Study: NCT00820248

Adverse event: Hearing (monitoring program)
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 25 affected / 156 at risk

Adverse event: Hearing (without monitoring program)
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 50 affected / 156 at risk

Adverse event: Pain External ear
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 156 at risk

Adverse event: Pain Middle ear
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 24 affected / 156 at risk

Adverse event: Tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 98 affected / 156 at risk

Adverse event: Hypothyroidism
Serious: no
Organ System: Endocrine disorders
Frequency: 21 affected / 156 at risk

Adverse event: Chelitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 156 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 123 affected / 156 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 29 affected / 156 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 141 affected / 156 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 144 affected / 156 at risk

Adverse event: GI - Other
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 156 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 36 affected / 156 at risk

Adverse event: Mucositis (clinical exam) Oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 120 affected / 156 at risk

Adverse event: Mucositis (functional/symptomatic) Oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 51 affected / 156 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 136 affected / 156 at risk

Adverse event: Pain Abdomen NOS
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 156 at risk

Adverse event: Pain Oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 32 affected / 156 at risk

Adverse event: Salivary gland changes
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 54 affected / 156 at risk

Adverse event: Teeth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 156 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 87 affected / 156 at risk

Adverse event: Edema: head and neck
Serious: no
Organ System: General disorders
Frequency: 38 affected / 156 at risk

Adverse event: Edema: limb
Serious: no
Organ System: General disorders
Frequency: 8 affected / 156 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 124 affected / 156 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 18 affected / 156 at risk

Adverse event: Pain - Other
Serious: no
Organ System: General disorders
Frequency: 26 affected / 156 at risk

Adverse event: Rigors/chills
Serious: no
Organ System: General disorders
Frequency: 4 affected / 156 at risk

Adverse event: Infection - Other
Serious: no
Organ System: Infections and infestations
Frequency: 44 affected / 156 at risk

Adverse event: Infection with normal ANC Catheter-related
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 156 at risk

Adverse event: Dermatitis Chemoradiation
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 64 affected / 156 at risk

Adverse event: Radiation skin injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 94 affected / 156 at risk

Adverse event: Blood creatinine
Serious: no
Organ System: Investigations
Frequency: 17 affected / 156 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Investigations
Frequency: 32 affected / 156 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 136 affected / 156 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 74 affected / 156 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 45 affected / 156 at risk

Adverse event: Fibrosis-deep connective tissue
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 9 affected / 156 at risk

Adverse event: Muscle weakness Whole body/generalized
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 156 at risk

Adverse event: Osteonecrosis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 156 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 156 at risk

Adverse event: Bone pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 156 at risk

Adverse event: Pain Extremity-limb
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 156 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 156 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 20 affected / 156 at risk

Adverse event: Trismus
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 20 affected / 156 at risk

Adverse event: Pain Tumor pain
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 25 affected / 156 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 19 affected / 156 at risk

Adverse event: Neuropathy-motor
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 156 at risk

Adverse event: Neuropathy-sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 61 affected / 156 at risk

Adverse event: Pain Head/headache
Serious: no
Organ System: Nervous system disorders
Frequency: 33 affected / 156 at risk

Adverse event: Taste disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 142 affected / 156 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 50 affected / 156 at risk

Adverse event: Mood alteration Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 22 affected / 156 at risk

Adverse event: Mood alteration Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 12 affected / 156 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 29 affected / 156 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 18 affected / 156 at risk

Adverse event: Edema, larynx
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 29 affected / 156 at risk

Adverse event: Hiccoughs
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 26 affected / 156 at risk

Adverse event: Mucositis (clinical exam) Pharynx
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 52 affected / 156 at risk

Adverse event: Pain Throat/pharynx/larynx
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 81 affected / 156 at risk

Adverse event: Voice changes
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 76 affected / 156 at risk

Adverse event: Acne
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 156 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 53 affected / 156 at risk

Adverse event: Dermatology - Other
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 156 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 10 affected / 156 at risk

Adverse event: Hand-foot
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 156 at risk

Adverse event: Hyperpigmentation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 21 affected / 156 at risk

Adverse event: Hypopigmentation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 156 at risk

Adverse event: Induration
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 156 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 156 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 15 affected / 156 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 156 at risk

Adverse event: Telangiectasia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 12 affected / 156 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 14 affected / 156 at risk

Adverse event: Hearing (monitoring program)
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 5 affected / 159 at risk

Adverse event: Hearing (without monitoring program)
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 20 affected / 159 at risk

Adverse event: Pain External ear
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 8 affected / 159 at risk

Adverse event: Pain Middle ear
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 29 affected / 159 at risk

Adverse event: Tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 18 affected / 159 at risk

Adverse event: Hypothyroidism
Serious: no
Organ System: Endocrine disorders
Frequency: 22 affected / 159 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 10 affected / 159 at risk

Adverse event: Chelitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 159 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 113 affected / 159 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 40 affected / 159 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 146 affected / 159 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 150 affected / 159 at risk

Adverse event: GI - Other
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 159 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 48 affected / 159 at risk

Adverse event: Mucositis (clinical exam) Oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 120 affected / 159 at risk

Adverse event: Mucositis (functional/symptomatic) Oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 55 affected / 159 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 94 affected / 159 at risk

Adverse event: Pain Abdomen NOS
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 159 at risk

Adverse event: Pain Oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 45 affected / 159 at risk

Adverse event: Salivary gland changes
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 67 affected / 159 at risk

Adverse event: Teeth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 159 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 63 affected / 159 at risk

Adverse event: Edema: head and neck
Serious: no
Organ System: General disorders
Frequency: 67 affected / 159 at risk

Adverse event: Edema: limb
Serious: no
Organ System: General disorders
Frequency: 6 affected / 159 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 123 affected / 159 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 17 affected / 159 at risk

Adverse event: Pain - Other
Serious: no
Organ System: General disorders
Frequency: 29 affected / 159 at risk

Adverse event: Rigors/chills
Serious: no
Organ System: General disorders
Frequency: 22 affected / 159 at risk

Adverse event: Infection - Other
Serious: no
Organ System: Infections and infestations
Frequency: 39 affected / 159 at risk

Adverse event: Infection with normal ANC Catheter-related
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 159 at risk

Adverse event: Dermatitis Chemoradiation
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 80 affected / 159 at risk

Adverse event: Radiation skin injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 72 affected / 159 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Investigations
Frequency: 34 affected / 159 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 127 affected / 159 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 69 affected / 159 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 38 affected / 159 at risk

Adverse event: Fibrosis-deep connective tissue
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 17 affected / 159 at risk

Adverse event: Muscle weakness Whole body/generalized
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 11 affected / 159 at risk

Adverse event: Osteonecrosis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 9 affected / 159 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 11 affected / 159 at risk

Adverse event: Bone pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 9 affected / 159 at risk

Adverse event: Pain Extremity-limb
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 159 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 10 affected / 159 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 29 affected / 159 at risk

Adverse event: Trismus
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 23 affected / 159 at risk

Adverse event: Pain Tumor pain
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 17 affected / 159 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 159 at risk

Adverse event: Neuropathy-motor
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 159 at risk

Adverse event: Neuropathy-sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 24 affected / 159 at risk

Adverse event: Pain Head/headache
Serious: no
Organ System: Nervous system disorders
Frequency: 34 affected / 159 at risk

Adverse event: Taste disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 139 affected / 159 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 46 affected / 159 at risk

Adverse event: Mood alteration Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 32 affected / 159 at risk

Adverse event: Mood alteration Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 13 affected / 159 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 38 affected / 159 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 16 affected / 159 at risk

Adverse event: Edema, larynx
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 32 affected / 159 at risk

Adverse event: Hiccoughs
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 159 at risk

Adverse event: Mucositis (clinical exam) Pharynx
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 53 affected / 159 at risk

Adverse event: Pain Throat/pharynx/larynx
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 86 affected / 159 at risk

Adverse event: Voice changes
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 74 affected / 159 at risk

Adverse event: Acne
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 147 affected / 159 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 50 affected / 159 at risk

Adverse event: Dermatology - Other
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 35 affected / 159 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 59 affected / 159 at risk

Adverse event: Hand-foot
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 25 affected / 159 at risk

Adverse event: Hyperpigmentation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 33 affected / 159 at risk

Adverse event: Hypopigmentation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 11 affected / 159 at risk

Adverse event: Induration
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 159 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 18 affected / 159 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 12 affected / 159 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 10 affected / 159 at risk

Adverse event: Telangiectasia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 10 affected / 159 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 22 affected / 159 at risk