Study: NCT02732691

Adverse event: Access Site Disection
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 68 at risk

Adverse event: Acute coronary syndrome
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 68 at risk

Adverse event: Acute Pancreatitis Secondary To Retained Gallstones
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 68 at risk

Adverse event: Hypersensitivity
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 68 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 68 at risk

Adverse event: Aortic rupture
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 68 at risk

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 68 at risk

Adverse event: Arterial occlusive disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 68 at risk

Adverse event: Arterial Occlusive Desease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 68 at risk

Adverse event: Bilious Attack
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 68 at risk

Adverse event: Bleeding (Life Threatening/Disabling)
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 68 at risk

Adverse event: Bleeding (Major)
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 68 at risk

Adverse event: Bleeding Complication
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 68 at risk

Adverse event: Bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 68 at risk

Adverse event: Cellulitus
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 68 at risk

Adverse event: Cerebral Hypoxia Due To Open Heart Surgery. Therefore Cerebral Iscemia Which Was Leading To Death.
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 68 at risk

Adverse event: Conduction Disturbance
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 68 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 68 at risk

Adverse event: Ectopic Deployment
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 68 at risk

Adverse event: Exacerbation COPD
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 68 at risk

Adverse event: Exacerbation Of COPD
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 68 at risk

Adverse event: Fall Secondary To Postural Hypotension
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 68 at risk

Adverse event: Febrile But No Infection Identified
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 68 at risk

Adverse event: Fluid Overload Secondary To Fludricortisone Use
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 68 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 68 at risk

Adverse event: Gastroenteritis norovirus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 68 at risk

Adverse event: GI Complication
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 68 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 68 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 68 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 68 at risk

Adverse event: Infection/Inflammation
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 68 at risk

Adverse event: INR > 8 And General Weakness
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 68 at risk

Adverse event: Maxillary Fracture (Le-Fort I Fracture)
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 68 at risk

Adverse event: Medication Reaction
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 68 at risk

Adverse event: Multiple Falls Secondary To Medication And Parkinsons
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 68 at risk

Adverse event: Myocardial Insufficiency
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 68 at risk

Adverse event: Neurological Event
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 68 at risk

Adverse event: Other Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 8 affected / 68 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 68 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 68 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 68 at risk

Adverse event: Premature Valve Deployment
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 68 at risk

Adverse event: Pseudomonas Bacteremia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 68 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 68 at risk

Adverse event: Recurring Subdural Hematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 68 at risk

Adverse event: Reduced Mobility
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 68 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 68 at risk

Adverse event: Restenosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 68 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 68 at risk

Adverse event: Spondylolisthesis/Foraminal Stenosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 68 at risk

Adverse event: Status epilepticus
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 68 at risk

Adverse event: Stroke/TIA
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 68 at risk

Adverse event: Subacute Cerebal Infarct Bilaterally.
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 68 at risk

Adverse event: Subdural haematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 68 at risk

Adverse event: Suspected Endocarditis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 68 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 68 at risk

Adverse event: Tooth extraction
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 68 at risk

Adverse event: Urosepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 68 at risk

Adverse event: Valve Malposition / Ectopic Deployment
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 68 at risk

Adverse event: Vascular dissection
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 68 at risk

Adverse event: Worsening Of Atrial Fibrilation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 68 at risk

Adverse event: Bleeding Complication
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 68 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Frequency: 4 affected / 68 at risk

Adverse event: Other
Serious: no
Organ System: General disorders
Frequency: 17 affected / 68 at risk

Adverse event: Respiratory Complication
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 68 at risk