Study: NCT00617409

Adverse event: Febrile neutopenia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 18 at risk

Adverse event: Pain - Bone
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 18 at risk

Adverse event: Pain - Head/headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 18 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 18 at risk

Adverse event: Suicide attempt
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 18 at risk

Adverse event: Vessel injury-artery - Other NOS
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 18 at risk

Adverse event: Edema: limb
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 18 at risk

Adverse event: Hemolysis (e.g., immune hemolytic anemia, drugrelated hemolysis)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 18 at risk

Adverse event: Leukocytes (total WBC) - Low
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 18 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 18 at risk

Adverse event: Neutrophils/granulocytes (ANC/AGC) - Low
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 18 at risk

Adverse event: Supraventricular and nodal arrhythmia - Sinus tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 18 at risk

Adverse event: Auditory/Ear - Other, Hearing loss
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 18 at risk

Adverse event: Ocular/Visual - Other, Keratotic lesion-left side
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 18 at risk

Adverse event: Ocular/Visual - Other, Right sided ptosis
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 18 at risk

Adverse event: Vision-blurred vision
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 18 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 18 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 18 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 18 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 18 at risk

Adverse event: Oesophagitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 18 at risk

Adverse event: Gastrointestinal - Other, Decrease color in stools
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 18 at risk

Adverse event: Gastrointestinal - Other, Increased burping
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 18 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 18 at risk

Adverse event: Pain - Absomen NOS
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 18 at risk

Adverse event: Pain - Esophagus
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 18 at risk

Adverse event: Pain - Stomach
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 18 at risk

Adverse event: Taste alteration (dysgeusia)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 18 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 18 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 8 affected / 18 at risk

Adverse event: Fever (in the absence of neutropenia)
Serious: no
Organ System: General disorders
Frequency: 2 affected / 18 at risk

Adverse event: Pain - Other, Upper quadrant
Serious: no
Organ System: General disorders
Frequency: 1 affected / 18 at risk

Adverse event: Rigors/chills
Serious: no
Organ System: General disorders
Frequency: 1 affected / 18 at risk

Adverse event: Sweating (diaphoresis)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 18 at risk

Adverse event: Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 18 at risk

Adverse event: Hemoglobin - Low
Serious: no
Organ System: Investigations
Frequency: 3 affected / 18 at risk

Adverse event: Lipase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 18 at risk

Adverse event: Metabolic/Laboratory - Other, Elevated AST
Serious: no
Organ System: Investigations
Frequency: 2 affected / 18 at risk

Adverse event: Platelets - Low
Serious: no
Organ System: Investigations
Frequency: 1 affected / 18 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 18 at risk

Adverse event: Albumin, serum-low (hypoalbuminemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 18 at risk

Adverse event: Blood alkaline phosphatase
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 18 at risk

Adverse event: Alkalosis (metabolic or respiratory)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 18 at risk

Adverse event: ALT, SGPT (serum glutamic pyruvic transaminase) - High
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 18 at risk

Adverse event: Amylase
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 18 at risk

Adverse event: Glucose, serum-high (hyperglycemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 18 at risk

Adverse event: Metabolic/Laboratory - Other, Hyperlipidemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 18 at risk

Adverse event: Metabolic/Laboratory - Other, Decreased HDL
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 18 at risk

Adverse event: Metabolic/Laboratory - Other, Decreased protein
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 18 at risk

Adverse event: Metabolic/Laboratory - Other, High total protein
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 18 at risk

Adverse event: Metabolic/Laboratory - Other, Increased ALT
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 18 at risk

Adverse event: Potassium, serum-high (hyperkalemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 18 at risk

Adverse event: Arthritis (non-septic)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 18 at risk

Adverse event: Muscle weakness, generalized or specific area (not due to neuropathy) - Extraocular
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 18 at risk

Adverse event: Muscle weakness, generalized or specific area (not due to neuropathy) - Whole body/generalized
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 18 at risk

Adverse event: Pain - Back
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 18 at risk

Adverse event: Pain - Chest wall
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 18 at risk

Adverse event: Pain - Extremity-limb
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 18 at risk

Adverse event: Pain - Joint
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 18 at risk

Adverse event: Pain - Muscle
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 18 at risk

Adverse event: Pain - Other, Flank
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 18 at risk

Adverse event: Pain - Other, Hip
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 18 at risk

Adverse event: Pain - Other, Rib/Rib cage
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 18 at risk

Adverse event: Pain - Other, Shoulder
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 18 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 18 at risk

Adverse event: Memory impairment
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 18 at risk

Adverse event: Neurology - Other, Numbness in lower legs and feet
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 18 at risk

Adverse event: Neuropathy: cranial - CN VIII Hearing and balance
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 18 at risk

Adverse event: Neuropathy: sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 18 at risk

Adverse event: Pain - Head/headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 18 at risk

Adverse event: Confusional state
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 18 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 18 at risk

Adverse event: Mental status
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 18 at risk

Adverse event: Mood alteration - Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 18 at risk

Adverse event: Mood alteration - Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 18 at risk

Adverse event: Incontinence, urinary
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 18 at risk

Adverse event: Obstruction, GU - Ureter
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 18 at risk

Adverse event: Urine color change
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 18 at risk

Adverse event: Pain - Breast
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 18 at risk

Adverse event: Pain - Pelvis
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 18 at risk

Adverse event: Bronchospasm, wheezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 18 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 18 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 18 at risk

Adverse event: Nasal cavity/paranasal sinus reactions
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 18 at risk

Adverse event: Pneumonitis/pulmonary infiltrates
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 18 at risk

Adverse event: Pulmonary/Upper Respiratory - Other, Wheezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 18 at risk

Adverse event: Pulmonary/Upper Respiratory - Other, Absent breath sounds-right base
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 18 at risk

Adverse event: Pulmonary/Upper Respiratory - Other, Congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 18 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: 1 affected / 18 at risk

Adverse event: Dermatology/Skin - Other, erythema- chest wall and scalp
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 18 at risk

Adverse event: Dermatology/Skin - Other, Tightness of skin on hands
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 18 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 18 at risk

Adverse event: Hair loss/alopecia (scalp or body)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 18 at risk

Adverse event: Hyperpigmentation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 18 at risk

Adverse event: Pruritus/itching
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 18 at risk

Adverse event: Rash: acne/acneiform
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 18 at risk

Adverse event: Rash: dermatitis associated with radiation - Chemoradiation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 18 at risk

Adverse event: Rash: dermatitis associated with radiation - Radiation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 18 at risk

Adverse event: Skin breakdown/decubitus ulcer
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 18 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 18 at risk

Adverse event: Vascular - Other, Chronic venous stasis in legs
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 18 at risk

Adverse event: Blood and lymphatic system disorders - Other, Leukopenia/Anemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 20 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 20 at risk

Adverse event: Fever (in the absence of neutropenia)
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 20 at risk

Adverse event: Pain - Chest/thorax NOS
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 20 at risk

Adverse event: Rigors/chills
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 20 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 / 20 at risk

Adverse event: Pain - Head/headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 20 at risk

Adverse event: Cough
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 20 at risk

Adverse event: Pneumonitis/pulmonary infiltrates
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Pulmonary/Upper Respiratory - Other
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Pulmonary/Upper Respiratory - Other, Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Thrombosis/thrombus/embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 20 at risk

Adverse event: Edema: limb
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 20 at risk

Adverse event: Hemolysis (e.g., immune hemolytic anemia, drugrelated hemolysis)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 20 at risk

Adverse event: Leukocytes (total WBC) - Low
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 20 at risk

Adverse event: Neutrophils/granulocytes (ANC/AGC) - Low
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 20 at risk

Adverse event: Vision-blurred vision
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 20 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 20 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 20 at risk

Adverse event: Dehydration
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 20 at risk

Adverse event: Flatulance
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Gastrointestinal - Other, GI virus
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Heartburn/dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 20 at risk

Adverse event: Mucositis/stomatitis (clinical exam) - Oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Mucositis/stomatitis (functional/symptomatic) - Oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 20 at risk

Adverse event: Pain - Absomen NOS
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 20 at risk

Adverse event: Pain - Other, Pain at distal margins
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 13 affected / 20 at risk

Adverse event: Fever (in the absence of neutropenia)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 20 at risk

Adverse event: Pain - Chest/thorax NOS
Serious: no
Organ System: General disorders
Frequency: 1 affected / 20 at risk

Adverse event: Pain - Pain NOS
Serious: no
Organ System: General disorders
Frequency: 1 affected / 20 at risk

Adverse event: Rigors/chills
Serious: no
Organ System: General disorders
Frequency: 1 affected / 20 at risk

Adverse event: Sweating (diaphoresis)
Serious: no
Organ System: General disorders
Frequency: 2 affected / 20 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils - Urinary tract NOS
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 20 at risk

Adverse event: Infection with unknown ANC - Lung (pneumonia)
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 20 at risk

Adverse event: Creatinine - High
Serious: no
Organ System: Investigations
Frequency: 1 affected / 20 at risk

Adverse event: Hemoglobin - Low
Serious: no
Organ System: Investigations
Frequency: 4 affected / 20 at risk

Adverse event: Platelets - Low
Serious: no
Organ System: Investigations
Frequency: 3 affected / 20 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 20 at risk

Adverse event: ALT, SGPT (serum glutamic pyruvic transaminase) - High
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 20 at risk

Adverse event: Calcium, serum-high (hypercalcemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 20 at risk

Adverse event: Glucose, serum-high (hyperglycemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 20 at risk

Adverse event: Magnesium, serum-low (hypomagnesemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 20 at risk

Adverse event: Metabolic/Laboratory - Other, Hyperglycemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 20 at risk

Adverse event: Phosphate, serum-low (hypophosphatemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 20 at risk

Adverse event: Potassium, serum-high (hyperkalemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 20 at risk

Adverse event: Sodium, serum-low (hyponatremia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 20 at risk

Adverse event: Muscle weakness, generalized or specific area (not due to neuropathy) - Extremitylower
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 20 at risk

Adverse event: Muscle weakness, generalized or specific area (not due to neuropathy) - Whole body/generalized
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 20 at risk

Adverse event: Pain - Back
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 20 at risk

Adverse event: Pain - Chest wall
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 20 at risk

Adverse event: Pain - Extremity-limb
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 20 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 20 at risk

Adverse event: Neuropathy: motor
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 20 at risk

Adverse event: Neuropathy: sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 20 at risk

Adverse event: Pain - Head/headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 20 at risk

Adverse event: Confusional state
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 20 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 20 at risk

Adverse event: Mood alteration - Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 20 at risk

Adverse event: Mood alteration - Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 20 at risk

Adverse event: Bronchospasm, wheezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 20 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 20 at risk

Adverse event: Hemorrhage/Bleeding - Other, Hemoptysis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Nasal cavity/paranasal sinus reactions
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Pain - Pleura
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Bruising (in absence of Grade 3 or 4 thrombocytopenia)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 20 at risk

Adverse event: Hair loss/alopecia (scalp or body)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 20 at risk

Adverse event: Injection site reaction/extravasation changes
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 20 at risk

Adverse event: Pain - Scalp
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 20 at risk

Adverse event: Pruritus/itching
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 20 at risk

Adverse event: Rash: acne/acneiform
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 20 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 20 at risk

Adverse event: Cardiac ischemia/infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 31 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 31 at risk

Adverse event: Dysphagia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 31 at risk

Adverse event: Mucositis/stomatitis (clinical exam) - Oral cavity
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 31 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 31 at risk

Adverse event: Pain - Chest wall
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 31 at risk

Adverse event: Febrile neutopenia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 31 at risk

Adverse event: Infection with Grade 3 or 4 neutrophils - Mucosa
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 31 at risk

Adverse event: Leukocytes (total WBC) - low
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 31 at risk

Adverse event: Platelets - low
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 31 at risk

Adverse event: Pain - Extremity-limb
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 31 at risk

Adverse event: Neuropathy: motor
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 31 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 31 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 31 at risk

Adverse event: Pulmonary/Upper Respiratory - Other
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 31 at risk

Adverse event: Superior vena cava syndrome
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 31 at risk

Adverse event: Thrombosis/embolism (vascular access-related)
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 31 at risk

Adverse event: Edema: limb
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 31 at risk

Adverse event: Hemolysis (e.g., immune hemolytic anemia, drugrelated hemolysis)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 31 at risk

Adverse event: Leukocytes (total WBC) - Low
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 31 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 31 at risk

Adverse event: Vision-blurred vision
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 31 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 31 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 31 at risk

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

Adverse event: Dry mouth/salivary gland (xerostomia)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 31 at risk

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

Adverse event: Oesophagitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 31 at risk

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

Adverse event: Mucositis/stomatitis (clinical exam) - Oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 31 at risk

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

Adverse event: Pain - Absomen NOS
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 31 at risk

Adverse event: Taste alteration (dysgeusia)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 31 at risk

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

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 22 affected / 31 at risk

Adverse event: Fever (in the absence of neutropenia)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 31 at risk

Adverse event: Flu-like syndrome
Serious: no
Organ System: General disorders
Frequency: 2 affected / 31 at risk

Adverse event: Pain - Chest/thorax NOS
Serious: no
Organ System: General disorders
Frequency: 1 affected / 31 at risk

Adverse event: Pain - Face
Serious: no
Organ System: General disorders
Frequency: 2 affected / 31 at risk

Adverse event: Sweating (diaphoresis)
Serious: no
Organ System: General disorders
Frequency: 2 affected / 31 at risk

Adverse event: Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)
Serious: no
Organ System: Immune system disorders
Frequency: 3 affected / 31 at risk

Adverse event: Infection with unknown ANC - Lung (pneumonia)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 31 at risk

Adverse event: Bilirubin (hyperbilirubinemia)
Serious: no
Organ System: Investigations
Frequency: 2 affected / 31 at risk

Adverse event: Creatinine - High
Serious: no
Organ System: Investigations
Frequency: 2 affected / 31 at risk

Adverse event: Hemoglobin - Low
Serious: no
Organ System: Investigations
Frequency: 6 affected / 31 at risk

Adverse event: Metabolic/Laboratory - Other, Elevated AST
Serious: no
Organ System: Investigations
Frequency: 3 affected / 31 at risk

Adverse event: Platelets - Low
Serious: no
Organ System: Investigations
Frequency: 6 affected / 31 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 31 at risk

Adverse event: Albumin, serum-low (hypoalbuminemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 31 at risk

Adverse event: Blood alkaline phosphatase
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 31 at risk

Adverse event: ALT, SGPT (serum glutamic pyruvic transaminase) - High
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 31 at risk

Adverse event: Calcium, serum-high (hypercalcemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 31 at risk

Adverse event: Glucose, serum-high (hyperglycemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 31 at risk

Adverse event: Magnesium, serum-low (hypomagnesemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 31 at risk

Adverse event: Metabolic/Laboratory - Other, Increased ALT
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 31 at risk

Adverse event: Potassium, serum-high (hyperkalemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 31 at risk

Adverse event: Potassium, serum-low (hypokalemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 31 at risk

Adverse event: Sodium, serum-low (hyponatremia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 31 at risk

Adverse event: Muscle weakness, generalized or specific area (not due to neuropathy) - Extraocular
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 31 at risk

Adverse event: Muscle weakness, generalized or specific area (not due to neuropathy) - Extremitylower
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 31 at risk

Adverse event: Muscle weakness, generalized or specific area (not due to neuropathy) - Whole body/generalized
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 31 at risk

Adverse event: Pain - Back
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 31 at risk

Adverse event: Pain - Bone
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 31 at risk

Adverse event: Pain - Chest wall
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 31 at risk

Adverse event: Pain - Extremity-limb
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 31 at risk

Adverse event: Pain - Joint
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 31 at risk

Adverse event: Pain - Muscle
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 31 at risk

Adverse event: Pain - Other, Shoulder
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 31 at risk

Adverse event: Ataxia (incoordination)
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 31 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 31 at risk

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

Adverse event: Neuropathy: cranial - CN IX Motor-pharynx; Sensory-ear, pharynx, tongue
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 31 at risk

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

Adverse event: Neuropathy: sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 31 at risk

Adverse event: Pain - Head/headache
Serious: no
Organ System: Nervous system disorders
Frequency: 22 affected / 31 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 31 at risk

Adverse event: Mood alteration - Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 31 at risk

Adverse event: Mood alteration - Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 31 at risk

Adverse event: Incontinence, urinary
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 31 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 31 at risk

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

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 31 at risk

Adverse event: Hair loss/alopecia (scalp or body)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 31 at risk

Adverse event: Injection site reaction/extravasation changes
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 31 at risk

Adverse event: Pruritus/itching
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 31 at risk

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

Adverse event: Rash: acne/acneiform
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 31 at risk

Adverse event: Rash: dermatitis associated with radiation - Radiation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 31 at risk

Adverse event: Rash: hand-foot skin reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 31 at risk