Study: NCT00826449

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 47 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 47 at risk

Adverse event: Multiple organ dysfunction syndrome
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 47 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 47 at risk

Adverse event: Acidosis
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 47 at risk

Adverse event: Activated partial thromboplastin time prolonged
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 47 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 9 affected / 47 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 11 affected / 47 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Immune system disorders
Frequency: 4 affected / 47 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 47 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 47 at risk

Adverse event: Anxiety
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 47 at risk

Adverse event: Arrhythmia supraventricular
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 47 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 15 affected / 47 at risk

Adverse event: Aspiration
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 47 at risk

Adverse event: Auditory/Ear
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 47 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 47 at risk

Adverse event: Blood bilirubin increased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 47 at risk

Adverse event: Urinary bladder haemorrhage
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 47 at risk

Adverse event: Blood glucose increased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 24 affected / 47 at risk

Adverse event: Blood uric acid increased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 47 at risk

Adverse event: Blood/Bone Marrow
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 47 at risk

Adverse event: Bone pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 47 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 47 at risk

Adverse event: Cardiac General
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 47 at risk

Adverse event: Angina pectoris
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 47 at risk

Adverse event: Troponin I increased
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 47 at risk

Adverse event: Chest pain
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 47 at risk

Adverse event: Musculoskeletal chest pain
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 47 at risk

Adverse event: Coagulation
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 47 at risk

Adverse event: Colitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 47 at risk

Adverse event: Colitis, infectious
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 47 at risk

Adverse event: Conjunctival disorder
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 47 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 47 at risk

Adverse event: Constitutional Symptoms
Serious: no
Organ System: General disorders
Frequency: 2 affected / 47 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 30 affected / 47 at risk

Adverse event: Blood creatine phosphokinase increased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 47 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 13 affected / 47 at risk

Adverse event: Dehydration
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 47 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 11 affected / 47 at risk

Adverse event: Dermatology/Skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 47 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 32 affected / 47 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 47 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 47 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 47 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 47 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 47 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 47 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 34 affected / 47 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 9 affected / 47 at risk

Adverse event: Electrocardiogram QT prolonged
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 47 at risk

Adverse event: Endocrine
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 47 at risk

Adverse event: Erectile dysfunction
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 47 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 38 affected / 47 at risk

Adverse event: Pyrexia
Serious: no
Organ System: Investigations
Frequency: 6 affected / 47 at risk

Adverse event: Flushing
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 47 at risk

Adverse event: Gait disturbance
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 47 at risk

Adverse event: Gallbladder obstruction
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 47 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 47 at risk

Adverse event: Gastrointestinal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 47 at risk

Adverse event: Gastrointestinal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 47 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 12 affected / 47 at risk

Adverse event: Deafness
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 3 affected / 47 at risk

Adverse event: Haemoglobin decreased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 34 affected / 47 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 47 at risk

Adverse event: Haemorrhage urinary tract
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 47 at risk

Adverse event: Hemorrhage/Bleeding
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 47 at risk

Adverse event: Hot flush
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 47 at risk

Adverse event: Hypercalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 47 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 9 affected / 47 at risk

Adverse event: Hypoparathyroidism
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 47 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 47 at risk

Adverse event: Hypothyroidism
Serious: no
Organ System: Endocrine disorders
Frequency: 2 affected / 47 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 47 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 47 at risk

Adverse event: Infection (Other)
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 47 at risk

Adverse event: International normalised ratio increased
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: INR - International Normalized Ratio of prothrombin time
Frequency: 1 affected / 47 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 8 affected / 47 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 47 at risk

Adverse event: Laryngeal haemorrhage
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 47 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 47 at risk

Adverse event: Localised oedema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 47 at risk

Adverse event: Lymphatics
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 47 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 9 affected / 47 at risk

Adverse event: Metabolic/Laboratory
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 11 affected / 47 at risk

Adverse event: Mini mental status examination abnormal
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 47 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 47 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 47 at risk

Adverse event: Musculoskeletal
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 47 at risk

Adverse event: Myocardial ischaemia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 47 at risk

Adverse event: Nail disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 47 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 30 affected / 47 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 47 at risk

Adverse event: Neurology
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 47 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 47 at risk

Adverse event: Nodal arrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 47 at risk

Adverse event: Oral pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 47 at risk

Adverse event: Osteonecrosis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 47 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 14 affected / 47 at risk

Adverse event: Pain (Other)
Serious: no
Organ System: General disorders
Frequency: 10 affected / 47 at risk