Study: NCT00592501

Adverse event: Blood/bone marrow
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 23 at risk

Adverse event: Constitutional Symptoms - Other
Serious: no
Organ System: General disorders
Notes: "jittery"
Frequency: 1 affected / 23 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 23 at risk

Adverse event: Blood/Bone Marrow - Other
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Neutropenia
Frequency: 2 affected / 23 at risk

Adverse event: Gastrointestinal - Other
Serious: no
Organ System: Gastrointestinal disorders
Notes: acid reflux
Frequency: 1 affected / 23 at risk

Adverse event: Renal failure
Serious: no
Organ System: Renal and urinary disorders
Notes: acute renal failure
Frequency: 2 affected / 23 at risk

Adverse event: Blood alkaline phosphatase
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Alkaline phosphatase increased
Frequency: 2 affected / 23 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 10 affected / 23 at risk

Adverse event: ALT, SGPT
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: ALT increased
Frequency: 4 affected / 23 at risk

Adverse event: Neutrophil count
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: ANC increased
Frequency: 6 affected / 23 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Anemia (hemoglobin decreased)
Frequency: 13 affected / 23 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 21 affected / 23 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 11 affected / 23 at risk

Adverse event: Arthritis (non-septic)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 23 at risk

Adverse event: Aspiration
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 23 at risk

Adverse event: Infection - lung (pneumonia)
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 23 at risk

Adverse event: AST, SGOT
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: AST increased
Frequency: 2 affected / 23 at risk

Adverse event: Bicarbonate, serum-low
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 23 at risk

Adverse event: Vision-blurred vision
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 23 at risk

Adverse event: Contusion
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 23 at risk

Adverse event: Calcium, serum-high (hypercalcemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 23 at risk

Adverse event: Infection - other
Serious: no
Organ System: Infections and infestations
Notes: Candidiasis
Frequency: 8 affected / 23 at risk

Adverse event: Constitutional Symptoms - Other
Serious: no
Organ System: General disorders
Notes: Carboplatin extravasation
Frequency: 1 affected / 23 at risk

Adverse event: Cardiac troponin T (cTnT)
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 23 at risk

Adverse event: Infections - skin (cellulitis)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 23 at risk

Adverse event: Rigors/chills
Serious: no
Organ System: General disorders
Frequency: 4 affected / 23 at risk

Adverse event: CNS necrosis/cystic progression
Serious: no
Organ System: Nervous system disorders
Notes: CNS necrosis
Frequency: 2 affected / 23 at risk

Adverse event: Confusional state
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 23 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 23 at risk

Adverse event: Salivary gland changes/saliva
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 23 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 23 at risk

Adverse event: Dehydration
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 23 at risk

Adverse event: Mood alteration - Depression
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 23 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: desquamation
Frequency: 3 affected / 23 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 23 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 12 affected / 23 at risk

Adverse event: Ophthalmoplegia/ diplopia (double vision)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 23 at risk

Adverse event: Dry mouth/salivary gland (xerostomia)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 20 affected / 23 at risk

Adverse event: Thrombosis/thrombus/embolism
Serious: no
Organ System: Vascular disorders
Notes: DVT: left leg
Frequency: 1 affected / 23 at risk

Adverse event: Voice changes/dysarthria
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: hoarseness
Frequency: 3 affected / 23 at risk

Adverse event: Taste alteration (dysgeusia)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 20 affected / 23 at risk

Adverse event: Neurology - other
Serious: no
Organ System: Nervous system disorders
Notes: Dysosmia
Frequency: 1 affected / 23 at risk

Adverse event: Heartburn/dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 23 at risk

Adverse event: Dysphagia (difficulty swallowing)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 22 affected / 23 at risk

Adverse event: Dyspnea (shortness of breath)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 23 at risk

Adverse event: Lymphatics - other
Serious: no
Organ System: General disorders
Notes: Edema unspecified
Frequency: 3 affected / 23 at risk

Adverse event: Edema: head and neck
Serious: no
Organ System: General disorders
Frequency: 5 affected / 23 at risk

Adverse event: Edema: limb
Serious: no
Organ System: General disorders
Frequency: 2 affected / 23 at risk

Adverse event: Hemorrhage, pulmonary/upper respiratory - nose
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Epistaxis
Frequency: 2 affected / 23 at risk

Adverse event: Dermatology/Skin - Other
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Erythema unspecified
Frequency: 9 affected / 23 at risk

Adverse event: Extrapyramidal/ involuntary movement/restlessness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 23 at risk

Adverse event: Fatigue (asthenia, lethargy, malaise)
Serious: no
Organ System: General disorders
Frequency: 22 affected / 23 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 23 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 5 affected / 23 at risk

Adverse event: Neuropathy: sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 23 at risk

Adverse event: Gastrointestinal - Other
Serious: no
Organ System: Gastrointestinal disorders
Notes: Soft palate defect
Frequency: 1 affected / 23 at risk

Adverse event: Glucose, serum-high (hyperglycemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 23 at risk

Adverse event: Rash: hand-foot skin reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 23 at risk

Adverse event: Pain - head/headache
Serious: no
Organ System: General disorders
Frequency: 9 affected / 23 at risk

Adverse event: Hearing: patients with/without baseline audiogram and enrolled in a monitoring program
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Hearing loss
Frequency: 15 affected / 23 at risk

Adverse event: Hemorrhage/Bleeding - Other
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Hemorrhage unspecified
Frequency: 1 affected / 23 at risk

Adverse event: Hiccoughs (hiccups, singultus)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 23 at risk

Adverse event: Hyperpigmentation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 13 affected / 23 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 23 at risk

Adverse event: Thyroid function, high (hyperthyroidism, thyrotoxicosis)
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 23 at risk

Adverse event: Potassium, serum-low (hypokalemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 23 at risk

Adverse event: Magnesium, serum-low (hypomagnesemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 23 at risk

Adverse event: Sodium, serum-low (hyponatremia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 23 at risk

Adverse event: Hypopigmentation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 23 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 23 at risk

Adverse event: Thyroid function, low (hypothyroidism)
Serious: no
Organ System: Endocrine disorders
Frequency: 2 affected / 23 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 23 at risk

Adverse event: Ileus, GI
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 23 at risk

Adverse event: Metabolic/Laboratory - Other
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: "increased transaminase/LFT"
Frequency: 1 affected / 23 at risk

Adverse event: Colitis, infectious (e.g., Clostridium difficile)
Serious: no
Organ System: Infections and infestations
Notes: c diff
Frequency: 1 affected / 23 at risk

Adverse event: Mucositis/stomatitis - oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Notes: thrush/oral mucositis
Frequency: 17 affected / 23 at risk

Adverse event: Injection site reaction/extravasation changes
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 23 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 6 affected / 23 at risk

Adverse event: Auditory/Ear - Other
Serious: no
Organ System: Ear and labyrinth disorders
Notes: ear fullness
Frequency: 1 affected / 23 at risk

Adverse event: Tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 14 affected / 23 at risk

Adverse event: Pain - extremity-limb
Serious: no
Organ System: General disorders
Frequency: 2 affected / 23 at risk

Adverse event: Leukocytes (total WBC)
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: leukocytes decreased
Frequency: 9 affected / 23 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 14 affected / 23 at risk

Adverse event: Magnesium, serum-high (hypermagnesemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 23 at risk

Adverse event: Memory impairment
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 23 at risk

Adverse event: Constitutional Symptoms - Other
Serious: no
Organ System: General disorders
Notes: mucositis unspecified
Frequency: 19 affected / 23 at risk

Adverse event: Mucositis/stomatitis - pharynx
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 23 at risk

Adverse event: Pulmonary/Upper Respiratory - Other
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: nasal congestion
Frequency: 14 affected / 23 at risk

Adverse event: Pulmonary/Upper Respiratory - Other
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Nasal Stenosis
Frequency: 2 affected / 23 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 21 affected / 23 at risk

Adverse event: Musculoskeletal/Soft Tissue - Other
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: neck stiffness
Frequency: 2 affected / 23 at risk

Adverse event: Neurology - Other
Serious: no
Organ System: Nervous system disorders
Notes: neuropathy unspecified
Frequency: 5 affected / 23 at risk

Adverse event: Apnoea
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 23 at risk

Adverse event: Gastrointestinal - Other
Serious: no
Organ System: Gastrointestinal disorders
Notes: Odynophagia
Frequency: 9 affected / 23 at risk

Adverse event: Pain: oral-gums
Serious: no
Organ System: General disorders
Frequency: 7 affected / 23 at risk

Adverse event: Infection - Middle ear (otitis media)
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 23 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 4 affected / 23 at risk

Adverse event: Pain - other
Serious: no
Organ System: General disorders
Notes: pain at g-tube site
Frequency: 3 affected / 23 at risk

Adverse event: pain - anus
Serious: no
Organ System: General disorders
Frequency: 1 affected / 23 at risk

Adverse event: pain - back
Serious: no
Organ System: General disorders
Frequency: 3 affected / 23 at risk

Adverse event: pain - other
Serious: no
Organ System: General disorders
Notes: ear pain unspecified
Frequency: 1 affected / 23 at risk

Adverse event: pain - face
Serious: no
Organ System: General disorders
Frequency: 1 affected / 23 at risk

Adverse event: pain - eye
Serious: no
Organ System: General disorders
Frequency: 1 affected / 23 at risk

Adverse event: pain - middle ear
Serious: no
Organ System: General disorders
Frequency: 1 affected / 23 at risk

Adverse event: pain - neck
Serious: no
Organ System: General disorders
Frequency: 1 affected / 23 at risk

Adverse event: pain - chest wall
Serious: no
Organ System: General disorders
Frequency: 1 affected / 23 at risk

Adverse event: pain - oral cavity
Serious: no
Organ System: General disorders
Frequency: 5 affected / 23 at risk

Adverse event: pain - throat/pharynx/larynx
Serious: no
Organ System: General disorders
Frequency: 15 affected / 23 at risk

Adverse event: Blood/Bone Marrow - Other
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Pancytopenia
Frequency: 1 affected / 23 at risk

Adverse event: neurology - other
Serious: no
Organ System: Nervous system disorders
Notes: peripheral neuropathy unspecified
Frequency: 2 affected / 23 at risk

Adverse event: platelets
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: platelets decreased
Frequency: 7 affected / 23 at risk

Adverse event: infection - bronchus
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 23 at risk

Adverse event: pain - joint
Serious: no
Organ System: General disorders
Frequency: 3 affected / 23 at risk

Adverse event: Pulmonary/Upper Respiratory - Other
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Pneumomediastinum
Frequency: 1 affected / 23 at risk

Adverse event: Potassium, serum-high (hyperkalemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 23 at risk

Adverse event: Pruritus/itching
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 23 at risk

Adverse event: Dry mouth/salivary gland (xerostomia)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 23 at risk

Adverse event: Weight decreased
Serious: no
Organ System: General disorders
Frequency: 22 affected / 23 at risk

Adverse event: Vasovagal episode
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 23 at risk

Adverse event: Trismus (difficulty, restriction or pain when opening mouth)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 9 affected / 23 at risk

Adverse event: infection - upper airway NOS
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 23 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 19 affected / 23 at risk

Adverse event: Syncope (fainting)
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 23 at risk

Adverse event: Sodium, serum-high (hypernatremia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 23 at risk

Adverse event: Somnolence/depressed level of consciousness
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 23 at risk

Adverse event: Dermatology/Skin - Other
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Sebaceous Cysts
Frequency: 1 affected / 23 at risk

Adverse event: Pulmonary/Upper Respiratory - Other
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Rhinorrhea
Frequency: 1 affected / 23 at risk

Adverse event: Sweating (diaphoresis)
Serious: no
Organ System: General disorders
Frequency: 2 affected / 23 at risk

Adverse event: Speech impairment (e.g., dysphasia or aphasia)
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 23 at risk

Adverse event: Gastrointestinal - Other
Serious: no
Organ System: Gastrointestinal disorders
Notes: Soft palate fusion to post-oropharynx
Frequency: 1 affected / 23 at risk

Adverse event: Dermatology/Skin --Other
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Skin breakdown - lips
Frequency: 2 affected / 23 at risk

Adverse event: Dermatology/Skin - Other
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: rash unspecified
Frequency: 13 affected / 23 at risk

Adverse event: Renal/Genitourinary - Other
Serious: no
Organ System: Renal and urinary disorders
Notes: renal insufficiency
Frequency: 1 affected / 23 at risk

Adverse event: Infection - Other
Serious: no
Organ System: Infections and infestations
Notes: ear infection unspecified
Frequency: 1 affected / 23 at risk

Adverse event: Musculoskeletal/Soft Tissue - Other
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: restless leg syndrome
Frequency: 1 affected / 23 at risk

Adverse event: Rash: dermatitis associated with radiation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 23 at risk

Adverse event: Thrombosis/thrombus/embolism
Serious: no
Organ System: Vascular disorders
Notes: Thromboplebitis (left arm)
Frequency: 1 affected / 23 at risk

Adverse event: Constitutional Symptoms - Other
Serious: no
Organ System: General disorders
Notes: thick mucus, unspecified
Frequency: 1 affected / 23 at risk