Study: NCT01612767

Adverse event: Arrhythmia supraventricular
Serious: yes
Organ System: Cardiac disorders
Frequency: 12 affected / 329 at risk

Adverse event: Ventricular arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 329 at risk

Adverse event: Unspecified arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 329 at risk

Adverse event: Bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 329 at risk

Adverse event: Cardiac decompensation
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 329 at risk

Adverse event: Cardiogenic shock
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 329 at risk

Adverse event: Cardio-respiratory arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 329 at risk

Adverse event: Chest pain
Serious: yes
Organ System: Cardiac disorders
Frequency: 33 affected / 329 at risk

Adverse event: Congestive/worsening heart failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 15 affected / 329 at risk

Adverse event: Diaphragmatic stimulation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 329 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Cardiac disorders
Frequency: 9 affected / 329 at risk

Adverse event: Oedema
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 329 at risk

Adverse event: Elective pacemaker/ICD implantation
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 329 at risk

Adverse event: Elevated cardiac enzymes
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 329 at risk

Adverse event: Atrioventricular block
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 329 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 329 at risk

Adverse event: Hypertensive urgency
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 329 at risk

Adverse event: Ischaemic cardiomyopathy
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 329 at risk

Adverse event: Left ventricle penetration observed on LV gram
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 329 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 17 affected / 329 at risk

Adverse event: Palpitations
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 329 at risk

Adverse event: Peri-procedural myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 329 at risk

Adverse event: Planned PCI procedure
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 329 at risk

Adverse event: Planned routine angiography
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 329 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 329 at risk

Adverse event: Stenosis/occlusion of target lesion within non-study stented segment
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 329 at risk

Adverse event: Stenosis/restenosis of non-target lesion in target vessel
Serious: yes
Organ System: Cardiac disorders
Frequency: 14 affected / 329 at risk

Adverse event: Stenosis/restenosis of non-target vessel
Serious: yes
Organ System: Cardiac disorders
Frequency: 27 affected / 329 at risk

Adverse event: Syncope
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 329 at risk

Adverse event: Valvular heart disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 329 at risk

Adverse event: Actinic keratosis/cheilitis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 329 at risk

Adverse event: Cicatricial changes to the left lower eyelid
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 329 at risk

Adverse event: Dermatitis contact
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 329 at risk

Adverse event: Non-healing wound
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 329 at risk

Adverse event: Ulcer
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 329 at risk

Adverse event: Hypercalcaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 329 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 329 at risk

Adverse event: Hypernatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 329 at risk

Adverse event: Hypokalemia and/or hypomagnaesemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 329 at risk

Adverse event: Hypothyroidism
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 329 at risk

Adverse event: Left adrenal mass
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 329 at risk

Adverse event: Thyroid mass
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 329 at risk

Adverse event: Worsening diabetes
Serious: yes
Organ System: Endocrine disorders
Frequency: 2 affected / 329 at risk

Adverse event: Abdominal distension
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 329 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 329 at risk

Adverse event: Acute gangrenous cholecystitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 329 at risk

Adverse event: Anastomotic disruption
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 329 at risk

Adverse event: Atypical chest pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 329 at risk

Adverse event: Oesophageal candidiasis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 329 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 329 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 329 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 329 at risk

Adverse event: Diverticulum intestinal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 329 at risk

Adverse event: Elective bariatric surgery
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 329 at risk

Adverse event: Abdominal pain upper
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 329 at risk

Adverse event: Epiploic appendagitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 329 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 329 at risk

Adverse event: Gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 329 at risk

Adverse event: Dyspepsia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 329 at risk

Adverse event: Intestinal ilius
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 329 at risk

Adverse event: Intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 329 at risk

Adverse event: Nausea and/or vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 329 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 329 at risk

Adverse event: Septic shock
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 329 at risk

Adverse event: Small intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 329 at risk

Adverse event: Tubulovillous adenoma of ascending colon
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 329 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 7 affected / 329 at risk

Adverse event: Acute onset chronic renal injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 329 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 7 affected / 329 at risk

Adverse event: Contrast induced increased creatinine/acute renal insufficiency
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 329 at risk

Adverse event: Haematuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 4 affected / 329 at risk

Adverse event: Polyuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 329 at risk

Adverse event: Prostatic haemorrhage
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 329 at risk

Adverse event: Nephrolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 329 at risk

Adverse event: Urinary retention
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 329 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 10 affected / 329 at risk

Adverse event: Bleeding requiring treatment
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 329 at risk

Adverse event: Coagulopathy
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 329 at risk

Adverse event: Coumadin toxicity
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 329 at risk

Adverse event: Hematoma - TAVI access site bleed
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 329 at risk

Adverse event: Pancytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 329 at risk

Adverse event: Anticoagulation drug level above therapeutic
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 329 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 7 affected / 329 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 329 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 329 at risk

Adverse event: Gastrointestinal viral infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 329 at risk

Adverse event: HSV pneumonitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 329 at risk

Adverse event: Leukocytosis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 329 at risk

Adverse event: Staphylococcal infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 329 at risk

Adverse event: Oral candidiasis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 329 at risk

Adverse event: Osteomyelitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 329 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 12 affected / 329 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 329 at risk

Adverse event: Surgical site dehiscence
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 329 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 11 affected / 329 at risk

Adverse event: Wound
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 329 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 329 at risk

Adverse event: Calcar fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 329 at risk

Adverse event: Carpal tunnel syndrome
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 329 at risk

Adverse event: Chest pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 329 at risk

Adverse event: Genu varus deformity of right knee
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 329 at risk

Adverse event: Muscular weakness
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 329 at risk

Adverse event: Musculoskeletal injury/fall
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 11 affected / 329 at risk

Adverse event: Musculoskeletal pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 329 at risk

Adverse event: Spinal fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 329 at risk

Adverse event: Worsening/degenerative osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 329 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 329 at risk

Adverse event: Encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 6 affected / 329 at risk

Adverse event: Lumbar radiculopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 329 at risk

Adverse event: Neuralgia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 329 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 329 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 329 at risk

Adverse event: Cataract
Serious: yes
Organ System: Eye disorders
Frequency: 2 affected / 329 at risk

Adverse event: Eye irritation
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 329 at risk

Adverse event: Herpes opthalmicus
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 329 at risk

Adverse event: Low pupillary dilation
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 329 at risk

Adverse event: Strabismus
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 329 at risk

Adverse event: Depression with suicidal ideations
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 329 at risk

Adverse event: Major depression, chronic, recurrent with psychotic features
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 329 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 329 at risk

Adverse event: Cough
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 329 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 329 at risk

Adverse event: End-stage lung disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 329 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 329 at risk

Adverse event: Lung rheumatism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 329 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 329 at risk

Adverse event: Respiratory arrest
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 329 at risk

Adverse event: Respiratory distress
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 329 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 329 at risk

Adverse event: Atypical chest pain
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 329 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 329 at risk

Adverse event: Dysphagia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 329 at risk

Adverse event: Extracardiac pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 329 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 329 at risk

Adverse event: Headache
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 329 at risk

Adverse event: Steroid toxicogenic reaction
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 329 at risk

Adverse event: Vasovagal episode
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 329 at risk

Adverse event: Aortic aneurysm
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 329 at risk

Adverse event: Carotid artery disease
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 329 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 329 at risk

Adverse event: Peripheral artery thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 329 at risk

Adverse event: Iliac artery stenosis / occlusion
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 329 at risk

Adverse event: Peripheral ischaemia
Serious: yes
Organ System: Vascular disorders
Frequency: 9 affected / 329 at risk

Adverse event: Vascular pseudoaneurysm
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 329 at risk

Adverse event: Systemic emboli - spleen
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 329 at risk

Adverse event: Vessel dissection or perforation
Serious: yes
Organ System: Vascular disorders
Frequency: 5 affected / 329 at risk

Adverse event: Worsening of peripheral artery disease
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 329 at risk

Adverse event: Worsening ulceration
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 329 at risk

Adverse event: Stenosis or occlusion of target lesion within stent segment
Serious: yes
Organ System: Vascular disorders
Frequency: 27 affected / 329 at risk

Adverse event: Vascular stent thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 5 affected / 329 at risk

Adverse event: Stent thrombosis, ARC assessment
Serious: yes
Organ System: Vascular disorders
Frequency: 9 affected / 329 at risk

Adverse event: Stent underexpansion
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 329 at risk

Adverse event: Vessel dissection or perforation during stenting procedure
Serious: yes
Organ System: Vascular disorders
Frequency: 8 affected / 329 at risk

Adverse event: Elevated troponin
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 329 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 329 at risk

Adverse event: Abdominal mass
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 329 at risk

Adverse event: B-cell lymphoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 329 at risk

Adverse event: Basal cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 329 at risk

Adverse event: Bladder cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 329 at risk

Adverse event: Brain cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 329 at risk

Adverse event: Hepatocellular carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 329 at risk

Adverse event: Lung neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 3 affected / 329 at risk

Adverse event: Malignant melanoma stage 0
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 329 at risk

Adverse event: Relapsed myeloma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 329 at risk

Adverse event: Squamous cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 3 affected / 329 at risk

Adverse event: Bronchial carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 329 at risk

Adverse event: Cecum and liver cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 329 at risk

Adverse event: Colon adenocarcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 329 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 329 at risk

Adverse event: Arrhythmia, Ventricular Extrasystole
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 329 at risk

Adverse event: Ascites
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 329 at risk

Adverse event: Fatigue
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 329 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 329 at risk

Adverse event: Hypertrophic cardiomyopathy
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 329 at risk

Adverse event: Non-specific ST-T changes
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 329 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 329 at risk

Adverse event: Ventricular extrasystoles
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 329 at risk

Adverse event: Pulmonary hypertension
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 329 at risk

Adverse event: Stenosis - location unknown
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 329 at risk

Adverse event: Vasospasm
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 329 at risk

Adverse event: Worsening Coronary Artery Disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 329 at risk

Adverse event: Adrenal mass
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 329 at risk

Adverse event: Gout
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 329 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 329 at risk

Adverse event: Abdominal distension
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 329 at risk

Adverse event: Abdominal incisional hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 329 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 329 at risk

Adverse event: Gall bladder stone
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 329 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 329 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 329 at risk

Adverse event: Hiatal hernie
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 329 at risk

Adverse event: Percutaneous endoscopic gastrostomy complication
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 329 at risk

Adverse event: Rectal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 329 at risk

Adverse event: Unbilica hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 329 at risk

Adverse event: Benign prostatic hyperplasia
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 329 at risk

Adverse event: Obstructive prostatism
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 329 at risk

Adverse event: Hypovolaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 329 at risk

Adverse event: Anticoagulation drug level below therapeutic
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 329 at risk

Adverse event: Knee arthooplasty
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 329 at risk

Adverse event: Sinusitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 329 at risk

Adverse event: Pancreas infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 329 at risk

Adverse event: Arthralgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 329 at risk

Adverse event: Left knee degenerative joint disease
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 329 at risk

Adverse event: Osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 329 at risk

Adverse event: Right hand weakness
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 329 at risk

Adverse event: Ulnar fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 329 at risk

Adverse event: Seisure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 329 at risk

Adverse event: Spinal stenosis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 329 at risk

Adverse event: Syndope
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 329 at risk

Adverse event: Anxiety
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 329 at risk

Adverse event: Acute renal injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 329 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 329 at risk

Adverse event: Renal obstruction
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 329 at risk

Adverse event: Acute respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 329 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 329 at risk

Adverse event: Chronic Fibrotic Lung Disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 329 at risk

Adverse event: Left pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 329 at risk

Adverse event: Nasal obstruction
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 329 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 329 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 329 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 329 at risk

Adverse event: Peripheral vascular disorder
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 329 at risk

Adverse event: Post-surgical bleeding
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 329 at risk

Adverse event: Saphenous vein insufficiency
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 329 at risk

Adverse event: Allergic reaction to contrast media
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 329 at risk

Adverse event: Allergic reaction with angioedema
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 329 at risk

Adverse event: Decreased hearing
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 329 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 329 at risk

Adverse event: Lymphadenopathy
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 329 at risk

Adverse event: Metabolic acidosis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 329 at risk

Adverse event: Non-cardiac chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 329 at risk

Adverse event: Syncope
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 329 at risk

Adverse event: Possible PCI
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 329 at risk

Adverse event: Pacemaker manfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 329 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 329 at risk

Adverse event: Chest pain
Serious: no
Organ System: Cardiac disorders
Frequency: 59 affected / 329 at risk

Adverse event: Dizziness
Serious: no
Organ System: Cardiac disorders
Frequency: 31 affected / 329 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Cardiac disorders
Frequency: 44 affected / 329 at risk

Adverse event: Fatigue
Serious: no
Organ System: Cardiac disorders
Frequency: 22 affected / 329 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 30 affected / 329 at risk

Adverse event: Muskuloskeletal injury/fall
Serious: no
Organ System: Cardiac disorders
Frequency: 18 affected / 329 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 25 affected / 329 at risk

Adverse event: Atrial Arrhyrhmia
Serious: no
Organ System: Cardiac disorders
Frequency: 17 affected / 329 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 18 affected / 329 at risk