Study: NCT00226239

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

Adverse event: Leukocytes (total WBC)
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 39 at risk

Adverse event: Neutrophils/granulocytes (ANC/AGC)
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 13 affected / 39 at risk

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

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

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

Adverse event: Dysphagia (difficulty swallowing)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 39 at risk

Adverse event: Hemorrhage, GI, Stomach
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 39 at risk

Adverse event: Hemorrhage, GI, Upper GI NOS
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 39 at risk

Adverse event: Hemorrhage/bleeding associated with surgery, intra-operative or postoperative
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 39 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 39 at risk

Adverse event: Ulcer, GI, Duodenum
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 39 at risk

Adverse event: Fatigue (asthenia, lethargy, malaise)
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 39 at risk

Adverse event: Rigors/chills
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 39 at risk

Adverse event: Colitis, infectious (e.g., Clostridium difficile)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 39 at risk

Adverse event: Infection - Other (Specify)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 39 at risk

Adverse event: ALT, SGPT (serum glutamic pyruvic transaminase)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 39 at risk

Adverse event: AST, SGOT(serum glutamic oxaloacetic transaminase)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 39 at risk

Adverse event: Glucose, serum-high (hyperglycemia)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 39 at risk

Adverse event: Magnesium, serum-low (hypomagnesemia)
Serious: yes
Organ System: Investigations
Frequency: 6 affected / 39 at risk

Adverse event: Potassium, serum-high (hyperkalemia)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 39 at risk

Adverse event: Potassium, serum-low (hypokalemia)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 39 at risk

Adverse event: Weight decreased
Serious: yes
Organ System: Investigations
Frequency: 3 affected / 39 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 39 at risk

Adverse event: Muscle weakness, generalized or specific area (not due to neuropathy), Whole body/generalized
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 39 at risk

Adverse event: Pain, Joint
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 39 at risk

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

Adverse event: Pain-Other
Serious: yes
Organ System: General disorders
Frequency: 1 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: Edema, larynx
Serious: yes
Organ System: Respiratory, thoracic and mediastinal 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: Pain, Throat/pharynx/larynx
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 39 at risk

Adverse event: Rash: acne/acneiform
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 39 at risk

Adverse event: Rash: dermatitis associated with radiation, Chemoradiation
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 39 at risk

Adverse event: Rash: dermatitis associated with radiation, Radiation
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 39 at risk

Adverse event: Thrombosis/thrombus/embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 39 at risk

Adverse event: Blood/Bone Marrow - Other
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 39 at risk

Adverse event: Febrile neutropenia (unknown origin without documented infection)(ANC <1.0 x 10^9/L)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 39 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 25 affected / 39 at risk

Adverse event: Hemolysis (e.g., immune hemolytic anemia, drug-related hemolysis)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 39 at risk

Adverse event: Hemorrhage/Bleeding - Other
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 39 at risk

Adverse event: Lymphatics - Other
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 39 at risk

Adverse event: Cardiac Arrhythmia - Other
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 39 at risk

Adverse event: Supraventricular and nodal arrhythmia, Atrial flutter
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 39 at risk

Adverse event: Auditory/Ear - Other
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 39 at risk

Adverse event: Pain, External ear
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 39 at risk

Adverse event: Pain, Middle ear
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 39 at risk

Adverse event: Tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 39 at risk

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

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

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

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

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 39 at risk

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

Adverse event: Dry mouth/salivary gland (xerostomia)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 39 at risk

Adverse event: Dysphagia (difficulty swallowing)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 31 affected / 39 at risk

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

Adverse event: Gastritis (including bile reflux gastritis)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 39 at risk

Adverse event: Gastrointestinal - Other
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 39 at risk

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

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

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

Adverse event: Mucositis/stomatitis (clinical exam), Oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 26 affected / 39 at risk

Adverse event: Mucositis/stomatitis (functional/symptomatic), Oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 39 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 27 affected / 39 at risk

Adverse event: Pain, Abdomen NOS
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 39 at risk

Adverse event: Pain, Oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 26 affected / 39 at risk

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

Adverse event: Perforation, GI, Esophagus
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 39 at risk

Adverse event: Taste alteration (dysgeusia)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 39 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 21 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: 3 affected / 39 at risk

Adverse event: Fatigue (asthenia, lethargy, malaise)
Serious: no
Organ System: General disorders
Frequency: 36 affected / 39 at risk

Adverse event: Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10^9/L)
Serious: no
Organ System: General disorders
Frequency: 12 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: Pain - Other
Serious: no
Organ System: General disorders
Frequency: 10 affected / 39 at risk

Adverse event: Pain, Face
Serious: no
Organ System: General disorders
Frequency: 4 affected / 39 at risk

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

Adverse event: Rigors/chills
Serious: no
Organ System: General disorders
Frequency: 4 affected / 39 at risk

Adverse event: Allergic reaction/hypersensitivity (including drug fever)
Serious: no
Organ System: Immune system disorders
Frequency: 4 affected / 39 at risk

Adverse event: Infection - Other
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 39 at risk

Adverse event: Infection (documented) with Grade 3 or 4 neutrophils (ANC <1.0 x 10^9/L), Eye NOS
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, Catheter-related
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, Joint
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, Lung (pneumonia)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 39 at risk

Adverse event: Infection with unknown ANC, Mucosa
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 39 at risk

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

Adverse event: ALT, SGPT (serum glutamic pyruvic transaminase)
Serious: no
Organ System: Investigations
Frequency: 1 affected / 39 at risk

Adverse event: AST, SGOT(serum glutamic oxaloacetic transaminase)
Serious: no
Organ System: Investigations
Frequency: 1 affected / 39 at risk

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

Adverse event: Leukocytes (total WBC)
Serious: no
Organ System: Investigations
Frequency: 19 affected / 39 at risk

Adverse event: Neutrophils/granulocytes (ANC/AGC)
Serious: no
Organ System: Investigations
Frequency: 16 affected / 39 at risk

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

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 10 affected / 39 at risk

Adverse event: Albumin, serum-low (hypoalbuminemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 39 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 12 affected / 39 at risk

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

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 39 at risk

Adverse event: Glucose, serum-high (hyperglycemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 39 at risk

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

Adverse event: Magnesium, serum-low (hypomagnesemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 23 affected / 39 at risk

Adverse event: Metabolic/Laboratory - Other
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 39 at risk

Adverse event: Phosphate, serum-low (hypophosphatemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 39 at risk

Adverse event: Potassium, serum-high (hyperkalemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 39 at risk

Adverse event: Potassium, serum-low (hypokalemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 39 at risk

Adverse event: Sodium, serum-low (hyponatremia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 39 at risk

Adverse event: Arthritis (non-septic)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 39 at risk

Adverse event: Musculoskeletal/Soft Tissue - Other
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 39 at risk

Adverse event: Pain, Back
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: Musculoskeletal and connective tissue disorders
Frequency: 1 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, Joint
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 39 at risk

Adverse event: Pain, Muscle
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 39 at risk

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

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 39 at risk

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

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

Adverse event: Neuropathy: sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 16 affected / 39 at risk

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

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

Adverse event: Speech impairment (e.g., dysphasia or aphasia)
Serious: no
Organ System: Nervous system 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: Confusional state
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 39 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 39 at risk

Adverse event: Mood alteration, Agitation
Serious: no
Organ System: Psychiatric 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: 3 affected / 39 at risk

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

Adverse event: Urinary frequency/urgency
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 39 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 39 at risk

Adverse event: Dyspnea (shortness of breath)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 39 at risk

Adverse event: Hemorrhage, pulmonary/upper respiratory, Nose
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 39 at risk

Adverse event: Hiccoughs (hiccups, singultus)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 39 at risk

Adverse event: Mucositis/stomatitis (clinical exam), Esophagus
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 39 at risk

Adverse event: Mucositis/stomatitis (functional/symptomatic), Esophagus
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 39 at risk

Adverse event: Mucositis/stomatitis (functional/symptomatic), Trachea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 39 at risk

Adverse event: Pain, Throat/pharynx/larynx
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 13 affected / 39 at risk

Adverse event: Pulmonary/Upper Respiratory - Other
Serious: no
Organ System: Respiratory, thoracic and mediastinal 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: 5 affected / 39 at risk

Adverse event: Dermatology/Skin - Other
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 39 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 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: Pain, Skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 39 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 16 affected / 39 at risk

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

Adverse event: Rash: dermatitis associated with radiation, Chemoradiation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 39 at risk

Adverse event: Rash: dermatitis associated with radiation, Radiation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 13 affected / 39 at risk

Adverse event: Rash: hand-foot skin reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 39 at risk

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

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

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