Study: NCT01634269

Adverse event: Aortic Valvular Disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 16 at risk

Adverse event: Cardiac Conduction Disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 16 at risk

Adverse event: Cardiac Disorders Nec
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 16 at risk

Adverse event: Heart Failures Nec
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 16 at risk

Adverse event: Pericardial Disorders Nec
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 16 at risk

Adverse event: Supraventricular Arrhythmias
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 16 at risk

Adverse event: Blindness (Excl Colour Blindness)
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 16 at risk

Adverse event: Non-Site Specific Gastrointestinal Haemorrhages
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 16 at risk

Adverse event: Oesophageal Stenosis And Obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 16 at risk

Adverse event: Device Issues Nec
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 16 at risk

Adverse event: Hepatic Fibrosis And Cirrhosis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 16 at risk

Adverse event: Hepatocellular Damage And Hepatitis Nec
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 16 at risk

Adverse event: Influenza Viral Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 16 at risk

Adverse event: Lower Respiratory Tract And Lung Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 16 at risk

Adverse event: Sepsis, Bacteraemia, Viraemia And Fungaemia Nec
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 16 at risk

Adverse event: Lower Limb Fractures And Dislocations
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 16 at risk

Adverse event: Skull Fractures, Facial Bone Fractures And Dislocations
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 16 at risk

Adverse event: Arthropathies Nec
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 16 at risk

Adverse event: Breast And Nipple Neoplasms Malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 16 at risk

Adverse event: Breathing Abnormalities
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 16 at risk

Adverse event: Aortic Necrosis And Vascular Insufficiency
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 16 at risk

Adverse event: Lymphangiopathies
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 16 at risk

Adverse event: Peripheral Embolism And Thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 16 at risk

Adverse event: Anaemias Nec
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 16 at risk

Adverse event: Cardiac Conduction Disorders
Serious: no
Organ System: Cardiac disorders
Frequency: 9 affected / 16 at risk

Adverse event: Heart Failures Nec
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 16 at risk

Adverse event: Supraventricular Arrhythmias
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 16 at risk

Adverse event: Ventricular Arrhythmias And Cardiac Arrest
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 16 at risk

Adverse event: Diarrhoea (Excl Infective)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 16 at risk

Adverse event: Gastrointestinal And Abdominal Pains (Excl Oral And Throat)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 16 at risk

Adverse event: Gastrointestinal Atonic And Hypomotility Disorders Nec
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 16 at risk

Adverse event: Nausea And Vomiting Symptoms
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 16 at risk

Adverse event: Administration Site Reactions Nec
Serious: no
Organ System: General disorders
Frequency: 1 affected / 16 at risk

Adverse event: Complications Associated With Device Nec
Serious: no
Organ System: General disorders
Frequency: 1 affected / 16 at risk

Adverse event: Device Physical Property And Chemical Issues
Serious: no
Organ System: General disorders
Frequency: 1 affected / 16 at risk

Adverse event: Febrile Disorders
Serious: no
Organ System: General disorders
Frequency: 1 affected / 16 at risk

Adverse event: Implant And Catheter Site Reactions
Serious: no
Organ System: General disorders
Frequency: 3 affected / 16 at risk

Adverse event: Inflammations
Serious: no
Organ System: General disorders
Frequency: 2 affected / 16 at risk

Adverse event: Infusion Site Reactions
Serious: no
Organ System: General disorders
Frequency: 1 affected / 16 at risk

Adverse event: Oedema Nec
Serious: no
Organ System: General disorders
Frequency: 1 affected / 16 at risk

Adverse event: Pain And Discomfort Nec
Serious: no
Organ System: General disorders
Frequency: 1 affected / 16 at risk

Adverse event: Hepatic Enzymes And Function Abnormalities
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 16 at risk

Adverse event: Herpes Viral Infections
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 16 at risk

Adverse event: Influenza Viral Infections
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 16 at risk

Adverse event: Upper Respiratory Tract Infections
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 16 at risk

Adverse event: Non-Site Specific Injuries Nec
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 16 at risk

Adverse event: Non-Site Specific Procedural Complications
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 16 at risk

Adverse event: Skin Injuries Nec
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 16 at risk

Adverse event: Spinal Fractures And Dislocations
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 16 at risk

Adverse event: Carbohydrate Tolerance Analyses (Incl Diabetes)
Serious: no
Organ System: Investigations
Frequency: 1 affected / 16 at risk

Adverse event: Liver Function Analyses
Serious: no
Organ System: Investigations
Frequency: 6 affected / 16 at risk

Adverse event: Metabolism Tests Nec
Serious: no
Organ System: Investigations
Frequency: 6 affected / 16 at risk

Adverse event: Mineral And Electrolyte Analyses
Serious: no
Organ System: Investigations
Frequency: 1 affected / 16 at risk

Adverse event: Platelet Analyses
Serious: no
Organ System: Investigations
Frequency: 7 affected / 16 at risk

Adverse event: Protein Analyses Nec
Serious: no
Organ System: Investigations
Frequency: 9 affected / 16 at risk

Adverse event: Renal Function Analyses
Serious: no
Organ System: Investigations
Frequency: 1 affected / 16 at risk

Adverse event: Skeletal And Cardiac Muscle Analyses
Serious: no
Organ System: Investigations
Frequency: 4 affected / 16 at risk

Adverse event: Tissue Enzyme Analyses Nec
Serious: no
Organ System: Investigations
Frequency: 3 affected / 16 at risk

Adverse event: Vascular Tests Nec (Incl Blood Pressure)
Serious: no
Organ System: Investigations
Frequency: 4 affected / 16 at risk

Adverse event: White Blood Cell Analyses
Serious: no
Organ System: Investigations
Frequency: 1 affected / 16 at risk

Adverse event: Lipid Metabolism And Deposit Disorders Nec
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 16 at risk

Adverse event: Potassium Imbalance
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 16 at risk

Adverse event: Protein Metabolism Disorders Nec
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 16 at risk

Adverse event: Muscle Related Signs And Symptoms Nec
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 16 at risk

Adverse event: Musculoskeletal And Connective Tissue Pain And Discomfort
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 16 at risk

Adverse event: Musculoskeletal And Connective Tissue Signs And Symptoms Nec
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 16 at risk

Adverse event: Rheumatoid Arthropathies
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 16 at risk

Adverse event: Soft Tissue Disorders Nec
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 16 at risk

Adverse event: Headaches Nec
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 16 at risk

Adverse event: Neurological Signs And Symptoms Nec
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 16 at risk

Adverse event: Urinary Abnormalities
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 16 at risk

Adverse event: Breathing Abnormalities
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 16 at risk

Adverse event: Lower Respiratory Tract Inflammatory And Immunologic Conditions
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 16 at risk

Adverse event: Nasal Disorders Nec
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 16 at risk

Adverse event: Pneumothorax And Pleural Effusions Nec
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 16 at risk

Adverse event: Dermatitis Ascribed To Specific Agent
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 16 at risk

Adverse event: Skin Haemorrhages
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 16 at risk

Adverse event: Haemorrhages Nec
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 16 at risk

Adverse event: Lymphangiopathies
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 16 at risk

Adverse event: Lymphoedemas
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 16 at risk

Adverse event: Peripheral Aneurysms And Dissections
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 16 at risk

Adverse event: Vascular Hypotensive Disorders
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 16 at risk

Adverse event: Pericardial Disorders Nec
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 4 at risk

Adverse event: Cataract Conditions
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 4 at risk

Adverse event: Device Issues Nec
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 4 at risk

Adverse event: Cardiac Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4 at risk

Adverse event: Staphylococcal Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4 at risk

Adverse event: Lower Limb Fractures And Dislocations
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 4 at risk

Adverse event: Spinal Fractures And Dislocations
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 4 at risk

Adverse event: Total Fluid Volume Decreased
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 4 at risk

Adverse event: Central Nervous System Haemorrhages And Cerebrovascular Accidents
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 4 at risk

Adverse event: Pneumothorax And Pleural Effusions Nec
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: Non-Site Specific Necrosis And Vascular Insufficiency Nec
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 4 at risk

Adverse event: Anaemia Deficiencies
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 4 at risk

Adverse event: Anaemias Nec
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 4 at risk

Adverse event: Lymphatic System Disorders Nec
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 4 at risk

Adverse event: Cardiac Conduction Disorders
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 4 at risk

Adverse event: Heart Failures Nec
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 4 at risk

Adverse event: Rate And Rhythm Disorders Nec
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 4 at risk

Adverse event: Gastrointestinal Atonic And Hypomotility Disorders Nec
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 4 at risk

Adverse event: Nausea And Vomiting Symptoms
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 4 at risk

Adverse event: Administration Site Reactions Nec
Serious: no
Organ System: General disorders
Frequency: 1 affected / 4 at risk

Adverse event: Oedema Nec
Serious: no
Organ System: General disorders
Frequency: 2 affected / 4 at risk

Adverse event: Pain And Discomfort Nec
Serious: no
Organ System: General disorders
Frequency: 1 affected / 4 at risk

Adverse event: Hepatic And Hepatobiliary Disorders Nec
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 4 at risk

Adverse event: Infections Nec
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 4 at risk

Adverse event: Urinary Tract Infections
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 4 at risk

Adverse event: Fractures And Dislocations Nec
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 4 at risk

Adverse event: Non-Site Specific Injuries Nec
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 4 at risk

Adverse event: Non-Site Specific Procedural Complications
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 4 at risk

Adverse event: Skin Injuries Nec
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 4 at risk

Adverse event: Liver Function Analyses
Serious: no
Organ System: Investigations
Frequency: 2 affected / 4 at risk

Adverse event: Metabolism Tests Nec
Serious: no
Organ System: Investigations
Frequency: 2 affected / 4 at risk

Adverse event: Mineral And Electrolyte Analyses
Serious: no
Organ System: Investigations
Frequency: 1 affected / 4 at risk

Adverse event: Platelet Analyses
Serious: no
Organ System: Investigations
Frequency: 3 affected / 4 at risk

Adverse event: Protein Analyses Nec
Serious: no
Organ System: Investigations
Frequency: 3 affected / 4 at risk

Adverse event: Renal Function Analyses
Serious: no
Organ System: Investigations
Frequency: 1 affected / 4 at risk

Adverse event: Skeletal And Cardiac Muscle Analyses
Serious: no
Organ System: Investigations
Frequency: 2 affected / 4 at risk

Adverse event: Tissue Enzyme Analyses Nec
Serious: no
Organ System: Investigations
Frequency: 1 affected / 4 at risk

Adverse event: Vascular Tests Nec (Incl Blood Pressure)
Serious: no
Organ System: Investigations
Frequency: 1 affected / 4 at risk

Adverse event: White Blood Cell Analyses
Serious: no
Organ System: Investigations
Frequency: 1 affected / 4 at risk

Adverse event: Hyperlipidaemias Nec
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 4 at risk

Adverse event: Potassium Imbalance
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 4 at risk

Adverse event: Protein Metabolism Disorders Nec
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 4 at risk

Adverse event: Joint Related Signs And Symptoms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 4 at risk

Adverse event: Musculoskeletal And Connective Tissue Pain And Discomfort
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 4 at risk

Adverse event: Musculoskeletal And Connective Tissue Signs And Symptoms Nec
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 4 at risk

Adverse event: Central Nervous System Haemorrhages And Cerebrovascular Accidents
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 4 at risk

Adverse event: Memory Loss (Excl Dementia)
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 4 at risk

Adverse event: Neurological Signs And Symptoms Nec
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 4 at risk

Adverse event: Structural Brain Disorders Nec
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 4 at risk

Adverse event: Confusion And Disorientation
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 4 at risk

Adverse event: Disturbances In Initiating And Maintaining Sleep
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 4 at risk

Adverse event: Breathing Abnormalities
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: Coughing And Associated Symptoms
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: Nasal Disorders Nec
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: Rashes, Eruptions And Exanthems Nec
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 4 at risk

Adverse event: Blood Pressure Disorders Nec
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 4 at risk

Adverse event: Vascular Hypotensive Disorders
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 4 at risk

Adverse event: Aortic Valvular Disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 20 at risk

Adverse event: Cardiac Conduction Disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 20 at risk

Adverse event: Cardiac Disorders Nec
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 20 at risk

Adverse event: Heart Failures Nec
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 20 at risk

Adverse event: Pericardial Disorders Nec
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 20 at risk

Adverse event: Supraventricular Arrhythmias
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 20 at risk

Adverse event: Blindness (Excl Colour Blindness)
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 20 at risk

Adverse event: Cataract Conditions
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 20 at risk

Adverse event: Non-Site Specific Gastrointestinal Haemorrhages
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Oesophageal Stenosis And Obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Device Issues Nec
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 20 at risk

Adverse event: Hepatic Fibrosis And Cirrhosis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 20 at risk

Adverse event: Hepatocellular Damage And Hepatitis Nec
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 20 at risk

Adverse event: Cardiac Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 20 at risk

Adverse event: Influenza Viral Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 20 at risk

Adverse event: Lower Respiratory Tract And Lung Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 20 at risk

Adverse event: Sepsis, Bacteraemia, Viraemia And Fungaemia Nec
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 20 at risk

Adverse event: Staphylococcal Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 20 at risk

Adverse event: Lower Limb Fractures And Dislocations
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 20 at risk

Adverse event: Skull Fractures, Facial Bone Fractures And Dislocations
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 20 at risk

Adverse event: Spinal Fractures And Dislocations
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 20 at risk

Adverse event: Total Fluid Volume Decreased
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 20 at risk

Adverse event: Arthropathies Nec
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 20 at risk

Adverse event: Breast And Nipple Neoplasms Malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 20 at risk

Adverse event: Central Nervous System Haemorrhages And Cerebrovascular Accidents
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 20 at risk

Adverse event: Breathing Abnormalities
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Pneumothorax And Pleural Effusions Nec
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Aortic Necrosis And Vascular Insufficiency
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 20 at risk

Adverse event: Lymphangiopathies
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 20 at risk

Adverse event: Non-Site Specific Necrosis And Vascular Insufficiency Nec
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 20 at risk

Adverse event: Peripheral Embolism And Thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 20 at risk

Adverse event: Anaemia Deficiencies
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 20 at risk

Adverse event: Anaemias Nec
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 8 affected / 20 at risk

Adverse event: Lymphatic System Disorders Nec
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 20 at risk

Adverse event: Cardiac Conduction Disorders
Serious: no
Organ System: Cardiac disorders
Frequency: 12 affected / 20 at risk

Adverse event: Heart Failures Nec
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 20 at risk

Adverse event: Rate And Rhythm Disorders Nec
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 20 at risk

Adverse event: Supraventricular Arrhythmias
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 20 at risk

Adverse event: Ventricular Arrhythmias And Cardiac Arrest
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 20 at risk

Adverse event: Diarrhoea (Excl Infective)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 20 at risk

Adverse event: Gastrointestinal And Abdominal Pains (Excl Oral And Throat)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 20 at risk

Adverse event: Gastrointestinal Atonic And Hypomotility Disorders Nec
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 20 at risk

Adverse event: Nausea And Vomiting Symptoms
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 20 at risk

Adverse event: Administration Site Reactions Nec
Serious: no
Organ System: General disorders
Frequency: 2 affected / 20 at risk

Adverse event: Complications Associated With Device Nec
Serious: no
Organ System: General disorders
Frequency: 1 affected / 20 at risk

Adverse event: Device Physical Property And Chemical Issues
Serious: no
Organ System: General disorders
Frequency: 1 affected / 20 at risk

Adverse event: Febrile Disorders
Serious: no
Organ System: General disorders
Frequency: 1 affected / 20 at risk

Adverse event: Implant And Catheter Site Reactions
Serious: no
Organ System: General disorders
Frequency: 3 affected / 20 at risk

Adverse event: Inflammations
Serious: no
Organ System: General disorders
Frequency: 2 affected / 20 at risk

Adverse event: Infusion Site Reactions
Serious: no
Organ System: General disorders
Frequency: 1 affected / 20 at risk

Adverse event: Oedema Nec
Serious: no
Organ System: General disorders
Frequency: 3 affected / 20 at risk

Adverse event: Pain And Discomfort Nec
Serious: no
Organ System: General disorders
Frequency: 2 affected / 20 at risk

Adverse event: Hepatic And Hepatobiliary Disorders Nec
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 20 at risk

Adverse event: Hepatic Enzymes And Function Abnormalities
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 20 at risk

Adverse event: Herpes Viral Infections
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 20 at risk

Adverse event: Infections Nec
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 20 at risk

Adverse event: Influenza Viral Infections
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 20 at risk

Adverse event: Upper Respiratory Tract Infections
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 20 at risk

Adverse event: Urinary Tract Infections
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 20 at risk

Adverse event: Fractures And Dislocations Nec
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 20 at risk

Adverse event: Non-Site Specific Injuries Nec
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 5 affected / 20 at risk

Adverse event: Non-Site Specific Procedural Complications
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 20 at risk

Adverse event: Skin Injuries Nec
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 20 at risk

Adverse event: Spinal Fractures And Dislocations
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 20 at risk

Adverse event: Carbohydrate Tolerance Analyses (Incl Diabetes)
Serious: no
Organ System: Investigations
Frequency: 1 affected / 20 at risk

Adverse event: Liver Function Analyses
Serious: no
Organ System: Investigations
Frequency: 8 affected / 20 at risk

Adverse event: Metabolism Tests Nec
Serious: no
Organ System: Investigations
Frequency: 8 affected / 20 at risk

Adverse event: Mineral And Electrolyte Analyses
Serious: no
Organ System: Investigations
Frequency: 2 affected / 20 at risk

Adverse event: Platelet Analyses
Serious: no
Organ System: Investigations
Frequency: 10 affected / 20 at risk

Adverse event: Protein Analyses Nec
Serious: no
Organ System: Investigations
Frequency: 12 affected / 20 at risk

Adverse event: Renal Function Analyses
Serious: no
Organ System: Investigations
Frequency: 2 affected / 20 at risk

Adverse event: Skeletal And Cardiac Muscle Analyses
Serious: no
Organ System: Investigations
Frequency: 6 affected / 20 at risk

Adverse event: Tissue Enzyme Analyses Nec
Serious: no
Organ System: Investigations
Frequency: 4 affected / 20 at risk

Adverse event: Vascular Tests Nec (Incl Blood Pressure)
Serious: no
Organ System: Investigations
Frequency: 5 affected / 20 at risk

Adverse event: White Blood Cell Analyses
Serious: no
Organ System: Investigations
Frequency: 2 affected / 20 at risk

Adverse event: Hyperlipidaemias Nec
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 20 at risk

Adverse event: Lipid Metabolism And Deposit Disorders Nec
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 20 at risk

Adverse event: Potassium Imbalance
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 20 at risk

Adverse event: Protein Metabolism Disorders Nec
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 20 at risk

Adverse event: Joint Related Signs And Symptoms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 20 at risk

Adverse event: Muscle Related Signs And Symptoms Nec
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 20 at risk

Adverse event: Musculoskeletal And Connective Tissue Pain And Discomfort
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 20 at risk

Adverse event: Musculoskeletal And Connective Tissue Signs And Symptoms Nec
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 20 at risk

Adverse event: Rheumatoid Arthropathies
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 20 at risk

Adverse event: Soft Tissue Disorders Nec
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 20 at risk

Adverse event: Central Nervous System Haemorrhages And Cerebrovascular Accidents
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 20 at risk

Adverse event: Headaches Nec
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 20 at risk

Adverse event: Memory Loss (Excl Dementia)
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 20 at risk

Adverse event: Neurological Signs And Symptoms Nec
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 20 at risk

Adverse event: Structural Brain Disorders Nec
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 20 at risk

Adverse event: Confusion And Disorientation
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 20 at risk

Adverse event: Disturbances In Initiating And Maintaining Sleep
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 20 at risk

Adverse event: Urinary Abnormalities
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 20 at risk

Adverse event: Breathing Abnormalities
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 20 at risk

Adverse event: Coughing And Associated Symptoms
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Lower Respiratory Tract Inflammatory And Immunologic Conditions
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Nasal Disorders Nec
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 20 at risk

Adverse event: Pneumothorax And Pleural Effusions Nec
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Dermatitis Ascribed To Specific Agent
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 20 at risk

Adverse event: Rashes, Eruptions And Exanthems Nec
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 20 at risk

Adverse event: Skin Haemorrhages
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 20 at risk

Adverse event: Blood Pressure Disorders Nec
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 20 at risk

Adverse event: Haemorrhages Nec
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 20 at risk

Adverse event: Lymphangiopathies
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 20 at risk

Adverse event: Lymphoedemas
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 20 at risk

Adverse event: Peripheral Aneurysms And Dissections
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 20 at risk

Adverse event: Vascular Hypotensive Disorders
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 20 at risk