Time Frame |
[Not Specified]
|
Adverse Event Reporting Description |
[Not Specified]
|
|
Arm/Group Title
|
Core-phase: Aliskiren
|
Core-phase: Placebo
|
Extension-phase: Aliskiren
|
Extension-phase: Placebo
|
Arm/Group Description |
In Core (Double Blind) phase, Alisk...
|
In Core (Double Blind) Phase, Place...
|
With the recommendation of Data Mon...
|
With the recommendation of Data Mon...
|
Arm/Group Description |
In Core (Double Blind) phase, Aliskiren 150 mg once daily (o.d.) for 4 weeks; then patient was uptitrated to 300 mg o.d. at Visit 5/Week 4 (or 150 mg o.d. if patient could not tolerate target dose of study drug). Visits took place at 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
|
In Core (Double Blind) Phase, Placebo to match aliskiren 150 mg once daily (o.d.) for 4 weeks; from Visit 5/Week 4 placebo to match aliskiren 300 mg o.d. (or placebo to match aliskiren 150 mg if patient could not tolerate target dose of study drug). Visits took place 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until final closure of the study.
|
With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.
|
With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.
|
|
|
Core-phase: Aliskiren
|
Core-phase: Placebo
|
Extension-phase: Aliskiren
|
Extension-phase: Placebo
|
|
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Total |
--/-- |
--/-- |
--/-- |
--/-- |
|
|
Core-phase: Aliskiren
|
Core-phase: Placebo
|
Extension-phase: Aliskiren
|
Extension-phase: Placebo
|
|
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Total |
1988/4272 (46.54%) |
1893/4285 (44.18%) |
704/3773 (18.66%) |
682/3817 (17.87%) |
Blood and lymphatic system disorders |
|
|
|
|
Anaemia |
55/4272 (1.29%) |
36/4285 (0.84%) |
13/3773 (0.34%) |
16/3817 (0.42%) |
Anaemia haemolytic autoimmune |
0/4272 (0.00%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Anaemia macrocytic |
1/4272 (0.02%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Anaemia of chronic disease |
2/4272 (0.05%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Anaemia vitamin B12 deficiency |
0/4272 (0.00%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Aplastic anaemia |
0/4272 (0.00%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
1/3817 (0.03%) |
Coagulopathy |
0/4272 (0.00%) |
1/4285 (0.02%) |
2/3773 (0.05%) |
0/3817 (0.00%) |
Disseminated intravascular coagulation |
2/4272 (0.05%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Haemolytic anaemia |
0/4272 (0.00%) |
2/4285 (0.05%) |
0/3773 (0.00%) |
1/3817 (0.03%) |
Haemorrhagic anaemia |
2/4272 (0.05%) |
3/4285 (0.07%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Iron deficiency anaemia |
3/4272 (0.07%) |
7/4285 (0.16%) |
0/3773 (0.00%) |
1/3817 (0.03%) |
Leukocytosis |
0/4272 (0.00%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Lymphadenopathy |
1/4272 (0.02%) |
1/4285 (0.02%) |
2/3773 (0.05%) |
0/3817 (0.00%) |
Lymphadenopathy mediastinal |
1/4272 (0.02%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Microcytic anaemia |
0/4272 (0.00%) |
2/4285 (0.05%) |
0/3773 (0.00%) |
1/3817 (0.03%) |
Nephrogenic anaemia |
2/4272 (0.05%) |
2/4285 (0.05%) |
0/3773 (0.00%) |
1/3817 (0.03%) |
Neutropenia |
1/4272 (0.02%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Normochromic normocytic anaemia |
1/4272 (0.02%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Pancytopenia |
0/4272 (0.00%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
1/3817 (0.03%) |
Spontaneous haematoma |
0/4272 (0.00%) |
0/4285 (0.00%) |
1/3773 (0.03%) |
0/3817 (0.00%) |
Thrombocytopenia |
2/4272 (0.05%) |
2/4285 (0.05%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Cardiac disorders |
|
|
|
|
Acute coronary syndrome |
27/4272 (0.63%) |
34/4285 (0.79%) |
5/3773 (0.13%) |
7/3817 (0.18%) |
Acute left ventricular failure |
4/4272 (0.09%) |
3/4285 (0.07%) |
1/3773 (0.03%) |
0/3817 (0.00%) |
Acute myocardial infarction |
48/4272 (1.12%) |
64/4285 (1.49%) |
21/3773 (0.56%) |
19/3817 (0.50%) |
Angina pectoris |
93/4272 (2.18%) |
85/4285 (1.98%) |
22/3773 (0.58%) |
22/3817 (0.58%) |
Angina unstable |
52/4272 (1.22%) |
43/4285 (1.00%) |
10/3773 (0.27%) |
11/3817 (0.29%) |
Aortic valve disease |
0/4272 (0.00%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Aortic valve stenosis |
5/4272 (0.12%) |
5/4285 (0.12%) |
1/3773 (0.03%) |
0/3817 (0.00%) |
Arrhythmia |
10/4272 (0.23%) |
13/4285 (0.30%) |
1/3773 (0.03%) |
3/3817 (0.08%) |
Arrhythmia supraventricular |
1/4272 (0.02%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Arteriosclerosis coronary artery |
10/4272 (0.23%) |
9/4285 (0.21%) |
1/3773 (0.03%) |
0/3817 (0.00%) |
Atrial fibrillation |
59/4272 (1.38%) |
64/4285 (1.49%) |
6/3773 (0.16%) |
17/3817 (0.45%) |
Atrial flutter |
12/4272 (0.28%) |
6/4285 (0.14%) |
6/3773 (0.16%) |
1/3817 (0.03%) |
Atrial tachycardia |
2/4272 (0.05%) |
1/4285 (0.02%) |
1/3773 (0.03%) |
0/3817 (0.00%) |
Atrioventricular block |
5/4272 (0.12%) |
5/4285 (0.12%) |
2/3773 (0.05%) |
0/3817 (0.00%) |
Atrioventricular block complete |
15/4272 (0.35%) |
10/4285 (0.23%) |
4/3773 (0.11%) |
2/3817 (0.05%) |
Atrioventricular block first degree |
1/4272 (0.02%) |
0/4285 (0.00%) |
1/3773 (0.03%) |
0/3817 (0.00%) |
Atrioventricular block second degree |
6/4272 (0.14%) |
6/4285 (0.14%) |
2/3773 (0.05%) |
1/3817 (0.03%) |
Bradyarrhythmia |
1/4272 (0.02%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
1/3817 (0.03%) |
Bradycardia |
16/4272 (0.37%) |
15/4285 (0.35%) |
2/3773 (0.05%) |
4/3817 (0.10%) |
Bundle branch block left |
1/4272 (0.02%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Cardiac amyloidosis |
0/4272 (0.00%) |
0/4285 (0.00%) |
1/3773 (0.03%) |
0/3817 (0.00%) |
Cardiac arrest |
30/4272 (0.70%) |
23/4285 (0.54%) |
7/3773 (0.19%) |
5/3817 (0.13%) |
Cardiac asthma |
2/4272 (0.05%) |
2/4285 (0.05%) |
2/3773 (0.05%) |
1/3817 (0.03%) |
Cardiac disorder |
2/4272 (0.05%) |
1/4285 (0.02%) |
2/3773 (0.05%) |
0/3817 (0.00%) |
Cardiac failure |
173/4272 (4.05%) |
173/4285 (4.04%) |
67/3773 (1.78%) |
50/3817 (1.31%) |
Cardiac failure acute |
14/4272 (0.33%) |
16/4285 (0.37%) |
4/3773 (0.11%) |
3/3817 (0.08%) |
Cardiac failure chronic |
14/4272 (0.33%) |
15/4285 (0.35%) |
2/3773 (0.05%) |
6/3817 (0.16%) |
Cardiac failure congestive |
90/4272 (2.11%) |
71/4285 (1.66%) |
18/3773 (0.48%) |
21/3817 (0.55%) |
Cardiac fibrillation |
1/4272 (0.02%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Cardiac tamponade |
1/4272 (0.02%) |
1/4285 (0.02%) |
2/3773 (0.05%) |
0/3817 (0.00%) |
Cardiac valve disease |
1/4272 (0.02%) |
0/4285 (0.00%) |
1/3773 (0.03%) |
0/3817 (0.00%) |
Cardio-respiratory arrest |
12/4272 (0.28%) |
13/4285 (0.30%) |
2/3773 (0.05%) |
3/3817 (0.08%) |
Cardiogenic shock |
6/4272 (0.14%) |
8/4285 (0.19%) |
1/3773 (0.03%) |
4/3817 (0.10%) |
Cardiomegaly |
1/4272 (0.02%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Cardiomyopathy |
2/4272 (0.05%) |
2/4285 (0.05%) |
0/3773 (0.00%) |
2/3817 (0.05%) |
Cardiopulmonary failure |
2/4272 (0.05%) |
4/4285 (0.09%) |
0/3773 (0.00%) |
1/3817 (0.03%) |
Cardiovascular disorder |
0/4272 (0.00%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Cardiovascular insufficiency |
0/4272 (0.00%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Congestive cardiomyopathy |
2/4272 (0.05%) |
1/4285 (0.02%) |
2/3773 (0.05%) |
1/3817 (0.03%) |
Coronary artery disease |
67/4272 (1.57%) |
71/4285 (1.66%) |
25/3773 (0.66%) |
20/3817 (0.52%) |
Coronary artery insufficiency |
1/4272 (0.02%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Coronary artery occlusion |
7/4272 (0.16%) |
4/4285 (0.09%) |
0/3773 (0.00%) |
3/3817 (0.08%) |
Coronary artery stenosis |
13/4272 (0.30%) |
13/4285 (0.30%) |
3/3773 (0.08%) |
2/3817 (0.05%) |
Diastolic dysfunction |
3/4272 (0.07%) |
2/4285 (0.05%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Dilatation ventricular |
0/4272 (0.00%) |
0/4285 (0.00%) |
1/3773 (0.03%) |
0/3817 (0.00%) |
Hypertensive cardiomyopathy |
1/4272 (0.02%) |
2/4285 (0.05%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Hypertensive heart disease |
5/4272 (0.12%) |
1/4285 (0.02%) |
2/3773 (0.05%) |
2/3817 (0.05%) |
Ischaemic cardiomyopathy |
7/4272 (0.16%) |
4/4285 (0.09%) |
0/3773 (0.00%) |
1/3817 (0.03%) |
Left ventricular dysfunction |
5/4272 (0.12%) |
3/4285 (0.07%) |
3/3773 (0.08%) |
0/3817 (0.00%) |
Left ventricular failure |
8/4272 (0.19%) |
10/4285 (0.23%) |
3/3773 (0.08%) |
2/3817 (0.05%) |
Left ventricular hypertrophy |
2/4272 (0.05%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Mitral valve incompetence |
4/4272 (0.09%) |
1/4285 (0.02%) |
1/3773 (0.03%) |
2/3817 (0.05%) |
Mitral valve stenosis |
1/4272 (0.02%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Myocardial infarction |
87/4272 (2.04%) |
65/4285 (1.52%) |
23/3773 (0.61%) |
30/3817 (0.79%) |
Myocardial ischaemia |
37/4272 (0.87%) |
35/4285 (0.82%) |
8/3773 (0.21%) |
8/3817 (0.21%) |
Nodal arrhythmia |
1/4272 (0.02%) |
2/4285 (0.05%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Nodal rhythm |
0/4272 (0.00%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Palpitations |
4/4272 (0.09%) |
5/4285 (0.12%) |
0/3773 (0.00%) |
1/3817 (0.03%) |
Pericardial effusion |
5/4272 (0.12%) |
6/4285 (0.14%) |
1/3773 (0.03%) |
0/3817 (0.00%) |
Pericarditis |
0/4272 (0.00%) |
0/4285 (0.00%) |
1/3773 (0.03%) |
0/3817 (0.00%) |
Pericarditis constrictive |
1/4272 (0.02%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Postinfarction angina |
1/4272 (0.02%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Pulseless electrical activity |
0/4272 (0.00%) |
0/4285 (0.00%) |
1/3773 (0.03%) |
0/3817 (0.00%) |
Right ventricular failure |
2/4272 (0.05%) |
2/4285 (0.05%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Sick sinus syndrome |
8/4272 (0.19%) |
5/4285 (0.12%) |
4/3773 (0.11%) |
4/3817 (0.10%) |
Silent myocardial infarction |
1/4272 (0.02%) |
3/4285 (0.07%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Sinus arrhythmia |
1/4272 (0.02%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Sinus bradycardia |
4/4272 (0.09%) |
3/4285 (0.07%) |
1/3773 (0.03%) |
0/3817 (0.00%) |
Supraventricular tachyarrhythmia |
0/4272 (0.00%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Supraventricular tachycardia |
3/4272 (0.07%) |
1/4285 (0.02%) |
2/3773 (0.05%) |
0/3817 (0.00%) |
Tachyarrhythmia |
0/4272 (0.00%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Tachycardia |
5/4272 (0.12%) |
6/4285 (0.14%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Tachycardia paroxysmal |
1/4272 (0.02%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Tricuspid valve incompetence |
1/4272 (0.02%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Trifascicular block |
1/4272 (0.02%) |
1/4285 (0.02%) |
1/3773 (0.03%) |
0/3817 (0.00%) |
Ventricular arrhythmia |
3/4272 (0.07%) |
3/4285 (0.07%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Ventricular dysfunction |
0/4272 (0.00%) |
0/4285 (0.00%) |
1/3773 (0.03%) |
0/3817 (0.00%) |
Ventricular extrasystoles |
3/4272 (0.07%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
1/3817 (0.03%) |
Ventricular fibrillation |
10/4272 (0.23%) |
5/4285 (0.12%) |
1/3773 (0.03%) |
3/3817 (0.08%) |
Ventricular tachyarrhythmia |
1/4272 (0.02%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Ventricular tachycardia |
7/4272 (0.16%) |
3/4285 (0.07%) |
0/3773 (0.00%) |
4/3817 (0.10%) |
Congenital, familial and genetic disorders |
|
|
|
|
Arnold-Chiari malformation |
0/4272 (0.00%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Atrial septal defect |
1/4272 (0.02%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Congenital arterial malformation |
0/4272 (0.00%) |
0/4285 (0.00%) |
1/3773 (0.03%) |
0/3817 (0.00%) |
Familial hypocalciuric hypercalcaemia |
0/4272 (0.00%) |
0/4285 (0.00%) |
1/3773 (0.03%) |
0/3817 (0.00%) |
Haemoglobinopathy |
1/4272 (0.02%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Hydrocele |
2/4272 (0.05%) |
2/4285 (0.05%) |
1/3773 (0.03%) |
0/3817 (0.00%) |
Hypertrophic cardiomyopathy |
1/4272 (0.02%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
1/3817 (0.03%) |
Phimosis |
1/4272 (0.02%) |
2/4285 (0.05%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Rathke's cleft cyst |
0/4272 (0.00%) |
0/4285 (0.00%) |
1/3773 (0.03%) |
0/3817 (0.00%) |
Sickle cell anaemia with crisis |
1/4272 (0.02%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Ear and labyrinth disorders |
|
|
|
|
Deafness |
0/4272 (0.00%) |
0/4285 (0.00%) |
1/3773 (0.03%) |
0/3817 (0.00%) |
Deafness neurosensory |
2/4272 (0.05%) |
2/4285 (0.05%) |
1/3773 (0.03%) |
0/3817 (0.00%) |
Deafness unilateral |
0/4272 (0.00%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Hearing impaired |
0/4272 (0.00%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Sudden hearing loss |
0/4272 (0.00%) |
3/4285 (0.07%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Tinnitus |
0/4272 (0.00%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Vertigo |
17/4272 (0.40%) |
9/4285 (0.21%) |
1/3773 (0.03%) |
4/3817 (0.10%) |
Vertigo positional |
2/4272 (0.05%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Vestibular disorder |
0/4272 (0.00%) |
2/4285 (0.05%) |
1/3773 (0.03%) |
0/3817 (0.00%) |
Endocrine disorders |
|
|
|
|
Basedow's disease |
0/4272 (0.00%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
1/3817 (0.03%) |
Cushing's syndrome |
1/4272 (0.02%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
1/3817 (0.03%) |
Goitre |
4/4272 (0.09%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Hyperparathyroidism |
1/4272 (0.02%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Hyperthyroidism |
0/4272 (0.00%) |
4/4285 (0.09%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Hypoparathyroidism |
0/4272 (0.00%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
1/3817 (0.03%) |
Hypothyroidism |
1/4272 (0.02%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Inappropriate antidiuretic hormone secretion |
0/4272 (0.00%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Primary hyperaldosteronism |
0/4272 (0.00%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Eye disorders |
|
|
|
|
Amaurosis |
0/4272 (0.00%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Angle closure glaucoma |
0/4272 (0.00%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
1/3817 (0.03%) |
Blindness |
1/4272 (0.02%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Blindness unilateral |
1/4272 (0.02%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Cataract |
33/4272 (0.77%) |
32/4285 (0.75%) |
12/3773 (0.32%) |
6/3817 (0.16%) |
Cataract diabetic |
1/4272 (0.02%) |
0/4285 (0.00%) |
1/3773 (0.03%) |
0/3817 (0.00%) |
Cataract nuclear |
0/4272 (0.00%) |
0/4285 (0.00%) |
1/3773 (0.03%) |
0/3817 (0.00%) |
Cataract subcapsular |
0/4272 (0.00%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
1/3817 (0.03%) |
Corneal degeneration |
0/4272 (0.00%) |
2/4285 (0.05%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Cystoid macular oedema |
1/4272 (0.02%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Detachment of macular retinal pigment epithelium |
0/4272 (0.00%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Diabetic eye disease |
1/4272 (0.02%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Diabetic retinopathy |
23/4272 (0.54%) |
18/4285 (0.42%) |
2/3773 (0.05%) |
4/3817 (0.10%) |
Diplopia |
0/4272 (0.00%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Ectropion |
1/4272 (0.02%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Eye haemorrhage |
3/4272 (0.07%) |
1/4285 (0.02%) |
2/3773 (0.05%) |
0/3817 (0.00%) |
Eyelid oedema |
2/4272 (0.05%) |
2/4285 (0.05%) |
1/3773 (0.03%) |
0/3817 (0.00%) |
Eyelid ptosis |
1/4272 (0.02%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Glaucoma |
4/4272 (0.09%) |
2/4285 (0.05%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Iridocyclitis |
0/4272 (0.00%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Iris adhesions |
0/4272 (0.00%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Lenticular opacities |
1/4272 (0.02%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Macular degeneration |
1/4272 (0.02%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
1/3817 (0.03%) |
Macular fibrosis |
4/4272 (0.09%) |
3/4285 (0.07%) |
1/3773 (0.03%) |
0/3817 (0.00%) |
Macular hole |
0/4272 (0.00%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Macular oedema |
0/4272 (0.00%) |
2/4285 (0.05%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Ocular hypertension |
1/4272 (0.02%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Optic neuropathy |
0/4272 (0.00%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Periorbital oedema |
2/4272 (0.05%) |
2/4285 (0.05%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Pterygium |
1/4272 (0.02%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Retinal artery occlusion |
1/4272 (0.02%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Retinal detachment |
6/4272 (0.14%) |
6/4285 (0.14%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Retinal haemorrhage |
4/4272 (0.09%) |
5/4285 (0.12%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Retinal tear |
0/4272 (0.00%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Retinal vein occlusion |
0/4272 (0.00%) |
2/4285 (0.05%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Retinopathy |
3/4272 (0.07%) |
4/4285 (0.09%) |
0/3773 (0.00%) |
1/3817 (0.03%) |
Retinopathy proliferative |
1/4272 (0.02%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Ulcerative keratitis |
0/4272 (0.00%) |
0/4285 (0.00%) |
1/3773 (0.03%) |
1/3817 (0.03%) |
Vision blurred |
1/4272 (0.02%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Visual impairment |
0/4272 (0.00%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Vitreous adhesions |
0/4272 (0.00%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
1/3817 (0.03%) |
Vitreous haemorrhage |
17/4272 (0.40%) |
11/4285 (0.26%) |
0/3773 (0.00%) |
2/3817 (0.05%) |
Gastrointestinal disorders |
|
|
|
|
Abdominal adhesions |
0/4272 (0.00%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Abdominal discomfort |
1/4272 (0.02%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
1/3817 (0.03%) |
Abdominal distension |
3/4272 (0.07%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Abdominal hernia |
1/4272 (0.02%) |
2/4285 (0.05%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Abdominal mass |
0/4272 (0.00%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Abdominal pain |
13/4272 (0.30%) |
13/4285 (0.30%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Abdominal pain lower |
0/4272 (0.00%) |
0/4285 (0.00%) |
1/3773 (0.03%) |
0/3817 (0.00%) |
Abdominal pain upper |
5/4272 (0.12%) |
3/4285 (0.07%) |
2/3773 (0.05%) |
1/3817 (0.03%) |
Abdominal strangulated hernia |
1/4272 (0.02%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Abdominal wall haematoma |
0/4272 (0.00%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
1/3817 (0.03%) |
Anal fistula |
1/4272 (0.02%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Ascites |
2/4272 (0.05%) |
4/4285 (0.09%) |
2/3773 (0.05%) |
0/3817 (0.00%) |
Colitis |
4/4272 (0.09%) |
5/4285 (0.12%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Colitis ischaemic |
1/4272 (0.02%) |
2/4285 (0.05%) |
0/3773 (0.00%) |
1/3817 (0.03%) |
Colitis microscopic |
0/4272 (0.00%) |
0/4285 (0.00%) |
1/3773 (0.03%) |
0/3817 (0.00%) |
Colitis ulcerative |
1/4272 (0.02%) |
0/4285 (0.00%) |
2/3773 (0.05%) |
2/3817 (0.05%) |
Constipation |
4/4272 (0.09%) |
7/4285 (0.16%) |
0/3773 (0.00%) |
1/3817 (0.03%) |
Crohn's disease |
1/4272 (0.02%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Dental caries |
1/4272 (0.02%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Diabetic enteropathy |
1/4272 (0.02%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Diabetic gastroenteropathy |
0/4272 (0.00%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
1/3817 (0.03%) |
Diabetic gastroparesis |
2/4272 (0.05%) |
2/4285 (0.05%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Diarrhoea |
12/4272 (0.28%) |
15/4285 (0.35%) |
4/3773 (0.11%) |
4/3817 (0.10%) |
Diverticular perforation |
2/4272 (0.05%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Diverticulitis intestinal haemorrhagic |
1/4272 (0.02%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Diverticulum |
2/4272 (0.05%) |
2/4285 (0.05%) |
1/3773 (0.03%) |
0/3817 (0.00%) |
Diverticulum intestinal |
2/4272 (0.05%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
1/3817 (0.03%) |
Diverticulum intestinal haemorrhagic |
2/4272 (0.05%) |
1/4285 (0.02%) |
1/3773 (0.03%) |
1/3817 (0.03%) |
Duodenal polyp |
1/4272 (0.02%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Duodenal ulcer |
5/4272 (0.12%) |
5/4285 (0.12%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Duodenal ulcer haemorrhage |
4/4272 (0.09%) |
5/4285 (0.12%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Duodenitis |
0/4272 (0.00%) |
3/4285 (0.07%) |
0/3773 (0.00%) |
1/3817 (0.03%) |
Dyspepsia |
2/4272 (0.05%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Dysphagia |
4/4272 (0.09%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
1/3817 (0.03%) |
Enteritis |
4/4272 (0.09%) |
3/4285 (0.07%) |
1/3773 (0.03%) |
0/3817 (0.00%) |
Enterocolitis |
2/4272 (0.05%) |
0/4285 (0.00%) |
1/3773 (0.03%) |
0/3817 (0.00%) |
Enterocolitis haemorrhagic |
0/4272 (0.00%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Epigastric discomfort |
1/4272 (0.02%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Faecal incontinence |
1/4272 (0.02%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Faecaloma |
3/4272 (0.07%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Food poisoning |
2/4272 (0.05%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Functional gastrointestinal disorder |
0/4272 (0.00%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
1/3817 (0.03%) |
Gastric haemorrhage |
1/4272 (0.02%) |
4/4285 (0.09%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Gastric mucosa erythema |
1/4272 (0.02%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Gastric perforation |
1/4272 (0.02%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Gastric polyps |
3/4272 (0.07%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Gastric ulcer |
7/4272 (0.16%) |
12/4285 (0.28%) |
1/3773 (0.03%) |
0/3817 (0.00%) |
Gastric ulcer haemorrhage |
1/4272 (0.02%) |
2/4285 (0.05%) |
0/3773 (0.00%) |
1/3817 (0.03%) |
Gastric ulcer perforation |
1/4272 (0.02%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Gastritis |
10/4272 (0.23%) |
16/4285 (0.37%) |
2/3773 (0.05%) |
3/3817 (0.08%) |
Gastritis atrophic |
1/4272 (0.02%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Gastritis erosive |
2/4272 (0.05%) |
3/4285 (0.07%) |
0/3773 (0.00%) |
1/3817 (0.03%) |
Gastritis haemorrhagic |
2/4272 (0.05%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Gastroduodenitis |
1/4272 (0.02%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Gastroduodenitis haemorrhagic |
0/4272 (0.00%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Gastrointestinal dysplasia |
0/4272 (0.00%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Gastrointestinal haemorrhage |
17/4272 (0.40%) |
14/4285 (0.33%) |
5/3773 (0.13%) |
3/3817 (0.08%) |
Gastrointestinal hypomotility |
1/4272 (0.02%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Gastrointestinal inflammation |
2/4272 (0.05%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Gastrointestinal ischaemia |
1/4272 (0.02%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Gastrointestinal necrosis |
0/4272 (0.00%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
1/3817 (0.03%) |
Gastrointestinal ulcer haemorrhage |
0/4272 (0.00%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Gastrooesophageal reflux disease |
3/4272 (0.07%) |
4/4285 (0.09%) |
0/3773 (0.00%) |
2/3817 (0.05%) |
Gingival bleeding |
0/4272 (0.00%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Haematemesis |
4/4272 (0.09%) |
3/4285 (0.07%) |
1/3773 (0.03%) |
0/3817 (0.00%) |
Haematochezia |
3/4272 (0.07%) |
2/4285 (0.05%) |
1/3773 (0.03%) |
0/3817 (0.00%) |
Haemorrhoidal haemorrhage |
0/4272 (0.00%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
1/3817 (0.03%) |
Haemorrhoids |
2/4272 (0.05%) |
5/4285 (0.12%) |
0/3773 (0.00%) |
1/3817 (0.03%) |
Hernial eventration |
2/4272 (0.05%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Hiatus hernia |
1/4272 (0.02%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Ileus |
3/4272 (0.07%) |
3/4285 (0.07%) |
0/3773 (0.00%) |
1/3817 (0.03%) |
Ileus paralytic |
2/4272 (0.05%) |
2/4285 (0.05%) |
2/3773 (0.05%) |
0/3817 (0.00%) |
Impaired gastric emptying |
2/4272 (0.05%) |
2/4285 (0.05%) |
1/3773 (0.03%) |
0/3817 (0.00%) |
Inguinal hernia |
8/4272 (0.19%) |
9/4285 (0.21%) |
2/3773 (0.05%) |
2/3817 (0.05%) |
Inguinal hernia, obstructive |
0/4272 (0.00%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Intestinal angina |
1/4272 (0.02%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Intestinal haemorrhage |
0/4272 (0.00%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
1/3817 (0.03%) |
Intestinal infarction |
2/4272 (0.05%) |
0/4285 (0.00%) |
1/3773 (0.03%) |
0/3817 (0.00%) |
Intestinal ischaemia |
0/4272 (0.00%) |
3/4285 (0.07%) |
0/3773 (0.00%) |
2/3817 (0.05%) |
Intestinal mass |
1/4272 (0.02%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Intestinal obstruction |
4/4272 (0.09%) |
4/4285 (0.09%) |
2/3773 (0.05%) |
1/3817 (0.03%) |
Intestinal perforation |
2/4272 (0.05%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Intestinal polyp |
4/4272 (0.09%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Intestinal stenosis |
0/4272 (0.00%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Intussusception |
0/4272 (0.00%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
1/3817 (0.03%) |
Irritable bowel syndrome |
0/4272 (0.00%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Ischaemic pancreatitis |
0/4272 (0.00%) |
0/4285 (0.00%) |
1/3773 (0.03%) |
0/3817 (0.00%) |
Large intestinal ulcer |
1/4272 (0.02%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Large intestine perforation |
2/4272 (0.05%) |
1/4285 (0.02%) |
1/3773 (0.03%) |
0/3817 (0.00%) |
Large intestine polyp |
17/4272 (0.40%) |
17/4285 (0.40%) |
2/3773 (0.05%) |
6/3817 (0.16%) |
Lip oedema |
0/4272 (0.00%) |
2/4285 (0.05%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Lip swelling |
1/4272 (0.02%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Lower gastrointestinal haemorrhage |
1/4272 (0.02%) |
2/4285 (0.05%) |
1/3773 (0.03%) |
0/3817 (0.00%) |
Mechanical ileus |
1/4272 (0.02%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Melaena |
5/4272 (0.12%) |
5/4285 (0.12%) |
3/3773 (0.08%) |
0/3817 (0.00%) |
Mesenteric occlusion |
1/4272 (0.02%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Mouth haemorrhage |
0/4272 (0.00%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Nausea |
11/4272 (0.26%) |
8/4285 (0.19%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Oesophageal haemorrhage |
0/4272 (0.00%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Oesophageal stenosis |
0/4272 (0.00%) |
0/4285 (0.00%) |
1/3773 (0.03%) |
0/3817 (0.00%) |
Oesophageal ulcer |
0/4272 (0.00%) |
2/4285 (0.05%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Oesophageal varices haemorrhage |
2/4272 (0.05%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Oesophagitis |
2/4272 (0.05%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Palatal disorder |
0/4272 (0.00%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Pancreatic mass |
1/4272 (0.02%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
1/3817 (0.03%) |
Pancreatitis |
5/4272 (0.12%) |
4/4285 (0.09%) |
4/3773 (0.11%) |
1/3817 (0.03%) |
Pancreatitis acute |
8/4272 (0.19%) |
5/4285 (0.12%) |
1/3773 (0.03%) |
1/3817 (0.03%) |
Pancreatitis chronic |
0/4272 (0.00%) |
0/4285 (0.00%) |
1/3773 (0.03%) |
1/3817 (0.03%) |
Pancreatolithiasis |
0/4272 (0.00%) |
0/4285 (0.00%) |
1/3773 (0.03%) |
1/3817 (0.03%) |
Peptic ulcer haemorrhage |
0/4272 (0.00%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Peptic ulcer perforation |
1/4272 (0.02%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Peritoneal haematoma |
0/4272 (0.00%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Pneumatosis intestinalis |
1/4272 (0.02%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Portal hypertensive gastropathy |
0/4272 (0.00%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Proctitis |
0/4272 (0.00%) |
0/4285 (0.00%) |
1/3773 (0.03%) |
0/3817 (0.00%) |
Rectal haemorrhage |
8/4272 (0.19%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
1/3817 (0.03%) |
Rectal polyp |
3/4272 (0.07%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
1/3817 (0.03%) |
Retroperitoneal haematoma |
0/4272 (0.00%) |
0/4285 (0.00%) |
1/3773 (0.03%) |
0/3817 (0.00%) |
Retroperitoneal haemorrhage |
0/4272 (0.00%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Retroperitoneal mass |
0/4272 (0.00%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
1/3817 (0.03%) |
Salivary gland calculus |
0/4272 (0.00%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Sciatic hernia |
0/4272 (0.00%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Small intestinal haemorrhage |
0/4272 (0.00%) |
0/4285 (0.00%) |
1/3773 (0.03%) |
0/3817 (0.00%) |
Small intestinal obstruction |
2/4272 (0.05%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
2/3817 (0.05%) |
Stress ulcer |
0/4272 (0.00%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Subileus |
1/4272 (0.02%) |
2/4285 (0.05%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Swollen tongue |
1/4272 (0.02%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Thrombosis mesenteric vessel |
1/4272 (0.02%) |
0/4285 (0.00%) |
1/3773 (0.03%) |
0/3817 (0.00%) |
Umbilical hernia |
1/4272 (0.02%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Upper gastrointestinal haemorrhage |
8/4272 (0.19%) |
11/4285 (0.26%) |
0/3773 (0.00%) |
2/3817 (0.05%) |
Varices oesophageal |
0/4272 (0.00%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Volvulus |
2/4272 (0.05%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Vomiting |
22/4272 (0.51%) |
18/4285 (0.42%) |
0/3773 (0.00%) |
2/3817 (0.05%) |
General disorders |
|
|
|
|
Adverse drug reaction |
0/4272 (0.00%) |
1/4285 (0.02%) |
1/3773 (0.03%) |
0/3817 (0.00%) |
Asthenia |
15/4272 (0.35%) |
4/4285 (0.09%) |
6/3773 (0.16%) |
5/3817 (0.13%) |
Cardiac death |
8/4272 (0.19%) |
7/4285 (0.16%) |
3/3773 (0.08%) |
2/3817 (0.05%) |
Catheter site haemorrhage |
0/4272 (0.00%) |
0/4285 (0.00%) |
2/3773 (0.05%) |
0/3817 (0.00%) |
Chest discomfort |
2/4272 (0.05%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Chest pain |
4/4272 (0.09%) |
7/4285 (0.16%) |
4/3773 (0.11%) |
1/3817 (0.03%) |
Chills |
2/4272 (0.05%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Death |
21/4272 (0.49%) |
15/4285 (0.35%) |
13/3773 (0.34%) |
17/3817 (0.45%) |
Device battery issue |
0/4272 (0.00%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
1/3817 (0.03%) |
Device dislocation |
1/4272 (0.02%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Device electrical finding |
1/4272 (0.02%) |
0/4285 (0.00%) |
1/3773 (0.03%) |
0/3817 (0.00%) |
Device failure |
1/4272 (0.02%) |
0/4285 (0.00%) |
1/3773 (0.03%) |
0/3817 (0.00%) |
Device lead issue |
1/4272 (0.02%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
1/3817 (0.03%) |
Device malfunction |
3/4272 (0.07%) |
1/4285 (0.02%) |
1/3773 (0.03%) |
1/3817 (0.03%) |
Discomfort |
1/4272 (0.02%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Disease progression |
0/4272 (0.00%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Drug intolerance |
1/4272 (0.02%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Face oedema |
11/4272 (0.26%) |
10/4285 (0.23%) |
2/3773 (0.05%) |
0/3817 (0.00%) |
Facial pain |
0/4272 (0.00%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Fat tissue increased |
0/4272 (0.00%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Fatigue |
3/4272 (0.07%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Gait disturbance |
1/4272 (0.02%) |
3/4285 (0.07%) |
1/3773 (0.03%) |
0/3817 (0.00%) |
General physical health deterioration |
2/4272 (0.05%) |
4/4285 (0.09%) |
2/3773 (0.05%) |
2/3817 (0.05%) |
General symptom |
1/4272 (0.02%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Generalised oedema |
10/4272 (0.23%) |
11/4285 (0.26%) |
5/3773 (0.13%) |
3/3817 (0.08%) |
Granuloma |
1/4272 (0.02%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Hyperplasia |
0/4272 (0.00%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Hyperthermia |
1/4272 (0.02%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Impaired healing |
1/4272 (0.02%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
1/3817 (0.03%) |
Inflammation |
0/4272 (0.00%) |
2/4285 (0.05%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Influenza like illness |
2/4272 (0.05%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Localised oedema |
2/4272 (0.05%) |
3/4285 (0.07%) |
2/3773 (0.05%) |
0/3817 (0.00%) |
Malaise |
2/4272 (0.05%) |
4/4285 (0.09%) |
1/3773 (0.03%) |
0/3817 (0.00%) |
Medical device complication |
1/4272 (0.02%) |
1/4285 (0.02%) |
1/3773 (0.03%) |
0/3817 (0.00%) |
Multi-organ failure |
0/4272 (0.00%) |
5/4285 (0.12%) |
4/3773 (0.11%) |
3/3817 (0.08%) |
Non-cardiac chest pain |
37/4272 (0.87%) |
39/4285 (0.91%) |
8/3773 (0.21%) |
2/3817 (0.05%) |
Oedema |
2/4272 (0.05%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Oedema due to cardiac disease |
0/4272 (0.00%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Oedema peripheral |
45/4272 (1.05%) |
41/4285 (0.96%) |
7/3773 (0.19%) |
9/3817 (0.24%) |
Pain |
0/4272 (0.00%) |
1/4285 (0.02%) |
1/3773 (0.03%) |
2/3817 (0.05%) |
Pelvic mass |
1/4272 (0.02%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Perforated ulcer |
1/4272 (0.02%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Pyrexia |
25/4272 (0.59%) |
13/4285 (0.30%) |
4/3773 (0.11%) |
3/3817 (0.08%) |
Spinal pain |
1/4272 (0.02%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Sudden cardiac death |
19/4272 (0.44%) |
13/4285 (0.30%) |
4/3773 (0.11%) |
3/3817 (0.08%) |
Sudden death |
20/4272 (0.47%) |
16/4285 (0.37%) |
9/3773 (0.24%) |
4/3817 (0.10%) |
Swelling |
0/4272 (0.00%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
1/3817 (0.03%) |
Systemic inflammatory response syndrome |
2/4272 (0.05%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Ulcer |
1/4272 (0.02%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Ulcer haemorrhage |
1/4272 (0.02%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Hepatobiliary disorders |
|
|
|
|
Acute hepatic failure |
0/4272 (0.00%) |
1/4285 (0.02%) |
2/3773 (0.05%) |
0/3817 (0.00%) |
Autoimmune hepatitis |
1/4272 (0.02%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Bile duct obstruction |
0/4272 (0.00%) |
1/4285 (0.02%) |
1/3773 (0.03%) |
0/3817 (0.00%) |
Bile duct stenosis |
0/4272 (0.00%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Bile duct stone |
7/4272 (0.16%) |
3/4285 (0.07%) |
0/3773 (0.00%) |
2/3817 (0.05%) |
Biliary cirrhosis primary |
1/4272 (0.02%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Biliary colic |
3/4272 (0.07%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
1/3817 (0.03%) |
Biliary cyst |
1/4272 (0.02%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Cholangitis |
6/4272 (0.14%) |
2/4285 (0.05%) |
1/3773 (0.03%) |
0/3817 (0.00%) |
Cholangitis acute |
2/4272 (0.05%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
1/3817 (0.03%) |
Cholecystitis |
13/4272 (0.30%) |
12/4285 (0.28%) |
3/3773 (0.08%) |
6/3817 (0.16%) |
Cholecystitis acute |
8/4272 (0.19%) |
11/4285 (0.26%) |
1/3773 (0.03%) |
2/3817 (0.05%) |
Cholecystitis chronic |
1/4272 (0.02%) |
3/4285 (0.07%) |
1/3773 (0.03%) |
0/3817 (0.00%) |
Cholelithiasis |
13/4272 (0.30%) |
20/4285 (0.47%) |
4/3773 (0.11%) |
2/3817 (0.05%) |
Cholestasis |
0/4272 (0.00%) |
0/4285 (0.00%) |
1/3773 (0.03%) |
0/3817 (0.00%) |
Dilatation intrahepatic duct acquired |
0/4272 (0.00%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Hepatic artery aneurysm |
0/4272 (0.00%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Hepatic cirrhosis |
7/4272 (0.16%) |
4/4285 (0.09%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Hepatic congestion |
0/4272 (0.00%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Hepatic cyst |
1/4272 (0.02%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Hepatic failure |
1/4272 (0.02%) |
1/4285 (0.02%) |
1/3773 (0.03%) |
0/3817 (0.00%) |
Hepatic function abnormal |
1/4272 (0.02%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
1/3817 (0.03%) |
Hepatitis |
2/4272 (0.05%) |
3/4285 (0.07%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Hepatitis acute |
0/4272 (0.00%) |
2/4285 (0.05%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Hepatitis cholestatic |
0/4272 (0.00%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Hepatorenal syndrome |
1/4272 (0.02%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Jaundice |
3/4272 (0.07%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
1/3817 (0.03%) |
Jaundice cholestatic |
0/4272 (0.00%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
1/3817 (0.03%) |
Liver disorder |
0/4272 (0.00%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Portal vein thrombosis |
0/4272 (0.00%) |
0/4285 (0.00%) |
1/3773 (0.03%) |
0/3817 (0.00%) |
Immune system disorders |
|
|
|
|
Anaphylactic shock |
1/4272 (0.02%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Contrast media allergy |
2/4272 (0.05%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Drug hypersensitivity |
2/4272 (0.05%) |
1/4285 (0.02%) |
2/3773 (0.05%) |
0/3817 (0.00%) |
Hypersensitivity |
0/4272 (0.00%) |
3/4285 (0.07%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Iodine allergy |
1/4272 (0.02%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Sarcoidosis |
0/4272 (0.00%) |
0/4285 (0.00%) |
1/3773 (0.03%) |
0/3817 (0.00%) |
Secondary immunodeficiency |
0/4272 (0.00%) |
0/4285 (0.00%) |
1/3773 (0.03%) |
0/3817 (0.00%) |
Infections and infestations |
|
|
|
|
Abdominal abscess |
1/4272 (0.02%) |
2/4285 (0.05%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Abdominal infection |
1/4272 (0.02%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Abdominal sepsis |
2/4272 (0.05%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Abscess limb |
2/4272 (0.05%) |
6/4285 (0.14%) |
2/3773 (0.05%) |
0/3817 (0.00%) |
American trypanosomiasis |
0/4272 (0.00%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Anal abscess |
2/4272 (0.05%) |
3/4285 (0.07%) |
1/3773 (0.03%) |
0/3817 (0.00%) |
Appendiceal abscess |
0/4272 (0.00%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Appendicitis |
5/4272 (0.12%) |
2/4285 (0.05%) |
3/3773 (0.08%) |
1/3817 (0.03%) |
Appendicitis perforated |
0/4272 (0.00%) |
1/4285 (0.02%) |
1/3773 (0.03%) |
1/3817 (0.03%) |
Arthritis infective |
1/4272 (0.02%) |
0/4285 (0.00%) |
2/3773 (0.05%) |
0/3817 (0.00%) |
Atypical pneumonia |
0/4272 (0.00%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Bacteraemia |
3/4272 (0.07%) |
2/4285 (0.05%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Bacterial infection |
1/4272 (0.02%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Biliary abscess |
1/4272 (0.02%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Biliary tract infection |
0/4272 (0.00%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Bone abscess |
1/4272 (0.02%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Breast abscess |
1/4272 (0.02%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Bronchiolitis |
0/4272 (0.00%) |
1/4285 (0.02%) |
1/3773 (0.03%) |
0/3817 (0.00%) |
Bronchitis |
22/4272 (0.51%) |
22/4285 (0.51%) |
4/3773 (0.11%) |
11/3817 (0.29%) |
Bronchitis bacterial |
0/4272 (0.00%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Bronchopneumonia |
21/4272 (0.49%) |
22/4285 (0.51%) |
6/3773 (0.16%) |
0/3817 (0.00%) |
Campylobacter gastroenteritis |
1/4272 (0.02%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Candidiasis |
0/4272 (0.00%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
1/3817 (0.03%) |
Carbuncle |
2/4272 (0.05%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Catheter site infection |
1/4272 (0.02%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Cellulitis |
41/4272 (0.96%) |
41/4285 (0.96%) |
16/3773 (0.42%) |
10/3817 (0.26%) |
Cellulitis of male external genital organ |
1/4272 (0.02%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Chronic hepatitis B |
1/4272 (0.02%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Chronic sinusitis |
3/4272 (0.07%) |
2/4285 (0.05%) |
2/3773 (0.05%) |
0/3817 (0.00%) |
Clostridial infection |
0/4272 (0.00%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Clostridium difficile colitis |
3/4272 (0.07%) |
2/4285 (0.05%) |
0/3773 (0.00%) |
1/3817 (0.03%) |
Clostridium difficile infection |
0/4272 (0.00%) |
2/4285 (0.05%) |
1/3773 (0.03%) |
0/3817 (0.00%) |
Cystitis |
1/4272 (0.02%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Cystitis bacterial |
0/4272 (0.00%) |
0/4285 (0.00%) |
1/3773 (0.03%) |
0/3817 (0.00%) |
Cystitis klebsiella |
1/4272 (0.02%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Cytomegalovirus hepatitis |
1/4272 (0.02%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Dengue fever |
0/4272 (0.00%) |
0/4285 (0.00%) |
1/3773 (0.03%) |
0/3817 (0.00%) |
Device related infection |
10/4272 (0.23%) |
5/4285 (0.12%) |
2/3773 (0.05%) |
1/3817 (0.03%) |
Device related sepsis |
2/4272 (0.05%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Diabetic foot infection |
5/4272 (0.12%) |
2/4285 (0.05%) |
1/3773 (0.03%) |
0/3817 (0.00%) |
Diabetic gangrene |
4/4272 (0.09%) |
4/4285 (0.09%) |
0/3773 (0.00%) |
3/3817 (0.08%) |
Diarrhoea infectious |
2/4272 (0.05%) |
0/4285 (0.00%) |
1/3773 (0.03%) |
0/3817 (0.00%) |
Diverticulitis |
4/4272 (0.09%) |
8/4285 (0.19%) |
2/3773 (0.05%) |
0/3817 (0.00%) |
Eczema infected |
1/4272 (0.02%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Emphysematous pyelonephritis |
0/4272 (0.00%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Endocarditis |
5/4272 (0.12%) |
2/4285 (0.05%) |
0/3773 (0.00%) |
4/3817 (0.10%) |
Endocarditis bacterial |
2/4272 (0.05%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Endocarditis staphylococcal |
0/4272 (0.00%) |
0/4285 (0.00%) |
1/3773 (0.03%) |
0/3817 (0.00%) |
Endometritis |
0/4272 (0.00%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
1/3817 (0.03%) |
Endophthalmitis |
0/4272 (0.00%) |
0/4285 (0.00%) |
1/3773 (0.03%) |
0/3817 (0.00%) |
Endotoxic shock |
0/4272 (0.00%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
1/3817 (0.03%) |
Enteritis infectious |
1/4272 (0.02%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Enteritis necroticans |
0/4272 (0.00%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Enterobacter infection |
0/4272 (0.00%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Enterococcal bacteraemia |
0/4272 (0.00%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
2/3817 (0.05%) |
Enterococcal sepsis |
0/4272 (0.00%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Enterocolitis infectious |
2/4272 (0.05%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
1/3817 (0.03%) |
Epiglottitis |
0/4272 (0.00%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Erysipelas |
18/4272 (0.42%) |
15/4285 (0.35%) |
6/3773 (0.16%) |
6/3817 (0.16%) |
Escherichia bacteraemia |
1/4272 (0.02%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Escherichia sepsis |
2/4272 (0.05%) |
2/4285 (0.05%) |
1/3773 (0.03%) |
1/3817 (0.03%) |
Escherichia urinary tract infection |
2/4272 (0.05%) |
1/4285 (0.02%) |
1/3773 (0.03%) |
0/3817 (0.00%) |
Febrile infection |
0/4272 (0.00%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Furuncle |
1/4272 (0.02%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Gallbladder abscess |
2/4272 (0.05%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Gangrene |
14/4272 (0.33%) |
23/4285 (0.54%) |
0/3773 (0.00%) |
2/3817 (0.05%) |
Gas gangrene |
0/4272 (0.00%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Gastritis viral |
1/4272 (0.02%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Gastroenteritis |
32/4272 (0.75%) |
23/4285 (0.54%) |
7/3773 (0.19%) |
8/3817 (0.21%) |
Gastroenteritis bacterial |
0/4272 (0.00%) |
0/4285 (0.00%) |
1/3773 (0.03%) |
0/3817 (0.00%) |
Gastroenteritis norovirus |
1/4272 (0.02%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Gastroenteritis viral |
0/4272 (0.00%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
2/3817 (0.05%) |
Gastrointestinal infection |
0/4272 (0.00%) |
2/4285 (0.05%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Gastrointestinal viral infection |
1/4272 (0.02%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
H1N1 influenza |
0/4272 (0.00%) |
2/4285 (0.05%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
HIV infection |
0/4272 (0.00%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Haematoma infection |
0/4272 (0.00%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Herpes zoster |
6/4272 (0.14%) |
6/4285 (0.14%) |
4/3773 (0.11%) |
0/3817 (0.00%) |
Incision site infection |
1/4272 (0.02%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Infected bites |
1/4272 (0.02%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Infected bunion |
0/4272 (0.00%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Infected fistula |
1/4272 (0.02%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Infected skin ulcer |
6/4272 (0.14%) |
8/4285 (0.19%) |
3/3773 (0.08%) |
0/3817 (0.00%) |
Infection |
1/4272 (0.02%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Infective exacerbation of bronchiectasis |
1/4272 (0.02%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Infective exacerbation of chronic obstructive airways disease |
0/4272 (0.00%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Infective spondylitis |
1/4272 (0.02%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Influenza |
4/4272 (0.09%) |
3/4285 (0.07%) |
1/3773 (0.03%) |
1/3817 (0.03%) |
Intervertebral discitis |
0/4272 (0.00%) |
1/4285 (0.02%) |
1/3773 (0.03%) |
1/3817 (0.03%) |
Keratitis bacterial |
0/4272 (0.00%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Kidney infection |
1/4272 (0.02%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Laryngitis |
0/4272 (0.00%) |
0/4285 (0.00%) |
1/3773 (0.03%) |
0/3817 (0.00%) |
Listeria sepsis |
0/4272 (0.00%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Liver abscess |
4/4272 (0.09%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Lobar pneumonia |
7/4272 (0.16%) |
8/4285 (0.19%) |
3/3773 (0.08%) |
4/3817 (0.10%) |
Localised infection |
14/4272 (0.33%) |
10/4285 (0.23%) |
1/3773 (0.03%) |
3/3817 (0.08%) |
Lower respiratory tract infection |
10/4272 (0.23%) |
6/4285 (0.14%) |
5/3773 (0.13%) |
3/3817 (0.08%) |
Lower respiratory tract infection viral |
1/4272 (0.02%) |
0/4285 (0.00%) |
1/3773 (0.03%) |
0/3817 (0.00%) |
Lung abscess |
0/4272 (0.00%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
1/3817 (0.03%) |
Lung infection |
21/4272 (0.49%) |
22/4285 (0.51%) |
6/3773 (0.16%) |
2/3817 (0.05%) |
Lymph node tuberculosis |
0/4272 (0.00%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Lymphangitis |
1/4272 (0.02%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Malaria |
1/4272 (0.02%) |
3/4285 (0.07%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Mastoid abscess |
1/4272 (0.02%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Mediastinitis |
0/4272 (0.00%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Meningitis |
0/4272 (0.00%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Meningitis aseptic |
1/4272 (0.02%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Meningitis bacterial |
0/4272 (0.00%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Myelitis |
0/4272 (0.00%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Myiasis |
1/4272 (0.02%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Nasopharyngitis |
1/4272 (0.02%) |
3/4285 (0.07%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Necrotising fasciitis |
0/4272 (0.00%) |
1/4285 (0.02%) |
1/3773 (0.03%) |
0/3817 (0.00%) |
Nosocomial infection |
1/4272 (0.02%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Oesophageal candidiasis |
2/4272 (0.05%) |
3/4285 (0.07%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Oral candidiasis |
0/4272 (0.00%) |
0/4285 (0.00%) |
1/3773 (0.03%) |
0/3817 (0.00%) |
Orchitis |
2/4272 (0.05%) |
2/4285 (0.05%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Oropharyngeal candidiasis |
1/4272 (0.02%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Osteomyelitis |
20/4272 (0.47%) |
17/4285 (0.40%) |
3/3773 (0.08%) |
8/3817 (0.21%) |
Osteomyelitis chronic |
1/4272 (0.02%) |
3/4285 (0.07%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Otitis externa |
1/4272 (0.02%) |
2/4285 (0.05%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Otitis media chronic |
1/4272 (0.02%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Paronychia |
0/4272 (0.00%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
1/3817 (0.03%) |
Parotitis |
0/4272 (0.00%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Parvovirus infection |
0/4272 (0.00%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Pericoronitis |
0/4272 (0.00%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Perihepatic abscess |
2/4272 (0.05%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Periodontitis |
0/4272 (0.00%) |
0/4285 (0.00%) |
1/3773 (0.03%) |
0/3817 (0.00%) |
Periorbital cellulitis |
0/4272 (0.00%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Perirectal abscess |
0/4272 (0.00%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Peritoneal abscess |
1/4272 (0.02%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Peritonitis |
6/4272 (0.14%) |
4/4285 (0.09%) |
1/3773 (0.03%) |
3/3817 (0.08%) |
Peritonsillar abscess |
1/4272 (0.02%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Pharyngitis |
1/4272 (0.02%) |
2/4285 (0.05%) |
0/3773 (0.00%) |
1/3817 (0.03%) |
Pneumococcal sepsis |
0/4272 (0.00%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Pneumonia |
121/4272 (2.83%) |
100/4285 (2.33%) |
42/3773 (1.11%) |
39/3817 (1.02%) |
Pneumonia bacterial |
2/4272 (0.05%) |
3/4285 (0.07%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Pneumonia legionella |
1/4272 (0.02%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Pneumonia necrotising |
0/4272 (0.00%) |
0/4285 (0.00%) |
1/3773 (0.03%) |
0/3817 (0.00%) |
Pneumonia pneumococcal |
1/4272 (0.02%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Pneumonia pseudomonas aeruginosa |
1/4272 (0.02%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Pneumonia staphylococcal |
0/4272 (0.00%) |
0/4285 (0.00%) |
1/3773 (0.03%) |
0/3817 (0.00%) |
Pneumonia streptococcal |
0/4272 (0.00%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Pneumonia viral |
0/4272 (0.00%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
1/3817 (0.03%) |
Post procedural cellulitis |
1/4272 (0.02%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Post procedural infection |
4/4272 (0.09%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Post procedural sepsis |
1/4272 (0.02%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Postoperative wound infection |
3/4272 (0.07%) |
7/4285 (0.16%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Prostate infection |
1/4272 (0.02%) |
0/4285 (0.00%) |
1/3773 (0.03%) |
1/3817 (0.03%) |
Proteus infection |
0/4272 (0.00%) |
0/4285 (0.00%) |
1/3773 (0.03%) |
0/3817 (0.00%) |
Pseudomembranous colitis |
0/4272 (0.00%) |
0/4285 (0.00%) |
1/3773 (0.03%) |
0/3817 (0.00%) |
Pulmonary sepsis |
2/4272 (0.05%) |
1/4285 (0.02%) |
1/3773 (0.03%) |
0/3817 (0.00%) |
Pulmonary tuberculosis |
4/4272 (0.09%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Purulent discharge |
1/4272 (0.02%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Pyelonephritis |
10/4272 (0.23%) |
3/4285 (0.07%) |
4/3773 (0.11%) |
3/3817 (0.08%) |
Pyelonephritis acute |
5/4272 (0.12%) |
8/4285 (0.19%) |
1/3773 (0.03%) |
0/3817 (0.00%) |
Pyelonephritis chronic |
0/4272 (0.00%) |
2/4285 (0.05%) |
0/3773 (0.00%) |
1/3817 (0.03%) |
Pyonephrosis |
1/4272 (0.02%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Q fever |
1/4272 (0.02%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Renal abscess |
0/4272 (0.00%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Respiratory moniliasis |
0/4272 (0.00%) |
0/4285 (0.00%) |
1/3773 (0.03%) |
0/3817 (0.00%) |
Respiratory tract infection |
11/4272 (0.26%) |
13/4285 (0.30%) |
2/3773 (0.05%) |
6/3817 (0.16%) |
Rhinitis |
1/4272 (0.02%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Salmonellosis |
0/4272 (0.00%) |
1/4285 (0.02%) |
1/3773 (0.03%) |
0/3817 (0.00%) |
Schistosomiasis liver |
1/4272 (0.02%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Scrotal infection |
1/4272 (0.02%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Sepsis |
28/4272 (0.66%) |
27/4285 (0.63%) |
9/3773 (0.24%) |
18/3817 (0.47%) |
Septic encephalopathy |
0/4272 (0.00%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
1/3817 (0.03%) |
Septic shock |
15/4272 (0.35%) |
14/4285 (0.33%) |
5/3773 (0.13%) |
7/3817 (0.18%) |
Sinusitis |
0/4272 (0.00%) |
2/4285 (0.05%) |
0/3773 (0.00%) |
1/3817 (0.03%) |
Sinusitis fungal |
0/4272 (0.00%) |
0/4285 (0.00%) |
1/3773 (0.03%) |
0/3817 (0.00%) |
Skin infection |
1/4272 (0.02%) |
4/4285 (0.09%) |
0/3773 (0.00%) |
1/3817 (0.03%) |
Soft tissue infection |
3/4272 (0.07%) |
3/4285 (0.07%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Splenic abscess |
1/4272 (0.02%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Staphylococcal abscess |
0/4272 (0.00%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Staphylococcal bacteraemia |
0/4272 (0.00%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
1/3817 (0.03%) |
Staphylococcal infection |
5/4272 (0.12%) |
2/4285 (0.05%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Staphylococcal sepsis |
0/4272 (0.00%) |
2/4285 (0.05%) |
4/3773 (0.11%) |
0/3817 (0.00%) |
Staphylococcal skin infection |
1/4272 (0.02%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Streptococcal bacteraemia |
0/4272 (0.00%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Streptococcal sepsis |
1/4272 (0.02%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Subcutaneous abscess |
4/4272 (0.09%) |
2/4285 (0.05%) |
2/3773 (0.05%) |
2/3817 (0.05%) |
Syphilis |
1/4272 (0.02%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Tongue abscess |
0/4272 (0.00%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
1/3817 (0.03%) |
Tonsillitis |
0/4272 (0.00%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Tooth abscess |
2/4272 (0.05%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Tooth infection |
0/4272 (0.00%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Tracheitis |
1/4272 (0.02%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Tracheobronchitis |
1/4272 (0.02%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
1/3817 (0.03%) |
Tuberculosis |
1/4272 (0.02%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Tuberculous pleurisy |
0/4272 (0.00%) |
1/4285 (0.02%) |
2/3773 (0.05%) |
0/3817 (0.00%) |
Upper respiratory tract infection |
4/4272 (0.09%) |
4/4285 (0.09%) |
1/3773 (0.03%) |
0/3817 (0.00%) |
Upper respiratory tract infection bacterial |
0/4272 (0.00%) |
0/4285 (0.00%) |
1/3773 (0.03%) |
0/3817 (0.00%) |
Ureteritis |
0/4272 (0.00%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Urethritis |
0/4272 (0.00%) |
0/4285 (0.00%) |
1/3773 (0.03%) |
0/3817 (0.00%) |
Urinary tract infection |
56/4272 (1.31%) |
44/4285 (1.03%) |
10/3773 (0.27%) |
15/3817 (0.39%) |
Urinary tract infection pseudomonal |
0/4272 (0.00%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Urosepsis |
5/4272 (0.12%) |
14/4285 (0.33%) |
4/3773 (0.11%) |
2/3817 (0.05%) |
Vestibular neuronitis |
0/4272 (0.00%) |
2/4285 (0.05%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Viral diarrhoea |
1/4272 (0.02%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Viral infection |
2/4272 (0.05%) |
6/4285 (0.14%) |
1/3773 (0.03%) |
0/3817 (0.00%) |
Viral pericarditis |
1/4272 (0.02%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Wound infection |
3/4272 (0.07%) |
4/4285 (0.09%) |
0/3773 (0.00%) |
1/3817 (0.03%) |
Wound infection staphylococcal |
0/4272 (0.00%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Injury, poisoning and procedural complications |
|
|
|
|
Abdominal injury |
1/4272 (0.02%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Abdominal wound dehiscence |
0/4272 (0.00%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Accidental exposure to product |
0/4272 (0.00%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
1/3817 (0.03%) |
Acetabulum fracture |
1/4272 (0.02%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Ankle fracture |
5/4272 (0.12%) |
3/4285 (0.07%) |
2/3773 (0.05%) |
2/3817 (0.05%) |
Arterial injury |
0/4272 (0.00%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Arterial restenosis |
0/4272 (0.00%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Arteriovenous fistula site complication |
0/4272 (0.00%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Bone contusion |
0/4272 (0.00%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Brain contusion |
1/4272 (0.02%) |
1/4285 (0.02%) |
1/3773 (0.03%) |
0/3817 (0.00%) |
Burns second degree |
2/4272 (0.05%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Burns third degree |
1/4272 (0.02%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Carbon monoxide poisoning |
0/4272 (0.00%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Cervical vertebral fracture |
0/4272 (0.00%) |
3/4285 (0.07%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Clavicle fracture |
2/4272 (0.05%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
1/3817 (0.03%) |
Comminuted fracture |
0/4272 (0.00%) |
0/4285 (0.00%) |
1/3773 (0.03%) |
0/3817 (0.00%) |
Compression fracture |
0/4272 (0.00%) |
0/4285 (0.00%) |
1/3773 (0.03%) |
0/3817 (0.00%) |
Concussion |
1/4272 (0.02%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
1/3817 (0.03%) |
Contusion |
3/4272 (0.07%) |
3/4285 (0.07%) |
1/3773 (0.03%) |
3/3817 (0.08%) |
Coronary artery restenosis |
1/4272 (0.02%) |
2/4285 (0.05%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Craniocerebral injury |
0/4272 (0.00%) |
2/4285 (0.05%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Excoriation |
3/4272 (0.07%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Eye injury |
1/4272 (0.02%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Face injury |
1/4272 (0.02%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Facial bones fracture |
0/4272 (0.00%) |
0/4285 (0.00%) |
1/3773 (0.03%) |
0/3817 (0.00%) |
Fall |
23/4272 (0.54%) |
10/4285 (0.23%) |
2/3773 (0.05%) |
5/3817 (0.13%) |
Fat embolism |
1/4272 (0.02%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Femoral neck fracture |
8/4272 (0.19%) |
9/4285 (0.21%) |
1/3773 (0.03%) |
2/3817 (0.05%) |
Femur fracture |
7/4272 (0.16%) |
13/4285 (0.30%) |
4/3773 (0.11%) |
3/3817 (0.08%) |
Fibula fracture |
2/4272 (0.05%) |
3/4285 (0.07%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Foot fracture |
4/4272 (0.09%) |
2/4285 (0.05%) |
0/3773 (0.00%) |
1/3817 (0.03%) |
Foreign body aspiration |
1/4272 (0.02%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Foreign body in eye |
0/4272 (0.00%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Gun shot wound |
0/4272 (0.00%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Haemodialysis complication |
0/4272 (0.00%) |
0/4285 (0.00%) |
1/3773 (0.03%) |
0/3817 (0.00%) |
Hand fracture |
2/4272 (0.05%) |
2/4285 (0.05%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Head injury |
7/4272 (0.16%) |
6/4285 (0.14%) |
1/3773 (0.03%) |
5/3817 (0.13%) |
Heat stroke |
1/4272 (0.02%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Hip fracture |
9/4272 (0.21%) |
14/4285 (0.33%) |
3/3773 (0.08%) |
0/3817 (0.00%) |
Humerus fracture |
10/4272 (0.23%) |
8/4285 (0.19%) |
0/3773 (0.00%) |
2/3817 (0.05%) |
Incision site complication |
1/4272 (0.02%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Incision site haematoma |
1/4272 (0.02%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Incision site haemorrhage |
2/4272 (0.05%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Incisional hernia |
1/4272 (0.02%) |
2/4285 (0.05%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Intentional overdose |
0/4272 (0.00%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Joint dislocation |
2/4272 (0.05%) |
2/4285 (0.05%) |
1/3773 (0.03%) |
0/3817 (0.00%) |
Joint injury |
2/4272 (0.05%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Laceration |
3/4272 (0.07%) |
2/4285 (0.05%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Ligament injury |
0/4272 (0.00%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Ligament sprain |
0/4272 (0.00%) |
2/4285 (0.05%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Limb injury |
5/4272 (0.12%) |
2/4285 (0.05%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Limb traumatic amputation |
1/4272 (0.02%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Lower limb fracture |
3/4272 (0.07%) |
4/4285 (0.09%) |
0/3773 (0.00%) |
1/3817 (0.03%) |
Lumbar vertebral fracture |
2/4272 (0.05%) |
2/4285 (0.05%) |
1/3773 (0.03%) |
2/3817 (0.05%) |
Meniscus injury |
2/4272 (0.05%) |
2/4285 (0.05%) |
2/3773 (0.05%) |
0/3817 (0.00%) |
Multiple injuries |
1/4272 (0.02%) |
0/4285 (0.00%) |
1/3773 (0.03%) |
0/3817 (0.00%) |
Muscle rupture |
1/4272 (0.02%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Muscle strain |
0/4272 (0.00%) |
0/4285 (0.00%) |
1/3773 (0.03%) |
0/3817 (0.00%) |
Overdose |
0/4272 (0.00%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
1/3817 (0.03%) |
Patella fracture |
2/4272 (0.05%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
2/3817 (0.05%) |
Pelvic fracture |
1/4272 (0.02%) |
3/4285 (0.07%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Peritoneal dialysis complication |
0/4272 (0.00%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Pneumothorax traumatic |
2/4272 (0.05%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Post laminectomy syndrome |
1/4272 (0.02%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Post procedural complication |
2/4272 (0.05%) |
4/4285 (0.09%) |
1/3773 (0.03%) |
1/3817 (0.03%) |
Post procedural diarrhoea |
1/4272 (0.02%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Post procedural haematoma |
1/4272 (0.02%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Post procedural haemorrhage |
2/4272 (0.05%) |
0/4285 (0.00%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Post procedural myocardial infarction |
0/4272 (0.00%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
Post-traumatic neck syndrome |
0/4272 (0.00%) |
1/4285 (0.02%) |
0/3773 (0.00%) |
0/3817 (0.00%) |
|