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A Long Term Study of Sibutramine and the Role of Obesity Management in Relation to Cardiovascular Disease in Overweight and Obese Patients (SCOUT)

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00234832
First received: September 13, 2005
Last updated: May 6, 2010
Last verified: May 2010
Results First Received: March 26, 2010  
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: Obesity
Interventions: Drug: Sibutramine hydrochloride
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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of the 10777 subjects enrolled into the study, 33 were not treated with Lead-in Period sibutramine. Of the 10744 subjects who took at least 1 dose of Lead-in Period sibutramine, 939 were not randomized. One of the remaining 9805 subjects was not dispensed randomized study drug and was not included in the intent-to-treat population (N = 9804).

Reporting Groups
  Description
Randomized Sibutramine Subjects who completed the 6-week Lead-in Period and who were randomized and dispensed sibutramine during the Treatment Period and continued standard care for weight management. If sibutramine was prematurely discontinued, subjects continued standard care for weight management during the Follow-up Period.
Randomized Placebo Subjects who completed the 6-week Lead-in Period and who were randomized and dispensed placebo during the Treatment Period and continued standard care for weight management. If placebo was prematurely discontinued, subjects continued standard care for weight management during the Follow-up Period.

Participant Flow:   Overall Study
    Randomized Sibutramine     Randomized Placebo  
STARTED     4906 [1]   4898 [1]
COMPLETED     3890 [2]   3902 [2]
NOT COMPLETED     1016     996  
[1] Subjects completed the 6-week Lead-in Period and were dispensed randomized study drug.
[2] Subjects completed the Randomization Phase.



  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
Randomized Sibutramine Subjects who completed the 6-week Lead-in Period and who were randomized and dispensed sibutramine during the Treatment Period and continued standard care for weight management. If sibutramine was prematurely discontinued, subjects continued standard care for weight management during the Follow-up Period.
Randomized Placebo Subjects who completed the 6-week Lead-in Period and who were randomized and dispensed placebo during the Treatment Period and continued standard care for weight management. If placebo was prematurely discontinued, subjects continued standard care for weight management during the Follow-up Period.
Total Total of all reporting groups

Baseline Measures
    Randomized Sibutramine     Randomized Placebo     Total  
Number of Participants  
[units: participants]
  4906     4898     9804  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     3040     2997     6037  
>=65 years     1866     1901     3767  
Age  
[units: years]
Mean ± Standard Deviation
  63.2  ± 6.09     63.3  ± 6.15     63.2  ± 6.12  
Gender  
[units: participants]
     
Female     2099     2055     4154  
Male     2807     2843     5650  
Region of Enrollment  
[units: participants]
     
Europe     4160     4150     8310  
Australia     384     385     769  
Brazil     233     234     467  
Mexico     129     129     258  
Cardiovascular (CV) risk group status [1]
[units: Participants]
     
DM only     1207     1178     2385  
CV only     759     793     1552  
CV + DM     2906     2901     5807  
Unknown CV risk group status     34     26     60  
[1] Subjects were categorized at study entry into 1 of 3 prespecified CV risk groups: 1) diabetes mellitus (DM) only = history of type 2 DM with at least one other risk factor but no history of CV disease, 2) CV only = history of coronary artery disease, cerebrovascular disease, or peripheral arterial occlusive disease, but no history of type 2 DM with at least one other risk factor, and 3) CV + DM = history of coronary artery disease, cerebrovascular disease, or peripheral arterial occlusive disease, and a history of type 2 DM with at least one other risk factor.



  Outcome Measures
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1.  Primary:   Risk of Experiencing a Primary Outcome Event (POE) (i.e., Nonfatal Myocardial Infarction [MI], Nonfatal Stroke, Resuscitated Cardiac Arrest, Cardiovascular [CV] Death)   [ Time Frame: From randomization up to 6 years ]

2.  Secondary:   Risk of Death From Any Cause (All-cause Mortality)   [ Time Frame: From randomization up to 6 years ]

3.  Secondary:   Risk of Experiencing a POE or a Revascularization Procedure   [ Time Frame: From randomization up to 6 years ]

4.  Secondary:   Risk of Experiencing a Nonfatal MI Included in the POE   [ Time Frame: From randomization up to 6 years ]

5.  Secondary:   Risk of Experiencing a Nonfatal Stroke Included in the POE   [ Time Frame: From randomization up to 6 years ]

6.  Secondary:   Risk of Experiencing a Resuscitated Cardiac Arrest Included in the POE   [ Time Frame: From randomization up to 6 years ]

7.  Secondary:   Risk of Experiencing Cardiovascular Death Included in the POE   [ Time Frame: From randomization up to 6 years ]


  Serious Adverse Events
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Time Frame Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose.
Additional Description

SAEs confirmed to be outcome events are included.

Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.


Reporting Groups
  Description
Lead-in Period Sibutramine Subjects who received sibutramine 10 mg QD plus standard care for weight management during a 6-week Lead-in Period.
Randomized Sibutramine Subjects who successfully completed a 6-week Lead-in Period and who were randomized to receive sibutramine plus standard care for weight management during the Treatment Period of the Randomization Phase, and if sibutramine was prematurely discontinued, they received standard care for weight management during the Follow-up Period of the Randomization Phase.
Randomized Placebo Subjects who successfully completed a 6-week Lead-in Period and who were randomized to receive placebo plus standard care for weight management during the Treatment Period of the Randomizaiton Phase, and if placebo was prematurely discontinued, they received standard care for weight management during the Follow-up Period of the Randomization Phase.

Serious Adverse Events
    Lead-in Period Sibutramine     Randomized Sibutramine     Randomized Placebo  
Total, serious adverse events        
# participants affected / at risk     425/10744 (3.96%)     2063/4904 (42.07%)     1977/4881 (40.50%)  
Blood and lymphatic system disorders        
Anemia * 1      
# participants affected / at risk     0/10744 (0.00%)     19/4904 (0.39%)     11/4881 (0.23%)  
Bicytopenia * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     0/4881 (0.00%)  
Coagulopathy * 1      
# participants affected / at risk     0/10744 (0.00%)     0/4904 (0.00%)     1/4881 (0.02%)  
Disseminated intravascular coagulation * 1      
# participants affected / at risk     0/10744 (0.00%)     0/4904 (0.00%)     1/4881 (0.02%)  
Hemolytic anemia * 1      
# participants affected / at risk     0/10744 (0.00%)     0/4904 (0.00%)     1/4881 (0.02%)  
Hemorrhagic anemia * 1      
# participants affected / at risk     0/10744 (0.00%)     0/4904 (0.00%)     3/4881 (0.06%)  
Hemorrhagic disorder * 1      
# participants affected / at risk     0/10744 (0.00%)     0/4904 (0.00%)     1/4881 (0.02%)  
Hypersplenism * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     0/4881 (0.00%)  
Hypochromic anemia * 1      
# participants affected / at risk     1/10744 (0.01%)     2/4904 (0.04%)     0/4881 (0.00%)  
Hypoprothrombinanemia * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     0/4881 (0.00%)  
Idiopathic thrombocytopenic purpura * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     0/4881 (0.00%)  
Iron deficiency anemia * 1      
# participants affected / at risk     0/10744 (0.00%)     4/4904 (0.08%)     4/4881 (0.08%)  
Leukocytosis * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     0/4881 (0.00%)  
Lymphadenitis * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     1/4881 (0.02%)  
Lymphadenopathy * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     0/4881 (0.00%)  
Lymphatic obstruction * 1      
# participants affected / at risk     1/10744 (0.01%)     0/4904 (0.00%)     0/4881 (0.00%)  
Lymphocytosis * 1      
# participants affected / at risk     0/10744 (0.00%)     0/4904 (0.00%)     1/4881 (0.02%)  
Microcytic anemia * 1      
# participants affected / at risk     0/10744 (0.00%)     2/4904 (0.04%)     1/4881 (0.02%)  
Neutropenia * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     0/4881 (0.00%)  
Normochromic normocytic anemia * 1      
# participants affected / at risk     0/10744 (0.00%)     2/4904 (0.04%)     2/4881 (0.04%)  
Thrombocytopenia * 1      
# participants affected / at risk     0/10744 (0.00%)     0/4904 (0.00%)     1/4881 (0.02%)  
Thrombocytosis * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     0/4881 (0.00%)  
Cardiac disorders        
Acute coronary syndrome * 1      
# participants affected / at risk     6/10744 (0.06%)     25/4904 (0.51%)     26/4881 (0.53%)  
Acute left ventricular failure * 1      
# participants affected / at risk     0/10744 (0.00%)     3/4904 (0.06%)     3/4881 (0.06%)  
Acute myocardial infarction * 1      
# participants affected / at risk     3/10744 (0.03%)     87/4904 (1.77%)     87/4881 (1.78%)  
Adams-Stokes syndrome * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     0/4881 (0.00%)  
Angina pectoris * 1      
# participants affected / at risk     21/10744 (0.20%)     111/4904 (2.26%)     133/4881 (2.72%)  
Angina unstable * 1      
# participants affected / at risk     23/10744 (0.21%)     122/4904 (2.49%)     104/4881 (2.13%)  
Aortic valve disease * 1      
# participants affected / at risk     1/10744 (0.01%)     2/4904 (0.04%)     0/4881 (0.00%)  
Aortic valve disease mixed * 1      
# participants affected / at risk     0/10744 (0.00%)     4/4904 (0.08%)     2/4881 (0.04%)  
Aortic valve incompetence * 1      
# participants affected / at risk     0/10744 (0.00%)     3/4904 (0.06%)     1/4881 (0.02%)  
Aortic valve stenosis * 1      
# participants affected / at risk     0/10744 (0.00%)     7/4904 (0.14%)     9/4881 (0.18%)  
Arrhythmia * 1      
# participants affected / at risk     0/10744 (0.00%)     0/4904 (0.00%)     6/4881 (0.12%)  
Arrhythmia supraventricular * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     0/4881 (0.00%)  
Arteriosclerosis coronary artery * 1      
# participants affected / at risk     0/10744 (0.00%)     4/4904 (0.08%)     8/4881 (0.16%)  
Atrial fibrillation * 1      
# participants affected / at risk     20/10744 (0.19%)     115/4904 (2.35%)     135/4881 (2.77%)  
Atrial flutter * 1      
# participants affected / at risk     4/10744 (0.04%)     21/4904 (0.43%)     29/4881 (0.59%)  
Atrial tachycardia * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     0/4881 (0.00%)  
Atrial thrombosis * 1      
# participants affected / at risk     0/10744 (0.00%)     2/4904 (0.04%)     0/4881 (0.00%)  
Atrioventricular block * 1      
# participants affected / at risk     1/10744 (0.01%)     2/4904 (0.04%)     1/4881 (0.02%)  
Atrioventricular block complete * 1      
# participants affected / at risk     2/10744 (0.02%)     8/4904 (0.16%)     16/4881 (0.33%)  
Atrioventricular block first degree * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     2/4881 (0.04%)  
Atrioventricular block second degree * 1      
# participants affected / at risk     0/10744 (0.00%)     3/4904 (0.06%)     16/4881 (0.33%)  
Bradyarrhythmia * 1      
# participants affected / at risk     0/10744 (0.00%)     2/4904 (0.04%)     3/4881 (0.06%)  
Bradycardia * 1      
# participants affected / at risk     1/10744 (0.01%)     7/4904 (0.14%)     7/4881 (0.14%)  
Bundle branch block right * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     1/4881 (0.02%)  
Cardiac aneurysm * 1      
# participants affected / at risk     0/10744 (0.00%)     2/4904 (0.04%)     0/4881 (0.00%)  
Cardiac arrest * 1      
# participants affected / at risk     0/10744 (0.00%)     24/4904 (0.49%)     14/4881 (0.29%)  
Cardiac asthma * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     1/4881 (0.02%)  
Cardiac disorder * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     1/4881 (0.02%)  
Cardiac failure * 1      
# participants affected / at risk     2/10744 (0.02%)     82/4904 (1.67%)     80/4881 (1.64%)  
Cardiac failure acute * 1      
# participants affected / at risk     0/10744 (0.00%)     3/4904 (0.06%)     9/4881 (0.18%)  
Cardiac failure chronic * 1      
# participants affected / at risk     0/10744 (0.00%)     5/4904 (0.10%)     8/4881 (0.16%)  
Cardiac failure congestive * 1      
# participants affected / at risk     3/10744 (0.03%)     53/4904 (1.08%)     41/4881 (0.84%)  
Cardiac tamponade * 1      
# participants affected / at risk     0/10744 (0.00%)     2/4904 (0.04%)     1/4881 (0.02%)  
Cardio-respiratory arrest * 1      
# participants affected / at risk     1/10744 (0.01%)     1/4904 (0.02%)     2/4881 (0.04%)  
Cardiogenic shock * 1      
# participants affected / at risk     0/10744 (0.00%)     4/4904 (0.08%)     5/4881 (0.10%)  
Cardiomyopathy * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     1/4881 (0.02%)  
Cardiopulmonary failure * 1      
# participants affected / at risk     0/10744 (0.00%)     3/4904 (0.06%)     2/4881 (0.04%)  
Cardiovascular insufficiency * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     0/4881 (0.00%)  
Chronic right ventricular failure * 1      
# participants affected / at risk     0/10744 (0.00%)     0/4904 (0.00%)     1/4881 (0.02%)  
Conduction disorder * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     1/4881 (0.02%)  
Congestive cardiomyopathy * 1      
# participants affected / at risk     1/10744 (0.01%)     7/4904 (0.14%)     6/4881 (0.12%)  
Cor pulmonale chronic * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     0/4881 (0.00%)  
Coronary artery disease * 1      
# participants affected / at risk     15/10744 (0.14%)     135/4904 (2.75%)     118/4881 (2.42%)  
Coronary artery dissection * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     0/4881 (0.00%)  
Coronary artery insufficiency * 1      
# participants affected / at risk     0/10744 (0.00%)     3/4904 (0.06%)     3/4881 (0.06%)  
Coronary artery occlusion * 1      
# participants affected / at risk     1/10744 (0.01%)     3/4904 (0.06%)     8/4881 (0.16%)  
Coronary artery stenosis * 1      
# participants affected / at risk     4/10744 (0.04%)     76/4904 (1.55%)     74/4881 (1.52%)  
Coronary artery thrombosis * 1      
# participants affected / at risk     1/10744 (0.01%)     2/4904 (0.04%)     2/4881 (0.04%)  
Diastolic dysfunction * 1      
# participants affected / at risk     0/10744 (0.00%)     0/4904 (0.00%)     1/4881 (0.02%)  
Extrasystoles * 1      
# participants affected / at risk     0/10744 (0.00%)     0/4904 (0.00%)     1/4881 (0.02%)  
Hypertensive cardiomyopathy * 1      
# participants affected / at risk     0/10744 (0.00%)     0/4904 (0.00%)     1/4881 (0.02%)  
Hypertensive heart disease * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     1/4881 (0.02%)  
Intracardiac thrombus * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     2/4881 (0.04%)  
Ischemic cardiomyopathy * 1      
# participants affected / at risk     0/10744 (0.00%)     10/4904 (0.20%)     13/4881 (0.27%)  
Left ventricular dysfunction * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     3/4881 (0.06%)  
Left ventricular failure * 1      
# participants affected / at risk     1/10744 (0.01%)     10/4904 (0.20%)     16/4881 (0.33%)  
Left ventricular hypertrophy * 1      
# participants affected / at risk     1/10744 (0.01%)     0/4904 (0.00%)     0/4881 (0.00%)  
Mitral valve incompetence * 1      
# participants affected / at risk     0/10744 (0.00%)     4/4904 (0.08%)     6/4881 (0.12%)  
Mitral valve stenosis * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     1/4881 (0.02%)  
Myocardial infarction * 1      
# participants affected / at risk     11/10744 (0.10%)     87/4904 (1.77%)     80/4881 (1.64%)  
Myocardial ischemia * 1      
# participants affected / at risk     5/10744 (0.05%)     57/4904 (1.16%)     36/4881 (0.74%)  
Nodal arrhythmia * 1      
# participants affected / at risk     0/10744 (0.00%)     0/4904 (0.00%)     1/4881 (0.02%)  
Palpitations * 1      
# participants affected / at risk     3/10744 (0.03%)     2/4904 (0.04%)     6/4881 (0.12%)  
Pericardial effusion * 1      
# participants affected / at risk     0/10744 (0.00%)     0/4904 (0.00%)     2/4881 (0.04%)  
Pericarditis * 1      
# participants affected / at risk     0/10744 (0.00%)     2/4904 (0.04%)     1/4881 (0.02%)  
Postinfarction angina * 1      
# participants affected / at risk     0/10744 (0.00%)     0/4904 (0.00%)     1/4881 (0.02%)  
Prinzmetal angina * 1      
# participants affected / at risk     0/10744 (0.00%)     0/4904 (0.00%)     1/4881 (0.02%)  
Right ventricular failure * 1      
# participants affected / at risk     0/10744 (0.00%)     4/4904 (0.08%)     3/4881 (0.06%)  
Sick sinus syndrome * 1      
# participants affected / at risk     2/10744 (0.02%)     11/4904 (0.22%)     12/4881 (0.25%)  
Silent myocardial infarction * 1      
# participants affected / at risk     0/10744 (0.00%)     5/4904 (0.10%)     4/4881 (0.08%)  
Sinoatrial block * 1      
# participants affected / at risk     0/10744 (0.00%)     2/4904 (0.04%)     1/4881 (0.02%)  
Sinus arrhythmia * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     3/4881 (0.06%)  
Sinus bradycardia * 1      
# participants affected / at risk     0/10744 (0.00%)     2/4904 (0.04%)     0/4881 (0.00%)  
Sinus tachycardia * 1      
# participants affected / at risk     0/10744 (0.00%)     0/4904 (0.00%)     1/4881 (0.02%)  
Subendocardial ischemia * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     0/4881 (0.00%)  
Supraventricular extrasystoles * 1      
# participants affected / at risk     0/10744 (0.00%)     0/4904 (0.00%)     2/4881 (0.04%)  
Supraventricular tachyarrhythmia * 1      
# participants affected / at risk     0/10744 (0.00%)     3/4904 (0.06%)     0/4881 (0.00%)  
Supraventricular tachycardia * 1      
# participants affected / at risk     3/10744 (0.03%)     12/4904 (0.24%)     6/4881 (0.12%)  
Tachyarrhythmia * 1      
# participants affected / at risk     0/10744 (0.00%)     3/4904 (0.06%)     2/4881 (0.04%)  
Tachycardia * 1      
# participants affected / at risk     0/10744 (0.00%)     0/4904 (0.00%)     2/4881 (0.04%)  
Torsade de pointes * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     0/4881 (0.00%)  
Tricuspid valve incompetence * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     0/4881 (0.00%)  
Trifascicular block * 1      
# participants affected / at risk     2/10744 (0.02%)     0/4904 (0.00%)     0/4881 (0.00%)  
Ventricular arrhythmia * 1      
# participants affected / at risk     0/10744 (0.00%)     3/4904 (0.06%)     1/4881 (0.02%)  
Ventricular extrasystoles * 1      
# participants affected / at risk     0/10744 (0.00%)     7/4904 (0.14%)     2/4881 (0.04%)  
Ventricular failure * 1      
# participants affected / at risk     0/10744 (0.00%)     0/4904 (0.00%)     1/4881 (0.02%)  
Ventricular fibrillation * 1      
# participants affected / at risk     2/10744 (0.02%)     5/4904 (0.10%)     6/4881 (0.12%)  
Ventricular tachyarrhythmia * 1      
# participants affected / at risk     0/10744 (0.00%)     2/4904 (0.04%)     0/4881 (0.00%)  
Ventricular tachycardia * 1      
# participants affected / at risk     1/10744 (0.01%)     25/4904 (0.51%)     18/4881 (0.37%)  
Congenital, familial and genetic disorders        
Atrial septal defect * 1      
# participants affected / at risk     0/10744 (0.00%)     0/4904 (0.00%)     1/4881 (0.02%)  
Congenital cystic kidney disease * 1      
# participants affected / at risk     0/10744 (0.00%)     0/4904 (0.00%)     1/4881 (0.02%)  
Congenital spondylolithesis * 1      
# participants affected / at risk     1/10744 (0.01%)     0/4904 (0.00%)     0/4881 (0.00%)  
Dysplastic naevus syndrome * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     0/4881 (0.00%)  
Gastrointestinal angiodysplasia * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     0/4881 (0.00%)  
Gastrointestinal angiodysplasia hemorrhagic * 1      
# participants affected / at risk     0/10744 (0.00%)     0/4904 (0.00%)     1/4881 (0.02%)  
Hydrocele * 1      
# participants affected / at risk     2/10744 (0.02%)     1/4904 (0.02%)     0/4881 (0.00%)  
Phimosis * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     3/4881 (0.06%)  
Ear and labyrinth disorders        
Acute vestibular syndrome * 1      
# participants affected / at risk     0/10744 (0.00%)     2/4904 (0.04%)     0/4881 (0.00%)  
Aural polyp * 1      
# participants affected / at risk     0/10744 (0.00%)     0/4904 (0.00%)     1/4881 (0.02%)  
Deafness unilateral * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     1/4881 (0.02%)  
Hearing impaired * 1      
# participants affected / at risk     0/10744 (0.00%)     0/4904 (0.00%)     1/4881 (0.02%)  
Hypoacusis * 1      
# participants affected / at risk     0/10744 (0.00%)     0/4904 (0.00%)     1/4881 (0.02%)  
Neurosensory hypoacusis * 1      
# participants affected / at risk     0/10744 (0.00%)     0/4904 (0.00%)     1/4881 (0.02%)  
Sudden hearing loss * 1      
# participants affected / at risk     0/10744 (0.00%)     0/4904 (0.00%)     1/4881 (0.02%)  
Vertigo * 1      
# participants affected / at risk     1/10744 (0.01%)     4/4904 (0.08%)     5/4881 (0.10%)  
Vertigo positional * 1      
# participants affected / at risk     0/10744 (0.00%)     2/4904 (0.04%)     2/4881 (0.04%)  
Vestibular disorder * 1      
# participants affected / at risk     0/10744 (0.00%)     3/4904 (0.06%)     0/4881 (0.00%)  
Endocrine disorders        
Autoimmune thyroiditis * 1      
# participants affected / at risk     0/10744 (0.00%)     0/4904 (0.00%)     1/4881 (0.02%)  
Goiter * 1      
# participants affected / at risk     0/10744 (0.00%)     7/4904 (0.14%)     6/4881 (0.12%)  
Hyperparathyroidism * 1      
# participants affected / at risk     0/10744 (0.00%)     3/4904 (0.06%)     0/4881 (0.00%)  
Hyperparathyroidism primary * 1      
# participants affected / at risk     1/10744 (0.01%)     0/4904 (0.00%)     2/4881 (0.04%)  
Hyperthyroidism * 1      
# participants affected / at risk     0/10744 (0.00%)     5/4904 (0.10%)     5/4881 (0.10%)  
Hypothyroidism * 1      
# participants affected / at risk     0/10744 (0.00%)     0/4904 (0.00%)     1/4881 (0.02%)  
Inappropriate antidiuretic hormone secretion * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     0/4881 (0.00%)  
Myxedema * 1      
# participants affected / at risk     0/10744 (0.00%)     0/4904 (0.00%)     1/4881 (0.02%)  
Toxic nodular goiter * 1      
# participants affected / at risk     1/10744 (0.01%)     1/4904 (0.02%)     1/4881 (0.02%)  
Eye disorders        
Amaurosis * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     0/4881 (0.00%)  
Angle closure glaucoma * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     2/4881 (0.04%)  
Aphakia * 1      
# participants affected / at risk     0/10744 (0.00%)     0/4904 (0.00%)     1/4881 (0.02%)  
Cataract * 1      
# participants affected / at risk     4/10744 (0.04%)     33/4904 (0.67%)     29/4881 (0.59%)  
Cataract diabetic * 1      
# participants affected / at risk     0/10744 (0.00%)     0/4904 (0.00%)     1/4881 (0.02%)  
Cataract nuclear * 1      
# participants affected / at risk     1/10744 (0.01%)     0/4904 (0.00%)     2/4881 (0.04%)  
Cataract subcapsular * 1      
# participants affected / at risk     0/10744 (0.00%)     2/4904 (0.04%)     0/4881 (0.00%)  
Diabetic retinopathy * 1      
# participants affected / at risk     0/10744 (0.00%)     6/4904 (0.12%)     4/4881 (0.08%)  
Diplopia * 1      
# participants affected / at risk     1/10744 (0.01%)     1/4904 (0.02%)     0/4881 (0.00%)  
Extraocular muscle paresis * 1      
# participants affected / at risk     1/10744 (0.01%)     0/4904 (0.00%)     0/4881 (0.00%)  
Eye hemorrhage * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     1/4881 (0.02%)  
Eye pain * 1      
# participants affected / at risk     1/10744 (0.01%)     0/4904 (0.00%)     0/4881 (0.00%)  
Glaucoma * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     3/4881 (0.06%)  
Iris bombe * 1      
# participants affected / at risk     0/10744 (0.00%)     0/4904 (0.00%)     1/4881 (0.02%)  
Keratitis * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     0/4881 (0.00%)  
Lens dislocation * 1      
# participants affected / at risk     0/10744 (0.00%)     0/4904 (0.00%)     1/4881 (0.02%)  
Macular hole * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     0/4881 (0.00%)  
Macular edema * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     0/4881 (0.00%)  
Maculopathy * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     0/4881 (0.00%)  
Ocular myasthenia * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     0/4881 (0.00%)  
Ocular vascular disorder * 1      
# participants affected / at risk     0/10744 (0.00%)     0/4904 (0.00%)     1/4881 (0.02%)  
Open-angle glaucoma * 1      
# participants affected / at risk     0/10744 (0.00%)     2/4904 (0.04%)     1/4881 (0.02%)  
Optic ischemic neuropathy * 1      
# participants affected / at risk     1/10744 (0.01%)     1/4904 (0.02%)     0/4881 (0.00%)  
Punctate keratitis * 1      
# participants affected / at risk     1/10744 (0.01%)     0/4904 (0.00%)     0/4881 (0.00%)  
Retinal artery occlusion * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     3/4881 (0.06%)  
Retinal detachment * 1      
# participants affected / at risk     0/10744 (0.00%)     10/4904 (0.20%)     5/4881 (0.10%)  
Retinal hemorrhage * 1      
# participants affected / at risk     1/10744 (0.01%)     2/4904 (0.04%)     0/4881 (0.00%)  
Retinal vein occlusion * 1      
# participants affected / at risk     0/10744 (0.00%)     0/4904 (0.00%)     1/4881 (0.02%)  
Retinal vein thrombosis * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     0/4881 (0.00%)  
Strabismus * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     0/4881 (0.00%)  
Synchysis scintillans * 1      
# participants affected / at risk     0/10744 (0.00%)     0/4904 (0.00%)     1/4881 (0.02%)  
Ulcerative keratitis * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     0/4881 (0.00%)  
Uveitis * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     0/4881 (0.00%)  
Visual impairment * 1      
# participants affected / at risk     0/10744 (0.00%)     0/4904 (0.00%)     1/4881 (0.02%)  
Vitreous detachment * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     0/4881 (0.00%)  
Vitreous disorder * 1      
# participants affected / at risk     1/10744 (0.01%)     0/4904 (0.00%)     0/4881 (0.00%)  
Vitreous hemorrhage * 1      
# participants affected / at risk     0/10744 (0.00%)     0/4904 (0.00%)     3/4881 (0.06%)  
Gastrointestinal disorders        
Abdominal distension * 1      
# participants affected / at risk     0/10744 (0.00%)     0/4904 (0.00%)     1/4881 (0.02%)  
Abdominal hernia * 1      
# participants affected / at risk     0/10744 (0.00%)     7/4904 (0.14%)     3/4881 (0.06%)  
Abdominal hernia obstructive * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     0/4881 (0.00%)  
Abdominal mass * 1      
# participants affected / at risk     0/10744 (0.00%)     0/4904 (0.00%)     1/4881 (0.02%)  
Abdominal pain * 1      
# participants affected / at risk     0/10744 (0.00%)     8/4904 (0.16%)     9/4881 (0.18%)  
Abdominal pain lower * 1      
# participants affected / at risk     0/10744 (0.00%)     0/4904 (0.00%)     1/4881 (0.02%)  
Abdominal pain upper * 1      
# participants affected / at risk     0/10744 (0.00%)     2/4904 (0.04%)     6/4881 (0.12%)  
Abdominal strangulated hernia * 1      
# participants affected / at risk     0/10744 (0.00%)     0/4904 (0.00%)     2/4881 (0.04%)  
Anal fissure * 1      
# participants affected / at risk     0/10744 (0.00%)     3/4904 (0.06%)     2/4881 (0.04%)  
Anal fistula * 1      
# participants affected / at risk     0/10744 (0.00%)     3/4904 (0.06%)     2/4881 (0.04%)  
Anal stenosis * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     1/4881 (0.02%)  
Anal ulcer * 1      
# participants affected / at risk     0/10744 (0.00%)     0/4904 (0.00%)     1/4881 (0.02%)  
Barrett's esophagus * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     1/4881 (0.02%)  
Cecitis * 1      
# participants affected / at risk     0/10744 (0.00%)     0/4904 (0.00%)     1/4881 (0.02%)  
Change of bowel habit * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     0/4881 (0.00%)  
Celiac artery stenosis * 1      
# participants affected / at risk     0/10744 (0.00%)     0/4904 (0.00%)     2/4881 (0.04%)  
Colitis * 1      
# participants affected / at risk     0/10744 (0.00%)     5/4904 (0.10%)     0/4881 (0.00%)  
Colitis ischemic * 1      
# participants affected / at risk     0/10744 (0.00%)     2/4904 (0.04%)     2/4881 (0.04%)  
Colonic polyp * 1      
# participants affected / at risk     2/10744 (0.02%)     3/4904 (0.06%)     10/4881 (0.20%)  
Constipation * 1      
# participants affected / at risk     1/10744 (0.01%)     5/4904 (0.10%)     4/4881 (0.08%)  
Diabetic gastroparesis * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     0/4881 (0.00%)  
Diarrhea * 1      
# participants affected / at risk     0/10744 (0.00%)     4/4904 (0.08%)     7/4881 (0.14%)  
Diarrhea hemorrhagic * 1      
# participants affected / at risk     1/10744 (0.01%)     0/4904 (0.00%)     0/4881 (0.00%)  
Diverticulitis intestinal hemorrhagic * 1      
# participants affected / at risk     1/10744 (0.01%)     1/4904 (0.02%)     0/4881 (0.00%)  
Diverticulum * 1      
# participants affected / at risk     1/10744 (0.01%)     2/4904 (0.04%)     2/4881 (0.04%)  
Diverticulum intestinal * 1      
# participants affected / at risk     0/10744 (0.00%)     2/4904 (0.04%)     5/4881 (0.10%)  
Diverticulum intestinal hemorrhagic * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     0/4881 (0.00%)  
Duodenal ulcer * 1      
# participants affected / at risk     1/10744 (0.01%)     5/4904 (0.10%)     4/4881 (0.08%)  
Duodenal ulcer hemorrhage * 1      
# participants affected / at risk     0/10744 (0.00%)     12/4904 (0.24%)     2/4881 (0.04%)  
Duodenal ulcer perforation * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     0/4881 (0.00%)  
Duodenitis * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     0/4881 (0.00%)  
Dyspepsia * 1      
# participants affected / at risk     0/10744 (0.00%)     4/4904 (0.08%)     3/4881 (0.06%)  
Enteritis * 1      
# participants affected / at risk     0/10744 (0.00%)     0/4904 (0.00%)     3/4881 (0.06%)  
Enterocolitis * 1      
# participants affected / at risk     0/10744 (0.00%)     0/4904 (0.00%)     1/4881 (0.02%)  
Erosive esophagitis * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     0/4881 (0.00%)  
Fecal incontinence * 1      
# participants affected / at risk     0/10744 (0.00%)     0/4904 (0.00%)     1/4881 (0.02%)  
Fecaloma * 1      
# participants affected / at risk     1/10744 (0.01%)     3/4904 (0.06%)     0/4881 (0.00%)  
Food poisoning * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     1/4881 (0.02%)  
Gastric hemorrhage * 1      
# participants affected / at risk     0/10744 (0.00%)     0/4904 (0.00%)     1/4881 (0.02%)  
Gastric mucosal lesion * 1      
# participants affected / at risk     0/10744 (0.00%)     0/4904 (0.00%)     1/4881 (0.02%)  
Gastric perforation * 1      
# participants affected / at risk     0/10744 (0.00%)     0/4904 (0.00%)     1/4881 (0.02%)  
Gastric polyps * 1      
# participants affected / at risk     0/10744 (0.00%)     4/4904 (0.08%)     2/4881 (0.04%)  
Gastric ulcer * 1      
# participants affected / at risk     3/10744 (0.03%)     5/4904 (0.10%)     7/4881 (0.14%)  
Gastric ulcer hemorrhage * 1      
# participants affected / at risk     0/10744 (0.00%)     9/4904 (0.18%)     9/4881 (0.18%)  
Gastritis * 1      
# participants affected / at risk     0/10744 (0.00%)     8/4904 (0.16%)     4/4881 (0.08%)  
Gastritis atrophic * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     0/4881 (0.00%)  
Gastritis erosive * 1      
# participants affected / at risk     0/10744 (0.00%)     4/4904 (0.08%)     3/4881 (0.06%)  
Gastritis hemorrhagic * 1      
# participants affected / at risk     1/10744 (0.01%)     2/4904 (0.04%)     5/4881 (0.10%)  
Gastroduodenitis * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     0/4881 (0.00%)  
Gastrointestinal disorder * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     0/4881 (0.00%)  
Gastrointestinal hemorrhage * 1      
# participants affected / at risk     0/10744 (0.00%)     3/4904 (0.06%)     4/4881 (0.08%)  
Gastrointestinal inflammation * 1      
# participants affected / at risk     2/10744 (0.02%)     1/4904 (0.02%)     1/4881 (0.02%)  
Gastrointestinal ulcer hemorrhage * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     0/4881 (0.00%)  
Gastroesophageal reflux disease * 1      
# participants affected / at risk     0/10744 (0.00%)     4/4904 (0.08%)     6/4881 (0.12%)  
Gastroesophageal sphincter insufficiency * 1      
# participants affected / at risk     0/10744 (0.00%)     0/4904 (0.00%)     1/4881 (0.02%)  
Gastroesophagitis * 1      
# participants affected / at risk     1/10744 (0.01%)     1/4904 (0.02%)     0/4881 (0.00%)  
Gingival pain * 1      
# participants affected / at risk     0/10744 (0.00%)     0/4904 (0.00%)     1/4881 (0.02%)  
Hematochezia * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     0/4881 (0.00%)  
Hemorrhagic erosive gastritis * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     0/4881 (0.00%)  
Hemorrhoidal hemorrhage * 1      
# participants affected / at risk     0/10744 (0.00%)     0/4904 (0.00%)     1/4881 (0.02%)  
Hemorrhoids * 1      
# participants affected / at risk     1/10744 (0.01%)     3/4904 (0.06%)     4/4881 (0.08%)  
Hernial eventration * 1      
# participants affected / at risk     0/10744 (0.00%)     5/4904 (0.10%)     2/4881 (0.04%)  
Hiatus hernia * 1      
# participants affected / at risk     0/10744 (0.00%)     3/4904 (0.06%)     2/4881 (0.04%)  
Ileitis * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     0/4881 (0.00%)  
Ileus * 1      
# participants affected / at risk     0/10744 (0.00%)     4/4904 (0.08%)     2/4881 (0.04%)  
Ileus paralytic * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     0/4881 (0.00%)  
Impaired gastric emptying * 1      
# participants affected / at risk     0/10744 (0.00%)     0/4904 (0.00%)     1/4881 (0.02%)  
Inguinal hernia * 1      
# participants affected / at risk     4/10744 (0.04%)     13/4904 (0.27%)     18/4881 (0.37%)  
Intestinal ischemia * 1      
# participants affected / at risk     0/10744 (0.00%)     4/4904 (0.08%)     0/4881 (0.00%)  
Intestinal obstruction * 1      
# participants affected / at risk     0/10744 (0.00%)     6/4904 (0.12%)     3/4881 (0.06%)  
Intra-abdominal hematoma * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     0/4881 (0.00%)  
Irritable bowel syndrome * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     0/4881 (0.00%)  
Large intestinal obstruction * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     0/4881 (0.00%)  
Large intestine perforation * 1      
# participants affected / at risk     0/10744 (0.00%)     0/4904 (0.00%)     1/4881 (0.02%)  
Lower gastrointestinal hemorrhage * 1      
# participants affected / at risk     0/10744 (0.00%)     0/4904 (0.00%)     2/4881 (0.04%)  
Mechanical ileus * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     1/4881 (0.02%)  
Melena * 1      
# participants affected / at risk     1/10744 (0.01%)     0/4904 (0.00%)     1/4881 (0.02%)  
Melanosis coli * 1      
# participants affected / at risk     0/10744 (0.00%)     0/4904 (0.00%)     1/4881 (0.02%)  
Mesenteric artery stenosis * 1      
# participants affected / at risk     0/10744 (0.00%)     0/4904 (0.00%)     2/4881 (0.04%)  
Mesenteric artery thrombosis * 1      
# participants affected / at risk     0/10744 (0.00%)     0/4904 (0.00%)     1/4881 (0.02%)  
Mesenteric occlusion * 1      
# participants affected / at risk     0/10744 (0.00%)     0/4904 (0.00%)     1/4881 (0.02%)  
Nausea * 1      
# participants affected / at risk     0/10744 (0.00%)     2/4904 (0.04%)     5/4881 (0.10%)  
Esophageal stenosis * 1      
# participants affected / at risk     0/10744 (0.00%)     0/4904 (0.00%)     1/4881 (0.02%)  
Esophageal ulcer hemorrhage * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     1/4881 (0.02%)  
Esophagitis * 1      
# participants affected / at risk     3/10744 (0.03%)     5/4904 (0.10%)     1/4881 (0.02%)  
Esophagitis ulcerative * 1      
# participants affected / at risk     0/10744 (0.00%)     0/4904 (0.00%)     1/4881 (0.02%)  
Pancreatitis * 1      
# participants affected / at risk     1/10744 (0.01%)     3/4904 (0.06%)     4/4881 (0.08%)  
Pancreatitis acute * 1      
# participants affected / at risk     0/10744 (0.00%)     3/4904 (0.06%)     14/4881 (0.29%)  
Pancreatitis chronic * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     1/4881 (0.02%)  
Pancreatitis necrotizing * 1      
# participants affected / at risk     0/10744 (0.00%)     0/4904 (0.00%)     1/4881 (0.02%)  
Papilla of Vater stenosis * 1      
# participants affected / at risk     0/10744 (0.00%)     0/4904 (0.00%)     1/4881 (0.02%)  
Peptic ulcer * 1      
# participants affected / at risk     0/10744 (0.00%)     2/4904 (0.04%)     3/4881 (0.06%)  
Peptic ulcer hemorrhage * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     0/4881 (0.00%)  
Periodontal disease * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     0/4881 (0.00%)  
Peritoneal adhesions * 1      
# participants affected / at risk     0/10744 (0.00%)     0/4904 (0.00%)     1/4881 (0.02%)  
Peritoneal hemorrhage * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     0/4881 (0.00%)  
Peritonitis * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     2/4881 (0.04%)  
Proctitis * 1      
# participants affected / at risk     0/10744 (0.00%)     0/4904 (0.00%)     1/4881 (0.02%)  
Rectal hemorrhage * 1      
# participants affected / at risk     1/10744 (0.01%)     2/4904 (0.04%)     2/4881 (0.04%)  
Rectal perforation * 1      
# participants affected / at risk     0/10744 (0.00%)     0/4904 (0.00%)     1/4881 (0.02%)  
Rectal polyp * 1      
# participants affected / at risk     0/10744 (0.00%)     2/4904 (0.04%)     2/4881 (0.04%)  
Rectal prolapse * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     0/4881 (0.00%)  
Reflux esophagitis * 1      
# participants affected / at risk     0/10744 (0.00%)     0/4904 (0.00%)     1/4881 (0.02%)  
Retroperitoneal fibrosis * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     0/4881 (0.00%)  
Retroperitoneal hematoma * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     1/4881 (0.02%)  
Small intestinal hemorrhage * 1      
# participants affected / at risk     0/10744 (0.00%)     0/4904 (0.00%)     1/4881 (0.02%)  
Small intestinal obstruction * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     0/4881 (0.00%)  
Subileus * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     0/4881 (0.00%)  
Tongue hemorrhage * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     0/4881 (0.00%)  
Tooth disorder * 1      
# participants affected / at risk     0/10744 (0.00%)     0/4904 (0.00%)     1/4881 (0.02%)  
Tooth loss * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     0/4881 (0.00%)  
Umbilical hernia * 1      
# participants affected / at risk     0/10744 (0.00%)     12/4904 (0.24%)     9/4881 (0.18%)  
Umbilical hernia, obstructive * 1      
# participants affected / at risk     0/10744 (0.00%)     0/4904 (0.00%)     1/4881 (0.02%)  
Upper gastrointestinal hemorrhage * 1      
# participants affected / at risk     0/10744 (0.00%)     3/4904 (0.06%)     3/4881 (0.06%)  
Varices esophageal * 1      
# participants affected / at risk     0/10744 (0.00%)     0/4904 (0.00%)     1/4881 (0.02%)  
Vomiting * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     5/4881 (0.10%)  
General disorders        
Abasia * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     0/4881 (0.00%)  
Adhesion * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     0/4881 (0.00%)  
Adverse drug reaction * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     2/4881 (0.04%)  
Asthenia * 1      
# participants affected / at risk     0/10744 (0.00%)     3/4904 (0.06%)     1/4881 (0.02%)  
Catheter-related complication * 1      
# participants affected / at risk     0/10744 (0.00%)     0/4904 (0.00%)     1/4881 (0.02%)  
Chest discomfort * 1      
# participants affected / at risk     1/10744 (0.01%)     2/4904 (0.04%)     2/4881 (0.04%)  
Chest pain * 1      
# participants affected / at risk     5/10744 (0.05%)     22/4904 (0.45%)     18/4881 (0.37%)  
Chills * 1      
# participants affected / at risk     0/10744 (0.00%)     0/4904 (0.00%)     2/4881 (0.04%)  
Cyst * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     0/4881 (0.00%)  
Death * 1      
# participants affected / at risk     17/10744 (0.16%)     25/4904 (0.51%)     18/4881 (0.37%)  
Drug intolerance * 1      
# participants affected / at risk     0/10744 (0.00%)     0/4904 (0.00%)     1/4881 (0.02%)  
Dysplasia * 1      
# participants affected / at risk     0/10744 (0.00%)     0/4904 (0.00%)     2/4881 (0.04%)  
Fatigue * 1      
# participants affected / at risk     1/10744 (0.01%)     2/4904 (0.04%)     5/4881 (0.10%)  
Foaming at mouth * 1      
# participants affected / at risk     0/10744 (0.00%)     0/4904 (0.00%)     1/4881 (0.02%)  
General physical health deterioration * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     0/4881 (0.00%)  
Hernia obstructive * 1      
# participants affected / at risk     1/10744 (0.01%)     1/4904 (0.02%)     1/4881 (0.02%)  
Impaired healing * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     0/4881 (0.00%)  
Implant expulsion * 1      
# participants affected / at risk     0/10744 (0.00%)     0/4904 (0.00%)     1/4881 (0.02%)  
Implant site fibrosis * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     0/4881 (0.00%)  
Implant site inflammation * 1      
# participants affected / at risk     0/10744 (0.00%)     0/4904 (0.00%)     1/4881 (0.02%)  
Inflammation * 1      
# participants affected / at risk     0/10744 (0.00%)     0/4904 (0.00%)     2/4881 (0.04%)  
Malaise * 1      
# participants affected / at risk     0/10744 (0.00%)     2/4904 (0.04%)     3/4881 (0.06%)  
Mechanical complication of implant * 1      
# participants affected / at risk     0/10744 (0.00%)     2/4904 (0.04%)     0/4881 (0.00%)  
Metaplasia * 1      
# participants affected / at risk     0/10744 (0.00%)     0/4904 (0.00%)     1/4881 (0.02%)  
Multi-organ failure * 1      
# participants affected / at risk     1/10744 (0.01%)     3/4904 (0.06%)     2/4881 (0.04%)  
Necrosis * 1      
# participants affected / at risk     0/10744 (0.00%)     0/4904 (0.00%)     2/4881 (0.04%)  
Non-cardiac chest pain * 1      
# participants affected / at risk     2/10744 (0.02%)     19/4904 (0.39%)     15/4881 (0.31%)  
Pain * 1      
# participants affected / at risk     2/10744 (0.02%)     2/4904 (0.04%)     0/4881 (0.00%)  
Peripheral edema * 1      
# participants affected / at risk     0/10744 (0.00%)     4/4904 (0.08%)     3/4881 (0.06%)  
Pyrexia * 1      
# participants affected / at risk     0/10744 (0.00%)     5/4904 (0.10%)     5/4881 (0.10%)  
Sudden cardiac death * 1      
# participants affected / at risk     0/10744 (0.00%)     11/4904 (0.22%)     4/4881 (0.08%)  
Sudden death * 1      
# participants affected / at risk     3/10744 (0.03%)     19/4904 (0.39%)     26/4881 (0.53%)  
Swelling * 1      
# participants affected / at risk     0/10744 (0.00%)     0/4904 (0.00%)     1/4881 (0.02%)  
Bile duct stone * 1      
# participants affected / at risk     0/10744 (0.00%)     0/4904 (0.00%)     1/4881 (0.02%)  
Hepatic lesion * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     0/4881 (0.00%)  
Hepatobiliary disorders        
Autoimmune hepatitis * 1      
# participants affected / at risk     0/10744 (0.00%)     0/4904 (0.00%)     1/4881 (0.02%)  
Bile duct obstruction * 1      
# participants affected / at risk     0/10744 (0.00%)     0/4904 (0.00%)     1/4881 (0.02%)  
Bile duct stenosis * 1      
# participants affected / at risk     0/10744 (0.00%)     0/4904 (0.00%)     1/4881 (0.02%)  
Biliary cirrhosis primary * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     1/4881 (0.02%)  
Biliary colic * 1      
# participants affected / at risk     1/10744 (0.01%)     1/4904 (0.02%)     2/4881 (0.04%)  
Cholangitis * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     4/4881 (0.08%)  
Cholangitis acute * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     1/4881 (0.02%)  
Cholecystitis * 1      
# participants affected / at risk     2/10744 (0.02%)     8/4904 (0.16%)     7/4881 (0.14%)  
Cholecystitis acute * 1      
# participants affected / at risk     0/10744 (0.00%)     7/4904 (0.14%)     5/4881 (0.10%)  
Cholecystitis chronic * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     4/4881 (0.08%)  
Cholelithiasis * 1      
# participants affected / at risk     2/10744 (0.02%)     26/4904 (0.53%)     25/4881 (0.51%)  
Cirrhosis alcoholic * 1      
# participants affected / at risk     1/10744 (0.01%)     0/4904 (0.00%)     1/4881 (0.02%)  
Gallbladder cholesterolosis * 1      
# participants affected / at risk     0/10744 (0.00%)     0/4904 (0.00%)     1/4881 (0.02%)  
Gallbladder disorder * 1      
# participants affected / at risk     1/10744 (0.01%)     0/4904 (0.00%)     1/4881 (0.02%)  
Gallbladder obstruction * 1      
# participants affected / at risk     0/10744 (0.00%)     0/4904 (0.00%)     1/4881 (0.02%)  
Gallbladder perforation * 1      
# participants affected / at risk     0/10744 (0.00%)     0/4904 (0.00%)     1/4881 (0.02%)  
Hepatic cirrhosis * 1      
# participants affected / at risk     0/10744 (0.00%)     2/4904 (0.04%)     0/4881 (0.00%)  
Hepatic mass * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     0/4881 (0.00%)  
Hepatitis * 1      
# participants affected / at risk     0/10744 (0.00%)     0/4904 (0.00%)     1/4881 (0.02%)  
Hepatitis acute * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     0/4881 (0.00%)  
Hepatorenal failure * 1      
# participants affected / at risk     0/10744 (0.00%)     0/4904 (0.00%)     1/4881 (0.02%)  
Liver disorder * 1      
# participants affected / at risk     1/10744 (0.01%)     1/4904 (0.02%)     0/4881 (0.00%)  
Liver injury * 1      
# participants affected / at risk     0/10744 (0.00%)     0/4904 (0.00%)     1/4881 (0.02%)  
Immune system disorders        
Anaphylactic reaction * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     1/4881 (0.02%)  
Anaphylactic shock * 1      
# participants affected / at risk     1/10744 (0.01%)     4/4904 (0.08%)     1/4881 (0.02%)  
Hypersensitivity * 1      
# participants affected / at risk     0/10744 (0.00%)     4/4904 (0.08%)     3/4881 (0.06%)  
Infections and infestations        
Abdominal abscess * 1      
# participants affected / at risk     0/10744 (0.00%)     0/4904 (0.00%)     1/4881 (0.02%)  
Abscess limb * 1      
# participants affected / at risk     0/10744 (0.00%)     2/4904 (0.04%)     2/4881 (0.04%)  
Abscess neck * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     0/4881 (0.00%)  
Abscess oral * 1      
# participants affected / at risk     0/10744 (0.00%)     0/4904 (0.00%)     1/4881 (0.02%)  
Acarodermatitis * 1      
# participants affected / at risk     0/10744 (0.00%)     0/4904 (0.00%)     1/4881 (0.02%)  
Anal abscess * 1      
# participants affected / at risk     1/10744 (0.01%)     1/4904 (0.02%)     3/4881 (0.06%)  
Appendicitis * 1      
# participants affected / at risk     0/10744 (0.00%)     6/4904 (0.12%)     3/4881 (0.06%)  
Appendicitis perforated * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     0/4881 (0.00%)  
Arteriosclerotic gangrene * 1      
# participants affected / at risk     0/10744 (0.00%)     0/4904 (0.00%)     2/4881 (0.04%)  
Arthritis bacterial * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     1/4881 (0.02%)  
Arthritis infective * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     0/4881 (0.00%)  
Bacterial infection * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     0/4881 (0.00%)  
Bacterial pyelonephritis * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     0/4881 (0.00%)  
Biliary sepsis * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     1/4881 (0.02%)  
Bronchiectasis * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     0/4881 (0.00%)  
Bronchitis * 1      
# participants affected / at risk     0/10744 (0.00%)     13/4904 (0.27%)     15/4881 (0.31%)  
Bronchitis bacterial * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     0/4881 (0.00%)  
Bronchitis viral * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     1/4881 (0.02%)  
Bronchopneumonia * 1      
# participants affected / at risk     2/10744 (0.02%)     14/4904 (0.29%)     17/4881 (0.35%)  
Bronchopulmonary aspergillosis allergic * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     0/4881 (0.00%)  
Campylobacter intestinal infection * 1      
# participants affected / at risk     0/10744 (0.00%)     2/4904 (0.04%)     0/4881 (0.00%)  
Catheter-site infection * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     0/4881 (0.00%)  
Cellulitis * 1      
# participants affected / at risk     3/10744 (0.03%)     19/4904 (0.39%)     17/4881 (0.35%)  
Cellulitis staphylococcal * 1      
# participants affected / at risk     0/10744 (0.00%)     0/4904 (0.00%)     1/4881 (0.02%)  
Central line infection * 1      
# participants affected / at risk     0/10744 (0.00%)     0/4904 (0.00%)     1/4881 (0.02%)  
Cholecystitis infective * 1      
# participants affected / at risk     0/10744 (0.00%)     3/4904 (0.06%)     4/4881 (0.08%)  
Chronic sinusitis * 1      
# participants affected / at risk     0/10744 (0.00%)     2/4904 (0.04%)     1/4881 (0.02%)  
Clostridium difficile colitis * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     0/4881 (0.00%)  
Cystitis * 1      
# participants affected / at risk     1/10744 (0.01%)     7/4904 (0.14%)     2/4881 (0.04%)  
Dengue fever * 1      
# participants affected / at risk     0/10744 (0.00%)     0/4904 (0.00%)     1/4881 (0.02%)  
Device-related infection * 1      
# participants affected / at risk     0/10744 (0.00%)     2/4904 (0.04%)     3/4881 (0.06%)  
Diabetic foot infection * 1      
# participants affected / at risk     0/10744 (0.00%)     7/4904 (0.14%)     6/4881 (0.12%)  
Diabetic gangrene * 1      
# participants affected / at risk     2/10744 (0.02%)     8/4904 (0.16%)     4/4881 (0.08%)  
Diarrhea infectious * 1      
# participants affected / at risk     0/10744 (0.00%)     0/4904 (0.00%)     1/4881 (0.02%)  
Diverticulitis * 1      
# participants affected / at risk     0/10744 (0.00%)     7/4904 (0.14%)     8/4881 (0.16%)  
Endocarditis * 1      
# participants affected / at risk     0/10744 (0.00%)     2/4904 (0.04%)     4/4881 (0.08%)  
Endocarditis bacterial * 1      
# participants affected / at risk     0/10744 (0.00%)     2/4904 (0.04%)     0/4881 (0.00%)  
Endocarditis staphylococcal * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     0/4881 (0.00%)  
Endophthalmitis * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     0/4881 (0.00%)  
Entereocolitis viral * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     0/4881 (0.00%)  
Erysipelas * 1      
# participants affected / at risk     5/10744 (0.05%)     23/4904 (0.47%)     14/4881 (0.29%)  
Escherichia sepsis * 1      
# participants affected / at risk     0/10744 (0.00%)     3/4904 (0.06%)     0/4881 (0.00%)  
Escherichia urinary tract infection * 1      
# participants affected / at risk     0/10744 (0.00%)     0/4904 (0.00%)     1/4881 (0.02%)  
Eye infection * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     0/4881 (0.00%)  
Furuncle * 1      
# participants affected / at risk     0/10744 (0.00%)     2/4904 (0.04%)     0/4881 (0.00%)  
Gallbladder empyema * 1      
# participants affected / at risk     0/10744 (0.00%)     0/4904 (0.00%)     1/4881 (0.02%)  
Gangrene * 1      
# participants affected / at risk     3/10744 (0.03%)     3/4904 (0.06%)     5/4881 (0.10%)  
Gastroenteritis * 1      
# participants affected / at risk     4/10744 (0.04%)     13/4904 (0.27%)     15/4881 (0.31%)  
Gastroenteritis bacterial * 1      
# participants affected / at risk     1/10744 (0.01%)     1/4904 (0.02%)     0/4881 (0.00%)  
Gastroenteritis clostridial * 1      
# participants affected / at risk     0/10744 (0.00%)     0/4904 (0.00%)     2/4881 (0.04%)  
Gastroenteritis rotavirus * 1      
# participants affected / at risk     0/10744 (0.00%)     2/4904 (0.04%)     0/4881 (0.00%)  
Gastroenteritis salmonella * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     1/4881 (0.02%)  
Gastroenteritis viral * 1      
# participants affected / at risk     0/10744 (0.00%)     2/4904 (0.04%)     3/4881 (0.06%)  
Gingival abscess * 1      
# participants affected / at risk     0/10744 (0.00%)     0/4904 (0.00%)     1/4881 (0.02%)  
Graft infection * 1      
# participants affected / at risk     0/10744 (0.00%)     0/4904 (0.00%)     1/4881 (0.02%)  
Groin abscess * 1      
# participants affected / at risk     1/10744 (0.01%)     1/4904 (0.02%)     2/4881 (0.04%)  
Hematoma infection * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     0/4881 (0.00%)  
Helicobacter infection * 1      
# participants affected / at risk     0/10744 (0.00%)     0/4904 (0.00%)     1/4881 (0.02%)  
Hepatitis A * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     0/4881 (0.00%)  
Hepatitis B * 1      
# participants affected / at risk     1/10744 (0.01%)     1/4904 (0.02%)     2/4881 (0.04%)  
Hepatitis C * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     1/4881 (0.02%)  
Hepatitis viral * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     0/4881 (0.00%)  
Herpes zoster * 1      
# participants affected / at risk     2/10744 (0.02%)     3/4904 (0.06%)     2/4881 (0.04%)  
Herpes zoster ophthalmic * 1      
# participants affected / at risk     0/10744 (0.00%)     2/4904 (0.04%)     1/4881 (0.02%)  
Infected sebaceous cyst * 1      
# participants affected / at risk     0/10744 (0.00%)     0/4904 (0.00%)     1/4881 (0.02%)  
Infected skin ulcer * 1      
# participants affected / at risk     1/10744 (0.01%)     7/4904 (0.14%)     2/4881 (0.04%)  
Infection * 1      
# participants affected / at risk     0/10744 (0.00%)     0/4904 (0.00%)     3/4881 (0.06%)  
Infective exacerbation of chronic obstructive airways disease * 1      
# participants affected / at risk     0/10744 (0.00%)     7/4904 (0.14%)     12/4881 (0.25%)  
Infective tenosynovitis * 1      
# participants affected / at risk     0/10744 (0.00%)     0/4904 (0.00%)     1/4881 (0.02%)  
Influenza * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     0/4881 (0.00%)  
Infusion site infection * 1      
# participants affected / at risk     1/10744 (0.01%)     1/4904 (0.02%)     0/4881 (0.00%)  
Intervertebral discitis * 1      
# participants affected / at risk     0/10744 (0.00%)     0/4904 (0.00%)     1/4881 (0.02%)  
Kidney infection * 1      
# participants affected / at risk     0/10744 (0.00%)     0/4904 (0.00%)     1/4881 (0.02%)  
Klebsiella sepsis * 1      
# participants affected / at risk     0/10744 (0.00%)     0/4904 (0.00%)     1/4881 (0.02%)  
Labyrinthitis * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     1/4881 (0.02%)  
Laryngitis * 1      
# participants affected / at risk     0/10744 (0.00%)     0/4904 (0.00%)     1/4881 (0.02%)  
Liver abscess * 1      
# participants affected / at risk     0/10744 (0.00%)     0/4904 (0.00%)     1/4881 (0.02%)  
Lobar pneumonia * 1      
# participants affected / at risk     0/10744 (0.00%)     13/4904 (0.27%)     6/4881 (0.12%)  
Localized infection * 1      
# participants affected / at risk     0/10744 (0.00%)     3/4904 (0.06%)     4/4881 (0.08%)  
Lower respiratory tract infection * 1      
# participants affected / at risk     1/10744 (0.01%)     4/4904 (0.08%)     10/4881 (0.20%)  
Lung abscess * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     1/4881 (0.02%)  
Lung infection * 1      
# participants affected / at risk     0/10744 (0.00%)     3/4904 (0.06%)     3/4881 (0.06%)  
Lung infection pseudomonal * 1      
# participants affected / at risk     0/10744 (0.00%)     0/4904 (0.00%)     1/4881 (0.02%)  
Lyme disease * 1      
# participants affected / at risk     0/10744 (0.00%)     3/4904 (0.06%)     1/4881 (0.02%)  
Lymph node tuberculosis * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     0/4881 (0.00%)  
Mastitis * 1      
# participants affected / at risk     0/10744 (0.00%)     0/4904 (0.00%)     1/4881 (0.02%)  
Mediastinitis * 1      
# participants affected / at risk     0/10744 (0.00%)     4/4904 (0.08%)     1/4881 (0.02%)  
Meningococcal sepsis * 1      
# participants affected / at risk     0/10744 (0.00%)     0/4904 (0.00%)     1/4881 (0.02%)  
Nasopharyngitis * 1      
# participants affected / at risk     0/10744 (0.00%)     0/4904 (0.00%)     1/4881 (0.02%)  
Neuroborreliosis * 1      
# participants affected / at risk     1/10744 (0.01%)     0/4904 (0.00%)     0/4881 (0.00%)  
Oral candidiasis * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     0/4881 (0.00%)  
Orchitis * 1      
# participants affected / at risk     1/10744 (0.01%)     2/4904 (0.04%)     0/4881 (0.00%)  
Osteomyelitis * 1      
# participants affected / at risk     3/10744 (0.03%)     13/4904 (0.27%)     4/4881 (0.08%)  
Otitis media acute * 1      
# participants affected / at risk     0/10744 (0.00%)     2/4904 (0.04%)     1/4881 (0.02%)  
Otitis media chronic * 1      
# participants affected / at risk     1/10744 (0.01%)     0/4904 (0.00%)     0/4881 (0.00%)  
Paronychia * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     0/4881 (0.00%)  
Parotitis * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     1/4881 (0.02%)  
Perihepatic abscess * 1      
# participants affected / at risk     0/10744 (0.00%)     0/4904 (0.00%)     1/4881 (0.02%)  
Perineal abscess * 1      
# participants affected / at risk     0/10744 (0.00%)     0/4904 (0.00%)     2/4881 (0.04%)  
Perirectal abscess * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     0/4881 (0.00%)  
Peritonsillar abscess * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     1/4881 (0.02%)  
Peritonsillitis * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     0/4881 (0.00%)  
Pharyngeal abscess * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     0/4881 (0.00%)  
Pharyngitis * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     0/4881 (0.00%)  
Pleurisy viral * 1      
# participants affected / at risk     1/10744 (0.01%)     0/4904 (0.00%)     0/4881 (0.00%)  
Pneumococcal sepsis * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     0/4881 (0.00%)  
Pneumonia * 1      
# participants affected / at risk     5/10744 (0.05%)     51/4904 (1.04%)     59/4881 (1.21%)  
Pneumonia bacterial * 1      
# participants affected / at risk     0/10744 (0.00%)     0/4904 (0.00%)     3/4881 (0.06%)  
Pneumonia escherichia * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     1/4881 (0.02%)  
Pneumonia legionella * 1      
# participants affected / at risk     0/10744 (0.00%)     0/4904 (0.00%)     2/4881 (0.04%)  
Pneumonia pneumococcal * 1      
# participants affected / at risk     0/10744 (0.00%)     0/4904 (0.00%)     1/4881 (0.02%)  
Post-procedural cellulitis * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     0/4881 (0.00%)  
Post-procedural infection * 1      
# participants affected / at risk     1/10744 (0.01%)     4/4904 (0.08%)     2/4881 (0.04%)  
Postoperative abscess * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     1/4881 (0.02%)  
Postoperative wound infection * 1      
# participants affected / at risk     0/10744 (0.00%)     3/4904 (0.06%)     6/4881 (0.12%)  
Prostatic abscess * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     0/4881 (0.00%)  
Pulmonary sepsis * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     0/4881 (0.00%)  
Pulmonary tuberculosis * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     2/4881 (0.04%)  
Pyelocystitis * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     0/4881 (0.00%)  
Pyelonephritis * 1      
# participants affected / at risk     1/10744 (0.01%)     6/4904 (0.12%)     8/4881 (0.16%)  
Pyelonephritis acute * 1      
# participants affected / at risk     1/10744 (0.01%)     1/4904 (0.02%)     3/4881 (0.06%)  
Pyothorax * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     0/4881 (0.00%)  
Rash pustular * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     0/4881 (0.00%)  
Rectal abscess * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     0/4881 (0.00%)  
Respiratory tract infection * 1      
# participants affected / at risk     1/10744 (0.01%)     7/4904 (0.14%)     8/4881 (0.16%)  
Salmonella sepsis * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     0/4881 (0.00%)  
Salmonellosis * 1      
# participants affected / at risk     3/10744 (0.03%)     0/4904 (0.00%)     1/4881 (0.02%)  
Sepsis * 1      
# participants affected / at risk     0/10744 (0.00%)     11/4904 (0.22%)     13/4881 (0.27%)  
Septic shock * 1      
# participants affected / at risk     0/10744 (0.00%)     9/4904 (0.18%)     6/4881 (0.12%)  
Sinusitis * 1      
# participants affected / at risk     0/10744 (0.00%)     2/4904 (0.04%)     0/4881 (0.00%)  
Sinusitis bacterial * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     0/4881 (0.00%)  
Skin bacterial infection * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     0/4881 (0.00%)  
Skin infection * 1      
# participants affected / at risk     0/10744 (0.00%)     2/4904 (0.04%)     0/4881 (0.00%)  
Staphylococcal infection * 1      
# participants affected / at risk     1/10744 (0.01%)     3/4904 (0.06%)     0/4881 (0.00%)  
Staphylococcal sepsis * 1      
# participants affected / at risk     0/10744 (0.00%)     3/4904 (0.06%)     2/4881 (0.04%)  
Sternitis * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     0/4881 (0.00%)  
Streptococcal sepsis * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     0/4881 (0.00%)  
Subacute endocarditis * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     0/4881 (0.00%)  
Subcutaneous abscess * 1      
# participants affected / at risk     0/10744 (0.00%)     2/4904 (0.04%)     1/4881 (0.02%)  
Sweat gland infection * 1      
# participants affected / at risk     1/10744 (0.01%)     0/4904 (0.00%)     1/4881 (0.02%)  
Testicular abscess * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     0/4881 (0.00%)  
Tonsillitis * 1      
# participants affected / at risk     0/10744 (0.00%)     0/4904 (0.00%)     1/4881 (0.02%)  
Tooth abscess * 1      
# participants affected / at risk     0/10744 (0.00%)     0/4904 (0.00%)     1/4881 (0.02%)  
Toxic shock syndrome * 1      
# participants affected / at risk     1/10744 (0.01%)     0/4904 (0.00%)     0/4881 (0.00%)  
Tracheitis * 1      
# participants affected / at risk     0/10744 (0.00%)     2/4904 (0.04%)     0/4881 (0.00%)  
Tracheobronchitis * 1      
# participants affected / at risk     0/10744 (0.00%)     0/4904 (0.00%)     2/4881 (0.04%)  
Tuberculosis * 1      
# participants affected / at risk     0/10744 (0.00%)     0/4904 (0.00%)     1/4881 (0.02%)  
Upper respiratory tract infection * 1      
# participants affected / at risk     1/10744 (0.01%)     4/4904 (0.08%)     1/4881 (0.02%)  
Urinary tract infection * 1      
# participants affected / at risk     0/10744 (0.00%)     16/4904 (0.33%)     23/4881 (0.47%)  
Urinary tract infection bacterial * 1      
# participants affected / at risk     0/10744 (0.00%)     0/4904 (0.00%)     1/4881 (0.02%)  
Urosepsis * 1      
# participants affected / at risk     0/10744 (0.00%)     6/4904 (0.12%)     3/4881 (0.06%)  
Vestibular neuronitis * 1      
# participants affected / at risk     0/10744 (0.00%)     2/4904 (0.04%)     2/4881 (0.04%)  
Viral infection * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     3/4881 (0.06%)  
Viral labyrinthitis * 1      
# participants affected / at risk     0/10744 (0.00%)     0/4904 (0.00%)     2/4881 (0.04%)  
Visceral leishmaniasis * 1      
# participants affected / at risk     0/10744 (0.00%)     0/4904 (0.00%)     1/4881 (0.02%)  
Vulval cellulitis * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     0/4881 (0.00%)  
Wound abscess * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     0/4881 (0.00%)  
Wound infection * 1      
# participants affected / at risk     0/10744 (0.00%)     2/4904 (0.04%)     3/4881 (0.06%)  
Wound infection staphylococcal * 1      
# participants affected / at risk     0/10744 (0.00%)     4/4904 (0.08%)     1/4881 (0.02%)  
Injury, poisoning and procedural complications        
Abdominal wound dehiscence * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     0/4881 (0.00%)  
Accidental needle stick * 1      
# participants affected / at risk     0/10744 (0.00%)     0/4904 (0.00%)     1/4881 (0.02%)  
Accidental overdose * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     0/4881 (0.00%)  
Alcohol poisoning * 1      
# participants affected / at risk     0/10744 (0.00%)     2/4904 (0.04%)     1/4881 (0.02%)  
Anastomotic complication * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     0/4881 (0.00%)  
Ankle fracture * 1      
# participants affected / at risk     1/10744 (0.01%)     4/4904 (0.08%)     4/4881 (0.08%)  
Arterial restenosis * 1      
# participants affected / at risk     0/10744 (0.00%)     2/4904 (0.04%)     1/4881 (0.02%)  
Ateriovenous fistula thrombosis * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     0/4881 (0.00%)  
Asbestosis * 1      
# participants affected / at risk     0/10744 (0.00%)     0/4904 (0.00%)     1/4881 (0.02%)  
Bladder injury * 1      
# participants affected / at risk     0/10744 (0.00%)     0/4904 (0.00%)     1/4881 (0.02%)  
Brachial plexus injury * 1      
# participants affected / at risk     0/10744 (0.00%)     0/4904 (0.00%)     1/4881 (0.02%)  
Brain contusion * 1      
# participants affected / at risk     1/10744 (0.01%)     0/4904 (0.00%)     0/4881 (0.00%)  
Cardiac pacemaker malfunction * 1      
# participants affected / at risk     0/10744 (0.00%)     3/4904 (0.06%)     3/4881 (0.06%)  
Cerebral hemorrhage traumatic * 1      
# participants affected / at risk     1/10744 (0.01%)     1/4904 (0.02%)     0/4881 (0.00%)  
Cerebral hyperperfusion syndrome * 1      
# participants affected / at risk     0/10744 (0.00%)     0/4904 (0.00%)     1/4881 (0.02%)  
Clavicle fracture * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     1/4881 (0.02%)  
Concussion * 1      
# participants affected / at risk     0/10744 (0.00%)     3/4904 (0.06%)     1/4881 (0.02%)  
Confusion postoperative * 1      
# participants affected / at risk     0/10744 (0.00%)     0/4904 (0.00%)     1/4881 (0.02%)  
Contusion * 1      
# participants affected / at risk     0/10744 (0.00%)     3/4904 (0.06%)     3/4881 (0.06%)  
Coronary artery restenosis * 1      
# participants affected / at risk     3/10744 (0.03%)     10/4904 (0.20%)     11/4881 (0.23%)  
Coronary bypass thrombosis * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     0/4881 (0.00%)  
Device breakage * 1      
# participants affected / at risk     0/10744 (0.00%)     0/4904 (0.00%)     2/4881 (0.04%)  
Device dislocation * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     0/4881 (0.00%)  
Device failure * 1      
# participants affected / at risk     1/10744 (0.01%)     5/4904 (0.10%)     5/4881 (0.10%)  
Device lead damage * 1      
# participants affected / at risk     0/10744 (0.00%)     0/4904 (0.00%)     1/4881 (0.02%)  
Device malfunction * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     2/4881 (0.04%)  
Device occlusion * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     0/4881 (0.00%)  
Dislocation of joint prosthesis * 1      
# participants affected / at risk     0/10744 (0.00%)     2/4904 (0.04%)     2/4881 (0.04%)  
Drug administration error * 1      
# participants affected / at risk     0/10744 (0.00%)     0/4904 (0.00%)     1/4881 (0.02%)  
Drug dispensing error * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     0/4881 (0.00%)  
Drug toxicity * 1      
# participants affected / at risk     0/10744 (0.00%)     0/4904 (0.00%)     1/4881 (0.02%)  
Eye injury * 1      
# participants affected / at risk     0/10744 (0.00%)     0/4904 (0.00%)     1/4881 (0.02%)  
Face injury * 1      
# participants affected / at risk     0/10744 (0.00%)     1/4904 (0.02%)     0/4881 (0.00%)  
Fall * 1      
# participants affected / at risk     0/10744 (0.00%)     4/4904 (0.08%)     5/4881 (0.10%)  
Femoral neck fracture * 1      
# participants affected / at risk     1/10744 (0.01%)     2/4904 (0.04%)     5/4881 (0.10%)  
Femur fracture * 1      
# participants affected / at risk     0/10744 (0.00%)     3/4904 (0.06%)