Study: NCT01191190

Adverse event: Infusion related reaction
Serious: no
Organ System: Immune system disorders
Frequency: 11 affected / 21 at risk

Adverse event: Flushing
Serious: no
Organ System: Immune system disorders
Frequency: 5 affected / 21 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 21 at risk

Adverse event: Cough
Serious: no
Organ System: General disorders
Frequency: 9 affected / 21 at risk

Adverse event: Oedema
Serious: no
Organ System: General disorders
Frequency: 7 affected / 21 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 5 affected / 21 at risk

Adverse event: Hypotension
Serious: no
Organ System: General disorders
Frequency: 4 affected / 21 at risk

Adverse event: Tachycardia
Serious: no
Organ System: General disorders
Frequency: 4 affected / 21 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: General disorders
Frequency: 4 affected / 21 at risk

Adverse event: Palpitations
Serious: no
Organ System: General disorders
Frequency: 3 affected / 21 at risk

Adverse event: Arrythmia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 21 at risk

Adverse event: Non-ST elevation Myocardial Infarction
Serious: no
Organ System: General disorders
Frequency: 1 affected / 21 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 16 affected / 21 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 11 affected / 21 at risk

Adverse event: Actinic keratosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 21 at risk

Adverse event: Atypical Squamous Proliferation, Folliculitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 21 at risk

Adverse event: Lichenoid keratosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 21 at risk

Adverse event: Elevated ALT
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 21 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 21 at risk

Adverse event: Elevated AST
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 21 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 21 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 21 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 21 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 21 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 21 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 21 at risk

Adverse event: Hyperbilirubinaemia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 21 at risk

Adverse event: Anemia (CTCAE)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 18 affected / 21 at risk

Adverse event: Thrombocytopenia (CTCAE)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 15 affected / 21 at risk

Adverse event: Neutropenia (CTCAE)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 10 affected / 21 at risk

Adverse event: Leukocytopenia, not captured by neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 21 at risk

Adverse event: Bleeding (superficial)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 21 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 21 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 21 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 21 at risk

Adverse event: Non-melanoma skin cancer
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 21 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: General disorders
Frequency: 18 affected / 21 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 13 affected / 21 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: General disorders
Frequency: 7 affected / 21 at risk

Adverse event: metabolic other Elevated LDH-
Serious: no
Organ System: General disorders
Frequency: 7 affected / 21 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: General disorders
Frequency: 5 affected / 21 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: General disorders
Frequency: 4 affected / 21 at risk

Adverse event: Night sweats
Serious: no
Organ System: General disorders
Frequency: 4 affected / 21 at risk

Adverse event: Weight increased
Serious: no
Organ System: General disorders
Frequency: 4 affected / 21 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 21 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 21 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 21 at risk

Adverse event: Hypernatraemia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 21 at risk

Adverse event: Hyperuricaemia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 21 at risk

Adverse event: Weight decreased
Serious: no
Organ System: General disorders
Frequency: 3 affected / 21 at risk

Adverse event: Rigors/ chills
Serious: no
Organ System: General disorders
Frequency: 2 affected / 21 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 21 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 15 affected / 21 at risk

Adverse event: Anxiety
Serious: no
Organ System: General disorders
Frequency: 7 affected / 21 at risk

Adverse event: Paraethesias
Serious: no
Organ System: General disorders
Frequency: 5 affected / 21 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 4 affected / 21 at risk

Adverse event: Tremor
Serious: no
Organ System: General disorders
Frequency: 3 affected / 21 at risk

Adverse event: Visual change
Serious: no
Organ System: General disorders
Frequency: 2 affected / 21 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: General disorders
Frequency: 2 affected / 21 at risk

Adverse event: Agitation
Serious: no
Organ System: General disorders
Frequency: 2 affected / 21 at risk

Adverse event: Pharyngolaryngeal pain/itching
Serious: no
Organ System: General disorders
Frequency: 4 affected / 21 at risk

Adverse event: Rhinnorhea
Serious: no
Organ System: General disorders
Frequency: 4 affected / 21 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: General disorders
Frequency: 3 affected / 21 at risk

Adverse event: Dysguesia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 21 at risk

Adverse event: Weak Voice
Serious: no
Organ System: General disorders
Frequency: 2 affected / 21 at risk

Adverse event: Dysphagia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 21 at risk

Adverse event: Oral ulcers
Serious: no
Organ System: General disorders
Frequency: 1 affected / 21 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: General disorders
Frequency: 5 affected / 21 at risk

Adverse event: Myalgia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 21 at risk

Adverse event: Lower Back Pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 21 at risk

Adverse event: Creatinine elevation
Serious: no
Organ System: Renal and urinary disorders
Frequency: 8 affected / 21 at risk

Adverse event: Nephrolithiasis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 21 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 21 at risk

Adverse event: Penile blister
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 21 at risk