Time Frame |
All serious adverse events, including deaths and adverse events (AEs) of special interest were collected from Day 0 (post-vaccination) up to Day 240 post-vaccination.
|
Adverse Event Reporting Description |
The total number (N) data for the serious adverse events were presented for each study year according to the study vaccine actually recieved by the participants - the Full (as treated) Analysis Set.
|
|
Arm/Group Title
|
Fluzone® High Dose Vaccine (Year 1)
|
Fluzone® Vaccine (Year 1)
|
Fluzone® High Dose Vaccine (Year 2)
|
Fluzone® Vaccine (Year 2)
|
Arm/Group Description |
Adults ≥65 years of age received on...
|
Adults ≥65 years of age received on...
|
Adults ≥65 years of age received on...
|
Adults ≥65 years of age received on...
|
Arm/Group Description |
Adults ≥65 years of age received one dose of Fluzone High Dose vaccine
|
Adults ≥65 years of age received one dose of Fluzone vaccine
|
Adults ≥65 years of age received one dose of Fluzone High Dose vaccine
|
Adults ≥65 years of age received one dose of Fluzone vaccine
|
|
|
Fluzone® High Dose Vaccine (Year 1)
|
Fluzone® Vaccine (Year 1)
|
Fluzone® High Dose Vaccine (Year 2)
|
Fluzone® Vaccine (Year 2)
|
|
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Total |
--/-- |
--/-- |
--/-- |
--/-- |
|
|
Fluzone® High Dose Vaccine (Year 1)
|
Fluzone® Vaccine (Year 1)
|
Fluzone® High Dose Vaccine (Year 2)
|
Fluzone® Vaccine (Year 2)
|
|
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Total |
680/7254 (9.37%) |
704/7243 (9.72%) |
643/8738 (7.36%) |
738/8748 (8.44%) |
Blood and lymphatic system disorders |
|
|
|
|
Anaemia |
8/7254 (0.11%) |
4/7243 (0.06%) |
9/8738 (0.10%) |
7/8748 (0.08%) |
Anaemia macrocytic |
0/7254 (0.00%) |
0/7243 (0.00%) |
1/8738 (0.01%) |
0/8748 (0.00%) |
Anaemia of chronic disease |
1/7254 (0.01%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Bone marrow failure |
0/7254 (0.00%) |
1/7243 (0.01%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Coagulopathy |
0/7254 (0.00%) |
0/7243 (0.00%) |
1/8738 (0.01%) |
0/8748 (0.00%) |
Haemorrhagic anaemia |
0/7254 (0.00%) |
3/7243 (0.04%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Idiopathic thrombocytopenic purpura |
1/7254 (0.01%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Iron deficiency anaemia |
1/7254 (0.01%) |
2/7243 (0.03%) |
2/8738 (0.02%) |
0/8748 (0.00%) |
Leukocytosis |
0/7254 (0.00%) |
1/7243 (0.01%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Microcytic anaemia |
1/7254 (0.01%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Splenic lesion |
0/7254 (0.00%) |
1/7243 (0.01%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Thrombocytopenia |
0/7254 (0.00%) |
2/7243 (0.03%) |
1/8738 (0.01%) |
1/8748 (0.01%) |
Cardiac disorders |
|
|
|
|
Acute coronary syndrome |
4/7254 (0.06%) |
1/7243 (0.01%) |
3/8738 (0.03%) |
2/8748 (0.02%) |
Acute myocardial infarction |
2/7254 (0.03%) |
7/7243 (0.10%) |
11/8738 (0.13%) |
9/8748 (0.10%) |
Angina pectoris |
2/7254 (0.03%) |
8/7243 (0.11%) |
5/8738 (0.06%) |
5/8748 (0.06%) |
Angina unstable |
2/7254 (0.03%) |
9/7243 (0.12%) |
8/8738 (0.09%) |
5/8748 (0.06%) |
Aortic valve disease mixed |
0/7254 (0.00%) |
0/7243 (0.00%) |
1/8738 (0.01%) |
0/8748 (0.00%) |
Aortic valve stenosis |
1/7254 (0.01%) |
0/7243 (0.00%) |
1/8738 (0.01%) |
2/8748 (0.02%) |
Arrhythmia |
4/7254 (0.06%) |
2/7243 (0.03%) |
2/8738 (0.02%) |
0/8748 (0.00%) |
Arteriosclerosis coronary artery |
2/7254 (0.03%) |
1/7243 (0.01%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Arteriospasm coronary |
0/7254 (0.00%) |
0/7243 (0.00%) |
1/8738 (0.01%) |
0/8748 (0.00%) |
Atrial fibrillation |
28/7254 (0.39%) |
29/7243 (0.40%) |
23/8738 (0.26%) |
38/8748 (0.43%) |
Atrial flutter |
3/7254 (0.04%) |
2/7243 (0.03%) |
4/8738 (0.05%) |
1/8748 (0.01%) |
Atrial tachycardia |
0/7254 (0.00%) |
1/7243 (0.01%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Atrial thrombosis |
1/7254 (0.01%) |
2/7243 (0.03%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Atrioventricular block |
0/7254 (0.00%) |
1/7243 (0.01%) |
1/8738 (0.01%) |
0/8748 (0.00%) |
Atrioventricular block complete |
1/7254 (0.01%) |
1/7243 (0.01%) |
0/8738 (0.00%) |
2/8748 (0.02%) |
Atrioventricular block second degree |
0/7254 (0.00%) |
1/7243 (0.01%) |
1/8738 (0.01%) |
2/8748 (0.02%) |
Bradyarrhythmia |
0/7254 (0.00%) |
0/7243 (0.00%) |
1/8738 (0.01%) |
0/8748 (0.00%) |
Bradycardia |
5/7254 (0.07%) |
4/7243 (0.06%) |
2/8738 (0.02%) |
2/8748 (0.02%) |
Bundle branch block left |
0/7254 (0.00%) |
0/7243 (0.00%) |
1/8738 (0.01%) |
0/8748 (0.00%) |
Cardiac arrest |
6/7254 (0.08%) |
1/7243 (0.01%) |
0/8738 (0.00%) |
5/8748 (0.06%) |
Cardiac disorder |
1/7254 (0.01%) |
0/7243 (0.00%) |
1/8738 (0.01%) |
0/8748 (0.00%) |
Cardiac failure |
2/7254 (0.03%) |
0/7243 (0.00%) |
2/8738 (0.02%) |
4/8748 (0.05%) |
Cardiac failure acute |
1/7254 (0.01%) |
0/7243 (0.00%) |
2/8738 (0.02%) |
0/8748 (0.00%) |
Cardiac failure chronic |
0/7254 (0.00%) |
1/7243 (0.01%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Cardiac failure congestive |
15/7254 (0.21%) |
22/7243 (0.30%) |
19/8738 (0.22%) |
29/8748 (0.33%) |
Cardiac valve disease |
0/7254 (0.00%) |
0/7243 (0.00%) |
2/8738 (0.02%) |
0/8748 (0.00%) |
Cardio-respiratory arrest |
3/7254 (0.04%) |
1/7243 (0.01%) |
1/8738 (0.01%) |
0/8748 (0.00%) |
Cardiomegaly |
1/7254 (0.01%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Cardiomyopathy |
1/7254 (0.01%) |
0/7243 (0.00%) |
2/8738 (0.02%) |
3/8748 (0.03%) |
Cardiopulmonary failure |
0/7254 (0.00%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Cardiovascular disorder |
0/7254 (0.00%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Congestive cardiomyopathy |
0/7254 (0.00%) |
1/7243 (0.01%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Coronary artery disease |
14/7254 (0.19%) |
18/7243 (0.25%) |
16/8738 (0.18%) |
18/8748 (0.21%) |
Coronary artery insufficiency |
0/7254 (0.00%) |
0/7243 (0.00%) |
1/8738 (0.01%) |
0/8748 (0.00%) |
Coronary artery occlusion |
4/7254 (0.06%) |
2/7243 (0.03%) |
3/8738 (0.03%) |
1/8748 (0.01%) |
Coronary artery stenosis |
1/7254 (0.01%) |
0/7243 (0.00%) |
2/8738 (0.02%) |
2/8748 (0.02%) |
Heart valve incompetence |
1/7254 (0.01%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Ischaemic cardiomyopathy |
1/7254 (0.01%) |
0/7243 (0.00%) |
1/8738 (0.01%) |
2/8748 (0.02%) |
Mitral valve disease |
0/7254 (0.00%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Mitral valve incompetence |
1/7254 (0.01%) |
1/7243 (0.01%) |
1/8738 (0.01%) |
0/8748 (0.00%) |
Mitral valve stenosis |
2/7254 (0.03%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Myocardial infarction |
21/7254 (0.29%) |
21/7243 (0.29%) |
14/8738 (0.16%) |
10/8748 (0.11%) |
Myocardial ischaemia |
0/7254 (0.00%) |
1/7243 (0.01%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Palpitations |
0/7254 (0.00%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Pericardial effusion |
0/7254 (0.00%) |
1/7243 (0.01%) |
0/8738 (0.00%) |
2/8748 (0.02%) |
Pericarditis |
1/7254 (0.01%) |
0/7243 (0.00%) |
1/8738 (0.01%) |
0/8748 (0.00%) |
Sick sinus syndrome |
1/7254 (0.01%) |
0/7243 (0.00%) |
3/8738 (0.03%) |
4/8748 (0.05%) |
Sinus arrhythmia |
1/7254 (0.01%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Sinus bradycardia |
0/7254 (0.00%) |
2/7243 (0.03%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Stress cardiomyopathy |
0/7254 (0.00%) |
1/7243 (0.01%) |
1/8738 (0.01%) |
0/8748 (0.00%) |
Supraventricular tachycardia |
3/7254 (0.04%) |
3/7243 (0.04%) |
1/8738 (0.01%) |
3/8748 (0.03%) |
Tachycardia |
2/7254 (0.03%) |
1/7243 (0.01%) |
2/8738 (0.02%) |
0/8748 (0.00%) |
Ventricular extrasystoles |
0/7254 (0.00%) |
1/7243 (0.01%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Ventricular fibrillation |
0/7254 (0.00%) |
0/7243 (0.00%) |
1/8738 (0.01%) |
0/8748 (0.00%) |
Ventricular tachycardia |
1/7254 (0.01%) |
2/7243 (0.03%) |
1/8738 (0.01%) |
2/8748 (0.02%) |
Congenital, familial and genetic disorders |
|
|
|
|
Arteriovenous malformation |
0/7254 (0.00%) |
0/7243 (0.00%) |
1/8738 (0.01%) |
0/8748 (0.00%) |
Gastrointestinal arteriovenous malformation |
0/7254 (0.00%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Ear and labyrinth disorders |
|
|
|
|
Vertigo |
2/7254 (0.03%) |
5/7243 (0.07%) |
2/8738 (0.02%) |
7/8748 (0.08%) |
Endocrine disorders |
|
|
|
|
Adrenocortical insufficiency acute |
0/7254 (0.00%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Goitre |
1/7254 (0.01%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
2/8748 (0.02%) |
Hyperparathyroidism |
0/7254 (0.00%) |
1/7243 (0.01%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Hyperthyroidism |
0/7254 (0.00%) |
1/7243 (0.01%) |
1/8738 (0.01%) |
0/8748 (0.00%) |
Thyroid mass |
1/7254 (0.01%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Eye disorders |
|
|
|
|
Cataract |
1/7254 (0.01%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Periorbital oedema |
0/7254 (0.00%) |
0/7243 (0.00%) |
1/8738 (0.01%) |
0/8748 (0.00%) |
Retinal artery occlusion |
1/7254 (0.01%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Retinal detachment |
0/7254 (0.00%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Gastrointestinal disorders |
|
|
|
|
Abdominal hernia |
1/7254 (0.01%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
3/8748 (0.03%) |
Abdominal mass |
1/7254 (0.01%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Abdominal pain |
1/7254 (0.01%) |
3/7243 (0.04%) |
5/8738 (0.06%) |
4/8748 (0.05%) |
Abdominal pain lower |
1/7254 (0.01%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Abdominal pain upper |
0/7254 (0.00%) |
1/7243 (0.01%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Abdominal wall haematoma |
0/7254 (0.00%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Abdominal wall haemorrhage |
0/7254 (0.00%) |
1/7243 (0.01%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Alcoholic pancreatitis |
1/7254 (0.01%) |
1/7243 (0.01%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Anal fistula |
0/7254 (0.00%) |
1/7243 (0.01%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Colitis |
2/7254 (0.03%) |
6/7243 (0.08%) |
1/8738 (0.01%) |
1/8748 (0.01%) |
Colitis ischaemic |
2/7254 (0.03%) |
2/7243 (0.03%) |
3/8738 (0.03%) |
4/8748 (0.05%) |
Colonic polyp |
0/7254 (0.00%) |
1/7243 (0.01%) |
0/8738 (0.00%) |
2/8748 (0.02%) |
Colonic stenosis |
1/7254 (0.01%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Constipation |
0/7254 (0.00%) |
0/7243 (0.00%) |
3/8738 (0.03%) |
0/8748 (0.00%) |
Crohn's disease |
0/7254 (0.00%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Diaphragmatic hernia |
0/7254 (0.00%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Diarrhoea |
0/7254 (0.00%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
2/8748 (0.02%) |
Dieulafoy's vascular malformation |
0/7254 (0.00%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Diverticular perforation |
2/7254 (0.03%) |
1/7243 (0.01%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Diverticulum |
0/7254 (0.00%) |
5/7243 (0.07%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Diverticulum intestinal |
0/7254 (0.00%) |
1/7243 (0.01%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Diverticulum intestinal haemorrhagic |
1/7254 (0.01%) |
1/7243 (0.01%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Duodenal stenosis |
1/7254 (0.01%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Duodenal ulcer |
1/7254 (0.01%) |
1/7243 (0.01%) |
0/8738 (0.00%) |
2/8748 (0.02%) |
Duodenal ulcer haemorrhage |
1/7254 (0.01%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Dysphagia |
1/7254 (0.01%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Erosive oesophagitis |
1/7254 (0.01%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Faecaloma |
1/7254 (0.01%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Food poisoning |
0/7254 (0.00%) |
1/7243 (0.01%) |
2/8738 (0.02%) |
0/8748 (0.00%) |
Gastric antral vascular ectasia |
0/7254 (0.00%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Gastric ulcer |
0/7254 (0.00%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Gastric ulcer haemorrhage |
0/7254 (0.00%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
3/8748 (0.03%) |
Gastritis |
1/7254 (0.01%) |
4/7243 (0.06%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Gastritis erosive |
0/7254 (0.00%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Gastroduodenitis |
1/7254 (0.01%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Gastrointestinal disorder |
0/7254 (0.00%) |
0/7243 (0.00%) |
1/8738 (0.01%) |
1/8748 (0.01%) |
Gastrointestinal haemorrhage |
6/7254 (0.08%) |
7/7243 (0.10%) |
5/8738 (0.06%) |
9/8748 (0.10%) |
Gastrooesophageal reflux disease |
1/7254 (0.01%) |
2/7243 (0.03%) |
1/8738 (0.01%) |
1/8748 (0.01%) |
Gastrooesophagitis |
0/7254 (0.00%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Haematemesis |
0/7254 (0.00%) |
2/7243 (0.03%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Haematochezia |
1/7254 (0.01%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Haemorrhagic erosive gastritis |
1/7254 (0.01%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Hiatus hernia |
2/7254 (0.03%) |
2/7243 (0.03%) |
1/8738 (0.01%) |
1/8748 (0.01%) |
Ileus |
1/7254 (0.01%) |
0/7243 (0.00%) |
1/8738 (0.01%) |
0/8748 (0.00%) |
Impaired gastric emptying |
0/7254 (0.00%) |
1/7243 (0.01%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Inguinal hernia |
1/7254 (0.01%) |
1/7243 (0.01%) |
0/8738 (0.00%) |
4/8748 (0.05%) |
Intestinal ischaemia |
0/7254 (0.00%) |
0/7243 (0.00%) |
2/8738 (0.02%) |
0/8748 (0.00%) |
Intestinal obstruction |
0/7254 (0.00%) |
1/7243 (0.01%) |
3/8738 (0.03%) |
3/8748 (0.03%) |
Intestinal perforation |
0/7254 (0.00%) |
1/7243 (0.01%) |
1/8738 (0.01%) |
2/8748 (0.02%) |
Intestinal polyp haemorrhage |
0/7254 (0.00%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Large intestine perforation |
1/7254 (0.01%) |
1/7243 (0.01%) |
0/8738 (0.00%) |
2/8748 (0.02%) |
Lower gastrointestinal haemorrhage |
0/7254 (0.00%) |
1/7243 (0.01%) |
1/8738 (0.01%) |
2/8748 (0.02%) |
Lumbar hernia |
1/7254 (0.01%) |
1/7243 (0.01%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Mallory-Weiss syndrome |
0/7254 (0.00%) |
1/7243 (0.01%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Nausea |
1/7254 (0.01%) |
0/7243 (0.00%) |
1/8738 (0.01%) |
0/8748 (0.00%) |
Obstruction gastric |
0/7254 (0.00%) |
1/7243 (0.01%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Oesophageal obstruction |
0/7254 (0.00%) |
2/7243 (0.03%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Oesophageal spasm |
0/7254 (0.00%) |
1/7243 (0.01%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Oesophageal varices haemorrhage |
0/7254 (0.00%) |
1/7243 (0.01%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Pancreatitis |
5/7254 (0.07%) |
2/7243 (0.03%) |
1/8738 (0.01%) |
0/8748 (0.00%) |
Pancreatitis acute |
3/7254 (0.04%) |
2/7243 (0.03%) |
0/8738 (0.00%) |
5/8748 (0.06%) |
Pancreatitis necrotising |
0/7254 (0.00%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Pancreatitis relapsing |
1/7254 (0.01%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Peptic ulcer |
0/7254 (0.00%) |
0/7243 (0.00%) |
1/8738 (0.01%) |
0/8748 (0.00%) |
Peptic ulcer haemorrhage |
1/7254 (0.01%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Pharyngoesophageal diverticulum |
0/7254 (0.00%) |
0/7243 (0.00%) |
1/8738 (0.01%) |
0/8748 (0.00%) |
Proctitis |
0/7254 (0.00%) |
0/7243 (0.00%) |
1/8738 (0.01%) |
0/8748 (0.00%) |
Rectal haemorrhage |
1/7254 (0.01%) |
4/7243 (0.06%) |
5/8738 (0.06%) |
1/8748 (0.01%) |
Retroperitoneal haematoma |
2/7254 (0.03%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Small intestinal obstruction |
5/7254 (0.07%) |
10/7243 (0.14%) |
4/8738 (0.05%) |
3/8748 (0.03%) |
Spigelian hernia |
0/7254 (0.00%) |
0/7243 (0.00%) |
1/8738 (0.01%) |
0/8748 (0.00%) |
Tongue oedema |
0/7254 (0.00%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Umbilical hernia, obstructive |
0/7254 (0.00%) |
2/7243 (0.03%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Upper gastrointestinal haemorrhage |
4/7254 (0.06%) |
3/7243 (0.04%) |
1/8738 (0.01%) |
2/8748 (0.02%) |
Volvulus |
0/7254 (0.00%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Vomiting |
1/7254 (0.01%) |
1/7243 (0.01%) |
2/8738 (0.02%) |
1/8748 (0.01%) |
General disorders |
|
|
|
|
Adverse drug reaction |
0/7254 (0.00%) |
1/7243 (0.01%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Asthenia |
1/7254 (0.01%) |
1/7243 (0.01%) |
1/8738 (0.01%) |
2/8748 (0.02%) |
Chest discomfort |
1/7254 (0.01%) |
2/7243 (0.03%) |
1/8738 (0.01%) |
2/8748 (0.02%) |
Chest pain |
42/7254 (0.58%) |
27/7243 (0.37%) |
18/8738 (0.21%) |
16/8748 (0.18%) |
Death |
0/7254 (0.00%) |
3/7243 (0.04%) |
0/8738 (0.00%) |
2/8748 (0.02%) |
Device dislocation |
0/7254 (0.00%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
2/8748 (0.02%) |
Device failure |
0/7254 (0.00%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Device lead damage |
0/7254 (0.00%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Device malfunction |
0/7254 (0.00%) |
2/7243 (0.03%) |
1/8738 (0.01%) |
0/8748 (0.00%) |
Device occlusion |
0/7254 (0.00%) |
1/7243 (0.01%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Fatigue |
0/7254 (0.00%) |
1/7243 (0.01%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Genaralized oedema |
0/7254 (0.00%) |
0/7243 (0.00%) |
1/8738 (0.01%) |
0/8748 (0.00%) |
Hernia |
1/7254 (0.01%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Hernia obstructive |
0/7254 (0.00%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Impaired healing |
1/7254 (0.01%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Implant site inflammation |
0/7254 (0.00%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Influenza like illness |
0/7254 (0.00%) |
1/7243 (0.01%) |
1/8738 (0.01%) |
0/8748 (0.00%) |
Ischaemic ulcer |
0/7254 (0.00%) |
1/7243 (0.01%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Non-cardiac chest pain |
6/7254 (0.08%) |
3/7243 (0.04%) |
2/8738 (0.02%) |
4/8748 (0.05%) |
Oedema peripheral |
2/7254 (0.03%) |
1/7243 (0.01%) |
1/8738 (0.01%) |
1/8748 (0.01%) |
Pelvic mass |
0/7254 (0.00%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Pneumatosis |
0/7254 (0.00%) |
1/7243 (0.01%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Pyrexia |
1/7254 (0.01%) |
1/7243 (0.01%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Sudden cardiac death |
0/7254 (0.00%) |
0/7243 (0.00%) |
1/8738 (0.01%) |
0/8748 (0.00%) |
Surgical failure |
0/7254 (0.00%) |
0/7243 (0.00%) |
1/8738 (0.01%) |
0/8748 (0.00%) |
Hepatobiliary disorders |
|
|
|
|
Bile duct obstruction |
0/7254 (0.00%) |
1/7243 (0.01%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Cholangitis |
0/7254 (0.00%) |
0/7243 (0.00%) |
1/8738 (0.01%) |
1/8748 (0.01%) |
Cholangitis acute |
1/7254 (0.01%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Cholecystitis |
1/7254 (0.01%) |
3/7243 (0.04%) |
8/8738 (0.09%) |
3/8748 (0.03%) |
Cholecystitis acute |
3/7254 (0.04%) |
2/7243 (0.03%) |
3/8738 (0.03%) |
4/8748 (0.05%) |
Cholecystitis chronic |
1/7254 (0.01%) |
1/7243 (0.01%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Cholelithiasis |
0/7254 (0.00%) |
7/7243 (0.10%) |
5/8738 (0.06%) |
1/8748 (0.01%) |
Chronic hepatic failure |
1/7254 (0.01%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Gallbladder pain |
0/7254 (0.00%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
2/8748 (0.02%) |
Gallbladder perforation |
0/7254 (0.00%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Hepatitis |
1/7254 (0.01%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Hepatorenal syndrome |
0/7254 (0.00%) |
0/7243 (0.00%) |
1/8738 (0.01%) |
0/8748 (0.00%) |
Immune system disorders |
|
|
|
|
Drug hypersensitivity |
2/7254 (0.03%) |
1/7243 (0.01%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Hypersensitivity |
2/7254 (0.03%) |
1/7243 (0.01%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Infections and infestations |
|
|
|
|
Abdominal abscess |
1/7254 (0.01%) |
1/7243 (0.01%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Abdominal sepsis |
0/7254 (0.00%) |
0/7243 (0.00%) |
1/8738 (0.01%) |
0/8748 (0.00%) |
Abdominal wall abscess |
0/7254 (0.00%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Abscess |
0/7254 (0.00%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Abscess limb |
1/7254 (0.01%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Acute sinusitis |
0/7254 (0.00%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Appendicitis |
2/7254 (0.03%) |
4/7243 (0.06%) |
3/8738 (0.03%) |
4/8748 (0.05%) |
Arthritis bacterial |
1/7254 (0.01%) |
0/7243 (0.00%) |
1/8738 (0.01%) |
0/8748 (0.00%) |
Arthritis infective |
1/7254 (0.01%) |
0/7243 (0.00%) |
1/8738 (0.01%) |
0/8748 (0.00%) |
Atypical myocobacterial pneumonia |
0/7254 (0.00%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Bronchitis |
5/7254 (0.07%) |
4/7243 (0.06%) |
9/8738 (0.10%) |
5/8748 (0.06%) |
Bronchopneumonia |
0/7254 (0.00%) |
1/7243 (0.01%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Bursitis infective |
0/7254 (0.00%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Cellulitis |
12/7254 (0.17%) |
9/7243 (0.12%) |
8/8738 (0.09%) |
12/8748 (0.14%) |
Cholecystitis infective |
0/7254 (0.00%) |
1/7243 (0.01%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Clostridium difficile colitis |
1/7254 (0.01%) |
3/7243 (0.04%) |
1/8738 (0.01%) |
0/8748 (0.00%) |
Cystitis |
0/7254 (0.00%) |
1/7243 (0.01%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Device related infection |
1/7254 (0.01%) |
1/7243 (0.01%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Diabetic foot infection |
0/7254 (0.00%) |
0/7243 (0.00%) |
1/8738 (0.01%) |
1/8748 (0.01%) |
Diabetic gangrene |
1/7254 (0.01%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Diverticulitis |
8/7254 (0.11%) |
5/7243 (0.07%) |
5/8738 (0.06%) |
11/8748 (0.13%) |
Endocarditis bacterial |
1/7254 (0.01%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Enterocolitis infectious |
0/7254 (0.00%) |
1/7243 (0.01%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Enterocolitis viral |
1/7254 (0.01%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Escherichia bacteraemia |
0/7254 (0.00%) |
1/7243 (0.01%) |
1/8738 (0.01%) |
1/8748 (0.01%) |
Escherichia urinary tract infection |
0/7254 (0.00%) |
0/7243 (0.00%) |
1/8738 (0.01%) |
1/8748 (0.01%) |
Gangrene |
0/7254 (0.00%) |
0/7243 (0.00%) |
1/8738 (0.01%) |
0/8748 (0.00%) |
Gastric ulcer helicobacter |
0/7254 (0.00%) |
0/7243 (0.00%) |
1/8738 (0.01%) |
0/8748 (0.00%) |
Gastroenteritis |
5/7254 (0.07%) |
6/7243 (0.08%) |
5/8738 (0.06%) |
9/8748 (0.10%) |
Gastroenteritis bacterial |
0/7254 (0.00%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Gastroenteritis salmonella |
2/7254 (0.03%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Gastroenteritis viral |
2/7254 (0.03%) |
1/7243 (0.01%) |
2/8738 (0.02%) |
1/8748 (0.01%) |
Gastrointestinal infection |
0/7254 (0.00%) |
1/7243 (0.01%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Groin infection |
1/7254 (0.01%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Herpes zoster |
0/7254 (0.00%) |
1/7243 (0.01%) |
1/8738 (0.01%) |
0/8748 (0.00%) |
Infected cyst |
0/7254 (0.00%) |
0/7243 (0.00%) |
1/8738 (0.01%) |
0/8748 (0.00%) |
Infective exacerbation of bronchiectasis |
0/7254 (0.00%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Influenza |
1/7254 (0.01%) |
0/7243 (0.00%) |
3/8738 (0.03%) |
6/8748 (0.07%) |
Kidney infection |
0/7254 (0.00%) |
1/7243 (0.01%) |
1/8738 (0.01%) |
2/8748 (0.02%) |
Laryngitis |
0/7254 (0.00%) |
0/7243 (0.00%) |
1/8738 (0.01%) |
0/8748 (0.00%) |
Liver abscess |
0/7254 (0.00%) |
0/7243 (0.00%) |
1/8738 (0.01%) |
1/8748 (0.01%) |
Lobar pneumonia |
0/7254 (0.00%) |
1/7243 (0.01%) |
2/8738 (0.02%) |
6/8748 (0.07%) |
Localised infection |
2/7254 (0.03%) |
2/7243 (0.03%) |
1/8738 (0.01%) |
0/8748 (0.00%) |
Lung infection |
0/7254 (0.00%) |
0/7243 (0.00%) |
1/8738 (0.01%) |
0/8748 (0.00%) |
Nocardiosis |
0/7254 (0.00%) |
0/7243 (0.00%) |
1/8738 (0.01%) |
0/8748 (0.00%) |
Osteomyelitis |
0/7254 (0.00%) |
1/7243 (0.01%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Peridiverticular abscess |
0/7254 (0.00%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Perineal abscess |
0/7254 (0.00%) |
0/7243 (0.00%) |
1/8738 (0.01%) |
0/8748 (0.00%) |
Periorbital cellulitis |
0/7254 (0.00%) |
1/7243 (0.01%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Perirectal abscess |
0/7254 (0.00%) |
0/7243 (0.00%) |
1/8738 (0.01%) |
0/8748 (0.00%) |
Peritonitis |
0/7254 (0.00%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Pneumonia |
28/7254 (0.39%) |
44/7243 (0.61%) |
35/8738 (0.40%) |
44/8748 (0.50%) |
Pneumonia bacterial |
0/7254 (0.00%) |
0/7243 (0.00%) |
1/8738 (0.01%) |
2/8748 (0.02%) |
Pneumonia pneumococcal |
0/7254 (0.00%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
2/8748 (0.02%) |
Pneumonia primary atypical |
0/7254 (0.00%) |
1/7243 (0.01%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Pneumonia staphylococcal |
0/7254 (0.00%) |
1/7243 (0.01%) |
0/8738 (0.00%) |
2/8748 (0.02%) |
Pneumonia viral |
0/7254 (0.00%) |
1/7243 (0.01%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Postoperative wound infection |
2/7254 (0.03%) |
1/7243 (0.01%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Pseudomonas infection |
0/7254 (0.00%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Pyelonephritis |
1/7254 (0.01%) |
3/7243 (0.04%) |
0/8738 (0.00%) |
3/8748 (0.03%) |
Pyelonephritis acute |
0/7254 (0.00%) |
1/7243 (0.01%) |
1/8738 (0.01%) |
0/8748 (0.00%) |
Respiratory syncytial virus infection |
0/7254 (0.00%) |
0/7243 (0.00%) |
1/8738 (0.01%) |
0/8748 (0.00%) |
Sepsis |
4/7254 (0.06%) |
3/7243 (0.04%) |
5/8738 (0.06%) |
5/8748 (0.06%) |
Septic shock |
0/7254 (0.00%) |
1/7243 (0.01%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Sinusitis |
1/7254 (0.01%) |
1/7243 (0.01%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Staphylococcal infection |
1/7254 (0.01%) |
0/7243 (0.00%) |
1/8738 (0.01%) |
3/8748 (0.03%) |
Tracheobronchitis |
2/7254 (0.03%) |
0/7243 (0.00%) |
1/8738 (0.01%) |
0/8748 (0.00%) |
Upper respiratory tract infection |
0/7254 (0.00%) |
0/7243 (0.00%) |
1/8738 (0.01%) |
0/8748 (0.00%) |
Urethritis |
0/7254 (0.00%) |
1/7243 (0.01%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Urinary tract infection |
9/7254 (0.12%) |
8/7243 (0.11%) |
5/8738 (0.06%) |
16/8748 (0.18%) |
Urosepsis |
5/7254 (0.07%) |
3/7243 (0.04%) |
0/8738 (0.00%) |
4/8748 (0.05%) |
Vestibular neuronitis |
0/7254 (0.00%) |
1/7243 (0.01%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Viral diarrhoea |
1/7254 (0.01%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Viral infection |
0/7254 (0.00%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
4/8748 (0.05%) |
Viral labyrinthitis |
0/7254 (0.00%) |
0/7243 (0.00%) |
2/8738 (0.02%) |
0/8748 (0.00%) |
Viral pericarditis |
1/7254 (0.01%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Clostridial infection |
0/7254 (0.00%) |
1/7243 (0.01%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Bacteraemia |
0/7254 (0.00%) |
0/7243 (0.00%) |
1/8738 (0.01%) |
1/8748 (0.01%) |
Bacterial infection |
0/7254 (0.00%) |
0/7243 (0.00%) |
1/8738 (0.01%) |
0/8748 (0.00%) |
Urinary tract infection bacterial |
0/7254 (0.00%) |
0/7243 (0.00%) |
1/8738 (0.01%) |
0/8748 (0.00%) |
Appendicitis perforated |
0/7254 (0.00%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Injury, poisoning and procedural complications |
|
|
|
|
Accident |
0/7254 (0.00%) |
1/7243 (0.01%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Accidental overdose |
0/7254 (0.00%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Alcohol poisoning |
0/7254 (0.00%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Ankle fracture |
1/7254 (0.01%) |
5/7243 (0.07%) |
5/8738 (0.06%) |
3/8748 (0.03%) |
Arteriovenous fistula site complication |
0/7254 (0.00%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Burns second degree |
0/7254 (0.00%) |
1/7243 (0.01%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Carbon monoxide poisoning |
0/7254 (0.00%) |
1/7243 (0.01%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Cervical vertebral fracture |
1/7254 (0.01%) |
1/7243 (0.01%) |
2/8738 (0.02%) |
0/8748 (0.00%) |
Compression fracture |
1/7254 (0.01%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Concussion |
0/7254 (0.00%) |
1/7243 (0.01%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Contusion |
1/7254 (0.01%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
3/8748 (0.03%) |
Craniocerebral injury |
0/7254 (0.00%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
2/8748 (0.02%) |
Ear injury |
1/7254 (0.01%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Fall |
0/7254 (0.00%) |
0/7243 (0.00%) |
4/8738 (0.05%) |
0/8748 (0.00%) |
Femoral neck fracture |
1/7254 (0.01%) |
5/7243 (0.07%) |
1/8738 (0.01%) |
0/8748 (0.00%) |
Femur fracture |
6/7254 (0.08%) |
5/7243 (0.07%) |
2/8738 (0.02%) |
2/8748 (0.02%) |
Foot fracture |
0/7254 (0.00%) |
0/7243 (0.00%) |
1/8738 (0.01%) |
0/8748 (0.00%) |
Forearm fracture |
0/7254 (0.00%) |
1/7243 (0.01%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Fractured sacrum |
1/7254 (0.01%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Gastrointestinal stoma complication |
0/7254 (0.00%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Graft complication |
0/7254 (0.00%) |
1/7243 (0.01%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Graft thrombosis |
1/7254 (0.01%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Head injury |
1/7254 (0.01%) |
0/7243 (0.00%) |
1/8738 (0.01%) |
0/8748 (0.00%) |
Hip fracture |
8/7254 (0.11%) |
4/7243 (0.06%) |
5/8738 (0.06%) |
11/8748 (0.13%) |
Humerus fracture |
3/7254 (0.04%) |
2/7243 (0.03%) |
4/8738 (0.05%) |
1/8748 (0.01%) |
Incisional hernia |
2/7254 (0.03%) |
2/7243 (0.03%) |
0/8738 (0.00%) |
2/8748 (0.02%) |
Injury |
2/7254 (0.03%) |
2/7243 (0.03%) |
2/8738 (0.02%) |
0/8748 (0.00%) |
Intentional overdose |
0/7254 (0.00%) |
0/7243 (0.00%) |
1/8738 (0.01%) |
0/8748 (0.00%) |
Joint dislocation |
2/7254 (0.03%) |
1/7243 (0.01%) |
1/8738 (0.01%) |
3/8748 (0.03%) |
Joint injury |
0/7254 (0.00%) |
1/7243 (0.01%) |
1/8738 (0.01%) |
1/8748 (0.01%) |
Joint sprain |
0/7254 (0.00%) |
1/7243 (0.01%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Laceration |
1/7254 (0.01%) |
0/7243 (0.00%) |
1/8738 (0.01%) |
1/8748 (0.01%) |
Ligament sprain |
0/7254 (0.00%) |
1/7243 (0.01%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Meniscus lesion |
0/7254 (0.00%) |
1/7243 (0.01%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Multiple fractures |
3/7254 (0.04%) |
3/7243 (0.04%) |
2/8738 (0.02%) |
0/8748 (0.00%) |
Multiple injuries |
0/7254 (0.00%) |
1/7243 (0.01%) |
1/8738 (0.01%) |
0/8748 (0.00%) |
Open fracture |
0/7254 (0.00%) |
0/7243 (0.00%) |
1/8738 (0.01%) |
0/8748 (0.00%) |
Patella fracture |
2/7254 (0.03%) |
1/7243 (0.01%) |
0/8738 (0.00%) |
2/8748 (0.02%) |
Pelvic fracture |
3/7254 (0.04%) |
1/7243 (0.01%) |
1/8738 (0.01%) |
3/8748 (0.03%) |
Periprosthetic fracture |
0/7254 (0.00%) |
1/7243 (0.01%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Post laminectomy syndrome |
0/7254 (0.00%) |
1/7243 (0.01%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Post procedural complication |
1/7254 (0.01%) |
0/7243 (0.00%) |
1/8738 (0.01%) |
2/8748 (0.02%) |
Post procedural haemorrhage |
1/7254 (0.01%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Postoperative fever |
0/7254 (0.00%) |
1/7243 (0.01%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Postoperative respiratory distress |
0/7254 (0.00%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Procedural pain |
1/7254 (0.01%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Pubis fracture |
0/7254 (0.00%) |
1/7243 (0.01%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Radius fracture |
0/7254 (0.00%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Respiratory fume inhalation disorder |
1/7254 (0.01%) |
0/7243 (0.00%) |
1/8738 (0.01%) |
0/8748 (0.00%) |
Rib fracture |
2/7254 (0.03%) |
3/7243 (0.04%) |
0/8738 (0.00%) |
3/8748 (0.03%) |
Road traffic accident |
0/7254 (0.00%) |
2/7243 (0.03%) |
3/8738 (0.03%) |
0/8748 (0.00%) |
Skull fracture |
1/7254 (0.01%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Skull fractured base |
0/7254 (0.00%) |
2/7243 (0.03%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Spinal compression fracture |
0/7254 (0.00%) |
0/7243 (0.00%) |
1/8738 (0.01%) |
0/8748 (0.00%) |
Spinal fracture |
0/7254 (0.00%) |
1/7243 (0.01%) |
1/8738 (0.01%) |
1/8748 (0.01%) |
Splenic rupture |
0/7254 (0.00%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Sternal fracture |
0/7254 (0.00%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Subdural haematoma |
5/7254 (0.07%) |
3/7243 (0.04%) |
1/8738 (0.01%) |
2/8748 (0.02%) |
Tendon rupture |
0/7254 (0.00%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Tibia fracture |
1/7254 (0.01%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Toxicity to various agents |
1/7254 (0.01%) |
1/7243 (0.01%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Traumatic fracture |
1/7254 (0.01%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Upper limb fracture |
2/7254 (0.03%) |
0/7243 (0.00%) |
1/8738 (0.01%) |
1/8748 (0.01%) |
Vascular graft complication |
0/7254 (0.00%) |
0/7243 (0.00%) |
1/8738 (0.01%) |
0/8748 (0.00%) |
Wound |
0/7254 (0.00%) |
1/7243 (0.01%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Wound dehiscence |
0/7254 (0.00%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Wrist fracture |
1/7254 (0.01%) |
0/7243 (0.00%) |
3/8738 (0.03%) |
0/8748 (0.00%) |
Extradural haematoma |
0/7254 (0.00%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Investigations |
|
|
|
|
Blood pressure increased |
0/7254 (0.00%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Cardiac stress test abnormal |
0/7254 (0.00%) |
1/7243 (0.01%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Prostatic specific antigen increased |
0/7254 (0.00%) |
1/7243 (0.01%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Metabolism and nutrition disorders |
|
|
|
|
Dehydration |
3/7254 (0.04%) |
4/7243 (0.06%) |
4/8738 (0.05%) |
5/8748 (0.06%) |
Diabetic ketoacidosis |
0/7254 (0.00%) |
1/7243 (0.01%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Diabetes mellitus inadequate control |
0/7254 (0.00%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Failure to thrive |
0/7254 (0.00%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Fluid overload |
0/7254 (0.00%) |
1/7243 (0.01%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Fluid retention |
0/7254 (0.00%) |
1/7243 (0.01%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Gout |
1/7254 (0.01%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Hypercalcaemia |
0/7254 (0.00%) |
0/7243 (0.00%) |
1/8738 (0.01%) |
0/8748 (0.00%) |
Hyperglycaemia |
1/7254 (0.01%) |
0/7243 (0.00%) |
2/8738 (0.02%) |
1/8748 (0.01%) |
Hypoglycaemia |
2/7254 (0.03%) |
3/7243 (0.04%) |
2/8738 (0.02%) |
5/8748 (0.06%) |
Hypokalaemia |
3/7254 (0.04%) |
2/7243 (0.03%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Hyponatraemia |
1/7254 (0.01%) |
1/7243 (0.01%) |
3/8738 (0.03%) |
3/8748 (0.03%) |
Malnutrition |
0/7254 (0.00%) |
1/7243 (0.01%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Type 2 diabetes mellitus |
0/7254 (0.00%) |
1/7243 (0.01%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Hypocalcaemia |
1/7254 (0.01%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Musculoskeletal and connective tissue disorders |
|
|
|
|
Arthralgia |
6/7254 (0.08%) |
4/7243 (0.06%) |
6/8738 (0.07%) |
1/8748 (0.01%) |
Arthritis |
4/7254 (0.06%) |
1/7243 (0.01%) |
4/8738 (0.05%) |
1/8748 (0.01%) |
Arthropathy |
0/7254 (0.00%) |
0/7243 (0.00%) |
1/8738 (0.01%) |
0/8748 (0.00%) |
Back pain |
4/7254 (0.06%) |
1/7243 (0.01%) |
2/8738 (0.02%) |
6/8748 (0.07%) |
Bursitis |
0/7254 (0.00%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Cervical spinal stenosis |
1/7254 (0.01%) |
3/7243 (0.04%) |
1/8738 (0.01%) |
5/8748 (0.06%) |
Chondrocalcinosis pyrophosphate |
0/7254 (0.00%) |
1/7243 (0.01%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Costochondritis |
0/7254 (0.00%) |
1/7243 (0.01%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Exostosis |
0/7254 (0.00%) |
0/7243 (0.00%) |
1/8738 (0.01%) |
1/8748 (0.01%) |
Foot deformity |
2/7254 (0.03%) |
2/7243 (0.03%) |
1/8738 (0.01%) |
0/8748 (0.00%) |
Fracture malunion |
0/7254 (0.00%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Gouty tophus |
1/7254 (0.01%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Groin pain |
0/7254 (0.00%) |
0/7243 (0.00%) |
3/8738 (0.03%) |
0/8748 (0.00%) |
Intervertebral disc degeneration |
3/7254 (0.04%) |
2/7243 (0.03%) |
1/8738 (0.01%) |
2/8748 (0.02%) |
Intervertebral disc displacement |
0/7254 (0.00%) |
0/7243 (0.00%) |
1/8738 (0.01%) |
0/8748 (0.00%) |
Intervertebral disc protrusion |
2/7254 (0.03%) |
5/7243 (0.07%) |
2/8738 (0.02%) |
1/8748 (0.01%) |
Knee deformity |
0/7254 (0.00%) |
1/7243 (0.01%) |
1/8738 (0.01%) |
0/8748 (0.00%) |
Kyphosis |
0/7254 (0.00%) |
1/7243 (0.01%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Lumbar spinal stenosis |
6/7254 (0.08%) |
7/7243 (0.10%) |
7/8738 (0.08%) |
4/8748 (0.05%) |
Monarthritis |
1/7254 (0.01%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Muscle atrophy |
1/7254 (0.01%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Muscle spasms |
0/7254 (0.00%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Muscular weakness |
1/7254 (0.01%) |
1/7243 (0.01%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Musculoskeletal chest pain |
1/7254 (0.01%) |
1/7243 (0.01%) |
0/8738 (0.00%) |
3/8748 (0.03%) |
Musculoskeletal pain |
3/7254 (0.04%) |
1/7243 (0.01%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Neck pain |
0/7254 (0.00%) |
3/7243 (0.04%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Osteoarthritis |
48/7254 (0.66%) |
29/7243 (0.40%) |
50/8738 (0.57%) |
35/8748 (0.40%) |
Osteonecrosis |
2/7254 (0.03%) |
0/7243 (0.00%) |
1/8738 (0.01%) |
0/8748 (0.00%) |
Osteoporosis |
0/7254 (0.00%) |
1/7243 (0.01%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Osteoporotic fracture |
0/7254 (0.00%) |
1/7243 (0.01%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Pain in extremity |
1/7254 (0.01%) |
0/7243 (0.00%) |
1/8738 (0.01%) |
0/8748 (0.00%) |
Periarthritis |
0/7254 (0.00%) |
1/7243 (0.01%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Polymyalgia rheumatica |
1/7254 (0.01%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Rhabdomyolysis |
0/7254 (0.00%) |
0/7243 (0.00%) |
1/8738 (0.01%) |
0/8748 (0.00%) |
Rheumatoid arthritis |
1/7254 (0.01%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Rotator cuff syndrome |
3/7254 (0.04%) |
2/7243 (0.03%) |
2/8738 (0.02%) |
1/8748 (0.01%) |
Spinal column stenosis |
1/7254 (0.01%) |
0/7243 (0.00%) |
4/8738 (0.05%) |
2/8748 (0.02%) |
Spinal osteoarthritis |
1/7254 (0.01%) |
0/7243 (0.00%) |
1/8738 (0.01%) |
0/8748 (0.00%) |
Spondylolisthesis |
0/7254 (0.00%) |
2/7243 (0.03%) |
4/8738 (0.05%) |
2/8748 (0.02%) |
Synovial cyst |
0/7254 (0.00%) |
0/7243 (0.00%) |
1/8738 (0.01%) |
0/8748 (0.00%) |
Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
|
|
|
Acute leukaemia |
0/7254 (0.00%) |
0/7243 (0.00%) |
1/8738 (0.01%) |
0/8748 (0.00%) |
Acute myeloid leukaemia |
0/7254 (0.00%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Acute promyelocytic leukaemia |
1/7254 (0.01%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Adenocarcinoma |
0/7254 (0.00%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Adenocarcinoma pancreas |
0/7254 (0.00%) |
0/7243 (0.00%) |
1/8738 (0.01%) |
1/8748 (0.01%) |
Adenoid cystic carcinoma |
0/7254 (0.00%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
B-cell small lymphocytic lymphoma |
0/7254 (0.00%) |
0/7243 (0.00%) |
1/8738 (0.01%) |
0/8748 (0.00%) |
Basal cell carcinoma |
0/7254 (0.00%) |
1/7243 (0.01%) |
1/8738 (0.01%) |
0/8748 (0.00%) |
Benign neoplasm |
0/7254 (0.00%) |
0/7243 (0.00%) |
2/8738 (0.02%) |
1/8748 (0.01%) |
Benign renal neoplasm |
0/7254 (0.00%) |
0/7243 (0.00%) |
1/8738 (0.01%) |
0/8748 (0.00%) |
Bile duct cancer |
0/7254 (0.00%) |
0/7243 (0.00%) |
1/8738 (0.01%) |
0/8748 (0.00%) |
Bladder cancer |
5/7254 (0.07%) |
3/7243 (0.04%) |
0/8738 (0.00%) |
3/8748 (0.03%) |
Bladder cancer recurrent |
0/7254 (0.00%) |
1/7243 (0.01%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Bladder neoplasm |
0/7254 (0.00%) |
1/7243 (0.01%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Bladder transitional cell carcinoma |
0/7254 (0.00%) |
1/7243 (0.01%) |
1/8738 (0.01%) |
0/8748 (0.00%) |
Bone cancer metastatic |
0/7254 (0.00%) |
1/7243 (0.01%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Bone neoplasm |
0/7254 (0.00%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Bone neoplasm malignant |
0/7254 (0.00%) |
1/7243 (0.01%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Brain neoplasm |
1/7254 (0.01%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
2/8748 (0.02%) |
Brain neoplasm malignant |
0/7254 (0.00%) |
1/7243 (0.01%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Breast cancer |
7/7254 (0.10%) |
11/7243 (0.15%) |
7/8738 (0.08%) |
7/8748 (0.08%) |
Breast cancer in situ |
1/7254 (0.01%) |
2/7243 (0.03%) |
2/8738 (0.02%) |
0/8748 (0.00%) |
Breast cancer metastatic |
1/7254 (0.01%) |
0/7243 (0.00%) |
1/8738 (0.01%) |
2/8748 (0.02%) |
Breast cancer recurrent |
1/7254 (0.01%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Breast cancer stage I |
1/7254 (0.01%) |
0/7243 (0.00%) |
1/8738 (0.01%) |
0/8748 (0.00%) |
Bronchial carcinoma |
1/7254 (0.01%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Chronic lymphocytic leukaemia |
0/7254 (0.00%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Colon adenoma |
0/7254 (0.00%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Colon cancer |
0/7254 (0.00%) |
3/7243 (0.04%) |
4/8738 (0.05%) |
5/8748 (0.06%) |
Colon cancer metastatic |
0/7254 (0.00%) |
0/7243 (0.00%) |
1/8738 (0.01%) |
0/8748 (0.00%) |
Colon cancer stage II |
1/7254 (0.01%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Colorectal cancer |
0/7254 (0.00%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Duodenal neoplasm |
1/7254 (0.01%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Endometrial cancer |
1/7254 (0.01%) |
1/7243 (0.01%) |
2/8738 (0.02%) |
0/8748 (0.00%) |
Endometrial cancer stage II |
1/7254 (0.01%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Gastric cancer |
1/7254 (0.01%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
2/8748 (0.02%) |
Gastric cancer recurrent |
0/7254 (0.00%) |
0/7243 (0.00%) |
1/8738 (0.01%) |
0/8748 (0.00%) |
Gastric cancer stage I |
1/7254 (0.01%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Gastrinoma |
0/7254 (0.00%) |
0/7243 (0.00%) |
1/8738 (0.01%) |
0/8748 (0.00%) |
Gastrointestinal stromal tumour |
1/7254 (0.01%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Glottis carcinoma |
0/7254 (0.00%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Head and neck cancer |
0/7254 (0.00%) |
0/7243 (0.00%) |
1/8738 (0.01%) |
0/8748 (0.00%) |
Hepatic cancer metastatic |
2/7254 (0.03%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Hepatic neoplasm malignant |
1/7254 (0.01%) |
2/7243 (0.03%) |
2/8738 (0.02%) |
0/8748 (0.00%) |
Hodgkin's disease |
0/7254 (0.00%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Intracranial meningioma malignant |
1/7254 (0.01%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Laryngeal cancer |
1/7254 (0.01%) |
1/7243 (0.01%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Laryngeal cancer stage I |
0/7254 (0.00%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Lentigo maligna stage unspecified |
0/7254 (0.00%) |
0/7243 (0.00%) |
1/8738 (0.01%) |
0/8748 (0.00%) |
Leukaemia |
0/7254 (0.00%) |
1/7243 (0.01%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Liposarcoma |
0/7254 (0.00%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Lung adenocarcinoma |
1/7254 (0.01%) |
1/7243 (0.01%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Lung cancer metastatic |
0/7254 (0.00%) |
1/7243 (0.01%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Lung carcinoma cell type unspecified stage I |
0/7254 (0.00%) |
1/7243 (0.01%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Lung carcinoma cell type unspecified stage 0 |
0/7254 (0.00%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Lung neoplasm |
1/7254 (0.01%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Lung neoplasm malignant |
4/7254 (0.06%) |
11/7243 (0.15%) |
6/8738 (0.07%) |
3/8748 (0.03%) |
Lung squamous cell carcinoma stage unspecified |
0/7254 (0.00%) |
0/7243 (0.00%) |
1/8738 (0.01%) |
2/8748 (0.02%) |
Lymphoma |
0/7254 (0.00%) |
0/7243 (0.00%) |
1/8738 (0.01%) |
0/8748 (0.00%) |
Malignant melanoma |
1/7254 (0.01%) |
1/7243 (0.01%) |
2/8738 (0.02%) |
1/8748 (0.01%) |
Meningioma |
1/7254 (0.01%) |
1/7243 (0.01%) |
1/8738 (0.01%) |
0/8748 (0.00%) |
Meningioma benign |
0/7254 (0.00%) |
1/7243 (0.01%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Metastases to bone |
0/7254 (0.00%) |
1/7243 (0.01%) |
1/8738 (0.01%) |
0/8748 (0.00%) |
Metastases to central nervous system |
1/7254 (0.01%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Metastases to lung |
2/7254 (0.03%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Metastatic carcinoid tumour |
0/7254 (0.00%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Metastatic malignant melanoma |
1/7254 (0.01%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Metastatic neoplasm |
0/7254 (0.00%) |
0/7243 (0.00%) |
1/8738 (0.01%) |
0/8748 (0.00%) |
Metastatic squamous cell carcinoma |
0/7254 (0.00%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Multiple myeloma |
1/7254 (0.01%) |
2/7243 (0.03%) |
2/8738 (0.02%) |
0/8748 (0.00%) |
Myelodysplastic syndrome |
1/7254 (0.01%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Myeloid leukaemia |
0/7254 (0.00%) |
0/7243 (0.00%) |
1/8738 (0.01%) |
0/8748 (0.00%) |
Myeloma recurrence |
0/7254 (0.00%) |
1/7243 (0.01%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Neoplasm malignant |
0/7254 (0.00%) |
2/7243 (0.03%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Neuroendocrine tumour |
0/7254 (0.00%) |
0/7243 (0.00%) |
1/8738 (0.01%) |
0/8748 (0.00%) |
Non-Hodgkin's lymphoma |
1/7254 (0.01%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Non-small cell lung cancer |
1/7254 (0.01%) |
0/7243 (0.00%) |
1/8738 (0.01%) |
0/8748 (0.00%) |
Non-small cell lung cancer metastatic |
0/7254 (0.00%) |
1/7243 (0.01%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Oesophageal adenocarcinoma |
0/7254 (0.00%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Oesophageal carcinoma |
1/7254 (0.01%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Ovarian cancer metastatic |
1/7254 (0.01%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Pancreatic carcinoma |
1/7254 (0.01%) |
3/7243 (0.04%) |
1/8738 (0.01%) |
0/8748 (0.00%) |
Pancreatic carcinoma metastatic |
1/7254 (0.01%) |
0/7243 (0.00%) |
2/8738 (0.02%) |
0/8748 (0.00%) |
Paraproteinaemia |
1/7254 (0.01%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Penis carcinoma |
0/7254 (0.00%) |
0/7243 (0.00%) |
1/8738 (0.01%) |
0/8748 (0.00%) |
Pituitary tumour |
1/7254 (0.01%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Pituitary tumour benign |
1/7254 (0.01%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Pleural neoplasm |
1/7254 (0.01%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Prostate cancer |
9/7254 (0.12%) |
2/7243 (0.03%) |
3/8738 (0.03%) |
4/8748 (0.05%) |
Prostate cancer metastatic |
0/7254 (0.00%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Rectal cancer |
1/7254 (0.01%) |
3/7243 (0.04%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Renal cancer |
1/7254 (0.01%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Renal cell carcinoma |
3/7254 (0.04%) |
1/7243 (0.01%) |
0/8738 (0.00%) |
2/8748 (0.02%) |
Retroperitoneal neoplasm |
0/7254 (0.00%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Salivary gland cancer |
1/7254 (0.01%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Sarcoma |
0/7254 (0.00%) |
1/7243 (0.01%) |
1/8738 (0.01%) |
0/8748 (0.00%) |
Skin cancer |
1/7254 (0.01%) |
2/7243 (0.03%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Small cell lung cancer extensive stage |
0/7254 (0.00%) |
0/7243 (0.00%) |
1/8738 (0.01%) |
0/8748 (0.00%) |
Small cell lung cancer stage unspecified |
1/7254 (0.01%) |
0/7243 (0.00%) |
2/8738 (0.02%) |
1/8748 (0.01%) |
Small intestine carcinoma |
1/7254 (0.01%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Squamous cell carcinoma |
0/7254 (0.00%) |
5/7243 (0.07%) |
2/8738 (0.02%) |
0/8748 (0.00%) |
Squamous cell carcinoma of skin |
0/7254 (0.00%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Throat cancer |
0/7254 (0.00%) |
0/7243 (0.00%) |
1/8738 (0.01%) |
0/8748 (0.00%) |
Thyroid cancer |
0/7254 (0.00%) |
4/7243 (0.06%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Thyroid neoplasm |
0/7254 (0.00%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Tongue neoplasm malignant stage unspecified |
1/7254 (0.01%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Tonsil cancer |
0/7254 (0.00%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Transitional cell carcinoma |
0/7254 (0.00%) |
2/7243 (0.03%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Uterine cancer |
0/7254 (0.00%) |
0/7243 (0.00%) |
3/8738 (0.03%) |
0/8748 (0.00%) |
Malignant melanoma in situ |
1/7254 (0.01%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Nervous system disorders |
|
|
|
|
Acute disseminated encephalomyelitis |
1/7254 (0.01%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Amnesia |
0/7254 (0.00%) |
0/7243 (0.00%) |
1/8738 (0.01%) |
0/8748 (0.00%) |
Ataxia |
1/7254 (0.01%) |
0/7243 (0.00%) |
2/8738 (0.02%) |
0/8748 (0.00%) |
Autonomic nervous system imbalance |
0/7254 (0.00%) |
1/7243 (0.01%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Basal ganglia infarction |
0/7254 (0.00%) |
0/7243 (0.00%) |
1/8738 (0.01%) |
0/8748 (0.00%) |
Carotid artery occlusion |
0/7254 (0.00%) |
1/7243 (0.01%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Carotid artery stenosis |
3/7254 (0.04%) |
2/7243 (0.03%) |
4/8738 (0.05%) |
0/8748 (0.00%) |
Cerebral amyloid angiopathy |
0/7254 (0.00%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Cerebral cyst |
0/7254 (0.00%) |
0/7243 (0.00%) |
1/8738 (0.01%) |
0/8748 (0.00%) |
Cerebral haemorrhage |
1/7254 (0.01%) |
1/7243 (0.01%) |
2/8738 (0.02%) |
0/8748 (0.00%) |
Cerebral infarction |
2/7254 (0.03%) |
1/7243 (0.01%) |
0/8738 (0.00%) |
2/8748 (0.02%) |
Cerebral Ischaemia |
1/7254 (0.01%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Cerebrovascular accident |
20/7254 (0.28%) |
19/7243 (0.26%) |
13/8738 (0.15%) |
21/8748 (0.24%) |
Cervicobrachial syndrome |
1/7254 (0.01%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Cervical myelopathy |
0/7254 (0.00%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Cognitive disorder |
0/7254 (0.00%) |
0/7243 (0.00%) |
1/8738 (0.01%) |
0/8748 (0.00%) |
Complex partial seizures |
1/7254 (0.01%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Convulsion |
3/7254 (0.04%) |
3/7243 (0.04%) |
1/8738 (0.01%) |
2/8748 (0.02%) |
Dementia Alzheimer's type |
0/7254 (0.00%) |
0/7243 (0.00%) |
1/8738 (0.01%) |
0/8748 (0.00%) |
Dementia with Lewy bodies |
0/7254 (0.00%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Depressed level of consciousness |
0/7254 (0.00%) |
1/7243 (0.01%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Dizziness |
2/7254 (0.03%) |
2/7243 (0.03%) |
1/8738 (0.01%) |
0/8748 (0.00%) |
Dizziness postural |
1/7254 (0.01%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Dyskinesia |
0/7254 (0.00%) |
1/7243 (0.01%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Encephalopathy |
2/7254 (0.03%) |
1/7243 (0.01%) |
2/8738 (0.02%) |
1/8748 (0.01%) |
Epilepsy |
0/7254 (0.00%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Guillain-Barre syndrome |
0/7254 (0.00%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Haemorrhage intracranial |
0/7254 (0.00%) |
2/7243 (0.03%) |
1/8738 (0.01%) |
2/8748 (0.02%) |
Haemorrhagic stroke |
0/7254 (0.00%) |
1/7243 (0.01%) |
1/8738 (0.01%) |
0/8748 (0.00%) |
Headache |
2/7254 (0.03%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Hemiparesis |
0/7254 (0.00%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Hydrocephalus |
0/7254 (0.00%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Hypertensive encephalopathy |
0/7254 (0.00%) |
0/7243 (0.00%) |
1/8738 (0.01%) |
0/8748 (0.00%) |
Intracranial aneurysm |
0/7254 (0.00%) |
1/7243 (0.01%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Intraventricular haemorrhage |
1/7254 (0.01%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Ischaemic stroke |
1/7254 (0.01%) |
0/7243 (0.00%) |
1/8738 (0.01%) |
0/8748 (0.00%) |
Lacunar infarction |
2/7254 (0.03%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Lethargy |
1/7254 (0.01%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Loss of consciousness |
0/7254 (0.00%) |
0/7243 (0.00%) |
1/8738 (0.01%) |
0/8748 (0.00%) |
Lumbar radiculopathy |
3/7254 (0.04%) |
0/7243 (0.00%) |
1/8738 (0.01%) |
0/8748 (0.00%) |
Metabolic encephalopathy |
0/7254 (0.00%) |
0/7243 (0.00%) |
1/8738 (0.01%) |
0/8748 (0.00%) |
Migraine |
0/7254 (0.00%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Myasthenia gravis |
1/7254 (0.01%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Myelopathy |
0/7254 (0.00%) |
0/7243 (0.00%) |
1/8738 (0.01%) |
1/8748 (0.01%) |
Normal pressure hydrocephalus |
3/7254 (0.04%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Paraesthesia |
0/7254 (0.00%) |
1/7243 (0.01%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Parkinson's disease |
0/7254 (0.00%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Presyncope |
1/7254 (0.01%) |
3/7243 (0.04%) |
3/8738 (0.03%) |
2/8748 (0.02%) |
Radiculopathy |
1/7254 (0.01%) |
1/7243 (0.01%) |
1/8738 (0.01%) |
0/8748 (0.00%) |
Sciatica |
0/7254 (0.00%) |
1/7243 (0.01%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Spondylitic myelopathy |
0/7254 (0.00%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
2/8748 (0.02%) |
Subarachnoid haemorrhage |
0/7254 (0.00%) |
4/7243 (0.06%) |
1/8738 (0.01%) |
1/8748 (0.01%) |
Syncope |
18/7254 (0.25%) |
19/7243 (0.26%) |
15/8738 (0.17%) |
16/8748 (0.18%) |
Thrombotic cerebral infarction |
1/7254 (0.01%) |
1/7243 (0.01%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Toxic encephalopathy |
0/7254 (0.00%) |
0/7243 (0.00%) |
1/8738 (0.01%) |
1/8748 (0.01%) |
Transient global amnesia |
1/7254 (0.01%) |
1/7243 (0.01%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Transient ischaemic attack |
12/7254 (0.17%) |
15/7243 (0.21%) |
9/8738 (0.10%) |
12/8748 (0.14%) |
VIIth nerve paralysis |
0/7254 (0.00%) |
2/7243 (0.03%) |
1/8738 (0.01%) |
3/8748 (0.03%) |
VIth nerve paralysis |
0/7254 (0.00%) |
0/7243 (0.00%) |
1/8738 (0.01%) |
1/8748 (0.01%) |
Basal ganglia haemorrhage |
0/7254 (0.00%) |
1/7243 (0.01%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Psychiatric disorders |
|
|
|
|
Affective disorder |
0/7254 (0.00%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Alcohol withdrawal syndrome |
1/7254 (0.01%) |
1/7243 (0.01%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Bipolar disorder |
1/7254 (0.01%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Bipolar I disorder |
0/7254 (0.00%) |
0/7243 (0.00%) |
1/8738 (0.01%) |
0/8748 (0.00%) |
Completed suicide |
0/7254 (0.00%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Delirium |
1/7254 (0.01%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Depression |
1/7254 (0.01%) |
2/7243 (0.03%) |
1/8738 (0.01%) |
0/8748 (0.00%) |
Hallucination, visual |
0/7254 (0.00%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Major depression |
1/7254 (0.01%) |
1/7243 (0.01%) |
1/8738 (0.01%) |
1/8748 (0.01%) |
Mental status changes |
1/7254 (0.01%) |
2/7243 (0.03%) |
5/8738 (0.06%) |
4/8748 (0.05%) |
Panic attack |
0/7254 (0.00%) |
0/7243 (0.00%) |
1/8738 (0.01%) |
0/8748 (0.00%) |
Psychotic disorder |
0/7254 (0.00%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Suicidal ideation |
0/7254 (0.00%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Renal and urinary disorders |
|
|
|
|
Bladder fibrosis |
0/7254 (0.00%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Bladder prolapse |
0/7254 (0.00%) |
0/7243 (0.00%) |
2/8738 (0.02%) |
0/8748 (0.00%) |
Calculus bladder |
0/7254 (0.00%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Calculus ureteric |
1/7254 (0.01%) |
2/7243 (0.03%) |
0/8738 (0.00%) |
2/8748 (0.02%) |
Calculus urinary |
0/7254 (0.00%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Dysuria |
1/7254 (0.01%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Haematuria |
1/7254 (0.01%) |
0/7243 (0.00%) |
1/8738 (0.01%) |
0/8748 (0.00%) |
Hydronephrosis |
0/7254 (0.00%) |
0/7243 (0.00%) |
2/8738 (0.02%) |
0/8748 (0.00%) |
Nephrolithiasis |
3/7254 (0.04%) |
5/7243 (0.07%) |
2/8738 (0.02%) |
1/8748 (0.01%) |
Obstructive uropathy |
0/7254 (0.00%) |
0/7243 (0.00%) |
1/8738 (0.01%) |
0/8748 (0.00%) |
Renal artery stenosis |
1/7254 (0.01%) |
1/7243 (0.01%) |
1/8738 (0.01%) |
1/8748 (0.01%) |
Renal colic |
0/7254 (0.00%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Renal failure |
2/7254 (0.03%) |
1/7243 (0.01%) |
1/8738 (0.01%) |
4/8748 (0.05%) |
Renal failure acute |
8/7254 (0.11%) |
5/7243 (0.07%) |
11/8738 (0.13%) |
14/8748 (0.16%) |
Renal failure chronic |
4/7254 (0.06%) |
2/7243 (0.03%) |
1/8738 (0.01%) |
3/8748 (0.03%) |
Renal mass |
0/7254 (0.00%) |
0/7243 (0.00%) |
1/8738 (0.01%) |
0/8748 (0.00%) |
Stress urinary incontinence |
0/7254 (0.00%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Urethral stenosis |
0/7254 (0.00%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Urinary incontinence |
1/7254 (0.01%) |
1/7243 (0.01%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Urinary retention |
0/7254 (0.00%) |
0/7243 (0.00%) |
2/8738 (0.02%) |
1/8748 (0.01%) |
Reproductive system and breast disorders |
|
|
|
|
Benign prostatic hyperplasia |
1/7254 (0.01%) |
3/7243 (0.04%) |
2/8738 (0.02%) |
0/8748 (0.00%) |
Cystocele |
1/7254 (0.01%) |
0/7243 (0.00%) |
1/8738 (0.01%) |
0/8748 (0.00%) |
Endometrial hyperplasia |
0/7254 (0.00%) |
0/7243 (0.00%) |
1/8738 (0.01%) |
0/8748 (0.00%) |
Erectile dysfunction |
1/7254 (0.01%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Genital prolapse |
0/7254 (0.00%) |
1/7243 (0.01%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Ovarian cyst |
0/7254 (0.00%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Ovarian mass |
1/7254 (0.01%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Pelvic pain |
0/7254 (0.00%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Pelvic prolapse |
1/7254 (0.01%) |
0/7243 (0.00%) |
1/8738 (0.01%) |
0/8748 (0.00%) |
Prostatitis |
0/7254 (0.00%) |
1/7243 (0.01%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Prostatomegaly |
0/7254 (0.00%) |
0/7243 (0.00%) |
1/8738 (0.01%) |
1/8748 (0.01%) |
Uterine prolapse |
1/7254 (0.01%) |
1/7243 (0.01%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Uterovaginal prolapse |
0/7254 (0.00%) |
1/7243 (0.01%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Vaginal haematoma |
1/7254 (0.01%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Respiratory, thoracic and mediastinal disorders |
|
|
|
|
Acute respiratory failure |
1/7254 (0.01%) |
6/7243 (0.08%) |
6/8738 (0.07%) |
7/8748 (0.08%) |
Alveolitis allergic |
0/7254 (0.00%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Asthma |
4/7254 (0.06%) |
2/7243 (0.03%) |
3/8738 (0.03%) |
5/8748 (0.06%) |
Bronchitis chronic |
0/7254 (0.00%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Chronic obstructive pulmonary disease |
21/7254 (0.29%) |
13/7243 (0.18%) |
15/8738 (0.17%) |
36/8748 (0.41%) |
Chronic respiratory failure |
0/7254 (0.00%) |
1/7243 (0.01%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Dyspnoea |
5/7254 (0.07%) |
6/7243 (0.08%) |
3/8738 (0.03%) |
8/8748 (0.09%) |
Dyspnoea exertional |
0/7254 (0.00%) |
1/7243 (0.01%) |
1/8738 (0.01%) |
2/8748 (0.02%) |
Emphysema |
0/7254 (0.00%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Eosinophilic pneumonia |
0/7254 (0.00%) |
1/7243 (0.01%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Epistaxis |
3/7254 (0.04%) |
1/7243 (0.01%) |
2/8738 (0.02%) |
0/8748 (0.00%) |
Haemoptysis |
0/7254 (0.00%) |
0/7243 (0.00%) |
1/8738 (0.01%) |
0/8748 (0.00%) |
Haemothorax |
0/7254 (0.00%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Hypoxia |
1/7254 (0.01%) |
2/7243 (0.03%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Interstitial lung disease |
0/7254 (0.00%) |
1/7243 (0.01%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Nasal septum deviation |
0/7254 (0.00%) |
0/7243 (0.00%) |
1/8738 (0.01%) |
0/8748 (0.00%) |
Pleural effusion |
1/7254 (0.01%) |
1/7243 (0.01%) |
1/8738 (0.01%) |
0/8748 (0.00%) |
Pleural haemorrhage |
1/7254 (0.01%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Pleurisy |
0/7254 (0.00%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Pleuritic pain |
0/7254 (0.00%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Pneumonia aspiration |
0/7254 (0.00%) |
3/7243 (0.04%) |
2/8738 (0.02%) |
1/8748 (0.01%) |
Pneumonitis |
0/7254 (0.00%) |
1/7243 (0.01%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Pneumothorax |
2/7254 (0.03%) |
2/7243 (0.03%) |
4/8738 (0.05%) |
2/8748 (0.02%) |
Pulmonary embolism |
5/7254 (0.07%) |
7/7243 (0.10%) |
6/8738 (0.07%) |
13/8748 (0.15%) |
Pulmonary fibrosis |
0/7254 (0.00%) |
1/7243 (0.01%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Pulmonary hypertension |
0/7254 (0.00%) |
2/7243 (0.03%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Pulmonary oedema |
1/7254 (0.01%) |
0/7243 (0.00%) |
1/8738 (0.01%) |
0/8748 (0.00%) |
Respiratory arrest |
0/7254 (0.00%) |
1/7243 (0.01%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Respiratory failure |
5/7254 (0.07%) |
5/7243 (0.07%) |
4/8738 (0.05%) |
5/8748 (0.06%) |
Sleep apnoea syndrome |
0/7254 (0.00%) |
1/7243 (0.01%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Skin and subcutaneous tissue disorders |
|
|
|
|
Angioedema |
1/7254 (0.01%) |
0/7243 (0.00%) |
2/8738 (0.02%) |
0/8748 (0.00%) |
Capillaritis |
0/7254 (0.00%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Decubitus ulcer |
0/7254 (0.00%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Diabetic foot |
0/7254 (0.00%) |
0/7243 (0.00%) |
1/8738 (0.01%) |
0/8748 (0.00%) |
Hypoaesthesia facial |
0/7254 (0.00%) |
1/7243 (0.01%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Panniculitis |
1/7254 (0.01%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Rash |
0/7254 (0.00%) |
0/7243 (0.00%) |
1/8738 (0.01%) |
0/8748 (0.00%) |
Stevens-Johnson syndrome |
1/7254 (0.01%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Skin hypertrophy |
0/7254 (0.00%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Social circumstances |
|
|
|
|
Activities of daily living impaired |
1/7254 (0.01%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Surgical and medical procedures |
|
|
|
|
Colostomy |
1/7254 (0.01%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Face lift |
0/7254 (0.00%) |
1/7243 (0.01%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Implantable defibrillator removal |
1/7254 (0.01%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Intraocular lens implant |
0/7254 (0.00%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Renal surgery |
0/7254 (0.00%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Surgery |
0/7254 (0.00%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Vascular disorders |
|
|
|
|
Accelerated hypertension |
0/7254 (0.00%) |
1/7243 (0.01%) |
0/8738 (0.00%) |
2/8748 (0.02%) |
Aneurysm ruptured |
0/7254 (0.00%) |
1/7243 (0.01%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Aortic aneurysm |
5/7254 (0.07%) |
3/7243 (0.04%) |
5/8738 (0.06%) |
6/8748 (0.07%) |
Aortic aneurysm rupture |
0/7254 (0.00%) |
0/7243 (0.00%) |
2/8738 (0.02%) |
0/8748 (0.00%) |
Aortic dissection |
0/7254 (0.00%) |
0/7243 (0.00%) |
2/8738 (0.02%) |
0/8748 (0.00%) |
Aortic rupture |
1/7254 (0.01%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Aortic stenosis |
2/7254 (0.03%) |
2/7243 (0.03%) |
2/8738 (0.02%) |
2/8748 (0.02%) |
Arterial occlusive disease |
1/7254 (0.01%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Arterial stenosis limb |
1/7254 (0.01%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Arterial thrombosis limb |
0/7254 (0.00%) |
0/7243 (0.00%) |
1/8738 (0.01%) |
0/8748 (0.00%) |
Arteriosclerosis |
1/7254 (0.01%) |
1/7243 (0.01%) |
0/8738 (0.00%) |
3/8748 (0.03%) |
Arteriovenous fistula |
0/7254 (0.00%) |
1/7243 (0.01%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Deep vein thrombosis |
5/7254 (0.07%) |
5/7243 (0.07%) |
1/8738 (0.01%) |
6/8748 (0.07%) |
Embolism venous |
0/7254 (0.00%) |
0/7243 (0.00%) |
1/8738 (0.01%) |
0/8748 (0.00%) |
Femoral artery occlusion |
1/7254 (0.01%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Haematoma |
4/7254 (0.06%) |
2/7243 (0.03%) |
1/8738 (0.01%) |
0/8748 (0.00%) |
Hypertension |
8/7254 (0.11%) |
4/7243 (0.06%) |
4/8738 (0.05%) |
3/8748 (0.03%) |
Hypertensive crisis |
0/7254 (0.00%) |
0/7243 (0.00%) |
1/8738 (0.01%) |
0/8748 (0.00%) |
Hypertensive emergency |
1/7254 (0.01%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Hypotension |
8/7254 (0.11%) |
4/7243 (0.06%) |
2/8738 (0.02%) |
2/8748 (0.02%) |
Hypovolaemic shock |
0/7254 (0.00%) |
0/7243 (0.00%) |
1/8738 (0.01%) |
0/8748 (0.00%) |
Infarction |
0/7254 (0.00%) |
1/7243 (0.01%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Intermittent claudication |
1/7254 (0.01%) |
1/7243 (0.01%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Intra-abdominal haematoma |
0/7254 (0.00%) |
1/7243 (0.01%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Ischaemia |
0/7254 (0.00%) |
1/7243 (0.01%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Malignant hypertension |
1/7254 (0.01%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Orthostatic hypertension |
0/7254 (0.00%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Orthostatic hypotension |
1/7254 (0.01%) |
5/7243 (0.07%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Peripheral arterial occlusive disease |
1/7254 (0.01%) |
0/7243 (0.00%) |
2/8738 (0.02%) |
1/8748 (0.01%) |
Peripheral artery aneurysm |
0/7254 (0.00%) |
0/7243 (0.00%) |
1/8738 (0.01%) |
0/8748 (0.00%) |
Peripheral ischaemia |
0/7254 (0.00%) |
0/7243 (0.00%) |
3/8738 (0.03%) |
0/8748 (0.00%) |
Peripheral vascular disorder |
1/7254 (0.01%) |
1/7243 (0.01%) |
1/8738 (0.01%) |
2/8748 (0.02%) |
Shock |
0/7254 (0.00%) |
0/7243 (0.00%) |
1/8738 (0.01%) |
0/8748 (0.00%) |
Steal syndrome |
0/7254 (0.00%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
1/8748 (0.01%) |
Thrombosis |
1/7254 (0.01%) |
1/7243 (0.01%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Venous insufficiency |
0/7254 (0.00%) |
1/7243 (0.01%) |
0/8738 (0.00%) |
0/8748 (0.00%) |
Indicates events were collected by non-systematic assessment
Term from vocabulary, MedDRA version 15.0
|
|
Frequency Threshold for Reporting Other Adverse Events
|
5.00%
|
|
Fluzone® High Dose Vaccine (Year 1)
|
Fluzone® Vaccine (Year 1)
|
Fluzone® High Dose Vaccine (Year 2)
|
Fluzone® Vaccine (Year 2)
|
|
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Total |
0/7254 (0.00%) |
0/7243 (0.00%) |
0/8738 (0.00%) |
0/8748 (0.00%) |