Study: NCT00281840

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 30 at risk

Adverse event: Thrombosis/embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 30 at risk

Adverse event: Wound-Infection
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 30 at risk

Adverse event: Diarrhea patients without colostomy
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Gastrointestinal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Infection without neutropenia
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 30 at risk

Adverse event: Pneumonitis/pulmonary infiltrates
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 30 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: Vascular disorders
Notes: map to v4.0 as vascular disorder (other)
Frequency: 1 affected / 30 at risk

Adverse event: Muscular weakness
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: not due to neuropathy
Frequency: 1 affected / 30 at risk

Adverse event: Abdominal pain or cramping
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Blood creatinine
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 30 at risk

Adverse event: Incontinence
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 30 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 20 affected / 30 at risk

Adverse event: Dysphagia, esophagitis, odynophagia (painful swallowing)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 20 affected / 30 at risk

Adverse event: Mouth dryness
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 19 affected / 30 at risk

Adverse event: Stomatitis/pharyngitis (oral/pharyngeal mucositis)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 19 affected / 30 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 30 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 30 at risk

Adverse event: Mucositis due to radiation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 30 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 30 at risk

Adverse event: Diarrhea patients without colostomy
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 30 at risk

Adverse event: Gastrointestinal (congestion)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 30 at risk

Adverse event: Taste disturbance (dysgeusia)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 30 at risk

Adverse event: Salivary gland changes
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 30 at risk

Adverse event: Dehydration
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 30 at risk

Adverse event: Dysphagia-pharyngeal related to radiation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 30 at risk

Adverse event: Fatigue (lethargy, malaise, asthenia)
Serious: no
Organ System: General disorders
Frequency: 29 affected / 30 at risk

Adverse event: Weight decreased
Serious: no
Organ System: General disorders
Frequency: 29 affected / 30 at risk

Adverse event: Fever (in the absence of neutropenia, where neutropenia is defined as AGC<1.0 x 10e9/L)
Serious: no
Organ System: General disorders
Frequency: 9 affected / 30 at risk

Adverse event: Rigors, chills
Serious: no
Organ System: General disorders
Frequency: 6 affected / 30 at risk

Adverse event: Sweating (diaphoresis)
Serious: no
Organ System: General disorders
Frequency: 4 affected / 30 at risk

Adverse event: Constitutional Symptoms
Serious: no
Organ System: General disorders
Frequency: 2 affected / 30 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 27 affected / 30 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 26 affected / 30 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 17 affected / 30 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 30 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 30 at risk

Adverse event: Hypermagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 30 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 30 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 30 at risk

Adverse event: Hypercalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 30 at risk

Adverse event: Hypernatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 30 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 30 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 26 affected / 30 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 26 affected / 30 at risk

Adverse event: Leukocytes (total WBC)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 30 at risk

Adverse event: Platelets
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 30 at risk

Adverse event: Radiation dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 23 affected / 30 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 16 affected / 30 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 30 at risk

Adverse event: Dermatology/Skin (erythema)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Erythema at PEG, neck erythema, abrasions from fall, neck fibrosis
Frequency: 4 affected / 30 at risk

Adverse event: Flushing
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 30 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 30 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 30 at risk

Adverse event: Erythema multiforme (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 30 at risk

Adverse event: Urticaria (hives, welts, wheals)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 30 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 22 affected / 30 at risk

Adverse event: SGOT (AST) (serum glutamic oxaloacetic transaminase)
Serious: no
Organ System: Investigations
Frequency: 15 affected / 30 at risk

Adverse event: SGPT (ALT) (serum glutamic pyruvic transaminase)
Serious: no
Organ System: Investigations
Frequency: 13 affected / 30 at risk

Adverse event: Blood alkaline phosphatase
Serious: no
Organ System: Investigations
Frequency: 7 affected / 30 at risk

Adverse event: Blood bilirubin
Serious: no
Organ System: Investigations
Frequency: 4 affected / 30 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 26 affected / 30 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 30 at risk

Adverse event: Arthralgia (joint pain)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 30 at risk

Adverse event: Chest pain (non-cardiac and non-pleuritic)
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 30 at risk

Adverse event: Earache (otalgia)
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 3 affected / 30 at risk

Adverse event: Pain due to radiation
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 30 at risk

Adverse event: Abdominal pain or cramping
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 30 at risk

Adverse event: Myalgia (muscle pain)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 30 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 17 affected / 30 at risk

Adverse event: Mood alteration-anxiety, agitation
Serious: no
Organ System: Psychiatric disorders
Frequency: 10 affected / 30 at risk

Adverse event: Neuropathy-sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 30 at risk

Adverse event: Mood alteration-depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 9 affected / 30 at risk

Adverse event: Dizziness/lightheadedness
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 30 at risk

Adverse event: Confusional state
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 30 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 30 at risk

Adverse event: Voice changes/stridor/larynx (e.g., hoarseness, loss of voice, laryngitis)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 30 at risk

Adverse event: Dyspnea (shortness of breath)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 30 at risk

Adverse event: Pulmonary
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 30 at risk

Adverse event: Pneumonitis/pulmonary infiltrates
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 30 at risk

Adverse event: Hiccoughs (hiccups, singultus)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 30 at risk

Adverse event: Infection without neutropenia
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 30 at risk

Adverse event: Musculoskeletal
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 30 at risk

Adverse event: Muscle weakness (not due to neuropathy)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 30 at risk

Adverse event: Blood creatinine
Serious: no
Organ System: Investigations
Frequency: 4 affected / 30 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 30 at risk

Adverse event: Incontinence
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 30 at risk

Adverse event: Oedema
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 30 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 30 at risk

Adverse event: Sinus tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 7 affected / 30 at risk

Adverse event: Sinus bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 30 at risk

Adverse event: Hemorrhage (bloody nose)
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 30 at risk

Adverse event: Hemorrhage/bleeding without grade 3 or 4 thrombocytopenia
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 30 at risk

Adverse event: Hot flashes/flushes
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 30 at risk

Adverse event: Hypothyroidism
Serious: no
Organ System: Endocrine disorders
Frequency: 3 affected / 30 at risk

Adverse event: Auditory/Hearing (hard of hearing)
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 4 affected / 30 at risk

Adverse event: Allergic reaction/hypersensitivity (including drug fever)
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 30 at risk

Adverse event: Partial thromboplastin time (PTT)
Serious: no
Organ System: Investigations
Frequency: 2 affected / 30 at risk

Adverse event: Prothrombin time (PT)
Serious: no
Organ System: Investigations
Frequency: 2 affected / 30 at risk

Adverse event: Vision-blurred vision
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 30 at risk