Time Frame |
Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized
|
Adverse Event Reporting Description |
The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
|
|
Arm/Group Title
|
BGF MDI 320/14.4/9.6 μg
|
BGF MDI 160/14.4/9.6 μg
|
GFF MDI 14.4/9.6 μg
|
BFF MDI 320/9.6 μg
|
Arm/Group Description |
Budesonide, Glycopyrronium, and For...
|
Budesonide, Glycopyrronium, and For...
|
Glycopyrronium, and Formoterol Fuma...
|
Budesonide, Glycopyrronium, and For...
|
Arm/Group Description |
Budesonide, Glycopyrronium, and Formoterol Fumarate Metered Dose Inhalation 320/14.4/9.6 μg
|
Budesonide, Glycopyrronium, and Formoterol Fumarate Metered Dose Inhalation 160/14.4/9.6 μg
|
Glycopyrronium, and Formoterol Fumarate Metered Dose Inhalation 14.4/9.6 μg
|
Budesonide, Glycopyrronium, and Formoterol Fumarate Metered Dose Inhalation 320/9.6 μg
|
|
|
BGF MDI 320/14.4/9.6 μg
|
BGF MDI 160/14.4/9.6 μg
|
GFF MDI 14.4/9.6 μg
|
BFF MDI 320/9.6 μg
|
|
Affected / at Risk (%) |
|
Affected / at Risk (%) |
|
Affected / at Risk (%) |
|
Affected / at Risk (%) |
|
Total |
27/2144 (1.26%)
|
|
42/2124 (1.98%)
|
|
47/2125 (2.21%)
|
|
35/2136 (1.64%)
|
|
|
|
BGF MDI 320/14.4/9.6 μg
|
BGF MDI 160/14.4/9.6 μg
|
GFF MDI 14.4/9.6 μg
|
BFF MDI 320/9.6 μg
|
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Total |
426/2144 (19.87%)
|
|
445/2124 (20.95%)
|
|
433/2125 (20.38%)
|
|
440/2136 (20.60%)
|
|
Blood and lymphatic system disorders |
|
|
|
|
Anaemia |
1/2144 (0.05%)
|
1 |
2/2124 (0.09%)
|
2 |
0/2125 (0.00%)
|
0 |
2/2136 (0.09%)
|
2 |
Iron deficiancy anaemia |
0/2144 (0.00%)
|
0 |
1/2124 (0.05%)
|
1 |
0/2125 (0.00%)
|
0 |
1/2136 (0.05%)
|
1 |
Anaemia macrocytic |
1/2144 (0.05%)
|
1 |
0/2124 (0.00%)
|
0 |
0/2125 (0.00%)
|
0 |
0/2136 (0.00%)
|
0 |
Immune thrombocytopenic purpura |
0/2144 (0.00%)
|
0 |
1/2124 (0.05%)
|
1 |
0/2125 (0.00%)
|
0 |
0/2136 (0.00%)
|
0 |
Lymphadenopathy |
0/2144 (0.00%)
|
0 |
1/2124 (0.05%)
|
1 |
0/2125 (0.00%)
|
0 |
0/2136 (0.00%)
|
0 |
Neutropenia |
0/2144 (0.00%)
|
0 |
0/2124 (0.00%)
|
0 |
0/2125 (0.00%)
|
0 |
1/2136 (0.05%)
|
1 |
Thrombocytopenia |
0/2144 (0.00%)
|
0 |
0/2124 (0.00%)
|
0 |
0/2125 (0.00%)
|
0 |
1/2136 (0.05%)
|
1 |
Cardiac disorders |
|
|
|
|
Acute myocardial infarction |
7/2144 (0.33%)
|
8 |
10/2124 (0.47%)
|
10 |
17/2125 (0.80%)
|
18 |
7/2136 (0.33%)
|
7 |
Atrial fibrilation |
9/2144 (0.42%)
|
9 |
8/2124 (0.38%)
|
8 |
14/2125 (0.66%)
|
15 |
3/2136 (0.14%)
|
3 |
Myocardial infarction |
5/2144 (0.23%)
|
5 |
5/2124 (0.24%)
|
5 |
7/2125 (0.33%)
|
7 |
4/2136 (0.19%)
|
4 |
Coronary artery disease |
5/2144 (0.23%)
|
5 |
5/2124 (0.24%)
|
5 |
7/2125 (0.33%)
|
7 |
1/2136 (0.05%)
|
1 |
Cardiac failure congestive |
5/2144 (0.23%)
|
6 |
3/2124 (0.14%)
|
3 |
5/2125 (0.24%)
|
6 |
2/2136 (0.09%)
|
2 |
Cardiac arrest |
3/2144 (0.14%)
|
3 |
1/2124 (0.05%)
|
1 |
8/2125 (0.38%)
|
8 |
0/2136 (0.00%)
|
0 |
Angina pectoris |
3/2144 (0.14%)
|
3 |
0/2124 (0.00%)
|
0 |
3/2125 (0.14%)
|
3 |
5/2136 (0.23%)
|
5 |
Cardiac failure |
1/2144 (0.05%)
|
1 |
3/2124 (0.14%)
|
3 |
2/2125 (0.09%)
|
2 |
3/2136 (0.14%)
|
3 |
Angina unstable |
3/2144 (0.14%)
|
3 |
1/2124 (0.05%)
|
1 |
3/2125 (0.14%)
|
3 |
1/2136 (0.05%)
|
1 |
Cardiac failure acute |
1/2144 (0.05%)
|
1 |
1/2124 (0.05%)
|
1 |
4/2125 (0.19%)
|
4 |
1/2136 (0.05%)
|
1 |
Cardiorespiratory arrest |
0/2144 (0.00%)
|
0 |
1/2124 (0.05%)
|
1 |
4/2125 (0.19%)
|
4 |
2/2136 (0.09%)
|
2 |
Acute coronary syndrome |
1/2144 (0.05%)
|
1 |
3/2124 (0.14%)
|
3 |
1/2125 (0.05%)
|
1 |
1/2136 (0.05%)
|
1 |
Stress cardiomyopathy |
0/2144 (0.00%)
|
0 |
3/2124 (0.14%)
|
3 |
1/2125 (0.05%)
|
1 |
1/2136 (0.05%)
|
1 |
Arteriosclerosis coronary artery |
0/2144 (0.00%)
|
0 |
1/2124 (0.05%)
|
1 |
1/2125 (0.05%)
|
1 |
2/2136 (0.09%)
|
2 |
Atrial flutter |
0/2144 (0.00%)
|
0 |
2/2124 (0.09%)
|
2 |
0/2125 (0.00%)
|
0 |
2/2136 (0.09%)
|
2 |
Supraventricular tachycardia |
2/2144 (0.09%)
|
2 |
1/2124 (0.05%)
|
1 |
1/2125 (0.05%)
|
1 |
0/2136 (0.00%)
|
0 |
Arrhythmia |
1/2144 (0.05%)
|
1 |
1/2124 (0.05%)
|
1 |
1/2125 (0.05%)
|
1 |
0/2136 (0.00%)
|
0 |
Bradycardia |
0/2144 (0.00%)
|
0 |
2/2124 (0.09%)
|
2 |
1/2125 (0.05%)
|
1 |
0/2136 (0.00%)
|
0 |
Acute left ventricular failure |
0/2144 (0.00%)
|
0 |
1/2124 (0.05%)
|
1 |
1/2125 (0.05%)
|
1 |
0/2136 (0.00%)
|
0 |
Atrioventricular block complete |
1/2144 (0.05%)
|
1 |
0/2124 (0.00%)
|
0 |
1/2125 (0.05%)
|
1 |
0/2136 (0.00%)
|
0 |
Coronary artery occulsion |
0/2144 (0.00%)
|
0 |
1/2124 (0.05%)
|
1 |
0/2125 (0.00%)
|
0 |
1/2136 (0.05%)
|
1 |
Myocardial ischaemia |
0/2144 (0.00%)
|
0 |
0/2124 (0.00%)
|
0 |
1/2125 (0.05%)
|
1 |
1/2136 (0.05%)
|
1 |
Pulseless electrical activity |
0/2144 (0.00%)
|
0 |
0/2124 (0.00%)
|
0 |
1/2125 (0.05%)
|
1 |
1/2136 (0.05%)
|
1 |
Ventricular fibrillation |
0/2144 (0.00%)
|
0 |
0/2124 (0.00%)
|
0 |
1/2125 (0.05%)
|
1 |
1/2136 (0.05%)
|
1 |
Atriventricular block second degree |
0/2144 (0.00%)
|
0 |
0/2124 (0.00%)
|
0 |
1/2125 (0.05%)
|
1 |
0/2136 (0.00%)
|
0 |
Cardiac disorder |
0/2144 (0.00%)
|
0 |
1/2124 (0.05%)
|
1 |
0/2125 (0.00%)
|
0 |
0/2136 (0.00%)
|
0 |
Cardio-respiratory distress |
1/2144 (0.05%)
|
1 |
0/2124 (0.00%)
|
0 |
0/2125 (0.00%)
|
0 |
0/2136 (0.00%)
|
0 |
Cardiac failure chronic |
0/2144 (0.00%)
|
0 |
0/2124 (0.00%)
|
0 |
1/2125 (0.05%)
|
1 |
0/2136 (0.00%)
|
0 |
Cardiogenic shock |
0/2144 (0.00%)
|
0 |
0/2124 (0.00%)
|
0 |
1/2125 (0.05%)
|
1 |
0/2136 (0.00%)
|
0 |
Cardiovascular disorder |
0/2144 (0.00%)
|
0 |
0/2124 (0.00%)
|
0 |
1/2125 (0.05%)
|
1 |
0/2136 (0.00%)
|
0 |
Cardiovascular insufficency |
0/2144 (0.00%)
|
0 |
0/2124 (0.00%)
|
0 |
0/2125 (0.00%)
|
0 |
1/2136 (0.05%)
|
1 |
Coronary artery stenosis |
0/2144 (0.00%)
|
0 |
0/2124 (0.00%)
|
0 |
1/2125 (0.05%)
|
1 |
0/2136 (0.00%)
|
0 |
Hypertensive heart disease |
0/2144 (0.00%)
|
0 |
1/2124 (0.05%)
|
1 |
0/2125 (0.00%)
|
0 |
0/2136 (0.00%)
|
0 |
Ischaemic cardiomyopathy |
0/2144 (0.00%)
|
0 |
1/2124 (0.05%)
|
1 |
0/2125 (0.00%)
|
0 |
0/2136 (0.00%)
|
0 |
Left ventricular failure |
0/2144 (0.00%)
|
0 |
1/2124 (0.05%)
|
1 |
0/2125 (0.00%)
|
0 |
0/2136 (0.00%)
|
0 |
Mitral valve incompetence |
0/2144 (0.00%)
|
0 |
0/2124 (0.00%)
|
0 |
0/2125 (0.00%)
|
0 |
1/2136 (0.05%)
|
1 |
Myocarditis |
1/2144 (0.05%)
|
1 |
0/2124 (0.00%)
|
0 |
0/2125 (0.00%)
|
0 |
0/2136 (0.00%)
|
0 |
Right ventricular failure |
0/2144 (0.00%)
|
0 |
0/2124 (0.00%)
|
0 |
1/2125 (0.05%)
|
1 |
0/2136 (0.00%)
|
0 |
Sinus node dysfunction |
0/2144 (0.00%)
|
0 |
1/2124 (0.05%)
|
1 |
0/2125 (0.00%)
|
0 |
0/2136 (0.00%)
|
0 |
Tachycardia |
0/2144 (0.00%)
|
0 |
0/2124 (0.00%)
|
0 |
1/2125 (0.05%)
|
1 |
0/2136 (0.00%)
|
0 |
Tricuspid valve incompetence |
0/2144 (0.00%)
|
0 |
0/2124 (0.00%)
|
0 |
0/2125 (0.00%)
|
0 |
1/2136 (0.05%)
|
1 |
Trifascicular black |
0/2144 (0.00%)
|
0 |
0/2124 (0.00%)
|
0 |
1/2125 (0.05%)
|
1 |
0/2136 (0.00%)
|
0 |
Ventricular tachycardia |
0/2144 (0.00%)
|
0 |
1/2124 (0.05%)
|
1 |
0/2125 (0.00%)
|
0 |
0/2136 (0.00%)
|
0 |
Cor pulmonale |
0/2144 (0.00%)
|
0 |
0/2124 (0.00%)
|
0 |
0/2125 (0.00%)
|
0 |
1/2136 (0.05%)
|
1 |
Ear and labyrinth disorders |
|
|
|
|
Vertigo |
0/2144 (0.00%)
|
0 |
2/2124 (0.09%)
|
2 |
1/2125 (0.05%)
|
1 |
1/2136 (0.05%)
|
1 |
Endocrine disorders |
|
|
|
|
Adrenal mass |
0/2144 (0.00%)
|
0 |
0/2124 (0.00%)
|
0 |
0/2125 (0.00%)
|
0 |
1/2136 (0.05%)
|
1 |
Goitre |
1/2144 (0.05%)
|
1 |
0/2124 (0.00%)
|
0 |
0/2125 (0.00%)
|
0 |
0/2136 (0.00%)
|
0 |
Eye disorders |
|
|
|
|
Cataract |
0/2144 (0.00%)
|
0 |
1/2124 (0.05%)
|
1 |
0/2125 (0.00%)
|
0 |
1/2136 (0.05%)
|
1 |
Retinal detachment |
1/2144 (0.05%)
|
1 |
1/2124 (0.05%)
|
1 |
0/2125 (0.00%)
|
0 |
0/2136 (0.00%)
|
0 |
Eyelid ptosis |
1/2144 (0.05%)
|
1 |
0/2124 (0.00%)
|
0 |
0/2125 (0.00%)
|
0 |
0/2136 (0.00%)
|
0 |
Retinal vascular thrombosis |
0/2144 (0.00%)
|
0 |
0/2124 (0.00%)
|
0 |
0/2125 (0.00%)
|
0 |
1/2136 (0.05%)
|
1 |
Visual impairment |
0/2144 (0.00%)
|
0 |
1/2124 (0.05%)
|
1 |
0/2125 (0.00%)
|
0 |
0/2136 (0.00%)
|
0 |
Retinal degeneration |
1/2144 (0.05%)
|
1 |
0/2124 (0.00%)
|
0 |
0/2125 (0.00%)
|
0 |
0/2136 (0.00%)
|
0 |
Gastrointestinal disorders |
|
|
|
|
Gastrointestinal haemorrhage |
2/2144 (0.09%)
|
3 |
2/2124 (0.09%)
|
2 |
1/2125 (0.05%)
|
1 |
2/2136 (0.09%)
|
2 |
Small intestine obstruction |
2/2144 (0.09%)
|
2 |
1/2124 (0.05%)
|
1 |
2/2125 (0.09%)
|
2 |
2/2136 (0.09%)
|
2 |
Abdonimal pain |
1/2144 (0.05%)
|
1 |
2/2124 (0.09%)
|
2 |
2/2125 (0.09%)
|
2 |
0/2136 (0.00%)
|
0 |
Inguinal hernia |
2/2144 (0.09%)
|
2 |
1/2124 (0.05%)
|
1 |
1/2125 (0.05%)
|
1 |
1/2136 (0.05%)
|
1 |
Colitis |
1/2144 (0.05%)
|
1 |
2/2124 (0.09%)
|
2 |
1/2125 (0.05%)
|
1 |
0/2136 (0.00%)
|
0 |
Pancreatitis acute |
2/2144 (0.09%)
|
2 |
1/2124 (0.05%)
|
1 |
1/2125 (0.05%)
|
1 |
0/2136 (0.00%)
|
0 |
Constipation |
2/2144 (0.09%)
|
2 |
0/2124 (0.00%)
|
0 |
1/2125 (0.05%)
|
1 |
0/2136 (0.00%)
|
0 |
Enteritis |
0/2144 (0.00%)
|
0 |
1/2124 (0.05%)
|
1 |
1/2125 (0.05%)
|
1 |
1/2136 (0.05%)
|
1 |
Upper gastrointestinal haemorrhage |
0/2144 (0.00%)
|
0 |
2/2124 (0.09%)
|
2 |
0/2125 (0.00%)
|
0 |
1/2136 (0.05%)
|
1 |
Abdominal hernia |
1/2144 (0.05%)
|
1 |
0/2124 (0.00%)
|
0 |
0/2125 (0.00%)
|
0 |
1/2136 (0.05%)
|
1 |
Colitis ulcerative |
1/2144 (0.05%)
|
1 |
0/2124 (0.00%)
|
0 |
0/2125 (0.00%)
|
0 |
1/2136 (0.05%)
|
1 |
Diverticular perforation |
0/2144 (0.00%)
|
0 |
0/2124 (0.00%)
|
0 |
1/2125 (0.05%)
|
1 |
1/2136 (0.05%)
|
1 |
Duodenal ulcenrn |
0/2144 (0.00%)
|
0 |
1/2124 (0.05%)
|
1 |
0/2125 (0.00%)
|
0 |
1/2136 (0.05%)
|
1 |
Gastrooesophageal reflux disease |
0/2144 (0.00%)
|
0 |
1/2124 (0.05%)
|
1 |
0/2125 (0.00%)
|
0 |
1/2136 (0.05%)
|
1 |
Ileus |
0/2144 (0.00%)
|
0 |
2/2124 (0.09%)
|
2 |
0/2125 (0.00%)
|
0 |
0/2136 (0.00%)
|
0 |
Large intestine polyp |
0/2144 (0.00%)
|
0 |
0/2124 (0.00%)
|
0 |
1/2125 (0.05%)
|
1 |
1/2136 (0.05%)
|
1 |
Anal fissure |
0/2144 (0.00%)
|
0 |
0/2124 (0.00%)
|
0 |
0/2125 (0.00%)
|
0 |
1/2136 (0.05%)
|
1 |
Colitis microscopic |
0/2144 (0.00%)
|
0 |
0/2124 (0.00%)
|
0 |
1/2125 (0.05%)
|
1 |
0/2136 (0.00%)
|
0 |
Diaphragmatic hernia |
1/2144 (0.05%)
|
1 |
0/2124 (0.00%)
|
0 |
0/2125 (0.00%)
|
0 |
0/2136 (0.00%)
|
0 |
Diverticulum |
0/2144 (0.00%)
|
0 |
0/2124 (0.00%)
|
0 |
0/2125 (0.00%)
|
0 |
1/2136 (0.05%)
|
1 |
Diverticulum intestinal haemorrhagic |
0/2144 (0.00%)
|
0 |
0/2124 (0.00%)
|
0 |
1/2125 (0.05%)
|
1 |
0/2136 (0.00%)
|
0 |
Duodenal perforation |
0/2144 (0.00%)
|
0 |
1/2124 (0.05%)
|
1 |
0/2125 (0.00%)
|
0 |
0/2136 (0.00%)
|
0 |
Duodenal ulcer haemorrhage |
0/2144 (0.00%)
|
0 |
0/2124 (0.00%)
|
0 |
0/2125 (0.00%)
|
0 |
1/2136 (0.05%)
|
1 |
Dysphagia |
0/2144 (0.00%)
|
0 |
0/2124 (0.00%)
|
0 |
0/2125 (0.00%)
|
0 |
1/2136 (0.05%)
|
1 |
Enterocolitis |
0/2144 (0.00%)
|
0 |
0/2124 (0.00%)
|
0 |
1/2125 (0.05%)
|
1 |
0/2136 (0.00%)
|
0 |
Gastric ulcer |
1/2144 (0.05%)
|
1 |
0/2124 (0.00%)
|
0 |
0/2125 (0.00%)
|
0 |
0/2136 (0.00%)
|
0 |
Gastric ulcer perforation |
1/2144 (0.05%)
|
1 |
0/2124 (0.00%)
|
0 |
0/2125 (0.00%)
|
0 |
0/2136 (0.00%)
|
0 |
Gastritis |
1/2144 (0.05%)
|
1 |
0/2124 (0.00%)
|
0 |
0/2125 (0.00%)
|
0 |
0/2136 (0.00%)
|
0 |
Haemoroidal haemorrhage |
0/2144 (0.00%)
|
0 |
0/2124 (0.00%)
|
0 |
1/2125 (0.05%)
|
1 |
0/2136 (0.00%)
|
0 |
Haemorrhoids thrombosed |
1/2144 (0.05%)
|
1 |
0/2124 (0.00%)
|
0 |
0/2125 (0.00%)
|
0 |
0/2136 (0.00%)
|
0 |
Impaired gastric emptying |
0/2144 (0.00%)
|
0 |
0/2124 (0.00%)
|
0 |
0/2125 (0.00%)
|
0 |
1/2136 (0.05%)
|
1 |
Intestinal Infarction |
0/2144 (0.00%)
|
0 |
0/2124 (0.00%)
|
0 |
0/2125 (0.00%)
|
0 |
1/2136 (0.05%)
|
1 |
Intestinal obstruction |
2/2144 (0.09%)
|
2 |
0/2124 (0.00%)
|
0 |
1/2125 (0.05%)
|
1 |
0/2136 (0.00%)
|
0 |
Intestinal polyp |
1/2144 (0.05%)
|
1 |
0/2124 (0.00%)
|
0 |
0/2125 (0.00%)
|
0 |
0/2136 (0.00%)
|
0 |
Mesenteric artery stenosis |
0/2144 (0.00%)
|
0 |
0/2124 (0.00%)
|
0 |
0/2125 (0.00%)
|
0 |
1/2136 (0.05%)
|
1 |
Obstructive pancreatitis |
0/2144 (0.00%)
|
0 |
1/2124 (0.05%)
|
1 |
0/2125 (0.00%)
|
0 |
0/2136 (0.00%)
|
0 |
Pharyngo-oesophageal diverticulum |
1/2144 (0.05%)
|
1 |
0/2124 (0.00%)
|
0 |
0/2125 (0.00%)
|
0 |
0/2136 (0.00%)
|
0 |
Retroperitoneal haemorrhage |
1/2144 (0.05%)
|
1 |
0/2124 (0.00%)
|
0 |
0/2125 (0.00%)
|
0 |
0/2136 (0.00%)
|
0 |
Toothache |
0/2144 (0.00%)
|
0 |
1/2124 (0.05%)
|
1 |
0/2125 (0.00%)
|
0 |
0/2136 (0.00%)
|
0 |
Varices oesophageal |
1/2144 (0.05%)
|
1 |
0/2124 (0.00%)
|
0 |
0/2125 (0.00%)
|
0 |
0/2136 (0.00%)
|
0 |
Vomiting |
1/2144 (0.05%)
|
1 |
0/2124 (0.00%)
|
0 |
0/2125 (0.00%)
|
0 |
0/2136 (0.00%)
|
0 |
Erosive oesophagitis |
0/2144 (0.00%)
|
0 |
0/2124 (0.00%)
|
0 |
1/2125 (0.05%)
|
1 |
0/2136 (0.00%)
|
0 |
Large intestinal haemorrhage |
1/2144 (0.05%)
|
1 |
0/2124 (0.00%)
|
0 |
0/2125 (0.00%)
|
0 |
0/2136 (0.00%)
|
0 |
General disorders |
|
|
|
|
Death |
1/2144 (0.05%)
|
1 |
4/2124 (0.19%)
|
4 |
7/2125 (0.33%)
|
7 |
2/2136 (0.09%)
|
2 |
Chest pain |
3/2144 (0.14%)
|
3 |
4/2124 (0.19%)
|
4 |
2/2125 (0.09%)
|
2 |
2/2136 (0.09%)
|
2 |
Multiple organ dysfunction syndrome |
1/2144 (0.05%)
|
1 |
1/2124 (0.05%)
|
1 |
0/2125 (0.00%)
|
0 |
1/2136 (0.05%)
|
1 |
Sudden death |
1/2144 (0.05%)
|
1 |
1/2124 (0.05%)
|
1 |
0/2125 (0.00%)
|
0 |
1/2136 (0.05%)
|
1 |
Non-cardiac chest pain |
4/2144 (0.19%)
|
4 |
1/2124 (0.05%)
|
1 |
2/2125 (0.09%)
|
2 |
4/2136 (0.19%)
|
4 |
Drug withdrawal syndrome |
0/2144 (0.00%)
|
0 |
1/2124 (0.05%)
|
1 |
0/2125 (0.00%)
|
0 |
1/2136 (0.05%)
|
1 |
Oedema peripheral |
1/2144 (0.05%)
|
1 |
0/2124 (0.00%)
|
0 |
0/2125 (0.00%)
|
0 |
1/2136 (0.05%)
|
1 |
Asthenia |
1/2144 (0.05%)
|
1 |
0/2124 (0.00%)
|
0 |
0/2125 (0.00%)
|
0 |
0/2136 (0.00%)
|
0 |
Capsular contracture associated with breast implant |
0/2144 (0.00%)
|
0 |
0/2124 (0.00%)
|
0 |
0/2125 (0.00%)
|
0 |
1/2136 (0.05%)
|
1 |
Fatigue |
1/2144 (0.05%)
|
1 |
0/2124 (0.00%)
|
0 |
0/2125 (0.00%)
|
0 |
0/2136 (0.00%)
|
0 |
Pain |
1/2144 (0.05%)
|
1 |
0/2124 (0.00%)
|
0 |
0/2125 (0.00%)
|
0 |
0/2136 (0.00%)
|
0 |
Soft tissue inflamation |
0/2144 (0.00%)
|
0 |
1/2124 (0.05%)
|
1 |
0/2125 (0.00%)
|
0 |
0/2136 (0.00%)
|
0 |
Sudden cardiac death |
0/2144 (0.00%)
|
0 |
0/2124 (0.00%)
|
0 |
1/2125 (0.05%)
|
1 |
0/2136 (0.00%)
|
0 |
Systemic inflammatory response syndrome |
1/2144 (0.05%)
|
1 |
0/2124 (0.00%)
|
0 |
0/2125 (0.00%)
|
0 |
0/2136 (0.00%)
|
0 |
Hepatobiliary disorders |
|
|
|
|
Cholecystitis acute |
2/2144 (0.09%)
|
2 |
2/2124 (0.09%)
|
2 |
3/2125 (0.14%)
|
3 |
3/2136 (0.14%)
|
3 |
Cholelithiasis |
3/2144 (0.14%)
|
3 |
0/2124 (0.00%)
|
0 |
4/2125 (0.19%)
|
4 |
1/2136 (0.05%)
|
1 |
Cholecystitis |
2/2144 (0.09%)
|
2 |
0/2124 (0.00%)
|
0 |
1/2125 (0.05%)
|
1 |
0/2136 (0.00%)
|
0 |
Hepatic cirrohsis |
1/2144 (0.05%)
|
1 |
0/2124 (0.00%)
|
0 |
0/2125 (0.00%)
|
0 |
1/2136 (0.05%)
|
1 |
Bile duct obstruction |
0/2144 (0.00%)
|
0 |
0/2124 (0.00%)
|
0 |
1/2125 (0.05%)
|
1 |
0/2136 (0.00%)
|
0 |
Cholangitis |
0/2144 (0.00%)
|
0 |
1/2124 (0.05%)
|
1 |
0/2125 (0.00%)
|
0 |
0/2136 (0.00%)
|
0 |
Cholecystitis Chronic |
0/2144 (0.00%)
|
0 |
0/2124 (0.00%)
|
0 |
0/2125 (0.00%)
|
0 |
1/2136 (0.05%)
|
1 |
Hepatic failure |
0/2144 (0.00%)
|
0 |
0/2124 (0.00%)
|
0 |
0/2125 (0.00%)
|
0 |
1/2136 (0.05%)
|
1 |
Hepatic function abnormal |
1/2144 (0.05%)
|
1 |
0/2124 (0.00%)
|
0 |
0/2125 (0.00%)
|
0 |
0/2136 (0.00%)
|
0 |
Hepatitis toxic |
0/2144 (0.00%)
|
0 |
0/2124 (0.00%)
|
0 |
0/2125 (0.00%)
|
0 |
1/2136 (0.05%)
|
1 |
Immune system disorders |
|
|
|
|
Drug hypersensitivity |
1/2144 (0.05%)
|
1 |
1/2124 (0.05%)
|
1 |
0/2125 (0.00%)
|
0 |
1/2136 (0.05%)
|
1 |
Anaphylactic reaction |
0/2144 (0.00%)
|
0 |
2/2124 (0.09%)
|
2 |
0/2125 (0.00%)
|
0 |
0/2136 (0.00%)
|
0 |
Allergy to arthropod sting |
1/2144 (0.05%)
|
1 |
0/2124 (0.00%)
|
0 |
0/2125 (0.00%)
|
0 |
0/2136 (0.00%)
|
0 |
Type I hypersensitivity |
0/2144 (0.00%)
|
0 |
1/2124 (0.05%)
|
1 |
0/2125 (0.00%)
|
0 |
0/2136 (0.00%)
|
0 |
Infections and infestations |
|
|
|
|
Pneumonia |
61/2144 (2.85%)
|
63 |
59/2124 (2.78%)
|
64 |
35/2125 (1.65%)
|
37 |
55/2136 (2.57%)
|
57 |
Sepsis |
7/2144 (0.33%)
|
8 |
5/2124 (0.24%)
|
5 |
5/2125 (0.24%)
|
5 |
3/2136 (0.14%)
|
3 |
Cellulitis |
4/2144 (0.19%)
|
4 |
6/2124 (0.28%)
|
6 |
4/2125 (0.19%)
|
4 |
3/2136 (0.14%)
|
3 |
Influenza |
4/2144 (0.19%)
|
4 |
2/2124 (0.09%)
|
2 |
2/2125 (0.09%)
|
2 |
7/2136 (0.33%)
|
7 |
Diverticulitis |
3/2144 (0.14%)
|
4 |
3/2124 (0.14%)
|
3 |
3/2125 (0.14%)
|
3 |
4/2136 (0.19%)
|
5 |
Bronchitis |
2/2144 (0.09%)
|
2 |
3/2124 (0.14%)
|
3 |
4/2125 (0.19%)
|
4 |
3/2136 (0.14%)
|
3 |
Urinary tract infection |
1/2144 (0.05%)
|
1 |
4/2124 (0.19%)
|
4 |
2/2125 (0.09%)
|
2 |
0/2136 (0.00%)
|
0 |
Respiratory tract infection |
2/2144 (0.09%)
|
3 |
2/2124 (0.09%)
|
2 |
0/2125 (0.00%)
|
0 |
2/2136 (0.09%)
|
2 |
Lung infection |
1/2144 (0.05%)
|
1 |
2/2124 (0.09%)
|
2 |
1/2125 (0.05%)
|
1 |
2/2136 (0.09%)
|
2 |
Lower respiratory tract infection |
0/2144 (0.00%)
|
0 |
2/2124 (0.09%)
|
2 |
2/2125 (0.09%)
|
2 |
1/2136 (0.05%)
|
1 |
Appendicitis |
2/2144 (0.09%)
|
2 |
0/2124 (0.00%)
|
0 |
2/2125 (0.09%)
|
2 |
0/2136 (0.00%)
|
0 |
Septic shock |
1/2144 (0.05%)
|
1 |
1/2124 (0.05%)
|
1 |
1/2125 (0.05%)
|
1 |
1/2136 (0.05%)
|
1 |
Erysipelas |
0/2144 (0.00%)
|
0 |
1/2124 (0.05%)
|
1 |
2/2125 (0.09%)
|
2 |
0/2136 (0.00%)
|
0 |
Pneumonia bacterial |
3/2144 (0.14%)
|
3 |
0/2124 (0.00%)
|
0 |
0/2125 (0.00%)
|
0 |
0/2136 (0.00%)
|
0 |
Pneumonia viral |
2/2144 (0.09%)
|
2 |
0/2124 (0.00%)
|
0 |
0/2125 (0.00%)
|
0 |
1/2136 (0.05%)
|
1 |
Staphylococcal infection |
0/2144 (0.00%)
|
0 |
0/2124 (0.00%)
|
0 |
3/2125 (0.14%)
|
3 |
0/2136 (0.00%)
|
0 |
Wound infection |
1/2144 (0.05%)
|
1 |
0/2124 (0.00%)
|
0 |
0/2125 (0.00%)
|
0 |
2/2136 (0.09%)
|
2 |
Anal abscess |
0/2144 (0.00%)
|
0 |
0/2124 (0.00%)
|
0 |
2/2125 (0.09%)
|
2 |
0/2136 (0.00%)
|
0 |
Device related infection |
0/2144 (0.00%)
|
0 |
2/2124 (0.09%)
|
2 |
0/2125 (0.00%)
|
0 |
0/2136 (0.00%)
|
0 |
Gastroenteritis |
0/2144 (0.00%)
|
0 |
0/2124 (0.00%)
|
0 |
1/2125 (0.05%)
|
1 |
1/2136 (0.05%)
|
1 |
Peritonitis |
1/2144 (0.05%)
|
1 |
0/2124 (0.00%)
|
0 |
1/2125 (0.05%)
|
1 |
0/2136 (0.00%)
|
0 |
Pneumonia pneumococcal |
1/2144 (0.05%)
|
1 |
0/2124 (0.00%)
|
0 |
0/2125 (0.00%)
|
0 |
1/2136 (0.05%)
|
1 |
Pulmonary tuberculosis |
0/2144 (0.00%)
|
0 |
1/2124 (0.05%)
|
1 |
0/2125 (0.00%)
|
0 |
1/2136 (0.05%)
|
1 |
Respiratory syncytial virus infection |
0/2144 (0.00%)
|
0 |
1/2124 (0.05%)
|
1 |
0/2125 (0.00%)
|
0 |
1/2136 (0.05%)
|
1 |
Urosepsis |
0/2144 (0.00%)
|
0 |
1/2124 (0.05%)
|
1 |
1/2125 (0.05%)
|
1 |
0/2136 (0.00%)
|
0 |
Arthritis bacterial |
0/2144 (0.00%)
|
0 |
1/2124 (0.05%)
|
1 |
0/2125 (0.00%)
|
0 |
0/2136 (0.00%)
|
0 |
Bacterial pyelonephritis |
0/2144 (0.00%)
|
0 |
1/2124 (0.05%)
|
1 |
0/2125 (0.00%)
|
0 |
0/2136 (0.00%)
|
0 |
Bronchitis viral |
0/2144 (0.00%)
|
0 |
0/2124 (0.00%)
|
0 |
1/2125 (0.05%)
|
1 |
0/2136 (0.00%)
|
0 |
Bronchopulmonary aspergillosis |
0/2144 (0.00%)
|
0 |
0/2124 (0.00%)
|
0 |
0/2125 (0.00%)
|
0 |
1/2136 (0.05%)
|
1 |
Bronchopulmonary aspergillosis allergic |
0/2144 (0.00%)
|
0 |
1/2124 (0.05%)
|
1 |
0/2125 (0.00%)
|
0 |
0/2136 (0.00%)
|
0 |
Bursitis infective |
1/2144 (0.05%)
|
1 |
0/2124 (0.00%)
|
0 |
0/2125 (0.00%)
|
0 |
0/2136 (0.00%)
|
0 |
Campylobacter infection |
0/2144 (0.00%)
|
0 |
0/2124 (0.00%)
|
0 |
0/2125 (0.00%)
|
0 |
1/2136 (0.05%)
|
1 |
Catheter site cellulitits |
0/2144 (0.00%)
|
0 |
0/2124 (0.00%)
|
0 |
1/2125 (0.05%)
|
1 |
0/2136 (0.00%)
|
0 |
Cellulitis of male external genital organ |
1/2144 (0.05%)
|
1 |
0/2124 (0.00%)
|
0 |
0/2125 (0.00%)
|
0 |
0/2136 (0.00%)
|
0 |
Cholecystitis infective |
0/2144 (0.00%)
|
0 |
0/2124 (0.00%)
|
0 |
1/2125 (0.05%)
|
1 |
0/2136 (0.00%)
|
0 |
Clostridium difficile colitis |
0/2144 (0.00%)
|
0 |
0/2124 (0.00%)
|
0 |
1/2125 (0.05%)
|
1 |
0/2136 (0.00%)
|
0 |
Colonic abscess |
0/2144 (0.00%)
|
0 |
1/2124 (0.05%)
|
1 |
0/2125 (0.00%)
|
0 |
0/2136 (0.00%)
|
0 |
Emphysematous cholecystitis |
0/2144 (0.00%)
|
0 |
0/2124 (0.00%)
|
0 |
0/2125 (0.00%)
|
0 |
1/2136 (0.05%)
|
1 |
Encephalitis brain stem |
0/2144 (0.00%)
|
0 |
1/2124 (0.05%)
|
1 |
0/2125 (0.00%)
|
0 |
0/2136 (0.00%)
|
0 |
Endocarditis |
0/2144 (0.00%)
|
0 |
1/2124 (0.05%)
|
1 |
0/2125 (0.00%)
|
0 |
0/2136 (0.00%)
|
0 |
Epididymitis |
0/2144 (0.00%)
|
0 |
0/2124 (0.00%)
|
0 |
1/2125 (0.05%)
|
1 |
0/2136 (0.00%)
|
0 |
Gastroenteritis norovirus |
0/2144 (0.00%)
|
0 |
0/2124 (0.00%)
|
0 |
0/2125 (0.00%)
|
0 |
1/2136 (0.05%)
|
1 |
Gastroenteritis salmonella |
1/2144 (0.05%)
|
1 |
0/2124 (0.00%)
|
0 |
0/2125 (0.00%)
|
0 |
0/2136 (0.00%)
|
0 |
Gastroenteritis shigella |
0/2144 (0.00%)
|
0 |
0/2124 (0.00%)
|
0 |
1/2125 (0.05%)
|
1 |
0/2136 (0.00%)
|
0 |
Gastroenteritis viral |
0/2144 (0.00%)
|
0 |
0/2124 (0.00%)
|
0 |
0/2125 (0.00%)
|
0 |
1/2136 (0.05%)
|
1 |
H1N1 influenza |
0/2144 (0.00%)
|
0 |
0/2124 (0.00%)
|
0 |
1/2125 (0.05%)
|
1 |
0/2136 (0.00%)
|
0 |
Histoplasmosis |
0/2144 (0.00%)
|
0 |
1/2124 (0.05%)
|
1 |
0/2125 (0.00%)
|
0 |
0/2136 (0.00%)
|
0 |
Infected bite |
1/2144 (0.05%)
|
1 |
0/2124 (0.00%)
|
0 |
0/2125 (0.00%)
|
0 |
0/2136 (0.00%)
|
0 |
Infected dermal cyst |
0/2144 (0.00%)
|
0 |
0/2124 (0.00%)
|
0 |
1/2125 (0.05%)
|
1 |
0/2136 (0.00%)
|
0 |
Infective exacerbation of bronshiectasis |
0/2144 (0.00%)
|
0 |
0/2124 (0.00%)
|
0 |
1/2125 (0.05%)
|
1 |
0/2136 (0.00%)
|
0 |
Laryngitis |
0/2144 (0.00%)
|
0 |
1/2124 (0.05%)
|
1 |
0/2125 (0.00%)
|
0 |
0/2136 (0.00%)
|
0 |
Localised infection |
0/2144 (0.00%)
|
0 |
0/2124 (0.00%)
|
0 |
1/2125 (0.05%)
|
1 |
0/2136 (0.00%)
|
0 |
Mastitis |
1/2144 (0.05%)
|
1 |
0/2124 (0.00%)
|
0 |
0/2125 (0.00%)
|
0 |
0/2136 (0.00%)
|
0 |
Mastoiditis |
0/2144 (0.00%)
|
0 |
0/2124 (0.00%)
|
0 |
0/2125 (0.00%)
|
0 |
1/2136 (0.05%)
|
1 |
Metapneumovirus infection |
0/2144 (0.00%)
|
0 |
0/2124 (0.00%)
|
0 |
0/2125 (0.00%)
|
0 |
1/2136 (0.05%)
|
1 |
Micrococcus infection |
1/2144 (0.05%)
|
1 |
0/2124 (0.00%)
|
0 |
0/2125 (0.00%)
|
0 |
0/2136 (0.00%)
|
0 |
Oesophageal candidiasis |
1/2144 (0.05%)
|
1 |
0/2124 (0.00%)
|
0 |
0/2125 (0.00%)
|
0 |
0/2136 (0.00%)
|
0 |
Osteomyelitis |
1/2144 (0.05%)
|
1 |
0/2124 (0.00%)
|
0 |
0/2125 (0.00%)
|
0 |
0/2136 (0.00%)
|
0 |
Otosalpingitis |
1/2144 (0.05%)
|
1 |
0/2124 (0.00%)
|
0 |
0/2125 (0.00%)
|
0 |
0/2136 (0.00%)
|
0 |
Perichondritis |
1/2144 (0.05%)
|
1 |
0/2124 (0.00%)
|
0 |
0/2125 (0.00%)
|
0 |
0/2136 (0.00%)
|
0 |
Periorbital cellulitis |
1/2144 (0.05%)
|
1 |
0/2124 (0.00%)
|
0 |
0/2125 (0.00%)
|
0 |
0/2136 (0.00%)
|
0 |
Pneumonia pseudomonal |
0/2144 (0.00%)
|
0 |
1/2124 (0.05%)
|
1 |
0/2125 (0.00%)
|
0 |
0/2136 (0.00%)
|
0 |
Post procedural sepsis |
1/2144 (0.05%)
|
1 |
0/2124 (0.00%)
|
0 |
0/2125 (0.00%)
|
0 |
0/2136 (0.00%)
|
0 |
Pyelonephritis |
1/2144 (0.05%)
|
1 |
0/2124 (0.00%)
|
0 |
0/2125 (0.00%)
|
0 |
0/2136 (0.00%)
|
0 |
Respiratory tract infection viral |
1/2144 (0.05%)
|
1 |
0/2124 (0.00%)
|
0 |
0/2125 (0.00%)
|
0 |
0/2136 (0.00%)
|
0 |
Sinusitis |
1/2144 (0.05%)
|
1 |
0/2124 (0.00%)
|
0 |
0/2125 (0.00%)
|
0 |
0/2136 (0.00%)
|
0 |
Soft tissue infection |
0/2144 (0.00%)
|
0 |
0/2124 (0.00%)
|
0 |
1/2125 (0.05%)
|
1 |
0/2136 (0.00%)
|
0 |
Tracheobronchitis |
0/2144 (0.00%)
|
0 |
0/2124 (0.00%)
|
0 |
0/2125 (0.00%)
|
0 |
1/2136 (0.05%)
|
1 |
Vaginal infection |
0/2144 (0.00%)
|
0 |
1/2124 (0.05%)
|
1 |
0/2125 (0.00%)
|
0 |
0/2136 (0.00%)
|
0 |
Viral infection |
0/2144 (0.00%)
|
0 |
1/2124 (0.05%)
|
1 |
0/2125 (0.00%)
|
0 |
0/2136 (0.00%)
|
0 |
Pneumonia streptococcal |
1/2144 (0.05%)
|
1 |
0/2124 (0.00%)
|
0 |
0/2125 (0.00%)
|
0 |
0/2136 (0.00%)
|
0 |
Injury, poisoning and procedural complications |
|
|
|
|
Hip fracture |
4/2144 (0.19%)
|
4 |
3/2124 (0.14%)
|
3 |
1/2125 (0.05%)
|
1 |
5/2136 (0.23%)
|
5 |
Ankle fracture |
3/2144 (0.14%)
|
3 |
0/2124 (0.00%)
|
0 |
0/2125 (0.00%)
|
0 |
3/2136 (0.14%)
|
3 |
Fall |
1/2144 (0.05%)
|
1 |
2/2124 (0.09%)
|
2 |
2/2125 (0.09%)
|
2 |
1/2136 (0.05%)
|
1 |
Femoral neck fracture |
2/2144 (0.09%)
|
2 |
2/2124 (0.09%)
|
2 |
0/2125 (0.00%)
|
0 |
2/2136 (0.09%)
|
2 |
Femur fracture |
1/2144 (0.05%)
|
1 |
1/2124 (0.05%)
|
1 |
2/2125 (0.09%)
|
2 |
1/2136 (0.05%)
|
1 |
Lower limb fracture |
1/2144 (0.05%)
|
1 |
1/2124 (0.05%)
|
1 |
1/2125 (0.05%)
|
1 |
1/2136 (0.05%)
|
1 |
Radius fracture |
1/2144 (0.05%)
|
1 |
2/2124 (0.09%)
|
2 |
1/2125 (0.05%)
|
1 |
0/2136 (0.00%)
|
0 |
Meniscus injury |
0/2144 (0.00%)
|
0 |
2/2124 (0.09%)
|
2 |
1/2125 (0.05%)
|
1 |
0/2136 (0.00%)
|
0 |
Road traffic accident |
1/2144 (0.05%)
|
1 |
1/2124 (0.05%)
|
1 |
0/2125 (0.00%)
|
0 |
1/2136 (0.05%)
|
1 |
Spinal compression fracture |
1/2144 (0.05%)
|
1 |
1/2124 (0.05%)
|
1 |
1/2125 (0.05%)
|
1 |
0/2136 (0.00%)
|
0 |
Abdominal wound dehiscene |
0/2144 (0.00%)
|
0 |
1/2124 (0.05%)
|
1 |
1/2125 (0.05%)
|
1 |
0/2136 (0.00%)
|
0 |
Foot fracture |
1/2144 (0.05%)
|
1 |
1/2124 (0.05%)
|
1 |
0/2125 (0.00%)
|
0 |
0/2136 (0.00%)
|
0 |
Lumbar vertebral fracture |
1/2144 (0.05%)
|
1 |
0/2124 (0.00%)
|
0 |
1/2125 (0.05%)
|
1 |
0/2136 (0.00%)
|
0 |
Multiple injuries |
0/2144 (0.00%)
|
0 |
1/2124 (0.05%)
|
1 |
0/2125 (0.00%)
|
0 |
1/2136 (0.05%)
|
1 |
Post procedural hemorrhage |
0/2144 (0.00%)
|
0 |
2/2124 (0.09%)
|
2 |
0/2125 (0.00%)
|
0 |
0/2136 (0.00%)
|
0 |
Thoracic vertebral fracture |
1/2144 (0.05%)
|
1 |
0/2124 (0.00%)
|
0 |
0/2125 (0.00%)
|
0 |
1/2136 (0.05%)
|
1 |
Tibia fracture |
0/2144 (0.00%)
|
0 |
0/2124 (0.00%)
|
0 |
0/2125 (0.00%)
|
0 |
2/2136 (0.09%)
|
2 |
Ulna fracture |
0/2144 (0.00%)
|
0 |
1/2124 (0.05%)
|
1 |
1/2125 (0.05%)
|
1 |
0/2136 (0.00%)
|
0 |
Accidental overdose |
0/2144 (0.00%)
|
0 |
1/2124 (0.05%)
|
1 |
0/2125 (0.00%)
|
0 |
0/2136 (0.00%)
|
0 |
Concussion |
0/2144 (0.00%)
|
0 |
0/2124 (0.00%)
|
0 |
1/2125 (0.05%)
|
1 |
0/2136 (0.00%)
|
0 |
Epicondylitis |
0/2144 (0.00%)
|
0 |
1/2124 (0.05%)
|
1 |
0/2125 (0.00%)
|
0 |
0/2136 (0.00%)
|
0 |
Foreign body aspiration |
0/2144 (0.00%)
|
0 |
0/2124 (0.00%)
|
0 |
1/2125 (0.05%)
|
1 |
0/2136 (0.00%)
|
0 |
Foreign body in gastrointestinal tract |
0/2144 (0.00%)
|
0 |
0/2124 (0.00%)
|
0 |
0/2125 (0.00%)
|
0 |
1/2136 (0.05%)
|
1 |
Hand Fracture |
0/2144 (0.00%)
|
0 |
1/2124 (0.05%)
|
1 |
0/2125 (0.00%)
|
0 |
0/2136 (0.00%)
|
0 |
Humerous fracture |
1/2144 (0.05%)
|
1 |
0/2124 (0.00%)
|
0 |
0/2125 (0.00%)
|
0 |
0/2136 (0.00%)
|
0 |
Jaw fracture |
0/2144 (0.00%)
|
0 |
1/2124 (0.05%)
|
1 |
0/2125 (0.00%)
|
0 |
0/2136 (0.00%)
|
0 |
Joint dislocation |
1/2144 (0.05%)
|
1 |
0/2124 (0.00%)
|
0 |
0/2125 (0.00%)
|
0 |
0/2136 (0.00%)
|
0 |
Limb traumatic amputation |
1/2144 (0.05%)
|
1 |
0/2124 (0.00%)
|
0 |
0/2125 (0.00%)
|
0 |
0/2136 (0.00%)
|
0 |
Multiple fractures |
0/2144 (0.00%)
|
0 |
1/2124 (0.05%)
|
1 |
0/2125 (0.00%)
|
0 |
0/2136 (0.00%)
|
0 |
Ocular procedural complication |
1/2144 (0.05%)
|
1 |
0/2124 (0.00%)
|
0 |
0/2125 (0.00%)
|
0 |
0/2136 (0.00%)
|
0 |
Pelvic fracture |
0/2144 (0.00%)
|
0 |
0/2124 (0.00%)
|
0 |
0/2125 (0.00%)
|
0 |
1/2136 (0.05%)
|
1 |
Procedural pneumothorax |
0/2144 (0.00%)
|
0 |
0/2124 (0.00%)
|
0 |
0/2125 (0.00%)
|
0 |
1/2136 (0.05%)
|
1 |
Pubis fracture |
0/2144 (0.00%)
|
0 |
1/2124 (0.05%)
|
1 |
0/2125 (0.00%)
|
0 |
0/2136 (0.00%)
|
0 |
Radiation proctitis |
0/2144 (0.00%)
|
0 |
0/2124 (0.00%)
|
0 |
0/2125 (0.00%)
|
0 |
1/2136 (0.05%)
|
1 |
Sternal fracture |
0/2144 (0.00%)
|
0 |
0/2124 (0.00%)
|
0 |
0/2125 (0.00%)
|
0 |
1/2136 (0.05%)
|
1 |
Subdural hematoma |
0/2144 (0.00%)
|
0 |
0/2124 (0.00%)
|
0 |
0/2125 (0.00%)
|
0 |
1/2136 (0.05%)
|
1 |
Tendon rupture |
1/2144 (0.05%)
|
1 |
0/2124 (0.00%)
|
0 |
0/2125 (0.00%)
|
0 |
0/2136 (0.00%)
|
0 |
Upper limb fracture |
0/2144 (0.00%)
|
0 |
0/2124 (0.00%)
|
0 |
1/2125 (0.05%)
|
1 |
0/2136 (0.00%)
|
0 |
Venomous bite |
0/2144 (0.00%)
|
0 |
1/2124 (0.05%)
|
1 |
0/2125 (0.00%)
|
0 |
0/2136 (0.00%)
|
0 |
Wound decomposition |
1/2144 (0.05%)
|
1 |
0/2124 (0.00%)
|
0 |
0/2125 (0.00%)
|
0 |
0/2136 (0.00%)
|
0 |
Wound dehiscence |
0/2144 (0.00%)
|
0 |
0/2124 (0.00%)
|
0 |
1/2125 (0.05%)
|
1 |
0/2136 (0.00%)
|
0 |
Wrist fracture |
1/2144 (0.05%)
|
1 |
0/2124 (0.00%)
|
0 |
0/2125 (0.00%)
|
0 |
0/2136 (0.00%)
|
0 |
Rib fracture |
1/2144 (0.05%)
|
1 |
1/2124 (0.05%)
|
1 |
1/2125 (0.05%)
|
1 |
1/2136 (0.05%)
|
1 |
Contussion |
0/2144 (0.00%)
|
0 |
0/2124 (0.00%)
|
0 |
1/2125 (0.05%)
|
1 |
0/2136 (0.00%)
|
0 |
Penetrating abdominal trauma |
1/2144 (0.05%)
|
1 |
0/2124 (0.00%)
|
0 |
0/2125 (0.00%)
|
0 |
0/2136 (0.00%)
|
0 |
Pneumoconiosis |
1/2144 (0.05%)
|
1 |
0/2124 (0.00%)
|
0 |
0/2125 (0.00%)
|
0 |
0/2136 (0.00%)
|
0 |
Spinal fracture |
0/2144 (0.00%)
|
0 |
0/2124 (0.00%)
|
0 |
1/2125 (0.05%)
|
1 |
0/2136 (0.00%)
|
0 |
Thermal burn |
0/2144 (0.00%)
|
0 |
0/2124 (0.00%)
|
0 |
1/2125 (0.05%)
|
1 |
0/2136 (0.00%)
|
0 |
Toxicity to various agents |
0/2144 (0.00%)
|
0 |
1/2124 (0.05%)
|
1 |
0/2125 (0.00%)
|
0 |
0/2136 (0.00%)
|
0 |
Wound evisceration |
0/2144 (0.00%)
|
0 |
0/2124 (0.00%)
|
0 |
1/2125 (0.05%)
|
1 |
0/2136 (0.00%)
|
0 |
Investigations |
|
|
|
|
Troponin increased |
1/2144 (0.05%)
|
1 |
1/2124 (0.05%)
|
1 |
0/2125 (0.00%)
|
0 |
0/2136 (0.00%)
|
0 |
Blood folate decreased |
0/2144 (0.00%)
|
0 |
1/2124 (0.05%)
|
1 |
0/2125 (0.00%)
|
0 |
0/2136 (0.00%)
|
0 |
Blood magnesium decreased |
0/2144 (0.00%)
|
0 |
1/2124 (0.05%)
|
1 |
0/2125 (0.00%)
|
0 |
0/2136 (0.00%)
|
0 |
Electrocradiogram ST-T change |
0/2144 (0.00%)
|
0 |
1/2124 (0.05%)
|
1 |
0/2125 (0.00%)
|
0 |
0/2136 (0.00%)
|
0 |
Electrocardiogram abnormal |
0/2144 (0.00%)
|
0 |
0/2124 (0.00%)
|
0 |
1/2125 (0.05%)
|
1 |
0/2136 (0.00%)
|
0 |
Oxygen saturation decreased |
0/2144 (0.00%)
|
0 |
1/2124 (0.05%)
|
1 |
0/2125 (0.00%)
|
0 |
0/2136 (0.00%)
|
0 |
Prothrombin time abnormal |
1/2144 (0.05%)
|
1 |
0/2124 (0.00%)
|
0 |
0/2125 (0.00%)
|
0 |
0/2136 (0.00%)
|
0 |
Metabolism and nutrition disorders |
|
|
|
|
Fluid overload |
0/2144 (0.00%)
|
0 |
2/2124 (0.09%)
|
2 |
0/2125 (0.00%)
|
0 |
0/2136 (0.00%)
|
0 |
Hyperglycaemia |
2/2144 (0.09%)
|
2 |
0/2124 (0.00%)
|
0 |
0/2125 (0.00%)
|
0 |
0/2136 (0.00%)
|
0 |
Hypoglycaemia |
1/2144 (0.05%)
|
1 |
1/2124 (0.05%)
|
1 |
0/2125 (0.00%)
|
0 |
0/2136 (0.00%)
|
0 |
Hyponatremia |
1/2144 (0.05%)
|
1 |
1/2124 (0.05%)
|
1 |
0/2125 (0.00%)
|
0 |
0/2136 (0.00%)
|
0 |
Abnormal loss of weight |
0/2144 (0.00%)
|
0 |
0/2124 (0.00%)
|
0 |
0/2125 (0.00%)
|
0 |
1/2136 (0.05%)
|
1 |
Dehydration |
0/2144 (0.00%)
|
0 |
0/2124 (0.00%)
|
0 |
0/2125 (0.00%)
|
0 |
1/2136 (0.05%)
|
1 |
Diabetes melitus |
0/2144 (0.00%)
|
0 |
0/2124 (0.00%)
|
0 |
1/2125 (0.05%)
|
1 |
0/2136 (0.00%)
|
0 |
Diabetes melitus inadequate control |
0/2144 (0.00%)
|
0 |
0/2124 (0.00%)
|
0 |
0/2125 (0.00%)
|
0 |
1/2136 (0.05%)
|
1 |
Hyperlipidemia |
1/2144 (0.05%)
|
1 |
0/2124 (0.00%)
|
0 |
0/2125 (0.00%)
|
0 |
0/2136 (0.00%)
|
0 |
Impaired fasting glucose |
0/2144 (0.00%)
|
0 |
1/2124 (0.05%)
|
1 |
0/2125 (0.00%)
|
0 |
0/2136 (0.00%)
|
0 |
Metabolic acidosis |
0/2144 (0.00%)
|
0 |
1/2124 (0.05%)
|
1 |
0/2125 (0.00%)
|
0 |
0/2136 (0.00%)
|
0 |
Obesity |
0/2144 (0.00%)
|
0 |
1/2124 (0.05%)
|
1 |
0/2125 (0.00%)
|
0 |
0/2136 (0.00%)
|
0 |
Vitamin B12 deficiency |
0/2144 (0.00%)
|
0 |
0/2124 (0.00%)
|
0 |
0/2125 (0.00%)
|
0 |
1/2136 (0.05%)
|
1 |
Musculoskeletal and connective tissue disorders |
|
|
|
|
Osteorthritis |
1/2144 (0.05%)
|
1 |
2/2124 (0.09%)
|
2 |
3/2125 (0.14%)
|
3 |
3/2136 (0.14%)
|
3 |
Back pain |
2/2144 (0.09%)
|
2 |
1/2124 (0.05%)
|
1 |
2/2125 (0.09%)
|
2 |
0/2136 (0.00%)
|
0 |
Intervertebral disc protrusion |
1/2144 (0.05%)
|
1 |
0/2124 (0.00%)
|
0 |
2/2125 (0.09%)
|
2 |
1/2136 (0.05%)
|
1 |
Osteonecrosis |
1/2144 (0.05%)
|
1 |
1/2124 (0.05%)
|
1 |
1/2125 (0.05%)
|
1 |
1/2136 (0.05%)
|
1 |
Rotator cuff syndrome |
0/2144 (0.00%)
|
0 |
0/2124 (0.00%)
|
0 |
4/2125 (0.19%)
|
4 |
0/2136 (0.00%)
|
0 |
Lumbar spinal stenosis |
1/2144 (0.05%)
|
1 |
1/2124 (0.05%)
|
1 |
0/2125 (0.00%)
|
0 |
1/2136 (0.05%)
|
1 |
Arthralgia |
0/2144 (0.00%)
|
0 |
1/2124 (0.05%)
|
1 |
1/2125 (0.05%)
|
1 |
0/2136 (0.00%)
|
0 |
Flank pain |
0/2144 (0.00%)
|
0 |
1/2124 (0.05%)
|
1 |
1/2125 (0.05%)
|
1 |
0/2136 (0.00%)
|
0 |
Bursitis |
1/2144 (0.05%)
|
1 |
0/2124 (0.00%)
|
0 |
0/2125 (0.00%)
|
0 |
0/2136 (0.00%)
|
0 |
Costochondritis |
1/2144 (0.05%)
|
1 |
0/2124 (0.00%)
|
0 |
0/2125 (0.00%)
|
0 |
0/2136 (0.00%)
|
0 |
Groin pain |
0/2144 (0.00%)
|
0 |
1/2124 (0.05%)
|
1 |
0/2125 (0.00%)
|
0 |
0/2136 (0.00%)
|
0 |
Intervertebral disc degeneration |
0/2144 (0.00%)
|
0 |
1/2124 (0.05%)
|
1 |
0/2125 (0.00%)
|
0 |
0/2136 (0.00%)
|
0 |
Muscular weakness |
0/2144 (0.00%)
|
0 |
0/2124 (0.00%)
|
0 |
1/2125 (0.05%)
|
1 |
0/2136 (0.00%)
|
0 |
Pain in extremity |
0/2144 (0.00%)
|
0 |
0/2124 (0.00%)
|
0 |
0/2125 (0.00%)
|
0 |
1/2136 (0.05%)
|
1 |
Rhabdomyolysis |
0/2144 (0.00%)
|
0 |
0/2124 (0.00%)
|
0 |
1/2125 (0.05%)
|
1 |
0/2136 (0.00%)
|
0 |
Spinal ligament |
1/2144 (0.05%)
|
1 |
0/2124 (0.00%)
|
0 |
0/2125 (0.00%)
|
0 |
0/2136 (0.00%)
|
0 |
Spinal osteoarthritis |
0/2144 (0.00%)
|
0 |
1/2124 (0.05%)
|
1 |
0/2125 (0.00%)
|
0 |
0/2136 (0.00%)
|
0 |
Spondylolisthesis |
0/2144 (0.00%)
|
0 |
0/2124 (0.00%)
|
0 |
0/2125 (0.00%)
|
0 |
1/2136 (0.05%)
|
1 |
Synovial cyst |
0/2144 (0.00%)
|
0 |
1/2124 (0.05%)
|
1 |
0/2125 (0.00%)
|
0 |
0/2136 (0.00%)
|
0 |
Synovitis |
0/2144 (0.00%)
|
0 |
1/2124 (0.05%)
|
1 |
0/2125 (0.00%)
|
0 |
0/2136 (0.00%)
|
0 |
Cervical spinal stenosis |
1/2144 (0.05%)
|
1 |
2/2124 (0.09%)
|
2 |
0/2125 (0.00%)
|
0 |
2/2136 (0.09%)
|
2 |
Musculoskeletal pain |
0/2144 (0.00%)
|
0 |
0/2124 (0.00%)
|
0 |
0/2125 (0.00%)
|
0 |
1/2136 (0.05%)
|
1 |
Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
|
|
|
Lung neoplasm malignant |
4/2144 (0.19%)
|
4 |
5/2124 (0.24%)
|
5 |
2/2125 (0.09%)
|
2 |
4/2136 (0.19%)
|
4 |
Prostate cancer |
3/2144 (0.14%)
|
3 |
1/2124 (0.05%)
|
1 |
2/2125 (0.09%)
|
2 |
3/2136 (0.14%)
|
3 |
Lung adenocarcinoma |
1/2144 (0.05%)
|
1 |
1/2124 (0.05%)
|
1 |
4/2125 (0.19%)
|
4 |
1/2136 (0.05%)
|
12 |
Non-small cell lung cancer |
2/2144 (0.09%)
|
2 |
1/2124 (0.05%)
|
1 |
0/2125 (0.00%)
|
0 |
2/2136 (0.09%)
|
2 |
Transitional cell carcinoma |
2/2144 (0.09%)
|
2 |
2/2124 (0.09%)
|
2 |
0/2125 (0.00%)
|
0 |
1/2136 (0.05%)
|
1 |
Metastases to liver |
1/2144 (0.05%)
|
1 |
1/2124 (0.05%)
|
1 |
1/2125 (0.05%)
|
1 |
1/2136 (0.05%)
|
1 |
Oesophageal carcinoma |
1/2144 (0.05%)
|
1 |
0/2124 (0.00%)
|
0 |
2/2125 (0.09%)
|
2 |
1/2136 (0.05%)
|
1 |
Squamous cell carcinoma of lung |
1/2144 (0.05%)
|
1 |
1/2124 (0.05%)
|
1 |
1/2125 (0.05%)
|
1 |
1/2136 (0.05%)
|
1 |
Breast cancer |
0/2144 (0.00%)
|
0 |
1/2124 (0.05%)
|
1 |
0/2125 (0.00%)
|
0 |
2/2136 (0.09%)
|
2 |
Pancreatic carcinoma |
2/2144 (0.09%)
|
2 |
1/2124 (0.05%)
|
1 |
0/2125 (0.00%)
|
0 |
0/2136 (0.00%)
|
0 |
Pancreatic carcinoma metastatic |
0/2144 (0.00%)
|
0 |
0/2124 (0.00%)
|
0 |
2/2125 (0.09%)
|
2 |
1/2136 (0.05%)
|
1 |
Small cell lung caner |
0/2144 (0.00%)
|
0 |
0/2124 (0.00%)
|
0 |
1/2125 (0.05%)
|
1 |
2/2136 (0.09%)
|
2 |
Adenocarcinoma |
0/2144 (0.00%)
|
0 |
1/2124 (0.05%)
|
1 |
1/2125 (0.05%)
|
1 |
0/2136 (0.00%)
|
0 |
Basal cell carcinoma |
1/2144 (0.05%)
|
1 |
0/2124 (0.00%)
|
0 |
0/2125 (0.00%)
|
0 |
1/2136 (0.05%)
|
1 |
Benign lung neoplasm |
0/2144 (0.00%)
|
0 |
1/2124 (0.05%)
|
1 |
0/2125 (0.00%)
|
0 |
1/2136 (0.05%)
|
1 |
Bronchial carcinoma |
1/2144 (0.05%)
|
1 |
0/2124 (0.00%)
|
0 |
0/2125 (0.00%)
|
0 |
1/2136 (0.05%)
|
1 |
Colorectal cancer |
1/2144 (0.05%)
|
1 |
0/2124 (0.00%)
|
0 |
0/2125 (0.00%)
|
0 |
1/2136 (0.05%)
|
1 |
Malignant palate neoplasm |
2/2144 (0.09%)
|
2 |
0/2124 (0.00%)
|
0 |
0/2125 (0.00%)
|
0 |
0/2136 (0.00%)
|
0 |
Metastases to central nervous system |
1/2144 (0.05%)
|
1 |
0/2124 (0.00%)
|
0 |
0/2125 (0.00%)
|
0 |
1/2136 (0.05%)
|
1 |
Metastases to lung |
0/2144 (0.00%)
|
0 |
0/2124 (0.00%)
|
0 |
2/2125 (0.09%)
|
2 |
0/2136 (0.00%)
|
0 |
Oesophageal squamous cell carcinoma |
0/2144 (0.00%)
|
0 |
0/2124 (0.00%)
|
0 |
1/2125 (0.05%)
|
1 |
1/2136 (0.05%)
|
1 |
Squamous cell carcinoma |
0/2144 (0.00%)
|
0 |
2/2124 (0.09%)
|
2 |
0/2125 (0.00%)
|
0 |
0/2136 (0.00%)
|
0 |
Abdominal wall neoplasm |
0/2144 (0.00%)
|
0 |
1/2124 (0.05%)
|
1 |
0/2125 (0.00%)
|
0 |
0/2136 (0.00%)
|
0 |
Acute myeloid leukaemia |
0/2144 (0.00%)
|
0 |
0/2124 (0.00%)
|
0 |
0/2125 (0.00%)
|
0 |
1/2136 (0.05%)
|
1 |
Adenocarcinoma gastric |
1/2144 (0.05%)
|
1 |
0/2124 (0.00%)
|
0 |
0/2125 (0.00%)
|
0 |
0/2136 (0.00%)
|
0 |
Adenocarcinoma of colon |
0/2144 (0.00%)
|
0 |
0/2124 (0.00%)
|
0 |
0/2125 (0.00%)
|
0 |
1/2136 (0.05%)
|
1 |
Adenocarcinoma pancreas |
1/2144 (0.05%)
|
1 |
0/2124 (0.00%)
|
0 |
0/2125 (0.00%)
|
0 |
0/2136 (0.00%)
|
0 |
Adenosquamous cell lung cancer |
1/2144 (0.05%)
|
1 |
0/2124 (0.00%)
|
0 |
0/2125 (0.00%)
|
0 |
0/2136 (0.00%)
|
0 |
Bladder cancer |
0/2144 (0.00%)
|
0 |
1/2124 (0.05%)
|
1 |
0/2125 (0.00%)
|
0 |
0/2136 (0.00%)
|
0 |
Breast cancer in situ |
0/2144 (0.00%)
|
0 |
0/2124 (0.00%)
|
0 |
0/2125 (0.00%)
|
0 |
1/2136 (0.05%)
|
1 |
Breast cancer stage IV |
1/2144 (0.05%)
|
1 |
0/2124 (0.00%)
|
0 |
0/2125 (0.00%)
|
0 |
0/2136 (0.00%)
|
0 |
Colon cancer metastatic |
0/2144 (0.00%)
|
0 |
0/2124 (0.00%)
|
0 |
0/2125 (0.00%)
|
0 |
1/2136 (0.05%)
|
1 |
Colon neopplasm |
0/2144 (0.00%)
|
0 |
0/2124 (0.00%)
|
0 |
1/2125 (0.05%)
|
1 |
0/2136 (0.00%)
|
0 |
Diffuse large B-cell lymphoma |
0/2144 (0.00%)
|
0 |
1/2124 (0.05%)
|
1 |
0/2125 (0.00%)
|
0 |
0/2136 (0.00%)
|
0 |
Gastric cancer |
0/2144 (0.00%)
|
0 |
0/2124 (0.00%)
|
0 |
0/2125 (0.00%)
|
0 |
1/2136 (0.05%)
|
1 |
Gastrointestinal lymphoma |
0/2144 (0.00%)
|
0 |
0/2124 (0.00%)
|
0 |
1/2125 (0.05%)
|
1 |
0/2136 (0.00%)
|
0 |
Gastrooesophageal cancer |
1/2144 (0.05%)
|
1 |
0/2124 (0.00%)
|
0 |
0/2125 (0.00%)
|
0 |
0/2136 (0.00%)
|
0 |
Glioblastoma |
0/2144 (0.00%)
|
0 |
0/2124 (0.00%)
|
0 |
1/2125 (0.05%)
|
1 |
0/2136 (0.00%)
|
0 |
Hepatic cancer metastatic |
0/2144 (0.00%)
|
0 |
1/2124 (0.05%)
|
1 |
0/2125 (0.00%)
|
0 |
0/2136 (0.00%)
|
0 |
Hepatocellular carcinoma |
0/2144 (0.00%)
|
0 |
0/2124 (0.00%)
|
0 |
0/2125 (0.00%)
|
0 |
1/2136 (0.05%)
|
1 |
Invasive breast carcinoma |
0/2144 (0.00%)
|
0 |
1/2124 (0.05%)
|
1 |
0/2125 (0.00%)
|
0 |
0/2136 (0.00%)
|
0 |
Invasive ductal breast carcinoma |
0/2144 (0.00%)
|
0 |
1/2124 (0.05%)
|
1 |
0/2125 (0.00%)
|
0 |
0/2136 (0.00%)
|
0 |
Laryngeal cancer |
0/2144 (0.00%)
|
0 |
1/2124 (0.05%)
|
1 |
0/2125 (0.00%)
|
0 |
0/2136 (0.00%)
|
0 |
Laryngeal squamous cell carcinoma |
0/2144 (0.00%)
|
0 |
0/2124 (0.00%)
|
0 |
1/2125 (0.05%)
|
1 |
0/2136 (0.00%)
|
0 |
Metasteses to bone |
0/2144 (0.00%)
|
0 |
0/2124 (0.00%)
|
0 |
0/2125 (0.00%)
|
0 |
1/2136 (0.05%)
|
1 |
Metastases to nervous system |
0/2144 (0.00%)
|
0 |
0/2124 (0.00%)
|
0 |
1/2125 (0.05%)
|
1 |
0/2136 (0.00%)
|
0 |
Metastatic bronchial carcinoma |
0/2144 (0.00%)
|
0 |
0/2124 (0.00%)
|
0 |
0/2125 (0.00%)
|
0 |
1/2136 (0.05%)
|
1 |
Oesophageal cancer metastatic |
0/2144 (0.00%)
|
0 |
0/2124 (0.00%)
|
0 |
1/2125 (0.05%)
|
1 |
0/2136 (0.00%)
|
0 |
Oropharyngeal squamous cell carcinoma |
0/2144 (0.00%)
|
0 |
0/2124 (0.00%)
|
0 |
0/2125 (0.00%)
|
0 |
1/2136 (0.05%)
|
1 |
Papillary renal cell carcinoma |
0/2144 (0.00%)
|
0 |
1/2124 (0.05%)
|
1 |
0/2125 (0.00%)
|
0 |
0/2136 (0.00%)
|
0 |
Rectal adenocarcinoma |
0/2144 (0.00%)
|
0 |
1/2124 (0.05%)
|
1 |
0/2125 (0.00%)
|
0 |
0/2136 (0.00%)
|
0 |
Recosigmoid cancer |
1/2144 (0.05%)
|
1 |
0/2124 (0.00%)
|
0 |
0/2125 (0.00%)
|
0 |
0/2136 (0.00%)
|
0 |
Renal cancer |
0/2144 (0.00%)
|
0 |
0/2124 (0.00%)
|
0 |
1/2125 (0.05%)
|
1 |
0/2136 (0.00%)
|
0 |
Renal cell carcinoma |
1/2144 (0.05%)
|
1 |
0/2124 (0.00%)
|
0 |
0/2125 (0.00%)
|
0 |
0/2136 (0.00%)
|
0 |
Renal neoplasm |
0/2144 (0.00%)
|
0 |
0/2124 (0.00%)
|
0 |
1/2125 (0.05%)
|
1 |
0/2136 (0.00%)
|
0 |
Tonsil cancer |
0/2144 (0.00%)
|
0 |
1/2124 (0.05%)
|
1 |
0/2125 (0.00%)
|
0 |
0/2136 (0.00%)
|
0 |
Non-Hodgkins lymphoma |
0/2144 (0.00%)
|
0 |
0/2124 (0.00%)
|
0 |
1/2125 (0.05%)
|
1 |
0/2136 (0.00%)
|
0 |
Rectal cancer |
0/2144 (0.00%)
|
0 |
0/2124 (0.00%)
|
0 |
0/2125 (0.00%)
|
0 |
1/2136 (0.05%)
|
1 |
Lung neoplasm |
1/2144 (0.05%)
|
1 |
0/2124 (0.00%)
|
0 |
0/2125 (0.00%)
|
0 |
1/2136 (0.05%)
|
1 |
Nervous system disorders |
|
|
|
|
Cerebrovascular accident |
8/2144 (0.37%)
|
8 |
2/2124 (0.09%)
|
3 |
4/2125 (0.19%)
|
4 |
3/2136 (0.14%)
|
3 |
Syncope |
2/2144 (0.09%)
|
2 |
3/2124 (0.14%)
|
3 |
1/2125 (0.05%)
|
1 |
4/2136 (0.19%)
|
4 |
Cerebral infarction |
1/2144 (0.05%)
|
1 |
1/2124 (0.05%)
|
1 |
0/2125 (0.00%)
|
0 |
5/2136 (0.23%)
|
5 |
Carotid artery stenosis |
2/2144 (0.09%)
|
2 |
2/2124 (0.09%)
|
2 |
0/2125 (0.00%)
|
0 |
2/2136 (0.09%)
|
2 |
Siezure |
1/2144 (0.05%)
|
1 |
4/2124 (0.19%)
|
4 |
1/2125 (0.05%)
|
1 |
0/2136 (0.00%)
|
0 |
Encephalopathy |
1/2144 (0.05%)
|
1 |
1/2124 (0.05%)
|
1 |
0/2125 (0.00%)
|
0 |
2/2136 (0.09%)
|
2 |
Cerebellar infarction |
1/2144 (0.05%)
|
1 |
1/2124 (0.05%)
|
1 |
1/2125 (0.05%)
|
1 |
0/2136 (0.00%)
|
0 |
Dizziness |
1/2144 (0.05%)
|
1 |
0/2124 (0.00%)
|
0 |
1/2125 (0.05%)
|
1 |
1/2136 (0.05%)
|
1 |
Subarachnoid haemorrhage |
1/2144 (0.05%)
|
1 |
0/2124 (0.00%)
|
0 |
1/2125 (0.05%)
|
1 |
1/2136 (0.05%)
|
1 |
Ataxia |
0/2144 (0.00%)
|
0 |
0/2124 (0.00%)
|
0 |
2/2125 (0.09%)
|
2 |
0/2136 (0.00%)
|
0 |
Cerebral ischaemia |
2/2144 (0.09%)
|
2 |
0/2124 (0.00%)
|
0 |
0/2125 (0.00%)
|
0 |
0/2136 (0.00%)
|
0 |
Intracranial aneurysm |
0/2144 (0.00%)
|
0 |
0/2124 (0.00%)
|
0 |
1/2125 (0.05%)
|
1 |
1/2136 (0.05%)
|
1 |
Ischaemic stroke |
0/2144 (0.00%)
|
0 |
0/2124 (0.00%)
|
0 |
2/2125 (0.09%)
|
2 |
0/2136 (0.00%)
|
0 |
Aphasia |
0/2144 (0.00%)
|
0 |
0/2124 (0.00%)
|
0 |
0/2125 (0.00%)
|
0 |
1/2136 (0.05%)
|
1 |
Brain injury |
0/2144 (0.00%)
|
0 |
0/2124 (0.00%)
|
0 |
1/2125 (0.05%)
|
1 |
0/2136 (0.00%)
|
0 |
Carpal tunnel syndrome |
1/2144 (0.05%)
|
1 |
0/2124 (0.00%)
|
0 |
0/2125 (0.00%)
|
0 |
0/2136 (0.00%)
|
0 |
Cerebral haemorrhage |
0/2144 (0.00%)
|
0 |
1/2124 (0.05%)
|
1 |
0/2125 (0.00%)
|
0 |
0/2136 (0.00%)
|
0 |
Cerebrospinal fluid leakage |
0/2144 (0.00%)
|
0 |
1/2124 (0.05%)
|
1 |
0/2125 (0.00%)
|
0 |
0/2136 (0.00%)
|
0 |
Cervical radiculopathy |
0/2144 (0.00%)
|
0 |
1/2124 (0.05%)
|
1 |
0/2125 (0.00%)
|
0 |
0/2136 (0.00%)
|
0 |
Colloid brain cyst |
1/2144 (0.05%)
|
1 |
0/2124 (0.00%)
|
0 |
0/2125 (0.00%)
|
0 |
0/2136 (0.00%)
|
0 |
Embolic Cerebral infarction |
1/2144 (0.05%)
|
1 |
0/2124 (0.00%)
|
0 |
0/2125 (0.00%)
|
0 |
0/2136 (0.00%)
|
0 |
Epilepsy |
0/2144 (0.00%)
|
0 |
0/2124 (0.00%)
|
0 |
1/2125 (0.05%)
|
1 |
0/2136 (0.00%)
|
0 |
Guillain-Barre syndrome |
0/2144 (0.00%)
|
0 |
0/2124 (0.00%)
|
0 |
0/2125 (0.00%)
|
0 |
1/2136 (0.05%)
|
1 |
Haemorrhage intercranial |
1/2144 (0.05%)
|
1 |
0/2124 (0.00%)
|
0 |
0/2125 (0.00%)
|
0 |
0/2136 (0.00%)
|
0 |