Study: NCT00464646

Adverse event: Pain- head/headache
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 76 at risk

Adverse event: Pain- back
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 76 at risk

Adverse event: Pain- extremity-limb
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 76 at risk

Adverse event: Pain- joint
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 76 at risk

Adverse event: Pain- NOS
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 76 at risk

Adverse event: Infection with normal ANC - skin (cellulites)
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 76 at risk

Adverse event: Infection with Normal ANC - bladder (urinary)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 76 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 76 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 76 at risk

Adverse event: Blood creatinine
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 76 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 76 at risk

Adverse event: Left ventricular systolic function
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 76 at risk

Adverse event: Neuropathy peripheral
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 76 at risk

Adverse event: Syncope
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 76 at risk

Adverse event: Mood alteration - depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 76 at risk

Adverse event: Pain - neck
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 76 at risk

Adverse event: Fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 76 at risk

Adverse event: Hypertriglyceridaemia
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 76 at risk

Adverse event: Infection documented clinically or micro with grade 4 neutrophils - blood
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 76 at risk

Adverse event: Infection with unknown ANC - wound
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 76 at risk

Adverse event: Infection other - colon
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 76 at risk

Adverse event: Infection other - skin (cellulitis)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 76 at risk

Adverse event: Myositis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 76 at risk

Adverse event: Neurology - other - loss of consciousness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 76 at risk

Adverse event: Perforation, GI - colon
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 76 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 76 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 65 affected / 76 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 13 affected / 76 at risk

Adverse event: Hand - foot
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 76 at risk

Adverse event: Pain - muscle
Serious: no
Organ System: General disorders
Frequency: 28 affected / 76 at risk

Adverse event: Pain - bone
Serious: no
Organ System: General disorders
Frequency: 25 affected / 76 at risk

Adverse event: Pain - joint
Serious: no
Organ System: General disorders
Frequency: 19 affected / 76 at risk

Adverse event: Pain - head/headache
Serious: no
Organ System: General disorders
Frequency: 19 affected / 76 at risk

Adverse event: Pain - extremity - limb
Serious: no
Organ System: General disorders
Frequency: 16 affected / 76 at risk

Adverse event: Pain - chest/thorax
Serious: no
Organ System: General disorders
Frequency: 11 affected / 76 at risk

Adverse event: Pain - breast
Serious: no
Organ System: General disorders
Frequency: 9 affected / 76 at risk

Adverse event: Pain - back
Serious: no
Organ System: General disorders
Frequency: 8 affected / 76 at risk

Adverse event: Pain - abdominal NOS
Serious: no
Organ System: General disorders
Frequency: 8 affected / 76 at risk

Adverse event: Pain - pain NOS
Serious: no
Organ System: General disorders
Frequency: 5 affected / 76 at risk

Adverse event: Mucositis (functional/symptomatic) - oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 31 affected / 76 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 24 affected / 76 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 23 affected / 76 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 76 at risk

Adverse event: Dehydration
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 76 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 76 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 76 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 47 affected / 76 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 4 affected / 76 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 29 affected / 76 at risk

Adverse event: Left ventricular systolic function
Serious: no
Organ System: Cardiac disorders
Frequency: 13 affected / 76 at risk

Adverse event: Neutrophil count
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 19 affected / 76 at risk

Adverse event: Leucocytes
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 17 affected / 76 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 10 affected / 76 at risk

Adverse event: Neuropathy - sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 18 affected / 76 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 76 at risk

Adverse event: Neuropathy - motor
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 76 at risk

Adverse event: Infection with normal ANC - skin (cellulites)
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 76 at risk

Adverse event: Infection with normal ANC - bladder (urinary)
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 76 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 76 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 76 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 76 at risk

Adverse event: Alanine aminotransferase
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 76 at risk

Adverse event: AST, SGOT
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 76 at risk

Adverse event: Nail disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 16 affected / 76 at risk

Adverse event: Hot flush
Serious: no
Organ System: General disorders
Frequency: 15 affected / 76 at risk

Adverse event: Mucositis (clinical exam) - oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 76 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 12 affected / 76 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Frequency: 12 affected / 76 at risk

Adverse event: Taste disorder
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 76 at risk

Adverse event: Mood alteration - depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 11 affected / 76 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 10 affected / 76 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 76 at risk

Adverse event: Mood alteration - anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 9 affected / 76 at risk

Adverse event: Edema - limb
Serious: no
Organ System: General disorders
Frequency: 6 affected / 76 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 76 at risk

Adverse event: Watery eye
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 76 at risk

Adverse event: Weight decreased
Serious: no
Organ System: General disorders
Frequency: 5 affected / 76 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Investigations
Frequency: 5 affected / 76 at risk

Adverse event: Tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 5 affected / 76 at risk

Adverse event: Infection with normal ANC - sinus
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 76 at risk

Adverse event: Infection with unknown ANC - sinus
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 76 at risk

Adverse event: Infection with unknown ANC - upper airway NOS
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 76 at risk

Adverse event: Oesophagitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 76 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 76 at risk

Adverse event: Infection with normal ANC - upper airway NOS
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 76 at risk

Adverse event: Infection with unknown ANC - bronchus
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 76 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 76 at risk

Adverse event: Hemorhoids
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 76 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 76 at risk

Adverse event: Blood - Other (low HCT)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 76 at risk

Adverse event: Vaginal infection
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 76 at risk

Adverse event: Infection - other- shingles
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 76 at risk

Adverse event: Pain- chest/thorax
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 29 at risk

Adverse event: Infection with normal ANC - skin (cellulites)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 29 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 29 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 29 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 29 at risk

Adverse event: Haemoglobin
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 29 at risk

Adverse event: Hemorrhage, GI - stomach
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 29 at risk

Adverse event: Syncope
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 29 at risk

Adverse event: Hemorrhage pulmonary - nose
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 29 at risk

Adverse event: Ulcer, GI - stomach
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 29 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 24 affected / 29 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 29 at risk

Adverse event: Hand - foot
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 29 at risk

Adverse event: Pain - muscle
Serious: no
Organ System: General disorders
Frequency: 11 affected / 29 at risk

Adverse event: Pain - bone
Serious: no
Organ System: General disorders
Frequency: 14 affected / 29 at risk

Adverse event: Pain - joint
Serious: no
Organ System: General disorders
Frequency: 12 affected / 29 at risk

Adverse event: Pain - head/headache
Serious: no
Organ System: General disorders
Frequency: 6 affected / 29 at risk

Adverse event: Pain - extremity - limb
Serious: no
Organ System: General disorders
Frequency: 4 affected / 29 at risk

Adverse event: Pain - chest/thorax
Serious: no
Organ System: General disorders
Frequency: 2 affected / 29 at risk

Adverse event: Pain - breast
Serious: no
Organ System: General disorders
Frequency: 1 affected / 29 at risk

Adverse event: Pain - back
Serious: no
Organ System: General disorders
Frequency: 6 affected / 29 at risk

Adverse event: Pain - abdominal NOS
Serious: no
Organ System: General disorders
Frequency: 2 affected / 29 at risk

Adverse event: Pain - pain NOS
Serious: no
Organ System: General disorders
Frequency: 6 affected / 29 at risk

Adverse event: Mucositis (functional/symptomatic) - oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 29 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 29 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 12 affected / 29 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 29 at risk

Adverse event: Dehydration
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 29 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 29 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 29 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 20 affected / 29 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 29 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 12 affected / 29 at risk

Adverse event: Left ventricular systolic function
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 29 at risk

Adverse event: Neutrophil count
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 29 at risk

Adverse event: Leucocytes
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 29 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 29 at risk

Adverse event: Neuropathy - sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 29 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 29 at risk

Adverse event: Neuropathy - motor
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 29 at risk

Adverse event: Infection with normal ANC - skin (cellulites)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 29 at risk

Adverse event: Infection with normal ANC - bladder (urinary)
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 29 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 29 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 29 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 29 at risk

Adverse event: Alanine aminotransferase
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 29 at risk

Adverse event: AST, SGOT
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 29 at risk

Adverse event: Nail disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 29 at risk

Adverse event: Hot flush
Serious: no
Organ System: General disorders
Frequency: 4 affected / 29 at risk

Adverse event: Mucositis (clinical exam) - oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 29 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 29 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Frequency: 5 affected / 29 at risk

Adverse event: Taste disorder
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 29 at risk

Adverse event: Mood alteration - depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 29 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 29 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 29 at risk

Adverse event: Mood alteration - anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 29 at risk

Adverse event: Edema - limb
Serious: no
Organ System: General disorders
Frequency: 1 affected / 29 at risk

Adverse event: Watery eye
Serious: no
Organ System: Eye disorders
Frequency: 6 affected / 29 at risk

Adverse event: Weight decreased
Serious: no
Organ System: General disorders
Frequency: 3 affected / 29 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Investigations
Frequency: 1 affected / 29 at risk

Adverse event: Tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 29 at risk

Adverse event: Oesophagitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 29 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 29 at risk

Adverse event: Infection with normal ANC - upper airway NOS
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 29 at risk

Adverse event: Infection with unknown ANC - bronchus
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 29 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 29 at risk

Adverse event: Hemorhoids
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 29 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 29 at risk

Adverse event: Vaginal infection
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 29 at risk

Adverse event: Infection - other- shingles
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 29 at risk