Study: NCT01700439

Adverse event: ANEMIA - BLEEDING RELATED - MAJOR
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 31 affected / 885 at risk

Adverse event: ANEMIA - BLEEDING RELATED - MINOR
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 45 affected / 885 at risk

Adverse event: ANEMIA - NON-BLEEDING RELATED
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 28 affected / 885 at risk

Adverse event: BLEEDING - CARDIOVASCULAR - MAJOR
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 20 affected / 885 at risk

Adverse event: BLEEDING - CARDIOVASCULAR - MINOR
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 12 affected / 885 at risk

Adverse event: BLEEDING - GASTROINTESTINAL LOWER - MAJOR
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 16 affected / 885 at risk

Adverse event: BLEEDING - GASTROINTESTINAL LOWER - MINOR
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 17 affected / 885 at risk

Adverse event: BLEEDING - GASTROINTESTINAL UPPER - MAJOR
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 18 affected / 885 at risk

Adverse event: BLEEDING - GASTROINTESTINAL UPPER - MINOR
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 10 affected / 885 at risk

Adverse event: BLEEDING - GENITOURINARY - MAJOR
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 885 at risk

Adverse event: BLEEDING - GENITOURINARY - MINOR
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 885 at risk

Adverse event: BLEEDING - MUSCULOSKELETAL/DERMATOLOGICAL - MAJOR (E.G. ECCHYMOSIS)
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 885 at risk

Adverse event: BLEEDING - MUSCULOSKELETAL/DERMATOLOGICAL - MINOR (E.G. ECCHYMOSIS)
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 885 at risk

Adverse event: BLEEDING - NEUROLOGICAL - MAJOR (E.G. CVA)
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 15 affected / 885 at risk

Adverse event: BLEEDING - NEUROLOGICAL - MINOR (E.G. CVA)
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 885 at risk

Adverse event: BLEEDING - PERIPHERAL VASCULAR - MAJOR (E.G. NOSEBLEEDS; HEMATOMAS)
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 885 at risk

Adverse event: BLEEDING - PULMONARY/RESPIRATORY - MAJOR (E.G. HEMOTHORAX)
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 885 at risk

Adverse event: BLEEDING - PULMONARY/RESPIRATORY - MINOR (E.G. HEMOTHORAX)
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 885 at risk

Adverse event: BLOOD SEPSIS
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 49 affected / 885 at risk

Adverse event: BLOOD/LYMPHATIC - OTHER
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 23 affected / 885 at risk

Adverse event: THROMBOCYTOPENIA - HEPARIN INDUCED (HIT)
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 885 at risk

Adverse event: THROMBOCYTOPENIA - NON-HEPARIN INDUCED
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 23 affected / 885 at risk

Adverse event: ANGINA, STABLE
Serious: yes
Organ System: Cardiac disorders
Frequency: 21 affected / 885 at risk

Adverse event: ANGINA, UNSTABLE
Serious: yes
Organ System: Cardiac disorders
Frequency: 22 affected / 885 at risk

Adverse event: Aortic dissection
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 885 at risk

Adverse event: ARRHYTHMIA - ATRIAL FLUTTER
Serious: yes
Organ System: Cardiac disorders
Frequency: 37 affected / 885 at risk

Adverse event: ARRHYTHMIA - AV BLOCK - 1ST DEGREE
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 885 at risk

Adverse event: ARRHYTHMIA - AV BLOCK - 2ND DEGREE
Serious: yes
Organ System: Cardiac disorders
Frequency: 17 affected / 885 at risk

Adverse event: ARRHYTHMIA - AV BLOCK - 3RD DEGREE
Serious: yes
Organ System: Cardiac disorders
Frequency: 94 affected / 885 at risk

Adverse event: ARRHYTHMIA - BRADYCARDIA
Serious: yes
Organ System: Cardiac disorders
Frequency: 28 affected / 885 at risk

Adverse event: ARRHYTHMIA - BUNDLE BRANCH BLOCK - LEFT
Serious: yes
Organ System: Cardiac disorders
Frequency: 9 affected / 885 at risk

Adverse event: ARRHYTHMIA - BUNDLE BRANCH BLOCK - RIGHT
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 885 at risk

Adverse event: ARRHYTHMIA - OTHER
Serious: yes
Organ System: Cardiac disorders
Frequency: 34 affected / 885 at risk

Adverse event: ARRHYTHMIA - PACEMAKER/ICD MALFUNCTION
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 885 at risk

Adverse event: ARRHYTHMIA - PAROXYSMAL ATRIAL FIBRILLATION (PAF)
Serious: yes
Organ System: Cardiac disorders
Frequency: 91 affected / 885 at risk

Adverse event: ARRHYTHMIA - PAROXYSMAL ATRIAL TACHYCARDIA (PAT)
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 885 at risk

Adverse event: ARRHYTHMIA - PERMANENT ATRIAL FIBRILLATION
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 885 at risk

Adverse event: ARRHYTHMIA - PERSISTENT ATRIAL FIBRILLATION
Serious: yes
Organ System: Cardiac disorders
Frequency: 68 affected / 885 at risk

Adverse event: ARRHYTHMIA - SUPRAVENTRICULAR TACHYCARDIA (SVT)
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 885 at risk

Adverse event: ARRHYTHMIA - TACHY-BRADYCARDIA
Serious: yes
Organ System: Cardiac disorders
Frequency: 12 affected / 885 at risk

Adverse event: ARRHYTHMIA - TACHYCARDIA - NON-VENTRICULAR
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 885 at risk

Adverse event: ARRHYTHMIA - TACHYCARDIA - VENTRICULAR
Serious: yes
Organ System: Cardiac disorders
Frequency: 8 affected / 885 at risk

Adverse event: ARRHYTHMIA - VENTRICULAR FIBRILLATION
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 885 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 27 affected / 885 at risk

Adverse event: CARDIAC DECOMPENSATION
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 885 at risk

Adverse event: Cardiogenic shock
Serious: yes
Organ System: Cardiac disorders
Frequency: 14 affected / 885 at risk

Adverse event: CARDIOVASCULAR - OTHER
Serious: yes
Organ System: Cardiac disorders
Frequency: 105 affected / 885 at risk

Adverse event: CORONARY ARTERY OSTIAL OBSTRUCTION
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 885 at risk

Adverse event: Endocarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 11 affected / 885 at risk

Adverse event: HEART FAILURE - ACUTE
Serious: yes
Organ System: Cardiac disorders
Frequency: 64 affected / 885 at risk

Adverse event: HEART FAILURE - CHRONIC (CHF)
Serious: yes
Organ System: Cardiac disorders
Frequency: 42 affected / 885 at risk

Adverse event: HYPERTENSION - SYSTEMIC
Serious: yes
Organ System: Cardiac disorders
Frequency: 16 affected / 885 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Cardiac disorders
Frequency: 25 affected / 885 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 34 affected / 885 at risk

Adverse event: PERFORATION - VENTRICULAR
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 885 at risk

Adverse event: PERICARDIAL EFFUSION - MAJOR
Serious: yes
Organ System: Cardiac disorders
Frequency: 14 affected / 885 at risk

Adverse event: PERICARDIAL EFFUSION - MINOR
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 885 at risk

Adverse event: Cardiac tamponade
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 885 at risk

Adverse event: Pericarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 885 at risk

Adverse event: REGURGITATION - AORTIC-CENTRAL/TRANSVALVULAR +4
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 885 at risk

Adverse event: REGURGITATION - MITRAL-CENTRAL/TRANSVALVULAR +3
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 885 at risk

Adverse event: REGURGITATION - MITRAL-CENTRAL/TRANSVALVULAR +4
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 885 at risk

Adverse event: REGURGITATION - MITRAL-INDETERMINATE +3
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 885 at risk

Adverse event: REGURGITATION - MITRAL-INDETERMINATE +4
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 885 at risk

Adverse event: REGURGITATION - TRICUSPID-CENTRAL/TRANSVALVULAR +3
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 885 at risk

Adverse event: REGURGITATION - TRICUSPID-CENTRAL/TRANSVALVULAR +4
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 885 at risk

Adverse event: REGURGITATION - TRICUSPID-INDETERMINATE +3
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 885 at risk

Adverse event: REGURGITATION - TRICUSPID-INDETERMINATE +4
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 885 at risk

Adverse event: STENOSIS - MITRAL - SEVERE
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 885 at risk

Adverse event: THROMBOEMBOLIC EVENT - OTHER - CENTRAL - NO PARESIS
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 885 at risk

Adverse event: THROMBOEMBOLIC EVENT - STROKE
Serious: yes
Organ System: Cardiac disorders
Frequency: 56 affected / 885 at risk

Adverse event: THROMBOEMBOLIC EVENT - TRANSIENT ISCHEMIC ATTACK (TIA)
Serious: yes
Organ System: Cardiac disorders
Frequency: 27 affected / 885 at risk

Adverse event: VALVE THROMBOSIS - AORTIC
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 885 at risk

Adverse event: HEARING DISORDER
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 3 affected / 885 at risk

Adverse event: ENDOCRINE COMPLICATIONS
Serious: yes
Organ System: Endocrine disorders
Frequency: 4 affected / 885 at risk

Adverse event: PANCREATIC COMPLICATION
Serious: yes
Organ System: Endocrine disorders
Frequency: 15 affected / 885 at risk

Adverse event: VISION DISORDER
Serious: yes
Organ System: Eye disorders
Frequency: 35 affected / 885 at risk

Adverse event: GASTROINTESTINAL - INFECTION
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 885 at risk

Adverse event: GASTROINTESTINAL - OTHER
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 108 affected / 885 at risk

Adverse event: ALLERGIC REACTION - MEDICATION RELATED
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 885 at risk

Adverse event: ALLERGIC REACTION - OTHER
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 885 at risk

Adverse event: Anaphylactic reaction
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 885 at risk

Adverse event: CANCER - NEWLY DIAGNOSED
Serious: yes
Organ System: General disorders
Frequency: 77 affected / 885 at risk

Adverse event: CANCER - PROGRESSION OF UNDERLYING DISEASE
Serious: yes
Organ System: General disorders
Frequency: 18 affected / 885 at risk

Adverse event: FEVER - UNKNOWN ORIGIN
Serious: yes
Organ System: General disorders
Frequency: 10 affected / 885 at risk

Adverse event: MULTI-SYSTEM ORGAN FAILURE
Serious: yes
Organ System: General disorders
Frequency: 8 affected / 885 at risk

Adverse event: NONSPECIFIC, UNKNOWN, OR OTHER BODY SYSTEM - OTHER COMPLICATION
Serious: yes
Organ System: General disorders
Frequency: 150 affected / 885 at risk

Adverse event: NSD - PARAVALVULAR LEAK +2
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 885 at risk

Adverse event: NSD - PARAVALVULAR LEAK +3
Serious: yes
Organ System: General disorders
Frequency: 8 affected / 885 at risk

Adverse event: NSD - PARAVALVULAR LEAK +4
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 885 at risk

Adverse event: NSD - PARAVALVULAR LEAK WITH HEMOLYSIS
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 885 at risk

Adverse event: NSD - STUDY VALVE STENOSIS - SEVERE
Serious: yes
Organ System: General disorders
Frequency: 9 affected / 885 at risk

Adverse event: Speech disorder
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 885 at risk

Adverse event: SVD - STUDY VALVE CALCIFICATION
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 885 at risk

Adverse event: BILIARY (GALLBLADDER)
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 29 affected / 885 at risk

Adverse event: HEPATIC COMPLICATION - OTHER
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 4 affected / 885 at risk

Adverse event: LIVER FAILURE - ACUTE
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 885 at risk

Adverse event: INFECTION/INFLAMMATION - OTHER
Serious: yes
Organ System: Infections and infestations
Frequency: 49 affected / 885 at risk

Adverse event: STERNAL WOUND/THORACIC INFECTION
Serious: yes
Organ System: Infections and infestations
Frequency: 11 affected / 885 at risk

Adverse event: WOUND INFECTION - OTHER
Serious: yes
Organ System: Infections and infestations
Frequency: 31 affected / 885 at risk

Adverse event: METABOLIC COMPLICATIONS
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 885 at risk

Adverse event: BONE FRACTURE/BREAK
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 57 affected / 885 at risk

Adverse event: MUSCULAR SKELETAL/DERMATOLOGIC - OTHER
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 177 affected / 885 at risk

Adverse event: PSYCHIATRIC - OTHER
Serious: yes
Organ System: Psychiatric disorders
Frequency: 20 affected / 885 at risk

Adverse event: PSYCHIATRIC DISORDER
Serious: yes
Organ System: Psychiatric disorders
Frequency: 6 affected / 885 at risk

Adverse event: Completed suicide
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 885 at risk

Adverse event: GENITOURINARY - OTHER
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 31 affected / 885 at risk

Adverse event: RENAL - OTHER
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 33 affected / 885 at risk

Adverse event: RENAL DYSFUNCTION
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 12 affected / 885 at risk

Adverse event: RENAL FAILURE - ACUTE
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 41 affected / 885 at risk

Adverse event: RENAL FAILURE - CHRONIC
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 885 at risk

Adverse event: URINARY TRACT INFECTION (UTI)
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 43 affected / 885 at risk

Adverse event: Atelectasis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 885 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 13 affected / 885 at risk

Adverse event: PLEURAL EFFUSION - BILATERAL
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 28 affected / 885 at risk

Adverse event: PLEURAL EFFUSION - LEFT
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 21 affected / 885 at risk

Adverse event: PLEURAL EFFUSION - RIGHT
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 33 affected / 885 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 885 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 885 at risk

Adverse event: PULMONARY EMBOLISM - BILATERAL
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 885 at risk

Adverse event: PULMONARY EMBOLISM - LEFT
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 885 at risk

Adverse event: PULMONARY EMBOLISM - RIGHT
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 885 at risk

Adverse event: Pulmonary hypertension
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 885 at risk

Adverse event: PULMONARY/RESPIRATORY - OTHER
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 31 affected / 885 at risk

Adverse event: RESPIRATORY DYSFUNCTION/INSUFFICIENCY
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 15 affected / 885 at risk

Adverse event: RESPIRATORY FAILURE - ACUTE RESPIRATORY DISTRESS SYNDROME (ARDS)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 885 at risk

Adverse event: RESPIRATORY FAILURE - ASTHMA
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 885 at risk

Adverse event: RESPIRATORY FAILURE - COPD
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 16 affected / 885 at risk

Adverse event: RESPIRATORY FAILURE - EMPHYSEMA
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 885 at risk

Adverse event: RESPIRATORY FAILURE - HEMOTHORAX
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 885 at risk

Adverse event: RESPIRATORY FAILURE - OTHER
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 50 affected / 885 at risk

Adverse event: RESPIRATORY FAILURE - PNEUMONIA
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 34 affected / 885 at risk

Adverse event: RESPIRATORY FAILURE - PNEUMOTHORAX
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 885 at risk

Adverse event: RESPIRATORY INFECTION - PNEUMONIA
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 69 affected / 885 at risk

Adverse event: RESPIRATORY INFECTION - UPPER (URI)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 17 affected / 885 at risk

Adverse event: VASCULAR - ACCESS SITE COMPLICATION
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 885 at risk

Adverse event: VASCULAR - DEEP VEIN THROMBOSIS (DVT)
Serious: yes
Organ System: Vascular disorders
Frequency: 15 affected / 885 at risk

Adverse event: VASCULAR - OTHER
Serious: yes
Organ System: Vascular disorders
Frequency: 44 affected / 885 at risk

Adverse event: THROMBOCYTOPENIA - NON-HEPARIN INDUCED
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 442 affected / 885 at risk

Adverse event: BLOOD/LYMPHATIC - OTHER
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 259 affected / 885 at risk

Adverse event: ANEMIA - BLEEDING RELATED - MINOR
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 196 affected / 885 at risk

Adverse event: ANEMIA - NON-BLEEDING RELATED
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 83 affected / 885 at risk

Adverse event: ARRHYTHMIA - PAROXYSMAL ATRIAL FIBRILLATION (PAF)
Serious: no
Organ System: Cardiac disorders
Frequency: 262 affected / 885 at risk

Adverse event: ARRHYTHMIA - BUNDLE BRANCH BLOCK - LEFT
Serious: no
Organ System: Cardiac disorders
Frequency: 279 affected / 885 at risk

Adverse event: ARRHYTHMIA - AV BLOCK - 1ST DEGREE
Serious: no
Organ System: Cardiac disorders
Frequency: 232 affected / 885 at risk

Adverse event: ARRHYTHMIA - OTHER
Serious: no
Organ System: Cardiac disorders
Frequency: 248 affected / 885 at risk

Adverse event: ARRHYTHMIA - BRADYCARDIA
Serious: no
Organ System: Cardiac disorders
Frequency: 137 affected / 885 at risk

Adverse event: ARRHYTHMIA - BUNDLE BRANCH BLOCK - RIGHT
Serious: no
Organ System: Cardiac disorders
Frequency: 92 affected / 885 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 161 affected / 885 at risk

Adverse event: CARDIOVASCULAR - OTHER
Serious: no
Organ System: Cardiac disorders
Frequency: 154 affected / 885 at risk

Adverse event: HYPERTENSION - SYSTEMIC
Serious: no
Organ System: Cardiac disorders
Frequency: 80 affected / 885 at risk

Adverse event: GASTROINTESTINAL - OTHER
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 137 affected / 885 at risk

Adverse event: URINARY TRACT INFECTION (UTI)
Serious: no
Organ System: Renal and urinary disorders
Frequency: 105 affected / 885 at risk

Adverse event: MUSCULAR SKELETAL/DERMATOLOGIC - OTHER
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 234 affected / 885 at risk

Adverse event: NONSPECIFIC, UNKNOWN, OR OTHER BODY SYSTEM - OTHER COMPLICATION
Serious: no
Organ System: General disorders
Frequency: 253 affected / 885 at risk

Adverse event: PSYCHIATRIC - OTHER
Serious: no
Organ System: Psychiatric disorders
Frequency: 77 affected / 885 at risk

Adverse event: Atelectasis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 348 affected / 885 at risk

Adverse event: PLEURAL EFFUSION - BILATERAL
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 63 affected / 885 at risk

Adverse event: ENDOCRINE COMPLICATIONS
Serious: no
Organ System: Endocrine disorders
Frequency: 61 affected / 885 at risk

Adverse event: RENAL DYSFUNCTION
Serious: no
Organ System: Renal and urinary disorders
Frequency: 61 affected / 885 at risk

Adverse event: RENAL - OTHER
Serious: no
Organ System: Renal and urinary disorders
Frequency: 59 affected / 885 at risk

Adverse event: RENAL FAILURE - ACUTE
Serious: no
Organ System: Renal and urinary disorders
Frequency: 57 affected / 885 at risk

Adverse event: INFECTION/INFLAMMATION - OTHER
Serious: no
Organ System: Infections and infestations
Frequency: 88 affected / 885 at risk

Adverse event: BONE FRACTURE/BREAK
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 54 affected / 885 at risk

Adverse event: VASCULAR - OTHER
Serious: no
Organ System: Vascular disorders
Frequency: 57 affected / 885 at risk

Adverse event: PULMONARY/RESPIRATORY - OTHER
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 108 affected / 885 at risk

Adverse event: RESPIRATORY INFECTION - UPPER (URI)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 60 affected / 885 at risk

Adverse event: THROMBOCYTOPENIA - HEPARIN INDUCED (HIT)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 12 affected / 885 at risk

Adverse event: ARRHYTHMIA - ATRIAL FLUTTER
Serious: no
Organ System: Cardiac disorders
Frequency: 44 affected / 885 at risk

Adverse event: ARRHYTHMIA - PERSISTENT ATRIAL FIBRILLATION
Serious: no
Organ System: Cardiac disorders
Frequency: 38 affected / 885 at risk

Adverse event: ARRHYTHMIA - TACHYCARDIA - NON-VENTRICULAR
Serious: no
Organ System: Cardiac disorders
Frequency: 36 affected / 885 at risk

Adverse event: HEART FAILURE - ACUTE
Serious: no
Organ System: Cardiac disorders
Frequency: 29 affected / 885 at risk

Adverse event: Pericarditis
Serious: no
Organ System: Cardiac disorders
Frequency: 13 affected / 885 at risk

Adverse event: GENITOURINARY - OTHER
Serious: no
Organ System: Renal and urinary disorders
Frequency: 35 affected / 885 at risk

Adverse event: VISION DISORDER
Serious: no
Organ System: Eye disorders
Frequency: 47 affected / 885 at risk

Adverse event: ANEMIA - BLEEDING RELATED - MAJOR
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 49 at risk

Adverse event: ANEMIA - BLEEDING RELATED - MINOR
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 49 at risk

Adverse event: ANEMIA - NON-BLEEDING RELATED
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 49 at risk

Adverse event: BLEEDING - CARDIOVASCULAR - MAJOR
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 49 at risk

Adverse event: BLEEDING - CARDIOVASCULAR - MINOR
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 49 at risk

Adverse event: BLEEDING - GASTROINTESTINAL LOWER - MAJOR
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 49 at risk

Adverse event: BLEEDING - GASTROINTESTINAL UPPER - MINOR
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 49 at risk

Adverse event: BLEEDING - GENITOURINARY - MAJOR
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 49 at risk

Adverse event: BLEEDING - MUSCULOSKELETAL/DERMATOLOGICAL - MINOR (E.G. ECCHYMOSIS)
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 49 at risk

Adverse event: BLOOD SEPSIS
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 49 at risk

Adverse event: BLOOD/LYMPHATIC - OTHER
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 49 at risk

Adverse event: THROMBOCYTOPENIA - NON-HEPARIN INDUCED
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 49 at risk

Adverse event: Aortic dissection
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 49 at risk

Adverse event: ARRHYTHMIA - AV BLOCK - 2ND DEGREE
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 49 at risk

Adverse event: ARRHYTHMIA - AV BLOCK - 3RD DEGREE
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 49 at risk

Adverse event: ARRHYTHMIA - BRADYCARDIA
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 49 at risk

Adverse event: ARRHYTHMIA - OTHER
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 49 at risk

Adverse event: ARRHYTHMIA - PAROXYSMAL ATRIAL FIBRILLATION (PAF)
Serious: yes
Organ System: Cardiac disorders
Frequency: 12 affected / 49 at risk

Adverse event: ARRHYTHMIA - PERSISTENT ATRIAL FIBRILLATION
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 49 at risk

Adverse event: ARRHYTHMIA - TACHY-BRADYCARDIA
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 49 at risk

Adverse event: ARRHYTHMIA - TACHYCARDIA - VENTRICULAR
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 49 at risk

Adverse event: ARRHYTHMIA - VENTRICULAR FIBRILLATION
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 49 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 49 at risk

Adverse event: Cardiogenic shock
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 49 at risk

Adverse event: CARDIOVASCULAR - OTHER
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 49 at risk

Adverse event: CORONARY ARTERY OSTIAL OBSTRUCTION
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 49 at risk

Adverse event: Endocarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 49 at risk

Adverse event: HEART FAILURE - ACUTE
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 49 at risk

Adverse event: HEART FAILURE - CHRONIC (CHF)
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 49 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 49 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 49 at risk

Adverse event: PERICARDIAL EFFUSION - MAJOR
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 49 at risk

Adverse event: Cardiac tamponade
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 49 at risk

Adverse event: REGURGITATION - MITRAL-INDETERMINATE +4
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 49 at risk

Adverse event: THROMBOEMBOLIC EVENT - STROKE
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 49 at risk

Adverse event: THROMBOEMBOLIC EVENT - TRANSIENT ISCHEMIC ATTACK (TIA)
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 49 at risk

Adverse event: GASTROINTESTINAL - INFECTION
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 49 at risk

Adverse event: GASTROINTESTINAL - OTHER
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 49 at risk

Adverse event: CANCER - NEWLY DIAGNOSED
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 49 at risk

Adverse event: CANCER - PROGRESSION OF UNDERLYING DISEASE
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 49 at risk

Adverse event: NONSPECIFIC, UNKNOWN, OR OTHER BODY SYSTEM - OTHER COMPLICATION
Serious: yes
Organ System: General disorders
Frequency: 7 affected / 49 at risk

Adverse event: NSD - PARAVALVULAR LEAK +4
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 49 at risk

Adverse event: BILIARY (GALLBLADDER)
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 49 at risk

Adverse event: INFECTION/INFLAMMATION - OTHER
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 49 at risk

Adverse event: STERNAL WOUND/THORACIC INFECTION
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 49 at risk

Adverse event: METABOLIC COMPLICATIONS
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 49 at risk

Adverse event: BONE FRACTURE/BREAK
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 49 at risk

Adverse event: MUSCULAR SKELETAL/DERMATOLOGIC - OTHER
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 49 at risk

Adverse event: GENITOURINARY - OTHER
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 49 at risk

Adverse event: RENAL - OTHER
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 49 at risk

Adverse event: RENAL FAILURE - ACUTE
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 49 at risk

Adverse event: URINARY TRACT INFECTION (UTI)
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 49 at risk

Adverse event: Atelectasis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 49 at risk

Adverse event: PLEURAL EFFUSION - LEFT
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 49 at risk

Adverse event: PLEURAL EFFUSION - RIGHT
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 49 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 49 at risk

Adverse event: PULMONARY/RESPIRATORY - OTHER
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 49 at risk

Adverse event: RESPIRATORY DYSFUNCTION/INSUFFICIENCY
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 49 at risk

Adverse event: RESPIRATORY FAILURE - OTHER
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 49 at risk

Adverse event: RESPIRATORY FAILURE - PNEUMONIA
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 49 at risk

Adverse event: RESPIRATORY FAILURE - PNEUMOTHORAX
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 49 at risk

Adverse event: RESPIRATORY INFECTION - PNEUMONIA
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 49 at risk

Adverse event: VASCULAR - DEEP VEIN THROMBOSIS (DVT)
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 49 at risk

Adverse event: PERFORATION - OTHER
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 49 at risk

Adverse event: THROMBOCYTOPENIA - NON-HEPARIN INDUCED
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 28 affected / 49 at risk

Adverse event: BLOOD/LYMPHATIC - OTHER
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 49 at risk

Adverse event: ANEMIA - BLEEDING RELATED - MINOR
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 10 affected / 49 at risk

Adverse event: ANEMIA - NON-BLEEDING RELATED
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 9 affected / 49 at risk

Adverse event: ARRHYTHMIA - PAROXYSMAL ATRIAL FIBRILLATION (PAF)
Serious: no
Organ System: Cardiac disorders
Frequency: 15 affected / 49 at risk

Adverse event: ARRHYTHMIA - BUNDLE BRANCH BLOCK - LEFT
Serious: no
Organ System: Cardiac disorders
Frequency: 9 affected / 49 at risk

Adverse event: ARRHYTHMIA - AV BLOCK - 1ST DEGREE
Serious: no
Organ System: Cardiac disorders
Frequency: 11 affected / 49 at risk

Adverse event: ARRHYTHMIA - OTHER
Serious: no
Organ System: Cardiac disorders
Frequency: 12 affected / 49 at risk

Adverse event: ARRHYTHMIA - BRADYCARDIA
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 49 at risk

Adverse event: ARRHYTHMIA - BUNDLE BRANCH BLOCK - RIGHT
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 49 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 49 at risk

Adverse event: CARDIOVASCULAR - OTHER
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 49 at risk

Adverse event: HYPERTENSION - SYSTEMIC
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 49 at risk

Adverse event: GASTROINTESTINAL - OTHER
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 49 at risk

Adverse event: URINARY TRACT INFECTION (UTI)
Serious: no
Organ System: Renal and urinary disorders
Frequency: 7 affected / 49 at risk

Adverse event: MUSCULAR SKELETAL/DERMATOLOGIC - OTHER
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 49 at risk

Adverse event: NONSPECIFIC, UNKNOWN, OR OTHER BODY SYSTEM - OTHER COMPLICATION
Serious: no
Organ System: General disorders
Frequency: 8 affected / 49 at risk

Adverse event: PSYCHIATRIC - OTHER
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 49 at risk

Adverse event: Atelectasis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 14 affected / 49 at risk

Adverse event: PLEURAL EFFUSION - BILATERAL
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 49 at risk

Adverse event: ENDOCRINE COMPLICATIONS
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 49 at risk

Adverse event: RENAL DYSFUNCTION
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 49 at risk

Adverse event: RENAL - OTHER
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 49 at risk

Adverse event: RENAL FAILURE - ACUTE
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 49 at risk

Adverse event: INFECTION/INFLAMMATION - OTHER
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 49 at risk

Adverse event: BONE FRACTURE/BREAK
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 49 at risk

Adverse event: VASCULAR - OTHER
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 49 at risk

Adverse event: PULMONARY/RESPIRATORY - OTHER
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 49 at risk

Adverse event: RESPIRATORY INFECTION - UPPER (URI)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 49 at risk

Adverse event: THROMBOCYTOPENIA - HEPARIN INDUCED (HIT)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 49 at risk

Adverse event: ARRHYTHMIA - ATRIAL FLUTTER
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 49 at risk

Adverse event: ARRHYTHMIA - PERSISTENT ATRIAL FIBRILLATION
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 49 at risk

Adverse event: ARRHYTHMIA - TACHYCARDIA - NON-VENTRICULAR
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 49 at risk

Adverse event: HEART FAILURE - ACUTE
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 49 at risk

Adverse event: Pericarditis
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 49 at risk

Adverse event: GENITOURINARY - OTHER
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 49 at risk