Study: NCT00012012

Adverse event: Red blood cell transfusion
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 26 at risk

Adverse event: Myocardial ischaemia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 26 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 26 at risk

Adverse event: Gastric ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 26 at risk

Adverse event: Late RT Toxicity: Small/Lg Intestine: NOS
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 26 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 26 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 26 at risk

Adverse event: Late RT Toxicity: Other: NOS
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 26 at risk

Adverse event: Pain-other
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 26 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 26 at risk

Adverse event: Alanine aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 26 at risk

Adverse event: Leukopenia
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 26 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 26 at risk

Adverse event: Blood magnesium decreased
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 26 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 26 at risk

Adverse event: Hyperglycemia NOS
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 26 at risk

Adverse event: Hypernatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 26 at risk

Adverse event: Hypocalcaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 26 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 26 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 26 at risk

Adverse event: Dyspnea NOS
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 26 at risk

Adverse event: Thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 26 at risk

Adverse event: Haemoglobin decreased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 24 affected / 26 at risk

Adverse event: Hearing-Other
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 26 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 26 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 26 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 26 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 26 at risk

Adverse event: Late RT Toxicity: Small/Lg Intestine: NOS
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 26 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 26 at risk

Adverse event: Rectal haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 26 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 26 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 14 affected / 26 at risk

Adverse event: Late RT Toxicity: Other: NOS
Serious: no
Organ System: General disorders
Frequency: 8 affected / 26 at risk

Adverse event: Pain due to radiation
Serious: no
Organ System: General disorders
Frequency: 2 affected / 26 at risk

Adverse event: Pain-other
Serious: no
Organ System: General disorders
Frequency: 6 affected / 26 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 26 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 26 at risk

Adverse event: Radiation skin injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 6 affected / 26 at risk

Adverse event: Late RT Toxicity: Skin (within the irradiated field): NOS
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 26 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 26 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 26 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Investigations
Frequency: 21 affected / 26 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Investigations
Frequency: 3 affected / 26 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Investigations
Frequency: 12 affected / 26 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 17 affected / 26 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 6 affected / 26 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 26 at risk

Adverse event: Blood albumin decreased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 26 at risk

Adverse event: Blood magnesium decreased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 12 affected / 26 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 26 at risk

Adverse event: Hyperglycemia NOS
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 26 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 26 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 26 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 26 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 26 at risk

Adverse event: Late RT Toxicity: Bone: NOS
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 26 at risk

Adverse event: Dizziness (exc vertigo)
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 26 at risk

Adverse event: Peripheral sensory neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 26 at risk

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 6 affected / 26 at risk

Adverse event: Late RT Toxicity: Bladder: NOS
Serious: no
Organ System: Renal and urinary disorders
Frequency: 8 affected / 26 at risk

Adverse event: Late RT Toxicity: Kidney: NOS
Serious: no
Organ System: Renal and urinary disorders
Frequency: 5 affected / 26 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 26 at risk

Adverse event: Pelvic pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 3 affected / 26 at risk

Adverse event: Vaginal haemorrhage
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 26 at risk

Adverse event: Dyspnea NOS
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 26 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 26 at risk

Adverse event: Dermatitis exfoliative
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 26 at risk

Adverse event: Menopausal symptoms
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 26 at risk

Adverse event: Red blood cell transfusion
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 15 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 15 at risk

Adverse event: Late RT Toxicity: Small/Lg Intestine: NOS
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 15 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 15 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 15 at risk

Adverse event: Late RT Toxicity: Other: NOS
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 15 at risk

Adverse event: Pain-other
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 15 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 15 at risk

Adverse event: Alanine aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 15 at risk

Adverse event: Leukopenia
Serious: yes
Organ System: Investigations
Frequency: 3 affected / 15 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 15 at risk

Adverse event: Blood magnesium decreased
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 15 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 15 at risk

Adverse event: Hypocalcaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 15 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 15 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 15 at risk

Adverse event: Thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 15 at risk

Adverse event: Haemoglobin decreased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 15 affected / 15 at risk

Adverse event: Hearing-Other
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 15 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 15 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 15 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 15 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 15 at risk

Adverse event: Late RT Toxicity: Small/Lg Intestine: NOS
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 15 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 15 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 15 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 10 affected / 15 at risk

Adverse event: Late RT Toxicity: Other: NOS
Serious: no
Organ System: General disorders
Frequency: 5 affected / 15 at risk

Adverse event: Pain due to radiation
Serious: no
Organ System: General disorders
Frequency: 2 affected / 15 at risk

Adverse event: Pain-other
Serious: no
Organ System: General disorders
Frequency: 3 affected / 15 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 15 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 15 at risk

Adverse event: Radiation skin injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 15 at risk

Adverse event: Late RT Toxicity: Skin (within the irradiated field): NOS
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 15 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 15 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 15 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Investigations
Frequency: 11 affected / 15 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Investigations
Frequency: 3 affected / 15 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Investigations
Frequency: 8 affected / 15 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 9 affected / 15 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 6 affected / 15 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 15 at risk

Adverse event: Blood albumin decreased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 15 at risk

Adverse event: Blood magnesium decreased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 15 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 15 at risk

Adverse event: Hyperglycemia NOS
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 15 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 15 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 15 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 15 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 15 at risk

Adverse event: Late RT Toxicity: Bone: NOS
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 15 at risk

Adverse event: Dizziness (exc vertigo)
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 15 at risk

Adverse event: Peripheral sensory neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 15 at risk

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 15 at risk

Adverse event: Late RT Toxicity: Bladder: NOS
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 15 at risk

Adverse event: Late RT Toxicity: Kidney: NOS
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 15 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 15 at risk

Adverse event: Vaginal haemorrhage
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 15 at risk

Adverse event: Dermatitis exfoliative
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 15 at risk

Adverse event: Menopausal symptoms
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 15 at risk