Study: NCT00057785

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 68 at risk

Adverse event: Haemoglobin decreased
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 10 affected / 68 at risk

Adverse event: Red blood cell transfusion
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 68 at risk

Adverse event: Oedema
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 68 at risk

Adverse event: Left ventricular failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 68 at risk

Adverse event: Sinus tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 68 at risk

Adverse event: Arrhythmia supraventricular
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 68 at risk

Adverse event: Ventricular arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 68 at risk

Adverse event: Hypoacusis
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 8 affected / 68 at risk

Adverse event: Hearing-Other
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 3 affected / 68 at risk

Adverse event: Otitis externa (exc boil of meatus) NOS
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 68 at risk

Adverse event: Endocrine-Other
Serious: yes
Organ System: Endocrine disorders
Frequency: 2 affected / 68 at risk

Adverse event: Hypothyroidism
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 68 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 68 at risk

Adverse event: Dry mouth
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 68 at risk

Adverse event: Dysphagia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 68 at risk

Adverse event: Oesophageal spasm
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 68 at risk

Adverse event: Esophagitis NOS
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 68 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 21 affected / 68 at risk

Adverse event: Radiation mucositis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 28 affected / 68 at risk

Adverse event: Salivary gland disorder
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 68 at risk

Adverse event: Stomatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 68 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 19 affected / 68 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 6 affected / 68 at risk

Adverse event: Pain due to radiation
Serious: yes
Organ System: General disorders
Frequency: 6 affected / 68 at risk

Adverse event: Pain-other
Serious: yes
Organ System: General disorders
Frequency: 6 affected / 68 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 68 at risk

Adverse event: Device related infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 68 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 68 at risk

Adverse event: Infection with grade 3 or 4 neutropenia
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 68 at risk

Adverse event: Infection with unknown ANC
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 68 at risk

Adverse event: Infection, Other
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 68 at risk

Adverse event: Radiation skin injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 6 affected / 68 at risk

Adverse event: Alanine aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 68 at risk

Adverse event: Aspartate aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 68 at risk

Adverse event: Blood creatinine increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 68 at risk

Adverse event: CD4 lymphocytes decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 68 at risk

Adverse event: Inappropriate antidiuretic hormone secretion
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 68 at risk

Adverse event: Leukocytes for BMT
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 68 at risk

Adverse event: Leukopenia
Serious: yes
Organ System: Investigations
Frequency: 4 affected / 68 at risk

Adverse event: Lymphopenia
Serious: yes
Organ System: Investigations
Frequency: 11 affected / 68 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Investigations
Frequency: 20 affected / 68 at risk

Adverse event: Platelet count decreased
Serious: yes
Organ System: Investigations
Frequency: 4 affected / 68 at risk

Adverse event: Weight decreased
Serious: yes
Organ System: Investigations
Frequency: 12 affected / 68 at risk

Adverse event: Weight increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 68 at risk

Adverse event: Acidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 68 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 68 at risk

Adverse event: Blood albumin decreased
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 68 at risk

Adverse event: Blood magnesium decreased
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 68 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 11 affected / 68 at risk

Adverse event: Hyperglycemia NOS
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 68 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 68 at risk

Adverse event: Hypocalcaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 68 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 68 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 12 affected / 68 at risk

Adverse event: Hypophosphataemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 68 at risk

Adverse event: Joint, muscle, or bone-Other
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 68 at risk

Adverse event: Tumour pain
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 68 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 68 at risk

Adverse event: Neurologic-Other
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 68 at risk

Adverse event: Peripheral motor neuropathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 68 at risk

Adverse event: Peripheral sensory neuropathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 68 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 68 at risk

Adverse event: Anxiety
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 68 at risk

Adverse event: Depression NEC
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 68 at risk

Adverse event: Hallucination
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 68 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 68 at risk

Adverse event: Renal/GU-Other
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 68 at risk

Adverse event: Dyspnea NOS
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 68 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 68 at risk

Adverse event: Pneumonitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 68 at risk

Adverse event: Pulmonary-other
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 68 at risk

Adverse event: Erythema multiforme
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 68 at risk

Adverse event: Skin-Other
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 68 at risk

Adverse event: Hemorrhage NOS
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 68 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 6 affected / 68 at risk

Adverse event: Thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 68 at risk

Adverse event: Hematologic-Other
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 8 affected / 68 at risk

Adverse event: Haemoglobin decreased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 51 affected / 68 at risk

Adverse event: Oedema
Serious: no
Organ System: Cardiac disorders
Frequency: 13 affected / 68 at risk

Adverse event: Ear pain
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 4 affected / 68 at risk

Adverse event: Hypoacusis
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 33 affected / 68 at risk

Adverse event: Hearing-Other
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 17 affected / 68 at risk

Adverse event: Late RT toxicity: Auditory/hearing: NOS
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 32 affected / 68 at risk

Adverse event: Otitis media
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 7 affected / 68 at risk

Adverse event: Hypothyroidism
Serious: no
Organ System: Endocrine disorders
Frequency: 10 affected / 68 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 68 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 68 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 61 affected / 68 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 24 affected / 68 at risk

Adverse event: Esophagitis NOS
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 28 affected / 68 at risk

Adverse event: GI-other
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 68 at risk

Adverse event: Late RT toxicity: Esophagus: NOS
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 28 affected / 68 at risk

Adverse event: Late RT toxicity: Larynx: NOS
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 68 at risk

Adverse event: Late RT toxicity: Mucous membrane: NOS
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 41 affected / 68 at risk

Adverse event: Late RT toxicity: Salivary gland: NOS
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 51 affected / 68 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 46 affected / 68 at risk

Adverse event: Radiation mucositis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 50 affected / 68 at risk

Adverse event: Salivary gland disorder
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 59 affected / 68 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 68 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 31 affected / 68 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 50 affected / 68 at risk

Adverse event: Late RT toxicity: Other: NOS
Serious: no
Organ System: General disorders
Frequency: 33 affected / 68 at risk

Adverse event: Pain due to radiation
Serious: no
Organ System: General disorders
Frequency: 24 affected / 68 at risk

Adverse event: Pain-other
Serious: no
Organ System: General disorders
Frequency: 24 affected / 68 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 10 affected / 68 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 5 affected / 68 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 68 at risk

Adverse event: Radiation skin injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 43 affected / 68 at risk

Adverse event: Late RT toxicity: Skin (within RT field): NOS
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 22 affected / 68 at risk

Adverse event: Late RT toxicity: Subcutaneous tissue (within RT field): NOS
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 27 affected / 68 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 13 affected / 68 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 9 affected / 68 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Investigations
Frequency: 9 affected / 68 at risk

Adverse event: Blood bilirubin increased
Serious: no
Organ System: Investigations
Frequency: 6 affected / 68 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 12 affected / 68 at risk

Adverse event: Gamma-glutamyltransferase increased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 68 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Investigations
Frequency: 50 affected / 68 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Investigations
Frequency: 16 affected / 68 at risk

Adverse event: Metabolic-Other
Serious: no
Organ System: Investigations
Frequency: 7 affected / 68 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Investigations
Frequency: 33 affected / 68 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 18 affected / 68 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 40 affected / 68 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 18 affected / 68 at risk

Adverse event: Blood albumin decreased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 19 affected / 68 at risk

Adverse event: Blood magnesium decreased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 15 affected / 68 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 19 affected / 68 at risk

Adverse event: Hyperglycemia NOS
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 16 affected / 68 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 68 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 17 affected / 68 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 15 affected / 68 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 26 affected / 68 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 68 at risk

Adverse event: Joint, muscle, or bone-Other
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 68 at risk

Adverse event: Late RT toxicity: Bone (incl. osteonecrosis): NOS
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 68 at risk

Adverse event: Late RT toxicity: Joint: NOS
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 13 affected / 68 at risk

Adverse event: Dizziness (exc vertigo)
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 68 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 68 at risk

Adverse event: Neuralgia
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 68 at risk

Adverse event: Peripheral motor neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 68 at risk

Adverse event: Peripheral sensory neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 23 affected / 68 at risk

Adverse event: Taste disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 19 affected / 68 at risk

Adverse event: Confusional state
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 68 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 68 at risk

Adverse event: Renal/GU-Other
Serious: no
Organ System: Renal and urinary disorders
Frequency: 13 affected / 68 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 68 at risk

Adverse event: Dysphonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 68 at risk

Adverse event: Dyspnea NOS
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 68 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 15 affected / 68 at risk

Adverse event: Hiccups
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 68 at risk

Adverse event: Pulmonary-other
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 68 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 68 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 20 affected / 68 at risk

Adverse event: Dermatitis exfoliative
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 68 at risk

Adverse event: Erythema multiforme
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 68 at risk

Adverse event: Skin discolouration
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 68 at risk

Adverse event: Skin-Other
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 68 at risk

Adverse event: Toxic skin eruption
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 68 at risk