Study: NCT00616967

Adverse event: Amemia (hemoglobin)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 6 at risk

Adverse event: Neutropenia (neutrophils)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 6 at risk

Adverse event: Thrombocytopenia (platelets)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 6 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

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

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 6 at risk

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

Adverse event: Nail disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 6 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 6 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 6 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 6 at risk

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

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 6 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 6 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 6 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 6 at risk

Adverse event: Taste disorder
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 6 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 6 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Hot flush
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 6 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 6 at risk

Adverse event: Peripheral sensory neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 6 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 6 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 6 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 6 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Myositis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 31 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 31 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 10 affected / 31 at risk

Adverse event: Amemia (hemoglobin)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 9 affected / 31 at risk

Adverse event: Neutropenia (neutrophils)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 28 affected / 31 at risk

Adverse event: Thrombocytopenia (platelets)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 10 affected / 31 at risk

Adverse event: ALT (elevated)
Serious: no
Organ System: Investigations
Frequency: 4 affected / 31 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 4 affected / 31 at risk

Adverse event: Fatigue
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 31 affected / 31 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 6 affected / 31 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 31 affected / 31 at risk

Adverse event: Nail disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 31 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 31 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 31 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 17 affected / 31 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 31 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 31 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 31 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 31 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 31 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 31 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 25 affected / 31 at risk

Adverse event: Taste disorder
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 31 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 31 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 14 affected / 31 at risk

Adverse event: Hot flush
Serious: no
Organ System: Vascular disorders
Frequency: 8 affected / 31 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Sinus infection
Frequency: 10 affected / 31 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 31 at risk

Adverse event: Peripheral sensory neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 25 affected / 31 at risk

Adverse event: Vision changes
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 31 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 31 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 13 affected / 31 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 31 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 11 affected / 31 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 31 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 31 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 31 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 31 at risk

Adverse event: Amemia (hemoglobin)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 20 affected / 31 at risk

Adverse event: Neutropenia (neutrophils)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 29 affected / 31 at risk

Adverse event: Thrombocytopenia (platelets)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 15 affected / 31 at risk

Adverse event: ALT (elevated)
Serious: no
Organ System: Investigations
Frequency: 1 affected / 31 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 5 affected / 31 at risk

Adverse event: Fatigue
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 27 affected / 31 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 31 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 29 affected / 31 at risk

Adverse event: Nail disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 31 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 31 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 31 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 19 affected / 31 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 31 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 31 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 31 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 31 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 31 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 31 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 29 affected / 31 at risk

Adverse event: Taste disorder
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 31 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 19 affected / 31 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 31 at risk

Adverse event: Hot flush
Serious: no
Organ System: Vascular disorders
Frequency: 7 affected / 31 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Sinus infection
Frequency: 7 affected / 31 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 31 at risk

Adverse event: Peripheral sensory neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 20 affected / 31 at risk

Adverse event: Vision changes
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 31 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 31 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 15 affected / 31 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 31 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 13 affected / 31 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 31 at risk