Study: NCT00559754

Adverse event: Febrile neutropaenia
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 72 at risk

Adverse event: Infection with normal absolute neutrophil count (ANC) or grade 1 or 2 neutrophils
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 72 at risk

Adverse event: Neutrophils/granulocytes
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 72 at risk

Adverse event: Mucositis/stomatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 72 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 72 at risk

Adverse event: Mucositis/stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 43 affected / 72 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 43 affected / 72 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 24 affected / 72 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 72 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 72 at risk

Adverse event: Taste alteration (dysgeusia)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 72 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 72 at risk

Adverse event: Heartburn/dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 72 at risk

Adverse event: Hair loss/alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 36 affected / 72 at risk

Adverse event: Nail disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 12 affected / 72 at risk

Adverse event: Rash: hand-foot skin reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 72 at risk

Adverse event: Other - not specified
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 72 at risk

Adverse event: Fatigue (asthenia, lethargy, malaise)
Serious: no
Organ System: General disorders
Frequency: 44 affected / 72 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 14 affected / 72 at risk

Adverse event: Other - not specified
Serious: no
Organ System: General disorders
Frequency: 5 affected / 72 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 36 affected / 72 at risk

Adverse event: Neutrophils/granulocytes
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 10 affected / 72 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 72 at risk

Adverse event: Leukocytes (total WBC)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 72 at risk

Adverse event: Infection with normal ANC or grade 1 or 2 neutrophils
Serious: no
Organ System: Infections and infestations
Frequency: 17 affected / 72 at risk

Adverse event: Febrile neutropaenia
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 72 at risk

Adverse event: Allergic reaction/hypersensitivity (including drug fever)
Serious: no
Organ System: Immune system disorders
Frequency: 14 affected / 72 at risk

Adverse event: Hemorrhage, pulmonary/upper respiratory
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 12 affected / 72 at risk

Adverse event: Watery eye (epiphora, tearing)
Serious: no
Organ System: Eye disorders
Frequency: 7 affected / 72 at risk

Adverse event: Irregular menses (change from baseline)
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 11 affected / 72 at risk

Adverse event: ALT, SGPT (serum glutamic pyruvic transaminase)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 72 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 72 at risk

Adverse event: Other - not specified
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 72 at risk

Adverse event: Other - not specified
Serious: no
Organ System: Renal and urinary disorders
Frequency: 5 affected / 72 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 7 affected / 72 at risk

Adverse event: Hot flashes/flushes
Serious: no
Organ System: Endocrine disorders
Frequency: 5 affected / 72 at risk

Adverse event: Flu-like syndrome
Serious: no
Organ System: General disorders
Frequency: 9 affected / 72 at risk