Study: NCT01177956

Adverse event: Anaphylactic reaction
Serious: yes
Organ System: Immune system disorders
Frequency: 2 affected / 68 at risk

Adverse event: Microcytic anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 68 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 68 at risk

Adverse event: Mouth haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 68 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 68 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 68 at risk

Adverse event: Staphylococcal skin infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 68 at risk

Adverse event: Electrolyte imbalance
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 68 at risk

Adverse event: Hypomagnesaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 68 at risk

Adverse event: Tumour haemorrhage
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 68 at risk

Adverse event: Toxic encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 68 at risk

Adverse event: Pneumonitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 68 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 68 at risk

Adverse event: Respiratory alkalosis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 68 at risk

Adverse event: Venous thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 68 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 29 affected / 68 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 19 affected / 68 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 68 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 68 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 21 affected / 68 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 68 at risk

Adverse event: Mouth ulceration
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 68 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 27 affected / 68 at risk

Adverse event: Oral pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 68 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 68 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 19 affected / 68 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 7 affected / 68 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 10 affected / 68 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: General disorders
Frequency: 9 affected / 68 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 15 affected / 68 at risk

Adverse event: Paronychia
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 68 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 68 at risk

Adverse event: Haemoglobin decreased
Serious: no
Organ System: Investigations
Frequency: 13 affected / 68 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 9 affected / 68 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 29 affected / 68 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 68 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 6 affected / 68 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 18 affected / 68 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 68 at risk

Adverse event: Hypochloraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 68 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 22 affected / 68 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 23 affected / 68 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 13 affected / 68 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 68 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 68 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 68 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 7 affected / 68 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 68 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 68 at risk

Adverse event: Acne
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 13 affected / 68 at risk

Adverse event: Dermatitis acneiform
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 68 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 10 affected / 68 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 24 affected / 68 at risk