Avoiding Cardiovascular Events Through Combination Therapy in Patients Living With Systolic Hypertension (ACCOMPLISH)

This study has been terminated.
(The study was terminated early because of significant efficacy results for the primary endpoint in favor of benazepril/amlodipine treatment.)
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00170950
First received: September 10, 2005
Last updated: April 19, 2011
Last verified: April 2011
Results First Received: January 13, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Hypertension
Interventions: Drug: Benazepril/amlodipine 20/5 mg - Dose Level 1 from Day 1 to Month 1
Drug: Benazepril/amlodipine 40/5 mg - Dose Level 2 from Month 1 to Month 2
Drug: Benazepril/amlodipine 40/10 mg - Dose Level 3 from Month 2 to Month 3 and thereafter
Drug: Benazepril/hydrochlorothiazide 20/12.5 mg - Dose Level 1 from Day 1 to Month 1
Drug: Benazepril/hydrochlorothiazide 40/12.5 mg - Dose Level 2 from Month 1 to Month 2
Drug: Benazepril/hydrochlorothiazide 40/25 mg - Dose Level 3 from Month 2 to Month 3 and thereafter

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Benazepril/Amlodipine Benazepril hydrochloride (HCl)/amlodipine besylate: 20/5 mg (Dose Level 1 from Day 1 to Month 1), 40/5 mg (Dose Level 2 from Month 1 to Month 2), and 40/10 mg (Dose Level 3 from Month 2 to Month 3 and thereafter) capsules for oral administration once daily
Benazepril/Hydrochlorothiazide Benazepril hydrochloride (HCl)/hydrochlorothiazide (HCTZ): 20/12.5 mg (Dose Level 1 from Day 1 to Month 1), 40/12.5 mg (Dose Level 2 from Month 1 to Month 2), and 40/25 mg (Dose Level 3 from Month 2 to Month 3 and thereafter) capsules for oral administration once daily

Participant Flow:   Overall Study
    Benazepril/Amlodipine     Benazepril/Hydrochlorothiazide  
STARTED     5744     5762  
COMPLETED     4859     4852  
NOT COMPLETED     885     910  
Death                 236                 274  
Withdrawal by Subject                 496                 498  
Lost to Follow-up                 134                 115  
Missing                 2                 1  
Termination Data Not Recorded                 17                 22  



  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
Benazepril/Amlodipine Benazepril hydrochloride (HCl)/amlodipine besylate: 20/5 mg (Dose Level 1 from Day 1 to Month 1), 40/5 mg (Dose Level 2 from Month 1 to Month 2), and 40/10 mg (Dose Level 3 from Month 2 to Month 3 and thereafter) capsules for oral administration once daily
Benazepril/Hydrochlorothiazide Benazepril hydrochloride (HCl)/hydrochlorothiazide (HCTZ): 20/12.5 mg (Dose Level 1 from Day 1 to Month 1), 40/12.5 mg (Dose Level 2 from Month 1 to Month 2), and 40/25 mg (Dose Level 3 from Month 2 to Month 3 and thereafter) capsules for oral administration once daily
Total Total of all reporting groups

Baseline Measures
    Benazepril/Amlodipine     Benazepril/Hydrochlorothiazide     Total  
Number of Participants  
[units: participants]
  5744     5761     11505  
Age [1]
[units: Years]
Mean ± Standard Deviation
  68.4  ± 6.86     68.3  ± 6.86     68.4  ± 6.86  
Gender [1]
[units: Participants]
     
Female     2296     2246     4542  
Male     3448     3515     6963  
[1] Demographic data for 1 patient in the benazepril/hydrochlorothiazide was not available.



  Outcome Measures
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1.  Primary:   Time-to-event Analysis of Percentage of Patients With a Composite Cardiovascular (CV) Morbidity or Mortality Event   [ Time Frame: For each patient, baseline to time of first CV morbidity or mortality event (or last exposure if no event occurred). (Median duration of exposure was 33.4 months. [25th to 75th percentiles: 21 to 41 months.]) ]

Measure Type Primary
Measure Title Time-to-event Analysis of Percentage of Patients With a Composite Cardiovascular (CV) Morbidity or Mortality Event
Measure Description CV morbidity was defined as non-fatal myocardial infarction (MI), non-fatal stroke, hospitalization for unstable angina, resuscitated sudden death, or coronary revascularization procedure. CV mortality was defined as death due to MI, stroke, coronary intervention, congestive heart failure (CHF), sudden cardiac death, or other CV causes.
Time Frame For each patient, baseline to time of first CV morbidity or mortality event (or last exposure if no event occurred). (Median duration of exposure was 33.4 months. [25th to 75th percentiles: 21 to 41 months.])  
Safety Issue No  

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.
Intent-to-treat population: All randomized patients by assigned treatment group

Reporting Groups
  Description
Benazepril/Amlodipine Benazepril hydrochloride (HCl)/amlodipine besylate: 20/5 mg (Dose Level 1 from Day 1 to Month 1), 40/5 mg (Dose Level 2 from Month 1 to Month 2), and 40/10 mg (Dose Level 3 from Month 2 to Month 3 and thereafter) capsules for oral administration once daily
Benazepril/Hydrochlorothiazide Benazepril hydrochloride (HCl)/hydrochlorothiazide (HCTZ): 20/12.5 mg (Dose Level 1 from Day 1 to Month 1), 40/12.5 mg (Dose Level 2 from Month 1 to Month 2), and 40/25 mg (Dose Level 3 from Month 2 to Month 3 and thereafter) capsules for oral administration once daily

Measured Values
    Benazepril/Amlodipine     Benazepril/Hydrochlorothiazide  
Number of Participants Analyzed  
[units: participants]
  5744     5762  
Time-to-event Analysis of Percentage of Patients With a Composite Cardiovascular (CV) Morbidity or Mortality Event  
[units: Percentage of Patients with an event]
  9.6     11.8  

No statistical analysis provided for Time-to-event Analysis of Percentage of Patients With a Composite Cardiovascular (CV) Morbidity or Mortality Event



2.  Secondary:   Time-to-event Analysis of Percentage of Patients With a Composite Cardiovascular (CV) Morbidity Event   [ Time Frame: For each patient, baseline to time of first CV morbidity event (or last exposure if no event occurred). (Median duration of exposure was 33.4 months. [25th to 75th percentiles: 21 to 41 months.])] ]

Measure Type Secondary
Measure Title Time-to-event Analysis of Percentage of Patients With a Composite Cardiovascular (CV) Morbidity Event
Measure Description Cardiovascular morbidity was defined as including any of the following events: non-fatal MI, non-fatal stroke, hospitalization for unstable angina, resuscitated sudden death, or coronary revascularization procedure (PCI or CABG).
Time Frame For each patient, baseline to time of first CV morbidity event (or last exposure if no event occurred). (Median duration of exposure was 33.4 months. [25th to 75th percentiles: 21 to 41 months.])]  
Safety Issue No  

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.
Intent-to-treat population: All randomized patients by assigned treatment group

Reporting Groups
  Description
Benazepril/Amlodipine Benazepril hydrochloride (HCl)/amlodipine besylate: 20/5 mg (Dose Level 1 from Day 1 to Month 1), 40/5 mg (Dose Level 2 from Month 1 to Month 2), and 40/10 mg (Dose Level 3 from Month 2 to Month 3 and thereafter) capsules for oral administration once daily
Benazepril/Hydrochlorothiazide Benazepril hydrochloride (HCl)/hydrochlorothiazide (HCTZ): 20/12.5 mg (Dose Level 1 from Day 1 to Month 1), 40/12.5 mg (Dose Level 2 from Month 1 to Month 2), and 40/25 mg (Dose Level 3 from Month 2 to Month 3 and thereafter) capsules for oral administration once daily

Measured Values
    Benazepril/Amlodipine     Benazepril/Hydrochlorothiazide  
Number of Participants Analyzed  
[units: participants]
  5744     5762  
Time-to-event Analysis of Percentage of Patients With a Composite Cardiovascular (CV) Morbidity Event  
[units: Percentage of Patients with an Event]
  8.6     10.3  

No statistical analysis provided for Time-to-event Analysis of Percentage of Patients With a Composite Cardiovascular (CV) Morbidity Event



3.  Secondary:   Time-to-event Analysis of Percentage of Patients With a Cardiovascular (CV) Mortality Event, Non-fatal Myocardial Infarction (MI), or Non-fatal Stroke   [ Time Frame: For each patient, baseline to time of first CV mortality event, MI (non-fatal), or stroke (non-fatal) (or last exposure if no event occurred). (Median duration of exposure was 33.4 months. [25th to 75th percentiles: 21 to 41 months.]) ]

Measure Type Secondary
Measure Title Time-to-event Analysis of Percentage of Patients With a Cardiovascular (CV) Mortality Event, Non-fatal Myocardial Infarction (MI), or Non-fatal Stroke
Measure Description CV mortality was defined as death due to sudden cardiac death, fatal MI, fatal stroke, coronary intervention, congestive heart failure (CHF), or other CV causes.
Time Frame For each patient, baseline to time of first CV mortality event, MI (non-fatal), or stroke (non-fatal) (or last exposure if no event occurred). (Median duration of exposure was 33.4 months. [25th to 75th percentiles: 21 to 41 months.])  
Safety Issue No  

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.
Intent-to-treat population: All randomized patients by assigned treatment group

Reporting Groups
  Description
Benazepril/Amlodipine Benazepril hydrochloride (HCl)/amlodipine besylate: 20/5 mg (Dose Level 1 from Day 1 to Month 1), 40/5 mg (Dose Level 2 from Month 1 to Month 2), and 40/10 mg (Dose Level 3 from Month 2 to Month 3 and thereafter) capsules for oral administration once daily
Benazepril/Hydrochlorothiazide Benazepril hydrochloride (HCl)/hydrochlorothiazide (HCTZ): 20/12.5 mg (Dose Level 1 from Day 1 to Month 1), 40/12.5 mg (Dose Level 2 from Month 1 to Month 2), and 40/25 mg (Dose Level 3 from Month 2 to Month 3 and thereafter) capsules for oral administration once daily

Measured Values
    Benazepril/Amlodipine     Benazepril/Hydrochlorothiazide  
Number of Participants Analyzed  
[units: participants]
  5744     5762  
Time-to-event Analysis of Percentage of Patients With a Cardiovascular (CV) Mortality Event, Non-fatal Myocardial Infarction (MI), or Non-fatal Stroke  
[units: Percentage of Patients with an Event]
  5.0     6.3  

No statistical analysis provided for Time-to-event Analysis of Percentage of Patients With a Cardiovascular (CV) Mortality Event, Non-fatal Myocardial Infarction (MI), or Non-fatal Stroke




  Serious Adverse Events
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Time Frame Double-blind period
Additional Description Safety population includes all randomized patients who took at least one dose of study medication by actual treatment group (7 Benazepril / Amlodipine and 2 Benazepril / HCTZ patients did not take study medication; 3 patients assigned to Benazepril / HCTZ received Benazepril / Amlodipine medication instead).

Reporting Groups
  Description
Benazepril / Amlodipine Benazepril hydrochloride (HCl)/amlodipine besylate: 20/5 mg (Dose Level 1), 40/5 mg (Dose Level 2), and 40/10 mg (Dose Level 3) capsules for oral administration once daily
Benazepril / HCTZ Benazepril hydrochloride (HCl)/hydrochlorothiazide (HCTZ): 20/12.5 mg (Dose Level 1), 40/12.5 mg (Dose Level 2), and 40/25 mg (Dose Level 3) capsules for oral administration once daily

Serious Adverse Events
    Benazepril / Amlodipine     Benazepril / HCTZ  
Total, serious adverse events      
# participants affected / at risk     1844/5740 (32.13%)     2026/5757 (35.19%)  
Blood and lymphatic system disorders      
Acquired haemophilia † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Anaemia † 1    
# participants affected / at risk     34/5740 (0.59%)     41/5757 (0.71%)  
Blood disorder † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Bone marrow failure † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Coagulopathy † 1    
# participants affected / at risk     1/5740 (0.02%)     2/5757 (0.03%)  
Eosinophilia † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Febrile neutropenia † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Haemorrhagic anaemia † 1    
# participants affected / at risk     2/5740 (0.03%)     2/5757 (0.03%)  
Haemorrhagic disorder † 1    
# participants affected / at risk     1/5740 (0.02%)     1/5757 (0.02%)  
Hypoprothrombinaemia † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Iron deficiency anaemia † 1    
# participants affected / at risk     4/5740 (0.07%)     3/5757 (0.05%)  
Leukocytosis † 1    
# participants affected / at risk     2/5740 (0.03%)     1/5757 (0.02%)  
Lymphadenopathy † 1    
# participants affected / at risk     2/5740 (0.03%)     0/5757 (0.00%)  
Neutropenia † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Pancytopenia † 1    
# participants affected / at risk     2/5740 (0.03%)     0/5757 (0.00%)  
Polycythaemia † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Retroperitoneal lymphadenopathy † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Thrombocythaemia † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Thrombocytopenia † 1    
# participants affected / at risk     2/5740 (0.03%)     1/5757 (0.02%)  
Cardiac disorders      
AV dissociation † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Acute coronary syndrome † 1    
# participants affected / at risk     5/5740 (0.09%)     9/5757 (0.16%)  
Acute myocardial infarction † 1    
# participants affected / at risk     17/5740 (0.30%)     11/5757 (0.19%)  
Angina pectoris † 1    
# participants affected / at risk     85/5740 (1.48%)     106/5757 (1.84%)  
Angina unstable † 1    
# participants affected / at risk     113/5740 (1.97%)     131/5757 (2.28%)  
Aortic valve disease † 1    
# participants affected / at risk     1/5740 (0.02%)     2/5757 (0.03%)  
Aortic valve incompetence † 1    
# participants affected / at risk     1/5740 (0.02%)     3/5757 (0.05%)  
Aortic valve stenosis † 1    
# participants affected / at risk     3/5740 (0.05%)     1/5757 (0.02%)  
Arrhythmia † 1    
# participants affected / at risk     6/5740 (0.10%)     8/5757 (0.14%)  
Arteriosclerosis coronary artery † 1    
# participants affected / at risk     14/5740 (0.24%)     12/5757 (0.21%)  
Atrial fibrillation † 1    
# participants affected / at risk     115/5740 (2.00%)     113/5757 (1.96%)  
Atrial flutter † 1    
# participants affected / at risk     7/5740 (0.12%)     8/5757 (0.14%)  
Atrial tachycardia † 1    
# participants affected / at risk     0/5740 (0.00%)     2/5757 (0.03%)  
Atrioventricular block † 1    
# participants affected / at risk     3/5740 (0.05%)     1/5757 (0.02%)  
Atrioventricular block complete † 1    
# participants affected / at risk     5/5740 (0.09%)     4/5757 (0.07%)  
Atrioventricular block first degree † 1    
# participants affected / at risk     1/5740 (0.02%)     1/5757 (0.02%)  
Atrioventricular block second degree † 1    
# participants affected / at risk     4/5740 (0.07%)     3/5757 (0.05%)  
Bradyarrhythmia † 1    
# participants affected / at risk     2/5740 (0.03%)     0/5757 (0.00%)  
Bradycardia † 1    
# participants affected / at risk     21/5740 (0.37%)     31/5757 (0.54%)  
Bundle branch block left † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Bundle branch block right † 1    
# participants affected / at risk     0/5740 (0.00%)     2/5757 (0.03%)  
Cardiac arrest † 1    
# participants affected / at risk     6/5740 (0.10%)     14/5757 (0.24%)  
Cardiac discomfort † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Cardiac disorder † 1    
# participants affected / at risk     1/5740 (0.02%)     2/5757 (0.03%)  
Cardiac failure † 1    
# participants affected / at risk     8/5740 (0.14%)     16/5757 (0.28%)  
Cardiac failure congestive † 1    
# participants affected / at risk     99/5740 (1.72%)     86/5757 (1.49%)  
Cardiac hypertrophy † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Cardiac tamponade † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Cardiac valve disease † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Cardiac ventricular disorder † 1    
# participants affected / at risk     2/5740 (0.03%)     0/5757 (0.00%)  
Cardio-respiratory arrest † 1    
# participants affected / at risk     5/5740 (0.09%)     3/5757 (0.05%)  
Cardiogenic shock † 1    
# participants affected / at risk     3/5740 (0.05%)     3/5757 (0.05%)  
Cardiomegaly † 1    
# participants affected / at risk     1/5740 (0.02%)     2/5757 (0.03%)  
Cardiomyopathy † 1    
# participants affected / at risk     3/5740 (0.05%)     1/5757 (0.02%)  
Cardiovascular disorder † 1    
# participants affected / at risk     0/5740 (0.00%)     2/5757 (0.03%)  
Congestive cardiomyopathy † 1    
# participants affected / at risk     2/5740 (0.03%)     0/5757 (0.00%)  
Coronary artery disease † 1    
# participants affected / at risk     112/5740 (1.95%)     124/5757 (2.15%)  
Coronary artery insufficiency † 1    
# participants affected / at risk     1/5740 (0.02%)     2/5757 (0.03%)  
Coronary artery occlusion † 1    
# participants affected / at risk     7/5740 (0.12%)     18/5757 (0.31%)  
Coronary artery restenosis † 1    
# participants affected / at risk     0/5740 (0.00%)     2/5757 (0.03%)  
Coronary artery stenosis † 1    
# participants affected / at risk     16/5740 (0.28%)     21/5757 (0.36%)  
Hypertensive heart disease † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Ischaemic cardiomyopathy † 1    
# participants affected / at risk     1/5740 (0.02%)     4/5757 (0.07%)  
Left ventricular dysfunction † 1    
# participants affected / at risk     0/5740 (0.00%)     2/5757 (0.03%)  
Mitral valve incompetence † 1    
# participants affected / at risk     3/5740 (0.05%)     2/5757 (0.03%)  
Myocardial infarction † 1    
# participants affected / at risk     91/5740 (1.59%)     126/5757 (2.19%)  
Myocardial ischaemia † 1    
# participants affected / at risk     10/5740 (0.17%)     13/5757 (0.23%)  
Palpitations † 1    
# participants affected / at risk     3/5740 (0.05%)     3/5757 (0.05%)  
Pericardial effusion † 1    
# participants affected / at risk     3/5740 (0.05%)     2/5757 (0.03%)  
Pericarditis † 1    
# participants affected / at risk     2/5740 (0.03%)     1/5757 (0.02%)  
Right ventricular failure † 1    
# participants affected / at risk     3/5740 (0.05%)     1/5757 (0.02%)  
Sick sinus syndrome † 1    
# participants affected / at risk     15/5740 (0.26%)     20/5757 (0.35%)  
Sinus arrest † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Sinus arrhythmia † 1    
# participants affected / at risk     2/5740 (0.03%)     1/5757 (0.02%)  
Sinus bradycardia † 1    
# participants affected / at risk     3/5740 (0.05%)     3/5757 (0.05%)  
Sinus tachycardia † 1    
# participants affected / at risk     2/5740 (0.03%)     1/5757 (0.02%)  
Supraventricular tachycardia † 1    
# participants affected / at risk     3/5740 (0.05%)     5/5757 (0.09%)  
Tachyarrhythmia † 1    
# participants affected / at risk     2/5740 (0.03%)     0/5757 (0.00%)  
Tachycardia † 1    
# participants affected / at risk     4/5740 (0.07%)     8/5757 (0.14%)  
Tachycardia paroxysmal † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Trifascicular block † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Ventricular arrhythmia † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Ventricular extrasystoles † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Ventricular fibrillation † 1    
# participants affected / at risk     3/5740 (0.05%)     1/5757 (0.02%)  
Ventricular hypokinesia † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Ventricular tachyarrhythmia † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Ventricular tachycardia † 1    
# participants affected / at risk     10/5740 (0.17%)     10/5757 (0.17%)  
Congenital, familial and genetic disorders      
Arteriovenous malformation † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Congenital syphilitic osteochondritis † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Hydrocele † 1    
# participants affected / at risk     0/5740 (0.00%)     2/5757 (0.03%)  
Ear and labyrinth disorders      
Meniere's disease † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Sudden hearing loss † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Vertigo † 1    
# participants affected / at risk     11/5740 (0.19%)     9/5757 (0.16%)  
Vertigo positional † 1    
# participants affected / at risk     2/5740 (0.03%)     0/5757 (0.00%)  
Vestibular disorder † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Endocrine disorders      
Adrenal insufficiency † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Adrenal mass † 1    
# participants affected / at risk     1/5740 (0.02%)     1/5757 (0.02%)  
Antidiuretic hormone abnormality † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Goitre † 1    
# participants affected / at risk     2/5740 (0.03%)     2/5757 (0.03%)  
Hyperparathyroidism † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Hyperparathyroidism primary † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Hyperthyroidism † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Hypothyroidism † 1    
# participants affected / at risk     3/5740 (0.05%)     1/5757 (0.02%)  
Inappropriate antidiuretic hormone secretion † 1    
# participants affected / at risk     0/5740 (0.00%)     2/5757 (0.03%)  
Thyroid mass † 1    
# participants affected / at risk     2/5740 (0.03%)     1/5757 (0.02%)  
Eye disorders      
Entropion † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Eye haemorrhage † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Eyelid ptosis † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Hyphaema † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Keratitis † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Optic ischaemic neuropathy † 1    
# participants affected / at risk     2/5740 (0.03%)     0/5757 (0.00%)  
Retinal detachment † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Retinal tear † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Retinal vein thrombosis † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Gastrointestinal disorders      
Abdominal discomfort † 1    
# participants affected / at risk     0/5740 (0.00%)     2/5757 (0.03%)  
Abdominal distension † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Abdominal hernia † 1    
# participants affected / at risk     2/5740 (0.03%)     2/5757 (0.03%)  
Abdominal hernia obstructive † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Abdominal mass † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Abdominal pain † 1    
# participants affected / at risk     21/5740 (0.37%)     20/5757 (0.35%)  
Abdominal pain lower † 1    
# participants affected / at risk     1/5740 (0.02%)     1/5757 (0.02%)  
Abdominal pain upper † 1    
# participants affected / at risk     9/5740 (0.16%)     12/5757 (0.21%)  
Abdominal strangulated hernia † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Ascites † 1    
# participants affected / at risk     0/5740 (0.00%)     2/5757 (0.03%)  
Barrett's oesophagus † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Caecitis † 1    
# participants affected / at risk     2/5740 (0.03%)     1/5757 (0.02%)  
Colitis † 1    
# participants affected / at risk     7/5740 (0.12%)     8/5757 (0.14%)  
Colitis ischaemic † 1    
# participants affected / at risk     6/5740 (0.10%)     1/5757 (0.02%)  
Colitis ulcerative † 1    
# participants affected / at risk     1/5740 (0.02%)     1/5757 (0.02%)  
Colonic fistula † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Colonic obstruction † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Colonic polyp † 1    
# participants affected / at risk     2/5740 (0.03%)     2/5757 (0.03%)  
Colonic stenosis † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Constipation † 1    
# participants affected / at risk     4/5740 (0.07%)     2/5757 (0.03%)  
Crohn's disease † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Diabetic gastroparesis † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Diabetic gastropathy † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Diarrhoea † 1    
# participants affected / at risk     17/5740 (0.30%)     20/5757 (0.35%)  
Diverticulum † 1    
# participants affected / at risk     4/5740 (0.07%)     5/5757 (0.09%)  
Diverticulum intestinal † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Diverticulum intestinal haemorrhagic † 1    
# participants affected / at risk     2/5740 (0.03%)     2/5757 (0.03%)  
Diverticulum oesophageal † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Duodenal ulcer † 1    
# participants affected / at risk     4/5740 (0.07%)     5/5757 (0.09%)  
Duodenal ulcer haemorrhage † 1    
# participants affected / at risk     1/5740 (0.02%)     3/5757 (0.05%)  
Duodenal ulcer perforation † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Duodenitis † 1    
# participants affected / at risk     1/5740 (0.02%)     2/5757 (0.03%)  
Dyspepsia † 1    
# participants affected / at risk     2/5740 (0.03%)     2/5757 (0.03%)  
Dysphagia † 1    
# participants affected / at risk     2/5740 (0.03%)     5/5757 (0.09%)  
Enterocele † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Erosive oesophagitis † 1    
# participants affected / at risk     3/5740 (0.05%)     2/5757 (0.03%)  
Faecal incontinence † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Faecaloma † 1    
# participants affected / at risk     1/5740 (0.02%)     1/5757 (0.02%)  
Food poisoning † 1    
# participants affected / at risk     2/5740 (0.03%)     0/5757 (0.00%)  
Gastric disorder † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Gastric haemorrhage † 1    
# participants affected / at risk     2/5740 (0.03%)     0/5757 (0.00%)  
Gastric ulcer † 1    
# participants affected / at risk     4/5740 (0.07%)     6/5757 (0.10%)  
Gastric ulcer haemorrhage † 1    
# participants affected / at risk     0/5740 (0.00%)     3/5757 (0.05%)  
Gastritis † 1    
# participants affected / at risk     14/5740 (0.24%)     17/5757 (0.30%)  
Gastritis erosive † 1    
# participants affected / at risk     2/5740 (0.03%)     1/5757 (0.02%)  
Gastritis haemorrhagic † 1    
# participants affected / at risk     1/5740 (0.02%)     1/5757 (0.02%)  
Gastrointestinal disorder † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Gastrointestinal haemorrhage † 1    
# participants affected / at risk     35/5740 (0.61%)     29/5757 (0.50%)  
Gastrointestinal necrosis † 1    
# participants affected / at risk     2/5740 (0.03%)     0/5757 (0.00%)  
Gastrointestinal obstruction † 1    
# participants affected / at risk     2/5740 (0.03%)     1/5757 (0.02%)  
Gastrooesophageal reflux disease † 1    
# participants affected / at risk     8/5740 (0.14%)     14/5757 (0.24%)  
Gastrooesophagitis † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Haematemesis † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Haematochezia † 1    
# participants affected / at risk     2/5740 (0.03%)     5/5757 (0.09%)  
Haemorrhoidal haemorrhage † 1    
# participants affected / at risk     1/5740 (0.02%)     1/5757 (0.02%)  
Haemorrhoids † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Hiatus hernia † 1    
# participants affected / at risk     3/5740 (0.05%)     2/5757 (0.03%)  
Ileus † 1    
# participants affected / at risk     2/5740 (0.03%)     8/5757 (0.14%)  
Ileus paralytic † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Impaired gastric emptying † 1    
# participants affected / at risk     2/5740 (0.03%)     3/5757 (0.05%)  
Inflammatory bowel disease † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Inguinal hernia † 1    
# participants affected / at risk     7/5740 (0.12%)     8/5757 (0.14%)  
Inguinal hernia, obstructive † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Intestinal haemorrhage † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Intestinal infarction † 1    
# participants affected / at risk     2/5740 (0.03%)     0/5757 (0.00%)  
Intestinal ischaemia † 1    
# participants affected / at risk     2/5740 (0.03%)     2/5757 (0.03%)  
Intestinal mass † 1    
# participants affected / at risk     1/5740 (0.02%)     1/5757 (0.02%)  
Intestinal obstruction † 1    
# participants affected / at risk     5/5740 (0.09%)     4/5757 (0.07%)  
Intestinal perforation † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Irritable bowel syndrome † 1    
# participants affected / at risk     2/5740 (0.03%)     0/5757 (0.00%)  
Large intestinal obstruction † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Large intestine perforation † 1    
# participants affected / at risk     3/5740 (0.05%)     2/5757 (0.03%)  
Lower gastrointestinal haemorrhage † 1    
# participants affected / at risk     6/5740 (0.10%)     5/5757 (0.09%)  
Mallory-Weiss syndrome † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Mechanical ileus † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Melaena † 1    
# participants affected / at risk     0/5740 (0.00%)     5/5757 (0.09%)  
Mesenteric artery stenosis † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Mesenteric artery thrombosis † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Nausea † 1    
# participants affected / at risk     9/5740 (0.16%)     18/5757 (0.31%)  
Obstruction gastric † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Oesophageal disorder † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Oesophageal haemorrhage † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Oesophageal rupture † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Oesophageal spasm † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Oesophageal stenosis † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Oesophageal ulcer † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Oesophagitis † 1    
# participants affected / at risk     3/5740 (0.05%)     1/5757 (0.02%)  
Oesophagitis ulcerative † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Pancreatic cyst † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Pancreatitis † 1    
# participants affected / at risk     16/5740 (0.28%)     23/5757 (0.40%)  
Pancreatitis acute † 1    
# participants affected / at risk     6/5740 (0.10%)     8/5757 (0.14%)  
Pancreatitis chronic † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Peptic ulcer † 1    
# participants affected / at risk     3/5740 (0.05%)     3/5757 (0.05%)  
Peritoneal haemorrhage † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Peritonitis † 1    
# participants affected / at risk     1/5740 (0.02%)     3/5757 (0.05%)  
Rectal haemorrhage † 1    
# participants affected / at risk     5/5740 (0.09%)     5/5757 (0.09%)  
Rectal polyp † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Rectal prolapse † 1    
# participants affected / at risk     0/5740 (0.00%)     2/5757 (0.03%)  
Retching † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Retroperitoneal fibrosis † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Retroperitoneal haematoma † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Small intestinal obstruction † 1    
# participants affected / at risk     7/5740 (0.12%)     7/5757 (0.12%)  
Tongue oedema † 1    
# participants affected / at risk     1/5740 (0.02%)     1/5757 (0.02%)  
Umbilical hernia † 1    
# participants affected / at risk     2/5740 (0.03%)     0/5757 (0.00%)  
Umbilical hernia, obstructive † 1    
# participants affected / at risk     2/5740 (0.03%)     2/5757 (0.03%)  
Upper gastrointestinal haemorrhage † 1    
# participants affected / at risk     7/5740 (0.12%)     9/5757 (0.16%)  
Volvulus † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Vomiting † 1    
# participants affected / at risk     13/5740 (0.23%)     13/5757 (0.23%)  
General disorders      
Adverse drug reaction † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Asthenia † 1    
# participants affected / at risk     9/5740 (0.16%)     16/5757 (0.28%)  
Cardiac death † 1    
# participants affected / at risk     4/5740 (0.07%)     2/5757 (0.03%)  
Catheter related complication † 1    
# participants affected / at risk     0/5740 (0.00%)     2/5757 (0.03%)  
Catheter site haematoma † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Chest discomfort † 1    
# participants affected / at risk     9/5740 (0.16%)     7/5757 (0.12%)  
Chest pain † 1    
# participants affected / at risk     35/5740 (0.61%)     40/5757 (0.69%)  
Chills † 1    
# participants affected / at risk     2/5740 (0.03%)     0/5757 (0.00%)  
Death † 1    
# participants affected / at risk     4/5740 (0.07%)     7/5757 (0.12%)  
Decapitation † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Drowning † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Face oedema † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Fatigue † 1    
# participants affected / at risk     3/5740 (0.05%)     8/5757 (0.14%)  
Gait disturbance † 1    
# participants affected / at risk     3/5740 (0.05%)     2/5757 (0.03%)  
General physical health deterioration † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Generalised oedema † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Hernia † 1    
# participants affected / at risk     3/5740 (0.05%)     2/5757 (0.03%)  
Hernia obstructive † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Impaired healing † 1    
# participants affected / at risk     3/5740 (0.05%)     2/5757 (0.03%)  
Malaise † 1    
# participants affected / at risk     1/5740 (0.02%)     1/5757 (0.02%)  
Multi-organ failure † 1    
# participants affected / at risk     3/5740 (0.05%)     1/5757 (0.02%)  
Non-cardiac chest pain † 1    
# participants affected / at risk     64/5740 (1.11%)     50/5757 (0.87%)  
Oedema † 1    
# participants affected / at risk     0/5740 (0.00%)     3/5757 (0.05%)  
Oedema peripheral † 1    
# participants affected / at risk     10/5740 (0.17%)     8/5757 (0.14%)  
Pelvic mass † 1    
# participants affected / at risk     1/5740 (0.02%)     2/5757 (0.03%)  
Perforated ulcer † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Pyrexia † 1    
# participants affected / at risk     7/5740 (0.12%)     7/5757 (0.12%)  
Sudden cardiac death † 1    
# participants affected / at risk     1/5740 (0.02%)     3/5757 (0.05%)  
Sudden death † 1    
# participants affected / at risk     6/5740 (0.10%)     10/5757 (0.17%)  
Ulcer † 1    
# participants affected / at risk     1/5740 (0.02%)     1/5757 (0.02%)  
Vestibulitis † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Hepatobiliary disorders      
Bile duct obstruction † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Bile duct stenosis † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Bile duct stone † 1    
# participants affected / at risk     0/5740 (0.00%)     3/5757 (0.05%)  
Biliary dilatation † 1    
# participants affected / at risk     1/5740 (0.02%)     1/5757 (0.02%)  
Cholecystitis † 1    
# participants affected / at risk     12/5740 (0.21%)     21/5757 (0.36%)  
Cholecystitis acute † 1    
# participants affected / at risk     7/5740 (0.12%)     9/5757 (0.16%)  
Cholecystitis chronic † 1    
# participants affected / at risk     0/5740 (0.00%)     5/5757 (0.09%)  
Cholelithiasis † 1    
# participants affected / at risk     16/5740 (0.28%)     27/5757 (0.47%)  
Cholestasis † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Chronic hepatitis † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Gallbladder disorder † 1    
# participants affected / at risk     0/5740 (0.00%)     3/5757 (0.05%)  
Hepatic cirrhosis † 1    
# participants affected / at risk     2/5740 (0.03%)     1/5757 (0.02%)  
Hepatic congestion † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Hepatic failure † 1    
# participants affected / at risk     1/5740 (0.02%)     1/5757 (0.02%)  
Hepatic lesion † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Hepatitis † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Hepatitis cholestatic † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Ischaemic hepatitis † 1    
# participants affected / at risk     0/5740 (0.00%)     2/5757 (0.03%)  
Jaundice † 1    
# participants affected / at risk     1/5740 (0.02%)     2/5757 (0.03%)  
Jaundice cholestatic † 1    
# participants affected / at risk     1/5740 (0.02%)     1/5757 (0.02%)  
Sphincter of Oddi dysfunction † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Immune system disorders      
Allergy to arthropod sting † 1    
# participants affected / at risk     1/5740 (0.02%)     2/5757 (0.03%)  
Allergy to vaccine † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Anaphylactic shock † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Drug hypersensitivity † 1    
# participants affected / at risk     2/5740 (0.03%)     2/5757 (0.03%)  
Food allergy † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Hypersensitivity † 1    
# participants affected / at risk     2/5740 (0.03%)     1/5757 (0.02%)  
Sarcoidosis † 1    
# participants affected / at risk     1/5740 (0.02%)     1/5757 (0.02%)  
Infections and infestations      
Abdominal abscess † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Abdominal wall abscess † 1    
# participants affected / at risk     1/5740 (0.02%)     1/5757 (0.02%)  
Abscess † 1    
# participants affected / at risk     3/5740 (0.05%)     0/5757 (0.00%)  
Abscess intestinal † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Abscess limb † 1    
# participants affected / at risk     2/5740 (0.03%)     2/5757 (0.03%)  
Abscess neck † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Acute sinusitis † 1    
# participants affected / at risk     1/5740 (0.02%)     1/5757 (0.02%)  
Amoebiasis † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Appendicitis † 1    
# participants affected / at risk     6/5740 (0.10%)     9/5757 (0.16%)  
Arthritis bacterial † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Arthritis infective † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Atypical mycobacterial infection † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Bacteraemia † 1    
# participants affected / at risk     0/5740 (0.00%)     2/5757 (0.03%)  
Bacterial sepsis † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Bronchitis † 1    
# participants affected / at risk     21/5740 (0.37%)     17/5757 (0.30%)  
Bronchitis bacterial † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Bronchopneumonia † 1    
# participants affected / at risk     1/5740 (0.02%)     2/5757 (0.03%)  
Bursitis infective † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Cellulitis † 1    
# participants affected / at risk     39/5740 (0.68%)     22/5757 (0.38%)  
Cellulitis orbital † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Cellulitis staphylococcal † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Cellulitis streptococcal † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Cholecystitis infective † 1    
# participants affected / at risk     3/5740 (0.05%)     3/5757 (0.05%)  
Clostridial infection † 1    
# participants affected / at risk     1/5740 (0.02%)     2/5757 (0.03%)  
Clostridium difficile colitis † 1    
# participants affected / at risk     2/5740 (0.03%)     7/5757 (0.12%)  
Coccidioidomycosis † 1    
# participants affected / at risk     0/5740 (0.00%)     2/5757 (0.03%)  
Cystitis † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Cystitis klebsiella † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Dacryocystitis † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Device related infection † 1    
# participants affected / at risk     5/5740 (0.09%)     2/5757 (0.03%)  
Diabetic foot infection † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Diabetic gangrene † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Diarrhoea infectious † 1    
# participants affected / at risk     1/5740 (0.02%)     1/5757 (0.02%)  
Diverticulitis † 1    
# participants affected / at risk     6/5740 (0.10%)     14/5757 (0.24%)  
Eczema infected † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Empyema † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Encephalitis herpes † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Endocarditis † 1    
# participants affected / at risk     0/5740 (0.00%)     2/5757 (0.03%)  
Endocarditis bacterial † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Enterocolitis infectious † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Erysipelas † 1    
# participants affected / at risk     10/5740 (0.17%)     2/5757 (0.03%)  
Escherichia infection † 1    
# participants affected / at risk     2/5740 (0.03%)     0/5757 (0.00%)  
Escherichia sepsis † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Escherichia urinary tract infection † 1    
# participants affected / at risk     2/5740 (0.03%)     1/5757 (0.02%)  
Febrile infection † 1    
# participants affected / at risk     0/5740 (0.00%)     3/5757 (0.05%)  
Fungal skin infection † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Gangrene † 1    
# participants affected / at risk     4/5740 (0.07%)     4/5757 (0.07%)  
Gastroenteritis † 1    
# participants affected / at risk     15/5740 (0.26%)     30/5757 (0.52%)  
Gastroenteritis rotavirus † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Gastroenteritis salmonella † 1    
# participants affected / at risk     1/5740 (0.02%)     1/5757 (0.02%)  
Gastroenteritis shigella † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Gastroenteritis viral † 1    
# participants affected / at risk     10/5740 (0.17%)     7/5757 (0.12%)  
Gastrointestinal infection † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Graft infection † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Groin abscess † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Groin infection † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Helicobacter gastritis † 1    
# participants affected / at risk     1/5740 (0.02%)     1/5757 (0.02%)  
Helicobacter infection † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Herpes zoster † 1    
# participants affected / at risk     4/5740 (0.07%)     1/5757 (0.02%)  
Histoplasmosis † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Infected epidermal cyst † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Infected skin ulcer † 1    
# participants affected / at risk     1/5740 (0.02%)     3/5757 (0.05%)  
Infection † 1    
# participants affected / at risk     1/5740 (0.02%)     4/5757 (0.07%)  
Infective tenosynovitis † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Influenza † 1    
# participants affected / at risk     0/5740 (0.00%)     3/5757 (0.05%)  
Intervertebral discitis † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Intestinal gangrene † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Kidney infection † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Labyrinthitis † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Liver abscess † 1    
# participants affected / at risk     0/5740 (0.00%)     2/5757 (0.03%)  
Lobar pneumonia † 1    
# participants affected / at risk     7/5740 (0.12%)     5/5757 (0.09%)  
Localised infection † 1    
# participants affected / at risk     5/5740 (0.09%)     2/5757 (0.03%)  
Lower respiratory tract infection † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Lung abscess † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Lung infection † 1    
# participants affected / at risk     2/5740 (0.03%)     1/5757 (0.02%)  
Lung infection pseudomonal † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Nasopharyngitis † 1    
# participants affected / at risk     1/5740 (0.02%)     1/5757 (0.02%)  
Necrotising fasciitis † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Neuroborreliosis † 1    
# participants affected / at risk     1/5740 (0.02%)     1/5757 (0.02%)  
Oral viral infection † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Orchitis † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Osteomyelitis † 1    
# participants affected / at risk     6/5740 (0.10%)     6/5757 (0.10%)  
Parainfluenzae virus infection † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Pelvic abscess † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Periorbital cellulitis † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Perirectal abscess † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Pilonidal cyst † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Pneumonia † 1    
# participants affected / at risk     105/5740 (1.83%)     73/5757 (1.27%)  
Pneumonia bacterial † 1    
# participants affected / at risk     3/5740 (0.05%)     0/5757 (0.00%)  
Pneumonia haemophilus † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Pneumonia klebsiella † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Pneumonia primary atypical † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Pneumonia staphylococcal † 1    
# participants affected / at risk     2/5740 (0.03%)     0/5757 (0.00%)  
Post procedural infection † 1    
# participants affected / at risk     4/5740 (0.07%)     1/5757 (0.02%)  
Postoperative abscess † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Postoperative wound infection † 1    
# participants affected / at risk     2/5740 (0.03%)     5/5757 (0.09%)  
Psoas abscess † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Pyelonephritis † 1    
# participants affected / at risk     6/5740 (0.10%)     10/5757 (0.17%)  
Pyelonephritis acute † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Pyothorax † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Respiratory tract infection † 1    
# participants affected / at risk     1/5740 (0.02%)     1/5757 (0.02%)  
Salmonella sepsis † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Scrotal abscess † 1    
# participants affected / at risk     0/5740 (0.00%)     2/5757 (0.03%)  
Scrotal infection † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Sepsis † 1    
# participants affected / at risk     14/5740 (0.24%)     20/5757 (0.35%)  
Sepsis syndrome † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Septic shock † 1    
# participants affected / at risk     1/5740 (0.02%)     2/5757 (0.03%)  
Sinusitis † 1    
# participants affected / at risk     1/5740 (0.02%)     1/5757 (0.02%)  
Staphylococcal abscess † 1    
# participants affected / at risk     2/5740 (0.03%)     2/5757 (0.03%)  
Staphylococcal bacteraemia † 1    
# participants affected / at risk     2/5740 (0.03%)     0/5757 (0.00%)  
Staphylococcal infection † 1    
# participants affected / at risk     4/5740 (0.07%)     6/5757 (0.10%)  
Staphylococcal osteomyelitis † 1    
# participants affected / at risk     1/5740 (0.02%)     1/5757 (0.02%)  
Staphylococcal sepsis † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Streptococcal bacteraemia † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Streptococcal infection † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Subcutaneous abscess † 1    
# participants affected / at risk     0/5740 (0.00%)     2/5757 (0.03%)  
Tooth infection † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Tracheitis † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Tracheobronchitis † 1    
# participants affected / at risk     1/5740 (0.02%)     1/5757 (0.02%)  
Upper respiratory tract infection † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Urinary tract infection † 1    
# participants affected / at risk     25/5740 (0.44%)     21/5757 (0.36%)  
Urinary tract infection staphylococcal † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Urosepsis † 1    
# participants affected / at risk     8/5740 (0.14%)     10/5757 (0.17%)  
Viral infection † 1    
# participants affected / at risk     2/5740 (0.03%)     3/5757 (0.05%)  
Viral labyrinthitis † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Viral myocarditis † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Vulval abscess † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Wound infection † 1    
# participants affected / at risk     2/5740 (0.03%)     4/5757 (0.07%)  
Wound infection pseudomonas † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Wound infection staphylococcal † 1    
# participants affected / at risk     0/5740 (0.00%)     2/5757 (0.03%)  
Injury, poisoning and procedural complications      
Abdominal injury † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Accident † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Accidental exposure † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Acetabulum fracture † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Alcohol poisoning † 1    
# participants affected / at risk     1/5740 (0.02%)     2/5757 (0.03%)  
Anaesthetic complication neurological † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Anastomotic leak † 1    
# participants affected / at risk     1/5740 (0.02%)     1/5757 (0.02%)  
Ankle fracture † 1    
# participants affected / at risk     15/5740 (0.26%)     7/5757 (0.12%)  
Arthropod bite † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Carbon monoxide poisoning † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Clavicle fracture † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Compression fracture † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Concussion † 1    
# participants affected / at risk     3/5740 (0.05%)     0/5757 (0.00%)  
Contrast media reaction † 1    
# participants affected / at risk     0/5740 (0.00%)     2/5757 (0.03%)  
Contusion † 1    
# participants affected / at risk     3/5740 (0.05%)     4/5757 (0.07%)  
Device failure † 1    
# participants affected / at risk     2/5740 (0.03%)     2/5757 (0.03%)  
Device migration † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Dislocation of joint prosthesis † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Drug toxicity † 1    
# participants affected / at risk     1/5740 (0.02%)     3/5757 (0.05%)  
Excoriation † 1    
# participants affected / at risk     1/5740 (0.02%)     1/5757 (0.02%)  
Exposure to toxic agent † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Extradural haematoma † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Eye injury † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Facial bones fracture † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Failure of implant † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Fall † 1    
# participants affected / at risk     13/5740 (0.23%)     13/5757 (0.23%)  
Femoral neck fracture † 1    
# participants affected / at risk     4/5740 (0.07%)     4/5757 (0.07%)  
Femur fracture † 1    
# participants affected / at risk     9/5740 (0.16%)     5/5757 (0.09%)  
Foot fracture † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Forearm fracture † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Fracture displacement † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Fractured sacrum † 1    
# participants affected / at risk     1/5740 (0.02%)     1/5757 (0.02%)  
Gastroenteritis radiation † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Graft dysfunction † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Hand fracture † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Head injury † 1    
# participants affected / at risk     3/5740 (0.05%)     2/5757 (0.03%)  
Heat exhaustion † 1    
# participants affected / at risk     1/5740 (0.02%)     2/5757 (0.03%)  
Heat stroke † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Hip fracture † 1    
# participants affected / at risk     22/5740 (0.38%)     20/5757 (0.35%)  
Humerus fracture † 1    
# participants affected / at risk     7/5740 (0.12%)     6/5757 (0.10%)  
Implantable defibrillator malfunction † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
In-stent arterial restenosis † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Incisional hernia † 1    
# participants affected / at risk     2/5740 (0.03%)     3/5757 (0.05%)  
Injury † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Jaw fracture † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Joint dislocation † 1    
# participants affected / at risk     4/5740 (0.07%)     0/5757 (0.00%)  
Joint injury † 1    
# participants affected / at risk     3/5740 (0.05%)     1/5757 (0.02%)  
Kidney rupture † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Ligament rupture † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Limb injury † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Limb traumatic amputation † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Lower limb fracture † 1    
# participants affected / at risk     3/5740 (0.05%)     3/5757 (0.05%)  
Lumbar vertebral fracture † 1    
# participants affected / at risk     2/5740 (0.03%)     4/5757 (0.07%)  
Lung injury † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Medical device complication † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Meniscus lesion † 1    
# participants affected / at risk     1/5740 (0.02%)     3/5757 (0.05%)  
Multiple injuries † 1    
# participants affected / at risk     2/5740 (0.03%)     0/5757 (0.00%)  
Muscle strain † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Neck injury † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Overdose † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Pacemaker complication † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Patella fracture † 1    
# participants affected / at risk     2/5740 (0.03%)     2/5757 (0.03%)  
Pelvic fracture † 1    
# participants affected / at risk     4/5740 (0.07%)     2/5757 (0.03%)  
Pneumonitis chemical † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Pocket erosion † 1    
# participants affected / at risk     1/5740 (0.02%)     1/5757 (0.02%)  
Post procedural complication † 1    
# participants affected / at risk     1/5740 (0.02%)     2/5757 (0.03%)  
Post procedural haematoma † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Post procedural haemorrhage † 1    
# participants affected / at risk     0/5740 (0.00%)     2/5757 (0.03%)  
Post procedural pulmonary embolism † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Postoperative thoracic procedure complication † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Postpericardiotomy syndrome † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Procedural complication † 1    
# participants affected / at risk     0/5740 (0.00%)     2/5757 (0.03%)  
Pubic rami fracture † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Radiation oesophagitis † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Radius fracture † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Rib fracture † 1    
# participants affected / at risk     2/5740 (0.03%)     9/5757 (0.16%)  
Road traffic accident † 1    
# participants affected / at risk     1/5740 (0.02%)     2/5757 (0.03%)  
Scapula fracture † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Seroma † 1    
# participants affected / at risk     1/5740 (0.02%)     1/5757 (0.02%)  
Skin laceration † 1    
# participants affected / at risk     1/5740 (0.02%)     1/5757 (0.02%)  
Spinal compression fracture † 1    
# participants affected / at risk     3/5740 (0.05%)     3/5757 (0.05%)  
Spinal cord injury † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Spinal fracture † 1    
# participants affected / at risk     2/5740 (0.03%)     0/5757 (0.00%)  
Splenic rupture † 1    
# participants affected / at risk     1/5740 (0.02%)     1/5757 (0.02%)  
Stent occlusion † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Subdural haematoma † 1    
# participants affected / at risk     6/5740 (0.10%)     13/5757 (0.23%)  
Subdural haemorrhage † 1    
# participants affected / at risk     0/5740 (0.00%)     2/5757 (0.03%)  
Surgical procedure repeated † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Tendon rupture † 1    
# participants affected / at risk     0/5740 (0.00%)     5/5757 (0.09%)  
Therapeutic agent toxicity † 1    
# participants affected / at risk     3/5740 (0.05%)     4/5757 (0.07%)  
Thermal burn † 1    
# participants affected / at risk     1/5740 (0.02%)     1/5757 (0.02%)  
Thoracic vertebral fracture † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Tibia fracture † 1    
# participants affected / at risk     2/5740 (0.03%)     2/5757 (0.03%)  
Traumatic brain injury † 1    
# participants affected / at risk     2/5740 (0.03%)     1/5757 (0.02%)  
Traumatic intracranial haemorrhage † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Ulna fracture † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Upper limb fracture † 1    
# participants affected / at risk     6/5740 (0.10%)     6/5757 (0.10%)  
Urethral stricture postoperative † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Vascular graft complication † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Vascular graft occlusion † 1    
# participants affected / at risk     1/5740 (0.02%)     1/5757 (0.02%)  
Wound † 1    
# participants affected / at risk     1/5740 (0.02%)     3/5757 (0.05%)  
Wound complication † 1    
# participants affected / at risk     1/5740 (0.02%)     1/5757 (0.02%)  
Wound dehiscence † 1    
# participants affected / at risk     0/5740 (0.00%)     2/5757 (0.03%)  
Wrist fracture † 1    
# participants affected / at risk     6/5740 (0.10%)     1/5757 (0.02%)  
Investigations      
Band neutrophil count increased † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Biopsy liver † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Blood creatinine increased † 1    
# participants affected / at risk     0/5740 (0.00%)     2/5757 (0.03%)  
Blood glucose abnormal † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Blood glucose decreased † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Blood glucose fluctuation † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Blood glucose increased † 1    
# participants affected / at risk     3/5740 (0.05%)     4/5757 (0.07%)  
Blood potassium decreased † 1    
# participants affected / at risk     2/5740 (0.03%)     0/5757 (0.00%)  
Blood potassium increased † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Blood pressure decreased † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Blood pressure increased † 1    
# participants affected / at risk     2/5740 (0.03%)     1/5757 (0.02%)  
Blood pressure orthostatic decreased † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Blood sodium decreased † 1    
# participants affected / at risk     1/5740 (0.02%)     1/5757 (0.02%)  
Cardiac murmur † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Cardiac stress test abnormal † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Cardiac stress test normal † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Cardioactive drug level increased † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Chest X-ray abnormal † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Coagulation test abnormal † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Ejection fraction decreased † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Electrocardiogram abnormal † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Haemoglobin decreased † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Heart rate decreased † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Heart rate increased † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Heart rate irregular † 1    
# participants affected / at risk     1/5740 (0.02%)     2/5757 (0.03%)  
Hepatic enzyme increased † 1    
# participants affected / at risk     2/5740 (0.03%)     1/5757 (0.02%)  
International normalised ratio increased † 1    
# participants affected / at risk     3/5740 (0.05%)     1/5757 (0.02%)  
Liver function test abnormal † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Occult blood positive † 1    
# participants affected / at risk     2/5740 (0.03%)     1/5757 (0.02%)  
Oxygen saturation decreased † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Red blood cell count increased † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Scan myocardial perfusion abnormal † 1    
# participants affected / at risk     1/5740 (0.02%)     1/5757 (0.02%)  
Transaminases increased † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Troponin increased † 1    
# participants affected / at risk     1/5740 (0.02%)     1/5757 (0.02%)  
Urine output decreased † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Weight decreased † 1    
# participants affected / at risk     2/5740 (0.03%)     0/5757 (0.00%)  
Weight increased † 1    
# participants affected / at risk     0/5740 (0.00%)     2/5757 (0.03%)  
White blood cell count increased † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Metabolism and nutrition disorders      
Acidosis † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Cachexia † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Decreased appetite † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Dehydration † 1    
# participants affected / at risk     39/5740 (0.68%)     51/5757 (0.89%)  
Diabetes mellitus † 1    
# participants affected / at risk     13/5740 (0.23%)     18/5757 (0.31%)  
Diabetes mellitus inadequate control † 1    
# participants affected / at risk     7/5740 (0.12%)     5/5757 (0.09%)  
Diabetic foot † 1    
# participants affected / at risk     5/5740 (0.09%)     1/5757 (0.02%)  
Diabetic ketoacidosis † 1    
# participants affected / at risk     4/5740 (0.07%)     5/5757 (0.09%)  
Electrolyte imbalance † 1    
# participants affected / at risk     0/5740 (0.00%)     3/5757 (0.05%)  
Failure to thrive † 1    
# participants affected / at risk     1/5740 (0.02%)     2/5757 (0.03%)  
Fluid overload † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Gout † 1    
# participants affected / at risk     3/5740 (0.05%)     7/5757 (0.12%)  
Hypercalcaemia † 1    
# participants affected / at risk     1/5740 (0.02%)     3/5757 (0.05%)  
Hyperglycaemia † 1    
# participants affected / at risk     10/5740 (0.17%)     11/5757 (0.19%)  
Hyperkalaemia † 1    
# participants affected / at risk     10/5740 (0.17%)     11/5757 (0.19%)  
Hypernatraemia † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Hyperuricaemia † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Hypocalcaemia † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Hypoglycaemia † 1    
# participants affected / at risk     32/5740 (0.56%)     24/5757 (0.42%)  
Hypokalaemia † 1    
# participants affected / at risk     2/5740 (0.03%)     12/5757 (0.21%)  
Hypomagnesaemia † 1    
# participants affected / at risk     0/5740 (0.00%)     2/5757 (0.03%)  
Hyponatraemia † 1    
# participants affected / at risk     3/5740 (0.05%)     17/5757 (0.30%)  
Hypovolaemia † 1    
# participants affected / at risk     5/5740 (0.09%)     3/5757 (0.05%)  
Ketosis † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Malnutrition † 1    
# participants affected / at risk     1/5740 (0.02%)     3/5757 (0.05%)  
Metabolic acidosis † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Obesity † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Overweight † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Podagra † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Type 2 diabetes mellitus † 1    
# participants affected / at risk     2/5740 (0.03%)     2/5757 (0.03%)  
Musculoskeletal and connective tissue disorders      
Arthralgia † 1    
# participants affected / at risk     13/5740 (0.23%)     12/5757 (0.21%)  
Arthritis † 1    
# participants affected / at risk     12/5740 (0.21%)     10/5757 (0.17%)  
Arthropathy † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Back pain † 1    
# participants affected / at risk     21/5740 (0.37%)     18/5757 (0.31%)  
Bone disorder † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Bone erosion † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Bursitis † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Cervical spinal stenosis † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Costochondritis † 1    
# participants affected / at risk     2/5740 (0.03%)     0/5757 (0.00%)  
Dupuytren's contracture † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Exostosis † 1    
# participants affected / at risk     1/5740 (0.02%)     1/5757 (0.02%)  
Flank pain † 1    
# participants affected / at risk     0/5740 (0.00%)     3/5757 (0.05%)  
Foot deformity † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Gouty arthritis † 1    
# participants affected / at risk     0/5740 (0.00%)     3/5757 (0.05%)  
Gouty tophus † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Groin pain † 1    
# participants affected / at risk     0/5740 (0.00%)     2/5757 (0.03%)  
Intervertebral disc compression † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Intervertebral disc degeneration † 1    
# participants affected / at risk     7/5740 (0.12%)     4/5757 (0.07%)  
Intervertebral disc disorder † 1    
# participants affected / at risk     0/5740 (0.00%)     3/5757 (0.05%)  
Intervertebral disc displacement † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Intervertebral disc protrusion † 1    
# participants affected / at risk     9/5740 (0.16%)     11/5757 (0.19%)  
Joint stiffness † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Lumbar spinal stenosis † 1    
# participants affected / at risk     13/5740 (0.23%)     7/5757 (0.12%)  
Monarthritis † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Muscular weakness † 1    
# participants affected / at risk     3/5740 (0.05%)     4/5757 (0.07%)  
Musculoskeletal chest pain † 1    
# participants affected / at risk     10/5740 (0.17%)     9/5757 (0.16%)  
Musculoskeletal pain † 1    
# participants affected / at risk     1/5740 (0.02%)     7/5757 (0.12%)  
Myalgia † 1    
# participants affected / at risk     1/5740 (0.02%)     3/5757 (0.05%)  
Myositis † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Neck mass † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Neck pain † 1    
# participants affected / at risk     4/5740 (0.07%)     0/5757 (0.00%)  
Osteoarthritis † 1    
# participants affected / at risk     41/5740 (0.71%)     58/5757 (1.01%)  
Osteonecrosis † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Osteoporosis † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Pain in extremity † 1    
# participants affected / at risk     5/5740 (0.09%)     5/5757 (0.09%)  
Pain in jaw † 1    
# participants affected / at risk     2/5740 (0.03%)     0/5757 (0.00%)  
Polyarthritis † 1    
# participants affected / at risk     2/5740 (0.03%)     1/5757 (0.02%)  
Polymyalgia rheumatica † 1    
# participants affected / at risk     2/5740 (0.03%)     4/5757 (0.07%)  
Pseudarthrosis † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Rhabdomyolysis † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Rotator cuff syndrome † 1    
# participants affected / at risk     7/5740 (0.12%)     5/5757 (0.09%)  
Sensation of heaviness † 1    
# participants affected / at risk     1/5740 (0.02%)     1/5757 (0.02%)  
Spinal column stenosis † 1    
# participants affected / at risk     11/5740 (0.19%)     11/5757 (0.19%)  
Spinal osteoarthritis † 1    
# participants affected / at risk     5/5740 (0.09%)     2/5757 (0.03%)  
Spondylolisthesis † 1    
# participants affected / at risk     3/5740 (0.05%)     2/5757 (0.03%)  
Synovial cyst † 1    
# participants affected / at risk     1/5740 (0.02%)     2/5757 (0.03%)  
Synovitis † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Torticollis † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Neoplasms benign, malignant and unspecified (incl cysts and polyps)      
Abdominal neoplasm † 1    
# participants affected / at risk     0/5740 (0.00%)     2/5757 (0.03%)  
Acute leukaemia † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Acute myeloid leukaemia † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Adenocarcinoma † 1    
# participants affected / at risk     2/5740 (0.03%)     0/5757 (0.00%)  
Adenocarcinoma pancreas † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Adenoma benign † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Anal cancer stage 0 † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Astrocytoma † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
B-cell lymphoma † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Basal cell carcinoma † 1    
# participants affected / at risk     13/5740 (0.23%)     6/5757 (0.10%)  
Benign breast neoplasm † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Benign colonic neoplasm † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Benign duodenal neoplasm † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Benign neoplasm of skin † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Benign renal neoplasm † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Bile duct cancer † 1    
# participants affected / at risk     3/5740 (0.05%)     0/5757 (0.00%)  
Bladder cancer † 1    
# participants affected / at risk     4/5740 (0.07%)     9/5757 (0.16%)  
Bladder cancer recurrent † 1    
# participants affected / at risk     0/5740 (0.00%)     2/5757 (0.03%)  
Bladder neoplasm † 1    
# participants affected / at risk     0/5740 (0.00%)     4/5757 (0.07%)  
Bladder transitional cell carcinoma † 1    
# participants affected / at risk     2/5740 (0.03%)     0/5757 (0.00%)  
Bone neoplasm † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Bone sarcoma † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Brain neoplasm † 1    
# participants affected / at risk     3/5740 (0.05%)     6/5757 (0.10%)  
Breast cancer † 1    
# participants affected / at risk     16/5740 (0.28%)     14/5757 (0.24%)  
Breast cancer in situ † 1    
# participants affected / at risk     0/5740 (0.00%)     2/5757 (0.03%)  
Breast cancer metastatic † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Breast cancer stage II † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Bronchioloalveolar carcinoma † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Castleman's disease † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Chronic lymphocytic leukaemia † 1    
# participants affected / at risk     0/5740 (0.00%)     2/5757 (0.03%)  
Colon cancer † 1    
# participants affected / at risk     14/5740 (0.24%)     18/5757 (0.31%)  
Colon cancer metastatic † 1    
# participants affected / at risk     3/5740 (0.05%)     2/5757 (0.03%)  
Colon cancer stage II † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Colon cancer stage III † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Colon neoplasm † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Colorectal cancer † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Diffuse large B-cell lymphoma † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Endometrial cancer † 1    
# participants affected / at risk     2/5740 (0.03%)     2/5757 (0.03%)  
Endometrial cancer metastatic † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Fallopian tube cancer † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Gastric cancer † 1    
# participants affected / at risk     2/5740 (0.03%)     1/5757 (0.02%)  
Gastric neoplasm † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Gastrointestinal tract adenoma † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Glioblastoma multiforme † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Glioma † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Gliosarcoma † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Haemangioma † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Hepatic cancer metastatic † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Hepatic neoplasm † 1    
# participants affected / at risk     3/5740 (0.05%)     0/5757 (0.00%)  
Hepatic neoplasm malignant † 1    
# participants affected / at risk     3/5740 (0.05%)     3/5757 (0.05%)  
Hodgkin's disease † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Laryngeal cancer † 1    
# participants affected / at risk     3/5740 (0.05%)     1/5757 (0.02%)  
Leiomyoma † 1    
# participants affected / at risk     1/5740 (0.02%)     0/5757 (0.00%)  
Leiomyosarcoma † 1    
# participants affected / at risk     0/5740 (0.00%)     1/5757 (0.02%)  
Leiomyosarcoma metastatic † 1    
# participants affected / at risk     0/5740 (0.00%)