Time Frame |
Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
|
Adverse Event Reporting Description |
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment
All-Cause Mortality: All randomized participants
|
|
Arm/Group Title
|
Vericiguat
|
Placebo
|
Arm/Group Description |
Participants received a starting do...
|
Participants received a starting ma...
|
Arm/Group Description |
Participants received a starting dose of 2.5 mg of vericiguat taken orally once daily with food, on a background of HF standard of care. The vericiguat dose was uptitrated to 5 mg and to 10 mg.
|
Participants received a starting matching placebo dose of 2.5 mg taken orally once daily with food, on a background of HF standard of care. The matching placebo dose was uptitrated to 5 mg and to 10 mg.
|
|
|
Vericiguat
|
Placebo
|
|
Affected / at Risk (%) |
|
Affected / at Risk (%) |
|
Total |
553/2526 (21.89%)
|
|
561/2524 (22.23%)
|
|
|
|
Vericiguat
|
Placebo
|
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Total |
852/2519 (33.82%)
|
|
897/2515 (35.67%)
|
|
Blood and lymphatic system disorders |
|
|
Anaemia |
41/2519 (1.63%)
|
50 |
24/2515 (0.95%)
|
25 |
Anaemia of chronic disease |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Autoimmune haemolytic anaemia |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Bicytopenia |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Blood loss anaemia |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Bone marrow failure |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Coagulopathy |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Disseminated intravascular coagulation |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Hypocoagulable state |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Iron deficiency anaemia |
3/2519 (0.12%)
|
3 |
2/2515 (0.08%)
|
2 |
Normochromic normocytic anaemia |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Normocytic anaemia |
1/2519 (0.04%)
|
1 |
1/2515 (0.04%)
|
1 |
Pancytopenia |
3/2519 (0.12%)
|
3 |
1/2515 (0.04%)
|
1 |
Splenic infarction |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Thrombocytopenia |
2/2519 (0.08%)
|
2 |
1/2515 (0.04%)
|
1 |
Cardiac disorders |
|
|
Acute coronary syndrome |
1/2519 (0.04%)
|
1 |
4/2515 (0.16%)
|
4 |
Acute myocardial infarction |
5/2519 (0.20%)
|
6 |
5/2515 (0.20%)
|
5 |
Angina pectoris |
9/2519 (0.36%)
|
10 |
8/2515 (0.32%)
|
9 |
Angina unstable |
2/2519 (0.08%)
|
2 |
7/2515 (0.28%)
|
13 |
Aortic valve calcification |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Aortic valve incompetence |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Aortic valve stenosis |
3/2519 (0.12%)
|
3 |
3/2515 (0.12%)
|
3 |
Arrhythmia |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Arteriosclerosis coronary artery |
2/2519 (0.08%)
|
2 |
0/2515 (0.00%)
|
0 |
Atrial fibrillation |
14/2519 (0.56%)
|
15 |
29/2515 (1.15%)
|
31 |
Atrial flutter |
6/2519 (0.24%)
|
7 |
7/2515 (0.28%)
|
7 |
Atrial tachycardia |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Atrial thrombosis |
0/2519 (0.00%)
|
0 |
2/2515 (0.08%)
|
2 |
Atrioventricular block |
2/2519 (0.08%)
|
2 |
0/2515 (0.00%)
|
0 |
Atrioventricular block complete |
0/2519 (0.00%)
|
0 |
2/2515 (0.08%)
|
2 |
Atrioventricular block second degree |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Bradyarrhythmia |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Bradycardia |
3/2519 (0.12%)
|
3 |
3/2515 (0.12%)
|
3 |
Bundle branch block left |
0/2519 (0.00%)
|
0 |
2/2515 (0.08%)
|
2 |
Cardiac arrest |
3/2519 (0.12%)
|
3 |
3/2515 (0.12%)
|
3 |
Cardiac asthma |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Cardiac failure |
82/2519 (3.26%)
|
88 |
116/2515 (4.61%)
|
128 |
Cardiac failure acute |
2/2519 (0.08%)
|
2 |
4/2515 (0.16%)
|
4 |
Cardiac failure chronic |
5/2519 (0.20%)
|
5 |
10/2515 (0.40%)
|
10 |
Cardiac failure congestive |
13/2519 (0.52%)
|
13 |
25/2515 (0.99%)
|
25 |
Cardiac perforation |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Cardiac ventricular thrombosis |
2/2519 (0.08%)
|
2 |
0/2515 (0.00%)
|
0 |
Cardio-respiratory arrest |
4/2519 (0.16%)
|
4 |
1/2515 (0.04%)
|
1 |
Cardiogenic shock |
8/2519 (0.32%)
|
8 |
4/2515 (0.16%)
|
4 |
Cardiopulmonary failure |
1/2519 (0.04%)
|
1 |
1/2515 (0.04%)
|
1 |
Cardiorenal syndrome |
3/2519 (0.12%)
|
3 |
2/2515 (0.08%)
|
2 |
Cardiovascular disorder |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Cardiovascular insufficiency |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Congestive cardiomyopathy |
3/2519 (0.12%)
|
3 |
3/2515 (0.12%)
|
3 |
Coronary artery disease |
7/2519 (0.28%)
|
8 |
3/2515 (0.12%)
|
3 |
Coronary artery occlusion |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Coronary artery stenosis |
3/2519 (0.12%)
|
4 |
2/2515 (0.08%)
|
2 |
Extrasystoles |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Heart valve incompetence |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Intracardiac thrombus |
0/2519 (0.00%)
|
0 |
2/2515 (0.08%)
|
2 |
Ischaemic cardiomyopathy |
1/2519 (0.04%)
|
1 |
2/2515 (0.08%)
|
2 |
Left ventricular dysfunction |
1/2519 (0.04%)
|
1 |
1/2515 (0.04%)
|
1 |
Left ventricular failure |
0/2519 (0.00%)
|
0 |
2/2515 (0.08%)
|
2 |
Mitral valve incompetence |
7/2519 (0.28%)
|
7 |
5/2515 (0.20%)
|
5 |
Myocardial infarction |
6/2519 (0.24%)
|
6 |
3/2515 (0.12%)
|
3 |
Myocardial ischaemia |
3/2519 (0.12%)
|
3 |
2/2515 (0.08%)
|
2 |
Palpitations |
2/2519 (0.08%)
|
2 |
1/2515 (0.04%)
|
1 |
Pericardial effusion |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Pericarditis |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Sinus bradycardia |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Sinus node dysfunction |
2/2519 (0.08%)
|
2 |
2/2515 (0.08%)
|
2 |
Supraventricular tachycardia |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Tachyarrhythmia |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Tachycardia |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Ventricular arrhythmia |
2/2519 (0.08%)
|
2 |
1/2515 (0.04%)
|
1 |
Ventricular dysfunction |
0/2519 (0.00%)
|
0 |
2/2515 (0.08%)
|
2 |
Ventricular extrasystoles |
2/2519 (0.08%)
|
2 |
2/2515 (0.08%)
|
2 |
Ventricular fibrillation |
9/2519 (0.36%)
|
10 |
7/2515 (0.28%)
|
9 |
Ventricular tachycardia |
14/2519 (0.56%)
|
18 |
27/2515 (1.07%)
|
29 |
Congenital, familial and genetic disorders |
|
|
Corneal dystrophy |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Gastrointestinal arteriovenous malformation |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Hydrocele |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Phimosis |
1/2519 (0.04%)
|
1 |
1/2515 (0.04%)
|
1 |
Pyloric stenosis |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Ear and labyrinth disorders |
|
|
Vertigo |
3/2519 (0.12%)
|
3 |
7/2515 (0.28%)
|
7 |
Vertigo positional |
1/2519 (0.04%)
|
1 |
3/2515 (0.12%)
|
4 |
Endocrine disorders |
|
|
Basedow's disease |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Carcinoid syndrome |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Glucocorticoid deficiency |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Hyperthyroidism |
4/2519 (0.16%)
|
4 |
1/2515 (0.04%)
|
1 |
Hypoparathyroidism secondary |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Hypothyroidism |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Eye disorders |
|
|
Blindness |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Cataract |
9/2519 (0.36%)
|
10 |
6/2515 (0.24%)
|
8 |
Diabetic retinopathy |
2/2519 (0.08%)
|
2 |
1/2515 (0.04%)
|
1 |
Diplopia |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Eye haemorrhage |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Eyelid ptosis |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Glaucoma |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Macular cyst |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Retinal artery thrombosis |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Retinal haemorrhage |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Vitreous haemorrhage |
2/2519 (0.08%)
|
2 |
1/2515 (0.04%)
|
1 |
Gastrointestinal disorders |
|
|
Abdominal distension |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Abdominal pain |
4/2519 (0.16%)
|
4 |
4/2515 (0.16%)
|
4 |
Abdominal pain lower |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Abdominal pain upper |
4/2519 (0.16%)
|
5 |
3/2515 (0.12%)
|
3 |
Abdominal rigidity |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Alcoholic pancreatitis |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Anorectal ulcer |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Ascites |
8/2519 (0.32%)
|
10 |
4/2515 (0.16%)
|
5 |
Barrett's oesophagus |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Colitis |
2/2519 (0.08%)
|
2 |
2/2515 (0.08%)
|
2 |
Colitis ischaemic |
1/2519 (0.04%)
|
1 |
1/2515 (0.04%)
|
1 |
Constipation |
3/2519 (0.12%)
|
3 |
2/2515 (0.08%)
|
2 |
Dental caries |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Dental cyst |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Diarrhoea |
10/2519 (0.40%)
|
10 |
7/2515 (0.28%)
|
7 |
Diverticulum |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Diverticulum intestinal |
1/2519 (0.04%)
|
1 |
1/2515 (0.04%)
|
1 |
Duodenal ulcer |
0/2519 (0.00%)
|
0 |
3/2515 (0.12%)
|
3 |
Erosive oesophagitis |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Faecaloma |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Gastric haemorrhage |
2/2519 (0.08%)
|
2 |
0/2515 (0.00%)
|
0 |
Gastric perforation |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Gastric ulcer |
1/2519 (0.04%)
|
1 |
2/2515 (0.08%)
|
2 |
Gastric ulcer haemorrhage |
1/2519 (0.04%)
|
1 |
2/2515 (0.08%)
|
2 |
Gastritis |
4/2519 (0.16%)
|
4 |
7/2515 (0.28%)
|
7 |
Gastritis erosive |
1/2519 (0.04%)
|
1 |
2/2515 (0.08%)
|
2 |
Gastritis haemorrhagic |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Gastrointestinal angiodysplasia |
1/2519 (0.04%)
|
1 |
2/2515 (0.08%)
|
2 |
Gastrointestinal haemorrhage |
12/2519 (0.48%)
|
14 |
7/2515 (0.28%)
|
7 |
Gastrointestinal toxicity |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Gastrooesophageal reflux disease |
0/2519 (0.00%)
|
0 |
4/2515 (0.16%)
|
4 |
Gingival bleeding |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Haematemesis |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Haematochezia |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Haemorrhoidal haemorrhage |
1/2519 (0.04%)
|
1 |
1/2515 (0.04%)
|
1 |
Haemorrhoids |
3/2519 (0.12%)
|
3 |
2/2515 (0.08%)
|
2 |
Ileus |
2/2519 (0.08%)
|
2 |
0/2515 (0.00%)
|
0 |
Impaired gastric emptying |
2/2519 (0.08%)
|
2 |
0/2515 (0.00%)
|
0 |
Incarcerated inguinal hernia |
0/2519 (0.00%)
|
0 |
3/2515 (0.12%)
|
3 |
Incarcerated umbilical hernia |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Inguinal hernia |
11/2519 (0.44%)
|
11 |
9/2515 (0.36%)
|
9 |
Inguinal hernia strangulated |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Inguinal hernia, obstructive |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Intestinal infarction |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Intestinal ischaemia |
1/2519 (0.04%)
|
1 |
2/2515 (0.08%)
|
2 |
Intestinal obstruction |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Intra-abdominal haematoma |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Ischaemic enteritis |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Large intestinal haemorrhage |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Large intestinal obstruction |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Large intestinal stenosis |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Large intestinal ulcer |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Large intestinal ulcer haemorrhage |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Large intestinal ulcer perforation |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Large intestine polyp |
1/2519 (0.04%)
|
2 |
4/2515 (0.16%)
|
4 |
Lower gastrointestinal haemorrhage |
1/2519 (0.04%)
|
1 |
1/2515 (0.04%)
|
1 |
Melaena |
1/2519 (0.04%)
|
1 |
2/2515 (0.08%)
|
2 |
Nausea |
2/2519 (0.08%)
|
2 |
0/2515 (0.00%)
|
0 |
Obstructive pancreatitis |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Oesophageal achalasia |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Oesophageal stenosis |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Oesophageal varices haemorrhage |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Pancreatitis |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Pancreatitis acute |
2/2519 (0.08%)
|
2 |
1/2515 (0.04%)
|
1 |
Pancreatitis chronic |
1/2519 (0.04%)
|
1 |
1/2515 (0.04%)
|
1 |
Pancreatolithiasis |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Peptic ulcer |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Pneumatosis intestinalis |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Rectal haemorrhage |
4/2519 (0.16%)
|
4 |
1/2515 (0.04%)
|
1 |
Small intestinal obstruction |
2/2519 (0.08%)
|
2 |
0/2515 (0.00%)
|
0 |
Subileus |
0/2519 (0.00%)
|
0 |
2/2515 (0.08%)
|
2 |
Umbilical hernia |
2/2519 (0.08%)
|
2 |
0/2515 (0.00%)
|
0 |
Upper gastrointestinal haemorrhage |
3/2519 (0.12%)
|
3 |
6/2515 (0.24%)
|
6 |
Vomiting |
4/2519 (0.16%)
|
4 |
2/2515 (0.08%)
|
2 |
General disorders |
|
|
Asthenia |
6/2519 (0.24%)
|
6 |
6/2515 (0.24%)
|
7 |
Cardiac complication associated with device |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Chest discomfort |
1/2519 (0.04%)
|
1 |
2/2515 (0.08%)
|
2 |
Chest pain |
10/2519 (0.40%)
|
10 |
8/2515 (0.32%)
|
14 |
Device related thrombosis |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Discomfort |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
General physical health deterioration |
6/2519 (0.24%)
|
6 |
1/2515 (0.04%)
|
1 |
Generalised oedema |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Hernia |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Impaired healing |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Implant site erythema |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Implant site haematoma |
2/2519 (0.08%)
|
2 |
0/2515 (0.00%)
|
0 |
Implant site haemorrhage |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Influenza like illness |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Medical device pain |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Medical device site haematoma |
2/2519 (0.08%)
|
2 |
0/2515 (0.00%)
|
0 |
Medical device site swelling |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Medical device site thrombosis |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Multiple organ dysfunction syndrome |
2/2519 (0.08%)
|
2 |
4/2515 (0.16%)
|
4 |
Non-cardiac chest pain |
4/2519 (0.16%)
|
4 |
7/2515 (0.28%)
|
7 |
Oedema |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Oedema peripheral |
0/2519 (0.00%)
|
0 |
3/2515 (0.12%)
|
3 |
Physical deconditioning |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Pyrexia |
3/2519 (0.12%)
|
3 |
2/2515 (0.08%)
|
2 |
Sensation of foreign body |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Strangulated hernia |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Sudden cardiac death |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
UGT1A1 gene polymorphism |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Vascular stent occlusion |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Vascular stent stenosis |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Vascular stent thrombosis |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Hepatobiliary disorders |
|
|
Acute hepatic failure |
1/2519 (0.04%)
|
1 |
3/2515 (0.12%)
|
3 |
Bile duct stone |
2/2519 (0.08%)
|
2 |
1/2515 (0.04%)
|
1 |
Biloma |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Cholangitis |
1/2519 (0.04%)
|
1 |
1/2515 (0.04%)
|
1 |
Cholangitis acute |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Cholecystitis |
4/2519 (0.16%)
|
4 |
4/2515 (0.16%)
|
4 |
Cholecystitis acute |
4/2519 (0.16%)
|
4 |
6/2515 (0.24%)
|
6 |
Cholecystitis chronic |
2/2519 (0.08%)
|
2 |
0/2515 (0.00%)
|
0 |
Cholelithiasis |
4/2519 (0.16%)
|
4 |
2/2515 (0.08%)
|
2 |
Cholestasis |
1/2519 (0.04%)
|
1 |
1/2515 (0.04%)
|
1 |
Chronic hepatic failure |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Hepatic cirrhosis |
2/2519 (0.08%)
|
2 |
1/2515 (0.04%)
|
1 |
Hepatic congestion |
4/2519 (0.16%)
|
4 |
0/2515 (0.00%)
|
0 |
Hepatic failure |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Hepatitis acute |
1/2519 (0.04%)
|
1 |
1/2515 (0.04%)
|
1 |
Hepatitis toxic |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Hepatocellular injury |
2/2519 (0.08%)
|
2 |
0/2515 (0.00%)
|
0 |
Ischaemic hepatitis |
4/2519 (0.16%)
|
4 |
2/2515 (0.08%)
|
2 |
Jaundice cholestatic |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Liver disorder |
2/2519 (0.08%)
|
2 |
0/2515 (0.00%)
|
0 |
Liver injury |
5/2519 (0.20%)
|
5 |
2/2515 (0.08%)
|
2 |
Portosplenomesenteric venous thrombosis |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Immune system disorders |
|
|
Amyloidosis |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Infections and infestations |
|
|
Abscess limb |
3/2519 (0.12%)
|
3 |
2/2515 (0.08%)
|
2 |
Acinetobacter bacteraemia |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Amoebic dysentery |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Anal abscess |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Appendicitis |
2/2519 (0.08%)
|
2 |
1/2515 (0.04%)
|
1 |
Arteriovenous fistula site infection |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Atypical pneumonia |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Bacteraemia |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Bacterial sepsis |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Bronchitis |
10/2519 (0.40%)
|
10 |
7/2515 (0.28%)
|
7 |
Bronchitis viral |
2/2519 (0.08%)
|
2 |
1/2515 (0.04%)
|
1 |
Campylobacter gastroenteritis |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Cellulitis |
25/2519 (0.99%)
|
27 |
19/2515 (0.76%)
|
20 |
Cellulitis gangrenous |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Chest wall abscess |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Cholecystitis infective |
0/2519 (0.00%)
|
0 |
2/2515 (0.08%)
|
2 |
Chronic sinusitis |
1/2519 (0.04%)
|
1 |
1/2515 (0.04%)
|
1 |
Clostridium difficile colitis |
2/2519 (0.08%)
|
2 |
0/2515 (0.00%)
|
0 |
Complicated appendicitis |
2/2519 (0.08%)
|
2 |
0/2515 (0.00%)
|
0 |
Cystitis |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Cystitis bacterial |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Device related infection |
4/2519 (0.16%)
|
4 |
2/2515 (0.08%)
|
2 |
Diabetic foot infection |
1/2519 (0.04%)
|
1 |
2/2515 (0.08%)
|
2 |
Diarrhoea infectious |
1/2519 (0.04%)
|
1 |
1/2515 (0.04%)
|
1 |
Disseminated tuberculosis |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Diverticulitis |
1/2519 (0.04%)
|
1 |
2/2515 (0.08%)
|
2 |
Endocarditis |
4/2519 (0.16%)
|
7 |
1/2515 (0.04%)
|
1 |
Enteritis infectious |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Enterobacter bacteraemia |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Enterococcal bacteraemia |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Enterococcal infection |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Enterocolitis viral |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Epididymitis |
2/2519 (0.08%)
|
2 |
0/2515 (0.00%)
|
0 |
Erysipelas |
2/2519 (0.08%)
|
2 |
6/2515 (0.24%)
|
6 |
Escherichia urinary tract infection |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Extradural abscess |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Eye infection bacterial |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Febrile infection |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Fungaemia |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Gangrene |
4/2519 (0.16%)
|
4 |
4/2515 (0.16%)
|
4 |
Gas gangrene |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Gastroenteritis |
16/2519 (0.64%)
|
16 |
10/2515 (0.40%)
|
10 |
Gastroenteritis bacterial |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Gastroenteritis norovirus |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Gastroenteritis salmonella |
1/2519 (0.04%)
|
1 |
1/2515 (0.04%)
|
1 |
Gastroenteritis viral |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Groin abscess |
0/2519 (0.00%)
|
0 |
2/2515 (0.08%)
|
2 |
H1N1 influenza |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Haematoma infection |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Herpes zoster |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Implant site cellulitis |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Implant site infection |
3/2519 (0.12%)
|
3 |
3/2515 (0.12%)
|
3 |
Infected bite |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Infected skin ulcer |
2/2519 (0.08%)
|
2 |
0/2515 (0.00%)
|
0 |
Infection |
0/2519 (0.00%)
|
0 |
3/2515 (0.12%)
|
3 |
Infectious pleural effusion |
1/2519 (0.04%)
|
1 |
1/2515 (0.04%)
|
1 |
Infective exacerbation of chronic obstructive airways disease |
1/2519 (0.04%)
|
1 |
3/2515 (0.12%)
|
3 |
Influenza |
11/2519 (0.44%)
|
11 |
8/2515 (0.32%)
|
8 |
Intervertebral discitis |
1/2519 (0.04%)
|
1 |
1/2515 (0.04%)
|
1 |
Intestinal sepsis |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Klebsiella sepsis |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Liver abscess |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Localised infection |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Lower respiratory tract infection |
7/2519 (0.28%)
|
8 |
4/2515 (0.16%)
|
4 |
Lower respiratory tract infection viral |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Lung infection |
10/2519 (0.40%)
|
12 |
3/2515 (0.12%)
|
3 |
Measles |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Medical device site abscess |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Myocarditis infectious |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Necrotising fasciitis |
2/2519 (0.08%)
|
2 |
0/2515 (0.00%)
|
0 |
Nosocomial infection |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Ophthalmic herpes zoster |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Osteomyelitis |
6/2519 (0.24%)
|
6 |
6/2515 (0.24%)
|
7 |
Osteomyelitis acute |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Osteomyelitis chronic |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Otitis externa |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Parainfluenzae virus infection |
1/2519 (0.04%)
|
1 |
1/2515 (0.04%)
|
1 |
Parotid abscess |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Periodontitis |
1/2519 (0.04%)
|
1 |
1/2515 (0.04%)
|
1 |
Perirectal abscess |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Peritonitis |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Peritonitis bacterial |
2/2519 (0.08%)
|
2 |
0/2515 (0.00%)
|
0 |
Pertussis |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Pneumonia |
104/2519 (4.13%)
|
113 |
116/2515 (4.61%)
|
127 |
Pneumonia bacterial |
3/2519 (0.12%)
|
3 |
4/2515 (0.16%)
|
4 |
Pneumonia chlamydial |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Pneumonia mycoplasmal |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Pneumonia pneumococcal |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Pneumonia respiratory syncytial viral |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Pneumonia staphylococcal |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Pneumonia streptococcal |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Pneumonia viral |
1/2519 (0.04%)
|
1 |
1/2515 (0.04%)
|
1 |
Postoperative wound infection |
2/2519 (0.08%)
|
2 |
1/2515 (0.04%)
|
1 |
Pseudomembranous colitis |
0/2519 (0.00%)
|
0 |
2/2515 (0.08%)
|
2 |
Psoas abscess |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Pulmonary sepsis |
2/2519 (0.08%)
|
2 |
3/2515 (0.12%)
|
3 |
Pyelonephritis |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Pyelonephritis acute |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Pyelonephritis chronic |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Renal abscess |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Respiratory tract infection |
5/2519 (0.20%)
|
5 |
4/2515 (0.16%)
|
4 |
Respiratory tract infection viral |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Salmonella bacteraemia |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Sepsis |
16/2519 (0.64%)
|
16 |
25/2515 (0.99%)
|
25 |
Septic shock |
11/2519 (0.44%)
|
11 |
14/2515 (0.56%)
|
14 |
Serratia bacteraemia |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Sinusitis |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Skin bacterial infection |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Skin infection |
2/2519 (0.08%)
|
4 |
0/2515 (0.00%)
|
0 |
Staphylococcal bacteraemia |
2/2519 (0.08%)
|
2 |
2/2515 (0.08%)
|
2 |
Staphylococcal infection |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Staphylococcal sepsis |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Staphylococcal skin infection |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Streptococcal bacteraemia |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Subcutaneous abscess |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Systemic candida |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Thrombophlebitis septic |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Tooth abscess |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Tracheobronchitis |
2/2519 (0.08%)
|
2 |
0/2515 (0.00%)
|
0 |
Tuberculous pleurisy |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Typhoid fever |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Upper respiratory tract infection |
11/2519 (0.44%)
|
11 |
10/2515 (0.40%)
|
10 |
Ureter abscess |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Urinary tract infection |
20/2519 (0.79%)
|
23 |
16/2515 (0.64%)
|
18 |
Urosepsis |
7/2519 (0.28%)
|
8 |
0/2515 (0.00%)
|
0 |
Vestibular neuronitis |
1/2519 (0.04%)
|
1 |
2/2515 (0.08%)
|
2 |
Viral diarrhoea |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Viral infection |
2/2519 (0.08%)
|
2 |
0/2515 (0.00%)
|
0 |
Viral upper respiratory tract infection |
3/2519 (0.12%)
|
3 |
0/2515 (0.00%)
|
0 |
West Nile viral infection |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Wound infection |
0/2519 (0.00%)
|
0 |
4/2515 (0.16%)
|
4 |
Wound sepsis |
0/2519 (0.00%)
|
0 |
2/2515 (0.08%)
|
2 |
Injury, poisoning and procedural complications |
|
|
Accidental overdose |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Acetabulum fracture |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Alcohol poisoning |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Ankle fracture |
2/2519 (0.08%)
|
2 |
0/2515 (0.00%)
|
0 |
Arterial bypass occlusion |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Arteriovenous fistula site complication |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Asbestosis |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Bone fissure |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Burns second degree |
1/2519 (0.04%)
|
1 |
1/2515 (0.04%)
|
1 |
Burns third degree |
0/2519 (0.00%)
|
0 |
2/2515 (0.08%)
|
2 |
Cardiac valve replacement complication |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Cervical vertebral fracture |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Chest injury |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Concussion |
3/2519 (0.12%)
|
3 |
0/2515 (0.00%)
|
0 |
Contusion |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Coronary vascular graft stenosis |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Costal cartilage fracture |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Craniocerebral injury |
1/2519 (0.04%)
|
1 |
2/2515 (0.08%)
|
2 |
Facial bones fracture |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Fall |
6/2519 (0.24%)
|
6 |
5/2515 (0.20%)
|
5 |
Femoral neck fracture |
2/2519 (0.08%)
|
3 |
8/2515 (0.32%)
|
8 |
Femur fracture |
3/2519 (0.12%)
|
3 |
12/2515 (0.48%)
|
12 |
Fibula fracture |
1/2519 (0.04%)
|
1 |
1/2515 (0.04%)
|
1 |
Foot fracture |
2/2519 (0.08%)
|
2 |
1/2515 (0.04%)
|
1 |
Head injury |
4/2519 (0.16%)
|
4 |
1/2515 (0.04%)
|
1 |
Heat illness |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Hip fracture |
6/2519 (0.24%)
|
6 |
3/2515 (0.12%)
|
3 |
Humerus fracture |
0/2519 (0.00%)
|
0 |
3/2515 (0.12%)
|
3 |
Incision site haemorrhage |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Limb crushing injury |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Limb injury |
1/2519 (0.04%)
|
1 |
5/2515 (0.20%)
|
5 |
Lower limb fracture |
1/2519 (0.04%)
|
1 |
2/2515 (0.08%)
|
2 |
Lumbar vertebral fracture |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Multiple injuries |
0/2519 (0.00%)
|
0 |
2/2515 (0.08%)
|
2 |
Overdose |
1/2519 (0.04%)
|
1 |
2/2515 (0.08%)
|
2 |
Patella fracture |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Pelvic fracture |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Penis injury |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Post procedural haematuria |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Post procedural haemorrhage |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Post procedural hypothyroidism |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
2 |
Postoperative hypotension |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Pubis fracture |
2/2519 (0.08%)
|
2 |
1/2515 (0.04%)
|
1 |
Radius fracture |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Rib fracture |
1/2519 (0.04%)
|
1 |
1/2515 (0.04%)
|
1 |
Road traffic accident |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Sedation complication |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Seroma |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Skin laceration |
3/2519 (0.12%)
|
3 |
0/2515 (0.00%)
|
0 |
Snake bite |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Spinal compression fracture |
1/2519 (0.04%)
|
1 |
1/2515 (0.04%)
|
1 |
Spinal fracture |
0/2519 (0.00%)
|
0 |
2/2515 (0.08%)
|
2 |
Subdural haematoma |
6/2519 (0.24%)
|
6 |
1/2515 (0.04%)
|
1 |
Subdural haemorrhage |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Suture related complication |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Tendon rupture |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Thermal burn |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Thoracic vertebral fracture |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Tibia fracture |
1/2519 (0.04%)
|
1 |
2/2515 (0.08%)
|
2 |
Toxicity to various agents |
1/2519 (0.04%)
|
1 |
6/2515 (0.24%)
|
6 |
Traumatic fracture |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Traumatic liver injury |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Traumatic ulcer |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Upper limb fracture |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Urinary retention postoperative |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Vascular graft occlusion |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Vascular pseudoaneurysm |
1/2519 (0.04%)
|
1 |
3/2515 (0.12%)
|
3 |
Vasoplegia syndrome |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Wrist fracture |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Investigations |
|
|
Alanine aminotransferase increased |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Angiocardiogram |
1/2519 (0.04%)
|
1 |
1/2515 (0.04%)
|
1 |
Anticoagulation drug level above therapeutic |
2/2519 (0.08%)
|
2 |
1/2515 (0.04%)
|
1 |
Aspartate aminotransferase increased |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Blood bilirubin increased |
0/2519 (0.00%)
|
0 |
2/2515 (0.08%)
|
2 |
Blood creatinine increased |
1/2519 (0.04%)
|
1 |
1/2515 (0.04%)
|
1 |
Blood potassium increased |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Blood sodium decreased |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Blood urea increased |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Bone density abnormal |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Cardiac index abnormal |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Cardiac stress test abnormal |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Catheterisation cardiac |
1/2519 (0.04%)
|
1 |
1/2515 (0.04%)
|
1 |
Cortisol decreased |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Ejection fraction decreased |
0/2519 (0.00%)
|
0 |
3/2515 (0.12%)
|
3 |
Gamma-glutamyltransferase increased |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Haemoglobin decreased |
1/2519 (0.04%)
|
1 |
1/2515 (0.04%)
|
1 |
Heart rate irregular |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Hepatic enzyme abnormal |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Hepatic enzyme increased |
2/2519 (0.08%)
|
2 |
2/2515 (0.08%)
|
2 |
Influenza A virus test positive |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
International normalised ratio increased |
1/2519 (0.04%)
|
1 |
2/2515 (0.08%)
|
2 |
Liver function test abnormal |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Liver function test increased |
1/2519 (0.04%)
|
1 |
1/2515 (0.04%)
|
1 |
Occult blood positive |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Transaminases increased |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Troponin increased |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Weight decreased |
1/2519 (0.04%)
|
1 |
1/2515 (0.04%)
|
1 |
Weight increased |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Metabolism and nutrition disorders |
|
|
Cachexia |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Dehydration |
7/2519 (0.28%)
|
7 |
12/2515 (0.48%)
|
13 |
Diabetes mellitus |
5/2519 (0.20%)
|
6 |
10/2515 (0.40%)
|
11 |
Diabetes mellitus inadequate control |
0/2519 (0.00%)
|
0 |
2/2515 (0.08%)
|
2 |
Diabetes with hyperosmolarity |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Diabetic ketoacidosis |
4/2519 (0.16%)
|
4 |
2/2515 (0.08%)
|
2 |
Diabetic metabolic decompensation |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Fluid overload |
2/2519 (0.08%)
|
2 |
1/2515 (0.04%)
|
1 |
Gout |
10/2519 (0.40%)
|
12 |
12/2515 (0.48%)
|
14 |
Hyperammonaemia |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Hypercalcaemia |
1/2519 (0.04%)
|
1 |
1/2515 (0.04%)
|
1 |
Hyperglycaemia |
6/2519 (0.24%)
|
6 |
4/2515 (0.16%)
|
4 |
Hyperglycaemic hyperosmolar nonketotic syndrome |
3/2519 (0.12%)
|
3 |
2/2515 (0.08%)
|
2 |
Hyperkalaemia |
13/2519 (0.52%)
|
13 |
14/2515 (0.56%)
|
14 |
Hypernatraemia |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Hyperosmolar state |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Hypoalbuminaemia |
0/2519 (0.00%)
|
0 |
2/2515 (0.08%)
|
2 |
Hypocalcaemia |
2/2519 (0.08%)
|
2 |
0/2515 (0.00%)
|
0 |
Hypochloraemia |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Hypoglycaemia |
12/2519 (0.48%)
|
13 |
9/2515 (0.36%)
|
9 |
Hypokalaemia |
7/2519 (0.28%)
|
8 |
7/2515 (0.28%)
|
7 |
Hypomagnesaemia |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Hyponatraemia |
5/2519 (0.20%)
|
5 |
5/2515 (0.20%)
|
5 |
Hypophosphataemia |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Hypovolaemia |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Ketoacidosis |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Marasmus |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Metabolic acidosis |
2/2519 (0.08%)
|
2 |
4/2515 (0.16%)
|
4 |
Metabolic alkalosis |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Mineral metabolism disorder |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Type 2 diabetes mellitus |
5/2519 (0.20%)
|
5 |
8/2515 (0.32%)
|
8 |
Musculoskeletal and connective tissue disorders |
|
|
Arthralgia |
4/2519 (0.16%)
|
4 |
1/2515 (0.04%)
|
1 |
Arthritis |
0/2519 (0.00%)
|
0 |
2/2515 (0.08%)
|
2 |
Back pain |
6/2519 (0.24%)
|
6 |
3/2515 (0.12%)
|
3 |
Cervical spinal stenosis |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Chondritis |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Enthesopathy |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Gouty arthritis |
7/2519 (0.28%)
|
9 |
6/2515 (0.24%)
|
7 |
Gouty tophus |
0/2519 (0.00%)
|
0 |
2/2515 (0.08%)
|
2 |
Haematoma muscle |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Intervertebral disc disorder |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Intervertebral disc protrusion |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Lumbar spinal stenosis |
1/2519 (0.04%)
|
2 |
5/2515 (0.20%)
|
5 |
Muscular weakness |
1/2519 (0.04%)
|
1 |
1/2515 (0.04%)
|
1 |
Musculoskeletal chest pain |
1/2519 (0.04%)
|
1 |
4/2515 (0.16%)
|
4 |
Musculoskeletal pain |
4/2519 (0.16%)
|
4 |
0/2515 (0.00%)
|
0 |
Osteoarthritis |
3/2519 (0.12%)
|
3 |
2/2515 (0.08%)
|
2 |
Osteonecrosis |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Pain in extremity |
1/2519 (0.04%)
|
1 |
3/2515 (0.12%)
|
4 |
Pathological fracture |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Polyarthritis |
1/2519 (0.04%)
|
1 |
1/2515 (0.04%)
|
1 |
Rhabdomyolysis |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Rheumatoid arthritis |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Sjogren's syndrome |
1/2519 (0.04%)
|
1 |
1/2515 (0.04%)
|
1 |
Spinal pain |
1/2519 (0.04%)
|
1 |
3/2515 (0.12%)
|
3 |
Spinal stenosis |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Spondylitis |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Tendonitis |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
|
Adenocarcinoma gastric |
3/2519 (0.12%)
|
3 |
1/2515 (0.04%)
|
1 |
Adenocarcinoma of colon |
2/2519 (0.08%)
|
2 |
1/2515 (0.04%)
|
1 |
Adenocarcinoma pancreas |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Adrenal gland cancer metastatic |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Angiocentric lymphoma |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Basal cell carcinoma |
1/2519 (0.04%)
|
1 |
2/2515 (0.08%)
|
2 |
Benign gastric neoplasm |
1/2519 (0.04%)
|
1 |
1/2515 (0.04%)
|
1 |
Benign neoplasm of bladder |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Bladder cancer |
2/2519 (0.08%)
|
2 |
0/2515 (0.00%)
|
0 |
Bladder cancer recurrent |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Bladder neoplasm |
1/2519 (0.04%)
|
1 |
1/2515 (0.04%)
|
1 |
Bladder transitional cell carcinoma |
0/2519 (0.00%)
|
0 |
2/2515 (0.08%)
|
2 |
Bowen's disease |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
2 |
Breast cancer |
0/2519 (0.00%)
|
0 |
4/2515 (0.16%)
|
4 |
Bronchial carcinoma |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Chronic lymphocytic leukaemia |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Colon adenoma |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Colon cancer |
1/2519 (0.04%)
|
1 |
1/2515 (0.04%)
|
1 |
Colon neoplasm |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Cutaneous T-cell lymphoma |
1/2519 (0.04%)
|
2 |
0/2515 (0.00%)
|
0 |
Diffuse large B-cell lymphoma |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Gastric cancer |
3/2519 (0.12%)
|
3 |
1/2515 (0.04%)
|
1 |
Glioblastoma multiforme |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Hepatic cancer |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Hepatic cancer metastatic |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Hepatic neoplasm |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Hepatobiliary cancer |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Hepatocellular carcinoma |
0/2519 (0.00%)
|
0 |
2/2515 (0.08%)
|
2 |
Inflammatory pseudotumour |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Lung adenocarcinoma |
1/2519 (0.04%)
|
1 |
1/2515 (0.04%)
|
1 |
Lung cancer metastatic |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Lung neoplasm malignant |
0/2519 (0.00%)
|
0 |
4/2515 (0.16%)
|
4 |
Lymphoma |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Lymphoproliferative disorder |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Malignant melanoma |
1/2519 (0.04%)
|
1 |
1/2515 (0.04%)
|
1 |
Meningioma |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Metastases to abdominal cavity |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Metastases to bone |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Metastases to central nervous system |
1/2519 (0.04%)
|
1 |
1/2515 (0.04%)
|
1 |
Metastases to lung |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Metastases to lymph nodes |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Metastatic neoplasm |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Myelodysplastic syndrome |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Oesophageal carcinoma |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Oropharyngeal cancer |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Oropharyngeal squamous cell carcinoma |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Ovarian cancer |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Pancreatic carcinoma |
1/2519 (0.04%)
|
1 |
1/2515 (0.04%)
|
1 |
Pancreatic carcinoma metastatic |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Plasma cell myeloma |
1/2519 (0.04%)
|
1 |
2/2515 (0.08%)
|
2 |
Plasmacytoma |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Polycythaemia vera |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Prostate cancer |
2/2519 (0.08%)
|
2 |
5/2515 (0.20%)
|
5 |
Prostate cancer metastatic |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Rectal cancer |
0/2519 (0.00%)
|
0 |
2/2515 (0.08%)
|
2 |
Rectosigmoid cancer |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Renal cancer |
1/2519 (0.04%)
|
1 |
1/2515 (0.04%)
|
1 |
Renal neoplasm |
3/2519 (0.12%)
|
3 |
0/2515 (0.00%)
|
0 |
Retroperitoneal cancer |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Skin cancer |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Squamous cell carcinoma |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Squamous cell carcinoma of head and neck |
2/2519 (0.08%)
|
2 |
0/2515 (0.00%)
|
0 |
Squamous cell carcinoma of lung |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Squamous cell carcinoma of the oral cavity |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Sweat gland tumour |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
T-cell lymphoma |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Tongue neoplasm malignant stage unspecified |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Tumour ulceration |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Uterine cancer |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Uterine leiomyoma |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Waldenstrom's macroglobulinaemia |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Nervous system disorders |
|
|
Altered state of consciousness |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Autonomic neuropathy |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Axonal neuropathy |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Brain hypoxia |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Brain injury |
2/2519 (0.08%)
|
2 |
1/2515 (0.04%)
|
1 |
Brain oedema |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Carotid artery stenosis |
0/2519 (0.00%)
|
0 |
3/2515 (0.12%)
|
3 |
Cauda equina syndrome |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Cerebral artery embolism |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Cerebral artery stenosis |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Cerebral haemorrhage |
1/2519 (0.04%)
|
1 |
1/2515 (0.04%)
|
1 |
Cerebral infarction |
1/2519 (0.04%)
|
1 |
2/2515 (0.08%)
|
2 |
Cerebral ischaemia |
1/2519 (0.04%)
|
1 |
1/2515 (0.04%)
|
1 |
Cerebrovascular accident |
3/2519 (0.12%)
|
3 |
6/2515 (0.24%)
|
6 |
Cerebrovascular disorder |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Cognitive disorder |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Coma |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Dementia |
2/2519 (0.08%)
|
2 |
0/2515 (0.00%)
|
0 |
Dementia Alzheimer's type |
0/2519 (0.00%)
|
0 |
2/2515 (0.08%)
|
2 |
Diabetic neuropathy |
0/2519 (0.00%)
|
0 |
2/2515 (0.08%)
|
2 |
Dizziness |
6/2519 (0.24%)
|
6 |
2/2515 (0.08%)
|
2 |
Dizziness postural |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Dysarthria |
0/2519 (0.00%)
|
0 |
2/2515 (0.08%)
|
2 |
Encephalopathy |
0/2519 (0.00%)
|
0 |
2/2515 (0.08%)
|
2 |
Facial paralysis |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Generalised tonic-clonic seizure |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Headache |
1/2519 (0.04%)
|
1 |
1/2515 (0.04%)
|
1 |
Hemiparesis |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Hepatic encephalopathy |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Hydrocephalus |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Hypoxic-ischaemic encephalopathy |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Ischaemic stroke |
2/2519 (0.08%)
|
2 |
2/2515 (0.08%)
|
2 |
Lethargy |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Loss of consciousness |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Lumbar radiculopathy |
2/2519 (0.08%)
|
2 |
0/2515 (0.00%)
|
0 |
Metabolic encephalopathy |
1/2519 (0.04%)
|
1 |
2/2515 (0.08%)
|
2 |
Myelopathy |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Myoclonus |
0/2519 (0.00%)
|
0 |
2/2515 (0.08%)
|
2 |
Neuropathy peripheral |
2/2519 (0.08%)
|
2 |
0/2515 (0.00%)
|
0 |
Paraesthesia |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Post stroke epilepsy |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Presyncope |
4/2519 (0.16%)
|
4 |
0/2515 (0.00%)
|
0 |
Sciatica |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Seizure |
2/2519 (0.08%)
|
2 |
2/2515 (0.08%)
|
2 |
Spinal cord compression |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Status epilepticus |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Subarachnoid haemorrhage |
1/2519 (0.04%)
|
1 |
1/2515 (0.04%)
|
1 |
Syncope |
43/2519 (1.71%)
|
45 |
33/2515 (1.31%)
|
35 |
Tension headache |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Toxic encephalopathy |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Transient ischaemic attack |
2/2519 (0.08%)
|
2 |
2/2515 (0.08%)
|
2 |
Vascular dementia |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Vertebrobasilar insufficiency |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Product Issues |
|
|
Device battery issue |
1/2519 (0.04%)
|
1 |
4/2515 (0.16%)
|
4 |
Device dislocation |
0/2519 (0.00%)
|
0 |
2/2515 (0.08%)
|
3 |
Device failure |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Device ineffective |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Device malfunction |
1/2519 (0.04%)
|
1 |
4/2515 (0.16%)
|
4 |
Lead dislodgement |
1/2519 (0.04%)
|
2 |
0/2515 (0.00%)
|
0 |
Psychiatric disorders |
|
|
Alcohol abuse |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Anxiety |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Anxiety disorder |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Confusional state |
1/2519 (0.04%)
|
1 |
2/2515 (0.08%)
|
2 |
Delirium |
0/2519 (0.00%)
|
0 |
3/2515 (0.12%)
|
4 |
Depression |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Drug use disorder |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Mental status changes |
0/2519 (0.00%)
|
0 |
2/2515 (0.08%)
|
2 |
Panic attack |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Suicide attempt |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Renal and urinary disorders |
|
|
Acute kidney injury |
66/2519 (2.62%)
|
69 |
51/2515 (2.03%)
|
53 |
Azotaemia |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Bladder cyst |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Bladder mass |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Calculus bladder |
2/2519 (0.08%)
|
2 |
0/2515 (0.00%)
|
0 |
Chronic kidney disease |
40/2519 (1.59%)
|
42 |
31/2515 (1.23%)
|
31 |
Costovertebral angle tenderness |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
End stage renal disease |
2/2519 (0.08%)
|
2 |
1/2515 (0.04%)
|
1 |
Haematuria |
3/2519 (0.12%)
|
3 |
7/2515 (0.28%)
|
7 |
Nephritis |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Nephrolithiasis |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Nephropathy |
3/2519 (0.12%)
|
3 |
1/2515 (0.04%)
|
1 |
Nephrotic syndrome |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Renal artery stenosis |
1/2519 (0.04%)
|
1 |
1/2515 (0.04%)
|
1 |
Renal colic |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Renal cyst |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Renal failure |
24/2519 (0.95%)
|
25 |
30/2515 (1.19%)
|
31 |
Renal impairment |
6/2519 (0.24%)
|
6 |
7/2515 (0.28%)
|
7 |
Renal infarct |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Renal mass |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Urate nephropathy |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Ureterolithiasis |
2/2519 (0.08%)
|
2 |
0/2515 (0.00%)
|
0 |
Urethral stenosis |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Urinary retention |
2/2519 (0.08%)
|
2 |
2/2515 (0.08%)
|
2 |
Reproductive system and breast disorders |
|
|
Benign prostatic hyperplasia |
1/2519 (0.04%)
|
1 |
8/2515 (0.32%)
|
8 |
Endometrial hyperplasia |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Respiratory, thoracic and mediastinal disorders |
|
|
Acute pulmonary oedema |
4/2519 (0.16%)
|
5 |
1/2515 (0.04%)
|
1 |
Acute respiratory failure |
9/2519 (0.36%)
|
9 |
7/2515 (0.28%)
|
7 |
Asthma |
6/2519 (0.24%)
|
6 |
4/2515 (0.16%)
|
6 |
Atelectasis |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Bronchial haemorrhage |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Bronchitis chronic |
2/2519 (0.08%)
|
2 |
0/2515 (0.00%)
|
0 |
Bronchospasm |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Chronic obstructive pulmonary disease |
38/2519 (1.51%)
|
51 |
30/2515 (1.19%)
|
50 |
Chylothorax |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Cough |
0/2519 (0.00%)
|
0 |
2/2515 (0.08%)
|
2 |
Dyspnoea |
11/2519 (0.44%)
|
11 |
7/2515 (0.28%)
|
7 |
Dyspnoea exertional |
0/2519 (0.00%)
|
0 |
3/2515 (0.12%)
|
3 |
Epistaxis |
1/2519 (0.04%)
|
1 |
2/2515 (0.08%)
|
2 |
Haemoptysis |
0/2519 (0.00%)
|
0 |
2/2515 (0.08%)
|
3 |
Haemothorax |
0/2519 (0.00%)
|
0 |
2/2515 (0.08%)
|
2 |
Hyperventilation |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Hypoxia |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Interstitial lung disease |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Obstructive airways disorder |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Pleural effusion |
6/2519 (0.24%)
|
8 |
13/2515 (0.52%)
|
15 |
Pleurisy |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Pleuritic pain |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Pneumonia aspiration |
6/2519 (0.24%)
|
7 |
2/2515 (0.08%)
|
2 |
Pneumothorax |
2/2519 (0.08%)
|
2 |
4/2515 (0.16%)
|
4 |
Pulmonary congestion |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Pulmonary embolism |
4/2519 (0.16%)
|
4 |
6/2515 (0.24%)
|
6 |
Pulmonary haematoma |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Pulmonary hypertension |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Pulmonary infarction |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Pulmonary mass |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Pulmonary oedema |
4/2519 (0.16%)
|
4 |
3/2515 (0.12%)
|
4 |
Respiratory disorder |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Respiratory failure |
3/2519 (0.12%)
|
3 |
5/2515 (0.20%)
|
5 |
Rhinitis hypertrophic |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Sleep apnoea syndrome |
1/2519 (0.04%)
|
1 |
1/2515 (0.04%)
|
1 |
Tonsillar haemorrhage |
1/2519 (0.04%)
|
2 |
0/2515 (0.00%)
|
0 |
Skin and subcutaneous tissue disorders |
|
|
Angioedema |
1/2519 (0.04%)
|
1 |
1/2515 (0.04%)
|
1 |
Dermatitis bullous |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Diabetic foot |
1/2519 (0.04%)
|
1 |
4/2515 (0.16%)
|
4 |
Drug eruption |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Ecchymosis |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Haemorrhage subcutaneous |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Henoch-Schonlein purpura |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Neurodermatitis |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Psoriasis |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Skin necrosis |
1/2519 (0.04%)
|
1 |
1/2515 (0.04%)
|
1 |
Skin ulcer |
5/2519 (0.20%)
|
5 |
9/2515 (0.36%)
|
14 |
Stasis dermatitis |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Stevens-Johnson syndrome |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Urticaria |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Surgical and medical procedures |
|
|
Aortic aneurysm repair |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Arrhythmia prophylaxis |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Cardiac pacemaker replacement |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Cardiac rehabilitation therapy |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Cardiac resynchronisation therapy |
2/2519 (0.08%)
|
2 |
7/2515 (0.28%)
|
7 |
Cardiovascular event prophylaxis |
1/2519 (0.04%)
|
1 |
4/2515 (0.16%)
|
4 |
Cardioversion |
1/2519 (0.04%)
|
3 |
0/2515 (0.00%)
|
0 |
Central venous catheter removal |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Gastrectomy |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Implantable defibrillator insertion |
5/2519 (0.20%)
|
5 |
2/2515 (0.08%)
|
2 |
Implantable defibrillator removal |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Implantable defibrillator replacement |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Inguinal hernia repair |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Intraocular lens implant |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Leg amputation |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Nephroprotective therapy |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Therapeutic procedure |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Toe operation |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Vascular disorders |
|
|
Aortic aneurysm |
1/2519 (0.04%)
|
1 |
2/2515 (0.08%)
|
2 |
Aortic dissection |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Aortic stenosis |
1/2519 (0.04%)
|
1 |
1/2515 (0.04%)
|
1 |
Arterial occlusive disease |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Bleeding varicose vein |
1/2519 (0.04%)
|
1 |
2/2515 (0.08%)
|
2 |
Circulatory collapse |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Deep vein thrombosis |
1/2519 (0.04%)
|
1 |
1/2515 (0.04%)
|
1 |
Diabetic vascular disorder |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Dry gangrene |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Extremity necrosis |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Haematoma |
4/2519 (0.16%)
|
4 |
2/2515 (0.08%)
|
3 |
Haemorrhagic vasculitis |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Hypertension |
5/2519 (0.20%)
|
5 |
4/2515 (0.16%)
|
4 |
Hypertensive crisis |
1/2519 (0.04%)
|
1 |
5/2515 (0.20%)
|
5 |
Hypotension |
33/2519 (1.31%)
|
34 |
44/2515 (1.75%)
|
45 |
Hypovolaemic shock |
2/2519 (0.08%)
|
2 |
0/2515 (0.00%)
|
0 |
Iliac artery occlusion |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Intermittent claudication |
2/2519 (0.08%)
|
2 |
1/2515 (0.04%)
|
1 |
Ischaemia |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Lymphorrhoea |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Orthostatic hypotension |
6/2519 (0.24%)
|
6 |
1/2515 (0.04%)
|
1 |
Peripheral arterial occlusive disease |
6/2519 (0.24%)
|
6 |
11/2515 (0.44%)
|
12 |
Peripheral artery occlusion |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Peripheral artery stenosis |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Peripheral artery thrombosis |
0/2519 (0.00%)
|
0 |
1/2515 (0.04%)
|
1 |
Peripheral embolism |
1/2519 (0.04%)
|
1 |
2/2515 (0.08%)
|
2 |
Peripheral ischaemia |
2/2519 (0.08%)
|
2 |
3/2515 (0.12%)
|
3 |
Peripheral vascular disorder |
4/2519 (0.16%)
|
6 |
3/2515 (0.12%)
|
3 |
Peripheral venous disease |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Shock |
1/2519 (0.04%)
|
1 |
1/2515 (0.04%)
|
1 |
Shock haemorrhagic |
0/2519 (0.00%)
|
0 |
2/2515 (0.08%)
|
2 |
Thrombophlebitis |
1/2519 (0.04%)
|
1 |
2/2515 (0.08%)
|
2 |
Varicose vein |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Varicose vein ruptured |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Vascular occlusion |
1/2519 (0.04%)
|
1 |
0/2515 (0.00%)
|
0 |
Term from vocabulary, MedDRA 22.0
Indicates events were collected by systematic assessment
|
|
Frequency Threshold for Reporting Other Adverse Events
|
5%
|
|
Vericiguat
|
Placebo
|
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Total |
958/2519 (38.03%)
|
|
925/2515 (36.78%)
|
|
Blood and lymphatic system disorders |
|
|
Anaemia |
165/2519 (6.55%)
|
181 |
134/2515 (5.33%)
|
139 |
Cardiac disorders |
|
|
Cardiac failure |
160/2519 (6.35%)
|
219 |
157/2515 (6.24%)
|
221 |
Gastrointestinal disorders |
|
|
Diarrhoea |
127/2519 (5.04%)
|
141 |
120/2515 (4.77%)
|
136 |
Infections and infestations |
|
|
Nasopharyngitis |
126/2519 (5.00%)
|
153 |
131/2515 (5.21%)
|
163 |
Metabolism and nutrition disorders |
|
|
Hyperkalaemia |
112/2519 (4.45%)
|
124 |
138/2515 (5.49%)
|
167 |
Nervous system disorders |
|
|
Dizziness |
169/2519 (6.71%)
|
195 |
152/2515 (6.04%)
|
169 |
Respiratory, thoracic and mediastinal disorders |
|
|
Dyspnoea |
127/2519 (5.04%)
|
161 |
132/2515 (5.25%)
|
158 |
Vascular disorders |
|
|
Hypotension |
369/2519 (14.65%)
|
487 |
331/2515 (13.16%)
|
437 |
Term from vocabulary, MedDRA 22.0
Indicates events were collected by systematic assessment
|