Study: NCT00265941

Adverse event: Blood/bone marrow - Other
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 447 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 31 affected / 447 at risk

Adverse event: Haemoglobin
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 24 affected / 447 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 447 at risk

Adverse event: Atrial flutter
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 447 at risk

Adverse event: Cor pulmonale
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 447 at risk

Adverse event: Left ventricular failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 447 at risk

Adverse event: Myocardial ischaemia
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 447 at risk

Adverse event: Sinus bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 447 at risk

Adverse event: Ventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 447 at risk

Adverse event: Hypoacusis
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 447 at risk

Adverse event: Otitis externa
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 447 at risk

Adverse event: Pain: External ear
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 447 at risk

Adverse event: Tinnitus
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 447 at risk

Adverse event: Endocrine - Other
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 447 at risk

Adverse event: Abdominal distention
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 447 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 447 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 447 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 447 at risk

Adverse event: Dry mouth
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 447 at risk

Adverse event: Dysphagia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 51 affected / 447 at risk

Adverse event: Enteritis necroticans
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 447 at risk

Adverse event: Oesophageal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 447 at risk

Adverse event: Oesophageal perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 447 at risk

Adverse event: Oesophageal stenosis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 447 at risk

Adverse event: Esophagitis NOS
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 447 at risk

Adverse event: Fistula, GI: Oral cavity
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 447 at risk

Adverse event: Gastric ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 447 at risk

Adverse event: Gastrointestinal - Other
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 447 at risk

Adverse event: Hemorrhage, GI: Upper GI NOS
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 447 at risk

Adverse event: Haemorrhoids
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 447 at risk

Adverse event: Lower gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 447 at risk

Adverse event: Malabsorption
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 447 at risk

Adverse event: Mucositis/stomatitis (clinical exam): Anus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 447 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 36 affected / 447 at risk

Adverse event: Oral pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 447 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 447 at risk

Adverse event: Radiation mucositis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 28 affected / 447 at risk

Adverse event: Salivary gland disorder
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 447 at risk

Adverse event: Stomatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 447 at risk

Adverse event: Tooth disorder
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 447 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 31 affected / 447 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 447 at risk

Adverse event: Constitutional Symptoms - Other
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 447 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 447 at risk

Adverse event: Edema: head and neck
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 447 at risk

Adverse event: Facial pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 447 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 8 affected / 447 at risk

Adverse event: Pain - Other
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 447 at risk

Adverse event: Pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 447 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 12 affected / 447 at risk

Adverse event: Chills
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 447 at risk

Adverse event: Sudden death
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 447 at risk

Adverse event: Hepatic failure
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 447 at risk

Adverse event: Anorectal infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 447 at risk

Adverse event: Cystitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 447 at risk

Adverse event: Osteomyelitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 447 at risk

Adverse event: Gingivitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 447 at risk

Adverse event: Implant site infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 447 at risk

Adverse event: Infection - Other
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 447 at risk

Adverse event: Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L): Abdomen NOS
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 447 at risk

Adverse event: Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L): Bladder (urinary)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 447 at risk

Adverse event: Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L): Blood
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 447 at risk

Adverse event: Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L): Bone (osteomyelitis)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 447 at risk

Adverse event: Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L): Catheter-related
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 447 at risk

Adverse event: Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L): Esophagus
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 447 at risk

Adverse event: Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L): Foreign body (e.g., graft, implant, pro
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 447 at risk

Adverse event: Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L): Lung (pneumonia)
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 447 at risk

Adverse event: Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L): Middle ear (otitis media)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 447 at risk

Adverse event: Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L): Mucosa
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 447 at risk

Adverse event: Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L): Nose
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 447 at risk

Adverse event: Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L): Pancreas
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 447 at risk

Adverse event: Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L): Wound
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 447 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils: Blood
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 447 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils: Esophagus
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 447 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils: Larynx
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 447 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils: Neck NOS
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 447 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils: Salivary gland
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 447 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils: Wound
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 447 at risk

Adverse event: Infection with unknown ANC: Lung (pneumonia)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 447 at risk

Adverse event: Infection with unknown ANC: Trachea
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 447 at risk

Adverse event: Nasopharyngitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 447 at risk

Adverse event: Opportunisitic infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 447 at risk

Adverse event: Otitis media
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 447 at risk

Adverse event: Peritonitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 447 at risk

Adverse event: Pharyngitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 447 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 11 affected / 447 at risk

Adverse event: Respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 447 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 447 at risk

Adverse event: Skin infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 447 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 447 at risk

Adverse event: Thermal burn
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 447 at risk

Adverse event: Culture wound negative
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 447 at risk

Adverse event: Radiation skin injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 5 affected / 447 at risk

Adverse event: Hemorrhage, Pulmonary/upper respiratory: Trachea
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 447 at risk

Adverse event: Recall phenomenon
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 447 at risk

Adverse event: Vascular access complication
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 447 at risk

Adverse event: Vessel injury-artery: Carotid
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 447 at risk

Adverse event: Alanine aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 3 affected / 447 at risk

Adverse event: Aspartate aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 3 affected / 447 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 447 at risk

Adverse event: Amylase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 447 at risk

Adverse event: Blood bilirubin increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 447 at risk

Adverse event: Blood creatinine increased
Serious: yes
Organ System: Investigations
Frequency: 20 affected / 447 at risk

Adverse event: Coagulopathy
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 447 at risk

Adverse event: Gamma-glutamyltransferase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 447 at risk

Adverse event: Inappropriate antidiuretic hormone secretion
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 447 at risk

Adverse event: Leukopenia
Serious: yes
Organ System: Investigations
Frequency: 34 affected / 447 at risk

Adverse event: Lipase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 447 at risk

Adverse event: Lymphopenia
Serious: yes
Organ System: Investigations
Frequency: 10 affected / 447 at risk

Adverse event: Neutrophil count
Serious: yes
Organ System: Investigations
Frequency: 31 affected / 447 at risk

Adverse event: Platelet count decreased
Serious: yes
Organ System: Investigations
Frequency: 7 affected / 447 at risk

Adverse event: Prothrombin time prolonged
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 447 at risk

Adverse event: Troponin I increased
Serious: yes
Organ System: Investigations
Frequency: 3 affected / 447 at risk

Adverse event: Weight decreased
Serious: yes
Organ System: Investigations
Frequency: 21 affected / 447 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 12 affected / 447 at risk

Adverse event: Blood iron increased
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 447 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 68 affected / 447 at risk

Adverse event: Hypercalcaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 447 at risk

Adverse event: Hyperglycemia NOS
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 447 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 447 at risk

Adverse event: Hypermagnesaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 447 at risk

Adverse event: Hypernatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 447 at risk

Adverse event: Hyperuricaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 447 at risk

Adverse event: Hypoalbuminaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 10 affected / 447 at risk

Adverse event: Hypocalcaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 447 at risk

Adverse event: Hypoglycemia NOS
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 447 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 11 affected / 447 at risk

Adverse event: Hypomagnesaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 447 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 15 affected / 447 at risk

Adverse event: Hypophosphataemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 447 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 447 at risk

Adverse event: Muscular weakness
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 447 at risk

Adverse event: Muscle weakness, generalized or specific area (not due to neuropathy): Extremity-lower
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 447 at risk

Adverse event: Neck pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 447 at risk

Adverse event: Osteonecrosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 447 at risk

Adverse event: Soft tissue necrosis: Head
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 447 at risk

Adverse event: Soft tissue necrosis: Neck
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 447 at risk

Adverse event: Cerebral ischaemia
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 447 at risk

Adverse event: Depressed level of consciousness
Serious: yes
Organ System: Nervous system disorders
Frequency: 6 affected / 447 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 447 at risk

Adverse event: Dysgeusia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 447 at risk

Adverse event: Memory impairment
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 447 at risk

Adverse event: Neuralgia
Serious: yes
Organ System: Nervous system disorders
Frequency: 5 affected / 447 at risk

Adverse event: Neurology - Other
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 447 at risk

Adverse event: Peripheral motor neuropathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 447 at risk

Adverse event: Peripheral sensory neuropathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 447 at risk

Adverse event: Speech disorder
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 447 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 447 at risk

Adverse event: Anxiety
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 447 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Psychiatric disorders
Frequency: 5 affected / 447 at risk

Adverse event: Insomnia
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 447 at risk

Adverse event: Bladder obstruction
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 447 at risk

Adverse event: Glomerular filtration rate
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 447 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 17 affected / 447 at risk

Adverse event: Renal/genitourinary - Other
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 447 at risk

Adverse event: Aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 447 at risk

Adverse event: Cough
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 447 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 15 affected / 447 at risk

Adverse event: Hemorrhage, Pulmonary/upper respiratory: Pharynx
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 447 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 447 at risk

Adverse event: Laryngeal discomfort
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 447 at risk

Adverse event: Laryngeal oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 447 at risk

Adverse event: Laryngeal stensos
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 447 at risk

Adverse event: Laryngitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 447 at risk

Adverse event: Mucositis/stomatitis (clinical exam): Larynx
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 447 at risk

Adverse event: Mucositis/stomatitis (clinical exam): Pharynx
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 447 at risk

Adverse event: Mucositis/stomatitis (functional/symptomatic): Larynx
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 447 at risk

Adverse event: Mucositis/stomatitis (functional/symptomatic): Pharynx
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 447 at risk

Adverse event: Obstruction/stenosis of airway: Pharynx
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 447 at risk

Adverse event: Laryngeal pain
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 12 affected / 447 at risk

Adverse event: Pneumonitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 447 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 447 at risk

Adverse event: Pulmonary/upper respiratory - Other
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 447 at risk

Adverse event: Alopecia
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 447 at risk

Adverse event: Decubitus ulcer
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 447 at risk

Adverse event: Dermatitis exfoliative
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 447 at risk

Adverse event: Dermatology/skin - Other
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 447 at risk

Adverse event: Skin atrophy
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 447 at risk

Adverse event: Skin fibrosis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 447 at risk

Adverse event: Skin hyperpigmentation
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 447 at risk

Adverse event: Telangiectasia
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 447 at risk

Adverse event: Ulcer
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 447 at risk

Adverse event: Hemorrhage/bleeding - Other
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 447 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 9 affected / 447 at risk

Adverse event: Peripheral ischaemia
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 447 at risk

Adverse event: Thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 447 at risk

Adverse event: Vascular - Other
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 447 at risk

Adverse event: Blood/bone marrow - Other
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 31 affected / 447 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 262 affected / 447 at risk

Adverse event: Ear pain
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 35 affected / 447 at risk

Adverse event: Hypoacusis
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 127 affected / 447 at risk

Adverse event: Tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 117 affected / 447 at risk

Adverse event: Hypothyroidism
Serious: no
Organ System: Endocrine disorders
Frequency: 82 affected / 447 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 25 affected / 447 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 170 affected / 447 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 76 affected / 447 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 352 affected / 447 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 52 affected / 447 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 431 affected / 447 at risk

Adverse event: Oesophageal stenosis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 28 affected / 447 at risk

Adverse event: Esophagitis NOS
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 19 affected / 447 at risk

Adverse event: Gastrointestinal - Other
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 55 affected / 447 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 252 affected / 447 at risk

Adverse event: Oral pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 143 affected / 447 at risk

Adverse event: Radiation mucositis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 349 affected / 447 at risk

Adverse event: Salivary gland disorder
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 179 affected / 447 at risk

Adverse event: Tooth disorder
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 39 affected / 447 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 170 affected / 447 at risk

Adverse event: Edema: head and neck
Serious: no
Organ System: General disorders
Frequency: 119 affected / 447 at risk

Adverse event: Edema: limb
Serious: no
Organ System: General disorders
Frequency: 23 affected / 447 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 323 affected / 447 at risk

Adverse event: Pain - Other
Serious: no
Organ System: General disorders
Frequency: 64 affected / 447 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 27 affected / 447 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 56 affected / 447 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 18 affected / 447 at risk

Adverse event: Gingivitis
Serious: no
Organ System: Infections and infestations
Frequency: 25 affected / 447 at risk

Adverse event: Infection - Other
Serious: no
Organ System: Infections and infestations
Frequency: 21 affected / 447 at risk

Adverse event: Radiation skin injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 264 affected / 447 at risk

Adverse event: Recall phenomenon
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 129 affected / 447 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 85 affected / 447 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 71 affected / 447 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Investigations
Frequency: 48 affected / 447 at risk

Adverse event: Blood bilirubin increased
Serious: no
Organ System: Investigations
Frequency: 17 affected / 447 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 108 affected / 447 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Investigations
Frequency: 207 affected / 447 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Investigations
Frequency: 98 affected / 447 at risk

Adverse event: Metabolic/laboratory - Other
Serious: no
Organ System: Investigations
Frequency: 46 affected / 447 at risk

Adverse event: Neutrophil count
Serious: no
Organ System: Investigations
Frequency: 134 affected / 447 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 100 affected / 447 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 253 affected / 447 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 163 affected / 447 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 118 affected / 447 at risk

Adverse event: Hyperglycemia NOS
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 149 affected / 447 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 40 affected / 447 at risk

Adverse event: Hypermagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 29 affected / 447 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 127 affected / 447 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 90 affected / 447 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 84 affected / 447 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 106 affected / 447 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 165 affected / 447 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 28 affected / 447 at risk

Adverse event: Fibrosis-deep connective tissue
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 23 affected / 447 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 23 affected / 447 at risk

Adverse event: Musculoskeletal/soft tissue - Other
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 33 affected / 447 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 80 affected / 447 at risk

Adverse event: Osteonecrosis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 46 affected / 447 at risk

Adverse event: Trismus
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 97 affected / 447 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 43 affected / 447 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 245 affected / 447 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 56 affected / 447 at risk

Adverse event: Neuralgia
Serious: no
Organ System: Nervous system disorders
Frequency: 94 affected / 447 at risk

Adverse event: Peripheral motor neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 21 affected / 447 at risk

Adverse event: Peripheral sensory neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 110 affected / 447 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 64 affected / 447 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 64 affected / 447 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 68 affected / 447 at risk

Adverse event: Aspiration
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 31 affected / 447 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 110 affected / 447 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 60 affected / 447 at risk

Adverse event: Hiccups
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 24 affected / 447 at risk

Adverse event: Laryngeal discomfort
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 23 affected / 447 at risk

Adverse event: Laryngeal oedema
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 209 affected / 447 at risk

Adverse event: Laryngitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 177 affected / 447 at risk

Adverse event: Mucositis/stomatitis (clinical exam): Larynx
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 85 affected / 447 at risk

Adverse event: Mucositis/stomatitis (clinical exam): Pharynx
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 240 affected / 447 at risk

Adverse event: Laryngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 185 affected / 447 at risk

Adverse event: Pulmonary/upper respiratory - Other
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 47 affected / 447 at risk

Adverse event: Acne
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 13 affected / 447 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 94 affected / 447 at risk

Adverse event: Dermatitis exfoliative
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 58 affected / 447 at risk

Adverse event: Dermatology/skin - Other
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 150 affected / 447 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 26 affected / 447 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 34 affected / 447 at risk

Adverse event: Skin fibrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 220 affected / 447 at risk

Adverse event: Skin hyperpigmentation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 94 affected / 447 at risk

Adverse event: Skin hypopigmentation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 26 affected / 447 at risk

Adverse event: Telangiectasia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 37 affected / 447 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 31 affected / 447 at risk

Adverse event: Blood/bone marrow - Other
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 444 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 24 affected / 444 at risk

Adverse event: Haemoglobin
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 32 affected / 444 at risk

Adverse event: Hemolysis NOS
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 444 at risk

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 444 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 444 at risk

Adverse event: Atrial flutter
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 444 at risk

Adverse event: Cardiac general - Other
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 444 at risk

Adverse event: Left ventricular failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 444 at risk

Adverse event: Myocardial ischaemia
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 444 at risk

Adverse event: Sinus arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 444 at risk

Adverse event: Hypoacusis
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 444 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 444 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 444 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 444 at risk

Adverse event: Dry mouth
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 444 at risk

Adverse event: Duodenal perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 444 at risk

Adverse event: Dysphagia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 46 affected / 444 at risk

Adverse event: Oesophageal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 444 at risk

Adverse event: Esophagitis NOS
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 444 at risk

Adverse event: Fistula, GI: Abdomen NOS
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 444 at risk

Adverse event: Fistula, Pulmonary/upper respiratory: Oral cavity
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 444 at risk

Adverse event: Gastric haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 444 at risk

Adverse event: Gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 444 at risk

Adverse event: Gastrointestinal - Other
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 444 at risk

Adverse event: Intra-abdominal hemorrhage NOS
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 444 at risk

Adverse event: Mucositis/stomatitis (functional/symptomatic): Esophagus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 444 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 59 affected / 444 at risk

Adverse event: Oral pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 444 at risk

Adverse event: Radiation mucositis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 52 affected / 444 at risk

Adverse event: Rectal perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 444 at risk

Adverse event: Rectal ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 444 at risk

Adverse event: Salivary gland disorder
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 444 at risk

Adverse event: Small intestinal stenosis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 444 at risk

Adverse event: Stomatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 444 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 45 affected / 444 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 444 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 444 at risk

Adverse event: Disease progression
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 444 at risk

Adverse event: Edema: limb
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 444 at risk

Adverse event: Edema: trunk/genital
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 444 at risk

Adverse event: Facial pain
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 444 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 27 affected / 444 at risk

Adverse event: Multiple organ dysfunction syndrome
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 444 at risk

Adverse event: Pain - Other
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 444 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 28 affected / 444 at risk

Adverse event: Chills
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 444 at risk

Adverse event: Sudden death
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 444 at risk

Adverse event: Gallbladder obstruction
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 444 at risk

Adverse event: Cytokine release syndrome
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 444 at risk

Adverse event: Hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 15 affected / 444 at risk

Adverse event: Abdominal infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 444 at risk

Adverse event: Cystitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 444 at risk

Adverse event: Osteomyelitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 444 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 444 at risk

Adverse event: Gingivitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 444 at risk

Adverse event: Infection - Other
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 444 at risk

Adverse event: Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L): Abdomen NOS
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 444 at risk

Adverse event: Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L): Bladder (urinary)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 444 at risk

Adverse event: Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L): Blood
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 444 at risk

Adverse event: Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L): Brain + Spinal cord (encephalomyelitis)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 444 at risk

Adverse event: Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L): Catheter-related
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 444 at risk

Adverse event: Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L): Dental-tooth
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 444 at risk

Adverse event: Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L): Lung (pneumonia)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 444 at risk

Adverse event: Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L): Oral cavity-gums (gingivitis)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 444 at risk

Adverse event: Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L): Stomach
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 444 at risk

Adverse event: Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L): Trachea
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 444 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils: Blood
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 444 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils: Catheter-related
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 444 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils: Lip/perioral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 444 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils: Wound
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 444 at risk

Adverse event: Infection with unknown ANC: Lung (pneumonia)
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 444 at risk

Adverse event: Opportunisitic infection
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 444 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 444 at risk

Adverse event: Respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 444 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 444 at risk

Adverse event: Skin infection
Serious: yes
Organ System: Infections and infestations
Frequency: 7 affected / 444 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 444 at risk

Adverse event: Wound infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 444 at risk

Adverse event: Culture wound negative
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 444 at risk

Adverse event: Radiation skin injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 444 at risk

Adverse event: Recall phenomenon
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 17 affected / 444 at risk

Adverse event: Tracheal stenosis
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 444 at risk

Adverse event: Vascular access complication
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 444 at risk

Adverse event: Activated partial thromboplastin time prolonged
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 444 at risk

Adverse event: Alanine aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 6 affected / 444 at risk

Adverse event: Aspartate aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 6 affected / 444 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: yes
Organ System: Investigations
Frequency: 3 affected / 444 at risk

Adverse event: Amylase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 444 at risk

Adverse event: Blood bilirubin increased
Serious: yes
Organ System: Investigations
Frequency: 5 affected / 444 at risk

Adverse event: Blood creatine phosphokinase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 444 at risk

Adverse event: Blood creatinine increased
Serious: yes
Organ System: Investigations
Frequency: 19 affected / 444 at risk

Adverse event: Coagulopathy
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 444 at risk

Adverse event: Inappropriate antidiuretic hormone secretion
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 444 at risk

Adverse event: Leukopenia
Serious: yes
Organ System: Investigations
Frequency: 38 affected / 444 at risk

Adverse event: Lymphopenia
Serious: yes
Organ System: Investigations
Frequency: 26 affected / 444 at risk

Adverse event: Metabolic/laboratory - Other
Serious: yes
Organ System: Investigations
Frequency: 3 affected / 444 at risk

Adverse event: Neutrophil count
Serious: yes
Organ System: Investigations
Frequency: 34 affected / 444 at risk

Adverse event: Platelet count decreased
Serious: yes
Organ System: Investigations
Frequency: 13 affected / 444 at risk

Adverse event: Troponin I increased
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 444 at risk

Adverse event: Troponin T increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 444 at risk

Adverse event: Weight decreased
Serious: yes
Organ System: Investigations
Frequency: 18 affected / 444 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 17 affected / 444 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 80 affected / 444 at risk

Adverse event: Hyperglycemia NOS
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 10 affected / 444 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 444 at risk

Adverse event: Hypernatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 444 at risk

Adverse event: Hypoalbuminaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 17 affected / 444 at risk

Adverse event: Hypocalcaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 16 affected / 444 at risk

Adverse event: Hypoglycemia NOS
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 444 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 25 affected / 444 at risk

Adverse event: Hypomagnesaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 18 affected / 444 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 32 affected / 444 at risk

Adverse event: Hypophosphataemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 444 at risk

Adverse event: Musculoskeletal chest pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 444 at risk

Adverse event: Muscular weakness
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 444 at risk

Adverse event: Neck pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 444 at risk

Adverse event: Osteonecrosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 444 at risk

Adverse event: Pain in extremity
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 444 at risk

Adverse event: Soft tissue necrosis: Head
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 444 at risk

Adverse event: Soft tissue necrosis: Neck
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 444 at risk

Adverse event: Trismus
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 444 at risk

Adverse event: Secondary Malignancy - possibly related to cancer treatment
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 444 at risk

Adverse event: Cerebral ischaemia
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 444 at risk

Adverse event: Cognitive disorder
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 444 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 444 at risk

Adverse event: Depressed level of consciousness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 444 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 444 at risk

Adverse event: Dysgeusia
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 444 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 444 at risk

Adverse event: Haemorrhagic stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 444 at risk

Adverse event: Memory impairment
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 444 at risk

Adverse event: Mental status changes
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 444 at risk

Adverse event: Neurology - Other
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 444 at risk

Adverse event: Peripheral sensory neuropathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 444 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 444 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 444 at risk

Adverse event: Agitation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 444 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Psychiatric disorders
Frequency: 7 affected / 444 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 4 affected / 444 at risk

Adverse event: Insomnia
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 444 at risk

Adverse event: Psychotic disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 444 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 12 affected / 444 at risk

Adverse event: Renal/genitourinary - Other
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 444 at risk

Adverse event: Acute respiratory distress syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 444 at risk

Adverse event: Aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 444 at risk

Adverse event: Cough
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 444 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 444 at risk

Adverse event: Epistaxis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 444 at risk

Adverse event: Hemorrhage, Pulmonary/upper respiratory: Bronchopulmonary NOS
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 444 at risk

Adverse event: Hemorrhage, Pulmonary/upper respiratory: Pharynx
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 444 at risk

Adverse event: Hiccups
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 444 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 444 at risk

Adverse event: Laryngeal oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 444 at risk

Adverse event: Laryngeal stensos
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 444 at risk

Adverse event: Laryngitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 444 at risk

Adverse event: Mucositis/stomatitis (clinical exam): Larynx
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 444 at risk

Adverse event: Mucositis/stomatitis (clinical exam): Pharynx
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 12 affected / 444 at risk

Adverse event: Mucositis/stomatitis (functional/symptomatic): Pharynx
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 444 at risk

Adverse event: Nasal cavity/paranasal sinus reactions
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 444 at risk

Adverse event: Obstruction/stenosis of airway: Pharynx
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 444 at risk

Adverse event: Oropharyngeal fistula
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 444 at risk

Adverse event: Laryngeal pain
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 444 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 444 at risk

Adverse event: Pneumonitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 444 at risk

Adverse event: Acne
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 11 affected / 444 at risk

Adverse event: Dermatitis exfoliative
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 10 affected / 444 at risk

Adverse event: Dermatology/skin - Other
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 444 at risk

Adverse event: Dry skin
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 444 at risk

Adverse event: Nail disorder
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 444 at risk

Adverse event: Pain of skin
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 444 at risk

Adverse event: Pruritus
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 444 at risk

Adverse event: Skin fibrosis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 444 at risk

Adverse event: Ulcer
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 444 at risk

Adverse event: Hemorrhage/bleeding - Other
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 444 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 444 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 16 affected / 444 at risk

Adverse event: Thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 8 affected / 444 at risk

Adverse event: Blood/bone marrow - Other
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 31 affected / 444 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 250 affected / 444 at risk

Adverse event: Ear pain
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 33 affected / 444 at risk

Adverse event: Hypoacusis
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 114 affected / 444 at risk

Adverse event: Tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 106 affected / 444 at risk

Adverse event: Hypothyroidism
Serious: no
Organ System: Endocrine disorders
Frequency: 70 affected / 444 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 32 affected / 444 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 146 affected / 444 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 92 affected / 444 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 344 affected / 444 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 50 affected / 444 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 415 affected / 444 at risk

Adverse event: Oesophageal stenosis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 35 affected / 444 at risk

Adverse event: Esophagitis NOS
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 26 affected / 444 at risk

Adverse event: Gastrointestinal - Other
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 51 affected / 444 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 243 affected / 444 at risk

Adverse event: Oral pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 158 affected / 444 at risk

Adverse event: Radiation mucositis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 364 affected / 444 at risk

Adverse event: Salivary gland disorder
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 159 affected / 444 at risk

Adverse event: Tooth disorder
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 33 affected / 444 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 179 affected / 444 at risk

Adverse event: Edema: head and neck
Serious: no
Organ System: General disorders
Frequency: 117 affected / 444 at risk

Adverse event: Edema: limb
Serious: no
Organ System: General disorders
Frequency: 19 affected / 444 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 316 affected / 444 at risk

Adverse event: Pain - Other
Serious: no
Organ System: General disorders
Frequency: 69 affected / 444 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 28 affected / 444 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 73 affected / 444 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 30 affected / 444 at risk

Adverse event: Gingivitis
Serious: no
Organ System: Infections and infestations
Frequency: 23 affected / 444 at risk

Adverse event: Infection - Other
Serious: no
Organ System: Infections and infestations
Frequency: 38 affected / 444 at risk

Adverse event: Radiation skin injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 229 affected / 444 at risk

Adverse event: Recall phenomenon
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 200 affected / 444 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 96 affected / 444 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 69 affected / 444 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Investigations
Frequency: 34 affected / 444 at risk

Adverse event: Blood bilirubin increased
Serious: no
Organ System: Investigations
Frequency: 38 affected / 444 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 81 affected / 444 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Investigations
Frequency: 206 affected / 444 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Investigations
Frequency: 87 affected / 444 at risk

Adverse event: Metabolic/laboratory - Other
Serious: no
Organ System: Investigations
Frequency: 46 affected / 444 at risk

Adverse event: Neutrophil count
Serious: no
Organ System: Investigations
Frequency: 124 affected / 444 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 108 affected / 444 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 263 affected / 444 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 160 affected / 444 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 104 affected / 444 at risk

Adverse event: Hyperglycemia NOS
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 170 affected / 444 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 46 affected / 444 at risk

Adverse event: Hypermagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 17 affected / 444 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 137 affected / 444 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 116 affected / 444 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 102 affected / 444 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 152 affected / 444 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 186 affected / 444 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 20 affected / 444 at risk

Adverse event: Fibrosis-deep connective tissue
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 21 affected / 444 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 31 affected / 444 at risk

Adverse event: Musculoskeletal/soft tissue - Other
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 48 affected / 444 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 96 affected / 444 at risk

Adverse event: Osteonecrosis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 44 affected / 444 at risk

Adverse event: Trismus
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 99 affected / 444 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 55 affected / 444 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 240 affected / 444 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 83 affected / 444 at risk

Adverse event: Neuralgia
Serious: no
Organ System: Nervous system disorders
Frequency: 87 affected / 444 at risk

Adverse event: Peripheral motor neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 29 affected / 444 at risk

Adverse event: Peripheral sensory neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 121 affected / 444 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 48 affected / 444 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 62 affected / 444 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 72 affected / 444 at risk

Adverse event: Aspiration
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 28 affected / 444 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 94 affected / 444 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 65 affected / 444 at risk

Adverse event: Hiccups
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 20 affected / 444 at risk

Adverse event: Laryngeal discomfort
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 13 affected / 444 at risk

Adverse event: Laryngeal oedema
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 200 affected / 444 at risk

Adverse event: Laryngitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 152 affected / 444 at risk

Adverse event: Mucositis/stomatitis (clinical exam): Larynx
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 74 affected / 444 at risk

Adverse event: Mucositis/stomatitis (clinical exam): Pharynx
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 218 affected / 444 at risk

Adverse event: Laryngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 154 affected / 444 at risk

Adverse event: Pulmonary/upper respiratory - Other
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 36 affected / 444 at risk

Adverse event: Acne
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 291 affected / 444 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 90 affected / 444 at risk

Adverse event: Dermatitis exfoliative
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 206 affected / 444 at risk

Adverse event: Dermatology/skin - Other
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 158 affected / 444 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 36 affected / 444 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 153 affected / 444 at risk

Adverse event: Skin fibrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 213 affected / 444 at risk

Adverse event: Skin hyperpigmentation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 87 affected / 444 at risk

Adverse event: Skin hypopigmentation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 28 affected / 444 at risk

Adverse event: Telangiectasia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 32 affected / 444 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 39 affected / 444 at risk