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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00345839
Recruitment Status : Completed
First Posted : June 29, 2006
Results First Posted : January 22, 2014
Last Update Posted : April 3, 2019
Sponsor:
Information provided by (Responsible Party):
Amgen

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Secondary Hyperparathyroidism
Chronic Kidney Disease
Interventions Drug: Cinacalcet
Drug: Placebo
Enrollment 3883
Recruitment Details Participants were recruited from dialysis clinics and hospitals between August 2006 to Jan 2008 from 22 countries.
Pre-assignment Details Participants were screened over a 30 day period.
Arm/Group Title Cinacalcet Placebo
Hide Arm/Group Description Cinacalcet administered orally in doses of 30, 60, 90, 120 or 180 mg per day. Participants could be titrated up to maximum dose based on PTH (parathyroid hormone), serum calcium and safety assessments. Participants were given matching placebo tablets compared to the cinacalcet group.
Period Title: Overall Study
Started 1948 [1] 1935 [2]
Completed 1799 [3] 1776 [3]
Not Completed 149 159
Reason Not Completed
Withdrawal by Subject             91             98
Lost to Follow-up             58             61
[1]
Randomized to cinacalcet
[2]
Randomized to placebo
[3]
Participants who completed study includes those with ended study due to death.
Arm/Group Title Cinacalcet Placebo Total
Hide Arm/Group Description Cinacalcet administered orally in doses of 30, 60, 90, 120 or 180 mg per day. Participants could be titrated up to maximum dose based on PTH (parathyroid hormone), serum calcium and safety assessments. Participants were given matching placebo tablets compared to the cinacalcet group. Total of all reporting groups
Overall Number of Baseline Participants 1948 1935 3883
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1948 participants 1935 participants 3883 participants
54.8  (14.5) 54.0  (14.2) 54.4  (14.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1948 participants 1935 participants 3883 participants
Female
809
  41.5%
769
  39.7%
1578
  40.6%
Male
1139
  58.5%
1166
  60.3%
2305
  59.4%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1948 participants 1935 participants 3883 participants
White or Caucasian 1124 1116 2240
Black or African American 409 428 837
Hispanic or Latino 317 310 627
Asian 47 38 85
Japanese 4 1 5
American Indian or Alaska Native 5 7 12
Native Hawaiian or Other Pacific Islander 12 9 21
Aborigine 1 4 5
Other 29 22 51
History of Diabetes Stratification Factor   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1948 participants 1935 participants 3883 participants
Diabetes 619 614 1233
No Diabetes 1329 1321 2650
[1]
Measure Description: History of diabetes stratification factor from the interactive voice response system.
Country stratification factor   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1948 participants 1935 participants 3883 participants
Argentina 171 170 341
Australia 74 75 149
Austria 31 29 60
Belgium 50 50 100
Brazil 151 150 301
Canada 73 73 146
Denmark 8 11 19
France 40 40 80
Germany 81 81 162
Hungary 66 67 133
Ireland 5 6 11
Italy 69 68 137
Mexico 23 22 45
Netherlands 15 14 29
Poland 59 57 116
Portugal 22 21 43
Russia 143 140 283
Spain 40 38 78
Sweden 13 10 23
Switzerland 18 19 37
United Kingdom 81 79 160
United States 715 715 1430
[1]
Measure Description: Country stratification factor from the interactive voice response system. Denmark and Sweden were combined to create Nordic stratum.
1.Primary Outcome
Title Time to Primary Composite Endpoint (All-cause Mortality, Myocardial Infarction, Hospitalization for Unstable Angina, Heart Failure or Peripheral Vascular Event)
Hide Description Time to Primary Composite Endpoint (All-cause Mortality, Myocardial Infarction, Hospitalization for Unstable Angina, Heart Failure or Peripheral Vascular Event). Stratified by history of diabetes and country.
Time Frame From date of randomization until date of first confirmed primary composite endpoint event, assessed up to 5.4 years
Hide Outcome Measure Data
Hide Analysis Population Description
Utilizes the Efficacy Analysis Set which includes all randomized participants. Participants were analyzed in the treatment group as randomized using the Intent-to-treat (ITT) method.
Arm/Group Title Cinacalcet Placebo
Hide Arm/Group Description:
Cinacalcet administered orally in doses of 30, 60, 90, 120 or 180 mg per day. Participants could be titrated up to maximum dose based on PTH (parathyroid hormone), serum calcium and safety assessments.
Participants were given matching placebo tablets compared to the cinacalcet group.
Overall Number of Participants Analyzed 1948 1935
Median (Inter-Quartile Range)
Unit of Measure: Months
55.0 [1] 
(22.6 to NA)
53.0 [1] 
(19.1 to NA)
[1]
NA (Not Applicable) indicates that the parameter is not estimable due to insufficient number of subjects with events.
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cinacalcet, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.112
Comments p-value<0.044 considered significant
Method Log Rank
Comments Stratified by history of diabetes and country. 2-sided test.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Cinacalcet, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Regression, Cox
Comments Stratified by history of diabetes and country.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.93
Confidence Interval (2-Sided) 95%
0.85 to 1.02
Estimation Comments HR is cinacalcet vs placebo.
2.Secondary Outcome
Title Time to All-cause Mortality
Hide Description Time to All-cause Mortality. Stratified by history of diabetes and country.
Time Frame From date of randomization until date of confirmed all-cause mortality endpoint event, assessed up to 5.4 years
Hide Outcome Measure Data
Hide Analysis Population Description
Utilizes the Efficacy Analysis Set which includes all randomized participants. Participants were analyzed in the treatment group as randomized using the Intent-to-treat (ITT) method.
Arm/Group Title Cinacalcet Placebo
Hide Arm/Group Description:
Cinacalcet administered orally in doses of 30, 60, 90, 120 or 180 mg per day. Participants could be titrated up to maximum dose based on PTH (parathyroid hormone), serum calcium and safety assessments.
Participants were given matching placebo tablets compared to the cinacalcet group.
Overall Number of Participants Analyzed 1948 1935
Median (Inter-Quartile Range)
Unit of Measure: Months
NA [1] 
(37.9 to NA)
NA [1] 
(31.6 to NA)
[1]
NA (Not Applicable) indicates that the parameter is not estimable due to insufficient number of subjects with events.
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cinacalcet, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.249
Comments No adjustments for multiple comparisons were made for the components of the primary composite endpoint since the purpose of these analyses is to show how each component contributes to the results of the composite.
Method Log Rank
Comments Stratified by history of diabetes and country. 2-sided test.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Cinacalcet, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Regression, Cox
Comments Stratified by history of diabetes and country.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.94
Confidence Interval (2-Sided) 95%
0.85 to 1.04
Estimation Comments HR is cinacalcet vs placebo.
3.Secondary Outcome
Title Time to Myocardial Infarction
Hide Description Time to Myocardial Infarction. Stratified by history of diabetes and country.
Time Frame From date of randomization until date of first confirmed myocardial infarction endpoint event, assessed up to 5.4 years
Hide Outcome Measure Data
Hide Analysis Population Description
Utilizes the Efficacy Analysis Set which includes all randomized participants. Participants were analyzed in the treatment group as randomized using the Intent-to-treat (ITT) method.
Arm/Group Title Cinacalcet Placebo
Hide Arm/Group Description:
Cinacalcet administered orally in doses of 30, 60, 90, 120 or 180 mg per day. Participants could be titrated up to maximum dose based on PTH (parathyroid hormone), serum calcium and safety assessments.
Participants were given matching placebo tablets compared to the cinacalcet group.
Overall Number of Participants Analyzed 1948 1935
Median (Inter-Quartile Range)
Unit of Measure: Months
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
NA (Not Applicable) indicates that the parameter is not estimable due to insufficient number of subjects with events.
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cinacalcet, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.800
Comments No adjustments for multiple comparisons were made for the components of the primary composite endpoint since the purpose of these analyses is to show how each component contributes to the results of the composite.
Method Log Rank
Comments Stratified by history of diabetes and country. 2-sided test.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Cinacalcet, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Regression, Cox
Comments Stratified by history of diabetes and country.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.97
Confidence Interval (2-Sided) 95%
0.79 to 1.19
Estimation Comments HR is cinacalcet vs placebo.
4.Secondary Outcome
Title Time to Hospitalization for Unstable Angina
Hide Description Time to Hospitalization for Unstable Angina. Stratified by history of diabetes and country.
Time Frame From date of randomization until date of first confirmed hospitalization for unstable angina endpoint event, assessed up to 5.4 years
Hide Outcome Measure Data
Hide Analysis Population Description
Utilizes the Efficacy Analysis Set which includes all randomized participants. Participants were analyzed in the treatment group as randomized using the Intent-to-treat (ITT) method.
Arm/Group Title Cinacalcet Placebo
Hide Arm/Group Description:
Cinacalcet administered orally in doses of 30, 60, 90, 120 or 180 mg per day. Participants could be titrated up to maximum dose based on PTH (parathyroid hormone), serum calcium and safety assessments.
Participants were given matching placebo tablets compared to the cinacalcet group.
Overall Number of Participants Analyzed 1948 1935
Median (Inter-Quartile Range)
Unit of Measure: Months
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
NA (Not Applicable) indicates that the parameter is not estimable due to insufficient number of subjects with events.
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cinacalcet, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.283
Comments No adjustments for multiple comparisons were made for the components of the primary composite endpoint since the purpose of these analyses is to show how each component contributes to the results of the composite.
Method Log Rank
Comments Stratified by history of diabetes and country. 2-sided test.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Cinacalcet, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Regression, Cox
Comments Stratified by history of diabetes and country.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.82
Confidence Interval (2-Sided) 95%
0.58 to 1.18
Estimation Comments HR is cinacalcet vs placebo.
5.Secondary Outcome
Title Time to Heart Failure
Hide Description Time to Heart Failure. Stratified by history of diabetes and country.
Time Frame From date of randomization until date of first confirmed heart failure endpoint event, assessed up to 5.4 years
Hide Outcome Measure Data
Hide Analysis Population Description
Utilizes the Efficacy Analysis Set which includes all randomized participants. Participants were analyzed in the treatment group as randomized using the Intent-to-treat (ITT) method.
Arm/Group Title Cinacalcet Placebo
Hide Arm/Group Description:
Cinacalcet administered orally in doses of 30, 60, 90, 120 or 180 mg per day. Participants could be titrated up to maximum dose based on PTH (parathyroid hormone), serum calcium and safety assessments.
Participants were given matching placebo tablets compared to the cinacalcet group.
Overall Number of Participants Analyzed 1948 1935
Median (Inter-Quartile Range)
Unit of Measure: Months
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
NA (Not Applicable) indicates that the parameter is not estimable due to insufficient number of subjects with events.
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cinacalcet, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.034
Comments No adjustments for multiple comparisons were made for the components of the primary composite endpoint since the purpose of these analyses is to show how each component contributes to the results of the composite.
Method Log Rank
Comments Stratified by history of diabetes and country. 2-sided test.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Cinacalcet, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Regression, Cox
Comments Stratified by history of diabetes and country.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.82
Confidence Interval (2-Sided) 95%
0.68 to 0.99
Estimation Comments HR is cinacalcet vs placebo.
6.Secondary Outcome
Title Time to Peripheral Vascular Event
Hide Description Time to Peripheral Vascular Event. Stratified by history of diabetes and country.
Time Frame From date of randomization until date of first confirmed peripheral vascular endpoint event, assessed up to 5.4 years
Hide Outcome Measure Data
Hide Analysis Population Description
Utilizes the Efficacy Analysis Set which includes all randomized participants. Participants were analyzed in the treatment group as randomized using the Intent-to-treat (ITT) method.
Arm/Group Title Cinacalcet Placebo
Hide Arm/Group Description:
Cinacalcet administered orally in doses of 30, 60, 90, 120 or 180 mg per day. Participants could be titrated up to maximum dose based on PTH (parathyroid hormone), serum calcium and safety assessments.
Participants were given matching placebo tablets compared to the cinacalcet group.
Overall Number of Participants Analyzed 1948 1935
Median (Inter-Quartile Range)
Unit of Measure: Months
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
NA (Not Applicable) indicates that the parameter is not estimable due to insufficient number of subjects with events.
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cinacalcet, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.190
Comments No adjustments for multiple comparisons were made for the components of the primary composite endpoint since the purpose of these analyses is to show how each component contributes to the results of the composite.
Method Log Rank
Comments Stratified by history of diabetes and country. 2-sided test.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Cinacalcet, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Regression, Cox
Comments Stratified by history of diabetes and country.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.87
Confidence Interval (2-Sided) 95%
0.72 to 1.07
Estimation Comments HR is cinacalcet vs placebo.
7.Secondary Outcome
Title Time to Cardiovascular Mortality
Hide Description Time to Cardiovascular Mortality. Stratified by history of diabetes and country.
Time Frame From date of randomization until date of first confirmed cardiovascular mortality endpoint event, assessed up to 5.4 years
Hide Outcome Measure Data
Hide Analysis Population Description
Utilizes the Efficacy Analysis Set which includes all randomized participants. Participants were analyzed in the treatment group as randomized using the Intent-to-treat (ITT) method.
Arm/Group Title Cinacalcet Placebo
Hide Arm/Group Description:
Cinacalcet administered orally in doses of 30, 60, 90, 120 or 180 mg per day. Participants could be titrated up to maximum dose based on PTH (parathyroid hormone), serum calcium and safety assessments.
Participants were given matching placebo tablets compared to the cinacalcet group.
Overall Number of Participants Analyzed 1948 1935
Median (Inter-Quartile Range)
Unit of Measure: Months
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
NA (Not Applicable) indicates that the parameter is not estimable due to insufficient number of subjects with events.
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cinacalcet, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.277
Comments No adjustments for multiple comparisons were made for this endpoint.
Method Log Rank
Comments Stratified by history of diabetes and country. 2-sided test.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Cinacalcet, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Regression, Cox
Comments Stratified by history of diabetes and country.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.92
Confidence Interval (2-Sided) 95%
0.80 to 1.07
Estimation Comments HR is cinacalcet vs placebo.
8.Secondary Outcome
Title Time to Stroke
Hide Description Time to Stroke. Stratified by history of diabetes and country.
Time Frame From date of randomization until date of first confirmed stroke endpoint event, assessed up to 5.4 years
Hide Outcome Measure Data
Hide Analysis Population Description
Utilizes the Efficacy Analysis Set which includes all randomized participants. Participants were analyzed in the treatment group as randomized using the Intent-to-treat (ITT) method.
Arm/Group Title Cinacalcet Placebo
Hide Arm/Group Description:
Cinacalcet administered orally in doses of 30, 60, 90, 120 or 180 mg per day. Participants could be titrated up to maximum dose based on PTH (parathyroid hormone), serum calcium and safety assessments.
Participants were given matching placebo tablets compared to the cinacalcet group.
Overall Number of Participants Analyzed 1948 1935
Median (Inter-Quartile Range)
Unit of Measure: Months
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
NA (Not Applicable) indicates that the parameter is not estimable due to insufficient number of subjects with events.
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cinacalcet, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.607
Comments No adjustments for multiple comparisons were made for this endpoint.
Method Log Rank
Comments Stratified by history of diabetes and country. 2-sided test.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Cinacalcet, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Regression, Cox
Comments Stratified by history of diabetes and country.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.07
Confidence Interval (2-Sided) 95%
0.82 to 1.40
Estimation Comments HR is cinacalcet vs placebo.
9.Secondary Outcome
Title Time to Bone Fracture
Hide Description Time to Bone Fracture. Stratified by history of diabetes and country.
Time Frame From date of randomization until date of first confirmed bone fracture endpoint event, assessed up to 5.4 years
Hide Outcome Measure Data
Hide Analysis Population Description
Utilizes the Efficacy Analysis Set which includes all randomized participants. Participants were analyzed in the treatment group as randomized using the Intent-to-treat (ITT) method.
Arm/Group Title Cinacalcet Placebo
Hide Arm/Group Description:
Cinacalcet administered orally in doses of 30, 60, 90, 120 or 180 mg per day. Participants could be titrated up to maximum dose based on PTH (parathyroid hormone), serum calcium and safety assessments.
Participants were given matching placebo tablets compared to the cinacalcet group.
Overall Number of Participants Analyzed 1948 1935
Median (Inter-Quartile Range)
Unit of Measure: Months
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
NA (Not Applicable) indicates that the parameter is not estimable due to insufficient number of subjects with events.
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cinacalcet, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.218
Comments No adjustments for multiple comparisons were made for this endpoint.
Method Log Rank
Comments Stratified by history of diabetes and country. 2-sided test.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Cinacalcet, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Regression, Cox
Comments Stratified by history of diabetes and country.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.89
Confidence Interval (2-Sided) 95%
0.75 to 1.07
Estimation Comments HR is cinacalcet vs placebo.
10.Secondary Outcome
Title Time to Parathyroidectomy
Hide Description Time to Parathyroidectomy. Stratified by history of diabetes and country.
Time Frame From date of randomization until date of first confirmed parathyroidectomy endpoint event, assessed up to 5.4 years
Hide Outcome Measure Data
Hide Analysis Population Description
Utilizes the Efficacy Analysis Set which includes all randomized participants. Participants were analyzed in the treatment group as randomized using the Intent-to-treat (ITT) method.
Arm/Group Title Cinacalcet Placebo
Hide Arm/Group Description:
Cinacalcet administered orally in doses of 30, 60, 90, 120 or 180 mg per day. Participants could be titrated up to maximum dose based on PTH (parathyroid hormone), serum calcium and safety assessments.
Participants were given matching placebo tablets compared to the cinacalcet group.
Overall Number of Participants Analyzed 1948 1935
Median (Inter-Quartile Range)
Unit of Measure: Months
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
NA (Not Applicable) indicates that the parameter is not estimable due to insufficient number of subjects with events.
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cinacalcet, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments No adjustments for multiple comparisons were made for this endpoint.
Method Log Rank
Comments Stratified by history of diabetes and country. 2-sided test.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Cinacalcet, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Regression, Cox
Comments Stratified by history of diabetes and country.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.44
Confidence Interval (2-Sided) 95%
0.36 to 0.54
Estimation Comments HR is cinacalcet vs placebo.
Time Frame Average 24 months
Adverse Event Reporting Description The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. The number of participants at risk includes subjects who received at least 1 dose of investigational product.
 
Arm/Group Title Placebo Cinacalcet
Hide Arm/Group Description [Not Specified] Cinacalcet administered orally in doses of 30, 60, 90, 120 or 180 mg per day. Participants could be titrated up to maximum dose based on PTH (parathyroid hormone), serum calcium and safety assessments.
All-Cause Mortality
Placebo Cinacalcet
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Placebo Cinacalcet
Affected / at Risk (%) Affected / at Risk (%)
Total   1351/1923 (70.25%)   1338/1938 (69.04%) 
Blood and lymphatic system disorders     
Anaemia  1  35/1923 (1.82%)  42/1938 (2.17%) 
Coagulopathy  1  1/1923 (0.05%)  2/1938 (0.10%) 
Febrile neutropenia  1  1/1923 (0.05%)  0/1938 (0.00%) 
Haemolysis  1  1/1923 (0.05%)  0/1938 (0.00%) 
Haemolytic anaemia  1  0/1923 (0.00%)  1/1938 (0.05%) 
Haemorrhagic anaemia  1  4/1923 (0.21%)  5/1938 (0.26%) 
Haemorrhagic disorder  1  0/1923 (0.00%)  1/1938 (0.05%) 
Leukocytosis  1  0/1923 (0.00%)  4/1938 (0.21%) 
Leukopenia  1  1/1923 (0.05%)  2/1938 (0.10%) 
Lymphadenitis  1  1/1923 (0.05%)  0/1938 (0.00%) 
Lymphadenopathy  1  1/1923 (0.05%)  1/1938 (0.05%) 
Lymphatic disorder  1  1/1923 (0.05%)  0/1938 (0.00%) 
Nephrogenic anaemia  1  1/1923 (0.05%)  0/1938 (0.00%) 
Neutropenia  1  0/1923 (0.00%)  2/1938 (0.10%) 
Pancytopenia  1  4/1923 (0.21%)  2/1938 (0.10%) 
Polycythaemia  1  1/1923 (0.05%)  1/1938 (0.05%) 
Retroperitoneal lymphadenopathy  1  1/1923 (0.05%)  0/1938 (0.00%) 
Splenic infarction  1  1/1923 (0.05%)  0/1938 (0.00%) 
Splenomegaly  1  2/1923 (0.10%)  0/1938 (0.00%) 
Thrombocytopenia  1  7/1923 (0.36%)  3/1938 (0.15%) 
Thrombocytopenic purpura  1  1/1923 (0.05%)  0/1938 (0.00%) 
Cardiac disorders     
Acute coronary syndrome  1  14/1923 (0.73%)  6/1938 (0.31%) 
Acute left ventricular failure  1  3/1923 (0.16%)  0/1938 (0.00%) 
Acute myocardial infarction  1  34/1923 (1.77%)  47/1938 (2.43%) 
Angina pectoris  1  42/1923 (2.18%)  36/1938 (1.86%) 
Angina unstable  1  42/1923 (2.18%)  52/1938 (2.68%) 
Aortic valve incompetence  1  1/1923 (0.05%)  1/1938 (0.05%) 
Aortic valve stenosis  1  2/1923 (0.10%)  7/1938 (0.36%) 
Arrhythmia  1  17/1923 (0.88%)  8/1938 (0.41%) 
Arrhythmia supraventricular  1  2/1923 (0.10%)  1/1938 (0.05%) 
Arteriosclerosis coronary artery  1  8/1923 (0.42%)  4/1938 (0.21%) 
Atrial fibrillation  1  68/1923 (3.54%)  56/1938 (2.89%) 
Atrial flutter  1  10/1923 (0.52%)  12/1938 (0.62%) 
Atrial tachycardia  1  0/1923 (0.00%)  1/1938 (0.05%) 
Atrioventricular block  1  3/1923 (0.16%)  5/1938 (0.26%) 
Atrioventricular block complete  1  7/1923 (0.36%)  6/1938 (0.31%) 
Atrioventricular block first degree  1  1/1923 (0.05%)  0/1938 (0.00%) 
Atrioventricular block second degree  1  2/1923 (0.10%)  1/1938 (0.05%) 
Atrioventricular dissociation  1  1/1923 (0.05%)  1/1938 (0.05%) 
Bradyarrhythmia  1  2/1923 (0.10%)  2/1938 (0.10%) 
Bradycardia  1  9/1923 (0.47%)  12/1938 (0.62%) 
Bundle branch block  1  0/1923 (0.00%)  1/1938 (0.05%) 
Bundle branch block right  1  1/1923 (0.05%)  0/1938 (0.00%) 
Cardiac arrest  1  57/1923 (2.96%)  60/1938 (3.10%) 
Cardiac disorder  1  1/1923 (0.05%)  0/1938 (0.00%) 
Cardiac failure  1  90/1923 (4.68%)  74/1938 (3.82%) 
Cardiac failure acute  1  4/1923 (0.21%)  6/1938 (0.31%) 
Cardiac failure chronic  1  5/1923 (0.26%)  4/1938 (0.21%) 
Cardiac failure congestive  1  86/1923 (4.47%)  64/1938 (3.30%) 
Cardiac flutter  1  1/1923 (0.05%)  0/1938 (0.00%) 
Cardiac tamponade  1  1/1923 (0.05%)  1/1938 (0.05%) 
Cardiac valve disease  1  2/1923 (0.10%)  0/1938 (0.00%) 
Cardio-respiratory arrest  1  21/1923 (1.09%)  27/1938 (1.39%) 
Cardiogenic shock  1  8/1923 (0.42%)  12/1938 (0.62%) 
Cardiomyopathy  1  7/1923 (0.36%)  6/1938 (0.31%) 
Cardiopulmonary failure  1  6/1923 (0.31%)  6/1938 (0.31%) 
Cardiovascular disorder  1  0/1923 (0.00%)  1/1938 (0.05%) 
Cardiovascular insufficiency  1  1/1923 (0.05%)  1/1938 (0.05%) 
Congestive cardiomyopathy  1  4/1923 (0.21%)  1/1938 (0.05%) 
Coronary artery disease  1  23/1923 (1.20%)  28/1938 (1.44%) 
Coronary artery insufficiency  1  0/1923 (0.00%)  1/1938 (0.05%) 
Coronary artery occlusion  1  1/1923 (0.05%)  1/1938 (0.05%) 
Coronary artery stenosis  1  4/1923 (0.21%)  5/1938 (0.26%) 
Diastolic dysfunction  1  1/1923 (0.05%)  1/1938 (0.05%) 
Dilatation ventricular  1  0/1923 (0.00%)  1/1938 (0.05%) 
Gastrocardiac syndrome  1  1/1923 (0.05%)  0/1938 (0.00%) 
Heart valve stenosis  1  1/1923 (0.05%)  0/1938 (0.00%) 
Hypertensive heart disease  1  2/1923 (0.10%)  0/1938 (0.00%) 
Ischaemic cardiomyopathy  1  4/1923 (0.21%)  2/1938 (0.10%) 
Left ventricular dysfunction  1  0/1923 (0.00%)  2/1938 (0.10%) 
Left ventricular failure  1  6/1923 (0.31%)  1/1938 (0.05%) 
Left ventricular hypertrophy  1  1/1923 (0.05%)  0/1938 (0.00%) 
Mitral valve calcification  1  0/1923 (0.00%)  1/1938 (0.05%) 
Mitral valve disease  1  0/1923 (0.00%)  2/1938 (0.10%) 
Mitral valve incompetence  1  3/1923 (0.16%)  2/1938 (0.10%) 
Mitral valve stenosis  1  3/1923 (0.16%)  2/1938 (0.10%) 
Myocardial infarction  1  105/1923 (5.46%)  109/1938 (5.62%) 
Myocardial ischaemia  1  10/1923 (0.52%)  11/1938 (0.57%) 
Myocarditis  1  1/1923 (0.05%)  0/1938 (0.00%) 
Palpitations  1  4/1923 (0.21%)  6/1938 (0.31%) 
Pericardial effusion  1  5/1923 (0.26%)  8/1938 (0.41%) 
Pericardial haemorrhage  1  1/1923 (0.05%)  0/1938 (0.00%) 
Pericarditis  1  2/1923 (0.10%)  3/1938 (0.15%) 
Pericarditis uraemic  1  2/1923 (0.10%)  2/1938 (0.10%) 
Pulseless electrical activity  1  5/1923 (0.26%)  2/1938 (0.10%) 
Right ventricular failure  1  1/1923 (0.05%)  2/1938 (0.10%) 
Sick sinus syndrome  1  3/1923 (0.16%)  3/1938 (0.15%) 
Sinus bradycardia  1  1/1923 (0.05%)  0/1938 (0.00%) 
Sinus tachycardia  1  0/1923 (0.00%)  2/1938 (0.10%) 
Supraventricular extrasystoles  1  0/1923 (0.00%)  1/1938 (0.05%) 
Supraventricular tachyarrhythmia  1  1/1923 (0.05%)  0/1938 (0.00%) 
Supraventricular tachycardia  1  6/1923 (0.31%)  6/1938 (0.31%) 
Tachyarrhythmia  1  1/1923 (0.05%)  0/1938 (0.00%) 
Tachycardia  1  6/1923 (0.31%)  6/1938 (0.31%) 
Tricuspid valve incompetence  1  1/1923 (0.05%)  1/1938 (0.05%) 
Tricuspid valve stenosis  1  1/1923 (0.05%)  0/1938 (0.00%) 
Ventricular arrhythmia  1  5/1923 (0.26%)  3/1938 (0.15%) 
Ventricular extrasystoles  1  1/1923 (0.05%)  1/1938 (0.05%) 
Ventricular failure  1  1/1923 (0.05%)  0/1938 (0.00%) 
Ventricular fibrillation  1  9/1923 (0.47%)  6/1938 (0.31%) 
Ventricular tachyarrhythmia  1  0/1923 (0.00%)  1/1938 (0.05%) 
Ventricular tachycardia  1  5/1923 (0.26%)  12/1938 (0.62%) 
Congenital, familial and genetic disorders     
Adenomatous polyposis coli  1  0/1923 (0.00%)  1/1938 (0.05%) 
Congenital cystic disease of liver  1  1/1923 (0.05%)  0/1938 (0.00%) 
Congenital cystic kidney disease  1  3/1923 (0.16%)  6/1938 (0.31%) 
Gastrointestinal arteriovenous malformation  1  1/1923 (0.05%)  2/1938 (0.10%) 
Left ventricle outflow tract obstruction  1  0/1923 (0.00%)  1/1938 (0.05%) 
Ear and labyrinth disorders     
Aural polyp  1  1/1923 (0.05%)  0/1938 (0.00%) 
Deafness unilateral  1  1/1923 (0.05%)  0/1938 (0.00%) 
Meniere's disease  1  0/1923 (0.00%)  1/1938 (0.05%) 
Vertigo  1  2/1923 (0.10%)  4/1938 (0.21%) 
Vertigo positional  1  0/1923 (0.00%)  1/1938 (0.05%) 
Vestibular disorder  1  0/1923 (0.00%)  1/1938 (0.05%) 
Endocrine disorders     
Adrenal insufficiency  1  0/1923 (0.00%)  1/1938 (0.05%) 
Goitre  1  1/1923 (0.05%)  0/1938 (0.00%) 
Hyperparathyroidism  1  86/1923 (4.47%)  23/1938 (1.19%) 
Hyperparathyroidism secondary  1  41/1923 (2.13%)  12/1938 (0.62%) 
Hyperparathyroidism tertiary  1  8/1923 (0.42%)  2/1938 (0.10%) 
Hyperthyroidism  1  2/1923 (0.10%)  1/1938 (0.05%) 
Parathyroid disorder  1  1/1923 (0.05%)  0/1938 (0.00%) 
Parathyroid gland enlargement  1  1/1923 (0.05%)  2/1938 (0.10%) 
Parathyroid haemorrhage  1  1/1923 (0.05%)  0/1938 (0.00%) 
Secondary hyperthyroidism  1  1/1923 (0.05%)  0/1938 (0.00%) 
Thyroid cyst  1  0/1923 (0.00%)  1/1938 (0.05%) 
Thyroiditis  1  0/1923 (0.00%)  1/1938 (0.05%) 
Eye disorders     
Age-related macular degeneration  1  0/1923 (0.00%)  1/1938 (0.05%) 
Cataract  1  5/1923 (0.26%)  8/1938 (0.41%) 
Cataract cortical  1  0/1923 (0.00%)  1/1938 (0.05%) 
Conjunctival haemorrhage  1  1/1923 (0.05%)  0/1938 (0.00%) 
Conjunctivitis  1  0/1923 (0.00%)  2/1938 (0.10%) 
Diabetic retinopathy  1  0/1923 (0.00%)  1/1938 (0.05%) 
Diplopia  1  1/1923 (0.05%)  1/1938 (0.05%) 
Exophthalmos  1  0/1923 (0.00%)  1/1938 (0.05%) 
Eye haemorrhage  1  0/1923 (0.00%)  3/1938 (0.15%) 
Glaucoma  1  1/1923 (0.05%)  0/1938 (0.00%) 
Keratitis  1  1/1923 (0.05%)  0/1938 (0.00%) 
Optic atrophy  1  0/1923 (0.00%)  1/1938 (0.05%) 
Optic ischaemic neuropathy  1  1/1923 (0.05%)  0/1938 (0.00%) 
Papilloedema  1  1/1923 (0.05%)  0/1938 (0.00%) 
Photopsia  1  1/1923 (0.05%)  0/1938 (0.00%) 
Retinal artery occlusion  1  1/1923 (0.05%)  0/1938 (0.00%) 
Retinal detachment  1  0/1923 (0.00%)  3/1938 (0.15%) 
Retinal vein thrombosis  1  0/1923 (0.00%)  1/1938 (0.05%) 
Retinopathy hypertensive  1  0/1923 (0.00%)  1/1938 (0.05%) 
Vision blurred  1  1/1923 (0.05%)  0/1938 (0.00%) 
Visual impairment  1  0/1923 (0.00%)  1/1938 (0.05%) 
Vitreous haemorrhage  1  1/1923 (0.05%)  2/1938 (0.10%) 
Gastrointestinal disorders     
Abdominal discomfort  1  3/1923 (0.16%)  1/1938 (0.05%) 
Abdominal distension  1  0/1923 (0.00%)  1/1938 (0.05%) 
Abdominal hernia  1  4/1923 (0.21%)  4/1938 (0.21%) 
Abdominal hernia obstructive  1  0/1923 (0.00%)  1/1938 (0.05%) 
Abdominal pain  1  42/1923 (2.18%)  33/1938 (1.70%) 
Abdominal pain lower  1  2/1923 (0.10%)  1/1938 (0.05%) 
Abdominal pain upper  1  1/1923 (0.05%)  5/1938 (0.26%) 
Abdominal rigidity  1  0/1923 (0.00%)  1/1938 (0.05%) 
Abdominal strangulated hernia  1  0/1923 (0.00%)  2/1938 (0.10%) 
Anal fistula  1  1/1923 (0.05%)  0/1938 (0.00%) 
Ascites  1  7/1923 (0.36%)  3/1938 (0.15%) 
Barrett's oesophagus  1  0/1923 (0.00%)  1/1938 (0.05%) 
Colitis  1  7/1923 (0.36%)  5/1938 (0.26%) 
Colitis ischaemic  1  3/1923 (0.16%)  9/1938 (0.46%) 
Colitis ulcerative  1  1/1923 (0.05%)  1/1938 (0.05%) 
Colonic polyp  1  7/1923 (0.36%)  2/1938 (0.10%) 
Colonic pseudo-obstruction  1  1/1923 (0.05%)  0/1938 (0.00%) 
Constipation  1  3/1923 (0.16%)  8/1938 (0.41%) 
Dental caries  1  1/1923 (0.05%)  0/1938 (0.00%) 
Diabetic gastroparesis  1  0/1923 (0.00%)  2/1938 (0.10%) 
Diarrhoea  1  24/1923 (1.25%)  32/1938 (1.65%) 
Diarrhoea haemorrhagic  1  1/1923 (0.05%)  0/1938 (0.00%) 
Dieulafoy's vascular malformation  1  0/1923 (0.00%)  1/1938 (0.05%) 
Diverticular perforation  1  1/1923 (0.05%)  2/1938 (0.10%) 
Diverticulum  1  0/1923 (0.00%)  1/1938 (0.05%) 
Diverticulum intestinal  1  2/1923 (0.10%)  0/1938 (0.00%) 
Diverticulum intestinal haemorrhagic  1  1/1923 (0.05%)  0/1938 (0.00%) 
Duodenal perforation  1  2/1923 (0.10%)  0/1938 (0.00%) 
Duodenal ulcer  1  4/1923 (0.21%)  7/1938 (0.36%) 
Duodenal ulcer haemorrhage  1  1/1923 (0.05%)  0/1938 (0.00%) 
Duodenitis  1  4/1923 (0.21%)  2/1938 (0.10%) 
Duodenitis haemorrhagic  1  1/1923 (0.05%)  0/1938 (0.00%) 
Dyspepsia  1  0/1923 (0.00%)  3/1938 (0.15%) 
Dysphagia  1  2/1923 (0.10%)  3/1938 (0.15%) 
Enteritis  1  1/1923 (0.05%)  5/1938 (0.26%) 
Enterocolitis  1  1/1923 (0.05%)  1/1938 (0.05%) 
Erosive duodenitis  1  1/1923 (0.05%)  1/1938 (0.05%) 
Erosive oesophagitis  1  0/1923 (0.00%)  1/1938 (0.05%) 
Faecaloma  1  1/1923 (0.05%)  3/1938 (0.15%) 
Faeces discoloured  1  1/1923 (0.05%)  1/1938 (0.05%) 
Gastric antral vascular ectasia  1  1/1923 (0.05%)  0/1938 (0.00%) 
Gastric haemorrhage  1  4/1923 (0.21%)  1/1938 (0.05%) 
Gastric hypermotility  1  0/1923 (0.00%)  1/1938 (0.05%) 
Gastric perforation  1  2/1923 (0.10%)  0/1938 (0.00%) 
Gastric polyps  1  1/1923 (0.05%)  1/1938 (0.05%) 
Gastric ulcer  1  6/1923 (0.31%)  12/1938 (0.62%) 
Gastric ulcer haemorrhage  1  0/1923 (0.00%)  2/1938 (0.10%) 
Gastritis  1  15/1923 (0.78%)  10/1938 (0.52%) 
Gastritis erosive  1  6/1923 (0.31%)  5/1938 (0.26%) 
Gastritis haemorrhagic  1  0/1923 (0.00%)  1/1938 (0.05%) 
Gastroduodenitis  1  0/1923 (0.00%)  1/1938 (0.05%) 
Gastrointestinal angiodysplasia  1  0/1923 (0.00%)  2/1938 (0.10%) 
Gastrointestinal haemorrhage  1  53/1923 (2.76%)  54/1938 (2.79%) 
Gastrointestinal hypomotility  1  1/1923 (0.05%)  0/1938 (0.00%) 
Gastrointestinal inflammation  1  1/1923 (0.05%)  2/1938 (0.10%) 
Gastrointestinal necrosis  1  2/1923 (0.10%)  0/1938 (0.00%) 
Gastrointestinal obstruction  1  1/1923 (0.05%)  0/1938 (0.00%) 
Gastrointestinal oedema  1  1/1923 (0.05%)  0/1938 (0.00%) 
Gastrointestinal perforation  1  2/1923 (0.10%)  0/1938 (0.00%) 
Gastrointestinal ulcer haemorrhage  1  0/1923 (0.00%)  1/1938 (0.05%) 
Gastrooesophageal reflux disease  1  2/1923 (0.10%)  4/1938 (0.21%) 
Haematemesis  1  3/1923 (0.16%)  5/1938 (0.26%) 
Haematochezia  1  2/1923 (0.10%)  2/1938 (0.10%) 
Haemorrhagic erosive gastritis  1  0/1923 (0.00%)  1/1938 (0.05%) 
Haemorrhoidal haemorrhage  1  2/1923 (0.10%)  2/1938 (0.10%) 
Haemorrhoids  1  2/1923 (0.10%)  5/1938 (0.26%) 
Hernial eventration  1  0/1923 (0.00%)  1/1938 (0.05%) 
Hiatus hernia  1  1/1923 (0.05%)  2/1938 (0.10%) 
Ileus  1  4/1923 (0.21%)  6/1938 (0.31%) 
Impaired gastric emptying  1  2/1923 (0.10%)  6/1938 (0.31%) 
Inguinal hernia  1  2/1923 (0.10%)  1/1938 (0.05%) 
Intestinal haemorrhage  1  0/1923 (0.00%)  2/1938 (0.10%) 
Intestinal infarction  1  3/1923 (0.16%)  3/1938 (0.15%) 
Intestinal ischaemia  1  6/1923 (0.31%)  9/1938 (0.46%) 
Intestinal mass  1  0/1923 (0.00%)  1/1938 (0.05%) 
Intestinal obstruction  1  3/1923 (0.16%)  5/1938 (0.26%) 
Intestinal perforation  1  0/1923 (0.00%)  1/1938 (0.05%) 
Intestinal polyp  1  1/1923 (0.05%)  0/1938 (0.00%) 
Intestinal strangulation  1  1/1923 (0.05%)  0/1938 (0.00%) 
Intestinal ulcer  1  0/1923 (0.00%)  1/1938 (0.05%) 
Intra-abdominal haemorrhage  1  1/1923 (0.05%)  1/1938 (0.05%) 
Irritable bowel syndrome  1  0/1923 (0.00%)  1/1938 (0.05%) 
Ischaemic gastritis  1  0/1923 (0.00%)  1/1938 (0.05%) 
Large intestinal haemorrhage  1  1/1923 (0.05%)  0/1938 (0.00%) 
Large intestinal ulcer  1  0/1923 (0.00%)  1/1938 (0.05%) 
Large intestine perforation  1  4/1923 (0.21%)  1/1938 (0.05%) 
Lower gastrointestinal haemorrhage  1  5/1923 (0.26%)  3/1938 (0.15%) 
Lumbar hernia  1  0/1923 (0.00%)  1/1938 (0.05%) 
Mechanical ileus  1  0/1923 (0.00%)  1/1938 (0.05%) 
Melaena  1  2/1923 (0.10%)  3/1938 (0.15%) 
Mesenteric artery stenosis  1  0/1923 (0.00%)  2/1938 (0.10%) 
Nausea  1  16/1923 (0.83%)  20/1938 (1.03%) 
Necrotising colitis  1  0/1923 (0.00%)  1/1938 (0.05%) 
Oesophageal achalasia  1  0/1923 (0.00%)  1/1938 (0.05%) 
Oesophageal disorder  1  1/1923 (0.05%)  0/1938 (0.00%) 
Oesophageal food impaction  1  0/1923 (0.00%)  1/1938 (0.05%) 
Oesophageal haemorrhage  1  1/1923 (0.05%)  0/1938 (0.00%) 
Oesophageal perforation  1  0/1923 (0.00%)  1/1938 (0.05%) 
Oesophageal rupture  1  1/1923 (0.05%)  0/1938 (0.00%) 
Oesophageal ulcer  1  2/1923 (0.10%)  0/1938 (0.00%) 
Oesophagitis  1  3/1923 (0.16%)  6/1938 (0.31%) 
Oesophagitis haemorrhagic  1  0/1923 (0.00%)  1/1938 (0.05%) 
Pancreatic mass  1  1/1923 (0.05%)  0/1938 (0.00%) 
Pancreatitis  1  11/1923 (0.57%)  10/1938 (0.52%) 
Pancreatitis acute  1  9/1923 (0.47%)  7/1938 (0.36%) 
Pancreatitis chronic  1  1/1923 (0.05%)  2/1938 (0.10%) 
Peptic ulcer  1  2/1923 (0.10%)  1/1938 (0.05%) 
Peptic ulcer haemorrhage  1  0/1923 (0.00%)  1/1938 (0.05%) 
Peritoneal disorder  1  1/1923 (0.05%)  0/1938 (0.00%) 
Portal hypertensive enteropathy  1  1/1923 (0.05%)  0/1938 (0.00%) 
Portal hypertensive gastropathy  1  1/1923 (0.05%)  0/1938 (0.00%) 
Proctitis  1  1/1923 (0.05%)  0/1938 (0.00%) 
Rectal haemorrhage  1  12/1923 (0.62%)  12/1938 (0.62%) 
Rectal ulcer  1  1/1923 (0.05%)  1/1938 (0.05%) 
Rectal ulcer haemorrhage  1  1/1923 (0.05%)  0/1938 (0.00%) 
Retroperitoneal haematoma  1  2/1923 (0.10%)  2/1938 (0.10%) 
Retroperitoneal haemorrhage  1  0/1923 (0.00%)  1/1938 (0.05%) 
Retroperitoneal mass  1  1/1923 (0.05%)  0/1938 (0.00%) 
Short-bowel syndrome  1  0/1923 (0.00%)  1/1938 (0.05%) 
Sigmoiditis  1  1/1923 (0.05%)  0/1938 (0.00%) 
Small intestinal obstruction  1  2/1923 (0.10%)  5/1938 (0.26%) 
Stomach mass  1  0/1923 (0.00%)  1/1938 (0.05%) 
Stress ulcer  1  0/1923 (0.00%)  1/1938 (0.05%) 
Subileus  1  0/1923 (0.00%)  1/1938 (0.05%) 
Tooth loss  1  0/1923 (0.00%)  1/1938 (0.05%) 
Tooth socket haemorrhage  1  0/1923 (0.00%)  1/1938 (0.05%) 
Toothache  1  2/1923 (0.10%)  0/1938 (0.00%) 
Umbilical hernia  1  3/1923 (0.16%)  1/1938 (0.05%) 
Umbilical hernia, obstructive  1  1/1923 (0.05%)  0/1938 (0.00%) 
Upper gastrointestinal haemorrhage  1  8/1923 (0.42%)  11/1938 (0.57%) 
Uraemic gastropathy  1  1/1923 (0.05%)  0/1938 (0.00%) 
Varices oesophageal  1  2/1923 (0.10%)  0/1938 (0.00%) 
Vomiting  1  23/1923 (1.20%)  33/1938 (1.70%) 
General disorders     
Adverse drug reaction  1  1/1923 (0.05%)  1/1938 (0.05%) 
Asthenia  1  20/1923 (1.04%)  15/1938 (0.77%) 
Calcinosis  1  2/1923 (0.10%)  0/1938 (0.00%) 
Catheter site haematoma  1  1/1923 (0.05%)  3/1938 (0.15%) 
Catheter site haemorrhage  1  5/1923 (0.26%)  3/1938 (0.15%) 
Catheter site pain  1  0/1923 (0.00%)  1/1938 (0.05%) 
Catheter site swelling  1  0/1923 (0.00%)  1/1938 (0.05%) 
Chest discomfort  1  3/1923 (0.16%)  4/1938 (0.21%) 
Chest pain  1  53/1923 (2.76%)  51/1938 (2.63%) 
Chills  1  2/1923 (0.10%)  4/1938 (0.21%) 
Condition aggravated  1  1/1923 (0.05%)  0/1938 (0.00%) 
Cyst  1  1/1923 (0.05%)  1/1938 (0.05%) 
Death  1  38/1923 (1.98%)  38/1938 (1.96%) 
Device breakage  1  1/1923 (0.05%)  0/1938 (0.00%) 
Device dislocation  1  1/1923 (0.05%)  2/1938 (0.10%) 
Device failure  1  2/1923 (0.10%)  0/1938 (0.00%) 
Device malfunction  1  2/1923 (0.10%)  2/1938 (0.10%) 
Device occlusion  1  1/1923 (0.05%)  2/1938 (0.10%) 
Drug intolerance  1  0/1923 (0.00%)  1/1938 (0.05%) 
Drug withdrawal syndrome  1  0/1923 (0.00%)  1/1938 (0.05%) 
Face oedema  1  1/1923 (0.05%)  1/1938 (0.05%) 
Fat necrosis  1  0/1923 (0.00%)  1/1938 (0.05%) 
Fatigue  1  3/1923 (0.16%)  1/1938 (0.05%) 
Feeling abnormal  1  1/1923 (0.05%)  0/1938 (0.00%) 
Gait disturbance  1  2/1923 (0.10%)  0/1938 (0.00%) 
General physical health deterioration  1  8/1923 (0.42%)  7/1938 (0.36%) 
Granuloma  1  1/1923 (0.05%)  0/1938 (0.00%) 
Hernia  1  0/1923 (0.00%)  1/1938 (0.05%) 
Hernia obstructive  1  4/1923 (0.21%)  0/1938 (0.00%) 
Hernia pain  1  0/1923 (0.00%)  1/1938 (0.05%) 
Hyperthermia  1  1/1923 (0.05%)  2/1938 (0.10%) 
Hypothermia  1  2/1923 (0.10%)  2/1938 (0.10%) 
Impaired healing  1  10/1923 (0.52%)  5/1938 (0.26%) 
Implant site effusion  1  1/1923 (0.05%)  0/1938 (0.00%) 
Implant site haematoma  1  0/1923 (0.00%)  1/1938 (0.05%) 
Inflammation  1  1/1923 (0.05%)  0/1938 (0.00%) 
Influenza like illness  1  0/1923 (0.00%)  1/1938 (0.05%) 
Infusion site thrombosis  1  1/1923 (0.05%)  0/1938 (0.00%) 
Ischaemic ulcer  1  4/1923 (0.21%)  0/1938 (0.00%) 
Localised oedema  1  0/1923 (0.00%)  1/1938 (0.05%) 
Malaise  1  4/1923 (0.21%)  4/1938 (0.21%) 
Medical device complication  1  17/1923 (0.88%)  9/1938 (0.46%) 
Multi-organ failure  1  5/1923 (0.26%)  8/1938 (0.41%) 
Necrosis  1  0/1923 (0.00%)  1/1938 (0.05%) 
Non-cardiac chest pain  1  23/1923 (1.20%)  27/1938 (1.39%) 
Oedema  1  1/1923 (0.05%)  0/1938 (0.00%) 
Oedema peripheral  1  5/1923 (0.26%)  4/1938 (0.21%) 
Organ failure  1  0/1923 (0.00%)  1/1938 (0.05%) 
Pain  1  4/1923 (0.21%)  1/1938 (0.05%) 
Pelvic mass  1  0/1923 (0.00%)  1/1938 (0.05%) 
Polyserositis  1  1/1923 (0.05%)  0/1938 (0.00%) 
Precancerous mucosal lesion  1  0/1923 (0.00%)  1/1938 (0.05%) 
Pyrexia  1  35/1923 (1.82%)  42/1938 (2.17%) 
Spinal pain  1  1/1923 (0.05%)  2/1938 (0.10%) 
Sudden cardiac death  1  7/1923 (0.36%)  7/1938 (0.36%) 
Sudden death  1  26/1923 (1.35%)  22/1938 (1.14%) 
Systemic inflammatory response syndrome  1  0/1923 (0.00%)  1/1938 (0.05%) 
Thrombosis in device  1  5/1923 (0.26%)  4/1938 (0.21%) 
Ulcer  1  2/1923 (0.10%)  1/1938 (0.05%) 
Ulcer haemorrhage  1  1/1923 (0.05%)  0/1938 (0.00%) 
Hepatobiliary disorders     
Bile duct obstruction  1  1/1923 (0.05%)  0/1938 (0.00%) 
Bile duct stone  1  0/1923 (0.00%)  3/1938 (0.15%) 
Biliary colic  1  2/1923 (0.10%)  0/1938 (0.00%) 
Biliary dyskinesia  1  1/1923 (0.05%)  0/1938 (0.00%) 
Cholangitis  1  2/1923 (0.10%)  3/1938 (0.15%) 
Cholangitis acute  1  0/1923 (0.00%)  1/1938 (0.05%) 
Cholecystitis  1  10/1923 (0.52%)  9/1938 (0.46%) 
Cholecystitis acute  1  5/1923 (0.26%)  7/1938 (0.36%) 
Cholecystitis chronic  1  0/1923 (0.00%)  1/1938 (0.05%) 
Cholelithiasis  1  12/1923 (0.62%)  16/1938 (0.83%) 
Cholestasis  1  1/1923 (0.05%)  2/1938 (0.10%) 
Chronic hepatic failure  1  1/1923 (0.05%)  0/1938 (0.00%) 
Gallbladder perforation  1  1/1923 (0.05%)  0/1938 (0.00%) 
Gallbladder polyp  1  0/1923 (0.00%)  2/1938 (0.10%) 
Hepatic cirrhosis  1  3/1923 (0.16%)  2/1938 (0.10%) 
Hepatic congestion  1  1/1923 (0.05%)  0/1938 (0.00%) 
Hepatic cyst ruptured  1  1/1923 (0.05%)  0/1938 (0.00%) 
Hepatic failure  1  3/1923 (0.16%)  2/1938 (0.10%) 
Hepatic function abnormal  1  0/1923 (0.00%)  1/1938 (0.05%) 
Hepatic lesion  1  0/1923 (0.00%)  1/1938 (0.05%) 
Hepatitis  1  2/1923 (0.10%)  0/1938 (0.00%) 
Hepatitis toxic  1  2/1923 (0.10%)  0/1938 (0.00%) 
Jaundice cholestatic  1  1/1923 (0.05%)  1/1938 (0.05%) 
Liver disorder  1  1/1923 (0.05%)  0/1938 (0.00%) 
Immune system disorders     
Amyloidosis  1  0/1923 (0.00%)  1/1938 (0.05%) 
Anaphylactic reaction  1  3/1923 (0.16%)  1/1938 (0.05%) 
Contrast media allergy  1  1/1923 (0.05%)  0/1938 (0.00%) 
Dialysis amyloidosis  1  1/1923 (0.05%)  1/1938 (0.05%) 
Kidney transplant rejection  1  3/1923 (0.16%)  6/1938 (0.31%) 
Transplant rejection  1  1/1923 (0.05%)  1/1938 (0.05%) 
Infections and infestations     
Abdominal abscess  1  1/1923 (0.05%)  2/1938 (0.10%) 
Abdominal sepsis  1  3/1923 (0.16%)  0/1938 (0.00%) 
Abdominal wall abscess  1  1/1923 (0.05%)  4/1938 (0.21%) 
Abdominal wall infection  1  1/1923 (0.05%)  0/1938 (0.00%) 
Abscess  1  2/1923 (0.10%)  3/1938 (0.15%) 
Abscess intestinal  1  2/1923 (0.10%)  1/1938 (0.05%) 
Abscess limb  1  5/1923 (0.26%)  9/1938 (0.46%) 
Abscess neck  1  0/1923 (0.00%)  1/1938 (0.05%) 
Abscess of eyelid  1  0/1923 (0.00%)  1/1938 (0.05%) 
Abscess oral  1  0/1923 (0.00%)  1/1938 (0.05%) 
Acute sinusitis  1  0/1923 (0.00%)  1/1938 (0.05%) 
Amoebic dysentery  1  1/1923 (0.05%)  0/1938 (0.00%) 
Appendicitis  1  4/1923 (0.21%)  6/1938 (0.31%) 
Appendicitis perforated  1  0/1923 (0.00%)  1/1938 (0.05%) 
Arteriosclerotic gangrene  1  0/1923 (0.00%)  1/1938 (0.05%) 
Arteriovenous fistula site infection  1  15/1923 (0.78%)  10/1938 (0.52%) 
Arteriovenous graft site infection  1  14/1923 (0.73%)  25/1938 (1.29%) 
Arthritis bacterial  1  2/1923 (0.10%)  4/1938 (0.21%) 
Arthritis infective  1  0/1923 (0.00%)  2/1938 (0.10%) 
Bacteraemia  1  24/1923 (1.25%)  27/1938 (1.39%) 
Bacterial infection  1  0/1923 (0.00%)  1/1938 (0.05%) 
Bacterial sepsis  1  2/1923 (0.10%)  1/1938 (0.05%) 
Bartholin's abscess  1  1/1923 (0.05%)  0/1938 (0.00%) 
Biliary sepsis  1  1/1923 (0.05%)  1/1938 (0.05%) 
Biliary tract infection  1  0/1923 (0.00%)  1/1938 (0.05%) 
Breast cellulitis  1  1/1923 (0.05%)  0/1938 (0.00%) 
Bronchitis  1  25/1923 (1.30%)  26/1938 (1.34%) 
Bronchitis bacterial  1  1/1923 (0.05%)  0/1938 (0.00%) 
Bronchitis viral  1  1/1923 (0.05%)  1/1938 (0.05%) 
Bronchopneumonia  1  7/1923 (0.36%)  5/1938 (0.26%) 
Carbuncle  1  2/1923 (0.10%)  0/1938 (0.00%) 
Catheter site cellulitis  1  0/1923 (0.00%)  2/1938 (0.10%) 
Catheter site infection  1  6/1923 (0.31%)  6/1938 (0.31%) 
Cellulitis  1  38/1923 (1.98%)  29/1938 (1.50%) 
Cellulitis gangrenous  1  1/1923 (0.05%)  0/1938 (0.00%) 
Cellulitis orbital  1  0/1923 (0.00%)  1/1938 (0.05%) 
Cellulitis staphylococcal  1  1/1923 (0.05%)  0/1938 (0.00%) 
Chest wall abscess  1  1/1923 (0.05%)  0/1938 (0.00%) 
Clostridial infection  1  1/1923 (0.05%)  3/1938 (0.15%) 
Clostridium colitis  1  0/1923 (0.00%)  1/1938 (0.05%) 
Clostridium difficile colitis  1  7/1923 (0.36%)  9/1938 (0.46%) 
Cystitis  1  2/1923 (0.10%)  2/1938 (0.10%) 
Dengue fever  1  0/1923 (0.00%)  2/1938 (0.10%) 
Dermo-hypodermitis  1  1/1923 (0.05%)  0/1938 (0.00%) 
Device related infection  1  28/1923 (1.46%)  29/1938 (1.50%) 
Device related sepsis  1  18/1923 (0.94%)  15/1938 (0.77%) 
Diabetic foot infection  1  5/1923 (0.26%)  1/1938 (0.05%) 
Diabetic gangrene  1  2/1923 (0.10%)  1/1938 (0.05%) 
Disseminated tuberculosis  1  1/1923 (0.05%)  0/1938 (0.00%) 
Diverticulitis  1  8/1923 (0.42%)  9/1938 (0.46%) 
Ear infection  1  1/1923 (0.05%)  0/1938 (0.00%) 
Embolic pneumonia  1  1/1923 (0.05%)  0/1938 (0.00%) 
Emphysematous cystitis  1  1/1923 (0.05%)  0/1938 (0.00%) 
Empyema  1  3/1923 (0.16%)  2/1938 (0.10%) 
Endocarditis  1  10/1923 (0.52%)  13/1938 (0.67%) 
Endocarditis bacterial  1  5/1923 (0.26%)  2/1938 (0.10%) 
Endocarditis staphylococcal  1  1/1923 (0.05%)  1/1938 (0.05%) 
Enteritis infectious  1  1/1923 (0.05%)  2/1938 (0.10%) 
Enterobacter bacteraemia  1  1/1923 (0.05%)  2/1938 (0.10%) 
Enterobacter pneumonia  1  0/1923 (0.00%)  1/1938 (0.05%) 
Enterobacter sepsis  1  0/1923 (0.00%)  3/1938 (0.15%) 
Enterococcal bacteraemia  1  2/1923 (0.10%)  3/1938 (0.15%) 
Enterococcal infection  1  0/1923 (0.00%)  1/1938 (0.05%) 
Enterocolitis bacterial  1  1/1923 (0.05%)  0/1938 (0.00%) 
Enterocolitis infectious  1  0/1923 (0.00%)  2/1938 (0.10%) 
Erysipelas  1  8/1923 (0.42%)  8/1938 (0.41%) 
Escherichia bacteraemia  1  0/1923 (0.00%)  1/1938 (0.05%) 
Escherichia infection  1  1/1923 (0.05%)  0/1938 (0.00%) 
Escherichia sepsis  1  2/1923 (0.10%)  2/1938 (0.10%) 
Extradural abscess  1  2/1923 (0.10%)  1/1938 (0.05%) 
Eye infection  1  0/1923 (0.00%)  2/1938 (0.10%) 
Fungaemia  1  1/1923 (0.05%)  1/1938 (0.05%) 
Fungal oesophagitis  1  0/1923 (0.00%)  1/1938 (0.05%) 
Furuncle  1  2/1923 (0.10%)  0/1938 (0.00%) 
Gangrene  1  42/1923 (2.18%)  38/1938 (1.96%) 
Gas gangrene  1  0/1923 (0.00%)  1/1938 (0.05%) 
Gastric infection  1  1/1923 (0.05%)  0/1938 (0.00%) 
Gastroenteritis  1  20/1923 (1.04%)  24/1938 (1.24%) 
Gastroenteritis clostridial  1  1/1923 (0.05%)  1/1938 (0.05%) 
Gastroenteritis norovirus  1  1/1923 (0.05%)  1/1938 (0.05%) 
Gastroenteritis salmonella  1  1/1923 (0.05%)  0/1938 (0.00%) 
Gastroenteritis viral  1  4/1923 (0.21%)  8/1938 (0.41%) 
Giardiasis  1  0/1923 (0.00%)  1/1938 (0.05%) 
Graft infection  1  6/1923 (0.31%)  2/1938 (0.10%) 
Groin abscess  1  1/1923 (0.05%)  0/1938 (0.00%) 
H1N1 influenza  1  1/1923 (0.05%)  3/1938 (0.15%) 
Haematoma infection  1  0/1923 (0.00%)  2/1938 (0.10%) 
Haemophilus infection  1  0/1923 (0.00%)  2/1938 (0.10%) 
Helicobacter infection  1  0/1923 (0.00%)  1/1938 (0.05%) 
Hepatitis B  1  1/1923 (0.05%)  1/1938 (0.05%) 
Hepatitis C  1  0/1923 (0.00%)  2/1938 (0.10%) 
Herpes zoster  1  2/1923 (0.10%)  4/1938 (0.21%) 
Herpes zoster ophthalmic  1  1/1923 (0.05%)  0/1938 (0.00%) 
Implant site infection  1  0/1923 (0.00%)  1/1938 (0.05%) 
Incision site infection  1  1/1923 (0.05%)  0/1938 (0.00%) 
Infected fistula  1  0/1923 (0.00%)  3/1938 (0.15%) 
Infected skin ulcer  1  7/1923 (0.36%)  5/1938 (0.26%) 
Infection  1  11/1923 (0.57%)  11/1938 (0.57%) 
Infectious peritonitis  1  0/1923 (0.00%)  1/1938 (0.05%) 
Infectious pleural effusion  1  1/1923 (0.05%)  0/1938 (0.00%) 
Infective aneurysm  1  0/1923 (0.00%)  1/1938 (0.05%) 
Infective exacerbation of chronic obstructive airways disease  1  1/1923 (0.05%)  1/1938 (0.05%) 
Infective tenosynovitis  1  0/1923 (0.00%)  1/1938 (0.05%) 
Influenza  1  2/1923 (0.10%)  4/1938 (0.21%) 
Intervertebral discitis  1  4/1923 (0.21%)  4/1938 (0.21%) 
Joint abscess  1  0/1923 (0.00%)  1/1938 (0.05%) 
Kidney infection  1  1/1923 (0.05%)  0/1938 (0.00%) 
Klebsiella bacteraemia  1  0/1923 (0.00%)  1/1938 (0.05%) 
Laryngitis  1  1/1923 (0.05%)  0/1938 (0.00%) 
Liver abscess  1  2/1923 (0.10%)  2/1938 (0.10%) 
Lobar pneumonia  1  17/1923 (0.88%)  14/1938 (0.72%) 
Localised infection  1  17/1923 (0.88%)  11/1938 (0.57%) 
Lower respiratory tract infection  1  8/1923 (0.42%)  11/1938 (0.57%) 
Lower respiratory tract infection bacterial  1  0/1923 (0.00%)  1/1938 (0.05%) 
Lower respiratory tract infection viral  1  1/1923 (0.05%)  0/1938 (0.00%) 
Lung infection  1  4/1923 (0.21%)  3/1938 (0.15%) 
Lymph gland infection  1  1/1923 (0.05%)  0/1938 (0.00%) 
Meningitis  1  2/1923 (0.10%)  1/1938 (0.05%) 
Meningitis bacterial  1  0/1923 (0.00%)  1/1938 (0.05%) 
Meningitis cryptococcal  1  0/1923 (0.00%)  1/1938 (0.05%) 
Meningitis viral  1  0/1923 (0.00%)  1/1938 (0.05%) 
Morganella infection  1  1/1923 (0.05%)  0/1938 (0.00%) 
Nasal abscess  1  0/1923 (0.00%)  1/1938 (0.05%) 
Necrotising fasciitis  1  2/1923 (0.10%)  2/1938 (0.10%) 
Oesophageal candidiasis  1  2/1923 (0.10%)  1/1938 (0.05%) 
Orchitis  1  0/1923 (0.00%)  1/1938 (0.05%) 
Osteomyelitis  1  26/1923 (1.35%)  15/1938 (0.77%) 
Osteomyelitis chronic  1  1/1923 (0.05%)  0/1938 (0.00%) 
Otitis externa  1  1/1923 (0.05%)  0/1938 (0.00%) 
Otitis externa bacterial  1  1/1923 (0.05%)  0/1938 (0.00%) 
Parotitis  1  1/1923 (0.05%)  0/1938 (0.00%) 
Perineal abscess  1  1/1923 (0.05%)  0/1938 (0.00%) 
Periorbital cellulitis  1  0/1923 (0.00%)  1/1938 (0.05%) 
Perirectal abscess  1  0/1923 (0.00%)  2/1938 (0.10%) 
Peritoneal abscess  1  0/1923 (0.00%)  1/1938 (0.05%) 
Peritonitis  1  7/1923 (0.36%)  9/1938 (0.46%) 
Peritonitis bacterial  1  3/1923 (0.16%)  1/1938 (0.05%) 
Peritonsillar abscess  1  0/1923 (0.00%)  1/1938 (0.05%) 
Pharyngitis  1  3/1923 (0.16%)  1/1938 (0.05%) 
Pilonidal cyst  1  0/1923 (0.00%)  1/1938 (0.05%) 
Pleural infection  1  1/1923 (0.05%)  0/1938 (0.00%) 
Pneumococcal bacteraemia  1  1/1923 (0.05%)  0/1938 (0.00%) 
Pneumonia  1  171/1923 (8.89%)  118/1938 (6.09%) 
Pneumonia bacterial  1  1/1923 (0.05%)  1/1938 (0.05%) 
Pneumonia cytomegaloviral  1  1/1923 (0.05%)  0/1938 (0.00%) 
Pneumonia escherichia  1  0/1923 (0.00%)  1/1938 (0.05%) 
Pneumonia fungal  1  0/1923 (0.00%)  1/1938 (0.05%) 
Pneumonia pneumococcal  1  1/1923 (0.05%)  0/1938 (0.00%) 
Pneumonia primary atypical  1  0/1923 (0.00%)  2/1938 (0.10%) 
Pneumonia staphylococcal  1  1/1923 (0.05%)  1/1938 (0.05%) 
Pneumonia streptococcal  1  2/1923 (0.10%)  0/1938 (0.00%) 
Pneumonia viral  1  0/1923 (0.00%)  2/1938 (0.10%) 
Post procedural infection  1  0/1923 (0.00%)  1/1938 (0.05%) 
Post procedural pneumonia  1  0/1923 (0.00%)  1/1938 (0.05%) 
Post procedural sepsis  1  1/1923 (0.05%)  0/1938 (0.00%) 
Postoperative abscess  1  1/1923 (0.05%)  3/1938 (0.15%) 
Postoperative wound infection  1  14/1923 (0.73%)  7/1938 (0.36%) 
Pseudomembranous colitis  1  2/1923 (0.10%)  0/1938 (0.00%) 
Pseudomonas infection  1  0/1923 (0.00%)  1/1938 (0.05%) 
Pulmonary sepsis  1  2/1923 (0.10%)  1/1938 (0.05%) 
Pulmonary tuberculosis  1  0/1923 (0.00%)  1/1938 (0.05%) 
Purulent discharge  1  1/1923 (0.05%)  0/1938 (0.00%) 
Pyelocystitis  1  0/1923 (0.00%)  1/1938 (0.05%) 
Pyelonephritis  1  3/1923 (0.16%)  9/1938 (0.46%) 
Pyelonephritis acute  1  0/1923 (0.00%)  2/1938 (0.10%) 
Pyelonephritis chronic  1  2/1923 (0.10%)  0/1938 (0.00%) 
Pyonephrosis  1  1/1923 (0.05%)  1/1938 (0.05%) 
Rectal abscess  1  0/1923 (0.00%)  1/1938 (0.05%) 
Renal abscess  1  1/1923 (0.05%)  1/1938 (0.05%) 
Renal cyst infection  1  1/1923 (0.05%)  2/1938 (0.10%) 
Respiratory tract infection  1  8/1923 (0.42%)  8/1938 (0.41%) 
Respiratory tract infection bacterial  1  0/1923 (0.00%)  1/1938 (0.05%) 
Respiratory tract infection fungal  1  1/1923 (0.05%)  1/1938 (0.05%) 
Respiratory tract infection viral  1  0/1923 (0.00%)  1/1938 (0.05%) 
Retroperitoneal abscess  1  1/1923 (0.05%)  1/1938 (0.05%) 
Scrotal abscess  1  0/1923 (0.00%)  1/1938 (0.05%) 
Scrotal gangrene  1  1/1923 (0.05%)  0/1938 (0.00%) 
Sepsis  1  111/1923 (5.77%)  123/1938 (6.35%) 
Sepsis syndrome  1  3/1923 (0.16%)  2/1938 (0.10%) 
Septic shock  1  35/1923 (1.82%)  35/1938 (1.81%) 
Serratia bacteraemia  1  0/1923 (0.00%)  1/1938 (0.05%) 
Serratia sepsis  1  1/1923 (0.05%)  0/1938 (0.00%) 
Shunt infection  1  3/1923 (0.16%)  3/1938 (0.15%) 
Sinusitis  1  2/1923 (0.10%)  2/1938 (0.10%) 
Skin infection  1  3/1923 (0.16%)  2/1938 (0.10%) 
Soft tissue infection  1  1/1923 (0.05%)  0/1938 (0.00%) 
Staphylococcal abscess  1  2/1923 (0.10%)  0/1938 (0.00%) 
Staphylococcal bacteraemia  1  8/1923 (0.42%)  9/1938 (0.46%) 
Staphylococcal infection  1  9/1923 (0.47%)  14/1938 (0.72%) 
Staphylococcal osteomyelitis  1  0/1923 (0.00%)  2/1938 (0.10%) 
Staphylococcal sepsis  1  7/1923 (0.36%)  12/1938 (0.62%) 
Streptococcal bacteraemia  1  1/1923 (0.05%)  1/1938 (0.05%) 
Streptococcal sepsis  1  0/1923 (0.00%)  1/1938 (0.05%) 
Subcutaneous abscess  1  4/1923 (0.21%)  6/1938 (0.31%) 
Systemic candida  1  2/1923 (0.10%)  0/1938 (0.00%) 
Testicular abscess  1  0/1923 (0.00%)  1/1938 (0.05%) 
Tooth abscess  1  0/1923 (0.00%)  1/1938 (0.05%) 
Tooth infection  1  0/1923 (0.00%)  1/1938 (0.05%) 
Tracheobronchitis  1  2/1923 (0.10%)  1/1938 (0.05%) 
Tuberculosis  1  2/1923 (0.10%)  1/1938 (0.05%) 
Upper respiratory tract infection  1  3/1923 (0.16%)  7/1938 (0.36%) 
Urethritis  1  1/1923 (0.05%)  0/1938 (0.00%) 
Urinary tract infection  1  23/1923 (1.20%)  18/1938 (0.93%) 
Urinary tract infection enterococcal  1  1/1923 (0.05%)  0/1938 (0.00%) 
Urinary tract infection fungal  1  1/1923 (0.05%)  0/1938 (0.00%) 
Urosepsis  1  3/1923 (0.16%)  2/1938 (0.10%) 
Vestibular neuronitis  1  0/1923 (0.00%)  1/1938 (0.05%) 
Viral infection  1  2/1923 (0.10%)  5/1938 (0.26%) 
Viral pharyngitis  1  0/1923 (0.00%)  1/1938 (0.05%) 
Wound infection  1  10/1923 (0.52%)  7/1938 (0.36%) 
Wound infection bacterial  1  0/1923 (0.00%)  1/1938 (0.05%) 
Wound infection staphylococcal  1  1/1923 (0.05%)  2/1938 (0.10%) 
Zygomycosis  1  0/1923 (0.00%)  1/1938 (0.05%) 
Injury, poisoning and procedural complications     
Acetabulum fracture  1  0/1923 (0.00%)  2/1938 (0.10%) 
Anastomotic stenosis  1  1/1923 (0.05%)  0/1938 (0.00%) 
Animal bite  1  0/1923 (0.00%)  1/1938 (0.05%) 
Ankle fracture  1  5/1923 (0.26%)  9/1938 (0.46%) 
Arteriovenous fistula aneurysm  1  10/1923 (0.52%)  3/1938 (0.15%) 
Arteriovenous fistula occlusion  1  8/1923 (0.42%)  13/1938 (0.67%) 
Arteriovenous fistula site complication  1  44/1923 (2.29%)  36/1938 (1.86%) 
Arteriovenous fistula site haematoma  1  2/1923 (0.10%)  3/1938 (0.15%) 
Arteriovenous fistula site haemorrhage  1  23/1923 (1.20%)  17/1938 (0.88%) 
Arteriovenous fistula thrombosis  1  43/1923 (2.24%)  49/1938 (2.53%) 
Arteriovenous graft aneurysm  1  0/1923 (0.00%)  2/1938 (0.10%) 
Arteriovenous graft site haematoma  1  2/1923 (0.10%)  0/1938 (0.00%) 
Arteriovenous graft site haemorrhage  1  7/1923 (0.36%)  9/1938 (0.46%) 
Brain contusion  1  1/1923 (0.05%)  0/1938 (0.00%) 
Brain herniation  1  0/1923 (0.00%)  1/1938 (0.05%) 
Burns second degree  1  1/1923 (0.05%)  0/1938 (0.00%) 
Cardiac valve replacement complication  1  1/1923 (0.05%)  0/1938 (0.00%) 
Cervical vertebral fracture  1  1/1923 (0.05%)  0/1938 (0.00%) 
Chest injury  1  1/1923 (0.05%)  0/1938 (0.00%) 
Clavicle fracture  1  2/1923 (0.10%)  2/1938 (0.10%) 
Complications of transplanted kidney  1  2/1923 (0.10%)  3/1938 (0.15%) 
Compression fracture  1  1/1923 (0.05%)  0/1938 (0.00%) 
Concussion  1  2/1923 (0.10%)  1/1938 (0.05%) 
Contusion  1  2/1923 (0.10%)  4/1938 (0.21%) 
Craniocerebral injury  1  3/1923 (0.16%)  2/1938 (0.10%) 
Crush injury  1  1/1923 (0.05%)  0/1938 (0.00%) 
Cystitis radiation  1  0/1923 (0.00%)  1/1938 (0.05%) 
Excoriation  1  1/1923 (0.05%)  0/1938 (0.00%) 
Extradural haematoma  1  1/1923 (0.05%)  0/1938 (0.00%) 
Eye operation complication  1  0/1923 (0.00%)  1/1938 (0.05%) 
Face injury  1  0/1923 (0.00%)  1/1938 (0.05%) 
Facial bones fracture  1  2/1923 (0.10%)  1/1938 (0.05%) 
Fall  1  14/1923 (0.73%)  8/1938 (0.41%) 
Femoral neck fracture  1  10/1923 (0.52%)  8/1938 (0.41%) 
Femur fracture  1  19/1923 (0.99%)  13/1938 (0.67%) 
Fibula fracture  1  1/1923 (0.05%)  0/1938 (0.00%) 
Foot fracture  1  4/1923 (0.21%)  2/1938 (0.10%) 
Forearm fracture  1  1/1923 (0.05%)  3/1938 (0.15%) 
Foreign body  1  0/1923 (0.00%)  1/1938 (0.05%) 
Fracture  1  2/1923 (0.10%)  3/1938 (0.15%) 
Fractured coccyx  1  0/1923 (0.00%)  1/1938 (0.05%) 
Fractured ischium  1  3/1923 (0.16%)  1/1938 (0.05%) 
Fractured sacrum  1  1/1923 (0.05%)  1/1938 (0.05%) 
Graft complication  1  0/1923 (0.00%)  1/1938 (0.05%) 
Graft haemorrhage  1  0/1923 (0.00%)  1/1938 (0.05%) 
Graft thrombosis  1  3/1923 (0.16%)  7/1938 (0.36%) 
Haemodialysis-induced symptom  1  3/1923 (0.16%)  4/1938 (0.21%) 
Hand fracture  1  3/1923 (0.16%)  2/1938 (0.10%) 
Head injury  1  4/1923 (0.21%)  2/1938 (0.10%) 
Hip fracture  1  10/1923 (0.52%)  9/1938 (0.46%) 
Humerus fracture  1  4/1923 (0.21%)  2/1938 (0.10%) 
In-stent coronary artery restenosis  1  0/1923 (0.00%)  2/1938 (0.10%) 
Incision site complication  1  1/1923 (0.05%)  0/1938 (0.00%) 
Incisional hernia  1  4/1923 (0.21%)  2/1938 (0.10%) 
Incisional hernia, obstructive  1  1/1923 (0.05%)  0/1938 (0.00%) 
Injury  1  2/1923 (0.10%)  0/1938 (0.00%) 
Joint dislocation  1  3/1923 (0.16%)  5/1938 (0.26%) 
Joint injury  1  3/1923 (0.16%)  0/1938 (0.00%) 
Kidney rupture  1  0/1923 (0.00%)  1/1938 (0.05%) 
Laceration  1  2/1923 (0.10%)  1/1938 (0.05%) 
Ligament injury  1  1/1923 (0.05%)  0/1938 (0.00%) 
Ligament rupture  1  4/1923 (0.21%)  0/1938 (0.00%) 
Ligament sprain  1  2/1923 (0.10%)  0/1938 (0.00%) 
Limb injury  1  1/1923 (0.05%)  1/1938 (0.05%) 
Lower limb fracture  1  4/1923 (0.21%)  3/1938 (0.15%) 
Meniscus lesion  1  1/1923 (0.05%)  0/1938 (0.00%) 
Multiple fractures  1  2/1923 (0.10%)  1/1938 (0.05%) 
Muscle rupture  1  2/1923 (0.10%)  0/1938 (0.00%) 
Open fracture  1  1/1923 (0.05%)  1/1938 (0.05%) 
Open wound  1  2/1923 (0.10%)  0/1938 (0.00%) 
Overdose  1  4/1923 (0.21%)  6/1938 (0.31%) 
Patella fracture  1  2/1923 (0.10%)  2/1938 (0.10%) 
Pelvic fracture  1  1/1923 (0.05%)  3/1938 (0.15%) 
Periorbital haematoma  1  1/1923 (0.05%)  0/1938 (0.00%) 
Periprosthetic fracture  1  1/1923 (0.05%)  0/1938 (0.00%) 
Perirenal haematoma  1  1/1923 (0.05%)  1/1938 (0.05%) 
Pneumothorax traumatic  1  0/1923 (0.00%)  1/1938 (0.05%) 
Post procedural complication  1  5/1923 (0.26%)  3/1938 (0.15%) 
Post procedural haematoma  1  1/1923 (0.05%)  0/1938 (0.00%) 
Post procedural haemorrhage  1  4/1923 (0.21%)  5/1938 (0.26%) 
Postoperative adhesion  1  0/1923 (0.00%)  1/1938 (0.05%) 
Postoperative ileus  1  0/1923 (0.00%)  1/1938 (0.05%) 
Postoperative thoracic procedure complication  1  0/1923 (0.00%)  1/1938 (0.05%) 
Postoperative wound complication  1  1/1923 (0.05%)  2/1938 (0.10%) 
Procedural complication  1  0/1923 (0.00%)  1/1938 (0.05%) 
Procedural haemorrhage  1  2/1923 (0.10%)  1/1938 (0.05%) 
Procedural hypotension  1  2/1923 (0.10%)  10/1938 (0.52%) 
Procedural pain  1  2/1923 (0.10%)  1/1938 (0.05%) 
Pubis fracture  1  6/1923 (0.31%)  1/1938 (0.05%) 
Radius fracture  1  6/1923 (0.31%)  3/1938 (0.15%) 
Renal haematoma  1  1/1923 (0.05%)  0/1938 (0.00%) 
Rib fracture  1  13/1923 (0.68%)  6/1938 (0.31%) 
Road traffic accident  1  2/1923 (0.10%)  2/1938 (0.10%) 
Shunt aneurysm  1  0/1923 (0.00%)  1/1938 (0.05%) 
Shunt malfunction  1  4/1923 (0.21%)  3/1938 (0.15%) 
Shunt occlusion  1  7/1923 (0.36%)  10/1938 (0.52%) 
Shunt stenosis  1  4/1923 (0.21%)  6/1938 (0.31%) 
Shunt thrombosis  1  7/1923 (0.36%)  8/1938 (0.41%) 
Skull fracture  1  1/1923 (0.05%)  0/1938 (0.00%) 
Spinal column injury  1  0/1923 (0.00%)  1/1938 (0.05%) 
Spinal compression fracture  1  5/1923 (0.26%)  5/1938 (0.26%) 
Spinal fracture  1  2/1923 (0.10%)  2/1938 (0.10%) 
Splenic rupture  1  0/1923 (0.00%)  1/1938 (0.05%) 
Sternal fracture  1  1/1923 (0.05%)  0/1938 (0.00%) 
Subcutaneous haematoma  1  1/1923 (0.05%)  0/1938 (0.00%) 
Subdural haematoma  1  6/1923 (0.31%)  8/1938 (0.41%) 
Subdural haemorrhage  1  1/1923 (0.05%)  0/1938 (0.00%) 
Suture rupture  1  0/1923 (0.00%)  1/1938 (0.05%) 
Tendon rupture  1  14/1923 (0.73%)  5/1938 (0.26%) 
Thermal burn  1  2/1923 (0.10%)  0/1938 (0.00%) 
Thoracic vertebral fracture  1  1/1923 (0.05%)  0/1938 (0.00%) 
Tibia fracture  1  6/1923 (0.31%)  1/1938 (0.05%) 
Toxicity to various agents  1  5/1923 (0.26%)  1/1938 (0.05%) 
Transfusion reaction  1  1/1923 (0.05%)  0/1938 (0.00%) 
Transplant failure  1  1/1923 (0.05%)  3/1938 (0.15%) 
Traumatic haematoma  1  1/1923 (0.05%)  1/1938 (0.05%) 
Traumatic intracranial haemorrhage  1  1/1923 (0.05%)  0/1938 (0.00%) 
Traumatic lung injury  1  1/1923 (0.05%)  0/1938 (0.00%) 
Ulna fracture  1  3/1923 (0.16%)  1/1938 (0.05%) 
Upper limb fracture  1  3/1923 (0.16%)  2/1938 (0.10%) 
Vascular access complication  1  13/1923 (0.68%)  15/1938 (0.77%) 
Vascular graft complication  1  11/1923 (0.57%)  13/1938 (0.67%) 
Vascular graft occlusion  1  6/1923 (0.31%)  8/1938 (0.41%) 
Vascular graft thrombosis  1  27/1923 (1.40%)  21/1938 (1.08%) 
Vascular pseudoaneurysm  1  6/1923 (0.31%)  8/1938 (0.41%) 
Vascular pseudoaneurysm ruptured  1  1/1923 (0.05%)  1/1938 (0.05%) 
Venous injury  1  1/1923 (0.05%)  1/1938 (0.05%) 
Wound  1  4/1923 (0.21%)  3/1938 (0.15%) 
Wound decomposition  1  1/1923 (0.05%)  0/1938 (0.00%) 
Wound dehiscence  1  1/1923 (0.05%)  4/1938 (0.21%) 
Wound haemorrhage  1  1/1923 (0.05%)  1/1938 (0.05%) 
Wound necrosis  1  1/1923 (0.05%)  1/1938 (0.05%) 
Wrist fracture  1  7/1923 (0.36%)  3/1938 (0.15%) 
Investigations     
Blood calcium decreased  1  0/1923 (0.00%)  1/1938 (0.05%) 
Blood culture positive  1  2/1923 (0.10%)  1/1938 (0.05%) 
Blood parathyroid hormone abnormal  1  1/1923 (0.05%)  0/1938 (0.00%) 
Blood parathyroid hormone increased  1  2/1923 (0.10%)  2/1938 (0.10%) 
Blood potassium increased  1  1/1923 (0.05%)  4/1938 (0.21%) 
Blood pressure increased  1  1/1923 (0.05%)  2/1938 (0.10%) 
C-reactive protein increased  1  0/1923 (0.00%)  2/1938 (0.10%) 
Cardioactive drug level increased  1  0/1923 (0.00%)  1/1938 (0.05%) 
Clostridium test positive  1  0/1923 (0.00%)  1/1938 (0.05%) 
Coagulation time prolonged  1  1/1923 (0.05%)  1/1938 (0.05%) 
Coagulation time shortened  1  1/1923 (0.05%)  0/1938 (0.00%) 
Ejection fraction decreased  1  1/1923 (0.05%)  0/1938 (0.00%) 
Electrocardiogram ST segment abnormal  1  0/1923 (0.00%)  1/1938 (0.05%) 
Electrocardiogram ST-T segment abnormal  1  0/1923 (0.00%)  1/1938 (0.05%) 
Electrocardiogram abnormal  1  0/1923 (0.00%)  2/1938 (0.10%) 
Electrocardiogram change  1  0/1923 (0.00%)  3/1938 (0.15%) 
Fibrin D dimer increased  1  0/1923 (0.00%)  1/1938 (0.05%) 
Haematocrit decreased  1  0/1923 (0.00%)  1/1938 (0.05%) 
Haemoglobin decreased  1  0/1923 (0.00%)  6/1938 (0.31%) 
Heart rate increased  1  1/1923 (0.05%)  0/1938 (0.00%) 
Heart rate irregular  1  0/1923 (0.00%)  1/1938 (0.05%) 
Influenza virus test positive  1  0/1923 (0.00%)  1/1938 (0.05%) 
International normalised ratio abnormal  1  1/1923 (0.05%)  0/1938 (0.00%) 
International normalised ratio decreased  1  0/1923 (0.00%)  1/1938 (0.05%) 
International normalised ratio fluctuation  1  0/1923 (0.00%)  1/1938 (0.05%) 
International normalised ratio increased  1  1/1923 (0.05%)  2/1938 (0.10%) 
Liver function test abnormal  1  0/1923 (0.00%)  1/1938 (0.05%) 
Myocardial strain  1  1/1923 (0.05%)  0/1938 (0.00%) 
Pulse absent  1  1/1923 (0.05%)  1/1938 (0.05%) 
Transaminases increased  1  1/1923 (0.05%)  0/1938 (0.00%) 
Troponin increased  1  4/1923 (0.21%)  1/1938 (0.05%) 
Weight decreased  1  3/1923 (0.16%)  1/1938 (0.05%) 
Metabolism and nutrition disorders     
Acidosis  1  0/1923 (0.00%)  3/1938 (0.15%) 
Cachexia  1  3/1923 (0.16%)  4/1938 (0.21%) 
Calciphylaxis  1  13/1923 (0.68%)  3/1938 (0.15%) 
Decreased appetite  1  0/1923 (0.00%)  3/1938 (0.15%) 
Dehydration  1  5/1923 (0.26%)  6/1938 (0.31%) 
Diabetes mellitus  1  2/1923 (0.10%)  0/1938 (0.00%) 
Diabetes mellitus inadequate control  1  3/1923 (0.16%)  3/1938 (0.15%) 
Diabetic ketoacidosis  1  3/1923 (0.16%)  4/1938 (0.21%) 
Dystrophic calcification  1  1/1923 (0.05%)  0/1938 (0.00%) 
Electrolyte imbalance  1  1/1923 (0.05%)  0/1938 (0.00%) 
Failure to thrive  1  5/1923 (0.26%)  6/1938 (0.31%) 
Fluid overload  1  51/1923 (2.65%)  40/1938 (2.06%) 
Fluid retention  1  8/1923 (0.42%)  2/1938 (0.10%) 
Hypercalcaemia  1  1/1923 (0.05%)  3/1938 (0.15%) 
Hyperglycaemia  1  7/1923 (0.36%)  5/1938 (0.26%) 
Hyperkalaemia  1  74/1923 (3.85%)  97/1938 (5.01%) 
Hyperphosphataemia  1  0/1923 (0.00%)  1/1938 (0.05%) 
Hypervolaemia  1  2/1923 (0.10%)  2/1938 (0.10%) 
Hypocalcaemia  1  8/1923 (0.42%)  16/1938 (0.83%) 
Hypoglycaemia  1  27/1923 (1.40%)  34/1938 (1.75%) 
Hypokalaemia  1  4/1923 (0.21%)  2/1938 (0.10%) 
Hyponatraemia  1  0/1923 (0.00%)  1/1938 (0.05%) 
Hypophosphataemia  1  1/1923 (0.05%)  0/1938 (0.00%) 
Lactic acidosis  1  0/1923 (0.00%)  1/1938 (0.05%) 
Malnutrition  1  1/1923 (0.05%)  2/1938 (0.10%) 
Shock hypoglycaemic  1  0/1923 (0.00%)  1/1938 (0.05%) 
Type 1 diabetes mellitus  1  0/1923 (0.00%)  1/1938 (0.05%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  9/1923 (0.47%)  11/1938 (0.57%) 
Arthritis  1  2/1923 (0.10%)  1/1938 (0.05%) 
Arthropathy  1  1/1923 (0.05%)  0/1938 (0.00%) 
Back pain  1  12/1923 (0.62%)  9/1938 (0.46%) 
Bone pain  1  3/1923 (0.16%)  2/1938 (0.10%) 
Bursitis  1  1/1923 (0.05%)  0/1938 (0.00%) 
Cervical spinal stenosis  1  0/1923 (0.00%)  2/1938 (0.10%) 
Chondrocalcinosis  1  1/1923 (0.05%)  0/1938 (0.00%) 
Chondrocalcinosis pyrophosphate  1  0/1923 (0.00%)  1/1938 (0.05%) 
Chondropathy  1  1/1923 (0.05%)  0/1938 (0.00%) 
Compartment syndrome  1  1/1923 (0.05%)  0/1938 (0.00%) 
Costochondritis  1  1/1923 (0.05%)  2/1938 (0.10%) 
Dupuytren's contracture  1  1/1923 (0.05%)  0/1938 (0.00%) 
Flank pain  1  2/1923 (0.10%)  0/1938 (0.00%) 
Fracture delayed union  1  1/1923 (0.05%)  0/1938 (0.00%) 
Fracture nonunion  1  1/1923 (0.05%)  0/1938 (0.00%) 
High turnover osteopathy  1  1/1923 (0.05%)  0/1938 (0.00%) 
Intervertebral disc degeneration  1  0/1923 (0.00%)  1/1938 (0.05%) 
Intervertebral disc disorder  1  0/1923 (0.00%)  2/1938 (0.10%) 
Intervertebral disc protrusion  1  0/1923 (0.00%)  6/1938 (0.31%) 
Joint destruction  1  0/1923 (0.00%)  1/1938 (0.05%) 
Joint effusion  1  4/1923 (0.21%)  0/1938 (0.00%) 
Joint swelling  1  2/1923 (0.10%)  2/1938 (0.10%) 
Kyphosis  1  1/1923 (0.05%)  0/1938 (0.00%) 
Ligamentitis  1  1/1923 (0.05%)  0/1938 (0.00%) 
Limb deformity  1  0/1923 (0.00%)  1/1938 (0.05%) 
Mobility decreased  1  0/1923 (0.00%)  1/1938 (0.05%) 
Muscle haemorrhage  1  1/1923 (0.05%)  0/1938 (0.00%) 
Muscle spasms  1  3/1923 (0.16%)  2/1938 (0.10%) 
Muscular weakness  1  6/1923 (0.31%)  9/1938 (0.46%) 
Musculoskeletal chest pain  1  4/1923 (0.21%)  3/1938 (0.15%) 
Musculoskeletal discomfort  1  1/1923 (0.05%)  0/1938 (0.00%) 
Musculoskeletal disorder  1  0/1923 (0.00%)  1/1938 (0.05%) 
Musculoskeletal pain  1  6/1923 (0.31%)  3/1938 (0.15%) 
Musculoskeletal stiffness  1  0/1923 (0.00%)  1/1938 (0.05%) 
Myalgia  1  1/1923 (0.05%)  0/1938 (0.00%) 
Neck deformity  1  1/1923 (0.05%)  0/1938 (0.00%) 
Neck pain  1  2/1923 (0.10%)  1/1938 (0.05%) 
Neuropathic arthropathy  1  0/1923 (0.00%)  1/1938 (0.05%) 
Osteitis  1  2/1923 (0.10%)  2/1938 (0.10%) 
Osteoarthritis  1  15/1923 (0.78%)  12/1938 (0.62%) 
Osteochondrosis  1  1/1923 (0.05%)  0/1938 (0.00%) 
Osteolysis  1  1/1923 (0.05%)  0/1938 (0.00%) 
Osteonecrosis  1  1/1923 (0.05%)  4/1938 (0.21%) 
Osteopenia  1  0/1923 (0.00%)  1/1938 (0.05%) 
Osteoporosis  1  1/1923 (0.05%)  0/1938 (0.00%) 
Pain in extremity  1  11/1923 (0.57%)  13/1938 (0.67%) 
Pathological fracture  1  1/1923 (0.05%)  0/1938 (0.00%) 
Periarthritis  1  0/1923 (0.00%)  1/1938 (0.05%) 
Polyarthritis  1  1/1923 (0.05%)  1/1938 (0.05%) 
Polymyalgia rheumatica  1  1/1923 (0.05%)  0/1938 (0.00%) 
Pseudarthrosis  1  0/1923 (0.00%)  1/1938 (0.05%) 
Psoriatic arthropathy  1  0/1923 (0.00%)  1/1938 (0.05%) 
Renal osteodystrophy  1  2/1923 (0.10%)  1/1938 (0.05%) 
Rotator cuff syndrome  1  1/1923 (0.05%)  2/1938 (0.10%) 
Scleroderma  1  0/1923 (0.00%)  1/1938 (0.05%) 
Soft tissue necrosis  1  1/1923 (0.05%)  0/1938 (0.00%) 
Spinal column stenosis  1  0/1923 (0.00%)  1/1938 (0.05%) 
Spinal disorder  1  2/1923 (0.10%)  0/1938 (0.00%) 
Spinal osteoarthritis  1  3/1923 (0.16%)  1/1938 (0.05%) 
Spondylolisthesis  1  0/1923 (0.00%)  1/1938 (0.05%) 
Systemic lupus erythematosus  1  1/1923 (0.05%)  1/1938 (0.05%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Acute myeloid leukaemia  1  0/1923 (0.00%)  1/1938 (0.05%) 
Adenocarcinoma  1  0/1923 (0.00%)  1/1938 (0.05%) 
Adenoma benign  1  0/1923 (0.00%)  1/1938 (0.05%) 
B-cell lymphoma  1  0/1923 (0.00%)  1/1938 (0.05%) 
Basal cell carcinoma  1  1/1923 (0.05%)  0/1938 (0.00%) 
Benign bone neoplasm  1  1/1923 (0.05%)  0/1938 (0.00%) 
Biliary neoplasm  1  1/1923 (0.05%)  0/1938 (0.00%) 
Bladder adenocarcinoma stage unspecified  1  1/1923 (0.05%)  0/1938 (0.00%) 
Bladder cancer  1  2/1923 (0.10%)  4/1938 (0.21%) 
Bladder cancer recurrent  1  0/1923 (0.00%)  1/1938 (0.05%) 
Bladder neoplasm  1  1/1923 (0.05%)  3/1938 (0.15%) 
Brain cancer metastatic  1  0/1923 (0.00%)  1/1938 (0.05%) 
Brain neoplasm  1  0/1923 (0.00%)  1/1938 (0.05%) 
Breast cancer  1  3/1923 (0.16%)  7/1938 (0.36%) 
Breast cancer in situ  1  2/1923 (0.10%)  0/1938 (0.00%) 
Breast cancer metastatic  1  0/1923 (0.00%)  2/1938 (0.10%) 
Breast cancer recurrent  1  1/1923 (0.05%)  0/1938 (0.00%) 
Breast neoplasm  1  1/1923 (0.05%)  0/1938 (0.00%) 
Bronchial carcinoma  1  1/1923 (0.05%)  0/1938 (0.00%) 
Chronic lymphocytic leukaemia  1  0/1923 (0.00%)  1/1938 (0.05%) 
Chronic myeloid leukaemia  1  0/1923 (0.00%)  1/1938 (0.05%) 
Colon adenoma  1  1/1923 (0.05%)  1/1938 (0.05%) 
Colon cancer  1  6/1923 (0.31%)  5/1938 (0.26%) 
Colon cancer metastatic  1  1/1923 (0.05%)  1/1938 (0.05%) 
Colon cancer recurrent  1  1/1923 (0.05%)  0/1938 (0.00%) 
Colon neoplasm  1  0/1923 (0.00%)  1/1938 (0.05%) 
Gastric cancer  1  1/1923 (0.05%)  1/1938 (0.05%) 
Glioblastoma multiforme  1  2/1923 (0.10%)  0/1938 (0.00%) 
Hepatic neoplasm malignant  1  0/1923 (0.00%)  1/1938 (0.05%) 
Intraocular melanoma  1  0/1923 (0.00%)  1/1938 (0.05%) 
Lentigo maligna stage unspecified  1  0/1923 (0.00%)  1/1938 (0.05%) 
Lung adenocarcinoma  1  1/1923 (0.05%)  2/1938 (0.10%) 
Lung cancer metastatic  1  1/1923 (0.05%)  1/1938 (0.05%) 
Lung neoplasm  1  2/1923 (0.10%)  2/1938 (0.10%) 
Lung neoplasm malignant  1  2/1923 (0.10%)  4/1938 (0.21%) 
Lymphoma  1  0/1923 (0.00%)  1/1938 (0.05%) 
Malignant melanoma  1  1/1923 (0.05%)  2/1938 (0.10%) 
Malignant pleural effusion  1  0/1923 (0.00%)  1/1938 (0.05%) 
Malignant urinary tract neoplasm  1  0/1923 (0.00%)  1/1938 (0.05%) 
Metastases to central nervous system  1  0/1923 (0.00%)  1/1938 (0.05%) 
Metastases to liver  1  3/1923 (0.16%)  1/1938 (0.05%) 
Metastases to lung  1  0/1923 (0.00%)  1/1938 (0.05%) 
Metastases to lymph nodes  1  1/1923 (0.05%)  0/1938 (0.00%) 
Metastases to peritoneum  1  0/1923 (0.00%)  1/1938 (0.05%) 
Metastasis  1  1/1923 (0.05%)  1/1938 (0.05%) 
Metastatic malignant melanoma  1  0/1923 (0.00%)  1/1938 (0.05%) 
Metastatic neoplasm  1  2/1923 (0.10%)  4/1938 (0.21%) 
Metastatic pain  1  1/1923 (0.05%)  0/1938 (0.00%) 
Multiple myeloma  1  2/1923 (0.10%)  0/1938 (0.00%) 
Myelodysplastic syndrome  1  1/1923 (0.05%)  0/1938 (0.00%) 
Neoplasm  1  4/1923 (0.21%)  1/1938 (0.05%) 
Neoplasm malignant  1  0/1923 (0.00%)  1/1938 (0.05%) 
Neoplasm recurrence  1  1/1923 (0.05%)  0/1938 (0.00%) 
Neoplasm skin  1  0/1923 (0.00%)  2/1938 (0.10%) 
Non-Hodgkin's lymphoma  1  0/1923 (0.00%)  1/1938 (0.05%) 
Non-small cell lung cancer metastatic  1  1/1923 (0.05%)  0/1938 (0.00%) 
Pancreatic carcinoma  1  0/1923 (0.00%)  2/1938 (0.10%) 
Pancreatic carcinoma metastatic  1  1/1923 (0.05%)  0/1938 (0.00%) 
Pancreatic neoplasm  1  1/1923 (0.05%)  0/1938 (0.00%) 
Paraganglion neoplasm  1  1/1923 (0.05%)  0/1938 (0.00%) 
Parathyroid tumour benign  1  6/1923 (0.31%)  1/1938 (0.05%) 
Pleural mesothelioma  1  1/1923 (0.05%)  0/1938 (0.00%) 
Prostate cancer  1  1/1923 (0.05%)  8/1938 (0.41%) 
Prostate cancer metastatic  1  0/1923 (0.00%)  1/1938 (0.05%) 
Rectal cancer  1  3/1923 (0.16%)  0/1938 (0.00%) 
Renal cancer  1  2/1923 (0.10%)  1/1938 (0.05%) 
Renal cancer metastatic  1  1/1923 (0.05%)  0/1938 (0.00%) 
Renal cell carcinoma  1  4/1923 (0.21%)  6/1938 (0.31%) 
Renal neoplasm  1  3/1923 (0.16%)  3/1938 (0.15%) 
Renal oncocytoma  1  0/1923 (0.00%)  1/1938 (0.05%) 
Small cell lung cancer stage unspecified  1  0/1923 (0.00%)  1/1938 (0.05%) 
Squamous cell carcinoma  1  1/1923 (0.05%)  0/1938 (0.00%) 
Thyroid adenoma  1  2/1923 (0.10%)  0/1938 (0.00%) 
Thyroid cancer  1  2/1923 (0.10%)  0/1938 (0.00%) 
Thyroid neoplasm  1  1/1923 (0.05%)  3/1938 (0.15%) 
Tongue neoplasm malignant stage unspecified  1  3/1923 (0.16%)  1/1938 (0.05%) 
Transitional cell carcinoma  1  0/1923 (0.00%)  1/1938 (0.05%) 
Tumour haemorrhage  1  0/1923 (0.00%)  1/1938 (0.05%) 
Tumour pain  1  1/1923 (0.05%)  0/1938 (0.00%) 
Urinary tract neoplasm  1  1/1923 (0.05%)  0/1938 (0.00%) 
Uterine leiomyoma  1  1/1923 (0.05%)  0/1938 (0.00%) 
Vaginal cancer  1  0/1923 (0.00%)  1/1938 (0.05%) 
Vocal cord neoplasm  1  1/1923 (0.05%)  0/1938 (0.00%) 
Nervous system disorders     
Altered state of consciousness  1  2/1923 (0.10%)  0/1938 (0.00%) 
Aphasia  1  0/1923 (0.00%)  1/1938 (0.05%) 
Ataxia  1  3/1923 (0.16%)  0/1938 (0.00%) 
Autonomic neuropathy  1  0/1923 (0.00%)  2/1938 (0.10%) 
Balance disorder  1  2/1923 (0.10%)  3/1938 (0.15%) 
Basal ganglia haemorrhage  1  0/1923 (0.00%)  1/1938 (0.05%) 
Benign intracranial hypertension  1  1/1923 (0.05%)  0/1938 (0.00%) 
Brain oedema  1  3/1923 (0.16%)  1/1938 (0.05%) 
Brain stem infarction  1  0/1923 (0.00%)  1/1938 (0.05%) 
Carotid artery stenosis  1  7/1923 (0.36%)  1/1938 (0.05%) 
Carpal tunnel syndrome  1  6/1923 (0.31%)  4/1938 (0.21%) 
Cerebellar atrophy  1  1/1923 (0.05%)  0/1938 (0.00%) 
Cerebral artery stenosis  1  1/1923 (0.05%)  0/1938 (0.00%) 
Cerebral atrophy  1  0/1923 (0.00%)  1/1938 (0.05%) 
Cerebral haemorrhage  1  9/1923 (0.47%)  10/1938 (0.52%) 
Cerebral hypoperfusion  1  1/1923 (0.05%)  0/1938 (0.00%) 
Cerebral infarction  1  0/1923 (0.00%)  5/1938 (0.26%) 
Cerebral ischaemia  1  3/1923 (0.16%)  2/1938 (0.10%) 
Cerebrovascular accident  1  66/1923 (3.43%)  60/1938 (3.10%) 
Cerebrovascular disorder  1  1/1923 (0.05%)  1/1938 (0.05%) 
Clonus  1  0/1923 (0.00%)  1/1938 (0.05%) 
Cognitive disorder  1  1/1923 (0.05%)  1/1938 (0.05%) 
Coma  1  0/1923 (0.00%)  3/1938 (0.15%) 
Convulsion  1  21/1923 (1.09%)  30/1938 (1.55%) 
Dementia  1  2/1923 (0.10%)  1/1938 (0.05%) 
Demyelinating polyneuropathy  1  1/1923 (0.05%)  0/1938 (0.00%) 
Depressed level of consciousness  1  2/1923 (0.10%)  0/1938 (0.00%) 
Dizziness  1  5/1923 (0.26%)  9/1938 (0.46%) 
Dysarthria  1  1/1923 (0.05%)  1/1938 (0.05%) 
Dyskinesia  1  0/1923 (0.00%)  1/1938 (0.05%) 
Encephalitis  1  0/1923 (0.00%)  1/1938 (0.05%) 
Encephalitis post varicella  1  0/1923 (0.00%)  1/1938 (0.05%) 
Encephalomalacia  1  0/1923 (0.00%)  1/1938 (0.05%) 
Encephalopathy  1  8/1923 (0.42%)  2/1938 (0.10%) 
Epilepsy  1  0/1923 (0.00%)  3/1938 (0.15%) 
Extrapyramidal disorder  1  1/1923 (0.05%)  2/1938 (0.10%) 
Guillain-Barre syndrome  1  0/1923 (0.00%)  1/1938 (0.05%) 
Haemorrhage intracranial  1  3/1923 (0.16%)  7/1938 (0.36%) 
Haemorrhagic cerebral infarction  1  1/1923 (0.05%)  0/1938 (0.00%) 
Haemorrhagic stroke  1  5/1923 (0.26%)  4/1938 (0.21%) 
Headache  1  3/1923 (0.16%)  6/1938 (0.31%) 
Hemianopia  1  0/1923 (0.00%)  1/1938 (0.05%) 
Hemiparesis  1  1/1923 (0.05%)  1/1938 (0.05%) 
Hemiplegia  1  1/1923 (0.05%)  0/1938 (0.00%) 
Hepatic encephalopathy  1  2/1923 (0.10%)  2/1938 (0.10%) 
Hydrocephalus  1  2/1923 (0.10%)  1/1938 (0.05%) 
Hypertensive encephalopathy  1  3/1923 (0.16%)  3/1938 (0.15%) 
Hypertonia  1  2/1923 (0.10%)  0/1938 (0.00%) 
Hypoaesthesia  1  2/1923 (0.10%)  1/1938 (0.05%) 
Hypogeusia  1  0/1923 (0.00%)  1/1938 (0.05%) 
Hypoglycaemic coma  1  2/1923 (0.10%)  1/1938 (0.05%) 
Hypoglycaemic encephalopathy  1  0/1923 (0.00%)  1/1938 (0.05%) 
Hypotonia  1  0/1923 (0.00%)  1/1938 (0.05%) 
Hypoxic-ischaemic encephalopathy  1  1/1923 (0.05%)  4/1938 (0.21%) 
Intracranial hypotension  1  1/1923 (0.05%)  0/1938 (0.00%) 
Intracranial pressure increased  1  1/1923 (0.05%)  0/1938 (0.00%) 
Ischaemic stroke  1  3/1923 (0.16%)  8/1938 (0.41%) 
Lacunar infarction  1  2/1923 (0.10%)  0/1938 (0.00%) 
Lethargy  1  2/1923 (0.10%)  1/1938 (0.05%) 
Loss of consciousness  1  6/1923 (0.31%)  5/1938 (0.26%) 
Mental impairment  1  1/1923 (0.05%)  1/1938 (0.05%) 
Metabolic encephalopathy  1  6/1923 (0.31%)  3/1938 (0.15%)