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Trial record 11 of 10870 for:    Placebo AND once

Exenatide Study of Cardiovascular Event Lowering Trial (EXSCEL): A Trial To Evaluate Cardiovascular Outcomes After Treatment With Exenatide Once Weekly In Patients With Type 2 Diabetes Mellitus

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: NCT01144338
Recruitment Status : Completed
First Posted : June 15, 2010
Results First Posted : August 8, 2018
Last Update Posted : August 8, 2018
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Type 2 Diabetes Mellitus
Interventions Drug: Exenatide Once Weekly
Drug: Placebo
Enrollment 14752
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Exenatide Once Weekly
Hide Arm/Group Description Matching placebo subcutaneous injections Exenatide 2mg once weekly subcutaneous injections
Period Title: Overall Study
Started 7396 7356
Completed 7093 7094
Not Completed 303 262
Arm/Group Title Placebo Exenatide Once Weekly Total
Hide Arm/Group Description Matching placebo subcutaneous injections Exenatide 2mg once weekly subcutaneous injections Total of all reporting groups
Overall Number of Baseline Participants 7396 7356 14752
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 7396 participants 7356 participants 14752 participants
61.9  (9.4) 61.8  (9.4) 61.9  (9.4)
[1]
Measure Description: Age at enrollment
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7396 participants 7356 participants 14752 participants
Female
2809
  38.0%
2794
  38.0%
5603
  38.0%
Male
4587
  62.0%
4562
  62.0%
9149
  62.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7396 participants 7356 participants 14752 participants
WHITE
5621
  76.0%
5554
  75.5%
11175
  75.8%
BLACK OR AFRICAN AMERICAN
436
   5.9%
442
   6.0%
878
   6.0%
ASIAN
727
   9.8%
725
   9.9%
1452
   9.8%
INDIAN (AMERICAN ) OR ALASKA NATIVE
35
   0.5%
38
   0.5%
73
   0.5%
NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER
17
   0.2%
18
   0.2%
35
   0.2%
HISPANIC
557
   7.5%
577
   7.8%
1134
   7.7%
MISSING
3
   0.0%
2
   0.0%
5
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Global Number Analyzed 7396 participants 7356 participants 14752 participants
ASIA PACIFIC
760
  10.3%
769
  10.5%
1529
  10.4%
EUROPE
3399
  46.0%
3389
  46.1%
6788
  46.0%
LATIN AMERICA
1363
  18.4%
1364
  18.5%
2727
  18.5%
NORTH AMERICA
1874
  25.3%
1834
  24.9%
3708
  25.1%
Prior CV Event   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7396 participants 7356 participants 14752 participants
Yes
5388
  72.9%
5394
  73.3%
10782
  73.1%
No
2008
  27.1%
1962
  26.7%
3970
  26.9%
[1]
Measure Description: Patient had prior cardiovascular event or not at randomization
1.Primary Outcome
Title Primary Efficacy Outcome MACE Events
Hide Description

The primary efficacy outcome variable is defined as the composite endpoint of cardiovascular death, nonfatal MI, or nonfatal stroke. The number of participants who had an event is reported in the results.

The primary efficacy endpoint is the same as the primary safety endpoint, and the statistical analysis tests the superiority of exenatide against the placebo.

Time Frame Time to first event. Information collected during study period (anticipated to be up to 7.5 years).
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population: all patients consented and randomized in the study without a major GCP violation. ITT population is analyzed as randomized.
Arm/Group Title Placebo Exenatide Once Weekly
Hide Arm/Group Description:
Matching placebo subcutaneous injections
Exenatide 2mg once weekly subcutaneous injections
Overall Number of Participants Analyzed 7396 7356
Measure Type: Count of Participants
Unit of Measure: Participants
Number of patients who had a MACE event
905
  12.2%
839
  11.4%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Exenatide Once Weekly
Comments [Not Specified]
Type of Statistical Test Superiority
Comments Superiority test of EQW over Placebo H0: HR ≥ 1 vs. H1: HR < 1
Statistical Test of Hypothesis P-Value 0.061
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%
0.832 to 1.004
Estimation Comments [Not Specified]
2.Primary Outcome
Title Primary Safety Outcome MACE Events
Hide Description

The primary safety outcome variable is defined as the composite endpoint of cardiovascular death, nonfatal MI, or nonfatal stroke. The number of participants who had an event is reported in the results.

The primary safety endpoint is the same as the primary efficacy endpoints, and the statistical analysis tests the non-inferiority of exenatide against placebo.

Time Frame Time to first event. Information collected during study period (anticipated to be up to 7.5 years).
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population: all patients consented and randomized in the study without a major GCP violation. ITT population is analyzed as randomized.
Arm/Group Title Placebo Exenatide Once Weekly
Hide Arm/Group Description:
Matching placebo subcutaneous injections
Exenatide 2mg once weekly subcutaneous injections
Overall Number of Participants Analyzed 7396 7356
Measure Type: Count of Participants
Unit of Measure: Participants
Number of patients who had a MACE event
905
  12.2%
839
  11.4%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Exenatide Once Weekly
Comments This analysis uses the same endpoint and cox regression method as the primary efficacy analysis. However, the statistical hypothesis is a non-inferiority test with a margin of HR=1.3.
Type of Statistical Test Non-Inferiority
Comments Non-inferiority test of EQW over Placebo H0: HR ≥ 1.3 vs. H1: HR < 1.3
Statistical Test of Hypothesis P-Value < 0.001
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%
0.832 to 1.004
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Secondary Efficacy Outcome All-Cause Mortality
Hide Description The secondary efficacy outcome variable is defined as the all-cause mortality (deaths). The number of participants who had an event is reported in the results.
Time Frame Time to first event. Information collected during study period (anticipated to be up to 7.5 years).
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population: all patients consented and randomized in the study without a major GCP violation. ITT population is analyzed as randomized.
Arm/Group Title Placebo Exenatide Once Weekly
Hide Arm/Group Description:
Matching placebo subcutaneous injections
Exenatide 2mg once weekly subcutaneous injections
Overall Number of Participants Analyzed 7396 7356
Measure Type: Count of Participants
Unit of Measure: Participants
Number of patients who died
584
   7.9%
507
   6.9%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Exenatide Once Weekly
Comments [Not Specified]
Type of Statistical Test Superiority
Comments Superiority test of EQW over Placebo H0: HR ≥ 1 vs. H1: HR < 1
Statistical Test of Hypothesis P-Value 0.016
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.86
Confidence Interval (2-Sided) 95%
0.77 to 0.97
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Secondary Efficacy Outcome CV Death
Hide Description Component of the primary efficacy outcome: cardiovascular death. The number of participants who had an event is reported in the results.
Time Frame Time to first event. Information collected during study period (anticipated to be up to 7.5 years).
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population: all patients consented and randomized in the study without a major GCP violation. ITT population is analyzed as randomized.
Arm/Group Title Placebo Exenatide Once Weekly
Hide Arm/Group Description:
Matching placebo subcutaneous injections
Exenatide 2mg once weekly subcutaneous injections
Overall Number of Participants Analyzed 7396 7356
Measure Type: Count of Participants
Unit of Measure: Participants
Number of patients who had CV death
383
   5.2%
340
   4.6%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Exenatide Once Weekly
Comments [Not Specified]
Type of Statistical Test Superiority
Comments Superiority test of EQW over Placebo H0: HR ≥ 1 vs. H1: HR < 1
Statistical Test of Hypothesis P-Value 0.096
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.88
Confidence Interval (2-Sided) 95%
0.76 to 1.02
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Secondary Efficacy Outcome MI
Hide Description Component of primary efficacy outcome: fatal or non-fatal MI. The number of participants who had an event is reported in the results.
Time Frame Time to first event. Information collected during study period (anticipated to be up to 7.5 years).
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population: all patients consented and randomized in the study without a major GCP violation. ITT population is analyzed as randomized.
Arm/Group Title Placebo Exenatide Once Weekly
Hide Arm/Group Description:
Matching placebo subcutaneous injections
Exenatide 2mg once weekly subcutaneous injections
Overall Number of Participants Analyzed 7396 7356
Measure Type: Count of Participants
Unit of Measure: Participants
Number of patients who died
493
   6.7%
483
   6.6%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Exenatide Once Weekly
Comments [Not Specified]
Type of Statistical Test Superiority
Comments Superiority test of EQW over Placebo H0: HR ≥ 1 vs. H1: HR < 1
Statistical Test of Hypothesis P-Value 0.622
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.97
Confidence Interval (2-Sided) 95%
0.85 to 1.10
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Secondary Efficacy Outcome Stroke
Hide Description Component of primary efficacy outcome: fatal or non-fatal stroke. The number of participants who had an event is reported in the results.
Time Frame Time to first event. Information collected during study period (anticipated to be up to 7.5 years).
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population: all patients consented and randomized in the study without a major GCP violation. ITT population is analyzed as randomized.
Arm/Group Title Placebo Exenatide Once Weekly
Hide Arm/Group Description:
Matching placebo subcutaneous injections
Exenatide 2mg once weekly subcutaneous injections
Overall Number of Participants Analyzed 7396 7356
Measure Type: Count of Participants
Unit of Measure: Participants
Number of patients who had stroke
218
   2.9%
187
   2.5%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Exenatide Once Weekly
Comments [Not Specified]
Type of Statistical Test Superiority
Comments Superiority test of EQW over Placebo H0: HR ≥ 1 vs. H1: HR < 1
Statistical Test of Hypothesis P-Value 0.095
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.85
Confidence Interval (2-Sided) 95%
0.70 to 1.03
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Secondary Efficacy Outcome Hospitalization for ACS
Hide Description The secondary efficacy outcome variable is defined as hospitalization for acute coronary syndrome. The number of participants who had an event is reported in the results.
Time Frame Time to first event. Information collected during study period (anticipated to be up to 7.5 years).
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population: all patients consented and randomized in the study without a major GCP violation. ITT population is analyzed as randomized.
Arm/Group Title Placebo Exenatide Once Weekly
Hide Arm/Group Description:
Matching placebo subcutaneous injections
Exenatide 2mg once weekly subcutaneous injections
Overall Number of Participants Analyzed 7396 7356
Measure Type: Count of Participants
Unit of Measure: Participants
Num of pts with hospitalization due to ACS
570
   7.7%
602
   8.2%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Exenatide Once Weekly
Comments [Not Specified]
Type of Statistical Test Superiority
Comments Superiority test of EQW over Placebo H0: HR ≥ 1 vs. H1: HR < 1
Statistical Test of Hypothesis P-Value 0.402
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.05
Confidence Interval (2-Sided) 95%
0.94 to 1.18
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Secondary Efficacy Outcome Hospitalization for HF
Hide Description The secondary efficacy outcome variable is defined as hospitalization for heart failure. The number of participants who had an event is reported in the results.
Time Frame Time to first event. Information collected during study period (anticipated to be up to 7.5 years).
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population: all patients consented and randomized in the study without a major GCP violation. ITT population is analyzed as randomized.
Arm/Group Title Placebo Exenatide Once Weekly
Hide Arm/Group Description:
Matching placebo subcutaneous injections
Exenatide 2mg once weekly subcutaneous injections
Overall Number of Participants Analyzed 7396 7356
Measure Type: Count of Participants
Unit of Measure: Participants
Number of patients who died
231
   3.1%
219
   3.0%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Exenatide Once Weekly
Comments [Not Specified]
Type of Statistical Test Superiority
Comments Superiority test of EQW over Placebo H0: HR ≥ 1 vs. H1: HR < 1
Statistical Test of Hypothesis P-Value 0.485
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%
0.78 to 1.13
Estimation Comments [Not Specified]
Time Frame During study period up to 7.5 years
Adverse Event Reporting Description Only SAEs are collected in this study. Other (not including non-serious) adverse events are not monitored/assessed.
 
Arm/Group Title Placebo Exenatide Once Weekly
Hide Arm/Group Description Matching placebo subcutaneous injections Exenatide 2mg once weekly subcutaneous injections
All-Cause Mortality
Placebo Exenatide Once Weekly
Affected / at Risk (%) Affected / at Risk (%)
Total   584/7372 (7.92%)      507/7344 (6.90%)    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Exenatide Once Weekly
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1222/7372 (16.58%)      1234/7344 (16.80%)    
Blood and lymphatic system disorders     
Anaemia  1  26/7372 (0.35%)  31 15/7344 (0.20%)  16
Antiphospholipid syndrome  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Autoimmune haemolytic anaemia  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Bone marrow disorder  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Bone marrow oedema  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Coagulopathy  1  2/7372 (0.03%)  2 0/7344 (0.00%)  0
Disseminated intravascular coagulation  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Febrile neutropenia  1  2/7372 (0.03%)  3 1/7344 (0.01%)  1
Haemolytic anaemia  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Haemorrhagic anaemia  1  1/7372 (0.01%)  1 3/7344 (0.04%)  3
Immune thrombocytopenic purpura  1  1/7372 (0.01%)  1 2/7344 (0.03%)  2
Iron deficiency anaemia  1  3/7372 (0.04%)  3 11/7344 (0.15%)  13
Lymphadenopathy  1  0/7372 (0.00%)  0 2/7344 (0.03%)  2
Lymphadenopathy mediastinal  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Mastocytosis  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Microcytic anaemia  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Neutropenia  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Thrombocytopenia  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Cardiac disorders     
Angina pectoris  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Myocardial ischaemia  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Congenital, familial and genetic disorders     
Arteriovenous malformation  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Gastrointestinal arteriovenous malformation  1  3/7372 (0.04%)  3 0/7344 (0.00%)  0
Haemorrhagic arteriovenous malformation  1  1/7372 (0.01%)  2 0/7344 (0.00%)  0
Hydrocele  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Phimosis  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Rathke's cleft cyst  1  1/7372 (0.01%)  2 0/7344 (0.00%)  0
Sacralisation  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Thalassaemia beta  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Ear and labyrinth disorders     
Acute vestibular syndrome  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Deafness  1  2/7372 (0.03%)  2 0/7344 (0.00%)  0
Hypoacusis  1  0/7372 (0.00%)  0 2/7344 (0.03%)  2
Mixed deafness  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Tympanic membrane disorder  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Tympanic membrane perforation  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Vertigo  1  6/7372 (0.08%)  6 6/7344 (0.08%)  7
Vertigo positional  1  0/7372 (0.00%)  0 6/7344 (0.08%)  6
Vestibular disorder  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Endocrine disorders     
Adrenal mass  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Autoimmune thyroiditis  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Cushing's syndrome  1  1/7372 (0.01%)  1 1/7344 (0.01%)  1
Goitre  1  3/7372 (0.04%)  4 7/7344 (0.10%)  7
Hyperaldosteronism  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Hyperthyroidism  1  2/7372 (0.03%)  3 1/7344 (0.01%)  1
Hypothyroidism  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Thyroid disorder  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Thyroid mass  1  1/7372 (0.01%)  1 1/7344 (0.01%)  1
Toxic nodular goitre  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Eye disorders     
Angle closure glaucoma  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Blindness unilateral  1  1/7372 (0.01%)  1 1/7344 (0.01%)  1
Cataract  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Diplopia  1  1/7372 (0.01%)  1 2/7344 (0.03%)  2
Extraocular muscle disorder  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Eye disorder  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Eye pain  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Glaucoma  1  1/7372 (0.01%)  2 1/7344 (0.01%)  1
Lens dislocation  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Macular fibrosis  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Macular hole  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Macular oedema  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Open angle glaucoma  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Retinal detachment  1  3/7372 (0.04%)  3 4/7344 (0.05%)  4
Retinal haemorrhage  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Ulcerative keratitis  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Visual impairment  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Vitreous haemorrhage  1  2/7372 (0.03%)  2 3/7344 (0.04%)  3
Gastrointestinal disorders     
Abdominal adhesions  1  0/7372 (0.00%)  0 1/7344 (0.01%)  2
Abdominal hernia  1  6/7372 (0.08%)  6 7/7344 (0.10%)  7
Abdominal incarcerated hernia  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Abdominal pain  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Abdominal pain upper  1  1/7372 (0.01%)  1 2/7344 (0.03%)  2
Abdominal strangulated hernia  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Abdominal wall haematoma  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Anal fissure  1  2/7372 (0.03%)  2 0/7344 (0.00%)  0
Anal fistula  1  1/7372 (0.01%)  2 0/7344 (0.00%)  0
Anal haemorrhage  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Anorectal stenosis  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Anorectal varices  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Ascites  1  2/7372 (0.03%)  2 1/7344 (0.01%)  1
Chronic gastritis  1  2/7372 (0.03%)  2 3/7344 (0.04%)  3
Colitis  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Colitis ischaemic  1  1/7372 (0.01%)  1 1/7344 (0.01%)  1
Colitis ulcerative  1  0/7372 (0.00%)  0 2/7344 (0.03%)  2
Constipation  1  2/7372 (0.03%)  2 2/7344 (0.03%)  2
Crohn's disease  1  1/7372 (0.01%)  1 1/7344 (0.01%)  2
Diaphragmatic hernia  1  1/7372 (0.01%)  1 1/7344 (0.01%)  1
Diverticular perforation  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Diverticulum  1  2/7372 (0.03%)  2 2/7344 (0.03%)  2
Diverticulum intestinal  1  1/7372 (0.01%)  1 1/7344 (0.01%)  1
Diverticulum intestinal haemorrhagic  1  2/7372 (0.03%)  3 1/7344 (0.01%)  1
Duodenal ulcer  1  1/7372 (0.01%)  1 2/7344 (0.03%)  2
Duodenal ulcer haemorrhage  1  0/7372 (0.00%)  0 4/7344 (0.05%)  4
Duodenitis  1  1/7372 (0.01%)  1 1/7344 (0.01%)  1
Duodenitis haemorrhagic  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Dyspepsia  1  1/7372 (0.01%)  1 2/7344 (0.03%)  2
Dysphagia  1  1/7372 (0.01%)  1 4/7344 (0.05%)  4
Enterocele  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Enterocutaneous fistula  1  1/7372 (0.01%)  1 1/7344 (0.01%)  1
Epigastric discomfort  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Erosive oesophagitis  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Faecaloma  1  2/7372 (0.03%)  2 1/7344 (0.01%)  1
Gastric antral vascular ectasia  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Gastric fistula  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Gastric perforation  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Gastric polyps  1  1/7372 (0.01%)  1 2/7344 (0.03%)  2
Gastric ulcer  1  2/7372 (0.03%)  2 2/7344 (0.03%)  2
Gastric ulcer haemorrhage  1  0/7372 (0.00%)  0 4/7344 (0.05%)  4
Gastric ulcer perforation  1  2/7372 (0.03%)  2 0/7344 (0.00%)  0
Gastric varices haemorrhage  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Gastritis  1  12/7372 (0.16%)  12 4/7344 (0.05%)  4
Gastritis erosive  1  3/7372 (0.04%)  3 1/7344 (0.01%)  1
Gastroduodenal haemorrhage  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Gastrointestinal disorder  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Gastrointestinal haemorrhage  1  34/7372 (0.46%)  37 27/7344 (0.37%)  30
Gastrointestinal hypomotility  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Gastrointestinal inflammation  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Gastrointestinal melanosis  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Gastrointestinal obstruction  1  2/7372 (0.03%)  2 3/7344 (0.04%)  3
Gastrooesophageal reflux disease  1  9/7372 (0.12%)  10 6/7344 (0.08%)  8
Gingival bleeding  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Haematochezia  1  1/7372 (0.01%)  1 3/7344 (0.04%)  3
Haemorrhoids  1  1/7372 (0.01%)  1 1/7344 (0.01%)  1
Hiatus hernia  1  1/7372 (0.01%)  1 3/7344 (0.04%)  3
Ileus  1  2/7372 (0.03%)  2 3/7344 (0.04%)  3
Impaired gastric emptying  1  1/7372 (0.01%)  1 1/7344 (0.01%)  1
Incarcerated umbilical hernia  1  0/7372 (0.00%)  0 2/7344 (0.03%)  2
Inflammatory bowel disease  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Inguinal hernia  1  4/7372 (0.05%)  4 9/7344 (0.12%)  9
Intestinal haematoma  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Intestinal haemorrhage  1  2/7372 (0.03%)  2 3/7344 (0.04%)  3
Intestinal obstruction  1  3/7372 (0.04%)  3 4/7344 (0.05%)  4
Intestinal perforation  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Jejunal perforation  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Large intestinal ulcer  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Large intestinal ulcer haemorrhage  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Large intestine perforation  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Large intestine polyp  1  10/7372 (0.14%)  11 1/7344 (0.01%)  1
Lower gastrointestinal haemorrhage  1  9/7372 (0.12%)  9 3/7344 (0.04%)  4
Lumbar hernia  1  2/7372 (0.03%)  2 1/7344 (0.01%)  1
Mallory-weiss syndrome  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Melaena  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Oesophageal obstruction  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Oesophageal perforation  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Oesophageal polyp  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Oesophageal ulcer  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Oesophageal varices haemorrhage  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Oesophagitis  1  2/7372 (0.03%)  2 1/7344 (0.01%)  1
Oral dysaesthesia  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Oroantral fistula  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Pancreatic cyst  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Pancreatic mass  1  1/7372 (0.01%)  1 1/7344 (0.01%)  1
Pancreatitis  1  22/7372 (0.30%)  24 37/7344 (0.50%)  37
Peptic ulcer  1  0/7372 (0.00%)  0 2/7344 (0.03%)  2
Peritoneal haematoma  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Rectal haemorrhage  1  3/7372 (0.04%)  3 5/7344 (0.07%)  5
Rectal polyp  1  1/7372 (0.01%)  1 1/7344 (0.01%)  1
Rectourethral fistula  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Retroperitoneal haematoma  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Retroperitoneal haemorrhage  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Retroperitoneal mass  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Small intestinal obstruction  1  8/7372 (0.11%)  9 7/7344 (0.10%)  7
Small intestinal perforation  1  1/7372 (0.01%)  1 1/7344 (0.01%)  1
Strangulated umbilical hernia  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Subileus  1  2/7372 (0.03%)  2 0/7344 (0.00%)  0
Tongue haemorrhage  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Umbilical hernia  1  14/7372 (0.19%)  14 5/7344 (0.07%)  5
Upper gastrointestinal haemorrhage  1  10/7372 (0.14%)  10 9/7344 (0.12%)  9
Varices oesophageal  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
General disorders     
Adverse drug reaction  1  1/7372 (0.01%)  1 1/7344 (0.01%)  1
Asthenia  1  5/7372 (0.07%)  5 4/7344 (0.05%)  4
Chest discomfort  1  1/7372 (0.01%)  1 1/7344 (0.01%)  1
Chest pain  1  5/7372 (0.07%)  5 5/7344 (0.07%)  5
Complication associated with device  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Cyst  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Drug interaction  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Fatigue  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Gait disturbance  1  1/7372 (0.01%)  1 2/7344 (0.03%)  2
General physical health deterioration  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Generalised oedema  1  0/7372 (0.00%)  0 2/7344 (0.03%)  2
Granuloma  1  1/7372 (0.01%)  1 1/7344 (0.01%)  1
Haemorrhagic cyst  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Hernia  1  2/7372 (0.03%)  2 0/7344 (0.00%)  0
Impaired healing  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Impaired self-care  1  0/7372 (0.00%)  0 1/7344 (0.01%)  2
Injection site inflammation  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Malaise  1  0/7372 (0.00%)  0 3/7344 (0.04%)  3
Non-cardiac chest pain  1  79/7372 (1.07%)  90 87/7344 (1.18%)  104
Oedema  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Oedema peripheral  1  4/7372 (0.05%)  4 1/7344 (0.01%)  1
Pain  1  2/7372 (0.03%)  2 1/7344 (0.01%)  1
Polyp  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Pyrexia  1  5/7372 (0.07%)  5 0/7344 (0.00%)  0
Strangulated hernia  1  0/7372 (0.00%)  0 2/7344 (0.03%)  2
Hepatobiliary disorders     
Acute hepatic failure  1  2/7372 (0.03%)  2 0/7344 (0.00%)  0
Bile duct stenosis  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Biliary cirrhosis  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Biliary colic  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Biliary cyst  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Chronic hepatic failure  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Cirrhosis alcoholic  1  1/7372 (0.01%)  3 1/7344 (0.01%)  1
Drug-induced liver injury  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Gallbladder fistula  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Gallbladder polyp  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Hepatic cirrhosis  1  3/7372 (0.04%)  3 4/7344 (0.05%)  5
Hepatic haematoma  1  1/7372 (0.01%)  1 1/7344 (0.01%)  1
Hepatic lesion  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Hepatic mass  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Hepatomegaly  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Hepatosplenomegaly  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Jaundice  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Jaundice cholestatic  1  1/7372 (0.01%)  1 1/7344 (0.01%)  1
Liver injury  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Portal vein thrombosis  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Immune system disorders     
Anaphylactic reaction  1  2/7372 (0.03%)  2 1/7344 (0.01%)  1
Drug hypersensitivity  1  2/7372 (0.03%)  2 0/7344 (0.00%)  0
Food allergy  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Hypersensitivity  1  0/7372 (0.00%)  0 3/7344 (0.04%)  3
Sarcoidosis  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Infections and infestations     
Bronchitis  1  2/7372 (0.03%)  2 0/7344 (0.00%)  0
Cellulitis  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Chronic sinusitis  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Chronic tonsillitis  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Cystitis  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Dengue fever  1  1/7372 (0.01%)  1 1/7344 (0.01%)  1
Endophthalmitis  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Epiglottitis  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Hepatitis e  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Herpes zoster  1  2/7372 (0.03%)  2 1/7344 (0.01%)  1
Herpes zoster oticus  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Infective exacerbation of chronic obstructive airways disease  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Keratouveitis  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Pseudomembranous colitis  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Pulmonary tuberculosis  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Sinusitis  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Vestibular neuronitis  1  0/7372 (0.00%)  0 2/7344 (0.03%)  2
Viral infection  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Injury, poisoning and procedural complications     
Accident  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Accidental overdose  1  2/7372 (0.03%)  2 0/7344 (0.00%)  0
Acetabulum fracture  1  0/7372 (0.00%)  0 2/7344 (0.03%)  2
Alcohol poisoning  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Anastomotic ulcer  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Ankle fracture  1  7/7372 (0.09%)  7 11/7344 (0.15%)  11
Arthropod sting  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Brain contusion  1  2/7372 (0.03%)  2 0/7344 (0.00%)  0
Carbon monoxide poisoning  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Cervical vertebral fracture  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Clavicle fracture  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Comminuted fracture  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Complicated fracture  1  0/7372 (0.00%)  0 2/7344 (0.03%)  2
Concussion  1  3/7372 (0.04%)  3 2/7344 (0.03%)  2
Contrast media reaction  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Contusion  1  4/7372 (0.05%)  4 3/7344 (0.04%)  3
Craniocerebral injury  1  1/7372 (0.01%)  1 3/7344 (0.04%)  3
Ear injury  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Exposure to toxic agent  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Extradural haematoma  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Eye injury  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Facial bones fracture  1  3/7372 (0.04%)  3 4/7344 (0.05%)  4
Fall  1  14/7372 (0.19%)  15 12/7344 (0.16%)  12
Femoral neck fracture  1  6/7372 (0.08%)  6 10/7344 (0.14%)  10
Femur fracture  1  13/7372 (0.18%)  14 9/7344 (0.12%)  9
Fibula fracture  1  2/7372 (0.03%)  2 2/7344 (0.03%)  2
Foot fracture  1  4/7372 (0.05%)  4 4/7344 (0.05%)  4
Forearm fracture  1  1/7372 (0.01%)  1 1/7344 (0.01%)  1
Foreign body  1  3/7372 (0.04%)  3 0/7344 (0.00%)  0
Gastrointestinal anastomotic leak  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Haematuria traumatic  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Hand fracture  1  1/7372 (0.01%)  1 2/7344 (0.03%)  2
Head injury  1  1/7372 (0.01%)  1 1/7344 (0.01%)  1
Hepatic haematoma  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Hip fracture  1  6/7372 (0.08%)  6 14/7344 (0.19%)  14
Humerus fracture  1  9/7372 (0.12%)  10 10/7344 (0.14%)  10
Ilium fracture  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Incarcerated incisional hernia  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Incisional hernia  1  4/7372 (0.05%)  4 2/7344 (0.03%)  2
Injury  1  1/7372 (0.01%)  1 2/7344 (0.03%)  2
Intentional overdose  1  1/7372 (0.01%)  1 1/7344 (0.01%)  1
Joint dislocation  1  2/7372 (0.03%)  2 2/7344 (0.03%)  2
Laceration  1  2/7372 (0.03%)  2 1/7344 (0.01%)  1
Ligament injury  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Limb injury  1  2/7372 (0.03%)  2 3/7344 (0.04%)  3
Lower limb fracture  1  5/7372 (0.07%)  5 4/7344 (0.05%)  4
Lumbar vertebral fracture  1  3/7372 (0.04%)  3 4/7344 (0.05%)  4
Meniscus injury  1  7/7372 (0.09%)  7 6/7344 (0.08%)  7
Multiple fractures  1  3/7372 (0.04%)  3 3/7344 (0.04%)  3
Multiple injuries  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Muscle injury  1  1/7372 (0.01%)  1 1/7344 (0.01%)  1
Muscle rupture  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Muscle strain  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Nail injury  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Overdose  1  7/7372 (0.09%)  7 5/7344 (0.07%)  5
Patella fracture  1  3/7372 (0.04%)  3 6/7344 (0.08%)  6
Pelvic fracture  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Periprosthetic fracture  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Perirenal haematoma  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Post laminectomy syndrome  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Post procedural haematoma  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Post procedural haemorrhage  1  2/7372 (0.03%)  2 3/7344 (0.04%)  3
Postoperative fever  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Postoperative ileus  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Postoperative respiratory failure  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Postoperative thoracic procedure complication  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Postoperative wound complication  1  1/7372 (0.01%)  1 1/7344 (0.01%)  1
Procedural haemorrhage  1  2/7372 (0.03%)  2 0/7344 (0.00%)  0
Procedural pain  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Procedural pneumothorax  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Pubis fracture  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Radiation pneumonitis  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Radius fracture  1  3/7372 (0.04%)  3 1/7344 (0.01%)  1
Rib fracture  1  14/7372 (0.19%)  14 5/7344 (0.07%)  5
Road traffic accident  1  1/7372 (0.01%)  1 3/7344 (0.04%)  3
Scapula fracture  1  2/7372 (0.03%)  2 0/7344 (0.00%)  0
Seroma  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Skin abrasion  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Skin injury  1  0/7372 (0.00%)  0 2/7344 (0.03%)  2
Skull fractured base  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Soft tissue injury  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Spinal column injury  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Spinal compression fracture  1  2/7372 (0.03%)  2 5/7344 (0.07%)  5
Spinal cord injury cervical  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Spinal fracture  1  1/7372 (0.01%)  1 1/7344 (0.01%)  1
Splenic injury  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Splenic rupture  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Subdural haematoma  1  9/7372 (0.12%)  9 11/7344 (0.15%)  11
Subdural haemorrhage  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Tendon rupture  1  3/7372 (0.04%)  3 4/7344 (0.05%)  4
Thermal burn  1  1/7372 (0.01%)  1 1/7344 (0.01%)  1
Thoracic vertebral fracture  1  3/7372 (0.04%)  3 0/7344 (0.00%)  0
Tibia fracture  1  8/7372 (0.11%)  8 8/7344 (0.11%)  8
Toxicity to various agents  1  2/7372 (0.03%)  2 4/7344 (0.05%)  4
Traumatic haemothorax  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Traumatic liver injury  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Ulna fracture  1  1/7372 (0.01%)  1 3/7344 (0.04%)  3
Upper limb fracture  1  3/7372 (0.04%)  3 7/7344 (0.10%)  7
Wound  1  1/7372 (0.01%)  1 1/7344 (0.01%)  1
Wound dehiscence  1  1/7372 (0.01%)  1 2/7344 (0.03%)  2
Wound evisceration  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Wrist fracture  1  2/7372 (0.03%)  3 3/7344 (0.04%)  3
Investigations     
Anticoagulation drug level increased  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Blood calcitonin increased  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Blood potassium decreased  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Eosinophil count increased  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Hiv test positive  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
International normalised ratio abnormal  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
International normalised ratio increased  1  1/7372 (0.01%)  1 3/7344 (0.04%)  3
Weight decreased  1  1/7372 (0.01%)  1 1/7344 (0.01%)  1
Metabolism and nutrition disorders     
Acidosis  1  1/7372 (0.01%)  1 1/7344 (0.01%)  1
Dehydration  1  8/7372 (0.11%)  8 10/7344 (0.14%)  10
Electrolyte imbalance  1  5/7372 (0.07%)  6 2/7344 (0.03%)  2
Fluid overload  1  2/7372 (0.03%)  2 1/7344 (0.01%)  1
Hypercalcaemia  1  1/7372 (0.01%)  1 1/7344 (0.01%)  1
Hyperkalaemia  1  2/7372 (0.03%)  2 5/7344 (0.07%)  5
Hypernatraemia  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Hypocalcaemia  1  1/7372 (0.01%)  3 0/7344 (0.00%)  0
Hypokalaemia  1  2/7372 (0.03%)  2 2/7344 (0.03%)  2
Hypomagnesaemia  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Hyponatraemia  1  2/7372 (0.03%)  2 8/7344 (0.11%)  9
Hypovolaemia  1  1/7372 (0.01%)  1 1/7344 (0.01%)  1
Lactic acidosis  1  1/7372 (0.01%)  1 1/7344 (0.01%)  1
Lactose intolerance  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Obesity  1  9/7372 (0.12%)  10 1/7344 (0.01%)  1
Musculoskeletal and connective tissue disorders     
Ankylosing spondylitis  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Arthralgia  1  9/7372 (0.12%)  10 5/7344 (0.07%)  5
Arthritis  1  3/7372 (0.04%)  3 6/7344 (0.08%)  6
Arthrofibrosis  1  1/7372 (0.01%)  1 1/7344 (0.01%)  1
Arthropathy  1  1/7372 (0.01%)  1 1/7344 (0.01%)  1
Articular calcification  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Back pain  1  12/7372 (0.16%)  14 14/7344 (0.19%)  15
Bursitis  1  0/7372 (0.00%)  0 2/7344 (0.03%)  2
Cervical spinal stenosis  1  1/7372 (0.01%)  1 3/7344 (0.04%)  3
Chest wall haematoma  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Chondrocalcinosis pyrophosphate  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Costochondritis  1  3/7372 (0.04%)  3 0/7344 (0.00%)  0
Crystal arthropathy  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Deformity thorax  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Dupuytren's contracture  1  0/7372 (0.00%)  0 3/7344 (0.04%)  3
Exostosis  1  1/7372 (0.01%)  1 1/7344 (0.01%)  1
Foot deformity  1  1/7372 (0.01%)  1 2/7344 (0.03%)  2
Fracture nonunion  1  1/7372 (0.01%)  1 1/7344 (0.01%)  1
Haemarthrosis  1  2/7372 (0.03%)  3 1/7344 (0.01%)  1
Intervertebral disc compression  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Intervertebral disc degeneration  1  4/7372 (0.05%)  4 3/7344 (0.04%)  3
Intervertebral disc disorder  1  4/7372 (0.05%)  5 5/7344 (0.07%)  5
Intervertebral disc protrusion  1  17/7372 (0.23%)  19 15/7344 (0.20%)  18
Intervertebral disc space narrowing  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Joint adhesion  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Joint effusion  1  2/7372 (0.03%)  2 0/7344 (0.00%)  0
Joint instability  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Lumbar spinal stenosis  1  20/7372 (0.27%)  21 12/7344 (0.16%)  13
Meniscal degeneration  1  0/7372 (0.00%)  0 1/7344 (0.01%)  2
Monarthritis  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Muscle spasms  1  2/7372 (0.03%)  2 0/7344 (0.00%)  0
Muscular weakness  1  2/7372 (0.03%)  2 1/7344 (0.01%)  1
Musculoskeletal chest pain  1  5/7372 (0.07%)  6 10/7344 (0.14%)  13
Musculoskeletal deformity  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Musculoskeletal pain  1  6/7372 (0.08%)  6 2/7344 (0.03%)  2
Myopathy  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Myositis  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Neck pain  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Neuropathic arthropathy  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Osteoarthritis  1  79/7372 (1.07%)  89 69/7344 (0.94%)  76
Osteochondritis  1  2/7372 (0.03%)  2 0/7344 (0.00%)  0
Osteochondrosis  1  2/7372 (0.03%)  2 1/7344 (0.01%)  1
Osteonecrosis  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Pain in extremity  1  4/7372 (0.05%)  4 1/7344 (0.01%)  1
Pathological fracture  1  1/7372 (0.01%)  1 2/7344 (0.03%)  2
Periarthritis  1  1/7372 (0.01%)  1 1/7344 (0.01%)  1
Periostitis  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Polyarthritis  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Polymyalgia rheumatica  1  2/7372 (0.03%)  2 1/7344 (0.01%)  1
Psoriatic arthropathy  1  1/7372 (0.01%)  1 1/7344 (0.01%)  1
Rhabdomyolysis  1  0/7372 (0.00%)  0 3/7344 (0.04%)  3
Rheumatic disorder  1  2/7372 (0.03%)  2 0/7344 (0.00%)  0
Rheumatoid arthritis  1  1/7372 (0.01%)  1 2/7344 (0.03%)  2
Rotator cuff syndrome  1  9/7372 (0.12%)  9 5/7344 (0.07%)  5
Sacroiliitis  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Spinal column stenosis  1  10/7372 (0.14%)  10 4/7344 (0.05%)  4
Spinal disorder  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Spinal osteoarthritis  1  9/7372 (0.12%)  10 11/7344 (0.15%)  13
Spinal pain  1  3/7372 (0.04%)  3 3/7344 (0.04%)  3
Spondyloarthropathy  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Spondylolisthesis  1  6/7372 (0.08%)  6 2/7344 (0.03%)  2
Synovial cyst  1  2/7372 (0.03%)  2 1/7344 (0.01%)  1
Synovitis  1  1/7372 (0.01%)  1 1/7344 (0.01%)  1
Tendon pain  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Tendonitis  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Vertebral foraminal stenosis  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Vertebral osteophyte  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Acth-producing pituitary tumour  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Acute myeloid leukaemia  1  4/7372 (0.05%)  4 1/7344 (0.01%)  1
Adenocarcinoma  1  3/7372 (0.04%)  3 1/7344 (0.01%)  1
Adenocarcinoma gastric  1  3/7372 (0.04%)  3 0/7344 (0.00%)  0
Adenocarcinoma of appendix  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Adenocarcinoma of colon  1  9/7372 (0.12%)  9 12/7344 (0.16%)  12
Adenoma benign  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Adrenal adenoma  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Adrenal neoplasm  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Anal cancer  1  1/7372 (0.01%)  1 2/7344 (0.03%)  2
Angiosarcoma  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Appendix cancer  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
B-cell lymphoma  1  3/7372 (0.04%)  3 2/7344 (0.03%)  2
Basal cell carcinoma  1  25/7372 (0.34%)  33 25/7344 (0.34%)  42
Basosquamous carcinoma  1  0/7372 (0.00%)  0 2/7344 (0.03%)  2
Benign gastric neoplasm  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Benign laryngeal neoplasm  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Benign lung neoplasm  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Benign neoplasm of bladder  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Benign neoplasm of thyroid gland  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Benign oesophageal neoplasm  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Benign ovarian tumour  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Benign salivary gland neoplasm  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Benign small intestinal neoplasm  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Bile duct cancer  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Bladder cancer  1  7/7372 (0.09%)  8 9/7344 (0.12%)  9
Bladder cancer recurrent  1  0/7372 (0.00%)  0 3/7344 (0.04%)  6
Bladder cancer stage 0, with cancer in situ  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Bladder neoplasm  1  2/7372 (0.03%)  2 3/7344 (0.04%)  3
Bladder papilloma  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Bladder transitional cell carcinoma  1  5/7372 (0.07%)  5 4/7344 (0.05%)  4
Bladder transitional cell carcinoma recurrent  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Bone cancer  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Bowen's disease  1  2/7372 (0.03%)  2 4/7344 (0.05%)  4
Brain neoplasm  1  2/7372 (0.03%)  2 0/7344 (0.00%)  0
Brain neoplasm malignant  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Breast cancer  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Breast cancer female  1  14/7372 (0.19%)  14 16/7344 (0.22%)  16
Breast cancer male  1  1/7372 (0.01%)  1 1/7344 (0.01%)  1
Breast cancer metastatic  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Breast neoplasm  1  0/7372 (0.00%)  0 3/7344 (0.04%)  3
Bronchial carcinoma  1  3/7372 (0.04%)  3 2/7344 (0.03%)  2
Cancer pain  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Carotid body tumour  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Cerebral haemangioma  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Cervix carcinoma  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Cervix carcinoma recurrent  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Cholangiocarcinoma  1  2/7372 (0.03%)  2 1/7344 (0.01%)  1
Choroid melanoma  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Chronic lymphocytic leukaemia  1  3/7372 (0.04%)  3 3/7344 (0.04%)  3
Chronic myeloid leukaemia  1  1/7372 (0.01%)  1 1/7344 (0.01%)  1
Clear cell endometrial carcinoma  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Clear cell renal cell carcinoma  1  0/7372 (0.00%)  0 2/7344 (0.03%)  2
Colon adenoma  1  4/7372 (0.05%)  4 3/7344 (0.04%)  3
Colon cancer  1  9/7372 (0.12%)  9 16/7344 (0.22%)  16
Colon cancer metastatic  1  2/7372 (0.03%)  2 5/7344 (0.07%)  5
Colon cancer stage i  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Colon neoplasm  1  1/7372 (0.01%)  1 2/7344 (0.03%)  2
Colorectal adenocarcinoma  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Colorectal cancer  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Desmoplastic melanoma  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Diffuse large b-cell lymphoma  1  0/7372 (0.00%)  0 3/7344 (0.04%)  3
Ear neoplasm  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Endometrial adenocarcinoma  1  1/7372 (0.01%)  1 5/7344 (0.07%)  5
Endometrial adenoma  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Endometrial cancer  1  2/7372 (0.03%)  2 4/7344 (0.05%)  4
Epithelioid mesothelioma  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Essential thrombocythaemia  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Extradural neoplasm  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Fibroma  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Fibrosarcoma  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Gallbladder cancer  1  0/7372 (0.00%)  0 3/7344 (0.04%)  3
Gastric adenoma  1  1/7372 (0.01%)  1 1/7344 (0.01%)  1
Gastric cancer  1  3/7372 (0.04%)  3 5/7344 (0.07%)  5
Gastric neoplasm  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Gastrointestinal carcinoma  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Gastrointestinal stromal tumour  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Gastrointestinal submucosal tumour  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Glioblastoma  1  1/7372 (0.01%)  1 2/7344 (0.03%)  2
Glioblastoma multiforme  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Haemangioblastoma  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Haemangioma  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Hairy cell leukaemia  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Hepatic adenoma  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Hepatic cancer  1  6/7372 (0.08%)  6 2/7344 (0.03%)  2
Hepatic cancer metastatic  1  3/7372 (0.04%)  3 1/7344 (0.01%)  1
Hepatocellular carcinoma  1  5/7372 (0.07%)  5 4/7344 (0.05%)  4
Hodgkin's disease  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Intraductal proliferative breast lesion  1  2/7372 (0.03%)  2 0/7344 (0.00%)  0
Invasive ductal breast carcinoma  1  1/7372 (0.01%)  1 4/7344 (0.05%)  4
Laryngeal cancer  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Laryngeal squamous cell carcinoma  1  2/7372 (0.03%)  2 1/7344 (0.01%)  1
Leukaemia  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Lip neoplasm  1  0/7372 (0.00%)  0 1/7344 (0.01%)  2
Lip squamous cell carcinoma  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Lipoma  1  3/7372 (0.04%)  3 4/7344 (0.05%)  4
Lung adenocarcinoma  1  4/7372 (0.05%)  4 1/7344 (0.01%)  2
Lung adenocarcinoma metastatic  1  0/7372 (0.00%)  0 3/7344 (0.04%)  4
Lung cancer metastatic  1  6/7372 (0.08%)  6 6/7344 (0.08%)  6
Lung carcinoma cell type unspecified stage iv  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Lung neoplasm  1  2/7372 (0.03%)  2 0/7344 (0.00%)  0
Lung neoplasm malignant  1  12/7372 (0.16%)  12 12/7344 (0.16%)  12
Lung squamous cell carcinoma metastatic  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Lymphoma  1  1/7372 (0.01%)  1 1/7344 (0.01%)  1
Malignant anorectal neoplasm  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Malignant ascites  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Malignant melanoma  1  7/7372 (0.09%)  8 8/7344 (0.11%)  8
Malignant melanoma in situ  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Malignant neoplasm of unknown primary site  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Malignant neoplasm progression  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Malignant pleural effusion  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Mantle cell lymphoma  1  1/7372 (0.01%)  1 2/7344 (0.03%)  2
Melanocytic naevus  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Meningioma  1  1/7372 (0.01%)  1 1/7344 (0.01%)  1
Mesothelioma  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Mesothelioma malignant  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Metastases to adrenals  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Metastases to bone  1  1/7372 (0.01%)  1 1/7344 (0.01%)  1
Metastases to central nervous system  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Metastases to liver  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Metastases to lymph nodes  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Metastasis  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Metastatic neoplasm  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Metastatic renal cell carcinoma  1  3/7372 (0.04%)  3 0/7344 (0.00%)  0
Metastatic uterine cancer  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Myelodysplastic syndrome  1  0/7372 (0.00%)  0 3/7344 (0.04%)  3
Myeloid leukaemia  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Myeloproliferative neoplasm  1  2/7372 (0.03%)  2 2/7344 (0.03%)  2
Nasal sinus cancer  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Neoplasm malignant  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Neoplasm prostate  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Neuroendocrine carcinoma  1  0/7372 (0.00%)  0 3/7344 (0.04%)  3
Neuroendocrine carcinoma of the skin  1  1/7372 (0.01%)  1 1/7344 (0.01%)  1
Neuroendocrine tumour  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Non-hodgkin's lymphoma  1  3/7372 (0.04%)  3 2/7344 (0.03%)  2
Non-small cell lung cancer  1  2/7372 (0.03%)  2 3/7344 (0.04%)  3
Non-small cell lung cancer metastatic  1  2/7372 (0.03%)  2 0/7344 (0.00%)  0
Non-small cell lung cancer stage iv  1  1/7372 (0.01%)  1 1/7344 (0.01%)  1
Oesophageal adenocarcinoma  1  2/7372 (0.03%)  2 1/7344 (0.01%)  1
Oesophageal cancer metastatic  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Oesophageal carcinoma  1  3/7372 (0.04%)  3 2/7344 (0.03%)  2
Oropharyngeal cancer  1  1/7372 (0.01%)  1 1/7344 (0.01%)  1
Oropharyngeal squamous cell carcinoma  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Ovarian adenoma  1  0/7372 (0.00%)  0 2/7344 (0.03%)  2
Ovarian cancer  1  2/7372 (0.03%)  2 3/7344 (0.04%)  3
Ovarian neoplasm  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Pancreatic carcinoma  1  15/7372 (0.20%)  15 15/7344 (0.20%)  15
Pancreatic neuroendocrine tumour  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Papillary cystadenoma lymphomatosum  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Papillary thyroid cancer  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Paraproteinaemia  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Parathyroid tumour benign  1  1/7372 (0.01%)  1 1/7344 (0.01%)  1
Penile cancer  1  1/7372 (0.01%)  1 1/7344 (0.01%)  1
Peripheral t-cell lymphoma unspecified  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Pituitary tumour benign  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Plasma cell myeloma  1  5/7372 (0.07%)  5 5/7344 (0.07%)  5
Prostate cancer  1  26/7372 (0.35%)  26 20/7344 (0.27%)  20
Prostate cancer metastatic  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Prostate cancer recurrent  1  2/7372 (0.03%)  3 2/7344 (0.03%)  2
Prostate cancer stage i  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Rectal adenocarcinoma  1  4/7372 (0.05%)  4 2/7344 (0.03%)  2
Rectal adenoma  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Rectal cancer  1  1/7372 (0.01%)  1 4/7344 (0.05%)  4
Rectal cancer metastatic  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Rectal neoplasm  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Rectosigmoid cancer  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Renal cancer  1  7/7372 (0.09%)  7 5/7344 (0.07%)  5
Renal cell carcinoma  1  3/7372 (0.04%)  3 4/7344 (0.05%)  4
Renal neoplasm  1  2/7372 (0.03%)  2 3/7344 (0.04%)  3
Renal oncocytoma  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Respiratory papilloma  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Retinal melanoma  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Salivary gland cancer  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Seborrhoeic keratosis  1  0/7372 (0.00%)  0 2/7344 (0.03%)  2
Sinonasal papilloma  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Skin cancer  1  3/7372 (0.04%)  3 1/7344 (0.01%)  1
Small cell lung cancer  1  2/7372 (0.03%)  2 3/7344 (0.04%)  3
Small intestine carcinoma  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Spinal meningioma benign  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Squamous cell carcinoma  1  13/7372 (0.18%)  16 12/7344 (0.16%)  15
Squamous cell carcinoma of head and neck  1  0/7372 (0.00%)  0 3/7344 (0.04%)  3
Squamous cell carcinoma of lung  1  3/7372 (0.04%)  3 4/7344 (0.05%)  4
Squamous cell carcinoma of skin  1  8/7372 (0.11%)  8 7/7344 (0.10%)  8
Squamous cell carcinoma of the hypopharynx  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Squamous cell carcinoma of the oral cavity  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Squamous cell carcinoma of the tongue  1  3/7372 (0.04%)  3 1/7344 (0.01%)  1
Thyroid cancer  1  7/7372 (0.09%)  7 14/7344 (0.19%)  14
Tongue neoplasm malignant stage unspecified  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Tonsil cancer metastatic  1  1/7372 (0.01%)  1 1/7344 (0.01%)  1
Transitional cell carcinoma  1  7/7372 (0.09%)  7 5/7344 (0.07%)  5
Transitional cell carcinoma urethra  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Uterine cancer  1  3/7372 (0.04%)  3 3/7344 (0.04%)  3
Uterine leiomyoma  1  2/7372 (0.03%)  2 3/7344 (0.04%)  3
Vulval cancer  1  2/7372 (0.03%)  2 0/7344 (0.00%)  0
Xanthogranuloma  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Nervous system disorders     
Altered state of consciousness  1  2/7372 (0.03%)  2 1/7344 (0.01%)  1
Amputation stump pain  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Asterixis  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Ataxia  1  2/7372 (0.03%)  2 0/7344 (0.00%)  0
Autonomic neuropathy  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Brain injury  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Carpal tunnel syndrome  1  4/7372 (0.05%)  5 5/7344 (0.07%)  5
Cauda equina syndrome  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Cerebellar haemorrhage  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Cerebellar syndrome  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Cerebral haemorrhage  1  5/7372 (0.07%)  5 1/7344 (0.01%)  1
Cerebrospinal fluid leakage  1  2/7372 (0.03%)  2 0/7344 (0.00%)  0
Cervical myelopathy  1  1/7372 (0.01%)  1 1/7344 (0.01%)  1
Cervical radiculopathy  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Cervicobrachial syndrome  1  3/7372 (0.04%)  3 0/7344 (0.00%)  0
Cervicogenic headache  1  1/7372 (0.01%)  1 1/7344 (0.01%)  1
Cognitive disorder  1  2/7372 (0.03%)  2 0/7344 (0.00%)  0
Coma  1  1/7372 (0.01%)  1 1/7344 (0.01%)  1
Coordination abnormal  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Dementia  1  2/7372 (0.03%)  2 2/7344 (0.03%)  2
Dementia alzheimer's type  1  0/7372 (0.00%)  0 3/7344 (0.04%)  3
Demyelinating polyneuropathy  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Dizziness  1  9/7372 (0.12%)  9 5/7344 (0.07%)  6
Encephalopathy  1  4/7372 (0.05%)  5 4/7344 (0.05%)  4
Epilepsy  1  2/7372 (0.03%)  2 5/7344 (0.07%)  5
Facial paralysis  1  6/7372 (0.08%)  6 4/7344 (0.05%)  4
Facial paresis  1  1/7372 (0.01%)  1 1/7344 (0.01%)  1
Frontotemporal dementia  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Generalised tonic-clonic seizure  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Guillain-barre syndrome  1  0/7372 (0.00%)  0 2/7344 (0.03%)  2
Haemorrhage intracranial  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Headache  1  3/7372 (0.04%)  4 2/7344 (0.03%)  2
Hepatic encephalopathy  1  3/7372 (0.04%)  5 4/7344 (0.05%)  5
Hydrocephalus  1  1/7372 (0.01%)  1 1/7344 (0.01%)  1
Hypoaesthesia  1  2/7372 (0.03%)  2 0/7344 (0.00%)  0
Hypotonia  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Iiird nerve paralysis  1  0/7372 (0.00%)  0 3/7344 (0.04%)  3
Idiopathic generalised epilepsy  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Intracranial aneurysm  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Intracranial pressure increased  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Loss of consciousness  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Lumbar radiculopathy  1  1/7372 (0.01%)  1 3/7344 (0.04%)  3
Lumbosacral radiculopathy  1  1/7372 (0.01%)  1 2/7344 (0.03%)  2
Memory impairment  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Metabolic encephalopathy  1  2/7372 (0.03%)  2 2/7344 (0.03%)  2
Migraine  1  2/7372 (0.03%)  2 6/7344 (0.08%)  6
Mixed dementia  1  1/7372 (0.01%)  1 1/7344 (0.01%)  1
Multiple sclerosis  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Myasthenia gravis  1  0/7372 (0.00%)  0 3/7344 (0.04%)  3
Myelitis transverse  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Nerve compression  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Nerve root compression  1  1/7372 (0.01%)  1 1/7344 (0.01%)  1
Neuralgia  1  0/7372 (0.00%)  0 2/7344 (0.03%)  2
Neuralgic amyotrophy  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Neuritis  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Neurodegenerative disorder  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Neuropathy peripheral  1  2/7372 (0.03%)  2 2/7344 (0.03%)  2
Normal pressure hydrocephalus  1  2/7372 (0.03%)  2 1/7344 (0.01%)  1
Paraesthesia  1  0/7372 (0.00%)  0 2/7344 (0.03%)  2
Parkinsonism  1  0/7372 (0.00%)  0 2/7344 (0.03%)  2
Partial seizures  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Peripheral sensory neuropathy  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Post herpetic neuralgia  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Post stroke seizure  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Radicular syndrome  1  1/7372 (0.01%)  1 1/7344 (0.01%)  1
Restless legs syndrome  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Sciatica  1  1/7372 (0.01%)  1 4/7344 (0.05%)  4
Seizure  1  10/7372 (0.14%)  10 6/7344 (0.08%)  7
Senile dementia  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Spinal claudication  1  1/7372 (0.01%)  1 1/7344 (0.01%)  1
Spinal cord compression  1  2/7372 (0.03%)  2 1/7344 (0.01%)  1
Spondylitic myelopathy  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Status epilepticus  1  3/7372 (0.04%)  3 0/7344 (0.00%)  0
Subacute combined cord degeneration  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Subarachnoid haemorrhage  1  2/7372 (0.03%)  2 2/7344 (0.03%)  2
Subdural hygroma  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Toxic encephalopathy  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Trigeminal neuralgia  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Vith nerve paralysis  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Vascular dementia  1  2/7372 (0.03%)  2 1/7344 (0.01%)  1
Vascular headache  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Vertebrobasilar insufficiency  1  4/7372 (0.05%)  5 2/7344 (0.03%)  2
Pregnancy, puerperium and perinatal conditions     
Cephalhaematoma  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Cephalo-pelvic disproportion  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Pre-eclampsia  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Product Issues     
Device battery issue  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Device dislocation  1  1/7372 (0.01%)  1 3/7344 (0.04%)  3
Device failure  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Device loosening  1  3/7372 (0.04%)  3 3/7344 (0.04%)  3
Device malfunction  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Device occlusion  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Patient-device incompatibility  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Psychiatric disorders     
Alcohol abuse  1  2/7372 (0.03%)  3 0/7344 (0.00%)  0
Alcohol withdrawal syndrome  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Alcoholism  1  3/7372 (0.04%)  3 0/7344 (0.00%)  0
Anxiety  1  2/7372 (0.03%)  2 0/7344 (0.00%)  0
Bipolar disorder  1  2/7372 (0.03%)  2 0/7344 (0.00%)  0
Confusional state  1  1/7372 (0.01%)  1 3/7344 (0.04%)  3
Delirium  1  1/7372 (0.01%)  1 1/7344 (0.01%)  1
Depressed mood  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Depression  1  14/7372 (0.19%)  15 6/7344 (0.08%)  7
Depression suicidal  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Major depression  1  2/7372 (0.03%)  2 3/7344 (0.04%)  3
Mental status changes  1  0/7372 (0.00%)  0 7/7344 (0.10%)  7
Personality change due to a general medical condition  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Post-traumatic stress disorder  1  0/7372 (0.00%)  0 1/7344 (0.01%)  1
Psychogenic seizure  1  1/7372 (0.01%)  1 0/7344 (0.00%)  0
Psychotic disorder  1  1/7372 (0.01%)  2 1/7344 (0.01%)  1
Suicidal ideation  1  1/7372 (0.01%)  2 2/7344 (0.03%)  2