Study: NCT00365417

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 45 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 45 at risk

Adverse event: Oesophagitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 45 at risk

Adverse event: Hand-foot
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 45 at risk

Adverse event: Haemoglobin
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 45 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 45 at risk

Adverse event: Infection - blood
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 45 at risk

Adverse event: Infection - catheter related
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 45 at risk

Adverse event: Infection - lung (pneumonia)
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 45 at risk

Adverse event: Infection - skin (cellulites)
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 45 at risk

Adverse event: Infection - ungual (nails)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 45 at risk

Adverse event: Infection - urinary tract NOS
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 45 at risk

Adverse event: Infection with normal ANC - sinus
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 45 at risk

Adverse event: Infection with normal ANC - skin (cellulites)
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 45 at risk

Adverse event: Infection with normal ANC - upper airway NOS
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 45 at risk

Adverse event: Infection with normal ANC - urinary tract NOS
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 45 at risk

Adverse event: Infection with normal ANC - wound
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 45 at risk

Adverse event: Insomnia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 45 at risk

Adverse event: Mucositis (clinical exam) - oral cavity
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 45 at risk

Adverse event: Mucositis (functional/symptomatic) - esophagus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 45 at risk

Adverse event: Mucositis (functional/symptomatic) - oral cavity
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 45 at risk

Adverse event: Pain - abdominal NOS
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 45 at risk

Adverse event: Pain - back
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 45 at risk

Adverse event: Pain - musculoskeletal (hip)
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 45 at risk

Adverse event: Syncope (fainting)
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 45 at risk

Adverse event: Thrombosis/thrombus/embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 45 at risk

Adverse event: Alanine aminotransferase
Serious: no
Organ System: Investigations
Frequency: 3 affected / 45 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 35 affected / 45 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Frequency: 15 affected / 45 at risk

Adverse event: Blood - other HCT
Serious: no
Organ System: Investigations
Frequency: 5 affected / 45 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 45 at risk

Adverse event: Cytokine release syndrome
Serious: no
Organ System: General disorders
Frequency: 4 affected / 45 at risk

Adverse event: Dehydration
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 45 at risk

Adverse event: Dermatitis - radiation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 45 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 45 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 45 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 45 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 45 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 32 affected / 45 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 45 at risk

Adverse event: Hand-foot
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 26 affected / 45 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 45 at risk

Adverse event: Hemaglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 12 affected / 45 at risk

Adverse event: Haemorrhoids
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 45 at risk

Adverse event: Hot flush
Serious: no
Organ System: Endocrine disorders
Frequency: 11 affected / 45 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Investigations
Frequency: 4 affected / 45 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 11 affected / 45 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Investigations
Frequency: 3 affected / 45 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Investigations
Frequency: 4 affected / 45 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Investigations
Frequency: 3 affected / 45 at risk

Adverse event: Infection (documented clincally) - upper airway NOS
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 45 at risk

Adverse event: Infection - bladder (urinary)
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 45 at risk

Adverse event: Infection - other (thrush)
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 45 at risk

Adverse event: Infection with normal ANC - bladder (urinary)
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 45 at risk

Adverse event: Infection with normal ANC - pharynx
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 45 at risk

Adverse event: Infection with normal ANC - skin (cellulites)
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 45 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 6 affected / 45 at risk

Adverse event: Irregular menses
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 4 affected / 45 at risk

Adverse event: Left ventricular systolic function
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 45 at risk

Adverse event: Leukocytes
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 14 affected / 45 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Investigations
Frequency: 18 affected / 45 at risk

Adverse event: Mood Alteration
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 45 at risk

Adverse event: Mood alteration - anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 45 at risk

Adverse event: Mucositis (clinical exam) - oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 45 at risk

Adverse event: Mucositis - oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 32 affected / 45 at risk

Adverse event: Muscle weakness - whole body/generalized
Serious: no
Organ System: General disorders
Frequency: 4 affected / 45 at risk

Adverse event: Nail disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 45 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 45 at risk

Adverse event: Neuropathy - motor
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 45 at risk

Adverse event: Neuropathy - sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 45 at risk

Adverse event: Neutrophil count
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 12 affected / 45 at risk

Adverse event: Pain - abdominal NOS
Serious: no
Organ System: General disorders
Frequency: 6 affected / 45 at risk

Adverse event: Pain - back
Serious: no
Organ System: General disorders
Frequency: 4 affected / 45 at risk

Adverse event: Pain - bone
Serious: no
Organ System: General disorders
Frequency: 11 affected / 45 at risk

Adverse event: Pain - chest/thorax
Serious: no
Organ System: General disorders
Frequency: 4 affected / 45 at risk

Adverse event: Pain - extremity-limb
Serious: no
Organ System: General disorders
Frequency: 9 affected / 45 at risk

Adverse event: Pain - head/headache
Serious: no
Organ System: General disorders
Frequency: 11 affected / 45 at risk

Adverse event: Pain - joint
Serious: no
Organ System: General disorders
Frequency: 8 affected / 45 at risk

Adverse event: Pain - muscle
Serious: no
Organ System: General disorders
Frequency: 11 affected / 45 at risk

Adverse event: Pain - oral cavity
Serious: no
Organ System: General disorders
Frequency: 4 affected / 45 at risk

Adverse event: Pain - pain NOS
Serious: no
Organ System: General disorders
Frequency: 4 affected / 45 at risk

Adverse event: Pain - throat/pharynx/larynx
Serious: no
Organ System: General disorders
Frequency: 4 affected / 45 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 10 affected / 45 at risk

Adverse event: Supraventricular arrhythmia - sinus tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 45 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: General disorders
Frequency: 3 affected / 45 at risk

Adverse event: Taste disorder
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 45 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 45 at risk

Adverse event: Weight decreased
Serious: no
Organ System: General disorders
Frequency: 11 affected / 45 at risk