Study: NCT00004859

Adverse event: Hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 16 affected / 289 at risk

Adverse event: Inner ear/hearing imparied
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 289 at risk

Adverse event: Hearing-other
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 289 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 8 affected / 289 at risk

Adverse event: Leukopenia
Serious: yes
Organ System: Investigations
Frequency: 69 affected / 289 at risk

Adverse event: Lymphopenia
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 289 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Investigations
Frequency: 146 affected / 289 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Investigations
Frequency: 10 affected / 289 at risk

Adverse event: Transfusion: platelets
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 289 at risk

Adverse event: Transfusion:pRBCs
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 15 affected / 289 at risk

Adverse event: Sinus tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 289 at risk

Adverse event: Supraventricular arrhythmias
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 289 at risk

Adverse event: Vasovagal episode
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 289 at risk

Adverse event: Ventricular function
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 289 at risk

Adverse event: Oedema
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 289 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 289 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 289 at risk

Adverse event: Pericardial effusion/pericarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 289 at risk

Adverse event: Thrombosis/Embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 6 affected / 289 at risk

Adverse event: Cardiac-other
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 289 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 16 affected / 289 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 289 at risk

Adverse event: Weight decreased
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 289 at risk

Adverse event: Elevated Partial Thromboplastin Time (PTT)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 289 at risk

Adverse event: Pruritus
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 289 at risk

Adverse event: Radiation dermatitis
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 289 at risk

Adverse event: Rash/desquamation
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 289 at risk

Adverse event: Urticaria
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 289 at risk

Adverse event: Wound -non infectious
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 289 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 10 affected / 289 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 289 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 10 affected / 289 at risk

Adverse event: Dyspepsia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 289 at risk

Adverse event: Dysphagia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 289 at risk

Adverse event: Dysphagia-esophageal radiation
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 289 at risk

Adverse event: Fistula-intestinal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 289 at risk

Adverse event: Mucositis due to radiation
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 289 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 289 at risk

Adverse event: Stomatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 289 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 289 at risk

Adverse event: Diarrhea w/o prior colostomy
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 289 at risk

Adverse event: Aspartate aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 289 at risk

Adverse event: Alanine aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 289 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 8 affected / 289 at risk

Adverse event: Infection w/ grade 3 or 4 neutropenia
Serious: yes
Organ System: Infections and infestations
Frequency: 9 affected / 289 at risk

Adverse event: Infection w/ unknown ANC
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 289 at risk

Adverse event: Infection w/o neutropenia
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 289 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 289 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 289 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 289 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 14 affected / 289 at risk

Adverse event: Muscular weakness
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 289 at risk

Adverse event: Depressed level of consciousness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 289 at risk

Adverse event: Dizziness/lightheadedness
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 289 at risk

Adverse event: Insomnia
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 289 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 289 at risk

Adverse event: Neuropathy-motor
Serious: yes
Organ System: Nervous system disorders
Frequency: 5 affected / 289 at risk

Adverse event: Neuropathy-sensory
Serious: yes
Organ System: Nervous system disorders
Frequency: 16 affected / 289 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 289 at risk

Adverse event: Vertigo
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 289 at risk

Adverse event: Arthralgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 289 at risk

Adverse event: Chest pain
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 289 at risk

Adverse event: Myalgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 289 at risk

Adverse event: Neuralgia
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 289 at risk

Adverse event: Pain due to radiation
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 289 at risk

Adverse event: Pain-other
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 289 at risk

Adverse event: Apnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 289 at risk

Adverse event: Cough
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 289 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 19 affected / 289 at risk

Adverse event: Hiccoughs
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 289 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 289 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 289 at risk

Adverse event: Pneumonitis/pulmonary infiltrates
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 289 at risk

Adverse event: Pulmonary fibrosis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 289 at risk

Adverse event: Voice changes/dysarthria
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 289 at risk

Adverse event: Pulmonary - other
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 289 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 289 at risk

Adverse event: Erectile impotence
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 289 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Investigations
Frequency: 223 affected / 289 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 238 affected / 289 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Investigations
Frequency: 187 affected / 289 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Investigations
Frequency: 109 affected / 289 at risk

Adverse event: Oedema
Serious: no
Organ System: General disorders
Frequency: 24 affected / 289 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 18 affected / 289 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 208 affected / 289 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 20 affected / 289 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 289 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 79 affected / 289 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 179 affected / 289 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 289 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 21 affected / 289 at risk

Adverse event: Radiation dermatitis
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 58 affected / 289 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 49 affected / 289 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 110 affected / 289 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 85 affected / 289 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 15 affected / 289 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 22 affected / 289 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 25 affected / 289 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 140 affected / 289 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 58 affected / 289 at risk

Adverse event: Taste disorder
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 47 affected / 289 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 68 affected / 289 at risk

Adverse event: Diarrhea w/o prior colostomy
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 62 affected / 289 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Investigations
Frequency: 62 affected / 289 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 34 affected / 289 at risk

Adverse event: Infection w/o neutropenia
Serious: no
Organ System: Infections and infestations
Frequency: 27 affected / 289 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 20 affected / 289 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 34 affected / 289 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 91 affected / 289 at risk

Adverse event: Depressed level of consciousness
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 289 at risk

Adverse event: Dizziness/lightheadedness
Serious: no
Organ System: Nervous system disorders
Frequency: 20 affected / 289 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 18 affected / 289 at risk

Adverse event: Anxiety/agitation
Serious: no
Organ System: Psychiatric disorders
Frequency: 15 affected / 289 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 8 affected / 289 at risk

Adverse event: Neuropathy-motor
Serious: no
Organ System: Nervous system disorders
Frequency: 34 affected / 289 at risk

Adverse event: Neuropathy-sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 161 affected / 289 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 289 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 74 affected / 289 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 28 affected / 289 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 110 affected / 289 at risk

Adverse event: Pain-other
Serious: no
Organ System: General disorders
Frequency: 17 affected / 289 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 51 affected / 289 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 65 affected / 289 at risk

Adverse event: Pneumonitis/pulmonary infiltrates
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 21 affected / 289 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 27 affected / 289 at risk

Adverse event: Hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 13 affected / 288 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 288 at risk

Adverse event: Leukopenia
Serious: yes
Organ System: Investigations
Frequency: 81 affected / 288 at risk

Adverse event: Lymphopenia
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 288 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Investigations
Frequency: 161 affected / 288 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Investigations
Frequency: 6 affected / 288 at risk

Adverse event: Transfusion:pRBCs
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 288 at risk

Adverse event: Sinus bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 288 at risk

Adverse event: Sinus tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 288 at risk

Adverse event: Supraventricular arrhythmias
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 288 at risk

Adverse event: Ventricular function
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 288 at risk

Adverse event: Oedema
Serious: yes
Organ System: General disorders
Frequency: 8 affected / 288 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 288 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 8 affected / 288 at risk

Adverse event: Pericardial effusion/pericarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 288 at risk

Adverse event: Peripheral ischaemia
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 288 at risk

Adverse event: Thrombosis/Embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 30 affected / 288 at risk

Adverse event: Intestinal ischaemia
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 288 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 42 affected / 288 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 288 at risk

Adverse event: Weight increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 288 at risk

Adverse event: Weight decreased
Serious: yes
Organ System: Investigations
Frequency: 5 affected / 288 at risk

Adverse event: Elevated Prothrombin Time (PT)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 288 at risk

Adverse event: Injection site reaction
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 288 at risk

Adverse event: Pruritus
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 288 at risk

Adverse event: Radiation dermatitis
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 288 at risk

Adverse event: Rash/desquamation
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 20 affected / 288 at risk

Adverse event: Urticaria
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 288 at risk

Adverse event: Wound -infectious
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 288 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 12 affected / 288 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 26 affected / 288 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 288 at risk

Adverse event: Dysphagia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 288 at risk

Adverse event: Dysphagia-esophageal radiation
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 288 at risk

Adverse event: Ileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 288 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 288 at risk

Adverse event: Stomatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 288 at risk

Adverse event: Taste disorder
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 288 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 288 at risk

Adverse event: Diarrhea w/o prior colostomy
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 288 at risk

Adverse event: GI-other
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 288 at risk

Adverse event: Melena/GI bleeding
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 288 at risk

Adverse event: Blood bilirubin increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 288 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 288 at risk

Adverse event: Infection w/ grade 3 or 4 neutropenia
Serious: yes
Organ System: Infections and infestations
Frequency: 15 affected / 288 at risk

Adverse event: Infection w/ unknown ANC
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 288 at risk

Adverse event: Infection w/o neutropenia
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 288 at risk

Adverse event: Hypercalcaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 288 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 288 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 288 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 11 affected / 288 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 15 affected / 288 at risk

Adverse event: Muscular weakness
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 288 at risk

Adverse event: Myositis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 288 at risk

Adverse event: Joint,muscle, bone-other
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 288 at risk

Adverse event: Cerebrovascular Ischemia
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 288 at risk

Adverse event: Cognitive disorder
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 288 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 288 at risk

Adverse event: Depressed level of consciousness
Serious: yes
Organ System: Nervous system disorders
Frequency: 15 affected / 288 at risk

Adverse event: Dizziness/lightheadedness
Serious: yes
Organ System: Psychiatric disorders
Frequency: 14 affected / 288 at risk

Adverse event: Hallucination
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 288 at risk

Adverse event: Amnesia
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 288 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 3 affected / 288 at risk

Adverse event: Neuropathy-motor
Serious: yes
Organ System: Nervous system disorders
Frequency: 9 affected / 288 at risk

Adverse event: Neuropathy-sensory
Serious: yes
Organ System: Nervous system disorders
Frequency: 33 affected / 288 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 288 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 7 affected / 288 at risk

Adverse event: Tremor
Serious: yes
Organ System: Nervous system disorders
Frequency: 5 affected / 288 at risk

Adverse event: Vertigo
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 288 at risk

Adverse event: Ocular-other
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 288 at risk

Adverse event: Abonominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 288 at risk

Adverse event: Arthralgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 14 affected / 288 at risk

Adverse event: Bone pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 288 at risk

Adverse event: Chest pain
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 288 at risk

Adverse event: Ear pain
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 288 at risk

Adverse event: Myalgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 14 affected / 288 at risk

Adverse event: Pain due to radiation
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 288 at risk

Adverse event: Tumour pain
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 288 at risk

Adverse event: Pain-other
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 288 at risk

Adverse event: Apnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 288 at risk

Adverse event: Cough
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 288 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 39 affected / 288 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 288 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 288 at risk

Adverse event: Pneumonitis/pulmonary infiltrates
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 12 affected / 288 at risk

Adverse event: Voice changes/dysarthria
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 288 at risk

Adverse event: Blood creatinine increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 288 at risk

Adverse event: Irregular menses
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 288 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Investigations
Frequency: 229 affected / 288 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 238 affected / 288 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Investigations
Frequency: 220 affected / 288 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Investigations
Frequency: 108 affected / 288 at risk

Adverse event: Oedema
Serious: no
Organ System: General disorders
Frequency: 83 affected / 288 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 31 affected / 288 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 223 affected / 288 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 15 affected / 288 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 17 affected / 288 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 64 affected / 288 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 176 affected / 288 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 25 affected / 288 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 18 affected / 288 at risk

Adverse event: Radiation dermatitis
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 55 affected / 288 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 89 affected / 288 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 97 affected / 288 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 179 affected / 288 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 21 affected / 288 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 25 affected / 288 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 30 affected / 288 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 130 affected / 288 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 68 affected / 288 at risk

Adverse event: Taste disorder
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 54 affected / 288 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 50 affected / 288 at risk

Adverse event: Diarrhea w/o prior colostomy
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 40 affected / 288 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Investigations
Frequency: 56 affected / 288 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 19 affected / 288 at risk

Adverse event: Infection w/o neutropenia
Serious: no
Organ System: Infections and infestations
Frequency: 28 affected / 288 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 29 affected / 288 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 45 affected / 288 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 94 affected / 288 at risk

Adverse event: Depressed level of consciousness
Serious: no
Organ System: Nervous system disorders
Frequency: 73 affected / 288 at risk

Adverse event: Dizziness/lightheadedness
Serious: no
Organ System: Nervous system disorders
Frequency: 80 affected / 288 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 12 affected / 288 at risk

Adverse event: Anxiety/agitation
Serious: no
Organ System: Psychiatric disorders
Frequency: 16 affected / 288 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 18 affected / 288 at risk

Adverse event: Neuropathy-motor
Serious: no
Organ System: Nervous system disorders
Frequency: 60 affected / 288 at risk

Adverse event: Neuropathy-sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 206 affected / 288 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 31 affected / 288 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 93 affected / 288 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 35 affected / 288 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 117 affected / 288 at risk

Adverse event: Pain-other
Serious: no
Organ System: General disorders
Frequency: 14 affected / 288 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 53 affected / 288 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 99 affected / 288 at risk

Adverse event: Pneumonitis/pulmonary infiltrates
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 25 affected / 288 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 32 affected / 288 at risk