Study: NCT00805961

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 68 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 68 at risk

Adverse event: Thrombotic microangiopathy
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Thrombotic Thrombocytopenic Purpura (TTP)
Frequency: 1 affected / 68 at risk

Adverse event: CNS Hemorrhage
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 68 at risk

Adverse event: Severe Epistaxis with Hematesis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 68 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 68 at risk

Adverse event: Fever in absence of neutropenia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 68 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 68 at risk

Adverse event: Pain
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 68 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 68 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 68 at risk

Adverse event: Infection with Unknown ANC
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 68 at risk

Adverse event: Infection with Normal ANC
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 68 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 68 at risk

Adverse event: Infection - Cellulitis
Serious: yes
Organ System: Infections and infestations
Notes: Herpes Orbital Cellulitis
Frequency: 1 affected / 68 at risk

Adverse event: Infection - Urinary Tract Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 68 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 68 at risk

Adverse event: Necrotising fasciitis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 68 at risk

Adverse event: Rhabdomyolysis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 68 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 6 affected / 68 at risk

Adverse event: Cognitive disorder
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 68 at risk

Adverse event: Neuropathy - Motor
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 68 at risk

Adverse event: Somnolence
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 68 at risk

Adverse event: CNS Ischemia
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 68 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 68 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 68 at risk

Adverse event: Mental Status
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 68 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 68 at risk

Adverse event: Neurology - Other
Serious: yes
Organ System: Nervous system disorders
Notes: Progressive Glioblastoma Multiforme
Frequency: 1 affected / 68 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 68 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 68 at risk

Adverse event: Pneumonitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 68 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 68 at risk

Adverse event: Thrombosis/Thrombus/Embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 10 affected / 68 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Maintenance Treatment
Frequency: 4 affected / 57 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Modality Treatment
Frequency: 11 affected / 68 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Modality Treatment
Frequency: 19 affected / 68 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Notes: Modality Treatment
Frequency: 4 affected / 68 at risk

Adverse event: Nausea/Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Modality Treatment
Frequency: 8 affected / 68 at risk

Adverse event: Stomatitis/Mucositis
Serious: no
Organ System: Gastrointestinal disorders
Notes: Modality Treatment
Frequency: 7 affected / 68 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Modality Treatment
Frequency: 4 affected / 68 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Maintenance Treatment
Frequency: 10 affected / 57 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Maintenance Treatment
Frequency: 27 affected / 57 at risk

Adverse event: Thrombosis/Embolism
Serious: no
Organ System: Vascular disorders
Notes: Maintenance Treatment
Frequency: 8 affected / 57 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Notes: Maintenance Treatment
Frequency: 22 affected / 57 at risk

Adverse event: Pneumonitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Maintenance Treatment
Frequency: 5 affected / 57 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Renal and urinary disorders
Notes: Maintenance Treatment
Frequency: 11 affected / 57 at risk

Adverse event: Stomatitis/Mucositis
Serious: no
Organ System: Gastrointestinal disorders
Notes: Maintenance Treatment
Frequency: 7 affected / 57 at risk

Adverse event: Hyperlipidaemia
Serious: no
Organ System: General disorders
Notes: Maintenance Treatment
Frequency: 5 affected / 57 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Maintenance Treatment
Frequency: 4 affected / 57 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Maintenance Treatment
Frequency: 9 affected / 57 at risk

Adverse event: Nausea/Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Maintenance Treatment
Frequency: 3 affected / 57 at risk