Study: NCT00175019

Adverse event: Anaemia Deficiencies
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 801 at risk

Adverse event: Thrombocytopenias
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 801 at risk

Adverse event: Aortic Valvular Disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 801 at risk

Adverse event: Cardiac Conduction Disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 801 at risk

Adverse event: Cardiomyopathies
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 801 at risk

Adverse event: Coronary Artery Disorders not elsewhere classified (NEC)
Serious: yes
Organ System: Cardiac disorders
Frequency: 13 affected / 801 at risk

Adverse event: Heart Failures NEC
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 801 at risk

Adverse event: Ischaemic Coronary Artery Disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 17 affected / 801 at risk

Adverse event: Myocardial Disorders NEC
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 801 at risk

Adverse event: Supraventricular Arrhythmias
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 801 at risk

Adverse event: Ventricular Arrhythmias and Cardiac Arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 801 at risk

Adverse event: Benign Neoplasms GastrointestinaI (Excluding Oral Cavity)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 801 at risk

Adverse event: Colitis (Excluding Infective)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 801 at risk

Adverse event: Diaphragmatic Hernias
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 801 at risk

Adverse event: Duodenal and Small Intestinal Stenosis and Obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 801 at risk

Adverse event: Gastrointestinal Disorders NEC
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 801 at risk

Adverse event: Hernias NEC
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 801 at risk

Adverse event: Pain and Discomfort NEC
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 801 at risk

Adverse event: Cholecystitis and Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 7 affected / 801 at risk

Adverse event: Hepatocellular Damage and Hepatitis NEC
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 801 at risk

Adverse event: Abdominal and Gastrointestinal Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 801 at risk

Adverse event: Bacterial Infections NEC
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 801 at risk

Adverse event: Bone and Joint Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 801 at risk

Adverse event: Cardiac Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 801 at risk

Adverse event: Infections NEC
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 801 at risk

Adverse event: Lower Respiratory Tract and Lung Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 7 affected / 801 at risk

Adverse event: Sepsis, Bacteraemia, Viraemia, and Fungaemia NEC
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 801 at risk

Adverse event: Staphylococcal Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 801 at risk

Adverse event: Upper Respiratory Tract Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 801 at risk

Adverse event: Urinary Tract Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 801 at risk

Adverse event: Cardiac and Vascular Procedural Complications
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 801 at risk

Adverse event: Cerebral Injuries NEC
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 801 at risk

Adverse event: Limb Injuries NEC (Including Traumatic Amputation)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 801 at risk

Adverse event: Lower limb Fractures and Dislocations
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 801 at risk

Adverse event: Muscle, Tendon and Ligament Injuries
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 801 at risk

Adverse event: Non-Site Specific Injuries NEC
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 801 at risk

Adverse event: Non-Site Specific Procedural Complications
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 801 at risk

Adverse event: Neurologic Diagnostic Procedures
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 801 at risk

Adverse event: Magnesium Metabolism Disorders
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 801 at risk

Adverse event: Potassium Imbalance
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 801 at risk

Adverse event: Bone Disorders NEC
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 801 at risk

Adverse event: Joint Related Disorders NEC
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 801 at risk

Adverse event: Muscle Related Signs and Symptoms NEC
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 801 at risk

Adverse event: Osteoarthropathies
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 801 at risk

Adverse event: Spine and Neck Deformities
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 801 at risk

Adverse event: B-cell Lymphomas NEC
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 801 at risk

Adverse event: Bile Duct Neoplasms Malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 801 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 / 801 at risk

Adverse event: Colonic Neoplasms Malignant
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 801 at risk

Adverse event: Endocrine Neoplasms Benign NEC
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 801 at risk

Adverse event: Neoplasms Benign Site Unspecified NEC
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 801 at risk

Adverse event: Ovarian Neoplasms Benign
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 801 at risk

Adverse event: Prostatic Neoplasms Malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 801 at risk

Adverse event: Renal cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 801 at risk

Adverse event: Central Nervous System Haemorrhages and CVA
Serious: yes
Organ System: Nervous system disorders
Frequency: 6 affected / 801 at risk

Adverse event: Central Nervous System Vascular Disorders NEC
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 801 at risk

Adverse event: Disturbances in Consciousness NEC
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 801 at risk

Adverse event: Neurological Signs and Symptoms NEC
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 801 at risk

Adverse event: Paralysis and Paresis (Excl Cranial Nerve)
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 801 at risk

Adverse event: Renal Failure and Impairment
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 801 at risk

Adverse event: Breathing Abnormalities
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 801 at risk

Adverse event: Bronchospasms and Obstruction
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 801 at risk

Adverse event: Pulmonary Thrombotic and Embolic Conditions
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 801 at risk

Adverse event: Apocrine and Eccrine Gland Disorders
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 801 at risk

Adverse event: Aortic Aneurysms and Dissections
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 801 at risk

Adverse event: Non-Site Specific Necrosis and Vascular Insufficiency NEC
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 801 at risk

Adverse event: Peripheral Embolism and Thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 801 at risk

Adverse event: Peripheral Vascular Disorders NEC
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 801 at risk

Adverse event: Peripheral Vasoconstriction, Necrosis and Vascular Insuff.
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 801 at risk

Adverse event: Vascular Hypertensive Disorders NEC
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 801 at risk

Adverse event: Diarrhoea (Excl Infective)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 38 affected / 801 at risk

Adverse event: Oedema NEC
Serious: no
Organ System: General disorders
Frequency: 49 affected / 801 at risk

Adverse event: Influenza Viral Infections
Serious: no
Organ System: Infections and infestations
Frequency: 44 affected / 801 at risk

Adverse event: Lower Respiratory Tract and Lung Infections
Serious: no
Organ System: Infections and infestations
Frequency: 60 affected / 801 at risk

Adverse event: Upper Respiratory Tract Infections
Serious: no
Organ System: Infections and infestations
Frequency: 246 affected / 801 at risk

Adverse event: Joint Related Signs and Symptoms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 100 affected / 801 at risk

Adverse event: Musculoskeletal and Connective Tissues Signs and Symptoms NEC
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 140 affected / 801 at risk

Adverse event: Headache NEC
Serious: no
Organ System: Nervous system disorders
Frequency: 45 affected / 801 at risk

Adverse event: Dermatitis and Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 44 affected / 801 at risk

Adverse event: Vascular Hypertensive Disorders NEC
Serious: no
Organ System: Vascular disorders
Frequency: 67 affected / 801 at risk

Adverse event: Coronary Artery Disorders not elsewhere classified (NEC)
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 487 at risk

Adverse event: Heart Failures NEC
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 487 at risk

Adverse event: Ischaemic Coronary Artery Disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 487 at risk

Adverse event: Supraventricular Arrhythmias
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 487 at risk

Adverse event: Male Reproductive Tract Disorders Congenital
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 487 at risk

Adverse event: Hearing Losses
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 487 at risk

Adverse event: Inner Ear Signs and Symptoms
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 487 at risk

Adverse event: Abdominal Hernias, Site Unspecified
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 487 at risk

Adverse event: Benign Neoplasms GastrointestinaI (Excluding Oral Cavity)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 487 at risk

Adverse event: Colitis (Excluding Infective)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 487 at risk

Adverse event: Gastrointestinal Atonic and Hypomotility Disorders NEC
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 487 at risk

Adverse event: Gastrointestinal Stenosis and Obstruction NEC
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 487 at risk

Adverse event: Inguinal Hernias
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 487 at risk

Adverse event: Pain and Discomfort NEC
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 487 at risk

Adverse event: Cholecystitis and Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 487 at risk

Adverse event: Abdominal and Gastrointestinal Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 487 at risk

Adverse event: Bacterial Infections NEC
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 487 at risk

Adverse event: Lower Respiratory Tract and Lung Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 487 at risk

Adverse event: Muscle, Tendon and Ligament Injuries
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 487 at risk

Adverse event: Diabetes Mellitus (Including Subtypes)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 487 at risk

Adverse event: General Nutritional Disorders NEC
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 487 at risk

Adverse event: Intervertebral disc disorder
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 487 at risk

Adverse event: Joint Related Disorders NEC
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 487 at risk

Adverse event: Osteoarthropathies
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 487 at risk

Adverse event: Non-Small Cell Malignant/Respiratory Tract Cell Type Specified
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 487 at risk

Adverse event: Oesophageal Neoplasms Malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 487 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: 1 affected / 487 at risk

Adverse event: Prostatic Neoplasms Malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 487 at risk

Adverse event: Central Nervous System Haemorrhages and CVA
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 487 at risk

Adverse event: Central Nervous System Vascular Disorders NEC
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 487 at risk

Adverse event: Disturbances in Consciousness NEC
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 487 at risk

Adverse event: Transient Cerebrovascular Events
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 487 at risk

Adverse event: Renal Lithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 487 at risk

Adverse event: Renal Vascular and Ischaemic Conditions
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 487 at risk

Adverse event: Bronchospasms and Obstruction
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 487 at risk

Adverse event: Lower Respiratory Tract Inflam. and Immunologic Conditions
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 487 at risk

Adverse event: Aortic Aneurysms and Dissections
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 487 at risk

Adverse event: Peripheral Aneurysms and Dissections
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 487 at risk

Adverse event: Vascular Hypotensive Disorders NEC
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 487 at risk

Adverse event: Diarrhoea (Excl Infective)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 33 affected / 487 at risk

Adverse event: Oedema NEC
Serious: no
Organ System: General disorders
Frequency: 17 affected / 487 at risk

Adverse event: Influenza Viral Infections
Serious: no
Organ System: Infections and infestations
Frequency: 16 affected / 487 at risk

Adverse event: Lower Respiratory Tract and Lung Infections
Serious: no
Organ System: Infections and infestations
Frequency: 27 affected / 487 at risk

Adverse event: Upper Respiratory Tract Infections
Serious: no
Organ System: Infections and infestations
Frequency: 119 affected / 487 at risk

Adverse event: Joint Related Signs and Symptoms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 50 affected / 487 at risk

Adverse event: Musculoskeletal and Connective Tissues Signs and Symptoms NEC
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 82 affected / 487 at risk

Adverse event: Headache NEC
Serious: no
Organ System: Nervous system disorders
Frequency: 38 affected / 487 at risk

Adverse event: Dermatitis and Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 23 affected / 487 at risk

Adverse event: Vascular Hypertensive Disorders NEC
Serious: no
Organ System: Vascular disorders
Frequency: 41 affected / 487 at risk

Adverse event: Coronary Artery Disorders not elsewhere classified (NEC)
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 178 at risk

Adverse event: Heart Failures NEC
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 178 at risk

Adverse event: Ischaemic Coronary Artery Disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 178 at risk

Adverse event: Supraventricular Arrhythmias
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 178 at risk

Adverse event: Intestinal Ulcers and Perforation NEC
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 178 at risk

Adverse event: Umbilical Hernias
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 178 at risk

Adverse event: Bile Duct Infections and Inflammations
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 178 at risk

Adverse event: Cholecystitis and Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 178 at risk

Adverse event: Abdominal and Gastrointestinal Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 178 at risk

Adverse event: Intervertebral disc disorder
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 178 at risk

Adverse event: Spine and Neck Deformities
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 178 at risk

Adverse event: Cervical Spinal Cord and Nerve Root Disorders
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 178 at risk

Adverse event: Neurologic Visual Problems NEC
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 178 at risk

Adverse event: Pulmonary Thrombotic and Embolic Conditions
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 178 at risk

Adverse event: Skin Neoplasms Benign
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 178 at risk

Adverse event: Peripheral Embolism and Thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 178 at risk

Adverse event: Vascular Hypertensive Disorders NEC
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 178 at risk

Adverse event: Diarrhoea (Excl Infective)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 178 at risk

Adverse event: Oedema NEC
Serious: no
Organ System: General disorders
Frequency: 3 affected / 178 at risk

Adverse event: Influenza Viral Infections
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 178 at risk

Adverse event: Lower Respiratory Tract and Lung Infections
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 178 at risk

Adverse event: Upper Respiratory Tract Infections
Serious: no
Organ System: Infections and infestations
Frequency: 30 affected / 178 at risk

Adverse event: Joint Related Signs and Symptoms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 12 affected / 178 at risk

Adverse event: Musculoskeletal and Connective Tissues Signs and Symptoms NEC
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 23 affected / 178 at risk

Adverse event: Headache NEC
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 178 at risk

Adverse event: Dermatitis and Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 178 at risk

Adverse event: Vascular Hypertensive Disorders NEC
Serious: no
Organ System: Vascular disorders
Frequency: 5 affected / 178 at risk