Study: NCT01757665

Adverse event: Anemia - Bleeding related - Major
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 12 affected / 689 at risk

Adverse event: Anemia - Bleeding related - Minor
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 11 affected / 689 at risk

Adverse event: Anemia - Non-bleeding related
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 689 at risk

Adverse event: Angina, stable
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 689 at risk

Adverse event: Angina, unstable
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 689 at risk

Adverse event: Arrhythmia - Atrial flutter
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 689 at risk

Adverse event: Arrhythmia - AV block - 1st degree
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 689 at risk

Adverse event: Arrhythmia - AV block - 2nd degree
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 689 at risk

Adverse event: Arrhythmia - AV block - 3rd degree
Serious: yes
Organ System: Cardiac disorders
Frequency: 24 affected / 689 at risk

Adverse event: Arrhythmia - Bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 689 at risk

Adverse event: Arrhythmia - Bundle branch block - Left
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 689 at risk

Adverse event: Arrhythmia - Bundle branch block - Right
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 689 at risk

Adverse event: Arrhythmia - Other
Serious: yes
Organ System: Cardiac disorders
Frequency: 10 affected / 689 at risk

Adverse event: Arrhythmia - Paroxysmal Atrial Fibrillation (PAF)
Serious: yes
Organ System: Cardiac disorders
Frequency: 39 affected / 689 at risk

Adverse event: Arrhythmia - Permanent atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 689 at risk

Adverse event: Arrhythmia - Persistent atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 14 affected / 689 at risk

Adverse event: Arrhythmia - Supraventricular Tachycardia (SVT)
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 689 at risk

Adverse event: Arrhythmia - Tachy-bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 689 at risk

Adverse event: Arrhythmia - Tachycardia - Ventricular
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 689 at risk

Adverse event: Arrhythmia - Ventricular fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 689 at risk

Adverse event: Biliary (gallbladder)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 689 at risk

Adverse event: Bleeding - Cardiovascular - Major
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 21 affected / 689 at risk

Adverse event: Bleeding - Cardiovascular - Minor
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 689 at risk

Adverse event: Bleeding - Gastrointestinal lower - Major
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 689 at risk

Adverse event: Bleeding - Gastrointestinal lower - Minor
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 689 at risk

Adverse event: Bleeding - Gastrointestinal upper - Major
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 689 at risk

Adverse event: Bleeding - Genitourinary - Minor
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 689 at risk

Adverse event: Bleeding - Musculoskeletal/Dermatological - Major (e.g. ecchymosis)
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 689 at risk

Adverse event: Bleeding - Neurological - Minor (e.g. CVA)
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 689 at risk

Adverse event: Bleeding - Pulmonary/Respiratory - Major (e.g. hemothorax)
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 689 at risk

Adverse event: Blood sepsis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 9 affected / 689 at risk

Adverse event: Blood/Lymphatic - Other
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 689 at risk

Adverse event: Bone fracture/Break
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 689 at risk

Adverse event: Cancer - Newly diagnosed
Serious: yes
Organ System: General disorders
Frequency: 9 affected / 689 at risk

Adverse event: Cancer - Progression of underlying disease
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 689 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 689 at risk

Adverse event: Cardiac decompensation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 689 at risk

Adverse event: Cardiogenic shock
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 689 at risk

Adverse event: Cardiovascular - Other
Serious: yes
Organ System: Cardiac disorders
Frequency: 23 affected / 689 at risk

Adverse event: Coronary artery ostial obstruction
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 689 at risk

Adverse event: Endocarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 689 at risk

Adverse event: Endocrine complications
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 689 at risk

Adverse event: Fever - Unknown origin
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 689 at risk

Adverse event: Gastrointestinal - Infection
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 689 at risk

Adverse event: Gastrointestinal - Other
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 20 affected / 689 at risk

Adverse event: Genitourinary - Other
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 9 affected / 689 at risk

Adverse event: Heart failure - Acute
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 689 at risk

Adverse event: Heart Failure - Chronic (CHF)
Serious: yes
Organ System: Cardiac disorders
Frequency: 11 affected / 689 at risk

Adverse event: Hepatic complication - Other
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 689 at risk

Adverse event: Hypertension - Systemic
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 689 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Cardiac disorders
Frequency: 8 affected / 689 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 689 at risk

Adverse event: Infection/Inflammation - Other
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 689 at risk

Adverse event: Metabolic complications
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 689 at risk

Adverse event: Muscular skeletal/Dermatologic - Other
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 27 affected / 689 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 689 at risk

Adverse event: Nonspecific, unknown, or other body system - Other complication
Serious: yes
Organ System: General disorders
Frequency: 43 affected / 689 at risk

Adverse event: NSD - Paravalvular leak +3 Major
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 689 at risk

Adverse event: NSD - Paravalvular leak +4 Major
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 689 at risk

Adverse event: Pancreatic complication
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 689 at risk

Adverse event: Pericardial effusion - Major
Serious: yes
Organ System: Cardiac disorders
Frequency: 8 affected / 689 at risk

Adverse event: Pericardial effusion - Minor
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 689 at risk

Adverse event: Cardiac tamponade
Serious: yes
Organ System: Cardiac disorders
Frequency: 10 affected / 689 at risk

Adverse event: Pericarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 689 at risk

Adverse event: Pleural effusion - Bilateral
Serious: yes
Organ System: Cardiac disorders
Frequency: 13 affected / 689 at risk

Adverse event: Pleural effusion - Left
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 689 at risk

Adverse event: Pleural effusion - Right
Serious: yes
Organ System: Cardiac disorders
Frequency: 15 affected / 689 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 14 affected / 689 at risk

Adverse event: Psychiatric - Other
Serious: yes
Organ System: Psychiatric disorders
Frequency: 7 affected / 689 at risk

Adverse event: Psychiatric disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 689 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 689 at risk

Adverse event: Pulmonary embolism - Bilateral
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 689 at risk

Adverse event: Pulmonary hypertension
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 689 at risk

Adverse event: Pulmonary/Respiratory - Other
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 689 at risk

Adverse event: Renal - Other
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 5 affected / 689 at risk

Adverse event: Renal failure - Acute
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 8 affected / 689 at risk

Adverse event: Renal failure - Chronic
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 689 at risk

Adverse event: Respiratory dysfunction/Insufficiency
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 689 at risk

Adverse event: Respiratory failure - Acute Respiratory Distress Syndrome (ARDS)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 689 at risk

Adverse event: Respiratory failure - COPD
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 689 at risk

Adverse event: Respiratory failure - Other
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 689 at risk

Adverse event: Respiratory failure - Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 689 at risk

Adverse event: Respiratory failure - Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 689 at risk

Adverse event: Respiratory infection - Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 689 at risk

Adverse event: Respiratory infection - Upper (URI)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 689 at risk

Adverse event: Speech disorder
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 689 at risk

Adverse event: Splenic complication
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 689 at risk

Adverse event: Sternal wound/Thoracic infection
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 13 affected / 689 at risk

Adverse event: Thrombocytopenia - Non-heparin induced
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 689 at risk

Adverse event: Thromboembolic event - Stroke
Serious: yes
Organ System: Cardiac disorders
Frequency: 15 affected / 689 at risk

Adverse event: Thromboembolic event - Transient Ischemic Attack (TIA)
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 689 at risk

Adverse event: Urinary Tract Infection (UTI)
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 4 affected / 689 at risk

Adverse event: Vascular - Deep Vein Thrombosis (DVT)
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 689 at risk

Adverse event: Vascular - Other
Serious: yes
Organ System: Vascular disorders
Frequency: 7 affected / 689 at risk

Adverse event: Vision disorder
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 689 at risk

Adverse event: Wound infection - Other
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 689 at risk

Adverse event: Allergic reaction - Medication related
Serious: no
Organ System: General disorders
Frequency: 4 affected / 589 at risk

Adverse event: Anemia - Bleeding related - Major
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 11 affected / 589 at risk

Adverse event: Anemia - Bleeding related - Minor
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 87 affected / 589 at risk

Adverse event: Anemia - Non-bleeding related
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 61 affected / 589 at risk

Adverse event: Angina, stable
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 589 at risk

Adverse event: Angina, unstable
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 589 at risk

Adverse event: Arrhythmia - Atrial flutter
Serious: no
Organ System: Cardiac disorders
Frequency: 10 affected / 589 at risk

Adverse event: Arrhythmia - AV block - 1st degree
Serious: no
Organ System: Cardiac disorders
Frequency: 39 affected / 589 at risk

Adverse event: Arrhythmia - AV block - 2nd degree
Serious: no
Organ System: Cardiac disorders
Frequency: 7 affected / 589 at risk

Adverse event: Arrhythmia - AV block - 3rd degree
Serious: no
Organ System: Cardiac disorders
Frequency: 7 affected / 589 at risk

Adverse event: Arrhythmia - Bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 17 affected / 589 at risk

Adverse event: Arrhythmia - Bundle branch block - Left
Serious: no
Organ System: Cardiac disorders
Frequency: 25 affected / 589 at risk

Adverse event: Arrhythmia - Bundle branch block - Right
Serious: no
Organ System: Cardiac disorders
Frequency: 28 affected / 589 at risk

Adverse event: Arrhythmia - Other
Serious: no
Organ System: Cardiac disorders
Frequency: 50 affected / 589 at risk

Adverse event: Arrhythmia - Paroxysmal Atrial Fibrillation (PAF)
Serious: no
Organ System: Cardiac disorders
Frequency: 136 affected / 589 at risk

Adverse event: Arrhythmia - Paroxysmal Atrial Tachycardia (PAT)
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 589 at risk

Adverse event: Arrhythmia - Permanent atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 589 at risk

Adverse event: Arrhythmia - Persistent atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 23 affected / 589 at risk

Adverse event: Arrhythmia - Supraventricular Tachycardia (SVT)
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 589 at risk

Adverse event: Arrhythmia - Tachycardia - Non-ventricular
Serious: no
Organ System: Cardiac disorders
Frequency: 20 affected / 589 at risk

Adverse event: Arrhythmia - Tachycardia - Ventricular
Serious: no
Organ System: Cardiac disorders
Frequency: 16 affected / 589 at risk

Adverse event: Atelectasis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 122 affected / 589 at risk

Adverse event: Biliary (gallbladder)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 589 at risk

Adverse event: Bleeding - Cardiovascular - Major
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 589 at risk

Adverse event: Bleeding - Cardiovascular - Minor
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 10 affected / 589 at risk

Adverse event: Bleeding - Gastrointestinal lower - Minor
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 589 at risk

Adverse event: Bleeding - Gastrointestinal upper - Minor
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 589 at risk

Adverse event: Bleeding - Genitourinary - Minor
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 589 at risk

Adverse event: Bleeding - Neurological - Major (e.g. CVA)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 589 at risk

Adverse event: Bleeding - Peripheral vascular - Minor (e.g. nosebleeds; hematomas)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 589 at risk

Adverse event: Blood sepsis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 589 at risk

Adverse event: Blood/Lymphatic - Other
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 138 affected / 589 at risk

Adverse event: Bone fracture/Break
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 589 at risk

Adverse event: Cancer - Progression of underlying disease
Serious: no
Organ System: General disorders
Frequency: 3 affected / 589 at risk

Adverse event: Cardiogenic shock
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 589 at risk

Adverse event: Cardiovascular - Other
Serious: no
Organ System: Cardiac disorders
Frequency: 85 affected / 589 at risk

Adverse event: Endocrine complications
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 589 at risk

Adverse event: Fever - Unknown origin
Serious: no
Organ System: General disorders
Frequency: 4 affected / 589 at risk

Adverse event: Gastrointestinal - Infection
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 589 at risk

Adverse event: Gastrointestinal - Other
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 29 affected / 589 at risk

Adverse event: Genitourinary - Other
Serious: no
Organ System: Renal and urinary disorders
Frequency: 22 affected / 589 at risk

Adverse event: Heart failure - Acute
Serious: no
Organ System: Cardiac disorders
Frequency: 65 affected / 589 at risk

Adverse event: Heart Failure - Chronic (CHF)
Serious: no
Organ System: Cardiac disorders
Frequency: 15 affected / 589 at risk

Adverse event: Hepatic complication - Other
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 589 at risk

Adverse event: Hypertension - Pulmonary
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 589 at risk

Adverse event: Hypertension - Systemic
Serious: no
Organ System: Cardiac disorders
Frequency: 17 affected / 589 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 38 affected / 589 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 589 at risk

Adverse event: Infection/Inflammation - Other
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 11 affected / 589 at risk

Adverse event: Liver Failure - Chronic
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 589 at risk

Adverse event: Metabolic complications
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 589 at risk

Adverse event: Muscular skeletal/Dermatologic - Other
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 87 affected / 589 at risk

Adverse event: Nonspecific, unknown, or other body system - Other complication
Serious: no
Organ System: General disorders
Frequency: 108 affected / 589 at risk

Adverse event: NSD - Paravalvular leak +1 Minor
Serious: no
Organ System: General disorders
Frequency: 1 affected / 589 at risk

Adverse event: NSD - Paravalvular leak +3 Major
Serious: no
Organ System: General disorders
Frequency: 3 affected / 589 at risk

Adverse event: Pancreatic complication
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 589 at risk

Adverse event: Perforation - Other
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 589 at risk

Adverse event: Pericardial effusion - Minor
Serious: no
Organ System: Cardiac disorders
Frequency: 21 affected / 589 at risk

Adverse event: Pericarditis
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 589 at risk

Adverse event: Pleural effusion - Bilateral
Serious: no
Organ System: Cardiac disorders
Frequency: 13 affected / 589 at risk

Adverse event: Pleural effusion - Left
Serious: no
Organ System: Cardiac disorders
Frequency: 10 affected / 589 at risk

Adverse event: Pleural effusion - Right
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 589 at risk

Adverse event: Pneumothorax
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 31 affected / 589 at risk

Adverse event: Psychiatric - Other
Serious: no
Organ System: Psychiatric disorders
Frequency: 44 affected / 589 at risk

Adverse event: Psychiatric disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 6 affected / 589 at risk

Adverse event: Pulmonary oedema
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 26 affected / 589 at risk

Adverse event: Pulmonary embolism - Left
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 589 at risk

Adverse event: Pulmonary embolism - Right
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 589 at risk

Adverse event: Pulmonary hypertension
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 589 at risk

Adverse event: Pulmonary/Respiratory - Other
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 31 affected / 589 at risk

Adverse event: Regurgitation - Aortic-central/Transvalvular +3
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 589 at risk

Adverse event: Regurgitation - Mitral-central/Transvalvular +4
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 589 at risk

Adverse event: Regurgitation - Mitral-indeterminate +2
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 589 at risk

Adverse event: Regurgitation - Mitral-indeterminate +3
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 589 at risk

Adverse event: Regurgitation - Tricuspid-indeterminate +3
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 589 at risk

Adverse event: Renal - Other
Serious: no
Organ System: Renal and urinary disorders
Frequency: 18 affected / 589 at risk

Adverse event: Renal dysfunction
Serious: no
Organ System: Renal and urinary disorders
Frequency: 10 affected / 589 at risk

Adverse event: Renal failure - Acute
Serious: no
Organ System: Renal and urinary disorders
Frequency: 19 affected / 589 at risk

Adverse event: Renal failure - Chronic
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 589 at risk

Adverse event: Respiratory dysfunction/Insufficiency
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 21 affected / 589 at risk

Adverse event: Respiratory failure - Asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 589 at risk

Adverse event: Respiratory failure - COPD
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 589 at risk

Adverse event: Respiratory failure - Other
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 13 affected / 589 at risk

Adverse event: Respiratory failure - Pneumonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 589 at risk

Adverse event: Respiratory failure - Pneumothorax
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 589 at risk

Adverse event: Respiratory infection - Pneumonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 589 at risk

Adverse event: Respiratory infection - Upper (URI)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 589 at risk

Adverse event: Speech disorder
Serious: no
Organ System: General disorders
Frequency: 1 affected / 589 at risk

Adverse event: Sternal wound/Thoracic infection
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 9 affected / 589 at risk

Adverse event: Thrombocytopenia - Heparin Induced (HIT)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 589 at risk

Adverse event: Thrombocytopenia - Non-heparin induced
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 134 affected / 589 at risk

Adverse event: Thromboembolic event - Stroke
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 589 at risk

Adverse event: Thromboembolic event - Transient Ischemic Attack (TIA)
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 589 at risk

Adverse event: Transient psychotic syndrome
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 589 at risk

Adverse event: Urinary Tract Infection (UTI)
Serious: no
Organ System: Renal and urinary disorders
Frequency: 26 affected / 589 at risk

Adverse event: Vascular - Access site complication
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 589 at risk

Adverse event: Vascular - Deep Vein Thrombosis (DVT)
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 589 at risk

Adverse event: Vascular - Other
Serious: no
Organ System: Vascular disorders
Frequency: 19 affected / 589 at risk

Adverse event: Vision disorder
Serious: no
Organ System: General disorders
Frequency: 12 affected / 589 at risk

Adverse event: Wound infection - Other
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 589 at risk

Adverse event: Anemia - Bleeding related - Major
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 82 at risk

Adverse event: Anemia - Bleeding related - Minor
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 82 at risk

Adverse event: Anemia - Non-bleeding related
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 82 at risk

Adverse event: Angina, stable
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 82 at risk

Adverse event: Arrhythmia - Atrial flutter
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 82 at risk

Adverse event: Arrhythmia - AV block - 3rd degree
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 82 at risk

Adverse event: Arrhythmia - Bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 82 at risk

Adverse event: Arrhythmia - Other
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 82 at risk

Adverse event: Arrhythmia - Paroxysmal Atrial Fibrillation (PAF)
Serious: yes
Organ System: Cardiac disorders
Frequency: 8 affected / 82 at risk

Adverse event: Arrhythmia - Permanent atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 82 at risk

Adverse event: Arrhythmia - Persistent atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 82 at risk

Adverse event: Arrhythmia - Supraventricular Tachycardia (SVT)
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 82 at risk

Adverse event: Arrhythmia - Tachy-bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 82 at risk

Adverse event: Biliary (gallbladder)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 82 at risk

Adverse event: Bleeding - Cardiovascular - Major
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 82 at risk

Adverse event: Bleeding - Cardiovascular - Minor
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 82 at risk

Adverse event: Bleeding - Gastrointestinal upper - Major
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 82 at risk

Adverse event: Bleeding - Neurological - Minor (e.g. CVA)
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 82 at risk

Adverse event: Bleeding - Peripheral vascular - Minor (e.g. nosebleeds; hematomas)
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 82 at risk

Adverse event: Blood sepsis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 82 at risk

Adverse event: Bone fracture/Break
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 82 at risk

Adverse event: Cancer - Newly diagnosed
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 82 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 82 at risk

Adverse event: Cardiac decompensation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 82 at risk

Adverse event: Cardiogenic shock
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 82 at risk

Adverse event: Cardiovascular - Other
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 82 at risk

Adverse event: Endocarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 82 at risk

Adverse event: Gastrointestinal - Esophageal rupture/tear
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 82 at risk

Adverse event: Gastrointestinal - Infection
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 82 at risk

Adverse event: Gastrointestinal - Other
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 82 at risk

Adverse event: Genitourinary - Other
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 82 at risk

Adverse event: Heart failure - Acute
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 82 at risk

Adverse event: Heart Failure - Chronic (CHF)
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 82 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 82 at risk

Adverse event: Muscular skeletal/Dermatologic - Other
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 82 at risk

Adverse event: Nonspecific, unknown, or other body system - Other complication
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 82 at risk

Adverse event: NSD - Paravalvular leak +2 Minor
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 82 at risk

Adverse event: NSD - Paravalvular leak +3 Major
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 82 at risk

Adverse event: Pericardial effusion - Major
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 82 at risk

Adverse event: Cardiac tamponade
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 82 at risk

Adverse event: Pleural effusion - Bilateral
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 82 at risk

Adverse event: Pleural effusion - Left
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 82 at risk

Adverse event: Pleural effusion - Right
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 82 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 82 at risk

Adverse event: Psychiatric - Other
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 82 at risk

Adverse event: Regurgitation - Tricuspid-indeterminate +4
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 82 at risk

Adverse event: Renal dysfunction
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 82 at risk

Adverse event: Renal failure - Acute
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 5 affected / 82 at risk

Adverse event: Respiratory dysfunction/Insufficiency
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 82 at risk

Adverse event: Respiratory failure - Acute Respiratory Distress Syndrome (ARDS)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 82 at risk

Adverse event: Respiratory failure - COPD
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 82 at risk

Adverse event: Respiratory failure - Hemothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 82 at risk

Adverse event: Respiratory failure - Other
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 82 at risk

Adverse event: Respiratory failure - Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 82 at risk

Adverse event: Respiratory infection - Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 82 at risk

Adverse event: Sternal wound/Thoracic infection
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 82 at risk

Adverse event: SVD - Study valve leaflet tear
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 82 at risk

Adverse event: Thrombocytopenia - Heparin Induced (HIT)
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 82 at risk

Adverse event: Thrombocytopenia - Non-heparin induced
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 82 at risk

Adverse event: Thromboembolic event - Other - Central - No paresis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 82 at risk

Adverse event: Thromboembolic event - Other - Peripheral - No paresis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 82 at risk

Adverse event: Thromboembolic event - Stroke
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 82 at risk

Adverse event: Urinary Tract Infection (UTI)
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 82 at risk

Adverse event: Valve thrombosis - Aortic
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 82 at risk

Adverse event: Vascular - Deep Vein Thrombosis (DVT)
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 82 at risk

Adverse event: Allergic reaction - Other
Serious: no
Organ System: General disorders
Frequency: 1 affected / 82 at risk

Adverse event: Anemia - Bleeding related - Major
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 82 at risk

Adverse event: Anemia - Bleeding related - Minor
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 18 affected / 82 at risk

Adverse event: Anemia - Non-bleeding related
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 14 affected / 82 at risk

Adverse event: Angina, stable
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 82 at risk

Adverse event: Arrhythmia - Atrial flutter
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 82 at risk

Adverse event: Arrhythmia - AV block - 1st degree
Serious: no
Organ System: Cardiac disorders
Frequency: 11 affected / 82 at risk

Adverse event: Arrhythmia - AV block - 2nd degree
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 82 at risk

Adverse event: Arrhythmia - AV block - 3rd degree
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 82 at risk

Adverse event: Arrhythmia - Bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 82 at risk

Adverse event: Arrhythmia - Bundle branch block - Right
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 82 at risk

Adverse event: Arrhythmia - Other
Serious: no
Organ System: Cardiac disorders
Frequency: 8 affected / 82 at risk

Adverse event: Arrhythmia - Pacemaker/ICD malfunction
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 82 at risk

Adverse event: Arrhythmia - Paroxysmal Atrial Fibrillation (PAF)
Serious: no
Organ System: Cardiac disorders
Frequency: 12 affected / 82 at risk

Adverse event: Arrhythmia - Persistent atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 82 at risk

Adverse event: Arrhythmia - Supraventricular Tachycardia (SVT)
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 82 at risk

Adverse event: Arrhythmia - Tachy-bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 82 at risk

Adverse event: Arrhythmia - Tachycardia - Non-ventricular
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 82 at risk

Adverse event: Arrhythmia - Tachycardia - Ventricular
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 82 at risk

Adverse event: Atelectasis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 82 at risk

Adverse event: Bleeding - Gastrointestinal lower - Minor
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 82 at risk

Adverse event: Bleeding - Genitourinary - Major
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 82 at risk

Adverse event: Bleeding - Genitourinary - Minor
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 82 at risk

Adverse event: Bleeding - Musculoskeletal/Dermatological - Minor (e.g. ecchymosis)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 82 at risk

Adverse event: Bleeding - Peripheral vascular - Minor (e.g. nosebleeds; hematomas)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 82 at risk

Adverse event: Bleeding - Pulmonary/Respiratory - Minor (e.g. hemothorax)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 82 at risk

Adverse event: Blood sepsis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 82 at risk

Adverse event: Blood/Lymphatic - Other
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 14 affected / 82 at risk

Adverse event: Bone fracture/Break
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 82 at risk

Adverse event: Cardiogenic shock
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 82 at risk

Adverse event: Cardiovascular - Other
Serious: no
Organ System: Cardiac disorders
Frequency: 13 affected / 82 at risk

Adverse event: Endocrine complications
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 82 at risk

Adverse event: Fever - Unknown origin
Serious: no
Organ System: General disorders
Frequency: 2 affected / 82 at risk

Adverse event: Gastrointestinal - Infection
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 82 at risk

Adverse event: Gastrointestinal - Other
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 82 at risk

Adverse event: Genitourinary - Other
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 82 at risk

Adverse event: Hearing disorder
Serious: no
Organ System: General disorders
Frequency: 1 affected / 82 at risk

Adverse event: Heart failure - Acute
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 82 at risk

Adverse event: Heart Failure - Chronic (CHF)
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 82 at risk

Adverse event: Hypertension - Systemic
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 82 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 14 affected / 82 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 82 at risk

Adverse event: Infection/Inflammation - Other
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 82 at risk

Adverse event: Liver Failure - Chronic
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 82 at risk

Adverse event: Metabolic complications
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 82 at risk

Adverse event: Muscular skeletal/Dermatologic - Other
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 10 affected / 82 at risk

Adverse event: Nonspecific, unknown, or other body system - Other complication
Serious: no
Organ System: General disorders
Frequency: 14 affected / 82 at risk

Adverse event: NSD - Paravalvular leak +2 Minor
Serious: no
Organ System: General disorders
Frequency: 2 affected / 82 at risk

Adverse event: Pancreatic complication
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 82 at risk

Adverse event: Pericardial effusion - Minor
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 82 at risk

Adverse event: Pericarditis
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 82 at risk

Adverse event: Pleural effusion - Bilateral
Serious: no
Organ System: Cardiac disorders
Frequency: 7 affected / 82 at risk

Adverse event: Pleural effusion - Left
Serious: no
Organ System: Cardiac disorders
Frequency: 7 affected / 82 at risk

Adverse event: Pleural effusion - Right
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 82 at risk

Adverse event: Pneumothorax
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 82 at risk

Adverse event: Psychiatric - Other
Serious: no
Organ System: Psychiatric disorders
Frequency: 6 affected / 82 at risk

Adverse event: Psychiatric disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 82 at risk

Adverse event: Pulmonary oedema
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 82 at risk

Adverse event: Pulmonary embolism - Right
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 82 at risk

Adverse event: Pulmonary hypertension
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 82 at risk

Adverse event: Pulmonary/Respiratory - Other
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 82 at risk

Adverse event: Regurgitation - Mitral-central/Transvalvular +1
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 82 at risk

Adverse event: Regurgitation - Mitral-central/Transvalvular +2
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 82 at risk

Adverse event: Regurgitation - Mitral-central/Transvalvular +3
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 82 at risk

Adverse event: Regurgitation - Tricuspid-indeterminate +4
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 82 at risk

Adverse event: Renal - Other
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 82 at risk

Adverse event: Renal dysfunction
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 82 at risk

Adverse event: Renal failure - Acute
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 82 at risk

Adverse event: Respiratory dysfunction/Insufficiency
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 82 at risk

Adverse event: Respiratory failure - Acute Respiratory Distress Syndrome (ARDS)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 82 at risk

Adverse event: Respiratory failure - Asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 82 at risk

Adverse event: Respiratory failure - Other
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 82 at risk

Adverse event: Respiratory failure - Pneumonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 82 at risk

Adverse event: Respiratory failure - Pneumothorax
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 82 at risk

Adverse event: Respiratory infection - Pneumonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 82 at risk

Adverse event: Respiratory infection - Upper (URI)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 82 at risk

Adverse event: Speech disorder
Serious: no
Organ System: General disorders
Frequency: 1 affected / 82 at risk

Adverse event: Thrombocytopenia - Heparin Induced (HIT)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 82 at risk

Adverse event: Thrombocytopenia - Non-heparin induced
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 18 affected / 82 at risk

Adverse event: Urinary Tract Infection (UTI)
Serious: no
Organ System: Renal and urinary disorders
Frequency: 6 affected / 82 at risk

Adverse event: Vascular - Deep Vein Thrombosis (DVT)
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 82 at risk

Adverse event: Vascular - Other
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 82 at risk

Adverse event: Vision disorder
Serious: no
Organ System: General disorders
Frequency: 3 affected / 82 at risk

Adverse event: Wound infection - Other
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 82 at risk