Time Frame |
From the first drug intake up to 30 days after administration
|
Adverse Event Reporting Description |
Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
|
|
Arm/Group Title
|
Tiotropium 2.5 mcg and Placebo
|
Tiotropium 5 mcg and Placebo
|
Tiotropium 18 mcg and Placebo
|
Arm/Group Description |
Patients receive one of the active ...
|
Patients receive one of the active ...
|
Patients receive one of the active ...
|
Arm/Group Description |
Patients receive one of the active tiotropium arms daily
tiotropium 1.25 mcg (2 actuations/day): soft mist inhaler 2 actuations=2 puffs/day
|
Patients receive one of the active tiotropium arms daily
tiotropium 2.5 mcg (2 actuations/day): soft mist inhaler (2 actuations=2 puffs/day)
|
Patients receive one of the active tiotropium arms daily
Tiotropium 18 mcg: HandiHaler
|
|
|
Tiotropium 2.5 mcg and Placebo
|
Tiotropium 5 mcg and Placebo
|
Tiotropium 18 mcg and Placebo
|
|
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Total |
--/-- |
--/-- |
--/-- |
|
|
Tiotropium 2.5 mcg and Placebo
|
Tiotropium 5 mcg and Placebo
|
Tiotropium 18 mcg and Placebo
|
|
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Total |
1932/5724 (33.75%) |
1876/5705 (32.88%) |
1928/5687 (33.90%) |
Blood and lymphatic system disorders |
|
|
|
Anaemia |
10/5724 (0.17%) |
10/5705 (0.18%) |
13/5687 (0.23%) |
Coagulopathy |
0/5724 (0.00%) |
0/5705 (0.00%) |
3/5687 (0.05%) |
Disseminated intravascular coagulation |
1/5724 (0.02%) |
0/5705 (0.00%) |
1/5687 (0.02%) |
Febrile neutropenia |
1/5724 (0.02%) |
1/5705 (0.02%) |
0/5687 (0.00%) |
Haemorrhagic anaemia |
0/5724 (0.00%) |
0/5705 (0.00%) |
4/5687 (0.07%) |
Hypercoagulation |
1/5724 (0.02%) |
0/5705 (0.00%) |
1/5687 (0.02%) |
Iron deficiency anaemia |
2/5724 (0.03%) |
0/5705 (0.00%) |
2/5687 (0.04%) |
Leukocytosis |
3/5724 (0.05%) |
0/5705 (0.00%) |
1/5687 (0.02%) |
Lymphadenitis |
0/5724 (0.00%) |
1/5705 (0.02%) |
1/5687 (0.02%) |
Lymphadenopathy |
0/5724 (0.00%) |
1/5705 (0.02%) |
1/5687 (0.02%) |
Lymphadenopathy mediastinal |
0/5724 (0.00%) |
0/5705 (0.00%) |
1/5687 (0.02%) |
Microcytic anaemia |
1/5724 (0.02%) |
0/5705 (0.00%) |
0/5687 (0.00%) |
Pancytopenia |
2/5724 (0.03%) |
0/5705 (0.00%) |
0/5687 (0.00%) |
Pernicious anaemia |
1/5724 (0.02%) |
0/5705 (0.00%) |
0/5687 (0.00%) |
Polycythaemia |
0/5724 (0.00%) |
1/5705 (0.02%) |
1/5687 (0.02%) |
Splenomegaly |
0/5724 (0.00%) |
1/5705 (0.02%) |
0/5687 (0.00%) |
Thrombocytopenia |
0/5724 (0.00%) |
0/5705 (0.00%) |
2/5687 (0.04%) |
Thrombocytosis |
0/5724 (0.00%) |
1/5705 (0.02%) |
0/5687 (0.00%) |
Cardiac disorders |
|
|
|
Acute coronary syndrome |
4/5724 (0.07%) |
3/5705 (0.05%) |
9/5687 (0.16%) |
Acute myocardial infarction |
21/5724 (0.37%) |
21/5705 (0.37%) |
13/5687 (0.23%) |
Adams-Stokes syndrome |
0/5724 (0.00%) |
0/5705 (0.00%) |
1/5687 (0.02%) |
Angina pectoris |
20/5724 (0.35%) |
28/5705 (0.49%) |
22/5687 (0.39%) |
Angina unstable |
10/5724 (0.17%) |
19/5705 (0.33%) |
10/5687 (0.18%) |
Aortic valve disease |
1/5724 (0.02%) |
0/5705 (0.00%) |
0/5687 (0.00%) |
Aortic valve disease mixed |
0/5724 (0.00%) |
1/5705 (0.02%) |
0/5687 (0.00%) |
Aortic valve incompetence |
0/5724 (0.00%) |
1/5705 (0.02%) |
3/5687 (0.05%) |
Aortic valve stenosis |
2/5724 (0.03%) |
3/5705 (0.05%) |
3/5687 (0.05%) |
Arrhythmia |
5/5724 (0.09%) |
8/5705 (0.14%) |
7/5687 (0.12%) |
Arrhythmia supraventricular |
1/5724 (0.02%) |
0/5705 (0.00%) |
0/5687 (0.00%) |
Arteriosclerosis coronary artery |
2/5724 (0.03%) |
2/5705 (0.04%) |
0/5687 (0.00%) |
Atrial fibrillation |
41/5724 (0.72%) |
37/5705 (0.65%) |
32/5687 (0.56%) |
Atrial flutter |
10/5724 (0.17%) |
6/5705 (0.11%) |
4/5687 (0.07%) |
Atrial tachycardia |
2/5724 (0.03%) |
0/5705 (0.00%) |
3/5687 (0.05%) |
Atrioventricular block |
3/5724 (0.05%) |
0/5705 (0.00%) |
1/5687 (0.02%) |
Atrioventricular block complete |
2/5724 (0.03%) |
1/5705 (0.02%) |
2/5687 (0.04%) |
Atrioventricular block second degree |
0/5724 (0.00%) |
0/5705 (0.00%) |
1/5687 (0.02%) |
Bradycardia |
4/5724 (0.07%) |
2/5705 (0.04%) |
2/5687 (0.04%) |
Bundle branch block left |
0/5724 (0.00%) |
1/5705 (0.02%) |
0/5687 (0.00%) |
Bundle branch block right |
0/5724 (0.00%) |
1/5705 (0.02%) |
0/5687 (0.00%) |
Cardiac arrest |
12/5724 (0.21%) |
7/5705 (0.12%) |
9/5687 (0.16%) |
Cardiac asthma |
1/5724 (0.02%) |
0/5705 (0.00%) |
0/5687 (0.00%) |
Cardiac disorder |
0/5724 (0.00%) |
0/5705 (0.00%) |
1/5687 (0.02%) |
Cardiac failure |
30/5724 (0.52%) |
23/5705 (0.40%) |
24/5687 (0.42%) |
Cardiac failure acute |
4/5724 (0.07%) |
4/5705 (0.07%) |
6/5687 (0.11%) |
Cardiac failure chronic |
2/5724 (0.03%) |
2/5705 (0.04%) |
3/5687 (0.05%) |
Cardiac failure congestive |
26/5724 (0.45%) |
22/5705 (0.39%) |
29/5687 (0.51%) |
Cardiac valve disease |
1/5724 (0.02%) |
0/5705 (0.00%) |
0/5687 (0.00%) |
Cardio-respiratory arrest |
9/5724 (0.16%) |
5/5705 (0.09%) |
8/5687 (0.14%) |
Cardiomegaly |
1/5724 (0.02%) |
0/5705 (0.00%) |
0/5687 (0.00%) |
Cardiomyopathy |
3/5724 (0.05%) |
4/5705 (0.07%) |
3/5687 (0.05%) |
Cardiomyopathy alcoholic |
1/5724 (0.02%) |
1/5705 (0.02%) |
0/5687 (0.00%) |
Cardiopulmonary failure |
9/5724 (0.16%) |
11/5705 (0.19%) |
9/5687 (0.16%) |
Cardiovascular disorder |
0/5724 (0.00%) |
1/5705 (0.02%) |
0/5687 (0.00%) |
Congestive cardiomyopathy |
1/5724 (0.02%) |
3/5705 (0.05%) |
1/5687 (0.02%) |
Cor pulmonale |
4/5724 (0.07%) |
4/5705 (0.07%) |
6/5687 (0.11%) |
Cor pulmonale acute |
1/5724 (0.02%) |
0/5705 (0.00%) |
1/5687 (0.02%) |
Cor pulmonale chronic |
3/5724 (0.05%) |
2/5705 (0.04%) |
4/5687 (0.07%) |
Coronary artery disease |
18/5724 (0.31%) |
25/5705 (0.44%) |
23/5687 (0.40%) |
Coronary artery insufficiency |
2/5724 (0.03%) |
1/5705 (0.02%) |
1/5687 (0.02%) |
Coronary artery occlusion |
2/5724 (0.03%) |
2/5705 (0.04%) |
2/5687 (0.04%) |
Coronary artery stenosis |
6/5724 (0.10%) |
2/5705 (0.04%) |
3/5687 (0.05%) |
Diastolic dysfunction |
0/5724 (0.00%) |
0/5705 (0.00%) |
1/5687 (0.02%) |
Hypertensive heart disease |
1/5724 (0.02%) |
0/5705 (0.00%) |
0/5687 (0.00%) |
Ischaemic cardiomyopathy |
1/5724 (0.02%) |
1/5705 (0.02%) |
4/5687 (0.07%) |
Left ventricular dysfunction |
0/5724 (0.00%) |
0/5705 (0.00%) |
1/5687 (0.02%) |
Left ventricular failure |
2/5724 (0.03%) |
2/5705 (0.04%) |
1/5687 (0.02%) |
Mitral valve incompetence |
0/5724 (0.00%) |
0/5705 (0.00%) |
1/5687 (0.02%) |
Myocardial infarction |
53/5724 (0.93%) |
45/5705 (0.79%) |
39/5687 (0.69%) |
Myocardial ischaemia |
7/5724 (0.12%) |
7/5705 (0.12%) |
11/5687 (0.19%) |
Palpitations |
1/5724 (0.02%) |
1/5705 (0.02%) |
0/5687 (0.00%) |
Pericardial effusion |
2/5724 (0.03%) |
1/5705 (0.02%) |
2/5687 (0.04%) |
Pericarditis |
1/5724 (0.02%) |
1/5705 (0.02%) |
2/5687 (0.04%) |
Postinfarction angina |
0/5724 (0.00%) |
0/5705 (0.00%) |
1/5687 (0.02%) |
Prinzmetal angina |
0/5724 (0.00%) |
1/5705 (0.02%) |
0/5687 (0.00%) |
Right ventricular failure |
2/5724 (0.03%) |
2/5705 (0.04%) |
1/5687 (0.02%) |
Sick sinus syndrome |
0/5724 (0.00%) |
2/5705 (0.04%) |
1/5687 (0.02%) |
Silent myocardial infarction |
0/5724 (0.00%) |
1/5705 (0.02%) |
0/5687 (0.00%) |
Sinus bradycardia |
1/5724 (0.02%) |
0/5705 (0.00%) |
1/5687 (0.02%) |
Stress cardiomyopathy |
0/5724 (0.00%) |
0/5705 (0.00%) |
1/5687 (0.02%) |
Supraventricular extrasystoles |
0/5724 (0.00%) |
1/5705 (0.02%) |
1/5687 (0.02%) |
Supraventricular tachycardia |
1/5724 (0.02%) |
3/5705 (0.05%) |
6/5687 (0.11%) |
Tachyarrhythmia |
0/5724 (0.00%) |
2/5705 (0.04%) |
1/5687 (0.02%) |
Tachycardia |
3/5724 (0.05%) |
2/5705 (0.04%) |
2/5687 (0.04%) |
Ventricular arrhythmia |
0/5724 (0.00%) |
2/5705 (0.04%) |
0/5687 (0.00%) |
Ventricular dysfunction |
1/5724 (0.02%) |
0/5705 (0.00%) |
1/5687 (0.02%) |
Ventricular extrasystoles |
1/5724 (0.02%) |
1/5705 (0.02%) |
1/5687 (0.02%) |
Ventricular fibrillation |
3/5724 (0.05%) |
2/5705 (0.04%) |
1/5687 (0.02%) |
Ventricular tachycardia |
1/5724 (0.02%) |
2/5705 (0.04%) |
3/5687 (0.05%) |
Congenital, familial and genetic disorders |
|
|
|
Alpha-1 anti-trypsin deficiency |
0/5724 (0.00%) |
0/5705 (0.00%) |
1/5687 (0.02%) |
Congenital absence of bile ducts |
1/5724 (0.02%) |
0/5705 (0.00%) |
0/5687 (0.00%) |
Hamartoma |
1/5724 (0.02%) |
0/5705 (0.00%) |
0/5687 (0.00%) |
Hydrocele |
0/5724 (0.00%) |
2/5705 (0.04%) |
0/5687 (0.00%) |
Ear and labyrinth disorders |
|
|
|
Deafness |
0/5724 (0.00%) |
1/5705 (0.02%) |
0/5687 (0.00%) |
Hypoacusis |
1/5724 (0.02%) |
0/5705 (0.00%) |
0/5687 (0.00%) |
Vertigo |
6/5724 (0.10%) |
1/5705 (0.02%) |
2/5687 (0.04%) |
Endocrine disorders |
|
|
|
Adrenal mass |
1/5724 (0.02%) |
0/5705 (0.00%) |
1/5687 (0.02%) |
Goitre |
1/5724 (0.02%) |
2/5705 (0.04%) |
1/5687 (0.02%) |
Hyperthyroidism |
1/5724 (0.02%) |
0/5705 (0.00%) |
0/5687 (0.00%) |
Hypothyroidism |
0/5724 (0.00%) |
1/5705 (0.02%) |
0/5687 (0.00%) |
Inappropriate antidiuretic hormone secretion |
2/5724 (0.03%) |
0/5705 (0.00%) |
2/5687 (0.04%) |
Thyroid mass |
1/5724 (0.02%) |
0/5705 (0.00%) |
0/5687 (0.00%) |
Eye disorders |
|
|
|
Amaurosis |
0/5724 (0.00%) |
1/5705 (0.02%) |
0/5687 (0.00%) |
Amaurosis fugax |
1/5724 (0.02%) |
0/5705 (0.00%) |
0/5687 (0.00%) |
Cataract |
13/5724 (0.23%) |
10/5705 (0.18%) |
14/5687 (0.25%) |
Cataract subcapsular |
0/5724 (0.00%) |
1/5705 (0.02%) |
0/5687 (0.00%) |
Eyelid ptosis |
0/5724 (0.00%) |
1/5705 (0.02%) |
0/5687 (0.00%) |
Glaucoma |
0/5724 (0.00%) |
1/5705 (0.02%) |
1/5687 (0.02%) |
Lens dislocation |
0/5724 (0.00%) |
0/5705 (0.00%) |
1/5687 (0.02%) |
Macular degeneration |
1/5724 (0.02%) |
1/5705 (0.02%) |
0/5687 (0.00%) |
Open angle glaucoma |
0/5724 (0.00%) |
1/5705 (0.02%) |
0/5687 (0.00%) |
Retinal detachment |
0/5724 (0.00%) |
3/5705 (0.05%) |
2/5687 (0.04%) |
Retinal haemorrhage |
0/5724 (0.00%) |
0/5705 (0.00%) |
1/5687 (0.02%) |
Retinal infarction |
1/5724 (0.02%) |
0/5705 (0.00%) |
0/5687 (0.00%) |
Strabismus |
0/5724 (0.00%) |
1/5705 (0.02%) |
0/5687 (0.00%) |
Ulcerative keratitis |
0/5724 (0.00%) |
0/5705 (0.00%) |
1/5687 (0.02%) |
Vitreous haemorrhage |
0/5724 (0.00%) |
1/5705 (0.02%) |
0/5687 (0.00%) |
Gastrointestinal disorders |
|
|
|
Abdominal adhesions |
1/5724 (0.02%) |
0/5705 (0.00%) |
0/5687 (0.00%) |
Abdominal distension |
2/5724 (0.03%) |
1/5705 (0.02%) |
0/5687 (0.00%) |
Abdominal hernia |
1/5724 (0.02%) |
3/5705 (0.05%) |
3/5687 (0.05%) |
Abdominal hernia obstructive |
0/5724 (0.00%) |
1/5705 (0.02%) |
0/5687 (0.00%) |
Abdominal pain |
4/5724 (0.07%) |
13/5705 (0.23%) |
4/5687 (0.07%) |
Abdominal pain upper |
0/5724 (0.00%) |
1/5705 (0.02%) |
0/5687 (0.00%) |
Abdominal wall haematoma |
2/5724 (0.03%) |
0/5705 (0.00%) |
1/5687 (0.02%) |
Acute abdomen |
0/5724 (0.00%) |
0/5705 (0.00%) |
1/5687 (0.02%) |
Anal fistula |
1/5724 (0.02%) |
0/5705 (0.00%) |
2/5687 (0.04%) |
Barrett's oesophagus |
0/5724 (0.00%) |
0/5705 (0.00%) |
1/5687 (0.02%) |
Colitis |
4/5724 (0.07%) |
0/5705 (0.00%) |
2/5687 (0.04%) |
Colitis ischaemic |
1/5724 (0.02%) |
2/5705 (0.04%) |
2/5687 (0.04%) |
Colitis ulcerative |
0/5724 (0.00%) |
0/5705 (0.00%) |
1/5687 (0.02%) |
Colonic fistula |
1/5724 (0.02%) |
0/5705 (0.00%) |
0/5687 (0.00%) |
Colonic stenosis |
0/5724 (0.00%) |
1/5705 (0.02%) |
0/5687 (0.00%) |
Constipation |
3/5724 (0.05%) |
3/5705 (0.05%) |
4/5687 (0.07%) |
Crohn's disease |
3/5724 (0.05%) |
2/5705 (0.04%) |
0/5687 (0.00%) |
Dental caries |
0/5724 (0.00%) |
0/5705 (0.00%) |
1/5687 (0.02%) |
Diarrhoea |
7/5724 (0.12%) |
4/5705 (0.07%) |
7/5687 (0.12%) |
Diverticular perforation |
1/5724 (0.02%) |
1/5705 (0.02%) |
0/5687 (0.00%) |
Diverticulum |
2/5724 (0.03%) |
1/5705 (0.02%) |
2/5687 (0.04%) |
Diverticulum intestinal |
1/5724 (0.02%) |
0/5705 (0.00%) |
2/5687 (0.04%) |
Diverticulum intestinal haemorrhagic |
1/5724 (0.02%) |
1/5705 (0.02%) |
0/5687 (0.00%) |
Duodenal scarring |
1/5724 (0.02%) |
0/5705 (0.00%) |
0/5687 (0.00%) |
Duodenal stenosis |
1/5724 (0.02%) |
0/5705 (0.00%) |
0/5687 (0.00%) |
Duodenal ulcer |
6/5724 (0.10%) |
2/5705 (0.04%) |
2/5687 (0.04%) |
Duodenal ulcer haemorrhage |
2/5724 (0.03%) |
2/5705 (0.04%) |
3/5687 (0.05%) |
Duodenal ulcer perforation |
0/5724 (0.00%) |
1/5705 (0.02%) |
0/5687 (0.00%) |
Duodenitis |
0/5724 (0.00%) |
0/5705 (0.00%) |
1/5687 (0.02%) |
Duodenogastric reflux |
0/5724 (0.00%) |
1/5705 (0.02%) |
0/5687 (0.00%) |
Dyspepsia |
1/5724 (0.02%) |
1/5705 (0.02%) |
1/5687 (0.02%) |
Dysphagia |
2/5724 (0.03%) |
3/5705 (0.05%) |
2/5687 (0.04%) |
Enteritis |
0/5724 (0.00%) |
1/5705 (0.02%) |
0/5687 (0.00%) |
Enterocolitis |
0/5724 (0.00%) |
0/5705 (0.00%) |
1/5687 (0.02%) |
Enterocutaneous fistula |
1/5724 (0.02%) |
1/5705 (0.02%) |
0/5687 (0.00%) |
Epiploic appendagitis |
0/5724 (0.00%) |
1/5705 (0.02%) |
0/5687 (0.00%) |
Faecaloma |
1/5724 (0.02%) |
0/5705 (0.00%) |
0/5687 (0.00%) |
Femoral hernia |
0/5724 (0.00%) |
0/5705 (0.00%) |
1/5687 (0.02%) |
Food poisoning |
1/5724 (0.02%) |
3/5705 (0.05%) |
0/5687 (0.00%) |
Gastric haemorrhage |
2/5724 (0.03%) |
1/5705 (0.02%) |
0/5687 (0.00%) |
Gastric polyps |
0/5724 (0.00%) |
1/5705 (0.02%) |
1/5687 (0.02%) |
Gastric ulcer |
4/5724 (0.07%) |
1/5705 (0.02%) |
4/5687 (0.07%) |
Gastric ulcer haemorrhage |
0/5724 (0.00%) |
0/5705 (0.00%) |
1/5687 (0.02%) |
Gastritis |
7/5724 (0.12%) |
6/5705 (0.11%) |
4/5687 (0.07%) |
Gastritis atrophic |
0/5724 (0.00%) |
0/5705 (0.00%) |
1/5687 (0.02%) |
Gastritis erosive |
0/5724 (0.00%) |
3/5705 (0.05%) |
1/5687 (0.02%) |
Gastritis haemorrhagic |
2/5724 (0.03%) |
0/5705 (0.00%) |
1/5687 (0.02%) |
Gastroduodenal ulcer |
0/5724 (0.00%) |
1/5705 (0.02%) |
0/5687 (0.00%) |
Gastroduodenitis |
2/5724 (0.03%) |
0/5705 (0.00%) |
0/5687 (0.00%) |
Gastrointestinal angiodysplasia |
1/5724 (0.02%) |
0/5705 (0.00%) |
0/5687 (0.00%) |
Gastrointestinal haemorrhage |
11/5724 (0.19%) |
12/5705 (0.21%) |
8/5687 (0.14%) |
Gastrointestinal inflammation |
1/5724 (0.02%) |
0/5705 (0.00%) |
1/5687 (0.02%) |
Gastrointestinal necrosis |
0/5724 (0.00%) |
0/5705 (0.00%) |
1/5687 (0.02%) |
Gastrooesophageal reflux disease |
7/5724 (0.12%) |
3/5705 (0.05%) |
3/5687 (0.05%) |
Gastrooesophagitis |
0/5724 (0.00%) |
0/5705 (0.00%) |
1/5687 (0.02%) |
Haematemesis |
1/5724 (0.02%) |
2/5705 (0.04%) |
0/5687 (0.00%) |
Haematochezia |
1/5724 (0.02%) |
3/5705 (0.05%) |
0/5687 (0.00%) |
Haemorrhoidal haemorrhage |
0/5724 (0.00%) |
1/5705 (0.02%) |
0/5687 (0.00%) |
Haemorrhoids |
3/5724 (0.05%) |
0/5705 (0.00%) |
3/5687 (0.05%) |
Hiatus hernia |
2/5724 (0.03%) |
2/5705 (0.04%) |
3/5687 (0.05%) |
Ileus |
2/5724 (0.03%) |
3/5705 (0.05%) |
8/5687 (0.14%) |
Ileus paralytic |
2/5724 (0.03%) |
0/5705 (0.00%) |
1/5687 (0.02%) |
Impaired gastric emptying |
0/5724 (0.00%) |
1/5705 (0.02%) |
0/5687 (0.00%) |
Inguinal hernia |
10/5724 (0.17%) |
16/5705 (0.28%) |
15/5687 (0.26%) |
Inguinal hernia, obstructive |
1/5724 (0.02%) |
0/5705 (0.00%) |
0/5687 (0.00%) |
Intestinal haemorrhage |
0/5724 (0.00%) |
0/5705 (0.00%) |
1/5687 (0.02%) |
Intestinal ischaemia |
0/5724 (0.00%) |
3/5705 (0.05%) |
0/5687 (0.00%) |
Intestinal mass |
0/5724 (0.00%) |
2/5705 (0.04%) |
0/5687 (0.00%) |
Intestinal obstruction |
9/5724 (0.16%) |
6/5705 (0.11%) |
7/5687 (0.12%) |
Intestinal perforation |
1/5724 (0.02%) |
1/5705 (0.02%) |
1/5687 (0.02%) |
Intestinal polyp |
0/5724 (0.00%) |
0/5705 (0.00%) |
1/5687 (0.02%) |
Irritable bowel syndrome |
1/5724 (0.02%) |
1/5705 (0.02%) |
1/5687 (0.02%) |
Jejunal ulcer |
1/5724 (0.02%) |
0/5705 (0.00%) |
0/5687 (0.00%) |
Large intestinal obstruction |
1/5724 (0.02%) |
0/5705 (0.00%) |
0/5687 (0.00%) |
Large intestine perforation |
1/5724 (0.02%) |
1/5705 (0.02%) |
1/5687 (0.02%) |
Large intestine polyp |
3/5724 (0.05%) |
0/5705 (0.00%) |
2/5687 (0.04%) |
Lower gastrointestinal haemorrhage |
0/5724 (0.00%) |
1/5705 (0.02%) |
1/5687 (0.02%) |
Lumbar hernia |
1/5724 (0.02%) |
0/5705 (0.00%) |
0/5687 (0.00%) |
Malabsorption |
0/5724 (0.00%) |
0/5705 (0.00%) |
1/5687 (0.02%) |
Mallory-Weiss syndrome |
0/5724 (0.00%) |
1/5705 (0.02%) |
1/5687 (0.02%) |
Mechanical ileus |
0/5724 (0.00%) |
1/5705 (0.02%) |
0/5687 (0.00%) |
Megacolon |
0/5724 (0.00%) |
1/5705 (0.02%) |
0/5687 (0.00%) |
Melaena |
3/5724 (0.05%) |
2/5705 (0.04%) |
3/5687 (0.05%) |
Mesenteric artery thrombosis |
1/5724 (0.02%) |
0/5705 (0.00%) |
0/5687 (0.00%) |
Mouth haemorrhage |
0/5724 (0.00%) |
1/5705 (0.02%) |
0/5687 (0.00%) |
Mouth ulceration |
0/5724 (0.00%) |
1/5705 (0.02%) |
0/5687 (0.00%) |
Nausea |
2/5724 (0.03%) |
2/5705 (0.04%) |
6/5687 (0.11%) |
Obstruction gastric |
0/5724 (0.00%) |
0/5705 (0.00%) |
1/5687 (0.02%) |
Oesophageal food impaction |
1/5724 (0.02%) |
0/5705 (0.00%) |
0/5687 (0.00%) |
Oesophageal perforation |
1/5724 (0.02%) |
0/5705 (0.00%) |
0/5687 (0.00%) |
Oesophageal stenosis |
1/5724 (0.02%) |
0/5705 (0.00%) |
1/5687 (0.02%) |
Oesophageal ulcer |
0/5724 (0.00%) |
0/5705 (0.00%) |
1/5687 (0.02%) |
Oesophagitis |
0/5724 (0.00%) |
2/5705 (0.04%) |
1/5687 (0.02%) |
Oesophagitis ulcerative |
1/5724 (0.02%) |
0/5705 (0.00%) |
0/5687 (0.00%) |
Pancreatic cyst |
0/5724 (0.00%) |
1/5705 (0.02%) |
0/5687 (0.00%) |
Pancreatitis |
9/5724 (0.16%) |
3/5705 (0.05%) |
4/5687 (0.07%) |
Pancreatitis acute |
5/5724 (0.09%) |
3/5705 (0.05%) |
4/5687 (0.07%) |
Pancreatitis chronic |
4/5724 (0.07%) |
1/5705 (0.02%) |
1/5687 (0.02%) |
Pancreatitis necrotising |
0/5724 (0.00%) |
1/5705 (0.02%) |
0/5687 (0.00%) |
Pancreatolithiasis |
1/5724 (0.02%) |
0/5705 (0.00%) |
0/5687 (0.00%) |
Papilla of Vater stenosis |
0/5724 (0.00%) |
1/5705 (0.02%) |
0/5687 (0.00%) |
Parotid gland enlargement |
0/5724 (0.00%) |
1/5705 (0.02%) |
0/5687 (0.00%) |
Peptic ulcer |
0/5724 (0.00%) |
0/5705 (0.00%) |
1/5687 (0.02%) |
Peptic ulcer haemorrhage |
1/5724 (0.02%) |
0/5705 (0.00%) |
0/5687 (0.00%) |
Peptic ulcer perforation |
1/5724 (0.02%) |
0/5705 (0.00%) |
0/5687 (0.00%) |
Pharyngo-oesophageal diverticulum |
0/5724 (0.00%) |
0/5705 (0.00%) |
1/5687 (0.02%) |
Proctalgia |
0/5724 (0.00%) |
0/5705 (0.00%) |
1/5687 (0.02%) |
Proctocolitis |
0/5724 (0.00%) |
1/5705 (0.02%) |
0/5687 (0.00%) |
Rectal haemorrhage |
1/5724 (0.02%) |
5/5705 (0.09%) |
2/5687 (0.04%) |
Rectal prolapse |
0/5724 (0.00%) |
1/5705 (0.02%) |
0/5687 (0.00%) |
Reflux gastritis |
1/5724 (0.02%) |
0/5705 (0.00%) |
0/5687 (0.00%) |
Retching |
1/5724 (0.02%) |
0/5705 (0.00%) |
0/5687 (0.00%) |
Retroperitoneal haemorrhage |
0/5724 (0.00%) |
1/5705 (0.02%) |
0/5687 (0.00%) |
Retroperitoneal mass |
1/5724 (0.02%) |
0/5705 (0.00%) |
0/5687 (0.00%) |
Small intestinal obstruction |
6/5724 (0.10%) |
7/5705 (0.12%) |
4/5687 (0.07%) |
Stomatitis |
0/5724 (0.00%) |
1/5705 (0.02%) |
0/5687 (0.00%) |
Subileus |
0/5724 (0.00%) |
2/5705 (0.04%) |
1/5687 (0.02%) |
Umbilical hernia |
5/5724 (0.09%) |
1/5705 (0.02%) |
2/5687 (0.04%) |
Umbilical hernia, obstructive |
0/5724 (0.00%) |
0/5705 (0.00%) |
1/5687 (0.02%) |
Upper gastrointestinal haemorrhage |
5/5724 (0.09%) |
3/5705 (0.05%) |
3/5687 (0.05%) |
Volvulus |
0/5724 (0.00%) |
1/5705 (0.02%) |
1/5687 (0.02%) |
Vomiting |
4/5724 (0.07%) |
3/5705 (0.05%) |
3/5687 (0.05%) |
General disorders |
|
|
|
Adverse drug reaction |
2/5724 (0.03%) |
1/5705 (0.02%) |
3/5687 (0.05%) |
Asthenia |
8/5724 (0.14%) |
3/5705 (0.05%) |
3/5687 (0.05%) |
Cardiac death |
1/5724 (0.02%) |
0/5705 (0.00%) |
2/5687 (0.04%) |
Chest discomfort |
1/5724 (0.02%) |
3/5705 (0.05%) |
3/5687 (0.05%) |
Chest pain |
4/5724 (0.07%) |
8/5705 (0.14%) |
6/5687 (0.11%) |
Condition aggravated |
0/5724 (0.00%) |
1/5705 (0.02%) |
0/5687 (0.00%) |
Cyst |
0/5724 (0.00%) |
0/5705 (0.00%) |
1/5687 (0.02%) |
Death |
28/5724 (0.49%) |
21/5705 (0.37%) |
13/5687 (0.23%) |
Device dislocation |
0/5724 (0.00%) |
2/5705 (0.04%) |
0/5687 (0.00%) |
Device failure |
0/5724 (0.00%) |
0/5705 (0.00%) |
1/5687 (0.02%) |
Device lead damage |
0/5724 (0.00%) |
0/5705 (0.00%) |
1/5687 (0.02%) |
Device malfunction |
0/5724 (0.00%) |
0/5705 (0.00%) |
2/5687 (0.04%) |
Device occlusion |
1/5724 (0.02%) |
0/5705 (0.00%) |
0/5687 (0.00%) |
Drowning |
0/5724 (0.00%) |
0/5705 (0.00%) |
1/5687 (0.02%) |
Drug withdrawal syndrome |
1/5724 (0.02%) |
0/5705 (0.00%) |
1/5687 (0.02%) |
Effusion |
0/5724 (0.00%) |
0/5705 (0.00%) |
1/5687 (0.02%) |
Exercise tolerance decreased |
0/5724 (0.00%) |
0/5705 (0.00%) |
1/5687 (0.02%) |
Fibrosis |
0/5724 (0.00%) |
1/5705 (0.02%) |
0/5687 (0.00%) |
General physical health deterioration |
1/5724 (0.02%) |
2/5705 (0.04%) |
1/5687 (0.02%) |
Hernia |
3/5724 (0.05%) |
3/5705 (0.05%) |
4/5687 (0.07%) |
Hernia obstructive |
0/5724 (0.00%) |
1/5705 (0.02%) |
0/5687 (0.00%) |
Hyperthermia |
0/5724 (0.00%) |
0/5705 (0.00%) |
1/5687 (0.02%) |
Impaired healing |
0/5724 (0.00%) |
1/5705 (0.02%) |
0/5687 (0.00%) |
Implant site calcification |
0/5724 (0.00%) |
1/5705 (0.02%) |
0/5687 (0.00%) |
Implant site inflammation |
0/5724 (0.00%) |
0/5705 (0.00%) |
1/5687 (0.02%) |
Malaise |
1/5724 (0.02%) |
0/5705 (0.00%) |
1/5687 (0.02%) |
Mass |
1/5724 (0.02%) |
0/5705 (0.00%) |
0/5687 (0.00%) |
Multi-organ disorder |
1/5724 (0.02%) |
0/5705 (0.00%) |
0/5687 (0.00%) |
Multi-organ failure |
2/5724 (0.03%) |
3/5705 (0.05%) |
7/5687 (0.12%) |
Necrosis |
2/5724 (0.03%) |
0/5705 (0.00%) |
0/5687 (0.00%) |
Non-cardiac chest pain |
19/5724 (0.33%) |
23/5705 (0.40%) |
22/5687 (0.39%) |
Oedema |
0/5724 (0.00%) |
1/5705 (0.02%) |
2/5687 (0.04%) |
Oedema peripheral |
2/5724 (0.03%) |
0/5705 (0.00%) |
5/5687 (0.09%) |
Polyp |
1/5724 (0.02%) |
0/5705 (0.00%) |
0/5687 (0.00%) |
Pyrexia |
1/5724 (0.02%) |
3/5705 (0.05%) |
5/5687 (0.09%) |
Spinal pain |
0/5724 (0.00%) |
0/5705 (0.00%) |
2/5687 (0.04%) |
Sudden cardiac death |
3/5724 (0.05%) |
9/5705 (0.16%) |
6/5687 (0.11%) |
Sudden death |
27/5724 (0.47%) |
13/5705 (0.23%) |
18/5687 (0.32%) |
Systemic inflammatory response syndrome |
0/5724 (0.00%) |
1/5705 (0.02%) |
0/5687 (0.00%) |
Ulcer haemorrhage |
1/5724 (0.02%) |
0/5705 (0.00%) |
0/5687 (0.00%) |
Vessel puncture site haemorrhage |
0/5724 (0.00%) |
1/5705 (0.02%) |
0/5687 (0.00%) |
Hepatobiliary disorders |
|
|
|
Alcoholic liver disease |
0/5724 (0.00%) |
0/5705 (0.00%) |
1/5687 (0.02%) |
Bile duct obstruction |
3/5724 (0.05%) |
0/5705 (0.00%) |
0/5687 (0.00%) |
Bile duct stone |
3/5724 (0.05%) |
2/5705 (0.04%) |
0/5687 (0.00%) |
Biliary colic |
0/5724 (0.00%) |
1/5705 (0.02%) |
0/5687 (0.00%) |
Biliary cyst |
0/5724 (0.00%) |
0/5705 (0.00%) |
1/5687 (0.02%) |
Biliary dyskinesia |
1/5724 (0.02%) |
0/5705 (0.00%) |
0/5687 (0.00%) |
Cholangitis |
2/5724 (0.03%) |
1/5705 (0.02%) |
0/5687 (0.00%) |
Cholecystitis |
11/5724 (0.19%) |
7/5705 (0.12%) |
6/5687 (0.11%) |
Cholecystitis acute |
10/5724 (0.17%) |
2/5705 (0.04%) |
10/5687 (0.18%) |
Cholecystitis chronic |
1/5724 (0.02%) |
1/5705 (0.02%) |
1/5687 (0.02%) |
Cholelithiasis |
12/5724 (0.21%) |
12/5705 (0.21%) |
4/5687 (0.07%) |
Gallbladder perforation |
1/5724 (0.02%) |
0/5705 (0.00%) |
0/5687 (0.00%) |
Hepatic cirrhosis |
1/5724 (0.02%) |
0/5705 (0.00%) |
2/5687 (0.04%) |
Hepatic congestion |
1/5724 (0.02%) |
0/5705 (0.00%) |
0/5687 (0.00%) |
Hepatic failure |
2/5724 (0.03%) |
0/5705 (0.00%) |
1/5687 (0.02%) |
Hepatic ischaemia |
0/5724 (0.00%) |
0/5705 (0.00%) |
1/5687 (0.02%) |
Hepatic mass |
0/5724 (0.00%) |
2/5705 (0.04%) |
0/5687 (0.00%) |
Hepatitis |
0/5724 (0.00%) |
1/5705 (0.02%) |
0/5687 (0.00%) |
Hepatitis acute |
2/5724 (0.03%) |
0/5705 (0.00%) |
0/5687 (0.00%) |
Hepatorenal syndrome |
0/5724 (0.00%) |
0/5705 (0.00%) |
1/5687 (0.02%) |
Liver disorder |
0/5724 (0.00%) |
1/5705 (0.02%) |
0/5687 (0.00%) |
Non-alcoholic steatohepatitis |
1/5724 (0.02%) |
0/5705 (0.00%) |
0/5687 (0.00%) |
Immune system disorders |
|
|
|
Amyloidosis |
0/5724 (0.00%) |
1/5705 (0.02%) |
0/5687 (0.00%) |
Anaphylactic reaction |
2/5724 (0.03%) |
1/5705 (0.02%) |
0/5687 (0.00%) |
Anaphylactic shock |
0/5724 (0.00%) |
0/5705 (0.00%) |
1/5687 (0.02%) |
Autoimmune disorder |
1/5724 (0.02%) |
0/5705 (0.00%) |
0/5687 (0.00%) |
Drug hypersensitivity |
0/5724 (0.00%) |
1/5705 (0.02%) |
1/5687 (0.02%) |
Food allergy |
0/5724 (0.00%) |
0/5705 (0.00%) |
1/5687 (0.02%) |
Hypersensitivity |
2/5724 (0.03%) |
2/5705 (0.04%) |
1/5687 (0.02%) |
Infections and infestations |
|
|
|
Abdominal abscess |
0/5724 (0.00%) |
1/5705 (0.02%) |
0/5687 (0.00%) |
Abdominal sepsis |
1/5724 (0.02%) |
0/5705 (0.00%) |
0/5687 (0.00%) |
Abscess |
0/5724 (0.00%) |
2/5705 (0.04%) |
0/5687 (0.00%) |
Abscess intestinal |
1/5724 (0.02%) |
1/5705 (0.02%) |
0/5687 (0.00%) |
Abscess limb |
0/5724 (0.00%) |
1/5705 (0.02%) |
3/5687 (0.05%) |
Abscess neck |
1/5724 (0.02%) |
0/5705 (0.00%) |
0/5687 (0.00%) |
Acinetobacter infection |
1/5724 (0.02%) |
0/5705 (0.00%) |
0/5687 (0.00%) |
Acute sinusitis |
0/5724 (0.00%) |
0/5705 (0.00%) |
2/5687 (0.04%) |
Amoebic dysentery |
0/5724 (0.00%) |
1/5705 (0.02%) |
0/5687 (0.00%) |
Anal abscess |
1/5724 (0.02%) |
1/5705 (0.02%) |
0/5687 (0.00%) |
Anal infection |
0/5724 (0.00%) |
0/5705 (0.00%) |
1/5687 (0.02%) |
Appendiceal abscess |
1/5724 (0.02%) |
0/5705 (0.00%) |
0/5687 (0.00%) |
Appendicitis |
7/5724 (0.12%) |
6/5705 (0.11%) |
7/5687 (0.12%) |
Appendicitis perforated |
3/5724 (0.05%) |
2/5705 (0.04%) |
2/5687 (0.04%) |
Arthritis bacterial |
2/5724 (0.03%) |
0/5705 (0.00%) |
0/5687 (0.00%) |
Arthritis infective |
2/5724 (0.03%) |
0/5705 (0.00%) |
1/5687 (0.02%) |
Atypical mycobacterial infection |
1/5724 (0.02%) |
0/5705 (0.00%) |
0/5687 (0.00%) |
Atypical pneumonia |
0/5724 (0.00%) |
1/5705 (0.02%) |
0/5687 (0.00%) |
Bacteraemia |
1/5724 (0.02%) |
1/5705 (0.02%) |
0/5687 (0.00%) |
Bacterial infection |
1/5724 (0.02%) |
0/5705 (0.00%) |
0/5687 (0.00%) |
Bacterial toxaemia |
0/5724 (0.00%) |
0/5705 (0.00%) |
1/5687 (0.02%) |
Bronchitis |
16/5724 (0.28%) |
9/5705 (0.16%) |
11/5687 (0.19%) |
Bronchitis bacterial |
1/5724 (0.02%) |
0/5705 (0.00%) |
0/5687 (0.00%) |
Bronchopneumonia |
4/5724 (0.07%) |
3/5705 (0.05%) |
4/5687 (0.07%) |
Bursitis infective |
0/5724 (0.00%) |
2/5705 (0.04%) |
0/5687 (0.00%) |
Campylobacter gastroenteritis |
0/5724 (0.00%) |
0/5705 (0.00%) |
1/5687 (0.02%) |
Campylobacter infection |
0/5724 (0.00%) |
1/5705 (0.02%) |
0/5687 (0.00%) |
Cellulitis |
6/5724 (0.10%) |
14/5705 (0.25%) |
14/5687 (0.25%) |
Cellulitis of male external genital organ |
0/5724 (0.00%) |
1/5705 (0.02%) |
0/5687 (0.00%) |
Cholecystitis infective |
0/5724 (0.00%) |
1/5705 (0.02%) |
0/5687 (0.00%) |
Chronic hepatitis C |
0/5724 (0.00%) |
1/5705 (0.02%) |
0/5687 (0.00%) |
Chronic sinusitis |
0/5724 (0.00%) |
1/5705 (0.02%) |
3/5687 (0.05%) |
Clostridium colitis |
0/5724 (0.00%) |
1/5705 (0.02%) |
0/5687 (0.00%) |
Clostridium difficile colitis |
2/5724 (0.03%) |
3/5705 (0.05%) |
2/5687 (0.04%) |
Clostridium difficile infection |
3/5724 (0.05%) |
2/5705 (0.04%) |
0/5687 (0.00%) |
Colon gangrene |
0/5724 (0.00%) |
0/5705 (0.00%) |
1/5687 (0.02%) |
Cystitis |
2/5724 (0.03%) |
3/5705 (0.05%) |
4/5687 (0.07%) |
Dengue fever |
0/5724 (0.00%) |
1/5705 (0.02%) |
0/5687 (0.00%) |
Device related infection |
1/5724 (0.02%) |
1/5705 (0.02%) |
1/5687 (0.02%) |
Diarrhoea infectious |
1/5724 (0.02%) |
0/5705 (0.00%) |
0/5687 (0.00%) |
Diverticulitis |
9/5724 (0.16%) |
6/5705 (0.11%) |
6/5687 (0.11%) |
Ear infection |
1/5724 (0.02%) |
0/5705 (0.00%) |
0/5687 (0.00%) |
Eczema infected |
0/5724 (0.00%) |
1/5705 (0.02%) |
0/5687 (0.00%) |
Empyema |
0/5724 (0.00%) |
1/5705 (0.02%) |
3/5687 (0.05%) |
Endocarditis |
0/5724 (0.00%) |
3/5705 (0.05%) |
3/5687 (0.05%) |
Endophthalmitis |
1/5724 (0.02%) |
0/5705 (0.00%) |
1/5687 (0.02%) |
Enterobacter pneumonia |
0/5724 (0.00%) |
1/5705 (0.02%) |
0/5687 (0.00%) |
Enterococcal sepsis |
0/5724 (0.00%) |
1/5705 (0.02%) |
0/5687 (0.00%) |
Enterocolitis infectious |
0/5724 (0.00%) |
1/5705 (0.02%) |
1/5687 (0.02%) |
Enterocolitis viral |
0/5724 (0.00%) |
1/5705 (0.02%) |
0/5687 (0.00%) |
Erysipelas |
2/5724 (0.03%) |
2/5705 (0.04%) |
3/5687 (0.05%) |
Eye infection |
0/5724 (0.00%) |
1/5705 (0.02%) |
0/5687 (0.00%) |
Febrile infection |
0/5724 (0.00%) |
0/5705 (0.00%) |
1/5687 (0.02%) |
Fungal infection |
2/5724 (0.03%) |
0/5705 (0.00%) |
1/5687 (0.02%) |
Gallbladder empyema |
1/5724 (0.02%) |
0/5705 (0.00%) |
0/5687 (0.00%) |
Gangrene |
0/5724 (0.00%) |
2/5705 (0.04%) |
1/5687 (0.02%) |
Gastritis viral |
0/5724 (0.00%) |
1/5705 (0.02%) |
0/5687 (0.00%) |
Gastroenteritis |
11/5724 (0.19%) |
5/5705 (0.09%) |
8/5687 (0.14%) |
Gastroenteritis bacterial |
0/5724 (0.00%) |
0/5705 (0.00%) |
1/5687 (0.02%) |
Gastroenteritis clostridial |
0/5724 (0.00%) |
0/5705 (0.00%) |
1/5687 (0.02%) |
Gastroenteritis norovirus |
0/5724 (0.00%) |
1/5705 (0.02%) |
0/5687 (0.00%) |
Gastroenteritis salmonella |
0/5724 (0.00%) |
1/5705 (0.02%) |
0/5687 (0.00%) |
Gastroenteritis viral |
2/5724 (0.03%) |
1/5705 (0.02%) |
0/5687 (0.00%) |
Groin abscess |
2/5724 (0.03%) |
0/5705 (0.00%) |
0/5687 (0.00%) |
Groin infection |
0/5724 (0.00%) |
1/5705 (0.02%) |
0/5687 (0.00%) |
H1N1 influenza |
1/5724 (0.02%) |
0/5705 (0.00%) |
0/5687 (0.00%) |
Haematoma infection |
0/5724 (0.00%) |
1/5705 (0.02%) |
0/5687 (0.00%) |
Helicobacter gastritis |
1/5724 (0.02%) |
0/5705 (0.00%) |
0/5687 (0.00%) |
Helicobacter infection |
0/5724 (0.00%) |
0/5705 (0.00%) |
1/5687 (0.02%) |
Hepatic cyst infection |
1/5724 (0.02%) |
0/5705 (0.00%) |
0/5687 (0.00%) |
Hepatitis B |
1/5724 (0.02%) |
0/5705 (0.00%) |
0/5687 (0.00%) |
Hepatitis C |
2/5724 (0.03%) |
0/5705 (0.00%) |
0/5687 (0.00%) |
Hepatitis viral |
1/5724 (0.02%) |
0/5705 (0.00%) |
0/5687 (0.00%) |
Herpes virus infection |
0/5724 (0.00%) |
1/5705 (0.02%) |
0/5687 (0.00%) |
Herpes zoster |
3/5724 (0.05%) |
2/5705 (0.04%) |
2/5687 (0.04%) |
Herpes zoster ophthalmic |
0/5724 (0.00%) |
0/5705 (0.00%) |
1/5687 (0.02%) |
Herpes zoster oticus |
0/5724 (0.00%) |
0/5705 (0.00%) |
1/5687 (0.02%) |
Implant site infection |
1/5724 (0.02%) |
1/5705 (0.02%) |
0/5687 (0.00%) |
Incision site infection |
0/5724 (0.00%) |
1/5705 (0.02%) |
0/5687 (0.00%) |
Infection |
1/5724 (0.02%) |
2/5705 (0.04%) |
4/5687 (0.07%) |
Infectious pleural effusion |
1/5724 (0.02%) |
2/5705 (0.04%) |
0/5687 (0.00%) |
Infective exacerbation of chronic obstructive airways disease |
16/5724 (0.28%) |
8/5705 (0.14%) |
8/5687 (0.14%) |
Influenza |
4/5724 (0.07%) |
6/5705 (0.11%) |
2/5687 (0.04%) |
Intervertebral discitis |
2/5724 (0.03%) |
0/5705 (0.00%) |
0/5687 (0.00%) |
Kidney infection |
1/5724 (0.02%) |
0/5705 (0.00%) |
0/5687 (0.00%) |
Klebsiella infection |
0/5724 (0.00%) |
0/5705 (0.00%) |
1/5687 (0.02%) |
Klebsiella sepsis |
1/5724 (0.02%) |
0/5705 (0.00%) |
0/5687 (0.00%) |
Labyrinthitis |
0/5724 (0.00%) |
0/5705 (0.00%) |
1/5687 (0.02%) |
Laryngitis |
0/5724 (0.00%) |
1/5705 (0.02%) |
1/5687 (0.02%) |
Liver abscess |
0/5724 (0.00%) |
1/5705 (0.02%) |
0/5687 (0.00%) |
Lobar pneumonia |
16/5724 (0.28%) |
15/5705 (0.26%) |
12/5687 (0.21%) |
Localised infection |
2/5724 (0.03%) |
2/5705 (0.04%) |
2/5687 (0.04%) |
Lower respiratory tract infection |
1/5724 (0.02%) |
0/5705 (0.00%) |
2/5687 (0.04%) |
Lung abscess |
2/5724 (0.03%) |
2/5705 (0.04%) |
2/5687 (0.04%) |
Lung infection |
0/5724 (0.00%) |
1/5705 (0.02%) |
3/5687 (0.05%) |
Lyme disease |
0/5724 (0.00%) |
1/5705 (0.02%) |
2/5687 (0.04%) |
Mastitis |
0/5724 (0.00%) |
0/5705 (0.00%) |
1/5687 (0.02%) |
Measles |
0/5724 (0.00%) |
0/5705 (0.00%) |
1/5687 (0.02%) |
Neutropenic sepsis |
1/5724 (0.02%) |
0/5705 (0.00%) |
0/5687 (0.00%) |
Nosocomial infection |
0/5724 (0.00%) |
1/5705 (0.02%) |
0/5687 (0.00%) |
Oesophageal candidiasis |
2/5724 (0.03%) |
1/5705 (0.02%) |
0/5687 (0.00%) |
Orchitis |
1/5724 (0.02%) |
0/5705 (0.00%) |
0/5687 (0.00%) |
Osteomyelitis |
3/5724 (0.05%) |
1/5705 (0.02%) |
1/5687 (0.02%) |
Otitis media |
0/5724 (0.00%) |
1/5705 (0.02%) |
1/5687 (0.02%) |
Pelvic abscess |
0/5724 (0.00%) |
0/5705 (0.00%) |
2/5687 (0.04%) |
Perineal abscess |
0/5724 (0.00%) |
1/5705 (0.02%) |
0/5687 (0.00%) |
Peritonitis |
4/5724 (0.07%) |
2/5705 (0.04%) |
1/5687 (0.02%) |
Pertussis |
0/5724 (0.00%) |
0/5705 (0.00%) |
1/5687 (0.02%) |
Pharyngitis |
0/5724 (0.00%) |
0/5705 (0.00%) |
1/5687 (0.02%) |
Pneumocystis jiroveci infection |
0/5724 (0.00%) |
0/5705 (0.00%) |
1/5687 (0.02%) |
Pneumonia |
339/5724 (5.92%) |
344/5705 (6.03%) |
340/5687 (5.98%) |
Pneumonia bacterial |
4/5724 (0.07%) |
1/5705 (0.02%) |
1/5687 (0.02%) |
Pneumonia influenzal |
2/5724 (0.03%) |
0/5705 (0.00%) |
0/5687 (0.00%) |
Pneumonia legionella |
1/5724 (0.02%) |
0/5705 (0.00%) |
0/5687 (0.00%) |
Pneumonia necrotising |
1/5724 (0.02%) |
0/5705 (0.00%) |
0/5687 (0.00%) |
Pneumonia pneumococcal |
0/5724 (0.00%) |
0/5705 (0.00%) |
1/5687 (0.02%) |
Pneumonia pseudomonas aeruginosa |
1/5724 (0.02%) |
0/5705 (0.00%) |
1/5687 (0.02%) |
Pneumonia staphylococcal |
1/5724 (0.02%) |
1/5705 (0.02%) |
2/5687 (0.04%) |
Pneumonia streptococcal |
0/5724 (0.00%) |
1/5705 (0.02%) |
1/5687 (0.02%) |
Pneumonia viral |
1/5724 (0.02%) |
0/5705 (0.00%) |
0/5687 (0.00%) |
Postoperative abscess |
0/5724 (0.00%) |
0/5705 (0.00%) |
2/5687 (0.04%) |
Postoperative wound infection |
0/5724 (0.00%) |
1/5705 (0.02%) |
3/5687 (0.05%) |
Pseudomembranous colitis |
0/5724 (0.00%) |
2/5705 (0.04%) |
0/5687 (0.00%) |
Pseudomonas bronchitis |
0/5724 (0.00%) |
1/5705 (0.02%) |
0/5687 (0.00%) |
Psoas abscess |
0/5724 (0.00%) |
1/5705 (0.02%) |
0/5687 (0.00%) |
Pulmonary tuberculoma |
1/5724 (0.02%) |
0/5705 (0.00%) |
0/5687 (0.00%) |
Pulmonary tuberculosis |
0/5724 (0.00%) |
1/5705 (0.02%) |
5/5687 (0.09%) |
Purulence |
1/5724 (0.02%) |
0/5705 (0.00%) |
0/5687 (0.00%) |
Pyelonephritis |
6/5724 (0.10%) |
6/5705 (0.11%) |
2/5687 (0.04%) |
Pyelonephritis acute |
0/5724 (0.00%) |
1/5705 (0.02%) |
1/5687 (0.02%) |
Pyelonephritis chronic |
1/5724 (0.02%) |
1/5705 (0.02%) |
2/5687 (0.04%) |
Pyoderma |
1/5724 (0.02%) |
0/5705 (0.00%) |
0/5687 (0.00%) |
Pyonephrosis |
0/5724 (0.00%) |
0/5705 (0.00%) |
1/5687 (0.02%) |
Rectal abscess |
0/5724 (0.00%) |
1/5705 (0.02%) |
0/5687 (0.00%) |
Respiratory tract infection |
3/5724 (0.05%) |
7/5705 (0.12%) |
3/5687 (0.05%) |
Scrotal abscess |
1/5724 (0.02%) |
2/5705 (0.04%) |
0/5687 (0.00%) |
Sepsis |
18/5724 (0.31%) |
22/5705 (0.39%) |
16/5687 (0.28%) |
Sepsis syndrome |
0/5724 (0.00%) |
0/5705 (0.00%) |
1/5687 (0.02%) |
Septic shock |
6/5724 (0.10%) |
6/5705 (0.11%) |
12/5687 (0.21%) |
Serratia infection |
0/5724 (0.00%) |
1/5705 (0.02%) |
0/5687 (0.00%) |
Sialoadenitis |
1/5724 (0.02%) |
0/5705 (0.00%) |
0/5687 (0.00%) |
Sinusitis |
3/5724 (0.05%) |
0/5705 (0.00%) |
0/5687 (0.00%) |
Skin infection |
1/5724 (0.02%) |
1/5705 (0.02%) |
1/5687 (0.02%) |
Soft tissue infection |
1/5724 (0.02%) |
0/5705 (0.00%) |
1/5687 (0.02%) |
Staphylococcal infection |
1/5724 (0.02%) |
0/5705 (0.00%) |
2/5687 (0.04%) |
Staphylococcal sepsis |
0/5724 (0.00%) |
2/5705 (0.04%) |
0/5687 (0.00%) |
Streptococcal sepsis |
1/5724 (0.02%) |
0/5705 (0.00%) |
0/5687 (0.00%) |
Subcutaneous abscess |
1/5724 (0.02%) |
1/5705 (0.02%) |
2/5687 (0.04%) |
Tracheobronchitis |
0/5724 (0.00%) |
1/5705 (0.02%) |
1/5687 (0.02%) |
Tuberculosis |
2/5724 (0.03%) |
3/5705 (0.05%) |
2/5687 (0.04%) |
Upper respiratory tract infection |
4/5724 (0.07%) |
5/5705 (0.09%) |
3/5687 (0.05%) |
Urethral abscess |
1/5724 (0.02%) |
0/5705 (0.00%) |
0/5687 (0.00%) |
Urinary tract infection |
9/5724 (0.16%) |
22/5705 (0.39%) |
6/5687 (0.11%) |
Urinary tract infection bacterial |
0/5724 (0.00%) |
0/5705 (0.00%) |
1/5687 (0.02%) |
Urinary tract infection staphylococcal |
0/5724 (0.00%) |
0/5705 (0.00%) |
1/5687 (0.02%) |
Urosepsis |
7/5724 (0.12%) |
2/5705 (0.04%) |
4/5687 (0.07%) |
Vestibular neuronitis |
1/5724 (0.02%) |
1/5705 (0.02%) |
1/5687 (0.02%) |
Viral diarrhoea |
0/5724 (0.00%) |
1/5705 (0.02%) |
0/5687 (0.00%) |
Viral infection |
1/5724 (0.02%) |
1/5705 (0.02%) |
0/5687 (0.00%) |
Wound infection |
2/5724 (0.03%) |
3/5705 (0.05%) |
3/5687 (0.05%) |
Injury, poisoning and procedural complications |
|
|
|
Abdominal wound dehiscence |
0/5724 (0.00%) |
1/5705 (0.02%) |
0/5687 (0.00%) |
Accident |
0/5724 (0.00%) |
0/5705 (0.00%) |
1/5687 (0.02%) |
Accidental overdose |
0/5724 (0.00%) |
1/5705 (0.02%) |
1/5687 (0.02%) |
Alcohol poisoning |
1/5724 (0.02%) |
1/5705 (0.02%) |
1/5687 (0.02%) |
Anaemia postoperative |
1/5724 (0.02%) |
0/5705 (0.00%) |
1/5687 (0.02%) |
Anastomotic leak |
0/5724 (0.00%) |
0/5705 (0.00%) |
1/5687 (0.02%) |
Animal bite |
0/5724 (0.00%) |
0/5705 (0.00%) |
2/5687 (0.04%) |
Ankle fracture |
2/5724 (0.03%) |
1/5705 (0.02%) |
1/5687 (0.02%) |
Arterial restenosis |
1/5724 (0.02%) |
0/5705 (0.00%) |
0/5687 (0.00%) |
Arthropod sting |
1/5724 (0.02%) |
0/5705 (0.00%) |
0/5687 (0.00%) |
Bone contusion |
1/5724 (0.02%) |
0/5705 (0.00%) |
0/5687 (0.00%) |
Burns second degree |
1/5724 (0.02%) |
1/5705 (0.02%) |
1/5687 (0.02%) |
Cataract operation complication |
0/5724 (0.00%) |
1/5705 (0.02%) |
0/5687 (0.00%) |
Cervical vertebral fracture |
0/5724 (0.00%) |
2/5705 (0.04%) |
1/5687 (0.02%) |
Chemical poisoning |
0/5724 (0.00%) |
1/5705 (0.02%) |
0/5687 (0.00%) |
Clavicle fracture |
1/5724 (0.02%) |
0/5705 (0.00%) |
0/5687 (0.00%) |
Comminuted fracture |
1/5724 (0.02%) |
1/5705 (0.02%) |
1/5687 (0.02%) |
Concussion |
1/5724 (0.02%) |
1/5705 (0.02%) |
2/5687 (0.04%) |
Contusion |
3/5724 (0.05%) |
1/5705 (0.02%) |
4/5687 (0.07%) |
Craniocerebral injury |
3/5724 (0.05%) |
1/5705 (0.02%) |
1/5687 (0.02%) |
Endotracheal intubation complication |
1/5724 (0.02%) |
0/5705 (0.00%) |
0/5687 (0.00%) |
Excoriation |
1/5724 (0.02%) |
1/5705 (0.02%) |
0/5687 (0.00%) |
Face injury |
0/5724 (0.00%) |
0/5705 (0.00%) |
1/5687 (0.02%) |
Facial bones fracture |
0/5724 (0.00%) |
3/5705 (0.05%) |
2/5687 (0.04%) |
Fall |
8/5724 (0.14%) |
19/5705 (0.33%) |
4/5687 (0.07%) |
Femoral neck fracture |
1/5724 (0.02%) |
3/5705 (0.05%) |
5/5687 (0.09%) |
Femur fracture |
5/5724 (0.09%) |
5/5705 (0.09%) |
4/5687 (0.07%) |
Fibula fracture |
3/5724 (0.05%) |
0/5705 (0.00%) |
1/5687 (0.02%) |
Foot fracture |
1/5724 (0.02%) |
3/5705 (0.05%) |
1/5687 (0.02%) |
Foreign body |
3/5724 (0.05%) |
0/5705 (0.00%) |
0/5687 (0.00%) |
Fracture |
1/5724 (0.02%) |
1/5705 (0.02%) |
0/5687 (0.00%) |
Fractured coccyx |
0/5724 (0.00%) |
0/5705 (0.00%) |
1/5687 (0.02%) |
Fractured sacrum |
0/5724 (0.00%) |
1/5705 (0.02%) |
0/5687 (0.00%) |
Hand fracture |
2/5724 (0.03%) |
0/5705 (0.00%) |
2/5687 (0.04%) |
Head injury |
1/5724 (0.02%) |
0/5705 (0.00%) |
1/5687 (0.02%) |
Hip fracture |
11/5724 (0.19%) |
5/5705 (0.09%) |
11/5687 (0.19%) |
Humerus fracture |
1/5724 (0.02%) |
4/5705 (0.07%) |
1/5687 (0.02%) |
Incisional hernia |
3/5724 (0.05%) |
2/5705 (0.04%) |
1/5687 (0.02%) |
Incisional hernia, obstructive |
0/5724 (0.00%) |
1/5705 (0.02%) |
0/5687 (0.00%) |
Injury |
0/5724 (0.00%) |
1/5705 (0.02%) |
1/5687 (0.02%) |
Injury corneal |
1/5724 (0.02%) |
0/5705 (0.00%) |
0/5687 (0.00%) |
Intentional overdose |
0/5724 (0.00%) |
0/5705 (0.00%) |
1/5687 (0.02%) |
Joint dislocation |
3/5724 (0.05%) |
2/5705 (0.04%) |
1/5687 (0.02%) |
Joint injury |
1/5724 (0.02%) |
0/5705 (0.00%) |
0/5687 (0.00%) |
Laceration |
1/5724 (0.02%) |
0/5705 (0.00%) |
2/5687 (0.04%) |
Ligament sprain |
0/5724 (0.00%) |
1/5705 (0.02%) |
1/5687 (0.02%) |
Limb crushing injury |
0/5724 (0.00%) |
0/5705 (0.00%) |
1/5687 (0.02%) |
Limb injury |
1/5724 (0.02%) |
0/5705 (0.00%) |
0/5687 (0.00%) |
Lower limb fracture |
2/5724 (0.03%) |
1/5705 (0.02%) |
0/5687 (0.00%) |
Lumbar vertebral fracture |
5/5724 (0.09%) |
0/5705 (0.00%) |
2/5687 (0.04%) |
Meniscus injury |
0/5724 (0.00%) |
1/5705 (0.02%) |
0/5687 (0.00%) |
Multiple fractures |
0/5724 (0.00%) |
0/5705 (0.00%) |
1/5687 (0.02%) |
Multiple injuries |
0/5724 (0.00%) |
0/5705 (0.00%) |
1/5687 (0.02%) |
Muscle strain |
0/5724 (0.00%) |
2/5705 (0.04%) |
1/5687 (0.02%) |
Open fracture |
1/5724 (0.02%) |
0/5705 (0.00%) |
0/5687 (0.00%) |
Overdose |
2/5724 (0.03%) |
3/5705 (0.05%) |
0/5687 (0.00%) |
Patella fracture |
1/5724 (0.02%) |
1/5705 (0.02%) |
1/5687 (0.02%) |
Pelvic fracture |
2/5724 (0.03%) |
0/5705 (0.00%) |
1/5687 (0.02%) |
Pneumoconiosis |
1/5724 (0.02%) |
0/5705 (0.00%) |
0/5687 (0.00%) |
Pneumonitis chemical |
1/5724 (0.02%) |
0/5705 (0.00%) |
0/5687 (0.00%) |
Post lumbar puncture syndrome |
0/5724 (0.00%) |
2/5705 (0.04%) |
0/5687 (0.00%) |
Post procedural complication |
1/5724 (0.02%) |
0/5705 (0.00%) |
0/5687 (0.00%) |
Post procedural contusion |
1/5724 (0.02%) |
0/5705 (0.00%) |
0/5687 (0.00%) |
Post procedural haematuria |
0/5724 (0.00%) |
1/5705 (0.02%) |
0/5687 (0.00%) |
Post procedural haemorrhage |
0/5724 (0.00%) |
0/5705 (0.00%) |
2/5687 (0.04%) |
Post procedural myocardial infarction |
0/5724 (0.00%) |
0/5705 (0.00%) |
1/5687 (0.02%) |
Postoperative ileus |
1/5724 (0.02%) |
0/5705 (0.00%) |
1/5687 (0.02%) |
Procedural hypotension |
0/5724 (0.00%) |
0/5705 (0.00%) |
1/5687 (0.02%) |
Procedural pain |
1/5724 (0.02%) |
0/5705 (0.00%) |
1/5687 (0.02%) |
Radius fracture |
4/5724 (0.07%) |
2/5705 (0.04%) |
0/5687 (0.00%) |
Rib fracture |
10/5724 (0.17%) |
9/5705 (0.16%) |
5/5687 (0.09%) |
Road traffic accident |
2/5724 (0.03%) |
3/5705 (0.05%) |
5/5687 (0.09%) |
Scar |
0/5724 (0.00%) |
0/5705 (0.00%) |
1/5687 (0.02%) |
Skin graft failure |
1/5724 (0.02%) |
0/5705 (0.00%) |
0/5687 (0.00%) |
Skin injury |
1/5724 (0.02%) |
0/5705 (0.00%) |
0/5687 (0.00%) |
Skull fracture |
2/5724 (0.03%) |
1/5705 (0.02%) |
0/5687 (0.00%) |
Spinal column injury |
0/5724 (0.00%) |
0/5705 (0.00%) |
1/5687 (0.02%) |
Spinal compression fracture |
4/5724 (0.07%) |
2/5705 (0.04%) |
4/5687 (0.07%) |
Spinal cord injury cervical |
0/5724 (0.00%) |
1/5705 (0.02%) |
0/5687 (0.00%) |
Spinal fracture |
6/5724 (0.10%) |
1/5705 (0.02%) |
2/5687 (0.04%) |
Splenic rupture |
0/5724 (0.00%) |
2/5705 (0.04%) |
1/5687 (0.02%) |
Splinter |
0/5724 (0.00%) |
1/5705 (0.02%) |
0/5687 (0.00%) |
Subdural haematoma |
2/5724 (0.03%) |
2/5705 (0.04%) |
5/5687 (0.09%) |
Subdural haemorrhage |
0/5724 (0.00%) |
1/5705 (0.02%) |
1/5687 (0.02%) |
Tendon rupture |
1/5724 (0.02%) |
3/5705 (0.05%) |
0/5687 (0.00%) |
Thermal burn |
0/5724 (0.00%) |
2/5705 (0.04%) |
0/5687 (0.00%) |
Thoracic vertebral fracture |
2/5724 (0.03%) |
1/5705 (0.02%) |
0/5687 (0.00%) |
Tibia fracture |
5/5724 (0.09%) |
2/5705 (0.04%) |
0/5687 (0.00%) |
Toxicity to various agents |
2/5724 (0.03%) |
2/5705 (0.04%) |
4/5687 (0.07%) |
Traumatic lung injury |
1/5724 (0.02%) |
0/5705 (0.00%) |
0/5687 (0.00%) |
Ulna fracture |
0/5724 (0.00%) |
1/5705 (0.02%) |
0/5687 (0.00%) |
Upper limb fracture |
6/5724 (0.10%) |
3/5705 (0.05%) |
0/5687 (0.00%) |
Urethral injury |
0/5724 (0.00%) |
1/5705 (0.02%) |
0/5687 (0.00%) |
Vascular graft occlusion |
1/5724 (0.02%) |
0/5705 (0.00%) |
0/5687 (0.00%) |
Vascular pseudoaneurysm |
2/5724 (0.03%) |
0/5705 (0.00%) |
2/5687 (0.04%) |
Wound |
1/5724 (0.02%) |
1/5705 (0.02%) |
2/5687 (0.04%) |
Wound dehiscence |
0/5724 (0.00%) |
2/5705 (0.04%) |
0/5687 (0.00%) |
Wound secretion |
0/5724 (0.00%) |
1/5705 (0.02%) |
0/5687 (0.00%) |
Wrist fracture |
2/5724 (0.03%) |
1/5705 (0.02%) |
4/5687 (0.07%) |
Investigations |
|
|
|
Angiogram |
1/5724 (0.02%) |
0/5705 (0.00%) |
0/5687 (0.00%) |
Arteriogram coronary normal |
0/5724 (0.00%) |
1/5705 (0.02%) |
0/5687 (0.00%) |
Arthroscopy |
0/5724 (0.00%) |
0/5705 (0.00%) |
1/5687 (0.02%) |
Biopsy lung |
1/5724 (0.02%) |
1/5705 (0.02%) |
0/5687 (0.00%) |
Biopsy vocal cord normal |
1/5724 (0.02%) |
0/5705 (0.00%) |
0/5687 (0.00%) |
Blood creatinine increased |
0/5724 (0.00%) |
0/5705 (0.00%) |
1/5687 (0.02%) |
Blood pressure increased |
1/5724 (0.02%) |
0/5705 (0.00%) |
1/5687 (0.02%) |
Catheterisation cardiac |
2/5724 (0.03%) |
1/5705 (0.02%) |
2/5687 (0.04%) |
Chest X-ray abnormal |
1/5724 (0.02%) |
0/5705 (0.00%) |
1/5687 (0.02%) |
Fibrin D dimer increased |
0/5724 (0.00%) |
1/5705 (0.02%) |
0/5687 (0.00%) |
Full blood count decreased |
0/5724 (0.00%) |
0/5705 (0.00%) |
1/5687 (0.02%) |
International normalised ratio abnormal |
1/5724 (0.02%) |
0/5705 (0.00%) |
0/5687 (0.00%) |
International normalised ratio increased |
0/5724 (0.00%) |
1/5705 (0.02%) |
0/5687 (0.00%) |
Investigation |
0/5724 (0.00%) |
0/5705 (0.00%) |
1/5687 (0.02%) |
Laparoscopy |
0/5724 (0.00%) |
1/5705 (0.02%) |
0/5687 (0.00%) |
Oxygen saturation decreased |
0/5724 (0.00%) |
0/5705 (0.00%) |
1/5687 (0.02%) |
Prostatic specific antigen increased |
1/5724 (0.02%) |
0/5705 (0.00%) |
0/5687 (0.00%) |
Troponin I increased |
1/5724 (0.02%) |
0/5705 (0.00%) |
0/5687 (0.00%) |
Weight decreased |
4/5724 (0.07%) |
3/5705 (0.05%) |
0/5687 (0.00%) |
Metabolism and nutrition disorders |
|
|
|
Decreased appetite |
0/5724 (0.00%) |
2/5705 (0.04%) |
1/5687 (0.02%) |
Dehydration |
8/5724 (0.14%) |
8/5705 (0.14%) |
5/5687 (0.09%) |
Diabetes mellitus |
2/5724 (0.03%) |
4/5705 (0.07%) |
1/5687 (0.02%) |
Diabetes mellitus inadequate control |
1/5724 (0.02%) |
1/5705 (0.02%) |
2/5687 (0.04%) |
Diabetes with hyperosmolarity |
0/5724 (0.00%) |
2/5705 (0.04%) |
0/5687 (0.00%) |
Diabetic ketoacidosis |
1/5724 (0.02%) |
1/5705 (0.02%) |
0/5687 (0.00%) |
Electrolyte imbalance |
0/5724 (0.00%) |
1/5705 (0.02%) |
0/5687 (0.00%) |
Failure to thrive |
0/5724 (0.00%) |
0/5705 (0.00%) |
4/5687 (0.07%) |
Feeding disorder |
0/5724 (0.00%) |
0/5705 (0.00%) |
1/5687 (0.02%) |
Glucose tolerance impaired |
0/5724 (0.00%) |
0/5705 (0.00%) |
1/5687 (0.02%) |
Gout |
1/5724 (0.02%) |
1/5705 (0.02%) |
1/5687 (0.02%) |
Hyperglycaemia |
3/5724 (0.05%) |
4/5705 (0.07%) |
0/5687 (0.00%) |
Hyperkalaemia |
1/5724 (0.02%) |
2/5705 (0.04%) |
2/5687 (0.04%) |
Hypoglycaemia |
2/5724 (0.03%) |
3/5705 (0.05%) |
2/5687 (0.04%) |
Hypokalaemia |
2/5724 (0.03%) |
2/5705 (0.04%) |
1/5687 (0.02%) |
Hyponatraemia |
8/5724 (0.14%) |
4/5705 (0.07%) |
5/5687 (0.09%) |
Hypophagia |
1/5724 (0.02%) |
0/5705 (0.00%) |
2/5687 (0.04%) |
Hypovolaemia |
2/5724 (0.03%) |
2/5705 (0.04%) |
1/5687 (0.02%) |
Lactic acidosis |
1/5724 (0.02%) |
0/5705 (0.00%) |
0/5687 (0.00%) |
Malnutrition |
1/5724 (0.02%) |
1/5705 (0.02%) |
1/5687 (0.02%) |
Metabolic acidosis |
0/5724 (0.00%) |
0/5705 (0.00%) |
1/5687 (0.02%) |
Obesity |
0/5724 (0.00%) |
2/5705 (0.04%) |
1/5687 (0.02%) |
Type 1 diabetes mellitus |
0/5724 (0.00%) |
0/5705 (0.00%) |
1/5687 (0.02%) |
Type 2 diabetes mellitus |
0/5724 (0.00%) |
1/5705 (0.02%) |
1/5687 (0.02%) |
Musculoskeletal and connective tissue disorders |
|
|
|
Arthralgia |
6/5724 (0.10%) |
1/5705 (0.02%) |
5/5687 (0.09%) |
Arthritis |
5/5724 (0.09%) |
8/5705 (0.14%) |
2/5687 (0.04%) |
Back pain |
11/5724 (0.19%) |
3/5705 (0.05%) |
6/5687 (0.11%) |
Bone infarction |
1/5724 (0.02%) |
0/5705 (0.00%) |
0/5687 (0.00%) |
Bursa disorder |
0/5724 (0.00%) |
1/5705 (0.02%) |
0/5687 (0.00%) |
Bursitis |
0/5724 (0.00%) |
1/5705 (0.02%) |
2/5687 (0.04%) |
Cervical spinal stenosis |
1/5724 (0.02%) |
1/5705 (0.02%) |
0/5687 (0.00%) |
Chondritis |
1/5724 (0.02%) |
0/5705 (0.00%) |
0/5687 (0.00%) |
Costochondritis |
0/5724 (0.00%) |
0/5705 (0.00%) |
2/5687 (0.04%) |
Diastasis recti abdominis |
0/5724 (0.00%) |
1/5705 (0.02%) |
0/5687 (0.00%) |
Dupuytren's contracture |
0/5724 (0.00%) |
0/5705 (0.00%) |
1/5687 (0.02%) |
Facet joint syndrome |
1/5724 (0.02%) |
1/5705 (0.02%) |
0/5687 (0.00%) |
Fibromyalgia |
0/5724 (0.00%) |
2/5705 (0.04%) |
0/5687 (0.00%) |
Fistula |
0/5724 (0.00%) |
1/5705 (0.02%) |
0/5687 (0.00%) |
Foot deformity |
0/5724 (0.00%) |
0/5705 (0.00%) |
2/5687 (0.04%) |
Fracture malunion |
0/5724 (0.00%) |
0/5705 (0.00%) |
1/5687 (0.02%) |
Fracture nonunion |
1/5724 (0.02%) |
0/5705 (0.00%) |
0/5687 (0.00%) |
Haemarthrosis |
0/5724 (0.00%) |
0/5705 (0.00%) |
2/5687 (0.04%) |
Intervertebral disc degeneration |
2/5724 (0.03%) |
1/5705 (0.02%) |
0/5687 (0.00%) |
Intervertebral disc disorder |
1/5724 (0.02%) |
0/5705 (0.00%) |
1/5687 (0.02%) |
Intervertebral disc protrusion |
10/5724 (0.17%) |
6/5705 (0.11%) |
10/5687 (0.18%) |
Joint ankylosis |
1/5724 (0.02%) |
0/5705 (0.00%) |
0/5687 (0.00%) |
Joint swelling |
1/5724 (0.02%) |
1/5705 (0.02%) |
0/5687 (0.00%) |
Knee deformity |
1/5724 (0.02%) |
0/5705 (0.00%) |
0/5687 (0.00%) |
Kyphosis |
0/5724 (0.00%) |
1/5705 (0.02%) |
0/5687 (0.00%) |
Lumbar spinal stenosis |
1/5724 (0.02%) |
4/5705 (0.07%) |
1/5687 (0.02%) |
Mixed connective tissue disease |
1/5724 (0.02%) |
0/5705 (0.00%) |
0/5687 (0.00%) |
Muscle spasms |
0/5724 (0.00%) |
0/5705 (0.00%) |
1/5687 (0.02%) |
Muscular weakness |
3/5724 (0.05%) |
0/5705 (0.00%) |
0/5687 (0.00%) |
Musculoskeletal chest pain |
0/5724 (0.00%) |
1/5705 (0.02%) |
2/5687 (0.04%) |
Musculoskeletal pain |
1/5724 (0.02%) |
4/5705 (0.07%) |
2/5687 (0.04%) |
Myalgia |
1/5724 (0.02%) |
1/5705 (0.02%) |
2/5687 (0.04%) |
Myopathy |
1/5724 (0.02%) |
0/5705 (0.00%) |
0/5687 (0.00%) |
Neck pain |
1/5724 (0.02%) |
0/5705 (0.00%) |
1/5687 (0.02%) |
Osteoarthritis |
10/5724 (0.17%) |
12/5705 (0.21%) |
23/5687 (0.40%) |
Osteochondrosis |
1/5724 (0.02%) |
1/5705 (0.02%) |
1/5687 (0.02%) |
Osteonecrosis |
3/5724 (0.05%) |
2/5705 (0.04%) |
2/5687 (0.04%) |
Osteoporosis |
2/5724 (0.03%) |
0/5705 (0.00%) |
0/5687 (0.00%) |
Osteoporotic fracture |
1/5724 (0.02%) |
0/5705 (0.00%) |
0/5687 (0.00%) |
Pain in extremity |
1/5724 (0.02%) |
1/5705 (0.02%) |
1/5687 (0.02%) |
Pain in jaw |
0/5724 (0.00%) |
0/5705 (0.00%) |
1/5687 (0.02%) |
Periarthritis |
1/5724 (0.02%) |
0/5705 (0.00%) |
0/5687 (0.00%) |
Polyarthritis |
0/5724 (0.00%) |
0/5705 (0.00%) |
1/5687 (0.02%) |
Polymyalgia rheumatica |
0/5724 (0.00%) |
1/5705 (0.02%) |
1/5687 (0.02%) |
Rhabdomyolysis |
0/5724 (0.00%) |
0/5705 (0.00%) |
1/5687 (0.02%) |
Rheumatoid arthritis |
2/5724 (0.03%) |
2/5705 (0.04%) |
1/5687 (0.02%) |
Rotator cuff syndrome |
1/5724 (0.02%) |
0/5705 (0.00%) |
0/5687 (0.00%) |
Spinal column stenosis |
6/5724 (0.10%) |
1/5705 (0.02%) |
2/5687 (0.04%) |
Spinal disorder |
0/5724 (0.00%) |
1/5705 (0.02%) |
1/5687 (0.02%) |
Spinal osteoarthritis |
4/5724 (0.07%) |
4/5705 (0.07%) |
6/5687 (0.11%) |
Spondyloarthropathy |
0/5724 (0.00%) |
0/5705 (0.00%) |
1/5687 (0.02%) |
Spondylolisthesis |
0/5724 (0.00%) |
1/5705 (0.02%) |
3/5687 (0.05%) |
Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
|
|
Acoustic neuroma |
0/5724 (0.00%) |
1/5705 (0.02%) |
0/5687 (0.00%) |
Acral lentiginous melanoma |
1/5724 (0.02%) |
0/5705 (0.00%) |
0/5687 (0.00%) |
Acute leukaemia |
1/5724 (0.02%) |
0/5705 (0.00%) |
0/5687 (0.00%) |
Acute myeloid leukaemia |
0/5724 (0.00%) |
0/5705 (0.00%) |
3/5687 (0.05%) |
Adenocarcinoma |
1/5724 (0.02%) |
2/5705 (0.04%) |
2/5687 (0.04%) |
Adenocarcinoma gastric |
2/5724 (0.03%) |
0/5705 (0.00%) |
1/5687 (0.02%) |
Adenocarcinoma of colon |
3/5724 (0.05%) |
2/5705 (0.04%) |
0/5687 (0.00%) |
Adenocarcinoma pancreas |
0/5724 (0.00%) |
1/5705 (0.02%) |
0/5687 (0.00%) |
Adenoma benign |
1/5724 (0.02%) |
0/5705 (0.00%) |
0/5687 (0.00%) |
Anal cancer |
1/5724 (0.02%) |
0/5705 (0.00%) |
0/5687 (0.00%) |
Angiosarcoma |
1/5724 (0.02%) |
0/5705 (0.00%) |
0/5687 (0.00%) |
Anogenital warts |
0/5724 (0.00%) |
0/5705 (0.00%) |
1/5687 (0.02%) |
B-cell lymphoma |
1/5724 (0.02%) |
0/5705 (0.00%) |
3/5687 (0.05%) |
B-cell unclassifiable lymphoma low grade |
0/5724 (0.00%) |
1/5705 (0.02%) |
1/5687 (0.02%) |
Basal cell carcinoma |
17/5724 (0.30%) |
26/5705 (0.46%) |
15/5687 (0.26%) |
Benign breast neoplasm |
1/5724 (0.02%) |
0/5705 (0.00%) |
0/5687 (0.00%) |
Benign neoplasm of adrenal gland |
0/5724 (0.00%) |
0/5705 (0.00%) |
1/5687 (0.02%) |
Benign neoplasm of bladder |
0/5724 (0.00%) |
1/5705 (0.02%) |
0/5687 (0.00%) |
Benign neoplasm of urethra |
0/5724 (0.00%) |
0/5705 (0.00%) |
1/5687 (0.02%) |
Benign ovarian tumour |
1/5724 (0.02%) |
0/5705 (0.00%) |
0/5687 (0.00%) |
Benign salivary gland neoplasm |
0/5724 (0.00%) |
0/5705 (0.00%) |
1/5687 (0.02%) |
Bile duct cancer |
1/5724 (0.02%) |
1/5705 (0.02%) |
1/5687 (0.02%) |
Bladder adenocarcinoma stage unspecified |
1/5724 (0.02%) |
0/5705 (0.00%) |
0/5687 (0.00%) |
Bladder cancer |
13/5724 (0.23%) |
10/5705 (0.18%) |
4/5687 (0.07%) |
Bladder cancer recurrent |
0/5724 (0.00%) |
1/5705 (0.02%) |
0/5687 (0.00%) |
Bladder cancer stage 0, with cancer in situ |
1/5724 (0.02%) |
0/5705 (0.00%) |
0/5687 (0.00%) |
Bladder neoplasm |
5/5724 (0.09%) |
1/5705 (0.02%) |
4/5687 (0.07%) |
Bladder transitional cell carcinoma |
0/5724 (0.00%) |
2/5705 (0.04%) |
0/5687 (0.00%) |
Bone cancer |
0/5724 (0.00%) |
1/5705 (0.02%) |
0/5687 (0.00%) |
Bone neoplasm |
0/5724 (0.00%) |
1/5705 (0.02%) |
0/5687 (0.00%) |
Bowen's disease |
0/5724 (0.00%) |
1/5705 (0.02%) |
1/5687 (0.02%) |
Brain cancer metastatic |
1/5724 (0.02%) |
1/5705 (0.02%) |
1/5687 (0.02%) |
Brain neoplasm |
1/5724 (0.02%) |
0/5705 (0.00%) |
1/5687 (0.02%) |
Brain neoplasm malignant |
0/5724 (0.00%) |
2/5705 (0.04%) |
0/5687 (0.00%) |
Breast cancer |
8/5724 (0.14%) |
8/5705 (0.14%) |
4/5687 (0.07%) |
Breast cancer metastatic |
1/5724 (0.02%) |
0/5705 (0.00%) |
1/5687 (0.02%) |
Breast cancer stage I |
1/5724 (0.02%) |
0/5705 (0.00%) |
0/5687 (0.00%) |
Breast cancer stage II |
1/5724 (0.02%) |
0/5705 (0.00%) |
0/5687 (0.00%) |
Breast neoplasm |
1/5724 (0.02%) |
2/5705 (0.04%) |
0/5687 (0.00%) |
Bronchial carcinoma |
8/5724 (0.14%) |
7/5705 (0.12%) |
4/5687 (0.07%) |
Bronchial neoplasm |
0/5724 (0.00%) |
0/5705 (0.00%) |
2/5687 (0.04%) |
Carcinoid tumour pulmonary |
0/5724 (0.00%) |
2/5705 (0.04%) |
1/5687 (0.02%) |
Cardiac myxoma |
1/5724 (0.02%) |
0/5705 (0.00%) |
0/5687 (0.00%) |
Cervix carcinoma |
0/5724 (0.00%) |
0/5705 (0.00%) |
1/5687 (0.02%) |
Cholangiocarcinoma |
0/5724 (0.00%) |
4/5705 (0.07%) |
1/5687 (0.02%) |
Chronic lymphocytic leukaemia |
1/5724 (0.02%) |
0/5705 (0.00%) |
0/5687 (0.00%) |
Chronic myeloid leukaemia |
0/5724 (0.00%) |
0/5705 (0.00%) |
2/5687 (0.04%) |
Colon adenoma |
1/5724 (0.02%) |
3/5705 (0.05%) |
0/5687 (0.00%) |
Colon cancer |
13/5724 (0.23%) |
4/5705 (0.07%) |
10/5687 (0.18%) |
Colon cancer metastatic |
0/5724 (0.00%) |
1/5705 (0.02%) |
0/5687 (0.00%) |
Colon neoplasm |
1/5724 (0.02%) |
2/5705 (0.04%) |
0/5687 (0.00%) |
Colorectal cancer |
1/5724 (0.02%) |
1/5705 (0.02%) |
1/5687 (0.02%) |
Gastric adenoma |
0/5724 (0.00%) |
1/5705 (0.02%) |
0/5687 (0.00%) |
Gastric cancer |
6/5724 (0.10%) |
3/5705 (0.05%) |
4/5687 (0.07%) |
Gastric neoplasm |
0/5724 (0.00%) |
0/5705 (0.00%) |
1/5687 (0.02%) |
Gastrointestinal cancer metastatic |
1/5724 (0.02%) |
0/5705 (0.00%) |
0/5687 (0.00%) |
Gastrointestinal carcinoma |
1/5724 (0.02%) |
0/5705 (0.00%) |
0/5687 (0.00%) |
Gastrointestinal neoplasm |
0/5724 (0.00%) |
0/5705 (0.00%) |
1/5687 (0.02%) |
Gastrointestinal tract adenoma |
0/5724 (0.00%) |
0/5705 (0.00%) |
1/5687 (0.02%) |
Glioblastoma |
0/5724 (0.00%) |
1/5705 (0.02%) |
1/5687 (0.02%) |
Glioblastoma multiforme |
1/5724 (0.02%) |
0/5705 (0.00%) |
0/5687 (0.00%) |
Glioma |
0/5724 (0.00%) |
1/5705 (0.02%) |
0/5687 (0.00%) |
Hepatic cancer |
3/5724 (0.05%) |
4/5705 (0.07%) |
1/5687 (0.02%) |
Hepatic cancer metastatic |
2/5724 (0.03%) |
0/5705 (0.00%) |
0/5687 (0.00%) |
Hepatic neoplasm |
1/5724 (0.02%) |
1/5705 (0.02%) |
0/5687 (0.00%) |
Hodgkin's disease |
0/5724 (0.00%) |
1/5705 (0.02%) |
0/5687 (0.00%) |
Intraductal proliferative breast lesion |
2/5724 (0.03%) |
0/5705 (0.00%) |
0/5687 (0.00%) |
Invasive ductal breast carcinoma |
1/5724 (0.02%) |
1/5705 (0.02%) |
1/5687 (0.02%) |
Invasive lobular breast carcinoma |
1/5724 (0.02%) |
0/5705 (0.00%) |
0/5687 (0.00%) |
Large cell lung cancer stage IV |
1/5724 (0.02%) |
0/5705 (0.00%) |
0/5687 (0.00%) |
Large intestine benign neoplasm |
0/5724 (0.00%) |
0/5705 (0.00%) |
1/5687 (0.02%) |
Laryngeal cancer |
1/5724 (0.02%) |
1/5705 (0.02%) |
2/5687 (0.04%) |
Laryngeal neoplasm |
1/5724 (0.02%) |
0/5705 (0.00%) |
0/5687 (0.00%) |
Laryngeal squamous cell carcinoma |
3/5724 (0.05%) |
0/5705 (0.00%) |
0/5687 (0.00%) |
Leukaemia |
3/5724 (0.05%) |
0/5705 (0.00%) |
1/5687 (0.02%) |
Lip squamous cell carcinoma |
0/5724 (0.00%) |
0/5705 (0.00%) |
1/5687 (0.02%) |
Lipoma |
1/5724 (0.02%) |
2/5705 (0.04%) |
0/5687 (0.00%) |
Lung adenocarcinoma |
10/5724 (0.17%) |
9/5705 (0.16%) |
6/5687 (0.11%) |
Lung adenocarcinoma metastatic |
1/5724 (0.02%) |
0/5705 (0.00%) |
0/5687 (0.00%) |
Lung adenocarcinoma stage IV |
1/5724 (0.02%) |
0/5705 (0.00%) |
1/5687 (0.02%) |
Lung cancer metastatic |
3/5724 (0.05%) |
7/5705 (0.12%) |
9/5687 (0.16%) |
Lung carcinoma cell type unspecified recurrent |
0/5724 (0.00%) |
0/5705 (0.00%) |
1/5687 (0.02%) |
Lung carcinoma cell type unspecified stage I |
1/5724 (0.02%) |
0/5705 (0.00%) |
0/5687 (0.00%) |
Lung carcinoma cell type unspecified stage IV |
4/5724 (0.07%) |
0/5705 (0.00%) |
0/5687 (0.00%) |
Lung neoplasm |
6/5724 (0.10%) |
7/5705 (0.12%) |
5/5687 (0.09%) |
Lung neoplasm malignant |
52/5724 (0.91%) |
60/5705 (1.05%) |
48/5687 (0.84%) |
Lung squamous cell carcinoma stage III |
0/5724 (0.00%) |
1/5705 (0.02%) |