Study: NCT00089297

Adverse event: Hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 3 affected / 70 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 70 at risk

Adverse event: Leukocytes, decreased
Serious: yes
Organ System: Investigations
Frequency: 28 affected / 70 at risk

Adverse event: Lymphopenia
Serious: yes
Organ System: Investigations
Frequency: 4 affected / 70 at risk

Adverse event: Neutrophils, decreased
Serious: yes
Organ System: Investigations
Frequency: 31 affected / 70 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 6 affected / 70 at risk

Adverse event: Weight decreased
Serious: yes
Organ System: Investigations
Frequency: 7 affected / 70 at risk

Adverse event: Thermal burn
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 70 at risk

Adverse event: Rash/desquamation
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 70 at risk

Adverse event: Rash: acne/acneiform
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 70 at risk

Adverse event: Radiation dermatitis
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 16 affected / 70 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 13 affected / 70 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 70 at risk

Adverse event: Diarrhea w/o prior colostomy
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 70 at risk

Adverse event: Dry mouth
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 70 at risk

Adverse event: Dysphagia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 20 affected / 70 at risk

Adverse event: Oesophagitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 70 at risk

Adverse event: Muco/stomatitis by exam, oral cavity
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 70 at risk

Adverse event: Muco/stomatitis (symptom) oral cavity
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 35 affected / 70 at risk

Adverse event: Muco/stomatitis (symptom) pharynx
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 70 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 70 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 70 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 70 at risk

Adverse event: Infection Gr0-2 neut, bladder
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 70 at risk

Adverse event: Infection Gr0-2 neut, catheter
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 70 at risk

Adverse event: Infection Gr0-2 neut, colon
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 70 at risk

Adverse event: Infection Gr0-2 neut, foreign body
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 70 at risk

Adverse event: Infection Gr0-2 neut, mucosa
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 70 at risk

Adverse event: Infection Gr0-2 neut, oral cavity
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 70 at risk

Adverse event: Infection Gr0-2 neut, pharynx
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 70 at risk

Adverse event: Infection Gr0-2 neut, skin
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 70 at risk

Adverse event: Infection Gr0-2 neut, urinary tract
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 70 at risk

Adverse event: Infection w/ unk ANC wound
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 70 at risk

Adverse event: Blood bilirubin increased
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 70 at risk

Adverse event: Hypocalcaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 70 at risk

Adverse event: Creatinine, increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 70 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 70 at risk

Adverse event: Hypomagnesaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 70 at risk

Adverse event: Hypophosphataemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 70 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 70 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 70 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 70 at risk

Adverse event: Neuropathy-motor
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 70 at risk

Adverse event: Esophagus, pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 70 at risk

Adverse event: Oral cavity, pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 70 at risk

Adverse event: Throat/pharynx/larynx, pain
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 70 at risk

Adverse event: Tumour pain
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 70 at risk

Adverse event: Bronchospasm, wheezing
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 70 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 70 at risk

Adverse event: Obstruction, airway-larynx
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 70 at risk

Adverse event: Voice changes/dysarthria
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 70 at risk

Adverse event: Thrombosis/thrombus/embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 70 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 62 affected / 70 at risk

Adverse event: Leukocytes, decreased
Serious: no
Organ System: Investigations
Frequency: 61 affected / 70 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Investigations
Frequency: 5 affected / 70 at risk

Adverse event: Neutrophils, decreased
Serious: no
Organ System: Investigations
Frequency: 35 affected / 70 at risk

Adverse event: Platelets, decreased
Serious: no
Organ System: Investigations
Frequency: 19 affected / 70 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 7 affected / 70 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 55 affected / 70 at risk

Adverse event: Fever w/o neutropenia
Serious: no
Organ System: General disorders
Frequency: 13 affected / 70 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 7 affected / 70 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 42 affected / 70 at risk

Adverse event: Activated partial thromboplastin time prolonged
Serious: no
Organ System: Investigations
Frequency: 5 affected / 70 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 16 affected / 70 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 45 affected / 70 at risk

Adverse event: Nail disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 70 at risk

Adverse event: Pruritus/itching
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 11 affected / 70 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 24 affected / 70 at risk

Adverse event: Rash: acne/acneiform
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 64 affected / 70 at risk

Adverse event: Radiation dermatitis
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 44 affected / 70 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 28 affected / 70 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 26 affected / 70 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 70 at risk

Adverse event: Diarrhea w/o prior colostomy
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 70 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 50 affected / 70 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 48 affected / 70 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 70 at risk

Adverse event: Muco/stomatitis (symptom) oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 51 affected / 70 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 31 affected / 70 at risk

Adverse event: Taste disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 21 affected / 70 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 19 affected / 70 at risk

Adverse event: Nose, hemorrhage
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 70 at risk

Adverse event: Infection Gr0-2 neut, oral cavity
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 70 at risk

Adverse event: Infection Gr0-2 neut, ungual
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 70 at risk

Adverse event: Edema limb
Serious: no
Organ System: General disorders
Frequency: 4 affected / 70 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 70 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 36 affected / 70 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 31 affected / 70 at risk

Adverse event: Blood bilirubin increased
Serious: no
Organ System: Investigations
Frequency: 9 affected / 70 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 70 at risk

Adverse event: Creatinine, increased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 70 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 9 affected / 70 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 15 affected / 70 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 9 affected / 70 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 70 at risk

Adverse event: Trismus
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 70 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 70 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 14 affected / 70 at risk

Adverse event: Neuropathy-sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 24 affected / 70 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 70 at risk

Adverse event: Ocular surface disease
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 70 at risk

Adverse event: Vision-blurred
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 70 at risk

Adverse event: Head/headache
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 70 at risk

Adverse event: Joint, pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 12 affected / 70 at risk

Adverse event: Muscle, pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 12 affected / 70 at risk

Adverse event: Neck, pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 70 at risk

Adverse event: Oral cavity, pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 70 at risk

Adverse event: Throat/pharynx/larynx, pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 70 at risk

Adverse event: Tumour pain
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 5 affected / 70 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 70 at risk

Adverse event: Voice changes/dysarthria
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 70 at risk