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RELY-ABLE Long Term Multi-center Extension of Dabigatran Treatment in Patients With Atrial Fibrillation Who Completed RE-LY Trial

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: NCT00808067
Recruitment Status : Completed
First Posted : December 15, 2008
Results First Posted : April 8, 2014
Last Update Posted : June 9, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double;   Primary Purpose: Treatment
Condition Atrial Fibrillation
Interventions Drug: dabigatran dose 1
Drug: dabigatran dose 2
Enrollment 5897
Recruitment Details  
Pre-assignment Details A total of 5897 subjects were enrolled (rolled over from RE-LY trial), and 5891 were entered in this study. There were 8 subjects not treated; therefore 5883 subjects comprise the 'started' treatment group.
Arm/Group Title Dabigatran 110 mg Dabigatran 150 mg
Hide Arm/Group Description Dabigatran etexilate 110 mg twice daily Dabigatran etexilate 150 mg twice daily
Period Title: Overall Study
Started 2927 [1] 2956 [1]
Completed 2446 2438
Not Completed 481 518
Reason Not Completed
Major/minor bleed             30             44
Outcome event - other             33             25
Adverse Event             111             121
Hospitalization (not including surgery)             18             17
Hospitalization due to surgery             37             40
Reduced creatinine clearance             53             55
Elevated LFT results             7             3
Patient refused to take study medication             65             76
Missing             1             0
Death             1             1
Procedure             6             7
Withdrawal by Subject             21             25
Site closed             4             3
Physician Decision             47             38
Protocol Violation             3             11
Patient elected             7             9
Site closed for cause             19             19
Other reason not defined above             5             5
Excluded from analysis             13             19
[1]
Number of patients which are treated.
Arm/Group Title Dabigatran 110 mg Dabigatran 150 mg Total
Hide Arm/Group Description Dabigatran etexilate 110 mg twice daily Dabigatran etexilate 150 mg twice daily Total of all reporting groups
Overall Number of Baseline Participants 2914 2937 5851
Hide Baseline Analysis Population Description
SAF - Safety set; included all treated subjects, but excluded subjects from sites 1059 and 0246.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 2914 participants 2937 participants 5851 participants
73.1  (8.4) 73.1  (8.4) 73.1  (8.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2914 participants 2937 participants 5851 participants
Female
1000
  34.3%
1026
  34.9%
2026
  34.6%
Male
1914
  65.7%
1911
  65.1%
3825
  65.4%
1.Primary Outcome
Title Major Bleeding, Annualized Rate of Subjects With Major Bleeds
Hide Description

Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.

Major bleeding must have satisfied one or more of the following criteria:

  • Bleeding associated with a reduction in hemoglobin of at least 20 g/L
  • Required transfusion of at least 2 units of blood or packed cells
  • Symptomatic bleeding in a critical area or organ: intraocular, intraspinal, intramuscular with compartment syndrome, retroperitoneal, intra-articular, pericardial, gastrointestinal

Major bleed were classified as life-threatening if they met one or more of the following criteria:

  • Reduction in hemoglobin of at least 50 g/L
  • Transfusion of at least 4 units of blood or packed cells
  • Symptomatic intracranial bleeding, either subdural or intracerebral
  • Associated with hypotension requiring use of intravenous inotropic agents
  • Required surgical intervention to stop bleeding
  • Resulted in death
Time Frame up to 43 months
Hide Outcome Measure Data
Hide Analysis Population Description
SAF-FAS interval
Arm/Group Title Dabigatran 110 mg Dabigatran 150 mg
Hide Arm/Group Description:
Dabigatran etexilate 110 mg twice daily
Dabigatran etexilate 150 mg twice daily
Overall Number of Participants Analyzed 2914 2937
Measure Type: Number
Unit of Measure: percentage of subject-years
2.79 3.59
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dabigatran 110 mg, Dabigatran 150 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0055
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.77
Confidence Interval (2-Sided) 95%
0.64 to 0.93
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Stroke, Annualized Rate of Subjects With Stroke
Hide Description

Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.

Stroke was an acute onset of a focal neurological deficit of presumed vascular origin lasting for 24 hours or more or resulting in death. The stroke was categorized as ischemic or hemorrhagic or cause unknown based on computerized tomography (CT), magnetic resonance (MR) scanning or autopsy. Fatal stroke was defined as death from any cause within 30 days of stroke. Severity of stroke was assessed by modified Rankin score at discharge from hospital
Time Frame up to 43 months
Hide Outcome Measure Data
Hide Analysis Population Description
SAF-FAS interval
Arm/Group Title Dabigatran 110 mg Dabigatran 150 mg
Hide Arm/Group Description:
Dabigatran etexilate 110 mg twice daily
Dabigatran etexilate 150 mg twice daily
Overall Number of Participants Analyzed 2914 2937
Measure Type: Number
Unit of Measure: percentage of subject-years
1.39 1.26
3.Secondary Outcome
Title Non CNS Systemic Embolism (SEE), Annualized Rate of Subjects With Non-CNS SEE
Hide Description

Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.

Systemic embolism was an acute vascular occlusion of the extremities or any organ (kidneys, mesenteric arteries, spleen, retina or grafts), and was to be documented by angiography, surgery, scintigraphy, or autopsy.
Time Frame up to 43 months
Hide Outcome Measure Data
Hide Analysis Population Description
SAF-FAS interval
Arm/Group Title Dabigatran 110 mg Dabigatran 150 mg
Hide Arm/Group Description:
Dabigatran etexilate 110 mg twice daily
Dabigatran etexilate 150 mg twice daily
Overall Number of Participants Analyzed 2914 2937
Measure Type: Number
Unit of Measure: percentage of subject-years
0.25 0.23
4.Secondary Outcome
Title Pulmonary Embolism (PE), Annualized Rate of Subjects With PE
Hide Description

Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.

Pulmonary Embolism was generally documented by one of the following:

  1. an intraluminal filling defect in segmental or more proximal branches on spiral CT scan
  2. an intraluminal filling defect or an extension of an existing defect or a sudden cutoff of vessels more than 2.5 mm in diameter on the pulmonary angiogram
  3. a perfusion defect of at least 75% of a segment with a local normal ventilation result (high-probability) on ventilation/perfusion lung scan (VPLS)
  4. inconclusive spiral CT, pulmonary angiography or lung scintigraphy with demonstration of DVT in the lower extremities by compression ultrasound or venography.
Time Frame up to 43 months
Hide Outcome Measure Data
Hide Analysis Population Description
SAF-FAS interval
Arm/Group Title Dabigatran 110 mg Dabigatran 150 mg
Hide Arm/Group Description:
Dabigatran etexilate 110 mg twice daily
Dabigatran etexilate 150 mg twice daily
Overall Number of Participants Analyzed 2914 2937
Measure Type: Number
Unit of Measure: percentage of subject-years
0.10 0.12
5.Secondary Outcome
Title Acute Myocardial Infarction (MI), Annualized Rate of Subjects With MI
Hide Description

Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.

a. In subjects not undergoing PCI or CABG a subject should have fulfilled at least 2 of the following: i. Typical prolonged severe chest pain or related symptoms or signs suggestive of MI. ii. Elevation of troponin or CK-MB to more than upper level of normal (ULN) or, if CK-MB was elevated at baseline, re-elevation to more than 50% increase above the previous level. iii. Development of significant Q-waves in at least 2 adjacent ECG leads. b. After percutaneous coronary intervention (within 24h). c. After coronary artery bypass grafting (within 72h). d. Silent myocardial infarction. e. Myocardial infarction could also have been demonstrated at autopsy.
Time Frame up to 43 months
Hide Outcome Measure Data
Hide Analysis Population Description
SAF-FAS interval
Arm/Group Title Dabigatran 110 mg Dabigatran 150 mg
Hide Arm/Group Description:
Dabigatran etexilate 110 mg twice daily
Dabigatran etexilate 150 mg twice daily
Overall Number of Participants Analyzed 2914 2937
Measure Type: Number
Unit of Measure: percentage of subject-years
0.72 0.66
6.Secondary Outcome
Title Deep Vein Thrombosis, Annualized Rate of Subjects With DVT
Hide Description

Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.

Deep Vein Thrombosis (DVT) was generally documented by one of the following:

  1. abnormal compression ultrasound (CUS),
  2. an intraluminal filling defect on venography.
Time Frame up to 43 months
Hide Outcome Measure Data
Hide Analysis Population Description
SAF-FAS interval
Arm/Group Title Dabigatran 110 mg Dabigatran 150 mg
Hide Arm/Group Description:
Dabigatran etexilate 110 mg twice daily
Dabigatran etexilate 150 mg twice daily
Overall Number of Participants Analyzed 2914 2937
Measure Type: Number
Unit of Measure: percentage of subject-years
0.06 0.11
7.Secondary Outcome
Title Death, Annualized Rate of Subject Death
Hide Description

Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.

Deaths were classified as being vascular (sudden/arrhythmic, pump failure death, or other vascular, including bleeding) or non-vascular, due to other specified causes (e.g., malignancy), or of unknown etiology.
Time Frame up to 43 months
Hide Outcome Measure Data
Hide Analysis Population Description
SAF-FAS interval
Arm/Group Title Dabigatran 110 mg Dabigatran 150 mg
Hide Arm/Group Description:
Dabigatran etexilate 110 mg twice daily
Dabigatran etexilate 150 mg twice daily
Overall Number of Participants Analyzed 2914 2937
Measure Type: Number
Unit of Measure: percentage of subject-years
3.18 2.99
8.Secondary Outcome
Title Annualized Rate of Subjects With Composite Incidence of Stroke, Non CNS Systemic Embolism (SEE)
Hide Description Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.
Time Frame up to 43 months
Hide Outcome Measure Data
Hide Analysis Population Description
SAF-FAS interval
Arm/Group Title Dabigatran 110 mg Dabigatran 150 mg
Hide Arm/Group Description:
Dabigatran etexilate 110 mg twice daily
Dabigatran etexilate 150 mg twice daily
Overall Number of Participants Analyzed 2914 2937
Measure Type: Number
Unit of Measure: percentage of subject-years
1.60 1.47
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dabigatran 110 mg, Dabigatran 150 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5119
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.09
Confidence Interval (2-Sided) 95%
0.84 to 1.42
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Annualized Rate of Subjects With Composite Incidence of Stroke, Non CNS Systemic Embolism (SEE) and All Cause Death
Hide Description Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.
Time Frame up to 43 months
Hide Outcome Measure Data
Hide Analysis Population Description
SAF-FAS interval
Arm/Group Title Dabigatran 110 mg Dabigatran 150 mg
Hide Arm/Group Description:
Dabigatran etexilate 110 mg twice daily
Dabigatran etexilate 150 mg twice daily
Overall Number of Participants Analyzed 2914 2937
Measure Type: Number
Unit of Measure: percentage of subject-years
4.40 4.02
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dabigatran 110 mg, Dabigatran 150 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2371
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.10
Confidence Interval (2-Sided) 95%
0.94 to 1.29
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Annualized Rate of Subjects With Composite Incidence of Stroke, Non CNS Systemic Embolism (SEE), Pulmonary Embolism (PE), Myocardial Infarction, Vascular Death
Hide Description Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.
Time Frame up to 43 months
Hide Outcome Measure Data
Hide Analysis Population Description
SAF-FAS interval
Arm/Group Title Dabigatran 110 mg Dabigatran 150 mg
Hide Arm/Group Description:
Dabigatran etexilate 110 mg twice daily
Dabigatran etexilate 150 mg twice daily
Overall Number of Participants Analyzed 2914 2937
Measure Type: Number
Unit of Measure: percentage of subject-years
3.51 3.32
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dabigatran 110 mg, Dabigatran 150 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5052
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%
0.89 to 1.27
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Annualized Rate of Subjects With Composite Incidence of Stroke, Non CNS Systemic Embolism (SEE), Pulmonary Embolism (PE), Myocardial Infarction (MI), All Cause Death and Major Bleed
Hide Description Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.
Time Frame up to 43 months
Hide Outcome Measure Data
Hide Analysis Population Description
SAF-FAS interval
Arm/Group Title Dabigatran 110 mg Dabigatran 150 mg
Hide Arm/Group Description:
Dabigatran etexilate 110 mg twice daily
Dabigatran etexilate 150 mg twice daily
Overall Number of Participants Analyzed 2914 2937
Measure Type: Number
Unit of Measure: percentage of subject-years
6.65 7.14
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dabigatran 110 mg, Dabigatran 150 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2241
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.93
Confidence Interval 95%
0.82 to 1.05
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Annualized Rate of Subjects With Minor Bleeds
Hide Description

Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.

Minor bleeds were clinical bleeds that did not fulfill the criteria for major bleeds. Minor bleeds were classified as associated with study medication discontinuation (temporary or permanent) or not.
Time Frame up to 43 months
Hide Outcome Measure Data
Hide Analysis Population Description
SAF-FAS interval
Arm/Group Title Dabigatran 110 mg Dabigatran 150 mg
Hide Arm/Group Description:
Dabigatran etexilate 110 mg twice daily
Dabigatran etexilate 150 mg twice daily
Overall Number of Participants Analyzed 2914 2937
Measure Type: Number
Unit of Measure: percentage of subject-years
7.49 8.98
13.Secondary Outcome
Title Annualized Rate of Subjects With Any Bleeds (Major Plus Minor)
Hide Description Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.
Time Frame up to 43 months
Hide Outcome Measure Data
Hide Analysis Population Description
SAF-FAS interval
Arm/Group Title Dabigatran 110 mg Dabigatran 150 mg
Hide Arm/Group Description:
Dabigatran etexilate 110 mg twice daily
Dabigatran etexilate 150 mg twice daily
Overall Number of Participants Analyzed 2914 2937
Measure Type: Number
Unit of Measure: percentage of subject-years
9.44 11.20
14.Secondary Outcome
Title Annualized Rate of Subjects With Intra-Cranial Hemorrhage (ICH)
Hide Description Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.
Time Frame up to 43 months
Hide Outcome Measure Data
Hide Analysis Population Description
SAF-FAS interval
Arm/Group Title Dabigatran 110 mg Dabigatran 150 mg
Hide Arm/Group Description:
Dabigatran etexilate 110 mg twice daily
Dabigatran etexilate 150 mg twice daily
Overall Number of Participants Analyzed 2914 2937
Measure Type: Number
Unit of Measure: percentage of subject-years
0.28 0.33
Time Frame Up to 43 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Dabigatran 110 mg Dabigatran 150 mg
Hide Arm/Group Description Dabigatran etexilate 110 mg twice daily Dabigatran etexilate 150 mg twice daily
All-Cause Mortality
Dabigatran 110 mg Dabigatran 150 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Dabigatran 110 mg Dabigatran 150 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   1028/2914 (35.28%)   1106/2937 (37.66%) 
Blood and lymphatic system disorders     
Anaemia † 1  23/2914 (0.79%)  36/2937 (1.23%) 
Coagulopathy † 1  1/2914 (0.03%)  2/2937 (0.07%) 
Disseminated intravascular coagulation † 1  2/2914 (0.07%)  0/2937 (0.00%) 
Haemolytic anaemia † 1  1/2914 (0.03%)  1/2937 (0.03%) 
Haemorrhagic anaemia † 1  1/2914 (0.03%)  4/2937 (0.14%) 
Heparin-induced thrombocytopenia † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Iron deficiency anaemia † 1  4/2914 (0.14%)  1/2937 (0.03%) 
Leukopenia † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Lymphadenopathy † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Microcytic anaemia † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Neutropenia † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Polycythaemia † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Thrombocytopenia † 1  5/2914 (0.17%)  5/2937 (0.17%) 
Cardiac disorders     
Acute coronary syndrome † 1  2/2914 (0.07%)  6/2937 (0.20%) 
Acute left ventricular failure † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Acute myocardial infarction † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Angina pectoris † 1  34/2914 (1.17%)  36/2937 (1.23%) 
Angina unstable † 1  2/2914 (0.07%)  13/2937 (0.44%) 
Aortic valve stenosis † 1  1/2914 (0.03%)  1/2937 (0.03%) 
Arrhythmia † 1  5/2914 (0.17%)  4/2937 (0.14%) 
Arteriosclerosis coronary artery † 1  1/2914 (0.03%)  2/2937 (0.07%) 
Atrial fibrillation † 1  84/2914 (2.88%)  95/2937 (3.23%) 
Atrial flutter † 1  4/2914 (0.14%)  6/2937 (0.20%) 
Atrial tachycardia † 1  1/2914 (0.03%)  1/2937 (0.03%) 
Atrial thrombosis † 1  1/2914 (0.03%)  2/2937 (0.07%) 
Atrioventricular block † 1  1/2914 (0.03%)  1/2937 (0.03%) 
Atrioventricular block complete † 1  2/2914 (0.07%)  4/2937 (0.14%) 
Bradyarrhythmia † 1  3/2914 (0.10%)  6/2937 (0.20%) 
Bradycardia † 1  19/2914 (0.65%)  23/2937 (0.78%) 
Cardiac arrest † 1  7/2914 (0.24%)  9/2937 (0.31%) 
Cardiac failure † 1  70/2914 (2.40%)  87/2937 (2.96%) 
Cardiac failure acute † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Cardiac failure chronic † 1  3/2914 (0.10%)  3/2937 (0.10%) 
Cardiac failure congestive † 1  68/2914 (2.33%)  71/2937 (2.42%) 
Cardiac valve disease † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Cardio-respiratory arrest † 1  2/2914 (0.07%)  2/2937 (0.07%) 
Cardiogenic shock † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Cardiomyopathy † 1  0/2914 (0.00%)  2/2937 (0.07%) 
Chronotropic incompetence † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Coronary artery disease † 1  14/2914 (0.48%)  12/2937 (0.41%) 
Coronary artery occlusion † 1  0/2914 (0.00%)  2/2937 (0.07%) 
Coronary artery stenosis † 1  0/2914 (0.00%)  2/2937 (0.07%) 
Dressler's syndrome † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Left ventricular dysfunction † 1  0/2914 (0.00%)  3/2937 (0.10%) 
Left ventricular failure † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Mitral valve incompetence † 1  7/2914 (0.24%)  5/2937 (0.17%) 
Mitral valve stenosis † 1  2/2914 (0.07%)  0/2937 (0.00%) 
Myocardial infarction † 1  3/2914 (0.10%)  2/2937 (0.07%) 
Myocardial ischaemia † 1  3/2914 (0.10%)  1/2937 (0.03%) 
Palpitations † 1  4/2914 (0.14%)  5/2937 (0.17%) 
Pericardial effusion † 1  3/2914 (0.10%)  0/2937 (0.00%) 
Pericarditis † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Right ventricular failure † 1  1/2914 (0.03%)  2/2937 (0.07%) 
Sick sinus syndrome † 1  13/2914 (0.45%)  10/2937 (0.34%) 
Sinus arrest † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Sinus bradycardia † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Sinus tachycardia † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Tachycardia † 1  2/2914 (0.07%)  5/2937 (0.17%) 
Tricuspid valve incompetence † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Ventricular arrhythmia † 1  7/2914 (0.24%)  8/2937 (0.27%) 
Ventricular fibrillation † 1  4/2914 (0.14%)  6/2937 (0.20%) 
Ventricular tachycardia † 1  7/2914 (0.24%)  6/2937 (0.20%) 
Ear and labyrinth disorders     
Deafness † 1  0/2914 (0.00%)  2/2937 (0.07%) 
Hearing impaired † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Vertigo † 1  6/2914 (0.21%)  4/2937 (0.14%) 
Vertigo positional † 1  2/2914 (0.07%)  0/2937 (0.00%) 
Endocrine disorders     
Addison's disease † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Goitre † 1  1/2914 (0.03%)  1/2937 (0.03%) 
Hyperparathyroidism † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Hyperthyroidism † 1  2/2914 (0.07%)  0/2937 (0.00%) 
Eye disorders     
Amaurosis fugax † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Blepharochalasis † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Blindness † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Cataract † 1  8/2914 (0.27%)  10/2937 (0.34%) 
Diplopia † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Eye haemorrhage † 1  0/2914 (0.00%)  2/2937 (0.07%) 
Glaucoma † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Macular pseudohole † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Optic ischaemic neuropathy † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Retinal detachment † 1  2/2914 (0.07%)  0/2937 (0.00%) 
Retinal haemorrhage † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Retinal vein occlusion † 1  1/2914 (0.03%)  1/2937 (0.03%) 
Scotoma † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Ulcerative keratitis † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Visual impairment † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Gastrointestinal disorders     
Abdominal distension † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Abdominal hernia † 1  1/2914 (0.03%)  1/2937 (0.03%) 
Abdominal mass † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Abdominal pain † 1  29/2914 (1.00%)  27/2937 (0.92%) 
Abdominal pain upper † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Anal fistula † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Ascites † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Colitis † 1  1/2914 (0.03%)  2/2937 (0.07%) 
Colitis ischaemic † 1  1/2914 (0.03%)  1/2937 (0.03%) 
Colonic obstruction † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Colonic polyp † 1  11/2914 (0.38%)  4/2937 (0.14%) 
Constipation † 1  2/2914 (0.07%)  1/2937 (0.03%) 
Dental caries † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Diarrhoea † 1  8/2914 (0.27%)  3/2937 (0.10%) 
Diverticulum † 1  0/2914 (0.00%)  3/2937 (0.10%) 
Diverticulum intestinal † 1  1/2914 (0.03%)  2/2937 (0.07%) 
Diverticulum intestinal haemorrhagic † 1  0/2914 (0.00%)  3/2937 (0.10%) 
Duodenal polyp † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Duodenal ulcer † 1  4/2914 (0.14%)  4/2937 (0.14%) 
Duodenal ulcer haemorrhage † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Duodenal ulcer perforation † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Dyspepsia † 1  7/2914 (0.24%)  12/2937 (0.41%) 
Dysphagia † 1  3/2914 (0.10%)  1/2937 (0.03%) 
Enterocolitis † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Gastric haemorrhage † 1  1/2914 (0.03%)  2/2937 (0.07%) 
Gastric ulcer † 1  8/2914 (0.27%)  5/2937 (0.17%) 
Gastric ulcer perforation † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Gastritis † 1  8/2914 (0.27%)  7/2937 (0.24%) 
Gastritis erosive † 1  0/2914 (0.00%)  2/2937 (0.07%) 
Gastritis haemorrhagic † 1  0/2914 (0.00%)  4/2937 (0.14%) 
Gastrointestinal haemorrhage † 1  20/2914 (0.69%)  20/2937 (0.68%) 
Gastrointestinal mucosal disorder † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Gingival bleeding † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Haematemesis † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Haematochezia † 1  3/2914 (0.10%)  1/2937 (0.03%) 
Haemorrhoidal haemorrhage † 1  1/2914 (0.03%)  2/2937 (0.07%) 
Hiatus hernia † 1  0/2914 (0.00%)  2/2937 (0.07%) 
Ileus † 1  6/2914 (0.21%)  7/2937 (0.24%) 
Inguinal hernia † 1  13/2914 (0.45%)  7/2937 (0.24%) 
Inguinal hernia, obstructive † 1  1/2914 (0.03%)  1/2937 (0.03%) 
Intestinal haemorrhage † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Intestinal ischaemia † 1  2/2914 (0.07%)  3/2937 (0.10%) 
Intestinal obstruction † 1  8/2914 (0.27%)  2/2937 (0.07%) 
Large intestinal obstruction † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Large intestinal ulcer † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Lower gastrointestinal haemorrhage † 1  1/2914 (0.03%)  6/2937 (0.20%) 
Melaena † 1  6/2914 (0.21%)  5/2937 (0.17%) 
Mesenteric artery stenosis † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Nausea † 1  3/2914 (0.10%)  1/2937 (0.03%) 
Obstruction gastric † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Odynophagia † 1  0/2914 (0.00%)  2/2937 (0.07%) 
Oesophageal achalasia † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Oesophageal obstruction † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Oesophageal rupture † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Oesophageal stenosis † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Oesophageal ulcer † 1  0/2914 (0.00%)  3/2937 (0.10%) 
Oesophagitis † 1  0/2914 (0.00%)  2/2937 (0.07%) 
Pancreatic cyst † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Pancreatitis † 1  1/2914 (0.03%)  4/2937 (0.14%) 
Pancreatitis acute † 1  1/2914 (0.03%)  1/2937 (0.03%) 
Peritoneal haemorrhage † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Rectal haemorrhage † 1  5/2914 (0.17%)  5/2937 (0.17%) 
Rectal prolapse † 1  1/2914 (0.03%)  1/2937 (0.03%) 
Salivary hypersecretion † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Small intestinal obstruction † 1  5/2914 (0.17%)  6/2937 (0.20%) 
Subileus † 1  1/2914 (0.03%)  1/2937 (0.03%) 
Upper gastrointestinal haemorrhage † 1  4/2914 (0.14%)  5/2937 (0.17%) 
Vomiting † 1  6/2914 (0.21%)  6/2937 (0.20%) 
General disorders     
Adverse drug reaction † 1  1/2914 (0.03%)  1/2937 (0.03%) 
Asthenia † 1  7/2914 (0.24%)  10/2937 (0.34%) 
Chest discomfort † 1  2/2914 (0.07%)  1/2937 (0.03%) 
Chest pain † 1  35/2914 (1.20%)  47/2937 (1.60%) 
Death † 1  1/2914 (0.03%)  1/2937 (0.03%) 
Device breakage † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Device dislocation † 1  3/2914 (0.10%)  1/2937 (0.03%) 
Device malfunction † 1  1/2914 (0.03%)  1/2937 (0.03%) 
Drug ineffective † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Fatigue † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Gait disturbance † 1  2/2914 (0.07%)  0/2937 (0.00%) 
General physical health deterioration † 1  1/2914 (0.03%)  3/2937 (0.10%) 
Generalised oedema † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Hernia † 1  6/2914 (0.21%)  4/2937 (0.14%) 
Hernia obstructive † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Impaired healing † 1  2/2914 (0.07%)  1/2937 (0.03%) 
Malaise † 1  1/2914 (0.03%)  1/2937 (0.03%) 
Medical device complication † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Multi-organ disorder † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Multi-organ failure † 1  3/2914 (0.10%)  2/2937 (0.07%) 
Necrosis † 1  1/2914 (0.03%)  1/2937 (0.03%) 
Non-cardiac chest pain † 1  5/2914 (0.17%)  3/2937 (0.10%) 
Oedema † 1  0/2914 (0.00%)  2/2937 (0.07%) 
Oedema peripheral † 1  5/2914 (0.17%)  4/2937 (0.14%) 
Pain † 1  1/2914 (0.03%)  1/2937 (0.03%) 
Pyrexia † 1  3/2914 (0.10%)  4/2937 (0.14%) 
Stent-graft endoleak † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Sudden cardiac death † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Sudden death † 1  0/2914 (0.00%)  2/2937 (0.07%) 
Hepatobiliary disorders     
Bile duct obstruction † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Bile duct stone † 1  4/2914 (0.14%)  1/2937 (0.03%) 
Biliary colic † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Cholangitis † 1  4/2914 (0.14%)  1/2937 (0.03%) 
Cholangitis acute † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Cholecystitis † 1  10/2914 (0.34%)  7/2937 (0.24%) 
Cholecystitis acute † 1  4/2914 (0.14%)  0/2937 (0.00%) 
Cholelithiasis † 1  10/2914 (0.34%)  4/2937 (0.14%) 
Hepatic cirrhosis † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Hepatic failure † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Hepatic function abnormal † 1  2/2914 (0.07%)  1/2937 (0.03%) 
Hepatitis toxic † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Hepatomegaly † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Hepatorenal syndrome † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Jaundice cholestatic † 1  1/2914 (0.03%)  1/2937 (0.03%) 
Immune system disorders     
Anaphylactic reaction † 1  1/2914 (0.03%)  1/2937 (0.03%) 
Anaphylactic shock † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Infections and infestations     
Abscess † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Abscess limb † 1  1/2914 (0.03%)  2/2937 (0.07%) 
Abscess neck † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Anal abscess † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Appendicitis † 1  3/2914 (0.10%)  3/2937 (0.10%) 
Arthritis bacterial † 1  2/2914 (0.07%)  1/2937 (0.03%) 
Arthritis infective † 1  0/2914 (0.00%)  2/2937 (0.07%) 
Atypical pneumonia † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Bacteraemia † 1  4/2914 (0.14%)  1/2937 (0.03%) 
Brain abscess † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Bronchitis † 1  11/2914 (0.38%)  8/2937 (0.27%) 
Bronchitis viral † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Bronchopneumonia † 1  2/2914 (0.07%)  1/2937 (0.03%) 
Cellulitis † 1  25/2914 (0.86%)  25/2937 (0.85%) 
Cellulitis staphylococcal † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Cholecystitis infective † 1  2/2914 (0.07%)  1/2937 (0.03%) 
Chronic sinusitis † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Clostridial infection † 1  3/2914 (0.10%)  0/2937 (0.00%) 
Clostridium difficile colitis † 1  0/2914 (0.00%)  2/2937 (0.07%) 
Corneal abscess † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Cystitis † 1  2/2914 (0.07%)  1/2937 (0.03%) 
Dengue fever † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Device related infection † 1  0/2914 (0.00%)  3/2937 (0.10%) 
Diabetic foot infection † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Diverticulitis † 1  1/2914 (0.03%)  6/2937 (0.20%) 
Ear infection † 1  1/2914 (0.03%)  1/2937 (0.03%) 
Endocarditis † 1  5/2914 (0.17%)  1/2937 (0.03%) 
Endocarditis bacterial † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Enterococcal sepsis † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Erysipelas † 1  7/2914 (0.24%)  6/2937 (0.20%) 
Escherichia sepsis † 1  1/2914 (0.03%)  1/2937 (0.03%) 
Escherichia urinary tract infection † 1  0/2914 (0.00%)  2/2937 (0.07%) 
Eye infection † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Fungal infection † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Gangrene † 1  2/2914 (0.07%)  2/2937 (0.07%) 
Gastric ulcer helicobacter † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Gastroenteritis † 1  3/2914 (0.10%)  4/2937 (0.14%) 
Gastroenteritis cryptosporidial † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Gastroenteritis viral † 1  0/2914 (0.00%)  2/2937 (0.07%) 
Gastrointestinal infection † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Groin abscess † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Groin infection † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Herpes ophthalmic † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Herpes zoster † 1  1/2914 (0.03%)  4/2937 (0.14%) 
Herpes zoster ophthalmic † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Herpes zoster oticus † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Implant site infection † 1  2/2914 (0.07%)  1/2937 (0.03%) 
Infected bites † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Infected cyst † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Infected skin ulcer † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Infection † 1  5/2914 (0.17%)  5/2937 (0.17%) 
Infective exacerbation of chronic obstructive airways disease † 1  1/2914 (0.03%)  1/2937 (0.03%) 
Influenza † 1  1/2914 (0.03%)  2/2937 (0.07%) 
Klebsiella sepsis † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Labyrinthitis † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Liver abscess † 1  2/2914 (0.07%)  0/2937 (0.00%) 
Lobar pneumonia † 1  3/2914 (0.10%)  3/2937 (0.10%) 
Localised infection † 1  4/2914 (0.14%)  5/2937 (0.17%) 
Lower respiratory tract infection † 1  2/2914 (0.07%)  2/2937 (0.07%) 
Lung infection † 1  0/2914 (0.00%)  2/2937 (0.07%) 
Nasopharyngitis † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Neuroborreliosis † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Oesophageal candidiasis † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Oesophageal infection † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Oral candidiasis † 1  0/2914 (0.00%)  2/2937 (0.07%) 
Osteomyelitis † 1  2/2914 (0.07%)  4/2937 (0.14%) 
Otitis externa † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Pancreatic abscess † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Parotitis † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Peritonitis † 1  1/2914 (0.03%)  1/2937 (0.03%) 
Peritonitis bacterial † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Peritonsillar abscess † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Pharyngeal abscess † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Pharyngolaryngeal abscess † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Pneumonia † 1  91/2914 (3.12%)  99/2937 (3.37%) 
Pneumonia bacterial † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Pneumonia legionella † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Pneumonia pneumococcal † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Post procedural infection † 1  3/2914 (0.10%)  2/2937 (0.07%) 
Postoperative wound infection † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Pyelonephritis † 1  1/2914 (0.03%)  3/2937 (0.10%) 
Pyelonephritis acute † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Respiratory tract infection † 1  5/2914 (0.17%)  3/2937 (0.10%) 
Sepsis † 1  19/2914 (0.65%)  23/2937 (0.78%) 
Septic shock † 1  2/2914 (0.07%)  1/2937 (0.03%) 
Sinusitis † 1  1/2914 (0.03%)  1/2937 (0.03%) 
Skin infection † 1  2/2914 (0.07%)  1/2937 (0.03%) 
Staphylococcal bacteraemia † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Staphylococcal sepsis † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Staphylococcal skin infection † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Streptococcal bacteraemia † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Tuberculosis † 1  0/2914 (0.00%)  2/2937 (0.07%) 
Upper respiratory tract infection † 1  5/2914 (0.17%)  5/2937 (0.17%) 
Urethritis chlamydial † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Urinary tract infection † 1  21/2914 (0.72%)  29/2937 (0.99%) 
Urinary tract infection bacterial † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Urinary tract infection pseudomonal † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Urinary tract infection staphylococcal † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Urosepsis † 1  3/2914 (0.10%)  2/2937 (0.07%) 
Viral infection † 1  1/2914 (0.03%)  3/2937 (0.10%) 
Vulvovaginal candidiasis † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Wound infection † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Injury, poisoning and procedural complications     
Alcohol poisoning † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Anaemia postoperative † 1  0/2914 (0.00%)  2/2937 (0.07%) 
Ankle fracture † 1  3/2914 (0.10%)  8/2937 (0.27%) 
Arterial injury † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Arthropod sting † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Carbon monoxide poisoning † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Cartilage injury † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Cervical vertebral fracture † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Comminuted fracture † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Concussion † 1  1/2914 (0.03%)  1/2937 (0.03%) 
Contusion † 1  3/2914 (0.10%)  2/2937 (0.07%) 
Craniocerebral injury † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Deafness traumatic † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Facial bones fracture † 1  1/2914 (0.03%)  1/2937 (0.03%) 
Fall † 1  26/2914 (0.89%)  31/2937 (1.06%) 
Fat embolism † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Femoral neck fracture † 1  4/2914 (0.14%)  9/2937 (0.31%) 
Femur fracture † 1  10/2914 (0.34%)  6/2937 (0.20%) 
Fibula fracture † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Fracture † 1  3/2914 (0.10%)  1/2937 (0.03%) 
Hand fracture † 1  1/2914 (0.03%)  1/2937 (0.03%) 
Head injury † 1  1/2914 (0.03%)  2/2937 (0.07%) 
Hip fracture † 1  11/2914 (0.38%)  11/2937 (0.37%) 
Humerus fracture † 1  2/2914 (0.07%)  1/2937 (0.03%) 
Iatrogenic injury † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Incision site haemorrhage † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Incisional hernia † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Jaw fracture † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Joint dislocation † 1  1/2914 (0.03%)  2/2937 (0.07%) 
Joint injury † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Laceration † 1  1/2914 (0.03%)  2/2937 (0.07%) 
Limb injury † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Lower limb fracture † 1  0/2914 (0.00%)  2/2937 (0.07%) 
Lumbar vertebral fracture † 1  3/2914 (0.10%)  3/2937 (0.10%) 
Meniscus lesion † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Multiple fractures † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Muscle rupture † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Open wound † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Overdose † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Pelvic fracture † 1  4/2914 (0.14%)  2/2937 (0.07%) 
Post procedural haemorrhage † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Procedural hypertension † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Pubis fracture † 1  1/2914 (0.03%)  3/2937 (0.10%) 
Radius fracture † 1  1/2914 (0.03%)  3/2937 (0.10%) 
Rib fracture † 1  3/2914 (0.10%)  3/2937 (0.10%) 
Road traffic accident † 1  2/2914 (0.07%)  4/2937 (0.14%) 
Skin injury † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Skull fracture † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Snake bite † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Soft tissue injury † 1  2/2914 (0.07%)  0/2937 (0.00%) 
Spinal compression fracture † 1  5/2914 (0.17%)  5/2937 (0.17%) 
Sternal fracture † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Subdural haematoma † 1  5/2914 (0.17%)  4/2937 (0.14%) 
Subdural haemorrhage † 1  2/2914 (0.07%)  2/2937 (0.07%) 
Tendon injury † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Tendon rupture † 1  1/2914 (0.03%)  1/2937 (0.03%) 
Tibia fracture † 1  2/2914 (0.07%)  3/2937 (0.10%) 
Toxicity to various agents † 1  5/2914 (0.17%)  1/2937 (0.03%) 
Traumatic arthritis † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Traumatic fracture † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Traumatic haematoma † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Ulna fracture † 1  0/2914 (0.00%)  3/2937 (0.10%) 
Upper limb fracture † 1  1/2914 (0.03%)  3/2937 (0.10%) 
Vascular pseudoaneurysm † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Wound dehiscence † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Wound necrosis † 1  3/2914 (0.10%)  0/2937 (0.00%) 
Wrist fracture † 1  2/2914 (0.07%)  2/2937 (0.07%) 
Investigations     
Blood glucagon abnormal † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Blood glucose increased † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Creatinine renal clearance decreased † 1  2/2914 (0.07%)  2/2937 (0.07%) 
Haemoglobin decreased † 1  5/2914 (0.17%)  0/2937 (0.00%) 
Heart rate decreased † 1  2/2914 (0.07%)  0/2937 (0.00%) 
Heart rate irregular † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Hepatic enzyme increased † 1  3/2914 (0.10%)  1/2937 (0.03%) 
International normalised ratio increased † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Liver function test abnormal † 1  2/2914 (0.07%)  2/2937 (0.07%) 
Platelet count decreased † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Troponin I increased † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Weight decreased † 1  2/2914 (0.07%)  2/2937 (0.07%) 
Metabolism and nutrition disorders     
Dehydration † 1  11/2914 (0.38%)  20/2937 (0.68%) 
Diabetes mellitus † 1  0/2914 (0.00%)  2/2937 (0.07%) 
Diabetes mellitus inadequate control † 1  3/2914 (0.10%)  2/2937 (0.07%) 
Diabetic complication † 1  0/2914 (0.00%)  2/2937 (0.07%) 
Diabetic ketoacidosis † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Electrolyte imbalance † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Failure to thrive † 1  0/2914 (0.00%)  2/2937 (0.07%) 
Fluid overload † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Gout † 1  4/2914 (0.14%)  6/2937 (0.20%) 
Haemochromatosis † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Hyperglycaemia † 1  2/2914 (0.07%)  2/2937 (0.07%) 
Hyperkalaemia † 1  4/2914 (0.14%)  1/2937 (0.03%) 
Hypoglycaemia † 1  4/2914 (0.14%)  3/2937 (0.10%) 
Hypokalaemia † 1  3/2914 (0.10%)  1/2937 (0.03%) 
Hypomagnesaemia † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Hyponatraemia † 1  8/2914 (0.27%)  8/2937 (0.27%) 
Lactic acidosis † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Malnutrition † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Metabolic acidosis † 1  1/2914 (0.03%)  2/2937 (0.07%) 
Type 1 diabetes mellitus † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Type 2 diabetes mellitus † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Vitamin B12 deficiency † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia † 1  9/2914 (0.31%)  7/2937 (0.24%) 
Arthritis † 1  7/2914 (0.24%)  5/2937 (0.17%) 
Arthropathy † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Back pain † 1  9/2914 (0.31%)  15/2937 (0.51%) 
Bursitis † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Cervical spinal stenosis † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Chondrocalcinosis pyrophosphate † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Crystal arthropathy † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Dupuytren's contracture † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Flank pain † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Foot deformity † 1  1/2914 (0.03%)  2/2937 (0.07%) 
Intervertebral disc degeneration † 1  1/2914 (0.03%)  1/2937 (0.03%) 
Intervertebral disc protrusion † 1  2/2914 (0.07%)  4/2937 (0.14%) 
Jaw cyst † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Joint swelling † 1  0/2914 (0.00%)  3/2937 (0.10%) 
Lumbar spinal stenosis † 1  0/2914 (0.00%)  8/2937 (0.27%) 
Muscular weakness † 1  0/2914 (0.00%)  2/2937 (0.07%) 
Musculoskeletal chest pain † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Musculoskeletal pain † 1  2/2914 (0.07%)  3/2937 (0.10%) 
Neck pain † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Osteoarthritis † 1  28/2914 (0.96%)  36/2937 (1.23%) 
Pain in extremity † 1  4/2914 (0.14%)  2/2937 (0.07%) 
Polyarthritis † 1  1/2914 (0.03%)  1/2937 (0.03%) 
Polymyalgia rheumatica † 1  2/2914 (0.07%)  0/2937 (0.00%) 
Pseudarthrosis † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Rhabdomyolysis † 1  1/2914 (0.03%)  3/2937 (0.10%) 
Rheumatoid arthritis † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Rotator cuff syndrome † 1  2/2914 (0.07%)  2/2937 (0.07%) 
Spinal column stenosis † 1  1/2914 (0.03%)  1/2937 (0.03%) 
Spinal osteoarthritis † 1  1/2914 (0.03%)  2/2937 (0.07%) 
Spondylolisthesis † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Synovitis † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Acute leukaemia † 1  1/2914 (0.03%)  1/2937 (0.03%) 
Adenoma benign † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Adrenal adenoma † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Angiosarcoma † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Basal cell carcinoma † 1  3/2914 (0.10%)  2/2937 (0.07%) 
Benign neoplasm of skin † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Bile duct cancer † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Bladder cancer † 1  8/2914 (0.27%)  9/2937 (0.31%) 
Bladder neoplasm † 1  1/2914 (0.03%)  1/2937 (0.03%) 
Bladder transitional cell carcinoma † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Bone neoplasm malignant † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Bone sarcoma † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Brain neoplasm † 1  1/2914 (0.03%)  1/2937 (0.03%) 
Brain neoplasm malignant † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Breast cancer † 1  8/2914 (0.27%)  9/2937 (0.31%) 
Breast cancer metastatic † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Bronchial carcinoma † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Carcinoid tumour † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Cervix carcinoma † 1  1/2914 (0.03%)  1/2937 (0.03%) 
Choroid melanoma † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Chronic lymphocytic leukaemia † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Colon adenoma † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Colon cancer † 1  13/2914 (0.45%)  6/2937 (0.20%) 
Colon cancer recurrent † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Colon cancer stage 0 † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Endometrial cancer † 1  1/2914 (0.03%)  1/2937 (0.03%) 
Gallbladder cancer † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Gastric cancer † 1  4/2914 (0.14%)  3/2937 (0.10%) 
Gastric neoplasm † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Gastrointestinal carcinoma † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Gastrointestinal tract adenoma † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Gastrooesophageal cancer † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Glioblastoma † 1  0/2914 (0.00%)  2/2937 (0.07%) 
Hepatic cancer metastatic † 1  2/2914 (0.07%)  0/2937 (0.00%) 
Hepatic neoplasm † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Hepatic neoplasm malignant † 1  2/2914 (0.07%)  2/2937 (0.07%) 
Hodgkin's disease † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Keratoacanthoma † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Langerhans' cell histiocytosis † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Large cell carcinoma of the respiratory tract stage unspecified † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Laryngeal cancer recurrent † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Lipoma † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Liposarcoma † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Lung adenocarcinoma † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Lung cancer metastatic † 1  3/2914 (0.10%)  0/2937 (0.00%) 
Lung carcinoma cell type unspecified recurrent † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Lung neoplasm † 1  0/2914 (0.00%)  2/2937 (0.07%) 
Lung neoplasm malignant † 1  16/2914 (0.55%)  5/2937 (0.17%) 
Lymphoma † 1  0/2914 (0.00%)  4/2937 (0.14%) 
Malignant melanoma † 1  0/2914 (0.00%)  5/2937 (0.17%) 
Malignant neoplasm of pleura † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Meningioma † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Metastases to bone † 1  1/2914 (0.03%)  1/2937 (0.03%) 
Metastases to central nervous system † 1  1/2914 (0.03%)  2/2937 (0.07%) 
Metastases to pelvis † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Metastatic neoplasm † 1  2/2914 (0.07%)  0/2937 (0.00%) 
Multiple myeloma † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Neoplasm malignant † 1  6/2914 (0.21%)  5/2937 (0.17%) 
Neoplasm prostate † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Neuroendocrine carcinoma † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Non-small cell lung cancer † 1  2/2914 (0.07%)  1/2937 (0.03%) 
Non-small cell lung cancer metastatic † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Oesophageal adenocarcinoma † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Oesophageal carcinoma † 1  2/2914 (0.07%)  1/2937 (0.03%) 
Ovarian cancer † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Pancreatic carcinoma † 1  1/2914 (0.03%)  4/2937 (0.14%) 
Pancreatic carcinoma metastatic † 1  2/2914 (0.07%)  2/2937 (0.07%) 
Pancreatic neoplasm † 1  3/2914 (0.10%)  0/2937 (0.00%) 
Parathyroid tumour benign † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Phaeochromocytoma † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Prostate cancer † 1  13/2914 (0.45%)  14/2937 (0.48%) 
Prostate cancer metastatic † 1  2/2914 (0.07%)  0/2937 (0.00%) 
Prostate cancer recurrent † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Rectal cancer † 1  2/2914 (0.07%)  2/2937 (0.07%) 
Rectal cancer recurrent † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Rectal neoplasm † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Renal cancer † 1  2/2914 (0.07%)  3/2937 (0.10%) 
Renal cell carcinoma † 1  0/2914 (0.00%)  3/2937 (0.10%) 
Small cell lung cancer stage unspecified † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Squamous cell carcinoma † 1  3/2914 (0.10%)  1/2937 (0.03%) 
Squamous cell carcinoma of skin † 1  4/2914 (0.14%)  2/2937 (0.07%) 
Thymoma † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Thyroid cancer † 1  2/2914 (0.07%)  2/2937 (0.07%) 
Thyroid cancer metastatic † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Tongue neoplasm malignant stage unspecified † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Transitional cell carcinoma † 1  2/2914 (0.07%)  1/2937 (0.03%) 
Ureteric cancer † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Uterine cancer † 1  1/2914 (0.03%)  1/2937 (0.03%) 
Vulval cancer † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Nervous system disorders     
Amnesia † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Aphasia † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Brachial plexopathy † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Brain stem stroke † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Carotid artery insufficiency † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Carotid artery occlusion † 1  1/2914 (0.03%)  1/2937 (0.03%) 
Carotid artery stenosis † 1  4/2914 (0.14%)  5/2937 (0.17%) 
Carotid sinus syndrome † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Carpal tunnel syndrome † 1  1/2914 (0.03%)  1/2937 (0.03%) 
Cerebellar haemorrhage † 1  2/2914 (0.07%)  0/2937 (0.00%) 
Cerebral haemorrhage † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Cerebral infarction † 1  2/2914 (0.07%)  0/2937 (0.00%) 
Cerebral ischaemia † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Cerebrovascular accident † 1  8/2914 (0.27%)  5/2937 (0.17%) 
Cervical root pain † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Chronic inflammatory demyelinating polyradiculoneuropathy † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Cognitive disorder † 1  2/2914 (0.07%)  1/2937 (0.03%) 
Coma † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Convulsion † 1  5/2914 (0.17%)  2/2937 (0.07%) 
Dementia † 1  2/2914 (0.07%)  3/2937 (0.10%) 
Dementia Alzheimer's type † 1  1/2914 (0.03%)  2/2937 (0.07%) 
Dizziness † 1  4/2914 (0.14%)  7/2937 (0.24%) 
Embolic stroke † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Encephalopathy † 1  4/2914 (0.14%)  2/2937 (0.07%) 
Epilepsy † 1  2/2914 (0.07%)  1/2937 (0.03%) 
Grand mal convulsion † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Haemorrhage intracranial † 1  2/2914 (0.07%)  1/2937 (0.03%) 
Haemorrhagic stroke † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Headache † 1  2/2914 (0.07%)  3/2937 (0.10%) 
Hemiparesis † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Hydrocephalus † 1  1/2914 (0.03%)  1/2937 (0.03%) 
Hypoaesthesia † 1  1/2914 (0.03%)  2/2937 (0.07%) 
IIIrd nerve paralysis † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Intraventricular haemorrhage † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Ischaemic stroke † 1  5/2914 (0.17%)  2/2937 (0.07%) 
Lumbar radiculopathy † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Migraine † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Myasthenia gravis † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Myelopathy † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Neuropathy peripheral † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Normal pressure hydrocephalus † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Paraesthesia † 1  3/2914 (0.10%)  0/2937 (0.00%) 
Paresis cranial nerve † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Parkinson's disease † 1  2/2914 (0.07%)  1/2937 (0.03%) 
Parkinsonism † 1  2/2914 (0.07%)  1/2937 (0.03%) 
Partial seizures † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Polyneuropathy † 1  1/2914 (0.03%)  1/2937 (0.03%) 
Presyncope † 1  1/2914 (0.03%)  4/2937 (0.14%) 
Sciatic nerve palsy † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Sciatica † 1  1/2914 (0.03%)  1/2937 (0.03%) 
Subarachnoid haemorrhage † 1  2/2914 (0.07%)  1/2937 (0.03%) 
Syncope † 1  24/2914 (0.82%)  24/2937 (0.82%) 
Transient ischaemic attack † 1  6/2914 (0.21%)  4/2937 (0.14%) 
Tremor † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Trigeminal neuralgia † 1  1/2914 (0.03%)  0/2937 (0.00%) 
VIIth nerve paralysis † 1  2/2914 (0.07%)  0/2937 (0.00%) 
Vertebrobasilar insufficiency † 1  2/2914 (0.07%)  0/2937 (0.00%) 
Vertigo CNS origin † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Psychiatric disorders     
Abnormal behaviour † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Alcohol abuse † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Alcohol withdrawal syndrome † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Anxiety † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Completed suicide † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Confusional state † 1  2/2914 (0.07%)  2/2937 (0.07%) 
Delirium † 1  3/2914 (0.10%)  2/2937 (0.07%) 
Depression † 1  1/2914 (0.03%)  5/2937 (0.17%) 
Disorientation † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Mental disorder † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Mental status changes † 1  5/2914 (0.17%)  1/2937 (0.03%) 
Panic attack † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Panic disorder † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Suicide attempt † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Renal and urinary disorders     
Bladder obstruction † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Bladder prolapse † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Dysuria † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Glomerulonephritis † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Haematuria † 1  2/2914 (0.07%)  7/2937 (0.24%) 
Hydronephrosis † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Nephrolithiasis † 1  4/2914 (0.14%)  1/2937 (0.03%) 
Nephrotic syndrome † 1  1/2914 (0.03%)  1/2937 (0.03%) 
Proteinuria † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Renal colic † 1  0/2914 (0.00%)  3/2937 (0.10%) 
Renal cyst † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Renal disorder † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Renal embolism † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Renal failure † 1  19/2914 (0.65%)  9/2937 (0.31%) 
Renal failure acute † 1  23/2914 (0.79%)  23/2937 (0.78%) 
Renal failure chronic † 1  1/2914 (0.03%)  2/2937 (0.07%) 
Renal impairment † 1  1/2914 (0.03%)  2/2937 (0.07%) 
Renal infarct † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Urethral stenosis † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Urinary retention † 1  0/2914 (0.00%)  3/2937 (0.10%) 
Reproductive system and breast disorders     
Benign prostatic hyperplasia † 1  12/2914 (0.41%)  13/2937 (0.44%) 
Ovarian cyst † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Pelvic haematoma † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Pelvic pain † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Spermatocele † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Uterine prolapse † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Vaginal haemorrhage † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Vaginal prolapse † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Acute pulmonary oedema † 1  1/2914 (0.03%)  4/2937 (0.14%) 
Acute respiratory failure † 1  4/2914 (0.14%)  0/2937 (0.00%) 
Alveolitis † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Aspiration † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Asthma † 1  4/2914 (0.14%)  4/2937 (0.14%) 
Bronchial secretion retention † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Bronchitis chronic † 1  2/2914 (0.07%)  2/2937 (0.07%) 
Chronic obstructive pulmonary disease † 1  27/2914 (0.93%)  30/2937 (1.02%) 
Dysphonia † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Dyspnoea † 1  34/2914 (1.17%)  32/2937 (1.09%) 
Dyspnoea exertional † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Epistaxis † 1  1/2914 (0.03%)  2/2937 (0.07%) 
Haemoptysis † 1  1/2914 (0.03%)  3/2937 (0.10%) 
Haemothorax † 1  2/2914 (0.07%)  3/2937 (0.10%) 
Hypercapnia † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Hypoxia † 1  1/2914 (0.03%)  2/2937 (0.07%) 
Idiopathic pulmonary fibrosis † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Laryngeal oedema † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Pleural effusion † 1  11/2914 (0.38%)  7/2937 (0.24%) 
Pleuritic pain † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Pneumonia aspiration † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Pneumothorax † 1  0/2914 (0.00%)  2/2937 (0.07%) 
Productive cough † 1  2/2914 (0.07%)  0/2937 (0.00%) 
Pulmonary congestion † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Pulmonary embolism † 1  1/2914 (0.03%)  2/2937 (0.07%) 
Pulmonary fibrosis † 1  1/2914 (0.03%)  1/2937 (0.03%) 
Pulmonary haemorrhage † 1  0/2914 (0.00%)  2/2937 (0.07%) 
Pulmonary hypertension † 1  3/2914 (0.10%)  3/2937 (0.10%) 
Pulmonary mass † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Pulmonary oedema † 1  2/2914 (0.07%)  5/2937 (0.17%) 
Respiratory distress † 1  3/2914 (0.10%)  4/2937 (0.14%) 
Respiratory failure † 1  6/2914 (0.21%)  5/2937 (0.17%) 
Sleep apnoea syndrome † 1  2/2914 (0.07%)  1/2937 (0.03%) 
Skin and subcutaneous tissue disorders     
Decubitus ulcer † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Diabetic foot † 1  2/2914 (0.07%)  1/2937 (0.03%) 
Eczema † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Pemphigoid † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Psoriasis † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Purpura † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Rash † 1  2/2914 (0.07%)  1/2937 (0.03%) 
Skin discolouration † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Skin haemorrhage † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Skin lesion † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Skin ulcer † 1  3/2914 (0.10%)  0/2937 (0.00%) 
Stasis dermatitis † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Urticaria † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Social circumstances     
Activities of daily living impaired † 1  1/2914 (0.03%)  1/2937 (0.03%) 
Surgical and medical procedures     
Dental implantation † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Lesion excision † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Tooth extraction † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Vascular disorders     
Aneurysm † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Aortic aneurysm † 1  11/2914 (0.38%)  8/2937 (0.27%) 
Aortic aneurysm rupture † 1  2/2914 (0.07%)  0/2937 (0.00%) 
Aortic dissection † 1  5/2914 (0.17%)  1/2937 (0.03%) 
Aortic intramural haematoma † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Aortic stenosis † 1  6/2914 (0.21%)  6/2937 (0.20%) 
Arteriosclerosis † 1  0/2914 (0.00%)  3/2937 (0.10%) 
Arteritis † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Blood pressure inadequately controlled † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Circulatory collapse † 1  2/2914 (0.07%)  0/2937 (0.00%) 
Deep vein thrombosis † 1  2/2914 (0.07%)  6/2937 (0.20%) 
Femoral artery aneurysm † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Femoral artery occlusion † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Haematoma † 1  2/2914 (0.07%)  3/2937 (0.10%) 
Haemorrhage † 1  4/2914 (0.14%)  5/2937 (0.17%) 
Hypertension † 1  11/2914 (0.38%)  10/2937 (0.34%) 
Hypertensive crisis † 1  1/2914 (0.03%)  1/2937 (0.03%) 
Hypotension † 1  8/2914 (0.27%)  9/2937 (0.31%) 
Intermittent claudication † 1  1/2914 (0.03%)  2/2937 (0.07%) 
Ischaemia † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Leriche syndrome † 1  1/2914 (0.03%)  1/2937 (0.03%) 
Malignant hypertension † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Orthostatic hypotension † 1  2/2914 (0.07%)  0/2937 (0.00%) 
Peripheral arterial occlusive disease † 1  4/2914 (0.14%)  2/2937 (0.07%) 
Peripheral artery aneurysm † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Peripheral artery stenosis † 1  2/2914 (0.07%)  4/2937 (0.14%) 
Peripheral artery thrombosis † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Peripheral embolism † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Peripheral ischaemia † 1  2/2914 (0.07%)  1/2937 (0.03%) 
Peripheral vascular disorder † 1  2/2914 (0.07%)  4/2937 (0.14%) 
Shock haemorrhagic † 1  0/2914 (0.00%)  1/2937 (0.03%) 
Temporal arteritis † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Thrombosis † 1  1/2914 (0.03%)  0/2937 (0.00%) 
Venous occlusion † 1  1/2914 (0.03%)  0/2937 (0.00%) 
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MEDDRA 15.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Dabigatran 110 mg Dabigatran 150 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Non-serious adverse events were not collected on subjects in this study.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim Pharmaceuticals
Phone: 1-800-243-0127
EMail: clintriage.rdg@boehringer-ingelheim.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00808067    
Other Study ID Numbers: 1160.71
2008-005248-17 ( EudraCT Number: EudraCT )
First Submitted: December 12, 2008
First Posted: December 15, 2008
Results First Submitted: December 20, 2013
Results First Posted: April 8, 2014
Last Update Posted: June 9, 2014