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E.V.O.L.V.E. Trial™: EValuation Of Cinacalcet Hydrochloride (HCl) Therapy to Lower CardioVascular Events (EVOLVE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00345839
First received: June 27, 2006
Last updated: July 11, 2014
Last verified: July 2014
Results First Received: June 6, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Conditions: Secondary Hyperparathyroidism
Chronic Kidney Disease
Interventions: Drug: Cinacalcet
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were recruited from dialysis clinics and hospitals between August 2006 to Jan 2008 from 22 countries.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants were screened over a 30 day period.

Reporting Groups
  Description
Cinacalcet Cinacalcet administered orally in doses of 30, 60, 90, 120 or 180 mg per day. Participants could be titrated up to maximum dose based on PTH (parathyroid hormone), serum calcium and safety assessments.
Placebo Participants were given matching placebo tablets compared to the cinacalcet group.

Participant Flow:   Overall Study
    Cinacalcet     Placebo  
STARTED     1948 [1]   1935 [2]
COMPLETED     1799 [3]   1776 [3]
NOT COMPLETED     149     159  
Withdrawal by Subject                 91                 98  
Lost to Follow-up                 58                 61  
[1] Randomized to cinacalcet
[2] Randomized to placebo
[3] Participants who completed study includes those with ended study due to death.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Cinacalcet Cinacalcet administered orally in doses of 30, 60, 90, 120 or 180 mg per day. Participants could be titrated up to maximum dose based on PTH (parathyroid hormone), serum calcium and safety assessments.
Placebo Participants were given matching placebo tablets compared to the cinacalcet group.
Total Total of all reporting groups

Baseline Measures
    Cinacalcet     Placebo     Total  
Number of Participants  
[units: participants]
  1948     1935     3883  
Age  
[units: Years]
Mean ± Standard Deviation
  54.8  ± 14.5     54.0  ± 14.2     54.4  ± 14.4  
Gender  
[units: Participants]
     
Female     809     769     1578  
Male     1139     1166     2305  
Race/Ethnicity, Customized  
[units: Participants]
     
White or Caucasian     1124     1116     2240  
Black or African American     409     428     837  
Hispanic or Latino     317     310     627  
Asian     47     38     85  
Japanese     4     1     5  
American Indian or Alaska Native     5     7     12  
Native Hawaiian or Other Pacific Islander     12     9     21  
Aborigine     1     4     5  
Other     29     22     51  
History of Diabetes Stratification Factor [1]
[units: Participants]
     
Diabetes     619     614     1233  
No Diabetes     1329     1321     2650  
Country stratification factor [2]
[units: Participants]
     
Argentina     171     170     341  
Australia     74     75     149  
Austria     31     29     60  
Belgium     50     50     100  
Brazil     151     150     301  
Canada     73     73     146  
Denmark     8     11     19  
France     40     40     80  
Germany     81     81     162  
Hungary     66     67     133  
Ireland     5     6     11  
Italy     69     68     137  
Mexico     23     22     45  
Netherlands     15     14     29  
Poland     59     57     116  
Portugal     22     21     43  
Russia     143     140     283  
Spain     40     38     78  
Sweden     13     10     23  
Switzerland     18     19     37  
United Kingdom     81     79     160  
United States     715     715     1430  
[1] History of diabetes stratification factor from the interactive voice response system.
[2] Country stratification factor from the interactive voice response system. Denmark and Sweden were combined to create Nordic stratum.



  Outcome Measures
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1.  Primary:   Time to Primary Composite Endpoint (All-cause Mortality, Myocardial Infarction, Hospitalization for Unstable Angina, Heart Failure or Peripheral Vascular Event)   [ Time Frame: From date of randomization until date of first confirmed primary composite endpoint event, assessed up to 5.4 years ]

2.  Secondary:   Time to All-cause Mortality   [ Time Frame: From date of randomization until date of confirmed all-cause mortality endpoint event, assessed up to 5.4 years ]

3.  Secondary:   Time to Myocardial Infarction   [ Time Frame: From date of randomization until date of first confirmed myocardial infarction endpoint event, assessed up to 5.4 years ]

4.  Secondary:   Time to Hospitalization for Unstable Angina   [ Time Frame: From date of randomization until date of first confirmed hospitalization for unstable angina endpoint event, assessed up to 5.4 years ]

5.  Secondary:   Time to Heart Failure   [ Time Frame: From date of randomization until date of first confirmed heart failure endpoint event, assessed up to 5.4 years ]

6.  Secondary:   Time to Peripheral Vascular Event   [ Time Frame: From date of randomization until date of first confirmed peripheral vascular endpoint event, assessed up to 5.4 years ]

7.  Secondary:   Time to Cardiovascular Mortality   [ Time Frame: From date of randomization until date of first confirmed cardiovascular mortality endpoint event, assessed up to 5.4 years ]

8.  Secondary:   Time to Stroke   [ Time Frame: From date of randomization until date of first confirmed stroke endpoint event, assessed up to 5.4 years ]

9.  Secondary:   Time to Bone Fracture   [ Time Frame: From date of randomization until date of first confirmed bone fracture endpoint event, assessed up to 5.4 years ]

10.  Secondary:   Time to Parathyroidectomy   [ Time Frame: From date of randomization until date of first confirmed parathyroidectomy endpoint event, assessed up to 5.4 years ]


  Serious Adverse Events
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Time Frame Average 24 months
Additional Description The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.

Reporting Groups
  Description
Placebo No text entered.
Cinacalcet Cinacalcet administered orally in doses of 30, 60, 90, 120 or 180 mg per day. Participants could be titrated up to maximum dose based on PTH (parathyroid hormone), serum calcium and safety assessments.

Serious Adverse Events
    Placebo     Cinacalcet  
Total, serious adverse events      
# participants affected / at risk     1351/1923 (70.25%)     1338/1938 (69.04%)  
Blood and lymphatic system disorders      
Anaemia † 1    
# participants affected / at risk     35/1923 (1.82%)     42/1938 (2.17%)  
Coagulopathy † 1    
# participants affected / at risk     1/1923 (0.05%)     2/1938 (0.10%)  
Febrile neutropenia † 1    
# participants affected / at risk     1/1923 (0.05%)     0/1938 (0.00%)  
Haemolysis † 1    
# participants affected / at risk     1/1923 (0.05%)     0/1938 (0.00%)  
Haemolytic anaemia † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Haemorrhagic anaemia † 1    
# participants affected / at risk     4/1923 (0.21%)     5/1938 (0.26%)  
Haemorrhagic disorder † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Leukocytosis † 1    
# participants affected / at risk     0/1923 (0.00%)     4/1938 (0.21%)  
Leukopenia † 1    
# participants affected / at risk     1/1923 (0.05%)     2/1938 (0.10%)  
Lymphadenitis † 1    
# participants affected / at risk     1/1923 (0.05%)     0/1938 (0.00%)  
Lymphadenopathy † 1    
# participants affected / at risk     1/1923 (0.05%)     1/1938 (0.05%)  
Lymphatic disorder † 1    
# participants affected / at risk     1/1923 (0.05%)     0/1938 (0.00%)  
Nephrogenic anaemia † 1    
# participants affected / at risk     1/1923 (0.05%)     0/1938 (0.00%)  
Neutropenia † 1    
# participants affected / at risk     0/1923 (0.00%)     2/1938 (0.10%)  
Pancytopenia † 1    
# participants affected / at risk     4/1923 (0.21%)     2/1938 (0.10%)  
Polycythaemia † 1    
# participants affected / at risk     1/1923 (0.05%)     1/1938 (0.05%)  
Retroperitoneal lymphadenopathy † 1    
# participants affected / at risk     1/1923 (0.05%)     0/1938 (0.00%)  
Splenic infarction † 1    
# participants affected / at risk     1/1923 (0.05%)     0/1938 (0.00%)  
Splenomegaly † 1    
# participants affected / at risk     2/1923 (0.10%)     0/1938 (0.00%)  
Thrombocytopenia † 1    
# participants affected / at risk     7/1923 (0.36%)     3/1938 (0.15%)  
Thrombocytopenic purpura † 1    
# participants affected / at risk     1/1923 (0.05%)     0/1938 (0.00%)  
Cardiac disorders      
Acute coronary syndrome † 1    
# participants affected / at risk     14/1923 (0.73%)     6/1938 (0.31%)  
Acute left ventricular failure † 1    
# participants affected / at risk     3/1923 (0.16%)     0/1938 (0.00%)  
Acute myocardial infarction † 1    
# participants affected / at risk     34/1923 (1.77%)     47/1938 (2.43%)  
Angina pectoris † 1    
# participants affected / at risk     42/1923 (2.18%)     36/1938 (1.86%)  
Angina unstable † 1    
# participants affected / at risk     42/1923 (2.18%)     52/1938 (2.68%)  
Aortic valve incompetence † 1    
# participants affected / at risk     1/1923 (0.05%)     1/1938 (0.05%)  
Aortic valve stenosis † 1    
# participants affected / at risk     2/1923 (0.10%)     7/1938 (0.36%)  
Arrhythmia † 1    
# participants affected / at risk     17/1923 (0.88%)     8/1938 (0.41%)  
Arrhythmia supraventricular † 1    
# participants affected / at risk     2/1923 (0.10%)     1/1938 (0.05%)  
Arteriosclerosis coronary artery † 1    
# participants affected / at risk     8/1923 (0.42%)     4/1938 (0.21%)  
Atrial fibrillation † 1    
# participants affected / at risk     68/1923 (3.54%)     56/1938 (2.89%)  
Atrial flutter † 1    
# participants affected / at risk     10/1923 (0.52%)     12/1938 (0.62%)  
Atrial tachycardia † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Atrioventricular block † 1    
# participants affected / at risk     3/1923 (0.16%)     5/1938 (0.26%)  
Atrioventricular block complete † 1    
# participants affected / at risk     7/1923 (0.36%)     6/1938 (0.31%)  
Atrioventricular block first degree † 1    
# participants affected / at risk     1/1923 (0.05%)     0/1938 (0.00%)  
Atrioventricular block second degree † 1    
# participants affected / at risk     2/1923 (0.10%)     1/1938 (0.05%)  
Atrioventricular dissociation † 1    
# participants affected / at risk     1/1923 (0.05%)     1/1938 (0.05%)  
Bradyarrhythmia † 1    
# participants affected / at risk     2/1923 (0.10%)     2/1938 (0.10%)  
Bradycardia † 1    
# participants affected / at risk     9/1923 (0.47%)     12/1938 (0.62%)  
Bundle branch block † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Bundle branch block right † 1    
# participants affected / at risk     1/1923 (0.05%)     0/1938 (0.00%)  
Cardiac arrest † 1    
# participants affected / at risk     57/1923 (2.96%)     60/1938 (3.10%)  
Cardiac disorder † 1    
# participants affected / at risk     1/1923 (0.05%)     0/1938 (0.00%)  
Cardiac failure † 1    
# participants affected / at risk     90/1923 (4.68%)     74/1938 (3.82%)  
Cardiac failure acute † 1    
# participants affected / at risk     4/1923 (0.21%)     6/1938 (0.31%)  
Cardiac failure chronic † 1    
# participants affected / at risk     5/1923 (0.26%)     4/1938 (0.21%)  
Cardiac failure congestive † 1    
# participants affected / at risk     86/1923 (4.47%)     64/1938 (3.30%)  
Cardiac flutter † 1    
# participants affected / at risk     1/1923 (0.05%)     0/1938 (0.00%)  
Cardiac tamponade † 1    
# participants affected / at risk     1/1923 (0.05%)     1/1938 (0.05%)  
Cardiac valve disease † 1    
# participants affected / at risk     2/1923 (0.10%)     0/1938 (0.00%)  
Cardio-respiratory arrest † 1    
# participants affected / at risk     21/1923 (1.09%)     27/1938 (1.39%)  
Cardiogenic shock † 1    
# participants affected / at risk     8/1923 (0.42%)     12/1938 (0.62%)  
Cardiomyopathy † 1    
# participants affected / at risk     7/1923 (0.36%)     6/1938 (0.31%)  
Cardiopulmonary failure † 1    
# participants affected / at risk     6/1923 (0.31%)     6/1938 (0.31%)  
Cardiovascular disorder † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Cardiovascular insufficiency † 1    
# participants affected / at risk     1/1923 (0.05%)     1/1938 (0.05%)  
Congestive cardiomyopathy † 1    
# participants affected / at risk     4/1923 (0.21%)     1/1938 (0.05%)  
Coronary artery disease † 1    
# participants affected / at risk     23/1923 (1.20%)     28/1938 (1.44%)  
Coronary artery insufficiency † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Coronary artery occlusion † 1    
# participants affected / at risk     1/1923 (0.05%)     1/1938 (0.05%)  
Coronary artery stenosis † 1    
# participants affected / at risk     4/1923 (0.21%)     5/1938 (0.26%)  
Diastolic dysfunction † 1    
# participants affected / at risk     1/1923 (0.05%)     1/1938 (0.05%)  
Dilatation ventricular † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Gastrocardiac syndrome † 1    
# participants affected / at risk     1/1923 (0.05%)     0/1938 (0.00%)  
Heart valve stenosis † 1    
# participants affected / at risk     1/1923 (0.05%)     0/1938 (0.00%)  
Hypertensive heart disease † 1    
# participants affected / at risk     2/1923 (0.10%)     0/1938 (0.00%)  
Ischaemic cardiomyopathy † 1    
# participants affected / at risk     4/1923 (0.21%)     2/1938 (0.10%)  
Left ventricular dysfunction † 1    
# participants affected / at risk     0/1923 (0.00%)     2/1938 (0.10%)  
Left ventricular failure † 1    
# participants affected / at risk     6/1923 (0.31%)     1/1938 (0.05%)  
Left ventricular hypertrophy † 1    
# participants affected / at risk     1/1923 (0.05%)     0/1938 (0.00%)  
Mitral valve calcification † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Mitral valve disease † 1    
# participants affected / at risk     0/1923 (0.00%)     2/1938 (0.10%)  
Mitral valve incompetence † 1    
# participants affected / at risk     3/1923 (0.16%)     2/1938 (0.10%)  
Mitral valve stenosis † 1    
# participants affected / at risk     3/1923 (0.16%)     2/1938 (0.10%)  
Myocardial infarction † 1    
# participants affected / at risk     105/1923 (5.46%)     109/1938 (5.62%)  
Myocardial ischaemia † 1    
# participants affected / at risk     10/1923 (0.52%)     11/1938 (0.57%)  
Myocarditis † 1    
# participants affected / at risk     1/1923 (0.05%)     0/1938 (0.00%)  
Palpitations † 1    
# participants affected / at risk     4/1923 (0.21%)     6/1938 (0.31%)  
Pericardial effusion † 1    
# participants affected / at risk     5/1923 (0.26%)     8/1938 (0.41%)  
Pericardial haemorrhage † 1    
# participants affected / at risk     1/1923 (0.05%)     0/1938 (0.00%)  
Pericarditis † 1    
# participants affected / at risk     2/1923 (0.10%)     3/1938 (0.15%)  
Pericarditis uraemic † 1    
# participants affected / at risk     2/1923 (0.10%)     2/1938 (0.10%)  
Pulseless electrical activity † 1    
# participants affected / at risk     5/1923 (0.26%)     2/1938 (0.10%)  
Right ventricular failure † 1    
# participants affected / at risk     1/1923 (0.05%)     2/1938 (0.10%)  
Sick sinus syndrome † 1    
# participants affected / at risk     3/1923 (0.16%)     3/1938 (0.15%)  
Sinus bradycardia † 1    
# participants affected / at risk     1/1923 (0.05%)     0/1938 (0.00%)  
Sinus tachycardia † 1    
# participants affected / at risk     0/1923 (0.00%)     2/1938 (0.10%)  
Supraventricular extrasystoles † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Supraventricular tachyarrhythmia † 1    
# participants affected / at risk     1/1923 (0.05%)     0/1938 (0.00%)  
Supraventricular tachycardia † 1    
# participants affected / at risk     6/1923 (0.31%)     6/1938 (0.31%)  
Tachyarrhythmia † 1    
# participants affected / at risk     1/1923 (0.05%)     0/1938 (0.00%)  
Tachycardia † 1    
# participants affected / at risk     6/1923 (0.31%)     6/1938 (0.31%)  
Tricuspid valve incompetence † 1    
# participants affected / at risk     1/1923 (0.05%)     1/1938 (0.05%)  
Tricuspid valve stenosis † 1    
# participants affected / at risk     1/1923 (0.05%)     0/1938 (0.00%)  
Ventricular arrhythmia † 1    
# participants affected / at risk     5/1923 (0.26%)     3/1938 (0.15%)  
Ventricular extrasystoles † 1    
# participants affected / at risk     1/1923 (0.05%)     1/1938 (0.05%)  
Ventricular failure † 1    
# participants affected / at risk     1/1923 (0.05%)     0/1938 (0.00%)  
Ventricular fibrillation † 1    
# participants affected / at risk     9/1923 (0.47%)     6/1938 (0.31%)  
Ventricular tachyarrhythmia † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Ventricular tachycardia † 1    
# participants affected / at risk     5/1923 (0.26%)     12/1938 (0.62%)  
Congenital, familial and genetic disorders      
Adenomatous polyposis coli † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Congenital cystic disease of liver † 1    
# participants affected / at risk     1/1923 (0.05%)     0/1938 (0.00%)  
Congenital cystic kidney disease † 1    
# participants affected / at risk     3/1923 (0.16%)     6/1938 (0.31%)  
Gastrointestinal arteriovenous malformation † 1    
# participants affected / at risk     1/1923 (0.05%)     2/1938 (0.10%)  
Left ventricle outflow tract obstruction † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Ear and labyrinth disorders      
Aural polyp † 1    
# participants affected / at risk     1/1923 (0.05%)     0/1938 (0.00%)  
Deafness unilateral † 1    
# participants affected / at risk     1/1923 (0.05%)     0/1938 (0.00%)  
Meniere's disease † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Vertigo † 1    
# participants affected / at risk     2/1923 (0.10%)     4/1938 (0.21%)  
Vertigo positional † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Vestibular disorder † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Endocrine disorders      
Adrenal insufficiency † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Goitre † 1    
# participants affected / at risk     1/1923 (0.05%)     0/1938 (0.00%)  
Hyperparathyroidism † 1    
# participants affected / at risk     86/1923 (4.47%)     23/1938 (1.19%)  
Hyperparathyroidism secondary † 1    
# participants affected / at risk     41/1923 (2.13%)     12/1938 (0.62%)  
Hyperparathyroidism tertiary † 1    
# participants affected / at risk     8/1923 (0.42%)     2/1938 (0.10%)  
Hyperthyroidism † 1    
# participants affected / at risk     2/1923 (0.10%)     1/1938 (0.05%)  
Parathyroid disorder † 1    
# participants affected / at risk     1/1923 (0.05%)     0/1938 (0.00%)  
Parathyroid gland enlargement † 1    
# participants affected / at risk     1/1923 (0.05%)     2/1938 (0.10%)  
Parathyroid haemorrhage † 1    
# participants affected / at risk     1/1923 (0.05%)     0/1938 (0.00%)  
Secondary hyperthyroidism † 1    
# participants affected / at risk     1/1923 (0.05%)     0/1938 (0.00%)  
Thyroid cyst † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Thyroiditis † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Eye disorders      
Age-related macular degeneration † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Cataract † 1    
# participants affected / at risk     5/1923 (0.26%)     8/1938 (0.41%)  
Cataract cortical † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Conjunctival haemorrhage † 1    
# participants affected / at risk     1/1923 (0.05%)     0/1938 (0.00%)  
Conjunctivitis † 1    
# participants affected / at risk     0/1923 (0.00%)     2/1938 (0.10%)  
Diabetic retinopathy † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Diplopia † 1    
# participants affected / at risk     1/1923 (0.05%)     1/1938 (0.05%)  
Exophthalmos † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Eye haemorrhage † 1    
# participants affected / at risk     0/1923 (0.00%)     3/1938 (0.15%)  
Glaucoma † 1    
# participants affected / at risk     1/1923 (0.05%)     0/1938 (0.00%)  
Keratitis † 1    
# participants affected / at risk     1/1923 (0.05%)     0/1938 (0.00%)  
Optic atrophy † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Optic ischaemic neuropathy † 1    
# participants affected / at risk     1/1923 (0.05%)     0/1938 (0.00%)  
Papilloedema † 1    
# participants affected / at risk     1/1923 (0.05%)     0/1938 (0.00%)  
Photopsia † 1    
# participants affected / at risk     1/1923 (0.05%)     0/1938 (0.00%)  
Retinal artery occlusion † 1    
# participants affected / at risk     1/1923 (0.05%)     0/1938 (0.00%)  
Retinal detachment † 1    
# participants affected / at risk     0/1923 (0.00%)     3/1938 (0.15%)  
Retinal vein thrombosis † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Retinopathy hypertensive † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Vision blurred † 1    
# participants affected / at risk     1/1923 (0.05%)     0/1938 (0.00%)  
Visual impairment † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Vitreous haemorrhage † 1    
# participants affected / at risk     1/1923 (0.05%)     2/1938 (0.10%)  
Gastrointestinal disorders      
Abdominal discomfort † 1    
# participants affected / at risk     3/1923 (0.16%)     1/1938 (0.05%)  
Abdominal distension † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Abdominal hernia † 1    
# participants affected / at risk     4/1923 (0.21%)     4/1938 (0.21%)  
Abdominal hernia obstructive † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Abdominal pain † 1    
# participants affected / at risk     42/1923 (2.18%)     33/1938 (1.70%)  
Abdominal pain lower † 1    
# participants affected / at risk     2/1923 (0.10%)     1/1938 (0.05%)  
Abdominal pain upper † 1    
# participants affected / at risk     1/1923 (0.05%)     5/1938 (0.26%)  
Abdominal rigidity † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Abdominal strangulated hernia † 1    
# participants affected / at risk     0/1923 (0.00%)     2/1938 (0.10%)  
Anal fistula † 1    
# participants affected / at risk     1/1923 (0.05%)     0/1938 (0.00%)  
Ascites † 1    
# participants affected / at risk     7/1923 (0.36%)     3/1938 (0.15%)  
Barrett's oesophagus † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Colitis † 1    
# participants affected / at risk     7/1923 (0.36%)     5/1938 (0.26%)  
Colitis ischaemic † 1    
# participants affected / at risk     3/1923 (0.16%)     9/1938 (0.46%)  
Colitis ulcerative † 1    
# participants affected / at risk     1/1923 (0.05%)     1/1938 (0.05%)  
Colonic polyp † 1    
# participants affected / at risk     7/1923 (0.36%)     2/1938 (0.10%)  
Colonic pseudo-obstruction † 1    
# participants affected / at risk     1/1923 (0.05%)     0/1938 (0.00%)  
Constipation † 1    
# participants affected / at risk     3/1923 (0.16%)     8/1938 (0.41%)  
Dental caries † 1    
# participants affected / at risk     1/1923 (0.05%)     0/1938 (0.00%)  
Diabetic gastroparesis † 1    
# participants affected / at risk     0/1923 (0.00%)     2/1938 (0.10%)  
Diarrhoea † 1    
# participants affected / at risk     24/1923 (1.25%)     32/1938 (1.65%)  
Diarrhoea haemorrhagic † 1    
# participants affected / at risk     1/1923 (0.05%)     0/1938 (0.00%)  
Dieulafoy's vascular malformation † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Diverticular perforation † 1    
# participants affected / at risk     1/1923 (0.05%)     2/1938 (0.10%)  
Diverticulum † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Diverticulum intestinal † 1    
# participants affected / at risk     2/1923 (0.10%)     0/1938 (0.00%)  
Diverticulum intestinal haemorrhagic † 1    
# participants affected / at risk     1/1923 (0.05%)     0/1938 (0.00%)  
Duodenal perforation † 1    
# participants affected / at risk     2/1923 (0.10%)     0/1938 (0.00%)  
Duodenal ulcer † 1    
# participants affected / at risk     4/1923 (0.21%)     7/1938 (0.36%)  
Duodenal ulcer haemorrhage † 1    
# participants affected / at risk     1/1923 (0.05%)     0/1938 (0.00%)  
Duodenitis † 1    
# participants affected / at risk     4/1923 (0.21%)     2/1938 (0.10%)  
Duodenitis haemorrhagic † 1    
# participants affected / at risk     1/1923 (0.05%)     0/1938 (0.00%)  
Dyspepsia † 1    
# participants affected / at risk     0/1923 (0.00%)     3/1938 (0.15%)  
Dysphagia † 1    
# participants affected / at risk     2/1923 (0.10%)     3/1938 (0.15%)  
Enteritis † 1    
# participants affected / at risk     1/1923 (0.05%)     5/1938 (0.26%)  
Enterocolitis † 1    
# participants affected / at risk     1/1923 (0.05%)     1/1938 (0.05%)  
Erosive duodenitis † 1    
# participants affected / at risk     1/1923 (0.05%)     1/1938 (0.05%)  
Erosive oesophagitis † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Faecaloma † 1    
# participants affected / at risk     1/1923 (0.05%)     3/1938 (0.15%)  
Faeces discoloured † 1    
# participants affected / at risk     1/1923 (0.05%)     1/1938 (0.05%)  
Gastric antral vascular ectasia † 1    
# participants affected / at risk     1/1923 (0.05%)     0/1938 (0.00%)  
Gastric haemorrhage † 1    
# participants affected / at risk     4/1923 (0.21%)     1/1938 (0.05%)  
Gastric hypermotility † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Gastric perforation † 1    
# participants affected / at risk     2/1923 (0.10%)     0/1938 (0.00%)  
Gastric polyps † 1    
# participants affected / at risk     1/1923 (0.05%)     1/1938 (0.05%)  
Gastric ulcer † 1    
# participants affected / at risk     6/1923 (0.31%)     12/1938 (0.62%)  
Gastric ulcer haemorrhage † 1    
# participants affected / at risk     0/1923 (0.00%)     2/1938 (0.10%)  
Gastritis † 1    
# participants affected / at risk     15/1923 (0.78%)     10/1938 (0.52%)  
Gastritis erosive † 1    
# participants affected / at risk     6/1923 (0.31%)     5/1938 (0.26%)  
Gastritis haemorrhagic † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Gastroduodenitis † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Gastrointestinal angiodysplasia † 1    
# participants affected / at risk     0/1923 (0.00%)     2/1938 (0.10%)  
Gastrointestinal haemorrhage † 1    
# participants affected / at risk     53/1923 (2.76%)     54/1938 (2.79%)  
Gastrointestinal hypomotility † 1    
# participants affected / at risk     1/1923 (0.05%)     0/1938 (0.00%)  
Gastrointestinal inflammation † 1    
# participants affected / at risk     1/1923 (0.05%)     2/1938 (0.10%)  
Gastrointestinal necrosis † 1    
# participants affected / at risk     2/1923 (0.10%)     0/1938 (0.00%)  
Gastrointestinal obstruction † 1    
# participants affected / at risk     1/1923 (0.05%)     0/1938 (0.00%)  
Gastrointestinal oedema † 1    
# participants affected / at risk     1/1923 (0.05%)     0/1938 (0.00%)  
Gastrointestinal perforation † 1    
# participants affected / at risk     2/1923 (0.10%)     0/1938 (0.00%)  
Gastrointestinal ulcer haemorrhage † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Gastrooesophageal reflux disease † 1    
# participants affected / at risk     2/1923 (0.10%)     4/1938 (0.21%)  
Haematemesis † 1    
# participants affected / at risk     3/1923 (0.16%)     5/1938 (0.26%)  
Haematochezia † 1    
# participants affected / at risk     2/1923 (0.10%)     2/1938 (0.10%)  
Haemorrhagic erosive gastritis † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Haemorrhoidal haemorrhage † 1    
# participants affected / at risk     2/1923 (0.10%)     2/1938 (0.10%)  
Haemorrhoids † 1    
# participants affected / at risk     2/1923 (0.10%)     5/1938 (0.26%)  
Hernial eventration † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Hiatus hernia † 1    
# participants affected / at risk     1/1923 (0.05%)     2/1938 (0.10%)  
Ileus † 1    
# participants affected / at risk     4/1923 (0.21%)     6/1938 (0.31%)  
Impaired gastric emptying † 1    
# participants affected / at risk     2/1923 (0.10%)     6/1938 (0.31%)  
Inguinal hernia † 1    
# participants affected / at risk     2/1923 (0.10%)     1/1938 (0.05%)  
Intestinal haemorrhage † 1    
# participants affected / at risk     0/1923 (0.00%)     2/1938 (0.10%)  
Intestinal infarction † 1    
# participants affected / at risk     3/1923 (0.16%)     3/1938 (0.15%)  
Intestinal ischaemia † 1    
# participants affected / at risk     6/1923 (0.31%)     9/1938 (0.46%)  
Intestinal mass † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Intestinal obstruction † 1    
# participants affected / at risk     3/1923 (0.16%)     5/1938 (0.26%)  
Intestinal perforation † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Intestinal polyp † 1    
# participants affected / at risk     1/1923 (0.05%)     0/1938 (0.00%)  
Intestinal strangulation † 1    
# participants affected / at risk     1/1923 (0.05%)     0/1938 (0.00%)  
Intestinal ulcer † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Intra-abdominal haemorrhage † 1    
# participants affected / at risk     1/1923 (0.05%)     1/1938 (0.05%)  
Irritable bowel syndrome † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Ischaemic gastritis † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Large intestinal haemorrhage † 1    
# participants affected / at risk     1/1923 (0.05%)     0/1938 (0.00%)  
Large intestinal ulcer † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Large intestine perforation † 1    
# participants affected / at risk     4/1923 (0.21%)     1/1938 (0.05%)  
Lower gastrointestinal haemorrhage † 1    
# participants affected / at risk     5/1923 (0.26%)     3/1938 (0.15%)  
Lumbar hernia † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Mechanical ileus † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Melaena † 1    
# participants affected / at risk     2/1923 (0.10%)     3/1938 (0.15%)  
Mesenteric artery stenosis † 1    
# participants affected / at risk     0/1923 (0.00%)     2/1938 (0.10%)  
Nausea † 1    
# participants affected / at risk     16/1923 (0.83%)     20/1938 (1.03%)  
Necrotising colitis † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Oesophageal achalasia † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Oesophageal disorder † 1    
# participants affected / at risk     1/1923 (0.05%)     0/1938 (0.00%)  
Oesophageal food impaction † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Oesophageal haemorrhage † 1    
# participants affected / at risk     1/1923 (0.05%)     0/1938 (0.00%)  
Oesophageal perforation † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Oesophageal rupture † 1    
# participants affected / at risk     1/1923 (0.05%)     0/1938 (0.00%)  
Oesophageal ulcer † 1    
# participants affected / at risk     2/1923 (0.10%)     0/1938 (0.00%)  
Oesophagitis † 1    
# participants affected / at risk     3/1923 (0.16%)     6/1938 (0.31%)  
Oesophagitis haemorrhagic † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Pancreatic mass † 1    
# participants affected / at risk     1/1923 (0.05%)     0/1938 (0.00%)  
Pancreatitis † 1    
# participants affected / at risk     11/1923 (0.57%)     10/1938 (0.52%)  
Pancreatitis acute † 1    
# participants affected / at risk     9/1923 (0.47%)     7/1938 (0.36%)  
Pancreatitis chronic † 1    
# participants affected / at risk     1/1923 (0.05%)     2/1938 (0.10%)  
Peptic ulcer † 1    
# participants affected / at risk     2/1923 (0.10%)     1/1938 (0.05%)  
Peptic ulcer haemorrhage † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Peritoneal disorder † 1    
# participants affected / at risk     1/1923 (0.05%)     0/1938 (0.00%)  
Portal hypertensive enteropathy † 1    
# participants affected / at risk     1/1923 (0.05%)     0/1938 (0.00%)  
Portal hypertensive gastropathy † 1    
# participants affected / at risk     1/1923 (0.05%)     0/1938 (0.00%)  
Proctitis † 1    
# participants affected / at risk     1/1923 (0.05%)     0/1938 (0.00%)  
Rectal haemorrhage † 1    
# participants affected / at risk     12/1923 (0.62%)     12/1938 (0.62%)  
Rectal ulcer † 1    
# participants affected / at risk     1/1923 (0.05%)     1/1938 (0.05%)  
Rectal ulcer haemorrhage † 1    
# participants affected / at risk     1/1923 (0.05%)     0/1938 (0.00%)  
Retroperitoneal haematoma † 1    
# participants affected / at risk     2/1923 (0.10%)     2/1938 (0.10%)  
Retroperitoneal haemorrhage † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Retroperitoneal mass † 1    
# participants affected / at risk     1/1923 (0.05%)     0/1938 (0.00%)  
Short-bowel syndrome † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Sigmoiditis † 1    
# participants affected / at risk     1/1923 (0.05%)     0/1938 (0.00%)  
Small intestinal obstruction † 1    
# participants affected / at risk     2/1923 (0.10%)     5/1938 (0.26%)  
Stomach mass † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Stress ulcer † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Subileus † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Tooth loss † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Tooth socket haemorrhage † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Toothache † 1    
# participants affected / at risk     2/1923 (0.10%)     0/1938 (0.00%)  
Umbilical hernia † 1    
# participants affected / at risk     3/1923 (0.16%)     1/1938 (0.05%)  
Umbilical hernia, obstructive † 1    
# participants affected / at risk     1/1923 (0.05%)     0/1938 (0.00%)  
Upper gastrointestinal haemorrhage † 1    
# participants affected / at risk     8/1923 (0.42%)     11/1938 (0.57%)  
Uraemic gastropathy † 1    
# participants affected / at risk     1/1923 (0.05%)     0/1938 (0.00%)  
Varices oesophageal † 1    
# participants affected / at risk     2/1923 (0.10%)     0/1938 (0.00%)  
Vomiting † 1    
# participants affected / at risk     23/1923 (1.20%)     33/1938 (1.70%)  
General disorders      
Adverse drug reaction † 1    
# participants affected / at risk     1/1923 (0.05%)     1/1938 (0.05%)  
Asthenia † 1    
# participants affected / at risk     20/1923 (1.04%)     15/1938 (0.77%)  
Calcinosis † 1    
# participants affected / at risk     2/1923 (0.10%)     0/1938 (0.00%)  
Catheter site haematoma † 1    
# participants affected / at risk     1/1923 (0.05%)     3/1938 (0.15%)  
Catheter site haemorrhage † 1    
# participants affected / at risk     5/1923 (0.26%)     3/1938 (0.15%)  
Catheter site pain † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Catheter site swelling † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Chest discomfort † 1    
# participants affected / at risk     3/1923 (0.16%)     4/1938 (0.21%)  
Chest pain † 1    
# participants affected / at risk     53/1923 (2.76%)     51/1938 (2.63%)  
Chills † 1    
# participants affected / at risk     2/1923 (0.10%)     4/1938 (0.21%)  
Condition aggravated † 1    
# participants affected / at risk     1/1923 (0.05%)     0/1938 (0.00%)  
Cyst † 1    
# participants affected / at risk     1/1923 (0.05%)     1/1938 (0.05%)  
Death † 1    
# participants affected / at risk     38/1923 (1.98%)     38/1938 (1.96%)  
Device breakage † 1    
# participants affected / at risk     1/1923 (0.05%)     0/1938 (0.00%)  
Device dislocation † 1    
# participants affected / at risk     1/1923 (0.05%)     2/1938 (0.10%)  
Device failure † 1    
# participants affected / at risk     2/1923 (0.10%)     0/1938 (0.00%)  
Device malfunction † 1    
# participants affected / at risk     2/1923 (0.10%)     2/1938 (0.10%)  
Device occlusion † 1    
# participants affected / at risk     1/1923 (0.05%)     2/1938 (0.10%)  
Drug intolerance † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Drug withdrawal syndrome † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Face oedema † 1    
# participants affected / at risk     1/1923 (0.05%)     1/1938 (0.05%)  
Fat necrosis † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Fatigue † 1    
# participants affected / at risk     3/1923 (0.16%)     1/1938 (0.05%)  
Feeling abnormal † 1    
# participants affected / at risk     1/1923 (0.05%)     0/1938 (0.00%)  
Gait disturbance † 1    
# participants affected / at risk     2/1923 (0.10%)     0/1938 (0.00%)  
General physical health deterioration † 1    
# participants affected / at risk     8/1923 (0.42%)     7/1938 (0.36%)  
Granuloma † 1    
# participants affected / at risk     1/1923 (0.05%)     0/1938 (0.00%)  
Hernia † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Hernia obstructive † 1    
# participants affected / at risk     4/1923 (0.21%)     0/1938 (0.00%)  
Hernia pain † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Hyperthermia † 1    
# participants affected / at risk     1/1923 (0.05%)     2/1938 (0.10%)  
Hypothermia † 1    
# participants affected / at risk     2/1923 (0.10%)     2/1938 (0.10%)  
Impaired healing † 1    
# participants affected / at risk     10/1923 (0.52%)     5/1938 (0.26%)  
Implant site effusion † 1    
# participants affected / at risk     1/1923 (0.05%)     0/1938 (0.00%)  
Implant site haematoma † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Inflammation † 1    
# participants affected / at risk     1/1923 (0.05%)     0/1938 (0.00%)  
Influenza like illness † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Infusion site thrombosis † 1    
# participants affected / at risk     1/1923 (0.05%)     0/1938 (0.00%)  
Ischaemic ulcer † 1    
# participants affected / at risk     4/1923 (0.21%)     0/1938 (0.00%)  
Localised oedema † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Malaise † 1    
# participants affected / at risk     4/1923 (0.21%)     4/1938 (0.21%)  
Medical device complication † 1    
# participants affected / at risk     17/1923 (0.88%)     9/1938 (0.46%)  
Multi-organ failure † 1    
# participants affected / at risk     5/1923 (0.26%)     8/1938 (0.41%)  
Necrosis † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Non-cardiac chest pain † 1    
# participants affected / at risk     23/1923 (1.20%)     27/1938 (1.39%)  
Oedema † 1    
# participants affected / at risk     1/1923 (0.05%)     0/1938 (0.00%)  
Oedema peripheral † 1    
# participants affected / at risk     5/1923 (0.26%)     4/1938 (0.21%)  
Organ failure † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Pain † 1    
# participants affected / at risk     4/1923 (0.21%)     1/1938 (0.05%)  
Pelvic mass † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Polyserositis † 1    
# participants affected / at risk     1/1923 (0.05%)     0/1938 (0.00%)  
Precancerous mucosal lesion † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Pyrexia † 1    
# participants affected / at risk     35/1923 (1.82%)     42/1938 (2.17%)  
Spinal pain † 1    
# participants affected / at risk     1/1923 (0.05%)     2/1938 (0.10%)  
Sudden cardiac death † 1    
# participants affected / at risk     7/1923 (0.36%)     7/1938 (0.36%)  
Sudden death † 1    
# participants affected / at risk     26/1923 (1.35%)     22/1938 (1.14%)  
Systemic inflammatory response syndrome † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Thrombosis in device † 1    
# participants affected / at risk     5/1923 (0.26%)     4/1938 (0.21%)  
Ulcer † 1    
# participants affected / at risk     2/1923 (0.10%)     1/1938 (0.05%)  
Ulcer haemorrhage † 1    
# participants affected / at risk     1/1923 (0.05%)     0/1938 (0.00%)  
Hepatobiliary disorders      
Bile duct obstruction † 1    
# participants affected / at risk     1/1923 (0.05%)     0/1938 (0.00%)  
Bile duct stone † 1    
# participants affected / at risk     0/1923 (0.00%)     3/1938 (0.15%)  
Biliary colic † 1    
# participants affected / at risk     2/1923 (0.10%)     0/1938 (0.00%)  
Biliary dyskinesia † 1    
# participants affected / at risk     1/1923 (0.05%)     0/1938 (0.00%)  
Cholangitis † 1    
# participants affected / at risk     2/1923 (0.10%)     3/1938 (0.15%)  
Cholangitis acute † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Cholecystitis † 1    
# participants affected / at risk     10/1923 (0.52%)     9/1938 (0.46%)  
Cholecystitis acute † 1    
# participants affected / at risk     5/1923 (0.26%)     7/1938 (0.36%)  
Cholecystitis chronic † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Cholelithiasis † 1    
# participants affected / at risk     12/1923 (0.62%)     16/1938 (0.83%)  
Cholestasis † 1    
# participants affected / at risk     1/1923 (0.05%)     2/1938 (0.10%)  
Chronic hepatic failure † 1    
# participants affected / at risk     1/1923 (0.05%)     0/1938 (0.00%)  
Gallbladder perforation † 1    
# participants affected / at risk     1/1923 (0.05%)     0/1938 (0.00%)  
Gallbladder polyp † 1    
# participants affected / at risk     0/1923 (0.00%)     2/1938 (0.10%)  
Hepatic cirrhosis † 1    
# participants affected / at risk     3/1923 (0.16%)     2/1938 (0.10%)  
Hepatic congestion † 1    
# participants affected / at risk     1/1923 (0.05%)     0/1938 (0.00%)  
Hepatic cyst ruptured † 1    
# participants affected / at risk     1/1923 (0.05%)     0/1938 (0.00%)  
Hepatic failure † 1    
# participants affected / at risk     3/1923 (0.16%)     2/1938 (0.10%)  
Hepatic function abnormal † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Hepatic lesion † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Hepatitis † 1    
# participants affected / at risk     2/1923 (0.10%)     0/1938 (0.00%)  
Hepatitis toxic † 1    
# participants affected / at risk     2/1923 (0.10%)     0/1938 (0.00%)  
Jaundice cholestatic † 1    
# participants affected / at risk     1/1923 (0.05%)     1/1938 (0.05%)  
Liver disorder † 1    
# participants affected / at risk     1/1923 (0.05%)     0/1938 (0.00%)  
Immune system disorders      
Amyloidosis † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Anaphylactic reaction † 1    
# participants affected / at risk     3/1923 (0.16%)     1/1938 (0.05%)  
Contrast media allergy † 1    
# participants affected / at risk     1/1923 (0.05%)     0/1938 (0.00%)  
Dialysis amyloidosis † 1    
# participants affected / at risk     1/1923 (0.05%)     1/1938 (0.05%)  
Kidney transplant rejection † 1    
# participants affected / at risk     3/1923 (0.16%)     6/1938 (0.31%)  
Transplant rejection † 1    
# participants affected / at risk     1/1923 (0.05%)     1/1938 (0.05%)  
Infections and infestations      
Abdominal abscess † 1    
# participants affected / at risk     1/1923 (0.05%)     2/1938 (0.10%)  
Abdominal sepsis † 1    
# participants affected / at risk     3/1923 (0.16%)     0/1938 (0.00%)  
Abdominal wall abscess † 1    
# participants affected / at risk     1/1923 (0.05%)     4/1938 (0.21%)  
Abdominal wall infection † 1    
# participants affected / at risk     1/1923 (0.05%)     0/1938 (0.00%)  
Abscess † 1    
# participants affected / at risk     2/1923 (0.10%)     3/1938 (0.15%)  
Abscess intestinal † 1    
# participants affected / at risk     2/1923 (0.10%)     1/1938 (0.05%)  
Abscess limb † 1    
# participants affected / at risk     5/1923 (0.26%)     9/1938 (0.46%)  
Abscess neck † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Abscess of eyelid † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Abscess oral † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Acute sinusitis † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Amoebic dysentery † 1    
# participants affected / at risk     1/1923 (0.05%)     0/1938 (0.00%)  
Appendicitis † 1    
# participants affected / at risk     4/1923 (0.21%)     6/1938 (0.31%)  
Appendicitis perforated † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Arteriosclerotic gangrene † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Arteriovenous fistula site infection † 1    
# participants affected / at risk     15/1923 (0.78%)     10/1938 (0.52%)  
Arteriovenous graft site infection † 1    
# participants affected / at risk     14/1923 (0.73%)     25/1938 (1.29%)  
Arthritis bacterial † 1    
# participants affected / at risk     2/1923 (0.10%)     4/1938 (0.21%)  
Arthritis infective † 1    
# participants affected / at risk     0/1923 (0.00%)     2/1938 (0.10%)  
Bacteraemia † 1    
# participants affected / at risk     24/1923 (1.25%)     27/1938 (1.39%)  
Bacterial infection † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Bacterial sepsis † 1    
# participants affected / at risk     2/1923 (0.10%)     1/1938 (0.05%)  
Bartholin's abscess † 1    
# participants affected / at risk     1/1923 (0.05%)     0/1938 (0.00%)  
Biliary sepsis † 1    
# participants affected / at risk     1/1923 (0.05%)     1/1938 (0.05%)  
Biliary tract infection † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Breast cellulitis † 1    
# participants affected / at risk     1/1923 (0.05%)     0/1938 (0.00%)  
Bronchitis † 1    
# participants affected / at risk     25/1923 (1.30%)     26/1938 (1.34%)  
Bronchitis bacterial † 1    
# participants affected / at risk     1/1923 (0.05%)     0/1938 (0.00%)  
Bronchitis viral † 1    
# participants affected / at risk     1/1923 (0.05%)     1/1938 (0.05%)  
Bronchopneumonia † 1    
# participants affected / at risk     7/1923 (0.36%)     5/1938 (0.26%)  
Carbuncle † 1    
# participants affected / at risk     2/1923 (0.10%)     0/1938 (0.00%)  
Catheter site cellulitis † 1    
# participants affected / at risk     0/1923 (0.00%)     2/1938 (0.10%)  
Catheter site infection † 1    
# participants affected / at risk     6/1923 (0.31%)     6/1938 (0.31%)  
Cellulitis † 1    
# participants affected / at risk     38/1923 (1.98%)     29/1938 (1.50%)  
Cellulitis gangrenous † 1    
# participants affected / at risk     1/1923 (0.05%)     0/1938 (0.00%)  
Cellulitis orbital † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Cellulitis staphylococcal † 1    
# participants affected / at risk     1/1923 (0.05%)     0/1938 (0.00%)  
Chest wall abscess † 1    
# participants affected / at risk     1/1923 (0.05%)     0/1938 (0.00%)  
Clostridial infection † 1    
# participants affected / at risk     1/1923 (0.05%)     3/1938 (0.15%)  
Clostridium colitis † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Clostridium difficile colitis † 1    
# participants affected / at risk     7/1923 (0.36%)     9/1938 (0.46%)  
Cystitis † 1    
# participants affected / at risk     2/1923 (0.10%)     2/1938 (0.10%)  
Dengue fever † 1    
# participants affected / at risk     0/1923 (0.00%)     2/1938 (0.10%)  
Dermo-hypodermitis † 1    
# participants affected / at risk     1/1923 (0.05%)     0/1938 (0.00%)  
Device related infection † 1    
# participants affected / at risk     28/1923 (1.46%)     29/1938 (1.50%)  
Device related sepsis † 1    
# participants affected / at risk     18/1923 (0.94%)     15/1938 (0.77%)  
Diabetic foot infection † 1    
# participants affected / at risk     5/1923 (0.26%)     1/1938 (0.05%)  
Diabetic gangrene † 1    
# participants affected / at risk     2/1923 (0.10%)     1/1938 (0.05%)  
Disseminated tuberculosis † 1    
# participants affected / at risk     1/1923 (0.05%)     0/1938 (0.00%)  
Diverticulitis † 1    
# participants affected / at risk     8/1923 (0.42%)     9/1938 (0.46%)  
Ear infection † 1    
# participants affected / at risk     1/1923 (0.05%)     0/1938 (0.00%)  
Embolic pneumonia † 1    
# participants affected / at risk     1/1923 (0.05%)     0/1938 (0.00%)  
Emphysematous cystitis † 1    
# participants affected / at risk     1/1923 (0.05%)     0/1938 (0.00%)  
Empyema † 1    
# participants affected / at risk     3/1923 (0.16%)     2/1938 (0.10%)  
Endocarditis † 1    
# participants affected / at risk     10/1923 (0.52%)     13/1938 (0.67%)  
Endocarditis bacterial † 1    
# participants affected / at risk     5/1923 (0.26%)     2/1938 (0.10%)  
Endocarditis staphylococcal † 1    
# participants affected / at risk     1/1923 (0.05%)     1/1938 (0.05%)  
Enteritis infectious † 1    
# participants affected / at risk     1/1923 (0.05%)     2/1938 (0.10%)  
Enterobacter bacteraemia † 1    
# participants affected / at risk     1/1923 (0.05%)     2/1938 (0.10%)  
Enterobacter pneumonia † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Enterobacter sepsis † 1    
# participants affected / at risk     0/1923 (0.00%)     3/1938 (0.15%)  
Enterococcal bacteraemia † 1    
# participants affected / at risk     2/1923 (0.10%)     3/1938 (0.15%)  
Enterococcal infection † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Enterocolitis bacterial † 1    
# participants affected / at risk     1/1923 (0.05%)     0/1938 (0.00%)  
Enterocolitis infectious † 1    
# participants affected / at risk     0/1923 (0.00%)     2/1938 (0.10%)  
Erysipelas † 1    
# participants affected / at risk     8/1923 (0.42%)     8/1938 (0.41%)  
Escherichia bacteraemia † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Escherichia infection † 1    
# participants affected / at risk     1/1923 (0.05%)     0/1938 (0.00%)  
Escherichia sepsis † 1    
# participants affected / at risk     2/1923 (0.10%)     2/1938 (0.10%)  
Extradural abscess † 1    
# participants affected / at risk     2/1923 (0.10%)     1/1938 (0.05%)  
Eye infection † 1    
# participants affected / at risk     0/1923 (0.00%)     2/1938 (0.10%)  
Fungaemia † 1    
# participants affected / at risk     1/1923 (0.05%)     1/1938 (0.05%)  
Fungal oesophagitis † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Furuncle † 1    
# participants affected / at risk     2/1923 (0.10%)     0/1938 (0.00%)  
Gangrene † 1    
# participants affected / at risk     42/1923 (2.18%)     38/1938 (1.96%)  
Gas gangrene † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Gastric infection † 1    
# participants affected / at risk     1/1923 (0.05%)     0/1938 (0.00%)  
Gastroenteritis † 1    
# participants affected / at risk     20/1923 (1.04%)     24/1938 (1.24%)  
Gastroenteritis clostridial † 1    
# participants affected / at risk     1/1923 (0.05%)     1/1938 (0.05%)  
Gastroenteritis norovirus † 1    
# participants affected / at risk     1/1923 (0.05%)     1/1938 (0.05%)  
Gastroenteritis salmonella † 1    
# participants affected / at risk     1/1923 (0.05%)     0/1938 (0.00%)  
Gastroenteritis viral † 1    
# participants affected / at risk     4/1923 (0.21%)     8/1938 (0.41%)  
Giardiasis † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Graft infection † 1    
# participants affected / at risk     6/1923 (0.31%)     2/1938 (0.10%)  
Groin abscess † 1    
# participants affected / at risk     1/1923 (0.05%)     0/1938 (0.00%)  
H1N1 influenza † 1    
# participants affected / at risk     1/1923 (0.05%)     3/1938 (0.15%)  
Haematoma infection † 1    
# participants affected / at risk     0/1923 (0.00%)     2/1938 (0.10%)  
Haemophilus infection † 1    
# participants affected / at risk     0/1923 (0.00%)     2/1938 (0.10%)  
Helicobacter infection † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Hepatitis B † 1    
# participants affected / at risk     1/1923 (0.05%)     1/1938 (0.05%)  
Hepatitis C † 1    
# participants affected / at risk     0/1923 (0.00%)     2/1938 (0.10%)  
Herpes zoster † 1    
# participants affected / at risk     2/1923 (0.10%)     4/1938 (0.21%)  
Herpes zoster ophthalmic † 1    
# participants affected / at risk     1/1923 (0.05%)     0/1938 (0.00%)  
Implant site infection † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Incision site infection † 1    
# participants affected / at risk     1/1923 (0.05%)     0/1938 (0.00%)  
Infected fistula † 1    
# participants affected / at risk     0/1923 (0.00%)     3/1938 (0.15%)  
Infected skin ulcer † 1    
# participants affected / at risk     7/1923 (0.36%)     5/1938 (0.26%)  
Infection † 1    
# participants affected / at risk     11/1923 (0.57%)     11/1938 (0.57%)  
Infectious peritonitis † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Infectious pleural effusion † 1    
# participants affected / at risk     1/1923 (0.05%)     0/1938 (0.00%)  
Infective aneurysm † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Infective exacerbation of chronic obstructive airways disease † 1    
# participants affected / at risk     1/1923 (0.05%)     1/1938 (0.05%)  
Infective tenosynovitis † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Influenza † 1    
# participants affected / at risk     2/1923 (0.10%)     4/1938 (0.21%)  
Intervertebral discitis † 1    
# participants affected / at risk     4/1923 (0.21%)     4/1938 (0.21%)  
Joint abscess † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Kidney infection † 1    
# participants affected / at risk     1/1923 (0.05%)     0/1938 (0.00%)  
Klebsiella bacteraemia † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Laryngitis † 1    
# participants affected / at risk     1/1923 (0.05%)     0/1938 (0.00%)  
Liver abscess † 1    
# participants affected / at risk     2/1923 (0.10%)     2/1938 (0.10%)  
Lobar pneumonia † 1    
# participants affected / at risk     17/1923 (0.88%)     14/1938 (0.72%)  
Localised infection † 1    
# participants affected / at risk     17/1923 (0.88%)     11/1938 (0.57%)  
Lower respiratory tract infection † 1    
# participants affected / at risk     8/1923 (0.42%)     11/1938 (0.57%)  
Lower respiratory tract infection bacterial † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Lower respiratory tract infection viral † 1    
# participants affected / at risk     1/1923 (0.05%)     0/1938 (0.00%)  
Lung infection † 1    
# participants affected / at risk     4/1923 (0.21%)     3/1938 (0.15%)  
Lymph gland infection † 1    
# participants affected / at risk     1/1923 (0.05%)     0/1938 (0.00%)  
Meningitis † 1    
# participants affected / at risk     2/1923 (0.10%)     1/1938 (0.05%)  
Meningitis bacterial † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Meningitis cryptococcal † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Meningitis viral † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Morganella infection † 1    
# participants affected / at risk     1/1923 (0.05%)     0/1938 (0.00%)  
Nasal abscess † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Necrotising fasciitis † 1    
# participants affected / at risk     2/1923 (0.10%)     2/1938 (0.10%)  
Oesophageal candidiasis † 1    
# participants affected / at risk     2/1923 (0.10%)     1/1938 (0.05%)  
Orchitis † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Osteomyelitis † 1    
# participants affected / at risk     26/1923 (1.35%)     15/1938 (0.77%)  
Osteomyelitis chronic † 1    
# participants affected / at risk     1/1923 (0.05%)     0/1938 (0.00%)  
Otitis externa † 1    
# participants affected / at risk     1/1923 (0.05%)     0/1938 (0.00%)  
Otitis externa bacterial † 1    
# participants affected / at risk     1/1923 (0.05%)     0/1938 (0.00%)  
Parotitis † 1    
# participants affected / at risk     1/1923 (0.05%)     0/1938 (0.00%)  
Perineal abscess † 1    
# participants affected / at risk     1/1923 (0.05%)     0/1938 (0.00%)  
Periorbital cellulitis † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Perirectal abscess † 1    
# participants affected / at risk     0/1923 (0.00%)     2/1938 (0.10%)  
Peritoneal abscess † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Peritonitis † 1    
# participants affected / at risk     7/1923 (0.36%)     9/1938 (0.46%)  
Peritonitis bacterial † 1    
# participants affected / at risk     3/1923 (0.16%)     1/1938 (0.05%)  
Peritonsillar abscess † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Pharyngitis † 1    
# participants affected / at risk     3/1923 (0.16%)     1/1938 (0.05%)  
Pilonidal cyst † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Pleural infection † 1    
# participants affected / at risk     1/1923 (0.05%)     0/1938 (0.00%)  
Pneumococcal bacteraemia † 1    
# participants affected / at risk     1/1923 (0.05%)     0/1938 (0.00%)  
Pneumonia † 1    
# participants affected / at risk     171/1923 (8.89%)     118/1938 (6.09%)  
Pneumonia bacterial † 1    
# participants affected / at risk     1/1923 (0.05%)     1/1938 (0.05%)  
Pneumonia cytomegaloviral † 1    
# participants affected / at risk     1/1923 (0.05%)     0/1938 (0.00%)  
Pneumonia escherichia † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Pneumonia fungal † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Pneumonia pneumococcal † 1    
# participants affected / at risk     1/1923 (0.05%)     0/1938 (0.00%)  
Pneumonia primary atypical † 1    
# participants affected / at risk     0/1923 (0.00%)     2/1938 (0.10%)  
Pneumonia staphylococcal † 1    
# participants affected / at risk     1/1923 (0.05%)     1/1938 (0.05%)  
Pneumonia streptococcal † 1    
# participants affected / at risk     2/1923 (0.10%)     0/1938 (0.00%)  
Pneumonia viral † 1    
# participants affected / at risk     0/1923 (0.00%)     2/1938 (0.10%)  
Post procedural infection † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Post procedural pneumonia † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Post procedural sepsis † 1    
# participants affected / at risk     1/1923 (0.05%)     0/1938 (0.00%)  
Postoperative abscess † 1    
# participants affected / at risk     1/1923 (0.05%)     3/1938 (0.15%)  
Postoperative wound infection † 1    
# participants affected / at risk     14/1923 (0.73%)     7/1938 (0.36%)  
Pseudomembranous colitis † 1    
# participants affected / at risk     2/1923 (0.10%)     0/1938 (0.00%)  
Pseudomonas infection † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Pulmonary sepsis † 1    
# participants affected / at risk     2/1923 (0.10%)     1/1938 (0.05%)  
Pulmonary tuberculosis † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Purulent discharge † 1    
# participants affected / at risk     1/1923 (0.05%)     0/1938 (0.00%)  
Pyelocystitis † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Pyelonephritis † 1    
# participants affected / at risk     3/1923 (0.16%)     9/1938 (0.46%)  
Pyelonephritis acute † 1    
# participants affected / at risk     0/1923 (0.00%)     2/1938 (0.10%)  
Pyelonephritis chronic † 1    
# participants affected / at risk     2/1923 (0.10%)     0/1938 (0.00%)  
Pyonephrosis † 1    
# participants affected / at risk     1/1923 (0.05%)     1/1938 (0.05%)  
Rectal abscess † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Renal abscess † 1    
# participants affected / at risk     1/1923 (0.05%)     1/1938 (0.05%)  
Renal cyst infection † 1    
# participants affected / at risk     1/1923 (0.05%)     2/1938 (0.10%)  
Respiratory tract infection † 1    
# participants affected / at risk     8/1923 (0.42%)     8/1938 (0.41%)  
Respiratory tract infection bacterial † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Respiratory tract infection fungal † 1    
# participants affected / at risk     1/1923 (0.05%)     1/1938 (0.05%)  
Respiratory tract infection viral † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Retroperitoneal abscess † 1    
# participants affected / at risk     1/1923 (0.05%)     1/1938 (0.05%)  
Scrotal abscess † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Scrotal gangrene † 1    
# participants affected / at risk     1/1923 (0.05%)     0/1938 (0.00%)  
Sepsis † 1    
# participants affected / at risk     111/1923 (5.77%)     123/1938 (6.35%)  
Sepsis syndrome † 1    
# participants affected / at risk     3/1923 (0.16%)     2/1938 (0.10%)  
Septic shock † 1    
# participants affected / at risk     35/1923 (1.82%)     35/1938 (1.81%)  
Serratia bacteraemia † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Serratia sepsis † 1    
# participants affected / at risk     1/1923 (0.05%)     0/1938 (0.00%)  
Shunt infection † 1    
# participants affected / at risk     3/1923 (0.16%)     3/1938 (0.15%)  
Sinusitis † 1    
# participants affected / at risk     2/1923 (0.10%)     2/1938 (0.10%)  
Skin infection † 1    
# participants affected / at risk     3/1923 (0.16%)     2/1938 (0.10%)  
Soft tissue infection † 1    
# participants affected / at risk     1/1923 (0.05%)     0/1938 (0.00%)  
Staphylococcal abscess † 1    
# participants affected / at risk     2/1923 (0.10%)     0/1938 (0.00%)  
Staphylococcal bacteraemia † 1    
# participants affected / at risk     8/1923 (0.42%)     9/1938 (0.46%)  
Staphylococcal infection † 1    
# participants affected / at risk     9/1923 (0.47%)     14/1938 (0.72%)  
Staphylococcal osteomyelitis † 1    
# participants affected / at risk     0/1923 (0.00%)     2/1938 (0.10%)  
Staphylococcal sepsis † 1    
# participants affected / at risk     7/1923 (0.36%)     12/1938 (0.62%)  
Streptococcal bacteraemia † 1    
# participants affected / at risk     1/1923 (0.05%)     1/1938 (0.05%)  
Streptococcal sepsis † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Subcutaneous abscess † 1    
# participants affected / at risk     4/1923 (0.21%)     6/1938 (0.31%)  
Systemic candida † 1    
# participants affected / at risk     2/1923 (0.10%)     0/1938 (0.00%)  
Testicular abscess † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Tooth abscess † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Tooth infection † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Tracheobronchitis † 1    
# participants affected / at risk     2/1923 (0.10%)     1/1938 (0.05%)  
Tuberculosis † 1    
# participants affected / at risk     2/1923 (0.10%)     1/1938 (0.05%)  
Upper respiratory tract infection † 1    
# participants affected / at risk     3/1923 (0.16%)     7/1938 (0.36%)  
Urethritis † 1    
# participants affected / at risk     1/1923 (0.05%)     0/1938 (0.00%)  
Urinary tract infection † 1    
# participants affected / at risk     23/1923 (1.20%)     18/1938 (0.93%)  
Urinary tract infection enterococcal † 1    
# participants affected / at risk     1/1923 (0.05%)     0/1938 (0.00%)  
Urinary tract infection fungal † 1    
# participants affected / at risk     1/1923 (0.05%)     0/1938 (0.00%)  
Urosepsis † 1    
# participants affected / at risk     3/1923 (0.16%)     2/1938 (0.10%)  
Vestibular neuronitis † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Viral infection † 1    
# participants affected / at risk     2/1923 (0.10%)     5/1938 (0.26%)  
Viral pharyngitis † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Wound infection † 1    
# participants affected / at risk     10/1923 (0.52%)     7/1938 (0.36%)  
Wound infection bacterial † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Wound infection staphylococcal † 1    
# participants affected / at risk     1/1923 (0.05%)     2/1938 (0.10%)  
Zygomycosis † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Injury, poisoning and procedural complications      
Acetabulum fracture † 1    
# participants affected / at risk     0/1923 (0.00%)     2/1938 (0.10%)  
Anastomotic stenosis † 1    
# participants affected / at risk     1/1923 (0.05%)     0/1938 (0.00%)  
Animal bite † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Ankle fracture † 1    
# participants affected / at risk     5/1923 (0.26%)     9/1938 (0.46%)  
Arteriovenous fistula aneurysm † 1    
# participants affected / at risk     10/1923 (0.52%)     3/1938 (0.15%)  
Arteriovenous fistula occlusion † 1    
# participants affected / at risk     8/1923 (0.42%)     13/1938 (0.67%)  
Arteriovenous fistula site complication † 1    
# participants affected / at risk     44/1923 (2.29%)     36/1938 (1.86%)  
Arteriovenous fistula site haematoma † 1    
# participants affected / at risk     2/1923 (0.10%)     3/1938 (0.15%)  
Arteriovenous fistula site haemorrhage † 1    
# participants affected / at risk     23/1923 (1.20%)     17/1938 (0.88%)  
Arteriovenous fistula thrombosis † 1    
# participants affected / at risk     43/1923 (2.24%)     49/1938 (2.53%)  
Arteriovenous graft aneurysm † 1    
# participants affected / at risk     0/1923 (0.00%)     2/1938 (0.10%)  
Arteriovenous graft site haematoma † 1    
# participants affected / at risk     2/1923 (0.10%)     0/1938 (0.00%)  
Arteriovenous graft site haemorrhage † 1    
# participants affected / at risk     7/1923 (0.36%)     9/1938 (0.46%)  
Brain contusion † 1    
# participants affected / at risk     1/1923 (0.05%)     0/1938 (0.00%)  
Brain herniation † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Burns second degree † 1    
# participants affected / at risk     1/1923 (0.05%)     0/1938 (0.00%)  
Cardiac valve replacement complication † 1    
# participants affected / at risk     1/1923 (0.05%)     0/1938 (0.00%)  
Cervical vertebral fracture † 1    
# participants affected / at risk     1/1923 (0.05%)     0/1938 (0.00%)  
Chest injury † 1    
# participants affected / at risk     1/1923 (0.05%)     0/1938 (0.00%)  
Clavicle fracture † 1    
# participants affected / at risk     2/1923 (0.10%)     2/1938 (0.10%)  
Complications of transplanted kidney † 1    
# participants affected / at risk     2/1923 (0.10%)     3/1938 (0.15%)  
Compression fracture † 1    
# participants affected / at risk     1/1923 (0.05%)     0/1938 (0.00%)  
Concussion † 1    
# participants affected / at risk     2/1923 (0.10%)     1/1938 (0.05%)  
Contusion † 1    
# participants affected / at risk     2/1923 (0.10%)     4/1938 (0.21%)  
Craniocerebral injury † 1    
# participants affected / at risk     3/1923 (0.16%)     2/1938 (0.10%)  
Crush injury † 1    
# participants affected / at risk     1/1923 (0.05%)     0/1938 (0.00%)  
Cystitis radiation † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Excoriation † 1    
# participants affected / at risk     1/1923 (0.05%)     0/1938 (0.00%)  
Extradural haematoma † 1    
# participants affected / at risk     1/1923 (0.05%)     0/1938 (0.00%)  
Eye operation complication † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Face injury † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Facial bones fracture † 1    
# participants affected / at risk     2/1923 (0.10%)     1/1938 (0.05%)  
Fall † 1    
# participants affected / at risk     14/1923 (0.73%)     8/1938 (0.41%)  
Femoral neck fracture † 1    
# participants affected / at risk     10/1923 (0.52%)     8/1938 (0.41%)  
Femur fracture † 1    
# participants affected / at risk     19/1923 (0.99%)     13/1938 (0.67%)  
Fibula fracture † 1    
# participants affected / at risk     1/1923 (0.05%)     0/1938 (0.00%)  
Foot fracture † 1    
# participants affected / at risk     4/1923 (0.21%)     2/1938 (0.10%)  
Forearm fracture † 1    
# participants affected / at risk     1/1923 (0.05%)     3/1938 (0.15%)  
Foreign body † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Fracture † 1    
# participants affected / at risk     2/1923 (0.10%)     3/1938 (0.15%)  
Fractured coccyx † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Fractured ischium † 1    
# participants affected / at risk     3/1923 (0.16%)     1/1938 (0.05%)  
Fractured sacrum † 1    
# participants affected / at risk     1/1923 (0.05%)     1/1938 (0.05%)  
Graft complication † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Graft haemorrhage † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Graft thrombosis † 1    
# participants affected / at risk     3/1923 (0.16%)     7/1938 (0.36%)  
Haemodialysis-induced symptom † 1    
# participants affected / at risk     3/1923 (0.16%)     4/1938 (0.21%)  
Hand fracture † 1    
# participants affected / at risk     3/1923 (0.16%)     2/1938 (0.10%)  
Head injury † 1    
# participants affected / at risk     4/1923 (0.21%)     2/1938 (0.10%)  
Hip fracture † 1    
# participants affected / at risk     10/1923 (0.52%)     9/1938 (0.46%)  
Humerus fracture † 1    
# participants affected / at risk     4/1923 (0.21%)     2/1938 (0.10%)  
In-stent coronary artery restenosis † 1    
# participants affected / at risk     0/1923 (0.00%)     2/1938 (0.10%)  
Incision site complication † 1    
# participants affected / at risk     1/1923 (0.05%)     0/1938 (0.00%)  
Incisional hernia † 1    
# participants affected / at risk     4/1923 (0.21%)     2/1938 (0.10%)  
Incisional hernia, obstructive † 1    
# participants affected / at risk     1/1923 (0.05%)     0/1938 (0.00%)  
Injury † 1    
# participants affected / at risk     2/1923 (0.10%)     0/1938 (0.00%)  
Joint dislocation † 1    
# participants affected / at risk     3/1923 (0.16%)     5/1938 (0.26%)  
Joint injury † 1    
# participants affected / at risk     3/1923 (0.16%)     0/1938 (0.00%)  
Kidney rupture † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Laceration † 1    
# participants affected / at risk     2/1923 (0.10%)     1/1938 (0.05%)  
Ligament injury † 1    
# participants affected / at risk     1/1923 (0.05%)     0/1938 (0.00%)  
Ligament rupture † 1    
# participants affected / at risk     4/1923 (0.21%)     0/1938 (0.00%)  
Ligament sprain † 1    
# participants affected / at risk     2/1923 (0.10%)     0/1938 (0.00%)  
Limb injury † 1    
# participants affected / at risk     1/1923 (0.05%)     1/1938 (0.05%)  
Lower limb fracture † 1    
# participants affected / at risk     4/1923 (0.21%)     3/1938 (0.15%)  
Meniscus lesion † 1    
# participants affected / at risk     1/1923 (0.05%)     0/1938 (0.00%)  
Multiple fractures † 1    
# participants affected / at risk     2/1923 (0.10%)     1/1938 (0.05%)  
Muscle rupture † 1    
# participants affected / at risk     2/1923 (0.10%)     0/1938 (0.00%)  
Open fracture † 1    
# participants affected / at risk     1/1923 (0.05%)     1/1938 (0.05%)  
Open wound † 1    
# participants affected / at risk     2/1923 (0.10%)     0/1938 (0.00%)  
Overdose † 1    
# participants affected / at risk     4/1923 (0.21%)     6/1938 (0.31%)  
Patella fracture † 1    
# participants affected / at risk     2/1923 (0.10%)     2/1938 (0.10%)  
Pelvic fracture † 1    
# participants affected / at risk     1/1923 (0.05%)     3/1938 (0.15%)  
Periorbital haematoma † 1    
# participants affected / at risk     1/1923 (0.05%)     0/1938 (0.00%)  
Periprosthetic fracture † 1    
# participants affected / at risk     1/1923 (0.05%)     0/1938 (0.00%)  
Perirenal haematoma † 1    
# participants affected / at risk     1/1923 (0.05%)     1/1938 (0.05%)  
Pneumothorax traumatic † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Post procedural complication † 1    
# participants affected / at risk     5/1923 (0.26%)     3/1938 (0.15%)  
Post procedural haematoma † 1    
# participants affected / at risk     1/1923 (0.05%)     0/1938 (0.00%)  
Post procedural haemorrhage † 1    
# participants affected / at risk     4/1923 (0.21%)     5/1938 (0.26%)  
Postoperative adhesion † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Postoperative ileus † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Postoperative thoracic procedure complication † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Postoperative wound complication † 1    
# participants affected / at risk     1/1923 (0.05%)     2/1938 (0.10%)  
Procedural complication † 1    
# participants affected / at risk     0/1923 (0.00%)     1/1938 (0.05%)  
Procedural haemorrhage † 1    
# participants affected / at risk     2/1923 (0.10%)     1/1938 (0.05%)  
Procedural hypotension † 1    
# participants affected / at risk     2/1923 (0.10%)     10/1938 (0.52%)  
Procedural pain † 1    
# participants affected / at risk     2/1923 (0.10%)     1/1938 (0.05%)  
Pubis fracture † 1    
# participants affected / at risk     6/1923 (0.31%)     1/1938 (0.05%)  
Radius fracture † 1    
# participants affected / at risk     6/1923 (0.31%)     3/1938 (0.15%)  
Renal haematoma † 1    
# participants affected / at risk     1/1923 (0.05%)