Study: NCT00577629

Adverse event: Supraventricular and nodal arrhythmia - Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 39 at risk

Adverse event: Speech impairment (e.g., dysphasia or aphasia)
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 39 at risk

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

Adverse event: Ataxia (incoordination)
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 39 at risk

Adverse event: Thrombosis / embolism (vascular access-related)
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 39 at risk

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

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 39 at risk

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

Adverse event: Dermatology / Skin - Other
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 39 at risk

Adverse event: Leukocytes (total WBC)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 39 at risk

Adverse event: Cardiac Arrhythmia - Other
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 39 at risk

Adverse event: Ascites (non-malignant)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 39 at risk

Adverse event: Infection with unknown ANC - Lung (pneumonia)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 39 at risk

Adverse event: Hemorrhage, pulmonary / upper respiratory - Nose
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 39 at risk

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

Adverse event: Colitis, infectious (e.g., Clostridium difficile)
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 39 at risk

Adverse event: Pain - Abdomen NOS
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 39 at risk

Adverse event: Mucositis / Stomatitis (clinical exam)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 39 at risk

Adverse event: Febrile neutropenia (fever of unknown origin without documented infection)
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 39 at risk

Adverse event: Infection - Other
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 39 at risk

Adverse event: Malignancy
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 8 affected / 39 at risk

Adverse event: Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 39 at risk

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

Adverse event: Supraventricular and nodal arrhythmia - Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 39 at risk

Adverse event: Oesophagitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 39 at risk

Adverse event: Hemorrhage, pulmonary / upper respiratory
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 39 at risk

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

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

Adverse event: Memory impairment
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 39 at risk

Adverse event: Neuropathy: motor
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 39 at risk

Adverse event: Speech impairment (e.g., dysphasia or aphasia)
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 39 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 2 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 - Rectum
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 39 at risk

Adverse event: Pain - Sinus
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 39 at risk

Adverse event: Pain-Pulmonary / Upper Respiratory
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 39 at risk

Adverse event: Pain-Renal / Genitourinary
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 39 at risk

Adverse event: Atelectasis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 39 at risk

Adverse event: Tumour lysis syndrome
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 39 at risk

Adverse event: Left ventricular dysfunction
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 39 at risk

Adverse event: Hemorrhage, GI
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: 3 affected / 39 at risk

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

Adverse event: Mood Alteration - Agitation
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 39 at risk

Adverse event: Somnolence / depressed level of consciousness
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 39 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 3 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: 3 affected / 39 at risk

Adverse event: Thrombosis / thrombus / embolism
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 39 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 39 at risk

Adverse event: Dry mouth / salivary gland (xerostomia)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 39 at risk

Adverse event: Hemorrhage, pulmonary / upper respiratory - Nose
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 39 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 39 at risk

Adverse event: Ataxia (incoordination)
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 39 at risk

Adverse event: Psychosis (hallucinations / delusions)
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 39 at risk

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

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 39 at risk

Adverse event: Metabolic / Laboratory - Other
Serious: no
Organ System: Investigations
Frequency: 3 affected / 39 at risk

Adverse event: Pain - Throat / pharynx / larynx
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 39 at risk

Adverse event: Renal / Genitourinary - Other
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 39 at risk

Adverse event: Supraventricular and nodal arrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 39 at risk

Adverse event: Hot flashes / flushes
Serious: no
Organ System: Vascular disorders
Frequency: 5 affected / 39 at risk

Adverse event: Mucositis / stomatitis (clinical exam) - Oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 39 at risk

Adverse event: Colitis, infectious (e.g., Clostridium difficile)
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 39 at risk

Adverse event: Sodium, serum-low (hyponatremia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 39 at risk

Adverse event: Vision - blurred vision
Serious: no
Organ System: Eye disorders
Frequency: 6 affected / 39 at risk

Adverse event: Pain - Extremity-limb
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 39 at risk

Adverse event: Thrombosis / embolism (vascular access-related)
Serious: no
Organ System: Surgical and medical procedures
Frequency: 5 affected / 39 at risk

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

Adverse event: Pruritus / itching
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 39 at risk

Adverse event: Pain - Abdomen NOS
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 39 at risk

Adverse event: Pain - Back
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 39 at risk

Adverse event: Dysphagia (difficulty swallowing)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 39 at risk

Adverse event: Gastrointestinal - Other
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 39 at risk

Adverse event: Taste Alteration (dysgeusia)
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 39 at risk

Adverse event: Potassium, serum-low (hypokalemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 39 at risk

Adverse event: Pain - Head / headache
Serious: no
Organ System: Nervous system disorders
Frequency: 7 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: 6 affected / 39 at risk

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

Adverse event: Mood Alteration - Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 7 affected / 39 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 39 at risk

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

Adverse event: Sweating (diaphoresis)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 10 affected / 39 at risk

Adverse event: Infection - Other
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 39 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 9 affected / 39 at risk

Adverse event: Pain-Musculoskeletal
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 39 at risk

Adverse event: Calcium, serum-low (hypocalcemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 11 affected / 39 at risk

Adverse event: Blood creatinine
Serious: no
Organ System: Investigations
Frequency: 9 affected / 39 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 11 affected / 39 at risk

Adverse event: Albumin, serum-low (hypoalbuminemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 12 affected / 39 at risk

Adverse event: Muscle weakness, generalized or specific area (not due to neuropathy)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 12 affected / 39 at risk

Adverse event: Neurology - Other
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 39 at risk

Adverse event: Joint-function
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 9 affected / 39 at risk

Adverse event: Dermatology / Skin - Other
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 10 affected / 39 at risk

Adverse event: Nail disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 14 affected / 39 at risk

Adverse event: Bilirubin (hyperbilirubinemia)
Serious: no
Organ System: Investigations
Frequency: 8 affected / 39 at risk

Adverse event: Urinary frequency / urgency
Serious: no
Organ System: Renal and urinary disorders
Frequency: 13 affected / 39 at risk

Adverse event: Edema: limb
Serious: no
Organ System: General disorders
Frequency: 13 affected / 39 at risk

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

Adverse event: Neuropathy: sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 39 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 15 affected / 39 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 18 affected / 39 at risk

Adverse event: Dyspnea (shortness of breath)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 17 affected / 39 at risk

Adverse event: Febrile neutropenia (fever of unknown origin without documented infection)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 19 affected / 39 at risk

Adverse event: Hair Loss / Alopecia (scalp or body)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 26 affected / 39 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 39 at risk

Adverse event: Rash / desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 19 affected / 39 at risk

Adverse event: Pulmonary / Upper Respiratory - Other
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 16 affected / 39 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 19 affected / 39 at risk

Adverse event: Neutrophils / granulocytes (ANC / AGC)
Serious: no
Organ System: Investigations
Frequency: 22 affected / 39 at risk

Adverse event: Pain - Other
Serious: no
Organ System: General disorders
Frequency: 17 affected / 39 at risk

Adverse event: Blood alkaline phosphatase
Serious: no
Organ System: Investigations
Frequency: 21 affected / 39 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 25 affected / 39 at risk

Adverse event: ALT, SGPT (serum glutamic pyruvic transaminase)
Serious: no
Organ System: Investigations
Frequency: 27 affected / 39 at risk

Adverse event: Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils
Serious: no
Organ System: Infections and infestations
Frequency: 27 affected / 39 at risk

Adverse event: Mucositis / Stomatitis (clinical exam)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 28 affected / 39 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 31 affected / 39 at risk

Adverse event: Fatigue (asthenia, lethargy, malaise)
Serious: no
Organ System: General disorders
Frequency: 32 affected / 39 at risk

Adverse event: AST, SGOT (serum glutamic oxaloacetic transaminase)
Serious: no
Organ System: Investigations
Frequency: 30 affected / 39 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 28 affected / 39 at risk

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

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

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