Study: NCT00947856

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 78 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 78 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 78 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 78 at risk

Adverse event: Peripheral motor neuropathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 78 at risk

Adverse event: Mental status changes
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 78 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 78 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 78 at risk

Adverse event: Small intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 78 at risk

Adverse event: Mucosal inflammation
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 78 at risk

Adverse event: Anaphylactic reaction
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 78 at risk

Adverse event: Atypical pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 78 at risk

Adverse event: Gangrene
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 78 at risk

Adverse event: Gastrointestinal candidiasis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 78 at risk

Adverse event: Influenza
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 78 at risk

Adverse event: Pneumocystis jirovecii pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 78 at risk

Adverse event: Pneumonia influenzal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 78 at risk

Adverse event: Pneumonia pseudomonal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 78 at risk

Adverse event: Pseudomonal sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 78 at risk

Adverse event: Respiratory syncytial virus bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 78 at risk

Adverse event: Hip fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 78 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 78 at risk

Adverse event: Metabolic acidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 78 at risk

Adverse event: Acute myeloid leukaemia
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 78 at risk

Adverse event: Hodgkin's disease
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 78 at risk

Adverse event: Oesophageal carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 78 at risk

Adverse event: Extrapyramidal disorder
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 78 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 78 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 78 at risk

Adverse event: Pneumonitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 78 at risk

Adverse event: Pulmonary haemorrhage
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 78 at risk

Adverse event: Respiratory acidosis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 78 at risk

Adverse event: Rash erythematous
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 78 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 78 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 78 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 10 affected / 78 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 78 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 78 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 78 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 78 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 78 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 78 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 78 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 19 affected / 78 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 5 affected / 78 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 23 affected / 78 at risk

Adverse event: Non-cardiac chest pain
Serious: no
Organ System: General disorders
Frequency: 6 affected / 78 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 7 affected / 78 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 20 affected / 78 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 78 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 25 affected / 78 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 78 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 11 affected / 78 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 78 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 78 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 12 affected / 78 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 78 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 12 affected / 78 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 11 affected / 78 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 78 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 78 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 78 at risk

Adverse event: Peripheral motor neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 78 at risk

Adverse event: Peripheral sensory neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 36 affected / 78 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 78 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 78 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 6 affected / 78 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 16 affected / 78 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 78 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 78 at risk

Adverse event: Wheezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 78 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 12 affected / 78 at risk

Adverse event: Night sweats
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 78 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 10 affected / 78 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 78 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 78 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 78 at risk

Adverse event: Chest discomfort
Serious: no
Organ System: General disorders
Frequency: 4 affected / 78 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 6 affected / 78 at risk

Adverse event: Herpes zoster
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 78 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 78 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 78 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 78 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 78 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 32 at risk

Adverse event: Leukocytosis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 32 at risk

Adverse event: Methaemoglobinaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 32 at risk

Adverse event: Thrombotic thrombocytopenic purpura
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 32 at risk

Adverse event: Glaucoma
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 32 at risk

Adverse event: Necrotising retinitis
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 32 at risk

Adverse event: Gastrointestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 32 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 32 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 32 at risk

Adverse event: Peptic ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 32 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 32 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 32 at risk

Adverse event: Graft versus host disease
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 32 at risk

Adverse event: Bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 32 at risk

Adverse event: Bronchitis viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 32 at risk

Adverse event: Bronchopulmonary aspergillosis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 32 at risk

Adverse event: Herpes zoster disseminated
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 32 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 32 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 32 at risk

Adverse event: Failure to thrive
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 32 at risk

Adverse event: Hypercalcaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 32 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 32 at risk

Adverse event: Arthralgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 32 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 32 at risk

Adverse event: Peripheral motor neuropathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 32 at risk

Adverse event: Peripheral sensory neuropathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 32 at risk

Adverse event: Mental status changes
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 32 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 32 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 32 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 32 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 32 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 32 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 32 at risk

Adverse event: Adrenal insufficiency
Serious: no
Organ System: Endocrine disorders
Frequency: 2 affected / 32 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 32 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 32 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 32 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 32 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 32 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 32 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 32 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 32 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 2 affected / 32 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 11 affected / 32 at risk

Adverse event: Infusion site extravasation
Serious: no
Organ System: General disorders
Frequency: 2 affected / 32 at risk

Adverse event: Non-cardiac chest pain
Serious: no
Organ System: General disorders
Frequency: 4 affected / 32 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 5 affected / 32 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 8 affected / 32 at risk

Adverse event: Hypogammaglobulinaemia
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 32 at risk

Adverse event: Oral candidiasis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 32 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 32 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 32 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 32 at risk

Adverse event: Skin injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 32 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 32 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 32 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 32 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 32 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 32 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 32 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 32 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 32 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 32 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 32 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 32 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 32 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 32 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 32 at risk

Adverse event: Peripheral motor neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 32 at risk

Adverse event: Peripheral sensory neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 17 affected / 32 at risk

Adverse event: Syncope
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 32 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 32 at risk

Adverse event: Confusional state
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 32 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 32 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 32 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 32 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 32 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 32 at risk

Adverse event: Wheezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 32 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 32 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 32 at risk

Adverse event: Night sweats
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 32 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 32 at risk

Adverse event: Rash erythematous
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 32 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 32 at risk

Adverse event: Skin lesion
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 32 at risk

Adverse event: Flushing
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 32 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 32 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 32 at risk