Study: NCT01240902

Adverse event: Anaemia Deficiencies
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 489 at risk

Adverse event: Anaemias Due To Chronic Disorders
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 489 at risk

Adverse event: Anaemias Haemolytic Immune
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 489 at risk

Adverse event: Anaemias Nec
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 140 affected / 489 at risk

Adverse event: Coagulopathies
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 489 at risk

Adverse event: Leukocytoses Nec
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 489 at risk

Adverse event: Marrow Depression And Hypoplastic Anaemias
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 489 at risk

Adverse event: Thrombocytopenias
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 11 affected / 489 at risk

Adverse event: Aortic Valvular Disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 44 affected / 489 at risk

Adverse event: Cardiac Conduction Disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 106 affected / 489 at risk

Adverse event: Cardiac Disorders Nec
Serious: yes
Organ System: Cardiac disorders
Frequency: 9 affected / 489 at risk

Adverse event: Cardiac Signs And Symptoms Nec
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 489 at risk

Adverse event: Cardiomyopathies
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 489 at risk

Adverse event: Coronary Artery Disorders Nec
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 489 at risk

Adverse event: Heart Failures Nec
Serious: yes
Organ System: Cardiac disorders
Frequency: 117 affected / 489 at risk

Adverse event: Ischaemic Coronary Artery Disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 28 affected / 489 at risk

Adverse event: Mitral Valvular Disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 9 affected / 489 at risk

Adverse event: Myocardial Disorders Nec
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 489 at risk

Adverse event: Pericardial Disorders Nec
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 489 at risk

Adverse event: Rate And Rhythm Disorders Nec
Serious: yes
Organ System: Cardiac disorders
Frequency: 28 affected / 489 at risk

Adverse event: Right Ventricular Failures
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 489 at risk

Adverse event: Supraventricular Arrhythmias
Serious: yes
Organ System: Cardiac disorders
Frequency: 65 affected / 489 at risk

Adverse event: Tricuspid Valvular Disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 489 at risk

Adverse event: Ventricular Arrhythmias And Cardiac Arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 48 affected / 489 at risk

Adverse event: Male Reproductive Tract Disorders Congenital
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 489 at risk

Adverse event: Hearing Losses
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 489 at risk

Adverse event: Thyroid Neoplasms
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 489 at risk

Adverse event: Blindness (Excl Colour Blindness)
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 489 at risk

Adverse event: Cataract Conditions
Serious: yes
Organ System: Eye disorders
Frequency: 2 affected / 489 at risk

Adverse event: Retinal Bleeding And Vascular Disorders (Excl Retinopathy)
Serious: yes
Organ System: Eye disorders
Frequency: 2 affected / 489 at risk

Adverse event: Retinal Structural Change, Deposit And Degeneration
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 489 at risk

Adverse event: Retinal, Choroid And Vitreous Infections And Inflammations
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 489 at risk

Adverse event: Visual Disorders Nec
Serious: yes
Organ System: Eye disorders
Frequency: 2 affected / 489 at risk

Adverse event: Abdominal Wall Conditions Nec
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 489 at risk

Adverse event: Acute And Chronic Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 489 at risk

Adverse event: Anal And Rectal Ulcers And Perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 489 at risk

Adverse event: Colitis (Excl Infective)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 489 at risk

Adverse event: Diaphragmatic Hernias
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 489 at risk

Adverse event: Diarrhoea (Excl Infective)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 489 at risk

Adverse event: Diverticula
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 489 at risk

Adverse event: Duodenal And Small Intestinal Stenosis And Obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 489 at risk

Adverse event: Dyspeptic Signs And Symptoms
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 489 at risk

Adverse event: Gastritis (Excl Infective)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 489 at risk

Adverse event: Gastrointestinal And Abdominal Pains (Excl Oral And Throat)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 489 at risk

Adverse event: Gastrointestinal Atonic And Hypomotility Disorders Nec
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 489 at risk

Adverse event: Gastrointestinal Disorders Nec
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 489 at risk

Adverse event: Gastrointestinal Signs And Symptoms Nec
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 489 at risk

Adverse event: Gastrointestinal Stenosis And Obstruction Nec
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 489 at risk

Adverse event: Gastrointestinal Ulcers And Perforation, Site Unspecified
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 489 at risk

Adverse event: Gastrointestinal Vascular Occlusion And Infarction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 489 at risk

Adverse event: Inguinal Hernias
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 489 at risk

Adverse event: Intestinal Haemorrhages
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 489 at risk

Adverse event: Intestinal Ulcers And Perforation Nec
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 489 at risk

Adverse event: Nausea And Vomiting Symptoms
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 489 at risk

Adverse event: Non-Site Specific Gastrointestinal Haemorrhages
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 35 affected / 489 at risk

Adverse event: Oesophageal Stenosis And Obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 489 at risk

Adverse event: Oesophageal Ulcers And Perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 489 at risk

Adverse event: Pancreatic Neoplasms
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 489 at risk

Adverse event: Peritoneal And Retroperitoneal Disorders
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 489 at risk

Adverse event: Peritoneal And Retroperitoneal Haemorrhages
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 489 at risk

Adverse event: Administration Site Reactions Nec
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 489 at risk

Adverse event: Asthenic Conditions
Serious: yes
Organ System: General disorders
Frequency: 11 affected / 489 at risk

Adverse event: Body Temperature Altered
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 489 at risk

Adverse event: Complications Associated With Device Nec
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 489 at risk

Adverse event: Death And Sudden Death
Serious: yes
Organ System: General disorders
Frequency: 10 affected / 489 at risk

Adverse event: Device Issues Nec
Serious: yes
Organ System: General disorders
Frequency: 40 affected / 489 at risk

Adverse event: Device Malfunction Events Nec
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 489 at risk

Adverse event: Febrile Disorders
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 489 at risk

Adverse event: Feelings And Sensations Nec
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 489 at risk

Adverse event: General Signs And Symptoms Nec
Serious: yes
Organ System: General disorders
Frequency: 7 affected / 489 at risk

Adverse event: Healing Abnormal Nec
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 489 at risk

Adverse event: Hernias Nec
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 489 at risk

Adverse event: Implant And Catheter Site Reactions
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 489 at risk

Adverse event: Mass Conditions Nec
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 489 at risk

Adverse event: Oedema Nec
Serious: yes
Organ System: General disorders
Frequency: 6 affected / 489 at risk

Adverse event: Pain And Discomfort Nec
Serious: yes
Organ System: General disorders
Frequency: 26 affected / 489 at risk

Adverse event: Product Physical Issues
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 489 at risk

Adverse event: Therapeutic And Nontherapeutic Responses
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 489 at risk

Adverse event: Bile Duct Infections And Inflammations
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 489 at risk

Adverse event: Cholecystitis And Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 3 affected / 489 at risk

Adverse event: Hepatic Failure And Associated Disorders
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 3 affected / 489 at risk

Adverse event: Hepatic Fibrosis And Cirrhosis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 489 at risk

Adverse event: Hepatocellular Damage And Hepatitis Nec
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 5 affected / 489 at risk

Adverse event: Abdominal And Gastrointestinal Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 489 at risk

Adverse event: Atypical Mycobacterial Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 489 at risk

Adverse event: Bacterial Infections Nec
Serious: yes
Organ System: Infections and infestations
Frequency: 22 affected / 489 at risk

Adverse event: Bone And Joint Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 489 at risk

Adverse event: Candida Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 489 at risk

Adverse event: Cardiac Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 489 at risk

Adverse event: Central Nervous System And Spinal Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 489 at risk

Adverse event: Clostridia Infections
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 489 at risk

Adverse event: Enterococcal Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 489 at risk

Adverse event: Escherichia Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 489 at risk

Adverse event: Fungal Infections Nec
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 489 at risk

Adverse event: Infections Nec
Serious: yes
Organ System: Infections and infestations
Frequency: 8 affected / 489 at risk

Adverse event: Klebsiella Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 489 at risk

Adverse event: Lower Respiratory Tract And Lung Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 74 affected / 489 at risk

Adverse event: Pseudomonal Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 489 at risk

Adverse event: Sepsis, Bacteraemia, Viraemia And Fungaemia Nec
Serious: yes
Organ System: Infections and infestations
Frequency: 32 affected / 489 at risk

Adverse event: Staphylococcal Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 489 at risk

Adverse event: Streptococcal Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 489 at risk

Adverse event: Upper Respiratory Tract Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 489 at risk

Adverse event: Urinary Tract Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 28 affected / 489 at risk

Adverse event: Viral Infections Nec
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 489 at risk

Adverse event: Anaesthetic Complications
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 489 at risk

Adverse event: Cardiac And Vascular Procedural Complications
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 16 affected / 489 at risk

Adverse event: Cardiovascular Injuries
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 489 at risk

Adverse event: Gastrointestinal And Hepatobiliary Procedural Complications
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 489 at risk

Adverse event: Limb Injuries Nec (Incl Traumatic Amputation)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 489 at risk

Adverse event: Lower Limb Fractures And Dislocations
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 18 affected / 489 at risk

Adverse event: Non-Site Specific Injuries Nec
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 13 affected / 489 at risk

Adverse event: Non-Site Specific Procedural Complications
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 25 affected / 489 at risk

Adverse event: Pelvic Fractures And Dislocations
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 489 at risk

Adverse event: Poisoning And Toxicity
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 489 at risk

Adverse event: Reproductive System And Breast Injuries
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 489 at risk

Adverse event: Site Specific Injuries Nec
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 489 at risk

Adverse event: Skin Injuries Nec
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 10 affected / 489 at risk

Adverse event: Skull Fractures, Facial Bone Fractures And Dislocations
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 489 at risk

Adverse event: Spinal Fractures And Dislocations
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 6 affected / 489 at risk

Adverse event: Thoracic Cage Fractures And Dislocations
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 489 at risk

Adverse event: Upper Limb Fractures And Dislocations
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 10 affected / 489 at risk

Adverse event: Blood Counts Nec
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 489 at risk

Adverse event: Carbohydrate Tolerance Analyses (Incl Diabetes)
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 489 at risk

Adverse event: Cardiac Function Diagnostic Procedures
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 489 at risk

Adverse event: Coagulation And Bleeding Analyses
Serious: yes
Organ System: Investigations
Frequency: 5 affected / 489 at risk

Adverse event: Ecg Investigations
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 489 at risk

Adverse event: Liver Function Analyses
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 489 at risk

Adverse event: Microbiology And Serology Tests Nec
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 489 at risk

Adverse event: Mineral And Electrolyte Analyses
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 489 at risk

Adverse event: Physical Examination Procedures
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 489 at risk

Adverse event: Red Blood Cell Analyses
Serious: yes
Organ System: Investigations
Frequency: 13 affected / 489 at risk

Adverse event: Renal Function Analyses
Serious: yes
Organ System: Investigations
Frequency: 4 affected / 489 at risk

Adverse event: Skeletal And Cardiac Muscle Analyses
Serious: yes
Organ System: Investigations
Frequency: 4 affected / 489 at risk

Adverse event: Urinary Tract Function Analyses Nec
Serious: yes
Organ System: Investigations
Frequency: 3 affected / 489 at risk

Adverse event: Vascular Tests Nec (Incl Blood Pressure)
Serious: yes
Organ System: Investigations
Frequency: 3 affected / 489 at risk

Adverse event: Appetite Disorders
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 489 at risk

Adverse event: Calcium Metabolism Disorders
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 489 at risk

Adverse event: Diabetic Complications Dermal
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 489 at risk

Adverse event: Diabetic Complications Nec
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 489 at risk

Adverse event: Disorders Of Purine Metabolism
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 489 at risk

Adverse event: Electrolyte Imbalance Nec
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 489 at risk

Adverse event: General Nutritional Disorders Nec
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 18 affected / 489 at risk

Adverse event: Hyperglycaemic Conditions Nec
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 489 at risk

Adverse event: Hypoglycaemic Conditions Nec
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 489 at risk

Adverse event: Metabolic Acidoses (Excl Diabetic Acidoses)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 489 at risk

Adverse event: Mixed Acid-Base Disorders
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 489 at risk

Adverse event: Potassium Imbalance
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 14 affected / 489 at risk

Adverse event: Sodium Imbalance
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 489 at risk

Adverse event: Total Fluid Volume Decreased
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 15 affected / 489 at risk

Adverse event: Total Fluid Volume Increased
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 12 affected / 489 at risk

Adverse event: Joint Related Signs And Symptoms
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 489 at risk

Adverse event: Muscle Weakness Conditions
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 489 at risk

Adverse event: Musculoskeletal And Connective Tissue Pain And Discomfort
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 489 at risk

Adverse event: Spine And Neck Deformities
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 489 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 / 489 at risk

Adverse event: Colonic Neoplasms Malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 489 at risk

Adverse event: Gastrointestinal Neoplasms Malignancy Unspecified Nec
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 489 at risk

Adverse event: Hepatic Neoplasms Malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 489 at risk

Adverse event: Myelodysplastic Syndromes
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 489 at risk

Adverse event: Neoplasms Malignant Site Unspecified Nec
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 3 affected / 489 at risk

Adverse event: Prostatic Neoplasms Malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 3 affected / 489 at risk

Adverse event: Renal Neoplasms Malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 489 at risk

Adverse event: Skin Neoplasms Malignant And Unspecified (Excl Melanoma)
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 489 at risk

Adverse event: Central Nervous System Haemorrhages And Cerebrovascular Accidents
Serious: yes
Organ System: Nervous system disorders
Frequency: 28 affected / 489 at risk

Adverse event: Central Nervous System Vascular Disorders Nec
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 489 at risk

Adverse event: Cerebellar Coordination And Balance Disturbances
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 489 at risk

Adverse event: Cortical Dysfunction Nec
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 489 at risk

Adverse event: Dementia (Excl Alzheimer's Type)
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 489 at risk

Adverse event: Disturbances In Consciousness Nec
Serious: yes
Organ System: Nervous system disorders
Frequency: 9 affected / 489 at risk

Adverse event: Dyskinesias And Movement Disorders Nec
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 489 at risk

Adverse event: Encephalopathies Nec
Serious: yes
Organ System: Nervous system disorders
Frequency: 14 affected / 489 at risk

Adverse event: Encephalopathies Toxic And Metabolic
Serious: yes
Organ System: Nervous system disorders
Frequency: 8 affected / 489 at risk

Adverse event: Migraine Headaches
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 489 at risk

Adverse event: Neurological Signs And Symptoms Nec
Serious: yes
Organ System: Nervous system disorders
Frequency: 7 affected / 489 at risk

Adverse event: Paralysis And Paresis (Excl Cranial Nerve)
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 489 at risk

Adverse event: Seizures And Seizure Disorders Nec
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 489 at risk

Adverse event: Speech And Language Abnormalities
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 489 at risk

Adverse event: Transient Cerebrovascular Events
Serious: yes
Organ System: Nervous system disorders
Frequency: 7 affected / 489 at risk

Adverse event: Tremor (Excl Congenital)
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 489 at risk

Adverse event: Confusion And Disorientation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 6 affected / 489 at risk

Adverse event: Deliria
Serious: yes
Organ System: Psychiatric disorders
Frequency: 3 affected / 489 at risk

Adverse event: Depressive Disorders
Serious: yes
Organ System: Psychiatric disorders
Frequency: 3 affected / 489 at risk

Adverse event: Mental Disorders Nec
Serious: yes
Organ System: Psychiatric disorders
Frequency: 13 affected / 489 at risk

Adverse event: Suicidal And Self-Injurious Behaviour
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 489 at risk

Adverse event: Bladder And Urethral Symptoms
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 7 affected / 489 at risk

Adverse event: Bladder Disorders Nec
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 489 at risk

Adverse event: Genital And Urinary Tract Disorders Nec
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 489 at risk

Adverse event: Nephritis Nec
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 489 at risk

Adverse event: Nephropathies And Tubular Disorders Nec
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 489 at risk

Adverse event: Renal Failure And Impairment
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 90 affected / 489 at risk

Adverse event: Renal Lithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 489 at risk

Adverse event: Renal Vascular And Ischaemic Conditions
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 489 at risk

Adverse event: Urinary Abnormalities
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 10 affected / 489 at risk

Adverse event: Pelvic Prolapse Conditions
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 489 at risk

Adverse event: Prostatic Neoplasms And Hypertrophy
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 489 at risk

Adverse event: Reproductive Tract Disorders Nec (Excl Neoplasms)
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 489 at risk

Adverse event: Scrotal Disorders Nec
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 489 at risk

Adverse event: Breathing Abnormalities
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 26 affected / 489 at risk

Adverse event: Bronchial Conditions Nec
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 489 at risk

Adverse event: Bronchospasm And Obstruction
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 25 affected / 489 at risk

Adverse event: Conditions Associated With Abnormal Gas Exchange
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 489 at risk

Adverse event: Coughing And Associated Symptoms
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 489 at risk

Adverse event: Lower Respiratory Tract Inflammatory And Immunologic Conditions
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 489 at risk

Adverse event: Lower Respiratory Tract Signs And Symptoms
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 489 at risk

Adverse event: Nasal Disorders Nec
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 489 at risk

Adverse event: Parenchymal Lung Disorders Nec
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 489 at risk

Adverse event: Pharyngeal Disorders (Excl Infections And Neoplasms)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 489 at risk

Adverse event: Pneumothorax And Pleural Effusions Nec
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 54 affected / 489 at risk

Adverse event: Pulmonary Hypertensions
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 489 at risk

Adverse event: Pulmonary Oedemas
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 23 affected / 489 at risk

Adverse event: Pulmonary Thrombotic And Embolic Conditions
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 489 at risk

Adverse event: Respiratory Failures (Excl Neonatal)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 54 affected / 489 at risk

Adverse event: Respiratory Tract Disorders Nec
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 489 at risk

Adverse event: Tracheal Disorders (Excl Infections And Neoplasms)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 489 at risk

Adverse event: Dermal And Epidermal Conditions Nec
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 489 at risk

Adverse event: Dermatitis Ascribed To Specific Agent
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 489 at risk

Adverse event: Purpura And Related Conditions
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 489 at risk

Adverse event: Rashes, Eruptions And Exanthems Nec
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 489 at risk

Adverse event: Skin And Subcutaneous Tissue Ulcerations
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 489 at risk

Adverse event: Skin Injuries And Mechanical Dermatoses
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 489 at risk

Adverse event: Housing Circumstances
Serious: yes
Organ System: Social circumstances
Frequency: 1 affected / 489 at risk

Adverse event: Cardiac Device Therapeutic Procedures
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 489 at risk

Adverse event: Fracture Treatments (Excl Skull And Spine)
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 489 at risk

Adverse event: Hernia Repairs
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 489 at risk

Adverse event: Joint Therapeutic Procedures
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 489 at risk

Adverse event: Therapeutic Procedures Nec
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 9 affected / 489 at risk

Adverse event: Accelerated And Malignant Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 489 at risk

Adverse event: Aortic Aneurysms And Dissections
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 489 at risk

Adverse event: Arterial And Aortic Injuries
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 489 at risk

Adverse event: Blood Pressure Disorders Nec
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 489 at risk

Adverse event: Circulatory Collapse And Shock
Serious: yes
Organ System: Vascular disorders
Frequency: 6 affected / 489 at risk

Adverse event: Haemorrhages Nec
Serious: yes
Organ System: Vascular disorders
Frequency: 20 affected / 489 at risk

Adverse event: Lymphangiopathies
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 489 at risk

Adverse event: Lymphoedemas
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 489 at risk

Adverse event: Non-Site Specific Embolism And Thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 6 affected / 489 at risk

Adverse event: Non-Site Specific Necrosis And Vascular Insufficiency Nec
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 489 at risk

Adverse event: Non-Site Specific Vascular Disorders Nec
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 489 at risk

Adverse event: Peripheral Aneurysms And Dissections
Serious: yes
Organ System: Vascular disorders
Frequency: 5 affected / 489 at risk

Adverse event: Peripheral Embolism And Thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 21 affected / 489 at risk

Adverse event: Peripheral Vascular Disorders Nec
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 489 at risk

Adverse event: Peripheral Vasoconstriction, Necrosis And Vascular Insufficiency
Serious: yes
Organ System: Vascular disorders
Frequency: 16 affected / 489 at risk

Adverse event: Site Specific Vascular Disorders Nec
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 489 at risk

Adverse event: Varicose Veins Non-Site Specific
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 489 at risk

Adverse event: Vascular Hypertensive Disorders Nec
Serious: yes
Organ System: Vascular disorders
Frequency: 11 affected / 489 at risk

Adverse event: Vascular Hypotensive Disorders
Serious: yes
Organ System: Vascular disorders
Frequency: 52 affected / 489 at risk

Adverse event: Vascular Malformations And Acquired Anomalies
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 489 at risk

Adverse event: Anaemias Nec
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 90 affected / 489 at risk

Adverse event: Leukocytoses Nec
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 38 affected / 489 at risk

Adverse event: Thrombocytopenias
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 68 affected / 489 at risk

Adverse event: Cardiac Conduction Disorders
Serious: no
Organ System: Cardiac disorders
Frequency: 114 affected / 489 at risk

Adverse event: Heart Failures Nec
Serious: no
Organ System: Cardiac disorders
Frequency: 30 affected / 489 at risk

Adverse event: Rate And Rhythm Disorders Nec
Serious: no
Organ System: Cardiac disorders
Frequency: 29 affected / 489 at risk

Adverse event: Supraventricular Arrhythmias
Serious: no
Organ System: Cardiac disorders
Frequency: 60 affected / 489 at risk

Adverse event: Ventricular Arrhythmias And Cardiac Arrest
Serious: no
Organ System: Cardiac disorders
Frequency: 31 affected / 489 at risk

Adverse event: Gastrointestinal Atonic And Hypomotility Disorders Nec
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 36 affected / 489 at risk

Adverse event: Nausea And Vomiting Symptoms
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 26 affected / 489 at risk

Adverse event: Febrile Disorders
Serious: no
Organ System: General disorders
Frequency: 36 affected / 489 at risk

Adverse event: Oedema Nec
Serious: no
Organ System: General disorders
Frequency: 44 affected / 489 at risk

Adverse event: Pain And Discomfort Nec
Serious: no
Organ System: General disorders
Frequency: 30 affected / 489 at risk

Adverse event: Lower Respiratory Tract And Lung Infections
Serious: no
Organ System: Infections and infestations
Frequency: 26 affected / 489 at risk

Adverse event: Urinary Tract Infections
Serious: no
Organ System: Infections and infestations
Frequency: 75 affected / 489 at risk

Adverse event: Non-Site Specific Injuries Nec
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 25 affected / 489 at risk

Adverse event: Non-Site Specific Procedural Complications
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 21 affected / 489 at risk

Adverse event: Skeletal And Cardiac Muscle Analyses
Serious: no
Organ System: Investigations
Frequency: 16 affected / 489 at risk

Adverse event: Hyperglycaemic Conditions Nec
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 22 affected / 489 at risk

Adverse event: Magnesium Metabolism Disorders
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 17 affected / 489 at risk

Adverse event: Potassium Imbalance
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 56 affected / 489 at risk

Adverse event: Sodium Imbalance
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 25 affected / 489 at risk

Adverse event: Total Fluid Volume Increased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 20 affected / 489 at risk

Adverse event: Musculoskeletal And Connective Tissue Pain And Discomfort
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 34 affected / 489 at risk

Adverse event: Neurological Signs And Symptoms Nec
Serious: no
Organ System: Nervous system disorders
Frequency: 18 affected / 489 at risk

Adverse event: Anxiety Symptoms
Serious: no
Organ System: Psychiatric disorders
Frequency: 25 affected / 489 at risk

Adverse event: Confusion And Disorientation
Serious: no
Organ System: Psychiatric disorders
Frequency: 32 affected / 489 at risk

Adverse event: Renal Failure And Impairment
Serious: no
Organ System: Renal and urinary disorders
Frequency: 67 affected / 489 at risk

Adverse event: Breathing Abnormalities
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 26 affected / 489 at risk

Adverse event: Bronchospasm And Obstruction
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 489 at risk

Adverse event: Conditions Associated With Abnormal Gas Exchange
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 12 affected / 489 at risk

Adverse event: Parenchymal Lung Disorders Nec
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 35 affected / 489 at risk

Adverse event: Pneumothorax And Pleural Effusions Nec
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 76 affected / 489 at risk

Adverse event: Pulmonary Oedemas
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 29 affected / 489 at risk

Adverse event: Haemorrhages Nec
Serious: no
Organ System: Vascular disorders
Frequency: 34 affected / 489 at risk

Adverse event: Vascular Hypertensive Disorders Nec
Serious: no
Organ System: Vascular disorders
Frequency: 45 affected / 489 at risk

Adverse event: Vascular Hypotensive Disorders
Serious: no
Organ System: Vascular disorders
Frequency: 68 affected / 489 at risk

Adverse event: Anaemias Nec
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 70 affected / 150 at risk

Adverse event: Coagulopathies
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 150 at risk

Adverse event: Leukocytoses Nec
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 150 at risk

Adverse event: Marrow Depression And Hypoplastic Anaemias
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 150 at risk

Adverse event: Thrombocytopenias
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 150 at risk

Adverse event: Aortic Valvular Disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 12 affected / 150 at risk

Adverse event: Cardiac Conduction Disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 24 affected / 150 at risk

Adverse event: Cardiac Disorders Nec
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 150 at risk

Adverse event: Coronary Artery Disorders Nec
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 150 at risk

Adverse event: Heart Failures Nec
Serious: yes
Organ System: Cardiac disorders
Frequency: 29 affected / 150 at risk

Adverse event: Ischaemic Coronary Artery Disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 8 affected / 150 at risk

Adverse event: Mitral Valvular Disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 150 at risk

Adverse event: Noninfectious Pericarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 150 at risk

Adverse event: Pericardial Disorders Nec
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 150 at risk

Adverse event: Rate And Rhythm Disorders Nec
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 150 at risk

Adverse event: Supraventricular Arrhythmias
Serious: yes
Organ System: Cardiac disorders
Frequency: 17 affected / 150 at risk

Adverse event: Tricuspid Valvular Disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 150 at risk

Adverse event: Ventricular Arrhythmias And Cardiac Arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 26 affected / 150 at risk

Adverse event: Inner Ear Signs And Symptoms
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 150 at risk

Adverse event: Blindness (Excl Colour Blindness)
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 150 at risk

Adverse event: Corneal Infections, Oedemas And Inflammations
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 150 at risk

Adverse event: Abdominal Wall Conditions Nec
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 150 at risk

Adverse event: Benign Neoplasms Gastrointestinal (Excl Oral Cavity)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 150 at risk

Adverse event: Colitis (Excl Infective)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 150 at risk

Adverse event: Diarrhoea (Excl Infective)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 150 at risk

Adverse event: Duodenal And Small Intestinal Stenosis And Obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 150 at risk

Adverse event: Faecal Abnormalities Nec
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 150 at risk

Adverse event: Gastritis (Excl Infective)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 150 at risk

Adverse event: Gastrointestinal And Abdominal Pains (Excl Oral And Throat)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 150 at risk

Adverse event: Gastrointestinal Atonic And Hypomotility Disorders Nec
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 150 at risk

Adverse event: Gastrointestinal Disorders Nec
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 150 at risk

Adverse event: Gastrointestinal Signs And Symptoms Nec
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 150 at risk

Adverse event: Gastrointestinal Stenosis And Obstruction Nec
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 150 at risk

Adverse event: Gastrointestinal Ulcers And Perforation, Site Unspecified
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 150 at risk

Adverse event: Gastrointestinal Vascular Occlusion And Infarction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 150 at risk

Adverse event: Haemorrhoids And Gastrointestinal Varices (Excl Oesophageal)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 150 at risk

Adverse event: Intestinal Haemorrhages
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 150 at risk

Adverse event: Nausea And Vomiting Symptoms
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 150 at risk

Adverse event: Non-Site Specific Gastrointestinal Haemorrhages
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 150 at risk

Adverse event: Peritoneal And Retroperitoneal Disorders
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 150 at risk

Adverse event: Peritoneal And Retroperitoneal Haemorrhages
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 150 at risk

Adverse event: Administration Site Reactions Nec
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 150 at risk

Adverse event: Asthenic Conditions
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 150 at risk

Adverse event: Body Temperature Altered
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 150 at risk

Adverse event: Death And Sudden Death
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 150 at risk

Adverse event: Device Issues Nec
Serious: yes
Organ System: General disorders
Frequency: 7 affected / 150 at risk

Adverse event: Device Malfunction Events Nec
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 150 at risk

Adverse event: Febrile Disorders
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 150 at risk

Adverse event: General Signs And Symptoms Nec
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 150 at risk

Adverse event: Oedema Nec
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 150 at risk

Adverse event: Pain And Discomfort Nec
Serious: yes
Organ System: General disorders
Frequency: 9 affected / 150 at risk

Adverse event: Withdrawal And Rebound Effects
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 150 at risk

Adverse event: Bile Duct Infections And Inflammations
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 150 at risk

Adverse event: Cholecystitis And Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 150 at risk

Adverse event: Abdominal And Gastrointestinal Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 150 at risk

Adverse event: Bacterial Infections Nec
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 150 at risk

Adverse event: Bone And Joint Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 150 at risk

Adverse event: Cardiac Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 150 at risk

Adverse event: Clostridia Infections
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 150 at risk

Adverse event: Herpes Viral Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 150 at risk

Adverse event: Infections Nec
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 150 at risk

Adverse event: Infectious Transmissions
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 150 at risk

Adverse event: Klebsiella Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 150 at risk

Adverse event: Lower Respiratory Tract And Lung Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 25 affected / 150 at risk

Adverse event: Pseudomonal Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 150 at risk

Adverse event: Sepsis, Bacteraemia, Viraemia And Fungaemia Nec
Serious: yes
Organ System: Infections and infestations
Frequency: 17 affected / 150 at risk

Adverse event: Staphylococcal Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 150 at risk

Adverse event: Streptococcal Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 150 at risk

Adverse event: Upper Respiratory Tract Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 150 at risk

Adverse event: Urinary Tract Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 9 affected / 150 at risk

Adverse event: Cardiac And Vascular Procedural Complications
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 150 at risk

Adverse event: Cardiovascular Injuries
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 150 at risk

Adverse event: Cerebral Injuries Nec
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 150 at risk

Adverse event: Fractures And Dislocations Nec
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 150 at risk

Adverse event: Gastrointestinal And Hepatobiliary Procedural Complications
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 150 at risk

Adverse event: Lower Limb Fractures And Dislocations
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 150 at risk

Adverse event: Non-Site Specific Injuries Nec
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 150 at risk

Adverse event: Non-Site Specific Procedural Complications
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 6 affected / 150 at risk

Adverse event: Pelvic Fractures And Dislocations
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 150 at risk

Adverse event: Respiratory Tract And Thoracic Cavity Procedural Complications
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 150 at risk

Adverse event: Site Specific Injuries Nec
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 150 at risk

Adverse event: Skin Injuries Nec
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 150 at risk

Adverse event: Skin Procedural Complications
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 150 at risk

Adverse event: Spinal Fractures And Dislocations
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 150 at risk

Adverse event: Transfusion Related Complications
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 150 at risk

Adverse event: Blood Counts Nec
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 150 at risk

Adverse event: Cardiac Function Diagnostic Procedures
Serious: yes
Organ System: Investigations
Frequency: 3 affected / 150 at risk

Adverse event: Coagulation And Bleeding Analyses
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 150 at risk

Adverse event: Metabolism Tests Nec
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 150 at risk

Adverse event: Protein Analyses Nec
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 150 at risk

Adverse event: Red Blood Cell Analyses
Serious: yes
Organ System: Investigations
Frequency: 4 affected / 150 at risk

Adverse event: Renal Function Analyses
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 150 at risk

Adverse event: Skeletal And Cardiac Muscle Analyses
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 150 at risk

Adverse event: Urinary Tract Function Analyses Nec
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 150 at risk

Adverse event: Appetite Disorders
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 150 at risk

Adverse event: Calcium Metabolism Disorders
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 150 at risk

Adverse event: General Nutritional Disorders Nec
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 150 at risk

Adverse event: Hyperglycaemic Conditions Nec
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 150 at risk

Adverse event: Hypoglycaemic Conditions Nec
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 150 at risk

Adverse event: Magnesium Metabolism Disorders
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 150 at risk

Adverse event: Metabolic Acidoses (Excl Diabetic Acidoses)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 150 at risk

Adverse event: Potassium Imbalance
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 150 at risk

Adverse event: Protein Metabolism Disorders Nec
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 150 at risk

Adverse event: Sodium Imbalance
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 150 at risk

Adverse event: Total Fluid Volume Decreased
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 150 at risk

Adverse event: Total Fluid Volume Increased
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 150 at risk

Adverse event: Arthropathies Nec
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 150 at risk

Adverse event: Bone Disorders Nec
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 150 at risk

Adverse event: Joint Related Signs And Symptoms
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 150 at risk

Adverse event: Muscle Weakness Conditions
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 150 at risk

Adverse event: Musculoskeletal And Connective Tissue Pain And Discomfort
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 150 at risk

Adverse event: Myopathies
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 150 at risk

Adverse event: Osteoarthropathies
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 150 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 / 150 at risk

Adverse event: Multiple Myelomas
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 150 at risk

Adverse event: Prostatic Neoplasms Malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 150 at risk

Adverse event: Respiratory Tract And Pleural Neoplasms Malignant Cell Type Unspecified Nec
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 150 at risk

Adverse event: Skin Neoplasms Malignant And Unspecified (Excl Melanoma)
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 150 at risk

Adverse event: Central Nervous System Haemorrhages And Cerebrovascular Accidents
Serious: yes
Organ System: Nervous system disorders
Frequency: 14 affected / 150 at risk

Adverse event: Disturbances In Consciousness Nec
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 150 at risk

Adverse event: Headaches Nec
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 150 at risk

Adverse event: Nervous System Disorders Nec
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 150 at risk

Adverse event: Neurological Signs And Symptoms Nec
Serious: yes
Organ System: Nervous system disorders
Frequency: 8 affected / 150 at risk

Adverse event: Seizures And Seizure Disorders Nec
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 150 at risk

Adverse event: Sensory Abnormalities Nec
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 150 at risk

Adverse event: Transient Cerebrovascular Events
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 150 at risk

Adverse event: Confusion And Disorientation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 150 at risk

Adverse event: Deliria
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 150 at risk

Adverse event: Mental Disorders Nec
Serious: yes
Organ System: Psychiatric disorders
Frequency: 3 affected / 150 at risk

Adverse event: Perception Disturbances
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 150 at risk

Adverse event: Bladder And Urethral Symptoms
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 8 affected / 150 at risk

Adverse event: Bladder Disorders Nec
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 150 at risk

Adverse event: Nephropathies And Tubular Disorders Nec
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 150 at risk

Adverse event: Renal Failure And Impairment
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 31 affected / 150 at risk

Adverse event: Renal Failure Complications
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 150 at risk

Adverse event: Renal Obstructive Disorders
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 150 at risk

Adverse event: Renal Vascular And Ischaemic Conditions
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 150 at risk

Adverse event: Ureteric Disorders Nec
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 150 at risk

Adverse event: Urinary Abnormalities
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 150 at risk

Adverse event: Breast Disorders Nec
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 150 at risk

Adverse event: Prostatic Neoplasms And Hypertrophy
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 150 at risk

Adverse event: Vulvovaginal Disorders Nec
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 150 at risk

Adverse event: Breathing Abnormalities
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 21 affected / 150 at risk

Adverse event: Bronchial Conditions Nec
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 150 at risk

Adverse event: Bronchospasm And Obstruction
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 16 affected / 150 at risk

Adverse event: Conditions Associated With Abnormal Gas Exchange
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 150 at risk

Adverse event: Coughing And Associated Symptoms
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 150 at risk

Adverse event: Diaphragmatic Disorders
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 150 at risk

Adverse event: Laryngeal And Adjacent Sites Disorders Nec (Excl Infections And Neoplasms)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 150 at risk

Adverse event: Lower Respiratory Tract Inflammatory And Immunologic Conditions
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 150 at risk

Adverse event: Mediastinal Disorders
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 150 at risk

Adverse event: Nasal Disorders Nec
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 150 at risk

Adverse event: Parenchymal Lung Disorders Nec
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 150 at risk

Adverse event: Pneumothorax And Pleural Effusions Nec
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 26 affected / 150 at risk

Adverse event: Pulmonary Hypertensions
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 150 at risk

Adverse event: Pulmonary Oedemas
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 150 at risk

Adverse event: Pulmonary Thrombotic And Embolic Conditions
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 150 at risk

Adverse event: Respiratory Failures (Excl Neonatal)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 28 affected / 150 at risk

Adverse event: Respiratory Tract Disorders Nec
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 150 at risk

Adverse event: Dermal And Epidermal Conditions Nec
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 150 at risk

Adverse event: Skin Injuries And Mechanical Dermatoses
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 150 at risk

Adverse event: Cardiac Device Therapeutic Procedures
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 150 at risk

Adverse event: Accelerated And Malignant Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 150 at risk

Adverse event: Aneurysms And Dissections Non-Site Specific
Serious: yes
Organ System: Vascular disorders
Frequency: 5 affected / 150 at risk

Adverse event: Aortic Aneurysms And Dissections
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 150 at risk

Adverse event: Blood Pressure Disorders Nec
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 150 at risk

Adverse event: Circulatory Collapse And Shock
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 150 at risk

Adverse event: Haemorrhages Nec
Serious: yes
Organ System: Vascular disorders
Frequency: 13 affected / 150 at risk

Adverse event: Non-Site Specific Embolism And Thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 150 at risk

Adverse event: Non-Site Specific Necrosis And Vascular Insufficiency Nec
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 150 at risk

Adverse event: Non-Site Specific Vascular Disorders Nec
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 150 at risk

Adverse event: Peripheral Embolism And Thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 5 affected / 150 at risk

Adverse event: Peripheral Vascular Disorders Nec
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 150 at risk

Adverse event: Peripheral Vasoconstriction, Necrosis And Vascular Insufficiency
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 150 at risk

Adverse event: Site Specific Vascular Disorders Nec
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 150 at risk

Adverse event: Vascular Hypertensive Disorders Nec
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 150 at risk

Adverse event: Vascular Hypotensive Disorders
Serious: yes
Organ System: Vascular disorders
Frequency: 15 affected / 150 at risk

Adverse event: Anaemias Nec
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 27 affected / 150 at risk

Adverse event: Leukocytoses Nec
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 18 affected / 150 at risk

Adverse event: Thrombocytopenias
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 32 affected / 150 at risk

Adverse event: Cardiac Conduction Disorders
Serious: no
Organ System: Cardiac disorders
Frequency: 32 affected / 150 at risk

Adverse event: Heart Failures Nec
Serious: no
Organ System: Cardiac disorders
Frequency: 9 affected / 150 at risk

Adverse event: Rate And Rhythm Disorders Nec
Serious: no
Organ System: Cardiac disorders
Frequency: 12 affected / 150 at risk

Adverse event: Supraventricular Arrhythmias
Serious: no
Organ System: Cardiac disorders
Frequency: 36 affected / 150 at risk

Adverse event: Ventricular Arrhythmias And Cardiac Arrest
Serious: no
Organ System: Cardiac disorders
Frequency: 8 affected / 150 at risk

Adverse event: Gastrointestinal Atonic And Hypomotility Disorders Nec
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 150 at risk

Adverse event: Nausea And Vomiting Symptoms
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 150 at risk

Adverse event: Febrile Disorders
Serious: no
Organ System: General disorders
Frequency: 7 affected / 150 at risk

Adverse event: Oedema Nec
Serious: no
Organ System: General disorders
Frequency: 16 affected / 150 at risk

Adverse event: Pain And Discomfort Nec
Serious: no
Organ System: General disorders
Frequency: 9 affected / 150 at risk

Adverse event: Lower Respiratory Tract And Lung Infections
Serious: no
Organ System: Infections and infestations
Frequency: 16 affected / 150 at risk

Adverse event: Urinary Tract Infections
Serious: no
Organ System: Infections and infestations
Frequency: 28 affected / 150 at risk

Adverse event: Non-Site Specific Injuries Nec
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 150 at risk

Adverse event: Non-Site Specific Procedural Complications
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 6 affected / 150 at risk

Adverse event: Skeletal And Cardiac Muscle Analyses
Serious: no
Organ System: Investigations
Frequency: 7 affected / 150 at risk

Adverse event: Hyperglycaemic Conditions Nec
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 150 at risk

Adverse event: Magnesium Metabolism Disorders
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 9 affected / 150 at risk

Adverse event: Potassium Imbalance
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 16 affected / 150 at risk

Adverse event: Sodium Imbalance
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 10 affected / 150 at risk

Adverse event: Total Fluid Volume Increased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 12 affected / 150 at risk

Adverse event: Musculoskeletal And Connective Tissue Pain And Discomfort
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 16 affected / 150 at risk

Adverse event: Neurological Signs And Symptoms Nec
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 150 at risk

Adverse event: Anxiety Symptoms
Serious: no
Organ System: Psychiatric disorders
Frequency: 6 affected / 150 at risk

Adverse event: Confusion And Disorientation
Serious: no
Organ System: Psychiatric disorders
Frequency: 13 affected / 150 at risk

Adverse event: Renal Failure And Impairment
Serious: no
Organ System: Renal and urinary disorders
Frequency: 16 affected / 150 at risk

Adverse event: Breathing Abnormalities
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 150 at risk

Adverse event: Bronchospasm And Obstruction
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 150 at risk

Adverse event: Conditions Associated With Abnormal Gas Exchange
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 150 at risk

Adverse event: Parenchymal Lung Disorders Nec
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 150 at risk

Adverse event: Pneumothorax And Pleural Effusions Nec
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 30 affected / 150 at risk

Adverse event: Pulmonary Oedemas
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 150 at risk

Adverse event: Haemorrhages Nec
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 150 at risk

Adverse event: Vascular Hypertensive Disorders Nec
Serious: no
Organ System: Vascular disorders
Frequency: 20 affected / 150 at risk

Adverse event: Vascular Hypotensive Disorders
Serious: no
Organ System: Vascular disorders
Frequency: 18 affected / 150 at risk

Adverse event: Anaemia Deficiencies
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 390 at risk

Adverse event: Anaemias Due To Chronic Disorders
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 390 at risk

Adverse event: Anaemias Nec
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 106 affected / 390 at risk

Adverse event: Coagulopathies
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 390 at risk

Adverse event: Leukocytoses Nec
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 390 at risk

Adverse event: Marrow Depression And Hypoplastic Anaemias
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 390 at risk

Adverse event: Thrombocytopenias
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 8 affected / 390 at risk

Adverse event: Aortic Valvular Disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 42 affected / 390 at risk

Adverse event: Cardiac Conduction Disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 79 affected / 390 at risk

Adverse event: Cardiac Disorders Nec
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 390 at risk

Adverse event: Cardiac Valve Disorders Nec
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 390 at risk

Adverse event: Cardiomyopathies
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 390 at risk

Adverse event: Coronary Artery Disorders Nec
Serious: yes
Organ System: Cardiac disorders
Frequency: 9 affected / 390 at risk

Adverse event: Heart Failures Nec
Serious: yes
Organ System: Cardiac disorders
Frequency: 69 affected / 390 at risk

Adverse event: Ischaemic Coronary Artery Disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 15 affected / 390 at risk

Adverse event: Mitral Valvular Disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 390 at risk

Adverse event: Myocardial Disorders Nec
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 390 at risk

Adverse event: Pericardial Disorders Nec
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 390 at risk

Adverse event: Rate And Rhythm Disorders Nec
Serious: yes
Organ System: Cardiac disorders
Frequency: 16 affected / 390 at risk

Adverse event: Right Ventricular Failures
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 390 at risk

Adverse event: Supraventricular Arrhythmias
Serious: yes
Organ System: Cardiac disorders
Frequency: 43 affected / 390 at risk

Adverse event: Ventricular Arrhythmias And Cardiac Arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 27 affected / 390 at risk

Adverse event: Vascular Anomalies Congenital Nec
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 390 at risk

Adverse event: Inner Ear Signs And Symptoms
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 390 at risk

Adverse event: Blindness (Excl Colour Blindness)
Serious: yes
Organ System: Eye disorders
Frequency: 2 affected / 390 at risk

Adverse event: Cataract Conditions
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 390 at risk

Adverse event: Lacrimal Disorders
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 390 at risk

Adverse event: Retinal Bleeding And Vascular Disorders (Excl Retinopathy)
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 390 at risk

Adverse event: Visual Disorders Nec
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 390 at risk

Adverse event: Acute And Chronic Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 390 at risk

Adverse event: Diarrhoea (Excl Infective)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 390 at risk

Adverse event: Duodenal And Small Intestinal Stenosis And Obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 390 at risk

Adverse event: Duodenal Ulcers And Perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 390 at risk

Adverse event: Flatulence, Bloating And Distension
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 390 at risk

Adverse event: Gastric Ulcers And Perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 390 at risk

Adverse event: Gastritis (Excl Infective)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 390 at risk

Adverse event: Gastrointestinal And Abdominal Pains (Excl Oral And Throat)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 390 at risk

Adverse event: Gastrointestinal Atonic And Hypomotility Disorders Nec
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 390 at risk

Adverse event: Gastrointestinal Fistulae
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 390 at risk

Adverse event: Gastrointestinal Signs And Symptoms Nec
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 390 at risk

Adverse event: Gastrointestinal Spastic And Hypermotility Disorders
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 390 at risk

Adverse event: Gastrointestinal Stenosis And Obstruction Nec
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 390 at risk

Adverse event: Haemorrhoids And Gastrointestinal Varices (Excl Oesophageal)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 390 at risk

Adverse event: Intestinal Haemorrhages
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 390 at risk

Adverse event: Nausea And Vomiting Symptoms
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 390 at risk

Adverse event: Non-Site Specific Gastrointestinal Haemorrhages
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 27 affected / 390 at risk

Adverse event: Oesophageal Ulcers And Perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 390 at risk

Adverse event: Oesophagitis (Excl Infective)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 390 at risk

Adverse event: Oral Soft Tissue Pain And Paraesthesia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 390 at risk

Adverse event: Peritoneal And Retroperitoneal Haemorrhages
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 390 at risk

Adverse event: Umbilical Hernias
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 390 at risk

Adverse event: Asthenic Conditions
Serious: yes
Organ System: General disorders
Frequency: 9 affected / 390 at risk

Adverse event: Cardiac Complications Associated With Device
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 390 at risk

Adverse event: Death And Sudden Death
Serious: yes
Organ System: General disorders
Frequency: 6 affected / 390 at risk

Adverse event: Device Issues Nec
Serious: yes
Organ System: General disorders
Frequency: 28 affected / 390 at risk

Adverse event: Device Malfunction Events Nec
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 390 at risk

Adverse event: Febrile Disorders
Serious: yes
Organ System: General disorders
Frequency: 7 affected / 390 at risk

Adverse event: Feelings And Sensations Nec
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 390 at risk

Adverse event: Gait Disturbances
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 390 at risk

Adverse event: General Signs And Symptoms Nec
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 390 at risk

Adverse event: Hernias Nec
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 390 at risk

Adverse event: Implant And Catheter Site Reactions
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 390 at risk

Adverse event: Inflammations
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 390 at risk

Adverse event: Oedema Nec
Serious: yes
Organ System: General disorders
Frequency: 6 affected / 390 at risk

Adverse event: Pain And Discomfort Nec
Serious: yes
Organ System: General disorders
Frequency: 23 affected / 390 at risk

Adverse event: Product Physical Issues
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 390 at risk

Adverse event: Therapeutic And Nontherapeutic Responses
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 390 at risk

Adverse event: Cholecystitis And Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 4 affected / 390 at risk

Adverse event: Hepatic Failure And Associated Disorders
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 390 at risk

Adverse event: Anaphylactic Responses
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 390 at risk

Adverse event: Abdominal And Gastrointestinal Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 390 at risk

Adverse event: Bacterial Infections Nec
Serious: yes
Organ System: Infections and infestations
Frequency: 15 affected / 390 at risk

Adverse event: Cardiac Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 390 at risk

Adverse event: Clostridia Infections
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 390 at risk

Adverse event: Ear Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 390 at risk

Adverse event: Fungal Infections Nec
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 390 at risk

Adverse event: Haemophilus Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 390 at risk

Adverse event: Herpes Viral Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 390 at risk

Adverse event: Infections Nec
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 390 at risk

Adverse event: Influenza Viral Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 390 at risk

Adverse event: Lower Respiratory Tract And Lung Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 44 affected / 390 at risk

Adverse event: Pseudomonal Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 390 at risk

Adverse event: Sepsis, Bacteraemia, Viraemia And Fungaemia Nec
Serious: yes
Organ System: Infections and infestations
Frequency: 32 affected / 390 at risk

Adverse event: Staphylococcal Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 390 at risk

Adverse event: Streptococcal Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 390 at risk

Adverse event: Upper Respiratory Tract Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 390 at risk

Adverse event: Urinary Tract Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 21 affected / 390 at risk

Adverse event: Vascular Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 390 at risk

Adverse event: Cardiac And Vascular Procedural Complications
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 7 affected / 390 at risk

Adverse event: Cerebral Injuries Nec
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 5 affected / 390 at risk

Adverse event: Chest And Lung Injuries Nec
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 390 at risk

Adverse event: Fractures And Dislocations Nec
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 390 at risk

Adverse event: Lower Limb Fractures And Dislocations
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 9 affected / 390 at risk

Adverse event: Non-Site Specific Injuries Nec
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 14 affected / 390 at risk

Adverse event: Non-Site Specific Procedural Complications
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 25 affected / 390 at risk

Adverse event: Pelvic Fractures And Dislocations
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 390 at risk

Adverse event: Site Specific Injuries Nec
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 390 at risk

Adverse event: Skin Injuries Nec
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 5 affected / 390 at risk

Adverse event: Skull Fractures, Facial Bone Fractures And Dislocations
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 390 at risk

Adverse event: Spinal Fractures And Dislocations
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 5 affected / 390 at risk

Adverse event: Thoracic Cage Fractures And Dislocations
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 390 at risk

Adverse event: Transfusion Related Complications
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 390 at risk

Adverse event: Upper Limb Fractures And Dislocations
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 390 at risk

Adverse event: Blood Counts Nec
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 390 at risk

Adverse event: Blood Gas And Acid Base Analyses
Serious: yes
Organ System: Investigations
Frequency: 3 affected / 390 at risk

Adverse event: Carbohydrate Tolerance Analyses (Incl Diabetes)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 390 at risk

Adverse event: Coagulation And Bleeding Analyses
Serious: yes
Organ System: Investigations
Frequency: 6 affected / 390 at risk

Adverse event: Ecg Investigations
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 390 at risk

Adverse event: Microbiology And Serology Tests Nec
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 390 at risk

Adverse event: Mineral And Electrolyte Analyses
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 390 at risk

Adverse event: Physical Examination Procedures
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 390 at risk

Adverse event: Platelet Analyses
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 390 at risk

Adverse event: Red Blood Cell Analyses
Serious: yes
Organ System: Investigations
Frequency: 10 affected / 390 at risk

Adverse event: Renal Function Analyses
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 390 at risk

Adverse event: Skeletal And Cardiac Muscle Analyses
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 390 at risk

Adverse event: Tissue Enzyme Analyses Nec
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 390 at risk

Adverse event: Urinalysis Nec
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 390 at risk

Adverse event: Vascular Tests Nec (Incl Blood Pressure)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 390 at risk

Adverse event: White Blood Cell Analyses
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 390 at risk

Adverse event: Appetite Disorders
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 390 at risk

Adverse event: Calcium Metabolism Disorders
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 390 at risk

Adverse event: Disorders Of Purine Metabolism
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 390 at risk

Adverse event: Electrolyte Imbalance Nec
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 390 at risk

Adverse event: General Nutritional Disorders Nec
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 390 at risk

Adverse event: Hyperglycaemic Conditions Nec
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 390 at risk

Adverse event: Hypoglycaemic Conditions Nec
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 390 at risk

Adverse event: Magnesium Metabolism Disorders
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 390 at risk

Adverse event: Metabolic Acidoses (Excl Diabetic Acidoses)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 390 at risk

Adverse event: Mixed Acid-Base Disorders
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 390 at risk

Adverse event: Potassium Imbalance
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 390 at risk

Adverse event: Protein Metabolism Disorders Nec
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 390 at risk

Adverse event: Sodium Imbalance
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 390 at risk

Adverse event: Total Fluid Volume Decreased
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 390 at risk

Adverse event: Total Fluid Volume Increased
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 390 at risk

Adverse event: Arthropathies Nec
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 390 at risk

Adverse event: Bone Related Signs And Symptoms
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 390 at risk

Adverse event: Joint Related Signs And Symptoms
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 390 at risk

Adverse event: Metabolic Bone Disorders
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 390 at risk

Adverse event: Musculoskeletal And Connective Tissue Pain And Discomfort
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 13 affected / 390 at risk

Adverse event: Osteoarthropathies
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 390 at risk

Adverse event: Spine And Neck Deformities
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 390 at risk

Adverse event: B-Cell Lymphomas Nec
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 390 at risk

Adverse event: Bladder Neoplasms Malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 390 at risk

Adverse event: Colonic Neoplasms Malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 390 at risk

Adverse event: Gastric Neoplasms Malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 390 at risk

Adverse event: Hepatic Neoplasms Malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 390 at risk

Adverse event: Leukaemias Acute Myeloid
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 390 at risk

Adverse event: Myelodysplastic Syndromes
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 390 at risk

Adverse event: Neoplasms Malignant Site Unspecified Nec
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 390 at risk

Adverse event: Pancreatic Neoplasms Malignant (Excl Islet Cell And Carcinoid)
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 390 at risk

Adverse event: Pharyngeal And Laryngeal Neoplasms Benign
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 390 at risk

Adverse event: Renal Neoplasms Malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 390 at risk

Adverse event: Respiratory Tract And Pleural Neoplasms Malignant Cell Type Unspecified Nec
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 390 at risk

Adverse event: Skin Neoplasms Malignant And Unspecified (Excl Melanoma)
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 390 at risk

Adverse event: Central Nervous System Haemorrhages And Cerebrovascular Accidents
Serious: yes
Organ System: Nervous system disorders
Frequency: 26 affected / 390 at risk

Adverse event: Central Nervous System Vascular Disorders Nec
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 390 at risk

Adverse event: Cerebellar Coordination And Balance Disturbances
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 390 at risk

Adverse event: Coma States
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 390 at risk

Adverse event: Dementia (Excl Alzheimer's Type)
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 390 at risk

Adverse event: Disturbances In Consciousness Nec
Serious: yes
Organ System: Nervous system disorders
Frequency: 14 affected / 390 at risk

Adverse event: Encephalopathies Nec
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 390 at risk

Adverse event: Encephalopathies Toxic And Metabolic
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 390 at risk

Adverse event: Headaches Nec
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 390 at risk

Adverse event: Hydrocephalic Conditions
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 390 at risk

Adverse event: Lumbar Spinal Cord And Nerve Root Disorders
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 390 at risk

Adverse event: Memory Loss (Excl Dementia)
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 390 at risk

Adverse event: Neurological Signs And Symptoms Nec
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 390 at risk

Adverse event: Peripheral Neuropathies Nec
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 390 at risk

Adverse event: Seizures And Seizure Disorders Nec
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 390 at risk

Adverse event: Transient Cerebrovascular Events
Serious: yes
Organ System: Nervous system disorders
Frequency: 6 affected / 390 at risk

Adverse event: Anxiety Symptoms
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 390 at risk

Adverse event: Confusion And Disorientation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 8 affected / 390 at risk

Adverse event: Deliria
Serious: yes
Organ System: Psychiatric disorders
Frequency: 4 affected / 390 at risk

Adverse event: Depressive Disorders
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 390 at risk

Adverse event: Mental Disorders Nec
Serious: yes
Organ System: Psychiatric disorders
Frequency: 4 affected / 390 at risk

Adverse event: Perception Disturbances
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 390 at risk

Adverse event: Bladder And Urethral Symptoms
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 8 affected / 390 at risk

Adverse event: Nephropathies And Tubular Disorders Nec
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 390 at risk

Adverse event: Renal Disorders Nec
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 390 at risk

Adverse event: Renal Failure And Impairment
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 38 affected / 390 at risk

Adverse event: Renal Vascular And Ischaemic Conditions
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 390 at risk

Adverse event: Urinary Abnormalities
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 8 affected / 390 at risk

Adverse event: Breathing Abnormalities
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 30 affected / 390 at risk

Adverse event: Bronchial Conditions Nec
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 390 at risk

Adverse event: Bronchospasm And Obstruction
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 13 affected / 390 at risk

Adverse event: Conditions Associated With Abnormal Gas Exchange
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 390 at risk

Adverse event: Coughing And Associated Symptoms
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 390 at risk

Adverse event: Laryngeal Spasm, Oedema And Obstruction
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 390 at risk

Adverse event: Lower Respiratory Tract Inflammatory And Immunologic Conditions
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 390 at risk

Adverse event: Mediastinal Disorders
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 390 at risk

Adverse event: Nasal Disorders Nec
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 390 at risk

Adverse event: Parenchymal Lung Disorders Nec
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 390 at risk

Adverse event: Pharyngeal Disorders (Excl Infections And Neoplasms)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 390 at risk

Adverse event: Pneumothorax And Pleural Effusions Nec
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 29 affected / 390 at risk

Adverse event: Pulmonary Hypertensions
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 390 at risk

Adverse event: Pulmonary Oedemas
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 390 at risk

Adverse event: Pulmonary Thrombotic And Embolic Conditions
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 390 at risk

Adverse event: Respiratory Failures (Excl Neonatal)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 36 affected / 390 at risk

Adverse event: Respiratory Tract Disorders Nec
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 390 at risk

Adverse event: Upper Respiratory Tract Signs And Symptoms
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 390 at risk

Adverse event: Bullous Conditions
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 390 at risk

Adverse event: Dermatitis And Eczema
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 390 at risk

Adverse event: Skin Haemorrhages
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 390 at risk

Adverse event: Skin Injuries And Mechanical Dermatoses
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 390 at risk

Adverse event: Cardiac Device Therapeutic Procedures
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 390 at risk

Adverse event: Corneal And Scleral Therapeutic Procedures
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 390 at risk

Adverse event: Lens Therapeutic Procedures
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 390 at risk

Adverse event: Limb Therapeutic Procedures
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 390 at risk

Adverse event: Renal Therapeutic Procedures
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 390 at risk

Adverse event: Therapeutic Procedures Nec
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 3 affected / 390 at risk

Adverse event: Aortic Aneurysms And Dissections
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 390 at risk

Adverse event: Circulatory Collapse And Shock
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 390 at risk

Adverse event: Haemorrhages Nec
Serious: yes
Organ System: Vascular disorders
Frequency: 19 affected / 390 at risk

Adverse event: Lymphangiopathies
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 390 at risk

Adverse event: Non-Site Specific Embolism And Thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 390 at risk

Adverse event: Non-Site Specific Necrosis And Vascular Insufficiency Nec
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 390 at risk

Adverse event: Non-Site Specific Vascular Disorders Nec
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 390 at risk

Adverse event: Peripheral Aneurysms And Dissections
Serious: yes
Organ System: Vascular disorders
Frequency: 9 affected / 390 at risk

Adverse event: Peripheral Embolism And Thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 7 affected / 390 at risk

Adverse event: Peripheral Vascular Disorders Nec
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 390 at risk

Adverse event: Peripheral Vasoconstriction, Necrosis And Vascular Insufficiency
Serious: yes
Organ System: Vascular disorders
Frequency: 12 affected / 390 at risk

Adverse event: Vascular Hypertensive Disorders Nec
Serious: yes
Organ System: Vascular disorders
Frequency: 14 affected / 390 at risk

Adverse event: Vascular Hypotensive Disorders
Serious: yes
Organ System: Vascular disorders
Frequency: 21 affected / 390 at risk

Adverse event: Anaemias Nec
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 76 affected / 390 at risk

Adverse event: Leukocytoses Nec
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 25 affected / 390 at risk

Adverse event: Thrombocytopenias
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 61 affected / 390 at risk

Adverse event: Cardiac Conduction Disorders
Serious: no
Organ System: Cardiac disorders
Frequency: 80 affected / 390 at risk

Adverse event: Heart Failures Nec
Serious: no
Organ System: Cardiac disorders
Frequency: 20 affected / 390 at risk

Adverse event: Rate And Rhythm Disorders Nec
Serious: no
Organ System: Cardiac disorders
Frequency: 21 affected / 390 at risk

Adverse event: Supraventricular Arrhythmias
Serious: no
Organ System: Cardiac disorders
Frequency: 59 affected / 390 at risk

Adverse event: Ventricular Arrhythmias And Cardiac Arrest
Serious: no
Organ System: Cardiac disorders
Frequency: 22 affected / 390 at risk

Adverse event: Gastrointestinal Atonic And Hypomotility Disorders Nec
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 22 affected / 390 at risk

Adverse event: Nausea And Vomiting Symptoms
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 23 affected / 390 at risk

Adverse event: Febrile Disorders
Serious: no
Organ System: General disorders
Frequency: 16 affected / 390 at risk

Adverse event: Oedema Nec
Serious: no
Organ System: General disorders
Frequency: 34 affected / 390 at risk

Adverse event: Pain And Discomfort Nec
Serious: no
Organ System: General disorders
Frequency: 26 affected / 390 at risk

Adverse event: Lower Respiratory Tract And Lung Infections
Serious: no
Organ System: Infections and infestations
Frequency: 18 affected / 390 at risk

Adverse event: Urinary Tract Infections
Serious: no
Organ System: Infections and infestations
Frequency: 51 affected / 390 at risk

Adverse event: Non-Site Specific Injuries Nec
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 21 affected / 390 at risk

Adverse event: Non-Site Specific Procedural Complications
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 20 affected / 390 at risk

Adverse event: Skeletal And Cardiac Muscle Analyses
Serious: no
Organ System: Investigations
Frequency: 15 affected / 390 at risk

Adverse event: Hyperglycaemic Conditions Nec
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 19 affected / 390 at risk

Adverse event: Magnesium Metabolism Disorders
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 390 at risk

Adverse event: Potassium Imbalance
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 36 affected / 390 at risk

Adverse event: Sodium Imbalance
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 22 affected / 390 at risk

Adverse event: Total Fluid Volume Increased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 21 affected / 390 at risk

Adverse event: Musculoskeletal And Connective Tissue Pain And Discomfort
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 34 affected / 390 at risk

Adverse event: Neurological Signs And Symptoms Nec
Serious: no
Organ System: Nervous system disorders
Frequency: 21 affected / 390 at risk

Adverse event: Anxiety Symptoms
Serious: no
Organ System: Psychiatric disorders
Frequency: 14 affected / 390 at risk

Adverse event: Confusion And Disorientation
Serious: no
Organ System: Psychiatric disorders
Frequency: 24 affected / 390 at risk

Adverse event: Renal Failure And Impairment
Serious: no
Organ System: Renal and urinary disorders
Frequency: 40 affected / 390 at risk

Adverse event: Breathing Abnormalities
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 27 affected / 390 at risk

Adverse event: Bronchospasm And Obstruction
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 390 at risk

Adverse event: Conditions Associated With Abnormal Gas Exchange
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 390 at risk

Adverse event: Parenchymal Lung Disorders Nec
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 23 affected / 390 at risk

Adverse event: Pneumothorax And Pleural Effusions Nec
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 52 affected / 390 at risk

Adverse event: Pulmonary Oedemas
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 20 affected / 390 at risk

Adverse event: Haemorrhages Nec
Serious: no
Organ System: Vascular disorders
Frequency: 26 affected / 390 at risk

Adverse event: Vascular Hypertensive Disorders Nec
Serious: no
Organ System: Vascular disorders
Frequency: 46 affected / 390 at risk

Adverse event: Vascular Hypotensive Disorders
Serious: no
Organ System: Vascular disorders
Frequency: 40 affected / 390 at risk

Adverse event: Anaemias Nec
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 151 affected / 357 at risk

Adverse event: Coagulopathies
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 357 at risk

Adverse event: Eosinophilic Disorders
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 357 at risk

Adverse event: Haematological Disorders
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 357 at risk

Adverse event: Leukocytoses Nec
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 357 at risk

Adverse event: Marrow Depression And Hypoplastic Anaemias
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 357 at risk

Adverse event: Thrombocytopenias
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 22 affected / 357 at risk

Adverse event: Aortic Valvular Disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 10 affected / 357 at risk

Adverse event: Cardiac Conduction Disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 18 affected / 357 at risk

Adverse event: Cardiac Disorders Nec
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 357 at risk

Adverse event: Cardiac Signs And Symptoms Nec
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 357 at risk

Adverse event: Cardiomyopathies
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 357 at risk

Adverse event: Coronary Artery Disorders Nec
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 357 at risk

Adverse event: Heart Failures Nec
Serious: yes
Organ System: Cardiac disorders
Frequency: 62 affected / 357 at risk

Adverse event: Ischaemic Coronary Artery Disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 12 affected / 357 at risk

Adverse event: Mitral Valvular Disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 357 at risk

Adverse event: Myocardial Disorders Nec
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 357 at risk

Adverse event: Noninfectious Pericarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 357 at risk

Adverse event: Pericardial Disorders Nec
Serious: yes
Organ System: Cardiac disorders
Frequency: 10 affected / 357 at risk

Adverse event: Rate And Rhythm Disorders Nec
Serious: yes
Organ System: Cardiac disorders
Frequency: 19 affected / 357 at risk

Adverse event: Right Ventricular Failures
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 357 at risk

Adverse event: Supraventricular Arrhythmias
Serious: yes
Organ System: Cardiac disorders
Frequency: 69 affected / 357 at risk

Adverse event: Tricuspid Valvular Disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 357 at risk

Adverse event: Ventricular Arrhythmias And Cardiac Arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 27 affected / 357 at risk

Adverse event: Cardiac Septal Defects Congenital
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 357 at risk

Adverse event: Coagulation Disorders Congenital
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 357 at risk

Adverse event: Male Reproductive Tract Disorders Congenital
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 357 at risk

Adverse event: Ear Disorders Nec
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 357 at risk

Adverse event: Cataract Conditions
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 357 at risk

Adverse event: Retinal Bleeding And Vascular Disorders (Excl Retinopathy)
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 357 at risk

Adverse event: Visual Disorders Nec
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 357 at risk

Adverse event: Acute And Chronic Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 357 at risk

Adverse event: Colitis (Excl Infective)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 357 at risk

Adverse event: Diarrhoea (Excl Infective)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 357 at risk

Adverse event: Diverticula
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 357 at risk

Adverse event: Duodenal And Small Intestinal Stenosis And Obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 357 at risk

Adverse event: Duodenal Ulcers And Perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 357 at risk

Adverse event: Dyspeptic Signs And Symptoms
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 357 at risk

Adverse event: Faecal Abnormalities Nec
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 357 at risk

Adverse event: Flatulence, Bloating And Distension
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 357 at risk

Adverse event: Gastric And Oesophageal Haemorrhages
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 357 at risk

Adverse event: Gastric Ulcers And Perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 357 at risk

Adverse event: Gastritis (Excl Infective)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 357 at risk

Adverse event: Gastrointestinal And Abdominal Pains (Excl Oral And Throat)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 357 at risk

Adverse event: Gastrointestinal Atonic And Hypomotility Disorders Nec
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 357 at risk

Adverse event: Gastrointestinal Necrosis And Gangrene (Excl Gangrenous Hernia)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 357 at risk

Adverse event: Gastrointestinal Signs And Symptoms Nec
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 357 at risk

Adverse event: Gastrointestinal Stenosis And Obstruction Nec
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 357 at risk

Adverse event: Gastrointestinal Vascular Occlusion And Infarction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 357 at risk

Adverse event: Inguinal Hernias
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 357 at risk

Adverse event: Intestinal Haemorrhages
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 357 at risk

Adverse event: Nausea And Vomiting Symptoms
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 357 at risk

Adverse event: Non-Site Specific Gastrointestinal Haemorrhages
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 357 at risk

Adverse event: Oesophageal Stenosis And Obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 357 at risk

Adverse event: Oesophageal Ulcers And Perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 357 at risk

Adverse event: Peritoneal And Retroperitoneal Disorders
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 357 at risk

Adverse event: Peritoneal And Retroperitoneal Haemorrhages
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 357 at risk

Adverse event: Asthenic Conditions
Serious: yes
Organ System: General disorders
Frequency: 9 affected / 357 at risk

Adverse event: Death And Sudden Death
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 357 at risk

Adverse event: Device Issues Nec
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 357 at risk

Adverse event: Device Malfunction Events Nec
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 357 at risk

Adverse event: Febrile Disorders
Serious: yes
Organ System: General disorders
Frequency: 6 affected / 357 at risk

Adverse event: General Signs And Symptoms Nec
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 357 at risk

Adverse event: Injection Site Reactions
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 357 at risk

Adverse event: Oedema Nec
Serious: yes
Organ System: General disorders
Frequency: 6 affected / 357 at risk

Adverse event: Pain And Discomfort Nec
Serious: yes
Organ System: General disorders
Frequency: 19 affected / 357 at risk

Adverse event: Cholecystitis And Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 357 at risk

Adverse event: Hepatic And Hepatobiliary Disorders Nec
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 357 at risk

Adverse event: Hepatic Failure And Associated Disorders
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 3 affected / 357 at risk

Adverse event: Hepatocellular Damage And Hepatitis Nec
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 357 at risk

Adverse event: Abdominal And Gastrointestinal Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 357 at risk

Adverse event: Bacterial Infections Nec
Serious: yes
Organ System: Infections and infestations
Frequency: 12 affected / 357 at risk

Adverse event: Bone And Joint Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 357 at risk

Adverse event: Cardiac Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 357 at risk

Adverse event: Central Nervous System And Spinal Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 357 at risk

Adverse event: Clostridia Infections
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 357 at risk

Adverse event: Enterobacter Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 357 at risk

Adverse event: Enterococcal Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 357 at risk

Adverse event: Escherichia Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 357 at risk

Adverse event: Fungal Infections Nec
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 357 at risk

Adverse event: Infections Nec
Serious: yes
Organ System: Infections and infestations
Frequency: 8 affected / 357 at risk

Adverse event: Lower Respiratory Tract And Lung Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 36 affected / 357 at risk

Adverse event: Pseudomonal Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 357 at risk

Adverse event: Sepsis, Bacteraemia, Viraemia And Fungaemia Nec
Serious: yes
Organ System: Infections and infestations
Frequency: 29 affected / 357 at risk

Adverse event: Staphylococcal Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 357 at risk

Adverse event: Urinary Tract Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 20 affected / 357 at risk

Adverse event: Viral Infections Nec
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 357 at risk

Adverse event: Cardiac And Vascular Procedural Complications
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 357 at risk

Adverse event: Cardiovascular Injuries
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 357 at risk

Adverse event: Cerebral Injuries Nec
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 357 at risk

Adverse event: Chest And Lung Injuries Nec
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 357 at risk

Adverse event: Fractures And Dislocations Nec
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 357 at risk

Adverse event: Gastrointestinal And Hepatobiliary Procedural Complications
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 357 at risk

Adverse event: Limb Injuries Nec (Incl Traumatic Amputation)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 357 at risk

Adverse event: Lower Limb Fractures And Dislocations
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 10 affected / 357 at risk

Adverse event: Non-Site Specific Injuries Nec
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 6 affected / 357 at risk

Adverse event: Non-Site Specific Procedural Complications
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 28 affected / 357 at risk

Adverse event: Pelvic Fractures And Dislocations
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 357 at risk

Adverse event: Poisoning And Toxicity
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 357 at risk

Adverse event: Radiation Injuries
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 357 at risk

Adverse event: Respiratory Tract And Thoracic Cavity Procedural Complications
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 357 at risk

Adverse event: Site Specific Injuries Nec
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 357 at risk

Adverse event: Skin Injuries Nec
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 5 affected / 357 at risk

Adverse event: Spinal Fractures And Dislocations
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 357 at risk

Adverse event: Thoracic Cage Fractures And Dislocations
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 357 at risk

Adverse event: Transfusion Related Complications
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 357 at risk

Adverse event: Upper Limb Fractures And Dislocations
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 5 affected / 357 at risk

Adverse event: Bacteria Identification And Serology (Excl Mycobacteria)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 357 at risk

Adverse event: Cardiac Function Diagnostic Procedures
Serious: yes
Organ System: Investigations
Frequency: 6 affected / 357 at risk

Adverse event: Coagulation And Bleeding Analyses
Serious: yes
Organ System: Investigations
Frequency: 6 affected / 357 at risk

Adverse event: Liver Function Analyses
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 357 at risk

Adverse event: Metabolism Tests Nec
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 357 at risk

Adverse event: Mineral And Electrolyte Analyses
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 357 at risk

Adverse event: Physical Examination Procedures
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 357 at risk

Adverse event: Platelet Analyses
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 357 at risk

Adverse event: Red Blood Cell Analyses
Serious: yes
Organ System: Investigations
Frequency: 11 affected / 357 at risk

Adverse event: Renal Function Analyses
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 357 at risk

Adverse event: Respiratory Tract And Thoracic Imaging Procedures
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 357 at risk

Adverse event: Skeletal And Cardiac Muscle Analyses
Serious: yes
Organ System: Investigations
Frequency: 5 affected / 357 at risk

Adverse event: Urinary Tract Function Analyses Nec
Serious: yes
Organ System: Investigations
Frequency: 3 affected / 357 at risk

Adverse event: Appetite Disorders
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 357 at risk

Adverse event: Calcium Metabolism Disorders
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 357 at risk

Adverse event: Diabetes Mellitus (Incl Subtypes)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 357 at risk

Adverse event: Diabetic Complications Nec
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 357 at risk

Adverse event: Electrolyte Imbalance Nec
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 357 at risk

Adverse event: General Nutritional Disorders Nec
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 15 affected / 357 at risk

Adverse event: Hyperglycaemic Conditions Nec
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 357 at risk

Adverse event: Hypoglycaemic Conditions Nec
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 357 at risk

Adverse event: Metabolic Acidoses (Excl Diabetic Acidoses)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 357 at risk

Adverse event: Metabolic Alkaloses
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 357 at risk

Adverse event: Potassium Imbalance
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 357 at risk

Adverse event: Sodium Imbalance
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 357 at risk

Adverse event: Total Fluid Volume Decreased
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 14 affected / 357 at risk

Adverse event: Total Fluid Volume Increased
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 11 affected / 357 at risk

Adverse event: Arthropathies Nec
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 357 at risk

Adverse event: Joint Related Signs And Symptoms
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 357 at risk

Adverse event: Muscle Weakness Conditions
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 357 at risk

Adverse event: Musculoskeletal And Connective Tissue Pain And Discomfort
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 357 at risk

Adverse event: Musculoskeletal And Connective Tissue Signs And Symptoms Nec
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 357 at risk

Adverse event: Myopathies
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 357 at risk

Adverse event: Osteoarthropathies
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 357 at risk

Adverse event: Bladder Neoplasms Malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 357 at risk

Adverse event: Colonic Neoplasms Malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 357 at risk

Adverse event: Hepatic Neoplasms Malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 357 at risk

Adverse event: Leukaemias Acute Myeloid
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 357 at risk

Adverse event: Multiple Myelomas
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 357 at risk

Adverse event: Neoplasms Malignant Site Unspecified Nec
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 357 at risk

Adverse event: Neuromas
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 357 at risk

Adverse event: Prostatic Neoplasms Malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 357 at risk

Adverse event: Skin Neoplasms Malignant And Unspecified (Excl Melanoma)
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 357 at risk

Adverse event: Thyroid Neoplasms Malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 357 at risk

Adverse event: Acute Polyneuropathies
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 357 at risk

Adverse event: Central Nervous System Haemorrhages And Cerebrovascular Accidents
Serious: yes
Organ System: Nervous system disorders
Frequency: 32 affected / 357 at risk

Adverse event: Cerebellar Coordination And Balance Disturbances
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 357 at risk

Adverse event: Coma States
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 357 at risk

Adverse event: Disturbances In Consciousness Nec
Serious: yes
Organ System: Nervous system disorders
Frequency: 7 affected / 357 at risk

Adverse event: Encephalopathies Nec
Serious: yes
Organ System: Nervous system disorders
Frequency: 5 affected / 357 at risk

Adverse event: Encephalopathies Toxic And Metabolic
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 357 at risk

Adverse event: Increased Intracranial Pressure Disorders
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 357 at risk

Adverse event: Lumbar Spinal Cord And Nerve Root Disorders
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 357 at risk

Adverse event: Memory Loss (Excl Dementia)
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 357 at risk

Adverse event: Mononeuropathies
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 357 at risk

Adverse event: Neurological Signs And Symptoms Nec
Serious: yes
Organ System: Nervous system disorders
Frequency: 11 affected / 357 at risk

Adverse event: Neuromuscular Junction Dysfunction
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 357 at risk

Adverse event: Paralysis And Paresis (Excl Cranial Nerve)
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 357 at risk

Adverse event: Seizures And Seizure Disorders Nec
Serious: yes
Organ System: Nervous system disorders
Frequency: 10 affected / 357 at risk

Adverse event: Speech And Language Abnormalities
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 357 at risk

Adverse event: Transient Cerebrovascular Events
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 357 at risk

Adverse event: Vagus Nerve Disorders
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 357 at risk

Adverse event: Behaviour And Socialisation Disturbances
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 357 at risk

Adverse event: Confusion And Disorientation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 4 affected / 357 at risk

Adverse event: Deliria
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 357 at risk

Adverse event: Depressive Disorders
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 357 at risk

Adverse event: Mental Disorders Nec
Serious: yes
Organ System: Psychiatric disorders
Frequency: 14 affected / 357 at risk

Adverse event: Bladder And Urethral Symptoms
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 9 affected / 357 at risk

Adverse event: Bladder Disorders Nec
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 357 at risk

Adverse event: Nephropathies And Tubular Disorders Nec
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 357 at risk

Adverse event: Renal Disorders Nec
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 357 at risk

Adverse event: Renal Failure And Impairment
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 58 affected / 357 at risk

Adverse event: Renal Obstructive Disorders
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 357 at risk

Adverse event: Renal Vascular And Ischaemic Conditions
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 357 at risk

Adverse event: Urinary Abnormalities
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 6 affected / 357 at risk

Adverse event: Breathing Abnormalities
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 26 affected / 357 at risk

Adverse event: Bronchospasm And Obstruction
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 357 at risk

Adverse event: Conditions Associated With Abnormal Gas Exchange
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 357 at risk

Adverse event: Lower Respiratory Tract Inflammatory And Immunologic Conditions
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 357 at risk

Adverse event: Mediastinal Disorders
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 357 at risk

Adverse event: Nasal Disorders Nec
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 357 at risk

Adverse event: Parenchymal Lung Disorders Nec
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 357 at risk

Adverse event: Pneumothorax And Pleural Effusions Nec
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 67 affected / 357 at risk

Adverse event: Pulmonary Oedemas
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 357 at risk

Adverse event: Respiratory Failures (Excl Neonatal)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 54 affected / 357 at risk

Adverse event: Respiratory Tract Disorders Nec
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 357 at risk

Adverse event: Dermal And Epidermal Conditions Nec
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 357 at risk

Adverse event: Dermatitis And Eczema
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 357 at risk

Adverse event: Skin And Subcutaneous Tissue Ulcerations
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 357 at risk

Adverse event: Skin Injuries And Mechanical Dermatoses
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 357 at risk

Adverse event: Skin Preneoplastic Conditions Nec
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 357 at risk

Adverse event: Hernia Repairs
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 357 at risk

Adverse event: Joint Therapeutic Procedures
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 357 at risk

Adverse event: Muscle Therapeutic Procedures
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 357 at risk

Adverse event: Prophylactic Procedures Nec
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 357 at risk

Adverse event: Therapeutic Procedures Nec
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 357 at risk

Adverse event: Tracheal Therapeutic Procedures
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 357 at risk

Adverse event: Ureteric Therapeutic Procedures
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 357 at risk

Adverse event: Accelerated And Malignant Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 357 at risk

Adverse event: Aortic Aneurysms And Dissections
Serious: yes
Organ System: Vascular disorders
Frequency: 5 affected / 357 at risk

Adverse event: Aortic Necrosis And Vascular Insufficiency
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 357 at risk

Adverse event: Blood Pressure Disorders Nec
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 357 at risk

Adverse event: Circulatory Collapse And Shock
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 357 at risk

Adverse event: Haemorrhages Nec
Serious: yes
Organ System: Vascular disorders
Frequency: 10 affected / 357 at risk

Adverse event: Non-Site Specific Embolism And Thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 357 at risk

Adverse event: Non-Site Specific Necrosis And Vascular Insufficiency Nec
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 357 at risk

Adverse event: Peripheral Aneurysms And Dissections
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 357 at risk

Adverse event: Peripheral Embolism And Thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 5 affected / 357 at risk

Adverse event: Peripheral Vasoconstriction, Necrosis And Vascular Insufficiency
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 357 at risk

Adverse event: Site Specific Vascular Disorders Nec
Serious: yes
Organ System: Vascular disorders
Frequency: 6 affected / 357 at risk

Adverse event: Vascular Hypertensive Disorders Nec
Serious: yes
Organ System: Vascular disorders
Frequency: 7 affected / 357 at risk

Adverse event: Vascular Hypotensive Disorders
Serious: yes
Organ System: Vascular disorders
Frequency: 38 affected / 357 at risk

Adverse event: Anaemias Nec
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 69 affected / 357 at risk

Adverse event: Leukocytoses Nec
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 46 affected / 357 at risk

Adverse event: Thrombocytopenias
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 90 affected / 357 at risk

Adverse event: Cardiac Conduction Disorders
Serious: no
Organ System: Cardiac disorders
Frequency: 54 affected / 357 at risk

Adverse event: Heart Failures Nec
Serious: no
Organ System: Cardiac disorders
Frequency: 21 affected / 357 at risk

Adverse event: Rate And Rhythm Disorders Nec
Serious: no
Organ System: Cardiac disorders
Frequency: 30 affected / 357 at risk

Adverse event: Supraventricular Arrhythmias
Serious: no
Organ System: Cardiac disorders
Frequency: 80 affected / 357 at risk

Adverse event: Ventricular Arrhythmias And Cardiac Arrest
Serious: no
Organ System: Cardiac disorders
Frequency: 9 affected / 357 at risk

Adverse event: Gastrointestinal Atonic And Hypomotility Disorders Nec
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 24 affected / 357 at risk

Adverse event: Nausea And Vomiting Symptoms
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 357 at risk

Adverse event: Febrile Disorders
Serious: no
Organ System: General disorders
Frequency: 16 affected / 357 at risk

Adverse event: Oedema Nec
Serious: no
Organ System: General disorders
Frequency: 26 affected / 357 at risk

Adverse event: Pain And Discomfort Nec
Serious: no
Organ System: General disorders
Frequency: 30 affected / 357 at risk

Adverse event: Lower Respiratory Tract And Lung Infections
Serious: no
Organ System: Infections and infestations
Frequency: 21 affected / 357 at risk

Adverse event: Urinary Tract Infections
Serious: no
Organ System: Infections and infestations
Frequency: 58 affected / 357 at risk

Adverse event: Non-Site Specific Injuries Nec
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 11 affected / 357 at risk

Adverse event: Non-Site Specific Procedural Complications
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 29 affected / 357 at risk

Adverse event: Skeletal And Cardiac Muscle Analyses
Serious: no
Organ System: Investigations
Frequency: 19 affected / 357 at risk

Adverse event: Hyperglycaemic Conditions Nec
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 29 affected / 357 at risk

Adverse event: Magnesium Metabolism Disorders
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 9 affected / 357 at risk

Adverse event: Potassium Imbalance
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 33 affected / 357 at risk

Adverse event: Sodium Imbalance
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 28 affected / 357 at risk

Adverse event: Total Fluid Volume Increased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 41 affected / 357 at risk

Adverse event: Musculoskeletal And Connective Tissue Pain And Discomfort
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 22 affected / 357 at risk

Adverse event: Neurological Signs And Symptoms Nec
Serious: no
Organ System: Nervous system disorders
Frequency: 17 affected / 357 at risk

Adverse event: Anxiety Symptoms
Serious: no
Organ System: Psychiatric disorders
Frequency: 14 affected / 357 at risk

Adverse event: Confusion And Disorientation
Serious: no
Organ System: Psychiatric disorders
Frequency: 23 affected / 357 at risk

Adverse event: Renal Failure And Impairment
Serious: no
Organ System: Renal and urinary disorders
Frequency: 44 affected / 357 at risk

Adverse event: Breathing Abnormalities
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 14 affected / 357 at risk

Adverse event: Bronchospasm And Obstruction
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 357 at risk

Adverse event: Conditions Associated With Abnormal Gas Exchange
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 357 at risk

Adverse event: Parenchymal Lung Disorders Nec
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 41 affected / 357 at risk

Adverse event: Pneumothorax And Pleural Effusions Nec
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 91 affected / 357 at risk

Adverse event: Pulmonary Oedemas
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 26 affected / 357 at risk

Adverse event: Haemorrhages Nec
Serious: no
Organ System: Vascular disorders
Frequency: 9 affected / 357 at risk

Adverse event: Vascular Hypertensive Disorders Nec
Serious: no
Organ System: Vascular disorders
Frequency: 37 affected / 357 at risk

Adverse event: Vascular Hypotensive Disorders
Serious: no
Organ System: Vascular disorders
Frequency: 40 affected / 357 at risk