Time Frame |
From first dose date (including) till the end of study
|
Adverse Event Reporting Description |
The number of patients at risk by study arm in the Adverse Events Results is based on Safety population, defined as patients who were randomized and received at least one dose of study drug. It leads to 3716 safety subjects in Betrixaban arm and 3716 in Enoxaprin arm which corresponds to the number of patients at risk in Adverse Events Results.
|
|
Arm/Group Title
|
Betrixaban
|
Enoxaparin
|
Arm/Group Description |
Daily oral (PO) betrixaban capsules...
|
Daily subcutaneous (SQ) injections ...
|
Arm/Group Description |
Daily oral (PO) betrixaban capsules for 35 to 42 days and subcutaneous (SQ) injections of enoxaparin placebo for 10 ± 4 days
|
Daily subcutaneous (SQ) injections of enoxaparin for 10 ± 4 days and oral (PO) betrixaban placebo capsules for 35 to 42 days
|
|
|
Betrixaban
|
Enoxaparin
|
|
Affected / at Risk (%) |
Affected / at Risk (%) |
Total |
--/-- |
--/-- |
|
|
Betrixaban
|
Enoxaparin
|
|
Affected / at Risk (%) |
Affected / at Risk (%) |
Total |
657/3716 (17.68%) |
615/3716 (16.55%) |
Blood and lymphatic system disorders |
|
|
Anaemia |
8/3716 (0.22%) |
4/3716 (0.11%) |
Iron deficiency anaemia |
1/3716 (0.03%) |
1/3716 (0.03%) |
Thrombocytopenia |
1/3716 (0.03%) |
1/3716 (0.03%) |
Coagulopathy |
1/3716 (0.03%) |
0/3716 (0.00%) |
Haemorrhagic anaemia |
1/3716 (0.03%) |
0/3716 (0.00%) |
Polycythaemia |
0/3716 (0.00%) |
1/3716 (0.03%) |
Spontaneous haematoma |
1/3716 (0.03%) |
0/3716 (0.00%) |
Cardiac disorders |
|
|
Cardiac failure |
83/3716 (2.23%) |
66/3716 (1.78%) |
Atrial fibrillation |
11/3716 (0.30%) |
23/3716 (0.62%) |
Cardiac failure congestive |
10/3716 (0.27%) |
15/3716 (0.40%) |
Cardiac failure acute |
10/3716 (0.27%) |
12/3716 (0.32%) |
Cardiac failure chronic |
13/3716 (0.35%) |
9/3716 (0.24%) |
Acute myocardial infarction |
6/3716 (0.16%) |
12/3716 (0.32%) |
Myocardial infarction |
7/3716 (0.19%) |
10/3716 (0.27%) |
Cardiogenic shock |
9/3716 (0.24%) |
6/3716 (0.16%) |
Cardiac arrest |
7/3716 (0.19%) |
5/3716 (0.13%) |
Coronary artery disease |
8/3716 (0.22%) |
3/3716 (0.08%) |
Angina unstable |
3/3716 (0.08%) |
7/3716 (0.19%) |
Acute coronary syndrome |
6/3716 (0.16%) |
3/3716 (0.08%) |
Atrioventricular block complete |
5/3716 (0.13%) |
3/3716 (0.08%) |
Myocardial ischaemia |
2/3716 (0.05%) |
6/3716 (0.16%) |
Angina pectoris |
5/3716 (0.13%) |
0/3716 (0.00%) |
Cardio-respiratory arrest |
3/3716 (0.08%) |
2/3716 (0.05%) |
Cardiopulmonary failure |
1/3716 (0.03%) |
4/3716 (0.11%) |
Ventricular tachycardia |
4/3716 (0.11%) |
1/3716 (0.03%) |
Coronary artery insufficiency |
2/3716 (0.05%) |
2/3716 (0.05%) |
Atrioventricular block |
1/3716 (0.03%) |
2/3716 (0.05%) |
Cardiovascular disorder |
1/3716 (0.03%) |
2/3716 (0.05%) |
Cardiovascular insufficiency |
0/3716 (0.00%) |
3/3716 (0.08%) |
Ventricular fibrillation |
1/3716 (0.03%) |
2/3716 (0.05%) |
Atrial flutter |
0/3716 (0.00%) |
2/3716 (0.05%) |
Atrioventricular block second degree |
1/3716 (0.03%) |
1/3716 (0.03%) |
Bradycardia |
2/3716 (0.05%) |
0/3716 (0.00%) |
Cardiomyopathy |
1/3716 (0.03%) |
1/3716 (0.03%) |
Cor pulmonale |
1/3716 (0.03%) |
1/3716 (0.03%) |
Pericardial effusion |
1/3716 (0.03%) |
1/3716 (0.03%) |
Sick sinus syndrome |
1/3716 (0.03%) |
1/3716 (0.03%) |
Supraventricular tachycardia |
2/3716 (0.05%) |
0/3716 (0.00%) |
Acute left ventricular failure |
0/3716 (0.00%) |
1/3716 (0.03%) |
Aortic valve incompetence |
0/3716 (0.00%) |
1/3716 (0.03%) |
Aortic valve stenosis |
0/3716 (0.00%) |
1/3716 (0.03%) |
Cardiac ventricular thrombosis |
1/3716 (0.03%) |
0/3716 (0.00%) |
Congestive cardiomyopathy |
0/3716 (0.00%) |
1/3716 (0.03%) |
Coronary artery stenosis |
0/3716 (0.00%) |
1/3716 (0.03%) |
Ischaemic cardiomyopathy |
1/3716 (0.03%) |
0/3716 (0.00%) |
Mitral valve incompetence |
0/3716 (0.00%) |
1/3716 (0.03%) |
Pericardial haemorrhage |
1/3716 (0.03%) |
0/3716 (0.00%) |
Sinoatrial block |
0/3716 (0.00%) |
1/3716 (0.03%) |
Stress cardiomyopathy |
0/3716 (0.00%) |
1/3716 (0.03%) |
Tricuspid valve incompetence |
1/3716 (0.03%) |
0/3716 (0.00%) |
Trifascicular block |
1/3716 (0.03%) |
0/3716 (0.00%) |
Ventricular extrasystoles |
1/3716 (0.03%) |
0/3716 (0.00%) |
Ventricular hypokinesia |
0/3716 (0.00%) |
1/3716 (0.03%) |
Ear and labyrinth disorders |
|
|
Vertigo |
1/3716 (0.03%) |
1/3716 (0.03%) |
Endocrine disorders |
|
|
Goitre |
1/3716 (0.03%) |
0/3716 (0.00%) |
Hypoparathyroidism |
0/3716 (0.00%) |
1/3716 (0.03%) |
Eye disorders |
|
|
Conjunctival haemorrhage |
1/3716 (0.03%) |
1/3716 (0.03%) |
Diabetic retinopathy |
0/3716 (0.00%) |
1/3716 (0.03%) |
Retinal haemorrhage |
0/3716 (0.00%) |
1/3716 (0.03%) |
Gastrointestinal disorders |
|
|
Gastrointestinal haemorrhage |
18/3716 (0.48%) |
5/3716 (0.13%) |
Rectal haemorrhage |
15/3716 (0.40%) |
3/3716 (0.08%) |
Abdominal pain |
2/3716 (0.05%) |
3/3716 (0.08%) |
Gastric ulcer haemorrhage |
3/3716 (0.08%) |
2/3716 (0.05%) |
Intestinal obstruction |
1/3716 (0.03%) |
4/3716 (0.11%) |
Haemorrhoidal haemorrhage |
1/3716 (0.03%) |
3/3716 (0.08%) |
Vomiting |
0/3716 (0.00%) |
4/3716 (0.11%) |
Colitis |
0/3716 (0.00%) |
3/3716 (0.08%) |
Diarrhoea |
1/3716 (0.03%) |
2/3716 (0.05%) |
Duodenal ulcer haemorrhage |
2/3716 (0.05%) |
1/3716 (0.03%) |
Upper gastrointestinal haemorrhage |
1/3716 (0.03%) |
2/3716 (0.05%) |
Gastric haemorrhage |
2/3716 (0.05%) |
0/3716 (0.00%) |
Gastric ulcer |
2/3716 (0.05%) |
0/3716 (0.00%) |
Gingival bleeding |
1/3716 (0.03%) |
1/3716 (0.03%) |
Intestinal haemorrhage |
0/3716 (0.00%) |
2/3716 (0.05%) |
Intestinal ischaemia |
2/3716 (0.05%) |
0/3716 (0.00%) |
Melaena |
1/3716 (0.03%) |
1/3716 (0.03%) |
Pharyngo-oesophageal diverticulum |
1/3716 (0.03%) |
1/3716 (0.03%) |
Abdominal strangulated hernia |
1/3716 (0.03%) |
0/3716 (0.00%) |
Abdominal wall haematoma |
1/3716 (0.03%) |
0/3716 (0.00%) |
Acute abdomen |
0/3716 (0.00%) |
1/3716 (0.03%) |
Constipation |
1/3716 (0.03%) |
0/3716 (0.00%) |
Duodenal ulcer |
1/3716 (0.03%) |
0/3716 (0.00%) |
Faecaloma |
0/3716 (0.00%) |
1/3716 (0.03%) |
Gastric ulcer perforation |
0/3716 (0.00%) |
1/3716 (0.03%) |
Gastroduodenal haemorrhage |
1/3716 (0.03%) |
0/3716 (0.00%) |
Gastrointestinal disorder |
1/3716 (0.03%) |
0/3716 (0.00%) |
Gastrointestinal necrosis |
0/3716 (0.00%) |
1/3716 (0.03%) |
Gastrointestinal polyp haemorrhage |
1/3716 (0.03%) |
0/3716 (0.00%) |
Intestinal perforation |
0/3716 (0.00%) |
1/3716 (0.03%) |
Large intestinal haemorrhage |
1/3716 (0.03%) |
0/3716 (0.00%) |
Lower gastrointestinal haemorrhage |
1/3716 (0.03%) |
0/3716 (0.00%) |
Mechanical ileus |
0/3716 (0.00%) |
1/3716 (0.03%) |
Nausea |
0/3716 (0.00%) |
1/3716 (0.03%) |
Pancreatitis |
0/3716 (0.00%) |
1/3716 (0.03%) |
Pancreatitis acute |
1/3716 (0.03%) |
0/3716 (0.00%) |
Peptic ulcer haemorrhage |
0/3716 (0.00%) |
1/3716 (0.03%) |
Volvulus |
0/3716 (0.00%) |
1/3716 (0.03%) |
General disorders |
|
|
Death |
9/3716 (0.24%) |
16/3716 (0.43%) |
Sudden cardiac death |
6/3716 (0.16%) |
5/3716 (0.13%) |
Multi-organ failure |
3/3716 (0.08%) |
6/3716 (0.16%) |
General physical health deterioration |
6/3716 (0.16%) |
2/3716 (0.05%) |
Sudden death |
3/3716 (0.08%) |
3/3716 (0.08%) |
Non-cardiac chest pain |
2/3716 (0.05%) |
1/3716 (0.03%) |
Pyrexia |
3/3716 (0.08%) |
0/3716 (0.00%) |
Cardiac death |
1/3716 (0.03%) |
1/3716 (0.03%) |
Chest pain |
1/3716 (0.03%) |
1/3716 (0.03%) |
Fatigue |
1/3716 (0.03%) |
1/3716 (0.03%) |
Asthenia |
0/3716 (0.00%) |
1/3716 (0.03%) |
Catheter site haemorrhage |
0/3716 (0.00%) |
1/3716 (0.03%) |
Condition aggravated |
1/3716 (0.03%) |
0/3716 (0.00%) |
Device malfunction |
1/3716 (0.03%) |
0/3716 (0.00%) |
Discomfort |
0/3716 (0.00%) |
1/3716 (0.03%) |
Fibrosis |
1/3716 (0.03%) |
0/3716 (0.00%) |
Generalised oedema |
0/3716 (0.00%) |
1/3716 (0.03%) |
Hyperthermia |
1/3716 (0.03%) |
0/3716 (0.00%) |
Impaired healing |
1/3716 (0.03%) |
0/3716 (0.00%) |
Injection site haemorrhage |
0/3716 (0.00%) |
1/3716 (0.03%) |
Necrosis |
1/3716 (0.03%) |
0/3716 (0.00%) |
Oedema peripheral |
1/3716 (0.03%) |
0/3716 (0.00%) |
Puncture site haemorrhage |
0/3716 (0.00%) |
1/3716 (0.03%) |
Ulcer |
1/3716 (0.03%) |
0/3716 (0.00%) |
Hepatobiliary disorders |
|
|
Cholecystitis |
4/3716 (0.11%) |
0/3716 (0.00%) |
Bile duct stone |
2/3716 (0.05%) |
0/3716 (0.00%) |
Cholecystitis acute |
2/3716 (0.05%) |
0/3716 (0.00%) |
Cholecystitis chronic |
2/3716 (0.05%) |
0/3716 (0.00%) |
Cholangitis |
0/3716 (0.00%) |
1/3716 (0.03%) |
Cholelithiasis |
1/3716 (0.03%) |
0/3716 (0.00%) |
Hepatitis |
1/3716 (0.03%) |
0/3716 (0.00%) |
Hepatocellular injury |
1/3716 (0.03%) |
0/3716 (0.00%) |
Ischaemic hepatitis |
0/3716 (0.00%) |
1/3716 (0.03%) |
Portal vein thrombosis |
1/3716 (0.03%) |
0/3716 (0.00%) |
Immune system disorders |
|
|
Drug hypersensitivity |
1/3716 (0.03%) |
1/3716 (0.03%) |
Anaphylactic reaction |
0/3716 (0.00%) |
1/3716 (0.03%) |
Hypersensitivity |
0/3716 (0.00%) |
1/3716 (0.03%) |
Infections and infestations |
|
|
Pneumonia |
46/3716 (1.24%) |
64/3716 (1.72%) |
Urinary tract infection |
13/3716 (0.35%) |
11/3716 (0.30%) |
Sepsis |
13/3716 (0.35%) |
7/3716 (0.19%) |
Septic shock |
7/3716 (0.19%) |
8/3716 (0.22%) |
Cellulitis |
3/3716 (0.08%) |
7/3716 (0.19%) |
Bronchitis |
1/3716 (0.03%) |
6/3716 (0.16%) |
Respiratory tract infection |
4/3716 (0.11%) |
3/3716 (0.08%) |
Erysipelas |
4/3716 (0.11%) |
2/3716 (0.05%) |
Gastroenteritis |
4/3716 (0.11%) |
0/3716 (0.00%) |
Bronchopneumonia |
2/3716 (0.05%) |
1/3716 (0.03%) |
Clostridium difficile colitis |
1/3716 (0.03%) |
2/3716 (0.05%) |
Endocarditis |
1/3716 (0.03%) |
2/3716 (0.05%) |
Infected skin ulcer |
2/3716 (0.05%) |
1/3716 (0.03%) |
Lobar pneumonia |
1/3716 (0.03%) |
2/3716 (0.05%) |
Pyelonephritis |
2/3716 (0.05%) |
1/3716 (0.03%) |
Pyelonephritis acute |
1/3716 (0.03%) |
2/3716 (0.05%) |
Wound infection |
2/3716 (0.05%) |
1/3716 (0.03%) |
Appendicitis |
1/3716 (0.03%) |
1/3716 (0.03%) |
Clostridium colitis |
0/3716 (0.00%) |
2/3716 (0.05%) |
Infection |
2/3716 (0.05%) |
0/3716 (0.00%) |
Osteomyelitis |
2/3716 (0.05%) |
0/3716 (0.00%) |
Pseudomembranous colitis |
2/3716 (0.05%) |
0/3716 (0.00%) |
Pulmonary sepsis |
2/3716 (0.05%) |
0/3716 (0.00%) |
Pulmonary tuberculosis |
2/3716 (0.05%) |
0/3716 (0.00%) |
Tracheobronchitis |
1/3716 (0.03%) |
1/3716 (0.03%) |
Urosepsis |
1/3716 (0.03%) |
1/3716 (0.03%) |
Abscess bacterial |
0/3716 (0.00%) |
1/3716 (0.03%) |
Appendicitis perforated |
1/3716 (0.03%) |
0/3716 (0.00%) |
Arthritis bacterial |
0/3716 (0.00%) |
1/3716 (0.03%) |
Atypical pneumonia |
0/3716 (0.00%) |
1/3716 (0.03%) |
Bacteraemia |
1/3716 (0.03%) |
0/3716 (0.00%) |
Bone abscess |
1/3716 (0.03%) |
0/3716 (0.00%) |
Bronchitis bacterial |
1/3716 (0.03%) |
0/3716 (0.00%) |
Clostridial infection |
0/3716 (0.00%) |
1/3716 (0.03%) |
Clostridium difficile infection |
0/3716 (0.00%) |
1/3716 (0.03%) |
Cystitis |
1/3716 (0.03%) |
0/3716 (0.00%) |
Device related infection |
1/3716 (0.03%) |
0/3716 (0.00%) |
Diverticulitis |
0/3716 (0.00%) |
1/3716 (0.03%) |
Empyema |
1/3716 (0.03%) |
0/3716 (0.00%) |
Endocarditis bacterial |
0/3716 (0.00%) |
1/3716 (0.03%) |
Enterococcal infection |
1/3716 (0.03%) |
0/3716 (0.00%) |
Epididymitis |
1/3716 (0.03%) |
0/3716 (0.00%) |
Escherichia bacteraemia |
1/3716 (0.03%) |
0/3716 (0.00%) |
Febrile infection |
1/3716 (0.03%) |
0/3716 (0.00%) |
Gallbladder empyema |
0/3716 (0.00%) |
1/3716 (0.03%) |
Gastrointestinal bacterial infection |
0/3716 (0.00%) |
1/3716 (0.03%) |
Infectious pleural effusion |
0/3716 (0.00%) |
1/3716 (0.03%) |
Infective exacerbation of chronic obstructive airways |
0/3716 (0.00%) |
1/3716 (0.03%) |
Influenza |
1/3716 (0.03%) |
0/3716 (0.00%) |
Intervertebral discitis |
0/3716 (0.00%) |
1/3716 (0.03%) |
Localised infection |
0/3716 (0.00%) |
1/3716 (0.03%) |
Mastoiditis |
1/3716 (0.03%) |
0/3716 (0.00%) |
Nosocomial infection |
0/3716 (0.00%) |
1/3716 (0.03%) |
Oral candidiasis |
0/3716 (0.00%) |
1/3716 (0.03%) |
Pneumonia staphylococcal |
1/3716 (0.03%) |
0/3716 (0.00%) |
Pneumonia streptococcal |
1/3716 (0.03%) |
0/3716 (0.00%) |
Pseudomonal sepsis |
0/3716 (0.00%) |
1/3716 (0.03%) |
Pseudomonas infection |
0/3716 (0.00%) |
1/3716 (0.03%) |
Psoas abscess |
1/3716 (0.03%) |
0/3716 (0.00%) |
Pyelocystitis |
0/3716 (0.00%) |
1/3716 (0.03%) |
Sinusitis |
0/3716 (0.00%) |
1/3716 (0.03%) |
Skin infection |
1/3716 (0.03%) |
0/3716 (0.00%) |
Soft tissue infection |
0/3716 (0.00%) |
1/3716 (0.03%) |
Staphylococcal sepsis |
0/3716 (0.00%) |
1/3716 (0.03%) |
Subcutaneous abscess |
0/3716 (0.00%) |
1/3716 (0.03%) |
Upper respiratory tract infection |
0/3716 (0.00%) |
1/3716 (0.03%) |
Viral upper respiratory tract infection |
1/3716 (0.03%) |
0/3716 (0.00%) |
Injury, poisoning and procedural complications |
|
|
Hip fracture |
1/3716 (0.03%) |
3/3716 (0.08%) |
Fall |
3/3716 (0.08%) |
0/3716 (0.00%) |
Rib fracture |
0/3716 (0.00%) |
3/3716 (0.08%) |
Cervical vertebral fracture |
1/3716 (0.03%) |
1/3716 (0.03%) |
Contusion |
1/3716 (0.03%) |
1/3716 (0.03%) |
Head injury |
1/3716 (0.03%) |
1/3716 (0.03%) |
Lumbar vertebral fracture |
2/3716 (0.05%) |
0/3716 (0.00%) |
Accident |
0/3716 (0.00%) |
1/3716 (0.03%) |
Accidental overdose |
0/3716 (0.00%) |
1/3716 (0.03%) |
Concussion |
1/3716 (0.03%) |
0/3716 (0.00%) |
Femur fracture |
1/3716 (0.03%) |
0/3716 (0.00%) |
Humerus fracture |
1/3716 (0.03%) |
0/3716 (0.00%) |
Iatrogenic injury |
0/3716 (0.00%) |
1/3716 (0.03%) |
Joint dislocation |
1/3716 (0.03%) |
0/3716 (0.00%) |
Patella fracture |
1/3716 (0.03%) |
0/3716 (0.00%) |
Pneumothorax traumatic |
0/3716 (0.00%) |
1/3716 (0.03%) |
Post procedural haemorrhage |
0/3716 (0.00%) |
1/3716 (0.03%) |
Procedural haemorrhage |
1/3716 (0.03%) |
0/3716 (0.00%) |
Pubis fracture |
0/3716 (0.00%) |
1/3716 (0.03%) |
Skin injury |
1/3716 (0.03%) |
0/3716 (0.00%) |
Spinal compression fracture |
1/3716 (0.03%) |
0/3716 (0.00%) |
Spinal cord injury |
1/3716 (0.03%) |
0/3716 (0.00%) |
Subdural haematoma |
0/3716 (0.00%) |
1/3716 (0.03%) |
Tendon rupture |
1/3716 (0.03%) |
0/3716 (0.00%) |
Traumatic fracture |
1/3716 (0.03%) |
0/3716 (0.00%) |
Traumatic haematoma |
1/3716 (0.03%) |
0/3716 (0.00%) |
Upper limb fracture |
1/3716 (0.03%) |
0/3716 (0.00%) |
Investigations |
|
|
Hepatic enzyme increased |
2/3716 (0.05%) |
5/3716 (0.13%) |
Aspiration bronchial |
2/3716 (0.05%) |
1/3716 (0.03%) |
Alanine aminotransferase increased |
1/3716 (0.03%) |
1/3716 (0.03%) |
General physical condition abnormal |
1/3716 (0.03%) |
1/3716 (0.03%) |
Blood alkaline phosphatase increased |
1/3716 (0.03%) |
0/3716 (0.00%) |
Blood creatinine increased |
1/3716 (0.03%) |
0/3716 (0.00%) |
Blood urea increased |
1/3716 (0.03%) |
0/3716 (0.00%) |
Blood urine present |
1/3716 (0.03%) |
0/3716 (0.00%) |
Catheterisation cardiac |
0/3716 (0.00%) |
1/3716 (0.03%) |
Transaminases increased |
1/3716 (0.03%) |
0/3716 (0.00%) |
Metabolism and nutrition disorders |
|
|
Type 2 diabetes mellitus |
1/3716 (0.03%) |
3/3716 (0.08%) |
Dehydration |
1/3716 (0.03%) |
2/3716 (0.05%) |
Diabetes mellitus |
0/3716 (0.00%) |
2/3716 (0.05%) |
Gout |
1/3716 (0.03%) |
1/3716 (0.03%) |
Hypokalaemia |
2/3716 (0.05%) |
0/3716 (0.00%) |
Hyponatraemia |
1/3716 (0.03%) |
1/3716 (0.03%) |
Failure to thrive |
0/3716 (0.00%) |
1/3716 (0.03%) |
Hypercalcaemia |
1/3716 (0.03%) |
0/3716 (0.00%) |
Hyperglycaemia |
0/3716 (0.00%) |
1/3716 (0.03%) |
Hyperkalaemia |
0/3716 (0.00%) |
1/3716 (0.03%) |
Hypernatraemia |
0/3716 (0.00%) |
1/3716 (0.03%) |
Hyperphosphataemia |
0/3716 (0.00%) |
1/3716 (0.03%) |
Hypoglycaemia |
1/3716 (0.03%) |
0/3716 (0.00%) |
Hypovolaemia |
0/3716 (0.00%) |
1/3716 (0.03%) |
Type 1 diabetes mellitus |
1/3716 (0.03%) |
0/3716 (0.00%) |
Musculoskeletal and connective tissue disorders |
|
|
Arthritis |
2/3716 (0.05%) |
0/3716 (0.00%) |
Musculoskeletal chest pain |
1/3716 (0.03%) |
1/3716 (0.03%) |
Arthralgia |
1/3716 (0.03%) |
0/3716 (0.00%) |
Cervical spinal stenosis |
1/3716 (0.03%) |
0/3716 (0.00%) |
Chondrocalcinosis |
1/3716 (0.03%) |
0/3716 (0.00%) |
Coccydynia |
1/3716 (0.03%) |
0/3716 (0.00%) |
Intervertebral disc degeneration |
1/3716 (0.03%) |
0/3716 (0.00%) |
Intervertebral disc disorder |
1/3716 (0.03%) |
0/3716 (0.00%) |
Intervertebral disc protrusion |
0/3716 (0.00%) |
1/3716 (0.03%) |
Osteoarthritis |
0/3716 (0.00%) |
1/3716 (0.03%) |
Osteochondrosis |
1/3716 (0.03%) |
0/3716 (0.00%) |
Polymyositis |
0/3716 (0.00%) |
1/3716 (0.03%) |
Scleroderma |
0/3716 (0.00%) |
1/3716 (0.03%) |
Synovial cyst |
1/3716 (0.03%) |
0/3716 (0.00%) |
Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
|
Lung neoplasm malignant |
10/3716 (0.27%) |
8/3716 (0.22%) |
Cervix carcinoma |
2/3716 (0.05%) |
1/3716 (0.03%) |
Metastases to central nervous system |
3/3716 (0.08%) |
0/3716 (0.00%) |
Adenocarcinoma of colon |
2/3716 (0.05%) |
0/3716 (0.00%) |
Gastric cancer |
1/3716 (0.03%) |
1/3716 (0.03%) |
Metastatic neoplasm |
2/3716 (0.05%) |
0/3716 (0.00%) |
Ovarian cancer |
2/3716 (0.05%) |
0/3716 (0.00%) |
Rectal cancer |
2/3716 (0.05%) |
0/3716 (0.00%) |
Adenocarcinoma |
0/3716 (0.00%) |
1/3716 (0.03%) |
Brain neoplasm |
1/3716 (0.03%) |
0/3716 (0.00%) |
Breast cancer metastatic |
1/3716 (0.03%) |
0/3716 (0.00%) |
Bronchial carcinoma |
1/3716 (0.03%) |
0/3716 (0.00%) |
Chronic lymphocytic leukaemia |
1/3716 (0.03%) |
0/3716 (0.00%) |
Colon cancer |
0/3716 (0.00%) |
1/3716 (0.03%) |
Colorectal adenocarcinoma |
0/3716 (0.00%) |
1/3716 (0.03%) |
Colorectal cancer |
1/3716 (0.03%) |
0/3716 (0.00%) |
Gastrointestinal stromal tumour |
1/3716 (0.03%) |
0/3716 (0.00%) |
Leukaemia |
1/3716 (0.03%) |
0/3716 (0.00%) |
Lung carcinoma cell type unspecified stage IV |
1/3716 (0.03%) |
0/3716 (0.00%) |
Malignant pleural effusion |
0/3716 (0.00%) |
1/3716 (0.03%) |
Meningioma |
1/3716 (0.03%) |
0/3716 (0.00%) |
Metastases to bone |
0/3716 (0.00%) |
1/3716 (0.03%) |
Metastases to liver |
1/3716 (0.03%) |
0/3716 (0.00%) |
Metastases to peritoneum |
1/3716 (0.03%) |
0/3716 (0.00%) |
Metastasis |
0/3716 (0.00%) |
1/3716 (0.03%) |
Myeloid leukaemia |
1/3716 (0.03%) |
0/3716 (0.00%) |
Neoplasm malignant |
0/3716 (0.00%) |
1/3716 (0.03%) |
Non-Hodgkin's lymphoma |
0/3716 (0.00%) |
1/3716 (0.03%) |
Oesophageal carcinoma |
0/3716 (0.00%) |
1/3716 (0.03%) |
Pancreatic carcinoma metastatic |
1/3716 (0.03%) |
0/3716 (0.00%) |
Plasma cell myeloma |
1/3716 (0.03%) |
0/3716 (0.00%) |
Plasmacytoma |
1/3716 (0.03%) |
0/3716 (0.00%) |
Pleural mesothelioma |
0/3716 (0.00%) |
1/3716 (0.03%) |
Rectosigmoid cancer |
1/3716 (0.03%) |
0/3716 (0.00%) |
Small cell lung cancer |
1/3716 (0.03%) |
0/3716 (0.00%) |
Throat cancer |
1/3716 (0.03%) |
0/3716 (0.00%) |
Transitional cell carcinoma |
0/3716 (0.00%) |
1/3716 (0.03%) |
Vulval cancer |
1/3716 (0.03%) |
0/3716 (0.00%) |
Nervous system disorders |
|
|
Ischaemic stroke |
19/3716 (0.51%) |
35/3716 (0.94%) |
Brain oedema |
8/3716 (0.22%) |
10/3716 (0.27%) |
Cerebrovascular accident |
7/3716 (0.19%) |
6/3716 (0.16%) |
Syncope |
4/3716 (0.11%) |
4/3716 (0.11%) |
Cerebral infarction |
3/3716 (0.08%) |
3/3716 (0.08%) |
Transient ischaemic attack |
2/3716 (0.05%) |
4/3716 (0.11%) |
Convulsion |
2/3716 (0.05%) |
3/3716 (0.08%) |
Loss of consciousness |
4/3716 (0.11%) |
1/3716 (0.03%) |
Haemorrhagic stroke |
1/3716 (0.03%) |
2/3716 (0.05%) |
Subarachnoid haemorrhage |
1/3716 (0.03%) |
2/3716 (0.05%) |
Coma |
2/3716 (0.05%) |
0/3716 (0.00%) |
Dizziness |
1/3716 (0.03%) |
1/3716 (0.03%) |
Encephalopathy |
0/3716 (0.00%) |
2/3716 (0.05%) |
Epilepsy |
1/3716 (0.03%) |
1/3716 (0.03%) |
Haemorrhagic transformation stroke |
0/3716 (0.00%) |
2/3716 (0.05%) |
Sciatica |
1/3716 (0.03%) |
1/3716 (0.03%) |
Carotid artery stenosis |
0/3716 (0.00%) |
1/3716 (0.03%) |
Cerebellar infarction |
0/3716 (0.00%) |
1/3716 (0.03%) |
Cerebral haemorrhage |
0/3716 (0.00%) |
1/3716 (0.03%) |
Cerebral ischaemia |
0/3716 (0.00%) |
1/3716 (0.03%) |
Hydrocephalus |
1/3716 (0.03%) |
0/3716 (0.00%) |
Hypoglycaemic coma |
1/3716 (0.03%) |
0/3716 (0.00%) |
Intraventricular haemorrhage |
0/3716 (0.00%) |
1/3716 (0.03%) |
Nervous system disorder |
1/3716 (0.03%) |
0/3716 (0.00%) |
Neuroglycopenia |
1/3716 (0.03%) |
0/3716 (0.00%) |
Neurological decompensation |
0/3716 (0.00%) |
1/3716 (0.03%) |
Paralysis flaccid |
1/3716 (0.03%) |
0/3716 (0.00%) |
Polyneuropathy |
0/3716 (0.00%) |
1/3716 (0.03%) |
Presyncope |
0/3716 (0.00%) |
1/3716 (0.03%) |
Unresponsive to stimuli |
1/3716 (0.03%) |
0/3716 (0.00%) |
Psychiatric disorders |
|
|
Confusional state |
2/3716 (0.05%) |
0/3716 (0.00%) |
Depression |
0/3716 (0.00%) |
2/3716 (0.05%) |
Anxiety |
1/3716 (0.03%) |
0/3716 (0.00%) |
Delirium |
0/3716 (0.00%) |
1/3716 (0.03%) |
Major depression |
1/3716 (0.03%) |
0/3716 (0.00%) |
Mental disorder |
1/3716 (0.03%) |
0/3716 (0.00%) |
Renal and urinary disorders |
|
|
Renal failure |
10/3716 (0.27%) |
15/3716 (0.40%) |
Renal failure acute |
12/3716 (0.32%) |
11/3716 (0.30%) |
Haematuria |
17/3716 (0.46%) |
5/3716 (0.13%) |
Renal failure chronic |
8/3716 (0.22%) |
4/3716 (0.11%) |
Haemorrhage urinary tract |
2/3716 (0.05%) |
1/3716 (0.03%) |
Renal impairment |
3/3716 (0.08%) |
0/3716 (0.00%) |
Acute prerenal failure |
1/3716 (0.03%) |
1/3716 (0.03%) |
Urinary retention |
1/3716 (0.03%) |
1/3716 (0.03%) |
Cystitis haemorrhagic |
0/3716 (0.00%) |
1/3716 (0.03%) |
Glomerulonephritis rapidly progressive |
1/3716 (0.03%) |
0/3716 (0.00%) |
Nephropathy |
0/3716 (0.00%) |
1/3716 (0.03%) |
Renal colic |
1/3716 (0.03%) |
0/3716 (0.00%) |
Urethral haemorrhage |
1/3716 (0.03%) |
0/3716 (0.00%) |
Reproductive system and breast disorders |
|
|
Benign prostatic hyperplasia |
1/3716 (0.03%) |
0/3716 (0.00%) |
Cervix haemorrhage uterine |
1/3716 (0.03%) |
0/3716 (0.00%) |
Genital haemorrhage |
1/3716 (0.03%) |
0/3716 (0.00%) |
Vaginal haemorrhage |
1/3716 (0.03%) |
0/3716 (0.00%) |
Respiratory, thoracic and mediastinal disorders |
|
|
Chronic obstructive pulmonary disease |
38/3716 (1.02%) |
43/3716 (1.16%) |
Respiratory failure |
30/3716 (0.81%) |
17/3716 (0.46%) |
Pulmonary embolism |
11/3716 (0.30%) |
26/3716 (0.70%) |
Acute respiratory failure |
13/3716 (0.35%) |
9/3716 (0.24%) |
Epistaxis |
10/3716 (0.27%) |
5/3716 (0.13%) |
Pulmonary oedema |
6/3716 (0.16%) |
4/3716 (0.11%) |
Pulmonary fibrosis |
3/3716 (0.08%) |
5/3716 (0.13%) |
Pleural effusion |
2/3716 (0.05%) |
5/3716 (0.13%) |
Asthma |
3/3716 (0.08%) |
3/3716 (0.08%) |
Dyspnoea |
6/3716 (0.16%) |
0/3716 (0.00%) |
Pneumothorax |
3/3716 (0.08%) |
3/3716 (0.08%) |
Acute pulmonary oedema |
3/3716 (0.08%) |
1/3716 (0.03%) |
Pneumonia aspiration |
2/3716 (0.05%) |
2/3716 (0.05%) |
Chronic respiratory failure |
1/3716 (0.03%) |
2/3716 (0.05%) |
Haemoptysis |
2/3716 (0.05%) |
1/3716 (0.03%) |
Respiratory distress |
2/3716 (0.05%) |
1/3716 (0.03%) |
Bronchiectasis |
1/3716 (0.03%) |
1/3716 (0.03%) |
Bronchitis chronic |
1/3716 (0.03%) |
1/3716 (0.03%) |
Bronchospasm |
0/3716 (0.00%) |
2/3716 (0.05%) |
Haemothorax |
1/3716 (0.03%) |
1/3716 (0.03%) |
Hypoxia |
1/3716 (0.03%) |
1/3716 (0.03%) |
Interstitial lung disease |
0/3716 (0.00%) |
2/3716 (0.05%) |
Lung disorder |
0/3716 (0.00%) |
2/3716 (0.05%) |
Pulmonary hypertension |
1/3716 (0.03%) |
1/3716 (0.03%) |
Respiratory arrest |
0/3716 (0.00%) |
2/3716 (0.05%) |
Sleep apnoea syndrome |
1/3716 (0.03%) |
1/3716 (0.03%) |
Acute respiratory distress syndrome |
0/3716 (0.00%) |
1/3716 (0.03%) |
Alveolitis allergic |
0/3716 (0.00%) |
1/3716 (0.03%) |
Bronchial obstruction |
0/3716 (0.00%) |
1/3716 (0.03%) |
Chylothorax |
0/3716 (0.00%) |
1/3716 (0.03%) |
Emphysema |
1/3716 (0.03%) |
0/3716 (0.00%) |
Paranasal cyst |
0/3716 (0.00%) |
1/3716 (0.03%) |
Pneumonitis |
1/3716 (0.03%) |
0/3716 (0.00%) |
Pneumothorax spontaneous |
1/3716 (0.03%) |
0/3716 (0.00%) |
Pulmonary haemorrhage |
0/3716 (0.00%) |
1/3716 (0.03%) |
Skin and subcutaneous tissue disorders |
|
|
Skin ulcer |
3/3716 (0.08%) |
1/3716 (0.03%) |
Decubitus ulcer |
0/3716 (0.00%) |
2/3716 (0.05%) |
Acute generalised exanthematous pustulosis |
0/3716 (0.00%) |
1/3716 (0.03%) |
Dermatitis bullous |
0/3716 (0.00%) |
1/3716 (0.03%) |
Ecchymosis |
0/3716 (0.00%) |
1/3716 (0.03%) |
Pemphigoid |
1/3716 (0.03%) |
0/3716 (0.00%) |
Petechiae |
0/3716 (0.00%) |
1/3716 (0.03%) |
Skin disorder |
0/3716 (0.00%) |
1/3716 (0.03%) |
Social circumstances |
|
|
Activities of daily living impaired |
0/3716 (0.00%) |
1/3716 (0.03%) |
Surgical and medical procedures |
|
|
Coronary artery bypass |
1/3716 (0.03%) |
0/3716 (0.00%) |
Glaucoma surgery |
1/3716 (0.03%) |
0/3716 (0.00%) |
Hip arthroplasty |
1/3716 (0.03%) |
0/3716 (0.00%) |
Hospitalisation |
1/3716 (0.03%) |
0/3716 (0.00%) |
Hysterectomy |
1/3716 (0.03%) |
0/3716 (0.00%) |
Leg amputation |
0/3716 (0.00%) |
1/3716 (0.03%) |
Mitral valve repair |
0/3716 (0.00%) |
1/3716 (0.03%) |
Surgery |
1/3716 (0.03%) |
0/3716 (0.00%) |
Vascular disorders |
|
|
Deep vein thrombosis |
16/3716 (0.43%) |
38/3716 (1.02%) |
Hypotension |
8/3716 (0.22%) |
3/3716 (0.08%) |
Haematoma |
5/3716 (0.13%) |
1/3716 (0.03%) |
Peripheral arterial occlusive disease |
1/3716 (0.03%) |
2/3716 (0.05%) |
Peripheral ischaemia |
1/3716 (0.03%) |
2/3716 (0.05%) |
Aortic aneurysm |
1/3716 (0.03%) |
1/3716 (0.03%) |
Aortic dissection |
1/3716 (0.03%) |
1/3716 (0.03%) |
Aortic stenosis |
2/3716 (0.05%) |
0/3716 (0.00%) |
Arteriosclerosis |
1/3716 (0.03%) |
1/3716 (0.03%) |
Haemorrhage |
2/3716 (0.05%) |
0/3716 (0.00%) |
Haemorrhagic vasculitis |
1/3716 (0.03%) |
1/3716 (0.03%) |
Hypertensive crisis |
1/3716 (0.03%) |
1/3716 (0.03%) |
Venous thrombosis |
0/3716 (0.00%) |
2/3716 (0.05%) |
Aneurysm |
0/3716 (0.00%) |
1/3716 (0.03%) |
Angiopathy |
1/3716 (0.03%) |
0/3716 (0.00%) |
Arterial disorder |
1/3716 (0.03%) |
0/3716 (0.00%) |
Arterial stenosis |
1/3716 (0.03%) |
0/3716 (0.00%) |
Bleeding varicose vein |
1/3716 (0.03%) |
0/3716 (0.00%) |
Embolism arterial |
1/3716 (0.03%) |
0/3716 (0.00%) |
Essential hypertension |
1/3716 (0.03%) |
0/3716 (0.00%) |
Femoral artery aneurysm |
0/3716 (0.00%) |
1/3716 (0.03%) |
Hypertension |
1/3716 (0.03%) |
0/3716 (0.00%) |
Intra-abdominal haematoma |
0/3716 (0.00%) |
1/3716 (0.03%) |
Ischaemia |
1/3716 (0.03%) |
0/3716 (0.00%) |
Peripheral artery aneurysm |
0/3716 (0.00%) |
1/3716 (0.03%) |
Peripheral artery stenosis |
1/3716 (0.03%) |
0/3716 (0.00%) |
Peripheral vascular disorder |
1/3716 (0.03%) |
0/3716 (0.00%) |
Phlebitis superficial |
0/3716 (0.00%) |
1/3716 (0.03%) |
Shock haemorrhagic |
0/3716 (0.00%) |
1/3716 (0.03%) |
Venous thrombosis limb |
0/3716 (0.00%) |
1/3716 (0.03%) |
Indicates events were collected by systematic assessment
|
|
Frequency Threshold for Reporting Other Adverse Events
|
1%
|
|
Betrixaban
|
Enoxaparin
|
|
Affected / at Risk (%) |
Affected / at Risk (%) |
Total |
879/3716 (23.65%) |
779/3716 (20.96%) |
Blood and lymphatic system disorders |
|
|
Anaemia |
44/3716 (1.18%) |
29/3716 (0.78%) |
Cardiac disorders |
|
|
Atrial fibrillation |
50/3716 (1.35%) |
85/3716 (2.29%) |
Cardiac failure |
48/3716 (1.29%) |
32/3716 (0.86%) |
Mitral valve incompetence |
41/3716 (1.10%) |
49/3716 (1.32%) |
Tricuspid valve incompetence |
38/3716 (1.02%) |
41/3716 (1.10%) |
Gastrointestinal disorders |
|
|
Constipation |
109/3716 (2.93%) |
102/3716 (2.74%) |
Nausea |
67/3716 (1.80%) |
55/3716 (1.48%) |
Diarrhoea |
63/3716 (1.70%) |
59/3716 (1.59%) |
General disorders |
|
|
Oedema peripheral |
39/3716 (1.05%) |
19/3716 (0.51%) |
Infections and infestations |
|
|
Urinary tract infection |
110/3716 (2.96%) |
78/3716 (2.10%) |
Metabolism and nutrition disorders |
|
|
Hypokalaemia |
91/3716 (2.45%) |
84/3716 (2.26%) |
Nervous system disorders |
|
|
Headache |
74/3716 (1.99%) |
59/3716 (1.59%) |
Psychiatric disorders |
|
|
Insomnia |
87/3716 (2.34%) |
89/3716 (2.40%) |
Renal and urinary disorders |
|
|
Renal cyst |
55/3716 (1.48%) |
47/3716 (1.26%) |
Haematuria |
46/3716 (1.24%) |
23/3716 (0.62%) |
Respiratory, thoracic and mediastinal disorders |
|
|
Chronic obstructive pulmonary disease |
53/3716 (1.43%) |
41/3716 (1.10%) |
Epistaxis |
48/3716 (1.29%) |
19/3716 (0.51%) |
Vascular disorders |
|
|
Hypertension |
88/3716 (2.37%) |
80/3716 (2.15%) |
Deep vein thrombosis |
29/3716 (0.78%) |
58/3716 (1.56%) |
Indicates events were collected by systematic assessment
|