Study: NCT00068237

Adverse event: Decreased appetite
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 43 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 43 at risk

Adverse event: Apnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 43 at risk

Adverse event: Acute Surgical Complication: Bleeding/hematoma
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 44 at risk

Adverse event: Acute Surgical Complication: Cerebral embolism/CVA
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 44 at risk

Adverse event: Acute Surgical Complication: Wound infection
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 44 at risk

Adverse event: Haemoglobin decreased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 43 at risk

Adverse event: Lymphatics-Other
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 43 at risk

Adverse event: Hypoacusis
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 43 at risk

Adverse event: Hearing-Other
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 3 affected / 43 at risk

Adverse event: Hypothyroidism
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 43 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 43 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 43 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 26 affected / 43 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 43 at risk

Adverse event: Oesophageal spasm
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 43 at risk

Adverse event: Esophagitis NOS
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 43 at risk

Adverse event: GI-other
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 43 at risk

Adverse event: Gastric ulcer
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 43 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 43 at risk

Adverse event: Radiation mucositis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 43 at risk

Adverse event: Salivary gland disorder
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 43 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 43 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 43 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 43 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 17 affected / 43 at risk

Adverse event: Infection
Serious: no
Organ System: General disorders
Frequency: 1 affected / 43 at risk

Adverse event: Late RT Toxicity: Esophagus
Serious: no
Organ System: General disorders
Frequency: 4 affected / 38 at risk

Adverse event: Late RT Toxicity: Joint
Serious: no
Organ System: General disorders
Frequency: 3 affected / 38 at risk

Adverse event: Late RT Toxicity: Larynx
Serious: no
Organ System: General disorders
Frequency: 6 affected / 38 at risk

Adverse event: Late RT Toxicity: Mucous Membrane
Serious: no
Organ System: General disorders
Frequency: 9 affected / 38 at risk

Adverse event: Late RT Toxicity: Other
Serious: no
Organ System: General disorders
Frequency: 10 affected / 38 at risk

Adverse event: Late RT Toxicity: Salivary Gland (xerostomia, taste impairme
Serious: no
Organ System: General disorders
Frequency: 22 affected / 38 at risk

Adverse event: Late RT Toxicity: Skin (within XRT field)
Serious: no
Organ System: General disorders
Frequency: 6 affected / 38 at risk

Adverse event: Late RT Toxicity: Subcutaneous Tissue (Within XRT field)
Serious: no
Organ System: General disorders
Frequency: 6 affected / 38 at risk

Adverse event: Pain due to radiation
Serious: no
Organ System: General disorders
Frequency: 11 affected / 43 at risk

Adverse event: Pain-other
Serious: no
Organ System: General disorders
Frequency: 8 affected / 43 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 43 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 1 affected / 43 at risk

Adverse event: Allergy-Other
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 43 at risk

Adverse event: Infection, Other
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 43 at risk

Adverse event: Radiation skin injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 12 affected / 43 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 43 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Investigations
Frequency: 3 affected / 43 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 12 affected / 43 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 43 at risk

Adverse event: Blood albumin decreased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 43 at risk

Adverse event: Blood magnesium decreased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 43 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 43 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 43 at risk

Adverse event: Joint, muscle, or bone-Other
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 43 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 43 at risk

Adverse event: Depressed level of consciousness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 43 at risk

Adverse event: Peripheral motor neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 43 at risk

Adverse event: Peripheral sensory neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 43 at risk

Adverse event: Taste disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 23 affected / 43 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 43 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 43 at risk

Adverse event: Sexual/reproductive function-Other
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 43 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 43 at risk

Adverse event: Dysphonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 43 at risk

Adverse event: Dyspnea NOS
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 43 at risk

Adverse event: Haemoptysis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 43 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 43 at risk

Adverse event: Pulmonary-other
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 43 at risk

Adverse event: Dermatitis exfoliative
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 43 at risk

Adverse event: Erythema multiforme
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 43 at risk

Adverse event: Skin discolouration
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 43 at risk

Adverse event: Skin-Other
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 43 at risk

Adverse event: Acute Surgical Complication: Facial edema
Serious: no
Organ System: Surgical and medical procedures
Frequency: 6 affected / 44 at risk

Adverse event: Acute Surgical Complication: Facial edema on the transfer si
Serious: no
Organ System: Surgical and medical procedures
Frequency: 6 affected / 44 at risk

Adverse event: Acute Surgical Complication: Gland movement out of position
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 44 at risk

Adverse event: Acute Surgical Complication: Neck numbness
Serious: no
Organ System: Surgical and medical procedures
Frequency: 3 affected / 44 at risk

Adverse event: Acute Surgical Complication: Neck numbness on the transfer s
Serious: no
Organ System: Surgical and medical procedures
Frequency: 2 affected / 44 at risk

Adverse event: Acute Surgical Complication: Nerve injury: hypoglossal
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 44 at risk

Adverse event: Acute Surgical Complication: Nerve injury: hypoglossal on th
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 44 at risk

Adverse event: Acute Surgical Complication: Nerve injury: lingual
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 44 at risk

Adverse event: Acute Surgical Complication: Other
Serious: no
Organ System: Surgical and medical procedures
Frequency: 4 affected / 44 at risk

Adverse event: Acute Surgical Complication: Shoulder weakness
Serious: no
Organ System: Surgical and medical procedures
Frequency: 2 affected / 44 at risk

Adverse event: Acute Surgical Complication: Shoulder weakness on the transf
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 44 at risk

Adverse event: Late Surgical Complication: Other
Serious: no
Organ System: Surgical and medical procedures
Frequency: 10 affected / 44 at risk

Adverse event: Late Surgical Complication: Recurrent adenitis
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 44 at risk

Adverse event: Late Surgical Complication: Submental fullness
Serious: no
Organ System: Surgical and medical procedures
Frequency: 8 affected / 44 at risk

Adverse event: Oedema
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 43 at risk

Adverse event: Hemorrhage-Other
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 43 at risk

Adverse event: Lymphangiopathy
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 43 at risk