Study: NCT01466881

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 37 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 37 at risk

Adverse event: Cardiac disorders-Other
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 37 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 37 at risk

Adverse event: Supraventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 37 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 37 at risk

Adverse event: Gastrointestinal disorders-Other
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 37 at risk

Adverse event: Stomatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 37 at risk

Adverse event: Multiple organ dysfunction syndrome
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 37 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 37 at risk

Adverse event: Lymph gland infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 37 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 37 at risk

Adverse event: Skin infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 37 at risk

Adverse event: Alanine aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 37 at risk

Adverse event: Blood bilirubin increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 37 at risk

Adverse event: Neutrophil count decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 37 at risk

Adverse event: Platelet count decreased
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 37 at risk

Adverse event: Hypercalcaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 37 at risk

Adverse event: Flank pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 37 at risk

Adverse event: Neoplasms benign, malignant and unspecified - Other
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 37 at risk

Adverse event: Second primary malignancy
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 37 at risk

Adverse event: Encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 37 at risk

Adverse event: Facial nerve disorder
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 37 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 37 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 37 at risk

Adverse event: Renal and urinary disorders-Other
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 37 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 37 at risk

Adverse event: Rash maculo-papular
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 37 at risk

Adverse event: Skin and subcutaneous tissue disorders - Other
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 37 at risk

Adverse event: Toxic epidermal necrolysis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 37 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 37 at risk

Adverse event: Embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 37 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 23 affected / 37 at risk

Adverse event: Blood and lymphatic system disorders - Other
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 37 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 37 at risk

Adverse event: Sinus tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 37 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 37 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 37 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 37 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 37 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 37 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 37 at risk

Adverse event: Oral pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 37 at risk

Adverse event: Rectal haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 37 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 37 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 2 affected / 37 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 8 affected / 37 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 23 affected / 37 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 11 affected / 37 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 9 affected / 37 at risk

Adverse event: Infections and infestations-Other
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 37 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 37 at risk

Adverse event: Skin infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 37 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 37 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 37 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 37 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 37 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Investigations
Frequency: 8 affected / 37 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 7 affected / 37 at risk

Adverse event: Blood bilirubin increased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 37 at risk

Adverse event: CD4 lymphocytes decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 37 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 7 affected / 37 at risk

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Investigations
Frequency: 14 affected / 37 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 15 affected / 37 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 19 affected / 37 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 37 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 15 affected / 37 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 37 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 37 at risk

Adverse event: Hypercalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 37 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 37 at risk

Adverse event: Hypernatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 37 at risk

Adverse event: Hyperuricaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 37 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 9 affected / 37 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 37 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 37 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 37 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 9 affected / 37 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 37 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 37 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 37 at risk

Adverse event: Memory impairment
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 37 at risk

Adverse event: Peripheral sensory neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 37 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 37 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 37 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 37 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 37 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 37 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 37 at risk

Adverse event: Productive cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 37 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 37 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 37 at risk

Adverse event: Rash maculo-papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 37 at risk

Adverse event: Skin and subcutaneous tissue disorders - Other
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 37 at risk

Adverse event: Skin hyperpigmentation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 37 at risk

Adverse event: Skin ulcer
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 37 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 37 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 37 at risk