Study: NCT01387269

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 320 at risk

Adverse event: Iliac artery occlusion
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 320 at risk

Adverse event: Inferior vena caval occlusion
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 320 at risk

Adverse event: Neoplasm progression
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 24 affected / 320 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 320 at risk

Adverse event: General physical health deterioration
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 320 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 320 at risk

Adverse event: Asthenia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 320 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 320 at risk

Adverse event: Mental status changes
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 320 at risk

Adverse event: Agitation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 320 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 320 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 320 at risk

Adverse event: Ischaemic cardiomyopathy
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 320 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 320 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 320 at risk

Adverse event: Pancytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 320 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 320 at risk

Adverse event: Leukocytosis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 320 at risk

Adverse event: Immune thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 320 at risk

Adverse event: Leukopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 320 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 320 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 320 at risk

Adverse event: Pulmonary haemorrhage
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 320 at risk

Adverse event: Pulmonary haemorrhage
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 320 at risk

Adverse event: Epistaxis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 320 at risk

Adverse event: Dyspnoea exertional
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 320 at risk

Adverse event: Pleuritic pain
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 320 at risk

Adverse event: Presyncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 320 at risk

Adverse event: Ischaemic stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 320 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 320 at risk

Adverse event: Gastrointestinal ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 320 at risk

Adverse event: Dysphagia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 320 at risk

Adverse event: Oesophagitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 320 at risk

Adverse event: Colitis ischaemic
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 320 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 320 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 320 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 320 at risk

Adverse event: Gastric haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 320 at risk

Adverse event: Small intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 320 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 320 at risk

Adverse event: Musculoskeletal chest pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 320 at risk

Adverse event: Bone pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 320 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 320 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 320 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 320 at risk

Adverse event: Hypocalcaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 320 at risk

Adverse event: Diabetes mellitus
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 320 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 320 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 320 at risk

Adverse event: Staphylococcal infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 320 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 320 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 320 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 320 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 320 at risk

Adverse event: Oral candidiasis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 320 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 320 at risk

Adverse event: Osteomyelitis acute
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 320 at risk

Adverse event: Hepatitis C
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 320 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 50 affected / 320 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 37 affected / 320 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Investigations
Frequency: 34 affected / 320 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 14 affected / 320 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 14 affected / 320 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 19 affected / 320 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 119 affected / 320 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 16 affected / 320 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 28 affected / 320 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 29 affected / 320 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 19 affected / 320 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 25 affected / 320 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 15 affected / 320 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 320 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 29 affected / 320 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 25 affected / 320 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 13 affected / 320 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 35 affected / 320 at risk

Adverse event: Neoplasm progression
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 12 affected / 161 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 161 at risk

Adverse event: General physical health deterioration
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 161 at risk

Adverse event: Pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 161 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 161 at risk

Adverse event: Asthenia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 161 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 161 at risk

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 161 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 161 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 161 at risk

Adverse event: Atrial flutter
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 161 at risk

Adverse event: Cardiopulmonary failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 161 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 161 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 161 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 161 at risk

Adverse event: Pancytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 161 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 161 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 161 at risk

Adverse event: Pulmonary haemorrhage
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 161 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 161 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 161 at risk

Adverse event: Haemoptysis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 161 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 161 at risk

Adverse event: Rectal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 161 at risk

Adverse event: Gastrointestinal ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 161 at risk

Adverse event: Dysphagia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 161 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 161 at risk

Adverse event: Urinary tract obstruction
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 161 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 161 at risk

Adverse event: Hepatic failure
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 161 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 161 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 161 at risk

Adverse event: Failure to thrive
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 161 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 161 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 161 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 161 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 161 at risk

Adverse event: Respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 161 at risk

Adverse event: Bronchopulmonary aspergillosis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 161 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 14 affected / 161 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 15 affected / 161 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Investigations
Frequency: 10 affected / 161 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 10 affected / 161 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 161 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 161 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 66 affected / 161 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 10 affected / 161 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 22 affected / 161 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 23 affected / 161 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 9 affected / 161 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 13 affected / 161 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 161 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 161 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 161 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 161 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 161 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 10 affected / 161 at risk