Study: NCT00070018

Adverse event: Febrile neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 46 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 28 affected / 46 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 46 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 46 at risk

Adverse event: Dry mouth/salivary gland (xerostomia)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 46 at risk

Adverse event: Dysphagia (difficulty swallowing)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 46 at risk

Adverse event: Oesophagitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 46 at risk

Adverse event: Heartburn/dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 46 at risk

Adverse event: Mucositis/stomatitis (clinical exam) - Oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 46 at risk

Adverse event: Mucositis/stomatitis (functional/symptomatic) - Oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 46 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 21 affected / 46 at risk

Adverse event: Pain - Oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 46 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 46 at risk

Adverse event: Edema: limb
Serious: no
Organ System: General disorders
Frequency: 3 affected / 46 at risk

Adverse event: Fatigue (asthenia, lethargy, malaise)
Serious: no
Organ System: General disorders
Frequency: 33 affected / 46 at risk

Adverse event: Fever (in the absence of neutropenia, where neutropenia is defined as ANC lt1.0 x 10e9/L)
Serious: no
Organ System: General disorders
Frequency: 4 affected / 46 at risk

Adverse event: Allergic reaction/hypersensitivity (including drug fever)
Serious: no
Organ System: Immune system disorders
Frequency: 3 affected / 46 at risk

Adverse event: Rash: dermatitis associated with radiation - Radiation
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 16 affected / 46 at risk

Adverse event: ALT, SGPT (serum glutamic pyruvic transaminase)
Serious: no
Organ System: Investigations
Frequency: 6 affected / 46 at risk

Adverse event: AST, SGOT (serum glutamic oxaloacetic transaminase)
Serious: no
Organ System: Investigations
Frequency: 8 affected / 46 at risk

Adverse event: Bilirubin (hyperbilirubinemia)
Serious: no
Organ System: Investigations
Frequency: 3 affected / 46 at risk

Adverse event: Blood creatinine
Serious: no
Organ System: Investigations
Frequency: 3 affected / 46 at risk

Adverse event: Leukocytes (total WBC)
Serious: no
Organ System: Investigations
Frequency: 29 affected / 46 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Investigations
Frequency: 19 affected / 46 at risk

Adverse event: Neutrophils/granulocytes (ANC/AGC)
Serious: no
Organ System: Investigations
Frequency: 27 affected / 46 at risk

Adverse event: Platelets
Serious: no
Organ System: Investigations
Frequency: 25 affected / 46 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 8 affected / 46 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 46 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 46 at risk

Adverse event: Glucose, serum-high (hyperglycemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 12 affected / 46 at risk

Adverse event: Muscle weakness, generalized or specific area (not due to neuropathy) - Whole body/generalized
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 46 at risk

Adverse event: Pain - Bone
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 46 at risk

Adverse event: Pain - Muscle
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 46 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 46 at risk

Adverse event: Neuropathy: sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 14 affected / 46 at risk

Adverse event: Pain - Head/headache
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 46 at risk

Adverse event: Taste alteration (dysgeusia)
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 46 at risk

Adverse event: Mood alteration - depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 46 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 46 at risk

Adverse event: Dyspnea (shortness of breath)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 46 at risk

Adverse event: Mucositis/stomatitis (clinical exam) - Pharynx
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 46 at risk

Adverse event: Mucositis/stomatitis (functional/symptomatic) - Pharynx
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 46 at risk

Adverse event: Voice changes/dysarthria (e.g., hoarseness, loss or alteration in voice, laryngitis)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 46 at risk

Adverse event: Dermatology/Skin-Other (Specify)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 46 at risk

Adverse event: Hair loss/Alopecia (scalp or body)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 24 affected / 46 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 46 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 46 at risk