2/7890 (0.03%)  1/7912 (0.01%) 
Dengue fever  1  1/7890 (0.01%)  2/7912 (0.03%) 
Diabetic foot infection  1  2/7890 (0.03%)  1/7912 (0.01%) 
Enterococcal sepsis  1  2/7890 (0.03%)  1/7912 (0.01%) 
H1N1 influenza  1  2/7890 (0.03%)  1/7912 (0.01%) 
Haematoma infection  1  2/7890 (0.03%)  1/7912 (0.01%) 
Intervertebral discitis  1  2/7890 (0.03%)  1/7912 (0.01%) 
Pneumonia klebsiella  1  1/7890 (0.01%)  2/7912 (0.03%) 
Salmonellosis  1  1/7890 (0.01%)  2/7912 (0.03%) 
Sepsis syndrome  1  1/7890 (0.01%)  2/7912 (0.03%) 
Soft tissue infection  1  0/7890 (0.00%)  3/7912 (0.04%) 
Staphylococcal bacteraemia  1  1/7890 (0.01%)  2/7912 (0.03%) 
Streptococcal bacteraemia  1  1/7890 (0.01%)  2/7912 (0.03%) 
Acute hepatitis B  1  1/7890 (0.01%)  1/7912 (0.01%) 
Arteriosclerotic gangrene  1  1/7890 (0.01%)  1/7912 (0.01%) 
Bacterial pyelonephritis  1  2/7890 (0.03%)  0/7912 (0.00%) 
Campylobacter gastroenteritis  1  1/7890 (0.01%)  1/7912 (0.01%) 
Chronic sinusitis  1  2/7890 (0.03%)  0/7912 (0.00%) 
Device related sepsis  1  1/7890 (0.01%)  1/7912 (0.01%) 
Dysentery  1  1/7890 (0.01%)  1/7912 (0.01%) 
Ear infection  1  1/7890 (0.01%)  1/7912 (0.01%) 
Escherichia urinary tract infection  1  0/7890 (0.00%)  2/7912 (0.03%) 
Extradural abscess  1  1/7890 (0.01%)  1/7912 (0.01%) 
Gastritis viral  1  1/7890 (0.01%)  1/7912 (0.01%) 
Gastroenteritis salmonella  1  1/7890 (0.01%)  1/7912 (0.01%) 
Giardiasis  1  2/7890 (0.03%)  0/7912 (0.00%) 
Hepatitis B  1  2/7890 (0.03%)  0/7912 (0.00%) 
Implant site infection  1  2/7890 (0.03%)  0/7912 (0.00%) 
Infected skin ulcer  1  1/7890 (0.01%)  1/7912 (0.01%) 
Infectious pleural effusion  1  1/7890 (0.01%)  1/7912 (0.01%) 
Klebsiella bacteraemia  1  1/7890 (0.01%)  1/7912 (0.01%) 
Klebsiella sepsis  1  1/7890 (0.01%)  1/7912 (0.01%) 
Liver abscess  1  1/7890 (0.01%)  1/7912 (0.01%) 
Lyme disease  1  2/7890 (0.03%)  0/7912 (0.00%) 
Nasopharyngitis  1  1/7890 (0.01%)  1/7912 (0.01%) 
Osteomyelitis chronic  1  0/7890 (0.00%)  2/7912 (0.03%) 
Peritonsillar abscess  1  2/7890 (0.03%)  0/7912 (0.00%) 
Pharyngitis  1  0/7890 (0.00%)  2/7912 (0.03%) 
Pneumonia streptococcal  1  2/7890 (0.03%)  0/7912 (0.00%) 
Pseudomonal bacteraemia  1  0/7890 (0.00%)  2/7912 (0.03%) 
Pyelonephritis chronic  1  2/7890 (0.03%)  0/7912 (0.00%) 
Retroperitoneal abscess  1  2/7890 (0.03%)  0/7912 (0.00%) 
Scrotal abscess  1  1/7890 (0.01%)  1/7912 (0.01%) 
Streptococcal infection  1  2/7890 (0.03%)  0/7912 (0.00%) 
Streptococcal sepsis  1  1/7890 (0.01%)  1/7912 (0.01%) 
Subcutaneous abscess  1  1/7890 (0.01%)  1/7912 (0.01%) 
Urinary tract infection bacterial  1  0/7890 (0.00%)  2/7912 (0.03%) 
Abdominal abscess  1  0/7890 (0.00%)  1/7912 (0.01%) 
Abdominal infection  1  0/7890 (0.00%)  1/7912 (0.01%) 
Abdominal sepsis  1  0/7890 (0.00%)  1/7912 (0.01%) 
Abdominal wall infection  1  1/7890 (0.01%)  0/7912 (0.00%) 
Abscess jaw  1  1/7890 (0.01%)  0/7912 (0.00%) 
Acute pulmonary histoplasmosis  1  0/7890 (0.00%)  1/7912 (0.01%) 
Amoebiasis  1  1/7890 (0.01%)  0/7912 (0.00%) 
Appendiceal abscess  1  1/7890 (0.01%)  0/7912 (0.00%) 
Bacterial sepsis  1  0/7890 (0.00%)  1/7912 (0.01%) 
Biliary sepsis  1  1/7890 (0.01%)  0/7912 (0.00%) 
Bone abscess  1  1/7890 (0.01%)  0/7912 (0.00%) 
Borrelia infection  1  1/7890 (0.01%)  0/7912 (0.00%) 
Bronchitis bacterial  1  1/7890 (0.01%)  0/7912 (0.00%) 
Bursitis infective  1  1/7890 (0.01%)  0/7912 (0.00%) 
Carbuncle  1  1/7890 (0.01%)  0/7912 (0.00%) 
Catheter site infection  1  1/7890 (0.01%)  0/7912 (0.00%) 
Cellulitis gangrenous  1  1/7890 (0.01%)  0/7912 (0.00%) 
Cellulitis staphylococcal  1  1/7890 (0.01%)  0/7912 (0.00%) 
Cholangitis suppurative  1  0/7890 (0.00%)  1/7912 (0.01%) 
Diarrhoea infectious  1  1/7890 (0.01%)  0/7912 (0.00%) 
Disseminated tuberculosis  1  1/7890 (0.01%)  0/7912 (0.00%) 
Echinococciasis  1  1/7890 (0.01%)  0/7912 (0.00%) 
Empyema  1  1/7890 (0.01%)  0/7912 (0.00%) 
Endocarditis bacterial  1  1/7890 (0.01%)  0/7912 (0.00%) 
Endocarditis enterococcal  1  0/7890 (0.00%)  1/7912 (0.01%) 
Endocarditis staphylococcal  1  1/7890 (0.01%)  0/7912 (0.00%) 
Endometritis  1  0/7890 (0.00%)  1/7912 (0.01%) 
Endophthalmitis  1  1/7890 (0.01%)  0/7912 (0.00%) 
Enteritis infectious  1  1/7890 (0.01%)  0/7912 (0.00%) 
Enterobacter infection  1  1/7890 (0.01%)  0/7912 (0.00%) 
Enterococcal bacteraemia  1  1/7890 (0.01%)  0/7912 (0.00%) 
Enterococcal infection  1  1/7890 (0.01%)  0/7912 (0.00%) 
Epiglottitis  1  0/7890 (0.00%)  1/7912 (0.01%) 
Escherichia infection  1  1/7890 (0.01%)  0/7912 (0.00%) 
External ear cellulitis  1  1/7890 (0.01%)  0/7912 (0.00%) 
Febrile infection  1  0/7890 (0.00%)  1/7912 (0.01%) 
Fungal oesophagitis  1  0/7890 (0.00%)  1/7912 (0.01%) 
Gallbladder empyema  1  1/7890 (0.01%)  0/7912 (0.00%) 
Gastroenteritis rotavirus  1  0/7890 (0.00%)  1/7912 (0.01%) 
Gastrointestinal viral infection  1  0/7890 (0.00%)  1/7912 (0.01%) 
Genital infection fungal  1  1/7890 (0.01%)  0/7912 (0.00%) 
Graft infection  1  1/7890 (0.01%)  0/7912 (0.00%) 
Groin abscess  1  1/7890 (0.01%)  0/7912 (0.00%) 
HIV infection  1  1/7890 (0.01%)  0/7912 (0.00%) 
Helicobacter gastritis  1  0/7890 (0.00%)  1/7912 (0.01%) 
Helicobacter infection  1  1/7890 (0.01%)  0/7912 (0.00%) 
Hepatitis A  1  1/7890 (0.01%)  0/7912 (0.00%) 
Hepatitis C  1  0/7890 (0.00%)  1/7912 (0.01%) 
Hepatitis E  1  1/7890 (0.01%)  0/7912 (0.00%) 
Hepatitis viral  1  1/7890 (0.01%)  0/7912 (0.00%) 
Herpes zoster ophthalmic  1  1/7890 (0.01%)  0/7912 (0.00%) 
Histoplasmosis  1  0/7890 (0.00%)  1/7912 (0.01%) 
Infected bites  1  0/7890 (0.00%)  1/7912 (0.01%) 
Infective myositis  1  0/7890 (0.00%)  1/7912 (0.01%) 
Intertrigo candida  1  0/7890 (0.00%)  1/7912 (0.01%) 
Keratitis herpetic  1  1/7890 (0.01%)  0/7912 (0.00%) 
Kidney infection  1  1/7890 (0.01%)  0/7912 (0.00%) 
Laryngitis  1  0/7890 (0.00%)  1/7912 (0.01%) 
Leptospirosis  1  0/7890 (0.00%)  1/7912 (0.01%) 
Lung abscess  1  1/7890 (0.01%)  0/7912 (0.00%) 
Lymphangitis  1  1/7890 (0.01%)  0/7912 (0.00%) 
Mastoiditis  1  0/7890 (0.00%)  1/7912 (0.01%) 
Mediastinitis  1  1/7890 (0.01%)  0/7912 (0.00%) 
Meningitis  1  0/7890 (0.00%)  1/7912 (0.01%) 
Meningitis bacterial  1  1/7890 (0.01%)  0/7912 (0.00%) 
Meningitis cryptococcal  1  1/7890 (0.01%)  0/7912 (0.00%) 
Mycoplasma infection  1  1/7890 (0.01%)  0/7912 (0.00%) 
Mycotoxicosis  1  1/7890 (0.01%)  0/7912 (0.00%) 
Necrotising fasciitis  1  1/7890 (0.01%)  0/7912 (0.00%) 
Oesophageal candidiasis  1  1/7890 (0.01%)  0/7912 (0.00%) 
Oral candidiasis  1  0/7890 (0.00%)  1/7912 (0.01%) 
Otitis media  1  0/7890 (0.00%)  1/7912 (0.01%) 
Otitis media chronic  1  0/7890 (0.00%)  1/7912 (0.01%) 
Paronychia  1  1/7890 (0.01%)  0/7912 (0.00%) 
Parotitis  1  1/7890 (0.01%)  0/7912 (0.00%) 
Perineal abscess  1  1/7890 (0.01%)  0/7912 (0.00%) 
Periorbital cellulitis  1  1/7890 (0.01%)  0/7912 (0.00%) 
Peritoneal abscess  1  1/7890 (0.01%)  0/7912 (0.00%) 
Peritonsillitis  1  1/7890 (0.01%)  0/7912 (0.00%) 
Plasmodium vivax infection  1  0/7890 (0.00%)  1/7912 (0.01%) 
Pneumococcal sepsis  1  1/7890 (0.01%)  0/7912 (0.00%) 
Pneumonia chlamydial  1  1/7890 (0.01%)  0/7912 (0.00%) 
Pneumonia necrotising  1  0/7890 (0.00%)  1/7912 (0.01%) 
Pneumonia viral  1  1/7890 (0.01%)  0/7912 (0.00%) 
Prostatic abscess  1  1/7890 (0.01%)  0/7912 (0.00%) 
Pseudomembranous colitis  1  1/7890 (0.01%)  0/7912 (0.00%) 
Pseudomonas infection  1  0/7890 (0.00%)  1/7912 (0.01%) 
Psoas abscess  1  0/7890 (0.00%)  1/7912 (0.01%) 
Pulmonary sepsis  1  1/7890 (0.01%)  0/7912 (0.00%) 
Pyopneumothorax  1  1/7890 (0.01%)  0/7912 (0.00%) 
Respiratory tract infection viral  1  0/7890 (0.00%)  1/7912 (0.01%) 
Retroperitoneal infection  1  1/7890 (0.01%)  0/7912 (0.00%) 
Salmonella sepsis  1  1/7890 (0.01%)  0/7912 (0.00%) 
Scrub typhus  1  1/7890 (0.01%)  0/7912 (0.00%) 
Septic embolus  1  0/7890 (0.00%)  1/7912 (0.01%) 
Sialoadenitis  1  1/7890 (0.01%)  0/7912 (0.00%) 
Sinobronchitis  1  1/7890 (0.01%)  0/7912 (0.00%) 
Sinusitis  1  0/7890 (0.00%)  1/7912 (0.01%) 
Staphylococcal osteomyelitis  1  1/7890 (0.01%)  0/7912 (0.00%) 
Staphylococcal sepsis  1  0/7890 (0.00%)  1/7912 (0.01%) 
Subacute endocarditis  1  0/7890 (0.00%)  1/7912 (0.01%) 
Superinfection  1  1/7890 (0.01%)  0/7912 (0.00%) 
Suspected transmission of an infectious agent via product  1  1/7890 (0.01%)  0/7912 (0.00%) 
Tinea pedis  1  0/7890 (0.00%)  1/7912 (0.01%) 
Tongue abscess  1  1/7890 (0.01%)  0/7912 (0.00%) 
Tonsillitis  1  1/7890 (0.01%)  0/7912 (0.00%) 
Tooth abscess  1  1/7890 (0.01%)  0/7912 (0.00%) 
Tracheitis  1  1/7890 (0.01%)  0/7912 (0.00%) 
Tracheobronchitis  1  0/7890 (0.00%)  1/7912 (0.01%) 
Tracheobronchitis viral  1  0/7890 (0.00%)  1/7912 (0.01%) 
Tuberculosis  1  0/7890 (0.00%)  1/7912 (0.01%) 
Urethritis  1  1/7890 (0.01%)  0/7912 (0.00%) 
Urinary tract infection pseudomonal  1  1/7890 (0.01%)  0/7912 (0.00%) 
Vaginal abscess  1  1/7890 (0.01%)  0/7912 (0.00%) 
Varicella  1  1/7890 (0.01%)  0/7912 (0.00%) 
Vestibular neuronitis  1  1/7890 (0.01%)  0/7912 (0.00%) 
Viral tracheitis  1  1/7890 (0.01%)  0/7912 (0.00%) 
Viral upper respiratory tract infection  1  1/7890 (0.01%)  0/7912 (0.00%) 
Wound infection staphylococcal  1  0/7890 (0.00%)  1/7912 (0.01%) 
Wound sepsis  1  1/7890 (0.01%)  0/7912 (0.00%) 
Injury, poisoning and procedural complications     
Coronary artery restenosis  1  28/7890 (0.35%)  19/7912 (0.24%) 
Fall  1  17/7890 (0.22%)  11/7912 (0.14%) 
Femur fracture  1  11/7890 (0.14%)  12/7912 (0.15%) 
Hip fracture  1  10/7890 (0.13%)  13/7912 (0.16%) 
Subdural haematoma  1  8/7890 (0.10%)  15/7912 (0.19%) 
Femoral neck fracture  1  12/7890 (0.15%)  6/7912 (0.08%) 
Head injury  1  11/7890 (0.14%)  7/7912 (0.09%) 
Tendon rupture  1  8/7890 (0.10%)  8/7912 (0.10%) 
Rib fracture  1  9/7890 (0.11%)  6/7912 (0.08%) 
Laceration  1  9/7890 (0.11%)  4/7912 (0.05%) 
Ankle fracture  1  7/7890 (0.09%)  4/7912 (0.05%) 
Contusion  1  6/7890 (0.08%)  5/7912 (0.06%) 
Radius fracture  1  5/7890 (0.06%)  6/7912 (0.08%) 
Humerus fracture  1  5/7890 (0.06%)  5/7912 (0.06%) 
Post procedural complication  1  5/7890 (0.06%)  5/7912 (0.06%) 
Post procedural haemorrhage  1  4/7890 (0.05%)  6/7912 (0.08%) 
Spinal compression fracture  1  5/7890 (0.06%)  5/7912 (0.06%) 
Tibia fracture  1  5/7890 (0.06%)  5/7912 (0.06%) 
Toxicity to various agents  1  6/7890 (0.08%)  4/7912 (0.05%) 
Joint dislocation  1  5/7890 (0.06%)  4/7912 (0.05%) 
Meniscus injury  1  8/7890 (0.10%)  1/7912 (0.01%) 
Road traffic accident  1  6/7890 (0.08%)  3/7912 (0.04%) 
Vascular graft occlusion  1  8/7890 (0.10%)  1/7912 (0.01%) 
Multiple injuries  1  5/7890 (0.06%)  3/7912 (0.04%) 
Vascular graft complication  1  6/7890 (0.08%)  2/7912 (0.03%) 
Vascular pseudoaneurysm  1  5/7890 (0.06%)  3/7912 (0.04%) 
Arterial restenosis  1  4/7890 (0.05%)  3/7912 (0.04%) 
Joint injury  1  3/7890 (0.04%)  4/7912 (0.05%) 
Lower limb fracture  1  4/7890 (0.05%)  3/7912 (0.04%) 
Pelvic fracture  1  5/7890 (0.06%)  2/7912 (0.03%) 
Concussion  1  4/7890 (0.05%)  2/7912 (0.03%) 
Fibula fracture  1  4/7890 (0.05%)  2/7912 (0.03%) 
Incisional hernia  1  4/7890 (0.05%)  2/7912 (0.03%) 
Lumbar vertebral fracture  1  2/7890 (0.03%)  4/7912 (0.05%) 
Overdose  1  5/7890 (0.06%)  1/7912 (0.01%) 
Patella fracture  1  4/7890 (0.05%)  2/7912 (0.03%) 
Thoracic vertebral fracture  1  2/7890 (0.03%)  4/7912 (0.05%) 
Wound  1  2/7890 (0.03%)  4/7912 (0.05%) 
Alcohol poisoning  1  4/7890 (0.05%)  1/7912 (0.01%) 
Craniocerebral injury  1  3/7890 (0.04%)  2/7912 (0.03%) 
Graft thrombosis  1  2/7890 (0.03%)  2/7912 (0.03%) 
Limb injury  1  3/7890 (0.04%)  2/7912 (0.03%) 
Post procedural myocardial infarction  1  3/7890 (0.04%)  2/7912 (0.03%) 
Subdural haemorrhage  1  2/7890 (0.03%)  3/7912 (0.04%) 
Accidental overdose  1  2/7890 (0.03%)  2/7912 (0.03%) 
Foot fracture  1  4/7890 (0.05%)  0/7912 (0.00%) 
Injury  1  3/7890 (0.04%)  1/7912 (0.01%) 
Limb traumatic amputation  1  1/7890 (0.01%)  3/7912 (0.04%) 
Procedural pain  1  3/7890 (0.04%)  1/7912 (0.01%) 
Thermal burn  1  4/7890 (0.05%)  0/7912 (0.00%) 
Wound dehiscence  1  2/7890 (0.03%)  2/7912 (0.03%) 
Acetabulum fracture  1  3/7890 (0.04%)  0/7912 (0.00%) 
Arterial injury  1  2/7890 (0.03%)  1/7912 (0.01%) 
Burns second degree  1  2/7890 (0.03%)  1/7912 (0.01%) 
Excoriation  1  3/7890 (0.04%)  0/7912 (0.00%) 
Gun shot wound  1  2/7890 (0.03%)  1/7912 (0.01%) 
Incisional hernia, Obstruction  1  3/7890 (0.04%)  0/7912 (0.00%) 
Ligament rupture  1  2/7890 (0.03%)  1/7912 (0.01%) 
Multiple fractures  1  1/7890 (0.01%)  2/7912 (0.03%) 
Postoperative respiratory failure  1  1/7890 (0.01%)  2/7912 (0.03%) 
Procedural haemorrhage  1  2/7890 (0.03%)  1/7912 (0.01%) 
Bone contusion  1  2/7890 (0.03%)  0/7912 (0.00%) 
Brain contusion  1  0/7890 (0.00%)  2/7912 (0.03%) 
Clavicle fracture  1  1/7890 (0.01%)  1/7912 (0.01%) 
Comminuted fracture  1  1/7890 (0.01%)  1/7912 (0.01%) 
Ligament injury  1  1/7890 (0.01%)  1/7912 (0.01%) 
Ligament sprain  1  1/7890 (0.01%)  1/7912 (0.01%) 
Liver contusion  1  2/7890 (0.03%)  0/7912 (0.00%) 
Muscle strain  1  1/7890 (0.01%)  1/7912 (0.01%) 
Postoperative hernia  1  1/7890 (0.01%)  1/7912 (0.01%) 
Procedural complication  1  2/7890 (0.03%)  0/7912 (0.00%) 
Procedural hypotension  1  0/7890 (0.00%)  2/7912 (0.03%) 
Pubis fracture  1  1/7890 (0.01%)  1/7912 (0.01%) 
Skull fracture  1  0/7890 (0.00%)  2/7912 (0.03%) 
Suture related complication  1  1/7890 (0.01%)  1/7912 (0.01%) 
Transplant failure  1  2/7890 (0.03%)  0/7912 (0.00%) 
Traumatic renal injury  1  1/7890 (0.01%)  1/7912 (0.01%) 
Upper limb fracture  1  1/7890 (0.01%)  1/7912 (0.01%) 
Vascular bypass dysfunction  1  2/7890 (0.03%)  0/7912 (0.00%) 
Wound necrosis  1  0/7890 (0.00%)  2/7912 (0.03%) 
Accident at home  1  1/7890 (0.01%)  0/7912 (0.00%) 
Anaemia postoperative  1  1/7890 (0.01%)  0/7912 (0.00%) 
Animal bite  1  1/7890 (0.01%)  0/7912 (0.00%) 
Arteriovenous fistula thrombosis  1  0/7890 (0.00%)  1/7912 (0.01%) 
Arthropod sting  1  0/7890 (0.00%)  1/7912 (0.01%) 
Back injury  1  0/7890 (0.00%)  1/7912 (0.01%) 
Burns first degree  1  1/7890 (0.01%)  0/7912 (0.00%) 
Cardiac function disturbance postoperative  1  0/7890 (0.00%)  1/7912 (0.01%) 
Cardiac procedure complication  1  1/7890 (0.01%)  0/7912 (0.00%) 
Carotid artery restenosis  1  1/7890 (0.01%)  0/7912 (0.00%) 
Chest injury  1  0/7890 (0.00%)  1/7912 (0.01%) 
Eschar  1  1/7890 (0.01%)  0/7912 (0.00%) 
Extradural haematoma  1  0/7890 (0.00%)  1/7912 (0.01%) 
Eye injury  1  0/7890 (0.00%)  1/7912 (0.01%) 
Eye penetration  1  0/7890 (0.00%)  1/7912 (0.01%) 
Face injury  1  1/7890 (0.01%)  0/7912 (0.00%) 
Forearm fracture  1  0/7890 (0.00%)  1/7912 (0.01%) 
Foreign body  1  0/7890 (0.00%)  1/7912 (0.01%) 
Fracture  1  0/7890 (0.00%)  1/7912 (0.01%) 
Fractured sacrum  1  1/7890 (0.01%)  0/7912 (0.00%) 
Gastrointestinal disorder postoperative  1  0/7890 (0.00%)  1/7912 (0.01%) 
Gastrointestinal stoma complication  1  1/7890 (0.01%)  0/7912 (0.00%) 
Hand fracture  1  1/7890 (0.01%)  0/7912 (0.00%) 
Heart injury  1  1/7890 (0.01%)  0/7912 (0.00%) 
Incision site haemorrhage  1  1/7890 (0.01%)  0/7912 (0.00%) 
Inflammation of wound  1  0/7890 (0.00%)  1/7912 (0.01%) 
Internal injury  1  0/7890 (0.00%)  1/7912 (0.01%) 
Intervertebral disc injury  1  1/7890 (0.01%)  0/7912 (0.00%) 
Jaw fracture  1  0/7890 (0.00%)  1/7912 (0.01%) 
Kidney contusion  1  0/7890 (0.00%)  1/7912 (0.01%) 
Limb crushing injury  1  1/7890 (0.01%)  0/7912 (0.00%) 
Mental status changes postoperative  1  1/7890 (0.01%)  0/7912 (0.00%) 
Muscle rupture  1  0/7890 (0.00%)  1/7912 (0.01%) 
Periprosthetic fracture  1  1/7890 (0.01%)  0/7912 (0.00%) 
Perirenal haematoma  1  1/7890 (0.01%)  0/7912 (0.00%) 
Poisoning  1  1/7890 (0.01%)  0/7912 (0.00%) 
Post laminectomy syndrome  1  1/7890 (0.01%)  0/7912 (0.00%) 
Post procedural fistula  1  0/7890 (0.00%)  1/7912 (0.01%) 
Post procedural haematoma  1  0/7890 (0.00%)  1/7912 (0.01%) 
Post procedural stroke  1  1/7890 (0.01%)  0/7912 (0.00%) 
Post procedural swelling  1  1/7890 (0.01%)  0/7912 (0.00%) 
Postoperative ileus  1  1/7890 (0.01%)  0/7912 (0.00%) 
Postoperative thoracic procedure complication  1  0/7890 (0.00%)  1/7912 (0.01%) 
Postoperative thrombosis  1  1/7890 (0.01%)  0/7912 (0.00%) 
Procedural headache  1  0/7890 (0.00%)  1/7912 (0.01%) 
Procedural nausea  1  1/7890 (0.01%)  0/7912 (0.00%) 
Procedural vomiting  1  1/7890 (0.01%)  0/7912 (0.00%) 
Pulmonary contusion  1  1/7890 (0.01%)  0/7912 (0.00%) 
Renal haematoma  1  0/7890 (0.00%)  1/7912 (0.01%) 
Shunt stenosis  1  1/7890 (0.01%)  0/7912 (0.00%) 
Skull fractured base  1  1/7890 (0.01%)  0/7912 (0.00%) 
Soft tissue injury  1  1/7890 (0.01%)  0/7912 (0.00%) 
Spinal column injury  1  0/7890 (0.00%)  1/7912 (0.01%) 
Spinal fracture  1  1/7890 (0.01%)  0/7912 (0.00%) 
Splenic rupture  1  1/7890 (0.01%)  0/7912 (0.00%) 
Splinter  1  0/7890 (0.00%)  1/7912 (0.01%) 
Subcutaneous haematoma  1  1/7890 (0.01%)  0/7912 (0.00%) 
Synovial rupture  1  0/7890 (0.00%)  1/7912 (0.01%) 
Tendon injury  1  1/7890 (0.01%)  0/7912 (0.00%) 
Testicular injury  1  0/7890 (0.00%)  1/7912 (0.01%) 
Transfusion reaction  1  1/7890 (0.01%)  0/7912 (0.00%) 
Traumatic haematoma  1  0/7890 (0.00%)  1/7912 (0.01%) 
Traumatic intracranial haemorrhage  1  1/7890 (0.01%)  0/7912 (0.00%) 
Ulna fracture  1  0/7890 (0.00%)  1/7912 (0.01%) 
Urinary bladder rupture  1  1/7890 (0.01%)  0/7912 (0.00%) 
Vascular graft thrombosis  1  1/7890 (0.01%)  0/7912 (0.00%) 
Vascular procedure complication  1  1/7890 (0.01%)  0/7912 (0.00%) 
Venomous sting  1  0/7890 (0.00%)  1/7912 (0.01%) 
Wound evisceration  1  0/7890 (0.00%)  1/7912 (0.01%) 
Wound haematoma  1  0/7890 (0.00%)  1/7912 (0.01%) 
Wrist fracture  1  0/7890 (0.00%)  1/7912 (0.01%) 
Investigations     
Alanine aminotransferase increased  1  11/7890 (0.14%)  4/7912 (0.05%) 
Hepatic enzyme increased  1  5/7890 (0.06%)  8/7912 (0.10%) 
International normalised ratio increased  1  5/7890 (0.06%)  3/7912 (0.04%) 
Weight decreased  1  5/7890 (0.06%)  3/7912 (0.04%) 
Aspartate aminotransferase increased  1  6/7890 (0.08%)  1/7912 (0.01%) 
Liver function test abnormal  1  2/7890 (0.03%)  5/7912 (0.06%) 
Blood bilirubin increased  1  2/7890 (0.03%)  4/7912 (0.05%) 
Troponin increased  1  3/7890 (0.04%)  3/7912 (0.04%) 
Blood creatinine increased  1  4/7890 (0.05%)  1/7912 (0.01%) 
Blood glucose increased  1  3/7890 (0.04%)  2/7912 (0.03%) 
Haemoglobin decreased  1  1/7890 (0.01%)  4/7912 (0.05%) 
Blood pressure increased  1  1/7890 (0.01%)  3/7912 (0.04%) 
Ejection fraction decreased  1  4/7890 (0.05%)  0/7912 (0.00%) 
Electrocardiogram ST segment depression  1  3/7890 (0.04%)  0/7912 (0.00%) 
Prostatic specific antigen increased  1  1/7890 (0.01%)  2/7912 (0.03%) 
Blood potassium decreased  1  2/7890 (0.03%)  0/7912 (0.00%) 
Blood pressure decreased  1  0/7890 (0.00%)  2/7912 (0.03%) 
Cardiac stress test abnormal  1  0/7890 (0.00%)  2/7912 (0.03%) 
Heart rate decreased  1  1/7890 (0.01%)  1/7912 (0.01%) 
Heart rate irregular  1  2/7890 (0.03%)  0/7912 (0.00%) 
Intraocular pressure increased  1  1/7890 (0.01%)  1/7912 (0.01%) 
Troponin I increased  1  1/7890 (0.01%)  1/7912 (0.01%) 
Activated partial thromboplastin time prolonged  1  0/7890 (0.00%)  1/7912 (0.01%) 
Alanine aminotransferase abnormal  1  0/7890 (0.00%)  1/7912 (0.01%) 
Aspartate aminotransferase abnormal  1  0/7890 (0.00%)  1/7912 (0.01%) 
Bile output abnormal  1  1/7890 (0.01%)  0/7912 (0.00%) 
Bilirubin conjugated increased  1  0/7890 (0.00%)  1/7912 (0.01%) 
Blood alkaline phosphatase increased  1  0/7890 (0.00%)  1/7912 (0.01%) 
Blood creatine phosphokinase increased  1  1/7890 (0.01%)  0/7912 (0.00%) 
Blood glucose decreased  1  0/7890 (0.00%)  1/7912 (0.01%) 
Blood urea increased  1  1/7890 (0.01%)  0/7912 (0.00%) 
Blood urine present  1  1/7890 (0.01%)  0/7912 (0.00%) 
C-reactive protein increased  1  1/7890 (0.01%)  0/7912 (0.00%) 
Cardiac murmur  1  1/7890 (0.01%)  0/7912 (0.00%) 
Carotid bruit  1  1/7890 (0.01%)  0/7912 (0.00%) 
ECG signs of myocardial ischaemia  1  0/7890 (0.00%)  1/7912 (0.01%) 
Gamma-glutamyltransferase increased  1  1/7890 (0.01%)  0/7912 (0.00%) 
Heart rate increased  1  0/7890 (0.00%)  1/7912 (0.01%) 
Hepatic enzyme abnormal  1  0/7890 (0.00%)  1/7912 (0.01%) 
Occult blood positive  1  0/7890 (0.00%)  1/7912 (0.01%) 
Oxygen saturation decreased  1  0/7890 (0.00%)  1/7912 (0.01%) 
Red blood cell sedimentation rate increased  1  0/7890 (0.00%)  1/7912 (0.01%) 
Scan myocardial perfusion abnormal  1  0/7890 (0.00%)  1/7912 (0.01%) 
Streptococcus test positive  1  0/7890 (0.00%)  1/7912 (0.01%) 
Stroke volume decreased  1  0/7890 (0.00%)  1/7912 (0.01%) 
Transaminases increased  1  0/7890 (0.00%)  1/7912 (0.01%) 
White blood cell count increased  1  0/7890 (0.00%)  1/7912 (0.01%) 
Metabolism and nutrition disorders     
Type 2 diabetes mellitus  1  37/7890 (0.47%)  27/7912 (0.34%) 
Dehydration  1  24/7890 (0.30%)  33/7912 (0.42%) 
Hypoglycaemia  1  26/7890 (0.33%)  24/7912 (0.30%) 
Diabetes mellitus inadequate control  1  8/7890 (0.10%)  26/7912 (0.33%) 
Hyperkalaemia  1  9/7890 (0.11%)  11/7912 (0.14%) 
Hyponatraemia  1  8/7890 (0.10%)  10/7912 (0.13%) 
Gout  1  5/7890 (0.06%)  5/7912 (0.06%) 
Hyperglycaemia  1  5/7890 (0.06%)  4/7912 (0.05%) 
Hypokalaemia  1  7/7890 (0.09%)  2/7912 (0.03%) 
Diabetic ketoacidosis  1  5/7890 (0.06%)  3/7912 (0.04%) 
Hypovolaemia  1  4/7890 (0.05%)  2/7912 (0.03%) 
Obesity  1  2/7890 (0.03%)  4/7912 (0.05%) 
Electrolyte imbalance  1  1/7890 (0.01%)  3/7912 (0.04%) 
Fluid overload  1  2/7890 (0.03%)  2/7912 (0.03%) 
Malnutrition  1  1/7890 (0.01%)  3/7912 (0.04%) 
Metabolic acidosis  1  2/7890 (0.03%)  2/7912 (0.03%) 
Type 1 diabetes mellitus  1  2/7890 (0.03%)  2/7912 (0.03%) 
Cachexia  1  1/7890 (0.01%)  1/7912 (0.01%) 
Diabetes mellitus  1  0/7890 (0.00%)  2/7912 (0.03%) 
Failure to thrive  1  1/7890 (0.01%)  1/7912 (0.01%) 
Hypertriglyceridaemia  1  1/7890 (0.01%)  1/7912 (0.01%) 
Hypoalbuminaemia  1  0/7890 (0.00%)  2/7912 (0.03%) 
Hypocalcaemia  1  0/7890 (0.00%)  2/7912 (0.03%) 
Hypomagnesaemia  1  1/7890 (0.01%)  1/7912 (0.01%) 
Ketoacidosis  1  1/7890 (0.01%)  1/7912 (0.01%) 
Acidosis  1  1/7890 (0.01%)  0/7912 (0.00%) 
Decreased appetite  1  1/7890 (0.01%)  0/7912 (0.00%) 
Diabetic complication  1  0/7890 (0.00%)  1/7912 (0.01%) 
Fluid retention  1  0/7890 (0.00%)  1/7912 (0.01%) 
Fructose intolerance  1  0/7890 (0.00%)  1/7912 (0.01%) 
Hypercalcaemia  1  0/7890 (0.00%)  1/7912 (0.01%) 
Hyperlipidaemia  1  0/7890 (0.00%)  1/7912 (0.01%) 
Hyperosmolar state  1  1/7890 (0.01%)  0/7912 (0.00%) 
Hypophosphataemia  1  1/7890 (0.01%)  0/7912 (0.00%) 
Insulin-requiring type 2 diabetes mellitus  1  1/7890 (0.01%)  0/7912 (0.00%) 
Metabolic syndrome  1  0/7890 (0.00%)  1/7912 (0.01%) 
Vitamin B12 deficiency  1  1/7890 (0.01%)  0/7912 (0.00%) 
Vitamin D deficiency  1  1/7890 (0.01%)  0/7912 (0.00%) 
Musculoskeletal and connective tissue disorders     
Osteoarthritis  1  78/7890 (0.99%)  73/7912 (0.92%) 
Back pain  1  27/7890 (0.34%)  20/7912 (0.25%) 
Intervertebral disc protrusion  1  24/7890 (0.30%)  16/7912 (0.20%) 
Arthralgia  1  19/7890 (0.24%)  13/7912 (0.16%) 
Spinal column stenosis  1  16/7890 (0.20%)  13/7912 (0.16%) 
Lumbar spinal stenosis  1  9/7890 (0.11%)  13/7912 (0.16%) 
Arthritis  1  7/7890 (0.09%)  13/7912 (0.16%) 
Musculoskeletal chest pain  1  9/7890 (0.11%)  11/7912 (0.14%) 
Spinal osteoarthritis  1  12/7890 (0.15%)  5/7912 (0.06%) 
Rotator cuff syndrome  1  9/7890 (0.11%)  7/7912 (0.09%) 
Myalgia  1  6/7890 (0.08%)  9/7912 (0.11%) 
Musculoskeletal pain  1  6/7890 (0.08%)  8/7912 (0.10%) 
Rhabdomyolysis  1  4/7890 (0.05%)  7/7912 (0.09%) 
Cervical spinal stenosis  1  9/7890 (0.11%)  1/7912 (0.01%) 
Muscular weakness  1  6/7890 (0.08%)  3/7912 (0.04%) 
Spondylolisthesis  1  3/7890 (0.04%)  5/7912 (0.06%) 
Polymyalgia rheumatica  1  4/7890 (0.05%)  3/7912 (0.04%) 
Gouty arthritis  1  3/7890 (0.04%)  3/7912 (0.04%) 
Osteonecrosis  1  5/7890 (0.06%)  1/7912 (0.01%) 
Intervertebral disc disorder  1  3/7890 (0.04%)  2/7912 (0.03%) 
Intervertebral disc degeneration  1  2/7890 (0.03%)  3/7912 (0.04%) 
Pain in extremity  1  2/7890 (0.03%)  3/7912 (0.04%) 
Rheumatoid arthritis  1  2/7890 (0.03%)  3/7912 (0.04%) 
Neck pain  1  0/7890 (0.00%)  4/7912 (0.05%) 
Periarthritis  1  1/7890 (0.01%)  3/7912 (0.04%) 
Arthritis reactive  1  1/7890 (0.01%)  2/7912 (0.03%) 
Bursitis  1  1/7890 (0.01%)  2/7912 (0.03%) 
Flank pain  1  1/7890 (0.01%)  2/7912 (0.03%) 
Muscle haemorrhage  1  2/7890 (0.03%)  1/7912 (0.01%) 
Articular calcification  1  1/7890 (0.01%)  1/7912 (0.01%) 
Foot deformity  1  2/7890 (0.03%)  0/7912 (0.00%) 
Intervertebral disc displacement  1  0/7890 (0.00%)  2/7912 (0.03%) 
Osteitis  1  2/7890 (0.03%)  0/7912 (0.00%) 
Polyarthritis  1  2/7890 (0.03%)  0/7912 (0.00%) 
Scoliosis  1  2/7890 (0.03%)  0/7912 (0.00%) 
Spondylitis  1  2/7890 (0.03%)  0/7912 (0.00%) 
Tendon disorder  1  0/7890 (0.00%)  2/7912 (0.03%) 
Arthropathy  1  0/7890 (0.00%)  1/7912 (0.01%) 
Back disorder  1  0/7890 (0.00%)  1/7912 (0.01%) 
Bone erosion  1  0/7890 (0.00%)  1/7912 (0.01%) 
Bone fistula  1  0/7890 (0.00%)  1/7912 (0.01%) 
Bone lesion  1  0/7890 (0.00%)  1/7912 (0.01%) 
Bone pain  1  0/7890 (0.00%)  1/7912 (0.01%) 
Chondromalacia  1  0/7890 (0.00%)  1/7912 (0.01%) 
Chondropathy  1  0/7890 (0.00%)  1/7912 (0.01%) 
Costochondritis  1  1/7890 (0.01%)  0/7912 (0.00%) 
Dupuytren's contracture  1  0/7890 (0.00%)  1/7912 (0.01%) 
Exostosis  1  1/7890 (0.01%)  0/7912 (0.00%) 
Fistula  1  1/7890 (0.01%)  0/7912 (0.00%) 
Haemarthrosis  1  1/7890 (0.01%)  0/7912 (0.00%) 
Inclusion body myositis  1  0/7890 (0.00%)  1/7912 (0.01%) 
Inguinal mass  1  0/7890 (0.00%)  1/7912 (0.01%) 
Joint effusion  1  0/7890 (0.00%)  1/7912 (0.01%) 
Joint swelling  1  0/7890 (0.00%)  1/7912 (0.01%) 
Limb discomfort  1  0/7890 (0.00%)  1/7912 (0.01%) 
Metatarsalgia  1  1/7890 (0.01%)  0/7912 (0.00%) 
Monarthritis  1  0/7890 (0.00%)  1/7912 (0.01%) 
Muscle spasms  1  0/7890 (0.00%)  1/7912 (0.01%) 
Musculoskeletal discomfort  1  1/7890 (0.01%)  0/7912 (0.00%) 
Myofascial pain syndrome  1  0/7890 (0.00%)  1/7912 (0.01%) 
Myositis  1  0/7890 (0.00%)  1/7912 (0.01%) 
Osteochondrosis  1  1/7890 (0.01%)  0/7912 (0.00%) 
Osteoporosis  1  1/7890 (0.01%)  0/7912 (0.00%) 
Osteoporotic fracture  1  1/7890 (0.01%)  0/7912 (0.00%) 
Pathological fracture  1  1/7890 (0.01%)  0/7912 (0.00%) 
Spinal deformity  1  0/7890 (0.00%)  1/7912 (0.01%) 
Spondylolysis  1  1/7890 (0.01%)  0/7912 (0.00%) 
Synovitis  1  1/7890 (0.01%)  0/7912 (0.00%) 
Tendonitis  1  0/7890 (0.00%)  1/7912 (0.01%) 
Tenosynovitis  1  0/7890 (0.00%)  1/7912 (0.01%) 
Tenosynovitis stenosans  1  1/7890 (0.01%)  0/7912 (0.00%) 
Vertebral foraminal stenosis  1  1/7890 (0.01%)  0/7912 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Prostate cancer  1  64/7890 (0.81%)  67/7912 (0.85%) 
Lung neoplasm malignant  1  37/7890 (0.47%)  33/7912 (0.42%) 
Colon cancer  1  32/7890 (0.41%)  21/7912 (0.27%) 
Bladder cancer  1  19/7890 (0.24%)  21/7912 (0.27%) 
Pancreatic carcinoma  1  8/7890 (0.10%)  17/7912 (0.21%) 
Gastric cancer  1  10/7890 (0.13%)  10/7912 (0.13%) 
Breast cancer  1  7/7890 (0.09%)  9/7912 (0.11%) 
Adenocarcinoma of colon  1  4/7890 (0.05%)  10/7912 (0.13%) 
Metastases to liver  1  9/7890 (0.11%)  5/7912 (0.06%) 
Renal cancer  1  6/7890 (0.08%)  8/7912 (0.10%) 
Hepatic cancer  1  6/7890 (0.08%)  7/7912 (0.09%) 
Lung cancer metastatic  1  7/7890 (0.09%)  6/7912 (0.08%) 
Malignant melanoma  1  3/7890 (0.04%)  9/7912 (0.11%) 
Rectal cancer  1  10/7890 (0.13%)  2/7912 (0.03%) 
Basal Cell Carcinoma  1  8/7890 (0.10%)  3/7912 (0.04%) 
Metastases to bone  1  6/7890 (0.08%)  5/7912 (0.06%) 
Metastases to lymph node  1  7/7890 (0.09%)  4/7912 (0.05%) 
Metastases to lung  1  7/7890 (0.09%)  3/7912 (0.04%) 
Small Cell Lung Cancer  1  5/7890 (0.06%)  5/7912 (0.06%) 
Transitional cell carcinoma  1  4/7890 (0.05%)  6/7912 (0.08%) 
Colon adenoma  1  5/7890 (0.06%)  4/7912 (0.05%) 
Laryngeal cancer  1  1/7890 (0.01%)  8/7912 (0.10%) 
Lung adenocarcinoma  1  3/7890 (0.04%)  6/7912 (0.08%) 
Non-Small cell lung cancer  1  5/7890 (0.06%)  4/7912 (0.05%) 
Oesophageal Carcinoma  1  5/7890 (0.06%)  4/7912 (0.05%) 
Renal Cell Carcinoma  1  5/7890 (0.06%)  4/7912 (0.05%) 
Chronic lymphocytic leukaemia  1  5/7890 (0.06%)  3/7912 (0.04%) 
Prostate cancer metastatic  1  4/7890 (0.05%)  4/7912 (0.05%) 
Squamous cell carcinoma  1  4/7890 (0.05%)  4/7912 (0.05%) 
Bladder neoplasm  1  2/7890 (0.03%)  5/7912 (0.06%) 
Cholangiocarcinoma  1  3/7890 (0.04%)  4/7912 (0.05%) 
Plasma cell myeloma  1  4/7890 (0.05%)  3/7912 (0.04%) 
Prostatic adenoma  1  4/7890 (0.05%)  3/7912 (0.04%) 
Acute myeloid leukaemia  1  0/7890 (0.00%)  6/7912 (0.08%) 
Myelodysplastic syndrome  1  3/7890 (0.04%)  3/7912 (0.04%) 
Rectal adenocarcinoma  1  4/7890 (0.05%)  2/7912 (0.03%) 
Adenocarcinoma  1  1/7890 (0.01%)  4/7912 (0.05%) 
Adenocarcinoma gastric  1  2/7890 (0.03%)  3/7912 (0.04%) 
Adenocarcinoma pancreas  1  3/7890 (0.04%)  2/7912 (0.03%) 
Bladder transitional cell carcinoma  1  2/7890 (0.03%)  3/7912 (0.04%) 
Bronchial carcinoma  1  4/7890 (0.05%)  1/7912 (0.01%) 
Hepatic cancer metastatic  1  3/7890 (0.04%)  2/7912 (0.03%) 
Lymphoma  1  4/7890 (0.05%)  1/7912 (0.01%) 
Meningioma benign  1  3/7890 (0.04%)  2/7912 (0.03%) 
Metastases to central nervous system  1  3/7890 (0.04%)  2/7912 (0.03%) 
Metastatic lymphoma  1  1/7890 (0.01%)  4/7912 (0.05%) 
B-cell lymphoma  1  2/7890 (0.03%)  2/7912 (0.03%) 
Benign neoplasm of bladder  1  2/7890 (0.03%)  2/7912 (0.03%) 
Benign salivary gland neoplasm  1  4/7890 (0.05%)  0/7912 (0.00%) 
Bile duct cancer  1  1/7890 (0.01%)  0/7912 (0.00%) 
Bladder cancer recurrent  1  3/7890 (0.04%)  1/7912 (0.01%) 
Hepatocellular carcinoma  1  1/7890 (0.01%)  3/7912 (0.04%) 
Lung neoplasm  1  2/7890 (0.03%)  2/7912 (0.03%) 
Meningioma  1  2/7890 (0.03%)  2/7912 (0.03%) 
Metastases to spine  1  4/7890 (0.05%)  0/7912 (0.00%) 
Metastatic malignant melanoma  1  0/7890 (0.00%)  4/7912 (0.05%) 
Metastatic neoplasm  1  2/7890 (0.03%)  2/7912 (0.03%) 
Adenoma benign  1  2/7890 (0.03%)  1/7912 (0.01%) 
Brain neoplasm  1  2/7890 (0.03%)  1/7912 (0.01%) 
Chronic myeloid leukaemia  1  3/7890 (0.04%)  0/7912 (0.00%) 
Endometrial cancer  1  1/7890 (0.01%)  2/7912 (0.03%) 
Lipoma  1  1/7890 (0.01%)  2/7912 (0.03%) 
Malignant neoplasm of unknown primary site  1  2/7890 (0.03%)  1/7912 (0.01%) 
Metastases to adrenals  1  3/7890 (0.04%)  0/7912 (0.00%) 
Non-Hodgkin's lymphoma  1  2/7890 (0.03%)  1/7912 (0.01%) 
Non-small cell lung cancer metastatic  1  1/7890 (0.01%)  2/7912 (0.03%) 
Oesophageal adenocarcinoma  1  0/7890 (0.00%)  3/7912 (0.04%) 
Penile cancer  1  3/7890 (0.04%)  0/7912 (0.00%) 
Renal neoplasm  1  1/7890 (0.01%)  2/7912 (0.03%) 
Squamous cell carcinoma of lung  1  2/7890 (0.03%)  1/7912 (0.01%) 
Benign breast neoplasm  1  1/7890 (0.01%)  1/7912 (0.01%) 
Benign neoplasm of thyroid gland  1  1/7890 (0.01%)  1/7912 (0.01%) 
Bile duct adenocarcinoma  1  2/7890 (0.03%)  0/7912 (0.00%) 
Bone cancer  1  1/7890 (0.01%)  1/7912 (0.01%) 
Bone cancer metastatic  1  1/7890 (0.01%)  1/7912 (0.01%) 
Brain neoplasm benign  1  1/7890 (0.01%)  1/7912 (0.01%) 
Cancer pain  1  1/7890 (0.01%)  1/7912 (0.01%) 
Carcinoid tumour of the duodenum  1  0/7890 (0.00%)  2/7912 (0.03%) 
Cervix carcinoma  1  0/7890 (0.00%)  2/7912 (0.03%) 
Cholesteatoma  1  2/7890 (0.03%)  0/7912 (0.00%) 
Colorectal cancer  1  0/7890 (0.00%)  2/7912 (0.03%) 
Endometrial adenocarcinoma  1  0/7890 (0.00%)  2/7912 (0.03%) 
Gallbladder cancer  1  2/7890 (0.03%)  0/7912 (0.00%) 
Gastric adenoma  1  0/7890 (0.00%)  2/7912 (0.03%) 
Glioma  1  1/7890 (0.01%)  1/7912 (0.01%) 
Hypopharyngeal cancer  1  0/7890 (0.00%)  2/7912 (0.03%) 
Laryngeal squamous cell carcinoma  1  2/7890 (0.03%)  0/7912 (0.00%) 
Lymphocytic lymphoma  1  2/7890 (0.03%)  0/7912 (0.00%) 
Malignant peritoneal neoplasm  1  0/7890 (0.00%)  2/7912 (0.03%) 
Metastases to abdominal cavity  1  0/7890 (0.00%)  2/7912 (0.03%) 
Metastatic carcinoma of the bladder  1  2/7890 (0.03%)  0/7912 (0.00%) 
Neoplasm malignant  1  2/7890 (0.03%)  0/7912 (0.00%) 
Neoplasm prostate  1  2/7890 (0.03%)  0/7912 (0.00%) 
Pancreatic carcinoma metastatic  1  1/7890 (0.01%)  1/7912 (0.01%) 
Papilloma  1  0/7890 (0.00%)  2/7912 (0.03%) 
Renal cancer metastatic  1  1/7890 (0.01%)  1/7912 (0.01%) 
Throat cancer  1  0/7890 (0.00%)  2/7912 (0.03%) 
Tonsil cancer  1  2/7890 (0.03%)  0/7912 (0.00%) 
Ureteric cancer  1  1/7890 (0.01%)  1/7912 (0.01%) 
Uterine leiomyoma  1  1/7890 (0.01%)  1/7912 (0.01%) 
Acoustic neuroma  1  0/7890 (0.00%)  1/7912 (0.01%) 
Acute lymphocytic leukaemia  1  1/7890 (0.01%)  0/7912 (0.00%) 
Adenoid cystic carcinoma  1  1/7890 (0.01%)  0/7912 (0.00%) 
Adrenocortical carcinoma  1  1/7890 (0.01%)  0/7912 (0.00%) 
Ameloblastoma  1  1/7890 (0.01%)  0/7912 (0.00%) 
Anaplastic astrocytoma  1  1/7890 (0.01%)  0/7912 (0.00%) 
Angiosarcoma  1  0/7890 (0.00%)  1/7912 (0.01%) 
Benign anorectal neoplasm  1  1/7890 (0.01%)  0/7912 (0.00%) 
Benign hepatic neoplasm  1  1/7890 (0.01%)  0/7912 (0.00%) 
Benign lung neoplasm  1  1/7890 (0.01%)  0/7912 (0.00%) 
Benign ovarian tumour  1  0/7890 (0.00%)  1/7912 (0.01%) 
Bladder papilloma  1  0/7890 (0.00%)  1/7912 (0.01%) 
Bowen's disease  1  0/7890 (0.00%)  1/7912 (0.01%) 
Brain cancer metastatic  1  0/7890 (0.00%)  1/7912 (0.01%) 
Brain neoplasm malignant  1  1/7890 (0.01%)  0/7912 (0.00%) 
Breast cancer metastatic  1  1/7890 (0.01%)  0/7912 (0.00%) 
Breast cancer stage I  1  1/7890 (0.01%)  0/7912 (0.00%) 
Breast neoplasm  1  1/7890 (0.01%)  0/7912 (0.00%) 
Carcinoid tumour of the gastrointestinal tract  1  1/7890 (0.01%)  0/7912 (0.00%) 
Cardiac myxoma  1  1/7890 (0.01%)  0/7912 (0.00%) 
Chondrosarcoma  1  1/7890 (0.01%)  0/7912 (0.00%) 
Chronic leukaemia  1  0/7890 (0.00%)  1/7912 (0.01%) 
Chronic lymphocytic leukaemia stage 0  1  0/7890 (0.00%)  1/7912 (0.01%) 
Clear cell renal cell carcinoma  1  1/7890 (0.01%)  0/7912 (0.00%) 
Colon cancer metastatic  1  0/7890 (0.00%)  1/7912 (0.01%) 
Colon cancer stage 0  1  0/7890 (0.00%)  1/7912 (0.01%) 
Colon cancer stage II  1  0/7890 (0.00%)  1/7912 (0.01%) 
Colorectal adenocarcinoma  1  0/7890 (0.00%)  1/7912 (0.01%) 
Diffuse large B-cell lymphoma  1  0/7890 (0.00%)  1/7912 (0.01%) 
Endometrial cancer metastatic  1  1/7890 (0.01%)  0/7912 (0.00%) 
Gastric cancer recurrent  1  1/7890 (0.01%)  0/7912 (0.00%) 
Gastrointestinal carcinoma  1  1/7890 (0.01%)  0/7912 (0.00%) 
Gastrointestinal stromal cancer  1  1/7890 (0.01%)  0/7912 (0.00%) 
Gastrointestinal tract adenoma  1  1/7890 (0.01%)  0/7912 (0.00%) 
Glioblastoma  1  0/7890 (0.00%)  1/7912 (0.01%) 
Glottis carcinoma  1  1/7890 (0.01%)  0/7912 (0.00%) 
Haemangioma  1  0/7890 (0.00%)  1/7912 (0.01%) 
Hepatic neoplasm  1  1/7890 (0.01%)  1/7912 (0.01%) 
Hypopharyngeal cancer recurrent  1  0/7890 (0.00%)  1/7912 (0.01%) 
Intraductal papillary-mucinous carcinoma of pancreas  1  0/7890 (0.00%)  1/7912 (0.01%) 
Invasive ductal breast carcinoma  1  1/7890 (0.01%)  0/7912 (0.00%) 
Invasive lobular breast carcinoma  1  0/7890 (0.00%)  1/7912 (0.01%) 
Large intestine benign neoplasm  1  1/7890 (0.01%)  0/7912 (0.00%) 
Laryngeal cancer recurrent  1  0/7890 (0.00%)  1/7912 (0.01%) 
Leiomyosarcoma  1  0/7890 (0.00%)  1/7912 (0.01%) 
Lentigo maligna  1  1/7890 (0.01%)  0/7912 (0.00%) 
Leukaemia  1  1/7890 (0.01%)  0/7912 (0.00%) 
Lip and/or oral cavity cancer  1  1/7890 (0.01%)  0/7912 (0.00%) 
Lip neoplasm malignant stage unspecified  1  1/7890 (0.01%)  0/7912 (0.00%) 
Lung adenocarcinoma stage II  1  0/7890 (0.00%)