Time Frame |
All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.
|
Adverse Event Reporting Description |
All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor.
Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.
|
|
Arm/Group Title
|
Ticagrelor 60 mg
|
Ticagrelor Placebo
|
Arm/Group Description |
Initially ticagrelor 90 mg or corre...
|
Initially ticagrelor 90 mg or corre...
|
Arm/Group Description |
Initially ticagrelor 90 mg or corresponding placebo was the selected dose, but reduced to ticagrelor 60 mg or corresponding placebo in Clinical Study Protocol Amendment No 1.
|
Initially ticagrelor 90 mg or corresponding placebo was the selected dose, but reduced to ticagrelor 60 mg or corresponding placebo in Clinical Study Protocol Amendment No 1.
|
|
|
Ticagrelor 60 mg
|
Ticagrelor Placebo
|
|
Affected / at Risk (%) |
|
Affected / at Risk (%) |
|
Total |
589/9619 (6.12%)
|
|
602/9601 (6.27%)
|
|
|
|
Ticagrelor 60 mg
|
Ticagrelor Placebo
|
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Total |
3049/9562 (31.89%)
|
|
3210/9531 (33.68%)
|
|
Blood and lymphatic system disorders |
|
|
Abdominal lymphadenopathy |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Agranulocytosis |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Anaemia |
20/9562 (0.21%)
|
20 |
14/9531 (0.15%)
|
14 |
Anaemia macrocytic |
3/9562 (0.03%)
|
3 |
0/9531 (0.00%)
|
0 |
Anaemia of chronic disease |
2/9562 (0.02%)
|
2 |
1/9531 (0.01%)
|
1 |
Anaemia of malignant disease |
2/9562 (0.02%)
|
2 |
1/9531 (0.01%)
|
1 |
Anaemia vitamin b12 deficiency |
1/9562 (0.01%)
|
1 |
1/9531 (0.01%)
|
1 |
Deficiency anaemia |
2/9562 (0.02%)
|
2 |
1/9531 (0.01%)
|
1 |
Disseminated intravascular coagulation |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Haemorrhagic anaemia |
10/9562 (0.10%)
|
10 |
3/9531 (0.03%)
|
3 |
Hypochromic anaemia |
1/9562 (0.01%)
|
1 |
1/9531 (0.01%)
|
1 |
Immune thrombocytopenic purpura |
1/9562 (0.01%)
|
1 |
1/9531 (0.01%)
|
1 |
Increased tendency to bruise |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Iron deficiency anaemia |
26/9562 (0.27%)
|
26 |
6/9531 (0.06%)
|
6 |
Leukocytosis |
2/9562 (0.02%)
|
2 |
1/9531 (0.01%)
|
1 |
Lymphadenopathy |
1/9562 (0.01%)
|
1 |
1/9531 (0.01%)
|
1 |
Microcytic anaemia |
3/9562 (0.03%)
|
3 |
1/9531 (0.01%)
|
1 |
Nephrogenic anaemia |
1/9562 (0.01%)
|
1 |
0/9531 (0.00%)
|
0 |
Neutropenia |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Normochromic normocytic anaemia |
2/9562 (0.02%)
|
2 |
0/9531 (0.00%)
|
0 |
Normocytic anaemia |
2/9562 (0.02%)
|
3 |
1/9531 (0.01%)
|
1 |
Pancytopenia |
3/9562 (0.03%)
|
3 |
0/9531 (0.00%)
|
0 |
Splenic infarction |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Spontaneous haematoma |
3/9562 (0.03%)
|
3 |
2/9531 (0.02%)
|
2 |
Spontaneous haemorrhage |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Thrombocytopenia |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Cardiac disorders |
|
|
Acute coronary syndrome |
20/9562 (0.21%)
|
20 |
22/9531 (0.23%)
|
22 |
Acute left ventricular failure |
5/9562 (0.05%)
|
6 |
2/9531 (0.02%)
|
2 |
Acute myocardial infarction |
126/9562 (1.32%)
|
133 |
197/9531 (2.07%)
|
203 |
Adams-stokes syndrome |
2/9562 (0.02%)
|
2 |
0/9531 (0.00%)
|
0 |
Angina pectoris |
200/9562 (2.09%)
|
239 |
251/9531 (2.63%)
|
267 |
Angina unstable |
354/9562 (3.70%)
|
403 |
405/9531 (4.25%)
|
449 |
Aortic valve disease |
1/9562 (0.01%)
|
1 |
1/9531 (0.01%)
|
1 |
Aortic valve incompetence |
1/9562 (0.01%)
|
1 |
2/9531 (0.02%)
|
2 |
Aortic valve stenosis |
8/9562 (0.08%)
|
8 |
14/9531 (0.15%)
|
14 |
Arrhythmia |
0/9562 (0.00%)
|
0 |
3/9531 (0.03%)
|
5 |
Arteriosclerosis coronary artery |
9/9562 (0.09%)
|
9 |
8/9531 (0.08%)
|
8 |
Atrial fibrillation |
82/9562 (0.86%)
|
84 |
76/9531 (0.80%)
|
80 |
Atrial flutter |
12/9562 (0.13%)
|
13 |
13/9531 (0.14%)
|
14 |
Atrial tachycardia |
2/9562 (0.02%)
|
2 |
4/9531 (0.04%)
|
4 |
Atrial thrombosis |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Atrioventricular block |
2/9562 (0.02%)
|
2 |
2/9531 (0.02%)
|
2 |
Atrioventricular block complete |
16/9562 (0.17%)
|
16 |
18/9531 (0.19%)
|
18 |
Atrioventricular block first degree |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Atrioventricular block second degree |
12/9562 (0.13%)
|
12 |
6/9531 (0.06%)
|
6 |
Bifascicular block |
1/9562 (0.01%)
|
1 |
0/9531 (0.00%)
|
0 |
Bradyarrhythmia |
2/9562 (0.02%)
|
2 |
2/9531 (0.02%)
|
2 |
Bradycardia |
15/9562 (0.16%)
|
15 |
6/9531 (0.06%)
|
6 |
Bundle branch block left |
1/9562 (0.01%)
|
1 |
1/9531 (0.01%)
|
1 |
Bundle branch block right |
1/9562 (0.01%)
|
1 |
0/9531 (0.00%)
|
0 |
Cardiac arrest |
7/9562 (0.07%)
|
7 |
12/9531 (0.13%)
|
12 |
Cardiac disorder |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Cardiac failure |
64/9562 (0.67%)
|
84 |
87/9531 (0.91%)
|
108 |
Cardiac failure acute |
20/9562 (0.21%)
|
27 |
14/9531 (0.15%)
|
15 |
Cardiac failure chronic |
18/9562 (0.19%)
|
19 |
30/9531 (0.31%)
|
44 |
Cardiac failure congestive |
60/9562 (0.63%)
|
71 |
47/9531 (0.49%)
|
53 |
Cardiac tamponade |
0/9562 (0.00%)
|
0 |
2/9531 (0.02%)
|
2 |
Cardiac valve disease |
0/9562 (0.00%)
|
0 |
2/9531 (0.02%)
|
2 |
Cardiac ventricular scarring |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Cardio-respiratory arrest |
3/9562 (0.03%)
|
3 |
3/9531 (0.03%)
|
3 |
Cardiogenic shock |
6/9562 (0.06%)
|
6 |
4/9531 (0.04%)
|
4 |
Cardiomyopathy |
1/9562 (0.01%)
|
1 |
2/9531 (0.02%)
|
2 |
Cardiopulmonary failure |
1/9562 (0.01%)
|
1 |
2/9531 (0.02%)
|
2 |
Cardiovascular insufficiency |
1/9562 (0.01%)
|
1 |
0/9531 (0.00%)
|
0 |
Coronary artery disease |
85/9562 (0.89%)
|
89 |
90/9531 (0.94%)
|
95 |
Coronary artery insufficiency |
2/9562 (0.02%)
|
2 |
2/9531 (0.02%)
|
2 |
Coronary artery occlusion |
2/9562 (0.02%)
|
2 |
2/9531 (0.02%)
|
2 |
Coronary artery stenosis |
14/9562 (0.15%)
|
14 |
4/9531 (0.04%)
|
4 |
Dressler's syndrome |
1/9562 (0.01%)
|
1 |
0/9531 (0.00%)
|
0 |
Extrasystoles |
1/9562 (0.01%)
|
1 |
0/9531 (0.00%)
|
0 |
Hypertensive heart disease |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Ischaemic cardiomyopathy |
3/9562 (0.03%)
|
3 |
2/9531 (0.02%)
|
4 |
Left ventricular dysfunction |
1/9562 (0.01%)
|
1 |
1/9531 (0.01%)
|
1 |
Left ventricular failure |
7/9562 (0.07%)
|
8 |
4/9531 (0.04%)
|
4 |
Microvascular coronary artery disease |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Mitral valve incompetence |
2/9562 (0.02%)
|
2 |
3/9531 (0.03%)
|
3 |
Mitral valve stenosis |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Myocardial fibrosis |
1/9562 (0.01%)
|
1 |
0/9531 (0.00%)
|
0 |
Myocardial infarction |
41/9562 (0.43%)
|
43 |
65/9531 (0.68%)
|
66 |
Myocardial ischaemia |
36/9562 (0.38%)
|
37 |
47/9531 (0.49%)
|
50 |
Myocarditis |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Nodal arrhythmia |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Palpitations |
4/9562 (0.04%)
|
4 |
2/9531 (0.02%)
|
2 |
Pericardial effusion |
2/9562 (0.02%)
|
2 |
1/9531 (0.01%)
|
1 |
Pericardial haemorrhage |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Pericarditis |
3/9562 (0.03%)
|
3 |
0/9531 (0.00%)
|
0 |
Pericarditis constrictive |
1/9562 (0.01%)
|
1 |
1/9531 (0.01%)
|
1 |
Prinzmetal angina |
0/9562 (0.00%)
|
0 |
3/9531 (0.03%)
|
4 |
Pulmonary valve incompetence |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Right ventricular failure |
1/9562 (0.01%)
|
1 |
2/9531 (0.02%)
|
2 |
Sinoatrial block |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Sinus arrhythmia |
1/9562 (0.01%)
|
1 |
0/9531 (0.00%)
|
0 |
Sinus bradycardia |
7/9562 (0.07%)
|
7 |
4/9531 (0.04%)
|
4 |
Sinus node dysfunction |
5/9562 (0.05%)
|
5 |
4/9531 (0.04%)
|
4 |
Sinus tachycardia |
1/9562 (0.01%)
|
1 |
1/9531 (0.01%)
|
1 |
Stress cardiomyopathy |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Supraventricular extrasystoles |
3/9562 (0.03%)
|
3 |
2/9531 (0.02%)
|
2 |
Supraventricular tachycardia |
5/9562 (0.05%)
|
5 |
9/9531 (0.09%)
|
11 |
Tachycardia |
1/9562 (0.01%)
|
2 |
4/9531 (0.04%)
|
4 |
Tricuspid valve incompetence |
1/9562 (0.01%)
|
1 |
0/9531 (0.00%)
|
0 |
Ventricular arrhythmia |
1/9562 (0.01%)
|
1 |
2/9531 (0.02%)
|
2 |
Ventricular asystole |
1/9562 (0.01%)
|
1 |
0/9531 (0.00%)
|
0 |
Ventricular extrasystoles |
4/9562 (0.04%)
|
4 |
7/9531 (0.07%)
|
7 |
Ventricular fibrillation |
2/9562 (0.02%)
|
2 |
3/9531 (0.03%)
|
3 |
Ventricular tachycardia |
10/9562 (0.10%)
|
10 |
6/9531 (0.06%)
|
6 |
Congenital, familial and genetic disorders |
|
|
Corneal dystrophy |
1/9562 (0.01%)
|
1 |
0/9531 (0.00%)
|
0 |
Glucose-6-phosphate dehydrogenase deficiency |
1/9562 (0.01%)
|
1 |
0/9531 (0.00%)
|
0 |
Neurofibromatosis |
1/9562 (0.01%)
|
1 |
0/9531 (0.00%)
|
0 |
Ear and labyrinth disorders |
|
|
Deafness |
1/9562 (0.01%)
|
1 |
2/9531 (0.02%)
|
2 |
Deafness neurosensory |
0/9562 (0.00%)
|
0 |
2/9531 (0.02%)
|
2 |
Deafness unilateral |
3/9562 (0.03%)
|
3 |
0/9531 (0.00%)
|
0 |
Ear pain |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Eustachian tube dysfunction |
1/9562 (0.01%)
|
1 |
0/9531 (0.00%)
|
0 |
Hypoacusis |
1/9562 (0.01%)
|
1 |
1/9531 (0.01%)
|
1 |
Inner ear disorder |
1/9562 (0.01%)
|
1 |
0/9531 (0.00%)
|
0 |
Meniere's disease |
1/9562 (0.01%)
|
1 |
0/9531 (0.00%)
|
0 |
Sudden hearing loss |
2/9562 (0.02%)
|
2 |
1/9531 (0.01%)
|
1 |
Tinnitus |
1/9562 (0.01%)
|
1 |
0/9531 (0.00%)
|
0 |
Tympanic membrane perforation |
1/9562 (0.01%)
|
1 |
0/9531 (0.00%)
|
0 |
Tympanosclerosis |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Vertigo |
13/9562 (0.14%)
|
13 |
7/9531 (0.07%)
|
7 |
Vertigo positional |
7/9562 (0.07%)
|
7 |
3/9531 (0.03%)
|
3 |
Vestibular disorder |
2/9562 (0.02%)
|
2 |
2/9531 (0.02%)
|
2 |
Endocrine disorders |
|
|
Adrenal insufficiency |
1/9562 (0.01%)
|
1 |
0/9531 (0.00%)
|
0 |
Goitre |
5/9562 (0.05%)
|
6 |
2/9531 (0.02%)
|
2 |
Hyperparathyroidism |
1/9562 (0.01%)
|
1 |
0/9531 (0.00%)
|
0 |
Hyperparathyroidism primary |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Hyperthyroidism |
1/9562 (0.01%)
|
1 |
2/9531 (0.02%)
|
2 |
Hypothyroidism |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Thyroiditis subacute |
1/9562 (0.01%)
|
1 |
0/9531 (0.00%)
|
0 |
Eye disorders |
|
|
Age-related macular degeneration |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Aphakia |
1/9562 (0.01%)
|
1 |
0/9531 (0.00%)
|
0 |
Cataract |
22/9562 (0.23%)
|
26 |
30/9531 (0.31%)
|
35 |
Cataract cortical |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Cataract diabetic |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Cataract nuclear |
1/9562 (0.01%)
|
1 |
1/9531 (0.01%)
|
1 |
Corneal degeneration |
1/9562 (0.01%)
|
1 |
0/9531 (0.00%)
|
0 |
Diabetic retinopathy |
3/9562 (0.03%)
|
5 |
4/9531 (0.04%)
|
4 |
Entropion |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Eye haemorrhage |
4/9562 (0.04%)
|
4 |
1/9531 (0.01%)
|
1 |
Eyelid ptosis |
1/9562 (0.01%)
|
1 |
0/9531 (0.00%)
|
0 |
Glaucoma |
2/9562 (0.02%)
|
2 |
3/9531 (0.03%)
|
4 |
Lacrimal disorder |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Macular degeneration |
1/9562 (0.01%)
|
1 |
1/9531 (0.01%)
|
1 |
Macular fibrosis |
2/9562 (0.02%)
|
2 |
2/9531 (0.02%)
|
2 |
Macular oedema |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Macular pseudohole |
1/9562 (0.01%)
|
1 |
0/9531 (0.00%)
|
0 |
Maculopathy |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Open angle glaucoma |
1/9562 (0.01%)
|
1 |
0/9531 (0.00%)
|
0 |
Optic ischaemic neuropathy |
1/9562 (0.01%)
|
1 |
0/9531 (0.00%)
|
0 |
Retinal artery occlusion |
1/9562 (0.01%)
|
1 |
0/9531 (0.00%)
|
0 |
Retinal artery thrombosis |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Retinal degeneration |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Retinal detachment |
2/9562 (0.02%)
|
2 |
3/9531 (0.03%)
|
3 |
Retinal haemorrhage |
2/9562 (0.02%)
|
2 |
5/9531 (0.05%)
|
5 |
Retinal vein occlusion |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Retinal vein thrombosis |
1/9562 (0.01%)
|
1 |
0/9531 (0.00%)
|
0 |
Retinopathy |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Retinopathy proliferative |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Rhegmatogenous retinal detachment |
1/9562 (0.01%)
|
1 |
0/9531 (0.00%)
|
0 |
Strabismus |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Trichiasis |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Ulcerative keratitis |
1/9562 (0.01%)
|
1 |
0/9531 (0.00%)
|
0 |
Visual impairment |
1/9562 (0.01%)
|
1 |
1/9531 (0.01%)
|
1 |
Vitreous haemorrhage |
9/9562 (0.09%)
|
9 |
5/9531 (0.05%)
|
5 |
Vitreous opacities |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Gastrointestinal disorders |
|
|
Abdominal discomfort |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Abdominal distension |
2/9562 (0.02%)
|
4 |
0/9531 (0.00%)
|
0 |
Abdominal hernia |
2/9562 (0.02%)
|
2 |
3/9531 (0.03%)
|
3 |
Abdominal pain |
7/9562 (0.07%)
|
7 |
4/9531 (0.04%)
|
4 |
Abdominal pain lower |
1/9562 (0.01%)
|
1 |
2/9531 (0.02%)
|
2 |
Abdominal pain upper |
1/9562 (0.01%)
|
1 |
5/9531 (0.05%)
|
5 |
Abdominal wall haematoma |
1/9562 (0.01%)
|
1 |
0/9531 (0.00%)
|
0 |
Anal fissure |
0/9562 (0.00%)
|
0 |
3/9531 (0.03%)
|
3 |
Anal fistula |
1/9562 (0.01%)
|
1 |
0/9531 (0.00%)
|
0 |
Anal haemorrhage |
1/9562 (0.01%)
|
1 |
0/9531 (0.00%)
|
0 |
Anal inflammation |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Appendicitis noninfective |
1/9562 (0.01%)
|
1 |
0/9531 (0.00%)
|
0 |
Appendix disorder |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Ascites |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Barrett's oesophagus |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Bezoar |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Change of bowel habit |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Chronic gastritis |
2/9562 (0.02%)
|
2 |
4/9531 (0.04%)
|
4 |
Chronic gastrointestinal bleeding |
1/9562 (0.01%)
|
1 |
0/9531 (0.00%)
|
0 |
Coeliac disease |
1/9562 (0.01%)
|
1 |
0/9531 (0.00%)
|
0 |
Colitis |
4/9562 (0.04%)
|
4 |
5/9531 (0.05%)
|
5 |
Colitis ischaemic |
1/9562 (0.01%)
|
1 |
1/9531 (0.01%)
|
1 |
Constipation |
4/9562 (0.04%)
|
4 |
3/9531 (0.03%)
|
3 |
Dental caries |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Diabetic gastroparesis |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
2 |
Diaphragmatic hernia |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Diarrhoea |
18/9562 (0.19%)
|
18 |
8/9531 (0.08%)
|
8 |
Diverticular perforation |
1/9562 (0.01%)
|
1 |
0/9531 (0.00%)
|
0 |
Diverticulitis oesophageal |
1/9562 (0.01%)
|
1 |
0/9531 (0.00%)
|
0 |
Diverticulum |
3/9562 (0.03%)
|
3 |
2/9531 (0.02%)
|
2 |
Diverticulum intestinal |
4/9562 (0.04%)
|
4 |
4/9531 (0.04%)
|
4 |
Diverticulum intestinal haemorrhagic |
5/9562 (0.05%)
|
6 |
2/9531 (0.02%)
|
2 |
Duodenal polyp |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Duodenal ulcer |
4/9562 (0.04%)
|
4 |
3/9531 (0.03%)
|
3 |
Duodenal ulcer haemorrhage |
7/9562 (0.07%)
|
8 |
4/9531 (0.04%)
|
4 |
Duodenitis |
1/9562 (0.01%)
|
1 |
0/9531 (0.00%)
|
0 |
Dyspepsia |
3/9562 (0.03%)
|
3 |
1/9531 (0.01%)
|
1 |
Dysphagia |
2/9562 (0.02%)
|
2 |
3/9531 (0.03%)
|
3 |
Enteritis |
2/9562 (0.02%)
|
2 |
4/9531 (0.04%)
|
4 |
Enterocolitis |
1/9562 (0.01%)
|
1 |
2/9531 (0.02%)
|
2 |
Epigastric discomfort |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Erosive oesophagitis |
1/9562 (0.01%)
|
1 |
0/9531 (0.00%)
|
0 |
Faecaloma |
1/9562 (0.01%)
|
1 |
1/9531 (0.01%)
|
1 |
Faeces discoloured |
2/9562 (0.02%)
|
2 |
0/9531 (0.00%)
|
0 |
Food poisoning |
0/9562 (0.00%)
|
0 |
2/9531 (0.02%)
|
2 |
Functional gastrointestinal disorder |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Gastric antral vascular ectasia |
1/9562 (0.01%)
|
1 |
0/9531 (0.00%)
|
0 |
Gastric disorder |
1/9562 (0.01%)
|
1 |
0/9531 (0.00%)
|
0 |
Gastric haemorrhage |
6/9562 (0.06%)
|
6 |
0/9531 (0.00%)
|
0 |
Gastric polyps |
5/9562 (0.05%)
|
5 |
6/9531 (0.06%)
|
8 |
Gastric ulcer |
18/9562 (0.19%)
|
18 |
9/9531 (0.09%)
|
9 |
Gastric ulcer haemorrhage |
6/9562 (0.06%)
|
6 |
3/9531 (0.03%)
|
3 |
Gastric ulcer perforation |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Gastritis |
8/9562 (0.08%)
|
8 |
12/9531 (0.13%)
|
12 |
Gastritis erosive |
9/9562 (0.09%)
|
9 |
2/9531 (0.02%)
|
2 |
Gastritis haemorrhagic |
6/9562 (0.06%)
|
6 |
1/9531 (0.01%)
|
1 |
Gastroduodenal ulcer |
2/9562 (0.02%)
|
2 |
0/9531 (0.00%)
|
0 |
Gastrointestinal angiodysplasia |
2/9562 (0.02%)
|
2 |
1/9531 (0.01%)
|
1 |
Gastrointestinal disorder |
2/9562 (0.02%)
|
2 |
1/9531 (0.01%)
|
1 |
Gastrointestinal haemorrhage |
43/9562 (0.45%)
|
44 |
22/9531 (0.23%)
|
23 |
Gastrointestinal inflammation |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Gastrointestinal ischaemia |
1/9562 (0.01%)
|
1 |
0/9531 (0.00%)
|
0 |
Gastrointestinal motility disorder |
1/9562 (0.01%)
|
1 |
0/9531 (0.00%)
|
0 |
Gastrointestinal polyp haemorrhage |
2/9562 (0.02%)
|
2 |
1/9531 (0.01%)
|
1 |
Gastrointestinal stenosis |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Gastrointestinal ulcer haemorrhage |
3/9562 (0.03%)
|
3 |
2/9531 (0.02%)
|
2 |
Gastrooesophageal reflux disease |
5/9562 (0.05%)
|
6 |
7/9531 (0.07%)
|
7 |
Haematemesis |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Haematochezia |
4/9562 (0.04%)
|
4 |
2/9531 (0.02%)
|
2 |
Haemorrhagic erosive gastritis |
1/9562 (0.01%)
|
1 |
2/9531 (0.02%)
|
2 |
Haemorrhoidal haemorrhage |
3/9562 (0.03%)
|
3 |
0/9531 (0.00%)
|
0 |
Haemorrhoids |
5/9562 (0.05%)
|
5 |
2/9531 (0.02%)
|
2 |
Hernial eventration |
1/9562 (0.01%)
|
1 |
0/9531 (0.00%)
|
0 |
Hiatus hernia |
1/9562 (0.01%)
|
1 |
2/9531 (0.02%)
|
2 |
Ileus |
4/9562 (0.04%)
|
5 |
3/9531 (0.03%)
|
3 |
Ileus paralytic |
2/9562 (0.02%)
|
2 |
0/9531 (0.00%)
|
0 |
Incarcerated inguinal hernia |
1/9562 (0.01%)
|
1 |
2/9531 (0.02%)
|
2 |
Inguinal hernia |
16/9562 (0.17%)
|
16 |
20/9531 (0.21%)
|
20 |
Intestinal haemorrhage |
6/9562 (0.06%)
|
6 |
3/9531 (0.03%)
|
3 |
Intestinal ischaemia |
0/9562 (0.00%)
|
0 |
3/9531 (0.03%)
|
3 |
Intestinal obstruction |
4/9562 (0.04%)
|
6 |
5/9531 (0.05%)
|
5 |
Intestinal perforation |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Intestinal polyp |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Intestinal pseudo-obstruction |
1/9562 (0.01%)
|
2 |
0/9531 (0.00%)
|
0 |
Intestinal strangulation |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Large intestinal haemorrhage |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Large intestine perforation |
1/9562 (0.01%)
|
1 |
2/9531 (0.02%)
|
2 |
Large intestine polyp |
18/9562 (0.19%)
|
18 |
14/9531 (0.15%)
|
14 |
Lower gastrointestinal haemorrhage |
3/9562 (0.03%)
|
3 |
3/9531 (0.03%)
|
3 |
Lumbar hernia |
0/9562 (0.00%)
|
0 |
2/9531 (0.02%)
|
2 |
Mallory-weiss syndrome |
2/9562 (0.02%)
|
2 |
1/9531 (0.01%)
|
1 |
Mechanical ileus |
1/9562 (0.01%)
|
1 |
0/9531 (0.00%)
|
0 |
Melaena |
12/9562 (0.13%)
|
12 |
4/9531 (0.04%)
|
4 |
Nausea |
0/9562 (0.00%)
|
0 |
2/9531 (0.02%)
|
2 |
Obstruction gastric |
1/9562 (0.01%)
|
1 |
0/9531 (0.00%)
|
0 |
Obstructive pancreatitis |
2/9562 (0.02%)
|
2 |
2/9531 (0.02%)
|
2 |
Oesophageal motility disorder |
1/9562 (0.01%)
|
1 |
0/9531 (0.00%)
|
0 |
Oesophageal spasm |
1/9562 (0.01%)
|
2 |
0/9531 (0.00%)
|
0 |
Oesophageal ulcer |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Oesophageal ulcer haemorrhage |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Oesophagitis |
2/9562 (0.02%)
|
2 |
1/9531 (0.01%)
|
1 |
Oesophagitis ulcerative |
1/9562 (0.01%)
|
1 |
0/9531 (0.00%)
|
0 |
Pancreatic mass |
1/9562 (0.01%)
|
1 |
1/9531 (0.01%)
|
1 |
Pancreatic pseudocyst |
1/9562 (0.01%)
|
1 |
0/9531 (0.00%)
|
0 |
Pancreatitis |
11/9562 (0.12%)
|
14 |
7/9531 (0.07%)
|
7 |
Pancreatitis acute |
2/9562 (0.02%)
|
2 |
5/9531 (0.05%)
|
6 |
Pancreatitis chronic |
4/9562 (0.04%)
|
4 |
2/9531 (0.02%)
|
2 |
Pancreatolithiasis |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Peptic ulcer |
1/9562 (0.01%)
|
1 |
0/9531 (0.00%)
|
0 |
Peptic ulcer haemorrhage |
2/9562 (0.02%)
|
2 |
0/9531 (0.00%)
|
0 |
Periodontal disease |
1/9562 (0.01%)
|
1 |
0/9531 (0.00%)
|
0 |
Peritoneal adhesions |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Peritoneal haemorrhage |
1/9562 (0.01%)
|
1 |
0/9531 (0.00%)
|
0 |
Proctitis |
1/9562 (0.01%)
|
1 |
0/9531 (0.00%)
|
0 |
Rectal haemorrhage |
13/9562 (0.14%)
|
13 |
2/9531 (0.02%)
|
2 |
Rectal polyp |
1/9562 (0.01%)
|
1 |
1/9531 (0.01%)
|
1 |
Rectal prolapse |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Reflux gastritis |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Salivary gland calculus |
1/9562 (0.01%)
|
1 |
0/9531 (0.00%)
|
0 |
Small intestinal haemorrhage |
2/9562 (0.02%)
|
2 |
0/9531 (0.00%)
|
0 |
Small intestinal obstruction |
3/9562 (0.03%)
|
3 |
4/9531 (0.04%)
|
4 |
Subileus |
2/9562 (0.02%)
|
2 |
1/9531 (0.01%)
|
1 |
Swollen tongue |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
2 |
Tooth disorder |
1/9562 (0.01%)
|
1 |
1/9531 (0.01%)
|
1 |
Tooth socket haemorrhage |
1/9562 (0.01%)
|
1 |
0/9531 (0.00%)
|
0 |
Ulcerative gastritis |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Umbilical hernia |
4/9562 (0.04%)
|
4 |
2/9531 (0.02%)
|
2 |
Umbilical hernia, obstructive |
1/9562 (0.01%)
|
1 |
0/9531 (0.00%)
|
0 |
Upper gastrointestinal haemorrhage |
22/9562 (0.23%)
|
23 |
10/9531 (0.10%)
|
10 |
Varices oesophageal |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Vomiting |
2/9562 (0.02%)
|
2 |
2/9531 (0.02%)
|
2 |
General disorders |
|
|
Administration site phlebitis |
1/9562 (0.01%)
|
1 |
0/9531 (0.00%)
|
0 |
Asthenia |
4/9562 (0.04%)
|
4 |
1/9531 (0.01%)
|
1 |
Capsular contracture associated with breast implant |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Cardiac death |
4/9562 (0.04%)
|
4 |
1/9531 (0.01%)
|
1 |
Catheter site haemorrhage |
1/9562 (0.01%)
|
1 |
0/9531 (0.00%)
|
0 |
Chest discomfort |
5/9562 (0.05%)
|
5 |
0/9531 (0.00%)
|
0 |
Chest pain |
6/9562 (0.06%)
|
6 |
11/9531 (0.12%)
|
11 |
Complication associated with device |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Death |
52/9562 (0.54%)
|
52 |
60/9531 (0.63%)
|
60 |
Drowning |
1/9562 (0.01%)
|
1 |
0/9531 (0.00%)
|
0 |
Facial pain |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Fatigue |
1/9562 (0.01%)
|
1 |
1/9531 (0.01%)
|
1 |
Foreign body reaction |
2/9562 (0.02%)
|
2 |
0/9531 (0.00%)
|
0 |
Gait disturbance |
1/9562 (0.01%)
|
1 |
1/9531 (0.01%)
|
1 |
Gait inability |
1/9562 (0.01%)
|
1 |
0/9531 (0.00%)
|
0 |
General physical health deterioration |
2/9562 (0.02%)
|
2 |
1/9531 (0.01%)
|
1 |
Impaired healing |
1/9562 (0.01%)
|
1 |
1/9531 (0.01%)
|
1 |
Medical device site haemorrhage |
1/9562 (0.01%)
|
1 |
0/9531 (0.00%)
|
0 |
Mucosal exfoliation |
1/9562 (0.01%)
|
1 |
0/9531 (0.00%)
|
0 |
Multiple organ dysfunction syndrome |
2/9562 (0.02%)
|
2 |
0/9531 (0.00%)
|
0 |
Necrobiosis |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Necrosis |
2/9562 (0.02%)
|
2 |
2/9531 (0.02%)
|
2 |
Nodule |
1/9562 (0.01%)
|
1 |
0/9531 (0.00%)
|
0 |
Non-cardiac chest pain |
54/9562 (0.56%)
|
60 |
66/9531 (0.69%)
|
72 |
Oedema |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Oedema peripheral |
1/9562 (0.01%)
|
1 |
4/9531 (0.04%)
|
4 |
Pacemaker generated arrhythmia |
1/9562 (0.01%)
|
1 |
0/9531 (0.00%)
|
0 |
Pain |
1/9562 (0.01%)
|
1 |
0/9531 (0.00%)
|
0 |
Peripheral swelling |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Pyrexia |
8/9562 (0.08%)
|
8 |
6/9531 (0.06%)
|
6 |
Sudden cardiac death |
6/9562 (0.06%)
|
6 |
8/9531 (0.08%)
|
8 |
Sudden death |
5/9562 (0.05%)
|
5 |
5/9531 (0.05%)
|
5 |
Ulcer haemorrhage |
1/9562 (0.01%)
|
1 |
0/9531 (0.00%)
|
0 |
Vascular stent occlusion |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Vascular stent stenosis |
6/9562 (0.06%)
|
6 |
4/9531 (0.04%)
|
5 |
Hepatobiliary disorders |
|
|
Acute hepatic failure |
3/9562 (0.03%)
|
3 |
0/9531 (0.00%)
|
0 |
Bile duct obstruction |
2/9562 (0.02%)
|
2 |
2/9531 (0.02%)
|
2 |
Bile duct stone |
7/9562 (0.07%)
|
7 |
3/9531 (0.03%)
|
3 |
Biliary colic |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
2 |
Biliary dyskinesia |
2/9562 (0.02%)
|
2 |
0/9531 (0.00%)
|
0 |
Cholangitis |
1/9562 (0.01%)
|
1 |
4/9531 (0.04%)
|
5 |
Cholangitis acute |
3/9562 (0.03%)
|
3 |
3/9531 (0.03%)
|
3 |
Cholangitis chronic |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Cholecystitis |
13/9562 (0.14%)
|
14 |
23/9531 (0.24%)
|
27 |
Cholecystitis acute |
19/9562 (0.20%)
|
19 |
14/9531 (0.15%)
|
15 |
Cholecystitis chronic |
5/9562 (0.05%)
|
5 |
6/9531 (0.06%)
|
6 |
Cholelithiasis |
23/9562 (0.24%)
|
24 |
25/9531 (0.26%)
|
25 |
Cholestasis |
0/9562 (0.00%)
|
0 |
2/9531 (0.02%)
|
2 |
Chronic hepatitis |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Cirrhosis alcoholic |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Drug-induced liver injury |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Gallbladder disorder |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Hepatic cirrhosis |
4/9562 (0.04%)
|
4 |
7/9531 (0.07%)
|
7 |
Hepatic failure |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Hepatic function abnormal |
1/9562 (0.01%)
|
1 |
2/9531 (0.02%)
|
2 |
Hepatitis |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Hepatitis acute |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Jaundice |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Jaundice cholestatic |
1/9562 (0.01%)
|
1 |
0/9531 (0.00%)
|
0 |
Liver injury |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Non-alcoholic steatohepatitis |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Portal vein thrombosis |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Steatohepatitis |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Immune system disorders |
|
|
Allergy to arthropod bite |
1/9562 (0.01%)
|
1 |
0/9531 (0.00%)
|
0 |
Anaphylactic reaction |
0/9562 (0.00%)
|
0 |
4/9531 (0.04%)
|
4 |
Anaphylactic shock |
2/9562 (0.02%)
|
2 |
1/9531 (0.01%)
|
1 |
Contrast media allergy |
1/9562 (0.01%)
|
1 |
0/9531 (0.00%)
|
0 |
Drug hypersensitivity |
0/9562 (0.00%)
|
0 |
4/9531 (0.04%)
|
4 |
Haemophagocytic lymphohistiocytosis |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Sarcoidosis |
1/9562 (0.01%)
|
1 |
0/9531 (0.00%)
|
0 |
Transplant rejection |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Infections and infestations |
|
|
Abdominal abscess |
1/9562 (0.01%)
|
1 |
2/9531 (0.02%)
|
2 |
Abdominal sepsis |
1/9562 (0.01%)
|
1 |
0/9531 (0.00%)
|
0 |
Abdominal wall abscess |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Abscess jaw |
1/9562 (0.01%)
|
1 |
1/9531 (0.01%)
|
1 |
Abscess limb |
5/9562 (0.05%)
|
5 |
1/9531 (0.01%)
|
1 |
Abscess neck |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Acinetobacter infection |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Acute endocarditis |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Acute hepatitis b |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Acute sinusitis |
1/9562 (0.01%)
|
1 |
1/9531 (0.01%)
|
1 |
Anal abscess |
3/9562 (0.03%)
|
3 |
2/9531 (0.02%)
|
2 |
Anal fistula infection |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Appendiceal abscess |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Appendicitis |
13/9562 (0.14%)
|
14 |
10/9531 (0.10%)
|
10 |
Appendicitis perforated |
3/9562 (0.03%)
|
3 |
0/9531 (0.00%)
|
0 |
Arthritis infective |
1/9562 (0.01%)
|
1 |
0/9531 (0.00%)
|
0 |
Atypical pneumonia |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Bacteraemia |
2/9562 (0.02%)
|
2 |
1/9531 (0.01%)
|
1 |
Bacterial diarrhoea |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Bacterial sepsis |
1/9562 (0.01%)
|
1 |
0/9531 (0.00%)
|
0 |
Biliary sepsis |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Brain abscess |
1/9562 (0.01%)
|
1 |
0/9531 (0.00%)
|
0 |
Breast abscess |
1/9562 (0.01%)
|
1 |
0/9531 (0.00%)
|
0 |
Breast cellulitis |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Bronchiolitis |
1/9562 (0.01%)
|
1 |
0/9531 (0.00%)
|
0 |
Bronchitis |
18/9562 (0.19%)
|
18 |
22/9531 (0.23%)
|
23 |
Bronchitis bacterial |
1/9562 (0.01%)
|
1 |
0/9531 (0.00%)
|
0 |
Bursitis infective |
1/9562 (0.01%)
|
1 |
0/9531 (0.00%)
|
0 |
Campylobacter gastroenteritis |
1/9562 (0.01%)
|
1 |
0/9531 (0.00%)
|
0 |
Cellulitis |
35/9562 (0.37%)
|
40 |
45/9531 (0.47%)
|
51 |
Cellulitis gangrenous |
0/9562 (0.00%)
|
0 |
2/9531 (0.02%)
|
2 |
Cellulitis of male external genital organ |
1/9562 (0.01%)
|
1 |
0/9531 (0.00%)
|
0 |
Cholangitis infective |
2/9562 (0.02%)
|
2 |
1/9531 (0.01%)
|
1 |
Cholecystitis infective |
3/9562 (0.03%)
|
3 |
2/9531 (0.02%)
|
2 |
Chronic hepatitis c |
1/9562 (0.01%)
|
1 |
2/9531 (0.02%)
|
2 |
Chronic sinusitis |
1/9562 (0.01%)
|
1 |
2/9531 (0.02%)
|
2 |
Clostridium difficile colitis |
1/9562 (0.01%)
|
1 |
1/9531 (0.01%)
|
1 |
Clostridium difficile infection |
2/9562 (0.02%)
|
2 |
3/9531 (0.03%)
|
5 |
Complicated appendicitis |
1/9562 (0.01%)
|
1 |
1/9531 (0.01%)
|
1 |
Cystitis |
4/9562 (0.04%)
|
4 |
4/9531 (0.04%)
|
4 |
Dacryocystitis |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Dengue fever |
1/9562 (0.01%)
|
1 |
1/9531 (0.01%)
|
1 |
Dengue haemorrhagic fever |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Device related infection |
1/9562 (0.01%)
|
1 |
1/9531 (0.01%)
|
1 |
Device related sepsis |
2/9562 (0.02%)
|
2 |
0/9531 (0.00%)
|
0 |
Diabetic foot infection |
3/9562 (0.03%)
|
4 |
3/9531 (0.03%)
|
4 |
Diabetic gangrene |
1/9562 (0.01%)
|
1 |
1/9531 (0.01%)
|
1 |
Diarrhoea infectious |
2/9562 (0.02%)
|
2 |
0/9531 (0.00%)
|
0 |
Diverticulitis |
11/9562 (0.12%)
|
12 |
4/9531 (0.04%)
|
4 |
Diverticulitis intestinal haemorrhagic |
3/9562 (0.03%)
|
3 |
2/9531 (0.02%)
|
2 |
Dysentery |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Ear infection |
1/9562 (0.01%)
|
1 |
0/9531 (0.00%)
|
0 |
Emphysematous cystitis |
1/9562 (0.01%)
|
1 |
0/9531 (0.00%)
|
0 |
Endocarditis |
0/9562 (0.00%)
|
0 |
5/9531 (0.05%)
|
5 |
Endophthalmitis |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
2 |
Enteritis infectious |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Enterobacter pneumonia |
1/9562 (0.01%)
|
1 |
0/9531 (0.00%)
|
0 |
Enterocolitis infectious |
1/9562 (0.01%)
|
1 |
0/9531 (0.00%)
|
0 |
Epididymitis |
4/9562 (0.04%)
|
4 |
0/9531 (0.00%)
|
0 |
Epiglottitis |
1/9562 (0.01%)
|
1 |
2/9531 (0.02%)
|
3 |
Erysipelas |
12/9562 (0.13%)
|
12 |
10/9531 (0.10%)
|
13 |
Escherichia urinary tract infection |
2/9562 (0.02%)
|
2 |
2/9531 (0.02%)
|
2 |
Eye infection viral |
1/9562 (0.01%)
|
1 |
0/9531 (0.00%)
|
0 |
Febrile infection |
1/9562 (0.01%)
|
1 |
0/9531 (0.00%)
|
0 |
Fungal infection |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Gangrene |
5/9562 (0.05%)
|
5 |
12/9531 (0.13%)
|
13 |
Gastroenteritis |
14/9562 (0.15%)
|
15 |
18/9531 (0.19%)
|
19 |
Gastroenteritis bacterial |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Gastroenteritis salmonella |
0/9562 (0.00%)
|
0 |
3/9531 (0.03%)
|
3 |
Gastroenteritis viral |
3/9562 (0.03%)
|
3 |
2/9531 (0.02%)
|
2 |
Gastrointestinal infection |
1/9562 (0.01%)
|
1 |
0/9531 (0.00%)
|
0 |
Genitourinary tract infection |
1/9562 (0.01%)
|
1 |
0/9531 (0.00%)
|
0 |
Graft infection |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Groin abscess |
0/9562 (0.00%)
|
0 |
2/9531 (0.02%)
|
2 |
H1n1 influenza |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Helicobacter gastritis |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Helicobacter infection |
1/9562 (0.01%)
|
1 |
0/9531 (0.00%)
|
0 |
Hepatitis a |
1/9562 (0.01%)
|
1 |
0/9531 (0.00%)
|
0 |
Hepatitis c |
2/9562 (0.02%)
|
2 |
0/9531 (0.00%)
|
0 |
Hepatitis e |
1/9562 (0.01%)
|
1 |
0/9531 (0.00%)
|
0 |
Herpes ophthalmic |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Herpes virus infection |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Herpes zoster |
5/9562 (0.05%)
|
5 |
5/9531 (0.05%)
|
5 |
Incision site abscess |
1/9562 (0.01%)
|
1 |
0/9531 (0.00%)
|
0 |
Infected bite |
1/9562 (0.01%)
|
1 |
0/9531 (0.00%)
|
0 |
Infected cyst |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Infected dermal cyst |
1/9562 (0.01%)
|
1 |
0/9531 (0.00%)
|
0 |
Infected skin ulcer |
1/9562 (0.01%)
|
1 |
0/9531 (0.00%)
|
0 |
Infection |
1/9562 (0.01%)
|
1 |
1/9531 (0.01%)
|
1 |
Infectious colitis |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Infectious pleural effusion |
1/9562 (0.01%)
|
1 |
1/9531 (0.01%)
|
1 |
Infective exacerbation of bronchiectasis |
0/9562 (0.00%)
|
0 |
2/9531 (0.02%)
|
3 |
Infective exacerbation of chronic obstructive airways disease |
1/9562 (0.01%)
|
2 |
1/9531 (0.01%)
|
1 |
Influenza |
8/9562 (0.08%)
|
8 |
10/9531 (0.10%)
|
10 |
Joint abscess |
1/9562 (0.01%)
|
1 |
0/9531 (0.00%)
|
0 |
Kidney infection |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Labyrinthitis |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Liver abscess |
1/9562 (0.01%)
|
1 |
2/9531 (0.02%)
|
2 |
Localised infection |
7/9562 (0.07%)
|
8 |
7/9531 (0.07%)
|
8 |
Lower respiratory tract infection |
4/9562 (0.04%)
|
4 |
5/9531 (0.05%)
|
5 |
Ludwig angina |
1/9562 (0.01%)
|
1 |
0/9531 (0.00%)
|
0 |
Lung abscess |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Lung infection |
10/9562 (0.10%)
|
12 |
6/9531 (0.06%)
|
7 |
Meningitis |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
2 |
Meningitis bacterial |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Meningococcal infection |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Necrotising fasciitis |
1/9562 (0.01%)
|
1 |
1/9531 (0.01%)
|
1 |
Neutropenic sepsis |
1/9562 (0.01%)
|
1 |
0/9531 (0.00%)
|
0 |
Oesophageal candidiasis |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Ophthalmic herpes zoster |
1/9562 (0.01%)
|
1 |
0/9531 (0.00%)
|
0 |
Orchitis |
5/9562 (0.05%)
|
5 |
1/9531 (0.01%)
|
1 |
Osteomyelitis |
14/9562 (0.15%)
|
16 |
7/9531 (0.07%)
|
8 |
Osteomyelitis acute |
1/9562 (0.01%)
|
1 |
0/9531 (0.00%)
|
0 |
Osteomyelitis chronic |
3/9562 (0.03%)
|
3 |
0/9531 (0.00%)
|
0 |
Otitis media |
1/9562 (0.01%)
|
1 |
1/9531 (0.01%)
|
1 |
Otitis media acute |
2/9562 (0.02%)
|
2 |
0/9531 (0.00%)
|
0 |
Otitis media chronic |
2/9562 (0.02%)
|
2 |
0/9531 (0.00%)
|
0 |
Pancreas infection |
1/9562 (0.01%)
|
1 |
0/9531 (0.00%)
|
0 |
Papilloma viral infection |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Parainfluenzae virus infection |
1/9562 (0.01%)
|
1 |
0/9531 (0.00%)
|
0 |
Parotitis |
2/9562 (0.02%)
|
2 |
1/9531 (0.01%)
|
1 |
Perineal abscess |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Periodontitis |
1/9562 (0.01%)
|
1 |
1/9531 (0.01%)
|
1 |
Periorbital cellulitis |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Peritonitis |
3/9562 (0.03%)
|
3 |
2/9531 (0.02%)
|
2 |
Peritonitis bacterial |
1/9562 (0.01%)
|
1 |
0/9531 (0.00%)
|
0 |
Peritonsillar abscess |
2/9562 (0.02%)
|
2 |
1/9531 (0.01%)
|
1 |
Pharyngeal abscess |
0/9562 (0.00%)
|
0 |
2/9531 (0.02%)
|
2 |
Pneumocystis jirovecii infection |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Pneumonia |
130/9562 (1.36%)
|
137 |
147/9531 (1.54%)
|
153 |
Pneumonia bacterial |
3/9562 (0.03%)
|
3 |
3/9531 (0.03%)
|
3 |
Pneumonia escherichia |
1/9562 (0.01%)
|
1 |
0/9531 (0.00%)
|
0 |
Pneumonia influenzal |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Pneumonia mycoplasmal |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Pneumonia staphylococcal |
1/9562 (0.01%)
|
1 |
1/9531 (0.01%)
|
1 |
Pneumonia streptococcal |
1/9562 (0.01%)
|
1 |
0/9531 (0.00%)
|
0 |
Pneumonia viral |
2/9562 (0.02%)
|
2 |
1/9531 (0.01%)
|
1 |
Post procedural infection |
2/9562 (0.02%)
|
2 |
3/9531 (0.03%)
|
3 |
Post procedural sepsis |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Postoperative abscess |
1/9562 (0.01%)
|
1 |
0/9531 (0.00%)
|
0 |
Postoperative wound infection |
3/9562 (0.03%)
|
3 |
7/9531 (0.07%)
|
7 |
Prostatic abscess |
1/9562 (0.01%)
|
1 |
0/9531 (0.00%)
|
0 |
Prostatitis escherichia coli |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Pyelonephritis |
8/9562 (0.08%)
|
8 |
4/9531 (0.04%)
|
4 |
Pyelonephritis acute |
3/9562 (0.03%)
|
3 |
12/9531 (0.13%)
|
12 |
Pyelonephritis chronic |
0/9562 (0.00%)
|
0 |
2/9531 (0.02%)
|
2 |
Rectal abscess |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Respiratory tract infection |
4/9562 (0.04%)
|
4 |
5/9531 (0.05%)
|
5 |
Respiratory tract infection viral |
2/9562 (0.02%)
|
2 |
1/9531 (0.01%)
|
1 |
Salmonellosis |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Scrotal abscess |
1/9562 (0.01%)
|
1 |
0/9531 (0.00%)
|
0 |
Sepsis |
14/9562 (0.15%)
|
15 |
20/9531 (0.21%)
|
20 |
Septic shock |
7/9562 (0.07%)
|
7 |
7/9531 (0.07%)
|
7 |
Sinusitis |
1/9562 (0.01%)
|
1 |
2/9531 (0.02%)
|
2 |
Skin infection |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Soft tissue infection |
0/9562 (0.00%)
|
0 |
2/9531 (0.02%)
|
2 |
Staphylococcal infection |
1/9562 (0.01%)
|
1 |
1/9531 (0.01%)
|
1 |
Staphylococcal sepsis |
1/9562 (0.01%)
|
1 |
1/9531 (0.01%)
|
1 |
Streptococcal infection |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Streptococcal sepsis |
4/9562 (0.04%)
|
4 |
0/9531 (0.00%)
|
0 |
Subcutaneous abscess |
2/9562 (0.02%)
|
3 |
1/9531 (0.01%)
|
1 |
Tonsillitis |
1/9562 (0.01%)
|
1 |
1/9531 (0.01%)
|
1 |
Tooth abscess |
2/9562 (0.02%)
|
2 |
1/9531 (0.01%)
|
1 |
Tracheobronchitis |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Tracheobronchitis mycoplasmal |
1/9562 (0.01%)
|
1 |
0/9531 (0.00%)
|
0 |
Tuberculosis |
2/9562 (0.02%)
|
2 |
0/9531 (0.00%)
|
0 |
Tuberculosis of genitourinary system |
1/9562 (0.01%)
|
1 |
0/9531 (0.00%)
|
0 |
Upper respiratory tract infection |
3/9562 (0.03%)
|
3 |
5/9531 (0.05%)
|
5 |
Ureteritis |
1/9562 (0.01%)
|
1 |
0/9531 (0.00%)
|
0 |
Urinary tract infection |
33/9562 (0.35%)
|
37 |
36/9531 (0.38%)
|
50 |
Urinary tract infection bacterial |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Urosepsis |
12/9562 (0.13%)
|
13 |
10/9531 (0.10%)
|
11 |
Vestibular neuronitis |
1/9562 (0.01%)
|
1 |
1/9531 (0.01%)
|
1 |
Viral infection |
2/9562 (0.02%)
|
2 |
6/9531 (0.06%)
|
6 |
Vulval abscess |
2/9562 (0.02%)
|
2 |
0/9531 (0.00%)
|
0 |
Vulval cellulitis |
1/9562 (0.01%)
|
1 |
0/9531 (0.00%)
|
0 |
West nile viral infection |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Wound infection |
5/9562 (0.05%)
|
5 |
4/9531 (0.04%)
|
5 |
Injury, poisoning and procedural complications |
|
|
Abdominal injury |
2/9562 (0.02%)
|
2 |
0/9531 (0.00%)
|
0 |
Accident at home |
1/9562 (0.01%)
|
1 |
0/9531 (0.00%)
|
0 |
Acetabulum fracture |
1/9562 (0.01%)
|
1 |
0/9531 (0.00%)
|
0 |
Adrenal gland injury |
1/9562 (0.01%)
|
1 |
0/9531 (0.00%)
|
0 |
Anaemia postoperative |
2/9562 (0.02%)
|
2 |
0/9531 (0.00%)
|
0 |
Anastomotic leak |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Anastomotic stenosis |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Ankle fracture |
8/9562 (0.08%)
|
8 |
8/9531 (0.08%)
|
8 |
Arterial bypass thrombosis |
0/9562 (0.00%)
|
0 |
2/9531 (0.02%)
|
2 |
Arthropod bite |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Avulsion fracture |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Brain contusion |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Burns third degree |
1/9562 (0.01%)
|
1 |
0/9531 (0.00%)
|
0 |
Carbon monoxide poisoning |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Carotid artery restenosis |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Cataract traumatic |
1/9562 (0.01%)
|
1 |
1/9531 (0.01%)
|
1 |
Cervical vertebral fracture |
2/9562 (0.02%)
|
2 |
1/9531 (0.01%)
|
1 |
Clavicle fracture |
1/9562 (0.01%)
|
1 |
3/9531 (0.03%)
|
3 |
Concussion |
2/9562 (0.02%)
|
2 |
1/9531 (0.01%)
|
1 |
Contusion |
7/9562 (0.07%)
|
7 |
7/9531 (0.07%)
|
7 |
Coronary artery restenosis |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Coronary vascular graft occlusion |
1/9562 (0.01%)
|
1 |
1/9531 (0.01%)
|
1 |
Coronary vascular graft stenosis |
1/9562 (0.01%)
|
1 |
0/9531 (0.00%)
|
0 |
Craniocerebral injury |
5/9562 (0.05%)
|
5 |
1/9531 (0.01%)
|
1 |
Dislocation of sternum |
1/9562 (0.01%)
|
2 |
0/9531 (0.00%)
|
0 |
Epidural haemorrhage |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Extradural haematoma |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Extraskeletal ossification |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Facial bones fracture |
1/9562 (0.01%)
|
1 |
2/9531 (0.02%)
|
2 |
Failure to anastomose |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Fall |
5/9562 (0.05%)
|
5 |
1/9531 (0.01%)
|
2 |
Femoral neck fracture |
3/9562 (0.03%)
|
3 |
4/9531 (0.04%)
|
4 |
Femur fracture |
8/9562 (0.08%)
|
8 |
15/9531 (0.16%)
|
15 |
Fibula fracture |
1/9562 (0.01%)
|
1 |
1/9531 (0.01%)
|
1 |
Foot fracture |
2/9562 (0.02%)
|
2 |
4/9531 (0.04%)
|
4 |
Foreign body |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Foreign body in gastrointestinal tract |
1/9562 (0.01%)
|
1 |
2/9531 (0.02%)
|
2 |
Fracture |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Fractured sacrum |
1/9562 (0.01%)
|
1 |
0/9531 (0.00%)
|
0 |
Hand fracture |
1/9562 (0.01%)
|
1 |
1/9531 (0.01%)
|
1 |
Head injury |
8/9562 (0.08%)
|
8 |
3/9531 (0.03%)
|
3 |
Heat stroke |
0/9562 (0.00%)
|
0 |
2/9531 (0.02%)
|
2 |
Hip fracture |
8/9562 (0.08%)
|
8 |
9/9531 (0.09%)
|
9 |
Humerus fracture |
12/9562 (0.13%)
|
12 |
8/9531 (0.08%)
|
8 |
Hyphaema |
1/9562 (0.01%)
|
1 |
1/9531 (0.01%)
|
1 |
Incisional hernia |
1/9562 (0.01%)
|
1 |
3/9531 (0.03%)
|
3 |
Intervertebral disc injury |
1/9562 (0.01%)
|
1 |
0/9531 (0.00%)
|
0 |
Joint dislocation |
2/9562 (0.02%)
|
2 |
2/9531 (0.02%)
|
2 |
Joint injury |
3/9562 (0.03%)
|
3 |
4/9531 (0.04%)
|
4 |
Ligament injury |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Ligament rupture |
4/9562 (0.04%)
|
4 |
2/9531 (0.02%)
|
2 |
Ligament sprain |
1/9562 (0.01%)
|
1 |
1/9531 (0.01%)
|
1 |
Limb injury |
12/9562 (0.13%)
|
13 |
7/9531 (0.07%)
|
8 |
Lower limb fracture |
2/9562 (0.02%)
|
2 |
2/9531 (0.02%)
|
2 |
Lumbar vertebral fracture |
1/9562 (0.01%)
|
1 |
2/9531 (0.02%)
|
2 |
Lumbosacral plexus injury |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Median nerve injury |
1/9562 (0.01%)
|
1 |
0/9531 (0.00%)
|
0 |
Meniscus injury |
9/9562 (0.09%)
|
9 |
5/9531 (0.05%)
|
5 |
Multiple fractures |
3/9562 (0.03%)
|
3 |
1/9531 (0.01%)
|
1 |
Multiple injuries |
1/9562 (0.01%)
|
1 |
1/9531 (0.01%)
|
1 |
Muscle injury |
0/9562 (0.00%)
|
0 |
2/9531 (0.02%)
|
2 |
Muscle strain |
1/9562 (0.01%)
|
1 |
0/9531 (0.00%)
|
0 |
Nail injury |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Nerve injury |
1/9562 (0.01%)
|
1 |
0/9531 (0.00%)
|
0 |
Nerve root injury |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Nerve root injury lumbar |
1/9562 (0.01%)
|
1 |
0/9531 (0.00%)
|
0 |
Overdose |
1/9562 (0.01%)
|
2 |
0/9531 (0.00%)
|
0 |
Patella fracture |
2/9562 (0.02%)
|
2 |
2/9531 (0.02%)
|
2 |
Pelvic fracture |
3/9562 (0.03%)
|
3 |
1/9531 (0.01%)
|
1 |
Periorbital haemorrhage |
1/9562 (0.01%)
|
1 |
0/9531 (0.00%)
|
0 |
Periprocedural myocardial infarction |
0/9562 (0.00%)
|
0 |
2/9531 (0.02%)
|
2 |
Post procedural complication |
1/9562 (0.01%)
|
1 |
2/9531 (0.02%)
|
2 |
Post procedural fever |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Post procedural haematoma |
4/9562 (0.04%)
|
4 |
1/9531 (0.01%)
|
1 |
Post procedural haemorrhage |
11/9562 (0.12%)
|
11 |
5/9531 (0.05%)
|
5 |
Postoperative ileus |
2/9562 (0.02%)
|
2 |
0/9531 (0.00%)
|
0 |
Postoperative respiratory failure |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Postoperative thoracic procedure complication |
2/9562 (0.02%)
|
2 |
0/9531 (0.00%)
|
0 |
Procedural complication |
2/9562 (0.02%)
|
2 |
0/9531 (0.00%)
|
0 |
Procedural haemorrhage |
2/9562 (0.02%)
|
2 |
3/9531 (0.03%)
|
3 |
Procedural pain |
1/9562 (0.01%)
|
1 |
2/9531 (0.02%)
|
2 |
Pubis fracture |
1/9562 (0.01%)
|
1 |
0/9531 (0.00%)
|
0 |
Pulmonary contusion |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Radiation pneumonitis |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Radius fracture |
6/9562 (0.06%)
|
7 |
8/9531 (0.08%)
|
8 |
Rib fracture |
4/9562 (0.04%)
|
4 |
10/9531 (0.10%)
|
10 |
Road traffic accident |
1/9562 (0.01%)
|
1 |
2/9531 (0.02%)
|
2 |
Scapula fracture |
0/9562 (0.00%)
|
0 |
2/9531 (0.02%)
|
2 |
Seroma |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Shunt malfunction |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Skeletal injury |
1/9562 (0.01%)
|
1 |
0/9531 (0.00%)
|
0 |
Skin abrasion |
1/9562 (0.01%)
|
1 |
0/9531 (0.00%)
|
0 |
Skin injury |
1/9562 (0.01%)
|
1 |
0/9531 (0.00%)
|
0 |
Skin laceration |
2/9562 (0.02%)
|
2 |
6/9531 (0.06%)
|
6 |
Skull fracture |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Skull fractured base |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Spinal column injury |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Spinal compression fracture |
0/9562 (0.00%)
|
0 |
7/9531 (0.07%)
|
7 |
Spinal cord injury cervical |
1/9562 (0.01%)
|
1 |
0/9531 (0.00%)
|
0 |
Spinal fracture |
1/9562 (0.01%)
|
1 |
1/9531 (0.01%)
|
1 |
Sternal fracture |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Stomal hernia |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Subcutaneous haematoma |
1/9562 (0.01%)
|
1 |
0/9531 (0.00%)
|
0 |
Subdural haematoma |
23/9562 (0.24%)
|
23 |
6/9531 (0.06%)
|
6 |
Subdural haemorrhage |
8/9562 (0.08%)
|
8 |
5/9531 (0.05%)
|
5 |
Tendon injury |
1/9562 (0.01%)
|
1 |
0/9531 (0.00%)
|
0 |
Tendon rupture |
2/9562 (0.02%)
|
2 |
8/9531 (0.08%)
|
8 |
Thermal burn |
1/9562 (0.01%)
|
1 |
0/9531 (0.00%)
|
0 |
Thoracic vertebral fracture |
0/9562 (0.00%)
|
0 |
2/9531 (0.02%)
|
2 |
Tibia fracture |
3/9562 (0.03%)
|
3 |
6/9531 (0.06%)
|
6 |
Toxicity to various agents |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Traumatic fracture |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Traumatic haematoma |
7/9562 (0.07%)
|
7 |
2/9531 (0.02%)
|
2 |
Traumatic haemorrhage |
2/9562 (0.02%)
|
2 |
1/9531 (0.01%)
|
1 |
Traumatic haemothorax |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Traumatic intracranial haemorrhage |
11/9562 (0.12%)
|
11 |
7/9531 (0.07%)
|
7 |
Ulna fracture |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Upper limb fracture |
6/9562 (0.06%)
|
6 |
0/9531 (0.00%)
|
0 |
Urinary retention postoperative |
1/9562 (0.01%)
|
1 |
0/9531 (0.00%)
|
0 |
Vascular graft complication |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Vascular graft thrombosis |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Vascular pseudoaneurysm |
2/9562 (0.02%)
|
2 |
0/9531 (0.00%)
|
0 |
Wound |
1/9562 (0.01%)
|
1 |
0/9531 (0.00%)
|
0 |
Wound dehiscence |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Wound haemorrhage |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Wound necrosis |
0/9562 (0.00%)
|
0 |
3/9531 (0.03%)
|
3 |
Wrist fracture |
2/9562 (0.02%)
|
2 |
3/9531 (0.03%)
|
3 |
Investigations |
|
|
Alanine aminotransferase increased |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Bile output decreased |
1/9562 (0.01%)
|
1 |
0/9531 (0.00%)
|
0 |
Blood follicle stimulating hormone increased |
1/9562 (0.01%)
|
1 |
0/9531 (0.00%)
|
0 |
Blood glucose fluctuation |
1/9562 (0.01%)
|
1 |
0/9531 (0.00%)
|
0 |
Blood glucose increased |
5/9562 (0.05%)
|
5 |
3/9531 (0.03%)
|
3 |
Blood lactic acid increased |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Blood potassium increased |
0/9562 (0.00%)
|
0 |
2/9531 (0.02%)
|
3 |
Blood pressure increased |
2/9562 (0.02%)
|
2 |
0/9531 (0.00%)
|
0 |
Blood urine present |
1/9562 (0.01%)
|
1 |
0/9531 (0.00%)
|
0 |
Cardiac stress test abnormal |
3/9562 (0.03%)
|
3 |
4/9531 (0.04%)
|
4 |
Electrocardiogram qrs complex prolonged |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Electrocardiogram st segment depression |
1/9562 (0.01%)
|
2 |
0/9531 (0.00%)
|
0 |
Electrocardiogram abnormal |
1/9562 (0.01%)
|
1 |
0/9531 (0.00%)
|
0 |
Glycosylated haemoglobin increased |
1/9562 (0.01%)
|
1 |
0/9531 (0.00%)
|
0 |
Haemoglobin decreased |
2/9562 (0.02%)
|
2 |
3/9531 (0.03%)
|
3 |
Heart rate irregular |
1/9562 (0.01%)
|
1 |
0/9531 (0.00%)
|
0 |
Hepatic enzyme increased |
1/9562 (0.01%)
|
1 |
1/9531 (0.01%)
|
1 |
Hepatitis b surface antigen positive |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Occult blood positive |
1/9562 (0.01%)
|
1 |
0/9531 (0.00%)
|
0 |
Oxygen saturation decreased |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Prostatic specific antigen increased |
2/9562 (0.02%)
|
2 |
0/9531 (0.00%)
|
0 |
Troponin increased |
1/9562 (0.01%)
|
1 |
2/9531 (0.02%)
|
2 |
Weight decreased |
2/9562 (0.02%)
|
2 |
1/9531 (0.01%)
|
1 |
White blood cell count decreased |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Metabolism and nutrition disorders |
|
|
Decreased appetite |
1/9562 (0.01%)
|
1 |
0/9531 (0.00%)
|
0 |
Dehydration |
6/9562 (0.06%)
|
7 |
5/9531 (0.05%)
|
5 |
Diabetes mellitus |
24/9562 (0.25%)
|
28 |
42/9531 (0.44%)
|
46 |
Diabetes mellitus inadequate control |
50/9562 (0.52%)
|
55 |
60/9531 (0.63%)
|
78 |
Diabetic complication |
0/9562 (0.00%)
|
0 |
2/9531 (0.02%)
|
2 |
Diabetic ketoacidosis |
10/9562 (0.10%)
|
11 |
11/9531 (0.12%)
|
13 |
Diabetic metabolic decompensation |
9/9562 (0.09%)
|
9 |
17/9531 (0.18%)
|
17 |
Euglycaemic diabetic ketoacidosis |
0/9562 (0.00%)
|
0 |
1/9531 (0.01%)
|
1 |
Fluid overload |
2/9562 (0.02%)
|
2 |
1/9531 (0.01%)
|
2 |
Gout |
5/9562 (0.05%)
|
7 |
6/9531 (0.06%)
|
6 |
Hypercalcaemia |
1/9562 (0.01%)
|
1 |
0/9531 (0.00%)
|
0 |
Hyperglycaemia |
20/9562 (0.21%)
|
21 |