Study: NCT01531374

Adverse event: Anaemia Deficiencies
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 1257 at risk

Adverse event: Anaemias Due To Chronic Disorders
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 1257 at risk

Adverse event: Anaemias
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 340 affected / 1257 at risk

Adverse event: Coagulopathies
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 9 affected / 1257 at risk

Adverse event: Leukocytoses
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 9 affected / 1257 at risk

Adverse event: Marrow Depression And Hypoplastic Anaemias
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 1257 at risk

Adverse event: Spleen Disorders
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 1257 at risk

Adverse event: Thrombocytopenias
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 34 affected / 1257 at risk

Adverse event: Aortic Valvular Disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 143 affected / 1257 at risk

Adverse event: Cardiac Conduction Disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 293 affected / 1257 at risk

Adverse event: Cardiac Disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 13 affected / 1257 at risk

Adverse event: Cardiac Signs And Symptoms
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1257 at risk

Adverse event: Cardiac Valve Disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1257 at risk

Adverse event: Cardiomyopathies
Serious: yes
Organ System: Cardiac disorders
Frequency: 16 affected / 1257 at risk

Adverse event: Coronary Artery Disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 26 affected / 1257 at risk

Adverse event: Heart Failures
Serious: yes
Organ System: Cardiac disorders
Frequency: 329 affected / 1257 at risk

Adverse event: Ischaemic Coronary Artery Disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 91 affected / 1257 at risk

Adverse event: Left Ventricular Failures
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1257 at risk

Adverse event: Mitral Valvular Disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 36 affected / 1257 at risk

Adverse event: Myocardial Disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 1257 at risk

Adverse event: Pericardial Disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 22 affected / 1257 at risk

Adverse event: Pulmonary Valvular Disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1257 at risk

Adverse event: Rate And Rhythm Disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 75 affected / 1257 at risk

Adverse event: Right Ventricular Failures
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 1257 at risk

Adverse event: Supraventricular Arrhythmias
Serious: yes
Organ System: Cardiac disorders
Frequency: 152 affected / 1257 at risk

Adverse event: Tricuspid Valvular Disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 11 affected / 1257 at risk

Adverse event: Ventricular Arrhythmias And Cardiac Arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 139 affected / 1257 at risk

Adverse event: Cardiac Malpositions Congenital
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 1257 at risk

Adverse event: Cardiac Septal Defects Congenital
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 2 affected / 1257 at risk

Adverse event: Cardiovascular Disorders Congenital
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 1257 at risk

Adverse event: Vascular Anomalies Congenital
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 2 affected / 1257 at risk

Adverse event: Eustachian Tube Disorders
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 1257 at risk

Adverse event: External Ear Disorders
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 1257 at risk

Adverse event: Inner Ear Signs And Symptoms
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 7 affected / 1257 at risk

Adverse event: Middle Ear Disorders
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 1257 at risk

Adverse event: Thyroid Hypofunction Disorders
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 1257 at risk

Adverse event: Cataract Conditions
Serious: yes
Organ System: Eye disorders
Frequency: 5 affected / 1257 at risk

Adverse event: Retinal Bleeding And Vascular Disorders (Excl Retinopathy)
Serious: yes
Organ System: Eye disorders
Frequency: 3 affected / 1257 at risk

Adverse event: Retinal Structural Change, Deposit And Degeneration
Serious: yes
Organ System: Eye disorders
Frequency: 2 affected / 1257 at risk

Adverse event: Retinal, Choroid And Vitreous Infections And Inflammations
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 1257 at risk

Adverse event: Visual Disorders
Serious: yes
Organ System: Eye disorders
Frequency: 2 affected / 1257 at risk

Adverse event: Abdominal Hernias, Site Unspecified
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 1257 at risk

Adverse event: Abdominal Wall Conditions
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1257 at risk

Adverse event: Acute And Chronic Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1257 at risk

Adverse event: Anal And Rectal Pains
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1257 at risk

Adverse event: Benign Neoplasms Gastrointestinal (Excl Oral Cavity)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 1257 at risk

Adverse event: Colitis (Excl Infective)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 1257 at risk

Adverse event: Dental And Periodontal Infections And Inflammations
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 1257 at risk

Adverse event: Dental Disorders
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1257 at risk

Adverse event: Diaphragmatic Hernias
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 1257 at risk

Adverse event: Diarrhoea (Excl Infective)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 1257 at risk

Adverse event: Diverticula
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 1257 at risk

Adverse event: Duodenal And Small Intestinal Stenosis And Obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 1257 at risk

Adverse event: Duodenal Ulcers And Perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 1257 at risk

Adverse event: Faecal Abnormalities
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 1257 at risk

Adverse event: Flatulence, Bloating And Distension
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 1257 at risk

Adverse event: Gastric And Oesophageal Haemorrhages
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 1257 at risk

Adverse event: Gastric Ulcers And Perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 1257 at risk

Adverse event: Gastritis (Excl Infective)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 1257 at risk

Adverse event: Gastrointestinal And Abdominal Pains (Excl Oral And Throat)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 1257 at risk

Adverse event: Gastrointestinal Atonic And Hypomotility Disorders
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 1257 at risk

Adverse event: Gastrointestinal Disorders
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1257 at risk

Adverse event: Gastrointestinal Dyskinetic Disorders
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1257 at risk

Adverse event: Gastrointestinal Fistulae
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1257 at risk

Adverse event: Gastrointestinal Inflammatory Disorders
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1257 at risk

Adverse event: Gastrointestinal Signs And Symptoms
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 35 affected / 1257 at risk

Adverse event: Gastrointestinal Stenosis And Obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 1257 at risk

Adverse event: Gastrointestinal Ulcers And Perforation, Site Unspecified
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 1257 at risk

Adverse event: Gastrointestinal Vascular Occlusion And Infarction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 1257 at risk

Adverse event: Gingival Disorders
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1257 at risk

Adverse event: Inguinal Hernias
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 1257 at risk

Adverse event: Intestinal Haemorrhages
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 1257 at risk

Adverse event: Intestinal Ulcers And Perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 1257 at risk

Adverse event: Large Intestinal Stenosis And Obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1257 at risk

Adverse event: Nausea And Vomiting Symptoms
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 1257 at risk

Adverse event: Non-Site Specific Gastrointestinal Haemorrhages
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 98 affected / 1257 at risk

Adverse event: Oesophageal Disorders
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1257 at risk

Adverse event: Oesophageal Stenosis And Obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 1257 at risk

Adverse event: Oesophageal Ulcers And Perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1257 at risk

Adverse event: Peritoneal And Retroperitoneal Disorders
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 1257 at risk

Adverse event: Peritoneal And Retroperitoneal Haemorrhages
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 1257 at risk

Adverse event: Umbilical Hernias
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1257 at risk

Adverse event: Administration Site Reactions
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 1257 at risk

Adverse event: Asthenic Conditions
Serious: yes
Organ System: General disorders
Frequency: 31 affected / 1257 at risk

Adverse event: Body Temperature Altered
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 1257 at risk

Adverse event: Complications Associated With Device
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 1257 at risk

Adverse event: Death And Sudden Death
Serious: yes
Organ System: General disorders
Frequency: 49 affected / 1257 at risk

Adverse event: Device Issues
Serious: yes
Organ System: General disorders
Frequency: 130 affected / 1257 at risk

Adverse event: Device Malfunction Events
Serious: yes
Organ System: General disorders
Frequency: 7 affected / 1257 at risk

Adverse event: Device Physical Property And Chemical Issues
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1257 at risk

Adverse event: Febrile Disorders
Serious: yes
Organ System: General disorders
Frequency: 24 affected / 1257 at risk

Adverse event: Gait Disturbances
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 1257 at risk

Adverse event: General Signs And Symptoms
Serious: yes
Organ System: General disorders
Frequency: 20 affected / 1257 at risk

Adverse event: Impaired healing
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 1257 at risk

Adverse event: Hernias
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1257 at risk

Adverse event: Implant And Catheter Site Reactions
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 1257 at risk

Adverse event: Inflammations
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 1257 at risk

Adverse event: Injection Site Reactions
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1257 at risk

Adverse event: Mucosal Findings Abnormal
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1257 at risk

Adverse event: Oedema
Serious: yes
Organ System: General disorders
Frequency: 31 affected / 1257 at risk

Adverse event: Pain And Discomfort
Serious: yes
Organ System: General disorders
Frequency: 67 affected / 1257 at risk

Adverse event: Product Physical Issues
Serious: yes
Organ System: General disorders
Frequency: 6 affected / 1257 at risk

Adverse event: Therapeutic And Nontherapeutic Responses
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1257 at risk

Adverse event: Vascular Complications Associated With Device
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1257 at risk

Adverse event: Bile Duct Infections And Inflammations
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 1257 at risk

Adverse event: Cholecystitis And Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 11 affected / 1257 at risk

Adverse event: Gallbladder Disorders
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 1257 at risk

Adverse event: Hepatic And Hepatobiliary Disorders
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 1257 at risk

Adverse event: Hepatic Failure And Associated Disorders
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 7 affected / 1257 at risk

Adverse event: Hepatic Fibrosis And Cirrhosis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 4 affected / 1257 at risk

Adverse event: Hepatic Vascular Disorders
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 1257 at risk

Adverse event: Hepatobiliary Signs And Symptoms
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 1257 at risk

Adverse event: Hepatocellular Damage And Hepatitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 4 affected / 1257 at risk

Adverse event: Obstructive Bile Duct Disorders (Excl Neoplasms)
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 4 affected / 1257 at risk

Adverse event: Allergic Conditions
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 1257 at risk

Adverse event: Abdominal And Gastrointestinal Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 14 affected / 1257 at risk

Adverse event: Aspergillus Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1257 at risk

Adverse event: Bacterial Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 54 affected / 1257 at risk

Adverse event: Bone And Joint Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 11 affected / 1257 at risk

Adverse event: Candida Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1257 at risk

Adverse event: Cardiac Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 15 affected / 1257 at risk

Adverse event: Clostridia Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 19 affected / 1257 at risk

Adverse event: Dental And Oral Soft Tissue Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1257 at risk

Adverse event: Ear Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1257 at risk

Adverse event: Enterococcal Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1257 at risk

Adverse event: Escherichia Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 1257 at risk

Adverse event: Helicobacter Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1257 at risk

Adverse event: Hepatobiliary And Spleen Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1257 at risk

Adverse event: Herpes Viral Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 1257 at risk

Adverse event: Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 28 affected / 1257 at risk

Adverse event: Infectious Disorders Carrier
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1257 at risk

Adverse event: Influenza Viral Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 14 affected / 1257 at risk

Adverse event: Lower Respiratory Tract And Lung Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 170 affected / 1257 at risk

Adverse event: Pseudomonal Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1257 at risk

Adverse event: Salmonella Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1257 at risk

Adverse event: Sepsis, Bacteraemia, Viraemia And Fungaemia
Serious: yes
Organ System: Infections and infestations
Frequency: 113 affected / 1257 at risk

Adverse event: Skin Structures And Soft Tissue Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1257 at risk

Adverse event: Staphylococcal Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 15 affected / 1257 at risk

Adverse event: Streptococcal Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1257 at risk

Adverse event: Upper Respiratory Tract Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 8 affected / 1257 at risk

Adverse event: Urinary Tract Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 112 affected / 1257 at risk

Adverse event: Viral Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 1257 at risk

Adverse event: Abdominal Injuries
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1257 at risk

Adverse event: Cardiac And Vascular Procedural Complications
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 37 affected / 1257 at risk

Adverse event: Cardiovascular Injuries
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 9 affected / 1257 at risk

Adverse event: Cerebral Injuries
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 16 affected / 1257 at risk

Adverse event: Chest And Lung Injuries
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 1257 at risk

Adverse event: Ear Injuries
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1257 at risk

Adverse event: Eye Injuries
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 1257 at risk

Adverse event: Fractures And Dislocations
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 7 affected / 1257 at risk

Adverse event: Gastrointestinal And Hepatobiliary Procedural Complications
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1257 at risk

Adverse event: Limb Injuries (Incl Traumatic Amputation)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 1257 at risk

Adverse event: Lower Limb Fractures And Dislocations
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 69 affected / 1257 at risk

Adverse event: Muscle, Tendon And Ligament Injuries
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1257 at risk

Adverse event: Neurological And Psychiatric Procedural Complications
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1257 at risk

Adverse event: Non-Site Specific Injuries
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 63 affected / 1257 at risk

Adverse event: Non-Site Specific Procedural Complications
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 78 affected / 1257 at risk

Adverse event: Overdoses
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1257 at risk

Adverse event: Pelvic Fractures And Dislocations
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 9 affected / 1257 at risk

Adverse event: Poisoning And Toxicity
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 1257 at risk

Adverse event: Respiratory Tract And Thoracic Cavity Procedural Complications
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1257 at risk

Adverse event: Site Specific Injuries
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 8 affected / 1257 at risk

Adverse event: Skin Injuries
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 21 affected / 1257 at risk

Adverse event: Skull Fractures, Facial Bone Fractures And Dislocations
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1257 at risk

Adverse event: Spinal Fractures And Dislocations
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 18 affected / 1257 at risk

Adverse event: Thermal Burns
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1257 at risk

Adverse event: Thoracic Cage Fractures And Dislocations
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 5 affected / 1257 at risk

Adverse event: Transfusion Related Complications
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 1257 at risk

Adverse event: Upper Limb Fractures And Dislocations
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 11 affected / 1257 at risk

Adverse event: Blood Counts
Serious: yes
Organ System: Investigations
Frequency: 7 affected / 1257 at risk

Adverse event: Blood Gas And Acid Base Analyses
Serious: yes
Organ System: Investigations
Frequency: 6 affected / 1257 at risk

Adverse event: Carbohydrate Tolerance Analyses (Incl Diabetes)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 1257 at risk

Adverse event: Cardiac Function Diagnostic Procedures
Serious: yes
Organ System: Investigations
Frequency: 16 affected / 1257 at risk

Adverse event: Coagulation And Bleeding Analyses
Serious: yes
Organ System: Investigations
Frequency: 22 affected / 1257 at risk

Adverse event: Ecg Investigations
Serious: yes
Organ System: Investigations
Frequency: 3 affected / 1257 at risk

Adverse event: Faecal Analyses
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 1257 at risk

Adverse event: Heart Rate And Pulse Investigations
Serious: yes
Organ System: Investigations
Frequency: 4 affected / 1257 at risk

Adverse event: Liver Function Analyses
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 1257 at risk

Adverse event: Mineral And Electrolyte Analyses
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 1257 at risk

Adverse event: Musculoskeletal And Soft Tissue Histopathology Procedures
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 1257 at risk

Adverse event: Physical Examination Procedures
Serious: yes
Organ System: Investigations
Frequency: 3 affected / 1257 at risk

Adverse event: Platelet Analyses
Serious: yes
Organ System: Investigations
Frequency: 3 affected / 1257 at risk

Adverse event: Protein Analyses
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 1257 at risk

Adverse event: Red Blood Cell Analyses
Serious: yes
Organ System: Investigations
Frequency: 11 affected / 1257 at risk

Adverse event: Renal Function Analyses
Serious: yes
Organ System: Investigations
Frequency: 10 affected / 1257 at risk

Adverse event: Respiratory And Pulmonary Function Diagnostic Procedures
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 1257 at risk

Adverse event: Respiratory Tract And Thoracic Imaging Procedures
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 1257 at risk

Adverse event: Skeletal And Cardiac Muscle Analyses
Serious: yes
Organ System: Investigations
Frequency: 9 affected / 1257 at risk

Adverse event: Urine analysis
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 1257 at risk

Adverse event: Urinary Tract Function Analyses
Serious: yes
Organ System: Investigations
Frequency: 5 affected / 1257 at risk

Adverse event: Vascular Auscultatory Investigations
Serious: yes
Organ System: Investigations
Frequency: 3 affected / 1257 at risk

Adverse event: Vascular Tests (Incl Blood Pressure)
Serious: yes
Organ System: Investigations
Frequency: 8 affected / 1257 at risk

Adverse event: White Blood Cell Analyses
Serious: yes
Organ System: Investigations
Frequency: 4 affected / 1257 at risk

Adverse event: Appetite Disorders
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 1257 at risk

Adverse event: Calcium Metabolism Disorders
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1257 at risk

Adverse event: Chloride Imbalance
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1257 at risk

Adverse event: Diabetes Mellitus (Incl Subtypes)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 1257 at risk

Adverse event: Diabetic Complications
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1257 at risk

Adverse event: Disorders Of Purine Metabolism
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 1257 at risk

Adverse event: Electrolyte imbalance
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 12 affected / 1257 at risk

Adverse event: General Nutritional Disorders
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 31 affected / 1257 at risk

Adverse event: Hyperglycaemic Conditions
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 18 affected / 1257 at risk

Adverse event: Hypoglycaemic Conditions
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 13 affected / 1257 at risk

Adverse event: Metabolic Acidoses (Excl Diabetic Acidoses)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 1257 at risk

Adverse event: Mixed Acid-Base Disorders
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1257 at risk

Adverse event: Phosphorus Metabolism Disorders
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 1257 at risk

Adverse event: Potassium Imbalance
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 34 affected / 1257 at risk

Adverse event: Protein Metabolism Disorders
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 1257 at risk

Adverse event: Sodium Imbalance
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 21 affected / 1257 at risk

Adverse event: Total Fluid Volume Decreased
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 37 affected / 1257 at risk

Adverse event: Total Fluid Volume Increased
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 35 affected / 1257 at risk

Adverse event: Arthropathies
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 1257 at risk

Adverse event: Bone Disorders
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 1257 at risk

Adverse event: Bursal Disorders
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1257 at risk

Adverse event: Connective Tissue Disorders (Excl Le)
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 1257 at risk

Adverse event: Crystal Arthropathic Disorders
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1257 at risk

Adverse event: Joint Related Disorders
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 1257 at risk

Adverse event: Joint Related Signs And Symptoms
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 10 affected / 1257 at risk

Adverse event: Muscle Infections And Inflammations
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1257 at risk

Adverse event: Muscle Related Signs And Symptoms
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1257 at risk

Adverse event: Muscle Weakness Conditions
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 1257 at risk

Adverse event: Musculoskeletal And Connective Tissue Pain And Discomfort
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 38 affected / 1257 at risk

Adverse event: Musculoskeletal And Connective Tissue Signs And Symptoms
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1257 at risk

Adverse event: Myopathies
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 1257 at risk

Adverse event: Osteoarthropathies
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 1257 at risk

Adverse event: Rheumatoid Arthropathies
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1257 at risk

Adverse event: Soft Tissue Disorders
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 1257 at risk

Adverse event: Spine And Neck Deformities
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1257 at risk

Adverse event: Tendon Disorders
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1257 at risk

Adverse event: B-Cell Lymphomas
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1257 at risk

Adverse event: Bladder Neoplasms Malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 5 affected / 1257 at risk

Adverse event: Bone Neoplasms Malignant (Excl Sarcomas)
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1257 at risk

Adverse event: Breast And Nipple Neoplasms Malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 5 affected / 1257 at risk

Adverse event: Cardiovascular Neoplasms Benign
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1257 at risk

Adverse event: Central Nervous System Neoplasms Malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1257 at risk

Adverse event: Colonic Neoplasms Malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 6 affected / 1257 at risk

Adverse event: Hepatic Neoplasms Malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1257 at risk

Adverse event: Leukaemias Chronic Lymphocytic
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1257 at risk

Adverse event: Lip And Oral Cavity Neoplasms Malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 1257 at risk

Adverse event: Multiple Myelomas
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1257 at risk

Adverse event: Myeloproliferative Disorders (Excl Leukaemias)
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1257 at risk

Adverse event: Neoplasms Malignant Site Unspecified
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 9 affected / 1257 at risk

Adverse event: Nervous System Neoplasms Unspecified Malignancy
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1257 at risk

Adverse event: Oesophageal Neoplasms Malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1257 at risk

Adverse event: Oncologic Complications And Emergencies
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1257 at risk

Adverse event: Prostatic Neoplasms Malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 4 affected / 1257 at risk

Adverse event: Rectal Neoplasms Malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 1257 at risk

Adverse event: Renal Neoplasms Malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 1257 at risk

Adverse event: Respiratory Tract And Pleural Neoplasms Malignant Cell Type Unspecified
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 6 affected / 1257 at risk

Adverse event: Skin Melanomas (Excl Ocular)
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1257 at risk

Adverse event: Skin Neoplasms Benign
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1257 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: 6 affected / 1257 at risk

Adverse event: Urinary Tract Neoplasms Malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1257 at risk

Adverse event: Uterine Neoplasms Benign
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1257 at risk

Adverse event: Uterine Neoplasms Malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1257 at risk

Adverse event: Vulval Neoplasms Malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1257 at risk

Adverse event: Acute Polyneuropathies
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1257 at risk

Adverse event: Alzheimer's Disease (Incl Subtypes)
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1257 at risk

Adverse event: Autonomic Nervous System Disorders
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1257 at risk

Adverse event: Central Nervous System Aneurysms
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1257 at risk

Adverse event: Central Nervous System Haemorrhages And Cerebrovascular Accidents
Serious: yes
Organ System: Nervous system disorders
Frequency: 98 affected / 1257 at risk

Adverse event: Central Nervous System Vascular Disorders
Serious: yes
Organ System: Nervous system disorders
Frequency: 10 affected / 1257 at risk

Adverse event: Cerebellar Coordination And Balance Disturbances
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 1257 at risk

Adverse event: Cortical Dysfunction
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1257 at risk

Adverse event: Dementia (Excl Alzheimer's Type)
Serious: yes
Organ System: Nervous system disorders
Frequency: 5 affected / 1257 at risk

Adverse event: Disturbances In Consciousness
Serious: yes
Organ System: Nervous system disorders
Frequency: 42 affected / 1257 at risk

Adverse event: Dyskinesias And Movement Disorders
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1257 at risk

Adverse event: Encephalopathies
Serious: yes
Organ System: Nervous system disorders
Frequency: 27 affected / 1257 at risk

Adverse event: Encephalopathies Toxic And Metabolic
Serious: yes
Organ System: Nervous system disorders
Frequency: 22 affected / 1257 at risk

Adverse event: Facial Cranial Nerve Disorders
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 1257 at risk

Adverse event: Headaches
Serious: yes
Organ System: Nervous system disorders
Frequency: 10 affected / 1257 at risk

Adverse event: Hydrocephalic Conditions
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1257 at risk

Adverse event: Lumbar Spinal Cord And Nerve Root Disorders
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 1257 at risk

Adverse event: Memory Loss (Excl Dementia)
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 1257 at risk

Adverse event: Mononeuropathies
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 1257 at risk

Adverse event: Multiple Sclerosis Acute And Progressive
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1257 at risk

Adverse event: Myelitis (Incl Infective)
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1257 at risk

Adverse event: Neurological Signs And Symptoms
Serious: yes
Organ System: Nervous system disorders
Frequency: 32 affected / 1257 at risk

Adverse event: Neuromuscular Junction Dysfunction
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1257 at risk

Adverse event: Paralysis And Paresis (Excl Cranial Nerve)
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1257 at risk

Adverse event: Parkinson's Disease And Parkinsonism
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 1257 at risk

Adverse event: Peripheral Neuropathies
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 1257 at risk

Adverse event: Seizures And Seizure Disorders
Serious: yes
Organ System: Nervous system disorders
Frequency: 12 affected / 1257 at risk

Adverse event: Sensory Abnormalities
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 1257 at risk

Adverse event: Speech And Language Abnormalities
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1257 at risk

Adverse event: Spinal Cord And Nerve Root Disorders
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1257 at risk

Adverse event: Structural Brain Disorders
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 1257 at risk

Adverse event: Transient Cerebrovascular Events
Serious: yes
Organ System: Nervous system disorders
Frequency: 30 affected / 1257 at risk

Adverse event: Vagus Nerve Disorders
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1257 at risk

Adverse event: Abnormal behaviour
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 1257 at risk

Adverse event: Anxiety Symptoms
Serious: yes
Organ System: Psychiatric disorders
Frequency: 8 affected / 1257 at risk

Adverse event: Confusion And Disorientation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 24 affected / 1257 at risk

Adverse event: Deliria
Serious: yes
Organ System: Psychiatric disorders
Frequency: 14 affected / 1257 at risk

Adverse event: Depressive Disorders
Serious: yes
Organ System: Psychiatric disorders
Frequency: 6 affected / 1257 at risk

Adverse event: Disturbances In Initiating And Maintaining Sleep
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 1257 at risk

Adverse event: Mental Disorders
Serious: yes
Organ System: Psychiatric disorders
Frequency: 56 affected / 1257 at risk

Adverse event: Perception Disturbances
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 1257 at risk

Adverse event: Psychotic disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 1257 at risk

Adverse event: Speech Articulation And Rhythm Disturbances
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 1257 at risk

Adverse event: Stress Disorders
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 1257 at risk

Adverse event: Substance-Related Disorders
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 1257 at risk

Adverse event: Suicidal And Self-Injurious Behaviour
Serious: yes
Organ System: Psychiatric disorders
Frequency: 3 affected / 1257 at risk

Adverse event: Bladder And Urethral Symptoms
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 51 affected / 1257 at risk

Adverse event: Genital And Urinary Tract Disorders
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1257 at risk

Adverse event: Myoneurogenic Bladder Disorders
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1257 at risk

Adverse event: Nephropathies And Tubular Disorders
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 1257 at risk

Adverse event: Renal Failure And Impairment
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 208 affected / 1257 at risk

Adverse event: Renal Failure Complications
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 1257 at risk

Adverse event: Renal Lithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 1257 at risk

Adverse event: Renal Obstructive Disorders
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 4 affected / 1257 at risk

Adverse event: Renal Vascular And Ischaemic Conditions
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 1257 at risk

Adverse event: Structural And Obstructive Urethral Disorders (Excl Congenital)
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1257 at risk

Adverse event: Ureteric Disorders
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1257 at risk

Adverse event: Urinary Abnormalities
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 29 affected / 1257 at risk

Adverse event: Breast Disorders
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 1257 at risk

Adverse event: Cervix Disorders
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1257 at risk

Adverse event: Ovarian And Fallopian Tube Cysts And Neoplasms
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1257 at risk

Adverse event: Penile And Scrotal Infections And Inflammations
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1257 at risk

Adverse event: Penile Disorders (Excl Erection And Ejaculation)
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 1257 at risk

Adverse event: Prostatic Neoplasms And Hypertrophy
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 4 affected / 1257 at risk

Adverse event: Prostatic Signs, Symptoms And Disorders
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 1257 at risk

Adverse event: Reproductive Tract Signs And Symptoms
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1257 at risk

Adverse event: Scrotal Disorders
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 3 affected / 1257 at risk

Adverse event: Vulvovaginal Disorders
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1257 at risk

Adverse event: Vulvovaginal Signs And Symptoms
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1257 at risk

Adverse event: Breathing Abnormalities
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 101 affected / 1257 at risk

Adverse event: Bronchial Conditions
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 1257 at risk

Adverse event: Bronchospasm And Obstruction
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 55 affected / 1257 at risk

Adverse event: Conditions Associated With Abnormal Gas Exchange
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 25 affected / 1257 at risk

Adverse event: Coughing And Associated Symptoms
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 18 affected / 1257 at risk

Adverse event: Laryngeal And Adjacent Sites Disorders (Excl Infections And Neoplasms)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 1257 at risk

Adverse event: Laryngeal Spasm, Oedema And Obstruction
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 1257 at risk

Adverse event: Lower Respiratory Tract Inflammatory And Immunologic Conditions
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 34 affected / 1257 at risk

Adverse event: Lower Respiratory Tract Signs And Symptoms
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 1257 at risk

Adverse event: Mediastinal Disorders
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 1257 at risk

Adverse event: Nasal Disorders
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 17 affected / 1257 at risk

Adverse event: Parenchymal Lung Disorders
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 13 affected / 1257 at risk

Adverse event: Pharyngeal Disorders (Excl Infections And Neoplasms)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 1257 at risk

Adverse event: Pleural Conditions
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1257 at risk

Adverse event: Pneumothorax And Pleural Effusions
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 106 affected / 1257 at risk

Adverse event: Pulmonary Hypertensions
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 1257 at risk

Adverse event: Pulmonary Oedemas
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 31 affected / 1257 at risk

Adverse event: Pulmonary Thrombotic And Embolic Conditions
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 1257 at risk

Adverse event: Respiratory Failures (Excl Neonatal)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 149 affected / 1257 at risk

Adverse event: Respiratory Tract Disorders
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 1257 at risk

Adverse event: Bullous Conditions
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1257 at risk

Adverse event: Dermal And Epidermal Conditions
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 1257 at risk

Adverse event: Erythemas
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 1257 at risk

Adverse event: Nail And Nail Bed Conditions (Excl Infections And Infestations)
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1257 at risk

Adverse event: Purpura And Related Conditions
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 1257 at risk

Adverse event: Rashes, Eruptions And Exanthems
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 1257 at risk

Adverse event: Skin And Subcutaneous Tissue Ulcerations
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 1257 at risk

Adverse event: Skin Injuries And Mechanical Dermatoses
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 1257 at risk

Adverse event: Skin Preneoplastic Conditions
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1257 at risk

Adverse event: Skin Vasomotor Conditions
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1257 at risk

Adverse event: Arterial Therapeutic Procedures (Excl Aortic)
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1257 at risk

Adverse event: Cardiac Device Therapeutic Procedures
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 8 affected / 1257 at risk

Adverse event: Joint Therapeutic Procedures
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 5 affected / 1257 at risk

Adverse event: Lens Therapeutic Procedures
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 1257 at risk

Adverse event: Prostatic Therapeutic Procedures
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1257 at risk

Adverse event: Therapeutic Bladder Catheterisation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1257 at risk

Adverse event: Therapeutic Procedures
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 20 affected / 1257 at risk

Adverse event: Tracheal Therapeutic Procedures
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1257 at risk

Adverse event: Accelerated And Malignant Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 13 affected / 1257 at risk

Adverse event: Aneurysms And Dissections Non-Site Specific
Serious: yes
Organ System: Vascular disorders
Frequency: 5 affected / 1257 at risk

Adverse event: Aortic Aneurysms And Dissections
Serious: yes
Organ System: Vascular disorders
Frequency: 8 affected / 1257 at risk

Adverse event: Aortic Necrosis And Vascular Insufficiency
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 1257 at risk

Adverse event: Arterial And Aortic Injuries
Serious: yes
Organ System: Vascular disorders
Frequency: 11 affected / 1257 at risk

Adverse event: Arterial Inflammations
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 1257 at risk

Adverse event: Blood Pressure Disorders
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 1257 at risk

Adverse event: Circulatory Collapse And Shock
Serious: yes
Organ System: Vascular disorders
Frequency: 7 affected / 1257 at risk

Adverse event: Haemorrhages
Serious: yes
Organ System: Vascular disorders
Frequency: 43 affected / 1257 at risk

Adverse event: Lymphangiopathies
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 1257 at risk

Adverse event: Lymphoedemas
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 1257 at risk

Adverse event: Non-Site Specific Embolism And Thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 9 affected / 1257 at risk

Adverse event: Non-Site Specific Necrosis And Vascular Insufficiency
Serious: yes
Organ System: Vascular disorders
Frequency: 6 affected / 1257 at risk

Adverse event: Non-Site Specific Vascular Disorders
Serious: yes
Organ System: Vascular disorders
Frequency: 16 affected / 1257 at risk

Adverse event: Peripheral Aneurysms And Dissections
Serious: yes
Organ System: Vascular disorders
Frequency: 24 affected / 1257 at risk

Adverse event: Peripheral Embolism And Thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 20 affected / 1257 at risk

Adverse event: Peripheral Vascular Disorders
Serious: yes
Organ System: Vascular disorders
Frequency: 5 affected / 1257 at risk

Adverse event: Peripheral Vasoconstriction, Necrosis And Vascular Insufficiency
Serious: yes
Organ System: Vascular disorders
Frequency: 35 affected / 1257 at risk

Adverse event: Site Specific Necrosis And Vascular Insufficiency
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 1257 at risk

Adverse event: Site Specific Vascular Disorders
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 1257 at risk

Adverse event: Vascular Hypertensive Disorders
Serious: yes
Organ System: Vascular disorders
Frequency: 54 affected / 1257 at risk

Adverse event: Vascular Hypotensive Disorders
Serious: yes
Organ System: Vascular disorders
Frequency: 137 affected / 1257 at risk

Adverse event: Vascular Malformations And Acquired Anomalies
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 1257 at risk

Adverse event: Anaemias
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 244 affected / 1257 at risk

Adverse event: Leukocytoses
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 82 affected / 1257 at risk

Adverse event: Thrombocytopenias
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 175 affected / 1257 at risk

Adverse event: Cardiac Conduction Disorders
Serious: no
Organ System: Cardiac disorders
Frequency: 286 affected / 1257 at risk

Adverse event: Heart Failures
Serious: no
Organ System: Cardiac disorders
Frequency: 96 affected / 1257 at risk

Adverse event: Rate And Rhythm Disorders
Serious: no
Organ System: Cardiac disorders
Frequency: 85 affected / 1257 at risk

Adverse event: Supraventricular Arrhythmias
Serious: no
Organ System: Cardiac disorders
Frequency: 153 affected / 1257 at risk

Adverse event: Ventricular Arrhythmias And Cardiac Arrest
Serious: no
Organ System: Cardiac disorders
Frequency: 64 affected / 1257 at risk

Adverse event: Gastrointestinal Atonic And Hypomotility Disorders
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 66 affected / 1257 at risk

Adverse event: Nausea And Vomiting Symptoms
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 57 affected / 1257 at risk

Adverse event: Asthenic Conditions
Serious: no
Organ System: General disorders
Frequency: 57 affected / 1257 at risk

Adverse event: Febrile Disorders
Serious: no
Organ System: General disorders
Frequency: 75 affected / 1257 at risk

Adverse event: Oedema
Serious: no
Organ System: General disorders
Frequency: 93 affected / 1257 at risk

Adverse event: Pain And Discomfort
Serious: no
Organ System: General disorders
Frequency: 72 affected / 1257 at risk

Adverse event: Lower Respiratory Tract And Lung Infections
Serious: no
Organ System: Infections and infestations
Frequency: 67 affected / 1257 at risk

Adverse event: Urinary Tract Infections
Serious: no
Organ System: Infections and infestations
Frequency: 149 affected / 1257 at risk

Adverse event: Non-Site Specific Injuries
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 86 affected / 1257 at risk

Adverse event: Non-Site Specific Procedural Complications
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 74 affected / 1257 at risk

Adverse event: Skeletal And Cardiac Muscle Analyses
Serious: no
Organ System: Investigations
Frequency: 52 affected / 1257 at risk

Adverse event: Hyperglycaemic Conditions
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 33 affected / 1257 at risk

Adverse event: Magnesium Metabolism Disorders
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 25 affected / 1257 at risk

Adverse event: Potassium Imbalance
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 84 affected / 1257 at risk

Adverse event: Sodium Imbalance
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 61 affected / 1257 at risk

Adverse event: Total Fluid Volume Increased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 85 affected / 1257 at risk

Adverse event: Musculoskeletal And Connective Tissue Pain And Discomfort
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 89 affected / 1257 at risk

Adverse event: Confusion And Disorientation
Serious: no
Organ System: Psychiatric disorders
Frequency: 57 affected / 1257 at risk

Adverse event: Bladder And Urethral Symptoms
Serious: no
Organ System: Renal and urinary disorders
Frequency: 35 affected / 1257 at risk

Adverse event: Renal Failure And Impairment
Serious: no
Organ System: Renal and urinary disorders
Frequency: 165 affected / 1257 at risk

Adverse event: Breathing Abnormalities
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 77 affected / 1257 at risk

Adverse event: Parenchymal Lung Disorders
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 72 affected / 1257 at risk

Adverse event: Pneumothorax And Pleural Effusions
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 138 affected / 1257 at risk

Adverse event: Pulmonary Oedemas
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 68 affected / 1257 at risk

Adverse event: Haemorrhages
Serious: no
Organ System: Vascular disorders
Frequency: 55 affected / 1257 at risk

Adverse event: Vascular Hypertensive Disorders
Serious: no
Organ System: Vascular disorders
Frequency: 146 affected / 1257 at risk

Adverse event: Vascular Hypotensive Disorders
Serious: no
Organ System: Vascular disorders
Frequency: 146 affected / 1257 at risk

Adverse event: Anaemia Deficiencies
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 367 at risk

Adverse event: Anaemias Due To Chronic Disorders
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 367 at risk

Adverse event: Anaemias
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 150 affected / 367 at risk

Adverse event: Coagulopathies
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 367 at risk

Adverse event: Haemolyses
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 367 at risk

Adverse event: Leukocytoses
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 367 at risk

Adverse event: Lymphatic System Disorders
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 367 at risk

Adverse event: Marrow Depression And Hypoplastic Anaemias
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 367 at risk

Adverse event: Thrombocytopenias
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 17 affected / 367 at risk

Adverse event: Aortic Valvular Disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 26 affected / 367 at risk

Adverse event: Cardiac Conduction Disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 63 affected / 367 at risk

Adverse event: Cardiac Disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 367 at risk

Adverse event: Cardiomyopathies
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 367 at risk

Adverse event: Coronary Artery Disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 367 at risk

Adverse event: Heart Failures
Serious: yes
Organ System: Cardiac disorders
Frequency: 105 affected / 367 at risk

Adverse event: Ischaemic Coronary Artery Disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 26 affected / 367 at risk

Adverse event: Mitral Valvular Disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 367 at risk

Adverse event: Myocardial Disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 367 at risk

Adverse event: Pericardial Disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 8 affected / 367 at risk

Adverse event: Rate And Rhythm Disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 20 affected / 367 at risk

Adverse event: Right Ventricular Failures
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 367 at risk

Adverse event: Supraventricular Arrhythmias
Serious: yes
Organ System: Cardiac disorders
Frequency: 47 affected / 367 at risk

Adverse event: Tricuspid Valvular Disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 367 at risk

Adverse event: Ventricular Arrhythmias And Cardiac Arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 43 affected / 367 at risk

Adverse event: Vascular Anomalies Congenital
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 367 at risk

Adverse event: Inner Ear Signs And Symptoms
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 3 affected / 367 at risk

Adverse event: Visual Disorders
Serious: yes
Organ System: Eye disorders
Frequency: 2 affected / 367 at risk

Adverse event: Abdominal Wall Conditions
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 367 at risk

Adverse event: Acute And Chronic Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 367 at risk

Adverse event: Colitis (Excl Infective)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 367 at risk

Adverse event: Dental Disorders
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 367 at risk

Adverse event: Diarrhoea (Excl Infective)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 367 at risk

Adverse event: Diverticula
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 367 at risk

Adverse event: Duodenal And Small Intestinal Stenosis And Obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 367 at risk

Adverse event: Gastric Ulcers And Perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 367 at risk

Adverse event: Gastritis (Excl Infective)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 367 at risk

Adverse event: Gastrointestinal And Abdominal Pains (Excl Oral And Throat)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 367 at risk

Adverse event: Gastrointestinal Disorders
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 367 at risk

Adverse event: Gastrointestinal Dyskinetic Disorders
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 367 at risk

Adverse event: Gastrointestinal Signs And Symptoms
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 367 at risk

Adverse event: Gastrointestinal Stenosis And Obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 367 at risk

Adverse event: Gastrointestinal Vascular Occlusion And Infarction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 367 at risk

Adverse event: Inguinal Hernias
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 367 at risk

Adverse event: Intestinal Haemorrhages
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 367 at risk

Adverse event: Nausea And Vomiting Symptoms
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 367 at risk

Adverse event: Non-Site Specific Gastrointestinal Haemorrhages
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 26 affected / 367 at risk

Adverse event: Oesophageal Ulcers And Perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 367 at risk

Adverse event: Peritoneal And Retroperitoneal Disorders
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 367 at risk

Adverse event: Peritoneal And Retroperitoneal Haemorrhages
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 367 at risk

Adverse event: Tongue Disorders
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 367 at risk

Adverse event: Umbilical Hernias
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 367 at risk

Adverse event: Asthenic Conditions
Serious: yes
Organ System: General disorders
Frequency: 8 affected / 367 at risk

Adverse event: Body Temperature Altered
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 367 at risk

Adverse event: Complications Associated With Device
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 367 at risk

Adverse event: Death And Sudden Death
Serious: yes
Organ System: General disorders
Frequency: 18 affected / 367 at risk

Adverse event: Device Issues
Serious: yes
Organ System: General disorders
Frequency: 17 affected / 367 at risk

Adverse event: Device Malfunction Events
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 367 at risk

Adverse event: Febrile Disorders
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 367 at risk

Adverse event: General Signs And Symptoms
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 367 at risk

Adverse event: Impaired healing
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 367 at risk

Adverse event: Implant And Catheter Site Reactions
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 367 at risk

Adverse event: Oedema
Serious: yes
Organ System: General disorders
Frequency: 7 affected / 367 at risk

Adverse event: Pain And Discomfort
Serious: yes
Organ System: General disorders
Frequency: 14 affected / 367 at risk

Adverse event: Therapeutic And Nontherapeutic Responses
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 367 at risk

Adverse event: Cholecystitis And Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 4 affected / 367 at risk

Adverse event: Cholestasis And Jaundice
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 367 at risk

Adverse event: Hepatic And Hepatobiliary Disorders
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 367 at risk

Adverse event: Hepatocellular Damage And Hepatitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 367 at risk

Adverse event: Obstructive Bile Duct Disorders (Excl Neoplasms)
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 3 affected / 367 at risk

Adverse event: Abdominal And Gastrointestinal Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 367 at risk

Adverse event: Atypical Mycobacterial Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 367 at risk

Adverse event: Bacterial Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 17 affected / 367 at risk

Adverse event: Bone And Joint Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 367 at risk

Adverse event: Candida Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 367 at risk

Adverse event: Cardiac Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 367 at risk

Adverse event: Clostridia Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 9 affected / 367 at risk

Adverse event: Dental And Oral Soft Tissue Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 367 at risk

Adverse event: Enterococcal Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 367 at risk

Adverse event: Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 8 affected / 367 at risk

Adverse event: Infectious Disorders Carrier
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 367 at risk

Adverse event: Influenza Viral Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 367 at risk

Adverse event: Klebsiella Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 367 at risk

Adverse event: Lower Respiratory Tract And Lung Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 61 affected / 367 at risk

Adverse event: Sepsis, Bacteraemia, Viraemia And Fungaemia
Serious: yes
Organ System: Infections and infestations
Frequency: 35 affected / 367 at risk

Adverse event: Staphylococcal Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 367 at risk

Adverse event: Streptococcal Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 367 at risk

Adverse event: Urinary Tract Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 25 affected / 367 at risk

Adverse event: Viral Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 367 at risk

Adverse event: Cardiac And Vascular Procedural Complications
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 7 affected / 367 at risk

Adverse event: Cardiovascular Injuries
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 367 at risk

Adverse event: Cerebral Injuries
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 367 at risk

Adverse event: Gastrointestinal And Hepatobiliary Procedural Complications
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 367 at risk

Adverse event: Limb Injuries (Incl Traumatic Amputation)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 367 at risk

Adverse event: Lower Limb Fractures And Dislocations
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 9 affected / 367 at risk

Adverse event: Nerve Injuries
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 367 at risk

Adverse event: Neurological And Psychiatric Procedural Complications
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 367 at risk

Adverse event: Non-Site Specific Injuries
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 16 affected / 367 at risk

Adverse event: Non-Site Specific Procedural Complications
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 25 affected / 367 at risk

Adverse event: Overdoses
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 367 at risk

Adverse event: Poisoning And Toxicity
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 367 at risk

Adverse event: Respiratory Tract And Thoracic Cavity Procedural Complications
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 367 at risk

Adverse event: Site Specific Injuries
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 367 at risk

Adverse event: Skin Injuries
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 6 affected / 367 at risk

Adverse event: Skull Fractures, Facial Bone Fractures And Dislocations
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 367 at risk

Adverse event: Spinal Fractures And Dislocations
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 367 at risk

Adverse event: Thoracic Cage Fractures And Dislocations
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 367 at risk

Adverse event: Upper Limb Fractures And Dislocations
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 367 at risk

Adverse event: Urinary Tract Procedural Complications
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 367 at risk

Adverse event: Blood Gas And Acid Base Analyses
Serious: yes
Organ System: Investigations
Frequency: 7 affected / 367 at risk

Adverse event: Carbohydrate Tolerance Analyses (Incl Diabetes)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 367 at risk

Adverse event: Cardiac Function Diagnostic Procedures
Serious: yes
Organ System: Investigations
Frequency: 4 affected / 367 at risk

Adverse event: Coagulation And Bleeding Analyses
Serious: yes
Organ System: Investigations
Frequency: 6 affected / 367 at risk

Adverse event: Ecg Investigations
Serious: yes
Organ System: Investigations
Frequency: 3 affected / 367 at risk

Adverse event: Faecal Analyses
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 367 at risk

Adverse event: Liver Function Analyses
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 367 at risk

Adverse event: Metabolism Tests
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 367 at risk

Adverse event: Physical Examination Procedures
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 367 at risk

Adverse event: Platelet Analyses
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 367 at risk

Adverse event: Red Blood Cell Analyses
Serious: yes
Organ System: Investigations
Frequency: 5 affected / 367 at risk

Adverse event: Renal Function Analyses
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 367 at risk

Adverse event: Skeletal And Cardiac Muscle Analyses
Serious: yes
Organ System: Investigations
Frequency: 3 affected / 367 at risk

Adverse event: Urinary Tract Function Analyses
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 367 at risk

Adverse event: Vascular Tests (Incl Blood Pressure)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 367 at risk

Adverse event: Appetite Disorders
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 367 at risk

Adverse event: Calcium Metabolism Disorders
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 367 at risk

Adverse event: Diabetes Mellitus (Incl Subtypes)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 367 at risk

Adverse event: Electrolyte imbalance
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 367 at risk

Adverse event: General Nutritional Disorders
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 12 affected / 367 at risk

Adverse event: Hyperglycaemic Conditions
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 367 at risk

Adverse event: Hypoglycaemic Conditions
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 9 affected / 367 at risk

Adverse event: Magnesium Metabolism Disorders
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 367 at risk

Adverse event: Metabolic Acidoses (Excl Diabetic Acidoses)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 367 at risk

Adverse event: Metabolic Alkaloses
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 367 at risk

Adverse event: Mixed Acid-Base Disorders
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 367 at risk

Adverse event: Potassium Imbalance
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 10 affected / 367 at risk

Adverse event: Sodium Imbalance
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 367 at risk

Adverse event: Total Fluid Volume Decreased
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 13 affected / 367 at risk

Adverse event: Total Fluid Volume Increased
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 10 affected / 367 at risk

Adverse event: Joint Related Signs And Symptoms
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 367 at risk

Adverse event: Muscle Weakness Conditions
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 367 at risk

Adverse event: Musculoskeletal And Connective Tissue Pain And Discomfort
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 367 at risk

Adverse event: Myopathies
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 367 at risk

Adverse event: Osteoarthropathies
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 367 at risk

Adverse event: Rheumatoid Arthropathies
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 367 at risk

Adverse event: Bile Duct Neoplasms Malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 367 at risk

Adverse event: Bladder Neoplasms Malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 367 at risk

Adverse event: Hepatic Neoplasms Malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 367 at risk

Adverse event: Leukaemias Chronic Lymphocytic
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 367 at risk

Adverse event: Myelodysplastic Syndromes
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 367 at risk

Adverse event: Neoplasms Malignant Site Unspecified
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 3 affected / 367 at risk

Adverse event: Nervous System Neoplasms Unspecified Malignancy
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 367 at risk

Adverse event: Non-Small Cell Neoplasms Malignant Of The Respiratory Tract Cell Type Specified
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 367 at risk

Adverse event: Oesophageal Neoplasms Malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 367 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 / 367 at risk

Adverse event: Prostatic Neoplasms Malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 367 at risk

Adverse event: Renal Neoplasms Malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 367 at risk

Adverse event: Respiratory Tract And Pleural Neoplasms Malignant Cell Type Unspecified
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 7 affected / 367 at risk

Adverse event: Skin Melanomas (Excl Ocular)
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 367 at risk

Adverse event: Alzheimer's Disease (Incl Subtypes)
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 367 at risk

Adverse event: Central Nervous System Aneurysms
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 367 at risk

Adverse event: Central Nervous System Haemorrhages And Cerebrovascular Accidents
Serious: yes
Organ System: Nervous system disorders
Frequency: 30 affected / 367 at risk

Adverse event: Central Nervous System Vascular Disorders
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 367 at risk

Adverse event: Coma States
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 367 at risk

Adverse event: Cortical Dysfunction
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 367 at risk

Adverse event: Disturbances In Consciousness
Serious: yes
Organ System: Nervous system disorders
Frequency: 13 affected / 367 at risk

Adverse event: Encephalopathies
Serious: yes
Organ System: Nervous system disorders
Frequency: 8 affected / 367 at risk

Adverse event: Encephalopathies Toxic And Metabolic
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 367 at risk

Adverse event: Headaches
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 367 at risk

Adverse event: Lumbar Spinal Cord And Nerve Root Disorders
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 367 at risk

Adverse event: Mononeuropathies
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 367 at risk

Adverse event: Motor Neurone Diseases
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 367 at risk

Adverse event: Nervous System Disorders
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 367 at risk

Adverse event: Neurological Signs And Symptoms
Serious: yes
Organ System: Nervous system disorders
Frequency: 6 affected / 367 at risk

Adverse event: Paralysis And Paresis (Excl Cranial Nerve)
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 367 at risk

Adverse event: Seizures And Seizure Disorders
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 367 at risk

Adverse event: Spinal Cord And Nerve Root Disorders
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 367 at risk

Adverse event: Transient Cerebrovascular Events
Serious: yes
Organ System: Nervous system disorders
Frequency: 5 affected / 367 at risk

Adverse event: Anxiety Symptoms
Serious: yes
Organ System: Psychiatric disorders
Frequency: 4 affected / 367 at risk

Adverse event: Bipolar Disorders
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 367 at risk

Adverse event: Confusion And Disorientation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 10 affected / 367 at risk

Adverse event: Deliria
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 367 at risk

Adverse event: Depressive Disorders
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 367 at risk

Adverse event: Eating Disorders
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 367 at risk

Adverse event: Mental Disorders
Serious: yes
Organ System: Psychiatric disorders
Frequency: 19 affected / 367 at risk

Adverse event: Psychiatric Symptoms
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 367 at risk

Adverse event: Bladder And Urethral Symptoms
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 6 affected / 367 at risk

Adverse event: Renal Disorders
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 367 at risk

Adverse event: Renal Failure And Impairment
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 76 affected / 367 at risk

Adverse event: Renal Failure Complications
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 367 at risk

Adverse event: Renal Obstructive Disorders
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 367 at risk

Adverse event: Renal Vascular And Ischaemic Conditions
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 367 at risk

Adverse event: Urinary Abnormalities
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 9 affected / 367 at risk

Adverse event: Breast Disorders
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 367 at risk

Adverse event: Pelvis And Broad Ligament Disorders
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 367 at risk

Adverse event: Prostatic Neoplasms And Hypertrophy
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 367 at risk

Adverse event: Vulvovaginal Disorders
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 367 at risk

Adverse event: Breathing Abnormalities
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 31 affected / 367 at risk

Adverse event: Bronchospasm And Obstruction
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 26 affected / 367 at risk

Adverse event: Conditions Associated With Abnormal Gas Exchange
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 367 at risk

Adverse event: Coughing And Associated Symptoms
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 367 at risk

Adverse event: Lower Respiratory Tract Inflammatory And Immunologic Conditions
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 367 at risk

Adverse event: Lower Respiratory Tract Signs And Symptoms
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 367 at risk

Adverse event: Mediastinal Disorders
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 367 at risk

Adverse event: Nasal Disorders
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 367 at risk

Adverse event: Parenchymal Lung Disorders
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 367 at risk

Adverse event: Pneumothorax And Pleural Effusions
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 70 affected / 367 at risk

Adverse event: Pulmonary Hypertensions
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 367 at risk

Adverse event: Pulmonary Oedemas
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 17 affected / 367 at risk

Adverse event: Pulmonary Thrombotic And Embolic Conditions
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 367 at risk

Adverse event: Respiratory Failures (Excl Neonatal)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 66 affected / 367 at risk

Adverse event: Respiratory Tract Disorders
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 367 at risk

Adverse event: Upper Respiratory Tract Signs And Symptoms
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 367 at risk

Adverse event: Dermal And Epidermal Conditions
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 367 at risk

Adverse event: Dermatitis And Eczema
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 367 at risk

Adverse event: Exfoliative Conditions
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 367 at risk

Adverse event: Pruritus
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 367 at risk

Adverse event: Purpura And Related Conditions
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 367 at risk

Adverse event: Rashes, Eruptions And Exanthems
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 367 at risk

Adverse event: Skin And Subcutaneous Conditions
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 367 at risk

Adverse event: Skin And Subcutaneous Tissue Ulcerations
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 367 at risk

Adverse event: Skin Injuries And Mechanical Dermatoses
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 367 at risk

Adverse event: Cardiac Device Therapeutic Procedures
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 367 at risk

Adverse event: Joint Therapeutic Procedures
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 367 at risk

Adverse event: Therapeutic Procedures
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 367 at risk

Adverse event: Accelerated And Malignant Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 367 at risk

Adverse event: Aneurysms And Dissections Non-Site Specific
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 367 at risk

Adverse event: Aortic Aneurysms And Dissections
Serious: yes
Organ System: Vascular disorders
Frequency: 6 affected / 367 at risk

Adverse event: Aortic Necrosis And Vascular Insufficiency
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 367 at risk

Adverse event: Blood Pressure Disorders
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 367 at risk

Adverse event: Circulatory Collapse And Shock
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 367 at risk

Adverse event: Haemorrhages
Serious: yes
Organ System: Vascular disorders
Frequency: 16 affected / 367 at risk

Adverse event: Lymphangiopathies
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 367 at risk

Adverse event: Non-Site Specific Embolism And Thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 367 at risk

Adverse event: Non-Site Specific Necrosis And Vascular Insufficiency
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 367 at risk

Adverse event: Non-Site Specific Vascular Disorders
Serious: yes
Organ System: Vascular disorders
Frequency: 10 affected / 367 at risk

Adverse event: Peripheral Aneurysms And Dissections
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 367 at risk

Adverse event: Peripheral Embolism And Thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 8 affected / 367 at risk

Adverse event: Peripheral Vascular Disorders
Serious: yes
Organ System: Vascular disorders
Frequency: 5 affected / 367 at risk

Adverse event: Peripheral Vasoconstriction, Necrosis And Vascular Insufficiency
Serious: yes
Organ System: Vascular disorders
Frequency: 16 affected / 367 at risk

Adverse event: Site Specific Vascular Disorders
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 367 at risk

Adverse event: Vascular Hypertensive Disorders
Serious: yes
Organ System: Vascular disorders
Frequency: 22 affected / 367 at risk

Adverse event: Vascular Hypotensive Disorders
Serious: yes
Organ System: Vascular disorders
Frequency: 50 affected / 367 at risk

Adverse event: Anaemias
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 92 affected / 367 at risk

Adverse event: Leukocytoses
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 38 affected / 367 at risk

Adverse event: Thrombocytopenias
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 70 affected / 367 at risk

Adverse event: Cardiac Conduction Disorders
Serious: no
Organ System: Cardiac disorders
Frequency: 56 affected / 367 at risk

Adverse event: Heart Failures
Serious: no
Organ System: Cardiac disorders
Frequency: 30 affected / 367 at risk

Adverse event: Rate And Rhythm Disorders
Serious: no
Organ System: Cardiac disorders
Frequency: 28 affected / 367 at risk

Adverse event: Supraventricular Arrhythmias
Serious: no
Organ System: Cardiac disorders
Frequency: 72 affected / 367 at risk

Adverse event: Ventricular Arrhythmias And Cardiac Arrest
Serious: no
Organ System: Cardiac disorders
Frequency: 15 affected / 367 at risk

Adverse event: Gastrointestinal Atonic And Hypomotility Disorders
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 27 affected / 367 at risk

Adverse event: Nausea And Vomiting Symptoms
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 19 affected / 367 at risk

Adverse event: Asthenic Conditions
Serious: no
Organ System: General disorders
Frequency: 23 affected / 367 at risk

Adverse event: Febrile Disorders
Serious: no
Organ System: General disorders
Frequency: 24 affected / 367 at risk

Adverse event: Oedema
Serious: no
Organ System: General disorders
Frequency: 17 affected / 367 at risk

Adverse event: Pain And Discomfort
Serious: no
Organ System: General disorders
Frequency: 22 affected / 367 at risk

Adverse event: Lower Respiratory Tract And Lung Infections
Serious: no
Organ System: Infections and infestations
Frequency: 22 affected / 367 at risk

Adverse event: Urinary Tract Infections
Serious: no
Organ System: Infections and infestations
Frequency: 45 affected / 367 at risk

Adverse event: Non-Site Specific Injuries
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 16 affected / 367 at risk

Adverse event: Non-Site Specific Procedural Complications
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 25 affected / 367 at risk

Adverse event: Skeletal And Cardiac Muscle Analyses
Serious: no
Organ System: Investigations
Frequency: 25 affected / 367 at risk

Adverse event: Hyperglycaemic Conditions
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 27 affected / 367 at risk

Adverse event: Magnesium Metabolism Disorders
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 12 affected / 367 at risk

Adverse event: Potassium Imbalance
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 34 affected / 367 at risk

Adverse event: Sodium Imbalance
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 28 affected / 367 at risk

Adverse event: Total Fluid Volume Increased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 28 affected / 367 at risk

Adverse event: Musculoskeletal And Connective Tissue Pain And Discomfort
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 29 affected / 367 at risk

Adverse event: Confusion And Disorientation
Serious: no
Organ System: Psychiatric disorders
Frequency: 24 affected / 367 at risk

Adverse event: Bladder And Urethral Symptoms
Serious: no
Organ System: Renal and urinary disorders
Frequency: 13 affected / 367 at risk

Adverse event: Renal Failure And Impairment
Serious: no
Organ System: Renal and urinary disorders
Frequency: 58 affected / 367 at risk

Adverse event: Breathing Abnormalities
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 16 affected / 367 at risk

Adverse event: Parenchymal Lung Disorders
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 25 affected / 367 at risk

Adverse event: Pneumothorax And Pleural Effusions
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 64 affected / 367 at risk

Adverse event: Pulmonary Oedemas
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 14 affected / 367 at risk

Adverse event: Haemorrhages
Serious: no
Organ System: Vascular disorders
Frequency: 9 affected / 367 at risk

Adverse event: Vascular Hypertensive Disorders
Serious: no
Organ System: Vascular disorders
Frequency: 56 affected / 367 at risk

Adverse event: Vascular Hypotensive Disorders
Serious: no
Organ System: Vascular disorders
Frequency: 45 affected / 367 at risk

Adverse event: Anaemia Deficiencies
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 1108 at risk

Adverse event: Anaemias Due To Chronic Disorders
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 1108 at risk

Adverse event: Anaemias
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 265 affected / 1108 at risk

Adverse event: Coagulopathies
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 1108 at risk

Adverse event: Haemolyses
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 1108 at risk

Adverse event: Leukocytoses
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 13 affected / 1108 at risk

Adverse event: Lymphatic System Disorders
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 1108 at risk

Adverse event: Marrow Depression And Hypoplastic Anaemias
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 1108 at risk

Adverse event: Spleen Disorders
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 1108 at risk

Adverse event: Thrombocytopenias
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 20 affected / 1108 at risk

Adverse event: Aortic Valvular Disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 103 affected / 1108 at risk

Adverse event: Cardiac Conduction Disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 277 affected / 1108 at risk

Adverse event: Cardiac Disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 13 affected / 1108 at risk

Adverse event: Cardiac Signs And Symptoms
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 1108 at risk

Adverse event: Cardiomyopathies
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 1108 at risk

Adverse event: Coronary Artery Disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 10 affected / 1108 at risk

Adverse event: Heart Failures
Serious: yes
Organ System: Cardiac disorders
Frequency: 248 affected / 1108 at risk

Adverse event: Ischaemic Coronary Artery Disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 78 affected / 1108 at risk

Adverse event: Mitral Valvular Disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 28 affected / 1108 at risk

Adverse event: Myocardial Disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 9 affected / 1108 at risk

Adverse event: Pericardial Disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 30 affected / 1108 at risk

Adverse event: Rate And Rhythm Disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 50 affected / 1108 at risk

Adverse event: Right Ventricular Failures
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 1108 at risk

Adverse event: Supraventricular Arrhythmias
Serious: yes
Organ System: Cardiac disorders
Frequency: 119 affected / 1108 at risk

Adverse event: Tricuspid Valvular Disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 1108 at risk

Adverse event: Ventricular Arrhythmias And Cardiac Arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 104 affected / 1108 at risk

Adverse event: Cardiac Septal Defects Congenital
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 3 affected / 1108 at risk

Adverse event: Cardiovascular Disorders Congenital
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 1108 at risk

Adverse event: Male Reproductive Tract Disorders Congenital
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 1108 at risk

Adverse event: Inner Ear Signs And Symptoms
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 1108 at risk

Adverse event: Thyroid Disorders
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 1108 at risk

Adverse event: Thyroid Hyperfunction Disorders
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 1108 at risk

Adverse event: Thyroid Hypofunction Disorders
Serious: yes
Organ System: Endocrine disorders
Frequency: 4 affected / 1108 at risk

Adverse event: Blindness (Excl Colour Blindness)
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 1108 at risk

Adverse event: Cataract Conditions
Serious: yes
Organ System: Eye disorders
Frequency: 6 affected / 1108 at risk

Adverse event: Conjunctival And Corneal Bleeding And Vascular Disorders
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 1108 at risk

Adverse event: Corneal Structural Change, Deposit And Degeneration
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 1108 at risk

Adverse event: Lens Structural Change, Deposit And Degeneration (Excl Cataracts)
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 1108 at risk

Adverse event: Lid, Lash And Lacrimal Structural Disorders
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 1108 at risk

Adverse event: Ocular Bleeding And Vascular Disorders
Serious: yes
Organ System: Eye disorders
Frequency: 2 affected / 1108 at risk

Adverse event: Partial Vision Loss
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 1108 at risk

Adverse event: Retinal Bleeding And Vascular Disorders (Excl Retinopathy)
Serious: yes
Organ System: Eye disorders
Frequency: 4 affected / 1108 at risk

Adverse event: Retinal Structural Change, Deposit And Degeneration
Serious: yes
Organ System: Eye disorders
Frequency: 2 affected / 1108 at risk

Adverse event: Visual Disorders
Serious: yes
Organ System: Eye disorders
Frequency: 3 affected / 1108 at risk

Adverse event: Abdominal Findings Abnormal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1108 at risk

Adverse event: Abdominal Hernias, Site Unspecified
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1108 at risk

Adverse event: Abdominal Wall Conditions
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 1108 at risk

Adverse event: Benign Neoplasms Gastrointestinal (Excl Oral Cavity)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 1108 at risk

Adverse event: Colitis (Excl Infective)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 1108 at risk

Adverse event: Dental And Periodontal Infections And Inflammations
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1108 at risk

Adverse event: Diaphragmatic Hernias
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1108 at risk

Adverse event: Diarrhoea (Excl Infective)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 1108 at risk

Adverse event: Diverticula
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 1108 at risk

Adverse event: Duodenal And Small Intestinal Stenosis And Obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 1108 at risk

Adverse event: Duodenal Ulcers And Perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1108 at risk

Adverse event: Dyspeptic Signs And Symptoms
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1108 at risk

Adverse event: Faecal Abnormalities
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 1108 at risk

Adverse event: Gastric And Oesophageal Haemorrhages
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 1108 at risk

Adverse event: Gastritis (Excl Infective)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 1108 at risk

Adverse event: Gastrointestinal And Abdominal Pains (Excl Oral And Throat)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 1108 at risk

Adverse event: Gastrointestinal Atonic And Hypomotility Disorders
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 1108 at risk

Adverse event: Gastrointestinal Fistulae
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1108 at risk

Adverse event: Gastrointestinal Necrosis And Gangrene (Excl Gangrenous Hernia)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 1108 at risk

Adverse event: Gastrointestinal Signs And Symptoms
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 1108 at risk

Adverse event: Gastrointestinal Stenosis And Obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 1108 at risk

Adverse event: Gastrointestinal Ulcers And Perforation, Site Unspecified
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 1108 at risk

Adverse event: Gastrointestinal Vascular Occlusion And Infarction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 1108 at risk

Adverse event: Haemorrhoids And Gastrointestinal Varices (Excl Oesophageal)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 1108 at risk

Adverse event: Inguinal Hernias
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 1108 at risk

Adverse event: Intestinal Haemorrhages
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 1108 at risk

Adverse event: Intestinal Ulcers And Perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1108 at risk

Adverse event: Nausea And Vomiting Symptoms
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 1108 at risk

Adverse event: Non-Site Specific Gastrointestinal Haemorrhages
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 71 affected / 1108 at risk

Adverse event: Oesophageal Disorders
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1108 at risk

Adverse event: Oesophageal Stenosis And Obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1108 at risk

Adverse event: Oesophagitis (Excl Infective)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1108 at risk

Adverse event: Peritoneal And Retroperitoneal Disorders
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 1108 at risk

Adverse event: Peritoneal And Retroperitoneal Haemorrhages
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 1108 at risk

Adverse event: Administration Site Reactions
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 1108 at risk

Adverse event: Asthenic Conditions
Serious: yes
Organ System: General disorders
Frequency: 23 affected / 1108 at risk

Adverse event: Body Temperature Altered
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1108 at risk

Adverse event: Complications Associated With Device
Serious: yes
Organ System: General disorders
Frequency: 7 affected / 1108 at risk

Adverse event: Death And Sudden Death
Serious: yes
Organ System: General disorders
Frequency: 38 affected / 1108 at risk

Adverse event: Device Issues
Serious: yes
Organ System: General disorders
Frequency: 93 affected / 1108 at risk

Adverse event: Device Malfunction Events
Serious: yes
Organ System: General disorders
Frequency: 7 affected / 1108 at risk

Adverse event: Febrile Disorders
Serious: yes
Organ System: General disorders
Frequency: 15 affected / 1108 at risk

Adverse event: Gait Disturbances
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 1108 at risk

Adverse event: General Signs And Symptoms
Serious: yes
Organ System: General disorders
Frequency: 11 affected / 1108 at risk

Adverse event: Impaired healing
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1108 at risk

Adverse event: Hernias
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 1108 at risk

Adverse event: Implant And Catheter Site Reactions
Serious: yes
Organ System: General disorders
Frequency: 9 affected / 1108 at risk

Adverse event: Inflammations
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 1108 at risk

Adverse event: Injection Site Reactions
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1108 at risk

Adverse event: Oedema
Serious: yes
Organ System: General disorders
Frequency: 15 affected / 1108 at risk

Adverse event: Pain And Discomfort
Serious: yes
Organ System: General disorders
Frequency: 40 affected / 1108 at risk

Adverse event: Therapeutic And Nontherapeutic Responses
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 1108 at risk

Adverse event: Ulcers
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 1108 at risk

Adverse event: Cholecystitis And Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 7 affected / 1108 at risk

Adverse event: Cholestasis And Jaundice
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 1108 at risk

Adverse event: Hepatic And Hepatobiliary Disorders
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 1108 at risk

Adverse event: Hepatic Failure And Associated Disorders
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 5 affected / 1108 at risk

Adverse event: Hepatocellular Damage And Hepatitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 5 affected / 1108 at risk

Adverse event: Obstructive Bile Duct Disorders (Excl Neoplasms)
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 1108 at risk

Adverse event: Acute And Chronic Sarcoidosis
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 1108 at risk

Adverse event: Allergic Conditions
Serious: yes
Organ System: Immune system disorders
Frequency: 2 affected / 1108 at risk

Adverse event: Allergies To Foods, Food Additives, Drugs And Other Chemicals
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 1108 at risk

Adverse event: Abdominal And Gastrointestinal Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 9 affected / 1108 at risk

Adverse event: Atypical Mycobacterial Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1108 at risk

Adverse event: Bacterial Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 37 affected / 1108 at risk

Adverse event: Bone And Joint Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 7 affected / 1108 at risk

Adverse event: Candida Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1108 at risk

Adverse event: Cardiac Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 10 affected / 1108 at risk

Adverse event: Clostridia Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 11 affected / 1108 at risk

Adverse event: Dental And Oral Soft Tissue Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 1108 at risk

Adverse event: Enterobacter Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1108 at risk

Adverse event: Enterococcal Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 1108 at risk

Adverse event: Escherichia Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1108 at risk

Adverse event: Eye And Eyelid Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1108 at risk

Adverse event: Fungal Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1108 at risk

Adverse event: Haemophilus Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1108 at risk

Adverse event: Hepatobiliary And Spleen Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1108 at risk

Adverse event: Herpes Viral Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 1108 at risk

Adverse event: Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 20 affected / 1108 at risk

Adverse event: Infectious Transmissions
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1108 at risk

Adverse event: Influenza Viral Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 11 affected / 1108 at risk

Adverse event: Klebsiella Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 1108 at risk

Adverse event: Lower Respiratory Tract And Lung Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 101 affected / 1108 at risk

Adverse event: Male Reproductive Tract Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1108 at risk

Adverse event: Pseudomonal Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1108 at risk

Adverse event: Respiratory Syncytial Viral Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1108 at risk

Adverse event: Sepsis, Bacteraemia, Viraemia And Fungaemia
Serious: yes
Organ System: Infections and infestations
Frequency: 82 affected / 1108 at risk

Adverse event: Skin Structures And Soft Tissue Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1108 at risk

Adverse event: Staphylococcal Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 8 affected / 1108 at risk

Adverse event: Streptococcal Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 1108 at risk

Adverse event: Upper Respiratory Tract Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 7 affected / 1108 at risk

Adverse event: Urinary Tract Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 58 affected / 1108 at risk

Adverse event: Vascular Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1108 at risk

Adverse event: Viral Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1108 at risk

Adverse event: Abdominal Injuries
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 1108 at risk

Adverse event: Cardiac And Vascular Procedural Complications
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 27 affected / 1108 at risk

Adverse event: Cardiovascular Injuries
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 1108 at risk

Adverse event: Cerebral Injuries
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 11 affected / 1108 at risk

Adverse event: Chest And Lung Injuries
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 1108 at risk

Adverse event: Fractures And Dislocations
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1108 at risk

Adverse event: Limb Injuries (Incl Traumatic Amputation)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 5 affected / 1108 at risk

Adverse event: Lower Limb Fractures And Dislocations
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 28 affected / 1108 at risk

Adverse event: Non-Site Specific Injuries
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 48 affected / 1108 at risk

Adverse event: Non-Site Specific Procedural Complications
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 52 affected / 1108 at risk

Adverse event: Overdoses
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1108 at risk

Adverse event: Pelvic Fractures And Dislocations
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 1108 at risk

Adverse event: Poisoning And Toxicity
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 5 affected / 1108 at risk

Adverse event: Renal And Urinary Tract Injuries
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 1108 at risk

Adverse event: Respiratory Tract And Thoracic Cavity Procedural Complications
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 1108 at risk

Adverse event: Site Specific Injuries
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 5 affected / 1108 at risk

Adverse event: Skin Injuries
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 12 affected / 1108 at risk

Adverse event: Skull Fractures, Facial Bone Fractures And Dislocations
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 1108 at risk

Adverse event: Spinal Fractures And Dislocations
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 7 affected / 1108 at risk

Adverse event: Thoracic Cage Fractures And Dislocations
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 1108 at risk

Adverse event: Transfusion Related Complications
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1108 at risk

Adverse event: Upper Limb Fractures And Dislocations
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 12 affected / 1108 at risk

Adverse event: Blood Counts
Serious: yes
Organ System: Investigations
Frequency: 4 affected / 1108 at risk

Adverse event: Blood Gas And Acid Base Analyses
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 1108 at risk

Adverse event: Carbohydrate Tolerance Analyses (Incl Diabetes)
Serious: yes
Organ System: Investigations
Frequency: 7 affected / 1108 at risk

Adverse event: Cardiac Function Diagnostic Procedures
Serious: yes
Organ System: Investigations
Frequency: 17 affected / 1108 at risk

Adverse event: Coagulation And Bleeding Analyses
Serious: yes
Organ System: Investigations
Frequency: 14 affected / 1108 at risk

Adverse event: Ecg Investigations
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 1108 at risk

Adverse event: Faecal Analyses
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 1108 at risk

Adverse event: Heart Rate And Pulse Investigations
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 1108 at risk

Adverse event: Hepatobiliary Histopathology Procedures
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 1108 at risk

Adverse event: Liver Function Analyses
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 1108 at risk

Adverse event: Metabolism Tests
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 1108 at risk

Adverse event: Mineral And Electrolyte Analyses
Serious: yes
Organ System: Investigations
Frequency: 3 affected / 1108 at risk

Adverse event: Red Blood Cell Analyses
Serious: yes
Organ System: Investigations
Frequency: 8 affected / 1108 at risk

Adverse event: Renal Function Analyses
Serious: yes
Organ System: Investigations
Frequency: 5 affected / 1108 at risk

Adverse event: Respiratory Tract And Thoracic Imaging Procedures
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 1108 at risk

Adverse event: Skeletal And Cardiac Muscle Analyses
Serious: yes
Organ System: Investigations
Frequency: 5 affected / 1108 at risk

Adverse event: Urine analysis
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 1108 at risk

Adverse event: Urinary Tract Function Analyses
Serious: yes
Organ System: Investigations
Frequency: 5 affected / 1108 at risk

Adverse event: Vascular Tests (Incl Blood Pressure)
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 1108 at risk

Adverse event: White Blood Cell Analyses
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 1108 at risk

Adverse event: Calcium Metabolism Disorders
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 1108 at risk

Adverse event: Diabetes Mellitus (Incl Subtypes)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 1108 at risk

Adverse event: Diabetic Complications
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1108 at risk

Adverse event: Disorders Of Purine Metabolism
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 1108 at risk

Adverse event: Electrolyte imbalance
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 1108 at risk

Adverse event: General Nutritional Disorders
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 10 affected / 1108 at risk

Adverse event: Hyperglycaemic Conditions
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 15 affected / 1108 at risk

Adverse event: Hypoglycaemic Conditions
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 1108 at risk

Adverse event: Magnesium Metabolism Disorders
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 1108 at risk

Adverse event: Metabolic Acidoses (Excl Diabetic Acidoses)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 1108 at risk

Adverse event: Metabolic Alkaloses
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 1108 at risk

Adverse event: Mixed Acid-Base Disorders
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 1108 at risk

Adverse event: Phosphorus Metabolism Disorders
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1108 at risk

Adverse event: Potassium Imbalance
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 25 affected / 1108 at risk

Adverse event: Sodium Imbalance
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 20 affected / 1108 at risk

Adverse event: Total Fluid Volume Decreased
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 29 affected / 1108 at risk

Adverse event: Total Fluid Volume Increased
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 23 affected / 1108 at risk

Adverse event: Arthropathies
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 1108 at risk

Adverse event: Connective Tissue Disorders (Excl Le)
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1108 at risk

Adverse event: Crystal Arthropathic Disorders
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1108 at risk

Adverse event: Extremity Deformities
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1108 at risk

Adverse event: Joint Related Signs And Symptoms
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 9 affected / 1108 at risk

Adverse event: Muscle Pains
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1108 at risk

Adverse event: Muscle Weakness Conditions
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 1108 at risk

Adverse event: Musculoskeletal And Connective Tissue Pain And Discomfort
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 23 affected / 1108 at risk

Adverse event: Musculoskeletal And Connective Tissue Signs And Symptoms
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 1108 at risk

Adverse event: Myopathies
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 1108 at risk

Adverse event: Osteoarthropathies
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 13 affected / 1108 at risk

Adverse event: Soft Tissue Disorders
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 1108 at risk

Adverse event: Spine And Neck Deformities
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 1108 at risk

Adverse event: Bladder Neoplasms Malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1108 at risk

Adverse event: Breast And Nipple Neoplasms Malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 1108 at risk

Adverse event: Burkitt's Lymphomas
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1108 at risk

Adverse event: Central Nervous System Neoplasms Malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 1108 at risk

Adverse event: Colonic Neoplasms Malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 4 affected / 1108 at risk

Adverse event: Leiomyosarcomas
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1108 at risk

Adverse event: Leukaemias Acute Myeloid
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1108 at risk

Adverse event: Leukaemias Chronic Lymphocytic
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 1108 at risk

Adverse event: Leukaemias
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 1108 at risk

Adverse event: Lymphomas Unspecified
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1108 at risk

Adverse event: Mantle Cell Lymphomas
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1108 at risk

Adverse event: Metastases To Specified Sites
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 1108 at risk

Adverse event: Myelodysplastic Syndromes
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 4 affected / 1108 at risk

Adverse event: Neoplasms Malignant Site Unspecified
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 6 affected / 1108 at risk

Adverse event: Nervous System Neoplasms Unspecified Malignancy
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1108 at risk

Adverse event: Oesophageal Neoplasms Malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1108 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: 3 affected / 1108 at risk

Adverse event: Prostatic Neoplasms Malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 1108 at risk

Adverse event: Renal Neoplasms Malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 1108 at risk

Adverse event: Respiratory Tract And Pleural Neoplasms Malignant Cell Type Unspecified
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 1108 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: 3 affected / 1108 at risk

Adverse event: Small Intestinal Neoplasms Malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1108 at risk

Adverse event: Soft Tissue Sarcomas Histology Unspecified
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1108 at risk

Adverse event: Thyroid Neoplasms Malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1108 at risk

Adverse event: Vulval Neoplasms Malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1108 at risk

Adverse event: Central Nervous System Aneurysms
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1108 at risk

Adverse event: Central Nervous System Haemorrhages And Cerebrovascular Accidents
Serious: yes
Organ System: Nervous system disorders
Frequency: 79 affected / 1108 at risk

Adverse event: Central Nervous System Vascular Disorders
Serious: yes
Organ System: Nervous system disorders
Frequency: 7 affected / 1108 at risk

Adverse event: Cerebellar Coordination And Balance Disturbances
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1108 at risk

Adverse event: Coma States
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1108 at risk

Adverse event: Cortical Dysfunction
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1108 at risk

Adverse event: Dementia (Excl Alzheimer's Type)
Serious: yes
Organ System: Nervous system disorders
Frequency: 5 affected / 1108 at risk

Adverse event: Disturbances In Consciousness
Serious: yes
Organ System: Nervous system disorders
Frequency: 32 affected / 1108 at risk

Adverse event: Encephalopathies
Serious: yes
Organ System: Nervous system disorders
Frequency: 13 affected / 1108 at risk

Adverse event: Encephalopathies Toxic And Metabolic
Serious: yes
Organ System: Nervous system disorders
Frequency: 14 affected / 1108 at risk

Adverse event: Facial Cranial Nerve Disorders
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 1108 at risk

Adverse event: Generalised Tonic-Clonic Seizures
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1108 at risk

Adverse event: Headaches
Serious: yes
Organ System: Nervous system disorders
Frequency: 8 affected / 1108 at risk

Adverse event: Hydrocephalic Conditions
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1108 at risk

Adverse event: Lumbar Spinal Cord And Nerve Root Disorders
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1108 at risk

Adverse event: Memory Loss (Excl Dementia)
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1108 at risk

Adverse event: Mental Impairment (Excl Dementia And Memory Loss)
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1108 at risk

Adverse event: Neurological Signs And Symptoms
Serious: yes
Organ System: Nervous system disorders
Frequency: 18 affected / 1108 at risk

Adverse event: Paralysis And Paresis (Excl Cranial Nerve)
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 1108 at risk

Adverse event: Parkinson's Disease And Parkinsonism
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1108 at risk

Adverse event: Peripheral Neuropathies
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1108 at risk

Adverse event: Seizures And Seizure Disorders
Serious: yes
Organ System: Nervous system disorders
Frequency: 5 affected / 1108 at risk

Adverse event: Sensory Abnormalities
Serious: yes
Organ System: Nervous system disorders
Frequency: 5 affected / 1108 at risk

Adverse event: Speech And Language Abnormalities
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1108 at risk

Adverse event: Spinal Cord And Nerve Root Disorders
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1108 at risk

Adverse event: Structural Brain Disorders
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1108 at risk

Adverse event: Transient Cerebrovascular Events
Serious: yes
Organ System: Nervous system disorders
Frequency: 24 affected / 1108 at risk

Adverse event: Tremor (Excl Congenital)
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 1108 at risk

Adverse event: Trigeminal Disorders
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1108 at risk

Adverse event: Vagus Nerve Disorders
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1108 at risk

Adverse event: Anxiety Disorders
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 1108 at risk

Adverse event: Anxiety Symptoms
Serious: yes
Organ System: Psychiatric disorders
Frequency: 10 affected / 1108 at risk

Adverse event: Behaviour And Socialisation Disturbances
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 1108 at risk

Adverse event: Confusion And Disorientation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 20 affected / 1108 at risk

Adverse event: Deliria
Serious: yes
Organ System: Psychiatric disorders
Frequency: 9 affected / 1108 at risk

Adverse event: Delusional Symptoms
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 1108 at risk

Adverse event: Depressive Disorders
Serious: yes
Organ System: Psychiatric disorders
Frequency: 4 affected / 1108 at risk

Adverse event: Disturbances In Initiating And Maintaining Sleep
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 1108 at risk

Adverse event: Mental Disorders
Serious: yes
Organ System: Psychiatric disorders
Frequency: 29 affected / 1108 at risk

Adverse event: Panic Attacks And Disorders
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 1108 at risk

Adverse event: Psychotic disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 1108 at risk

Adverse event: Suicidal And Self-Injurious Behaviour
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 1108 at risk

Adverse event: Bladder And Urethral Symptoms
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 48 affected / 1108 at risk

Adverse event: Bladder Disorders
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 4 affected / 1108 at risk

Adverse event: Myoneurogenic Bladder Disorders
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1108 at risk

Adverse event: Nephropathies And Tubular Disorders
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 1108 at risk

Adverse event: Renal Disorders
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1108 at risk

Adverse event: Renal Failure And Impairment
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 154 affected / 1108 at risk

Adverse event: Renal Failure Complications
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1108 at risk

Adverse event: Renal Lithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 6 affected / 1108 at risk

Adverse event: Renal Neoplasms
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1108 at risk

Adverse event: Renal Vascular And Ischaemic Conditions
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 4 affected / 1108 at risk

Adverse event: Structural And Obstructive Urethral Disorders (Excl Congenital)
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 1108 at risk

Adverse event: Urinary Abnormalities
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 29 affected / 1108 at risk

Adverse event: Urinary Tract Lithiasis (Excl Renal)
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 1108 at risk

Adverse event: Pelvis And Broad Ligament Disorders
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1108 at risk

Adverse event: Prostatic Neoplasms And Hypertrophy
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 1108 at risk

Adverse event: Reproductive Tract Signs And Symptoms
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1108 at risk

Adverse event: Scrotal Disorders
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1108 at risk

Adverse event: Testicular And Epididymal Disorders
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1108 at risk

Adverse event: Breathing Abnormalities
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 66 affected / 1108 at risk

Adverse event: Bronchial Conditions
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1108 at risk

Adverse event: Bronchospasm And Obstruction
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 35 affected / 1108 at risk

Adverse event: Conditions Associated With Abnormal Gas Exchange
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 22 affected / 1108 at risk

Adverse event: Coughing And Associated Symptoms
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 1108 at risk

Adverse event: Diaphragmatic Disorders
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1108 at risk

Adverse event: Lower Respiratory Tract Inflammatory And Immunologic Conditions
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 14 affected / 1108 at risk

Adverse event: Lower Respiratory Tract Signs And Symptoms
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1108 at risk

Adverse event: Mediastinal Disorders
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1108 at risk

Adverse event: Nasal Disorders
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 14 affected / 1108 at risk

Adverse event: Parenchymal Lung Disorders
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 1108 at risk

Adverse event: Pharyngeal Disorders (Excl Infections And Neoplasms)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1108 at risk

Adverse event: Pneumothorax And Pleural Effusions
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 75 affected / 1108 at risk

Adverse event: Pulmonary Hypertensions
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 1108 at risk

Adverse event: Pulmonary Oedemas
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 35 affected / 1108 at risk

Adverse event: Pulmonary Thrombotic And Embolic Conditions
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 1108 at risk

Adverse event: Respiratory Failures (Excl Neonatal)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 108 affected / 1108 at risk

Adverse event: Respiratory Tract Disorders
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1108 at risk

Adverse event: Upper Respiratory Tract Signs And Symptoms
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1108 at risk

Adverse event: Dermal And Epidermal Conditions
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 1108 at risk

Adverse event: Erythemas
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 1108 at risk

Adverse event: Hyperkeratoses
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1108 at risk

Adverse event: Pruritus
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1108 at risk

Adverse event: Rashes, Eruptions And Exanthems
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 1108 at risk

Adverse event: Skin And Subcutaneous Tissue Ulcerations
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 1108 at risk

Adverse event: Skin Injuries And Mechanical Dermatoses
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1108 at risk

Adverse event: Skin Preneoplastic Conditions
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1108 at risk

Adverse event: Skin Vasculitides
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1108 at risk

Adverse event: Cardiac Device Therapeutic Procedures
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 3 affected / 1108 at risk

Adverse event: Haematological Therapeutic Procedures
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1108 at risk

Adverse event: Joint Therapeutic Procedures
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1108 at risk

Adverse event: Large Intestine Therapeutic Procedures
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 1108 at risk

Adverse event: Renal Therapeutic Procedures
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1108 at risk

Adverse event: Therapeutic Bladder Catheterisation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1108 at risk

Adverse event: Therapeutic Procedures
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 11 affected / 1108 at risk

Adverse event: Venous Therapeutic Procedures
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1108 at risk

Adverse event: Accelerated And Malignant Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 13 affected / 1108 at risk

Adverse event: Aneurysms And Dissections Non-Site Specific
Serious: yes
Organ System: Vascular disorders
Frequency: 6 affected / 1108 at risk

Adverse event: Aortic Aneurysms And Dissections
Serious: yes
Organ System: Vascular disorders
Frequency: 5 affected / 1108 at risk

Adverse event: Aortic Embolism And Thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 1108 at risk

Adverse event: Aortic Necrosis And Vascular Insufficiency
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 1108 at risk

Adverse event: Arterial And Aortic Injuries
Serious: yes
Organ System: Vascular disorders
Frequency: 10 affected / 1108 at risk

Adverse event: Blood Pressure Disorders
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 1108 at risk

Adverse event: Circulatory Collapse And Shock
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 1108 at risk

Adverse event: Haemorrhages
Serious: yes
Organ System: Vascular disorders
Frequency: 33 affected / 1108 at risk

Adverse event: Lymphangiopathies
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 1108 at risk

Adverse event: Lymphoedemas
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 1108 at risk

Adverse event: Non-Site Specific Embolism And Thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 7 affected / 1108 at risk

Adverse event: Non-Site Specific Necrosis And Vascular Insufficiency
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 1108 at risk

Adverse event: Non-Site Specific Vascular Disorders
Serious: yes
Organ System: Vascular disorders
Frequency: 12 affected / 1108 at risk

Adverse event: Peripheral Aneurysms And Dissections
Serious: yes
Organ System: Vascular disorders
Frequency: 11 affected / 1108 at risk

Adverse event: Peripheral Embolism And Thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 17 affected / 1108 at risk

Adverse event: Peripheral Vascular Disorders
Serious: yes
Organ System: Vascular disorders
Frequency: 6 affected / 1108 at risk

Adverse event: Peripheral Vasoconstriction, Necrosis And Vascular Insufficiency
Serious: yes
Organ System: Vascular disorders
Frequency: 41 affected / 1108 at risk

Adverse event: Phlebitis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 1108 at risk

Adverse event: Site Specific Necrosis And Vascular Insufficiency
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 1108 at risk

Adverse event: Site Specific Vascular Disorders
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 1108 at risk

Adverse event: Vascular Hypertensive Disorders
Serious: yes
Organ System: Vascular disorders
Frequency: 53 affected / 1108 at risk

Adverse event: Vascular Hypotensive Disorders
Serious: yes
Organ System: Vascular disorders
Frequency: 90 affected / 1108 at risk

Adverse event: Vascular Malformations And Acquired Anomalies
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 1108 at risk

Adverse event: Anaemias
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 260 affected / 1108 at risk

Adverse event: Leukocytoses
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 79 affected / 1108 at risk

Adverse event: Thrombocytopenias
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 217 affected / 1108 at risk

Adverse event: Cardiac Conduction Disorders
Serious: no
Organ System: Cardiac disorders
Frequency: 331 affected / 1108 at risk

Adverse event: Heart Failures
Serious: no
Organ System: Cardiac disorders
Frequency: 68 affected / 1108 at risk

Adverse event: Rate And Rhythm Disorders
Serious: no
Organ System: Cardiac disorders
Frequency: 99 affected / 1108 at risk

Adverse event: Supraventricular Arrhythmias
Serious: no
Organ System: Cardiac disorders
Frequency: 159 affected / 1108 at risk

Adverse event: Ventricular Arrhythmias And Cardiac Arrest
Serious: no
Organ System: Cardiac disorders
Frequency: 66 affected / 1108 at risk

Adverse event: Gastrointestinal Atonic And Hypomotility Disorders
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 74 affected / 1108 at risk

Adverse event: Nausea And Vomiting Symptoms
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 45 affected / 1108 at risk

Adverse event: Asthenic Conditions
Serious: no
Organ System: General disorders
Frequency: 43 affected / 1108 at risk

Adverse event: Febrile Disorders
Serious: no
Organ System: General disorders
Frequency: 69 affected / 1108 at risk

Adverse event: Oedema
Serious: no
Organ System: General disorders
Frequency: 85 affected / 1108 at risk

Adverse event: Pain And Discomfort
Serious: no
Organ System: General disorders
Frequency: 71 affected / 1108 at risk

Adverse event: Lower Respiratory Tract And Lung Infections
Serious: no
Organ System: Infections and infestations
Frequency: 55 affected / 1108 at risk

Adverse event: Urinary Tract Infections
Serious: no
Organ System: Infections and infestations
Frequency: 141 affected / 1108 at risk

Adverse event: Non-Site Specific Injuries
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 68 affected / 1108 at risk

Adverse event: Non-Site Specific Procedural Complications
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 87 affected / 1108 at risk

Adverse event: Skeletal And Cardiac Muscle Analyses
Serious: no
Organ System: Investigations
Frequency: 42 affected / 1108 at risk

Adverse event: Hyperglycaemic Conditions
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 46 affected / 1108 at risk

Adverse event: Magnesium Metabolism Disorders
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 64 affected / 1108 at risk

Adverse event: Potassium Imbalance
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 87 affected / 1108 at risk

Adverse event: Sodium Imbalance
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 58 affected / 1108 at risk

Adverse event: Total Fluid Volume Increased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 116 affected / 1108 at risk

Adverse event: Musculoskeletal And Connective Tissue Pain And Discomfort
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 99 affected / 1108 at risk

Adverse event: Confusion And Disorientation
Serious: no
Organ System: Psychiatric disorders
Frequency: 68 affected / 1108 at risk

Adverse event: Bladder And Urethral Symptoms
Serious: no
Organ System: Renal and urinary disorders
Frequency: 57 affected / 1108 at risk

Adverse event: Renal Failure And Impairment
Serious: no
Organ System: Renal and urinary disorders
Frequency: 201 affected / 1108 at risk

Adverse event: Breathing Abnormalities
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 64 affected / 1108 at risk

Adverse event: Parenchymal Lung Disorders
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 94 affected / 1108 at risk

Adverse event: Pneumothorax And Pleural Effusions
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 168 affected / 1108 at risk

Adverse event: Pulmonary Oedemas
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 67 affected / 1108 at risk

Adverse event: Haemorrhages
Serious: no
Organ System: Vascular disorders
Frequency: 61 affected / 1108 at risk

Adverse event: Vascular Hypertensive Disorders
Serious: no
Organ System: Vascular disorders
Frequency: 192 affected / 1108 at risk

Adverse event: Vascular Hypotensive Disorders
Serious: no
Organ System: Vascular disorders
Frequency: 120 affected / 1108 at risk