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Trial record 1 of 1 for:    20818901 [PUBMED-IDS]
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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)

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ClinicalTrials.gov Identifier: NCT00234832
Recruitment Status : Completed
First Posted : October 10, 2005
Results First Posted : April 15, 2010
Last Update Posted : May 11, 2010
Sponsor:
Information provided by:
Abbott

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Obesity
Interventions Drug: Sibutramine hydrochloride
Drug: Placebo
Enrollment 10777
Recruitment Details  
Pre-assignment Details 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).
Arm/Group Title Randomized Sibutramine Randomized Placebo
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
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.
Arm/Group Title Randomized Sibutramine Randomized Placebo Total
Hide Arm/Group Description 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. 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 of all reporting groups
Overall Number of Baseline Participants 4906 4898 9804
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4906 participants 4898 participants 9804 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
3040
  62.0%
2997
  61.2%
6037
  61.6%
>=65 years
1866
  38.0%
1901
  38.8%
3767
  38.4%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 4906 participants 4898 participants 9804 participants
63.2  (6.09) 63.3  (6.15) 63.2  (6.12)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4906 participants 4898 participants 9804 participants
Female
2099
  42.8%
2055
  42.0%
4154
  42.4%
Male
2807
  57.2%
2843
  58.0%
5650
  57.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 4906 participants 4898 participants 9804 participants
Europe 4160 4150 8310
Australia 384 385 769
Brazil 233 234 467
Mexico 129 129 258
Cardiovascular (CV) risk group status   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 4906 participants 4898 participants 9804 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]
Measure Description: 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.
1.Primary Outcome
Title Risk of Experiencing a Primary Outcome Event (POE) (i.e., Nonfatal Myocardial Infarction [MI], Nonfatal Stroke, Resuscitated Cardiac Arrest, Cardiovascular [CV] Death)
Hide Description For each subject, POE status (with/without an event) and time to first occurrence of a POE using time-to-event analysis were evaluated. All POE confirmed by an independent adjudication committee were included in the analysis.
Time Frame From randomization up to 6 years
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis based on intent-to-treat (ITT) population, which consists of all randomized subjects dispensed randomized study drug and grouped according to the intervention to which they were randomized. Subjects were also categorized into 1 of 3 prespecified CV risk groups: diabetes mellitus (DM) only, CV only, and CV + DM.
Arm/Group Title Randomized Sibutramine Randomized Placebo DM Only Randomized to Sibutramine DM Only Randomized to Placebo CV Only Randomized to Sibutramine CV Only Randomized to Placebo CV + DM Randomized to Sibutramine CV + DM Randomized to Placebo
Hide Arm/Group Description:
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.
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.
Subjects with a history of type 2 DM with at least one other risk factor (i.e., hypertension controlled on medication, dyslipidemia, current cigarette smoking, diabetic nephropathy with evidence of microalbuminuria), but no history of coronary artery disease, cerebrovascular disease, or peripheral arterial occlusive disease 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.
Subjects with a history of type 2 DM with at least one other risk factor (i.e., hypertension controlled on medication, dyslipidemia, current cigarette smoking, diabetic nephropathy with evidence of microalbuminuria), but no history of coronary artery disease, cerebrovascular disease, or peripheral arterial occlusive disease 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.
Subjects with a 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 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.
Subjects with a 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 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.
Subjects with a history of coronary artery disease, cerebrovascular disease, or peripheral arterial occlusive disease, and with a history of type 2 DM with at least one other risk factor 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.
Subjects with a history of coronary artery disease, cerebrovascular disease, or peripheral arterial occlusive disease, and with a history of type 2 DM with at least one other risk factor 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.
Overall Number of Participants Analyzed 4906 4898 1207 1178 759 793 2906 2901
Measure Type: Number
Unit of Measure: Participants
Intent-to-treat population 561 490 79 77 77 66 403 346
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Randomized Sibutramine, Randomized Placebo
Comments For the sample size calculation, a two-tailed alpha level of 0.05 was used along with power of 90%. The annual composite event rate in the placebo arm was assumed to be 7.0%. A sample of 3983 subjects in each of the 2 groups, corrected for a 30% noncompliance rate (15% in Year 1 and 6.3% in each year, Years 2 to 4), followed for at least 3 years was expected to have 90% power to detect a relative risk reduction of 15% with sibutramine relative to placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.015
Comments No adjustment for multiple testing or interim analysis was performed. The primary outcome was tested at a 2-sided alpha level of 0.05.
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 1.162
Confidence Interval (2-Sided) 95%
1.029 to 1.311
Estimation Comments The Cox model included factors for treatment, country, gender, and age (continuous) at Lead-in Period baseline. For the calculation of risk, the sibutramine arm is the numerator and the placebo arm is the denominator.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection DM Only Randomized to Sibutramine, DM Only Randomized to Placebo
Comments This analysis included only subjects with DM only in a comparison of sibutramine and placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.948
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 1.010
Confidence Interval (2-Sided) 95%
0.738 to 1.384
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection CV Only Randomized to Sibutramine, CV Only Randomized to Placebo
Comments This analysis included only subjects with CV only in a comparison of sibutramine and placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.149
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 1.276
Confidence Interval (2-Sided) 95%
0.916 to 1.776
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection CV + DM Randomized to Sibutramine, CV + DM Randomized to Placebo
Comments This analysis included only subjects with CV + DM in a comparison of sibutramine and placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.022
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 1.182
Confidence Interval (2-Sided) 95%
1.024 to 1.365
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Risk of Death From Any Cause (All-cause Mortality)
Hide Description For each subject who died, the time to death was evaluated using time-to-event analysis.
Time Frame From randomization up to 6 years
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis based on ITT population, which consists of all randomized subjects dispensed randomized study drug and grouped according to the intervention to which they were randomized.
Arm/Group Title Randomized Sibutramine Randomized Placebo
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 4906 4898
Measure Type: Number
Unit of Measure: Participants
418 404
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Randomized Sibutramine, Randomized Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.543
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 1.043
Confidence Interval (2-Sided) 95%
0.910 to 1.196
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Risk of Experiencing a POE or a Revascularization Procedure
Hide Description This outcome includes nonfatal MI, nonfatal stroke, resuscitated cardiac arrest, CV death (including events such as fatal MI and fatal stroke), and any of the following revascularization procedures: percutaneous transluminal coronary angioplasty, coronary artery bypass graft, coronary artery stent placement, cardiac transplant, peripheral vascular bypass or angioplasty, and carotid endarterectomy. For each subject, the POE or revascularization status (yes/no) and time to first occurrence of an event using time-to-event analysis were evaluated.
Time Frame From randomization up to 6 years
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis based on ITT population, which consists of all randomized subjects dispensed randomized study drug and grouped according to the intervention to which they were randomized.
Arm/Group Title Randomized Sibutramine Randomized Placebo
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 4906 4898
Measure Type: Number
Unit of Measure: Participants
927 856
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Randomized Sibutramine, Randomized Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.051
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 1.097
Confidence Interval (2-Sided) 95%
0.999 to 1.204
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Risk of Experiencing a Nonfatal MI Included in the POE
Hide Description For each subject, the first occurrence of a nonfatal MI included in the POE was evaluated using time-to-event analysis.
Time Frame From randomization up to 6 years
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis based on ITT population, which consists of all randomized subjects dispensed randomized study drug and grouped according to the intervention to which they were randomized.
Arm/Group Title Randomized Sibutramine Randomized Placebo
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 4906 4898
Measure Type: Number
Unit of Measure: Participants
200 159
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Randomized Sibutramine, Randomized Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.022
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 1.276
Confidence Interval (2-Sided) 95%
1.036 to 1.571
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Risk of Experiencing a Nonfatal Stroke Included in the POE
Hide Description For each subject, the time to first occurrence of a nonfatal stroke included in the POE was evaluated using time-to-event analysis.
Time Frame From randomization up to 6 years
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis based on ITT population, which consists of all randomized subjects dispensed randomized study drug and grouped according to the intervention to which they were randomized.
Arm/Group Title Randomized Sibutramine Randomized Placebo
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 4906 4898
Measure Type: Number
Unit of Measure: Participants
127 95
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Randomized Sibutramine, Randomized Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.025
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 1.355
Confidence Interval (2-Sided) 95%
1.038 to 1.767
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Risk of Experiencing a Resuscitated Cardiac Arrest Included in the POE
Hide Description For each subject, the time to first occurrence of a resuscitated cardiac arrest included in the POE was evaluated using time-to-event analysis.
Time Frame From randomization up to 6 years
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis based on ITT population, which consists of all randomized subjects dispensed randomized study drug and grouped according to the intervention to which they were randomized.
Arm/Group Title Randomized Sibutramine Randomized Placebo
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 4906 4898
Measure Type: Number
Unit of Measure: Participants
11 7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Randomized Sibutramine, Randomized Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.343
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 1.582
Confidence Interval (2-Sided) 95%
0.613 to 4.081
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Risk of Experiencing Cardiovascular Death Included in the POE
Hide Description For each subject, the time to cardiovascular death included in the POE was evaluated using time-to-event analysis.
Time Frame From randomization up to 6 years
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis based on ITT population, which consists of all randomized subjects dispensed randomized study drug and grouped according to the intervention to which they were randomized.
Arm/Group Title Randomized Sibutramine Randomized Placebo
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 4906 4898
Measure Type: Number
Unit of Measure: Participants
223 229
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Randomized Sibutramine, Randomized Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.899
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 0.988
Confidence Interval (2-Sided) 95%
0.822 to 1.188
Estimation Comments [Not Specified]
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.
Adverse Event Reporting 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.

 
Arm/Group Title Lead-in Period Sibutramine Randomized Sibutramine Randomized Placebo
Hide Arm/Group Description Subjects who received sibutramine 10 mg QD plus standard care for weight management during a 6-week Lead-in Period. 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. 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.
All-Cause Mortality
Lead-in Period Sibutramine Randomized Sibutramine Randomized Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Lead-in Period Sibutramine Randomized Sibutramine Randomized Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   425/10744 (3.96%)   2063/4904 (42.07%)   1977/4881 (40.50%) 
Blood and lymphatic system disorders       
Anemia * 1  0/10744 (0.00%)  19/4904 (0.39%)  11/4881 (0.23%) 
Bicytopenia * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Coagulopathy * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Disseminated intravascular coagulation * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Hemolytic anemia * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Hemorrhagic anemia * 1  0/10744 (0.00%)  0/4904 (0.00%)  3/4881 (0.06%) 
Hemorrhagic disorder * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Hypersplenism * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Hypochromic anemia * 1  1/10744 (0.01%)  2/4904 (0.04%)  0/4881 (0.00%) 
Hypoprothrombinanemia * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Idiopathic thrombocytopenic purpura * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Iron deficiency anemia * 1  0/10744 (0.00%)  4/4904 (0.08%)  4/4881 (0.08%) 
Leukocytosis * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Lymphadenitis * 1  0/10744 (0.00%)  1/4904 (0.02%)  1/4881 (0.02%) 
Lymphadenopathy * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Lymphatic obstruction * 1  1/10744 (0.01%)  0/4904 (0.00%)  0/4881 (0.00%) 
Lymphocytosis * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Microcytic anemia * 1  0/10744 (0.00%)  2/4904 (0.04%)  1/4881 (0.02%) 
Neutropenia * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Normochromic normocytic anemia * 1  0/10744 (0.00%)  2/4904 (0.04%)  2/4881 (0.04%) 
Thrombocytopenia * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Thrombocytosis * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Cardiac disorders       
Acute coronary syndrome * 1  6/10744 (0.06%)  25/4904 (0.51%)  26/4881 (0.53%) 
Acute left ventricular failure * 1  0/10744 (0.00%)  3/4904 (0.06%)  3/4881 (0.06%) 
Acute myocardial infarction * 1  3/10744 (0.03%)  87/4904 (1.77%)  87/4881 (1.78%) 
Adams-Stokes syndrome * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Angina pectoris * 1  21/10744 (0.20%)  111/4904 (2.26%)  133/4881 (2.72%) 
Angina unstable * 1  23/10744 (0.21%)  122/4904 (2.49%)  104/4881 (2.13%) 
Aortic valve disease * 1  1/10744 (0.01%)  2/4904 (0.04%)  0/4881 (0.00%) 
Aortic valve disease mixed * 1  0/10744 (0.00%)  4/4904 (0.08%)  2/4881 (0.04%) 
Aortic valve incompetence * 1  0/10744 (0.00%)  3/4904 (0.06%)  1/4881 (0.02%) 
Aortic valve stenosis * 1  0/10744 (0.00%)  7/4904 (0.14%)  9/4881 (0.18%) 
Arrhythmia * 1  0/10744 (0.00%)  0/4904 (0.00%)  6/4881 (0.12%) 
Arrhythmia supraventricular * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Arteriosclerosis coronary artery * 1  0/10744 (0.00%)  4/4904 (0.08%)  8/4881 (0.16%) 
Atrial fibrillation * 1  20/10744 (0.19%)  115/4904 (2.35%)  135/4881 (2.77%) 
Atrial flutter * 1  4/10744 (0.04%)  21/4904 (0.43%)  29/4881 (0.59%) 
Atrial tachycardia * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Atrial thrombosis * 1  0/10744 (0.00%)  2/4904 (0.04%)  0/4881 (0.00%) 
Atrioventricular block * 1  1/10744 (0.01%)  2/4904 (0.04%)  1/4881 (0.02%) 
Atrioventricular block complete * 1  2/10744 (0.02%)  8/4904 (0.16%)  16/4881 (0.33%) 
Atrioventricular block first degree * 1  0/10744 (0.00%)  1/4904 (0.02%)  2/4881 (0.04%) 
Atrioventricular block second degree * 1  0/10744 (0.00%)  3/4904 (0.06%)  16/4881 (0.33%) 
Bradyarrhythmia * 1  0/10744 (0.00%)  2/4904 (0.04%)  3/4881 (0.06%) 
Bradycardia * 1  1/10744 (0.01%)  7/4904 (0.14%)  7/4881 (0.14%) 
Bundle branch block right * 1  0/10744 (0.00%)  1/4904 (0.02%)  1/4881 (0.02%) 
Cardiac aneurysm * 1  0/10744 (0.00%)  2/4904 (0.04%)  0/4881 (0.00%) 
Cardiac arrest * 1  0/10744 (0.00%)  24/4904 (0.49%)  14/4881 (0.29%) 
Cardiac asthma * 1  0/10744 (0.00%)  1/4904 (0.02%)  1/4881 (0.02%) 
Cardiac disorder * 1  0/10744 (0.00%)  1/4904 (0.02%)  1/4881 (0.02%) 
Cardiac failure * 1  2/10744 (0.02%)  82/4904 (1.67%)  80/4881 (1.64%) 
Cardiac failure acute * 1  0/10744 (0.00%)  3/4904 (0.06%)  9/4881 (0.18%) 
Cardiac failure chronic * 1  0/10744 (0.00%)  5/4904 (0.10%)  8/4881 (0.16%) 
Cardiac failure congestive * 1  3/10744 (0.03%)  53/4904 (1.08%)  41/4881 (0.84%) 
Cardiac tamponade * 1  0/10744 (0.00%)  2/4904 (0.04%)  1/4881 (0.02%) 
Cardio-respiratory arrest * 1  1/10744 (0.01%)  1/4904 (0.02%)  2/4881 (0.04%) 
Cardiogenic shock * 1  0/10744 (0.00%)  4/4904 (0.08%)  5/4881 (0.10%) 
Cardiomyopathy * 1  0/10744 (0.00%)  1/4904 (0.02%)  1/4881 (0.02%) 
Cardiopulmonary failure * 1  0/10744 (0.00%)  3/4904 (0.06%)  2/4881 (0.04%) 
Cardiovascular insufficiency * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Chronic right ventricular failure * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Conduction disorder * 1  0/10744 (0.00%)  1/4904 (0.02%)  1/4881 (0.02%) 
Congestive cardiomyopathy * 1  1/10744 (0.01%)  7/4904 (0.14%)  6/4881 (0.12%) 
Cor pulmonale chronic * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Coronary artery disease * 1  15/10744 (0.14%)  135/4904 (2.75%)  118/4881 (2.42%) 
Coronary artery dissection * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Coronary artery insufficiency * 1  0/10744 (0.00%)  3/4904 (0.06%)  3/4881 (0.06%) 
Coronary artery occlusion * 1  1/10744 (0.01%)  3/4904 (0.06%)  8/4881 (0.16%) 
Coronary artery stenosis * 1  4/10744 (0.04%)  76/4904 (1.55%)  74/4881 (1.52%) 
Coronary artery thrombosis * 1  1/10744 (0.01%)  2/4904 (0.04%)  2/4881 (0.04%) 
Diastolic dysfunction * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Extrasystoles * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Hypertensive cardiomyopathy * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Hypertensive heart disease * 1  0/10744 (0.00%)  1/4904 (0.02%)  1/4881 (0.02%) 
Intracardiac thrombus * 1  0/10744 (0.00%)  1/4904 (0.02%)  2/4881 (0.04%) 
Ischemic cardiomyopathy * 1  0/10744 (0.00%)  10/4904 (0.20%)  13/4881 (0.27%) 
Left ventricular dysfunction * 1  0/10744 (0.00%)  1/4904 (0.02%)  3/4881 (0.06%) 
Left ventricular failure * 1  1/10744 (0.01%)  10/4904 (0.20%)  16/4881 (0.33%) 
Left ventricular hypertrophy * 1  1/10744 (0.01%)  0/4904 (0.00%)  0/4881 (0.00%) 
Mitral valve incompetence * 1  0/10744 (0.00%)  4/4904 (0.08%)  6/4881 (0.12%) 
Mitral valve stenosis * 1  0/10744 (0.00%)  1/4904 (0.02%)  1/4881 (0.02%) 
Myocardial infarction * 1  11/10744 (0.10%)  87/4904 (1.77%)  80/4881 (1.64%) 
Myocardial ischemia * 1  5/10744 (0.05%)  57/4904 (1.16%)  36/4881 (0.74%) 
Nodal arrhythmia * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Palpitations * 1  3/10744 (0.03%)  2/4904 (0.04%)  6/4881 (0.12%) 
Pericardial effusion * 1  0/10744 (0.00%)  0/4904 (0.00%)  2/4881 (0.04%) 
Pericarditis * 1  0/10744 (0.00%)  2/4904 (0.04%)  1/4881 (0.02%) 
Postinfarction angina * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Prinzmetal angina * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Right ventricular failure * 1  0/10744 (0.00%)  4/4904 (0.08%)  3/4881 (0.06%) 
Sick sinus syndrome * 1  2/10744 (0.02%)  11/4904 (0.22%)  12/4881 (0.25%) 
Silent myocardial infarction * 1  0/10744 (0.00%)  5/4904 (0.10%)  4/4881 (0.08%) 
Sinoatrial block * 1  0/10744 (0.00%)  2/4904 (0.04%)  1/4881 (0.02%) 
Sinus arrhythmia * 1  0/10744 (0.00%)  1/4904 (0.02%)  3/4881 (0.06%) 
Sinus bradycardia * 1  0/10744 (0.00%)  2/4904 (0.04%)  0/4881 (0.00%) 
Sinus tachycardia * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Subendocardial ischemia * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Supraventricular extrasystoles * 1  0/10744 (0.00%)  0/4904 (0.00%)  2/4881 (0.04%) 
Supraventricular tachyarrhythmia * 1  0/10744 (0.00%)  3/4904 (0.06%)  0/4881 (0.00%) 
Supraventricular tachycardia * 1  3/10744 (0.03%)  12/4904 (0.24%)  6/4881 (0.12%) 
Tachyarrhythmia * 1  0/10744 (0.00%)  3/4904 (0.06%)  2/4881 (0.04%) 
Tachycardia * 1  0/10744 (0.00%)  0/4904 (0.00%)  2/4881 (0.04%) 
Torsade de pointes * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Tricuspid valve incompetence * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Trifascicular block * 1  2/10744 (0.02%)  0/4904 (0.00%)  0/4881 (0.00%) 
Ventricular arrhythmia * 1  0/10744 (0.00%)  3/4904 (0.06%)  1/4881 (0.02%) 
Ventricular extrasystoles * 1  0/10744 (0.00%)  7/4904 (0.14%)  2/4881 (0.04%) 
Ventricular failure * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Ventricular fibrillation * 1  2/10744 (0.02%)  5/4904 (0.10%)  6/4881 (0.12%) 
Ventricular tachyarrhythmia * 1  0/10744 (0.00%)  2/4904 (0.04%)  0/4881 (0.00%) 
Ventricular tachycardia * 1  1/10744 (0.01%)  25/4904 (0.51%)  18/4881 (0.37%) 
Congenital, familial and genetic disorders       
Atrial septal defect * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Congenital cystic kidney disease * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Congenital spondylolithesis * 1  1/10744 (0.01%)  0/4904 (0.00%)  0/4881 (0.00%) 
Dysplastic naevus syndrome * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Gastrointestinal angiodysplasia * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Gastrointestinal angiodysplasia hemorrhagic * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Hydrocele * 1  2/10744 (0.02%)  1/4904 (0.02%)  0/4881 (0.00%) 
Phimosis * 1  0/10744 (0.00%)  1/4904 (0.02%)  3/4881 (0.06%) 
Ear and labyrinth disorders       
Acute vestibular syndrome * 1  0/10744 (0.00%)  2/4904 (0.04%)  0/4881 (0.00%) 
Aural polyp * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Deafness unilateral * 1  0/10744 (0.00%)  1/4904 (0.02%)  1/4881 (0.02%) 
Hearing impaired * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Hypoacusis * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Neurosensory hypoacusis * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Sudden hearing loss * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Vertigo * 1  1/10744 (0.01%)  4/4904 (0.08%)  5/4881 (0.10%) 
Vertigo positional * 1  0/10744 (0.00%)  2/4904 (0.04%)  2/4881 (0.04%) 
Vestibular disorder * 1  0/10744 (0.00%)  3/4904 (0.06%)  0/4881 (0.00%) 
Endocrine disorders       
Autoimmune thyroiditis * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Goiter * 1  0/10744 (0.00%)  7/4904 (0.14%)  6/4881 (0.12%) 
Hyperparathyroidism * 1  0/10744 (0.00%)  3/4904 (0.06%)  0/4881 (0.00%) 
Hyperparathyroidism primary * 1  1/10744 (0.01%)  0/4904 (0.00%)  2/4881 (0.04%) 
Hyperthyroidism * 1  0/10744 (0.00%)  5/4904 (0.10%)  5/4881 (0.10%) 
Hypothyroidism * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Inappropriate antidiuretic hormone secretion * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Myxedema * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Toxic nodular goiter * 1  1/10744 (0.01%)  1/4904 (0.02%)  1/4881 (0.02%) 
Eye disorders       
Amaurosis * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Angle closure glaucoma * 1  0/10744 (0.00%)  1/4904 (0.02%)  2/4881 (0.04%) 
Aphakia * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Cataract * 1  4/10744 (0.04%)  33/4904 (0.67%)  29/4881 (0.59%) 
Cataract diabetic * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Cataract nuclear * 1  1/10744 (0.01%)  0/4904 (0.00%)  2/4881 (0.04%) 
Cataract subcapsular * 1  0/10744 (0.00%)  2/4904 (0.04%)  0/4881 (0.00%) 
Diabetic retinopathy * 1  0/10744 (0.00%)  6/4904 (0.12%)  4/4881 (0.08%) 
Diplopia * 1  1/10744 (0.01%)  1/4904 (0.02%)  0/4881 (0.00%) 
Extraocular muscle paresis * 1  1/10744 (0.01%)  0/4904 (0.00%)  0/4881 (0.00%) 
Eye hemorrhage * 1  0/10744 (0.00%)  1/4904 (0.02%)  1/4881 (0.02%) 
Eye pain * 1  1/10744 (0.01%)  0/4904 (0.00%)  0/4881 (0.00%) 
Glaucoma * 1  0/10744 (0.00%)  1/4904 (0.02%)  3/4881 (0.06%) 
Iris bombe * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Keratitis * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Lens dislocation * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Macular hole * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Macular edema * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Maculopathy * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Ocular myasthenia * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Ocular vascular disorder * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Open-angle glaucoma * 1  0/10744 (0.00%)  2/4904 (0.04%)  1/4881 (0.02%) 
Optic ischemic neuropathy * 1  1/10744 (0.01%)  1/4904 (0.02%)  0/4881 (0.00%) 
Punctate keratitis * 1  1/10744 (0.01%)  0/4904 (0.00%)  0/4881 (0.00%) 
Retinal artery occlusion * 1  0/10744 (0.00%)  1/4904 (0.02%)  3/4881 (0.06%) 
Retinal detachment * 1  0/10744 (0.00%)  10/4904 (0.20%)  5/4881 (0.10%) 
Retinal hemorrhage * 1  1/10744 (0.01%)  2/4904 (0.04%)  0/4881 (0.00%) 
Retinal vein occlusion * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Retinal vein thrombosis * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Strabismus * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Synchysis scintillans * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Ulcerative keratitis * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Uveitis * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Visual impairment * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Vitreous detachment * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Vitreous disorder * 1  1/10744 (0.01%)  0/4904 (0.00%)  0/4881 (0.00%) 
Vitreous hemorrhage * 1  0/10744 (0.00%)  0/4904 (0.00%)  3/4881 (0.06%) 
Gastrointestinal disorders       
Abdominal distension * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Abdominal hernia * 1  0/10744 (0.00%)  7/4904 (0.14%)  3/4881 (0.06%) 
Abdominal hernia obstructive * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Abdominal mass * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Abdominal pain * 1  0/10744 (0.00%)  8/4904 (0.16%)  9/4881 (0.18%) 
Abdominal pain lower * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Abdominal pain upper * 1  0/10744 (0.00%)  2/4904 (0.04%)  6/4881 (0.12%) 
Abdominal strangulated hernia * 1  0/10744 (0.00%)  0/4904 (0.00%)  2/4881 (0.04%) 
Anal fissure * 1  0/10744 (0.00%)  3/4904 (0.06%)  2/4881 (0.04%) 
Anal fistula * 1  0/10744 (0.00%)  3/4904 (0.06%)  2/4881 (0.04%) 
Anal stenosis * 1  0/10744 (0.00%)  1/4904 (0.02%)  1/4881 (0.02%) 
Anal ulcer * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Barrett's esophagus * 1  0/10744 (0.00%)  1/4904 (0.02%)  1/4881 (0.02%) 
Cecitis * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Change of bowel habit * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Celiac artery stenosis * 1  0/10744 (0.00%)  0/4904 (0.00%)  2/4881 (0.04%) 
Colitis * 1  0/10744 (0.00%)  5/4904 (0.10%)  0/4881 (0.00%) 
Colitis ischemic * 1  0/10744 (0.00%)  2/4904 (0.04%)  2/4881 (0.04%) 
Colonic polyp * 1  2/10744 (0.02%)  3/4904 (0.06%)  10/4881 (0.20%) 
Constipation * 1  1/10744 (0.01%)  5/4904 (0.10%)  4/4881 (0.08%) 
Diabetic gastroparesis * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Diarrhea * 1  0/10744 (0.00%)  4/4904 (0.08%)  7/4881 (0.14%) 
Diarrhea hemorrhagic * 1  1/10744 (0.01%)  0/4904 (0.00%)  0/4881 (0.00%) 
Diverticulitis intestinal hemorrhagic * 1  1/10744 (0.01%)  1/4904 (0.02%)  0/4881 (0.00%) 
Diverticulum * 1  1/10744 (0.01%)  2/4904 (0.04%)  2/4881 (0.04%) 
Diverticulum intestinal * 1  0/10744 (0.00%)  2/4904 (0.04%)  5/4881 (0.10%) 
Diverticulum intestinal hemorrhagic * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Duodenal ulcer * 1  1/10744 (0.01%)  5/4904 (0.10%)  4/4881 (0.08%) 
Duodenal ulcer hemorrhage * 1  0/10744 (0.00%)  12/4904 (0.24%)  2/4881 (0.04%) 
Duodenal ulcer perforation * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Duodenitis * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Dyspepsia * 1  0/10744 (0.00%)  4/4904 (0.08%)  3/4881 (0.06%) 
Enteritis * 1  0/10744 (0.00%)  0/4904 (0.00%)  3/4881 (0.06%) 
Enterocolitis * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Erosive esophagitis * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Fecal incontinence * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Fecaloma * 1  1/10744 (0.01%)  3/4904 (0.06%)  0/4881 (0.00%) 
Food poisoning * 1  0/10744 (0.00%)  1/4904 (0.02%)  1/4881 (0.02%) 
Gastric hemorrhage * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Gastric mucosal lesion * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Gastric perforation * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Gastric polyps * 1  0/10744 (0.00%)  4/4904 (0.08%)  2/4881 (0.04%) 
Gastric ulcer * 1  3/10744 (0.03%)  5/4904 (0.10%)  7/4881 (0.14%) 
Gastric ulcer hemorrhage * 1  0/10744 (0.00%)  9/4904 (0.18%)  9/4881 (0.18%) 
Gastritis * 1  0/10744 (0.00%)  8/4904 (0.16%)  4/4881 (0.08%) 
Gastritis atrophic * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Gastritis erosive * 1  0/10744 (0.00%)  4/4904 (0.08%)  3/4881 (0.06%) 
Gastritis hemorrhagic * 1  1/10744 (0.01%)  2/4904 (0.04%)  5/4881 (0.10%) 
Gastroduodenitis * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Gastrointestinal disorder * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Gastrointestinal hemorrhage * 1  0/10744 (0.00%)  3/4904 (0.06%)  4/4881 (0.08%) 
Gastrointestinal inflammation * 1  2/10744 (0.02%)  1/4904 (0.02%)  1/4881 (0.02%) 
Gastrointestinal ulcer hemorrhage * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Gastroesophageal reflux disease * 1  0/10744 (0.00%)  4/4904 (0.08%)  6/4881 (0.12%) 
Gastroesophageal sphincter insufficiency * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Gastroesophagitis * 1  1/10744 (0.01%)  1/4904 (0.02%)  0/4881 (0.00%) 
Gingival pain * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Hematochezia * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Hemorrhagic erosive gastritis * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Hemorrhoidal hemorrhage * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Hemorrhoids * 1  1/10744 (0.01%)  3/4904 (0.06%)  4/4881 (0.08%) 
Hernial eventration * 1  0/10744 (0.00%)  5/4904 (0.10%)  2/4881 (0.04%) 
Hiatus hernia * 1  0/10744 (0.00%)  3/4904 (0.06%)  2/4881 (0.04%) 
Ileitis * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Ileus * 1  0/10744 (0.00%)  4/4904 (0.08%)  2/4881 (0.04%) 
Ileus paralytic * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Impaired gastric emptying * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Inguinal hernia * 1  4/10744 (0.04%)  13/4904 (0.27%)  18/4881 (0.37%) 
Intestinal ischemia * 1  0/10744 (0.00%)  4/4904 (0.08%)  0/4881 (0.00%) 
Intestinal obstruction * 1  0/10744 (0.00%)  6/4904 (0.12%)  3/4881 (0.06%) 
Intra-abdominal hematoma * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Irritable bowel syndrome * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Large intestinal obstruction * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Large intestine perforation * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Lower gastrointestinal hemorrhage * 1  0/10744 (0.00%)  0/4904 (0.00%)  2/4881 (0.04%) 
Mechanical ileus * 1  0/10744 (0.00%)  1/4904 (0.02%)  1/4881 (0.02%) 
Melena * 1  1/10744 (0.01%)  0/4904 (0.00%)  1/4881 (0.02%) 
Melanosis coli * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Mesenteric artery stenosis * 1  0/10744 (0.00%)  0/4904 (0.00%)  2/4881 (0.04%) 
Mesenteric artery thrombosis * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Mesenteric occlusion * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Nausea * 1  0/10744 (0.00%)  2/4904 (0.04%)  5/4881 (0.10%) 
Esophageal stenosis * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Esophageal ulcer hemorrhage * 1  0/10744 (0.00%)  1/4904 (0.02%)  1/4881 (0.02%) 
Esophagitis * 1  3/10744 (0.03%)  5/4904 (0.10%)  1/4881 (0.02%) 
Esophagitis ulcerative * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Pancreatitis * 1  1/10744 (0.01%)  3/4904 (0.06%)  4/4881 (0.08%) 
Pancreatitis acute * 1  0/10744 (0.00%)  3/4904 (0.06%)  14/4881 (0.29%) 
Pancreatitis chronic * 1  0/10744 (0.00%)  1/4904 (0.02%)  1/4881 (0.02%) 
Pancreatitis necrotizing * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Papilla of Vater stenosis * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Peptic ulcer * 1  0/10744 (0.00%)  2/4904 (0.04%)  3/4881 (0.06%) 
Peptic ulcer hemorrhage * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Periodontal disease * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Peritoneal adhesions * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Peritoneal hemorrhage * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Peritonitis * 1  0/10744 (0.00%)  1/4904 (0.02%)  2/4881 (0.04%) 
Proctitis * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Rectal hemorrhage * 1  1/10744 (0.01%)  2/4904 (0.04%)  2/4881 (0.04%) 
Rectal perforation * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Rectal polyp * 1  0/10744 (0.00%)  2/4904 (0.04%)  2/4881 (0.04%) 
Rectal prolapse * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Reflux esophagitis * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Retroperitoneal fibrosis * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Retroperitoneal hematoma * 1  0/10744 (0.00%)  1/4904 (0.02%)  1/4881 (0.02%) 
Small intestinal hemorrhage * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Small intestinal obstruction * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Subileus * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Tongue hemorrhage * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Tooth disorder * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Tooth loss * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Umbilical hernia * 1  0/10744 (0.00%)  12/4904 (0.24%)  9/4881 (0.18%) 
Umbilical hernia, obstructive * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Upper gastrointestinal hemorrhage * 1  0/10744 (0.00%)  3/4904 (0.06%)  3/4881 (0.06%) 
Varices esophageal * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Vomiting * 1  0/10744 (0.00%)  1/4904 (0.02%)  5/4881 (0.10%) 
General disorders       
Abasia * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Adhesion * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Adverse drug reaction * 1  0/10744 (0.00%)  1/4904 (0.02%)  2/4881 (0.04%) 
Asthenia * 1  0/10744 (0.00%)  3/4904 (0.06%)  1/4881 (0.02%) 
Catheter-related complication * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Chest discomfort * 1  1/10744 (0.01%)  2/4904 (0.04%)  2/4881 (0.04%) 
Chest pain * 1  5/10744 (0.05%)  22/4904 (0.45%)  18/4881 (0.37%) 
Chills * 1  0/10744 (0.00%)  0/4904 (0.00%)  2/4881 (0.04%) 
Cyst * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Death * 1  17/10744 (0.16%)  25/4904 (0.51%)  18/4881 (0.37%) 
Drug intolerance * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Dysplasia * 1  0/10744 (0.00%)  0/4904 (0.00%)  2/4881 (0.04%) 
Fatigue * 1  1/10744 (0.01%)  2/4904 (0.04%)  5/4881 (0.10%) 
Foaming at mouth * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
General physical health deterioration * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Hernia obstructive * 1  1/10744 (0.01%)  1/4904 (0.02%)  1/4881 (0.02%) 
Impaired healing * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Implant expulsion * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Implant site fibrosis * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Implant site inflammation * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Inflammation * 1  0/10744 (0.00%)  0/4904 (0.00%)  2/4881 (0.04%) 
Malaise * 1  0/10744 (0.00%)  2/4904 (0.04%)  3/4881 (0.06%) 
Mechanical complication of implant * 1  0/10744 (0.00%)  2/4904 (0.04%)  0/4881 (0.00%) 
Metaplasia * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Multi-organ failure * 1  1/10744 (0.01%)  3/4904 (0.06%)  2/4881 (0.04%) 
Necrosis * 1  0/10744 (0.00%)  0/4904 (0.00%)  2/4881 (0.04%) 
Non-cardiac chest pain * 1  2/10744 (0.02%)  19/4904 (0.39%)  15/4881 (0.31%) 
Pain * 1  2/10744 (0.02%)  2/4904 (0.04%)  0/4881 (0.00%) 
Peripheral edema * 1  0/10744 (0.00%)  4/4904 (0.08%)  3/4881 (0.06%) 
Pyrexia * 1  0/10744 (0.00%)  5/4904 (0.10%)  5/4881 (0.10%) 
Sudden cardiac death * 1  0/10744 (0.00%)  11/4904 (0.22%)  4/4881 (0.08%) 
Sudden death * 1  3/10744 (0.03%)  19/4904 (0.39%)  26/4881 (0.53%) 
Swelling * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Bile duct stone * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Hepatic lesion * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Hepatobiliary disorders       
Autoimmune hepatitis * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Bile duct obstruction * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Bile duct stenosis * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Biliary cirrhosis primary * 1  0/10744 (0.00%)  1/4904 (0.02%)  1/4881 (0.02%) 
Biliary colic * 1  1/10744 (0.01%)  1/4904 (0.02%)  2/4881 (0.04%) 
Cholangitis * 1  0/10744 (0.00%)  1/4904 (0.02%)  4/4881 (0.08%) 
Cholangitis acute * 1  0/10744 (0.00%)  1/4904 (0.02%)  1/4881 (0.02%) 
Cholecystitis * 1  2/10744 (0.02%)  8/4904 (0.16%)  7/4881 (0.14%) 
Cholecystitis acute * 1  0/10744 (0.00%)  7/4904 (0.14%)  5/4881 (0.10%) 
Cholecystitis chronic * 1  0/10744 (0.00%)  1/4904 (0.02%)  4/4881 (0.08%) 
Cholelithiasis * 1  2/10744 (0.02%)  26/4904 (0.53%)  25/4881 (0.51%) 
Cirrhosis alcoholic * 1  1/10744 (0.01%)  0/4904 (0.00%)  1/4881 (0.02%) 
Gallbladder cholesterolosis * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Gallbladder disorder * 1  1/10744 (0.01%)  0/4904 (0.00%)  1/4881 (0.02%) 
Gallbladder obstruction * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Gallbladder perforation * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Hepatic cirrhosis * 1  0/10744 (0.00%)  2/4904 (0.04%)  0/4881 (0.00%) 
Hepatic mass * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Hepatitis * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Hepatitis acute * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Hepatorenal failure * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Liver disorder * 1  1/10744 (0.01%)  1/4904 (0.02%)  0/4881 (0.00%) 
Liver injury * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Immune system disorders       
Anaphylactic reaction * 1  0/10744 (0.00%)  1/4904 (0.02%)  1/4881 (0.02%) 
Anaphylactic shock * 1  1/10744 (0.01%)  4/4904 (0.08%)  1/4881 (0.02%) 
Hypersensitivity * 1  0/10744 (0.00%)  4/4904 (0.08%)  3/4881 (0.06%) 
Infections and infestations       
Abdominal abscess * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Abscess limb * 1  0/10744 (0.00%)  2/4904 (0.04%)  2/4881 (0.04%) 
Abscess neck * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Abscess oral * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Acarodermatitis * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Anal abscess * 1  1/10744 (0.01%)  1/4904 (0.02%)  3/4881 (0.06%) 
Appendicitis * 1  0/10744 (0.00%)  6/4904 (0.12%)  3/4881 (0.06%) 
Appendicitis perforated * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Arteriosclerotic gangrene * 1  0/10744 (0.00%)  0/4904 (0.00%)  2/4881 (0.04%) 
Arthritis bacterial * 1  0/10744 (0.00%)  1/4904 (0.02%)  1/4881 (0.02%) 
Arthritis infective * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Bacterial infection * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Bacterial pyelonephritis * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Biliary sepsis * 1  0/10744 (0.00%)  1/4904 (0.02%)  1/4881 (0.02%) 
Bronchiectasis * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Bronchitis * 1  0/10744 (0.00%)  13/4904 (0.27%)  15/4881 (0.31%) 
Bronchitis bacterial * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Bronchitis viral * 1  0/10744 (0.00%)  1/4904 (0.02%)  1/4881 (0.02%) 
Bronchopneumonia * 1  2/10744 (0.02%)  14/4904 (0.29%)  17/4881 (0.35%) 
Bronchopulmonary aspergillosis allergic * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Campylobacter intestinal infection * 1  0/10744 (0.00%)  2/4904 (0.04%)  0/4881 (0.00%) 
Catheter-site infection * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Cellulitis * 1  3/10744 (0.03%)  19/4904 (0.39%)  17/4881 (0.35%) 
Cellulitis staphylococcal * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Central line infection * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Cholecystitis infective * 1  0/10744 (0.00%)  3/4904 (0.06%)  4/4881 (0.08%) 
Chronic sinusitis * 1  0/10744 (0.00%)  2/4904 (0.04%)  1/4881 (0.02%) 
Clostridium difficile colitis * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Cystitis * 1  1/10744 (0.01%)  7/4904 (0.14%)  2/4881 (0.04%) 
Dengue fever * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Device-related infection * 1  0/10744 (0.00%)  2/4904 (0.04%)  3/4881 (0.06%) 
Diabetic foot infection * 1  0/10744 (0.00%)  7/4904 (0.14%)  6/4881 (0.12%) 
Diabetic gangrene * 1  2/10744 (0.02%)  8/4904 (0.16%)  4/4881 (0.08%) 
Diarrhea infectious * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Diverticulitis * 1  0/10744 (0.00%)  7/4904 (0.14%)  8/4881 (0.16%) 
Endocarditis * 1  0/10744 (0.00%)  2/4904 (0.04%)  4/4881 (0.08%) 
Endocarditis bacterial * 1  0/10744 (0.00%)  2/4904 (0.04%)  0/4881 (0.00%) 
Endocarditis staphylococcal * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Endophthalmitis * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Entereocolitis viral * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Erysipelas * 1  5/10744 (0.05%)  23/4904 (0.47%)  14/4881 (0.29%) 
Escherichia sepsis * 1  0/10744 (0.00%)  3/4904 (0.06%)  0/4881 (0.00%) 
Escherichia urinary tract infection * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Eye infection * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Furuncle * 1  0/10744 (0.00%)  2/4904 (0.04%)  0/4881 (0.00%) 
Gallbladder empyema * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Gangrene * 1  3/10744 (0.03%)  3/4904 (0.06%)  5/4881 (0.10%) 
Gastroenteritis * 1  4/10744 (0.04%)  13/4904 (0.27%)  15/4881 (0.31%) 
Gastroenteritis bacterial * 1  1/10744 (0.01%)  1/4904 (0.02%)  0/4881 (0.00%) 
Gastroenteritis clostridial * 1  0/10744 (0.00%)  0/4904 (0.00%)  2/4881 (0.04%) 
Gastroenteritis rotavirus * 1  0/10744 (0.00%)  2/4904 (0.04%)  0/4881 (0.00%) 
Gastroenteritis salmonella * 1  0/10744 (0.00%)  1/4904 (0.02%)  1/4881 (0.02%) 
Gastroenteritis viral * 1  0/10744 (0.00%)  2/4904 (0.04%)  3/4881 (0.06%) 
Gingival abscess * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Graft infection * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Groin abscess * 1  1/10744 (0.01%)  1/4904 (0.02%)  2/4881 (0.04%) 
Hematoma infection * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Helicobacter infection * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Hepatitis A * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Hepatitis B * 1  1/10744 (0.01%)  1/4904 (0.02%)  2/4881 (0.04%) 
Hepatitis C * 1  0/10744 (0.00%)  1/4904 (0.02%)  1/4881 (0.02%) 
Hepatitis viral * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Herpes zoster * 1  2/10744 (0.02%)  3/4904 (0.06%)  2/4881 (0.04%) 
Herpes zoster ophthalmic * 1  0/10744 (0.00%)  2/4904 (0.04%)  1/4881 (0.02%) 
Infected sebaceous cyst * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Infected skin ulcer * 1  1/10744 (0.01%)  7/4904 (0.14%)  2/4881 (0.04%) 
Infection * 1  0/10744 (0.00%)  0/4904 (0.00%)  3/4881 (0.06%) 
Infective exacerbation of chronic obstructive airways disease * 1  0/10744 (0.00%)  7/4904 (0.14%)  12/4881 (0.25%) 
Infective tenosynovitis * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Influenza * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Infusion site infection * 1  1/10744 (0.01%)  1/4904 (0.02%)  0/4881 (0.00%) 
Intervertebral discitis * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Kidney infection * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Klebsiella sepsis * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Labyrinthitis * 1  0/10744 (0.00%)  1/4904 (0.02%)  1/4881 (0.02%) 
Laryngitis * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Liver abscess * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Lobar pneumonia * 1  0/10744 (0.00%)  13/4904 (0.27%)  6/4881 (0.12%) 
Localized infection * 1  0/10744 (0.00%)  3/4904 (0.06%)  4/4881 (0.08%) 
Lower respiratory tract infection * 1  1/10744 (0.01%)  4/4904 (0.08%)  10/4881 (0.20%) 
Lung abscess * 1  0/10744 (0.00%)  1/4904 (0.02%)  1/4881 (0.02%) 
Lung infection * 1  0/10744 (0.00%)  3/4904 (0.06%)  3/4881 (0.06%) 
Lung infection pseudomonal * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Lyme disease * 1  0/10744 (0.00%)  3/4904 (0.06%)  1/4881 (0.02%) 
Lymph node tuberculosis * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Mastitis * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Mediastinitis * 1  0/10744 (0.00%)  4/4904 (0.08%)  1/4881 (0.02%) 
Meningococcal sepsis * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Nasopharyngitis * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Neuroborreliosis * 1  1/10744 (0.01%)  0/4904 (0.00%)  0/4881 (0.00%) 
Oral candidiasis * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Orchitis * 1  1/10744 (0.01%)  2/4904 (0.04%)  0/4881 (0.00%) 
Osteomyelitis * 1  3/10744 (0.03%)  13/4904 (0.27%)  4/4881 (0.08%) 
Otitis media acute * 1  0/10744 (0.00%)  2/4904 (0.04%)  1/4881 (0.02%) 
Otitis media chronic * 1  1/10744 (0.01%)  0/4904 (0.00%)  0/4881 (0.00%) 
Paronychia * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Parotitis * 1  0/10744 (0.00%)  1/4904 (0.02%)  1/4881 (0.02%) 
Perihepatic abscess * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Perineal abscess * 1  0/10744 (0.00%)  0/4904 (0.00%)  2/4881 (0.04%) 
Perirectal abscess * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Peritonsillar abscess * 1  0/10744 (0.00%)  1/4904 (0.02%)  1/4881 (0.02%) 
Peritonsillitis * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Pharyngeal abscess * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Pharyngitis * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Pleurisy viral * 1  1/10744 (0.01%)  0/4904 (0.00%)  0/4881 (0.00%) 
Pneumococcal sepsis * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Pneumonia * 1  5/10744 (0.05%)  51/4904 (1.04%)  59/4881 (1.21%) 
Pneumonia bacterial * 1  0/10744 (0.00%)  0/4904 (0.00%)  3/4881 (0.06%) 
Pneumonia escherichia * 1  0/10744 (0.00%)  1/4904 (0.02%)  1/4881 (0.02%) 
Pneumonia legionella * 1  0/10744 (0.00%)  0/4904 (0.00%)  2/4881 (0.04%) 
Pneumonia pneumococcal * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Post-procedural cellulitis * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Post-procedural infection * 1  1/10744 (0.01%)  4/4904 (0.08%)  2/4881 (0.04%) 
Postoperative abscess * 1  0/10744 (0.00%)  1/4904 (0.02%)  1/4881 (0.02%) 
Postoperative wound infection * 1  0/10744 (0.00%)  3/4904 (0.06%)  6/4881 (0.12%) 
Prostatic abscess * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Pulmonary sepsis * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Pulmonary tuberculosis * 1  0/10744 (0.00%)  1/4904 (0.02%)  2/4881 (0.04%) 
Pyelocystitis * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Pyelonephritis * 1  1/10744 (0.01%)  6/4904 (0.12%)  8/4881 (0.16%) 
Pyelonephritis acute * 1  1/10744 (0.01%)  1/4904 (0.02%)  3/4881 (0.06%) 
Pyothorax * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Rash pustular * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Rectal abscess * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Respiratory tract infection * 1  1/10744 (0.01%)  7/4904 (0.14%)  8/4881 (0.16%) 
Salmonella sepsis * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Salmonellosis * 1  3/10744 (0.03%)  0/4904 (0.00%)  1/4881 (0.02%) 
Sepsis * 1  0/10744 (0.00%)  11/4904 (0.22%)  13/4881 (0.27%) 
Septic shock * 1  0/10744 (0.00%)  9/4904 (0.18%)  6/4881 (0.12%) 
Sinusitis * 1  0/10744 (0.00%)  2/4904 (0.04%)  0/4881 (0.00%) 
Sinusitis bacterial * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Skin bacterial infection * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Skin infection * 1  0/10744 (0.00%)  2/4904 (0.04%)  0/4881 (0.00%) 
Staphylococcal infection * 1  1/10744 (0.01%)  3/4904 (0.06%)  0/4881 (0.00%) 
Staphylococcal sepsis * 1  0/10744 (0.00%)  3/4904 (0.06%)  2/4881 (0.04%) 
Sternitis * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Streptococcal sepsis * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Subacute endocarditis * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Subcutaneous abscess * 1  0/10744 (0.00%)  2/4904 (0.04%)  1/4881 (0.02%) 
Sweat gland infection * 1  1/10744 (0.01%)  0/4904 (0.00%)  1/4881 (0.02%) 
Testicular abscess * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Tonsillitis * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Tooth abscess * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Toxic shock syndrome * 1  1/10744 (0.01%)  0/4904 (0.00%)  0/4881 (0.00%) 
Tracheitis * 1  0/10744 (0.00%)  2/4904 (0.04%)  0/4881 (0.00%) 
Tracheobronchitis * 1  0/10744 (0.00%)  0/4904 (0.00%)  2/4881 (0.04%) 
Tuberculosis * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Upper respiratory tract infection * 1  1/10744 (0.01%)  4/4904 (0.08%)  1/4881 (0.02%) 
Urinary tract infection * 1  0/10744 (0.00%)  16/4904 (0.33%)  23/4881 (0.47%) 
Urinary tract infection bacterial * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Urosepsis * 1  0/10744 (0.00%)  6/4904 (0.12%)  3/4881 (0.06%) 
Vestibular neuronitis * 1  0/10744 (0.00%)  2/4904 (0.04%)  2/4881 (0.04%) 
Viral infection * 1  0/10744 (0.00%)  1/4904 (0.02%)  3/4881 (0.06%) 
Viral labyrinthitis * 1  0/10744 (0.00%)  0/4904 (0.00%)  2/4881 (0.04%) 
Visceral leishmaniasis * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Vulval cellulitis * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Wound abscess * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Wound infection * 1  0/10744 (0.00%)  2/4904 (0.04%)  3/4881 (0.06%) 
Wound infection staphylococcal * 1  0/10744 (0.00%)  4/4904 (0.08%)  1/4881 (0.02%) 
Injury, poisoning and procedural complications       
Abdominal wound dehiscence * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Accidental needle stick * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Accidental overdose * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Alcohol poisoning * 1  0/10744 (0.00%)  2/4904 (0.04%)  1/4881 (0.02%) 
Anastomotic complication * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Ankle fracture * 1  1/10744 (0.01%)  4/4904 (0.08%)  4/4881 (0.08%) 
Arterial restenosis * 1  0/10744 (0.00%)  2/4904 (0.04%)  1/4881 (0.02%) 
Ateriovenous fistula thrombosis * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Asbestosis * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Bladder injury * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Brachial plexus injury * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Brain contusion * 1  1/10744 (0.01%)  0/4904 (0.00%)  0/4881 (0.00%) 
Cardiac pacemaker malfunction * 1  0/10744 (0.00%)  3/4904 (0.06%)  3/4881 (0.06%) 
Cerebral hemorrhage traumatic * 1  1/10744 (0.01%)  1/4904 (0.02%)  0/4881 (0.00%) 
Cerebral hyperperfusion syndrome * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Clavicle fracture * 1  0/10744 (0.00%)  1/4904 (0.02%)  1/4881 (0.02%) 
Concussion * 1  0/10744 (0.00%)  3/4904 (0.06%)  1/4881 (0.02%) 
Confusion postoperative * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Contusion * 1  0/10744 (0.00%)  3/4904 (0.06%)  3/4881 (0.06%) 
Coronary artery restenosis * 1  3/10744 (0.03%)  10/4904 (0.20%)  11/4881 (0.23%) 
Coronary bypass thrombosis * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Device breakage * 1  0/10744 (0.00%)  0/4904 (0.00%)  2/4881 (0.04%) 
Device dislocation * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Device failure * 1  1/10744 (0.01%)  5/4904 (0.10%)  5/4881 (0.10%) 
Device lead damage * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Device malfunction * 1  0/10744 (0.00%)  1/4904 (0.02%)  2/4881 (0.04%) 
Device occlusion * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Dislocation of joint prosthesis * 1  0/10744 (0.00%)  2/4904 (0.04%)  2/4881 (0.04%) 
Drug administration error * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Drug dispensing error * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Drug toxicity * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Eye injury * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Face injury * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Fall * 1  0/10744 (0.00%)  4/4904 (0.08%)  5/4881 (0.10%) 
Femoral neck fracture * 1  1/10744 (0.01%)  2/4904 (0.04%)  5/4881 (0.10%) 
Femur fracture * 1  0/10744 (0.00%)  3/4904 (0.06%)  1/4881 (0.02%) 
Fibula fracture * 1  0/10744 (0.00%)  1/4904 (0.02%)  4/4881 (0.08%) 
Forearm fracture * 1  0/10744 (0.00%)  2/4904 (0.04%)  0/4881 (0.00%) 
Foreign body trauma * 1  0/10744 (0.00%)  1/4904 (0.02%)  1/4881 (0.02%) 
Fracture displacement * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Fractured sacrum * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Gastroenteritis radiation * 1  0/10744 (0.00%)  2/4904 (0.04%)  1/4881 (0.02%) 
Gastrointestinal stoma complication * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Graft thrombosis * 1  0/10744 (0.00%)  5/4904 (0.10%)  2/4881 (0.04%) 
Hand fracture * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Head injury * 1  0/10744 (0.00%)  1/4904 (0.02%)  1/4881 (0.02%) 
Hip fracture * 1  0/10744 (0.00%)  0/4904 (0.00%)  6/4881 (0.12%) 
Humerus fracture * 1  0/10744 (0.00%)  1/4904 (0.02%)  4/4881 (0.08%) 
Iatrogenic injury * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Implantable defibrillator malfunction * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
In-stent arterial restenosis * 1  0/10744 (0.00%)  2/4904 (0.04%)  5/4881 (0.10%) 
In-stent coronary artery restenosis * 1  0/10744 (0.00%)  8/4904 (0.16%)  6/4881 (0.12%) 
Inappropriate device stimulation of tissue * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Incision site complication * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Incisional hernia * 1  0/10744 (0.00%)  3/4904 (0.06%)  6/4881 (0.12%) 
Incisional hernia, obstructive * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Injury * 1  1/10744 (0.01%)  6/4904 (0.12%)  4/4881 (0.08%) 
Intervertebral disc injury * 1  0/10744 (0.00%)  0/4904 (0.00%)  2/4881 (0.04%) 
Joint dislocation * 1  1/10744 (0.01%)  3/4904 (0.06%)  8/4881 (0.16%) 
Joint injury * 1  0/10744 (0.00%)  2/4904 (0.04%)  2/4881 (0.04%) 
Joint sprain * 1  0/10744 (0.00%)  1/4904 (0.02%)  1/4881 (0.02%) 
Keratorhexis * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Lead dislodgement * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Ligament rupture * 1  1/10744 (0.01%)  4/4904 (0.08%)  0/4881 (0.00%) 
Limb injury * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Limb traumatic amputation * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Lower limb fracture * 1  0/10744 (0.00%)  2/4904 (0.04%)  2/4881 (0.04%) 
Lumbar vertebral fracture * 1  0/10744 (0.00%)  2/4904 (0.04%)  3/4881 (0.06%) 
Medical device complication * 1  0/10744 (0.00%)  2/4904 (0.04%)  4/4881 (0.08%) 
Medical device pain * 1  0/10744 (0.00%)  3/4904 (0.06%)  0/4881 (0.00%) 
Meniscus lesion * 1  4/10744 (0.04%)  5/4904 (0.10%)  6/4881 (0.12%) 
Multiple fractures * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Multiple injuries * 1  1/10744 (0.01%)  2/4904 (0.04%)  6/4881 (0.12%) 
Muscle injury * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Muscle rupture * 1  0/10744 (0.00%)  2/4904 (0.04%)  0/4881 (0.00%) 
Operative hemorrhage * 1  0/10744 (0.00%)  2/4904 (0.04%)  0/4881 (0.00%) 
Overdose * 1  1/10744 (0.01%)  2/4904 (0.04%)  0/4881 (0.00%) 
Patella fracture * 1  0/10744 (0.00%)  0/4904 (0.00%)  2/4881 (0.04%) 
Pelvic fracture * 1  1/10744 (0.01%)  1/4904 (0.02%)  1/4881 (0.02%) 
Periprosthetic osteolysis * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Post lumbar puncture syndrome * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Post procedural complication * 1  1/10744 (0.01%)  4/4904 (0.08%)  4/4881 (0.08%) 
Post procedural fistula * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Post procedural hematoma * 1  0/10744 (0.00%)  4/4904 (0.08%)  4/4881 (0.08%) 
Post procedural hemorrhage * 1  2/10744 (0.02%)  5/4904 (0.10%)  2/4881 (0.04%) 
Post procedural myocardial infarction * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Post procedural stroke * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Post procedural swelling * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Postmastectomy lymphedema syndrome * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Postoperative adhesion * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Postoperative hernia * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Postoperative thoracic procedure complication * 1  2/10744 (0.02%)  3/4904 (0.06%)  3/4881 (0.06%) 
Postoperative thrombosis * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Postoperative wound complication * 1  1/10744 (0.01%)  1/4904 (0.02%)  0/4881 (0.00%) 
Postpericardiotomy syndrome * 1  0/10744 (0.00%)  0/4904 (0.00%)  2/4881 (0.04%) 
Procedural complication * 1  0/10744 (0.00%)  0/4904 (0.00%)  2/4881 (0.04%) 
Procedural hypotension * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Radius fracture * 1  0/10744 (0.00%)  0/4904 (0.00%)  3/4881 (0.06%) 
Rib fracture * 1  0/10744 (0.00%)  2/4904 (0.04%)  3/4881 (0.06%) 
Seroma * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Skin laceration * 1  0/10744 (0.00%)  2/4904 (0.04%)  2/4881 (0.04%) 
Skull fractured base * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Soft tissue injury * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Spinal compression fracture * 1  0/10744 (0.00%)  3/4904 (0.06%)  0/4881 (0.00%) 
Spinal fracture * 1  0/10744 (0.00%)  1/4904 (0.02%)  1/4881 (0.02%) 
Stent occlusion * 1  0/10744 (0.00%)  3/4904 (0.06%)  3/4881 (0.06%) 
Sternal fracture * 1  0/10744 (0.00%)  2/4904 (0.04%)  0/4881 (0.00%) 
Subcutaneous hematoma * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Subdural hematoma * 1  0/10744 (0.00%)  4/4904 (0.08%)  3/4881 (0.06%) 
Tendon injury * 1  0/10744 (0.00%)  1/4904 (0.02%)  1/4881 (0.02%) 
Tendon rupture * 1  0/10744 (0.00%)  2/4904 (0.04%)  10/4881 (0.20%) 
Therapeutic agent toxicity * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Thoracic vertebral fracture * 1  0/10744 (0.00%)  1/4904 (0.02%)  1/4881 (0.02%) 
Thrombosis in device * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Tibia fracture * 1  0/10744 (0.00%)  1/4904 (0.02%)  2/4881 (0.04%) 
Tongue injury * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Traumatic amputation * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Traumatic brain injury * 1  0/10744 (0.00%)  5/4904 (0.10%)  2/4881 (0.04%) 
Traumatic fracture * 1  4/10744 (0.04%)  13/4904 (0.27%)  18/4881 (0.37%) 
Traumatic hematoma * 1  0/10744 (0.00%)  3/4904 (0.06%)  1/4881 (0.02%) 
Traumatic lung injury * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Traumatic shock * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Traumatic ulcer * 1  1/10744 (0.01%)  0/4904 (0.00%)  1/4881 (0.02%) 
Upper limb fracture * 1  0/10744 (0.00%)  1/4904 (0.02%)  3/4881 (0.06%) 
Ureteric anastomosis complication * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Urinary retention postoperative * 1  0/10744 (0.00%)  1/4904 (0.02%)  1/4881 (0.02%) 
Vaccination complication * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Vascular graft complication * 1  1/10744 (0.01%)  6/4904 (0.12%)  5/4881 (0.10%) 
Vascular graft occlusion * 1  1/10744 (0.01%)  5/4904 (0.10%)  3/4881 (0.06%) 
Vascular pseudoaneurysm * 1  0/10744 (0.00%)  3/4904 (0.06%)  0/4881 (0.00%) 
Wound * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Wound dehiscence * 1  0/10744 (0.00%)  1/4904 (0.02%)  1/4881 (0.02%) 
Wound evisceration * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Wound hemorrhage * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Wound necrosis * 1  0/10744 (0.00%)  3/4904 (0.06%)  2/4881 (0.04%) 
Wrist fracture * 1  0/10744 (0.00%)  1/4904 (0.02%)  1/4881 (0.02%) 
Investigations       
Angiogram * 1  0/10744 (0.00%)  0/4904 (0.00%)  2/4881 (0.04%) 
Anticoagulation drug level above therapeutic * 1  0/10744 (0.00%)  1/4904 (0.02%)  1/4881 (0.02%) 
Arteriogram coronary * 1  0/10744 (0.00%)  2/4904 (0.04%)  1/4881 (0.02%) 
Arteriogram renal * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Blood creatinine increased * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Blood glucose increased * 1  0/10744 (0.00%)  1/4904 (0.02%)  1/4881 (0.02%) 
Blood iron decreased * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Blood potassium decreased * 1  0/10744 (0.00%)  1/4904 (0.02%)  1/4881 (0.02%) 
Body temperature increased * 1  1/10744 (0.01%)  0/4904 (0.00%)  0/4881 (0.00%) 
Cardiac stress test abnormal * 1  0/10744 (0.00%)  2/4904 (0.04%)  1/4881 (0.02%) 
Catheterization cardiac * 1  0/10744 (0.00%)  3/4904 (0.06%)  0/4881 (0.00%) 
Coagulation time prolonged * 1  0/10744 (0.00%)  1/4904 (0.02%)  5/4881 (0.10%) 
Colonoscopy * 1  0/10744 (0.00%)  1/4904 (0.02%)  1/4881 (0.02%) 
Diagnostic procedure * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Ejection fraction decreased * 1  0/10744 (0.00%)  1/4904 (0.02%)  1/4881 (0.02%) 
Hemoglobin decreased * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Heart rate irregular * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Hepatic enzyme increased * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
International normalized ratio increased * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Investigation * 1  0/10744 (0.00%)  2/4904 (0.04%)  1/4881 (0.02%) 
Laboratory test abnormal * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Medical observation * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Platelet count decreased * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Renal function test abnormal * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Scan myocardial perfusion abnormal * 1  0/10744 (0.00%)  1/4904 (0.02%)  1/4881 (0.02%) 
Urine output decreased * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Weight decreased * 1  0/10744 (0.00%)  1/4904 (0.02%)  1/4881 (0.02%) 
Weight increased * 1  0/10744 (0.00%)  4/4904 (0.08%)  2/4881 (0.04%) 
X-ray abnormal * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Metabolism and nutrition disorders       
Dehydration * 1  1/10744 (0.01%)  5/4904 (0.10%)  5/4881 (0.10%) 
Diabetes mellitus * 1  3/10744 (0.03%)  30/4904 (0.61%)  28/4881 (0.57%) 
Diabetes mellitus inadequate control * 1  4/10744 (0.04%)  67/4904 (1.37%)  50/4881 (1.02%) 
Diabetes with hyperosmolarity * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Diabetic foot * 1  3/10744 (0.03%)  17/4904 (0.35%)  15/4881 (0.31%) 
Diabetic ketoacidosis * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Glucose tolerance impaired * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Gout * 1  0/10744 (0.00%)  3/4904 (0.06%)  2/4881 (0.04%) 
Hyperglycemia * 1  0/10744 (0.00%)  6/4904 (0.12%)  13/4881 (0.27%) 
Hyperkalemia * 1  3/10744 (0.03%)  6/4904 (0.12%)  5/4881 (0.10%) 
Hyperphagia * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Hypertriglyceridemia * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Hypocalcemia * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Hypoglycemia * 1  1/10744 (0.01%)  17/4904 (0.35%)  15/4881 (0.31%) 
Hypokalemia * 1  1/10744 (0.01%)  2/4904 (0.04%)  1/4881 (0.02%) 
Hyponatremia * 1  1/10744 (0.01%)  0/4904 (0.00%)  1/4881 (0.02%) 
Hypovolemia * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Insulin-requiring type 2 diabetes mellitus * 1  0/10744 (0.00%)  0/4904 (0.00%)  2/4881 (0.04%) 
Lactic acidosis * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Metabolic acidosis * 1  0/10744 (0.00%)  1/4904 (0.02%)  1/4881 (0.02%) 
Metabolic disorder * 1  0/10744 (0.00%)  2/4904 (0.04%)  0/4881 (0.00%) 
Neuroglycopenia * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Obesity * 1  0/10744 (0.00%)  4/4904 (0.08%)  5/4881 (0.10%) 
Type 2 diabetes mellitus * 1  0/10744 (0.00%)  4/4904 (0.08%)  2/4881 (0.04%) 
Weight loss poor * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Cervical spinal stenosis * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Facet joint syndrome * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Fibromyalgia * 1  1/10744 (0.01%)  0/4904 (0.00%)  1/4881 (0.02%) 
Musculoskeletal and connective tissue disorders       
Arthralgia * 1  0/10744 (0.00%)  2/4904 (0.04%)  3/4881 (0.06%) 
Arthritis * 1  0/10744 (0.00%)  7/4904 (0.14%)  10/4881 (0.20%) 
Arthrofibrosis * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Arthropathy * 1  0/10744 (0.00%)  3/4904 (0.06%)  1/4881 (0.02%) 
Back pain * 1  0/10744 (0.00%)  9/4904 (0.18%)  13/4881 (0.27%) 
Bone pain * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Bunion * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Bursitis * 1  0/10744 (0.00%)  4/4904 (0.08%)  3/4881 (0.06%) 
Chondrocalcinosis * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Chondrocalcinosis pyrophosphate * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Chrondopathy * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Costochondritis * 1  1/10744 (0.01%)  1/4904 (0.02%)  1/4881 (0.02%) 
Dupuytren's contracture * 1  0/10744 (0.00%)  2/4904 (0.04%)  2/4881 (0.04%) 
Exostosis * 1  1/10744 (0.01%)  1/4904 (0.02%)  2/4881 (0.04%) 
Foot deformity * 1  1/10744 (0.01%)  5/4904 (0.10%)  6/4881 (0.12%) 
Gouty arthritis * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Gouty tophus * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Hand deformity * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Intervertebral disc degeneration * 1  0/10744 (0.00%)  1/4904 (0.02%)  1/4881 (0.02%) 
Intervertebral disc disorder * 1  1/10744 (0.01%)  2/4904 (0.04%)  2/4881 (0.04%) 
Intervertebral disc protrusion * 1  2/10744 (0.02%)  15/4904 (0.31%)  15/4881 (0.31%) 
Intervertebral disc space narrowing * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Joint contracture * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Joint effusion * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Joint swelling * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Knee deformity * 1  0/10744 (0.00%)  1/4904 (0.02%)  1/4881 (0.02%) 
Ligament disorder * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Lumbar spinal stenosis * 1  0/10744 (0.00%)  9/4904 (0.18%)  12/4881 (0.25%) 
Metatarsalgia * 1  0/10744 (0.00%)  2/4904 (0.04%)  0/4881 (0.00%) 
Mobility decreased * 1  0/10744 (0.00%)  1/4904 (0.02%)  1/4881 (0.02%) 
Monarthritis * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Muscle hemorrhage * 1  0/10744 (0.00%)  1/4904 (0.02%)  1/4881 (0.02%) 
Muscular weakness * 1  0/10744 (0.00%)  2/4904 (0.04%)  0/4881 (0.00%) 
Musculoskeletal chest pain * 1  3/10744 (0.03%)  6/4904 (0.12%)  14/4881 (0.29%) 
Musculoskeletal discomfort * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Musculoskeletal pain * 1  1/10744 (0.01%)  8/4904 (0.16%)  11/4881 (0.23%) 
Myalgia * 1  0/10744 (0.00%)  3/4904 (0.06%)  3/4881 (0.06%) 
Myalgia intercostal * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Myositis * 1  0/10744 (0.00%)  1/4904 (0.02%)  1/4881 (0.02%) 
Neck pain * 1  0/10744 (0.00%)  0/4904 (0.00%)  2/4881 (0.04%) 
Neuropathic arthropathy * 1  1/10744 (0.01%)  3/4904 (0.06%)  1/4881 (0.02%) 
Osteitis * 1  0/10744 (0.00%)  2/4904 (0.04%)  1/4881 (0.02%) 
Osteoarthritis * 1  9/10744 (0.08%)  107/4904 (2.18%)  88/4881 (1.80%) 
Osteochondrosis * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Osteonecrosis * 1  0/10744 (0.00%)  4/4904 (0.08%)  0/4881 (0.00%) 
Osteoporosis * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Osteoporotic fracture * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Pain in extremity * 1  0/10744 (0.00%)  6/4904 (0.12%)  1/4881 (0.02%) 
Pain in jaw * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Patellofemoral pain syndrome * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Pathological fracture * 1  0/10744 (0.00%)  2/4904 (0.04%)  1/4881 (0.02%) 
Periarthritis * 1  0/10744 (0.00%)  1/4904 (0.02%)  1/4881 (0.02%) 
Polyarthritis * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Polymyalgia rheumatica * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Pseudarthrosis * 1  0/10744 (0.00%)  1/4904 (0.02%)  2/4881 (0.04%) 
Psoriatic arthropathy * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Rhabdomyolysis * 1  1/10744 (0.01%)  0/4904 (0.00%)  1/4881 (0.02%) 
Rheumatoid arthritis * 1  0/10744 (0.00%)  5/4904 (0.10%)  1/4881 (0.02%) 
Rotator cuff syndrome * 1  0/10744 (0.00%)  8/4904 (0.16%)  8/4881 (0.16%) 
Scleroderma * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Senile ankylosing vertebral hyperostosis * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Spinal column stenosis * 1  0/10744 (0.00%)  6/4904 (0.12%)  6/4881 (0.12%) 
Spinal disorder * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Spinal osteoarthritis * 1  1/10744 (0.01%)  6/4904 (0.12%)  12/4881 (0.25%) 
Spondylolisthesis * 1  0/10744 (0.00%)  0/4904 (0.00%)  3/4881 (0.06%) 
Synovial cyst * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Synovitis * 1  0/10744 (0.00%)  1/4904 (0.02%)  2/4881 (0.04%) 
Tendinous contracture * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Tendon calcification * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Tendonitis * 1  0/10744 (0.00%)  2/4904 (0.04%)  0/4881 (0.00%) 
Tenosynovitis stenosans * 1  0/10744 (0.00%)  1/4904 (0.02%)  1/4881 (0.02%) 
Trigger finger * 1  1/10744 (0.01%)  2/4904 (0.04%)  0/4881 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Acoustic neuroma * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Acute lymphocytic leukemia * 1  0/10744 (0.00%)  0/4904 (0.00%)  2/4881 (0.04%) 
Acute myeloid leukemia * 1  0/10744 (0.00%)  0/4904 (0.00%)  2/4881 (0.04%) 
Adenocarcinoma pancreas * 1  0/10744 (0.00%)  1/4904 (0.02%)  1/4881 (0.02%) 
Adrenal adenoma * 1  0/10744 (0.00%)  0/4904 (0.00%)  4/4881 (0.08%) 
Anal cancer * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Astrocytoma malignant * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
B-cell lymphoma * 1  0/10744 (0.00%)  3/4904 (0.06%)  0/4881 (0.00%) 
Basal cell carcinoma * 1  0/10744 (0.00%)  2/4904 (0.04%)  4/4881 (0.08%) 
Basosquamous carcinoma * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Benign anorectal neoplasm * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Benign breast neoplasm * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Benign colonic neoplasm * 1  0/10744 (0.00%)  0/4904 (0.00%)  2/4881 (0.04%) 
Benign lung neoplasm * 1  1/10744 (0.01%)  2/4904 (0.04%)  0/4881 (0.00%) 
Benign neoplasm of bladder * 1  0/10744 (0.00%)  3/4904 (0.06%)  1/4881 (0.02%) 
Benign renal neoplasm * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Benign salivary gland neoplasm * 1  0/10744 (0.00%)  0/4904 (0.00%)  2/4881 (0.04%) 
Bile duct cancer * 1  0/10744 (0.00%)  0/4904 (0.00%)  4/4881 (0.08%) 
Bladder adenocarcinoma stage unspecified * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Bladder cancer * 1  1/10744 (0.01%)  7/4904 (0.14%)  6/4881 (0.12%) 
Bladder cancer recurrent * 1  0/10744 (0.00%)  1/4904 (0.02%)  2/4881 (0.04%) 
Bladder cancer stage 0, with cancer in situ * 1  1/10744 (0.01%)  0/4904 (0.00%)  1/4881 (0.02%) 
Bladder cancer stage II * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Bladder cancer stage III * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Bladder neoplasm * 1  1/10744 (0.01%)  1/4904 (0.02%)  2/4881 (0.04%) 
Bladder papilloma * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Bladder transitional cell carcinoma * 1  1/10744 (0.01%)  12/4904 (0.24%)  4/4881 (0.08%) 
Bladder transitional cell carcinoma recurrent * 1  1/10744 (0.01%)  5/4904 (0.10%)  2/4881 (0.04%) 
Bladder transitional cell carcinoma stage II * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Bladder transitional cell carcinoma stage IV * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Bowen's disease * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Breast cancer * 1  0/10744 (0.00%)  20/4904 (0.41%)  15/4881 (0.31%) 
Breast cancer metastatic * 1  0/10744 (0.00%)  5/4904 (0.10%)  2/4881 (0.04%) 
Breast cancer recurrent * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Breast cancer stage I * 1  0/10744 (0.00%)  1/4904 (0.02%)  1/4881 (0.02%) 
Breast cancer stage II * 1  0/10744 (0.00%)  1/4904 (0.02%)  2/4881 (0.04%) 
Breast cancer stage III * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Breast cancer stage IV * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Breast fibroma * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Bronchial carcinoma * 1  0/10744 (0.00%)  4/4904 (0.08%)  0/4881 (0.00%) 
Bronchioalveolar carcinoma * 1  1/10744 (0.01%)  0/4904 (0.00%)  0/4881 (0.00%) 
Cervix carcinoma * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Chloroma * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Cholesteatoma * 1  1/10744 (0.01%)  2/4904 (0.04%)  0/4881 (0.00%) 
Chronic lymphocytic leukemia * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Colon adenoma * 1  0/10744 (0.00%)  3/4904 (0.06%)  2/4881 (0.04%) 
Colon cancer * 1  0/10744 (0.00%)  11/4904 (0.22%)  10/4881 (0.20%) 
Colon cancer metastatic * 1  0/10744 (0.00%)  4/4904 (0.08%)  4/4881 (0.08%) 
Colon cancer stage 0 * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Colon cancer stage III * 1  0/10744 (0.00%)  2/4904 (0.04%)  0/4881 (0.00%) 
Colorectal cancer * 1  0/10744 (0.00%)  2/4904 (0.04%)  0/4881 (0.00%) 
Colorectal cancer metastatic * 1  0/10744 (0.00%)  2/4904 (0.04%)  0/4881 (0.00%) 
Diffuse large B-cell lymphoma * 1  0/10744 (0.00%)  2/4904 (0.04%)  0/4881 (0.00%) 
Endometrial cancer * 1  0/10744 (0.00%)  2/4904 (0.04%)  2/4881 (0.04%) 
Endometrial cancer metastatic * 1  0/10744 (0.00%)  0/4904 (0.00%)  2/4881 (0.04%) 
Endometrial cancer stage I * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Follicle center lymphoma, follicular grade I, II, III * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Gallbladder cancer metastatic * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Gammopathy * 1  0/10744 (0.00%)  0/4904 (0.00%)  2/4881 (0.04%) 
Gastric cancer * 1  1/10744 (0.01%)  6/4904 (0.12%)  3/4881 (0.06%) 
Gastrointestinal carcinoma * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Glioblastoma * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Glioblastoma multiforme * 1  0/10744 (0.00%)  1/4904 (0.02%)  1/4881 (0.02%) 
Head and neck cancer * 1  0/10744 (0.00%)  1/4904 (0.02%)  1/4881 (0.02%) 
Hepatic cancer metastatic * 1  0/10744 (0.00%)  0/4904 (0.00%)  2/4881 (0.04%) 
Hepatic neoplasm * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Hepatic neoplasm malignant * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Hodgkin's disease * 1  0/10744 (0.00%)  1/4904 (0.02%)  1/4881 (0.02%) 
Intraductal papilloma of breast * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Laryngeal cancer * 1  0/10744 (0.00%)  3/4904 (0.06%)  3/4881 (0.06%) 
Leiomyoma * 1  0/10744 (0.00%)  0/4904 (0.00%)  2/4881 (0.04%) 
Leiomyosarcoma metastatic * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Lentigo maligna stage unspecified * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Lip and/or oral cavity cancer * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Lip neoplasm malignant stage unspecified * 1  0/10744 (0.00%)  0/4904 (0.00%)  2/4881 (0.04%) 
Lipoma * 1  0/10744 (0.00%)  2/4904 (0.04%)  2/4881 (0.04%) 
Lung adenocarcinoma * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Lung adenocarcinoma metastatic * 1  0/10744 (0.00%)  1/4904 (0.02%)  1/4881 (0.02%) 
Lung adenocarcinoma stage II * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Lung cancer metastatic * 1  2/10744 (0.02%)  9/4904 (0.18%)  4/4881 (0.08%) 
Lung neoplasm * 1  0/10744 (0.00%)  3/4904 (0.06%)  1/4881 (0.02%) 
Lung neoplasm malignant * 1  2/10744 (0.02%)  5/4904 (0.10%)  8/4881 (0.16%) 
Lung squamous cell carcinoma stage unspecified * 1  0/10744 (0.00%)  2/4904 (0.04%)  1/4881 (0.02%) 
Lymphoma * 1  1/10744 (0.01%)  0/4904 (0.00%)  0/4881 (0.00%) 
Malignant melanoma * 1  1/10744 (0.01%)  4/4904 (0.08%)  4/4881 (0.08%) 
Malignant neoplasm of renal pelvis * 1  0/10744 (0.00%)  1/4904 (0.02%)  1/4881 (0.02%) 
Malignant neoplasm of uterine adnexa * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Malignant peritoneal neoplasm * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Malignant pleural effusion * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Meningioma * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Meningioma benign * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Mesothelioma malignant * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Metastases to bladder * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Metastases to bone marrow * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Metastases to liver * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Metastasis * 1  0/10744 (0.00%)  0/4904 (0.00%)  1/4881 (0.02%) 
Metastatic bronchial carcinoma * 1  1/10744 (0.01%)  4/4904 (0.08%)  1/4881 (0.02%) 
Metastatic carcinoma of the bladder * 1  0/10744 (0.00%)  3/4904 (0.06%)  1/4881 (0.02%) 
Metastatic gastric cancer * 1  0/10744 (0.00%)  0/4904 (0.00%)  2/4881 (0.04%) 
Metastatic malignant melanoma * 1  0/10744 (0.00%)  1/4904 (0.02%)  1/4881 (0.02%) 
Metastatic neoplasm * 1  0/10744 (0.00%)  3/4904 (0.06%)  6/4881 (0.12%) 
Metastatic renal cell carcinoma * 1  0/10744 (0.00%)  0/4904 (0.00%)  3/4881 (0.06%) 
Metastatic uterine cancer * 1  0/10744 (0.00%)  2/4904 (0.04%)  0/4881 (0.00%) 
Multiple myeloma * 1  0/10744 (0.00%)  6/4904 (0.12%)  2/4881 (0.04%) 
Mycosis fungoides * 1  1/10744 (0.01%)  0/4904 (0.00%)  0/4881 (0.00%) 
Myelodysplastic syndrome * 1  1/10744 (0.01%)  1/4904 (0.02%)  1/4881 (0.02%) 
Neoplasm malignant * 1  0/10744 (0.00%)  1/4904 (0.02%)  0/4881 (0.00%) 
Neoplasm of appendix * 1