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Study Of Diabetic Nephropathy With Atrasentan (SONAR)

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ClinicalTrials.gov Identifier: NCT01858532
Recruitment Status : Terminated (Strategic considerations)
First Posted : May 21, 2013
Results First Posted : April 24, 2019
Last Update Posted : April 24, 2019
Sponsor:
Information provided by (Responsible Party):
AbbVie

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Diabetic Nephropathy
Interventions Drug: Atrasentan
Drug: Placebo
Enrollment 5107
Recruitment Details  
Pre-assignment Details 5107 participants dosed in Enrichment Period (EP); 1441 prematurely discontinued Tx or did not proceed to Double-Blind Treatment Period per criteria. 3666 participants completed EP and proceeded to Double-Blind Treatment Period, along with 2 additional participants who discontinued study drug in EP but were randomized in error.
Arm/Group Title Intent-to-Treat (ITT) Responder Atrasentan Intent-to-Treat (ITT) Responder Placebo Intent-to-Treat (ITT) Non-responder Atrasentan Intent-to-Treat (ITT) Non-responder Placebo
Hide Arm/Group Description Participants who achieved at least 30% reduction in their albumin to creatinine ratio (UACR) in the Enrichment Period and were randomized to receive atrasentan in the Double-Blind Treatment Period Participants who achieved at least 30% reduction in their albumin to creatinine ratio (UACR) in the Enrichment Period and were randomized to receive placebo in the Double-Blind Treatment Period Participants who achieved < 30% reduction in their urinary albumin to creatinine ratio (UACR) in the Enrichment Period and were randomized to receive atrasentan in the Double-Blind Treatment Period Participants who achieved < 30% reduction in their urinary albumin to creatinine ratio (UACR) in the Enrichment Period and were randomized to receive placebo in the Double-Blind Treatment Period
Period Title: Overall Study
Started 1325 1323 509 511
Completed 1144 1131 411 418
Not Completed 181 192 98 93
Reason Not Completed
Adverse Event             58             50             23             28
Withdrew consent             71             93             46             27
Lost to Follow-up             17             26             11             14
Deterioration of medical status             3             4             3             7
Investigator request             3             4             2             6
Other, not specified             29             15             13             11
Arm/Group Title Intent-to-Treat (ITT) Responder Atrasentan Intent-to-Treat (ITT) Responder Placebo Intent-to-Treat (ITT) Non-responder Atrasentan Intent-to-Treat (ITT) Non-responder Placebo Total
Hide Arm/Group Description Participants who achieved at least 30% reduction in their albumin to creatinine ratio (UACR) in the Enrichment Period and were randomized to receive atrasentan in the Double-Blind Treatment Period Participants who achieved at least 30% reduction in their albumin to creatinine ratio (UACR) in the Enrichment Period and were randomized to receive placebo in the Double-Blind Treatment Period Participants who achieved < 30% reduction in their urinary albumin to creatinine ratio (UACR) in the Enrichment Period and were randomized to receive atrasentan in the Double-Blind Treatment Period Participants who achieved < 30% reduction in their urinary albumin to creatinine ratio (UACR) in the Enrichment Period and were randomized to receive placebo in the Double-Blind Treatment Period Total of all reporting groups
Overall Number of Baseline Participants 1325 1323 509 511 3668
Hide Baseline Analysis Population Description
Intent-to-Treat (ITT) Responders (participants who achieved at least 30% reduction in their albumin to creatinine ratio [UACR] in the Enrichment Period [EP]) and ITT Non-responders (Participants who achieved < 30% reduction in their UACR in the EP)
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1325 participants 1323 participants 509 participants 511 participants 3668 participants
64.9  (8.64) 64.7  (8.66) 63.8  (9.12) 63.6  (8.93) 64.5  (8.77)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1325 participants 1323 participants 509 participants 511 participants 3668 participants
Female 331 352 127 136 946
Male 994 971 382 375 2722
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1325 participants 1323 participants 509 participants 511 participants 3668 participants
American Indian or Alaska Native 30 29 7 10 76
Asian 446 455 143 154 1198
Native Hawaiian or Other Pacific Islander 9 9 7 3 28
Black or African American 73 76 36 39 224
White 753 744 313 300 2110
More than one race 14 10 3 5 32
Unknown or Not Reported 0 0 0 0 0
1.Primary Outcome
Title Time to the First Occurrence of a Component of the Composite Renal Endpoint in the Intent-to-Treat (ITT) Responder Set (as Randomized)
Hide Description Time to the first occurrence of a component of the composite renal endpoint was defined as doubling of serum creatinine (confirmed by a 30-day serum creatinine measurement) or the onset of end stage renal disease (estimated glomerular filtration rate [eGFR] less than 15 ml/min/1.73 m^2 confirmed by a 90-day eGFR measurement, receiving chronic dialysis, renal transplantation, or renal death). Only events adjudicated by the Events Adjudication Committee (EAC) were considered in defining this endpoint. Data are presented as number of participants with a primary renal composite event (first event per participant).
Time Frame From randomization to individual end of observation, up to 53 months
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) Responders (participants who achieved at least 30% reduction in their albumin to creatinine ratio [UACR] in the Enrichment Period [EP])
Arm/Group Title Intent-to-Treat (ITT) Responder Atrasentan Intent-to-Treat (ITT) Responder Placebo
Hide Arm/Group Description:
Participants who achieved at least 30% reduction in their albumin to creatinine ratio (UACR) in the Enrichment Period and were randomized to receive atrasentan in the Double-Blind Treatment Period
Participants who achieved at least 30% reduction in their albumin to creatinine ratio (UACR) in the Enrichment Period and were randomized to receive placebo in the Double-Blind Treatment Period
Overall Number of Participants Analyzed 1325 1323
Measure Type: Count of Participants
Unit of Measure: Participants
79
   6.0%
105
   7.9%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intent-to-Treat (ITT) Responder Atrasentan, Intent-to-Treat (ITT) Responder Placebo
Comments The endpoint was analyzed using the stratified log-rank test for treatment comparison.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.029
Comments [Not Specified]
Method Stratified log-rank test
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Intent-to-Treat (ITT) Responder Atrasentan, Intent-to-Treat (ITT) Responder Placebo
Comments A Cox Proportional Hazards regression model with pre-specified covariates adjusted was used to estimate the hazard ratio of atrasentan to placebo and its 95% confidence interval.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.005
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.654
Confidence Interval (2-Sided) 95%
0.488 to 0.878
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Time to a 50% Estimated Glomerular Filtration Rate Reduction in the Intent-to-Treat (ITT) Responder Set (as Randomized)
Hide Description The event of interest for this outcome was a 50% reduction in a participant's estimated glomerular filtration rate (eGFR) value as compared to baseline, confirmed by a repeated value at least 20 days apart. The event time was defined as the first time that a 50% reduction in eGFR was observed. Data are presented as number of participants with a 50% reduction in eGFR (first event per participant).
Time Frame From randomization to individual end of observation, up to 53 months
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) Responders (participants who achieved at least 30% reduction in their albumin to creatinine ratio [UACR] in the Enrichment Period [EP])
Arm/Group Title Intent-to-Treat (ITT) Responder Atrasentan Intent-to-Treat (ITT) Responder Placebo
Hide Arm/Group Description:
Participants who achieved at least 30% reduction in their albumin to creatinine ratio (UACR) in the Enrichment Period and were randomized to receive atrasentan in the Double-Blind Treatment Period
Participants who achieved at least 30% reduction in their albumin to creatinine ratio (UACR) in the Enrichment Period and were randomized to receive placebo in the Double-Blind Treatment Period
Overall Number of Participants Analyzed 1325 1323
Measure Type: Count of Participants
Unit of Measure: Participants
78
   5.9%
88
   6.7%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intent-to-Treat (ITT) Responder Atrasentan, Intent-to-Treat (ITT) Responder Placebo
Comments The endpoint was analyzed using the stratified log-rank test for treatment comparison.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.289
Comments [Not Specified]
Method Stratified log-rank test
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Intent-to-Treat (ITT) Responder Atrasentan, Intent-to-Treat (ITT) Responder Placebo
Comments A Cox Proportional Hazards regression model with pre-specified covariates adjusted was used to estimate the hazard ratio of atrasentan to placebo and its 95% confidence interval.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.112
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.779
Confidence Interval (2-Sided) 95%
0.573 to 1.060
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Time to Cardio-renal Composite Endpoint in the Intent-to-Treat (ITT) Responder Set (as Randomized)
Hide Description The composite event of interest for this outcome consisted of doubling of serum creatinine, end-stage renal disease (ESRD), cardiovascular (CV) death (including CV death and presumed CV death), nonfatal myocardial infarction (MI; heart attack) and nonfatal stroke. Presumed sudden cardiac death was included as a subcategory of presumed CV death. Only events adjudicated by the Events Adjudication Committee (EAC) were considered in defining this endpoint. Data are presented as number of participants with a cardio-renal composite event (first event per participant).
Time Frame From randomization to individual end of observation, up to 53 months
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) Responders (participants who achieved at least 30% reduction in their albumin to creatinine ratio [UACR] in the Enrichment Period [EP])
Arm/Group Title Intent-to-Treat (ITT) Responder Atrasentan Intent-to-Treat (ITT) Responder Placebo
Hide Arm/Group Description:
Participants who achieved at least 30% reduction in their albumin to creatinine ratio (UACR) in the Enrichment Period and were randomized to receive atrasentan in the Double-Blind Treatment Period
Participants who achieved at least 30% reduction in their albumin to creatinine ratio (UACR) in the Enrichment Period and were randomized to receive placebo in the Double-Blind Treatment Period
Overall Number of Participants Analyzed 1325 1323
Measure Type: Count of Participants
Unit of Measure: Participants
147
  11.1%
172
  13.0%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intent-to-Treat (ITT) Responder Atrasentan, Intent-to-Treat (ITT) Responder Placebo
Comments The endpoint was analyzed using the stratified log-rank test for treatment comparison.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.089
Comments [Not Specified]
Method Stratified log-rank test
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Intent-to-Treat (ITT) Responder Atrasentan, Intent-to-Treat (ITT) Responder Placebo
Comments A Cox Proportional Hazards regression model with pre-specified covariates adjusted was used to estimate the hazard ratio of atrasentan to placebo and its 95% confidence interval.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.049
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.801
Confidence Interval (2-Sided) 95%
0.642 to 0.999
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Time to First Occurrence of a Component of Composite Renal Endpoint for All Randomized Participants (Pooled)
Hide Description Time to the first occurrence of a component of the composite renal endpoint was defined as doubling of serum creatinine (confirmed by a 30-day serum creatinine measurement) or the onset of end stage renal disease (estimated glomerular filtration rate [eGFR] less than 15 ml/min/1.73 m^2 confirmed by a 90-day eGFR measurement, receiving chronic dialysis, renal transplantation, or renal death). Data for all randomized participants were pooled by treatment and analyzed. Data are presented as number of participants with a renal composite event (first event per participant).
Time Frame From randomization to individual end of observation, up to 53 months
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population: participants who were randomized to receive either atrasentan or placebo during the Double-Blind Treatment Period
Arm/Group Title Intent-to-Treat (ITT) Atrasentan Intent-to-Treat Placebo
Hide Arm/Group Description:
All randomized participants who entered the Double-Blind Treatment Period and were randomized to receive atrasentan
All randomized participants who entered the Double-Blind Treatment Period and were randomized to receive placebo
Overall Number of Participants Analyzed 1834 1834
Measure Type: Count of Participants
Unit of Measure: Participants
152
   8.3%
192
  10.5%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intent-to-Treat (ITT) Atrasentan, Intent-to-Treat Placebo
Comments A Cox Proportional Hazards regression model with pre-specified covariates adjusted was used to estimate the hazard ratio of atrasentan to placebo and its 95% confidence interval.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.72
Confidence Interval (2-Sided) 95%
0.58 to 0.89
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Time to the Cardiovascular Composite Endpoint in the Intent-to-Treat (ITT) Responder Set (as Randomized)
Hide Description The composite event of interest for this outcome was cardiovascular (CV) death (CV death, presumed CV death), nonfatal myocardial infarction (MI; heart attack), and nonfatal stroke. Presumed sudden cardiac death was included as a sub-category of presumed CV death. Only events adjudicated by the Events Adjudication Committee (EAC) were used. Data are presented as number of participants with a cardiovascular composite event (first event per participant).
Time Frame From randomization to individual end of observation, up to 53 months
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) Responders (participants who achieved at least 30% reduction in their albumin to creatinine ratio [UACR] in the Enrichment Period [EP])
Arm/Group Title Intent-to-Treat (ITT) Responder Atrasentan Intent-to-Treat (ITT) Responder Placebo
Hide Arm/Group Description:
Participants who achieved at least 30% reduction in their albumin to creatinine ratio (UACR) in the Enrichment Period and were randomized to receive atrasentan in the Double-Blind Treatment Period
Intent-to-Treat (ITT) Responder Placebo: Participants who achieved at least 30% reduction in their albumin to creatinine ratio (UACR) in the Enrichment Period and were randomized to receive placebo in the Double-Blind Treatment Period
Overall Number of Participants Analyzed 1325 1323
Measure Type: Count of Participants
Unit of Measure: Participants
72
   5.4%
81
   6.1%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intent-to-Treat (ITT) Responder Atrasentan, Intent-to-Treat (ITT) Responder Placebo
Comments The endpoint was analyzed using the stratified log-rank test for treatment comparison.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.446
Comments [Not Specified]
Method Stratified log-rank test
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Intent-to-Treat (ITT) Responder Atrasentan, Intent-to-Treat (ITT) Responder Placebo
Comments A Cox Proportional Hazards regression model with pre-specified covariates adjusted was used to estimate the hazard ratio of atrasentan to placebo and its 95% confidence interval.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.447
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.884
Confidence Interval (2-Sided) 95%
0.643 to 1.215
Estimation Comments [Not Specified]
Time Frame Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were reported from the time of study drug administration until 45 days after the last dose of study drug (up to 24 weeks for the All Atrasentan Set in the Enrichment Period; up to 54 months for the ITT sets in the Double-Blind Period)
Adverse Event Reporting Description TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 45 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
 
Arm/Group Title Enrichment Atrasentan Double-Blind Atrasentan Double-Blind Placebo
Hide Arm/Group Description Participants who received at least one dose of atrasentan, including both Enrichment and Double-Blind Treatment Periods All participants who received at least one dose of atrasentan during the Double-Blind Treatment Period All participants who received at least one dose of placebo during the Double-Blind Treatment Period
All-Cause Mortality
Enrichment Atrasentan Double-Blind Atrasentan Double-Blind Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   25/5107 (0.49%)      84/1829 (4.59%)      79/1830 (4.32%)    
Show Serious Adverse Events Hide Serious Adverse Events
Enrichment Atrasentan Double-Blind Atrasentan Double-Blind Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   292/5107 (5.72%)      685/1829 (37.45%)      626/1830 (34.21%)    
Blood and lymphatic system disorders       
ANAEMIA  1  7/5107 (0.14%)  7 27/1829 (1.48%)  28 11/1830 (0.60%)  15
ANAEMIA OF CHRONIC DISEASE  1  0/5107 (0.00%)  0 2/1829 (0.11%)  2 1/1830 (0.05%)  1
AUTOIMMUNE HAEMOLYTIC ANAEMIA  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 0/1830 (0.00%)  0
COAGULOPATHY  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 0/1830 (0.00%)  0
DISSEMINATED INTRAVASCULAR COAGULATION  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 1/1830 (0.05%)  1
HAEMORRHAGIC ANAEMIA  1  1/5107 (0.02%)  1 1/1829 (0.05%)  1 1/1830 (0.05%)  1
IRON DEFICIENCY ANAEMIA  1  1/5107 (0.02%)  1 4/1829 (0.22%)  4 2/1830 (0.11%)  2
LEUKOCYTOSIS  1  1/5107 (0.02%)  1 0/1829 (0.00%)  0 0/1830 (0.00%)  0
MICROCYTIC ANAEMIA  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 0/1830 (0.00%)  0
NEPHROGENIC ANAEMIA  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 0/1830 (0.00%)  0
NEUTROPENIA  1  0/5107 (0.00%)  0 0/1829 (0.00%)  0 1/1830 (0.05%)  1
PANCYTOPENIA  1  0/5107 (0.00%)  0 0/1829 (0.00%)  0 1/1830 (0.05%)  2
THROMBOCYTOPENIA  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 0/1830 (0.00%)  0
Cardiac disorders       
ACUTE CORONARY SYNDROME  1  1/5107 (0.02%)  1 5/1829 (0.27%)  5 2/1830 (0.11%)  2
ACUTE LEFT VENTRICULAR FAILURE  1  1/5107 (0.02%)  1 1/1829 (0.05%)  1 3/1830 (0.16%)  4
ACUTE MYOCARDIAL INFARCTION  1  7/5107 (0.14%)  7 34/1829 (1.86%)  40 28/1830 (1.53%)  29
ADAMS-STOKES SYNDROME  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 0/1830 (0.00%)  0
ANGINA PECTORIS  1  4/5107 (0.08%)  5 10/1829 (0.55%)  11 10/1830 (0.55%)  10
ANGINA UNSTABLE  1  4/5107 (0.08%)  4 7/1829 (0.38%)  7 3/1830 (0.16%)  3
AORTIC VALVE STENOSIS  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 0/1830 (0.00%)  0
ARRHYTHMIA  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 0/1830 (0.00%)  0
ARRHYTHMIA SUPRAVENTRICULAR  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 0/1830 (0.00%)  0
ARTERIOSCLEROSIS CORONARY ARTERY  1  0/5107 (0.00%)  0 2/1829 (0.11%)  2 0/1830 (0.00%)  0
ATRIAL FIBRILLATION  1  2/5107 (0.04%)  2 16/1829 (0.87%)  17 10/1830 (0.55%)  11
ATRIAL FLUTTER  1  2/5107 (0.04%)  2 5/1829 (0.27%)  5 2/1830 (0.11%)  2
ATRIAL TACHYCARDIA  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 0/1830 (0.00%)  0
ATRIOVENTRICULAR BLOCK  1  0/5107 (0.00%)  0 2/1829 (0.11%)  2 1/1830 (0.05%)  1
ATRIOVENTRICULAR BLOCK COMPLETE  1  1/5107 (0.02%)  1 7/1829 (0.38%)  7 2/1830 (0.11%)  2
ATRIOVENTRICULAR BLOCK FIRST DEGREE  1  0/5107 (0.00%)  0 0/1829 (0.00%)  0 1/1830 (0.05%)  1
ATRIOVENTRICULAR BLOCK SECOND DEGREE  1  1/5107 (0.02%)  1 1/1829 (0.05%)  1 1/1830 (0.05%)  1
BRADYARRHYTHMIA  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 0/1830 (0.00%)  0
BRADYCARDIA  1  3/5107 (0.06%)  3 4/1829 (0.22%)  5 2/1830 (0.11%)  2
BUNDLE BRANCH BLOCK BILATERAL  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 0/1830 (0.00%)  0
BUNDLE BRANCH BLOCK LEFT  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 0/1830 (0.00%)  0
BUNDLE BRANCH BLOCK RIGHT  1  0/5107 (0.00%)  0 0/1829 (0.00%)  0 2/1830 (0.11%)  2
CARDIAC ARREST  1  3/5107 (0.06%)  3 4/1829 (0.22%)  4 5/1830 (0.27%)  5
CARDIAC FAILURE  1  5/5107 (0.10%)  5 19/1829 (1.04%)  20 11/1830 (0.60%)  11
CARDIAC FAILURE ACUTE  1  4/5107 (0.08%)  4 5/1829 (0.27%)  6 4/1830 (0.22%)  5
CARDIAC FAILURE CHRONIC  1  3/5107 (0.06%)  3 5/1829 (0.27%)  5 2/1830 (0.11%)  2
CARDIAC FAILURE CONGESTIVE  1  22/5107 (0.43%)  22 37/1829 (2.02%)  41 22/1830 (1.20%)  23
CARDIO-RESPIRATORY ARREST  1  1/5107 (0.02%)  1 3/1829 (0.16%)  3 1/1830 (0.05%)  1
CARDIOGENIC SHOCK  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 1/1830 (0.05%)  1
CARDIOMYOPATHY  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 0/1830 (0.00%)  0
CARDIOPULMONARY FAILURE  1  0/5107 (0.00%)  0 0/1829 (0.00%)  0 1/1830 (0.05%)  1
CARDIORENAL SYNDROME  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 1/1830 (0.05%)  1
CARDIOVASCULAR DISORDER  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 0/1830 (0.00%)  0
CHRONIC LEFT VENTRICULAR FAILURE  1  0/5107 (0.00%)  0 0/1829 (0.00%)  0 1/1830 (0.05%)  1
CORONARY ARTERY DISEASE  1  6/5107 (0.12%)  6 29/1829 (1.59%)  31 19/1830 (1.04%)  20
CORONARY ARTERY OCCLUSION  1  0/5107 (0.00%)  0 2/1829 (0.11%)  2 3/1830 (0.16%)  3
CORONARY ARTERY STENOSIS  1  3/5107 (0.06%)  3 5/1829 (0.27%)  5 2/1830 (0.11%)  2
CORONARY ARTERY THROMBOSIS  1  0/5107 (0.00%)  0 0/1829 (0.00%)  0 1/1830 (0.05%)  1
CYANOSIS  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 0/1830 (0.00%)  0
DIASTOLIC DYSFUNCTION  1  1/5107 (0.02%)  1 1/1829 (0.05%)  1 0/1830 (0.00%)  0
HYPERTENSIVE CARDIOMYOPATHY  1  1/5107 (0.02%)  1 0/1829 (0.00%)  0 0/1830 (0.00%)  0
HYPERTENSIVE HEART DISEASE  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 0/1830 (0.00%)  0
ISCHAEMIC CARDIOMYOPATHY  1  0/5107 (0.00%)  0 0/1829 (0.00%)  0 1/1830 (0.05%)  1
LEFT VENTRICULAR FAILURE  1  3/5107 (0.06%)  3 4/1829 (0.22%)  4 1/1830 (0.05%)  1
MITRAL VALVE INCOMPETENCE  1  0/5107 (0.00%)  0 0/1829 (0.00%)  0 1/1830 (0.05%)  1
MYOCARDIAL INFARCTION  1  7/5107 (0.14%)  7 13/1829 (0.71%)  15 8/1830 (0.44%)  8
MYOCARDIAL ISCHAEMIA  1  1/5107 (0.02%)  1 9/1829 (0.49%)  11 4/1830 (0.22%)  4
PALPITATIONS  1  1/5107 (0.02%)  1 0/1829 (0.00%)  0 2/1830 (0.11%)  2
PERICARDIAL EFFUSION  1  0/5107 (0.00%)  0 4/1829 (0.22%)  4 1/1830 (0.05%)  1
SINOATRIAL BLOCK  1  1/5107 (0.02%)  1 0/1829 (0.00%)  0 1/1830 (0.05%)  1
SINUS ARREST  1  0/5107 (0.00%)  0 2/1829 (0.11%)  2 0/1830 (0.00%)  0
SINUS NODE DYSFUNCTION  1  1/5107 (0.02%)  1 2/1829 (0.11%)  2 2/1830 (0.11%)  2
SUPRAVENTRICULAR TACHYCARDIA  1  2/5107 (0.04%)  2 1/1829 (0.05%)  1 1/1830 (0.05%)  1
TACHYCARDIA  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 2/1830 (0.11%)  2
VENTRICULAR EXTRASYSTOLES  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 0/1830 (0.00%)  0
VENTRICULAR FIBRILLATION  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 0/1830 (0.00%)  0
VENTRICULAR TACHYCARDIA  1  0/5107 (0.00%)  0 2/1829 (0.11%)  2 0/1830 (0.00%)  0
Congenital, familial and genetic disorders       
GLUCOSE-6-PHOSPHATE DEHYDROGENASE DEFICIENCY  1  0/5107 (0.00%)  0 0/1829 (0.00%)  0 1/1830 (0.05%)  1
Ear and labyrinth disorders       
MENIERE'S DISEASE  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 0/1830 (0.00%)  0
VERTIGO  1  1/5107 (0.02%)  1 0/1829 (0.00%)  0 7/1830 (0.38%)  7
VERTIGO POSITIONAL  1  0/5107 (0.00%)  0 2/1829 (0.11%)  2 0/1830 (0.00%)  0
Endocrine disorders       
GOITRE  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 1/1830 (0.05%)  1
HYPERPARATHYROIDISM PRIMARY  1  0/5107 (0.00%)  0 0/1829 (0.00%)  0 1/1830 (0.05%)  1
Eye disorders       
AGE-RELATED MACULAR DEGENERATION  1  0/5107 (0.00%)  0 0/1829 (0.00%)  0 1/1830 (0.05%)  1
ANGLE CLOSURE GLAUCOMA  1  0/5107 (0.00%)  0 0/1829 (0.00%)  0 1/1830 (0.05%)  1
BLINDNESS TRANSIENT  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 0/1830 (0.00%)  0
CATARACT  1  3/5107 (0.06%)  3 19/1829 (1.04%)  19 10/1830 (0.55%)  12
CATARACT DIABETIC  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 0/1830 (0.00%)  0
CATARACT NUCLEAR  1  0/5107 (0.00%)  0 2/1829 (0.11%)  2 0/1830 (0.00%)  0
CORNEAL EPITHELIUM DEFECT  1  0/5107 (0.00%)  0 0/1829 (0.00%)  0 1/1830 (0.05%)  1
CORNEAL OPACITY  1  0/5107 (0.00%)  0 1/1829 (0.05%)  2 0/1830 (0.00%)  0
DACRYOSTENOSIS ACQUIRED  1  1/5107 (0.02%)  1 0/1829 (0.00%)  0 0/1830 (0.00%)  0
DIABETIC RETINOPATHY  1  2/5107 (0.04%)  2 3/1829 (0.16%)  4 0/1830 (0.00%)  0
DIPLOPIA  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 0/1830 (0.00%)  0
EYE HAEMORRHAGE  1  1/5107 (0.02%)  1 1/1829 (0.05%)  1 1/1830 (0.05%)  1
EYELID PTOSIS  1  0/5107 (0.00%)  0 0/1829 (0.00%)  0 1/1830 (0.05%)  1
GLAUCOMA  1  0/5107 (0.00%)  0 3/1829 (0.16%)  4 0/1830 (0.00%)  0
LAGOPHTHALMOS  1  0/5107 (0.00%)  0 0/1829 (0.00%)  0 1/1830 (0.05%)  1
MACULAR FIBROSIS  1  0/5107 (0.00%)  0 0/1829 (0.00%)  0 1/1830 (0.05%)  2
MACULAR OEDEMA  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 1/1830 (0.05%)  1
OPTIC ISCHAEMIC NEUROPATHY  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 0/1830 (0.00%)  0
PERIORBITAL OEDEMA  1  1/5107 (0.02%)  1 0/1829 (0.00%)  0 0/1830 (0.00%)  0
RETINAL DETACHMENT  1  0/5107 (0.00%)  0 2/1829 (0.11%)  2 2/1830 (0.11%)  2
RETINAL HAEMORRHAGE  1  1/5107 (0.02%)  1 2/1829 (0.11%)  2 0/1830 (0.00%)  0
RETINOPATHY PROLIFERATIVE  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 0/1830 (0.00%)  0
RHEGMATOGENOUS RETINAL DETACHMENT  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 0/1830 (0.00%)  0
TRACTIONAL RETINAL DETACHMENT  1  0/5107 (0.00%)  0 0/1829 (0.00%)  0 1/1830 (0.05%)  1
VISUAL IMPAIRMENT  1  0/5107 (0.00%)  0 0/1829 (0.00%)  0 1/1830 (0.05%)  1
VITREOUS ADHESIONS  1  0/5107 (0.00%)  0 0/1829 (0.00%)  0 1/1830 (0.05%)  1
VITREOUS HAEMORRHAGE  1  4/5107 (0.08%)  4 9/1829 (0.49%)  9 5/1830 (0.27%)  7
Gastrointestinal disorders       
ABDOMINAL DISTENSION  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 0/1830 (0.00%)  0
ABDOMINAL HERNIA  1  0/5107 (0.00%)  0 0/1829 (0.00%)  0 2/1830 (0.11%)  2
ABDOMINAL PAIN  1  1/5107 (0.02%)  1 3/1829 (0.16%)  3 2/1830 (0.11%)  2
ANAL INCONTINENCE  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 0/1830 (0.00%)  0
ANORECTAL ULCER  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 0/1830 (0.00%)  0
ASCITES  1  1/5107 (0.02%)  1 1/1829 (0.05%)  1 0/1830 (0.00%)  0
CHRONIC GASTRITIS  1  0/5107 (0.00%)  0 1/1829 (0.05%)  2 1/1830 (0.05%)  1
COLITIS  1  0/5107 (0.00%)  0 0/1829 (0.00%)  0 2/1830 (0.11%)  2
COLITIS ULCERATIVE  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 0/1830 (0.00%)  0
CONSTIPATION  1  0/5107 (0.00%)  0 2/1829 (0.11%)  2 1/1830 (0.05%)  1
DENTAL CARIES  1  0/5107 (0.00%)  0 0/1829 (0.00%)  0 1/1830 (0.05%)  1
DIABETIC GASTROPARESIS  1  0/5107 (0.00%)  0 0/1829 (0.00%)  0 1/1830 (0.05%)  1
DIABETIC GASTROPATHY  1  1/5107 (0.02%)  1 0/1829 (0.00%)  0 0/1830 (0.00%)  0
DIARRHOEA  1  0/5107 (0.00%)  0 4/1829 (0.22%)  4 3/1830 (0.16%)  3
DIVERTICULUM  1  0/5107 (0.00%)  0 0/1829 (0.00%)  0 1/1830 (0.05%)  1
DIVERTICULUM INTESTINAL HAEMORRHAGIC  1  0/5107 (0.00%)  0 0/1829 (0.00%)  0 1/1830 (0.05%)  1
DUODENAL ULCER  1  0/5107 (0.00%)  0 0/1829 (0.00%)  0 1/1830 (0.05%)  1
DUODENAL ULCER HAEMORRHAGE  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 2/1830 (0.11%)  2
DUODENITIS  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 0/1830 (0.00%)  0
DYSPHAGIA  1  1/5107 (0.02%)  1 0/1829 (0.00%)  0 2/1830 (0.11%)  2
ENTEROVESICAL FISTULA  1  0/5107 (0.00%)  0 0/1829 (0.00%)  0 1/1830 (0.05%)  1
EROSIVE DUODENITIS  1  0/5107 (0.00%)  0 0/1829 (0.00%)  0 2/1830 (0.11%)  2
GASTRIC DISORDER  1  0/5107 (0.00%)  0 2/1829 (0.11%)  2 0/1830 (0.00%)  0
GASTRIC FISTULA  1  0/5107 (0.00%)  0 0/1829 (0.00%)  0 1/1830 (0.05%)  1
GASTRIC MUCOSAL HYPERTROPHY  1  0/5107 (0.00%)  0 0/1829 (0.00%)  0 1/1830 (0.05%)  1
GASTRIC POLYPS  1  0/5107 (0.00%)  0 2/1829 (0.11%)  2 0/1830 (0.00%)  0
GASTRIC ULCER  1  0/5107 (0.00%)  0 3/1829 (0.16%)  3 2/1830 (0.11%)  2
GASTRIC ULCER HAEMORRHAGE  1  2/5107 (0.04%)  2 2/1829 (0.11%)  2 3/1830 (0.16%)  3
GASTRITIS  1  1/5107 (0.02%)  1 1/1829 (0.05%)  1 0/1830 (0.00%)  0
GASTRITIS HAEMORRHAGIC  1  0/5107 (0.00%)  0 0/1829 (0.00%)  0 1/1830 (0.05%)  1
GASTROINTESTINAL HAEMORRHAGE  1  1/5107 (0.02%)  1 6/1829 (0.33%)  6 3/1830 (0.16%)  3
GASTROINTESTINAL MUCOSAL DISORDER  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 0/1830 (0.00%)  0
GASTROOESOPHAGEAL REFLUX DISEASE  1  1/5107 (0.02%)  1 3/1829 (0.16%)  3 2/1830 (0.11%)  2
HAEMORRHOIDS  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 1/1830 (0.05%)  1
HIATUS HERNIA  1  0/5107 (0.00%)  0 1/1829 (0.05%)  2 0/1830 (0.00%)  0
ILEUS  1  0/5107 (0.00%)  0 2/1829 (0.11%)  2 2/1830 (0.11%)  2
IMPAIRED GASTRIC EMPTYING  1  0/5107 (0.00%)  0 0/1829 (0.00%)  0 1/1830 (0.05%)  1
INGUINAL HERNIA  1  0/5107 (0.00%)  0 3/1829 (0.16%)  3 2/1830 (0.11%)  2
INTESTINAL HAEMORRHAGE  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 0/1830 (0.00%)  0
INTESTINAL OBSTRUCTION  1  0/5107 (0.00%)  0 3/1829 (0.16%)  3 0/1830 (0.00%)  0
INTESTINAL PERFORATION  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 0/1830 (0.00%)  0
IRRITABLE BOWEL SYNDROME  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 0/1830 (0.00%)  0
LARGE INTESTINE PERFORATION  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 0/1830 (0.00%)  0
LARGE INTESTINE POLYP  1  1/5107 (0.02%)  1 7/1829 (0.38%)  7 2/1830 (0.11%)  2
LOWER GASTROINTESTINAL HAEMORRHAGE  1  0/5107 (0.00%)  0 2/1829 (0.11%)  2 2/1830 (0.11%)  2
LYMPHOCYTIC OESOPHAGITIS  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 0/1830 (0.00%)  0
MELAENA  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 0/1830 (0.00%)  0
NAUSEA  1  2/5107 (0.04%)  2 4/1829 (0.22%)  5 1/1830 (0.05%)  1
OBSTRUCTIVE PANCREATITIS  1  0/5107 (0.00%)  0 0/1829 (0.00%)  0 2/1830 (0.11%)  2
OESOPHAGEAL SPASM  1  0/5107 (0.00%)  0 1/1829 (0.05%)  2 0/1830 (0.00%)  0
OESOPHAGEAL ULCER HAEMORRHAGE  1  1/5107 (0.02%)  1 0/1829 (0.00%)  0 0/1830 (0.00%)  0
OESOPHAGITIS  1  0/5107 (0.00%)  0 1/1829 (0.05%)  3 0/1830 (0.00%)  0
PANCREATIC DISORDER  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 0/1830 (0.00%)  0
PANCREATITIS  1  2/5107 (0.04%)  2 2/1829 (0.11%)  2 4/1830 (0.22%)  5
PANCREATITIS ACUTE  1  1/5107 (0.02%)  1 5/1829 (0.27%)  5 4/1830 (0.22%)  4
PEPTIC ULCER  1  0/5107 (0.00%)  0 0/1829 (0.00%)  0 1/1830 (0.05%)  1
PEPTIC ULCER HAEMORRHAGE  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 0/1830 (0.00%)  0
PROCTITIS  1  0/5107 (0.00%)  0 0/1829 (0.00%)  0 1/1830 (0.05%)  1
RECTAL HAEMORRHAGE  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 1/1830 (0.05%)  1
RECTAL POLYP  1  1/5107 (0.02%)  1 0/1829 (0.00%)  0 1/1830 (0.05%)  1
RECTAL ULCER HAEMORRHAGE  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 0/1830 (0.00%)  0
SMALL INTESTINAL OBSTRUCTION  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 1/1830 (0.05%)  1
ULCERATIVE GASTRITIS  1  0/5107 (0.00%)  0 0/1829 (0.00%)  0 1/1830 (0.05%)  1
UMBILICAL HERNIA  1  1/5107 (0.02%)  1 1/1829 (0.05%)  1 0/1830 (0.00%)  0
UPPER GASTROINTESTINAL HAEMORRHAGE  1  0/5107 (0.00%)  0 5/1829 (0.27%)  5 3/1830 (0.16%)  3
VOMITING  1  3/5107 (0.06%)  3 7/1829 (0.38%)  8 5/1830 (0.27%)  5
General disorders       
ASTHENIA  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 2/1830 (0.11%)  2
BRAIN DEATH  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 0/1830 (0.00%)  0
CHEST DISCOMFORT  1  0/5107 (0.00%)  0 0/1829 (0.00%)  0 1/1830 (0.05%)  1
CHEST PAIN  1  1/5107 (0.02%)  1 7/1829 (0.38%)  7 4/1830 (0.22%)  4
CHILLS  1  0/5107 (0.00%)  0 0/1829 (0.00%)  0 1/1830 (0.05%)  1
DEATH  1  3/5107 (0.06%)  3 5/1829 (0.27%)  5 4/1830 (0.22%)  4
DISEASE COMPLICATION  1  0/5107 (0.00%)  0 0/1829 (0.00%)  0 1/1830 (0.05%)  1
FACE OEDEMA  1  0/5107 (0.00%)  0 0/1829 (0.00%)  0 1/1830 (0.05%)  1
FATIGUE  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 0/1830 (0.00%)  0
FEELING ABNORMAL  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 0/1830 (0.00%)  0
GENERAL PHYSICAL HEALTH DETERIORATION  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 0/1830 (0.00%)  0
GENERALISED OEDEMA  1  2/5107 (0.04%)  2 3/1829 (0.16%)  4 3/1830 (0.16%)  3
HYPOTHERMIA  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 0/1830 (0.00%)  0
IMPAIRED HEALING  1  0/5107 (0.00%)  0 3/1829 (0.16%)  3 1/1830 (0.05%)  1
INFLUENZA LIKE ILLNESS  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 0/1830 (0.00%)  0
MULTIPLE ORGAN DYSFUNCTION SYNDROME  1  0/5107 (0.00%)  0 5/1829 (0.27%)  5 3/1830 (0.16%)  3
NECROSIS  1  0/5107 (0.00%)  0 0/1829 (0.00%)  0 1/1830 (0.05%)  1
NON-CARDIAC CHEST PAIN  1  0/5107 (0.00%)  0 4/1829 (0.22%)  4 3/1830 (0.16%)  3
OEDEMA PERIPHERAL  1  4/5107 (0.08%)  4 6/1829 (0.33%)  6 3/1830 (0.16%)  3
PERIPHERAL SWELLING  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 0/1830 (0.00%)  0
PYREXIA  1  1/5107 (0.02%)  1 0/1829 (0.00%)  0 2/1830 (0.11%)  2
SUDDEN CARDIAC DEATH  1  0/5107 (0.00%)  0 0/1829 (0.00%)  0 1/1830 (0.05%)  1
SUDDEN DEATH  1  1/5107 (0.02%)  1 8/1829 (0.44%)  8 5/1830 (0.27%)  5
SYSTEMIC INFLAMMATORY RESPONSE SYNDROME  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 0/1830 (0.00%)  0
ULCER HAEMORRHAGE  1  0/5107 (0.00%)  0 0/1829 (0.00%)  0 1/1830 (0.05%)  1
VASCULAR STENT STENOSIS  1  1/5107 (0.02%)  1 0/1829 (0.00%)  0 1/1830 (0.05%)  1
Hepatobiliary disorders       
BILE DUCT STONE  1  1/5107 (0.02%)  1 0/1829 (0.00%)  0 3/1830 (0.16%)  3
BILIARY COLIC  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 0/1830 (0.00%)  0
CHOLANGITIS  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 2/1830 (0.11%)  2
CHOLECYSTITIS  1  2/5107 (0.04%)  2 1/1829 (0.05%)  1 2/1830 (0.11%)  2
CHOLECYSTITIS ACUTE  1  0/5107 (0.00%)  0 6/1829 (0.33%)  6 3/1830 (0.16%)  3
CHOLECYSTITIS CHRONIC  1  1/5107 (0.02%)  1 1/1829 (0.05%)  1 0/1830 (0.00%)  0
CHOLELITHIASIS  1  0/5107 (0.00%)  0 5/1829 (0.27%)  5 3/1830 (0.16%)  3
DRUG-INDUCED LIVER INJURY  1  1/5107 (0.02%)  1 0/1829 (0.00%)  0 0/1830 (0.00%)  0
GALLBLADDER PERFORATION  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 0/1830 (0.00%)  0
HEPATIC CIRRHOSIS  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 0/1830 (0.00%)  0
HEPATIC LESION  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 0/1830 (0.00%)  0
HEPATIC STEATOSIS  1  0/5107 (0.00%)  0 0/1829 (0.00%)  0 1/1830 (0.05%)  1
HEPATITIS  1  0/5107 (0.00%)  0 0/1829 (0.00%)  0 1/1830 (0.05%)  1
HEPATITIS ACUTE  1  1/5107 (0.02%)  1 0/1829 (0.00%)  0 0/1830 (0.00%)  0
Immune system disorders       
ALLERGY TO ARTHROPOD BITE  1  0/5107 (0.00%)  0 0/1829 (0.00%)  0 1/1830 (0.05%)  1
ANAPHYLACTIC SHOCK  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 1/1830 (0.05%)  1
DRUG HYPERSENSITIVITY  1  1/5107 (0.02%)  1 1/1829 (0.05%)  1 0/1830 (0.00%)  0
HYPERSENSITIVITY  1  1/5107 (0.02%)  1 1/1829 (0.05%)  1 0/1830 (0.00%)  0
Infections and infestations       
ABDOMINAL ABSCESS  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 0/1830 (0.00%)  0
ABSCESS LIMB  1  0/5107 (0.00%)  0 6/1829 (0.33%)  6 6/1830 (0.33%)  7
ABSCESS SOFT TISSUE  1  0/5107 (0.00%)  0 0/1829 (0.00%)  0 1/1830 (0.05%)  1
ACUTE SINUSITIS  1  1/5107 (0.02%)  1 0/1829 (0.00%)  0 0/1830 (0.00%)  0
ANAL ABSCESS  1  0/5107 (0.00%)  0 2/1829 (0.11%)  2 0/1830 (0.00%)  0
APPENDICITIS  1  2/5107 (0.04%)  2 3/1829 (0.16%)  3 3/1830 (0.16%)  3
ARTERIOSCLEROTIC GANGRENE  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 0/1830 (0.00%)  0
ARTHRITIS BACTERIAL  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 2/1830 (0.11%)  3
ARTHRITIS INFECTIVE  1  0/5107 (0.00%)  0 0/1829 (0.00%)  0 1/1830 (0.05%)  1
BACTERAEMIA  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 0/1830 (0.00%)  0
BACTERIAL DIARRHOEA  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 0/1830 (0.00%)  0
BACTERIAL SEPSIS  1  0/5107 (0.00%)  0 2/1829 (0.11%)  2 0/1830 (0.00%)  0
BILIARY SEPSIS  1  1/5107 (0.02%)  1 0/1829 (0.00%)  0 1/1830 (0.05%)  1
BRAIN ABSCESS  1  0/5107 (0.00%)  0 0/1829 (0.00%)  0 1/1830 (0.05%)  1
BRONCHITIS  1  1/5107 (0.02%)  1 9/1829 (0.49%)  9 4/1830 (0.22%)  4
BRONCHITIS BACTERIAL  1  1/5107 (0.02%)  1 0/1829 (0.00%)  0 0/1830 (0.00%)  0
CAMPYLOBACTER GASTROENTERITIS  1  1/5107 (0.02%)  1 0/1829 (0.00%)  0 0/1830 (0.00%)  0
CAMPYLOBACTER INFECTION  1  1/5107 (0.02%)  1 0/1829 (0.00%)  0 0/1830 (0.00%)  0
CELLULITIS  1  5/5107 (0.10%)  5 14/1829 (0.77%)  15 22/1830 (1.20%)  24
CELLULITIS GANGRENOUS  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 0/1830 (0.00%)  0
CHOLECYSTITIS INFECTIVE  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 1/1830 (0.05%)  1
CHRONIC TONSILLITIS  1  0/5107 (0.00%)  0 0/1829 (0.00%)  0 1/1830 (0.05%)  1
CLOSTRIDIAL SEPSIS  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 0/1830 (0.00%)  0
CLOSTRIDIUM DIFFICILE COLITIS  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 1/1830 (0.05%)  1
CLOSTRIDIUM DIFFICILE INFECTION  1  1/5107 (0.02%)  1 1/1829 (0.05%)  1 0/1830 (0.00%)  0
CYSTITIS  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 0/1830 (0.00%)  0
CYSTITIS KLEBSIELLA  1  0/5107 (0.00%)  0 0/1829 (0.00%)  0 1/1830 (0.05%)  1
DENGUE FEVER  1  0/5107 (0.00%)  0 2/1829 (0.11%)  2 0/1830 (0.00%)  0
DEVICE RELATED INFECTION  1  0/5107 (0.00%)  0 2/1829 (0.11%)  2 1/1830 (0.05%)  1
DIABETIC FOOT INFECTION  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 2/1830 (0.11%)  2
DIABETIC GANGRENE  1  0/5107 (0.00%)  0 2/1829 (0.11%)  3 3/1830 (0.16%)  3
DIVERTICULITIS  1  1/5107 (0.02%)  1 4/1829 (0.22%)  4 4/1830 (0.22%)  4
EMPHYSEMATOUS PYELONEPHRITIS  1  0/5107 (0.00%)  0 0/1829 (0.00%)  0 1/1830 (0.05%)  1
ENDOCARDITIS  1  0/5107 (0.00%)  0 3/1829 (0.16%)  3 0/1830 (0.00%)  0
ENDOPHTHALMITIS  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 0/1830 (0.00%)  0
ENTERITIS INFECTIOUS  1  0/5107 (0.00%)  0 0/1829 (0.00%)  0 1/1830 (0.05%)  1
ENTEROBACTER INFECTION  1  0/5107 (0.00%)  0 0/1829 (0.00%)  0 1/1830 (0.05%)  1
ENTEROCOCCAL INFECTION  1  0/5107 (0.00%)  0 0/1829 (0.00%)  0 2/1830 (0.11%)  2
ERYSIPELAS  1  1/5107 (0.02%)  1 3/1829 (0.16%)  3 3/1830 (0.16%)  3
ESCHERICHIA BACTERAEMIA  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 0/1830 (0.00%)  0
ESCHERICHIA INFECTION  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 1/1830 (0.05%)  1
ESCHERICHIA SEPSIS  1  0/5107 (0.00%)  0 2/1829 (0.11%)  2 2/1830 (0.11%)  2
ESCHERICHIA URINARY TRACT INFECTION  1  1/5107 (0.02%)  1 0/1829 (0.00%)  0 1/1830 (0.05%)  1
GANGRENE  1  1/5107 (0.02%)  3 4/1829 (0.22%)  4 7/1830 (0.38%)  7
GAS GANGRENE  1  0/5107 (0.00%)  0 0/1829 (0.00%)  0 1/1830 (0.05%)  1
GASTROENTERITIS  1  1/5107 (0.02%)  1 8/1829 (0.44%)  8 10/1830 (0.55%)  10
GASTROENTERITIS VIRAL  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 0/1830 (0.00%)  0
GRAFT INFECTION  1  0/5107 (0.00%)  0 0/1829 (0.00%)  0 1/1830 (0.05%)  1
HELICOBACTER INFECTION  1  0/5107 (0.00%)  0 0/1829 (0.00%)  0 1/1830 (0.05%)  1
HEPATITIS B  1  1/5107 (0.02%)  1 0/1829 (0.00%)  0 0/1830 (0.00%)  0
HEPATITIS C  1  0/5107 (0.00%)  0 0/1829 (0.00%)  0 1/1830 (0.05%)  1
HERPES ZOSTER  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 0/1830 (0.00%)  0
INFECTED SKIN ULCER  1  1/5107 (0.02%)  1 2/1829 (0.11%)  2 1/1830 (0.05%)  1
INFECTION  1  0/5107 (0.00%)  0 0/1829 (0.00%)  0 1/1830 (0.05%)  1
INFECTIVE EXACERBATION OF BRONCHIECTASIS  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 0/1830 (0.00%)  0
INFLUENZA  1  2/5107 (0.04%)  2 0/1829 (0.00%)  0 1/1830 (0.05%)  1
INTERVERTEBRAL DISCITIS  1  0/5107 (0.00%)  0 2/1829 (0.11%)  2 0/1830 (0.00%)  0
JOINT ABSCESS  1  1/5107 (0.02%)  1 0/1829 (0.00%)  0 0/1830 (0.00%)  0
KLEBSIELLA INFECTION  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 0/1830 (0.00%)  0
LEPTOSPIROSIS  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 0/1830 (0.00%)  0
LIVER ABSCESS  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 0/1830 (0.00%)  0
LOCALISED INFECTION  1  0/5107 (0.00%)  0 3/1829 (0.16%)  4 2/1830 (0.11%)  2
LOWER RESPIRATORY TRACT INFECTION  1  2/5107 (0.04%)  2 2/1829 (0.11%)  2 1/1830 (0.05%)  1
LUNG INFECTION  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 3/1830 (0.16%)  3
MASTOIDITIS  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 2/1830 (0.11%)  2
MEDICAL DEVICE SITE INFECTION  1  0/5107 (0.00%)  0 0/1829 (0.00%)  0 1/1830 (0.05%)  1
MORGANELLA INFECTION  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 0/1830 (0.00%)  0
NASOPHARYNGITIS  1  0/5107 (0.00%)  0 0/1829 (0.00%)  0 1/1830 (0.05%)  1
NECROTISING FASCIITIS  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 2/1830 (0.11%)  2
NEUTROPENIC SEPSIS  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 0/1830 (0.00%)  0
NOSOCOMIAL INFECTION  1  1/5107 (0.02%)  1 1/1829 (0.05%)  1 0/1830 (0.00%)  0
ORCHITIS  1  0/5107 (0.00%)  0 0/1829 (0.00%)  0 1/1830 (0.05%)  1
OSTEOMYELITIS  1  1/5107 (0.02%)  1 9/1829 (0.49%)  11 10/1830 (0.55%)  11
OSTEOMYELITIS ACUTE  1  0/5107 (0.00%)  0 0/1829 (0.00%)  0 2/1830 (0.11%)  2
OSTEOMYELITIS CHRONIC  1  1/5107 (0.02%)  1 1/1829 (0.05%)  1 0/1830 (0.00%)  0
OTITIS EXTERNA  1  0/5107 (0.00%)  0 0/1829 (0.00%)  0 1/1830 (0.05%)  1
OTITIS MEDIA ACUTE  1  0/5107 (0.00%)  0 0/1829 (0.00%)  0 1/1830 (0.05%)  1
OTITIS MEDIA CHRONIC  1  0/5107 (0.00%)  0 0/1829 (0.00%)  0 1/1830 (0.05%)  1
PANCREATITIS BACTERIAL  1  0/5107 (0.00%)  0 0/1829 (0.00%)  0 1/1830 (0.05%)  1
PAROTID ABSCESS  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 0/1830 (0.00%)  0
PERIODONTITIS  1  0/5107 (0.00%)  0 0/1829 (0.00%)  0 1/1830 (0.05%)  1
PERIRECTAL ABSCESS  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 0/1830 (0.00%)  0
PERITONITIS  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 3/1830 (0.16%)  3
PERITONSILLAR ABSCESS  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 0/1830 (0.00%)  0
PHARYNGEAL ABSCESS  1  0/5107 (0.00%)  0 0/1829 (0.00%)  0 1/1830 (0.05%)  1
PILONIDAL CYST  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 0/1830 (0.00%)  0
PNEUMONIA  1  14/5107 (0.27%)  14 54/1829 (2.95%)  63 41/1830 (2.24%)  43
PNEUMONIA BACTERIAL  1  1/5107 (0.02%)  1 4/1829 (0.22%)  4 0/1830 (0.00%)  0
PNEUMONIA LEGIONELLA  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 0/1830 (0.00%)  0
PNEUMONIA PARAINFLUENZAE VIRAL  1  0/5107 (0.00%)  0 0/1829 (0.00%)  0 1/1830 (0.05%)  1
PNEUMONIA PSEUDOMONAL  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 0/1830 (0.00%)  0
PNEUMONIA STAPHYLOCOCCAL  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 0/1830 (0.00%)  0
PNEUMONIA STREPTOCOCCAL  1  0/5107 (0.00%)  0 0/1829 (0.00%)  0 1/1830 (0.05%)  1
PNEUMONIA VIRAL  1  1/5107 (0.02%)  1 0/1829 (0.00%)  0 1/1830 (0.05%)  1
POST PROCEDURAL CELLULITIS  1  0/5107 (0.00%)  0 0/1829 (0.00%)  0 1/1830 (0.05%)  1
POST PROCEDURAL INFECTION  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 0/1830 (0.00%)  0
POSTOPERATIVE ABSCESS  1  0/5107 (0.00%)  0 0/1829 (0.00%)  0 1/1830 (0.05%)  1
POSTOPERATIVE WOUND INFECTION  1  1/5107 (0.02%)  1 0/1829 (0.00%)  0 1/1830 (0.05%)  1
PROSTATIC ABSCESS  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 0/1830 (0.00%)  0
PROSTATITIS ESCHERICHIA COLI  1  0/5107 (0.00%)  0 0/1829 (0.00%)  0 1/1830 (0.05%)  1
PSEUDOMONAS INFECTION  1  0/5107 (0.00%)  0 0/1829 (0.00%)  0 1/1830 (0.05%)  1
PULMONARY TUBERCULOMA  1  1/5107 (0.02%)  1 0/1829 (0.00%)  0 0/1830 (0.00%)  0
PYELONEPHRITIS  1  3/5107 (0.06%)  3 2/1829 (0.11%)  2 4/1830 (0.22%)  4
PYELONEPHRITIS ACUTE  1  0/5107 (0.00%)  0 0/1829 (0.00%)  0 4/1830 (0.22%)  4
PYELONEPHRITIS CHRONIC  1  0/5107 (0.00%)  0 0/1829 (0.00%)  0 1/1830 (0.05%)  1
RESPIRATORY TRACT INFECTION  1  1/5107 (0.02%)  1 2/1829 (0.11%)  2 1/1830 (0.05%)  1
RHINITIS  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 0/1830 (0.00%)  0
SEPSIS  1  4/5107 (0.08%)  4 16/1829 (0.87%)  17 18/1830 (0.98%)  18
SEPSIS SYNDROME  1  0/5107 (0.00%)  0 0/1829 (0.00%)  0 1/1830 (0.05%)  1
SEPTIC EMBOLUS  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 0/1830 (0.00%)  0
SEPTIC ENCEPHALOPATHY  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 0/1830 (0.00%)  0
SEPTIC NECROSIS  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 0/1830 (0.00%)  0
SEPTIC SHOCK  1  1/5107 (0.02%)  1 5/1829 (0.27%)  5 6/1830 (0.33%)  6
SIALOADENITIS  1  0/5107 (0.00%)  0 1/1829 (0.05%)  2 0/1830 (0.00%)  0
STAPHYLOCOCCAL ABSCESS  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 0/1830 (0.00%)  0
STAPHYLOCOCCAL BACTERAEMIA  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 1/1830 (0.05%)  1
STAPHYLOCOCCAL SEPSIS  1  0/5107 (0.00%)  0 2/1829 (0.11%)  2 1/1830 (0.05%)  1
STREPTOCOCCAL BACTERAEMIA  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 0/1830 (0.00%)  0
SYSTEMIC CANDIDA  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 0/1830 (0.00%)  0
TOOTH ABSCESS  1  0/5107 (0.00%)  0 0/1829 (0.00%)  0 1/1830 (0.05%)  1
TOXIC SHOCK SYNDROME  1  0/5107 (0.00%)  0 0/1829 (0.00%)  0 1/1830 (0.05%)  1
TUBERCULOSIS  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 2/1830 (0.11%)  2
UPPER RESPIRATORY TRACT INFECTION  1  0/5107 (0.00%)  0 2/1829 (0.11%)  5 1/1830 (0.05%)  1
URINARY TRACT INFECTION  1  6/5107 (0.12%)  6 21/1829 (1.15%)  21 12/1830 (0.66%)  15
URINARY TRACT INFECTION BACTERIAL  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 0/1830 (0.00%)  0
URINARY TRACT INFECTION ENTEROCOCCAL  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 0/1830 (0.00%)  0
UROSEPSIS  1  0/5107 (0.00%)  0 2/1829 (0.11%)  2 2/1830 (0.11%)  2
VIRAL INFECTION  1  1/5107 (0.02%)  1 0/1829 (0.00%)  0 0/1830 (0.00%)  0
VULVAL ABSCESS  1  0/5107 (0.00%)  0 0/1829 (0.00%)  0 1/1830 (0.05%)  1
WOUND INFECTION  1  0/5107 (0.00%)  0 3/1829 (0.16%)  3 2/1830 (0.11%)  2
WOUND INFECTION STAPHYLOCOCCAL  1  1/5107 (0.02%)  1 2/1829 (0.11%)  2 0/1830 (0.00%)  0
WOUND SEPSIS  1  0/5107 (0.00%)  0 0/1829 (0.00%)  0 1/1830 (0.05%)  1
Injury, poisoning and procedural complications       
ABDOMINAL INJURY  1  1/5107 (0.02%)  1 0/1829 (0.00%)  0 0/1830 (0.00%)  0
ABDOMINAL WOUND DEHISCENCE  1  0/5107 (0.00%)  0 0/1829 (0.00%)  0 1/1830 (0.05%)  1
ANKLE FRACTURE  1  0/5107 (0.00%)  0 3/1829 (0.16%)  3 2/1830 (0.11%)  2
BLADDER INJURY  1  0/5107 (0.00%)  0 0/1829 (0.00%)  0 1/1830 (0.05%)  1
BRAIN CONTUSION  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 1/1830 (0.05%)  1
BURNS SECOND DEGREE  1  1/5107 (0.02%)  1 0/1829 (0.00%)  0 0/1830 (0.00%)  0
CERVICAL VERTEBRAL FRACTURE  1  1/5107 (0.02%)  1 0/1829 (0.00%)  0 0/1830 (0.00%)  0
CLAVICLE FRACTURE  1  0/5107 (0.00%)  0 2/1829 (0.11%)  2 0/1830 (0.00%)  0
CONCUSSION  1  0/5107 (0.00%)  0 2/1829 (0.11%)  2 3/1830 (0.16%)  3
CONTUSION  1  1/5107 (0.02%)  1 1/1829 (0.05%)  1 2/1830 (0.11%)  2
CRANIOCEREBRAL INJURY  1  0/5107 (0.00%)  0 0/1829 (0.00%)  0 1/1830 (0.05%)  1
CYSTITIS RADIATION  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 0/1830 (0.00%)  0
DISLOCATION OF VERTEBRA  1  0/5107 (0.00%)  0 0/1829 (0.00%)  0 1/1830 (0.05%)  1
FACIAL BONES FRACTURE  1  1/5107 (0.02%)  1 2/1829 (0.11%)  2 1/1830 (0.05%)  1
FALL  1  7/5107 (0.14%)  7 12/1829 (0.66%)  12 5/1830 (0.27%)  6
FEMORAL NECK FRACTURE  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 3/1830 (0.16%)  3
FEMUR FRACTURE  1  1/5107 (0.02%)  1 3/1829 (0.16%)  3 3/1830 (0.16%)  3
FIBULA FRACTURE  1  0/5107 (0.00%)  0 0/1829 (0.00%)  0 1/1830 (0.05%)  1
FOOT FRACTURE  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 2/1830 (0.11%)  2
FOREIGN BODY IN GASTROINTESTINAL TRACT  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 0/1830 (0.00%)  0
GRAFT THROMBOSIS  1  0/5107 (0.00%)  0 0/1829 (0.00%)  0 1/1830 (0.05%)  1
HAND FRACTURE  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 1/1830 (0.05%)  1
HEAD INJURY  1  1/5107 (0.02%)  1 1/1829 (0.05%)  1 3/1830 (0.16%)  3
HIP FRACTURE  1  0/5107 (0.00%)  0 0/1829 (0.00%)  0 2/1830 (0.11%)  2
HUMERUS FRACTURE  1  2/5107 (0.04%)  2 3/1829 (0.16%)  3 2/1830 (0.11%)  2
ILIUM FRACTURE  1  0/5107 (0.00%)  0 0/1829 (0.00%)  0 2/1830 (0.11%)  2
INCISIONAL HERNIA  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 0/1830 (0.00%)  0
INJURY  1  1/5107 (0.02%)  1 0/1829 (0.00%)  0 1/1830 (0.05%)  1
JAW FRACTURE  1  1/5107 (0.02%)  1 0/1829 (0.00%)  0 0/1830 (0.00%)  0
JOINT DISLOCATION  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 0/1830 (0.00%)  0
LACERATION  1  1/5107 (0.02%)  1 2/1829 (0.11%)  2 0/1830 (0.00%)  0
LIGAMENT SPRAIN  1  1/5107 (0.02%)  1 2/1829 (0.11%)  2 1/1830 (0.05%)  1
LIMB INJURY  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 1/1830 (0.05%)  1
LIMB TRAUMATIC AMPUTATION  1  0/5107 (0.00%)  0 0/1829 (0.00%)  0 1/1830 (0.05%)  1
LISFRANC FRACTURE  1  1/5107 (0.02%)  1 0/1829 (0.00%)  0 0/1830 (0.00%)  0
LOWER LIMB FRACTURE  1  0/5107 (0.00%)  0 3/1829 (0.16%)  3 1/1830 (0.05%)  1
LUMBAR VERTEBRAL FRACTURE  1  0/5107 (0.00%)  0 0/1829 (0.00%)  0 4/1830 (0.22%)  4
MENISCUS INJURY  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 0/1830 (0.00%)  0
MULTIPLE FRACTURES  1  0/5107 (0.00%)  0 2/1829 (0.11%)  2 0/1830 (0.00%)  0
MUSCLE RUPTURE  1  1/5107 (0.02%)  1 0/1829 (0.00%)  0 1/1830 (0.05%)  1
OVERDOSE  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 0/1830 (0.00%)  0
PANCREATIC LEAK  1  0/5107 (0.00%)  0 0/1829 (0.00%)  0 1/1830 (0.05%)  1
PATELLA FRACTURE  1  1/5107 (0.02%)  1 0/1829 (0.00%)  0 1/1830 (0.05%)  1
PELVIC FRACTURE  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 2/1830 (0.11%)  2
POST CONCUSSION SYNDROME  1  0/5107 (0.00%)  0 0/1829 (0.00%)  0 1/1830 (0.05%)  1
POST PROCEDURAL DISCHARGE  1  0/5107 (0.00%)  0 0/1829 (0.00%)  0 1/1830 (0.05%)  1
POST PROCEDURAL HAEMATOMA  1  0/5107 (0.00%)  0 0/1829 (0.00%)  0 1/1830 (0.05%)  1
POST PROCEDURAL HAEMORRHAGE  1  1/5107 (0.02%)  1 0/1829 (0.00%)  0 2/1830 (0.11%)  2
POST PROCEDURAL SWELLING  1  0/5107 (0.00%)  0 0/1829 (0.00%)  0 1/1830 (0.05%)  1
POSTOPERATIVE WOUND COMPLICATION  1  1/5107 (0.02%)  1 0/1829 (0.00%)  0 0/1830 (0.00%)  0
PROCEDURAL PAIN  1  0/5107 (0.00%)  0 0/1829 (0.00%)  0 1/1830 (0.05%)  1
PUBIS FRACTURE  1  0/5107 (0.00%)  0 0/1829 (0.00%)  0 1/1830 (0.05%)  1
RADIUS FRACTURE  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 2/1830 (0.11%)  2
RIB FRACTURE  1  1/5107 (0.02%)  1 3/1829 (0.16%)  3 0/1830 (0.00%)  0
ROAD TRAFFIC ACCIDENT  1  1/5107 (0.02%)  1 3/1829 (0.16%)  3 1/1830 (0.05%)  1
SKIN ABRASION  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 1/1830 (0.05%)  1
SPINAL COMPRESSION FRACTURE  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 0/1830 (0.00%)  0
SPINAL CORD INJURY CERVICAL  1  1/5107 (0.02%)  1 0/1829 (0.00%)  0 0/1830 (0.00%)  0
SPINAL FRACTURE  1  0/5107 (0.00%)  0 0/1829 (0.00%)  0 1/1830 (0.05%)  1
SUBARACHNOID HAEMORRHAGE  1  1/5107 (0.02%)  1 1/1829 (0.05%)  1 0/1830 (0.00%)  0
SUBDURAL HAEMATOMA  1  2/5107 (0.04%)  2 3/1829 (0.16%)  3 2/1830 (0.11%)  3
SUBDURAL HAEMORRHAGE  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 0/1830 (0.00%)  0
TENDON RUPTURE  1  0/5107 (0.00%)  0 2/1829 (0.11%)  2 0/1830 (0.00%)  0
THERMAL BURN  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 0/1830 (0.00%)  0
THORACIC VERTEBRAL FRACTURE  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 0/1830 (0.00%)  0
TIBIA FRACTURE  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 2/1830 (0.11%)  2
TOXICITY TO VARIOUS AGENTS  1  0/5107 (0.00%)  0 0/1829 (0.00%)  0 1/1830 (0.05%)  1
TRAUMATIC FRACTURE  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 0/1830 (0.00%)  0
TRAUMATIC HAEMATOMA  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 0/1830 (0.00%)  0
TRAUMATIC HAEMOTHORAX  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 0/1830 (0.00%)  0
TRAUMATIC LUNG INJURY  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 0/1830 (0.00%)  0
ULNA FRACTURE  1  1/5107 (0.02%)  1 0/1829 (0.00%)  0 0/1830 (0.00%)  0
ULNAR NERVE INJURY  1  0/5107 (0.00%)  0 0/1829 (0.00%)  0 1/1830 (0.05%)  1
URINARY RETENTION POSTOPERATIVE  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 0/1830 (0.00%)  0
VASCULAR PSEUDOANEURYSM  1  0/5107 (0.00%)  0 0/1829 (0.00%)  0 2/1830 (0.11%)  2
WOUND  1  0/5107 (0.00%)  0 3/1829 (0.16%)  3 0/1830 (0.00%)  0
WOUND COMPLICATION  1  0/5107 (0.00%)  0 0/1829 (0.00%)  0 1/1830 (0.05%)  1
WOUND DEHISCENCE  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 1/1830 (0.05%)  1
WOUND HAEMORRHAGE  1  0/5107 (0.00%)  0 0/1829 (0.00%)  0 1/1830 (0.05%)  1
WOUND NECROSIS  1  0/5107 (0.00%)  0 0/1829 (0.00%)  0 1/1830 (0.05%)  1
Investigations       
BLOOD ALKALINE PHOSPHATASE INCREASED  1  0/5107 (0.00%)  0 0/1829 (0.00%)  0 1/1830 (0.05%)  1
BLOOD BICARBONATE DECREASED  1  1/5107 (0.02%)  1 0/1829 (0.00%)  0 0/1830 (0.00%)  0
BLOOD CREATININE INCREASED  1  1/5107 (0.02%)  1 5/1829 (0.27%)  5 7/1830 (0.38%)  8
BLOOD GLUCOSE DECREASED  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 0/1830 (0.00%)  0
BLOOD POTASSIUM INCREASED  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 1/1830 (0.05%)  1
BLOOD UREA INCREASED  1  1/5107 (0.02%)  1 0/1829 (0.00%)  0 1/1830 (0.05%)  1
BRAIN NATRIURETIC PEPTIDE INCREASED  1  2/5107 (0.04%)  2 0/1829 (0.00%)  0 0/1830 (0.00%)  0
ELECTROCARDIOGRAM Q WAVE ABNORMAL  1  0/5107 (0.00%)  0 0/1829 (0.00%)  0 1/1830 (0.05%)  1
GLOMERULAR FILTRATION RATE DECREASED  1  0/5107 (0.00%)  0 0/1829 (0.00%)  0 1/1830 (0.05%)  1
HAEMOGLOBIN DECREASED  1  0/5107 (0.00%)  0 2/1829 (0.11%)  2 0/1830 (0.00%)  0
HELICOBACTER TEST POSITIVE  1  0/5107 (0.00%)  0 0/1829 (0.00%)  0 1/1830 (0.05%)  1
HEPATIC ENZYME INCREASED  1  0/5107 (0.00%)  0 0/1829 (0.00%)  0 1/1830 (0.05%)  1
INTRAOCULAR PRESSURE INCREASED  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 0/1830 (0.00%)  0
LIPASE INCREASED  1  0/5107 (0.00%)  0 0/1829 (0.00%)  0 1/1830 (0.05%)  1
PROSTATIC SPECIFIC ANTIGEN INCREASED  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 1/1830 (0.05%)  1
PROTEIN URINE PRESENT  1  1/5107 (0.02%)  1 1/1829 (0.05%)  1 1/1830 (0.05%)  1
TROPONIN INCREASED  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 2/1830 (0.11%)  2
URINE CYTOLOGY ABNORMAL  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 0/1830 (0.00%)  0
WEIGHT INCREASED  1  1/5107 (0.02%)  1 1/1829 (0.05%)  1 0/1830 (0.00%)  0
Metabolism and nutrition disorders       
CACHEXIA  1  0/5107 (0.00%)  0 2/1829 (0.11%)  2 0/1830 (0.00%)  0
DECREASED APPETITE  1  1/5107 (0.02%)  1 0/1829 (0.00%)  0 1/1830 (0.05%)  1
DEHYDRATION  1  7/5107 (0.14%)  7 11/1829 (0.60%)  11 8/1830 (0.44%)  8
DIABETES MELLITUS  1  1/5107 (0.02%)  1 1/1829 (0.05%)  1 4/1830 (0.22%)  4
DIABETES MELLITUS INADEQUATE CONTROL  1  3/5107 (0.06%)  3 9/1829 (0.49%)  9 7/1830 (0.38%)  7
DIABETIC KETOACIDOSIS  1  1/5107 (0.02%)  1 1/1829 (0.05%)  1 1/1830 (0.05%)  1
DIABETIC KETOSIS  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 0/1830 (0.00%)  0
DIABETIC METABOLIC DECOMPENSATION  1  0/5107 (0.00%)  0 0/1829 (0.00%)  0 3/1830 (0.16%)  5
ELECTROLYTE IMBALANCE  1  0/5107 (0.00%)  0 0/1829 (0.00%)  0 2/1830 (0.11%)  2
FLUID OVERLOAD  1  2/5107 (0.04%)  2 9/1829 (0.49%)  10 3/1830 (0.16%)  3
FLUID RETENTION  1  2/5107 (0.04%)  2 0/1829 (0.00%)  0 0/1830 (0.00%)  0
GOUT  1  1/5107 (0.02%)  1 1/1829 (0.05%)  2 2/1830 (0.11%)  3
HYPERCALCAEMIA  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 0/1830 (0.00%)  0
HYPERGLYCAEMIA  1  2/5107 (0.04%)  2 8/1829 (0.44%)  8 9/1830 (0.49%)  11
HYPERGLYCAEMIC HYPEROSMOLAR NONKETOTIC SYNDROME  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 1/1830 (0.05%)  1
HYPERKALAEMIA  1  5/5107 (0.10%)  6 16/1829 (0.87%)  18 16/1830 (0.87%)  19
HYPERURICAEMIA  1  0/5107 (0.00%)  0 0/1829 (0.00%)  0 1/1830 (0.05%)  1
HYPOALBUMINAEMIA  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 0/1830 (0.00%)  0
HYPOCALCAEMIA  1  0/5107 (0.00%)  0 2/1829 (0.11%)  2 0/1830 (0.00%)  0
HYPOGLYCAEMIA  1  13/5107 (0.25%)  13 22/1829 (1.20%)  24 12/1830 (0.66%)  14
HYPOMAGNESAEMIA  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 1/1830 (0.05%)  1
HYPONATRAEMIA  1  2/5107 (0.04%)  2 3/1829 (0.16%)  3 2/1830 (0.11%)  2
HYPOPHAGIA  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 0/1830 (0.00%)  0
HYPOVOLAEMIA  1  0/5107 (0.00%)  0 2/1829 (0.11%)  2 1/1830 (0.05%)  1
METABOLIC ACIDOSIS  1  0/5107 (0.00%)  0 5/1829 (0.27%)  5 6/1830 (0.33%)  6
OBESITY  1  0/5107 (0.00%)  0 2/1829 (0.11%)  2 1/1830 (0.05%)  1
TYPE 2 DIABETES MELLITUS  1  0/5107 (0.00%)  0 0/1829 (0.00%)  0 1/1830 (0.05%)  1
Musculoskeletal and connective tissue disorders       
ARTHRALGIA  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 3/1830 (0.16%)  3
ARTHRITIS  1  0/5107 (0.00%)  0 4/1829 (0.22%)  4 2/1830 (0.11%)  3
ARTHROPATHY  1  0/5107 (0.00%)  0 0/1829 (0.00%)  0 1/1830 (0.05%)  1
BACK PAIN  1  0/5107 (0.00%)  0 2/1829 (0.11%)  2 4/1830 (0.22%)  4
CERVICAL SPINAL STENOSIS  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 1/1830 (0.05%)  1
CHRONIC KIDNEY DISEASE-MINERAL AND BONE DISORDER  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 0/1830 (0.00%)  0
COMPARTMENT SYNDROME  1  0/5107 (0.00%)  0 0/1829 (0.00%)  0 1/1830 (0.05%)  1
COSTOCHONDRITIS  1  0/5107 (0.00%)  0 2/1829 (0.11%)  2 0/1830 (0.00%)  0
GOUTY ARTHRITIS  1  0/5107 (0.00%)  0 2/1829 (0.11%)  3 4/1830 (0.22%)  4
HAEMARTHROSIS  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 0/1830 (0.00%)  0
INTERVERTEBRAL DISC DEGENERATION  1  1/5107 (0.02%)  1 1/1829 (0.05%)  1 0/1830 (0.00%)  0
INTERVERTEBRAL DISC DISORDER  1  0/5107 (0.00%)  0 0/1829 (0.00%)  0 1/1830 (0.05%)  1
INTERVERTEBRAL DISC DISPLACEMENT  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 0/1830 (0.00%)  0
INTERVERTEBRAL DISC PROTRUSION  1  0/5107 (0.00%)  0 4/1829 (0.22%)  4 4/1830 (0.22%)  4
JOINT SWELLING  1  0/5107 (0.00%)  0 0/1829 (0.00%)  0 1/1830 (0.05%)  1
LUMBAR SPINAL STENOSIS  1  0/5107 (0.00%)  0 5/1829 (0.27%)  5 3/1830 (0.16%)  3
MENISCAL DEGENERATION  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 0/1830 (0.00%)  0
MOBILITY DECREASED  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 0/1830 (0.00%)  0
MUSCULAR WEAKNESS  1  0/5107 (0.00%)  0 0/1829 (0.00%)  0 2/1830 (0.11%)  2
MUSCULOSKELETAL CHEST PAIN  1  0/5107 (0.00%)  0 3/1829 (0.16%)  3 5/1830 (0.27%)  5
MYALGIA  1  1/5107 (0.02%)  1 0/1829 (0.00%)  0 0/1830 (0.00%)  0
NECK PAIN  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 1/1830 (0.05%)  1
NEUROPATHIC ARTHROPATHY  1  1/5107 (0.02%)  1 1/1829 (0.05%)  1 1/1830 (0.05%)  1
OSTEITIS  1  0/5107 (0.00%)  0 0/1829 (0.00%)  0 1/1830 (0.05%)  1
OSTEOARTHRITIS  1  1/5107 (0.02%)  1 8/1829 (0.44%)  8 16/1830 (0.87%)  19
OSTEOPOROSIS  1  0/5107 (0.00%)  0 0/1829 (0.00%)  0 1/1830 (0.05%)  1
PAIN IN EXTREMITY  1  1/5107 (0.02%)  1 0/1829 (0.00%)  0 1/1830 (0.05%)  1
POLYARTHRITIS  1  0/5107 (0.00%)  0 0/1829 (0.00%)  0 1/1830 (0.05%)  1
RHABDOMYOLYSIS  1  1/5107 (0.02%)  1 2/1829 (0.11%)  2 0/1830 (0.00%)  0
ROTATOR CUFF SYNDROME  1  0/5107 (0.00%)  0 0/1829 (0.00%)  0 1/1830 (0.05%)  1
SACROILIITIS  1  0/5107 (0.00%)  0 0/1829 (0.00%)  0 1/1830 (0.05%)  1
SOFT TISSUE NECROSIS  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 0/1830 (0.00%)  0
SPINAL COLUMN STENOSIS  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 1/1830 (0.05%)  1
SPINAL INSTABILITY  1  1/5107 (0.02%)  1 0/1829 (0.00%)  0 0/1830 (0.00%)  0
SPINAL LIGAMENT OSSIFICATION  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 0/1830 (0.00%)  0
SPINAL OSTEOARTHRITIS  1  0/5107 (0.00%)  0 3/1829 (0.16%)  5 1/1830 (0.05%)  1
SPONDYLITIS  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 0/1830 (0.00%)  0
SPONDYLOLISTHESIS  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 1/1830 (0.05%)  1
SYMPATHETIC POSTERIOR CERVICAL SYNDROME  1  0/5107 (0.00%)  0 0/1829 (0.00%)  0 1/1830 (0.05%)  1
SYNOVIAL CYST  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 0/1830 (0.00%)  0
SYNOVITIS  1  0/5107 (0.00%)  0 0/1829 (0.00%)  0 1/1830 (0.05%)  1
THORACIC SPINAL STENOSIS  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 0/1830 (0.00%)  0
TORTICOLLIS  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 0/1830 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
ACUTE MYELOID LEUKAEMIA  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 0/1830 (0.00%)  0
ADENOCARCINOMA  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 0/1830 (0.00%)  0
ADENOCARCINOMA GASTRIC  1  0/5107 (0.00%)  0 0/1829 (0.00%)  0 1/1830 (0.05%)  1
ADENOCARCINOMA OF COLON  1  2/5107 (0.04%)  2 3/1829 (0.16%)  3 1/1830 (0.05%)  1
ADENOCARCINOMA PANCREAS  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 0/1830 (0.00%)  0
ADRENAL NEOPLASM  1  0/5107 (0.00%)  0 0/1829 (0.00%)  0 1/1830 (0.05%)  1
ATYPICAL FIBROXANTHOMA  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 0/1830 (0.00%)  0
BASAL CELL CARCINOMA  1  0/5107 (0.00%)  0 0/1829 (0.00%)  0 1/1830 (0.05%)  2
BENIGN NEOPLASM OF BLADDER  1  0/5107 (0.00%)  0 0/1829 (0.00%)  0 1/1830 (0.05%)  2
BENIGN NEOPLASM OF THYROID GLAND  1  0/5107 (0.00%)  0 0/1829 (0.00%)  0 1/1830 (0.05%)  1
BENIGN RENAL NEOPLASM  1  0/5107 (0.00%)  0 0/1829 (0.00%)  0 1/1830 (0.05%)  1
BILE DUCT CANCER  1  0/5107 (0.00%)  0 0/1829 (0.00%)  0 1/1830 (0.05%)  1
BLADDER CANCER  1  1/5107 (0.02%)  1 3/1829 (0.16%)  3 3/1830 (0.16%)  3
BLADDER CANCER RECURRENT  1  0/5107 (0.00%)  0 1/1829 (0.05%)  2 0/1830 (0.00%)  0
BLADDER CANCER STAGE I, WITH CANCER IN SITU  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 0/1830 (0.00%)  0
BLADDER NEOPLASM  1  1/5107 (0.02%)  1 2/1829 (0.11%)  2 3/1830 (0.16%)  3
BLADDER TRANSITIONAL CELL CARCINOMA  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 3/1830 (0.16%)  3
BONE NEOPLASM  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 0/1830 (0.00%)  0
BRAIN NEOPLASM  1  0/5107 (0.00%)  0 2/1829 (0.11%)  2 0/1830 (0.00%)  0
BRAIN NEOPLASM BENIGN  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 0/1830 (0.00%)  0
BREAST CANCER  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 1/1830 (0.05%)  1
BREAST CANCER RECURRENT  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 0/1830 (0.00%)  0
BREAST NEOPLASM  1  1/5107 (0.02%)  1 0/1829 (0.00%)  0 0/1830 (0.00%)  0
BRONCHIAL CARCINOMA  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 0/1830 (0.00%)  0
CARCINOID TUMOUR PULMONARY  1  0/5107 (0.00%)  0 0/1829 (0.00%)  0 1/1830 (0.05%)  1
CHOLANGIOCARCINOMA  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 2/1830 (0.11%)  2
CHRONIC LYMPHOCYTIC LEUKAEMIA  1  1/5107 (0.02%)  1 0/1829 (0.00%)  0 0/1830 (0.00%)  0
COLON ADENOMA  1  1/5107 (0.02%)  1 7/1829 (0.38%)  7 1/1830 (0.05%)  1
COLON CANCER  1  0/5107 (0.00%)  0 3/1829 (0.16%)  3 2/1830 (0.11%)  2
COLON NEOPLASM  1  0/5107 (0.00%)  0 0/1829 (0.00%)  0 1/1830 (0.05%)  1
COLORECTAL CANCER  1  0/5107 (0.00%)  0 0/1829 (0.00%)  0 1/1830 (0.05%)  1
DIFFUSE LARGE B-CELL LYMPHOMA  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 1/1830 (0.05%)  1
ENDOMETRIAL CANCER  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 0/1830 (0.00%)  0
GALLBLADDER CANCER METASTATIC  1  0/5107 (0.00%)  0 0/1829 (0.00%)  0 1/1830 (0.05%)  1
GASTRIC ADENOMA  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 0/1830 (0.00%)  0
GASTRIC CANCER  1  0/5107 (0.00%)  0 3/1829 (0.16%)  4 6/1830 (0.33%)  6
GASTROINTESTINAL TRACT ADENOMA  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 0/1830 (0.00%)  0
GLIOBLASTOMA  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 0/1830 (0.00%)  0
HEPATIC CANCER  1  0/5107 (0.00%)  0 2/1829 (0.11%)  2 0/1830 (0.00%)  0
HEPATOCELLULAR CARCINOMA  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 3/1830 (0.16%)  3
HUERTHLE CELL CARCINOMA  1  1/5107 (0.02%)  1 0/1829 (0.00%)  0 0/1830 (0.00%)  0
INFLAMMATORY PSEUDOTUMOUR  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 0/1830 (0.00%)  0
INTESTINAL ADENOCARCINOMA  1  0/5107 (0.00%)  0 0/1829 (0.00%)  0 1/1830 (0.05%)  1
INTRADUCTAL PROLIFERATIVE BREAST LESION  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 0/1830 (0.00%)  0
LANGERHANS CELL SARCOMA  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 0/1830 (0.00%)  0
LARYNGEAL SQUAMOUS CELL CARCINOMA  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 0/1830 (0.00%)  0
LIPOMA  1  0/5107 (0.00%)  0 0/1829 (0.00%)  0 1/1830 (0.05%)  1
LIPOSARCOMA  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 0/1830 (0.00%)  0
LUNG ADENOCARCINOMA  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 0/1830 (0.00%)  0
LUNG ADENOCARCINOMA STAGE IV  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 0/1830 (0.00%)  0
LUNG CANCER METASTATIC  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 1/1830 (0.05%)  1
LUNG NEOPLASM  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 0/1830 (0.00%)  0
LUNG NEOPLASM MALIGNANT  1  0/5107 (0.00%)  0 2/1829 (0.11%)  2 0/1830 (0.00%)  0
LYMPHOMA  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 0/1830 (0.00%)  0
MALIGNANT PALATE NEOPLASM  1  0/5107 (0.00%)  0 0/1829 (0.00%)  0 1/1830 (0.05%)  1
METASTATIC CARCINOMA OF THE BLADDER  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 0/1830 (0.00%)  0
METASTATIC MALIGNANT MELANOMA  1  1/5107 (0.02%)  1 0/1829 (0.00%)  0 1/1830 (0.05%)  1
METASTATIC NEOPLASM  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 0/1830 (0.00%)  0
MUCINOUS ADENOCARCINOMA OF APPENDIX  1  0/5107 (0.00%)  0 1/1829 (0.05%)  1 0/1830 (0.00%)  0
NASOPHARYNGEAL CANCER  1  1/5107 (0.02%)