Acute Medically Ill VTE Prevention With Extended Duration... | NCT01583218

Label	Type	Description	Intervention Names
Betrixaban	Experimental	Daily oral (PO) betrixaban capsules for 35 to 42 days and subcutaneous (SQ) injections of enoxaparin placebo for 10 ± 4 days	Drug: Betrixaban
Enoxaparin	Active Comparator	Daily subcutaneous (SQ) injections of enoxaparin for 10 ± 4 days and oral (PO) betrixaban placebo capsules for 35 to 42 days	Drug: Enoxaparin

Name	Type	Description	Arm Group Labels	Other Names
Betrixaban	Drug	Betrixaban 80 mg PO once daily (QD) for 35 day + 7 days. Enoxaparin Placebo: Once daily, 6-14 days	Betrixaban

Measure	Description	Time Frame
Modified Intent-to-Treat (mITT) Cohort 1: Percentage of Participants Experiencing the Composite Event of Symptomatic Deep Vein Thrombosis (DVT), Non-fatal Pulmonary Emboli (PE), VTE-related Death, or Asymptomatic Proximal DVT, Through Visit 3	mITT Cohort 1: Percentage of participants experiencing either symptomatic DVT, non-fatal PE, venous thromboembolism (VTE) related death adjudicated by a blinded independent Clinical Events Committee (CEC) between randomization and on or before Visit 3 or Day 42 if patient did not have a Visit 3, or a blinded ultrasound core laboratory measuring of asymptomatic proximal DVT between randomization and Day 47. Visit 3 is between day 35-42 after randomization (day 1).	mITT Cohort 1: Between randomization and Day 47 (max)
mITT Cohort 2: Percentage of Participants Experiencing the Composite Event of Symptomatic DVT, Non-fatal PE, VTE-related Death, or Asymptomatic Proximal DVT, Through Visit 3	mITT Cohort 2: Percentage of participants experiencing either symptomatic DVT, non-fatal PE, VTE related death adjudicated by a blinded independent CEC between randomization and on or before Visit 3 or Day 42 if patient did not have a Visit 3, or a blinded ultrasound core laboratory measuring of asymptomatic proximal DVT between randomization and Day 47. Visit 3 is between day 35-42 after randomization (day 1).	mITT Cohort 2: Between randomization and Day 47 (max)
mITT: Percentage of Participants Experiencing the Composite Event of Symptomatic DVT, Non-fatal PE, VTE-related Death, or Asymptomatic Proximal DVT, Through Visit 3	mITT: Percentage of participants experiencing either symptomatic DVT, non-fatal PE, VTE related death adjudicated by a blinded independent CEC between randomization and on or before Visit 3 or Day 42 if patient did not have a Visit 3, or a blinded ultrasound core laboratory measuring of asymptomatic proximal DVT between randomization and Day 47. Visit 3 is between day 35-42 after randomization (day 1).	mITT: Between randomization and Day 47 (max)
Percentage of Participants Experiencing Major Bleeding Through Seven Days After Discontinuation of All Study Medication

Measure	Description	Time Frame
mITT Cohort 1: Percentage of Participants Experiencing the Composite Event of Symptomatic DVT, Non-fatal PE, or VTE-related Death, Through Visit 3	mITT Cohort 1: Percentage of participants experiencing either symptomatic DVT, non-fatal PE, or VTE related death adjudicated by a blinded independent CEC between randomization and on or before Visit 3 or Day 42 if patient did not have a Visit 3. Visit 3 is between day 35-42 after randomization (day 1).

Facility	Status	City	State	ZIP	Country	Contacts
		Birmingham	Alabama	35294	United States

PubMed Identifier	Type	Citation	Retractions
36566304	Derived	Chi G, Violi F, Pignatelli P, Vestri A, Spagnoli A, Loffredo L, Hernandez AF, Hull RD, Cohen AT, Harrington RA, Goldhaber SZ, Gibson CM. External validation of the ADA score for predicting thrombosis among acutely ill hospitalized medical patients from the APEX Trial. J Thromb Thrombolysis. 2023 Feb;55(2):211-221. doi: 10.1007/s11239-022-02757-8. Epub 2022 Dec 24.
32657973

ID	Title	Description
FG000	Betrixaban	Daily oral (PO) betrixaban capsules for 35 to 42 days and subcutaneous (SQ) injections of enoxaparin placebo for 10 ± 4 days
FG001	Enoxaparin	Daily subcutaneous (SQ) injections of enoxaparin for 10 ± 4 days and oral (PO) betrixaban placebo capsules for 35 to 42 days

Serious Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Cardiac failure	Cardiac disorders	Systematic Assessment	EG00083 affected3,716 at risk EG00166 affected3,716 at risk
Atrial fibrillation	Cardiac disorders	Systematic Assessment	EG00011 affected3,716 at risk EG00123 affected3,716 at risk
Cardiac failure congestive	Cardiac disorders	Systematic Assessment	EG00010 affected3,716 at risk EG00115 affected3,716 at risk
Cardiac failure acute	Cardiac disorders	Systematic Assessment	EG00010 affected3,716 at risk EG00112 affected3,716 at risk
Cardiac failure chronic	Cardiac disorders	Systematic Assessment	EG00013 affected3,716 at risk EG0019 affected3,716 at risk
Acute myocardial infarction	Cardiac disorders	Systematic Assessment	EG0006 affected3,716 at risk EG00112 affected3,716 at risk
Myocardial infarction	Cardiac disorders	Systematic Assessment	EG0007 affected3,716 at risk EG00110 affected3,716 at risk
Cardiogenic shock	Cardiac disorders	Systematic Assessment	EG0009 affected3,716 at risk EG0016 affected3,716 at risk
Cardiac arrest	Cardiac disorders	Systematic Assessment	EG0007 affected3,716 at risk EG0015 affected3,716 at risk
Coronary artery disease	Cardiac disorders	Systematic Assessment	EG0008 affected3,716 at risk EG0013 affected3,716 at risk
Angina unstable	Cardiac disorders	Systematic Assessment	EG0003 affected3,716 at risk EG0017 affected3,716 at risk
Acute coronary syndrome	Cardiac disorders	Systematic Assessment	EG0006 affected3,716 at risk EG0013 affected3,716 at risk
Atrioventricular block complete	Cardiac disorders	Systematic Assessment	EG0005 affected3,716 at risk EG0013 affected3,716 at risk
Myocardial ischaemia	Cardiac disorders	Systematic Assessment	EG0002 affected3,716 at risk EG0016 affected3,716 at risk
Angina pectoris	Cardiac disorders	Systematic Assessment	EG0005 affected3,716 at risk EG0010 affected3,716 at risk
Cardio-respiratory arrest	Cardiac disorders	Systematic Assessment	EG0003 affected3,716 at risk EG0012 affected3,716 at risk
Cardiopulmonary failure	Cardiac disorders	Systematic Assessment	EG0001 affected3,716 at risk EG0014 affected3,716 at risk
Ventricular tachycardia	Cardiac disorders	Systematic Assessment	EG0004 affected3,716 at risk EG0011 affected3,716 at risk
Coronary artery insufficiency	Cardiac disorders	Systematic Assessment	EG0002 affected3,716 at risk EG0012 affected3,716 at risk
Atrioventricular block	Cardiac disorders	Systematic Assessment	EG0001 affected3,716 at risk EG0012 affected3,716 at risk
Cardiovascular disorder	Cardiac disorders	Systematic Assessment	EG0001 affected3,716 at risk EG0012 affected3,716 at risk
Cardiovascular insufficiency	Cardiac disorders	Systematic Assessment	EG0000 affected3,716 at risk EG0013 affected3,716 at risk
Ventricular fibrillation	Cardiac disorders	Systematic Assessment	EG0001 affected3,716 at risk EG0012 affected3,716 at risk
Atrial flutter	Cardiac disorders	Systematic Assessment	EG0000 affected3,716 at risk EG0012 affected3,716 at risk
Atrioventricular block second degree	Cardiac disorders	Systematic Assessment	EG0001 affected3,716 at risk EG0011 affected3,716 at risk
Bradycardia	Cardiac disorders	Systematic Assessment	EG0002 affected3,716 at risk EG0010 affected3,716 at risk
Cardiomyopathy	Cardiac disorders	Systematic Assessment	EG0001 affected3,716 at risk EG0011 affected3,716 at risk
Cor pulmonale	Cardiac disorders	Systematic Assessment	EG0001 affected3,716 at risk EG0011 affected3,716 at risk
Pericardial effusion	Cardiac disorders	Systematic Assessment	EG0001 affected3,716 at risk EG0011 affected3,716 at risk
Sick sinus syndrome	Cardiac disorders	Systematic Assessment	EG0001 affected3,716 at risk EG0011 affected3,716 at risk
Supraventricular tachycardia	Cardiac disorders	Systematic Assessment	EG0002 affected3,716 at risk EG0010 affected3,716 at risk
Acute left ventricular failure	Cardiac disorders	Systematic Assessment	EG0000 affected3,716 at risk EG0011 affected3,716 at risk
Aortic valve incompetence	Cardiac disorders	Systematic Assessment	EG0000 affected3,716 at risk EG0011 affected3,716 at risk
Aortic valve stenosis	Cardiac disorders	Systematic Assessment	EG0000 affected3,716 at risk EG0011 affected3,716 at risk
Cardiac ventricular thrombosis	Cardiac disorders	Systematic Assessment	EG0001 affected3,716 at risk EG0010 affected3,716 at risk
Congestive cardiomyopathy	Cardiac disorders	Systematic Assessment	EG0000 affected3,716 at risk EG0011 affected3,716 at risk
Coronary artery stenosis	Cardiac disorders	Systematic Assessment	EG0000 affected3,716 at risk EG0011 affected3,716 at risk
Ischaemic cardiomyopathy	Cardiac disorders	Systematic Assessment	EG0001 affected3,716 at risk EG0010 affected3,716 at risk
Mitral valve incompetence	Cardiac disorders	Systematic Assessment	EG0000 affected3,716 at risk EG0011 affected3,716 at risk
Pericardial haemorrhage	Cardiac disorders	Systematic Assessment	EG0001 affected3,716 at risk EG0010 affected3,716 at risk
Sinoatrial block	Cardiac disorders	Systematic Assessment	EG0000 affected3,716 at risk EG0011 affected3,716 at risk
Stress cardiomyopathy	Cardiac disorders	Systematic Assessment	EG0000 affected3,716 at risk EG0011 affected3,716 at risk
Tricuspid valve incompetence	Cardiac disorders	Systematic Assessment	EG0001 affected3,716 at risk EG0010 affected3,716 at risk
Trifascicular block	Cardiac disorders	Systematic Assessment	EG0001 affected3,716 at risk EG0010 affected3,716 at risk
Ventricular extrasystoles	Cardiac disorders	Systematic Assessment	EG0001 affected3,716 at risk EG0010 affected3,716 at risk
Ventricular hypokinesia	Cardiac disorders	Systematic Assessment	EG0000 affected3,716 at risk EG0011 affected3,716 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG00038 affected3,716 at risk EG00143 affected3,716 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG00030 affected3,716 at risk EG00117 affected3,716 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG00011 affected3,716 at risk EG00126 affected3,716 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG00013 affected3,716 at risk EG0019 affected3,716 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG00010 affected3,716 at risk EG0015 affected3,716 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0006 affected3,716 at risk EG0014 affected3,716 at risk
Pulmonary fibrosis	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0003 affected3,716 at risk EG0015 affected3,716 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0002 affected3,716 at risk EG0015 affected3,716 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0003 affected3,716 at risk EG0013 affected3,716 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0006 affected3,716 at risk EG0010 affected3,716 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0003 affected3,716 at risk EG0013 affected3,716 at risk
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0003 affected3,716 at risk EG0011 affected3,716 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0002 affected3,716 at risk EG0012 affected3,716 at risk
Chronic respiratory failure	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 affected3,716 at risk EG0012 affected3,716 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0002 affected3,716 at risk EG0011 affected3,716 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0002 affected3,716 at risk EG0011 affected3,716 at risk
Bronchiectasis	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 affected3,716 at risk EG0011 affected3,716 at risk
Bronchitis chronic	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 affected3,716 at risk EG0011 affected3,716 at risk
Bronchospasm	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 affected3,716 at risk EG0012 affected3,716 at risk
Haemothorax	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 affected3,716 at risk EG0011 affected3,716 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 affected3,716 at risk EG0011 affected3,716 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 affected3,716 at risk EG0012 affected3,716 at risk
Lung disorder	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 affected3,716 at risk EG0012 affected3,716 at risk
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 affected3,716 at risk EG0011 affected3,716 at risk
Respiratory arrest	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 affected3,716 at risk EG0012 affected3,716 at risk
Sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 affected3,716 at risk EG0011 affected3,716 at risk
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 affected3,716 at risk EG0011 affected3,716 at risk
Alveolitis allergic	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 affected3,716 at risk EG0011 affected3,716 at risk
Bronchial obstruction	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 affected3,716 at risk EG0011 affected3,716 at risk
Chylothorax	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 affected3,716 at risk EG0011 affected3,716 at risk
Emphysema	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 affected3,716 at risk EG0010 affected3,716 at risk
Paranasal cyst	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 affected3,716 at risk EG0011 affected3,716 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 affected3,716 at risk EG0010 affected3,716 at risk
Pneumothorax spontaneous	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 affected3,716 at risk EG0010 affected3,716 at risk
Pulmonary haemorrhage	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 affected3,716 at risk EG0011 affected3,716 at risk
Pneumonia	Infections and infestations	Systematic Assessment	EG00046 affected3,716 at risk EG00164 affected3,716 at risk
Urinary tract infection	Infections and infestations	Systematic Assessment	EG00013 affected3,716 at risk EG00111 affected3,716 at risk
Sepsis	Infections and infestations	Systematic Assessment	EG00013 affected3,716 at risk EG0017 affected3,716 at risk
Septic shock	Infections and infestations	Systematic Assessment	EG0007 affected3,716 at risk EG0018 affected3,716 at risk
Cellulitis	Infections and infestations	Systematic Assessment	EG0003 affected3,716 at risk EG0017 affected3,716 at risk
Bronchitis	Infections and infestations	Systematic Assessment	EG0001 affected3,716 at risk EG0016 affected3,716 at risk
Respiratory tract infection	Infections and infestations	Systematic Assessment	EG0004 affected3,716 at risk EG0013 affected3,716 at risk
Erysipelas	Infections and infestations	Systematic Assessment	EG0004 affected3,716 at risk EG0012 affected3,716 at risk
Gastroenteritis	Infections and infestations	Systematic Assessment	EG0004 affected3,716 at risk EG0010 affected3,716 at risk
Bronchopneumonia	Infections and infestations	Systematic Assessment	EG0002 affected3,716 at risk EG0011 affected3,716 at risk
Clostridium difficile colitis	Infections and infestations	Systematic Assessment	EG0001 affected3,716 at risk EG0012 affected3,716 at risk
Endocarditis	Infections and infestations	Systematic Assessment	EG0001 affected3,716 at risk EG0012 affected3,716 at risk
Infected skin ulcer	Infections and infestations	Systematic Assessment	EG0002 affected3,716 at risk EG0011 affected3,716 at risk
Lobar pneumonia	Infections and infestations	Systematic Assessment	EG0001 affected3,716 at risk EG0012 affected3,716 at risk
Pyelonephritis	Infections and infestations	Systematic Assessment	EG0002 affected3,716 at risk EG0011 affected3,716 at risk
Pyelonephritis acute	Infections and infestations	Systematic Assessment	EG0001 affected3,716 at risk EG0012 affected3,716 at risk
Wound infection	Infections and infestations	Systematic Assessment	EG0002 affected3,716 at risk EG0011 affected3,716 at risk
Appendicitis	Infections and infestations	Systematic Assessment	EG0001 affected3,716 at risk EG0011 affected3,716 at risk
Clostridium colitis	Infections and infestations	Systematic Assessment	EG0000 affected3,716 at risk EG0012 affected3,716 at risk
Infection	Infections and infestations	Systematic Assessment	EG0002 affected3,716 at risk EG0010 affected3,716 at risk
Osteomyelitis	Infections and infestations	Systematic Assessment	EG0002 affected3,716 at risk EG0010 affected3,716 at risk
Pseudomembranous colitis	Infections and infestations	Systematic Assessment	EG0002 affected3,716 at risk EG0010 affected3,716 at risk
Pulmonary sepsis	Infections and infestations	Systematic Assessment	EG0002 affected3,716 at risk EG0010 affected3,716 at risk
Pulmonary tuberculosis	Infections and infestations	Systematic Assessment	EG0002 affected3,716 at risk EG0010 affected3,716 at risk
Tracheobronchitis	Infections and infestations	Systematic Assessment	EG0001 affected3,716 at risk EG0011 affected3,716 at risk
Urosepsis	Infections and infestations	Systematic Assessment	EG0001 affected3,716 at risk EG0011 affected3,716 at risk
Abscess bacterial	Infections and infestations	Systematic Assessment	EG0000 affected3,716 at risk EG0011 affected3,716 at risk
Appendicitis perforated	Infections and infestations	Systematic Assessment	EG0001 affected3,716 at risk EG0010 affected3,716 at risk
Arthritis bacterial	Infections and infestations	Systematic Assessment	EG0000 affected3,716 at risk EG0011 affected3,716 at risk
Atypical pneumonia	Infections and infestations	Systematic Assessment	EG0000 affected3,716 at risk EG0011 affected3,716 at risk
Bacteraemia	Infections and infestations	Systematic Assessment	EG0001 affected3,716 at risk EG0010 affected3,716 at risk
Bone abscess	Infections and infestations	Systematic Assessment	EG0001 affected3,716 at risk EG0010 affected3,716 at risk
Bronchitis bacterial	Infections and infestations	Systematic Assessment	EG0001 affected3,716 at risk EG0010 affected3,716 at risk
Clostridial infection	Infections and infestations	Systematic Assessment	EG0000 affected3,716 at risk EG0011 affected3,716 at risk
Clostridium difficile infection	Infections and infestations	Systematic Assessment	EG0000 affected3,716 at risk EG0011 affected3,716 at risk
Cystitis	Infections and infestations	Systematic Assessment	EG0001 affected3,716 at risk EG0010 affected3,716 at risk
Device related infection	Infections and infestations	Systematic Assessment	EG0001 affected3,716 at risk EG0010 affected3,716 at risk
Diverticulitis	Infections and infestations	Systematic Assessment	EG0000 affected3,716 at risk EG0011 affected3,716 at risk
Empyema	Infections and infestations	Systematic Assessment	EG0001 affected3,716 at risk EG0010 affected3,716 at risk
Endocarditis bacterial	Infections and infestations	Systematic Assessment	EG0000 affected3,716 at risk EG0011 affected3,716 at risk
Enterococcal infection	Infections and infestations	Systematic Assessment	EG0001 affected3,716 at risk EG0010 affected3,716 at risk
Epididymitis	Infections and infestations	Systematic Assessment	EG0001 affected3,716 at risk EG0010 affected3,716 at risk
Escherichia bacteraemia	Infections and infestations	Systematic Assessment	EG0001 affected3,716 at risk EG0010 affected3,716 at risk
Febrile infection	Infections and infestations	Systematic Assessment	EG0001 affected3,716 at risk EG0010 affected3,716 at risk
Gallbladder empyema	Infections and infestations	Systematic Assessment	EG0000 affected3,716 at risk EG0011 affected3,716 at risk
Gastrointestinal bacterial infection	Infections and infestations	Systematic Assessment	EG0000 affected3,716 at risk EG0011 affected3,716 at risk
Infectious pleural effusion	Infections and infestations	Systematic Assessment	EG0000 affected3,716 at risk EG0011 affected3,716 at risk
Infective exacerbation of chronic obstructive airways	Infections and infestations	Systematic Assessment	EG0000 affected3,716 at risk EG0011 affected3,716 at risk
Influenza	Infections and infestations	Systematic Assessment	EG0001 affected3,716 at risk EG0010 affected3,716 at risk
Intervertebral discitis	Infections and infestations	Systematic Assessment	EG0000 affected3,716 at risk EG0011 affected3,716 at risk
Localised infection	Infections and infestations	Systematic Assessment	EG0000 affected3,716 at risk EG0011 affected3,716 at risk
Mastoiditis	Infections and infestations	Systematic Assessment	EG0001 affected3,716 at risk EG0010 affected3,716 at risk
Nosocomial infection	Infections and infestations	Systematic Assessment	EG0000 affected3,716 at risk EG0011 affected3,716 at risk
Oral candidiasis	Infections and infestations	Systematic Assessment	EG0000 affected3,716 at risk EG0011 affected3,716 at risk
Pneumonia staphylococcal	Infections and infestations	Systematic Assessment	EG0001 affected3,716 at risk EG0010 affected3,716 at risk
Pneumonia streptococcal	Infections and infestations	Systematic Assessment	EG0001 affected3,716 at risk EG0010 affected3,716 at risk
Pseudomonal sepsis	Infections and infestations	Systematic Assessment	EG0000 affected3,716 at risk EG0011 affected3,716 at risk
Pseudomonas infection	Infections and infestations	Systematic Assessment	EG0000 affected3,716 at risk EG0011 affected3,716 at risk
Psoas abscess	Infections and infestations	Systematic Assessment	EG0001 affected3,716 at risk EG0010 affected3,716 at risk
Pyelocystitis	Infections and infestations	Systematic Assessment	EG0000 affected3,716 at risk EG0011 affected3,716 at risk
Sinusitis	Infections and infestations	Systematic Assessment	EG0000 affected3,716 at risk EG0011 affected3,716 at risk
Skin infection	Infections and infestations	Systematic Assessment	EG0001 affected3,716 at risk EG0010 affected3,716 at risk
Soft tissue infection	Infections and infestations	Systematic Assessment	EG0000 affected3,716 at risk EG0011 affected3,716 at risk
Staphylococcal sepsis	Infections and infestations	Systematic Assessment	EG0000 affected3,716 at risk EG0011 affected3,716 at risk
Subcutaneous abscess	Infections and infestations	Systematic Assessment	EG0000 affected3,716 at risk EG0011 affected3,716 at risk
Upper respiratory tract infection	Infections and infestations	Systematic Assessment	EG0000 affected3,716 at risk EG0011 affected3,716 at risk
Viral upper respiratory tract infection	Infections and infestations	Systematic Assessment	EG0001 affected3,716 at risk EG0010 affected3,716 at risk
Ischaemic stroke	Nervous system disorders	Systematic Assessment	EG00019 affected3,716 at risk EG00135 affected3,716 at risk
Brain oedema	Nervous system disorders	Systematic Assessment	EG0008 affected3,716 at risk EG00110 affected3,716 at risk
Cerebrovascular accident	Nervous system disorders	Systematic Assessment	EG0007 affected3,716 at risk EG0016 affected3,716 at risk
Syncope	Nervous system disorders	Systematic Assessment	EG0004 affected3,716 at risk EG0014 affected3,716 at risk
Cerebral infarction	Nervous system disorders	Systematic Assessment	EG0003 affected3,716 at risk EG0013 affected3,716 at risk
Transient ischaemic attack	Nervous system disorders	Systematic Assessment	EG0002 affected3,716 at risk EG0014 affected3,716 at risk
Convulsion	Nervous system disorders	Systematic Assessment	EG0002 affected3,716 at risk EG0013 affected3,716 at risk
Loss of consciousness	Nervous system disorders	Systematic Assessment	EG0004 affected3,716 at risk EG0011 affected3,716 at risk
Haemorrhagic stroke	Nervous system disorders	Systematic Assessment	EG0001 affected3,716 at risk EG0012 affected3,716 at risk
Subarachnoid haemorrhage	Nervous system disorders	Systematic Assessment	EG0001 affected3,716 at risk EG0012 affected3,716 at risk
Coma	Nervous system disorders	Systematic Assessment	EG0002 affected3,716 at risk EG0010 affected3,716 at risk
Dizziness	Nervous system disorders	Systematic Assessment	EG0001 affected3,716 at risk EG0011 affected3,716 at risk
Encephalopathy	Nervous system disorders	Systematic Assessment	EG0000 affected3,716 at risk EG0012 affected3,716 at risk
Epilepsy	Nervous system disorders	Systematic Assessment	EG0001 affected3,716 at risk EG0011 affected3,716 at risk
Haemorrhagic transformation stroke	Nervous system disorders	Systematic Assessment	EG0000 affected3,716 at risk EG0012 affected3,716 at risk
Sciatica	Nervous system disorders	Systematic Assessment	EG0001 affected3,716 at risk EG0011 affected3,716 at risk
Carotid artery stenosis	Nervous system disorders	Systematic Assessment	EG0000 affected3,716 at risk EG0011 affected3,716 at risk
Cerebellar infarction	Nervous system disorders	Systematic Assessment	EG0000 affected3,716 at risk EG0011 affected3,716 at risk
Cerebral haemorrhage	Nervous system disorders	Systematic Assessment	EG0000 affected3,716 at risk EG0011 affected3,716 at risk
Cerebral ischaemia	Nervous system disorders	Systematic Assessment	EG0000 affected3,716 at risk EG0011 affected3,716 at risk
Hydrocephalus	Nervous system disorders	Systematic Assessment	EG0001 affected3,716 at risk EG0010 affected3,716 at risk
Hypoglycaemic coma	Nervous system disorders	Systematic Assessment	EG0001 affected3,716 at risk EG0010 affected3,716 at risk
Intraventricular haemorrhage	Nervous system disorders	Systematic Assessment	EG0000 affected3,716 at risk EG0011 affected3,716 at risk
Nervous system disorder	Nervous system disorders	Systematic Assessment	EG0001 affected3,716 at risk EG0010 affected3,716 at risk
Neuroglycopenia	Nervous system disorders	Systematic Assessment	EG0001 affected3,716 at risk EG0010 affected3,716 at risk
Neurological decompensation	Nervous system disorders	Systematic Assessment	EG0000 affected3,716 at risk EG0011 affected3,716 at risk
Paralysis flaccid	Nervous system disorders	Systematic Assessment	EG0001 affected3,716 at risk EG0010 affected3,716 at risk
Polyneuropathy	Nervous system disorders	Systematic Assessment	EG0000 affected3,716 at risk EG0011 affected3,716 at risk
Presyncope	Nervous system disorders	Systematic Assessment	EG0000 affected3,716 at risk EG0011 affected3,716 at risk
Unresponsive to stimuli	Nervous system disorders	Systematic Assessment	EG0001 affected3,716 at risk EG0010 affected3,716 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	Systematic Assessment	EG00018 affected3,716 at risk EG0015 affected3,716 at risk
Rectal haemorrhage	Gastrointestinal disorders	Systematic Assessment	EG00015 affected3,716 at risk EG0013 affected3,716 at risk
Abdominal pain	Gastrointestinal disorders	Systematic Assessment	EG0002 affected3,716 at risk EG0013 affected3,716 at risk
Gastric ulcer haemorrhage	Gastrointestinal disorders	Systematic Assessment	EG0003 affected3,716 at risk EG0012 affected3,716 at risk
Intestinal obstruction	Gastrointestinal disorders	Systematic Assessment	EG0001 affected3,716 at risk EG0014 affected3,716 at risk
Haemorrhoidal haemorrhage	Gastrointestinal disorders	Systematic Assessment	EG0001 affected3,716 at risk EG0013 affected3,716 at risk
Vomiting	Gastrointestinal disorders	Systematic Assessment	EG0000 affected3,716 at risk EG0014 affected3,716 at risk
Colitis	Gastrointestinal disorders	Systematic Assessment	EG0000 affected3,716 at risk EG0013 affected3,716 at risk
Diarrhoea	Gastrointestinal disorders	Systematic Assessment	EG0001 affected3,716 at risk EG0012 affected3,716 at risk
Duodenal ulcer haemorrhage	Gastrointestinal disorders	Systematic Assessment	EG0002 affected3,716 at risk EG0011 affected3,716 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	Systematic Assessment	EG0001 affected3,716 at risk EG0012 affected3,716 at risk
Gastric haemorrhage	Gastrointestinal disorders	Systematic Assessment	EG0002 affected3,716 at risk EG0010 affected3,716 at risk
Gastric ulcer	Gastrointestinal disorders	Systematic Assessment	EG0002 affected3,716 at risk EG0010 affected3,716 at risk
Gingival bleeding	Gastrointestinal disorders	Systematic Assessment	EG0001 affected3,716 at risk EG0011 affected3,716 at risk
Intestinal haemorrhage	Gastrointestinal disorders	Systematic Assessment	EG0000 affected3,716 at risk EG0012 affected3,716 at risk
Intestinal ischaemia	Gastrointestinal disorders	Systematic Assessment	EG0002 affected3,716 at risk EG0010 affected3,716 at risk
Melaena	Gastrointestinal disorders	Systematic Assessment	EG0001 affected3,716 at risk EG0011 affected3,716 at risk
Pharyngo-oesophageal diverticulum	Gastrointestinal disorders	Systematic Assessment	EG0001 affected3,716 at risk EG0011 affected3,716 at risk
Abdominal strangulated hernia	Gastrointestinal disorders	Systematic Assessment	EG0001 affected3,716 at risk EG0010 affected3,716 at risk
Abdominal wall haematoma	Gastrointestinal disorders	Systematic Assessment	EG0001 affected3,716 at risk EG0010 affected3,716 at risk
Acute abdomen	Gastrointestinal disorders	Systematic Assessment	EG0000 affected3,716 at risk EG0011 affected3,716 at risk
Constipation	Gastrointestinal disorders	Systematic Assessment	EG0001 affected3,716 at risk EG0010 affected3,716 at risk
Duodenal ulcer	Gastrointestinal disorders	Systematic Assessment	EG0001 affected3,716 at risk EG0010 affected3,716 at risk
Faecaloma	Gastrointestinal disorders	Systematic Assessment	EG0000 affected3,716 at risk EG0011 affected3,716 at risk
Gastric ulcer perforation	Gastrointestinal disorders	Systematic Assessment	EG0000 affected3,716 at risk EG0011 affected3,716 at risk
Gastroduodenal haemorrhage	Gastrointestinal disorders	Systematic Assessment	EG0001 affected3,716 at risk EG0010 affected3,716 at risk
Gastrointestinal disorder	Gastrointestinal disorders	Systematic Assessment	EG0001 affected3,716 at risk EG0010 affected3,716 at risk
Gastrointestinal necrosis	Gastrointestinal disorders	Systematic Assessment	EG0000 affected3,716 at risk EG0011 affected3,716 at risk
Gastrointestinal polyp haemorrhage	Gastrointestinal disorders	Systematic Assessment	EG0001 affected3,716 at risk EG0010 affected3,716 at risk
Intestinal perforation	Gastrointestinal disorders	Systematic Assessment	EG0000 affected3,716 at risk EG0011 affected3,716 at risk
Large intestinal haemorrhage	Gastrointestinal disorders	Systematic Assessment	EG0001 affected3,716 at risk EG0010 affected3,716 at risk
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	Systematic Assessment	EG0001 affected3,716 at risk EG0010 affected3,716 at risk
Mechanical ileus	Gastrointestinal disorders	Systematic Assessment	EG0000 affected3,716 at risk EG0011 affected3,716 at risk
Nausea	Gastrointestinal disorders	Systematic Assessment	EG0000 affected3,716 at risk EG0011 affected3,716 at risk
Pancreatitis	Gastrointestinal disorders	Systematic Assessment	EG0000 affected3,716 at risk EG0011 affected3,716 at risk
Pancreatitis acute	Gastrointestinal disorders	Systematic Assessment	EG0001 affected3,716 at risk EG0010 affected3,716 at risk
Peptic ulcer haemorrhage	Gastrointestinal disorders	Systematic Assessment	EG0000 affected3,716 at risk EG0011 affected3,716 at risk
Volvulus	Gastrointestinal disorders	Systematic Assessment	EG0000 affected3,716 at risk EG0011 affected3,716 at risk
Deep vein thrombosis	Vascular disorders	Systematic Assessment	EG00016 affected3,716 at risk EG00138 affected3,716 at risk
Hypotension	Vascular disorders	Systematic Assessment	EG0008 affected3,716 at risk EG0013 affected3,716 at risk
Haematoma	Vascular disorders	Systematic Assessment	EG0005 affected3,716 at risk EG0011 affected3,716 at risk
Peripheral arterial occlusive disease	Vascular disorders	Systematic Assessment	EG0001 affected3,716 at risk EG0012 affected3,716 at risk
Peripheral ischaemia	Vascular disorders	Systematic Assessment	EG0001 affected3,716 at risk EG0012 affected3,716 at risk
Aortic aneurysm	Vascular disorders	Systematic Assessment	EG0001 affected3,716 at risk EG0011 affected3,716 at risk
Aortic dissection	Vascular disorders	Systematic Assessment	EG0001 affected3,716 at risk EG0011 affected3,716 at risk
Aortic stenosis	Vascular disorders	Systematic Assessment	EG0002 affected3,716 at risk EG0010 affected3,716 at risk
Arteriosclerosis	Vascular disorders	Systematic Assessment	EG0001 affected3,716 at risk EG0011 affected3,716 at risk
Haemorrhage	Vascular disorders	Systematic Assessment	EG0002 affected3,716 at risk EG0010 affected3,716 at risk
Haemorrhagic vasculitis	Vascular disorders	Systematic Assessment	EG0001 affected3,716 at risk EG0011 affected3,716 at risk
Hypertensive crisis	Vascular disorders	Systematic Assessment	EG0001 affected3,716 at risk EG0011 affected3,716 at risk
Venous thrombosis	Vascular disorders	Systematic Assessment	EG0000 affected3,716 at risk EG0012 affected3,716 at risk
Aneurysm	Vascular disorders	Systematic Assessment	EG0000 affected3,716 at risk EG0011 affected3,716 at risk
Angiopathy	Vascular disorders	Systematic Assessment	EG0001 affected3,716 at risk EG0010 affected3,716 at risk
Arterial disorder	Vascular disorders	Systematic Assessment	EG0001 affected3,716 at risk EG0010 affected3,716 at risk
Arterial stenosis	Vascular disorders	Systematic Assessment	EG0001 affected3,716 at risk EG0010 affected3,716 at risk
Bleeding varicose vein	Vascular disorders	Systematic Assessment	EG0001 affected3,716 at risk EG0010 affected3,716 at risk
Embolism arterial	Vascular disorders	Systematic Assessment	EG0001 affected3,716 at risk EG0010 affected3,716 at risk
Essential hypertension	Vascular disorders	Systematic Assessment	EG0001 affected3,716 at risk EG0010 affected3,716 at risk
Femoral artery aneurysm	Vascular disorders	Systematic Assessment	EG0000 affected3,716 at risk EG0011 affected3,716 at risk
Hypertension	Vascular disorders	Systematic Assessment	EG0001 affected3,716 at risk EG0010 affected3,716 at risk
Intra-abdominal haematoma	Vascular disorders	Systematic Assessment	EG0000 affected3,716 at risk EG0011 affected3,716 at risk
Ischaemia	Vascular disorders	Systematic Assessment	EG0001 affected3,716 at risk EG0010 affected3,716 at risk
Peripheral artery aneurysm	Vascular disorders	Systematic Assessment	EG0000 affected3,716 at risk EG0011 affected3,716 at risk
Peripheral artery stenosis	Vascular disorders	Systematic Assessment	EG0001 affected3,716 at risk EG0010 affected3,716 at risk
Peripheral vascular disorder	Vascular disorders	Systematic Assessment	EG0001 affected3,716 at risk EG0010 affected3,716 at risk
Phlebitis superficial	Vascular disorders	Systematic Assessment	EG0000 affected3,716 at risk EG0011 affected3,716 at risk
Shock haemorrhagic	Vascular disorders	Systematic Assessment	EG0000 affected3,716 at risk EG0011 affected3,716 at risk
Venous thrombosis limb	Vascular disorders	Systematic Assessment	EG0000 affected3,716 at risk EG0011 affected3,716 at risk
Renal failure	Renal and urinary disorders	Systematic Assessment	EG00010 affected3,716 at risk EG00115 affected3,716 at risk
Renal failure acute	Renal and urinary disorders	Systematic Assessment	EG00012 affected3,716 at risk EG00111 affected3,716 at risk
Haematuria	Renal and urinary disorders	Systematic Assessment	EG00017 affected3,716 at risk EG0015 affected3,716 at risk
Renal failure chronic	Renal and urinary disorders	Systematic Assessment	EG0008 affected3,716 at risk EG0014 affected3,716 at risk
Haemorrhage urinary tract	Renal and urinary disorders	Systematic Assessment	EG0002 affected3,716 at risk EG0011 affected3,716 at risk
Renal impairment	Renal and urinary disorders	Systematic Assessment	EG0003 affected3,716 at risk EG0010 affected3,716 at risk
Acute prerenal failure	Renal and urinary disorders	Systematic Assessment	EG0001 affected3,716 at risk EG0011 affected3,716 at risk
Urinary retention	Renal and urinary disorders	Systematic Assessment	EG0001 affected3,716 at risk EG0011 affected3,716 at risk
Cystitis haemorrhagic	Renal and urinary disorders	Systematic Assessment	EG0000 affected3,716 at risk EG0011 affected3,716 at risk
Glomerulonephritis rapidly progressive	Renal and urinary disorders	Systematic Assessment	EG0001 affected3,716 at risk EG0010 affected3,716 at risk
Nephropathy	Renal and urinary disorders	Systematic Assessment	EG0000 affected3,716 at risk EG0011 affected3,716 at risk
Renal colic	Renal and urinary disorders	Systematic Assessment	EG0001 affected3,716 at risk EG0010 affected3,716 at risk
Urethral haemorrhage	Renal and urinary disorders	Systematic Assessment	EG0001 affected3,716 at risk EG0010 affected3,716 at risk
Death	General disorders	Systematic Assessment	EG0009 affected3,716 at risk EG00116 affected3,716 at risk
Sudden cardiac death	General disorders	Systematic Assessment	EG0006 affected3,716 at risk EG0015 affected3,716 at risk
Multi-organ failure	General disorders	Systematic Assessment	EG0003 affected3,716 at risk EG0016 affected3,716 at risk
General physical health deterioration	General disorders	Systematic Assessment	EG0006 affected3,716 at risk EG0012 affected3,716 at risk
Sudden death	General disorders	Systematic Assessment	EG0003 affected3,716 at risk EG0013 affected3,716 at risk
Non-cardiac chest pain	General disorders	Systematic Assessment	EG0002 affected3,716 at risk EG0011 affected3,716 at risk
Pyrexia	General disorders	Systematic Assessment	EG0003 affected3,716 at risk EG0010 affected3,716 at risk
Cardiac death	General disorders	Systematic Assessment	EG0001 affected3,716 at risk EG0011 affected3,716 at risk
Chest pain	General disorders	Systematic Assessment	EG0001 affected3,716 at risk EG0011 affected3,716 at risk
Fatigue	General disorders	Systematic Assessment	EG0001 affected3,716 at risk EG0011 affected3,716 at risk
Asthenia	General disorders	Systematic Assessment	EG0000 affected3,716 at risk EG0011 affected3,716 at risk
Catheter site haemorrhage	General disorders	Systematic Assessment	EG0000 affected3,716 at risk EG0011 affected3,716 at risk
Condition aggravated	General disorders	Systematic Assessment	EG0001 affected3,716 at risk EG0010 affected3,716 at risk
Device malfunction	General disorders	Systematic Assessment	EG0001 affected3,716 at risk EG0010 affected3,716 at risk
Discomfort	General disorders	Systematic Assessment	EG0000 affected3,716 at risk EG0011 affected3,716 at risk
Fibrosis	General disorders	Systematic Assessment	EG0001 affected3,716 at risk EG0010 affected3,716 at risk
Generalised oedema	General disorders	Systematic Assessment	EG0000 affected3,716 at risk EG0011 affected3,716 at risk
Hyperthermia	General disorders	Systematic Assessment	EG0001 affected3,716 at risk EG0010 affected3,716 at risk
Impaired healing	General disorders	Systematic Assessment	EG0001 affected3,716 at risk EG0010 affected3,716 at risk
Injection site haemorrhage	General disorders	Systematic Assessment	EG0000 affected3,716 at risk EG0011 affected3,716 at risk
Necrosis	General disorders	Systematic Assessment	EG0001 affected3,716 at risk EG0010 affected3,716 at risk
Oedema peripheral	General disorders	Systematic Assessment	EG0001 affected3,716 at risk EG0010 affected3,716 at risk
Puncture site haemorrhage	General disorders	Systematic Assessment	EG0000 affected3,716 at risk EG0011 affected3,716 at risk
Ulcer	General disorders	Systematic Assessment	EG0001 affected3,716 at risk EG0010 affected3,716 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG00010 affected3,716 at risk EG0018 affected3,716 at risk
Cervix carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0002 affected3,716 at risk EG0011 affected3,716 at risk
Metastases to central nervous system	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0003 affected3,716 at risk EG0010 affected3,716 at risk
Adenocarcinoma of colon	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0002 affected3,716 at risk EG0010 affected3,716 at risk
Gastric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 affected3,716 at risk EG0011 affected3,716 at risk
Metastatic neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0002 affected3,716 at risk EG0010 affected3,716 at risk
Ovarian cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0002 affected3,716 at risk EG0010 affected3,716 at risk
Rectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0002 affected3,716 at risk EG0010 affected3,716 at risk
Adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 affected3,716 at risk EG0011 affected3,716 at risk
Brain neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 affected3,716 at risk EG0010 affected3,716 at risk
Breast cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 affected3,716 at risk EG0010 affected3,716 at risk
Bronchial carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 affected3,716 at risk EG0010 affected3,716 at risk
Chronic lymphocytic leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 affected3,716 at risk EG0010 affected3,716 at risk
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 affected3,716 at risk EG0011 affected3,716 at risk
Colorectal adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 affected3,716 at risk EG0011 affected3,716 at risk
Colorectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 affected3,716 at risk EG0010 affected3,716 at risk
Gastrointestinal stromal tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 affected3,716 at risk EG0010 affected3,716 at risk
Leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 affected3,716 at risk EG0010 affected3,716 at risk
Lung carcinoma cell type unspecified stage IV	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 affected3,716 at risk EG0010 affected3,716 at risk
Malignant pleural effusion	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 affected3,716 at risk EG0011 affected3,716 at risk
Meningioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 affected3,716 at risk EG0010 affected3,716 at risk
Metastases to bone	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 affected3,716 at risk EG0011 affected3,716 at risk
Metastases to liver	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 affected3,716 at risk EG0010 affected3,716 at risk
Metastases to peritoneum	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 affected3,716 at risk EG0010 affected3,716 at risk
Metastasis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 affected3,716 at risk EG0011 affected3,716 at risk
Myeloid leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 affected3,716 at risk EG0010 affected3,716 at risk
Neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 affected3,716 at risk EG0011 affected3,716 at risk
Non-Hodgkin's lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 affected3,716 at risk EG0011 affected3,716 at risk
Oesophageal carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 affected3,716 at risk EG0011 affected3,716 at risk
Pancreatic carcinoma metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 affected3,716 at risk EG0010 affected3,716 at risk
Plasma cell myeloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 affected3,716 at risk EG0010 affected3,716 at risk
Plasmacytoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 affected3,716 at risk EG0010 affected3,716 at risk
Pleural mesothelioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 affected3,716 at risk EG0011 affected3,716 at risk
Rectosigmoid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 affected3,716 at risk EG0010 affected3,716 at risk
Small cell lung cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 affected3,716 at risk EG0010 affected3,716 at risk
Throat cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 affected3,716 at risk EG0010 affected3,716 at risk
Transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 affected3,716 at risk EG0011 affected3,716 at risk
Vulval cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 affected3,716 at risk EG0010 affected3,716 at risk
Hip fracture	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 affected3,716 at risk EG0013 affected3,716 at risk
Fall	Injury, poisoning and procedural complications	Systematic Assessment	EG0003 affected3,716 at risk EG0010 affected3,716 at risk
Rib fracture	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 affected3,716 at risk EG0013 affected3,716 at risk
Cervical vertebral fracture	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 affected3,716 at risk EG0011 affected3,716 at risk
Contusion	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 affected3,716 at risk EG0011 affected3,716 at risk
Head injury	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 affected3,716 at risk EG0011 affected3,716 at risk
Lumbar vertebral fracture	Injury, poisoning and procedural complications	Systematic Assessment	EG0002 affected3,716 at risk EG0010 affected3,716 at risk
Accident	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 affected3,716 at risk EG0011 affected3,716 at risk
Accidental overdose	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 affected3,716 at risk EG0011 affected3,716 at risk
Concussion	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 affected3,716 at risk EG0010 affected3,716 at risk
Femur fracture	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 affected3,716 at risk EG0010 affected3,716 at risk
Humerus fracture	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 affected3,716 at risk EG0010 affected3,716 at risk
Iatrogenic injury	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 affected3,716 at risk EG0011 affected3,716 at risk
Joint dislocation	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 affected3,716 at risk EG0010 affected3,716 at risk
Patella fracture	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 affected3,716 at risk EG0010 affected3,716 at risk
Pneumothorax traumatic	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 affected3,716 at risk EG0011 affected3,716 at risk
Post procedural haemorrhage	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 affected3,716 at risk EG0011 affected3,716 at risk
Procedural haemorrhage	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 affected3,716 at risk EG0010 affected3,716 at risk
Pubis fracture	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 affected3,716 at risk EG0011 affected3,716 at risk
Skin injury	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 affected3,716 at risk EG0010 affected3,716 at risk
Spinal compression fracture	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 affected3,716 at risk EG0010 affected3,716 at risk
Spinal cord injury	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 affected3,716 at risk EG0010 affected3,716 at risk
Subdural haematoma	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 affected3,716 at risk EG0011 affected3,716 at risk
Tendon rupture	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 affected3,716 at risk EG0010 affected3,716 at risk
Traumatic fracture	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 affected3,716 at risk EG0010 affected3,716 at risk
Traumatic haematoma	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 affected3,716 at risk EG0010 affected3,716 at risk
Upper limb fracture	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 affected3,716 at risk EG0010 affected3,716 at risk
Type 2 diabetes mellitus	Metabolism and nutrition disorders	Systematic Assessment	EG0001 affected3,716 at risk EG0013 affected3,716 at risk
Dehydration	Metabolism and nutrition disorders	Systematic Assessment	EG0001 affected3,716 at risk EG0012 affected3,716 at risk
Diabetes mellitus	Metabolism and nutrition disorders	Systematic Assessment	EG0000 affected3,716 at risk EG0012 affected3,716 at risk
Gout	Metabolism and nutrition disorders	Systematic Assessment	EG0001 affected3,716 at risk EG0011 affected3,716 at risk
Hypokalaemia	Metabolism and nutrition disorders	Systematic Assessment	EG0002 affected3,716 at risk EG0010 affected3,716 at risk
Hyponatraemia	Metabolism and nutrition disorders	Systematic Assessment	EG0001 affected3,716 at risk EG0011 affected3,716 at risk
Failure to thrive	Metabolism and nutrition disorders	Systematic Assessment	EG0000 affected3,716 at risk EG0011 affected3,716 at risk
Hypercalcaemia	Metabolism and nutrition disorders	Systematic Assessment	EG0001 affected3,716 at risk EG0010 affected3,716 at risk
Hyperglycaemia	Metabolism and nutrition disorders	Systematic Assessment	EG0000 affected3,716 at risk EG0011 affected3,716 at risk
Hyperkalaemia	Metabolism and nutrition disorders	Systematic Assessment	EG0000 affected3,716 at risk EG0011 affected3,716 at risk
Hypernatraemia	Metabolism and nutrition disorders	Systematic Assessment	EG0000 affected3,716 at risk EG0011 affected3,716 at risk
Hyperphosphataemia	Metabolism and nutrition disorders	Systematic Assessment	EG0000 affected3,716 at risk EG0011 affected3,716 at risk
Hypoglycaemia	Metabolism and nutrition disorders	Systematic Assessment	EG0001 affected3,716 at risk EG0010 affected3,716 at risk
Hypovolaemia	Metabolism and nutrition disorders	Systematic Assessment	EG0000 affected3,716 at risk EG0011 affected3,716 at risk
Type 1 diabetes mellitus	Metabolism and nutrition disorders	Systematic Assessment	EG0001 affected3,716 at risk EG0010 affected3,716 at risk
Anaemia	Blood and lymphatic system disorders	Systematic Assessment	EG0008 affected3,716 at risk EG0014 affected3,716 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	Systematic Assessment	EG0001 affected3,716 at risk EG0011 affected3,716 at risk
Thrombocytopenia	Blood and lymphatic system disorders	Systematic Assessment	EG0001 affected3,716 at risk EG0011 affected3,716 at risk
Coagulopathy	Blood and lymphatic system disorders	Systematic Assessment	EG0001 affected3,716 at risk EG0010 affected3,716 at risk
Haemorrhagic anaemia	Blood and lymphatic system disorders	Systematic Assessment	EG0001 affected3,716 at risk EG0010 affected3,716 at risk
Polycythaemia	Blood and lymphatic system disorders	Systematic Assessment	EG0000 affected3,716 at risk EG0011 affected3,716 at risk
Spontaneous haematoma	Blood and lymphatic system disorders	Systematic Assessment	EG0001 affected3,716 at risk EG0010 affected3,716 at risk
Hepatic enzyme increased	Investigations	Systematic Assessment	EG0002 affected3,716 at risk EG0015 affected3,716 at risk
Aspiration bronchial	Investigations	Systematic Assessment	EG0002 affected3,716 at risk EG0011 affected3,716 at risk
Alanine aminotransferase increased	Investigations	Systematic Assessment	EG0001 affected3,716 at risk EG0011 affected3,716 at risk
General physical condition abnormal	Investigations	Systematic Assessment	EG0001 affected3,716 at risk EG0011 affected3,716 at risk
Blood alkaline phosphatase increased	Investigations	Systematic Assessment	EG0001 affected3,716 at risk EG0010 affected3,716 at risk
Blood creatinine increased	Investigations	Systematic Assessment	EG0001 affected3,716 at risk EG0010 affected3,716 at risk
Blood urea increased	Investigations	Systematic Assessment	EG0001 affected3,716 at risk EG0010 affected3,716 at risk
Blood urine present	Investigations	Systematic Assessment	EG0001 affected3,716 at risk EG0010 affected3,716 at risk
Catheterisation cardiac	Investigations	Systematic Assessment	EG0000 affected3,716 at risk EG0011 affected3,716 at risk
Transaminases increased	Investigations	Systematic Assessment	EG0001 affected3,716 at risk EG0010 affected3,716 at risk
Arthritis	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0002 affected3,716 at risk EG0010 affected3,716 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 affected3,716 at risk EG0011 affected3,716 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 affected3,716 at risk EG0010 affected3,716 at risk
Cervical spinal stenosis	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 affected3,716 at risk EG0010 affected3,716 at risk
Chondrocalcinosis	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 affected3,716 at risk EG0010 affected3,716 at risk
Coccydynia	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 affected3,716 at risk EG0010 affected3,716 at risk
Intervertebral disc degeneration	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 affected3,716 at risk EG0010 affected3,716 at risk
Intervertebral disc disorder	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 affected3,716 at risk EG0010 affected3,716 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 affected3,716 at risk EG0011 affected3,716 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 affected3,716 at risk EG0011 affected3,716 at risk
Osteochondrosis	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 affected3,716 at risk EG0010 affected3,716 at risk
Polymyositis	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 affected3,716 at risk EG0011 affected3,716 at risk
Scleroderma	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 affected3,716 at risk EG0011 affected3,716 at risk
Synovial cyst	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 affected3,716 at risk EG0010 affected3,716 at risk
Cholecystitis	Hepatobiliary disorders	Systematic Assessment	EG0004 affected3,716 at risk EG0010 affected3,716 at risk
Bile duct stone	Hepatobiliary disorders	Systematic Assessment	EG0002 affected3,716 at risk EG0010 affected3,716 at risk
Cholecystitis acute	Hepatobiliary disorders	Systematic Assessment	EG0002 affected3,716 at risk EG0010 affected3,716 at risk
Cholecystitis chronic	Hepatobiliary disorders	Systematic Assessment	EG0002 affected3,716 at risk EG0010 affected3,716 at risk
Cholangitis	Hepatobiliary disorders	Systematic Assessment	EG0000 affected3,716 at risk EG0011 affected3,716 at risk
Cholelithiasis	Hepatobiliary disorders	Systematic Assessment	EG0001 affected3,716 at risk EG0010 affected3,716 at risk
Hepatitis	Hepatobiliary disorders	Systematic Assessment	EG0001 affected3,716 at risk EG0010 affected3,716 at risk
Hepatocellular injury	Hepatobiliary disorders	Systematic Assessment	EG0001 affected3,716 at risk EG0010 affected3,716 at risk
Ischaemic hepatitis	Hepatobiliary disorders	Systematic Assessment	EG0000 affected3,716 at risk EG0011 affected3,716 at risk
Portal vein thrombosis	Hepatobiliary disorders	Systematic Assessment	EG0001 affected3,716 at risk EG0010 affected3,716 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0003 affected3,716 at risk EG0011 affected3,716 at risk
Decubitus ulcer	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 affected3,716 at risk EG0012 affected3,716 at risk
Acute generalised exanthematous pustulosis	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 affected3,716 at risk EG0011 affected3,716 at risk
Dermatitis bullous	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 affected3,716 at risk EG0011 affected3,716 at risk
Ecchymosis	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 affected3,716 at risk EG0011 affected3,716 at risk
Pemphigoid	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0001 affected3,716 at risk EG0010 affected3,716 at risk
Petechiae	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 affected3,716 at risk EG0011 affected3,716 at risk
Skin disorder	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 affected3,716 at risk EG0011 affected3,716 at risk
Confusional state	Psychiatric disorders	Systematic Assessment	EG0002 affected3,716 at risk EG0010 affected3,716 at risk
Depression	Psychiatric disorders	Systematic Assessment	EG0000 affected3,716 at risk EG0012 affected3,716 at risk
Anxiety	Psychiatric disorders	Systematic Assessment	EG0001 affected3,716 at risk EG0010 affected3,716 at risk
Delirium	Psychiatric disorders	Systematic Assessment	EG0000 affected3,716 at risk EG0011 affected3,716 at risk
Major depression	Psychiatric disorders	Systematic Assessment	EG0001 affected3,716 at risk EG0010 affected3,716 at risk
Mental disorder	Psychiatric disorders	Systematic Assessment	EG0001 affected3,716 at risk EG0010 affected3,716 at risk
Coronary artery bypass	Surgical and medical procedures	Systematic Assessment	EG0001 affected3,716 at risk EG0010 affected3,716 at risk
Glaucoma surgery	Surgical and medical procedures	Systematic Assessment	EG0001 affected3,716 at risk EG0010 affected3,716 at risk
Hip arthroplasty	Surgical and medical procedures	Systematic Assessment	EG0001 affected3,716 at risk EG0010 affected3,716 at risk
Hospitalisation	Surgical and medical procedures	Systematic Assessment	EG0001 affected3,716 at risk EG0010 affected3,716 at risk
Hysterectomy	Surgical and medical procedures	Systematic Assessment	EG0001 affected3,716 at risk EG0010 affected3,716 at risk
Leg amputation	Surgical and medical procedures	Systematic Assessment	EG0000 affected3,716 at risk EG0011 affected3,716 at risk
Mitral valve repair	Surgical and medical procedures	Systematic Assessment	EG0000 affected3,716 at risk EG0011 affected3,716 at risk
Surgery	Surgical and medical procedures	Systematic Assessment	EG0001 affected3,716 at risk EG0010 affected3,716 at risk
Conjunctival haemorrhage	Eye disorders	Systematic Assessment	EG0001 affected3,716 at risk EG0011 affected3,716 at risk
Diabetic retinopathy	Eye disorders	Systematic Assessment	EG0000 affected3,716 at risk EG0011 affected3,716 at risk
Retinal haemorrhage	Eye disorders	Systematic Assessment	EG0000 affected3,716 at risk EG0011 affected3,716 at risk
Drug hypersensitivity	Immune system disorders	Systematic Assessment	EG0001 affected3,716 at risk EG0011 affected3,716 at risk
Anaphylactic reaction	Immune system disorders	Systematic Assessment	EG0000 affected3,716 at risk EG0011 affected3,716 at risk
Hypersensitivity	Immune system disorders	Systematic Assessment	EG0000 affected3,716 at risk EG0011 affected3,716 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	Systematic Assessment	EG0001 affected3,716 at risk EG0010 affected3,716 at risk
Cervix haemorrhage uterine	Reproductive system and breast disorders	Systematic Assessment	EG0001 affected3,716 at risk EG0010 affected3,716 at risk
Genital haemorrhage	Reproductive system and breast disorders	Systematic Assessment	EG0001 affected3,716 at risk EG0010 affected3,716 at risk
Vaginal haemorrhage	Reproductive system and breast disorders	Systematic Assessment	EG0001 affected3,716 at risk EG0010 affected3,716 at risk
Vertigo	Ear and labyrinth disorders	Systematic Assessment	EG0001 affected3,716 at risk EG0011 affected3,716 at risk
Goitre	Endocrine disorders	Systematic Assessment	EG0001 affected3,716 at risk EG0010 affected3,716 at risk
Hypoparathyroidism	Endocrine disorders	Systematic Assessment	EG0000 affected3,716 at risk EG0011 affected3,716 at risk
Activities of daily living impaired	Social circumstances	Systematic Assessment	EG0000 affected3,716 at risk EG0011 affected3,716 at risk

ID	Term
D013923	Thromboembolism
D016769	Embolism and Thrombosis
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

ID	Term
D006495	Heparin, Low-Molecular-Weight
D006493	Heparin
D006025	Glycosaminoglycans
D011134	Polysaccharides
D002241	Carbohydrates

ID	Title	Description
BG000	Betrixaban	Daily oral (PO) betrixaban capsules for 35 to 42 days and subcutaneous (SQ) injections of enoxaparin placebo for 10 ± 4 days
BG001	Enoxaparin	Daily subcutaneous (SQ) injections of enoxaparin for 10 ± 4 days and oral (PO) betrixaban placebo capsules for 35 to 42 days
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Betrixaban	Daily oral (PO) betrixaban capsules for 35 to 42 days and subcutaneous (SQ) injections of enoxaparin placebo for 10 ± 4 days			657	3,716	879	3,716
EG001	Enoxaparin	Daily subcutaneous (SQ) injections of enoxaparin for 10 ± 4 days and oral (PO) betrixaban placebo capsules for 35 to 42 days			615	3,716	779	3,716