Study: NCT00047008

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 15 affected / 361 at risk

Adverse event: Haemoglobin decreased
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 33 affected / 361 at risk

Adverse event: Lymphatics-Other
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 361 at risk

Adverse event: Red blood cell transfusion
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 361 at risk

Adverse event: Circulatory or cardiac-Other
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 361 at risk

Adverse event: Myocardial ischaemia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 361 at risk

Adverse event: Palpitations
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 361 at risk

Adverse event: Arrhythmia supraventricular
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 361 at risk

Adverse event: Hypoacusis
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 361 at risk

Adverse event: Endocrine-Other
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 361 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 361 at risk

Adverse event: Dyspepsia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 361 at risk

Adverse event: Dysphagia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 82 affected / 361 at risk

Adverse event: Oesophageal spasm
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 37 affected / 361 at risk

Adverse event: Esophagitis NOS
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 30 affected / 361 at risk

Adverse event: GI-other
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 361 at risk

Adverse event: Ileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 361 at risk

Adverse event: Late RT Toxicity: Esophagus: NOS
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 28 affected / 361 at risk

Adverse event: Late RT Toxicity: Larynx: NOS
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 361 at risk

Adverse event: Late RT Toxicity: Mucous Membrane: NOS
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 361 at risk

Adverse event: Late RT Toxicity: Other: dysphagia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 361 at risk

Adverse event: Late RT Toxicity: Other: tongue edema
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 361 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 72 affected / 361 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 361 at risk

Adverse event: Radiation mucositis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 141 affected / 361 at risk

Adverse event: Salivary gland disorder
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 361 at risk

Adverse event: Stomatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 361 at risk

Adverse event: Stomatitis/pharyngitis for BMT
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 361 at risk

Adverse event: Tracheo-oesophageal fistula
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 361 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 66 affected / 361 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 361 at risk

Adverse event: Late RT Toxicity: Other: pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 361 at risk

Adverse event: Pain due to radiation
Serious: yes
Organ System: General disorders
Frequency: 30 affected / 361 at risk

Adverse event: Pain-other
Serious: yes
Organ System: General disorders
Frequency: 9 affected / 361 at risk

Adverse event: Device related infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 361 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 13 affected / 361 at risk

Adverse event: Infection with grade 3 or 4 neutropenia
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 361 at risk

Adverse event: Infection, Other
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 361 at risk

Adverse event: Radiation skin injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 29 affected / 361 at risk

Adverse event: Late RT Toxicity: Subcutaneous Tissue (within XRT field): NOS
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 361 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 361 at risk

Adverse event: Blood creatine phosphokinase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 361 at risk

Adverse event: Blood creatinine increased
Serious: yes
Organ System: Investigations
Frequency: 16 affected / 361 at risk

Adverse event: Troponin T increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 361 at risk

Adverse event: Leukopenia
Serious: yes
Organ System: Investigations
Frequency: 14 affected / 361 at risk

Adverse event: Metabolic-Other
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 361 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Investigations
Frequency: 17 affected / 361 at risk

Adverse event: Platelet count decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 361 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 27 affected / 361 at risk

Adverse event: Blood magnesium decreased
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 361 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 76 affected / 361 at risk

Adverse event: Hypercalcaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 361 at risk

Adverse event: Hyperglycemia NOS
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 13 affected / 361 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 361 at risk

Adverse event: Hypermagnesaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 361 at risk

Adverse event: Hypernatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 361 at risk

Adverse event: Hyperuricaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 361 at risk

Adverse event: Hypocalcaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 361 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 28 affected / 361 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 41 affected / 361 at risk

Adverse event: Hypophosphataemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 361 at risk

Adverse event: Late RT Toxicity: Bone: NOS
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 14 affected / 361 at risk

Adverse event: Osteonecrosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 361 at risk

Adverse event: Dizziness (exc vertigo)
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 361 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 361 at risk

Adverse event: Late RT Toxicity: Brain: NOS
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 361 at risk

Adverse event: Neurologic-Other
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 361 at risk

Adverse event: Peripheral motor neuropathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 361 at risk

Adverse event: Peripheral sensory neuropathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 361 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 5 affected / 361 at risk

Adverse event: Presyncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 361 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 361 at risk

Adverse event: Renal/GU-Other
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 7 affected / 361 at risk

Adverse event: Urinary retention
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 361 at risk

Adverse event: Dysphonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 361 at risk

Adverse event: Dyspnea NOS
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 361 at risk

Adverse event: Late RT Toxicity: Other: laryngeal hemorrhage
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 361 at risk

Adverse event: Late RT Toxicity: Other: upper airway obstruction
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 361 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 361 at risk

Adverse event: Pneumonitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 361 at risk

Adverse event: Pulmonary-other
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 361 at risk

Adverse event: Hemorrhage-Other
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 361 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 361 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 6 affected / 361 at risk

Adverse event: Thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 361 at risk

Adverse event: Haemoglobin decreased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 325 affected / 361 at risk

Adverse event: Hypoacusis
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 63 affected / 361 at risk

Adverse event: Hearing-Other
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 52 affected / 361 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 73 affected / 361 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 37 affected / 361 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 184 affected / 361 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 112 affected / 361 at risk

Adverse event: Oesophageal spasm
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 58 affected / 361 at risk

Adverse event: Esophagitis NOS
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 118 affected / 361 at risk

Adverse event: Late RT Toxicity: Esophagus: NOS
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 145 affected / 361 at risk

Adverse event: Late RT Toxicity: Larynx: NOS
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 161 affected / 361 at risk

Adverse event: Late RT Toxicity: Mucous Membrane: NOS
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 143 affected / 361 at risk

Adverse event: Late RT Toxicity: Salivary Gland (xerostomia, taste impairment)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 270 affected / 361 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 210 affected / 361 at risk

Adverse event: Radiation mucositis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 282 affected / 361 at risk

Adverse event: Salivary gland disorder
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 120 affected / 361 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 29 affected / 361 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 140 affected / 361 at risk

Adverse event: Oedema
Serious: no
Organ System: General disorders
Frequency: 14 affected / 361 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 212 affected / 361 at risk

Adverse event: Late RT Toxicity: Other: NOS
Serious: no
Organ System: General disorders
Frequency: 173 affected / 361 at risk

Adverse event: Pain due to radiation
Serious: no
Organ System: General disorders
Frequency: 144 affected / 361 at risk

Adverse event: Pain-other
Serious: no
Organ System: General disorders
Frequency: 46 affected / 361 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 31 affected / 361 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 21 affected / 361 at risk

Adverse event: Infection, Other
Serious: no
Organ System: Infections and infestations
Frequency: 20 affected / 361 at risk

Adverse event: Radiation skin injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 236 affected / 361 at risk

Adverse event: Late RT Toxicity: Skin(within RT field): NOS
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 145 affected / 361 at risk

Adverse event: Late RT Toxicity: Subcutaneous Tissue (within XRT field): NOS
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 159 affected / 361 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 32 affected / 361 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 27 affected / 361 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Investigations
Frequency: 27 affected / 361 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 122 affected / 361 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Investigations
Frequency: 302 affected / 361 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Investigations
Frequency: 48 affected / 361 at risk

Adverse event: Metabolic-Other
Serious: no
Organ System: Investigations
Frequency: 26 affected / 361 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Investigations
Frequency: 227 affected / 361 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 103 affected / 361 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 171 affected / 361 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 95 affected / 361 at risk

Adverse event: Blood albumin decreased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 79 affected / 361 at risk

Adverse event: Blood magnesium decreased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 96 affected / 361 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 166 affected / 361 at risk

Adverse event: Hyperglycemia NOS
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 67 affected / 361 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 47 affected / 361 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 71 affected / 361 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 84 affected / 361 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 126 affected / 361 at risk

Adverse event: Joint, muscle, or bone-Other
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 20 affected / 361 at risk

Adverse event: Late RT Toxicity: Bone: NOS
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 24 affected / 361 at risk

Adverse event: Late RT Toxicity: Joint: NOS
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 48 affected / 361 at risk

Adverse event: Late RT Toxicity: Spinal Cord: NOS
Serious: no
Organ System: Nervous system disorders
Frequency: 15 affected / 361 at risk

Adverse event: Peripheral sensory neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 55 affected / 361 at risk

Adverse event: Taste disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 114 affected / 361 at risk

Adverse event: Depression NEC
Serious: no
Organ System: Psychiatric disorders
Frequency: 21 affected / 361 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 21 affected / 361 at risk

Adverse event: Renal/GU-Other
Serious: no
Organ System: Renal and urinary disorders
Frequency: 40 affected / 361 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 28 affected / 361 at risk

Adverse event: Dysphonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 75 affected / 361 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 25 affected / 361 at risk

Adverse event: Dermatitis exfoliative
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 20 affected / 361 at risk

Adverse event: Skin-Other
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 27 affected / 361 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 17 affected / 360 at risk

Adverse event: Haemoglobin decreased
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 24 affected / 360 at risk

Adverse event: Red blood cell transfusion
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 360 at risk

Adverse event: Myocardial ischaemia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 360 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 360 at risk

Adverse event: Dysphagia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 76 affected / 360 at risk

Adverse event: Oesophageal spasm
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 31 affected / 360 at risk

Adverse event: Esophagitis NOS
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 48 affected / 360 at risk

Adverse event: GI-other
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 360 at risk

Adverse event: Haematemesis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 360 at risk

Adverse event: Late RT Toxicity: Esophagus: NOS
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 37 affected / 360 at risk

Adverse event: Late RT Toxicity: Larynx: NOS
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 360 at risk

Adverse event: Late RT Toxicity: Mucous Membrane: NOS
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 360 at risk

Adverse event: Melaena
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 360 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 52 affected / 360 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 360 at risk

Adverse event: Proctalgia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 360 at risk

Adverse event: Radiation mucositis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 117 affected / 360 at risk

Adverse event: Stomatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 360 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 42 affected / 360 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 360 at risk

Adverse event: Pain due to radiation
Serious: yes
Organ System: General disorders
Frequency: 31 affected / 360 at risk

Adverse event: Pain-other
Serious: yes
Organ System: General disorders
Frequency: 7 affected / 360 at risk

Adverse event: Culture wound positive
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 360 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 8 affected / 360 at risk

Adverse event: Infection with grade 3 or 4 neutropenia
Serious: yes
Organ System: Infections and infestations
Frequency: 13 affected / 360 at risk

Adverse event: Infection with unknown ANC
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 360 at risk

Adverse event: Infection, Other
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 360 at risk

Adverse event: Radiation skin injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 31 affected / 360 at risk

Adverse event: Late RT Toxicity: Subcutaneous Tissue (within XRT field): NOS
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 360 at risk

Adverse event: Blood creatinine increased
Serious: yes
Organ System: Investigations
Frequency: 10 affected / 360 at risk

Adverse event: Leukopenia
Serious: yes
Organ System: Investigations
Frequency: 13 affected / 360 at risk

Adverse event: Lymphopenia
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 360 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Investigations
Frequency: 14 affected / 360 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 22 affected / 360 at risk

Adverse event: Blood magnesium decreased
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 360 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 67 affected / 360 at risk

Adverse event: Hypercalcaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 360 at risk

Adverse event: Hyperglycemia NOS
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 360 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 360 at risk

Adverse event: Hypermagnesaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 360 at risk

Adverse event: Hypernatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 360 at risk

Adverse event: Hyperuricaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 360 at risk

Adverse event: Hypocalcaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 360 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 360 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 17 affected / 360 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 33 affected / 360 at risk

Adverse event: Hypophosphataemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 360 at risk

Adverse event: Joint, muscle, or bone-Other
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 360 at risk

Adverse event: Late RT Toxicity: Bone: NOS
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 18 affected / 360 at risk

Adverse event: Amnesia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 360 at risk

Adverse event: Cerebral ischaemia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 360 at risk

Adverse event: Dizziness (exc vertigo)
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 360 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 360 at risk

Adverse event: Haemorrhagic stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 360 at risk

Adverse event: Late RT Toxicity: Brain: NOS
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 360 at risk

Adverse event: Late RT Toxicity: Spinal Cord: NOS
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 360 at risk

Adverse event: Peripheral motor neuropathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 360 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 360 at risk

Adverse event: Presyncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 360 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 360 at risk

Adverse event: Renal/GU-Other
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 360 at risk

Adverse event: Acute respiratory distress syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 360 at risk

Adverse event: Dyspnea NOS
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 360 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 360 at risk

Adverse event: Late RT Toxicity: Other: airway obstruction
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 360 at risk

Adverse event: Late RT Toxicity: Other: pharyngeal bleed
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 360 at risk

Adverse event: Late RT Toxicity: Other: stenosis of airway
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 360 at risk

Adverse event: Pneumonitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 360 at risk

Adverse event: Pulmonary-other
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 360 at risk

Adverse event: Hemorrhage-Other
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 360 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 7 affected / 360 at risk

Adverse event: Late RT Toxicity: Other: arteritis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 360 at risk

Adverse event: Thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 360 at risk

Adverse event: Intestinal ischaemia
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 360 at risk

Adverse event: Haemoglobin decreased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 301 affected / 360 at risk

Adverse event: Hypoacusis
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 35 affected / 360 at risk

Adverse event: Hearing-Other
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 53 affected / 360 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 54 affected / 360 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 27 affected / 360 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 156 affected / 360 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 94 affected / 360 at risk

Adverse event: Oesophageal spasm
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 52 affected / 360 at risk

Adverse event: Esophagitis NOS
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 101 affected / 360 at risk

Adverse event: Late RT Toxicity: Esophagus: NOS
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 152 affected / 360 at risk

Adverse event: Late RT Toxicity: Larynx: NOS
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 132 affected / 360 at risk

Adverse event: Late RT Toxicity: Mucous Membrane: NOS
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 147 affected / 360 at risk

Adverse event: Late RT Toxicity: Salivary Gland (xerostomia, taste impairment)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 271 affected / 360 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 197 affected / 360 at risk

Adverse event: Radiation mucositis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 267 affected / 360 at risk

Adverse event: Salivary gland disorder
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 116 affected / 360 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 19 affected / 360 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 131 affected / 360 at risk

Adverse event: Oedema
Serious: no
Organ System: General disorders
Frequency: 19 affected / 360 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 198 affected / 360 at risk

Adverse event: Late RT Toxicity: Other: NOS
Serious: no
Organ System: General disorders
Frequency: 171 affected / 360 at risk

Adverse event: Pain due to radiation
Serious: no
Organ System: General disorders
Frequency: 135 affected / 360 at risk

Adverse event: Pain-other
Serious: no
Organ System: General disorders
Frequency: 41 affected / 360 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 33 affected / 360 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 30 affected / 360 at risk

Adverse event: Infection, Other
Serious: no
Organ System: Infections and infestations
Frequency: 14 affected / 360 at risk

Adverse event: Radiation skin injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 213 affected / 360 at risk

Adverse event: Late RT Toxicity: Skin(within RT field): NOS
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 145 affected / 360 at risk

Adverse event: Late RT Toxicity: Subcutaneous Tissue (within XRT field): NOS
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 171 affected / 360 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 34 affected / 360 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 29 affected / 360 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Investigations
Frequency: 13 affected / 360 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 85 affected / 360 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Investigations
Frequency: 254 affected / 360 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Investigations
Frequency: 42 affected / 360 at risk

Adverse event: Metabolic-Other
Serious: no
Organ System: Investigations
Frequency: 28 affected / 360 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Investigations
Frequency: 176 affected / 360 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 87 affected / 360 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 153 affected / 360 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 72 affected / 360 at risk

Adverse event: Blood albumin decreased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 64 affected / 360 at risk

Adverse event: Blood magnesium decreased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 73 affected / 360 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 108 affected / 360 at risk

Adverse event: Hyperglycemia NOS
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 57 affected / 360 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 24 affected / 360 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 51 affected / 360 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 67 affected / 360 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 92 affected / 360 at risk

Adverse event: Joint, muscle, or bone-Other
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 18 affected / 360 at risk

Adverse event: Late RT Toxicity: Bone: NOS
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 29 affected / 360 at risk

Adverse event: Late RT Toxicity: Joint: NOS
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 59 affected / 360 at risk

Adverse event: Late RT Toxicity: Spinal Cord: NOS
Serious: no
Organ System: Nervous system disorders
Frequency: 20 affected / 360 at risk

Adverse event: Peripheral sensory neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 29 affected / 360 at risk

Adverse event: Taste disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 117 affected / 360 at risk

Adverse event: Depression NEC
Serious: no
Organ System: Psychiatric disorders
Frequency: 20 affected / 360 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 17 affected / 360 at risk

Adverse event: Renal/GU-Other
Serious: no
Organ System: Renal and urinary disorders
Frequency: 23 affected / 360 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 33 affected / 360 at risk

Adverse event: Dysphonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 55 affected / 360 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 15 affected / 360 at risk

Adverse event: Dermatitis exfoliative
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 21 affected / 360 at risk

Adverse event: Skin-Other
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 12 affected / 360 at risk