Study: NCT02088554

Adverse event: Anaemias Haemolytic Immune
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 1132 at risk

Adverse event: Anaemias Nec
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 98 affected / 1132 at risk

Adverse event: Bleeding Tendencies
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 1132 at risk

Adverse event: Coagulopathies
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 10 affected / 1132 at risk

Adverse event: Haemolyses Nec
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 1132 at risk

Adverse event: Leukocytoses Nec
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 1132 at risk

Adverse event: Leukopenias Nec
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 1132 at risk

Adverse event: Spleen Disorders
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 1132 at risk

Adverse event: Thrombocytopenias
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 18 affected / 1132 at risk

Adverse event: Cardiac Conduction Disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 49 affected / 1132 at risk

Adverse event: Cardiac Disorders Nec
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 1132 at risk

Adverse event: Cardiomyopathies
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 1132 at risk

Adverse event: Coronary Artery Disorders Nec
Serious: yes
Organ System: Cardiac disorders
Frequency: 12 affected / 1132 at risk

Adverse event: Heart Failures Nec
Serious: yes
Organ System: Cardiac disorders
Frequency: 43 affected / 1132 at risk

Adverse event: Ischaemic Coronary Artery Disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 13 affected / 1132 at risk

Adverse event: Left Ventricular Failures
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 1132 at risk

Adverse event: Mitral Valvular Disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 1132 at risk

Adverse event: Myocardial Disorders Nec
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 1132 at risk

Adverse event: Noninfectious Pericarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 1132 at risk

Adverse event: Pericardial Disorders Nec
Serious: yes
Organ System: Cardiac disorders
Frequency: 49 affected / 1132 at risk

Adverse event: Rate And Rhythm Disorders Nec
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 1132 at risk

Adverse event: Supraventricular Arrhythmias
Serious: yes
Organ System: Cardiac disorders
Frequency: 146 affected / 1132 at risk

Adverse event: Tricuspid Valvular Disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1132 at risk

Adverse event: Ventricular Arrhythmias And Cardiac Arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 31 affected / 1132 at risk

Adverse event: Cardiac Septal Defects Congenital
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 1132 at risk

Adverse event: Inner Ear Signs And Symptoms
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 1132 at risk

Adverse event: Thyroid Disorders Nec
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 1132 at risk

Adverse event: Optic Nerve Bleeding And Vascular Disorders
Serious: yes
Organ System: Eye disorders
Frequency: 2 affected / 1132 at risk

Adverse event: Retinal Structural Change, Deposit And Degeneration
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 1132 at risk

Adverse event: Visual Impairment And Blindness (Excl Colour Blindness)
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 1132 at risk

Adverse event: Acute And Chronic Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 1132 at risk

Adverse event: Anal And Rectal Disorders Nec
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1132 at risk

Adverse event: Anal And Rectal Ulcers And Perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1132 at risk

Adverse event: Benign Neoplasms Gastrointestinal (Excl Oral Cavity)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 1132 at risk

Adverse event: Colitis (Excl Infective)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1132 at risk

Adverse event: Diaphragmatic Hernias
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 1132 at risk

Adverse event: Diarrhoea (Excl Infective)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1132 at risk

Adverse event: Diverticula
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 1132 at risk

Adverse event: Duodenal And Small Intestinal Stenosis And Obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1132 at risk

Adverse event: Duodenal Ulcers And Perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 1132 at risk

Adverse event: Gastric And Oesophageal Haemorrhages
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 1132 at risk

Adverse event: Gastritis (Excl Infective)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1132 at risk

Adverse event: Gastrointestinal Atonic And Hypomotility Disorders Nec
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 1132 at risk

Adverse event: Gastrointestinal Signs And Symptoms Nec
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 1132 at risk

Adverse event: Gastrointestinal Stenosis And Obstruction Nec
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 1132 at risk

Adverse event: Gastrointestinal Ulcers And Perforation, Site Unspecified
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1132 at risk

Adverse event: Gastrointestinal Vascular Occlusion And Infarction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1132 at risk

Adverse event: Inguinal Hernias
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 1132 at risk

Adverse event: Intestinal Haemorrhages
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 1132 at risk

Adverse event: Non-Mechanical Ileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1132 at risk

Adverse event: Non-Site Specific Gastrointestinal Haemorrhages
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 1132 at risk

Adverse event: Peritoneal And Retroperitoneal Disorders
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1132 at risk

Adverse event: Cardiac Complications Associated With Device
Serious: yes
Organ System: General disorders
Frequency: 8 affected / 1132 at risk

Adverse event: Complications Associated With Device Nec
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 1132 at risk

Adverse event: Death And Sudden Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1132 at risk

Adverse event: Febrile Disorders
Serious: yes
Organ System: General disorders
Frequency: 6 affected / 1132 at risk

Adverse event: General Signs And Symptoms Nec
Serious: yes
Organ System: General disorders
Frequency: 9 affected / 1132 at risk

Adverse event: Healing Abnormal Nec
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 1132 at risk

Adverse event: Hernias Nec
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1132 at risk

Adverse event: Oedema Nec
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 1132 at risk

Adverse event: Pain And Discomfort Nec
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 1132 at risk

Adverse event: Vascular Complications Associated With Device
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1132 at risk

Adverse event: Cholecystitis And Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 7 affected / 1132 at risk

Adverse event: Cholestasis And Jaundice
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 1132 at risk

Adverse event: Hepatic And Hepatobiliary Disorders Nec
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 1132 at risk

Adverse event: Hepatic Failure And Associated Disorders
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 1132 at risk

Adverse event: Obstructive Bile Duct Disorders (Excl Neoplasms)
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 1132 at risk

Adverse event: Structural And Other Bile Duct Disorders
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 1132 at risk

Adverse event: Allergies To Foods, Food Additives, Drugs And Other Chemicals
Serious: yes
Organ System: Immune system disorders
Frequency: 4 affected / 1132 at risk

Adverse event: Anaphylactic And Anaphylactoid Responses
Serious: yes
Organ System: Immune system disorders
Frequency: 4 affected / 1132 at risk

Adverse event: Abdominal And Gastrointestinal Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 1132 at risk

Adverse event: Bacterial Infections Nec
Serious: yes
Organ System: Infections and infestations
Frequency: 9 affected / 1132 at risk

Adverse event: Bone And Joint Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1132 at risk

Adverse event: Cardiac Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 15 affected / 1132 at risk

Adverse event: Clostridia Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1132 at risk

Adverse event: Coronavirus Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1132 at risk

Adverse event: Fungal Infections Nec
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1132 at risk

Adverse event: Herpes Viral Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1132 at risk

Adverse event: Infections Nec
Serious: yes
Organ System: Infections and infestations
Frequency: 16 affected / 1132 at risk

Adverse event: Lower Respiratory Tract And Lung Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 36 affected / 1132 at risk

Adverse event: Sepsis, Bacteraemia, Viraemia And Fungaemia Nec
Serious: yes
Organ System: Infections and infestations
Frequency: 31 affected / 1132 at risk

Adverse event: Streptococcal Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1132 at risk

Adverse event: Upper Respiratory Tract Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1132 at risk

Adverse event: Urinary Tract Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 9 affected / 1132 at risk

Adverse event: Vascular Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1132 at risk

Adverse event: Viral Infections Nec
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1132 at risk

Adverse event: Abdominal And Gastrointestinal Injuries Nec
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1132 at risk

Adverse event: Anaesthetic And Allied Procedural Complications
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1132 at risk

Adverse event: Bone And Joint Injuries Nec
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1132 at risk

Adverse event: Cardiac And Vascular Procedural Complications
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 15 affected / 1132 at risk

Adverse event: Cardiovascular Injuries
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 5 affected / 1132 at risk

Adverse event: Cerebral Injuries Nec
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1132 at risk

Adverse event: Eye Injuries Nec
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1132 at risk

Adverse event: Gastrointestinal And Hepatobiliary Procedural Complications
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1132 at risk

Adverse event: Limb Fractures And Dislocations
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 1132 at risk

Adverse event: Medication Errors, Product Use Errors And Issues Nec
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1132 at risk

Adverse event: Nerve Injuries Nec
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1132 at risk

Adverse event: Non-Site Specific Injuries Nec
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 1132 at risk

Adverse event: Non-Site Specific Procedural Complications
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 55 affected / 1132 at risk

Adverse event: Respiratory Tract And Thoracic Cavity Procedural Complications
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 8 affected / 1132 at risk

Adverse event: Site Specific Injuries Nec
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 1132 at risk

Adverse event: Skin Injuries Nec
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 1132 at risk

Adverse event: Spinal Fractures And Dislocations
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1132 at risk

Adverse event: Thoracic Cage Fractures And Dislocations
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1132 at risk

Adverse event: Urinary Tract Procedural Complications
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1132 at risk

Adverse event: Carbohydrate Tolerance Analyses (Incl Diabetes)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 1132 at risk

Adverse event: Cardiac Function Diagnostic Procedures
Serious: yes
Organ System: Investigations
Frequency: 3 affected / 1132 at risk

Adverse event: Coagulation And Bleeding Analyses
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 1132 at risk

Adverse event: Mineral And Electrolyte Analyses
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 1132 at risk

Adverse event: Protein Analyses Nec
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 1132 at risk

Adverse event: Red Blood Cell Analyses
Serious: yes
Organ System: Investigations
Frequency: 3 affected / 1132 at risk

Adverse event: Renal Function Analyses
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 1132 at risk

Adverse event: Respiratory Tract And Thoracic Histopathology Procedures
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 1132 at risk

Adverse event: Skeletal And Cardiac Muscle Analyses
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 1132 at risk

Adverse event: Vascular Tests Nec (Incl Blood Pressure)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 1132 at risk

Adverse event: White Blood Cell Analyses
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 1132 at risk

Adverse event: Disorders Of Purine Metabolism
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 1132 at risk

Adverse event: Hyperglycaemic Conditions Nec
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 1132 at risk

Adverse event: Metabolic Acidoses (Excl Diabetic Acidoses)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 1132 at risk

Adverse event: Sodium Imbalance
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 1132 at risk

Adverse event: Total Fluid Volume Decreased
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 1132 at risk

Adverse event: Total Fluid Volume Increased
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 1132 at risk

Adverse event: Cartilage Disorders
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1132 at risk

Adverse event: Joint Related Disorders Nec
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1132 at risk

Adverse event: Muscle Weakness Conditions
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1132 at risk

Adverse event: Musculoskeletal And Connective Tissue Conditions Nec
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1132 at risk

Adverse event: Musculoskeletal And Connective Tissue Pain And Discomfort
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 12 affected / 1132 at risk

Adverse event: Myopathies
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1132 at risk

Adverse event: Osteoarthropathies
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 1132 at risk

Adverse event: Spine And Neck Deformities
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 1132 at risk

Adverse event: Bladder Neoplasms Malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1132 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 / 1132 at risk

Adverse event: Central Nervous System Neoplasms Malignant Nec
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1132 at risk

Adverse event: Endocrine Neoplasms Malignant And Unspecified Nec
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1132 at risk

Adverse event: Female Reproductive Neoplasms Unspecified Malignancy
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1132 at risk

Adverse event: Gallbladder Neoplasms Malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1132 at risk

Adverse event: Laryngeal Neoplasms Malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1132 at risk

Adverse event: Leukaemias Acute Myeloid
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1132 at risk

Adverse event: Lower Gastrointestinal Neoplasms Benign
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1132 at risk

Adverse event: Myelodysplastic Syndromes
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1132 at risk

Adverse event: Neoplasms Malignant Site Unspecified Nec
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 21 affected / 1132 at risk

Adverse event: Prostatic Neoplasms Malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1132 at risk

Adverse event: Renal Neoplasms Benign
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1132 at risk

Adverse event: Renal Neoplasms Malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1132 at risk

Adverse event: Urinary Tract Neoplasms Unspecified Malignancy Nec
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 1132 at risk

Adverse event: Acute Polyneuropathies
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1132 at risk

Adverse event: Central Nervous System Haemorrhages And Cerebrovascular Accidents
Serious: yes
Organ System: Nervous system disorders
Frequency: 37 affected / 1132 at risk

Adverse event: Central Nervous System Vascular Disorders Nec
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 1132 at risk

Adverse event: Coordination And Balance Disturbances
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1132 at risk

Adverse event: Dementia (Excl Alzheimer's Type)
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1132 at risk

Adverse event: Disturbances In Consciousness Nec
Serious: yes
Organ System: Nervous system disorders
Frequency: 10 affected / 1132 at risk

Adverse event: Encephalopathies Nec
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 1132 at risk

Adverse event: Encephalopathies Toxic And Metabolic
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 1132 at risk

Adverse event: Headaches Nec
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1132 at risk

Adverse event: Hydrocephalic Conditions
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1132 at risk

Adverse event: Increased Intracranial Pressure Disorders
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1132 at risk

Adverse event: Lumbar Spinal Cord And Nerve Root Disorders
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 1132 at risk

Adverse event: Neurological Signs And Symptoms Nec
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 1132 at risk

Adverse event: Neuromuscular Disorders Nec
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1132 at risk

Adverse event: Parkinson's Disease And Parkinsonism
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1132 at risk

Adverse event: Peripheral Neuropathies Nec
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1132 at risk

Adverse event: Seizures And Seizure Disorders Nec
Serious: yes
Organ System: Nervous system disorders
Frequency: 9 affected / 1132 at risk

Adverse event: Spinal Cord And Nerve Root Disorders Nec
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 1132 at risk

Adverse event: Structural Brain Disorders Nec
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1132 at risk

Adverse event: Transient Cerebrovascular Events
Serious: yes
Organ System: Nervous system disorders
Frequency: 14 affected / 1132 at risk

Adverse event: Tremor (Excl Congenital)
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 1132 at risk

Adverse event: Device Incompatibility Issues
Serious: yes
Organ System: Product Issues
Frequency: 3 affected / 1132 at risk

Adverse event: Device Issues Nec
Serious: yes
Organ System: Product Issues
Frequency: 2 affected / 1132 at risk

Adverse event: Device Malfunction Events Nec
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 1132 at risk

Adverse event: Anxiety Symptoms
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 1132 at risk

Adverse event: Confusion And Disorientation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 12 affected / 1132 at risk

Adverse event: Delusional Symptoms
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 1132 at risk

Adverse event: Depressive Disorders
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 1132 at risk

Adverse event: Mental Disorders Nec
Serious: yes
Organ System: Psychiatric disorders
Frequency: 9 affected / 1132 at risk

Adverse event: Substance Related And Addictive Disorders
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 1132 at risk

Adverse event: Bladder And Urethral Symptoms
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 6 affected / 1132 at risk

Adverse event: Nephritis Nec
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1132 at risk

Adverse event: Renal Disorders Nec
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1132 at risk

Adverse event: Renal Failure And Impairment
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 38 affected / 1132 at risk

Adverse event: Renal Lithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 1132 at risk

Adverse event: Renal Obstructive Disorders
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1132 at risk

Adverse event: Urinary Abnormalities
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1132 at risk

Adverse event: Testicular And Epididymal Disorders Nec
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1132 at risk

Adverse event: Breathing Abnormalities
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 1132 at risk

Adverse event: Bronchospasm And Obstruction
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 1132 at risk

Adverse event: Conditions Associated With Abnormal Gas Exchange
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 1132 at risk

Adverse event: Coughing And Associated Symptoms
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 1132 at risk

Adverse event: Lower Respiratory Tract Inflammatory And Immunologic Conditions
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1132 at risk

Adverse event: Lower Respiratory Tract Signs And Symptoms
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1132 at risk

Adverse event: Mediastinal Disorders
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 1132 at risk

Adverse event: Nasal Disorders Nec
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1132 at risk

Adverse event: Parenchymal Lung Disorders Nec
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 1132 at risk

Adverse event: Pneumothorax And Pleural Effusions Nec
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 111 affected / 1132 at risk

Adverse event: Pulmonary Oedemas
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 1132 at risk

Adverse event: Pulmonary Thrombotic And Embolic Conditions
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 1132 at risk

Adverse event: Respiratory Failures (Excl Neonatal)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 40 affected / 1132 at risk

Adverse event: Respiratory Tract Disorders Nec
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 1132 at risk

Adverse event: Dermal And Epidermal Conditions Nec
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1132 at risk

Adverse event: Rashes, Eruptions And Exanthems Nec
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1132 at risk

Adverse event: Skin Injuries And Mechanical Dermatoses
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1132 at risk

Adverse event: Skin Preneoplastic Conditions Nec
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1132 at risk

Adverse event: Cardiac Device Therapeutic Procedures
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1132 at risk

Adverse event: Cardiac Therapeutic Procedures Nec
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1132 at risk

Adverse event: Gastrointestinal Therapeutic Procedures Nec
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1132 at risk

Adverse event: Therapeutic Procedures Nec
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1132 at risk

Adverse event: Aortic Aneurysms And Dissections
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 1132 at risk

Adverse event: Aortic Necrosis And Vascular Insufficiency
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 1132 at risk

Adverse event: Circulatory Collapse And Shock
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 1132 at risk

Adverse event: Haemorrhages Nec
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 1132 at risk

Adverse event: Lymphangiopathies
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 1132 at risk

Adverse event: Non-Site Specific Embolism And Thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 1132 at risk

Adverse event: Non-Site Specific Necrosis And Vascular Insufficiency Nec
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 1132 at risk

Adverse event: Non-Site Specific Vascular Disorders Nec
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 1132 at risk

Adverse event: Peripheral Embolism And Thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 1132 at risk

Adverse event: Peripheral Vascular Disorders Nec
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 1132 at risk

Adverse event: Site Specific Necrosis And Vascular Insufficiency Nec
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 1132 at risk

Adverse event: Site Specific Vascular Disorders Nec
Serious: yes
Organ System: Vascular disorders
Frequency: 6 affected / 1132 at risk

Adverse event: Vascular Hypertensive Disorders Nec
Serious: yes
Organ System: Vascular disorders
Frequency: 9 affected / 1132 at risk

Adverse event: Vascular Hypotensive Disorders
Serious: yes
Organ System: Vascular disorders
Frequency: 26 affected / 1132 at risk

Adverse event: Anaemias Nec
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 420 affected / 1132 at risk

Adverse event: Leukocytoses Nec
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 87 affected / 1132 at risk

Adverse event: Thrombocytopenias
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 255 affected / 1132 at risk

Adverse event: Cardiac Conduction Disorders
Serious: no
Organ System: Cardiac disorders
Frequency: 396 affected / 1132 at risk

Adverse event: Heart Failures Nec
Serious: no
Organ System: Cardiac disorders
Frequency: 69 affected / 1132 at risk

Adverse event: Pericardial Disorders Nec
Serious: no
Organ System: Cardiac disorders
Frequency: 167 affected / 1132 at risk

Adverse event: Supraventricular Arrhythmias
Serious: no
Organ System: Cardiac disorders
Frequency: 674 affected / 1132 at risk

Adverse event: Tricuspid Valvular Disorders
Serious: no
Organ System: Cardiac disorders
Frequency: 77 affected / 1132 at risk

Adverse event: Ventricular Arrhythmias And Cardiac Arrest
Serious: no
Organ System: Cardiac disorders
Frequency: 128 affected / 1132 at risk

Adverse event: Gastrointestinal Atonic And Hypomotility Disorders Nec
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 65 affected / 1132 at risk

Adverse event: Nausea And Vomiting Symptoms
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 96 affected / 1132 at risk

Adverse event: Oedema Nec
Serious: no
Organ System: General disorders
Frequency: 183 affected / 1132 at risk

Adverse event: Lower Respiratory Tract And Lung Infections
Serious: no
Organ System: Infections and infestations
Frequency: 73 affected / 1132 at risk

Adverse event: Urinary Tract Infections
Serious: no
Organ System: Infections and infestations
Frequency: 70 affected / 1132 at risk

Adverse event: Gastrointestinal And Hepatobiliary Procedural Complications
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 58 affected / 1132 at risk

Adverse event: Non-Site Specific Procedural Complications
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 276 affected / 1132 at risk

Adverse event: Physical Examination Procedures And Organ System Status
Serious: no
Organ System: Investigations
Frequency: 73 affected / 1132 at risk

Adverse event: Electrolyte Imbalance Nec
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 70 affected / 1132 at risk

Adverse event: Hyperglycaemic Conditions Nec
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 220 affected / 1132 at risk

Adverse event: Potassium Imbalance
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 60 affected / 1132 at risk

Adverse event: Total Fluid Volume Increased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 65 affected / 1132 at risk

Adverse event: Musculoskeletal And Connective Tissue Pain And Discomfort
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 127 affected / 1132 at risk

Adverse event: Neurological Signs And Symptoms Nec
Serious: no
Organ System: Nervous system disorders
Frequency: 83 affected / 1132 at risk

Adverse event: Confusion And Disorientation
Serious: no
Organ System: Psychiatric disorders
Frequency: 120 affected / 1132 at risk

Adverse event: Bladder And Urethral Symptoms
Serious: no
Organ System: Renal and urinary disorders
Frequency: 101 affected / 1132 at risk

Adverse event: Renal Failure And Impairment
Serious: no
Organ System: Renal and urinary disorders
Frequency: 164 affected / 1132 at risk

Adverse event: Breathing Abnormalities
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 77 affected / 1132 at risk

Adverse event: Parenchymal Lung Disorders Nec
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 127 affected / 1132 at risk

Adverse event: Pneumothorax And Pleural Effusions Nec
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 387 affected / 1132 at risk

Adverse event: Pulmonary Oedemas
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 122 affected / 1132 at risk

Adverse event: Respiratory Failures (Excl Neonatal)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 129 affected / 1132 at risk

Adverse event: Vascular Hypertensive Disorders Nec
Serious: no
Organ System: Vascular disorders
Frequency: 158 affected / 1132 at risk

Adverse event: Vascular Hypotensive Disorders
Serious: no
Organ System: Vascular disorders
Frequency: 225 affected / 1132 at risk