Study: NCT00102440

Adverse event: Heart Failures NEC
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 256 at risk

Adverse event: Ischaemic Coronary Artery Disorders NEC
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 256 at risk

Adverse event: Supraventricular Arrhythmias
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 256 at risk

Adverse event: Peritoneal and Retroperitoneal Haemorrhages
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 256 at risk

Adverse event: Allergies to Food, Food Additives, Drugs and Other Chemicals
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 256 at risk

Adverse event: Infections NEC
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 256 at risk

Adverse event: Chest and Lung Injuries NEC
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 256 at risk

Adverse event: Non-Site Specific Injuries NEC
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 256 at risk

Adverse event: Site Specific Injuries NEC
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 256 at risk

Adverse event: Coagulation and Bleeding Analyses
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 256 at risk

Adverse event: Joint Related Signs and Symptoms
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 256 at risk

Adverse event: Spine and Neck Deformities
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 256 at risk

Adverse event: Renal Failure and Impairment
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 256 at risk

Adverse event: Bronchospasm and Obstruction
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 256 at risk

Adverse event: Pneumothorax and Pleural Effusions NEC
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 256 at risk

Adverse event: Respiratory Failures (Excluding [Excl] Neonatal)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 256 at risk

Adverse event: Diarrhoea (Excl Infective)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 27 affected / 256 at risk

Adverse event: Nausea and Vomiting Symptoms
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 19 affected / 256 at risk

Adverse event: Oedema NEC
Serious: no
Organ System: General disorders
Frequency: 18 affected / 256 at risk

Adverse event: Influenza Viral Infections
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 256 at risk

Adverse event: Lower Respiratory Tract and Lung Infections
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 256 at risk

Adverse event: Upper Respiratory Tract Infections
Serious: no
Organ System: Infections and infestations
Frequency: 77 affected / 256 at risk

Adverse event: Limb Injuries NEC (Including [Incl] Traumatic Amputation)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 12 affected / 256 at risk

Adverse event: Non-Site Specific Injuries NEC
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 11 affected / 256 at risk

Adverse event: Liver Function Analyses
Serious: no
Organ System: Investigations
Frequency: 13 affected / 256 at risk

Adverse event: Joint Related Signs and Symptoms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 39 affected / 256 at risk

Adverse event: Musculoskeletal and Connective Tissue Signs and Symptoms NEC
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 35 affected / 256 at risk

Adverse event: Headache NEC
Serious: no
Organ System: Nervous system disorders
Frequency: 23 affected / 256 at risk

Adverse event: Neurological Signs and Symptoms NEC
Serious: no
Organ System: Nervous system disorders
Frequency: 17 affected / 256 at risk

Adverse event: Upper Respiratory Tract Signs and Symptoms
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 13 affected / 256 at risk

Adverse event: Vascular Hypertensive Disorders NEC
Serious: no
Organ System: Vascular disorders
Frequency: 7 affected / 256 at risk

Adverse event: Heart Failures NEC
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 251 at risk

Adverse event: Ischaemic Coronary Artery Disorders NEC
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 251 at risk

Adverse event: Supraventricular Arrhythmias
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 251 at risk

Adverse event: Ventricular Arrhythmias and Cardiac Arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 251 at risk

Adverse event: Acute and Chronic Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 251 at risk

Adverse event: Intestinal Haemorrhages
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 251 at risk

Adverse event: Intestinal Ulcers and Perforation NEC
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 251 at risk

Adverse event: Febrile Disorders
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 251 at risk

Adverse event: Abdominal and Gastrointestinal Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 251 at risk

Adverse event: Lower Respiratory Tract and Lung Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 251 at risk

Adverse event: Skin Structures and Soft Tissue Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 251 at risk

Adverse event: Urinary Tract Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 251 at risk

Adverse event: Viral Infections NEC
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 251 at risk

Adverse event: Colonic Neoplasms Malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 251 at risk

Adverse event: Prostatic Neoplasms Malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 251 at risk

Adverse event: Central Nervous System Vascular Disorders NEC
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 251 at risk

Adverse event: Central nervous system Hemorrhages & Cerebrovascular Accidents
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 251 at risk

Adverse event: Cervical Spinal Cord and Nerve Root Disorders
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 251 at risk

Adverse event: Disturbances in Consciousness NEC
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 251 at risk

Adverse event: Encephalopathies NEC
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 251 at risk

Adverse event: Pulmonary Thrombotic and Embolic Conditions
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 251 at risk

Adverse event: Respiratory Failures (Excluding [Excl] Neonatal)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 251 at risk

Adverse event: Peripheral Embolism and Thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 251 at risk

Adverse event: Diarrhoea (Excl Infective)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 25 affected / 251 at risk

Adverse event: Nausea and Vomiting Symptoms
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 251 at risk

Adverse event: Oedema NEC
Serious: no
Organ System: General disorders
Frequency: 8 affected / 251 at risk

Adverse event: Influenza Viral Infections
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 251 at risk

Adverse event: Lower Respiratory Tract and Lung Infections
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 251 at risk

Adverse event: Upper Respiratory Tract Infections
Serious: no
Organ System: Infections and infestations
Frequency: 53 affected / 251 at risk

Adverse event: Limb Injuries NEC (Including [Incl] Traumatic Amputation)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 10 affected / 251 at risk

Adverse event: Non-Site Specific Injuries NEC
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 10 affected / 251 at risk

Adverse event: Liver Function Analyses
Serious: no
Organ System: Investigations
Frequency: 16 affected / 251 at risk

Adverse event: Joint Related Signs and Symptoms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 32 affected / 251 at risk

Adverse event: Musculoskeletal and Connective Tissue Signs and Symptoms NEC
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 38 affected / 251 at risk

Adverse event: Headache NEC
Serious: no
Organ System: Nervous system disorders
Frequency: 23 affected / 251 at risk

Adverse event: Neurological Signs and Symptoms NEC
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 251 at risk

Adverse event: Upper Respiratory Tract Signs and Symptoms
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 251 at risk

Adverse event: Vascular Hypertensive Disorders NEC
Serious: no
Organ System: Vascular disorders
Frequency: 10 affected / 251 at risk

Adverse event: Cardiac Disorders not elsewhere classified (NEC)
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 253 at risk

Adverse event: Coronary Artery Disorders NEC
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 253 at risk

Adverse event: Ischaemic Coronary Artery Disorders NEC
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 253 at risk

Adverse event: Rate and Rhythm Disorders NEC
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 253 at risk

Adverse event: Ventricular Arrhythmias and Cardiac Arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 253 at risk

Adverse event: Gastrointestinal Fistulae
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 253 at risk

Adverse event: Gastrointestinal Ulcers and Perforation, Site Unspecified
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 253 at risk

Adverse event: Umbilical Hernias
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 253 at risk

Adverse event: Abdominal and Gastrointestinal Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 253 at risk

Adverse event: Staphylococcal Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 253 at risk

Adverse event: Musculoskeletal and Connective Tissue Signs and Symptoms NEC
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 253 at risk

Adverse event: Osteoarthropathies
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 253 at risk

Adverse event: Testicular Neoplasms Malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 253 at risk

Adverse event: Disturbances in Consciousness NEC
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 253 at risk

Adverse event: Renal Lithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 253 at risk

Adverse event: Diarrhoea (Excl Infective)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 253 at risk

Adverse event: Nausea and Vomiting Symptoms
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 253 at risk

Adverse event: Oedema NEC
Serious: no
Organ System: General disorders
Frequency: 8 affected / 253 at risk

Adverse event: Influenza Viral Infections
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 253 at risk

Adverse event: Lower Respiratory Tract and Lung Infections
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 253 at risk

Adverse event: Upper Respiratory Tract Infections
Serious: no
Organ System: Infections and infestations
Frequency: 72 affected / 253 at risk

Adverse event: Limb Injuries NEC (Including [Incl] Traumatic Amputation)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 11 affected / 253 at risk

Adverse event: Non-Site Specific Injuries NEC
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 12 affected / 253 at risk

Adverse event: Liver Function Analyses
Serious: no
Organ System: Investigations
Frequency: 12 affected / 253 at risk

Adverse event: Joint Related Signs and Symptoms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 37 affected / 253 at risk

Adverse event: Musculoskeletal and Connective Tissue Signs and Symptoms NEC
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 37 affected / 253 at risk

Adverse event: Headache NEC
Serious: no
Organ System: Nervous system disorders
Frequency: 22 affected / 253 at risk

Adverse event: Neurological Signs and Symptoms NEC
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 253 at risk

Adverse event: Upper Respiratory Tract Signs and Symptoms
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 17 affected / 253 at risk

Adverse event: Vascular Hypertensive Disorders NEC
Serious: no
Organ System: Vascular disorders
Frequency: 14 affected / 253 at risk