Time Frame |
All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP).
|
Adverse Event Reporting Description |
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
|
|
Arm/Group Title
|
Placebo
|
Alirocumab
|
Arm/Group Description |
Placebo (for alirocumab) SC injecti...
|
Alirocumab 75 mg SC injection Q2W a...
|
Arm/Group Description |
Placebo (for alirocumab) SC injection Q2W added to stable LMT for up to 64 months.
|
Alirocumab 75 mg SC injection Q2W added to stable LMT for up to 64 months. Alirocumab dose up-titrated to 150 mg Q2W from Month 2 when LDL-C levels >=50 mg/dL (1.29 mmol/L) at Month 1; or if up-titration was missed due to unavailability of LDL-C value, it was up-titrated at month 4 based on LDL-C value at Month 2. For participants receiving 150 mg Q2W, alirocumab dose was down-titrated in a blinded manner to 75 mg Q2W if two consecutive values of LDL-C were <25 mg/dL (0.65 mmol/L). For participants receiving 75 mg Q2W, alirocumab dose was switched to placebo in a blinded manner if two consecutive values of LDL-C were <15 mg/dL (0.39 mmol/L).
|
|
|
Placebo
|
Alirocumab
|
|
Affected / at Risk (%) |
|
Affected / at Risk (%) |
|
Total |
278/9443 (2.94%)
|
|
238/9451 (2.52%)
|
|
|
|
Placebo
|
Alirocumab
|
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Total |
2350/9443 (24.89%)
|
|
2202/9451 (23.30%)
|
|
Blood and lymphatic system disorders |
|
|
Anaemia |
15/9443 (0.16%)
|
15 |
11/9451 (0.12%)
|
11 |
Anaemia Of Chronic Disease |
2/9443 (0.02%)
|
2 |
0/9451 (0.00%)
|
0 |
Anaemia Of Malignant Disease |
1/9443 (0.01%)
|
1 |
1/9451 (0.01%)
|
1 |
Anaemia Vitamin B12 Deficiency |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Autoimmune Haemolytic Anaemia |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Coagulopathy |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Disseminated Intravascular Coagulation |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Febrile Neutropenia |
0/9443 (0.00%)
|
0 |
3/9451 (0.03%)
|
3 |
Haemolytic Anaemia |
1/9443 (0.01%)
|
1 |
1/9451 (0.01%)
|
1 |
Haemorrhagic Anaemia |
17/9443 (0.18%)
|
18 |
14/9451 (0.15%)
|
15 |
Haemorrhagic Diathesis |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Hypochromic Anaemia |
5/9443 (0.05%)
|
5 |
3/9451 (0.03%)
|
3 |
Iron Deficiency Anaemia |
8/9443 (0.08%)
|
8 |
7/9451 (0.07%)
|
7 |
Leukocytosis |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Leukopenia |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Lymphadenitis |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Lymphadenopathy |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Microcytic Anaemia |
2/9443 (0.02%)
|
2 |
1/9451 (0.01%)
|
1 |
Nephrogenic Anaemia |
3/9443 (0.03%)
|
3 |
0/9451 (0.00%)
|
0 |
Normochromic Normocytic Anaemia |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Normocytic Anaemia |
1/9443 (0.01%)
|
1 |
2/9451 (0.02%)
|
2 |
Thrombocytopenia |
6/9443 (0.06%)
|
7 |
2/9451 (0.02%)
|
2 |
Thrombotic Thrombocytopenic Purpura |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Cardiac disorders |
|
|
Acute Coronary Syndrome |
1/9443 (0.01%)
|
1 |
1/9451 (0.01%)
|
1 |
Acute Left Ventricular Failure |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Acute Myocardial Infarction |
3/9443 (0.03%)
|
3 |
6/9451 (0.06%)
|
6 |
Adams-Stokes Syndrome |
2/9443 (0.02%)
|
2 |
0/9451 (0.00%)
|
0 |
Angina Pectoris |
133/9443 (1.41%)
|
148 |
113/9451 (1.20%)
|
136 |
Angina Unstable |
8/9443 (0.08%)
|
8 |
10/9451 (0.11%)
|
10 |
Aortic Valve Disease Mixed |
2/9443 (0.02%)
|
2 |
1/9451 (0.01%)
|
1 |
Aortic Valve Incompetence |
1/9443 (0.01%)
|
1 |
4/9451 (0.04%)
|
4 |
Aortic Valve Sclerosis |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Aortic Valve Stenosis |
17/9443 (0.18%)
|
17 |
7/9451 (0.07%)
|
7 |
Arrhythmia |
1/9443 (0.01%)
|
1 |
5/9451 (0.05%)
|
5 |
Arrhythmia Supraventricular |
2/9443 (0.02%)
|
2 |
3/9451 (0.03%)
|
3 |
Arteriosclerosis Coronary Artery |
4/9443 (0.04%)
|
4 |
2/9451 (0.02%)
|
2 |
Arteriospasm Coronary |
2/9443 (0.02%)
|
2 |
0/9451 (0.00%)
|
0 |
Atrial Fibrillation |
98/9443 (1.04%)
|
110 |
82/9451 (0.87%)
|
103 |
Atrial Flutter |
10/9443 (0.11%)
|
14 |
14/9451 (0.15%)
|
16 |
Atrial Tachycardia |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Atrioventricular Block |
2/9443 (0.02%)
|
2 |
1/9451 (0.01%)
|
1 |
Atrioventricular Block Complete |
6/9443 (0.06%)
|
6 |
5/9451 (0.05%)
|
5 |
Atrioventricular Block First Degree |
0/9443 (0.00%)
|
0 |
2/9451 (0.02%)
|
2 |
Atrioventricular Block Second Degree |
5/9443 (0.05%)
|
5 |
3/9451 (0.03%)
|
3 |
Bradycardia |
9/9443 (0.10%)
|
9 |
8/9451 (0.08%)
|
8 |
Bundle Branch Block Left |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Bundle Branch Block Right |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Cardiac Aneurysm |
1/9443 (0.01%)
|
1 |
2/9451 (0.02%)
|
2 |
Cardiac Arrest |
9/9443 (0.10%)
|
10 |
9/9451 (0.10%)
|
9 |
Cardiac Discomfort |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Cardiac Failure |
4/9443 (0.04%)
|
4 |
4/9451 (0.04%)
|
4 |
Cardiac Failure Acute |
3/9443 (0.03%)
|
4 |
2/9451 (0.02%)
|
2 |
Cardiac Failure Chronic |
2/9443 (0.02%)
|
2 |
1/9451 (0.01%)
|
1 |
Cardiac Failure Congestive |
5/9443 (0.05%)
|
5 |
4/9451 (0.04%)
|
4 |
Cardiac Flutter |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Cardiac Perforation |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Cardiac Tamponade |
1/9443 (0.01%)
|
1 |
1/9451 (0.01%)
|
1 |
Cardio-Respiratory Arrest |
3/9443 (0.03%)
|
3 |
4/9451 (0.04%)
|
4 |
Cardiogenic Shock |
6/9443 (0.06%)
|
6 |
4/9451 (0.04%)
|
4 |
Cardiomyopathy |
6/9443 (0.06%)
|
6 |
1/9451 (0.01%)
|
1 |
Chordae Tendinae Rupture |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Conduction Disorder |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Congestive Cardiomyopathy |
0/9443 (0.00%)
|
0 |
3/9451 (0.03%)
|
3 |
Coronary Artery Disease |
20/9443 (0.21%)
|
20 |
25/9451 (0.26%)
|
26 |
Coronary Artery Dissection |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Coronary Artery Occlusion |
1/9443 (0.01%)
|
1 |
3/9451 (0.03%)
|
3 |
Coronary Artery Stenosis |
3/9443 (0.03%)
|
3 |
6/9451 (0.06%)
|
6 |
Diastolic Dysfunction |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Extrasystoles |
1/9443 (0.01%)
|
1 |
1/9451 (0.01%)
|
1 |
Intracardiac Mass |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Intracardiac Thrombus |
4/9443 (0.04%)
|
4 |
2/9451 (0.02%)
|
2 |
Ischaemic Cardiomyopathy |
9/9443 (0.10%)
|
9 |
9/9451 (0.10%)
|
9 |
Ischaemic Mitral Regurgitation |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Left Ventricular Dysfunction |
3/9443 (0.03%)
|
3 |
2/9451 (0.02%)
|
2 |
Low Cardiac Output Syndrome |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Microvascular Coronary Artery Disease |
1/9443 (0.01%)
|
1 |
1/9451 (0.01%)
|
1 |
Mitral Valve Incompetence |
7/9443 (0.07%)
|
7 |
9/9451 (0.10%)
|
9 |
Mitral Valve Prolapse |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Myocardial Haemorrhage |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Myocardial Infarction |
4/9443 (0.04%)
|
4 |
2/9451 (0.02%)
|
2 |
Myocardial Ischaemia |
13/9443 (0.14%)
|
13 |
4/9451 (0.04%)
|
4 |
Myocardial Rupture |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Myocarditis |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Nodal Arrhythmia |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Nodal Rhythm |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Palpitations |
5/9443 (0.05%)
|
5 |
2/9451 (0.02%)
|
2 |
Papillary Muscle Rupture |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Pericardial Effusion |
5/9443 (0.05%)
|
5 |
3/9451 (0.03%)
|
3 |
Pericardial Haemorrhage |
1/9443 (0.01%)
|
1 |
1/9451 (0.01%)
|
1 |
Pericarditis |
3/9443 (0.03%)
|
3 |
6/9451 (0.06%)
|
6 |
Pleuropericarditis |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Prinzmetal Angina |
1/9443 (0.01%)
|
3 |
1/9451 (0.01%)
|
1 |
Pulseless Electrical Activity |
3/9443 (0.03%)
|
3 |
1/9451 (0.01%)
|
1 |
Rhythm Idioventricular |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Sinus Arrest |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Sinus Arrhythmia |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Sinus Bradycardia |
1/9443 (0.01%)
|
1 |
4/9451 (0.04%)
|
4 |
Sinus Node Dysfunction |
9/9443 (0.10%)
|
9 |
13/9451 (0.14%)
|
13 |
Sinus Tachycardia |
3/9443 (0.03%)
|
3 |
3/9451 (0.03%)
|
3 |
Stress Cardiomyopathy |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Supraventricular Extrasystoles |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Supraventricular Tachycardia |
12/9443 (0.13%)
|
16 |
9/9451 (0.10%)
|
11 |
Systolic Dysfunction |
2/9443 (0.02%)
|
2 |
1/9451 (0.01%)
|
1 |
Tachyarrhythmia |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Tachycardia |
1/9443 (0.01%)
|
1 |
2/9451 (0.02%)
|
2 |
Tricuspid Valve Disease |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Ventricular Arrhythmia |
1/9443 (0.01%)
|
1 |
2/9451 (0.02%)
|
2 |
Ventricular Extrasystoles |
5/9443 (0.05%)
|
5 |
7/9451 (0.07%)
|
7 |
Ventricular Fibrillation |
17/9443 (0.18%)
|
17 |
8/9451 (0.08%)
|
8 |
Ventricular Hypokinesia |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Ventricular Tachycardia |
29/9443 (0.31%)
|
33 |
24/9451 (0.25%)
|
28 |
Congenital, familial and genetic disorders |
|
|
Atrial Septal Defect |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Bicuspid Aortic Valve |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Bronchogenic Cyst |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Dermoid Cyst |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Gastrointestinal Arteriovenous Malformation |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Haemorrhagic Arteriovenous Malformation |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Hereditary Optic Atrophy |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Spinocerebellar Ataxia |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Thyroglossal Cyst |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Von Hippel-Lindau Disease |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Ear and labyrinth disorders |
|
|
Acute Vestibular Syndrome |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Deafness Neurosensory |
1/9443 (0.01%)
|
1 |
1/9451 (0.01%)
|
1 |
Hypoacusis |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Sudden Hearing Loss |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Tinnitus |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Tympanic Membrane Disorder |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Tympanic Membrane Perforation |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Vertigo |
12/9443 (0.13%)
|
12 |
9/9451 (0.10%)
|
9 |
Vertigo Labyrinthine |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Vertigo Positional |
3/9443 (0.03%)
|
3 |
4/9451 (0.04%)
|
4 |
Endocrine disorders |
|
|
Adrenal Insufficiency |
3/9443 (0.03%)
|
3 |
0/9451 (0.00%)
|
0 |
Adrenocortical Insufficiency Acute |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Adrenocorticotropic Hormone Deficiency |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Autoimmune Hypothyroidism |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Basedow's Disease |
1/9443 (0.01%)
|
1 |
1/9451 (0.01%)
|
1 |
Goitre |
2/9443 (0.02%)
|
2 |
0/9451 (0.00%)
|
0 |
Hyperthyroidism |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Hypothyroidism |
3/9443 (0.03%)
|
3 |
1/9451 (0.01%)
|
1 |
Inappropriate Antidiuretic Hormone Secretion |
1/9443 (0.01%)
|
1 |
1/9451 (0.01%)
|
1 |
Pituitary Cyst |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Thyroid Mass |
1/9443 (0.01%)
|
1 |
1/9451 (0.01%)
|
1 |
Toxic Goitre |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Toxic Nodular Goitre |
2/9443 (0.02%)
|
2 |
2/9451 (0.02%)
|
2 |
Eye disorders |
|
|
Amaurosis Fugax |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Blepharochalasis |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Cataract |
13/9443 (0.14%)
|
13 |
11/9451 (0.12%)
|
11 |
Cataract Diabetic |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Cataract Subcapsular |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Conjunctival Haemorrhage |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Corneal Degeneration |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Diabetic Retinopathy |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Eye Muscle Entrapment |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Glaucoma |
0/9443 (0.00%)
|
0 |
2/9451 (0.02%)
|
2 |
Macular Degeneration |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Ocular Myasthenia |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Optic Ischaemic Neuropathy |
1/9443 (0.01%)
|
1 |
1/9451 (0.01%)
|
1 |
Posterior Capsule Opacification |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Retinal Artery Embolism |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Retinal Artery Occlusion |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Retinal Detachment |
1/9443 (0.01%)
|
1 |
2/9451 (0.02%)
|
2 |
Retinal Haemorrhage |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Retinal Vein Occlusion |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Ulcerative Keratitis |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Visual Acuity Reduced |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Vitreous Detachment |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Vitreous Haemorrhage |
2/9443 (0.02%)
|
2 |
1/9451 (0.01%)
|
1 |
Gastrointestinal disorders |
|
|
Abdominal Adhesions |
2/9443 (0.02%)
|
2 |
2/9451 (0.02%)
|
2 |
Abdominal Discomfort |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Abdominal Distension |
1/9443 (0.01%)
|
1 |
1/9451 (0.01%)
|
1 |
Abdominal Hernia |
5/9443 (0.05%)
|
5 |
4/9451 (0.04%)
|
4 |
Abdominal Incarcerated Hernia |
0/9443 (0.00%)
|
0 |
2/9451 (0.02%)
|
2 |
Abdominal Pain |
12/9443 (0.13%)
|
12 |
9/9451 (0.10%)
|
10 |
Abdominal Pain Upper |
6/9443 (0.06%)
|
6 |
9/9451 (0.10%)
|
9 |
Abdominal Strangulated Hernia |
2/9443 (0.02%)
|
2 |
0/9451 (0.00%)
|
0 |
Abdominal Wall Haematoma |
2/9443 (0.02%)
|
2 |
1/9451 (0.01%)
|
1 |
Alcoholic Pancreatitis |
3/9443 (0.03%)
|
4 |
5/9451 (0.05%)
|
5 |
Anal Fissure |
4/9443 (0.04%)
|
4 |
1/9451 (0.01%)
|
1 |
Anal Fistula |
1/9443 (0.01%)
|
1 |
1/9451 (0.01%)
|
1 |
Anal Incontinence |
1/9443 (0.01%)
|
1 |
1/9451 (0.01%)
|
1 |
Anal Polyp |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Aphthous Ulcer |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Appendix Disorder |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Ascites |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Barrett's Oesophagus |
1/9443 (0.01%)
|
1 |
3/9451 (0.03%)
|
3 |
Bile Acid Malabsorption |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Breath Odour |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Chronic Gastritis |
5/9443 (0.05%)
|
5 |
3/9451 (0.03%)
|
3 |
Colitis |
7/9443 (0.07%)
|
7 |
2/9451 (0.02%)
|
2 |
Colitis Ischaemic |
6/9443 (0.06%)
|
6 |
1/9451 (0.01%)
|
1 |
Colitis Microscopic |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Colitis Ulcerative |
1/9443 (0.01%)
|
1 |
2/9451 (0.02%)
|
2 |
Constipation |
4/9443 (0.04%)
|
4 |
4/9451 (0.04%)
|
4 |
Crohn's Disease |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Dental Caries |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Diabetic Gastroparesis |
2/9443 (0.02%)
|
3 |
0/9451 (0.00%)
|
0 |
Diarrhoea |
7/9443 (0.07%)
|
7 |
4/9451 (0.04%)
|
4 |
Diarrhoea Haemorrhagic |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Dieulafoy's Vascular Malformation |
2/9443 (0.02%)
|
2 |
0/9451 (0.00%)
|
0 |
Diverticular Perforation |
0/9443 (0.00%)
|
0 |
2/9451 (0.02%)
|
2 |
Diverticulum |
1/9443 (0.01%)
|
1 |
1/9451 (0.01%)
|
1 |
Diverticulum Intestinal |
3/9443 (0.03%)
|
3 |
1/9451 (0.01%)
|
1 |
Diverticulum Intestinal Haemorrhagic |
4/9443 (0.04%)
|
4 |
6/9451 (0.06%)
|
8 |
Duodenal Obstruction |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Duodenal Ulcer |
5/9443 (0.05%)
|
5 |
3/9451 (0.03%)
|
3 |
Duodenal Ulcer Haemorrhage |
9/9443 (0.10%)
|
10 |
4/9451 (0.04%)
|
4 |
Duodenal Vascular Ectasia |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Duodenitis |
1/9443 (0.01%)
|
1 |
1/9451 (0.01%)
|
1 |
Duodenitis Haemorrhagic |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Dyspepsia |
6/9443 (0.06%)
|
6 |
7/9451 (0.07%)
|
7 |
Dysphagia |
1/9443 (0.01%)
|
2 |
4/9451 (0.04%)
|
4 |
Enteritis |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Enterocolitis |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Enterocolitis Haemorrhagic |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Erosive Duodenitis |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Erosive Oesophagitis |
1/9443 (0.01%)
|
1 |
2/9451 (0.02%)
|
2 |
Faecaloma |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Femoral Hernia, Obstructive |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Fistula Of Small Intestine |
0/9443 (0.00%)
|
0 |
2/9451 (0.02%)
|
2 |
Food Poisoning |
1/9443 (0.01%)
|
1 |
1/9451 (0.01%)
|
1 |
Functional Gastrointestinal Disorder |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Gastric Haemorrhage |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Gastric Polyps |
1/9443 (0.01%)
|
1 |
2/9451 (0.02%)
|
2 |
Gastric Ulcer |
3/9443 (0.03%)
|
3 |
4/9451 (0.04%)
|
4 |
Gastric Ulcer Haemorrhage |
11/9443 (0.12%)
|
12 |
14/9451 (0.15%)
|
14 |
Gastric Ulcer, Obstructive |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Gastritis |
17/9443 (0.18%)
|
19 |
11/9451 (0.12%)
|
11 |
Gastritis Erosive |
3/9443 (0.03%)
|
3 |
7/9451 (0.07%)
|
7 |
Gastritis Haemorrhagic |
3/9443 (0.03%)
|
3 |
0/9451 (0.00%)
|
0 |
Gastroduodenitis |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Gastroduodenitis Haemorrhagic |
2/9443 (0.02%)
|
2 |
0/9451 (0.00%)
|
0 |
Gastrointestinal Angiectasia |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Gastrointestinal Angiodysplasia |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Gastrointestinal Angiodysplasia Haemorrhagic |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Gastrointestinal Disorder |
0/9443 (0.00%)
|
0 |
2/9451 (0.02%)
|
2 |
Gastrointestinal Haemorrhage |
13/9443 (0.14%)
|
13 |
11/9451 (0.12%)
|
12 |
Gastrointestinal Inflammation |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Gastrointestinal Mucosal Disorder |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Gastrointestinal Pain |
2/9443 (0.02%)
|
2 |
0/9451 (0.00%)
|
0 |
Gastrointestinal Polyp Haemorrhage |
3/9443 (0.03%)
|
3 |
1/9451 (0.01%)
|
1 |
Gastrointestinal Ulcer |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Gastrointestinal Ulcer Haemorrhage |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Gastrooesophageal Reflux Disease |
19/9443 (0.20%)
|
20 |
21/9451 (0.22%)
|
24 |
Gingival Bleeding |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Haematemesis |
2/9443 (0.02%)
|
2 |
0/9451 (0.00%)
|
0 |
Haematochezia |
2/9443 (0.02%)
|
2 |
5/9451 (0.05%)
|
5 |
Haemorrhagic Erosive Gastritis |
2/9443 (0.02%)
|
2 |
3/9451 (0.03%)
|
3 |
Haemorrhoidal Haemorrhage |
4/9443 (0.04%)
|
4 |
5/9451 (0.05%)
|
5 |
Haemorrhoids |
4/9443 (0.04%)
|
4 |
5/9451 (0.05%)
|
5 |
Hiatus Hernia |
3/9443 (0.03%)
|
3 |
2/9451 (0.02%)
|
2 |
Hiatus Hernia Strangulated |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Ileal Perforation |
2/9443 (0.02%)
|
2 |
0/9451 (0.00%)
|
0 |
Ileus |
4/9443 (0.04%)
|
4 |
2/9451 (0.02%)
|
2 |
Ileus Paralytic |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Incarcerated Hiatus Hernia |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Incarcerated Inguinal Hernia |
1/9443 (0.01%)
|
1 |
1/9451 (0.01%)
|
1 |
Incarcerated Umbilical Hernia |
1/9443 (0.01%)
|
1 |
4/9451 (0.04%)
|
4 |
Inguinal Hernia |
15/9443 (0.16%)
|
15 |
29/9451 (0.31%)
|
29 |
Intestinal Haemorrhage |
1/9443 (0.01%)
|
1 |
1/9451 (0.01%)
|
1 |
Intestinal Infarction |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Intestinal Ischaemia |
2/9443 (0.02%)
|
3 |
2/9451 (0.02%)
|
2 |
Intestinal Obstruction |
6/9443 (0.06%)
|
7 |
5/9451 (0.05%)
|
5 |
Intestinal Perforation |
2/9443 (0.02%)
|
2 |
3/9451 (0.03%)
|
3 |
Irritable Bowel Syndrome |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Large Intestinal Obstruction |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Large Intestinal Ulcer |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Large Intestine Perforation |
1/9443 (0.01%)
|
1 |
1/9451 (0.01%)
|
2 |
Large Intestine Polyp |
2/9443 (0.02%)
|
2 |
4/9451 (0.04%)
|
4 |
Lower Gastrointestinal Haemorrhage |
4/9443 (0.04%)
|
4 |
3/9451 (0.03%)
|
3 |
Lumbar Hernia |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Mallory-Weiss Syndrome |
1/9443 (0.01%)
|
1 |
3/9451 (0.03%)
|
3 |
Megacolon |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Melaena |
1/9443 (0.01%)
|
1 |
1/9451 (0.01%)
|
1 |
Mesenteric Artery Thrombosis |
1/9443 (0.01%)
|
1 |
1/9451 (0.01%)
|
1 |
Mesenteric Panniculitis |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Nausea |
1/9443 (0.01%)
|
1 |
4/9451 (0.04%)
|
5 |
Obstruction Gastric |
1/9443 (0.01%)
|
1 |
1/9451 (0.01%)
|
1 |
Obstructive Pancreatitis |
2/9443 (0.02%)
|
2 |
5/9451 (0.05%)
|
7 |
Odynophagia |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Oedematous Pancreatitis |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Oesophageal Achalasia |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Oesophageal Disorder |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Oesophageal Rupture |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Oesophageal Spasm |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Oesophageal Stenosis |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Oesophageal Ulcer Haemorrhage |
2/9443 (0.02%)
|
2 |
0/9451 (0.00%)
|
0 |
Oesophageal Varices Haemorrhage |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Oesophagitis |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Oesophagitis Haemorrhagic |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Pancreatic Failure |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Pancreatic Haemorrhage |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Pancreatic Pseudocyst |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Pancreatitis |
6/9443 (0.06%)
|
6 |
3/9451 (0.03%)
|
3 |
Pancreatitis Acute |
16/9443 (0.17%)
|
16 |
15/9451 (0.16%)
|
15 |
Pancreatitis Chronic |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Pancreatitis Necrotising |
1/9443 (0.01%)
|
1 |
3/9451 (0.03%)
|
3 |
Peptic Ulcer |
2/9443 (0.02%)
|
2 |
1/9451 (0.01%)
|
1 |
Peptic Ulcer Haemorrhage |
2/9443 (0.02%)
|
2 |
0/9451 (0.00%)
|
0 |
Periodontal Disease |
2/9443 (0.02%)
|
2 |
0/9451 (0.00%)
|
0 |
Peritoneal Cyst |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Peritoneal Haemorrhage |
0/9443 (0.00%)
|
0 |
2/9451 (0.02%)
|
2 |
Rectal Haemorrhage |
4/9443 (0.04%)
|
6 |
2/9451 (0.02%)
|
2 |
Rectal Prolapse |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Rectal Ulcer Haemorrhage |
1/9443 (0.01%)
|
1 |
1/9451 (0.01%)
|
1 |
Retroperitoneal Haemorrhage |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Salivary Duct Obstruction |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Salivary Gland Calculus |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Small Intestinal Obstruction |
4/9443 (0.04%)
|
6 |
7/9451 (0.07%)
|
7 |
Small Intestinal Perforation |
1/9443 (0.01%)
|
1 |
1/9451 (0.01%)
|
1 |
Small Intestinal Ulcer Haemorrhage |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Swollen Tongue |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Tongue Haematoma |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Toothache |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Umbilical Hernia |
7/9443 (0.07%)
|
7 |
7/9451 (0.07%)
|
7 |
Umbilical Hernia, Obstructive |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Upper Gastrointestinal Haemorrhage |
7/9443 (0.07%)
|
8 |
6/9451 (0.06%)
|
6 |
Varices Oesophageal |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Vomiting |
6/9443 (0.06%)
|
6 |
5/9451 (0.05%)
|
5 |
General disorders |
|
|
Asthenia |
3/9443 (0.03%)
|
3 |
6/9451 (0.06%)
|
6 |
Chest Discomfort |
5/9443 (0.05%)
|
5 |
4/9451 (0.04%)
|
4 |
Chest Pain |
29/9443 (0.31%)
|
32 |
25/9451 (0.26%)
|
27 |
Death |
33/9443 (0.35%)
|
33 |
25/9451 (0.26%)
|
25 |
Device Related Thrombosis |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Exercise Tolerance Decreased |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Facial Pain |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Fatigue |
4/9443 (0.04%)
|
4 |
1/9451 (0.01%)
|
1 |
Gait Disturbance |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
General Physical Health Deterioration |
1/9443 (0.01%)
|
1 |
1/9451 (0.01%)
|
1 |
Granuloma |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Impaired Healing |
3/9443 (0.03%)
|
4 |
1/9451 (0.01%)
|
1 |
Implant Site Haematoma |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Implant Site Pain |
1/9443 (0.01%)
|
1 |
1/9451 (0.01%)
|
1 |
Incarcerated Hernia |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Influenza Like Illness |
0/9443 (0.00%)
|
0 |
2/9451 (0.02%)
|
2 |
Injection Site Reaction |
0/9443 (0.00%)
|
0 |
2/9451 (0.02%)
|
2 |
Malaise |
1/9443 (0.01%)
|
1 |
1/9451 (0.01%)
|
1 |
Medical Device Pain |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Medical Device Site Dermatitis |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Medical Device Site Joint Pain |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Medical Device Site Pain |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Multiple Organ Dysfunction Syndrome |
8/9443 (0.08%)
|
8 |
5/9451 (0.05%)
|
5 |
Non-Cardiac Chest Pain |
222/9443 (2.35%)
|
256 |
219/9451 (2.32%)
|
264 |
Oedema Peripheral |
0/9443 (0.00%)
|
0 |
2/9451 (0.02%)
|
2 |
Pacemaker Generated Arrhythmia |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Pain |
1/9443 (0.01%)
|
1 |
1/9451 (0.01%)
|
1 |
Pelvic Mass |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Peripheral Swelling |
2/9443 (0.02%)
|
2 |
0/9451 (0.00%)
|
0 |
Pyrexia |
6/9443 (0.06%)
|
6 |
6/9451 (0.06%)
|
6 |
Soft Tissue Inflammation |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Strangulated Hernia |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Sudden Cardiac Death |
42/9443 (0.44%)
|
42 |
36/9451 (0.38%)
|
36 |
Sudden Death |
9/9443 (0.10%)
|
9 |
14/9451 (0.15%)
|
14 |
Systemic Inflammatory Response Syndrome |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Vascular Stent Restenosis |
1/9443 (0.01%)
|
1 |
9/9451 (0.10%)
|
9 |
Vascular Stent Thrombosis |
2/9443 (0.02%)
|
2 |
1/9451 (0.01%)
|
1 |
Vessel Puncture Site Haematoma |
2/9443 (0.02%)
|
2 |
0/9451 (0.00%)
|
0 |
Vessel Puncture Site Haemorrhage |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Hepatobiliary disorders |
|
|
Acute Hepatic Failure |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Ampulla Of Vater Stenosis |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Bile Duct Stenosis |
0/9443 (0.00%)
|
0 |
2/9451 (0.02%)
|
2 |
Bile Duct Stone |
7/9443 (0.07%)
|
7 |
3/9451 (0.03%)
|
3 |
Biliary Colic |
3/9443 (0.03%)
|
3 |
2/9451 (0.02%)
|
2 |
Biliary Dyskinesia |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Biliary Tract Disorder |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Cholangitis |
3/9443 (0.03%)
|
3 |
3/9451 (0.03%)
|
3 |
Cholangitis Acute |
2/9443 (0.02%)
|
2 |
0/9451 (0.00%)
|
0 |
Cholangitis Sclerosing |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Cholecystitis |
14/9443 (0.15%)
|
14 |
8/9451 (0.08%)
|
9 |
Cholecystitis Acute |
14/9443 (0.15%)
|
14 |
11/9451 (0.12%)
|
11 |
Cholecystitis Chronic |
6/9443 (0.06%)
|
6 |
1/9451 (0.01%)
|
1 |
Cholelithiasis |
35/9443 (0.37%)
|
35 |
25/9451 (0.26%)
|
25 |
Cholestasis |
1/9443 (0.01%)
|
1 |
1/9451 (0.01%)
|
1 |
Chronic Hepatitis |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Cirrhosis Alcoholic |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Drug-Induced Liver Injury |
6/9443 (0.06%)
|
6 |
15/9451 (0.16%)
|
15 |
Gallbladder Disorder |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Gallbladder Necrosis |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Gallbladder Perforation |
1/9443 (0.01%)
|
1 |
1/9451 (0.01%)
|
1 |
Hepatic Cirrhosis |
1/9443 (0.01%)
|
1 |
1/9451 (0.01%)
|
1 |
Hepatic Congestion |
1/9443 (0.01%)
|
1 |
1/9451 (0.01%)
|
1 |
Hepatic Failure |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Hepatic Function Abnormal |
2/9443 (0.02%)
|
2 |
0/9451 (0.00%)
|
0 |
Hepatic Haemorrhage |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Hepatic Lesion |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Hepatic Necrosis |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Hepatic Steatosis |
2/9443 (0.02%)
|
2 |
0/9451 (0.00%)
|
0 |
Hepatic Vein Dilatation |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Hepatitis Acute |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Hepatitis Alcoholic |
1/9443 (0.01%)
|
1 |
1/9451 (0.01%)
|
1 |
Hepatitis Chronic Active |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Hepatitis Toxic |
2/9443 (0.02%)
|
2 |
0/9451 (0.00%)
|
0 |
Hepatocellular Injury |
1/9443 (0.01%)
|
1 |
1/9451 (0.01%)
|
1 |
Hyperplastic Cholecystopathy |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Ischaemic Hepatitis |
3/9443 (0.03%)
|
3 |
3/9451 (0.03%)
|
4 |
Jaundice Cholestatic |
0/9443 (0.00%)
|
0 |
2/9451 (0.02%)
|
2 |
Liver Disorder |
1/9443 (0.01%)
|
1 |
2/9451 (0.02%)
|
2 |
Liver Injury |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Steatohepatitis |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Immune system disorders |
|
|
Allergy To Arthropod Bite |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Allergy To Arthropod Sting |
1/9443 (0.01%)
|
1 |
1/9451 (0.01%)
|
1 |
Anaphylactic Reaction |
2/9443 (0.02%)
|
2 |
4/9451 (0.04%)
|
4 |
Anaphylactic Shock |
0/9443 (0.00%)
|
0 |
2/9451 (0.02%)
|
2 |
Contrast Media Allergy |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Drug Hypersensitivity |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Hypersensitivity |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Iodine Allergy |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Infections and infestations |
|
|
Abdominal Abscess |
1/9443 (0.01%)
|
1 |
3/9451 (0.03%)
|
3 |
Abdominal Infection |
1/9443 (0.01%)
|
1 |
1/9451 (0.01%)
|
1 |
Abdominal Sepsis |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Abdominal Wall Abscess |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Abscess |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Abscess Limb |
4/9443 (0.04%)
|
4 |
4/9451 (0.04%)
|
4 |
Acute Endocarditis |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Acute Hepatitis C |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Anal Abscess |
1/9443 (0.01%)
|
1 |
4/9451 (0.04%)
|
4 |
Appendiceal Abscess |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Appendicitis |
10/9443 (0.11%)
|
10 |
13/9451 (0.14%)
|
13 |
Appendicitis Perforated |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Arthritis Bacterial |
0/9443 (0.00%)
|
0 |
2/9451 (0.02%)
|
2 |
Atypical Pneumonia |
1/9443 (0.01%)
|
1 |
1/9451 (0.01%)
|
1 |
Bacteraemia |
1/9443 (0.01%)
|
1 |
1/9451 (0.01%)
|
1 |
Bacterial Infection |
1/9443 (0.01%)
|
1 |
1/9451 (0.01%)
|
1 |
Bacterial Prostatitis |
2/9443 (0.02%)
|
2 |
0/9451 (0.00%)
|
0 |
Bacterial Sepsis |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Biliary Sepsis |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Bone Tuberculosis |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Borrelia Infection |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Breast Abscess |
1/9443 (0.01%)
|
1 |
1/9451 (0.01%)
|
1 |
Breast Cellulitis |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Bronchiolitis |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Bronchitis |
17/9443 (0.18%)
|
21 |
16/9451 (0.17%)
|
17 |
Bronchitis Bacterial |
2/9443 (0.02%)
|
2 |
1/9451 (0.01%)
|
1 |
Bronchitis Viral |
1/9443 (0.01%)
|
2 |
2/9451 (0.02%)
|
2 |
Brucellosis |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Bursitis Infective |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Campylobacter Gastroenteritis |
1/9443 (0.01%)
|
1 |
1/9451 (0.01%)
|
1 |
Candida Sepsis |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Cellulitis |
37/9443 (0.39%)
|
40 |
32/9451 (0.34%)
|
35 |
Cellulitis Of Male External Genital Organ |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Cellulitis Staphylococcal |
2/9443 (0.02%)
|
2 |
1/9451 (0.01%)
|
1 |
Cholangitis Infective |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Cholecystitis Infective |
2/9443 (0.02%)
|
2 |
7/9451 (0.07%)
|
7 |
Chronic Sinusitis |
1/9443 (0.01%)
|
1 |
2/9451 (0.02%)
|
2 |
Citrobacter Sepsis |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Clostridium Difficile Colitis |
3/9443 (0.03%)
|
3 |
3/9451 (0.03%)
|
3 |
Cutaneous Tuberculosis |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Cystitis |
2/9443 (0.02%)
|
2 |
2/9451 (0.02%)
|
2 |
Cytomegalovirus Infection |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Dengue Fever |
8/9443 (0.08%)
|
8 |
3/9451 (0.03%)
|
3 |
Dermo-Hypodermitis |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Device Related Infection |
2/9443 (0.02%)
|
2 |
0/9451 (0.00%)
|
0 |
Diabetic Foot Infection |
5/9443 (0.05%)
|
5 |
1/9451 (0.01%)
|
1 |
Diabetic Gangrene |
1/9443 (0.01%)
|
2 |
0/9451 (0.00%)
|
0 |
Diverticulitis |
10/9443 (0.11%)
|
11 |
9/9451 (0.10%)
|
9 |
Diverticulitis Intestinal Haemorrhagic |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Encephalitis |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Endocarditis |
1/9443 (0.01%)
|
1 |
1/9451 (0.01%)
|
1 |
Enterobacter Bacteraemia |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Enterococcal Bacteraemia |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Enterococcal Sepsis |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Enterocolitis Bacterial |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Enterocolitis Infectious |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Epididymitis |
1/9443 (0.01%)
|
1 |
1/9451 (0.01%)
|
1 |
Erysipelas |
8/9443 (0.08%)
|
9 |
7/9451 (0.07%)
|
7 |
Escherichia Pyelonephritis |
2/9443 (0.02%)
|
2 |
1/9451 (0.01%)
|
1 |
Escherichia Sepsis |
3/9443 (0.03%)
|
3 |
1/9451 (0.01%)
|
1 |
Escherichia Urinary Tract Infection |
3/9443 (0.03%)
|
3 |
6/9451 (0.06%)
|
6 |
External Ear Cellulitis |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Extradural Abscess |
0/9443 (0.00%)
|
0 |
2/9451 (0.02%)
|
2 |
Gallbladder Empyema |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Gangrene |
6/9443 (0.06%)
|
6 |
4/9451 (0.04%)
|
4 |
Gastric Ulcer Helicobacter |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Gastritis Viral |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Gastroenteritis |
25/9443 (0.26%)
|
25 |
26/9451 (0.28%)
|
31 |
Gastroenteritis Bacterial |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Gastroenteritis Salmonella |
1/9443 (0.01%)
|
1 |
1/9451 (0.01%)
|
1 |
Gastroenteritis Viral |
3/9443 (0.03%)
|
3 |
2/9451 (0.02%)
|
2 |
Graft Infection |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Groin Abscess |
2/9443 (0.02%)
|
2 |
2/9451 (0.02%)
|
2 |
Haemophilus Sepsis |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Hantaviral Infection |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Helicobacter Gastritis |
1/9443 (0.01%)
|
1 |
1/9451 (0.01%)
|
1 |
Hepatic Amoebiasis |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Hepatic Infection Bacterial |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Hepatitis C |
1/9443 (0.01%)
|
1 |
1/9451 (0.01%)
|
1 |
Herpes Virus Infection |
0/9443 (0.00%)
|
0 |
2/9451 (0.02%)
|
2 |
Herpes Zoster |
0/9443 (0.00%)
|
0 |
4/9451 (0.04%)
|
4 |
Iatrogenic Infection |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Implant Site Infection |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Infected Bite |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Infected Cyst |
2/9443 (0.02%)
|
2 |
0/9451 (0.00%)
|
0 |
Infected Skin Ulcer |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Infection |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Infectious Colitis |
4/9443 (0.04%)
|
4 |
0/9451 (0.00%)
|
0 |
Infectious Pleural Effusion |
1/9443 (0.01%)
|
1 |
1/9451 (0.01%)
|
1 |
Infective Exacerbation Of Chronic Obstructive Airways Disease |
7/9443 (0.07%)
|
9 |
11/9451 (0.12%)
|
12 |
Influenza |
5/9443 (0.05%)
|
5 |
5/9451 (0.05%)
|
5 |
Injection Site Cellulitis |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Klebsiella Bacteraemia |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Labyrinthitis |
1/9443 (0.01%)
|
1 |
1/9451 (0.01%)
|
1 |
Laryngitis |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Latent Tuberculosis |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Liver Abscess |
1/9443 (0.01%)
|
1 |
1/9451 (0.01%)
|
1 |
Localised Infection |
5/9443 (0.05%)
|
5 |
0/9451 (0.00%)
|
0 |
Lower Respiratory Tract Infection |
10/9443 (0.11%)
|
10 |
11/9451 (0.12%)
|
12 |
Ludwig Angina |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Lung Abscess |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Lung Infection |
2/9443 (0.02%)
|
2 |
5/9451 (0.05%)
|
6 |
Lyme Disease |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Mastitis |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Mastoiditis |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Mediastinitis |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Medical Device Site Infection |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Meningitis Aseptic |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Meningoencephalitis Bacterial |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Necrotising Fasciitis |
1/9443 (0.01%)
|
1 |
3/9451 (0.03%)
|
3 |
Neutropenic Sepsis |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Ophthalmic Herpes Zoster |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Oral Herpes |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Orchitis |
2/9443 (0.02%)
|
2 |
2/9451 (0.02%)
|
2 |
Osteomyelitis |
8/9443 (0.08%)
|
13 |
5/9451 (0.05%)
|
6 |
Osteomyelitis Acute |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Osteomyelitis Chronic |
1/9443 (0.01%)
|
1 |
1/9451 (0.01%)
|
1 |
Otitis Externa |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Otitis Media |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Otitis Media Acute |
0/9443 (0.00%)
|
0 |
2/9451 (0.02%)
|
2 |
Pancreas Infection |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Pelvic Abscess |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Pelvic Inflammatory Disease |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Perichondritis |
3/9443 (0.03%)
|
3 |
0/9451 (0.00%)
|
0 |
Perihepatic Abscess |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Perineal Abscess |
1/9443 (0.01%)
|
1 |
1/9451 (0.01%)
|
1 |
Periodontitis |
2/9443 (0.02%)
|
2 |
0/9451 (0.00%)
|
0 |
Periorbital Cellulitis |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Perirectal Abscess |
1/9443 (0.01%)
|
2 |
1/9451 (0.01%)
|
1 |
Peritoneal Abscess |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Peritonitis |
2/9443 (0.02%)
|
2 |
5/9451 (0.05%)
|
5 |
Peritonsillar Abscess |
2/9443 (0.02%)
|
2 |
2/9451 (0.02%)
|
2 |
Pharyngitis |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Pharyngolaryngeal Abscess |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Pilonidal Cyst |
0/9443 (0.00%)
|
0 |
2/9451 (0.02%)
|
2 |
Pleurisy Viral |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Pneumonia |
108/9443 (1.14%)
|
123 |
96/9451 (1.02%)
|
98 |
Pneumonia Bacterial |
3/9443 (0.03%)
|
3 |
5/9451 (0.05%)
|
5 |
Pneumonia Chlamydial |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Pneumonia Escherichia |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Pneumonia Haemophilus |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Pneumonia Influenzal |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Pneumonia Klebsiella |
2/9443 (0.02%)
|
2 |
0/9451 (0.00%)
|
0 |
Pneumonia Legionella |
0/9443 (0.00%)
|
0 |
3/9451 (0.03%)
|
3 |
Pneumonia Mycoplasmal |
2/9443 (0.02%)
|
2 |
1/9451 (0.01%)
|
1 |
Pneumonia Pneumococcal |
2/9443 (0.02%)
|
2 |
0/9451 (0.00%)
|
0 |
Pneumonia Staphylococcal |
2/9443 (0.02%)
|
2 |
0/9451 (0.00%)
|
0 |
Pneumonia Streptococcal |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Pneumonia Viral |
3/9443 (0.03%)
|
3 |
1/9451 (0.01%)
|
1 |
Post Procedural Cellulitis |
1/9443 (0.01%)
|
1 |
2/9451 (0.02%)
|
2 |
Post Procedural Infection |
2/9443 (0.02%)
|
2 |
2/9451 (0.02%)
|
2 |
Post Procedural Pneumonia |
1/9443 (0.01%)
|
1 |
1/9451 (0.01%)
|
1 |
Post Procedural Sepsis |
2/9443 (0.02%)
|
2 |
1/9451 (0.01%)
|
1 |
Post Viral Fatigue Syndrome |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Postoperative Wound Infection |
13/9443 (0.14%)
|
14 |
13/9451 (0.14%)
|
13 |
Proctitis Bacterial |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Pseudomembranous Colitis |
2/9443 (0.02%)
|
2 |
1/9451 (0.01%)
|
1 |
Pseudomonal Bacteraemia |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Pseudomonal Sepsis |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Psoas Abscess |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Pulmonary Sepsis |
1/9443 (0.01%)
|
1 |
4/9451 (0.04%)
|
4 |
Pulmonary Tuberculosis |
4/9443 (0.04%)
|
4 |
3/9451 (0.03%)
|
3 |
Pyelonephritis |
9/9443 (0.10%)
|
9 |
4/9451 (0.04%)
|
4 |
Pyelonephritis Acute |
5/9443 (0.05%)
|
5 |
6/9451 (0.06%)
|
6 |
Pyelonephritis Chronic |
1/9443 (0.01%)
|
1 |
1/9451 (0.01%)
|
2 |
Renal Abscess |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Respiratory Syncytial Virus Infection |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Respiratory Tract Infection |
4/9443 (0.04%)
|
4 |
1/9451 (0.01%)
|
1 |
Scrotal Abscess |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Scrub Typhus |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Sepsis |
35/9443 (0.37%)
|
38 |
20/9451 (0.21%)
|
20 |
Septic Shock |
12/9443 (0.13%)
|
13 |
11/9451 (0.12%)
|
11 |
Sinusitis |
2/9443 (0.02%)
|
2 |
1/9451 (0.01%)
|
1 |
Sinusitis Bacterial |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Staphylococcal Abscess |
0/9443 (0.00%)
|
0 |
2/9451 (0.02%)
|
2 |
Staphylococcal Bacteraemia |
2/9443 (0.02%)
|
2 |
0/9451 (0.00%)
|
0 |
Staphylococcal Osteomyelitis |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Staphylococcal Sepsis |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Streptococcal Bacteraemia |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Streptococcal Endocarditis |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Streptococcal Sepsis |
1/9443 (0.01%)
|
1 |
1/9451 (0.01%)
|
1 |
Subcutaneous Abscess |
5/9443 (0.05%)
|
5 |
6/9451 (0.06%)
|
6 |
Systemic Infection |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Tonsillitis |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Tooth Abscess |
5/9443 (0.05%)
|
5 |
0/9451 (0.00%)
|
0 |
Toxic Shock Syndrome |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Tracheitis |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Tracheobronchitis |
1/9443 (0.01%)
|
1 |
1/9451 (0.01%)
|
1 |
Tuberculosis |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Tuberculous Pleurisy |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Upper Respiratory Tract Infection |
9/9443 (0.10%)
|
9 |
7/9451 (0.07%)
|
7 |
Urethritis |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Urinary Tract Infection |
33/9443 (0.35%)
|
35 |
27/9451 (0.29%)
|
28 |
Urinary Tract Infection Bacterial |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Urinary Tract Infection Enterococcal |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Urinary Tract Infection Staphylococcal |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Urosepsis |
10/9443 (0.11%)
|
11 |
16/9451 (0.17%)
|
16 |
Vestibular Neuronitis |
3/9443 (0.03%)
|
3 |
2/9451 (0.02%)
|
2 |
Viral Cardiomyopathy |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Viral Infection |
6/9443 (0.06%)
|
6 |
8/9451 (0.08%)
|
8 |
Viral Labyrinthitis |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Viral Myocarditis |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Viral Pericarditis |
1/9443 (0.01%)
|
1 |
3/9451 (0.03%)
|
3 |
Viral Upper Respiratory Tract Infection |
2/9443 (0.02%)
|
2 |
3/9451 (0.03%)
|
3 |
Visceral Leishmaniasis |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Vulval Abscess |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Vulvovaginal Candidiasis |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Wound Infection |
4/9443 (0.04%)
|
4 |
0/9451 (0.00%)
|
0 |
Wound Infection Staphylococcal |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Injury, poisoning and procedural complications |
|
|
Abdominal Injury |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Abdominal Wound Dehiscence |
1/9443 (0.01%)
|
1 |
1/9451 (0.01%)
|
1 |
Accidental Overdose |
9/9443 (0.10%)
|
14 |
8/9451 (0.08%)
|
8 |
Acetabulum Fracture |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Alcohol Poisoning |
1/9443 (0.01%)
|
1 |
2/9451 (0.02%)
|
2 |
Allergic Transfusion Reaction |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Anaemia Postoperative |
3/9443 (0.03%)
|
3 |
3/9451 (0.03%)
|
3 |
Anaesthetic Complication Neurological |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Anastomotic Haemorrhage |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Ankle Fracture |
8/9443 (0.08%)
|
9 |
7/9451 (0.07%)
|
7 |
Aortic Injury |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Arterial Bypass Thrombosis |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Arterial Injury |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Arthropod Bite |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Arthropod Sting |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Auricular Haematoma |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Blast Injury |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Bone Contusion |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Brachial Plexus Injury |
1/9443 (0.01%)
|
1 |
1/9451 (0.01%)
|
1 |
Brain Contusion |
1/9443 (0.01%)
|
1 |
4/9451 (0.04%)
|
4 |
Brain Herniation |
1/9443 (0.01%)
|
1 |
1/9451 (0.01%)
|
1 |
Carbon Monoxide Poisoning |
2/9443 (0.02%)
|
2 |
0/9451 (0.00%)
|
0 |
Cardiac Contusion |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Cardiac Valve Replacement Complication |
1/9443 (0.01%)
|
1 |
1/9451 (0.01%)
|
1 |
Cervical Vertebral Fracture |
3/9443 (0.03%)
|
3 |
1/9451 (0.01%)
|
1 |
Chemical Burn Of Gastrointestinal Tract |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Chest Injury |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Clavicle Fracture |
5/9443 (0.05%)
|
5 |
1/9451 (0.01%)
|
1 |
Concussion |
8/9443 (0.08%)
|
8 |
2/9451 (0.02%)
|
2 |
Confusion Postoperative |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Contusion |
4/9443 (0.04%)
|
6 |
3/9451 (0.03%)
|
3 |
Coronary Artery Restenosis |
8/9443 (0.08%)
|
8 |
1/9451 (0.01%)
|
1 |
Craniocerebral Injury |
3/9443 (0.03%)
|
3 |
3/9451 (0.03%)
|
3 |
Delayed Recovery From Anaesthesia |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Electric Shock |
0/9443 (0.00%)
|
0 |
3/9451 (0.03%)
|
3 |
Extra-Axial Haemorrhage |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Extradural Haematoma |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Eye Injury |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Face Injury |
2/9443 (0.02%)
|
2 |
1/9451 (0.01%)
|
1 |
Facial Bones Fracture |
4/9443 (0.04%)
|
4 |
2/9451 (0.02%)
|
2 |
Fall |
32/9443 (0.34%)
|
34 |
26/9451 (0.28%)
|
26 |
Femoral Neck Fracture |
6/9443 (0.06%)
|
6 |
6/9451 (0.06%)
|
6 |
Femur Fracture |
9/9443 (0.10%)
|
9 |
13/9451 (0.14%)
|
14 |
Fibula Fracture |
4/9443 (0.04%)
|
4 |
0/9451 (0.00%)
|
0 |
Foot Fracture |
4/9443 (0.04%)
|
4 |
1/9451 (0.01%)
|
1 |
Forearm Fracture |
2/9443 (0.02%)
|
2 |
0/9451 (0.00%)
|
0 |
Foreign Body In Urogenital Tract |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Fracture Displacement |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Fractured Skull Depressed |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Gastrointestinal Stoma Necrosis |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Gun Shot Wound |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Hand Fracture |
3/9443 (0.03%)
|
3 |
5/9451 (0.05%)
|
5 |
Head Injury |
1/9443 (0.01%)
|
1 |
4/9451 (0.04%)
|
4 |
Heat Stroke |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Hip Fracture |
2/9443 (0.02%)
|
2 |
7/9451 (0.07%)
|
8 |
Humerus Fracture |
4/9443 (0.04%)
|
4 |
4/9451 (0.04%)
|
4 |
Hyphaema |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Incision Site Pain |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Incisional Hernia |
2/9443 (0.02%)
|
2 |
3/9451 (0.03%)
|
3 |
Injury |
2/9443 (0.02%)
|
2 |
0/9451 (0.00%)
|
0 |
Intentional Overdose |
8/9443 (0.08%)
|
18 |
6/9451 (0.06%)
|
6 |
Jaw Fracture |
2/9443 (0.02%)
|
2 |
0/9451 (0.00%)
|
0 |
Joint Dislocation |
3/9443 (0.03%)
|
3 |
2/9451 (0.02%)
|
2 |
Joint Injury |
1/9443 (0.01%)
|
1 |
2/9451 (0.02%)
|
2 |
Laceration |
4/9443 (0.04%)
|
4 |
1/9451 (0.01%)
|
1 |
Ligament Injury |
1/9443 (0.01%)
|
1 |
1/9451 (0.01%)
|
1 |
Ligament Rupture |
1/9443 (0.01%)
|
1 |
1/9451 (0.01%)
|
1 |
Ligament Sprain |
1/9443 (0.01%)
|
2 |
1/9451 (0.01%)
|
1 |
Limb Crushing Injury |
0/9443 (0.00%)
|
0 |
1/9451 (0.01%)
|
1 |
Limb Injury |
6/9443 (0.06%)
|
6 |
2/9451 (0.02%)
|
2 |
Limb Traumatic Amputation |
1/9443 (0.01%)
|
1 |
0/9451 (0.00%)
|
0 |
Lip Injury |
2/9443 (0.02%)
|
2 |
0/9451 (0.00%)
|
0 |
Lower Limb Fracture |
4/9443 (0.04%)
|
4 |
2/9451 (0.02%)
|
2 |
Lumbar Vertebral Fracture |
5/9443 (0.05%)
|
5 |
6/9451 (0.06%)
|