Study: NCT00721513

Adverse event: Low WBC
Serious: yes
Organ System: Investigations
Frequency: 7 affected / 20 at risk

Adverse event: Platelet count decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 20 at risk

Adverse event: Low Hemoglobin
Serious: yes
Organ System: Investigations
Frequency: 10 affected / 20 at risk

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

Adverse event: Decreased appetite
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 20 at risk

Adverse event: Low ANC
Serious: yes
Organ System: Investigations
Frequency: 9 affected / 20 at risk

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

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

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Investigations
Frequency: 3 affected / 20 at risk

Adverse event: Hypocalcaemia
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 20 at risk

Adverse event: Hypomagnesaemia
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 20 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Investigations
Frequency: 13 affected / 20 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Investigations
Frequency: 9 affected / 20 at risk

Adverse event: Bicarbonate serum-low
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 20 at risk

Adverse event: Hyperbilirubinaemia
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 20 at risk

Adverse event: Hypophosphataemia
Serious: yes
Organ System: Investigations
Frequency: 4 affected / 20 at risk

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

Adverse event: Hypermagnesaemia
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 20 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 20 at risk

Adverse event: Dysphagia
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 20 at risk

Adverse event: Fever without neutropenia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 20 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 20 at risk

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

Adverse event: Hypoxia
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 20 at risk

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

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

Adverse event: Acidosis
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 20 at risk

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

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

Adverse event: Colitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 20 at risk

Adverse event: Death not associated with any term
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 20 at risk

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

Adverse event: Lymphopenia
Serious: yes
Organ System: Investigations
Frequency: 17 affected / 20 at risk

Adverse event: Pain Oral cavity
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 20 at risk

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

Adverse event: Rash: dermatitis associated with radiation: Chemoradiation
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 20 at risk

Adverse event: Dental problems
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 20 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils: Pleura
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 20 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils: Abdomen
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 20 at risk

Adverse event: Pain: Tumor pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 20 at risk

Adverse event: Mucositis/stomatitis Oral cavity
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 20 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils: Wound
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 20 at risk

Adverse event: Low WBC
Serious: no
Organ System: Investigations
Frequency: 10 affected / 20 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 14 affected / 20 at risk

Adverse event: Low Hemoglobin
Serious: no
Organ System: Investigations
Frequency: 10 affected / 20 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 20 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 20 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 20 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Frequency: 7 affected / 20 at risk

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

Adverse event: Blood alkaline phosphatase
Serious: no
Organ System: Investigations
Frequency: 9 affected / 20 at risk

Adverse event: Blood creatinine
Serious: no
Organ System: Investigations
Frequency: 6 affected / 20 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Investigations
Frequency: 4 affected / 20 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 20 at risk

Adverse event: Pleural effusion (non-malignant)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 20 at risk

Adverse event: Hypertension
Serious: no
Organ System: General disorders
Frequency: 5 affected / 20 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 8 affected / 20 at risk

Adverse event: Neuropathy: sensory
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 20 at risk

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

Adverse event: Low ANC
Serious: no
Organ System: Investigations
Frequency: 2 affected / 20 at risk

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

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 6 affected / 20 at risk

Adverse event: Taste disorder
Serious: no
Organ System: General disorders
Frequency: 6 affected / 20 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 20 at risk

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

Adverse event: Rigors/chills
Serious: no
Organ System: General disorders
Frequency: 6 affected / 20 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: General disorders
Frequency: 2 affected / 20 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 16 affected / 20 at risk

Adverse event: Weight decreased
Serious: no
Organ System: General disorders
Frequency: 8 affected / 20 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Investigations
Frequency: 17 affected / 20 at risk

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

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

Adverse event: Hypocalcaemia
Serious: no
Organ System: Investigations
Frequency: 18 affected / 20 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Investigations
Frequency: 16 affected / 20 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Investigations
Frequency: 7 affected / 20 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Investigations
Frequency: 5 affected / 20 at risk

Adverse event: Bicarbonate serum-low
Serious: no
Organ System: Investigations
Frequency: 5 affected / 20 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Investigations
Frequency: 18 affected / 20 at risk

Adverse event: Hyperbilirubinaemia
Serious: no
Organ System: Investigations
Frequency: 5 affected / 20 at risk

Adverse event: serum glutamic pyruvic transaminase
Serious: no
Organ System: Investigations
Frequency: 6 affected / 20 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Investigations
Frequency: 9 affected / 20 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 20 at risk

Adverse event: Pain: Head/headache
Serious: no
Organ System: General disorders
Frequency: 9 affected / 20 at risk

Adverse event: serum glutamic oxaloacetic transaminase
Serious: no
Organ System: Investigations
Frequency: 6 affected / 20 at risk

Adverse event: Hypermagnesaemia
Serious: no
Organ System: Investigations
Frequency: 3 affected / 20 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Investigations
Frequency: 2 affected / 20 at risk

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

Adverse event: Ocular/Visual - Other
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 20 at risk

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

Adverse event: Fever without neutropenia
Serious: no
Organ System: General disorders
Frequency: 5 affected / 20 at risk

Adverse event: Urinary frequency/urgency
Serious: no
Organ System: General disorders
Frequency: 2 affected / 20 at risk

Adverse event: Infection - Other
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 20 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 20 at risk

Adverse event: Edema: head and neck
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 20 at risk

Adverse event: Edema: limb
Serious: no
Organ System: Vascular disorders
Frequency: 6 affected / 20 at risk

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

Adverse event: Heartburn/dyspepsia
Serious: no
Organ System: General disorders
Frequency: 4 affected / 20 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Frequency: 7 affected / 20 at risk

Adverse event: Dehydration
Serious: no
Organ System: General disorders
Frequency: 5 affected / 20 at risk

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

Adverse event: Pruritus/itching
Serious: no
Organ System: General disorders
Frequency: 3 affected / 20 at risk

Adverse event: Anxiety
Serious: no
Organ System: General disorders
Frequency: 4 affected / 20 at risk

Adverse event: Depression
Serious: no
Organ System: General disorders
Frequency: 5 affected / 20 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 10 affected / 20 at risk

Adverse event: Distension bloating, abdominal
Serious: no
Organ System: General disorders
Frequency: 1 affected / 20 at risk

Adverse event: Pain: Abdomen
Serious: no
Organ System: General disorders
Frequency: 8 affected / 20 at risk

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

Adverse event: Rash: acne/acneiform
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 20 at risk

Adverse event: Partial Thromboplastin Time
Serious: no
Organ System: Investigations
Frequency: 5 affected / 20 at risk

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

Adverse event: Aspiration
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 20 at risk

Adverse event: Atelectasis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 20 at risk

Adverse event: Pain: Back
Serious: no
Organ System: General disorders
Frequency: 3 affected / 20 at risk

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

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils: Bronchus
Serious: no
Organ System: Infections and infestations
Frequency: 1 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: Pain: Chest/thorax
Serious: no
Organ System: General disorders
Frequency: 1 affected / 20 at risk

Adverse event: Pain: Chest wall
Serious: no
Organ System: General disorders
Frequency: 2 affected / 20 at risk

Adverse event: Colitis infectious
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 20 at risk

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

Adverse event: Wound complication, non-infectious
Serious: no
Organ System: General disorders
Frequency: 2 affected / 20 at risk

Adverse event: Skin breakdown/decubitus ulcer
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 20 at risk

Adverse event: Rash: dermatitis associated with radiation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 20 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 20 at risk

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

Adverse event: Extrapyramidal/involuntary movement/restlessness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 20 at risk

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

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

Adverse event: Fracture
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 20 at risk

Adverse event: gamma-Glutamyl transpeptidase
Serious: no
Organ System: Investigations
Frequency: 2 affected / 20 at risk

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

Adverse event: Glomerular filtration rate
Serious: no
Organ System: Investigations
Frequency: 5 affected / 20 at risk

Adverse event: Cholesterol, serum-high
Serious: no
Organ System: Investigations
Frequency: 1 affected / 20 at risk

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

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

Adverse event: functional obstruction of bowel
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 20 at risk

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

Adverse event: Voice changes
Serious: no
Organ System: General disorders
Frequency: 2 affected / 20 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Investigations
Frequency: 3 affected / 20 at risk

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

Adverse event: Muscular weakness
Serious: no
Organ System: General disorders
Frequency: 7 affected / 20 at risk

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

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

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

Adverse event: Pain: Neck
Serious: no
Organ System: General disorders
Frequency: 7 affected / 20 at risk

Adverse event: infection associated with Lymphopenia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 20 at risk

Adverse event: Pain Oral cavity
Serious: no
Organ System: General disorders
Frequency: 5 affected / 20 at risk

Adverse event: Pain: Extremity-limb
Serious: no
Organ System: General disorders
Frequency: 2 affected / 20 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 3 affected / 20 at risk

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

Adverse event: Pain: Throat/pharynx/larynx
Serious: no
Organ System: General disorders
Frequency: 10 affected / 20 at risk

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

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 20 at risk

Adverse event: Rash: dermatitis associated with radiation: Chemoradiation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 20 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 20 at risk

Adverse event: Salivary gland changes/saliva
Serious: no
Organ System: General disorders
Frequency: 6 affected / 20 at risk

Adverse event: Supraventricular and nodal arrhythmia: Sinus bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 20 at risk

Adverse event: Sinus tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 20 at risk

Adverse event: Mucositis/stomatitis Oral cavity
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 20 at risk

Adverse event: Tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 3 affected / 20 at risk

Adverse event: Pain: Dental/teeth/peridontal
Serious: no
Organ System: General disorders
Frequency: 1 affected / 20 at risk

Adverse event: Neuropathy: cranial: CN V Motor-jaw muscles; Sensory-facial
Serious: no
Organ System: General disorders
Frequency: 2 affected / 20 at risk

Adverse event: Trismus (difficulty, restriction or pain when opening mouth)
Serious: no
Organ System: General disorders
Frequency: 4 affected / 20 at risk

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

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 20 at risk

Adverse event: Hemorrhage GU: Urinary
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 20 at risk

Adverse event: Induration/fibrosis (skin and subcutaneous tissue)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 20 at risk

Adverse event: Cytokine release syndrome/acute infusion reaction
Serious: no
Organ System: General disorders
Frequency: 1 affected / 20 at risk

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

Adverse event: Pain: Tumor pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 20 at risk

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

Adverse event: Mucositis/stomatitis Oral cavity
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 20 at risk

Adverse event: Hemorrhage pulmonary/upper respiratory
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 20 at risk

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

Adverse event: Fibrosis-deep connective tissue
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): Extremity-lower
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 20 at risk

Adverse event: Neuropathy: cranial: CN VIII Hearing and balance
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 20 at risk

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