Study: NCT00430248

Adverse event: Coronary Artery Disorders NEC
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 757 at risk

Adverse event: Heart Failures NEC
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 757 at risk

Adverse event: Ischaemic Coronary Artery Disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 757 at risk

Adverse event: Benign Neoplasms GastrointestinaI (Excluding Oral Cavity)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 757 at risk

Adverse event: Intestinal Ulcers and Perforation NEC
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 757 at risk

Adverse event: General Signs and Symptoms NEC
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 757 at risk

Adverse event: Pain and Discomfort NEC
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 757 at risk

Adverse event: Anaphylactic Responses
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 757 at risk

Adverse event: Abdominal and Gastrointestinal Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 757 at risk

Adverse event: Bacterial Infections NEC
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 757 at risk

Adverse event: Lower Respiratory Tract and Lung Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 757 at risk

Adverse event: Non-Site Specific Procedural Complications
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 757 at risk

Adverse event: Total Fluid Volume Decreased
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 757 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 / 757 at risk

Adverse event: Neurological Signs and Symptoms NEC
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 757 at risk

Adverse event: Transient Cerebrovascular Events
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 757 at risk

Adverse event: Aortic Aneurysms and Dissections
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 757 at risk

Adverse event: Upper Respiratory Tract Infections
Serious: no
Organ System: Infections and infestations
Frequency: 71 affected / 757 at risk

Adverse event: Liver Function Analyses
Serious: no
Organ System: Investigations
Frequency: 63 affected / 757 at risk

Adverse event: Diarrhoea (Excluding Infective)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 45 affected / 757 at risk

Adverse event: Musculoskeletal and Connective Tissues Signs and Symptoms NEC
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 43 affected / 757 at risk

Adverse event: Leukocytoses not elsewhere classified (NEC)
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 756 at risk

Adverse event: Thrombocytopenias
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 756 at risk

Adverse event: Cardiac Conduction Disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 756 at risk

Adverse event: Ischaemic Coronary Artery Disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 756 at risk

Adverse event: Supraventricular Arrhythmias
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 756 at risk

Adverse event: Inner Ear Signs and Symptoms
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 756 at risk

Adverse event: Acute and Chronic Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 756 at risk

Adverse event: Intestinal Ulcers and Perforation NEC
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 756 at risk

Adverse event: Non-Site Specific Gastrointestinal Haemorrhages
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 756 at risk

Adverse event: Pain and Discomfort NEC
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 756 at risk

Adverse event: Bacterial Infections NEC
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 756 at risk

Adverse event: Lower Respiratory Tract and Lung Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 756 at risk

Adverse event: Sepsis, Bacteraemia, Viraemia, and Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 756 at risk

Adverse event: Fractures and Dislocations NEC
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 756 at risk

Adverse event: Muscle, Tendon and Ligament Injuries
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 756 at risk

Adverse event: Non-Site Specific Injuries NEC
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 756 at risk

Adverse event: Upper limb Fractures and Dislocations
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 756 at risk

Adverse event: Purine Metabolism Disorders NEC
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 756 at risk

Adverse event: Joint Related Disorders NEC
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 756 at risk

Adverse event: Joint Related Signs and Symptoms
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 756 at risk

Adverse event: Osteoarthropathies
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 756 at risk

Adverse event: Bladder Neoplasms Malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 756 at risk

Adverse event: Prostatic Neoplasms Benign
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 756 at risk

Adverse event: Prostatic Neoplasms Malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 756 at risk

Adverse event: Central Nervous System Hemorrhages & Cerebrovascular Accidents
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 756 at risk

Adverse event: Increased Intracranial Pressure Disorders
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 756 at risk

Adverse event: Transient Cerebrovascular Events
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 756 at risk

Adverse event: Renal Failure and Impairment
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 756 at risk

Adverse event: Renal Vascular and Ischaemic Conditions
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 756 at risk

Adverse event: Prostatic Signs, Symptoms and Disorders NEC
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 756 at risk

Adverse event: Bronchospasms and Obstruction
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 756 at risk

Adverse event: Pulmonary Thrombotic and Embolic Conditions
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 756 at risk

Adverse event: Upper Respiratory Tract Infections
Serious: no
Organ System: Infections and infestations
Frequency: 53 affected / 756 at risk

Adverse event: Liver Function Analyses
Serious: no
Organ System: Investigations
Frequency: 52 affected / 756 at risk

Adverse event: Diarrhoea (Excluding Infective)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 47 affected / 756 at risk

Adverse event: Musculoskeletal and Connective Tissues Signs and Symptoms NEC
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 38 affected / 756 at risk

Adverse event: Cardiac Hypertensive Complications
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 756 at risk

Adverse event: Coronary Artery Disorders NEC
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 756 at risk

Adverse event: Heart Failures NEC
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 756 at risk

Adverse event: Ischaemic Coronary Artery Disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 756 at risk

Adverse event: Dyspeptic Signs and Symptoms
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 756 at risk

Adverse event: Gastrointestinal & Abdominal Pains (Excluding Oral and Throat)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 756 at risk

Adverse event: Gastrointestinal Ulcers and Perforation, Site Unspecified
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 756 at risk

Adverse event: Intestinal Haemorrhages
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 756 at risk

Adverse event: Nausea and Vomiting Symptoms
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 756 at risk

Adverse event: Pain and Discomfort NEC
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 756 at risk

Adverse event: Cholecystitis and Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 3 affected / 756 at risk

Adverse event: Allergies to Food, Food Additives, Drugs and Other Chemicals
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 756 at risk

Adverse event: Abdominal and Gastrointestinal Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 756 at risk

Adverse event: Bacterial Infections NEC
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 756 at risk

Adverse event: Lower Respiratory Tract and Lung Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 756 at risk

Adverse event: Sepsis, Bacteraemia, Viraemia, and Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 756 at risk

Adverse event: Non-Site Specific Procedural Complications
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 756 at risk

Adverse event: Upper limb Fractures and Dislocations
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 756 at risk

Adverse event: Purine Metabolism Disorders NEC
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 756 at risk

Adverse event: Colonic Neoplasms Malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 756 at risk

Adverse event: Nervous System Neoplasms Unpecified Malignancy NEC
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 756 at risk

Adverse event: Nonsmall Cell Neoplasm Malignant/Respiratory Type Specified
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 756 at risk

Adverse event: Prostatic Neoplasms Malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 3 affected / 756 at risk

Adverse event: Central Nervous System Hemorrhages & Cerebrovascular Accidents
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 756 at risk

Adverse event: Disturbances in Consciousness NEC
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 756 at risk

Adverse event: Transient Cerebrovascular Events
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 756 at risk

Adverse event: Bronchospasms and Obstruction
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 756 at risk

Adverse event: Aortic Aneurysms and Dissections
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 756 at risk

Adverse event: Upper Respiratory Tract Infections
Serious: no
Organ System: Infections and infestations
Frequency: 57 affected / 756 at risk

Adverse event: Liver Function Analyses
Serious: no
Organ System: Investigations
Frequency: 50 affected / 756 at risk

Adverse event: Diarrhoea (Excluding Infective)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 57 affected / 756 at risk

Adverse event: Musculoskeletal and Connective Tissues Signs and Symptoms NEC
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 32 affected / 756 at risk