Study: NCT00177255

Adverse event: Blood/Bone Marrow-Other
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 39 at risk

Adverse event: Neutrophils/granulocytes (ANC/AGC)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 39 at risk

Adverse event: Ventricular arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 39 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 39 at risk

Adverse event: Cardiovascular/General-Other
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 39 at risk

Adverse event: Thrombosis/Embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 39 at risk

Adverse event: Constitutional Symptoms-Other
Serious: yes
Organ System: General disorders
Frequency: 6 affected / 39 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 39 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 39 at risk

Adverse event: Gastrointestinal-Other
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 39 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 39 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 39 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 39 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 39 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 39 at risk

Adverse event: Calcium, serum-low (hypocalcemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 39 at risk

Adverse event: Phosphate, serum-low (hypophosphatemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 39 at risk

Adverse event: Ocular/Visual-Other
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 39 at risk

Adverse event: Pulmonary-Other
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 39 at risk

Adverse event: Dyspnea (shortness of breath)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 39 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils, Lung (pneumonia)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 39 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 39 at risk

Adverse event: Allergic reaction/hypersensitivity (including drug fever)
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 39 at risk

Adverse event: Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 39 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 14 affected / 39 at risk

Adverse event: Bruising (in absence of Grade 3 or 4 thrombocytopenia)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 39 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 39 at risk

Adverse event: Constitutional Symptoms - Other
Serious: no
Organ System: General disorders
Frequency: 2 affected / 39 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 39 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 39 at risk

Adverse event: Dermatology/Skin - Other
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 39 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 39 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 39 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 39 at risk

Adverse event: Dry mouth/salivary gland (xerostomia)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 39 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 39 at risk

Adverse event: Dysphagia (difficulty swallowing)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 39 at risk

Adverse event: Dyspnea (shortness of breath)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 39 at risk

Adverse event: Edema: head and neck
Serious: no
Organ System: General disorders
Frequency: 2 affected / 39 at risk

Adverse event: Edema: limb
Serious: no
Organ System: General disorders
Frequency: 9 affected / 39 at risk

Adverse event: Edema: trunk/genital
Serious: no
Organ System: General disorders
Frequency: 2 affected / 39 at risk

Adverse event: Fatigue (asthenia, lethargy, malaise)
Serious: no
Organ System: General disorders
Frequency: 26 affected / 39 at risk

Adverse event: Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
Serious: no
Organ System: General disorders
Frequency: 3 affected / 39 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 39 at risk

Adverse event: Flushing
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 39 at risk

Adverse event: Fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 39 at risk

Adverse event: Gastrointestinal - Other
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 39 at risk

Adverse event: Glucose, serum-high (hyperglycemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 39 at risk

Adverse event: Hair loss/alopecia (scalp or body)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 39 at risk

Adverse event: Heartburn/dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 39 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 14 affected / 39 at risk

Adverse event: Hemorrhage, GI, Lower GI NOS
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 39 at risk

Adverse event: Hemorrhage, GI, Rectum
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 39 at risk

Adverse event: Hemorrhage/Bleeding - Other
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 39 at risk

Adverse event: Haemorrhoids
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 39 at risk

Adverse event: Hiccoughs (hiccups, singultus)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 39 at risk

Adverse event: Hyperpigmentation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 39 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 39 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils, Sinus
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 39 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils, Upper airway NOS
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 39 at risk

Adverse event: Injection site reaction/extravasation changes
Serious: no
Organ System: General disorders
Frequency: 1 affected / 39 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 39 at risk

Adverse event: Irregular menses (change from baseline)
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 39 at risk

Adverse event: Leukocytes (total WBC)
Serious: no
Organ System: Investigations
Frequency: 5 affected / 39 at risk

Adverse event: Metabolic/Laboratory - Other
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 39 at risk

Adverse event: Mood alteration, Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 39 at risk

Adverse event: Mood alteration, Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 39 at risk

Adverse event: Mucositis/stomatitis (clinical exam), Oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 39 at risk

Adverse event: Nail disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 39 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 19 affected / 39 at risk

Adverse event: Neurology - Other
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 39 at risk

Adverse event: Neuropathy: motor
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 39 at risk

Adverse event: Neuropathy: sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 12 affected / 39 at risk

Adverse event: Neutrophils/granulocytes (ANC/AGC)
Serious: no
Organ System: Investigations
Frequency: 3 affected / 39 at risk

Adverse event: Ocular/Visual - Other
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 39 at risk

Adverse event: Pain, Abdomen NOS
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 39 at risk

Adverse event: Pain, Anus
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 39 at risk

Adverse event: Pain, Back
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 39 at risk

Adverse event: Pain, Bone
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 39 at risk

Adverse event: Pain, Chest/thorax NOS
Serious: no
Organ System: General disorders
Frequency: 2 affected / 39 at risk

Adverse event: Pain, Extremity-limb
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 39 at risk

Adverse event: Pain, Head/headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 39 at risk

Adverse event: Pain, Joint
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 39 at risk

Adverse event: Pain, Rectum
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 39 at risk

Adverse event: Pain, Stomach
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 39 at risk

Adverse event: Photosensitivity reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 39 at risk

Adverse event: Platelets
Serious: no
Organ System: Investigations
Frequency: 3 affected / 39 at risk

Adverse event: Potassium, serum-high (hyperkalemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 39 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 39 at risk

Adverse event: Rash: hand-foot skin reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 17 affected / 39 at risk

Adverse event: Renal/Genitourinary - Other
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 39 at risk

Adverse event: Rigors/chills
Serious: no
Organ System: General disorders
Frequency: 1 affected / 39 at risk

Adverse event: Salivary gland changes/saliva
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 39 at risk

Adverse event: Somnolence/depressed level of consciousness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 39 at risk

Adverse event: Sweating (diaphoresis)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 39 at risk

Adverse event: Taste alteration (dysgeusia)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 39 at risk

Adverse event: Thrombosis/thrombus/embolism
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 39 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 39 at risk

Adverse event: Ulcer
Serious: no
Organ System: General disorders
Frequency: 1 affected / 39 at risk

Adverse event: Urinary frequency/urgency
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 39 at risk

Adverse event: Urinary retention (including neurogenic bladder)
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 39 at risk

Adverse event: Vessel injury-vein, Other NOS
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 39 at risk

Adverse event: Vision-blurred vision
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 39 at risk

Adverse event: Voice changes/dysarthria (e.g., hoarseness, loss or alteration in voice, laryngitis)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 39 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 39 at risk

Adverse event: Watery eye (epiphora, tearing)
Serious: no
Organ System: Eye disorders
Frequency: 7 affected / 39 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 7 affected / 39 at risk