Study: NCT01472562

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 38 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 38 at risk

Adverse event: Basal cell carcinoma
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 38 at risk

Adverse event: Cholangitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 38 at risk

Adverse event: Malignant melanoma
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 38 at risk

Adverse event: Neuroendocrine carcinoma of the skin
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 38 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 38 at risk

Adverse event: Ventricular fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 38 at risk

Adverse event: Hip fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 38 at risk

Adverse event: Tumour flare
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 38 at risk

Adverse event: Blood Bilirubin Increase
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 38 at risk

Adverse event: Infusion related reaction
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 38 at risk

Adverse event: Rash pruritic
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 38 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 38 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 15 affected / 38 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 23 affected / 38 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 28 affected / 38 at risk

Adverse event: Blood bilirubin increased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 9 affected / 38 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 23 affected / 38 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 7 affected / 38 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 15 affected / 38 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 38 at risk

Adverse event: Bronchial Infection/ Lung Infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 38 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 38 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 38 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 21 affected / 38 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 12 affected / 38 at risk

Adverse event: Vomit
Serious: no
Organ System: General disorders
Frequency: 5 affected / 38 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 11 affected / 38 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 13 affected / 38 at risk

Adverse event: Hyperalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 13 affected / 38 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 17 affected / 38 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 12 affected / 38 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 9 affected / 38 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 38 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 13 affected / 38 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 19 affected / 38 at risk

Adverse event: Elevated Creatinine
Serious: no
Organ System: Renal and urinary disorders
Frequency: 8 affected / 38 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 38 at risk

Adverse event: Hypothyroidism
Serious: no
Organ System: Endocrine disorders
Frequency: 6 affected / 38 at risk

Adverse event: Hyperthyroidism
Serious: no
Organ System: Endocrine disorders
Frequency: 3 affected / 38 at risk

Adverse event: Elevated Alanine Aminotransferase
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 13 affected / 38 at risk

Adverse event: Elevated Aspartate Aminotransferase
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 11 affected / 38 at risk

Adverse event: Elevated Alkaline Phosphatase
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 9 affected / 38 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 22 affected / 38 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 28 affected / 38 at risk

Adverse event: Night sweats
Serious: no
Organ System: General disorders
Frequency: 9 affected / 38 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: General disorders
Frequency: 11 affected / 38 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: General disorders
Frequency: 9 affected / 38 at risk

Adverse event: Cough
Serious: no
Organ System: General disorders
Frequency: 21 affected / 38 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 12 affected / 38 at risk

Adverse event: Macro Papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 25 affected / 38 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 10 affected / 38 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 38 at risk

Adverse event: Cramping
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 38 at risk

Adverse event: Gout Flares
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 38 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 38 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 38 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 38 at risk

Adverse event: Tinnitus
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 38 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: General disorders
Frequency: 9 affected / 38 at risk

Adverse event: Head Pain/Headache/Migraine
Serious: no
Organ System: General disorders
Frequency: 10 affected / 38 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 4 affected / 38 at risk

Adverse event: Oedema
Serious: no
Organ System: General disorders
Frequency: 16 affected / 38 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 5 affected / 38 at risk

Adverse event: Tumour flare
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 13 affected / 38 at risk

Adverse event: Infusion related reaction
Serious: no
Organ System: Product Issues
Frequency: 13 affected / 38 at risk

Adverse event: Serum sickness
Serious: no
Organ System: General disorders
Frequency: 3 affected / 38 at risk