Study: NCT01076504

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 80 affected / 80 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 80 affected / 80 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 80 affected / 80 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 80 affected / 80 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 80 affected / 80 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 80 affected / 80 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 80 affected / 80 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 80 affected / 80 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 80 affected / 80 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 80 affected / 80 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 80 affected / 80 at risk

Adverse event: Gastrointestinal disorders - Other, stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 80 affected / 80 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 80 affected / 80 at risk

Adverse event: Infections and infestations - Other, pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 80 affected / 80 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 80 affected / 80 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 80 affected / 80 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 80 affected / 80 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 80 affected / 80 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 80 affected / 80 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 80 affected / 80 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 80 affected / 80 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 80 affected / 80 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 35 affected / 80 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 31 affected / 80 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 29 affected / 80 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 26 affected / 80 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 25 affected / 80 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Investigations
Frequency: 23 affected / 80 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 20 affected / 80 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 18 affected / 80 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 17 affected / 80 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 16 affected / 80 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 16 affected / 80 at risk

Adverse event: Blood bilirubin increased
Serious: no
Organ System: Investigations
Frequency: 15 affected / 80 at risk

Adverse event: Investigations - Other, blood protein decreased
Serious: no
Organ System: Investigations
Frequency: 15 affected / 80 at risk

Adverse event: Investigations - Other, blood urea nitrogen increased
Serious: no
Organ System: Investigations
Frequency: 14 affected / 80 at risk

Adverse event: Investigations - Other, creatinine decreased
Serious: no
Organ System: Investigations
Frequency: 14 affected / 80 at risk

Adverse event: Cardiac disorders - Other, tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 13 affected / 80 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 13 affected / 80 at risk

Adverse event: Investigations - Other, blood chloride decreased
Serious: no
Organ System: Investigations
Frequency: 13 affected / 80 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 12 affected / 80 at risk

Adverse event: Investigations - Other, blood urea nitrogen decreased
Serious: no
Organ System: Investigations
Frequency: 12 affected / 80 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 12 affected / 80 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 80 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 11 affected / 80 at risk

Adverse event: Investigations - Other, blood bicarbonate decreased
Serious: no
Organ System: Investigations
Frequency: 11 affected / 80 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 11 affected / 80 at risk

Adverse event: Skin and subcutaneous tissue disorders - Other, erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 11 affected / 80 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 80 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 10 affected / 80 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 10 affected / 80 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 80 at risk

Adverse event: Investigations - Other, blood bicarbonate increased
Serious: no
Organ System: Investigations
Frequency: 9 affected / 80 at risk

Adverse event: Investigations - Other, blood chloride increased
Serious: no
Organ System: Investigations
Frequency: 9 affected / 80 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 80 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 80 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 7 affected / 80 at risk

Adverse event: Confusional state
Serious: no
Organ System: Psychiatric disorders
Frequency: 7 affected / 80 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 7 affected / 80 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 7 affected / 80 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 80 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 80 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 6 affected / 80 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 6 affected / 80 at risk

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Investigations
Frequency: 6 affected / 80 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 6 affected / 80 at risk

Adverse event: Peripheral sensory neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 80 at risk

Adverse event: Embolism
Serious: no
Organ System: Vascular disorders
Frequency: 6 affected / 80 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 80 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 80 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 80 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 80 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 80 at risk

Adverse event: Dysphonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 80 at risk

Adverse event: Infections and infestations - Other, oral infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 80 at risk

Adverse event: Infections and infestations - Other, unspecified
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 80 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 80 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 5 affected / 80 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 80 at risk

Adverse event: Flushing
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 80 at risk

Adverse event: Hypernatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 80 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 80 at risk

Adverse event: Psychiatric disorders - Other, change in mental status
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 80 at risk

Adverse event: Respiratory, thoracic and mediastinal disorders - Other, decreased breath sounds
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 80 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 80 at risk

Adverse event: Skin and subcutaneous tissue disorders - Other, decreased turgor
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 80 at risk

Adverse event: Syncope
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 80 at risk