Study: NCT01370408

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 85 at risk

Adverse event: abdominal cramping
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 19 affected / 85 at risk

Adverse event: increased alkaline phosphatase
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 11 affected / 85 at risk

Adverse event: increased ALT
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 8 affected / 85 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 65 affected / 85 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 53 affected / 85 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 85 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 32 affected / 85 at risk

Adverse event: increased AST
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 19 affected / 85 at risk

Adverse event: Abdominal tenderness
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 85 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 85 at risk

Adverse event: Rectal haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 85 at risk

Adverse event: Contusion
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 85 at risk

Adverse event: Chills
Serious: no
Organ System: Investigations
Frequency: 10 affected / 85 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 85 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 85 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 37 affected / 85 at risk

Adverse event: deconditioning
Serious: no
Organ System: Investigations
Frequency: 5 affected / 85 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 48 affected / 85 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 20 affected / 85 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 85 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 85 at risk

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 11 affected / 85 at risk

Adverse event: lower extremity edema
Serious: no
Organ System: Cardiac disorders
Frequency: 15 affected / 85 at risk

Adverse event: Fatigue
Serious: no
Organ System: Investigations
Frequency: 56 affected / 85 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 85 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 24 affected / 85 at risk

Adverse event: Hiccups
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 85 at risk

Adverse event: Hyperbilirubinaemia
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 14 affected / 85 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 47 affected / 85 at risk

Adverse event: Hypermagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 85 at risk

Adverse event: Hypernatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 11 affected / 85 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 9 affected / 85 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 33 affected / 85 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 33 affected / 85 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 85 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 23 affected / 85 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 9 affected / 85 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 14 affected / 85 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 12 affected / 85 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 23 affected / 85 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 24 affected / 85 at risk

Adverse event: memory changes
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 85 at risk

Adverse event: Oral pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 85 at risk

Adverse event: mouth sores
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 85 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 19 affected / 85 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 74 affected / 85 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Infections and infestations
Frequency: 14 affected / 85 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 85 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 85 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 15 affected / 85 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 85 at risk

Adverse event: shortness of breath with exertion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 12 affected / 85 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 85 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 19 affected / 85 at risk

Adverse event: Taste disorder
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 85 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 85 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 53 affected / 85 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 7 affected / 85 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 49 affected / 85 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 74 affected / 85 at risk

Adverse event: generalized weakness
Serious: no
Organ System: Investigations
Frequency: 16 affected / 85 at risk