Study: NCT01088802

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grade 3
Frequency: 2 affected / 60 at risk

Adverse event: Akathisia
Serious: yes
Organ System: Nervous system disorders
Notes: Grade 3
Frequency: 1 affected / 60 at risk

Adverse event: ANC decreased
Serious: yes
Organ System: Investigations
Notes: Grade 3
Frequency: 1 affected / 60 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Grade 3
Frequency: 2 affected / 60 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Grade 3
Frequency: 2 affected / 60 at risk

Adverse event: Aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade 3
Frequency: 1 affected / 60 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Notes: Grade 3
Frequency: 2 affected / 60 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Grade 3
Frequency: 1 affected / 60 at risk

Adverse event: Chronic kidney disease
Serious: yes
Organ System: Renal and urinary disorders
Notes: Grade 3
Frequency: 1 affected / 60 at risk

Adverse event: Large intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grade 3
Frequency: 1 affected / 60 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grade 3
Frequency: 1 affected / 60 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Grade 3
Frequency: 6 affected / 60 at risk

Adverse event: Dermatitis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: Grade 3
Frequency: 1 affected / 60 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grade 3
Frequency: 1 affected / 60 at risk

Adverse event: Dysphagia
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grade 3
Frequency: 4 affected / 60 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade 3
Frequency: 2 affected / 60 at risk

Adverse event: Oedema peripheral
Serious: yes
Organ System: General disorders
Notes: Grade 3
Frequency: 1 affected / 60 at risk

Adverse event: Enterocolitis infectious
Serious: yes
Organ System: Infections and infestations
Notes: Grade 3
Frequency: 1 affected / 60 at risk

Adverse event: Oesophageal stenosis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grade 3
Frequency: 2 affected / 60 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Notes: Grade 3
Frequency: 5 affected / 60 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Grade 3
Frequency: 4 affected / 60 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Notes: Grade 3
Frequency: 3 affected / 60 at risk

Adverse event: Flatulence
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grade 3
Frequency: 1 affected / 60 at risk

Adverse event: general NOS: failure to thrive
Serious: yes
Organ System: General disorders
Notes: Grade 3
Frequency: 1 affected / 60 at risk

Adverse event: hearing changes
Serious: yes
Organ System: Ear and labyrinth disorders
Notes: Grade 3
Frequency: 3 affected / 60 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Grade 3
Frequency: 2 affected / 60 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Grade 3
Frequency: 1 affected / 60 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Grade 3
Frequency: 1 affected / 60 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Grade 3
Frequency: 1 affected / 60 at risk

Adverse event: Hypomagnesia
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Grade 3
Frequency: 1 affected / 60 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Grade 3
Frequency: 2 affected / 60 at risk

Adverse event: injury/procedure complication: bleeding at PEG site
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Grade 3
Frequency: 1 affected / 60 at risk

Adverse event: injury/procedure complication: g-tube dysfunction
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Grade 3
Frequency: 1 affected / 60 at risk

Adverse event: injury/procedure complication: PEG dysfunction
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Grade 3
Frequency: 2 affected / 60 at risk

Adverse event: injury/procedure complication-NOS: admitted following left neck dissection
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Grade 3
Frequency: 1 affected / 60 at risk

Adverse event: injury/procedure complication-NOS: PEG insertion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Grade 3
Frequency: 1 affected / 60 at risk

Adverse event: Leukocytosis
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Grade 3
Frequency: 1 affected / 60 at risk

Adverse event: lower GI hemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grade 3
Frequency: 1 affected / 60 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade 3
Frequency: 3 affected / 60 at risk

Adverse event: Metastases to lung
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Grade 3
Frequency: 1 affected / 60 at risk

Adverse event: Lymphocyte count decreased
Serious: yes
Organ System: Investigations
Notes: Grade 3
Frequency: 27 affected / 60 at risk

Adverse event: Metastatic neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Grade 3
Frequency: 1 affected / 60 at risk

Adverse event: Mucosal inflammation
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade 3
Frequency: 28 affected / 60 at risk

Adverse event: Mucous membrane
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade 3
Frequency: 1 affected / 60 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grade 3
Frequency: 3 affected / 60 at risk

Adverse event: Oral pain
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grade 3
Frequency: 1 affected / 60 at risk

Adverse event: Pain
Serious: yes
Organ System: General disorders
Notes: Grade 3
Frequency: 3 affected / 60 at risk

Adverse event: pain due to XRT
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Grade 3
Frequency: 5 affected / 60 at risk

Adverse event: Pain NCI
Serious: yes
Organ System: General disorders
Notes: Grade 3
Frequency: 1 affected / 60 at risk

Adverse event: pharyngeal pain
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade 3
Frequency: 1 affected / 60 at risk

Adverse event: psych NOS
Serious: yes
Organ System: Psychiatric disorders
Notes: Grade 3
Frequency: 1 affected / 60 at risk

Adverse event: Restlessness
Serious: yes
Organ System: Psychiatric disorders
Notes: Grade 3
Frequency: 1 affected / 60 at risk

Adverse event: saliva/salivary gland
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grade 3
Frequency: 11 affected / 60 at risk

Adverse event: Skin infection
Serious: yes
Organ System: Infections and infestations
Notes: Grade 3
Frequency: 1 affected / 60 at risk

Adverse event: Subcutaneous tissue
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: Grade 3
Frequency: 2 affected / 60 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade 3
Frequency: 1 affected / 60 at risk

Adverse event: Vascular access complication
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Grade 3
Frequency: 1 affected / 60 at risk

Adverse event: Venous thrombosis
Serious: yes
Organ System: Vascular disorders
Notes: Grade 3
Frequency: 1 affected / 60 at risk

Adverse event: Voice changes
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade 3
Frequency: 1 affected / 60 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grade 3
Frequency: 3 affected / 60 at risk

Adverse event: White blood cell count decreased
Serious: yes
Organ System: Investigations
Notes: Grade 3
Frequency: 2 affected / 60 at risk

Adverse event: Dry mouth
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grade 3
Frequency: 1 affected / 60 at risk

Adverse event: Lymphocyte count decreased
Serious: yes
Organ System: Investigations
Notes: Grade 4
Frequency: 23 affected / 60 at risk

Adverse event: Neutrophils decreased
Serious: yes
Organ System: Investigations
Notes: Grade 4
Frequency: 1 affected / 60 at risk

Adverse event: Pain
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Grade 4
Frequency: 1 affected / 60 at risk

Adverse event: PsychNOS: mood disorder
Serious: yes
Organ System: Psychiatric disorders
Notes: Grade 4
Frequency: 1 affected / 60 at risk

Adverse event: White blood cell count decreased
Serious: yes
Organ System: Investigations
Notes: Grade 4
Frequency: 4 affected / 60 at risk

Adverse event: Arterial injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Grade 5
Frequency: 1 affected / 60 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Notes: Grade 1
Frequency: 22 affected / 60 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 1
Frequency: 49 affected / 60 at risk

Adverse event: Aspiration
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade 1
Frequency: 17 affected / 60 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Notes: Grade 1
Frequency: 6 affected / 60 at risk

Adverse event: Blood bilirubin increased
Serious: no
Organ System: Investigations
Notes: Grade 1
Frequency: 5 affected / 60 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade 1
Frequency: 20 affected / 60 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Notes: Grade 1
Frequency: 12 affected / 60 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Grade 1
Frequency: 11 affected / 60 at risk

Adverse event: dermal caries
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 1
Frequency: 10 affected / 60 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Grade 1
Frequency: 9 affected / 60 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Notes: Grade 1
Frequency: 16 affected / 60 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 1
Frequency: 35 affected / 60 at risk

Adverse event: Oesophageal stenosis
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 1
Frequency: 8 affected / 60 at risk

Adverse event: esophagus/RTOG
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 1
Frequency: 3 affected / 60 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Grade 1
Frequency: 28 affected / 60 at risk

Adverse event: hearing changes
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Grade 1
Frequency: 4 affected / 60 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Grade 1
Frequency: 45 affected / 60 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Grade 1
Frequency: 8 affected / 60 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Grade 1
Frequency: 3 affected / 60 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Grade 1
Frequency: 6 affected / 60 at risk

Adverse event: hypomagnesia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Grade 1
Frequency: 5 affected / 60 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Grade 1
Frequency: 19 affected / 60 at risk

Adverse event: larynx/RTOG
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade 1
Frequency: 15 affected / 60 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade 1
Frequency: 11 affected / 60 at risk

Adverse event: mucous membrane/RTOG
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade 1
Frequency: 27 affected / 60 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 1
Frequency: 33 affected / 60 at risk

Adverse event: pain due to XRT
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Grade 1
Frequency: 16 affected / 60 at risk

Adverse event: platelets/count decreased
Serious: no
Organ System: Investigations
Notes: Grade 1
Frequency: 29 affected / 60 at risk

Adverse event: saliva/salivary gland
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 1
Frequency: 6 affected / 60 at risk

Adverse event: skin acute
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Grade 1
Frequency: 12 affected / 60 at risk

Adverse event: skin acute
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Grade 1
Frequency: 5 affected / 60 at risk

Adverse event: skin late
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Grade 1
Frequency: 25 affected / 60 at risk

Adverse event: subcutaneous tissue/RTOG
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Grade 1
Frequency: 34 affected / 60 at risk

Adverse event: Tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Grade 1
Frequency: 36 affected / 60 at risk

Adverse event: Trismus
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Grade 1
Frequency: 13 affected / 60 at risk

Adverse event: voice changes/alteration
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade 1
Frequency: 38 affected / 60 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 1
Frequency: 13 affected / 60 at risk

Adverse event: watery eye
Serious: no
Organ System: Eye disorders
Notes: Grade 1
Frequency: 3 affected / 60 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Notes: Grade 1
Frequency: 30 affected / 60 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Notes: Grade 1
Frequency: 26 affected / 60 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 1
Frequency: 4 affected / 60 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 2
Frequency: 7 affected / 60 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Grade 2
Frequency: 6 affected / 60 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Grade 2
Frequency: 6 affected / 60 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Grade 2
Frequency: 28 affected / 60 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Notes: Grade 2
Frequency: 41 affected / 60 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 2
Frequency: 14 affected / 60 at risk

Adverse event: Oesophagitis
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 2
Frequency: 5 affected / 60 at risk

Adverse event: esophagus/RTOC
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 2
Frequency: 8 affected / 60 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Grade 2
Frequency: 22 affected / 60 at risk

Adverse event: hearing changes/impairment
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Grade 2
Frequency: 5 affected / 60 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Grade 2
Frequency: 9 affected / 60 at risk

Adverse event: hypomagnesia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Grade 2
Frequency: 3 affected / 60 at risk

Adverse event: larynx/RTOG
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade 2
Frequency: 8 affected / 60 at risk

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Investigations
Notes: Grade 2
Frequency: 6 affected / 60 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade 2
Frequency: 21 affected / 60 at risk

Adverse event: mucous membrane/RTOG
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade 2
Frequency: 11 affected / 60 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 2
Frequency: 19 affected / 60 at risk

Adverse event: Neuralgia
Serious: no
Organ System: Nervous system disorders
Notes: Grade 2
Frequency: 3 affected / 60 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Notes: Grade 2
Frequency: 5 affected / 60 at risk

Adverse event: pain due to XRT
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Grade 2
Frequency: 32 affected / 60 at risk

Adverse event: salivary gland
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 2
Frequency: 48 affected / 60 at risk

Adverse event: skin acute
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Grade 2
Frequency: 43 affected / 60 at risk

Adverse event: skin late
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Grade 2
Frequency: 5 affected / 60 at risk

Adverse event: subcutaneous tissue
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Grade 2
Frequency: 13 affected / 60 at risk

Adverse event: Tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Grade 2
Frequency: 7 affected / 60 at risk

Adverse event: voice changes
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade 2
Frequency: 7 affected / 60 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 2
Frequency: 4 affected / 60 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Notes: Grade 2
Frequency: 15 affected / 60 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Notes: Grade 2
Frequency: 13 affected / 60 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 2
Frequency: 53 affected / 60 at risk