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A Study to Assess All-Cause Mortality and Cardiovascular Morbidity in Participants With Chronic Kidney Disease (CKD) on Dialysis and Those Not on Renal Replacement Therapy Receiving Methoxy Polyethylene Glycol-Epoetin Beta (Mircera) or Reference Erythropoietin Stimulating Agents (ESAs)

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ClinicalTrials.gov Identifier: NCT00773513
Recruitment Status : Completed
First Posted : October 16, 2008
Results First Posted : August 15, 2018
Last Update Posted : September 19, 2018
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Chronic Renal Anemia
Interventions Drug: Darbepoetin Alfa
Drug: Epoetin Alfa
Drug: Epoetin Beta
Drug: methoxy polyethylene glycol-epoetin beta
Enrollment 2825
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Erythropoiesis Stimulating Agents (ESA) Methoxy Polyethylene Glycol-Epoetin Beta
Hide Arm/Group Description Participants received reference ESA according to approved label. No biosimilar ESAs were accepted in the study. The approved reference ESA compounds in the study were darbepoetin alfa, epoetin alfa and epoetin beta. Participants not currently being treated with an ESA received 0.6 micrograms per kilogram (mcg/kg) methoxy polyethylene glycol-epoetin beta intravenously (iv) or subcutaneously (sc) once every 2 weeks for correction of renal anemia (target hemoglobin [Hb] 10-12 grams per deciliter [g/dL]). Participants currently treated with an ESA received a starting dose of 120, 200 or 360 mcg/kg methoxy polyethylene glycol-epoetin beta iv or sc once monthly based on the calculated weekly ESA dose prior to the switch for maintenance of anemia treatment. Once corrected and in participants currently being treated with an ESA, methoxy polyethylene glycol-epoetin beta was administered once monthly.
Period Title: Overall Study
Started [1] 1413 1412
Received Study Treatment 1409 1409
Completed 312 303
Not Completed 1101 1109
Reason Not Completed
Renal Transplant             254             263
Adverse Event / Intercurrent Illness             40             48
Withdrew Consent             68             69
Refused Treatment / Did not Cooperate             26             32
Failure to Return             22             8
Insufficient Therapeutic Response             1             18
Reason Not Specified             159             126
Death             531             545
[1]
Randomized with informed consent
Arm/Group Title Erythropoiesis Stimulating Agents Methoxy Polyethylene Glycol-Epoetin Beta Total
Hide Arm/Group Description Participants received reference ESA according to approved label. No biosimilar ESAs were accepted in the study. The approved reference ESA compounds in the study were darbepoetin alfa, epoetin alfa and epoetin beta. Participants not currently being treated with an ESA received 0.6 micrograms per kilogram (mcg/kg) methoxy polyethylene glycol-epoetin beta intravenously (iv) or subcutaneously (sc) once every 2 weeks for correction of renal anemia (target hemoglobin [Hb] 10-12 grams per deciliter [g/dL]). Participants currently treated with an ESA received a starting dose of 120, 200 or 360 mcg/kg methoxy polyethylene glycol-epoetin beta iv or sc once monthly based on the calculated weekly ESA dose prior to the switch for maintenance of anemia treatment. Once corrected and in participants currently being treated with an ESA, methoxy polyethylene glycol-epoetin beta was administered once monthly. Total of all reporting groups
Overall Number of Baseline Participants 1413 1412 2825
Hide Baseline Analysis Population Description
The intention-to treat (ITT) population consisted of all participants randomized with the appropriate signed consent documentation.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1413 participants 1412 participants 2825 participants
62.6  (14.8) 62.2  (15.0) 62.4  (14.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1413 participants 1412 participants 2825 participants
Female
581
  41.1%
605
  42.8%
1186
  42.0%
Male
832
  58.9%
807
  57.2%
1639
  58.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1413 participants 1412 participants 2825 participants
White
1221
  86.4%
1218
  86.3%
2439
  86.3%
Asian
111
   7.9%
119
   8.4%
230
   8.1%
Black or African American
40
   2.8%
37
   2.6%
77
   2.7%
Other
41
   2.9%
38
   2.7%
79
   2.8%
1.Primary Outcome
Title Time to Composite of All-Cause Mortality and Non-Fatal Cardiovascular Events (Myocardial Infarction, Stroke) Defined as Time Between First Dose of Study Medication and Date of Death or Non-Fatal Cardiovascular Events, Whichever Occurred First
Hide Description [Not Specified]
Time Frame Baseline up to approximately 8.5 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The safety population included all participants randomized (with the appropriate signed consent documentation), who received at least one dose of the trial medication and had at least one post-dose safety assessment. Data are reported for participants with an event.
Arm/Group Title Erythropoiesis Stimulating Agents Methoxy Polyethylene Glycol-Epoetin Beta
Hide Arm/Group Description:
Participants received reference ESA according to approved label. No biosimilar ESAs were accepted in the study. The approved reference ESA compounds in the study were darbepoetin alfa, epoetin alfa and epoetin beta.
Participants not currently being treated with an ESA received 0.6 micrograms per kilogram (mcg/kg) methoxy polyethylene glycol-epoetin beta intravenously (iv) or subcutaneously (sc) once every 2 weeks for correction of renal anemia (target hemoglobin [Hb] 10-12 grams per deciliter [g/dL]). Participants currently treated with an ESA received a starting dose of 120, 200 or 360 mcg/kg methoxy polyethylene glycol-epoetin beta iv or sc once monthly based on the calculated weekly ESA dose prior to the switch for maintenance of anemia treatment. Once corrected and in participants currently being treated with an ESA, methoxy polyethylene glycol-epoetin beta was administered once monthly.
Overall Number of Participants Analyzed 1409 1409
Median (95% Confidence Interval)
Unit of Measure: years
5.1
(4.8 to 5.6)
5.1
(4.7 to 5.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Erythropoiesis Stimulating Agents, Methoxy Polyethylene Glycol-Epoetin Beta
Comments [Not Specified]
Type of Statistical Test Non-Inferiority
Comments The critical alpha level for the non-inferiority test was 0.025.
Statistical Test of Hypothesis P-Value 0.0039
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.03
Confidence Interval (2-Sided) 95%
0.93 to 1.15
Estimation Comments The pre-specified upper non-inferiority limit was 95% CI <1.20.
2.Secondary Outcome
Title Time to All-Cause Mortality
Hide Description [Not Specified]
Time Frame Baseline up to approximately 8.5 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The safety population included all participants randomized (with the appropriate signed consent documentation), who received at least one dose of the trial medication and had at least one post-dose safety assessment. Data are reported for participants with an event.
Arm/Group Title Erythropoiesis Stimulating Agents Methoxy Polyethylene Glycol-Epoetin Beta
Hide Arm/Group Description:
Participants received reference ESA according to approved label. No biosimilar ESAs were accepted in the study. The approved reference ESA compounds in the study were darbepoetin alfa, epoetin alfa and epoetin beta.
Participants not currently being treated with an ESA received 0.6 micrograms per kilogram (mcg/kg) methoxy polyethylene glycol-epoetin beta intravenously (iv) or subcutaneously (sc) once every 2 weeks for correction of renal anemia (target hemoglobin [Hb] 10-12 grams per deciliter [g/dL]). Participants currently treated with an ESA received a starting dose of 120, 200 or 360 mcg/kg methoxy polyethylene glycol-epoetin beta iv or sc once monthly based on the calculated weekly ESA dose prior to the switch for maintenance of anemia treatment. Once corrected and in participants currently being treated with an ESA, methoxy polyethylene glycol-epoetin beta was administered once monthly.
Overall Number of Participants Analyzed 1409 1409
Median (95% Confidence Interval)
Unit of Measure: years
6.1
(5.6 to 6.5)
5.9
(5.5 to 6.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Erythropoiesis Stimulating Agents, Methoxy Polyethylene Glycol-Epoetin Beta
Comments [Not Specified]
Type of Statistical Test Non-Inferiority
Comments The critical alpha level for the non-inferiority test was 0.025
Statistical Test of Hypothesis P-Value 0.0166
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.06
Confidence Interval (2-Sided) 95%
0.94 to 1.19
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Time to Non-Fatal and Fatal Myocardial Infarction
Hide Description [Not Specified]
Time Frame Baseline up to approximately 8.5 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The safety population included all participants randomized (with the appropriate signed consent documentation), who received at least one dose of the trial medication and had at least one post-dose safety assessment. Analysis was performed on data for participants with an event.
Arm/Group Title Erythropoiesis Stimulating Agents Methoxy Polyethylene Glycol-Epoetin Beta
Hide Arm/Group Description:
Participants received reference ESA according to approved label. No biosimilar ESAs were accepted in the study. The approved reference ESA compounds in the study were darbepoetin alfa, epoetin alfa and epoetin beta.
Participants not currently being treated with an ESA received 0.6 micrograms per kilogram (mcg/kg) methoxy polyethylene glycol-epoetin beta intravenously (iv) or subcutaneously (sc) once every 2 weeks for correction of renal anemia (target hemoglobin [Hb] 10-12 grams per deciliter [g/dL]). Participants currently treated with an ESA received a starting dose of 120, 200 or 360 mcg/kg methoxy polyethylene glycol-epoetin beta iv or sc once monthly based on the calculated weekly ESA dose prior to the switch for maintenance of anemia treatment. Once corrected and in participants currently being treated with an ESA, methoxy polyethylene glycol-epoetin beta was administered once monthly.
Overall Number of Participants Analyzed 1409 1409
Median (95% Confidence Interval)
Unit of Measure: years
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
The median time to event was not reached.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Erythropoiesis Stimulating Agents, Methoxy Polyethylene Glycol-Epoetin Beta
Comments [Not Specified]
Type of Statistical Test Non-Inferiority
Comments The critical alpha level for the non-inferiority test was 0.025
Statistical Test of Hypothesis P-Value 0.0219
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.95
Confidence Interval (2-Sided) 95%
0.76 to 1.19
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Time to Non-Fatal and Fatal Stroke
Hide Description [Not Specified]
Time Frame Baseline up to approximately 8.5 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The safety population included all participants randomized (with the appropriate signed consent documentation), who received at least one dose of the trial medication and had at least one post-dose safety assessment. Analysis was performed on data for participants with an event.
Arm/Group Title Erythropoiesis Stimulating Agents Methoxy Polyethylene Glycol-Epoetin Beta
Hide Arm/Group Description:
Participants received reference ESA according to approved label. No biosimilar ESAs were accepted in the study. The approved reference ESA compounds in the study were darbepoetin alfa, epoetin alfa and epoetin beta.
Participants not currently being treated with an ESA received 0.6 micrograms per kilogram (mcg/kg) methoxy polyethylene glycol-epoetin beta intravenously (iv) or subcutaneously (sc) once every 2 weeks for correction of renal anemia (target hemoglobin [Hb] 10-12 grams per deciliter [g/dL]). Participants currently treated with an ESA received a starting dose of 120, 200 or 360 mcg/kg methoxy polyethylene glycol-epoetin beta iv or sc once monthly based on the calculated weekly ESA dose prior to the switch for maintenance of anemia treatment. Once corrected and in participants currently being treated with an ESA, methoxy polyethylene glycol-epoetin beta was administered once monthly.
Overall Number of Participants Analyzed 1409 1409
Median (95% Confidence Interval)
Unit of Measure: years
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
The median time to event was not reached.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Erythropoiesis Stimulating Agents, Methoxy Polyethylene Glycol-Epoetin Beta
Comments [Not Specified]
Type of Statistical Test Non-Inferiority
Comments The critical alpha level for the non-inferiority test was 0.025
Statistical Test of Hypothesis P-Value 0.0459
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.94
Confidence Interval (2-Sided) 95%
0.70 to 1.25
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Time to Non-Fatal Cardiovascular Events (Myocardial Infarction or Stroke, Whichever Occurred First)
Hide Description [Not Specified]
Time Frame Baseline up to approximately 8.5 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The safety population included all participants randomized (with the appropriate signed consent documentation), who received at least one dose of the trial medication and had at least one post-dose safety assessment. Analysis was performed on data for participants with an event.
Arm/Group Title Erythropoiesis Stimulating Agents Methoxy Polyethylene Glycol-Epoetin Beta
Hide Arm/Group Description:
Participants received reference ESA according to approved label. No biosimilar ESAs were accepted in the study. The approved reference ESA compounds in the study were darbepoetin alfa, epoetin alfa and epoetin beta.
Participants not currently being treated with an ESA received 0.6 micrograms per kilogram (mcg/kg) methoxy polyethylene glycol-epoetin beta intravenously (iv) or subcutaneously (sc) once every 2 weeks for correction of renal anemia (target hemoglobin [Hb] 10-12 grams per deciliter [g/dL]). Participants currently treated with an ESA received a starting dose of 120, 200 or 360 mcg/kg methoxy polyethylene glycol-epoetin beta iv or sc once monthly based on the calculated weekly ESA dose prior to the switch for maintenance of anemia treatment. Once corrected and in participants currently being treated with an ESA, methoxy polyethylene glycol-epoetin beta was administered once monthly.
Overall Number of Participants Analyzed 1409 1409
Median (95% Confidence Interval)
Unit of Measure: years
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
The median time to event was not reached.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Erythropoiesis Stimulating Agents, Methoxy Polyethylene Glycol-Epoetin Beta
Comments [Not Specified]
Type of Statistical Test Non-Inferiority
Comments The critical alpha level for the non-inferiority test was 0.025
Statistical Test of Hypothesis P-Value 0.0048
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.91
Confidence Interval (2-Sided) 95%
0.74 to 1.12
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Percentage of Participants With Anti-Erythropoietin Antibody-Mediated Pure Red Cell Aplasia (PRCA)
Hide Description [Not Specified]
Time Frame Baseline up to approximately 8.5 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The safety population included all participants randomized (with the appropriate signed consent documentation), who received at least one dose of the trial medication and had at least one post-dose safety assessment.
Arm/Group Title Erythropoiesis Stimulating Agents Methoxy Polyethylene Glycol-Epoetin Beta
Hide Arm/Group Description:
Participants received reference ESA according to approved label. No biosimilar ESAs were accepted in the study. The approved reference ESA compounds in the study were darbepoetin alfa, epoetin alfa and epoetin beta.
Participants not currently being treated with an ESA received 0.6 micrograms per kilogram (mcg/kg) methoxy polyethylene glycol-epoetin beta intravenously (iv) or subcutaneously (sc) once every 2 weeks for correction of renal anemia (target hemoglobin [Hb] 10-12 grams per deciliter [g/dL]). Participants currently treated with an ESA received a starting dose of 120, 200 or 360 mcg/kg methoxy polyethylene glycol-epoetin beta iv or sc once monthly based on the calculated weekly ESA dose prior to the switch for maintenance of anemia treatment. Once corrected and in participants currently being treated with an ESA, methoxy polyethylene glycol-epoetin beta was administered once monthly.
Overall Number of Participants Analyzed 1409 1409
Measure Type: Number
Unit of Measure: percentage of participants
0 0
7.Secondary Outcome
Title Percentage of Participants With Gastrointestinal Bleeding
Hide Description [Not Specified]
Time Frame Baseline up to approximately 8.5 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The safety population included all participants randomized (with the appropriate signed consent documentation), who received at least one dose of the trial medication and had at least one post-dose safety assessment.
Arm/Group Title Erythropoiesis Stimulating Agents Methoxy Polyethylene Glycol-Epoetin Beta
Hide Arm/Group Description:
Participants received reference ESA according to approved label. No biosimilar ESAs were accepted in the study. The approved reference ESA compounds in the study were darbepoetin alfa, epoetin alfa and epoetin beta.
Participants not currently being treated with an ESA received 0.6 micrograms per kilogram (mcg/kg) methoxy polyethylene glycol-epoetin beta intravenously (iv) or subcutaneously (sc) once every 2 weeks for correction of renal anemia (target hemoglobin [Hb] 10-12 grams per deciliter [g/dL]). Participants currently treated with an ESA received a starting dose of 120, 200 or 360 mcg/kg methoxy polyethylene glycol-epoetin beta iv or sc once monthly based on the calculated weekly ESA dose prior to the switch for maintenance of anemia treatment. Once corrected and in participants currently being treated with an ESA, methoxy polyethylene glycol-epoetin beta was administered once monthly.
Overall Number of Participants Analyzed 1409 1409
Measure Type: Number
Unit of Measure: percentage of participants
11.1 11.7
8.Secondary Outcome
Title Percentage of Participants With Thromboembolic Events
Hide Description [Not Specified]
Time Frame Baseline up to approximately 8.5 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The safety population included all participants randomized (with the appropriate signed consent documentation), who received at least one dose of the trial medication and had at least one post-dose safety assessment.
Arm/Group Title Erythropoiesis Stimulating Agents Methoxy Polyethylene Glycol-Epoetin Beta
Hide Arm/Group Description:
Participants received reference ESA according to approved label. No biosimilar ESAs were accepted in the study. The approved reference ESA compounds in the study were darbepoetin alfa, epoetin alfa and epoetin beta.
Participants not currently being treated with an ESA received 0.6 micrograms per kilogram (mcg/kg) methoxy polyethylene glycol-epoetin beta intravenously (iv) or subcutaneously (sc) once every 2 weeks for correction of renal anemia (target hemoglobin [Hb] 10-12 grams per deciliter [g/dL]). Participants currently treated with an ESA received a starting dose of 120, 200 or 360 mcg/kg methoxy polyethylene glycol-epoetin beta iv or sc once monthly based on the calculated weekly ESA dose prior to the switch for maintenance of anemia treatment. Once corrected and in participants currently being treated with an ESA, methoxy polyethylene glycol-epoetin beta was administered once monthly.
Overall Number of Participants Analyzed 1409 1409
Measure Type: Number
Unit of Measure: percentage of participants
34.5 32.8
Time Frame Baseline up to approximately 8.5 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Erythropoiesis Stimulating Agents Methoxy Polyethylene Glycol-Epoetin Beta
Hide Arm/Group Description Participants received reference ESA according to approved label. No biosimilar ESAs were accepted in the study. The approved reference ESA compounds in the study were darbepoetin alfa, epoetin alfa and epoetin beta. Participants not currently being treated with an ESA received 0.6 micrograms per kilogram (mcg/kg) methoxy polyethylene glycol-epoetin beta intravenously (iv) or subcutaneously (sc) once every 2 weeks for correction of renal anemia (target hemoglobin [Hb] 10-12 grams per deciliter [g/dL]). Participants currently treated with an ESA received a starting dose of 120, 200 or 360 mcg/kg methoxy polyethylene glycol-epoetin beta iv or sc once monthly based on the calculated weekly ESA dose prior to the switch for maintenance of anemia treatment. Once corrected and in participants currently being treated with an ESA, methoxy polyethylene glycol-epoetin beta was administered once monthly.
All-Cause Mortality
Erythropoiesis Stimulating Agents Methoxy Polyethylene Glycol-Epoetin Beta
Affected / at Risk (%) Affected / at Risk (%)
Total   557/1409 (39.53%)   558/1409 (39.60%) 
Show Serious Adverse Events Hide Serious Adverse Events
Erythropoiesis Stimulating Agents Methoxy Polyethylene Glycol-Epoetin Beta
Affected / at Risk (%) Affected / at Risk (%)
Total   1123/1409 (79.70%)   1097/1409 (77.86%) 
Blood and lymphatic system disorders     
Anaemia  1  22/1409 (1.56%)  25/1409 (1.77%) 
Haemolysis  1  2/1409 (0.14%)  2/1409 (0.14%) 
Thrombocytopenia  1  3/1409 (0.21%)  1/1409 (0.07%) 
Bone marrow failure  1  2/1409 (0.14%)  1/1409 (0.07%) 
Anaemia of chronic disease  1  0/1409 (0.00%)  2/1409 (0.14%) 
Anaemia of malignant disease  1  2/1409 (0.14%)  0/1409 (0.00%) 
Disseminated intravascular coagulation  1  1/1409 (0.07%)  1/1409 (0.07%) 
Lymphadenopathy  1  0/1409 (0.00%)  2/1409 (0.14%) 
Nephrogenic anaemia  1  1/1409 (0.07%)  1/1409 (0.07%) 
Spontaneous haematoma  1  0/1409 (0.00%)  2/1409 (0.14%) 
Thrombotic thrombocytopenic purpura  1  1/1409 (0.07%)  1/1409 (0.07%) 
Bone marrow toxicity  1  1/1409 (0.07%)  0/1409 (0.00%) 
Febrile bone marrow aplasia  1  1/1409 (0.07%)  0/1409 (0.00%) 
Haemolytic anaemia  1  1/1409 (0.07%)  0/1409 (0.00%) 
Haemorrhagic anaemia  1  1/1409 (0.07%)  0/1409 (0.00%) 
Histiocytosis haematophagic  1  0/1409 (0.00%)  1/1409 (0.07%) 
Immune thrombocytopenic purpura  1  0/1409 (0.00%)  1/1409 (0.07%) 
Leukopenia  1  1/1409 (0.07%)  0/1409 (0.00%) 
Neutropenia  1  0/1409 (0.00%)  1/1409 (0.07%) 
Normochromic anaemia  1  0/1409 (0.00%)  1/1409 (0.07%) 
Pancytopenia  1  1/1409 (0.07%)  0/1409 (0.00%) 
Polycythaemia  1  1/1409 (0.07%)  0/1409 (0.00%) 
Splenic infarction  1  0/1409 (0.00%)  1/1409 (0.07%) 
Spontaneous haemorrhage  1  0/1409 (0.00%)  1/1409 (0.07%) 
Cardiac disorders     
Acute myocardial infarction  1  74/1409 (5.25%)  63/1409 (4.47%) 
Atrial fibrillation  1  57/1409 (4.05%)  49/1409 (3.48%) 
Myocardial infarction  1  50/1409 (3.55%)  54/1409 (3.83%) 
Cardiac arrest  1  44/1409 (3.12%)  55/1409 (3.90%) 
Angina pectoris  1  37/1409 (2.63%)  35/1409 (2.48%) 
Cardiac failure  1  34/1409 (2.41%)  25/1409 (1.77%) 
Acute coronary syndrome  1  25/1409 (1.77%)  29/1409 (2.06%) 
Cardiac failure congestive  1  24/1409 (1.70%)  20/1409 (1.42%) 
Coronary artery disease  1  24/1409 (1.70%)  20/1409 (1.42%) 
Angina unstable  1  16/1409 (1.14%)  24/1409 (1.70%) 
Myocardial ischaemia  1  21/1409 (1.49%)  17/1409 (1.21%) 
Bradycardia  1  20/1409 (1.42%)  8/1409 (0.57%) 
Cardio-respiratory arrest  1  12/1409 (0.85%)  10/1409 (0.71%) 
Aortic valve stenosis  1  8/1409 (0.57%)  8/1409 (0.57%) 
Atrioventricular block complete  1  7/1409 (0.50%)  9/1409 (0.64%) 
Coronary artery stenosis  1  7/1409 (0.50%)  9/1409 (0.64%) 
Cardiogenic shock  1  9/1409 (0.64%)  5/1409 (0.35%) 
Atrial flutter  1  9/1409 (0.64%)  4/1409 (0.28%) 
Cardiac failure acute  1  4/1409 (0.28%)  9/1409 (0.64%) 
Cardiopulmonary failure  1  3/1409 (0.21%)  8/1409 (0.57%) 
Ventricular fibrillation  1  3/1409 (0.21%)  7/1409 (0.50%) 
Arrhythmia  1  7/1409 (0.50%)  2/1409 (0.14%) 
Left ventricular failure  1  5/1409 (0.35%)  4/1409 (0.28%) 
Cardiac failure chronic  1  5/1409 (0.35%)  2/1409 (0.14%) 
Atrioventricular block  1  4/1409 (0.28%)  2/1409 (0.14%) 
Cardiomyopathy  1  5/1409 (0.35%)  1/1409 (0.07%) 
Sinus node dysfunction  1  4/1409 (0.28%)  2/1409 (0.14%) 
Ventricular tachycardia  1  2/1409 (0.14%)  3/1409 (0.21%) 
Aortic valve disease  1  2/1409 (0.14%)  2/1409 (0.14%) 
Atrial tachycardia  1  4/1409 (0.28%)  0/1409 (0.00%) 
Atrioventricular block second degree  1  3/1409 (0.21%)  1/1409 (0.07%) 
Pericardial effusion  1  2/1409 (0.14%)  2/1409 (0.14%) 
Pericarditis  1  2/1409 (0.14%)  2/1409 (0.14%) 
Sinus bradycardia  1  2/1409 (0.14%)  2/1409 (0.14%) 
Acute left ventricular failure  1  2/1409 (0.14%)  1/1409 (0.07%) 
Arteriosclerosis coronary artery  1  3/1409 (0.21%)  0/1409 (0.00%) 
Atrial thrombosis  1  3/1409 (0.21%)  0/1409 (0.00%) 
Bradyarrhythmia  1  1/1409 (0.07%)  2/1409 (0.14%) 
Coronary artery thrombosis  1  2/1409 (0.14%)  1/1409 (0.07%) 
Ischaemic cardiomyopathy  1  2/1409 (0.14%)  1/1409 (0.07%) 
Right ventricular failure  1  2/1409 (0.14%)  1/1409 (0.07%) 
Tachyarrhythmia  1  1/1409 (0.07%)  2/1409 (0.14%) 
Aortic valve disease mixed  1  1/1409 (0.07%)  1/1409 (0.07%) 
Atrioventricular block first degree  1  1/1409 (0.07%)  1/1409 (0.07%) 
Cardiac disorder  1  0/1409 (0.00%)  2/1409 (0.14%) 
Congestive cardiomyopathy  1  1/1409 (0.07%)  1/1409 (0.07%) 
Coronary artery insufficiency  1  1/1409 (0.07%)  1/1409 (0.07%) 
Mitral valve incompetence  1  0/1409 (0.00%)  2/1409 (0.14%) 
Pericarditis uraemic  1  1/1409 (0.07%)  1/1409 (0.07%) 
Pulseless electrical activity  1  1/1409 (0.07%)  1/1409 (0.07%) 
Sinus tachycardia  1  2/1409 (0.14%)  0/1409 (0.00%) 
Supraventricular tachycardia  1  1/1409 (0.07%)  1/1409 (0.07%) 
Ventricular extrasystoles  1  0/1409 (0.00%)  2/1409 (0.14%) 
Adams-Stokes syndrome  1  0/1409 (0.00%)  1/1409 (0.07%) 
Aortic valve incompetence  1  0/1409 (0.00%)  1/1409 (0.07%) 
Bundle branch block left  1  1/1409 (0.07%)  0/1409 (0.00%) 
Cardiac dysfunction  1  0/1409 (0.00%)  1/1409 (0.07%) 
Cardiac tamponade  1  1/1409 (0.07%)  0/1409 (0.00%) 
Cardiovascular insufficiency  1  1/1409 (0.07%)  0/1409 (0.00%) 
Chordae tendinae rupture  1  1/1409 (0.07%)  0/1409 (0.00%) 
Conduction disorder  1  0/1409 (0.00%)  1/1409 (0.07%) 
Coronary artery dissection  1  1/1409 (0.07%)  0/1409 (0.00%) 
Coronary artery occlusion  1  1/1409 (0.07%)  0/1409 (0.00%) 
Diabetic cardiomyopathy  1  0/1409 (0.00%)  1/1409 (0.07%) 
Dressler's syndrome  1  0/1409 (0.00%)  1/1409 (0.07%) 
Extrasystoles  1  0/1409 (0.00%)  1/1409 (0.07%) 
Heart valve incompetence  1  0/1409 (0.00%)  1/1409 (0.07%) 
Heart valve stenosis  1  0/1409 (0.00%)  1/1409 (0.07%) 
Hypertensive heart disease  1  1/1409 (0.07%)  0/1409 (0.00%) 
Low cardiac output syndrome  1  0/1409 (0.00%)  1/1409 (0.07%) 
Mitral valve stenosis  1  1/1409 (0.07%)  0/1409 (0.00%) 
Myocarditis  1  0/1409 (0.00%)  1/1409 (0.07%) 
Palpitations  1  1/1409 (0.07%)  0/1409 (0.00%) 
Paroxysmal atrioventricular block  1  1/1409 (0.07%)  0/1409 (0.00%) 
Pericardial haemorrhage  1  0/1409 (0.00%)  1/1409 (0.07%) 
Sinoatrial block  1  1/1409 (0.07%)  0/1409 (0.00%) 
Stress cardiomyopathy  1  0/1409 (0.00%)  1/1409 (0.07%) 
Tachycardia  1  1/1409 (0.07%)  0/1409 (0.00%) 
Torsade de pointes  1  0/1409 (0.00%)  1/1409 (0.07%) 
Tricuspid valve incompetence  1  0/1409 (0.00%)  1/1409 (0.07%) 
Ventricular dyssynchrony  1  1/1409 (0.07%)  0/1409 (0.00%) 
Ventricular tachyarrhythmia  1  1/1409 (0.07%)  0/1409 (0.00%) 
Congenital, familial and genetic disorders     
Congenital cystic kidney disease  1  1/1409 (0.07%)  2/1409 (0.14%) 
Hydrocele  1  0/1409 (0.00%)  2/1409 (0.14%) 
Congenital bladder anomaly  1  0/1409 (0.00%)  1/1409 (0.07%) 
Nonketotic hyperglycinaemia  1  0/1409 (0.00%)  1/1409 (0.07%) 
Phimosis  1  1/1409 (0.07%)  0/1409 (0.00%) 
Ear and labyrinth disorders     
Vertigo  1  3/1409 (0.21%)  2/1409 (0.14%) 
Sudden hearing loss  1  2/1409 (0.14%)  0/1409 (0.00%) 
Acute vestibular syndrome  1  1/1409 (0.07%)  0/1409 (0.00%) 
Deafness unilateral  1  1/1409 (0.07%)  0/1409 (0.00%) 
Vertigo labyrinthine  1  0/1409 (0.00%)  1/1409 (0.07%) 
Endocrine disorders     
Hyperparathyroidism secondary  1  19/1409 (1.35%)  23/1409 (1.63%) 
Hyperparathyroidism tertiary  1  4/1409 (0.28%)  4/1409 (0.28%) 
Adrenal insufficiency  1  3/1409 (0.21%)  2/1409 (0.14%) 
Hyperparathyroidism  1  3/1409 (0.21%)  1/1409 (0.07%) 
Goitre  1  2/1409 (0.14%)  1/1409 (0.07%) 
Hypothyroidism  1  0/1409 (0.00%)  3/1409 (0.21%) 
Basedow's disease  1  1/1409 (0.07%)  1/1409 (0.07%) 
Parathyroid hyperplasia  1  2/1409 (0.14%)  0/1409 (0.00%) 
Eye disorders     
Cataract  1  9/1409 (0.64%)  10/1409 (0.71%) 
Vitreous haemorrhage  1  4/1409 (0.28%)  2/1409 (0.14%) 
Glaucoma  1  2/1409 (0.14%)  3/1409 (0.21%) 
Diabetic retinopathy  1  1/1409 (0.07%)  3/1409 (0.21%) 
Retinal artery occlusion  1  1/1409 (0.07%)  1/1409 (0.07%) 
Cataract diabetic  1  1/1409 (0.07%)  0/1409 (0.00%) 
Endocrine ophthalmopathy  1  0/1409 (0.00%)  1/1409 (0.07%) 
Ocular vasculitis  1  0/1409 (0.00%)  1/1409 (0.07%) 
Optic ischaemic neuropathy  1  1/1409 (0.07%)  0/1409 (0.00%) 
Papilloedema  1  1/1409 (0.07%)  0/1409 (0.00%) 
Retinal neovascularisation  1  1/1409 (0.07%)  0/1409 (0.00%) 
Retinal vein thrombosis  1  1/1409 (0.07%)  0/1409 (0.00%) 
Vision blurred  1  0/1409 (0.00%)  1/1409 (0.07%) 
Visual impairment  1  1/1409 (0.07%)  0/1409 (0.00%) 
Vitreous haematoma  1  1/1409 (0.07%)  0/1409 (0.00%) 
Gastrointestinal disorders     
Gastrointestinal haemorrhage  1  23/1409 (1.63%)  24/1409 (1.70%) 
Abdominal pain  1  16/1409 (1.14%)  13/1409 (0.92%) 
Diarrhoea  1  9/1409 (0.64%)  18/1409 (1.28%) 
Large intestine polyp  1  10/1409 (0.71%)  9/1409 (0.64%) 
Rectal haemorrhage  1  8/1409 (0.57%)  10/1409 (0.71%) 
Gastritis  1  11/1409 (0.78%)  5/1409 (0.35%) 
Constipation  1  8/1409 (0.57%)  7/1409 (0.50%) 
Gastric ulcer  1  5/1409 (0.35%)  10/1409 (0.71%) 
Inguinal hernia  1  7/1409 (0.50%)  8/1409 (0.57%) 
Colitis ischaemic  1  7/1409 (0.50%)  7/1409 (0.50%) 
Gastric ulcer haemorrhage  1  8/1409 (0.57%)  6/1409 (0.43%) 
Intestinal ischaemia  1  9/1409 (0.64%)  5/1409 (0.35%) 
Intestinal obstruction  1  9/1409 (0.64%)  5/1409 (0.35%) 
Melaena  1  7/1409 (0.50%)  7/1409 (0.50%) 
Colitis  1  8/1409 (0.57%)  5/1409 (0.35%) 
Pancreatitis acute  1  9/1409 (0.64%)  3/1409 (0.21%) 
Pancreatitis  1  5/1409 (0.35%)  6/1409 (0.43%) 
Duodenal ulcer haemorrhage  1  6/1409 (0.43%)  4/1409 (0.28%) 
Abdominal pain upper  1  6/1409 (0.43%)  3/1409 (0.21%) 
Gastritis erosive  1  3/1409 (0.21%)  6/1409 (0.43%) 
Gastritis haemorrhagic  1  6/1409 (0.43%)  3/1409 (0.21%) 
Haemorrhoidal haemorrhage  1  2/1409 (0.14%)  7/1409 (0.50%) 
Umbilical hernia  1  7/1409 (0.50%)  1/1409 (0.07%) 
Upper gastrointestinal haemorrhage  1  3/1409 (0.21%)  5/1409 (0.35%) 
Diverticulum  1  5/1409 (0.35%)  2/1409 (0.14%) 
Diverticulum intestinal haemorrhagic  1  2/1409 (0.14%)  5/1409 (0.35%) 
Enteritis  1  5/1409 (0.35%)  2/1409 (0.14%) 
Small intestinal obstruction  1  3/1409 (0.21%)  4/1409 (0.28%) 
Vomiting  1  4/1409 (0.28%)  3/1409 (0.21%) 
Gastrointestinal angiodysplasia  1  3/1409 (0.21%)  3/1409 (0.21%) 
Gastrointestinal angiodysplasia haemorrhagic  1  3/1409 (0.21%)  3/1409 (0.21%) 
Haematemesis  1  5/1409 (0.35%)  1/1409 (0.07%) 
Haemorrhoids  1  3/1409 (0.21%)  3/1409 (0.21%) 
Intestinal infarction  1  4/1409 (0.28%)  2/1409 (0.14%) 
Gastrointestinal disorder  1  3/1409 (0.21%)  2/1409 (0.14%) 
Haematochezia  1  2/1409 (0.14%)  3/1409 (0.21%) 
Intestinal haemorrhage  1  2/1409 (0.14%)  3/1409 (0.21%) 
Mallory-Weiss syndrome  1  3/1409 (0.21%)  2/1409 (0.14%) 
Chronic gastritis  1  1/1409 (0.07%)  3/1409 (0.21%) 
Duodenal ulcer  1  1/1409 (0.07%)  3/1409 (0.21%) 
Dyspepsia  1  3/1409 (0.21%)  1/1409 (0.07%) 
Enterocolitis  1  3/1409 (0.21%)  1/1409 (0.07%) 
Gastric haemorrhage  1  1/1409 (0.07%)  3/1409 (0.21%) 
Gastrooesophageal reflux disease  1  1/1409 (0.07%)  3/1409 (0.21%) 
Incarcerated inguinal hernia  1  0/1409 (0.00%)  4/1409 (0.28%) 
Large intestine perforation  1  1/1409 (0.07%)  3/1409 (0.21%) 
Subileus  1  1/1409 (0.07%)  3/1409 (0.21%) 
Abdominal discomfort  1  1/1409 (0.07%)  2/1409 (0.14%) 
Abdominal wall haematoma  1  1/1409 (0.07%)  2/1409 (0.14%) 
Acute abdomen  1  2/1409 (0.14%)  1/1409 (0.07%) 
Anal fistula  1  2/1409 (0.14%)  1/1409 (0.07%) 
Diabetic gastroparesis  1  2/1409 (0.14%)  1/1409 (0.07%) 
Encapsulating peritoneal sclerosis  1  2/1409 (0.14%)  1/1409 (0.07%) 
Gastric antral vascular ectasia  1  2/1409 (0.14%)  1/1409 (0.07%) 
Gastroduodenitis  1  1/1409 (0.07%)  2/1409 (0.14%) 
Gastrointestinal angiectasia  1  2/1409 (0.14%)  1/1409 (0.07%) 
Gastrointestinal polyp haemorrhage  1  3/1409 (0.21%)  0/1409 (0.00%) 
Haemorrhagic erosive gastritis  1  0/1409 (0.00%)  3/1409 (0.21%) 
Ileus  1  1/1409 (0.07%)  2/1409 (0.14%) 
Large intestinal ulcer haemorrhage  1  0/1409 (0.00%)  3/1409 (0.21%) 
Necrotising colitis  1  1/1409 (0.07%)  2/1409 (0.14%) 
Oesophagitis  1  1/1409 (0.07%)  2/1409 (0.14%) 
Pancreatitis necrotising  1  2/1409 (0.14%)  1/1409 (0.07%) 
Peptic ulcer haemorrhage  1  2/1409 (0.14%)  1/1409 (0.07%) 
Rectal prolapse  1  2/1409 (0.14%)  1/1409 (0.07%) 
Abdominal hernia  1  1/1409 (0.07%)  1/1409 (0.07%) 
Ascites  1  0/1409 (0.00%)  2/1409 (0.14%) 
Colitis erosive  1  1/1409 (0.07%)  1/1409 (0.07%) 
Dental caries  1  2/1409 (0.14%)  0/1409 (0.00%) 
Diverticulum intestinal  1  1/1409 (0.07%)  1/1409 (0.07%) 
Enterocutaneous fistula  1  0/1409 (0.00%)  2/1409 (0.14%) 
Erosive duodenitis  1  1/1409 (0.07%)  1/1409 (0.07%) 
Erosive oesophagitis  1  1/1409 (0.07%)  1/1409 (0.07%) 
Food poisoning  1  1/1409 (0.07%)  1/1409 (0.07%) 
Gastrointestinal necrosis  1  1/1409 (0.07%)  1/1409 (0.07%) 
Gastrointestinal ulcer haemorrhage  1  2/1409 (0.14%)  0/1409 (0.00%) 
Ileus paralytic  1  2/1409 (0.14%)  0/1409 (0.00%) 
Incarcerated umbilical hernia  1  2/1409 (0.14%)  0/1409 (0.00%) 
Intestinal perforation  1  1/1409 (0.07%)  1/1409 (0.07%) 
Intestinal polyp  1  1/1409 (0.07%)  1/1409 (0.07%) 
Large intestinal haemorrhage  1  0/1409 (0.00%)  2/1409 (0.14%) 
Large intestinal ulcer  1  0/1409 (0.00%)  2/1409 (0.14%) 
Lower gastrointestinal haemorrhage  1  0/1409 (0.00%)  2/1409 (0.14%) 
Pancreatitis chronic  1  2/1409 (0.14%)  0/1409 (0.00%) 
Peritoneal perforation  1  2/1409 (0.14%)  0/1409 (0.00%) 
Rectal polyp  1  1/1409 (0.07%)  1/1409 (0.07%) 
Abdominal wall haemorrhage  1  0/1409 (0.00%)  1/1409 (0.07%) 
Anal fissure  1  1/1409 (0.07%)  0/1409 (0.00%) 
Anal stenosis  1  1/1409 (0.07%)  0/1409 (0.00%) 
Anal ulcer  1  0/1409 (0.00%)  1/1409 (0.07%) 
Anorectal varices  1  0/1409 (0.00%)  1/1409 (0.07%) 
Appendiceal mucocoele  1  1/1409 (0.07%)  0/1409 (0.00%) 
Colitis ulcerative  1  0/1409 (0.00%)  1/1409 (0.07%) 
Defaecation urgency  1  1/1409 (0.07%)  0/1409 (0.00%) 
Diabetic gastropathy  1  0/1409 (0.00%)  1/1409 (0.07%) 
Diverticular perforation  1  0/1409 (0.00%)  1/1409 (0.07%) 
Diverticulum oesophageal  1  1/1409 (0.07%)  0/1409 (0.00%) 
Duodenitis  1  1/1409 (0.07%)  0/1409 (0.00%) 
Enterocolitis haemorrhagic  1  0/1409 (0.00%)  1/1409 (0.07%) 
Faecaloma  1  1/1409 (0.07%)  0/1409 (0.00%) 
Flatulence  1  0/1409 (0.00%)  1/1409 (0.07%) 
Gallstone ileus  1  0/1409 (0.00%)  1/1409 (0.07%) 
Gastroduodenal ulcer  1  1/1409 (0.07%)  0/1409 (0.00%) 
Gastrointestinal hypomotility  1  1/1409 (0.07%)  0/1409 (0.00%) 
Ileal perforation  1  1/1409 (0.07%)  0/1409 (0.00%) 
Inguinal hernia strangulated  1  1/1409 (0.07%)  0/1409 (0.00%) 
Intestinal angina  1  0/1409 (0.00%)  1/1409 (0.07%) 
Intestinal mass  1  1/1409 (0.07%)  0/1409 (0.00%) 
Intestinal pseudo-obstruction  1  0/1409 (0.00%)  1/1409 (0.07%) 
Intestinal varices  1  0/1409 (0.00%)  1/1409 (0.07%) 
Intra-abdominal fluid collection  1  1/1409 (0.07%)  0/1409 (0.00%) 
Irritable bowel syndrome  1  1/1409 (0.07%)  0/1409 (0.00%) 
Ischaemic enteritis  1  1/1409 (0.07%)  0/1409 (0.00%) 
Large intestinal stenosis  1  1/1409 (0.07%)  0/1409 (0.00%) 
Lumbar hernia  1  1/1409 (0.07%)  0/1409 (0.00%) 
Mesenteric arterial occlusion  1  0/1409 (0.00%)  1/1409 (0.07%) 
Nausea  1  1/1409 (0.07%)  0/1409 (0.00%) 
Oesophageal spasm  1  1/1409 (0.07%)  0/1409 (0.00%) 
Oesophageal ulcer  1  0/1409 (0.00%)  1/1409 (0.07%) 
Oesophagitis haemorrhagic  1  1/1409 (0.07%)  0/1409 (0.00%) 
Oral disorder  1  0/1409 (0.00%)  1/1409 (0.07%) 
Peptic ulcer perforation  1  1/1409 (0.07%)  0/1409 (0.00%) 
Rectal ulcer haemorrhage  1  1/1409 (0.07%)  0/1409 (0.00%) 
Reflux gastritis  1  0/1409 (0.00%)  1/1409 (0.07%) 
Retroperitoneal haematoma  1  1/1409 (0.07%)  0/1409 (0.00%) 
Retroperitoneal haemorrhage  1  1/1409 (0.07%)  0/1409 (0.00%) 
Salivary gland enlargement  1  0/1409 (0.00%)  1/1409 (0.07%) 
Small intestinal haemorrhage  1  1/1409 (0.07%)  0/1409 (0.00%) 
Tongue oedema  1  1/1409 (0.07%)  0/1409 (0.00%) 
Umbilical hernia, obstructive  1  1/1409 (0.07%)  0/1409 (0.00%) 
Varices oesophageal  1  0/1409 (0.00%)  1/1409 (0.07%) 
Volvulus  1  1/1409 (0.07%)  0/1409 (0.00%) 
Strangulated umbilical hernia  1  0/1409 (0.00%)  1/1409 (0.07%) 
General disorders     
Death  1  33/1409 (2.34%)  39/1409 (2.77%) 
Sudden death  1  26/1409 (1.85%)  44/1409 (3.12%) 
Pyrexia  1  30/1409 (2.13%)  26/1409 (1.85%) 
General physical health deterioration  1  16/1409 (1.14%)  12/1409 (0.85%) 
Chest pain  1  13/1409 (0.92%)  10/1409 (0.71%) 
Catheter site haemorrhage  1  7/1409 (0.50%)  7/1409 (0.50%) 
Non-cardiac chest pain  1  11/1409 (0.78%)  3/1409 (0.21%) 
Asthenia  1  7/1409 (0.50%)  2/1409 (0.14%) 
Inflammation  1  4/1409 (0.28%)  5/1409 (0.35%) 
Multiple organ dysfunction syndrome  1  6/1409 (0.43%)  3/1409 (0.21%) 
Complication associated with device  1  3/1409 (0.21%)  5/1409 (0.35%) 
Sudden cardiac death  1  4/1409 (0.28%)  3/1409 (0.21%) 
Hyperthermia  1  5/1409 (0.35%)  1/1409 (0.07%) 
Adverse drug reaction  1  0/1409 (0.00%)  4/1409 (0.28%) 
Device related thrombosis  1  1/1409 (0.07%)  3/1409 (0.21%) 
Hyperpyrexia  1  1/1409 (0.07%)  3/1409 (0.21%) 
Malaise  1  3/1409 (0.21%)  1/1409 (0.07%) 
Oedema due to renal disease  1  2/1409 (0.14%)  2/1409 (0.14%) 
Fatigue  1  2/1409 (0.14%)  1/1409 (0.07%) 
Hernia  1  1/1409 (0.07%)  2/1409 (0.14%) 
Oedema peripheral  1  1/1409 (0.07%)  2/1409 (0.14%) 
Swelling  1  3/1409 (0.21%)  0/1409 (0.00%) 
Catheter site inflammation  1  1/1409 (0.07%)  1/1409 (0.07%) 
Chest discomfort  1  2/1409 (0.14%)  0/1409 (0.00%) 
Gait disturbance  1  0/1409 (0.00%)  2/1409 (0.14%) 
Oedema  1  1/1409 (0.07%)  1/1409 (0.07%) 
Strangulated hernia  1  2/1409 (0.14%)  0/1409 (0.00%) 
Systemic inflammatory response syndrome  1  2/1409 (0.14%)  0/1409 (0.00%) 
Accidental death  1  1/1409 (0.07%)  0/1409 (0.00%) 
Discomfort  1  0/1409 (0.00%)  1/1409 (0.07%) 
Drug intolerance  1  0/1409 (0.00%)  1/1409 (0.07%) 
Dysplasia  1  1/1409 (0.07%)  0/1409 (0.00%) 
Heteroplasia  1  1/1409 (0.07%)  0/1409 (0.00%) 
Impaired healing  1  0/1409 (0.00%)  1/1409 (0.07%) 
Implant site extravasation  1  1/1409 (0.07%)  0/1409 (0.00%) 
Incarcerated hernia  1  0/1409 (0.00%)  1/1409 (0.07%) 
Injection site extravasation  1  0/1409 (0.00%)  1/1409 (0.07%) 
Injection site scab  1  0/1409 (0.00%)  1/1409 (0.07%) 
Medical device pain  1  0/1409 (0.00%)  1/1409 (0.07%) 
Mucosal ulceration  1  0/1409 (0.00%)  1/1409 (0.07%) 
Necrosis  1  1/1409 (0.07%)  0/1409 (0.00%) 
Oedema due to cardiac disease  1  1/1409 (0.07%)  0/1409 (0.00%) 
Pseudocyst  1  0/1409 (0.00%)  1/1409 (0.07%) 
Stent-graft endoleak  1  1/1409 (0.07%)  0/1409 (0.00%) 
Surgical failure  1  1/1409 (0.07%)  0/1409 (0.00%) 
Treatment failure  1  1/1409 (0.07%)  0/1409 (0.00%) 
Vascular stent restenosis  1  1/1409 (0.07%)  0/1409 (0.00%) 
Vascular stent stenosis  1  0/1409 (0.00%)  1/1409 (0.07%) 
Vascular stent thrombosis  1  1/1409 (0.07%)  0/1409 (0.00%) 
Vessel puncture site haematoma  1  1/1409 (0.07%)  0/1409 (0.00%) 
Hepatobiliary disorders     
Cholecystitis  1  10/1409 (0.71%)  12/1409 (0.85%) 
Cholecystitis acute  1  13/1409 (0.92%)  7/1409 (0.50%) 
Cholelithiasis  1  7/1409 (0.50%)  8/1409 (0.57%) 
Cholangitis  1  5/1409 (0.35%)  5/1409 (0.35%) 
Jaundice cholestatic  1  4/1409 (0.28%)  1/1409 (0.07%) 
Bile duct stone  1  3/1409 (0.21%)  1/1409 (0.07%) 
Hepatic failure  1  2/1409 (0.14%)  2/1409 (0.14%) 
Cholestasis  1  2/1409 (0.14%)  1/1409 (0.07%) 
Hepatic cirrhosis  1  3/1409 (0.21%)  0/1409 (0.00%) 
Biliary colic  1  1/1409 (0.07%)  1/1409 (0.07%) 
Cholangitis acute  1  1/1409 (0.07%)  1/1409 (0.07%) 
Drug-induced liver injury  1  1/1409 (0.07%)  1/1409 (0.07%) 
Acute hepatic failure  1  1/1409 (0.07%)  0/1409 (0.00%) 
Bile duct obstruction  1  1/1409 (0.07%)  0/1409 (0.00%) 
Cholecystitis chronic  1  1/1409 (0.07%)  0/1409 (0.00%) 
Cirrhosis alcoholic  1  1/1409 (0.07%)  0/1409 (0.00%) 
Gallbladder enlargement  1  0/1409 (0.00%)  1/1409 (0.07%) 
Gallbladder perforation  1  1/1409 (0.07%)  0/1409 (0.00%) 
Haemobilia  1  1/1409 (0.07%)  0/1409 (0.00%) 
Hepatic artery stenosis  1  0/1409 (0.00%)  1/1409 (0.07%) 
Hepatitis acute  1  0/1409 (0.00%)  1/1409 (0.07%) 
Hepatotoxicity  1  1/1409 (0.07%)  0/1409 (0.00%) 
Hydrocholecystis  1  0/1409 (0.00%)  1/1409 (0.07%) 
Ischaemic hepatitis  1  1/1409 (0.07%)  0/1409 (0.00%) 
Jaundice  1  0/1409 (0.00%)  1/1409 (0.07%) 
Liver disorder  1  1/1409 (0.07%)  0/1409 (0.00%) 
Liver injury  1  1/1409 (0.07%)  0/1409 (0.00%) 
Immune system disorders     
Drug hypersensitivity  1  4/1409 (0.28%)  2/1409 (0.14%) 
Hypersensitivity  1  4/1409 (0.28%)  1/1409 (0.07%) 
Anti-neutrophil cytoplasmic antibody positive vasculitis  1  2/1409 (0.14%)  1/1409 (0.07%) 
Kidney transplant rejection  1  2/1409 (0.14%)  0/1409 (0.00%) 
Anaphylactic shock  1  0/1409 (0.00%)  1/1409 (0.07%) 
Graft versus host disease  1  1/1409 (0.07%)  0/1409 (0.00%) 
Immune reconstitution inflammatory syndrome  1  0/1409 (0.00%)  1/1409 (0.07%) 
Pancreas transplant rejection  1  0/1409 (0.00%)  1/1409 (0.07%) 
Sarcoidosis  1  1/1409 (0.07%)  0/1409 (0.00%) 
Transplant rejection  1  0/1409 (0.00%)  1/1409 (0.07%) 
Infections and infestations     
Pneumonia  1  163/1409 (11.57%)  180/1409 (12.78%) 
Sepsis  1  85/1409 (6.03%)  69/1409 (4.90%) 
Peritonitis  1  46/1409 (3.26%)  47/1409 (3.34%) 
Septic shock  1  49/1409 (3.48%)  36/1409 (2.56%) 
Gastroenteritis  1  27/1409 (1.92%)  39/1409 (2.77%) 
Urinary tract infection  1  33/1409 (2.34%)  31/1409 (2.20%) 
Device related sepsis  1  30/1409 (2.13%)  21/1409 (1.49%) 
Lower respiratory tract infection  1  28/1409 (1.99%)  21/1409 (1.49%) 
Cellulitis  1  25/1409 (1.77%)  22/1409 (1.56%) 
Device related infection  1  28/1409 (1.99%)  19/1409 (1.35%) 
Bronchitis  1  24/1409 (1.70%)  20/1409 (1.42%) 
Gangrene  1  20/1409 (1.42%)  22/1409 (1.56%) 
Respiratory tract infection  1  23/1409 (1.63%)  16/1409 (1.14%) 
Staphylococcal sepsis  1  18/1409 (1.28%)  14/1409 (0.99%) 
Urosepsis  1  11/1409 (0.78%)  19/1409 (1.35%) 
Bacteraemia  1  14/1409 (0.99%)  10/1409 (0.71%) 
Arteriovenous fistula site infection  1  14/1409 (0.99%)  9/1409 (0.64%) 
Infection  1  7/1409 (0.50%)  15/1409 (1.06%) 
Upper respiratory tract infection  1  10/1409 (0.71%)  10/1409 (0.71%) 
Diabetic foot infection  1  9/1409 (0.64%)  10/1409 (0.71%) 
Diverticulitis  1  13/1409 (0.92%)  5/1409 (0.35%) 
Erysipelas  1  8/1409 (0.57%)  10/1409 (0.71%) 
Endocarditis  1  10/1409 (0.71%)  7/1409 (0.50%) 
Catheter site infection  1  10/1409 (0.71%)  4/1409 (0.28%) 
Postoperative wound infection  1  10/1409 (0.71%)  4/1409 (0.28%) 
Pyelonephritis  1  7/1409 (0.50%)  5/1409 (0.35%) 
Staphylococcal bacteraemia  1  9/1409 (0.64%)  3/1409 (0.21%) 
Arteriovenous graft site infection  1  7/1409 (0.50%)  4/1409 (0.28%) 
Arthritis bacterial  1  8/1409 (0.57%)  3/1409 (0.21%) 
Infected skin ulcer  1  8/1409 (0.57%)  3/1409 (0.21%) 
Lung infection  1  8/1409 (0.57%)  3/1409 (0.21%) 
Viral infection  1  3/1409 (0.21%)  8/1409 (0.57%) 
Pyelonephritis acute  1  5/1409 (0.35%)  5/1409 (0.35%) 
Wound infection  1  4/1409 (0.28%)  6/1409 (0.43%) 
Escherichia sepsis  1  4/1409 (0.28%)  5/1409 (0.35%) 
Localised infection  1  4/1409 (0.28%)  5/1409 (0.35%) 
Pneumonia bacterial  1  4/1409 (0.28%)  5/1409 (0.35%) 
Pulmonary sepsis  1  7/1409 (0.50%)  2/1409 (0.14%) 
Staphylococcal infection  1  1/1409 (0.07%)  8/1409 (0.57%) 
Influenza  1  5/1409 (0.35%)  3/1409 (0.21%) 
Osteomyelitis  1  3/1409 (0.21%)  5/1409 (0.35%) 
Peritonitis bacterial  1  3/1409 (0.21%)  5/1409 (0.35%) 
Clostridium difficile colitis  1  4/1409 (0.28%)  3/1409 (0.21%) 
Herpes zoster  1  3/1409 (0.21%)  4/1409 (0.28%) 
Necrotising fasciitis  1  4/1409 (0.28%)  3/1409 (0.21%) 
Renal cyst infection  1  3/1409 (0.21%)  4/1409 (0.28%) 
Appendicitis  1  5/1409 (0.35%)  1/1409 (0.07%) 
Bacterial sepsis  1  5/1409 (0.35%)  1/1409 (0.07%) 
Cystitis  1  4/1409 (0.28%)  2/1409 (0.14%) 
Diabetic gangrene  1  1/1409 (0.07%)  5/1409 (0.35%) 
Enterococcal sepsis  1  2/1409 (0.14%)  4/1409 (0.28%) 
Infective exacerbation of chronic obstructive airways disease  1  3/1409 (0.21%)  3/1409 (0.21%) 
Abdominal abscess  1  4/1409 (0.28%)  1/1409 (0.07%) 
Abscess limb  1  3/1409 (0.21%)  2/1409 (0.14%) 
Anal abscess  1  4/1409 (0.28%)  1/1409 (0.07%) 
Diverticulitis intestinal haemorrhagic  1  2/1409 (0.14%)  3/1409 (0.21%) 
Infectious colitis  1  2/1409 (0.14%)  3/1409 (0.21%) 
Infectious pleural effusion  1  3/1409 (0.21%)  2/1409 (0.14%) 
Pseudomonal sepsis  1  1/1409 (0.07%)  4/1409 (0.28%) 
Soft tissue infection  1  3/1409 (0.21%)  2/1409 (0.14%) 
Abscess  1  3/1409 (0.21%)  1/1409 (0.07%) 
Biliary sepsis  1  2/1409 (0.14%)  2/1409 (0.14%) 
Fungal peritonitis  1  0/1409 (0.00%)  4/1409 (0.28%) 
Gastroenteritis viral  1  3/1409 (0.21%)  1/1409 (0.07%) 
Graft infection  1  0/1409 (0.00%)  4/1409 (0.28%) 
H1N1 influenza  1  3/1409 (0.21%)  1/1409 (0.07%) 
Infective exacerbation of bronchiectasis  1  2/1409 (0.14%)  2/1409 (0.14%) 
Ophthalmic herpes zoster  1  2/1409 (0.14%)  2/1409 (0.14%) 
Pseudomembranous colitis  1  3/1409 (0.21%)  1/1409 (0.07%) 
Pyelonephritis chronic  1  2/1409 (0.14%)  2/1409 (0.14%) 
Acute sinusitis  1  3/1409 (0.21%)  0/1409 (0.00%) 
Cellulitis gangrenous  1  2/1409 (0.14%)  1/1409 (0.07%) 
Cholangitis infective  1  2/1409 (0.14%)  1/1409 (0.07%) 
Cholecystitis infective  1  0/1409 (0.00%)  3/1409 (0.21%) 
Gastroenteritis clostridial  1  2/1409 (0.14%)  1/1409 (0.07%) 
Intervertebral discitis  1  1/1409 (0.07%)  2/1409 (0.14%) 
Pneumonia staphylococcal  1  3/1409 (0.21%)  0/1409 (0.00%) 
Post procedural infection  1  3/1409 (0.21%)  0/1409 (0.00%) 
Post procedural sepsis  1  1/1409 (0.07%)  2/1409 (0.14%) 
Pyonephrosis  1  2/1409 (0.14%)  1/1409 (0.07%) 
Septic necrosis  1  2/1409 (0.14%)  1/1409 (0.07%) 
Sialoadenitis  1  1/1409 (0.07%)  2/1409 (0.14%) 
Streptococcal sepsis  1  1/1409 (0.07%)  2/1409 (0.14%) 
Subcutaneous abscess  1  2/1409 (0.14%)  1/1409 (0.07%) 
Tonsillitis  1  2/1409 (0.14%)  1/1409 (0.07%) 
Wound sepsis  1  2/1409 (0.14%)  1/1409 (0.07%) 
Abdominal sepsis  1  2/1409 (0.14%)  0/1409 (0.00%) 
Appendicitis perforated  1  1/1409 (0.07%)  1/1409 (0.07%) 
Arteriosclerotic gangrene  1  1/1409 (0.07%)  1/1409 (0.07%) 
Atypical pneumonia  1  1/1409 (0.07%)  1/1409 (0.07%) 
Bacterial infection  1  2/1409 (0.14%)  0/1409 (0.00%) 
Clostridium difficile infection  1  2/1409 (0.14%)  0/1409 (0.00%) 
Diarrhoea infectious  1  0/1409 (0.00%)  2/1409 (0.14%) 
Empyema  1  0/1409 (0.00%)  2/1409 (0.14%) 
Encephalitis  1  1/1409 (0.07%)  1/1409 (0.07%) 
Endocarditis bacterial  1  0/1409 (0.00%)  2/1409 (0.14%) 
Endocarditis staphylococcal  1  1/1409 (0.07%)  1/1409 (0.07%) 
Enterobacter sepsis  1  1/1409 (0.07%)  1/1409 (0.07%) 
Epididymitis  1  0/1409 (0.00%)  2/1409 (0.14%) 
Epiglottitis  1  1/1409 (0.07%)  1/1409 (0.07%) 
Fungal oesophagitis  1  1/1409 (0.07%)  1/1409 (0.07%) 
Gastroenteritis salmonella  1  1/1409 (0.07%)  1/1409 (0.07%) 
Groin abscess  1  2/1409 (0.14%)  0/1409 (0.00%) 
Haematoma infection  1  1/1409 (0.07%)  1/1409 (0.07%) 
Haemophilus infection  1  0/1409 (0.00%)  2/1409 (0.14%) 
Joint tuberculosis  1  2/1409 (0.14%)  0/1409 (0.00%) 
Klebsiella sepsis  1  2/1409 (0.14%)  0/1409 (0.00%) 
Listeriosis  1  0/1409 (0.00%)  2/1409 (0.14%) 
Lymph node tuberculosis  1  1/1409 (0.07%)  1/1409 (0.07%) 
Osteomyelitis chronic  1  1/1409 (0.07%)  1/1409 (0.07%) 
Otitis media  1  1/1409 (0.07%)  1/1409 (0.07%) 
Pneumococcal sepsis  1  2/1409 (0.14%)  0/1409 (0.00%) 
Pneumonia klebsiella  1  1/1409 (0.07%)  1/1409 (0.07%) 
Proteus infection  1  1/1409 (0.07%)  1/1409 (0.07%) 
Pulmonary tuberculosis  1  1/1409 (0.07%)  1/1409 (0.07%) 
Renal graft infection  1  0/1409 (0.00%)  2/1409 (0.14%) 
Retroperitoneal abscess  1  2/1409 (0.14%)  0/1409 (0.00%) 
Septic arthritis staphylococcal  1  2/1409 (0.14%)  0/1409 (0.00%) 
Sinusitis  1  1/1409 (0.07%)  1/1409 (0.07%) 
Skin bacterial infection  1  1/1409 (0.07%)  1/1409 (0.07%) 
Staphylococcal skin infection  1  2/1409 (0.14%)  0/1409 (0.00%) 
Streptococcal bacteraemia  1  1/1409 (0.07%)  1/1409 (0.07%) 
Systemic candida  1  2/1409 (0.14%)  0/1409 (0.00%) 
Tuberculosis  1  1/1409 (0.07%)  1/1409 (0.07%) 
Urinary tract infection enterococcal  1  2/1409 (0.14%)  0/1409 (0.00%) 
Viral upper respiratory tract infection  1  1/1409 (0.07%)  1/1409 (0.07%) 
Abdominal wall abscess  1  0/1409 (0.00%)  1/1409 (0.07%) 
Abdominal wall infection  1  1/1409 (0.07%)  0/1409 (0.00%) 
Abscess jaw  1  1/1409 (0.07%)  0/1409 (0.00%) 
Appendiceal abscess  1  1/1409 (0.07%)  0/1409 (0.00%) 
Atypical mycobacterial infection  1  0/1409 (0.00%)  1/1409 (0.07%) 
Bacterial colitis  1  0/1409 (0.00%)  1/1409 (0.07%) 
Bacterial diarrhoea  1  0/1409 (0.00%)  1/1409 (0.07%) 
Bone abscess  1  0/1409 (0.00%)  1/1409 (0.07%) 
Bone tuberculosis  1  0/1409 (0.00%)  1/1409 (0.07%) 
Bronchitis viral  1  0/1409 (0.00%)  1/1409 (0.07%) 
Bronchopulmonary aspergillosis  1  1/1409 (0.07%)  0/1409 (0.00%) 
Campylobacter gastroenteritis  1  0/1409 (0.00%)  1/1409 (0.07%) 
Cat scratch disease  1  1/1409 (0.07%)  0/1409 (0.00%) 
Catheter site abscess  1  1/1409 (0.07%)  0/1409 (0.00%) 
Cellulitis staphylococcal  1  0/1409 (0.00%)  1/1409 (0.07%) 
Chronic tonsillitis  1  1/1409 (0.07%)  0/1409 (0.00%) 
Citrobacter sepsis  1  1/1409 (0.07%)  0/1409 (0.00%) 
Colon gangrene  1  1/1409 (0.07%)  0/1409 (0.00%) 
Colonic abscess  1  1/1409 (0.07%)  0/1409 (0.00%) 
Corneal abscess  1  1/1409 (0.07%)  0/1409 (0.00%) 
Corynebacterium sepsis  1  1/1409 (0.07%)  0/1409 (0.00%) 
Cystitis bacterial  1  0/1409 (0.00%)  1/1409 (0.07%) 
Dacryocystitis  1  1/1409 (0.07%)  0/1409 (0.00%) 
Disseminated tuberculosis  1  0/1409 (0.00%)  1/1409 (0.07%) 
Endophthalmitis  1  0/1409 (0.00%)  1/1409 (0.07%) 
Enteritis infectious  1  1/1409 (0.07%)  0/1409 (0.00%) 
Escherichia infection  1  1/1409 (0.07%)  0/1409 (0.00%) 
Escherichia pyelonephritis  1  0/1409 (0.00%)  1/1409 (0.07%) 
Escherichia urinary tract infection  1  0/1409 (0.00%)  1/1409 (0.07%) 
Febrile infection  1  0/1409 (0.00%)  1/1409 (0.07%) 
Gastroenteritis bacterial  1  1/1409 (0.07%)  0/1409 (0.00%) 
Gastroenteritis norovirus  1  0/1409 (0.00%)  1/1409 (0.07%) 
Gastrointestinal infection  1  1/1409 (0.07%)  0/1409 (0.00%) 
Genitourinary tract infection  1  0/1409 (0.00%)  1/1409 (0.07%) 
Hepatic cyst infection  1  0/1409 (0.00%)  1/1409 (0.07%) 
Herpes sepsis  1  0/1409 (0.00%)  1/1409 (0.07%) 
Herpes zoster meningoencephalitis  1  1/1409 (0.07%)  0/1409 (0.00%) 
Implant site infection  1  1/1409 (0.07%)  0/1409 (0.00%) 
Infected bunion  1  0/1409 (0.00%)  1/1409 (0.07%) 
Infected dermal cyst  1  1/1409 (0.07%)  0/1409 (0.00%) 
Infected fistula  1  1/1409 (0.07%)  0/1409 (0.00%) 
Infective gastroduodenitis  1  0/1409 (0.00%)  1/1409 (0.07%) 
Injection site infection  1  1/1409 (0.07%)  0/1409 (0.00%) 
Intestinal fistula infection  1  0/1409 (0.00%)  1/1409 (0.07%) 
Joint abscess  1  0/1409 (0.00%)  1/1409 (0.07%) 
Klebsiella infection  1  0/1409 (0.00%)  1/1409 (0.07%) 
Listeria encephalitis  1  1/1409 (0.07%)  0/1409 (0.00%) 
Liver abscess  1  0/1409 (0.00%)  1/1409 (0.07%) 
Lung abscess  1  0/1409 (0.00%)  1/1409 (0.07%) 
Mesenteric abscess  1  1/1409 (0.07%)  0/1409 (0.00%) 
Muscle abscess  1  0/1409 (0.00%)  1/1409 (0.07%) 
Mycetoma mycotic  1  1/1409 (0.07%)  0/1409 (0.00%) 
Nail infection  1  0/1409 (0.00%)  1/1409 (0.07%) 
Nasopharyngitis  1  1/1409 (0.07%)  0/1409 (0.00%) 
Nosocomial infection  1  1/1409 (0.07%)  0/1409 (0.00%) 
Oropharyngeal candidiasis  1  1/1409 (0.07%)  0/1409 (0.00%) 
Osteomyelitis acute  1  1/1409 (0.07%)  0/1409 (0.00%) 
Otitis externa  1  1/1409 (0.07%)  0/1409 (0.00%) 
Otitis media acute  1  0/1409 (0.00%)  1/1409 (0.07%) 
Parotitis  1  0/1409 (0.00%)  1/1409 (0.07%) 
Pelvic abscess  1  0/1409 (0.00%)  1/1409 (0.07%) 
Pelvic inflammatory disease  1  1/1409 (0.07%)  0/1409 (0.00%) 
Perihepatic abscess  1  0/1409 (0.00%)  1/1409 (0.07%) 
Periodontal destruction  1  1/1409 (0.07%)  0/1409 (0.00%) 
Periodontitis  1  1/1409 (0.07%)  0/1409 (0.00%) 
Peritonsillar abscess  1  1/1409 (0.07%)  0/1409 (0.00%) 
Pharyngitis  1  0/1409 (0.00%)  1/1409 (0.07%) 
Pneumonia legionella  1  0/1409 (0.00%)  1/1409 (0.07%) 
Pneumonia necrotising  1  0/1409 (0.00%)  1/1409 (0.07%) 
Pneumonia pneumococcal  1  0/1409 (0.00%)  1/1409 (0.07%) 
Pneumonia pseudomonal  1  0/1409 (0.00%)  1/1409 (0.07%) 
Pneumonia respiratory syncytial viral  1  1/1409 (0.07%)  0/1409 (0.00%) 
Postoperative abscess  1  1/1409 (0.07%)  0/1409 (0.00%) 
Pyomyositis  1  1/1409 (0.07%)  0/1409 (0.00%) 
Renal abscess  1  1/1409 (0.07%)  0/1409 (0.00%) 
Respiratory syncytial virus infection  1  1/1409 (0.07%)  0/1409 (0.00%) 
Rotavirus infection  1  1/1409 (0.07%)  0/1409 (0.00%) 
Salmonellosis  1  1/1409 (0.07%)  0/1409 (0.00%) 
Salpingitis  1  0/1409 (0.00%)  1/1409 (0.07%) 
Seminal vesicle abscess  1  1/1409 (0.07%)  0/1409 (0.00%) 
Skin infection  1  0/1409 (0.00%)  1/1409 (0.07%) 
Staphylococcal abscess  1  0/1409 (0.00%)  1/1409 (0.07%) 
Subacute endocarditis  1  1/1409 (0.07%)  0/1409 (0.00%) 
Tooth abscess  1  0/1409 (0.00%)  1/1409 (0.07%) 
Tubo-ovarian abscess  1  0/1409 (0.00%)  1/1409 (0.07%) 
Urethral abscess  1  1/1409 (0.07%)  0/1409 (0.00%) 
Urinary tract infection staphylococcal  1  0/1409 (0.00%)  1/1409 (0.07%) 
Vaginal infection  1  1/1409 (0.07%)  0/1409 (0.00%) 
Varicella  1  0/1409 (0.00%)  1/1409 (0.07%) 
Injury, poisoning and procedural complications     
Arteriovenous fistula thrombosis  1  110/1409 (7.81%)  77/1409 (5.46%) 
Arteriovenous fistula site complication  1  57/1409 (4.05%)  47/1409 (3.34%) 
Femur fracture  1  23/1409 (1.63%)  26/1409 (1.85%) 
Arteriovenous fistula site haemorrhage  1  16/1409 (1.14%)  23/1409 (1.63%) 
Arteriovenous graft thrombosis  1  13/1409 (0.92%)  23/1409 (1.63%) 
Femoral neck fracture  1  19/1409 (1.35%)  14/1409 (0.99%) 
Procedural hypotension  1  13/1409 (0.92%)  16/1409 (1.14%) 
Arteriovenous fistula aneurysm  1  15/1409 (1.06%)  6/1409 (0.43%) 
Subdural haematoma  1  8/1409 (0.57%)  12/1409 (0.85%) 
Hip fracture  1  8/1409 (0.57%)  11/1409 (0.78%) 
Post procedural haemorrhage  1  11/1409 (0.78%)  7/1409 (0.50%) 
Rib fracture  1  8/1409 (0.57%)  9/1409 (0.64%) 
Head injury  1  9/1409 (0.64%)  5/1409 (0.35%) 
Humerus fracture  1  7/1409 (0.50%)  7/1409 (0.50%) 
Fall  1  8/1409 (0.57%)  5/1409 (0.35%) 
Multiple fractures  1  5/1409 (0.35%)  8/1409 (0.57%) 
Overdose  1  6/1409 (0.43%)  5/1409 (0.35%) 
Pelvic fracture  1  8/1409 (0.57%)  3/1409 (0.21%) 
Lumbar vertebral fracture  1  3/1409 (0.21%)  7/1409 (0.50%) 
Limb injury  1  5/1409 (0.35%)  4/1409 (0.28%) 
Radius fracture  1  5/1409 (0.35%)  4/1409 (0.28%) 
Subarachnoid haemorrhage  1  4/1409 (0.28%)  5/1409 (0.35%) 
Ankle fracture  1  6/1409 (0.43%)  2/1409 (0.14%) 
Arteriovenous graft site stenosis  1  3/1409 (0.21%)  5/1409 (0.35%) 
Lower limb fracture  1  4/1409 (0.28%)  4/1409 (0.28%) 
Spinal compression fracture  1  2/1409 (0.14%)  6/1409 (0.43%) 
Arteriovenous fistula site haematoma  1  4/1409 (0.28%)  3/1409 (0.21%) 
Contusion  1  3/1409 (0.21%)  4/1409 (0.28%) 
Post procedural haematoma  1  4/1409 (0.28%)  3/1409 (0.21%) 
Pubis fracture  1  2/1409 (0.14%)  5/1409 (0.35%) 
Incisional hernia  1  3/1409 (0.21%)  3/1409 (0.21%) 
Joint dislocation  1  3/1409 (0.21%)  3/1409 (0.21%) 
Tendon rupture  1  5/1409 (0.35%)  1/1409 (0.07%) 
Tibia fracture  1  3/1409 (0.21%)  3/1409 (0.21%) 
Toxicity to various agents  1  4/1409 (0.28%)  2/1409 (0.14%) 
Upper limb fracture  1  2/1409 (0.14%)  4/1409 (0.28%) 
Anaemia postoperative  1  4/1409 (0.28%)  1/1409 (0.07%) 
Arterial bypass thrombosis  1  4/1409 (0.28%)  1/1409 (0.07%) 
Arteriovenous graft site haemorrhage  1  1/1409 (0.07%)  4/1409 (0.28%) 
Forearm fracture  1  3/1409 (0.21%)  2/1409 (0.14%) 
Ulna fracture  1  4/1409 (0.28%)  1/1409 (0.07%) 
Vascular graft complication  1  4/1409 (0.28%)  1/1409 (0.07%) 
Vascular pseudoaneurysm  1  3/1409 (0.21%)  2/1409 (0.14%) 
Cervical vertebral fracture  1  2/1409 (0.14%)  2/1409 (0.14%) 
Concussion  1  2/1409 (0.14%)  2/1409 (0.14%) 
Facial bones fracture  1  2/1409 (0.14%)  2/1409 (0.14%) 
Peritoneal dialysis complication  1  0/1409 (0.00%)  4/1409 (0.28%) 
Thoracic vertebral fracture  1  3/1409 (0.21%)  1/1409 (0.07%) 
Acetabulum fracture  1  2/1409 (0.14%)  1/1409 (0.07%) 
Craniocerebral injury  1  1/1409 (0.07%)  2/1409 (0.14%) 
Fibula fracture  1  1/1409 (0.07%)  2/1409 (0.14%) 
Foot fracture  1  1/1409 (0.07%)  2/1409 (0.14%) 
Gastrointestinal stoma complication  1  0/1409 (0.00%)  3/1409 (0.21%) 
Laceration  1  0/1409 (0.00%)  3/1409 (0.21%) 
Muscle rupture  1  2/1409 (0.14%)  1/1409 (0.07%) 
Perirenal haematoma  1  1/1409 (0.07%)  2/1409 (0.14%) 
Post-traumatic pain  1  2/1409 (0.14%)  1/1409 (0.07%) 
Subdural haemorrhage  1  2/1409 (0.14%)  1/1409 (0.07%) 
Thermal burn  1  2/1409 (0.14%)  1/1409 (0.07%) 
Wound dehiscence  1  1/1409 (0.07%)  2/1409 (0.14%) 
Wound necrosis  1  2/1409 (0.14%)  1/1409 (0.07%) 
Wrist fracture  1  2/1409 (0.14%)  1/1409 (0.07%) 
Arteriovenous graft aneurysm  1  2/1409 (0.14%)  0/1409 (0.00%) 
Arteriovenous graft site haematoma  1  1/1409 (0.07%)  1/1409 (0.07%) 
Burns second degree  1  2/1409 (0.14%)  0/1409 (0.00%) 
Clavicle fracture  1  2/1409 (0.14%)  0/1409 (0.00%) 
Coronary artery restenosis  1  1/1409 (0.07%)  1/1409 (0.07%) 
Extradural haematoma  1  2/1409 (0.14%)  0/1409 (0.00%) 
Face injury  1  1/1409 (0.07%)  1/1409 (0.07%) 
Graft haemorrhage  1  1/1409 (0.07%)  1/1409 (0.07%) 
Ligament rupture  1  0/1409 (0.00%)  2/1409 (0.14%) 
Patella fracture  1  0/1409 (0.00%)  2/1409 (0.14%) 
Postoperative hernia  1  0/1409 (0.00%)  2/1409 (0.14%) 
Procedural complication  1  1/1409 (0.07%)  1/1409 (0.07%) 
Procedural haemorrhage  1  0/1409 (0.00%)  2/1409 (0.14%) 
Procedural intestinal perforation  1  1/1409 (0.07%)  1/1409 (0.07%) 
Shunt aneurysm  1  2/1409 (0.14%)  0/1409 (0.00%) 
Shunt stenosis  1  1/1409 (0.07%)  1/1409 (0.07%) 
Skin wound  1  1/1409 (0.07%)  1/1409 (0.07%) 
Spinal fracture  1  2/1409 (0.14%)  0/1409 (0.00%) 
Traumatic haematoma  1  1/1409 (0.07%)  1/1409 (0.07%) 
Vascular graft occlusion  1  1/1409 (0.07%)  1/1409 (0.07%) 
Vascular graft thrombosis  1  2/1409 (0.14%)  0/1409 (0.00%) 
Abdominal injury  1  1/1409 (0.07%)  0/1409 (0.00%) 
Abdominal wound dehiscence  1  1/1409 (0.07%)  0/1409 (0.00%) 
Arterial bypass occlusion  1  1/1409 (0.07%)  0/1409 (0.00%) 
Arterial injury  1  0/1409 (0.00%)  1/1409 (0.07%) 
Arteriovenous fistula occlusion  1  1/1409 (0.07%)  0/1409 (0.00%) 
Avulsion fracture  1  1/1409 (0.07%)  0/1409 (0.00%) 
Bone contusion  1  1/1409 (0.07%)  0/1409 (0.00%) 
Bone fissure  1  0/1409 (0.00%)  1/1409 (0.07%) 
Brain contusion  1  0/1409 (0.00%)  1/1409 (0.07%) 
Carbon monoxide poisoning  1  0/1409 (0.00%)  1/1409 (0.07%) 
Cardiac valve replacement complication  1  0/1409 (0.00%)  1/1409 (0.07%) 
Chest injury  1  1/1409 (0.07%)  0/1409 (0.00%) 
Complications of transplant surgery  1  1/1409 (0.07%)  0/1409 (0.00%) 
Complications of transplanted kidney  1  0/1409 (0.00%)  1/1409 (0.07%) 
Device deployment issue  1  1/1409 (0.07%)  0/1409 (0.00%) 
Dislocation of vertebra  1  1/1409 (0.07%)  0/1409 (0.00%) 
Eschar  1  0/1409 (0.00%)  1/1409 (0.07%) 
Extensive interdialytic weight gain  1  0/1409 (0.00%)  1/1409 (0.07%) 
Fracture  1  0/1409 (0.00%)  1/1409 (0.07%) 
Gastrointestinal anastomotic leak  1  0/1409 (0.00%)  1/1409 (0.07%) 
Haemodialysis complication  1  1/1409 (0.07%)  0/1409 (0.00%) 
Hyphaema  1  0/1409 (0.00%)  1/1409 (0.07%) 
Incarcerated incisional hernia  1  1/1409 (0.07%)  0/1409 (0.00%) 
Intentional overdose  1  1/1409 (0.07%)  0/1409 (0.00%) 
Intestinal anastomosis complication  1  1/1409 (0.07%)  0/1409 (0.00%) 
Joint injury  1  1/1409 (0.07%)  0/1409 (0.00%) 
Kidney rupture  1  1/1409 (0.07%)  0/1409 (0.00%) 
Ligament sprain  1  1/1409 (0.07%)  0/1409 (0.00%) 
Lip injury  1  1/1409 (0.07%)  0/1409 (0.00%) 
Multiple injuries  1  1/1409 (0.07%)  0/1409 (0.00%) 
Muscle strain  1  1/1409 (0.07%)  0/1409 (0.00%) 
Periorbital haematoma  1  1/1409 (0.07%)  0/1409 (0.00%) 
Peripheral artery restenosis  1  1/1409 (0.07%)  0/1409 (0.00%) 
Post procedural complication  1  0/1409 (0.00%)  1/1409 (0.07%) 
Post procedural haematuria  1  1/1409 (0.07%)  0/1409 (0.00%) 
Postoperative delirium  1  1/1409 (0.07%)  0/1409 (0.00%) 
Postoperative ileus  1  0/1409 (0.00%)  1/1409 (0.07%) 
Postpericardiotomy syndrome  1  0/1409 (0.00%)  1/1409 (0.07%) 
Procedural dizziness  1  1/1409 (0.07%)  0/1409 (0.00%) 
Procedural hypertension  1  1/1409 (0.07%)  0/1409 (0.00%) 
Procedural pain  1  0/1409 (0.00%)  1/1409 (0.07%) 
Procedural pneumothorax  1  1/1409 (0.07%)  0/1409 (0.00%) 
Radiation proctitis  1  1/1409 (0.07%)  0/1409 (0.00%) 
Seroma  1  0/1409 (0.00%)  1/1409 (0.07%) 
Skull fractured base  1  1/1409 (0.07%)  0/1409 (0.00%) 
Splenic injury  1  1/1409 (0.07%)  0/1409 (0.00%) 
Splenic rupture  1  1/1409 (0.07%)  0/1409 (0.00%) 
Stoma site haemorrhage  1  0/1409 (0.00%)  1/1409 (0.07%) 
Stomal hernia  1  1/1409 (0.07%)  0/1409 (0.00%) 
Subcutaneous haematoma  1  1/1409 (0.07%)  0/1409 (0.00%) 
Tendon injury  1  1/1409 (0.07%)  0/1409 (0.00%) 
Traumatic coma  1  0/1409 (0.00%)  1/1409 (0.07%) 
Traumatic haemorrhage  1  0/1409 (0.00%)  1/1409 (0.07%) 
Traumatic haemothorax  1  1/1409 (0.07%)  0/1409 (0.00%) 
Traumatic intracranial haemorrhage  1  1/1409 (0.07%)  0/1409 (0.00%) 
Vascular access complication  1  1/1409 (0.07%)  0/1409 (0.00%) 
Vascular bypass dysfunction  1  1/1409 (0.07%)  0/1409 (0.00%) 
Vasoplegia syndrome  1  1/1409 (0.07%)  0/1409 (0.00%) 
Wound  1  1/1409 (0.07%)  0/1409 (0.00%) 
Wound complication  1  1/1409 (0.07%)  0/1409 (0.00%) 
Investigations     
Weight decreased  1  1/1409 (0.07%)  3/1409 (0.21%) 
International normalised ratio increased  1  0/1409 (0.00%)  2/1409 (0.14%) 
Coagulation time prolonged  1  0/1409 (0.00%)  1/1409 (0.07%) 
Investigation abnormal  1  1/1409 (0.07%)  0/1409 (0.00%) 
Troponin increased  1  0/1409 (0.00%)  1/1409 (0.07%) 
Metabolism and nutrition disorders     
Fluid overload  1  44/1409 (3.12%)  43/1409 (3.05%) 
Hyperkalaemia  1  18/1409 (1.28%)  32/1409 (2.27%) 
Hypoglycaemia  1  12/1409 (0.85%)  17/1409 (1.21%) 
Cachexia  1  9/1409 (0.64%)  10/1409 (0.71%) 
Hyperglycaemia  1  9/1409 (0.64%)  3/1409 (0.21%) 
Dehydration  1  3/1409 (0.21%)  7/1409 (0.50%) 
Diabetes mellitus inadequate control  1  3/1409 (0.21%)  5/1409 (0.35%) 
Hypocalcaemia  1  2/1409 (0.14%)  6/1409 (0.43%) 
Malnutrition  1  4/1409 (0.28%)  4/1409 (0.28%) 
Hypervolaemia  1  2/1409 (0.14%)  4/1409 (0.28%) 
Calciphylaxis  1  1/1409 (0.07%)  4/1409 (0.28%) 
Diabetic complication  1  1/1409 (0.07%)  4/1409 (0.28%) 
Hypercalcaemia  1  2/1409 (0.14%)  3/1409 (0.21%) 
Diabetes mellitus  1  2/1409 (0.14%)  2/1409 (0.14%) 
Hyponatraemia  1  1/1409 (0.07%)  3/1409 (0.21%) 
Electrolyte imbalance  1  2/1409 (0.14%)  1/1409 (0.07%) 
Gout  1  2/1409 (0.14%)  1/1409 (0.07%) 
Hypokalaemia  1  1/1409 (0.07%)  2/1409 (0.14%) 
Hyperinsulinaemic hypoglycaemia  1  2/1409 (0.14%)  0/1409 (0.00%) 
Hypovolaemia  1  1/1409 (0.07%)  1/1409 (0.07%) 
Type 2 diabetes mellitus  1  1/1409 (0.07%)  1/1409 (0.07%) 
Decreased appetite  1  1/1409 (0.07%)  0/1409 (0.00%) 
Diabetic ketoacidosis  1  1/1409 (0.07%)  0/1409 (0.00%) 
Diabetic metabolic decompensation  1  0/1409 (0.00%)  1/1409 (0.07%) 
Fluid retention  1  1/1409 (0.07%)  0/1409 (0.00%) 
Haemochromatosis  1  1/1409 (0.07%)  0/1409 (0.00%) 
Hypoalbuminaemia  1  1/1409 (0.07%)  0/1409 (0.00%) 
Hypophosphataemia  1  0/1409 (0.00%)  1/1409 (0.07%) 
Lactic acidosis  1  1/1409 (0.07%)  0/1409 (0.00%) 
Metabolic acidosis  1  0/1409 (0.00%)  1/1409 (0.07%) 
Metabolic disorder  1  0/1409 (0.00%)  1/1409 (0.07%) 
Mitochondrial cytopathy  1  1/1409 (0.07%)  0/1409 (0.00%) 
Obesity  1  0/1409 (0.00%)  1/1409 (0.07%) 
Type 1 diabetes mellitus  1  0/1409 (0.00%)  1/1409 (0.07%) 
Musculoskeletal and connective tissue disorders     
Osteoarthritis  1  19/1409 (1.35%)  16/1409 (1.14%) 
Musculoskeletal chest pain  1  4/1409 (0.28%)  8/1409 (0.57%) 
Back pain  1  9/1409 (0.64%)  2/1409 (0.14%) 
Arthralgia  1  6/1409 (0.43%)  2/1409 (0.14%) 
Intervertebral disc protrusion  1  5/1409 (0.35%)  3/1409 (0.21%) 
Bursitis  1  3/1409 (0.21%)  4/1409 (0.28%) 
Osteitis  1  2/1409 (0.14%)  4/1409 (0.28%) 
Spinal osteoarthritis  1  5/1409 (0.35%)  0/1409 (0.00%) 
Arthritis  1  3/1409 (0.21%)  1/1409 (0.07%) 
Muscular weakness  1  2/1409 (0.14%)  2/1409 (0.14%) 
Systemic lupus erythematosus  1  2/1409 (0.14%)  2/1409 (0.14%) 
Gouty arthritis  1  1/1409 (0.07%)  2/1409 (0.14%) 
Haemarthrosis  1  2/1409 (0.14%)  1/1409 (0.07%) 
Lumbar spinal stenosis  1  2/1409 (0.14%)  1/1409 (0.07%) 
Pathological fracture  1  2/1409 (0.14%)  1/1409 (0.07%) 
Polymyalgia rheumatica  1  1/1409 (0.07%)  2/1409 (0.14%) 
Rhabdomyolysis  1  2/1409 (0.14%)  1/1409 (0.07%) 
Spinal column stenosis  1  2/1409 (0.14%)  1/1409 (0.07%) 
Synovitis  1  2/1409 (0.14%)  1/1409 (0.07%) 
Joint effusion  1  0/1409 (0.00%)  2/1409 (0.14%) 
Neuropathic arthropathy  1  0/1409 (0.00%)  2/1409 (0.14%) 
Osteolysis  1  1/1409 (0.07%)  1/1409 (0.07%) 
Osteonecrosis  1  1/1409 (0.07%)  1/1409 (0.07%) 
Osteoporotic fracture  1  1/1409 (0.07%)  1/1409 (0.07%) 
Rotator cuff syndrome  1  2/1409 (0.14%)  0/1409 (0.00%) 
Arthrofibrosis  1  0/1409 (0.00%)  1/1409 (0.07%) 
Arthropathy  1  1/1409 (0.07%)  0/1409 (0.00%) 
Chondropathy  1  1/1409 (0.07%)  0/1409 (0.00%) 
Chronic kidney disease-mineral and bone disorder  1  1/1409 (0.07%)  0/1409 (0.00%) 
Collagen disorder  1  0/1409 (0.00%)  1/1409 (0.07%) 
Compartment syndrome  1  0/1409 (0.00%)  1/1409 (0.07%) 
Dupuytren's contracture  1  0/1409 (0.00%)  1/1409 (0.07%) 
Fibromyalgia  1  0/1409 (0.00%)  1/1409 (0.07%) 
Flank pain  1  0/1409 (0.00%)  1/1409 (0.07%) 
High turnover osteopathy  1  0/1409 (0.00%)  1/1409 (0.07%) 
Muscle haemorrhage  1  1/1409 (0.07%)  0/1409 (0.00%) 
Muscle necrosis  1  1/1409 (0.07%)  0/1409 (0.00%) 
Musculoskeletal pain  1  0/1409 (0.00%)  1/1409 (0.07%) 
Myalgia  1  0/1409 (0.00%)  1/1409 (0.07%) 
Myositis  1  1/1409 (0.07%)  0/1409 (0.00%) 
Neck pain  1  1/1409 (0.07%)  0/1409 (0.00%) 
Pain in extremity  1  0/1409 (0.00%)  1/1409 (0.07%) 
Plantar fasciitis  1  0/1409 (0.00%)  1/1409 (0.07%) 
Polyarthritis  1  0/1409 (0.00%)  1/1409 (0.07%) 
Rheumatoid arthritis  1  0/1409 (0.00%)  1/1409 (0.07%) 
Sarcopenia  1  1/1409 (0.07%)  0/1409 (0.00%) 
Soft tissue necrosis  1  1/1409 (0.07%)  0/1409 (0.00%) 
Spondylitis  1  1/1409 (0.07%)  0/1409 (0.00%) 
Sympathetic posterior cervical syndrome  1  0/1409 (0.00%)  1/1409 (0.07%) 
Torticollis  1  1/1409 (0.07%)  0/1409 (0.00%) 
Vertebral foraminal stenosis  1  1/1409 (0.07%)  0/1409 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Basal cell carcinoma  1  6/1409 (0.43%)  8/1409 (0.57%) 
Breast cancer  1  3/1409 (0.21%)  6/1409 (0.43%) 
Squamous cell carcinoma  1  5/1409 (0.35%)  4/1409 (0.28%) 
Prostate cancer  1  3/1409 (0.21%)  5/1409 (0.35%) 
Metastases to liver  1  4/1409 (0.28%)  3/1409 (0.21%) 
Renal cell carcinoma  1  1/1409 (0.07%)  6/1409 (0.43%) 
Bladder neoplasm  1  4/1409 (0.28%)  2/1409 (0.14%) 
Colon cancer metastatic  1  1/1409 (0.07%)  5/1409 (0.35%) 
Myelodysplastic syndrome  1  0/1409 (0.00%)  6/1409 (0.43%) 
Renal cancer  1  3/1409 (0.21%)  3/1409 (0.21%) 
Squamous cell carcinoma of skin  1  2/1409 (0.14%)  4/1409 (0.28%) 
Adenocarcinoma of colon  1  2/1409 (0.14%)  3/1409 (0.21%) 
Bladder transitional cell carcinoma  1  5/1409 (0.35%)  0/1409 (0.00%) 
Colon adenoma  1  2/1409 (0.14%)  3/1409 (0.21%) 
Prostate cancer metastatic  1  4/1409 (0.28%)  1/1409 (0.07%) 
Rectal cancer  1  2/1409 (0.14%)  3/1409 (0.21%) 
Cholangiocarcinoma  1  3/1409 (0.21%)  1/1409 (0.07%) 
Intestinal adenocarcinoma  1  1/1409 (0.07%)  3/1409 (0.21%) 
Renal cancer metastatic  1  0/1409 (0.00%)  4/1409 (0.28%) 
Skin cancer  1  3/1409 (0.21%)  1/1409 (0.07%) 
B-cell lymphoma  1  1/1409 (0.07%)  2/1409 (0.14%) 
Bladder cancer  1  3/1409 (0.21%)  0/1409 (0.00%) 
Colon cancer  1  1/1409 (0.07%)  2/1409 (0.14%) 
Colon neoplasm  1  0/1409 (0.00%)  3/1409 (0.21%) 
Gastrointestinal tract adenoma  1  2/1409 (0.14%)  1/1409 (0.07%) 
Lung neoplasm  1  2/1409 (0.14%)  1/1409 (0.07%) 
Lung neoplasm malignant  1  1/1409 (0.07%)  2/1409 (0.14%) 
Malignant melanoma  1  2/1409 (0.14%)  1/1409 (0.07%) 
Malignant pleural effusion  1  1/1409 (0.07%)  2/1409 (0.14%) 
Metastases to central nervous system  1  3/1409 (0.21%)  0/1409 (0.00%) 
Metastases to lung  1  1/1409 (0.07%)  2/1409 (0.14%) 
Pancreatic carcinoma  1  2/1409 (0.14%)  1/1409 (0.07%) 
Pituitary tumour benign  1  2/1409 (0.14%)  1/1409 (0.07%) 
Squamous cell carcinoma of lung  1  0/1409 (0.00%)  3/1409 (0.21%) 
Transitional cell carcinoma  1  3/1409 (0.21%)  0/1409 (0.00%) 
Bladder papilloma  1  1/1409 (0.07%)  1/1409 (0.07%) 
Bone neoplasm  1  0/1409 (0.00%)  2/1409 (0.14%) 
Breast cancer metastatic  1  1/1409 (0.07%)  1/1409 (0.07%) 
Bronchial carcinoma  1  1/1409 (0.07%)  1/1409 (0.07%) 
Colorectal cancer  1  2/1409 (0.14%)  0/1409 (0.00%) 
Gastric cancer  1  1/1409 (0.07%)  1/1409 (0.07%) 
Hepatic cancer  1  0/1409 (0.00%)  2/1409 (0.14%) 
Hepatic cancer metastatic  1  1/1409 (0.07%)  1/1409 (0.07%) 
Hepatocellular carcinoma  1  1/1409 (0.07%)  1/1409 (0.07%) 
Lung adenocarcinoma  1  2/1409 (0.14%)  0/1409 (0.00%) 
Metastases to bone  1  0/1409 (0.00%)  2/1409 (0.14%) 
Metastatic carcinoma of the bladder  1  0/1409 (0.00%)  2/1409 (0.14%) 
Metastatic malignant melanoma  1  1/1409 (0.07%)  1/1409 (0.07%) 
Metastatic neoplasm  1  1/1409 (0.07%)  1/1409 (0.07%) 
Neuroendocrine tumour  1  1/1409 (0.07%)  1/1409 (0.07%) 
Oesophageal carcinoma  1  1/1409 (0.07%)  1/1409 (0.07%) 
Pancreatic neoplasm  1  1/1409 (0.07%)  1/1409 (0.07%) 
Papillary thyroid cancer  1  0/1409 (0.00%)  2/1409 (0.14%) 
Plasma cell myeloma  1  1/1409 (0.07%)  1/1409 (0.07%) 
Prostate cancer recurrent  1  1/1409 (0.07%)  1/1409 (0.07%) 
Rectal adenocarcinoma  1  1/1409 (0.07%)  1/1409 (0.07%) 
Renal neoplasm  1  2/1409 (0.14%)  0/1409 (0.00%) 
Squamous cell carcinoma of the tongue  1  0/1409 (0.00%)  2/1409 (0.14%) 
Thyroid adenoma  1  1/1409 (0.07%)  1/1409 (0.07%) 
Thyroid cancer metastatic  1  1/1409 (0.07%)  1/1409 (0.07%) 
Acute myeloid leukaemia  1  1/1409 (0.07%)  0/1409 (0.00%) 
Acute myelomonocytic leukaemia  1  0/1409 (0.00%)  1/1409 (0.07%) 
Adenoma benign  1  0/1409 (0.00%)  1/1409 (0.07%) 
Adrenal adenoma  1  1/1409 (0.07%)  0/1409 (0.00%) 
Benign lung neoplasm  1  0/1409 (0.00%)  1/1409 (0.07%) 
Benign neoplasm of bladder  1  1/1409 (0.07%)  0/1409 (0.00%) 
Benign neoplasm of epididymis  1  0/1409 (0.00%)  1/1409 (0.07%) 
Benign urinary tract neoplasm  1  0/1409 (0.00%)  1/1409 (0.07%) 
Bladder cancer recurrent  1  1/1409 (0.07%)  0/1409 (0.00%) 
Bladder transitional cell carcinoma metastatic  1  0/1409 (0.00%)  1/1409 (0.07%) 
Brain neoplasm  1  0/1409 (0.00%)  1/1409 (0.07%) 
Brain neoplasm malignant  1  0/1409 (0.00%)  1/1409 (0.07%) 
Cancer pain  1  1/1409 (0.07%)  0/1409 (0.00%) 
Carcinoid tumour of the duodenum  1  1/1409 (0.07%)  0/1409 (0.00%) 
Carcinoid tumour of the stomach  1  0/1409 (0.00%)  1/1409 (0.07%) 
Carcinoma in situ of penis  1  0/1409 (0.00%)  1/1409 (0.07%) 
Central nervous system lymphoma  1  1/1409 (0.07%)  0/1409 (0.00%) 
Central nervous system neoplasm  1  0/1409 (0.00%)  1/1409 (0.07%) 
Cerebral hygroma  1  0/1409 (0.00%)  1/1409 (0.07%) 
Cervix cancer metastatic  1  1/1409 (0.07%)  0/1409 (0.00%) 
Cervix carcinoma  1  1/1409 (0.07%)  0/1409 (0.00%) 
Choroid melanoma  1  1/1409 (0.07%)  0/1409 (0.00%) 
Chronic myeloid leukaemia  1  0/1409 (0.00%)  1/1409 (0.07%) 
Colorectal adenocarcinoma  1  1/1409 (0.07%)  0/1409 (0.00%) 
Connective tissue neoplasm  1  1/1409 (0.07%)  0/1409 (0.00%) 
Ear neoplasm malignant  1  0/1409 (0.00%)  1/1409 (0.07%) 
Endometrial cancer  1  1/1409 (0.07%)  0/1409 (0.00%) 
Endometrial neoplasm  1  1/1409 (0.07%)  0/1409 (0.00%) 
Extranodal marginal zone B-cell lymphoma (malt type)  1  0/1409 (0.00%)  1/1409 (0.07%) 
Gallbladder adenocarcinoma  1  1/1409 (0.07%)  0/1409 (0.00%) 
Gastrointestinal stromal tumour  1  1/1409 (0.07%)  0/1409 (0.00%) 
Glioma  1  0/1409 (0.00%)  1/1409 (0.07%) 
Hepatic neoplasm  1  0/1409 (0.00%)  1/1409 (0.07%) 
Invasive ductal breast carcinoma  1  0/1409 (0.00%)  1/1409 (0.07%) 
Invasive lobular breast carcinoma  1  0/1409 (0.00%)  1/1409 (0.07%) 
Keratoacanthoma  1  1/1409 (0.07%)  0/1409 (0.00%) 
Laryngeal papilloma  1  0/1409 (0.00%)  1/1409 (0.07%) 
Lentigo maligna  1  1/1409 (0.07%)  0/1409 (0.00%) 
Lung cancer metastatic  1  1/1409 (0.07%)  0/1409 (0.00%) 
Lung squamous cell carcinoma metastatic  1  0/1409 (0.00%)  1/1409 (0.07%) 
Malignant fibrous histiocytoma  1  1/1409 (0.07%)  0/1409 (0.00%) 
Metastases to peritoneum  1  1/1409 (0.07%)  0/1409 (0.00%) 
Metastases to spine  1  1/1409 (0.07%)  0/1409 (0.00%) 
Metastatic carcinoid tumour  1  0/1409 (0.00%)  1/1409 (0.07%) 
Metastatic gastric cancer  1  0/1409 (0.00%)  1/1409 (0.07%) 
Metastatic renal cell carcinoma  1  0/1409 (0.00%)  1/1409 (0.07%) 
Metastatic squamous cell carcinoma  1  0/1409 (0.00%)  1/1409 (0.07%) 
Myelofibrosis  1  0/1409 (0.00%)  1/1409 (0.07%) 
Neoplasm skin  1  0/1409 (0.00%)  1/1409 (0.07%) 
Neuroendocrine carcinoma metastatic  1  1/1409 (0.07%)  0/1409 (0.00%) 
Non-Hodgkin's lymphoma  1  0/1409 (0.00%)  1/1409 (0.07%) 
Non-small cell lung cancer  1  1/1409 (0.07%)  0/1409 (0.00%) 
Oesophageal adenocarcinoma  1  1/1409 (0.07%)  0/1409 (0.00%) 
Oligodendroglioma  1  0/1409 (0.00%)  1/1409 (0.07%) 
Ovarian adenoma  1  0/1409 (0.00%)  1/1409 (0.07%) 
Paget's disease of nipple  1  0/1409 (0.00%)  1/1409 (0.07%) 
Pancreatic carcinoma metastatic  1  1/1409 (0.07%)  0/1409 (0.00%) 
Parathyroid tumour benign  1  0/1409 (0.00%)  1/1409 (0.07%) 
Pelvic neoplasm  1  1/1409 (0.07%)  0/1409 (0.00%) 
Plasma cell myeloma recurrent  1  1/1409 (0.07%)  0/1409 (0.00%) 
Rectal cancer metastatic  1  1/1409 (0.07%)  0/1409 (0.00%) 
Rectal cancer recurrent  1  1/1409 (0.07%)  0/1409 (0.00%) 
Rectosigmoid cancer  1  1/1409 (0.07%)  0/1409 (0.00%) 
Refractory cytopenia with unilineage dysplasia  1  0/1409 (0.00%)  1/1409 (0.07%) 
Renal cell carcinoma recurrent  1  1/1409 (0.07%)  0/1409 (0.00%) 
Renal haemangioma  1  0/1409 (0.00%)  1/1409 (0.07%) 
Small cell lung cancer metastatic  1  0/1409 (0.00%)  1/1409 (0.07%) 
Squamous cell carcinoma of the oral cavity  1  0/1409 (0.00%)  1/1409 (0.07%) 
Testicular neoplasm  1  1/1409 (0.07%)  0/1409 (0.00%) 
Thymoma  1  0/1409 (0.00%)  1/1409 (0.07%) 
Thyroid cancer  1  0/1409 (0.00%)  1/1409 (0.07%) 
Tongue neoplasm malignant stage unspecified  1  1/1409 (0.07%)  0/1409 (0.00%) 
Tonsil cancer  1  1/1409 (0.07%)  0/1409 (0.00%) 
Transitional cell cancer of renal pelvis and ureter metastatic  1  1/1409 (0.07%)  0/1409 (0.00%) 
Transitional cell carcinoma urethra  1  1/1409 (0.07%)  0/1409 (0.00%) 
Tumour haemorrhage  1  0/1409 (0.00%)  1/1409 (0.07%) 
Urinary bladder adenoma  1  1/1409 (0.07%)  0/1409 (0.00%) 
Uterine leiomyoma  1  1/1409 (0.07%)  0/1409 (0.00%) 
Nervous system disorders     
Ischaemic stroke  1  28/1409 (1.99%)  21/1409 (1.49%) 
Cerebrovascular accident  1  23/1409 (1.63%)  24/1409 (1.70%) 
Transient ischaemic attack  1  17/1409 (1.21%)  30/1409 (2.13%) 
Syncope  1  22/1409 (1.56%)  15/1409 (1.06%) 
Cerebral haemorrhage  1  7/1409 (0.50%)  8/1409 (0.57%) 
Seizure  1  10/1409 (0.71%)  5/1409 (0.35%) 
Cerebral infarction  1  4/1409 (0.28%)  9/1409 (0.64%) 
Dizziness  1  4/1409 (0.28%)  9/1409 (0.64%) 
Carpal tunnel syndrome  1  7/1409 (0.50%)  3/1409 (0.21%) 
Cerebral ischaemia  1  4/1409 (0.28%)  6/1409 (0.43%) 
Haemorrhagic stroke  1  7/1409 (0.50%)  3/1409 (0.21%) 
Haemorrhage intracranial  1  5/1409 (0.35%)  4/1409 (0.28%) 
Dementia  1  3/1409 (0.21%)  5/1409 (0.35%) 
Sciatica  1  5/1409 (0.35%)  3/1409 (0.21%) 
Epilepsy  1  4/1409 (0.28%)  3/1409 (0.21%) 
Headache  1  3/1409 (0.21%)  3/1409 (0.21%) 
Hepatic encephalopathy  1  3/1409 (0.21%)  3/1409 (0.21%) 
Carotid artery stenosis  1  2/1409 (0.14%)  3/1409 (0.21%) 
Vascular dementia  1  2/1409 (0.14%)  3/1409 (0.21%) 
Cerebrovascular disorder  1  2/1409 (0.14%)  2/1409 (0.14%) 
Presyncope  1  3/1409 (0.21%)  1/1409 (0.07%) 
Thrombotic stroke  1  1/1409 (0.07%)  3/1409 (0.21%) 
Altered state of consciousness  1  2/1409 (0.14%)  1/1409 (0.07%) 
Cerebral haematoma  1  3/1409 (0.21%)  0/1409 (0.00%) 
Dementia Alzheimer's type  1  3/1409 (0.21%)  0/1409 (0.00%) 
Facial paralysis  1  1/1409 (0.07%)  2/1409 (0.14%) 
Hypertensive encephalopathy  1  1/1409 (0.07%)  2/1409 (0.14%) 
Stupor  1  1/1409 (0.07%)  2/1409 (0.14%) 
Aphasia  1  1/1409 (0.07%)  1/1409 (0.07%) 
Ataxia  1  0/1409 (0.00%)  2/1409 (0.14%) 
Brain stem infarction  1  1/1409 (0.07%)  1/1409 (0.07%) 
Dyskinesia  1  1/1409 (0.07%)  1/1409 (0.07%) 
Embolic stroke  1  0/1409 (0.00%)  2/1409 (0.14%) 
Encephalopathy  1  1/1409 (0.07%)  1/1409 (0.07%) 
Generalised tonic-clonic seizure  1  0/1409 (0.00%)  2/1409 (0.14%) 
Hypoglycaemic coma  1  2/1409 (0.14%)  0/1409 (0.00%) 
Hypoxic-ischaemic encephalopathy  1  2/1409 (0.14%)  0/1409 (0.00%) 
Intracranial aneurysm  1  1/1409 (0.07%)  1/1409 (0.07%) 
Intraventricular haemorrhage  1  2/1409 (0.14%)  0/1409 (0.00%) 
Lacunar infarction  1  1/1409 (0.07%)  1/1409 (0.07%) 
Peripheral sensorimotor neuropathy  1  0/1409 (0.00%)  2/1409 (0.14%) 
Polyneuropathy  1  1/1409 (0.07%)  1/1409 (0.07%) 
Posterior reversible encephalopathy syndrome  1  1/1409 (0.07%)  1/1409 (0.07%) 
Trigeminal neuralgia  1  0/1409 (0.00%)  2/1409 (0.14%) 
Balance disorder  1  1/1409 (0.07%)  0/1409 (0.00%) 
Brain hypoxia  1  1/1409 (0.07%)  0/1409 (0.00%) 
Brain injury  1  0/1409 (0.00%)  1/1409 (0.07%) 
Cauda equina syndrome  1  1/1409 (0.07%)  0/1409 (0.00%) 
Cerebellar stroke  1  0/1409 (0.00%)  1/1409 (0.07%) 
Cerebral arteriosclerosis  1  1/1409 (0.07%)  0/1409 (0.00%) 
Cerebral ataxia  1  1/1409 (0.07%)  0/1409 (0.00%) 
Cerebral small vessel ischaemic disease  1  1/1409 (0.07%)  0/1409 (0.00%) 
Cerebrovascular insufficiency  1  0/1409 (0.00%)  1/1409 (0.07%) 
Cervical radiculopathy  1  0/1409 (0.00%)  1/1409 (0.07%) 
Cognitive disorder  1  1/1409 (0.07%)  0/1409 (0.00%) 
Dementia with Lewy bodies  1  1/1409 (0.07%)  0/1409 (0.00%) 
Demyelination  1  0/1409 (0.00%)  1/1409 (0.07%) 
Depressed level of consciousness  1  0/1409 (0.00%)  1/1409 (0.07%) 
Diabetic hyperosmolar coma  1  0/1409 (0.00%)  1/1409 (0.07%) 
Diabetic mononeuropathy  1  1/1409 (0.07%)  0/1409 (0.00%) 
Diabetic neuropathy  1  0/1409 (0.00%)  1/1409 (0.07%) 
Essential tremor  1  1/1409 (0.07%)  0/1409 (0.00%) 
Facial paresis  1  1/1409 (0.07%)  0/1409 (0.00%) 
Guillain-Barre syndrome  1  0/1409 (0.00%)  1/1409 (0.07%) 
Hemianopia homonymous  1  1/1409 (0.07%)  0/1409 (0.00%) 
Hemiparesis  1  0/1409 (0.00%)  1/1409 (0.07%) 
Hypocalcaemic seizure  1  1/1409 (0.07%)  0/1409 (0.00%) 
Hypoglycaemic seizure  1  0/1409 (0.00%)  1/1409 (0.07%) 
Hypoglycaemic unconsciousness  1  0/1409 (0.00%)  1/1409 (0.07%) 
IIIrd nerve paralysis  1  0/1409 (0.00%)  1/1409 (0.07%) 
Ischaemic cerebral infarction  1  0/1409 (0.00%)  1/1409 (0.07%) 
Ischaemic neuropathy  1  0/1409 (0.00%)  1/1409 (0.07%) 
IVth nerve paresis  1  0/1409 (0.00%)  1/1409 (0.07%) 
Lacunar stroke  1  1/1409 (0.07%)  0/1409 (0.00%) 
Lethargy  1  0/1409 (0.00%)  1/1409 (0.07%) 
Loss of consciousness  1  0/1409 (0.00%)  1/1409 (0.07%) 
Memory impairment  1  1/1409 (0.07%)  0/1409 (0.00%) 
Metabolic encephalopathy  1  0/1409 (0.00%)  1/1409 (0.07%) 
Migraine  1  0/1409 (0.00%)  1/1409 (0.07%) 
Monoparesis  1  1/1409 (0.07%)  0/1409 (0.00%) 
Movement disorder  1  1/1409 (0.07%)  0/1409 (0.00%) 
Myelopathy  1  0/1409 (0.00%)  1/1409 (0.07%) 
Myoclonic epilepsy  1  1/1409 (0.07%)  0/1409 (0.00%) 
Nerve root compression  1  0/1409 (0.00%)  1/1409 (0.07%) 
Nervous system disorder  1  1/1409 (0.07%)  0/1409 (0.00%) 
Noninfective encephalitis  1  1/1409 (0.07%)  0/1409 (0.00%) 
Paraparesis  1  1/1409 (0.07%)  0/1409 (0.00%) 
Retrograde amnesia  1  0/1409 (0.00%)  1/1409 (0.07%) 
Reversible ischaemic neurological deficit  1  1/1409 (0.07%)  0/1409 (0.00%) 
Somnolence  1  1/1409 (0.07%)  0/1409 (0.00%) 
Spinal subarachnoid haemorrhage  1  1/1409 (0.07%)  0/1409 (0.00%) 
Status epilepticus  1  0/1409 (0.00%)  1/1409 (0.07%) 
Tension headache  1  0/1409 (0.00%)  1/1409 (0.07%) 
Thalamus haemorrhage  1  1/1409 (0.07%)  0/1409 (0.00%) 
Transient global amnesia  1  1/1409 (0.07%)  0/1409 (0.00%) 
Unresponsive to stimuli  1  1/1409 (0.07%)  0/1409 (0.00%) 
VIth nerve paralysis  1  0/1409 (0.00%)  1/1409 (0.07%) 
Wallerian degeneration  1  0/1409 (0.00%)  1/1409 (0.07%) 
Product Issues     
Device malfunction  1  7/1409 (0.50%)  8/1409 (0.57%) 
Thrombosis in device  1  6/1409 (0.43%)  9/1409 (0.64%) 
Device dislocation  1  4/1409 (0.28%)  1/1409 (0.07%) 
Device loosening  1  3/1409 (0.21%)  1/1409 (0.07%) 
Device breakage  1  1/1409 (0.07%)  0/1409 (0.00%) 
Device damage  1  0/1409 (0.00%)  1/1409 (0.07%) 
Device extrusion  1  1/1409 (0.07%)  0/1409 (0.00%) 
Device failure  1  1/1409 (0.07%)  0/1409 (0.00%) 
Device occlusion  1  0/1409 (0.00%)  1/1409 (0.07%) 
Psychiatric disorders     
Confusional state  1  14/1409 (0.99%)  10/1409 (0.71%) 
Delirium  1  3/1409 (0.21%)  3/1409 (0.21%) 
Completed suicide  1  3/1409 (0.21%)  1/1409 (0.07%) 
Depression  1  2/1409 (0.14%)  2/1409 (0.14%) 
Hallucination  1  1/1409 (0.07%)  2/1409 (0.14%) 
Sopor  1  1/1409 (0.07%)  2/1409 (0.14%) 
Adjustment disorder  1  1/1409 (0.07%)  1/1409 (0.07%) 
Mania  1  0/1409 (0.00%)  2/1409 (0.14%) 
Mental status changes  1  2/1409 (0.14%)  0/1409 (0.00%) 
Organic brain syndrome  1  1/1409 (0.07%)  1/1409 (0.07%) 
Suicide attempt  1  2/1409 (0.14%)  0/1409 (0.00%) 
Abnormal behaviour  1  1/1409 (0.07%)  0/1409 (0.00%) 
Acute psychosis  1  1/1409 (0.07%)  0/1409 (0.00%) 
Anxiety  1  1/1409 (0.07%)  0/1409 (0.00%) 
Anxiety disorder  1  1/1409 (0.07%)  0/1409 (0.00%) 
Bipolar disorder  1  0/1409 (0.00%)  1/1409 (0.07%) 
Drug abuse  1  0/1409 (0.00%)  1/1409 (0.07%) 
Mental disorder  1  1/1409 (0.07%)  0/1409 (0.00%) 
Psychotic disorder  1  0/1409 (0.00%)  1/1409 (0.07%) 
Substance-induced psychotic disorder  1  0/1409 (0.00%)  1/1409 (0.07%) 
Renal and urinary disorders     
End stage renal disease  1  31/1409 (2.20%)  26/1409 (1.85%) 
Renal impairment  1  20/1409 (1.42%)  18/1409 (1.28%) 
Haematuria  1  7/1409 (0.50%)  8/1409 (0.57%) 
Chronic kidney disease  1  7/1409 (0.50%)  4/1409 (0.28%) 
Azotaemia  1  4/1409 (0.28%)  6/1409 (0.43%) 
Acute kidney injury  1  6/1409 (0.43%)  3/1409 (0.21%) 
Nephrolithiasis  1  2/1409 (0.14%)  4/1409 (0.28%) 
Renal cyst haemorrhage  1  2/1409 (0.14%)  3/1409 (0.21%) 
Hydronephrosis  1  2/1409 (0.14%)  2/1409 (0.14%) 
Renal failure  1  1/1409 (0.07%)  3/1409 (0.21%) 
Renal colic  1  1/1409 (0.07%)  2/1409 (0.14%) 
Urinary retention  1  3/1409 (0.21%)  0/1409 (0.00%) 
Ureteric stenosis  1  2/1409 (0.14%)  0/1409 (0.00%) 
Ureterolithiasis  1  2/1409 (0.14%)  0/1409 (0.00%) 
Urinary bladder polyp  1  1/1409 (0.07%)  1/1409 (0.07%) 
Bladder tamponade  1  0/1409 (0.00%)  1/1409 (0.07%) 
Calculus urethral  1  0/1409 (0.00%)  1/1409 (0.07%) 
Cystitis haemorrhagic  1  1/1409 (0.07%)  0/1409 (0.00%) 
Cystitis interstitial  1  1/1409 (0.07%)  0/1409 (0.00%) 
Glomerulonephritis  1  0/1409 (0.00%)  1/1409 (0.07%) 
Haemorrhage urinary tract  1  1/1409 (0.07%)  0/1409 (0.00%) 
Kidney enlargement  1  1/1409 (0.07%)  0/1409 (0.00%) 
Lupus nephritis  1  0/1409 (0.00%)  1/1409 (0.07%) 
Malnutrition-inflammation-atherosclerosis syndrome  1  0/1409 (0.00%)  1/1409 (0.07%) 
Nephritis  1  0/1409 (0.00%)  1/1409 (0.07%) 
Nephropathy toxic  1  1/1409 (0.07%)  0/1409 (0.00%) 
Proteinuria  1  1/1409 (0.07%)  0/1409 (0.00%) 
Renal artery stenosis  1  0/1409 (0.00%)  1/1409 (0.07%) 
Renal cyst ruptured  1  1/1409 (0.07%)  0/1409 (0.00%) 
Renal haematoma  1  1/1409 (0.07%)  0/1409 (0.00%) 
Renal ischaemia  1  1/1409 (0.07%)  0/1409 (0.00%) 
Urethral stenosis  1  1/1409 (0.07%)  0/1409 (0.00%) 
Urinary bladder haemorrhage  1  1/1409 (0.07%)  0/1409 (0.00%) 
Urinary tract obstruction  1  1/1409 (0.07%)  0/1409 (0.00%) 
Reproductive system and breast disorders     
Benign prostatic hyperplasia  1  2/1409 (0.14%)  3/1409 (0.21%) 
Prostatitis  1  1/1409 (0.07%)  3/1409 (0.21%) 
Endometrial hyperplasia  1  2/1409 (0.14%)  1/1409 (0.07%) 
Cervical dysplasia  1  1/1409 (0.07%)  1/1409 (0.07%) 
Haemorrhagic ovarian cyst  1  0/1409 (0.00%)  2/1409 (0.14%) 
Ovarian cyst  1  0/1409 (0.00%)  2/1409 (0.14%) 
Postmenopausal haemorrhage  1  1/1409 (0.07%)  1/1409 (0.07%) 
Vaginal haemorrhage  1  0/1409 (0.00%)  2/1409 (0.14%) 
Breast mass  1  1/1409 (0.07%)  0/1409 (0.00%) 
Female genital tract fistula  1  1/1409 (0.07%)  0/1409 (0.00%) 
Hysterocele  1  0/1409 (0.00%)  1/1409 (0.07%) 
Menorrhagia  1  1/1409 (0.07%)  0/1409 (0.00%) 
Metrorrhagia  1  0/1409 (0.00%)  1/1409 (0.07%) 
Uterine polyp  1  0/1409 (0.00%)  1/1409 (0.07%) 
Respiratory, thoracic and mediastinal disorders     
Pleural effusion  1  22/1409 (1.56%)  22/1409 (1.56%) 
Non-cardiogenic pulmonary oedema  1  23/1409 (1.63%)  15/1409 (1.06%) 
Dyspnoea  1  14/1409 (0.99%)  16/1409 (1.14%) 
Pulmonary oedema  1  12/1409 (0.85%)  18/1409 (1.28%) 
Acute pulmonary oedema  1  14/1409 (0.99%)  11/1409 (0.78%) 
Chronic obstructive pulmonary disease  1  11/1409 (0.78%)  12/1409 (0.85%) 
Respiratory failure  1  7/1409 (0.50%)  13/1409 (0.92%) 
Pneumonia aspiration  1  9/1409 (0.64%)  8/1409 (0.57%) 
Pulmonary embolism  1  9/1409 (0.64%)  5/1409 (0.35%) 
Epistaxis  1  8/1409 (0.57%)  4/1409 (0.28%) 
Acute respiratory failure  1  5/1409 (0.35%)  6/1409 (0.43%) 
Pulmonary congestion  1  6/1409 (0.43%)  5/1409 (0.35%) 
Lung disorder  1  5/1409 (0.35%)  4/1409 (0.28%) 
Pneumonitis  1  2/1409 (0.14%)  7/1409 (0.50%) 
Haemothorax  1  3/1409 (0.21%)  4/1409 (0.28%) 
Respiratory arrest  1  4/1409 (0.28%)  1/1409 (0.07%) 
Aspiration  1  1/1409 (0.07%)  3/1409 (0.21%) 
Asthma  1  4/1409 (0.28%)  0/1409 (0.00%) 
Bronchitis chronic  1  3/1409 (0.21%)  1/1409 (0.07%) 
Respiratory distress  1  2/1409 (0.14%)  2/1409 (0.14%)