Study: NCT01437098

Adverse event: Anaemias Nec
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 44 at risk

Adverse event: Aortic Valvular Disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 44 at risk

Adverse event: Cardiac Conduction Disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 11 affected / 44 at risk

Adverse event: Cardiac Disorders Nec
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 44 at risk

Adverse event: Coronary Artery Disorders Nec
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 44 at risk

Adverse event: Heart Failures Nec
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 44 at risk

Adverse event: Ischaemic Coronary Artery Disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 44 at risk

Adverse event: Myocardial Disorders Nec
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 44 at risk

Adverse event: Pericardial Disorders Nec
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 44 at risk

Adverse event: Supraventricular Arrhythmias
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 44 at risk

Adverse event: Ventricular Arrhythmias And Cardiac Arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 44 at risk

Adverse event: Cataract Conditions
Serious: yes
Organ System: Eye disorders
Frequency: 3 affected / 44 at risk

Adverse event: Gastrointestinal Ulcers And Perforation, Site Unspecified
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 44 at risk

Adverse event: Non-Site Specific Gastrointestinal Haemorrhages
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 44 at risk

Adverse event: Asthenic Conditions
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 44 at risk

Adverse event: Death And Sudden Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 44 at risk

Adverse event: Device Issues Nec
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 44 at risk

Adverse event: Febrile Disorders
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 44 at risk

Adverse event: General Signs And Symptoms Nec
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 44 at risk

Adverse event: Pain And Discomfort Nec
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 44 at risk

Adverse event: Cholecystitis And Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 44 at risk

Adverse event: Hepatic Enzymes And Function Abnormalities
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 44 at risk

Adverse event: Hepatic Failure And Associated Disorders
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 44 at risk

Adverse event: Obstructive Bile Duct Disorders (Excl Neoplasms)
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 44 at risk

Adverse event: Abdominal And Gastrointestinal Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 44 at risk

Adverse event: Bacterial Infections Nec
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 44 at risk

Adverse event: Infections Nec
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 44 at risk

Adverse event: Lower Respiratory Tract And Lung Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 44 at risk

Adverse event: Stretococcal Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 44 at risk

Adverse event: Cerebral Injuries Nec
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 44 at risk

Adverse event: Lower Limb Fractures And Dislocations
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 44 at risk

Adverse event: Non-Site Specific Procedural Complications
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 44 at risk

Adverse event: Pelvic Fractures And Dislocations
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 44 at risk

Adverse event: Spinal Fractures And Dislocations
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 44 at risk

Adverse event: Physical Examination Procedures
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 44 at risk

Adverse event: Diabetes Mellitus (Incl Subtypes)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 44 at risk

Adverse event: General Nutritional Disorders Nec
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 44 at risk

Adverse event: Muscle Weakness Conditions
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 44 at risk

Adverse event: Musculoskeletal And Connective Tissue Pain And Discomfort
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 44 at risk

Adverse event: Osteoarthropathies
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 44 at risk

Adverse event: Hepatic Neoplasms Malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 44 at risk

Adverse event: Hepatobiliary Neoplasms Malignancy Unspecified
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 44 at risk

Adverse event: Lymphomas Unspecified Nec
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 44 at risk

Adverse event: Central Nervous System Haemorrhages And Cerebrovascular Accidents
Serious: yes
Organ System: Nervous system disorders
Frequency: 6 affected / 44 at risk

Adverse event: Central Nervous System Vascular Disorders Nec
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 44 at risk

Adverse event: Anxiety Disorders Nec
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 44 at risk

Adverse event: Renal Failure And Impairment
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 44 at risk

Adverse event: Pelvic Prolapse Conditions
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 44 at risk

Adverse event: Lower Respiratory Tract Inflammatory And Immunologic Conditions
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 44 at risk

Adverse event: Mediastinal Disorders
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 44 at risk

Adverse event: Nasal Disorders Nec
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 44 at risk

Adverse event: Parenchymal Lung Disorders Nec
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 44 at risk

Adverse event: Pneumothorax And Pleural Effusions Nec
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 44 at risk

Adverse event: Pulmonary Oedemas
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 44 at risk

Adverse event: Respiratory Failures (Excl Neonatal)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 44 at risk

Adverse event: Dermatitis Ascribed To Specific Agent
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 44 at risk

Adverse event: Circulatory Collapse And Shock
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 44 at risk

Adverse event: Peripheral Vasoconstriction, Necrosis And Vascular Insufficiency
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 44 at risk

Adverse event: Vascular Hypotensive Disorders
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 44 at risk

Adverse event: Anaemias Nec
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 13 affected / 44 at risk

Adverse event: Coagulopathies
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 44 at risk

Adverse event: Thrombocytopenias
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 44 at risk

Adverse event: Cardiac Conduction Disorders
Serious: no
Organ System: Cardiac disorders
Frequency: 27 affected / 44 at risk

Adverse event: Cardiac Signs And Symptoms Nec
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 44 at risk

Adverse event: Heart Failures Nec
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 44 at risk

Adverse event: Mitral Valvular Disorders
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 44 at risk

Adverse event: Pericardial Disorders Nec
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 44 at risk

Adverse event: Rate And Rhythm Disorders Nec
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 44 at risk

Adverse event: Supraventricular Arrhythmias
Serious: no
Organ System: Cardiac disorders
Frequency: 9 affected / 44 at risk

Adverse event: Ventricular Arrhythmias And Cardiac Arrest
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 44 at risk

Adverse event: Ear Disorders Nec
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 44 at risk

Adverse event: Inner Ear Signs And Symptoms
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 44 at risk

Adverse event: Adrenal Cortical Hypofunctions
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 44 at risk

Adverse event: Thyroid Hypofunction Disorders
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 44 at risk

Adverse event: Diarrhoea (Excl Infective)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 44 at risk

Adverse event: Gastrointestinal Atonic And Hypomotility Disorders Nec
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 44 at risk

Adverse event: Gastrointestinal Inflammatory Disorders Nec
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 44 at risk

Adverse event: Nausea And Vomiting Symptoms
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 44 at risk

Adverse event: Non-Site Specific Gastrointestinal Haemorrhages
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 44 at risk

Adverse event: Oral Soft Tissue Disorders Nec
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 44 at risk

Adverse event: Tongue Disorders
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 44 at risk

Adverse event: Tongue Signs And Symptoms
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 44 at risk

Adverse event: Administration Site Reactions Nec
Serious: no
Organ System: General disorders
Frequency: 4 affected / 44 at risk

Adverse event: Asthenic Conditions
Serious: no
Organ System: General disorders
Frequency: 2 affected / 44 at risk

Adverse event: Complications Associated With Device Nec
Serious: no
Organ System: General disorders
Frequency: 2 affected / 44 at risk

Adverse event: Febrile Disorders
Serious: no
Organ System: General disorders
Frequency: 11 affected / 44 at risk

Adverse event: Feelings And Sensations Nec
Serious: no
Organ System: General disorders
Frequency: 1 affected / 44 at risk

Adverse event: Implant And Catheter Site Reactions
Serious: no
Organ System: General disorders
Frequency: 3 affected / 44 at risk

Adverse event: Inflammations
Serious: no
Organ System: General disorders
Frequency: 3 affected / 44 at risk

Adverse event: Injection Site Reactions
Serious: no
Organ System: General disorders
Frequency: 1 affected / 44 at risk

Adverse event: Oedema Nec
Serious: no
Organ System: General disorders
Frequency: 8 affected / 44 at risk

Adverse event: Pain And Discomfort Nec
Serious: no
Organ System: General disorders
Frequency: 3 affected / 44 at risk

Adverse event: Hepatic Enzymes And Function Abnormalities
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 44 at risk

Adverse event: Bacterial Infections Nec
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 44 at risk

Adverse event: Infections Nec
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 44 at risk

Adverse event: Staphylococcal Infections
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 44 at risk

Adverse event: Tinea Infections
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 44 at risk

Adverse event: Upper Respiratory Tract Infections
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 44 at risk

Adverse event: Urinary Tract Infections
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 44 at risk

Adverse event: Non-Site Specific Injuries Nec
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 10 affected / 44 at risk

Adverse event: Non-Site Specific Procedural Complications
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 12 affected / 44 at risk

Adverse event: Skin Injuries Nec
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 44 at risk

Adverse event: Spinal Fractures And Dislocations
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 44 at risk

Adverse event: Blood Counts Nec
Serious: no
Organ System: Investigations
Frequency: 2 affected / 44 at risk

Adverse event: Heart Rate And Pulse Investigations
Serious: no
Organ System: Investigations
Frequency: 1 affected / 44 at risk

Adverse event: Lipoprotein And Lipid Tests Nec
Serious: no
Organ System: Investigations
Frequency: 1 affected / 44 at risk

Adverse event: Liver Function Analyses
Serious: no
Organ System: Investigations
Frequency: 12 affected / 44 at risk

Adverse event: Metabolism Tests Nec
Serious: no
Organ System: Investigations
Frequency: 5 affected / 44 at risk

Adverse event: Mineral And Electrolyte Analyses
Serious: no
Organ System: Investigations
Frequency: 1 affected / 44 at risk

Adverse event: Physical Examination Procedures
Serious: no
Organ System: Investigations
Frequency: 1 affected / 44 at risk

Adverse event: Platelet Analyses
Serious: no
Organ System: Investigations
Frequency: 10 affected / 44 at risk

Adverse event: Protein Analyses Nec
Serious: no
Organ System: Investigations
Frequency: 29 affected / 44 at risk

Adverse event: Red Blood Cell Analyses
Serious: no
Organ System: Investigations
Frequency: 6 affected / 44 at risk

Adverse event: Renal Function Analyses
Serious: no
Organ System: Investigations
Frequency: 3 affected / 44 at risk

Adverse event: Skeletal And Cardiac Muscle Analyses
Serious: no
Organ System: Investigations
Frequency: 12 affected / 44 at risk

Adverse event: Tissue Enzyme Analyses Nec
Serious: no
Organ System: Investigations
Frequency: 7 affected / 44 at risk

Adverse event: Triglyceride Analyses
Serious: no
Organ System: Investigations
Frequency: 1 affected / 44 at risk

Adverse event: Urinary Tract Function Analyses Nec
Serious: no
Organ System: Investigations
Frequency: 2 affected / 44 at risk

Adverse event: Vascular Tests Nec (Incl Blood Pressure)
Serious: no
Organ System: Investigations
Frequency: 14 affected / 44 at risk

Adverse event: White Blood Cell Analyses
Serious: no
Organ System: Investigations
Frequency: 12 affected / 44 at risk

Adverse event: Appetite Disorders
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 44 at risk

Adverse event: Disorders Of Purine Metabolism
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 44 at risk

Adverse event: General Nutritional Disorders Nec
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 44 at risk

Adverse event: Hyperglycaemic Conditions Nec
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 44 at risk

Adverse event: Potassium Imbalance
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 44 at risk

Adverse event: Protein Metabolism Disorders Nec
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 44 at risk

Adverse event: Total Fluid Volume Decreased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 44 at risk

Adverse event: Connective Tissue Disorders (Excl Le)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 44 at risk

Adverse event: Joint Related Disorders Nec
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 44 at risk

Adverse event: Musculoskeletal And Connective Tissue Pain And Discomfort
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 44 at risk

Adverse event: Musculoskeletal And Connective Tissue Signs And Symptoms Nec
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 44 at risk

Adverse event: Soft Tissue Disorders Nec
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 44 at risk

Adverse event: Tendon Disorders
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 44 at risk

Adverse event: Central Nervous System Haemorrhages And Cerebrovascular Accidents
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 44 at risk

Adverse event: Cortical Dysfunction Nec
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 44 at risk

Adverse event: Headaches Nec
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 44 at risk

Adverse event: Neurological Signs And Symptoms Nec
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 44 at risk

Adverse event: Paralysis And Paresis (Excl Cranial Nerve)
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 44 at risk

Adverse event: Anxiety Disorders Nec
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 44 at risk

Adverse event: Depressive Disorders
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 44 at risk

Adverse event: Disturbances In Initiating And Maintaining Sleep
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 44 at risk

Adverse event: Increased Physical Activity Levels
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 44 at risk

Adverse event: Renal Failure And Impairment
Serious: no
Organ System: Renal and urinary disorders
Frequency: 5 affected / 44 at risk

Adverse event: Urinary Abnormalities
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 44 at risk

Adverse event: Breast Disorders Nec
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 44 at risk

Adverse event: Breast Signs And Symptoms
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 44 at risk

Adverse event: Breathing Abnormalities
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 44 at risk

Adverse event: Coughing And Associated Symptoms
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 44 at risk

Adverse event: Pneumothorax And Pleural Effusions Nec
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 44 at risk

Adverse event: Respiratory Failures (Excl Neonatal)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 44 at risk

Adverse event: Upper Respiratory Tract Signs And Symptoms
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 44 at risk

Adverse event: Dermal And Epidermal Conditions Nec
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 44 at risk

Adverse event: Dermatitis And Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 44 at risk

Adverse event: Dermatitis Ascribed To Specific Agent
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 44 at risk

Adverse event: Erythemas
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 44 at risk

Adverse event: Exfoliative Conditions
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 44 at risk

Adverse event: Hyperkeratoses
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 44 at risk

Adverse event: Pruritus Nec
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 44 at risk

Adverse event: Skin And Subcutaneous Tissue Ulcerations
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 44 at risk

Adverse event: Skin Haemorrhages
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 44 at risk

Adverse event: Skin Injuries And Mechanical Dermatoses
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 44 at risk

Adverse event: Aortic Aneurysms And Dissections
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 44 at risk

Adverse event: Blood Pressure Disorders Nec
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 44 at risk

Adverse event: Non-Site Specific Necrosis And Vascular Insufficiency Nec
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 44 at risk

Adverse event: Peripheral Aneurysms And Dissections
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 44 at risk

Adverse event: Peripheral Vasoconstriction, Necrosis And Vascular Insufficiency
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 44 at risk

Adverse event: Vascular Hypotensive Disorders
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 44 at risk

Adverse event: Vascular Malformations And Acquired Anomalies
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 44 at risk

Adverse event: Cardiac Conduction Disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 5 at risk

Adverse event: Heart Failures Nec
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 5 at risk

Adverse event: Ischaemic Coronary Artery Disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 5 at risk

Adverse event: Ventricular Arrhythmias And Cardiac Arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 5 at risk

Adverse event: Device Issues Nec
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 5 at risk

Adverse event: Osteoarthropathies
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 5 at risk

Adverse event: Upper Respiratory Tract Signs And Symptoms
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 5 at risk

Adverse event: Aortic Aneurysms And Dissections
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 5 at risk

Adverse event: Anaemias Nec
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 5 at risk

Adverse event: Cardiac Conduction Disorders
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 5 at risk

Adverse event: Cardiac Signs And Symptoms Nec
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 5 at risk

Adverse event: Heart Failures Nec
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 5 at risk

Adverse event: Ventricular Arrhythmias And Cardiac Arrest
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 5 at risk

Adverse event: Diarrhoea (Excl Infective)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 5 at risk

Adverse event: Gastrointestinal Atonic And Hypomotility Disorders Nec
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 5 at risk

Adverse event: Nausea And Vomiting Symptoms
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 5 at risk

Adverse event: Administration Site Reactions Nec
Serious: no
Organ System: General disorders
Frequency: 2 affected / 5 at risk

Adverse event: Febrile Disorders
Serious: no
Organ System: General disorders
Frequency: 2 affected / 5 at risk

Adverse event: Implant And Catheter Site Reactions
Serious: no
Organ System: General disorders
Frequency: 1 affected / 5 at risk

Adverse event: Hepatic Enzymes And Function Abnormalities
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 5 at risk

Adverse event: Upper Respiratory Tract Infections
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 5 at risk

Adverse event: Non-Site Specific Injuries Nec
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 5 at risk

Adverse event: Faecal Analyses Nec
Serious: no
Organ System: Investigations
Frequency: 1 affected / 5 at risk

Adverse event: Liver Function Analyses
Serious: no
Organ System: Investigations
Frequency: 1 affected / 5 at risk

Adverse event: Platelet Analyses
Serious: no
Organ System: Investigations
Frequency: 1 affected / 5 at risk

Adverse event: Protein Analyses Nec
Serious: no
Organ System: Investigations
Frequency: 3 affected / 5 at risk

Adverse event: Renal Function Analyses
Serious: no
Organ System: Investigations
Frequency: 1 affected / 5 at risk

Adverse event: Skeletal And Cardiac Muscle Analyses
Serious: no
Organ System: Investigations
Frequency: 3 affected / 5 at risk

Adverse event: Triglyceride Analyses
Serious: no
Organ System: Investigations
Frequency: 1 affected / 5 at risk

Adverse event: Vascular Tests Nec (Incl Blood Pressure)
Serious: no
Organ System: Investigations
Frequency: 2 affected / 5 at risk

Adverse event: White Blood Cell Analyses
Serious: no
Organ System: Investigations
Frequency: 3 affected / 5 at risk

Adverse event: Disorders Of Purine Metabolism
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 5 at risk

Adverse event: Osteoarthropathies
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 5 at risk

Adverse event: Disturbances In Initiating And Maintaining Sleep
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 5 at risk

Adverse event: Renal Failure And Impairment
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 5 at risk

Adverse event: Breast Signs And Symptoms
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 5 at risk

Adverse event: Breathing Abnormalities
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 5 at risk

Adverse event: Coughing And Associated Symptoms
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 5 at risk

Adverse event: Pulmonary Oedemas
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 5 at risk

Adverse event: Dermatitis And Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 5 at risk

Adverse event: Haemorrhages Nec
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 5 at risk

Adverse event: Coronary Artery Disorders Nec
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 6 at risk

Adverse event: Heart Failures Nec
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 6 at risk

Adverse event: Non-Site Specific Gastrointestinal Haemorrhages
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Bacterial Infections Nec
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 6 at risk

Adverse event: Lower Respiratory Tract And Lung Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 6 at risk

Adverse event: Sepsis, Bacteraemia, Viraemia And Fungaemia Nec
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 6 at risk

Adverse event: Non-Site Specific Injuries Nec
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 6 at risk

Adverse event: Diabetes Mellitus (Incl Subtypes)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 6 at risk

Adverse event: Breast And Nipple Neoplasms Malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 6 at risk

Adverse event: Central Nervous System Haemorrhages And Cerebrovascular Accidents
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 6 at risk

Adverse event: Renal Vascular And Ischaemic Conditions
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 6 at risk

Adverse event: Breathing Abnormalities
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Peripheral Embolism And Thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 6 at risk

Adverse event: Anaemias Nec
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 6 at risk

Adverse event: Cardiac Conduction Disorders
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 6 at risk

Adverse event: Heart Failures Nec
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 6 at risk

Adverse event: Ischaemic Coronary Artery Disorders
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 6 at risk

Adverse event: Rate And Rhythm Disorders Nec
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 6 at risk

Adverse event: Supraventricular Arrhythmias
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 6 at risk

Adverse event: Cataract Conditions
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 6 at risk

Adverse event: Diarrhoea (Excl Infective)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 6 at risk

Adverse event: Gastrointestinal Atonic And Hypomotility Disorders Nec
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 6 at risk

Adverse event: Gastrointestinal Signs And Symptoms Nec
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Nausea And Vomiting Symptoms
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Administration Site Reactions Nec
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Febrile Disorders
Serious: no
Organ System: General disorders
Frequency: 2 affected / 6 at risk

Adverse event: Inflammations
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Injection Site Reactions
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Oedema Nec
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Urinary Tract Infections
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 6 at risk

Adverse event: Fractures And Dislocations Nec
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 6 at risk

Adverse event: Gastrointestinal And Hepatobiliary Procedural Complications
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 6 at risk

Adverse event: Non-Site Specific Injuries Nec
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 5 affected / 6 at risk

Adverse event: Non-Site Specific Procedural Complications
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 6 at risk

Adverse event: Coagulation And Bleeding Analyses
Serious: no
Organ System: Investigations
Frequency: 1 affected / 6 at risk

Adverse event: Lipoprotein And Lipid Tests Nec
Serious: no
Organ System: Investigations
Frequency: 1 affected / 6 at risk

Adverse event: Liver Function Analyses
Serious: no
Organ System: Investigations
Frequency: 2 affected / 6 at risk

Adverse event: Metabolism Tests Nec
Serious: no
Organ System: Investigations
Frequency: 3 affected / 6 at risk

Adverse event: Mineral And Electrolyte Analyses
Serious: no
Organ System: Investigations
Frequency: 1 affected / 6 at risk

Adverse event: Platelet Analyses
Serious: no
Organ System: Investigations
Frequency: 1 affected / 6 at risk

Adverse event: Protein Analyses Nec
Serious: no
Organ System: Investigations
Frequency: 2 affected / 6 at risk

Adverse event: Renal Function Analyses
Serious: no
Organ System: Investigations
Frequency: 1 affected / 6 at risk

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

Adverse event: Tissue Enzyme Analyses Nec
Serious: no
Organ System: Investigations
Frequency: 3 affected / 6 at risk

Adverse event: Vascular Tests Nec (Incl Blood Pressure)
Serious: no
Organ System: Investigations
Frequency: 3 affected / 6 at risk

Adverse event: Appetite Disorders
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 6 at risk

Adverse event: Diabetes Mellitus (Incl Subtypes)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 6 at risk

Adverse event: Potassium Imbalance
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 6 at risk

Adverse event: Protein Metabolism Disorders Nec
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 6 at risk

Adverse event: Musculoskeletal And Connective Tissue Pain And Discomfort
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 6 at risk

Adverse event: Headaches Nec
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 6 at risk

Adverse event: Sensory Abnormalities Nec
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 6 at risk

Adverse event: Vagus Nerve Disorders
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 6 at risk

Adverse event: Anxiety Symptoms
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 6 at risk

Adverse event: Renal Failure And Impairment
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 6 at risk

Adverse event: Vulvovaginal Disorders Nec
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 6 at risk

Adverse event: Nasal Disorders Nec
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Pneumothorax And Pleural Effusions Nec
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 6 at risk

Adverse event: Pulmonary Oedemas
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 6 at risk

Adverse event: Dermatitis And Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 6 at risk

Adverse event: Ichthyoses
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 6 at risk

Adverse event: Purpura And Related Conditions
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 6 at risk

Adverse event: Blood Pressure Disorders Nec
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 6 at risk

Adverse event: Vascular Hypotensive Disorders
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 6 at risk

Adverse event: Anaemias Nec
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 55 at risk

Adverse event: Aortic Valvular Disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 55 at risk

Adverse event: Cardiac Conduction Disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 13 affected / 55 at risk

Adverse event: Cardiac Disorders Nec
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 55 at risk

Adverse event: Coronary Artery Disorders Nec
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 55 at risk

Adverse event: Heart Failures Nec
Serious: yes
Organ System: Cardiac disorders
Frequency: 10 affected / 55 at risk

Adverse event: Ischaemic Coronary Artery Disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 55 at risk

Adverse event: Myocardial Disorders Nec
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 55 at risk

Adverse event: Pericardial Disorders Nec
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 55 at risk

Adverse event: Supraventricular Arrhythmias
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 55 at risk

Adverse event: Ventricular Arrhythmias And Cardiac Arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 55 at risk

Adverse event: Cataract Conditions
Serious: yes
Organ System: Eye disorders
Frequency: 3 affected / 55 at risk

Adverse event: Gastrointestinal Ulcers And Perforation, Site Unspecified
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 55 at risk

Adverse event: Non-Site Specific Gastrointestinal Haemorrhages
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 55 at risk

Adverse event: Asthenic Conditions
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 55 at risk

Adverse event: Death And Sudden Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 55 at risk

Adverse event: Device Issues Nec
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 55 at risk

Adverse event: Febrile Disorders
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 55 at risk

Adverse event: General Signs And Symptoms Nec
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 55 at risk

Adverse event: Pain And Discomfort Nec
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 55 at risk

Adverse event: Cholecystitis And Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 55 at risk

Adverse event: Hepatic Enzymes And Function Abnormalities
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 55 at risk

Adverse event: Hepatic Failure And Associated Disorders
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 55 at risk

Adverse event: Obstructive Bile Duct Disorders (Excl Neoplasms)
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 55 at risk

Adverse event: Abdominal And Gastrointestinal Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 55 at risk

Adverse event: Bacterial Infections Nec
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 55 at risk

Adverse event: Infections Nec
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 55 at risk

Adverse event: Lower Respiratory Tract And Lung Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 7 affected / 55 at risk

Adverse event: Sepsis, Bacteraemia, Viraemia And Fungaemia Nec
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 55 at risk

Adverse event: Stretococcal Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 55 at risk

Adverse event: Cerebral Injuries Nec
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 55 at risk

Adverse event: Lower Limb Fractures And Dislocations
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 55 at risk

Adverse event: Non-Site Specific Injuries Nec
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 55 at risk

Adverse event: Non-Site Specific Procedural Complications
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 55 at risk

Adverse event: Pelvic Fractures And Dislocations
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 55 at risk

Adverse event: Spinal Fractures And Dislocations
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 55 at risk

Adverse event: Physical Examination Procedures
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 55 at risk

Adverse event: Diabetes Mellitus (Incl Subtypes)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 55 at risk

Adverse event: General Nutritional Disorders Nec
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 55 at risk

Adverse event: Muscle Weakness Conditions
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 55 at risk

Adverse event: Musculoskeletal And Connective Tissue Pain And Discomfort
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 55 at risk

Adverse event: Osteoarthropathies
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 55 at risk

Adverse event: Breast And Nipple Neoplasms Malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 55 at risk

Adverse event: Hepatic Neoplasms Malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 55 at risk

Adverse event: Hepatobiliary Neoplasms Malignancy Unspecified
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 55 at risk

Adverse event: Lymphomas Unspecified Nec
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 55 at risk

Adverse event: Central Nervous System Haemorrhages And Cerebrovascular Accidents
Serious: yes
Organ System: Nervous system disorders
Frequency: 8 affected / 55 at risk

Adverse event: Central Nervous System Vascular Disorders Nec
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 55 at risk

Adverse event: Anxiety Disorders Nec
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 55 at risk

Adverse event: Renal Failure And Impairment
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 55 at risk

Adverse event: Renal Vascular And Ischaemic Conditions
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 55 at risk

Adverse event: Pelvic Prolapse Conditions
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 55 at risk

Adverse event: Breathing Abnormalities
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 55 at risk

Adverse event: Lower Respiratory Tract Inflammatory And Immunologic Conditions
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 55 at risk

Adverse event: Mediastinal Disorders
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 55 at risk

Adverse event: Nasal Disorders Nec
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 55 at risk

Adverse event: Parenchymal Lung Disorders Nec
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 55 at risk

Adverse event: Pneumothorax And Pleural Effusions Nec
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 55 at risk

Adverse event: Pulmonary Oedemas
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 55 at risk

Adverse event: Respiratory Failures (Excl Neonatal)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 55 at risk

Adverse event: Upper Respiratory Tract Signs And Symptoms
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 55 at risk

Adverse event: Dermatitis Ascribed To Specific Agent
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 55 at risk

Adverse event: Aortic Aneurysms And Dissections
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 55 at risk

Adverse event: Circulatory Collapse And Shock
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 55 at risk

Adverse event: Peripheral Embolism And Thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 55 at risk

Adverse event: Peripheral Vasoconstriction, Necrosis And Vascular Insufficiency
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 55 at risk

Adverse event: Vascular Hypotensive Disorders
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 55 at risk

Adverse event: Anaemias Nec
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 16 affected / 55 at risk

Adverse event: Coagulopathies
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 55 at risk

Adverse event: Thrombocytopenias
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 55 at risk

Adverse event: Cardiac Conduction Disorders
Serious: no
Organ System: Cardiac disorders
Frequency: 33 affected / 55 at risk

Adverse event: Cardiac Signs And Symptoms Nec
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 55 at risk

Adverse event: Heart Failures Nec
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 55 at risk

Adverse event: Ischaemic Coronary Artery Disorders
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 55 at risk

Adverse event: Mitral Valvular Disorders
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 55 at risk

Adverse event: Pericardial Disorders Nec
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 55 at risk

Adverse event: Rate And Rhythm Disorders Nec
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 55 at risk

Adverse event: Supraventricular Arrhythmias
Serious: no
Organ System: Cardiac disorders
Frequency: 11 affected / 55 at risk

Adverse event: Ventricular Arrhythmias And Cardiac Arrest
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 55 at risk

Adverse event: Ear Disorders Nec
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 55 at risk

Adverse event: Inner Ear Signs And Symptoms
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 55 at risk

Adverse event: Adrenal Cortical Hypofunctions
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 55 at risk

Adverse event: Thyroid Hypofunction Disorders
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 55 at risk

Adverse event: Cataract Conditions
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 55 at risk

Adverse event: Diarrhoea (Excl Infective)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 55 at risk

Adverse event: Gastrointestinal Atonic And Hypomotility Disorders Nec
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 55 at risk

Adverse event: Gastrointestinal Inflammatory Disorders Nec
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 55 at risk

Adverse event: Gastrointestinal Signs And Symptoms Nec
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 55 at risk

Adverse event: Nausea And Vomiting Symptoms
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 55 at risk

Adverse event: Non-Site Specific Gastrointestinal Haemorrhages
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 55 at risk

Adverse event: Oral Soft Tissue Disorders Nec
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 55 at risk

Adverse event: Tongue Disorders
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 55 at risk

Adverse event: Tongue Signs And Symptoms
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 55 at risk

Adverse event: Administration Site Reactions Nec
Serious: no
Organ System: General disorders
Frequency: 7 affected / 55 at risk

Adverse event: Asthenic Conditions
Serious: no
Organ System: General disorders
Frequency: 2 affected / 55 at risk

Adverse event: Complications Associated With Device Nec
Serious: no
Organ System: General disorders
Frequency: 2 affected / 55 at risk

Adverse event: Febrile Disorders
Serious: no
Organ System: General disorders
Frequency: 15 affected / 55 at risk

Adverse event: Feelings And Sensations Nec
Serious: no
Organ System: General disorders
Frequency: 1 affected / 55 at risk

Adverse event: Implant And Catheter Site Reactions
Serious: no
Organ System: General disorders
Frequency: 4 affected / 55 at risk

Adverse event: Inflammations
Serious: no
Organ System: General disorders
Frequency: 4 affected / 55 at risk

Adverse event: Injection Site Reactions
Serious: no
Organ System: General disorders
Frequency: 2 affected / 55 at risk

Adverse event: Oedema Nec
Serious: no
Organ System: General disorders
Frequency: 9 affected / 55 at risk

Adverse event: Pain And Discomfort Nec
Serious: no
Organ System: General disorders
Frequency: 3 affected / 55 at risk

Adverse event: Hepatic Enzymes And Function Abnormalities
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 3 affected / 55 at risk

Adverse event: Bacterial Infections Nec
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 55 at risk

Adverse event: Infections Nec
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 55 at risk

Adverse event: Staphylococcal Infections
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 55 at risk

Adverse event: Tinea Infections
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 55 at risk

Adverse event: Upper Respiratory Tract Infections
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 55 at risk

Adverse event: Urinary Tract Infections
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 55 at risk

Adverse event: Fractures And Dislocations Nec
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 55 at risk

Adverse event: Gastrointestinal And Hepatobiliary Procedural Complications
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 55 at risk

Adverse event: Non-Site Specific Injuries Nec
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 16 affected / 55 at risk

Adverse event: Non-Site Specific Procedural Complications
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 16 affected / 55 at risk

Adverse event: Skin Injuries Nec
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 55 at risk

Adverse event: Spinal Fractures And Dislocations
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 55 at risk

Adverse event: Blood Counts Nec
Serious: no
Organ System: Investigations
Frequency: 2 affected / 55 at risk

Adverse event: Coagulation And Bleeding Analyses
Serious: no
Organ System: Investigations
Frequency: 1 affected / 55 at risk

Adverse event: Faecal Analyses Nec
Serious: no
Organ System: Investigations
Frequency: 1 affected / 55 at risk

Adverse event: Heart Rate And Pulse Investigations
Serious: no
Organ System: Investigations
Frequency: 1 affected / 55 at risk

Adverse event: Lipoprotein And Lipid Tests Nec
Serious: no
Organ System: Investigations
Frequency: 2 affected / 55 at risk

Adverse event: Liver Function Analyses
Serious: no
Organ System: Investigations
Frequency: 15 affected / 55 at risk

Adverse event: Metabolism Tests Nec
Serious: no
Organ System: Investigations
Frequency: 8 affected / 55 at risk

Adverse event: Mineral And Electrolyte Analyses
Serious: no
Organ System: Investigations
Frequency: 2 affected / 55 at risk

Adverse event: Physical Examination Procedures
Serious: no
Organ System: Investigations
Frequency: 1 affected / 55 at risk

Adverse event: Platelet Analyses
Serious: no
Organ System: Investigations
Frequency: 12 affected / 55 at risk

Adverse event: Protein Analyses Nec
Serious: no
Organ System: Investigations
Frequency: 34 affected / 55 at risk

Adverse event: Red Blood Cell Analyses
Serious: no
Organ System: Investigations
Frequency: 6 affected / 55 at risk

Adverse event: Renal Function Analyses
Serious: no
Organ System: Investigations
Frequency: 5 affected / 55 at risk

Adverse event: Skeletal And Cardiac Muscle Analyses
Serious: no
Organ System: Investigations
Frequency: 21 affected / 55 at risk

Adverse event: Tissue Enzyme Analyses Nec
Serious: no
Organ System: Investigations
Frequency: 10 affected / 55 at risk

Adverse event: Triglyceride Analyses
Serious: no
Organ System: Investigations
Frequency: 2 affected / 55 at risk

Adverse event: Urinary Tract Function Analyses Nec
Serious: no
Organ System: Investigations
Frequency: 2 affected / 55 at risk

Adverse event: Vascular Tests Nec (Incl Blood Pressure)
Serious: no
Organ System: Investigations
Frequency: 19 affected / 55 at risk

Adverse event: White Blood Cell Analyses
Serious: no
Organ System: Investigations
Frequency: 15 affected / 55 at risk

Adverse event: Appetite Disorders
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 55 at risk

Adverse event: Diabetes Mellitus (Incl Subtypes)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 55 at risk

Adverse event: Disorders Of Purine Metabolism
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 55 at risk

Adverse event: General Nutritional Disorders Nec
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 55 at risk

Adverse event: Hyperglycaemic Conditions Nec
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 55 at risk

Adverse event: Potassium Imbalance
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 55 at risk

Adverse event: Protein Metabolism Disorders Nec
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 55 at risk

Adverse event: Total Fluid Volume Decreased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 55 at risk

Adverse event: Connective Tissue Disorders (Excl Le)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 55 at risk

Adverse event: Joint Related Disorders Nec
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 55 at risk

Adverse event: Musculoskeletal And Connective Tissue Pain And Discomfort
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 55 at risk

Adverse event: Musculoskeletal And Connective Tissue Signs And Symptoms Nec
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 55 at risk

Adverse event: Osteoarthropathies
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 55 at risk

Adverse event: Soft Tissue Disorders Nec
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 55 at risk

Adverse event: Tendon Disorders
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 55 at risk

Adverse event: Central Nervous System Haemorrhages And Cerebrovascular Accidents
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 55 at risk

Adverse event: Cortical Dysfunction Nec
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 55 at risk

Adverse event: Headaches Nec
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 55 at risk

Adverse event: Neurological Signs And Symptoms Nec
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 55 at risk

Adverse event: Paralysis And Paresis (Excl Cranial Nerve)
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 55 at risk

Adverse event: Sensory Abnormalities Nec
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 55 at risk

Adverse event: Vagus Nerve Disorders
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 55 at risk

Adverse event: Anxiety Disorders Nec
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 55 at risk

Adverse event: Anxiety Symptoms
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 55 at risk

Adverse event: Depressive Disorders
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 55 at risk

Adverse event: Disturbances In Initiating And Maintaining Sleep
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 55 at risk

Adverse event: Increased Physical Activity Levels
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 55 at risk

Adverse event: Renal Failure And Impairment
Serious: no
Organ System: Renal and urinary disorders
Frequency: 8 affected / 55 at risk

Adverse event: Urinary Abnormalities
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 55 at risk

Adverse event: Breast Disorders Nec
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 55 at risk

Adverse event: Breast Signs And Symptoms
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 55 at risk

Adverse event: Vulvovaginal Disorders Nec
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 55 at risk

Adverse event: Breathing Abnormalities
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 55 at risk

Adverse event: Coughing And Associated Symptoms
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 55 at risk

Adverse event: Nasal Disorders Nec
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 55 at risk

Adverse event: Pneumothorax And Pleural Effusions Nec
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 55 at risk

Adverse event: Pulmonary Oedemas
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 55 at risk

Adverse event: Respiratory Failures (Excl Neonatal)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 55 at risk

Adverse event: Upper Respiratory Tract Signs And Symptoms
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 55 at risk

Adverse event: Dermal And Epidermal Conditions Nec
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 55 at risk

Adverse event: Dermatitis And Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 55 at risk

Adverse event: Dermatitis Ascribed To Specific Agent
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 55 at risk

Adverse event: Erythemas
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 55 at risk

Adverse event: Exfoliative Conditions
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 55 at risk

Adverse event: Hyperkeratoses
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 55 at risk

Adverse event: Ichthyoses
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 55 at risk

Adverse event: Pruritus Nec
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 55 at risk

Adverse event: Purpura And Related Conditions
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 55 at risk

Adverse event: Skin And Subcutaneous Tissue Ulcerations
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 55 at risk

Adverse event: Skin Haemorrhages
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 55 at risk

Adverse event: Skin Injuries And Mechanical Dermatoses
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 55 at risk

Adverse event: Aortic Aneurysms And Dissections
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 55 at risk

Adverse event: Blood Pressure Disorders Nec
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 55 at risk

Adverse event: Haemorrhages Nec
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 55 at risk

Adverse event: Non-Site Specific Necrosis And Vascular Insufficiency Nec
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 55 at risk

Adverse event: Peripheral Aneurysms And Dissections
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 55 at risk

Adverse event: Peripheral Vasoconstriction, Necrosis And Vascular Insufficiency
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 55 at risk

Adverse event: Vascular Hypotensive Disorders
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 55 at risk

Adverse event: Vascular Malformations And Acquired Anomalies
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 55 at risk