Study: NCT00096174

Adverse event: Hearing w/w-o audiogr in monitor prg
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 66 at risk

Adverse event: Hearing w/w-o audiogr not in monitor prg
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 66 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 66 at risk

Adverse event: Leukopenia
Serious: yes
Organ System: Investigations
Frequency: 19 affected / 66 at risk

Adverse event: Lymphopenia
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 66 at risk

Adverse event: Neutrophenia
Serious: yes
Organ System: Investigations
Frequency: 17 affected / 66 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 66 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 66 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 66 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 15 affected / 66 at risk

Adverse event: Fever w/o neutropenia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 66 at risk

Adverse event: Insomnia
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 66 at risk

Adverse event: Weight decreased
Serious: yes
Organ System: Investigations
Frequency: 18 affected / 66 at risk

Adverse event: Dry skin
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 66 at risk

Adverse event: Rash/desquamation
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 66 at risk

Adverse event: Rash: acne/acneiform
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 17 affected / 66 at risk

Adverse event: Radiation dermatitis
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 12 affected / 66 at risk

Adverse event: Wound - non-infectious
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 66 at risk

Adverse event: Skin-other
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 66 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 23 affected / 66 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 66 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 13 affected / 66 at risk

Adverse event: Dental problems
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 66 at risk

Adverse event: Diarrhea w/o prior colostomy
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 66 at risk

Adverse event: Dry mouth
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 66 at risk

Adverse event: Dysphagia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 30 affected / 66 at risk

Adverse event: Oesophagitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 66 at risk

Adverse event: Muco/stomatitis by exam, oral cavity
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 66 at risk

Adverse event: Muco/stomatitis by exam, pharynx
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 66 at risk

Adverse event: Muco/stomatitis (symptom) anus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 66 at risk

Adverse event: Muco/stomatitis (symptom) oral cavity
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 36 affected / 66 at risk

Adverse event: Salivary problems
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 66 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 66 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 66 at risk

Adverse event: Larynx, hemorrhage
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 66 at risk

Adverse event: Hypoalbuminaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 66 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 66 at risk

Adverse event: Alkalosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 66 at risk

Adverse event: Alanine aminotransferase increased
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 66 at risk

Adverse event: Aspartate aminotransferase increased
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 66 at risk

Adverse event: Blood bilirubin increased
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 66 at risk

Adverse event: Hypocalcaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 66 at risk

Adverse event: Blood creatinine increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 66 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 66 at risk

Adverse event: Hypermagnesaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 66 at risk

Adverse event: Hypomagnesaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 66 at risk

Adverse event: Hypophosphataemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 66 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 13 affected / 66 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 14 affected / 66 at risk

Adverse event: Trismus
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 66 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 66 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 66 at risk

Adverse event: Agitation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 66 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 66 at risk

Adverse event: Neuropathy-motor
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 66 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 66 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 66 at risk

Adverse event: Ocular-other
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 66 at risk

Adverse event: Abdomen, pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 66 at risk

Adverse event: Back, pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 66 at risk

Adverse event: Chest/thoracic pain NOS
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 66 at risk

Adverse event: Esophagus, pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 66 at risk

Adverse event: Head/headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 66 at risk

Adverse event: Neck, pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 66 at risk

Adverse event: Oral cavity, pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 66 at risk

Adverse event: Pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 66 at risk

Adverse event: Skin, pain
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 66 at risk

Adverse event: Throat/pharynx/larynx, pain
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 66 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 66 at risk

Adverse event: Edema, larynx
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 66 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 66 at risk

Adverse event: Pneumonitis/pulmonary infiltrates
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 66 at risk

Adverse event: Voice changes/dysarthria
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 66 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 66 at risk

Adverse event: Infection w/ gr3-4 neut, lung
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 66 at risk

Adverse event: Infection w/ gr3-4 neut, urinary tract
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 66 at risk

Adverse event: Infection Gr0-2 neut, abdomen
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 66 at risk

Adverse event: Infection Gr0-2 neut, foreign body
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 66 at risk

Adverse event: Infection Gr0-2 neut, lung
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 66 at risk

Adverse event: Infection Gr0-2 neut, oral cavity
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 66 at risk

Adverse event: Infection Gr0-2 neut, skin
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 66 at risk

Adverse event: Infection Gr0-2 neut, upper airway
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 66 at risk

Adverse event: Infection w/ unk ANC bronchus
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 66 at risk

Adverse event: Infection w/ unk ANC conjunctiva
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 66 at risk

Adverse event: Infection w/ gr3-4 neut, blood
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 66 at risk

Adverse event: Infection Gr0-2 neut, blood
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 66 at risk

Adverse event: Hearing w/o audiogr not in monitor prg
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 5 affected / 66 at risk

Adverse event: Tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 5 affected / 66 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 60 affected / 66 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Investigations
Frequency: 55 affected / 66 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Investigations
Frequency: 34 affected / 66 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Investigations
Frequency: 20 affected / 66 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 12 affected / 66 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 55 affected / 66 at risk

Adverse event: Fever w/o neutropenia
Serious: no
Organ System: General disorders
Frequency: 15 affected / 66 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 8 affected / 66 at risk

Adverse event: Rigor/chills
Serious: no
Organ System: General disorders
Frequency: 4 affected / 66 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 57 affected / 66 at risk

Adverse event: Thermal burn
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 12 affected / 66 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 29 affected / 66 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 15 affected / 66 at risk

Adverse event: Pruritus/itching
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 66 at risk

Adverse event: Rash: ache/acneiform
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 58 affected / 66 at risk

Adverse event: Radiation dermatitis
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 18 affected / 66 at risk

Adverse event: Skin-other
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 31 affected / 66 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 45 affected / 66 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 33 affected / 66 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 12 affected / 66 at risk

Adverse event: Dental problems
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 66 at risk

Adverse event: Diarrhea w/o prior colostomy
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 21 affected / 66 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 38 affected / 66 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 48 affected / 66 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 66 at risk

Adverse event: Muco/stomatitis by exam, oral activity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 66 at risk

Adverse event: Muco/stomatitis (symptom) oral activity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 59 affected / 66 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 50 affected / 66 at risk

Adverse event: Salivary problems
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 26 affected / 66 at risk

Adverse event: Taste disorder
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 27 affected / 66 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 34 affected / 66 at risk

Adverse event: Infection Gr0-2 neut,oral cavity
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 66 at risk

Adverse event: Infection Gr0-2 neut,skin
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 66 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 49 affected / 66 at risk

Adverse event: Blood alkaline phosphatase
Serious: no
Organ System: Investigations
Frequency: 23 affected / 66 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 34 affected / 66 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 26 affected / 66 at risk

Adverse event: Blood bilirubin
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 5 affected / 66 at risk

Adverse event: Hypercalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 66 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 24 affected / 66 at risk

Adverse event: Blood creatinine
Serious: no
Organ System: Investigations
Frequency: 18 affected / 66 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 66 at risk

Adverse event: Hypermagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 66 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 46 affected / 66 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 66 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 30 affected / 66 at risk

Adverse event: Hypernatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 9 affected / 66 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 47 affected / 66 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 66 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 66 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 11 affected / 66 at risk

Adverse event: Neutropathy-sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 66 at risk

Adverse event: Abdomen,pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 66 at risk

Adverse event: Head/headache
Serious: no
Organ System: Nervous system disorders
Frequency: 13 affected / 66 at risk

Adverse event: Middle ear, pain
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 6 affected / 66 at risk

Adverse event: Oral cavity, pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 66 at risk

Adverse event: Skin, pain
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 66 at risk

Adverse event: Throat/pharynx/larynx, pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 22 affected / 66 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 66 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 66 at risk

Adverse event: Edema, larynx
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 66 at risk

Adverse event: Hiccoughs
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 66 at risk

Adverse event: Voice changes/dysarthria
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 18 affected / 66 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 66 at risk