Study: NCT00302159

Adverse event: Amylase
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 43 at risk

Adverse event: Ataxia (incoordination)
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 43 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 43 at risk

Adverse event: Death not associated with CTCAE term::Disease progression NOS
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 43 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 43 at risk

Adverse event: Dyspnea (shortness of breath)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 43 at risk

Adverse event: Encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 43 at risk

Adverse event: Fatigue (asthenia, lethargy, malaise)
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 43 at risk

Adverse event: Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 43 at risk

Adverse event: Hemorrhage, CNS
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 43 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 43 at risk

Adverse event: Infection - Other (Specify, pneumonia)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 43 at risk

Adverse event: Lymphopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 43 at risk

Adverse event: Metabolic/Laboratory - Other (Specify, high ammonia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 43 at risk

Adverse event: Mood alteration::Agitation
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 43 at risk

Adverse event: Neuropathy: motor
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 43 at risk

Adverse event: Pain::Head/headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 43 at risk

Adverse event: Platelets
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 43 at risk

Adverse event: Pulmonary/Upper Respiratory - Other (Specify, PE)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 43 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 43 at risk

Adverse event: Speech impairment (e.g., dysphasia or aphasia)
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 43 at risk

Adverse event: Vision-blurred vision
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 43 at risk

Adverse event: ALT, SGPT (serum glutamic pyruvic transaminase)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 15 affected / 43 at risk

Adverse event: AST, SGOT(serum glutamic oxaloacetic transaminase)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 43 at risk

Adverse event: Albumin, serum-low (hypoalbuminemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 27 affected / 43 at risk

Adverse event: Blood alkaline phosphatase
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 43 at risk

Adverse event: Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)
Serious: no
Organ System: Immune system disorders
Frequency: 4 affected / 43 at risk

Adverse event: Amylase
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 43 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 43 at risk

Adverse event: Arthritis (non-septic)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 43 at risk

Adverse event: Ataxia (incoordination)
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 43 at risk

Adverse event: Auditory/Ear - Other (Specify, decreased hearing)
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 43 at risk

Adverse event: Bilirubin (hyperbilirubinemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 43 at risk

Adverse event: Bronchospasm, wheezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 43 at risk

Adverse event: Calcium, serum-high (hypercalcemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 43 at risk

Adverse event: Calcium, serum-low (hypocalcemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 43 at risk

Adverse event: Cardiac General - Other (Specify, systolic ejection murmur noted)
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 43 at risk

Adverse event: Cognitive disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 43 at risk

Adverse event: Confusional state
Serious: no
Organ System: Nervous system disorders
Frequency: 16 affected / 43 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 43 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 43 at risk

Adverse event: Blood creatinine
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 43 at risk

Adverse event: Cushingoid appearance (e.g., moon face, buffalo hump, centripetal obesity, cutaneous striae)
Serious: no
Organ System: Endocrine disorders
Frequency: 2 affected / 43 at risk

Adverse event: Dehydration
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 43 at risk

Adverse event: Dermatology/Skin - Other (Specify, cyst R axilla)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 43 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 43 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 43 at risk

Adverse event: Dry mouth/salivary gland (xerostomia)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 43 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 43 at risk

Adverse event: Dysphagia (difficulty swallowing)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 43 at risk

Adverse event: Edema: head and neck
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 43 at risk

Adverse event: Edema: limb
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 43 at risk

Adverse event: Encephalopathy
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 43 at risk

Adverse event: Extrapyramidal/involuntary movement/restlessness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 43 at risk

Adverse event: Extremity-upper (function)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 43 at risk

Adverse event: Eyelid dysfunction
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 43 at risk

Adverse event: Fatigue (asthenia, lethargy, malaise)
Serious: no
Organ System: General disorders
Frequency: 25 affected / 43 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: 2 affected / 43 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 43 at risk

Adverse event: Gastritis (including bile reflux gastritis)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 43 at risk

Adverse event: Gastrointestinal - Other (Specify, GERD)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 43 at risk

Adverse event: Glucose, serum-high (hyperglycemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 43 at risk

Adverse event: Hair loss/alopecia (scalp or body)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 23 affected / 43 at risk

Adverse event: Hearing: patients without baseline audiogram and not enrolled in a monitoring program
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 43 at risk

Adverse event: Heartburn/dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 43 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 13 affected / 43 at risk

Adverse event: Hemorrhage, GI::Anus
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 43 at risk

Adverse event: Hemorrhage, GU::Vagina
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 43 at risk

Adverse event: Haemorrhoids
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 43 at risk

Adverse event: Hyperpigmentation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 43 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 43 at risk

Adverse event: Hypopigmentation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 43 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 43 at risk

Adverse event: INR (International Normalized Ratio of prothrombin time)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 43 at risk

Adverse event: Incontinence, urinary
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 43 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils::Conjunctiva
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 43 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils::Middle ear (otitis media)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 43 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils::Skin (cellulitis)
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 43 at risk

Adverse event: Infection with unknown ANC::Bronchus
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 43 at risk

Adverse event: Infection with unknown ANC::Paranasal
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 43 at risk

Adverse event: Infection with unknown ANC::Skin (cellulites)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 43 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 7 affected / 43 at risk

Adverse event: Leukocytes (total WBC)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 14 affected / 43 at risk

Adverse event: Lipase
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 43 at risk

Adverse event: Lymphatics - Other (Specify)
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: L facial edema; Tonsillar edema; Mobile node L axilla
Frequency: 2 affected / 43 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 27 affected / 43 at risk

Adverse event: Magnesium, serum-high (hypermagnesemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 15 affected / 43 at risk

Adverse event: Magnesium, serum-low (hypomagnesemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 43 at risk

Adverse event: Memory impairment
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 43 at risk

Adverse event: Mental status
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 43 at risk

Adverse event: Metabolic/Laboratory - Other (Specify)
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Elevated LD; Hypokalemia; Low protein; Phosphorus elevated
Frequency: 4 affected / 43 at risk

Adverse event: Mood alteration::Agitation
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 43 at risk

Adverse event: Mood alteration::Anxiety
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 43 at risk

Adverse event: Mood alteration::Depression
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 43 at risk

Adverse event: Mood alteration::Euphoria
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 43 at risk

Adverse event: Mucositis/stomatitis (clinical exam)::Oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 43 at risk

Adverse event: Mucositis/stomatitis (functional/symptomatic)::Oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 43 at risk

Adverse event: Muscle weakness, generalized or specific area (not due to neuropathy)::Extremity-upper
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 43 at risk

Adverse event: Muscle weakness, generalized or specific area (not due to neuropathy)::Facial
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 43 at risk

Adverse event: Muscle weakness, generalized or specific area (not due to neuropathy)::Left-sided
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 43 at risk

Adverse event: Muscle weakness, generalized or specific area (not due to neuropathy)::Right-sided
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 43 at risk

Adverse event: Musculoskeletal/Soft Tissue - Other (Specify, ® rotator cuff injury)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 43 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 23 affected / 43 at risk

Adverse event: Neurology - Other (Specify)
Serious: no
Organ System: Nervous system disorders
Notes: Dizziness; Hyperreflexivity; Decreased affect; Decreased attention span; Pronator drift
Frequency: 5 affected / 43 at risk

Adverse event: Neuropathy: cranial::CN II Vision
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 43 at risk

Adverse event: Neuropathy: cranial::CN V Motor-jaw muscles; Sensory-facial
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 43 at risk

Adverse event: Neuropathy: cranial::CN VII Motor-face; Sensory-taste
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 43 at risk

Adverse event: Neuropathy: cranial::CN VIII Hearing and balance
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 43 at risk

Adverse event: Neuropathy: motor
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 43 at risk

Adverse event: Neuropathy: sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 43 at risk

Adverse event: Neutrophils/granulocytes (ANC/AGC)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 8 affected / 43 at risk

Adverse event: Nystagmus
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 43 at risk

Adverse event: Ocular/Visual - Other (Specify)
Serious: no
Organ System: Eye disorders
Notes: "Seeing shapes" in cloth; Eye irritation; Problems seeing bright lights
Frequency: 3 affected / 43 at risk

Adverse event: Otitis, middle ear (non-infectious)
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 43 at risk

Adverse event: Pain - Other (Specify,jaw; right shoulder; whole body)
Serious: no
Organ System: General disorders
Frequency: 2 affected / 43 at risk

Adverse event: Pain::Abdomen NOS
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 43 at risk

Adverse event: Pain::Back
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 43 at risk

Adverse event: Pain::Chest/thorax NOS
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 43 at risk

Adverse event: Pain::Dental/teeth/peridontal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 43 at risk

Adverse event: Pain::Esophagus
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 43 at risk

Adverse event: Pain::External ear
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 43 at risk

Adverse event: Pain::Extremity-limb
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 43 at risk

Adverse event: Pain::Head/headache
Serious: no
Organ System: Nervous system disorders
Frequency: 14 affected / 43 at risk

Adverse event: Pain::Joint
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 43 at risk

Adverse event: Pain::Muscle
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 43 at risk

Adverse event: Pain::Pain NOS
Serious: no
Organ System: General disorders
Frequency: 1 affected / 43 at risk

Adverse event: Pain::Scalp
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 43 at risk

Adverse event: Pain::Throat/pharynx/larynx
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 43 at risk

Adverse event: Pancreatitis
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 43 at risk

Adverse event: Petechiae/purpura (hemorrhage/bleeding into skin or mucosa)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 43 at risk

Adverse event: Phosphate, serum-low (hypophosphatemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 43 at risk

Adverse event: Platelets
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 27 affected / 43 at risk

Adverse event: Potassium, serum-high (hyperkalemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 14 affected / 43 at risk

Adverse event: Pruritus/itching
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 43 at risk

Adverse event: Psychosis (hallucinations/delusions)
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 43 at risk

Adverse event: Pulmonary/Upper Respiratory - Other (Specify, pulomonary embolism)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 43 at risk

Adverse event: Pyramidal tract dysfunction
Serious: no
Organ System: Nervous system disorders
Notes: (e.g., increased tone, hyperreflexia, positive Babinski, decreased fine motor coordination)
Frequency: 1 affected / 43 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 43 at risk

Adverse event: Rash: acne/acneiform
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 43 at risk

Adverse event: Rash: dermatitis associated with radiation::Chemoradiation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 43 at risk

Adverse event: Rash: dermatitis associated with radiation::Radiation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 43 at risk

Adverse event: Seizure
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 43 at risk

Adverse event: Sodium, serum-high (hypernatremia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 11 affected / 43 at risk

Adverse event: Sodium, serum-low (hyponatremia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 11 affected / 43 at risk

Adverse event: Somnolence/depressed level of consciousness
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 43 at risk

Adverse event: Speech impairment (e.g., dysphasia or aphasia)
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 43 at risk

Adverse event: Supraventricular and nodal arrhythmia::Sinus tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 43 at risk

Adverse event: Sweating (diaphoresis)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 43 at risk

Adverse event: Taste alteration (dysgeusia)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 43 at risk

Adverse event: Tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 4 affected / 43 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 43 at risk

Adverse event: Uric acid, serum-high (hyperuricemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 43 at risk

Adverse event: Vision-blurred vision
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 43 at risk

Adverse event: Vision-flashing lights/floaters
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 43 at risk

Adverse event: Vision-photophobia
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 43 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 43 at risk

Adverse event: Watery eye (epiphora, tearing)
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 43 at risk

Adverse event: Weight increased
Serious: no
Organ System: General disorders
Frequency: 1 affected / 43 at risk

Adverse event: Weight decreased
Serious: no
Organ System: General disorders
Frequency: 2 affected / 43 at risk