Study: NCT00573989

Adverse event: Hypoxia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 4 at risk

Adverse event: Neutrophils/granulocytes
Serious: yes
Organ System: Immune system disorders
Notes: (ANC/AGC) 1.6-7.3
Frequency: 1 affected / 4 at risk

Adverse event: Obstruction/stenosis of airway
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Trachea
Frequency: 1 affected / 4 at risk

Adverse event: ALT, SGPT
Serious: no
Organ System: Hepatobiliary disorders
Notes: (serum glutamic pyruvic transaminase) ((2 -50)
Frequency: 3 affected / 4 at risk

Adverse event: AST, SGOT
Serious: no
Organ System: Hepatobiliary disorders
Notes: (serum glutamic oxaloacetic transaminase) (5-40)
Frequency: 1 affected / 4 at risk

Adverse event: Albumin, serum-low
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: (hypoalbuminemia) (3.5-5.0)
Frequency: 3 affected / 4 at risk

Adverse event: Blood alkaline phosphatase
Serious: no
Organ System: General disorders
Notes: (25-125)
Frequency: 1 affected / 4 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Immune system disorders
Notes: (including sneezing, nasal stuffiness, postnasal drip)
Frequency: 2 affected / 4 at risk

Adverse event: Blood bilirubin
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: (hyperbilirubinemia) (0.1-1.2)
Frequency: 3 affected / 4 at risk

Adverse event: Calcium, serum-low
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: (hypocalcemia)
Frequency: 3 affected / 4 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 4 at risk

Adverse event: Cough
Serious: no
Organ System: General disorders
Frequency: 2 affected / 4 at risk

Adverse event: Dehydration
Serious: no
Organ System: General disorders
Frequency: 1 affected / 4 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 2 affected / 4 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 4 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 4 at risk

Adverse event: Dysphagia
Serious: no
Organ System: General disorders
Notes: (difficulty swallowing)
Frequency: 3 affected / 4 at risk

Adverse event: Oedema
Serious: no
Organ System: General disorders
Notes: head and neck
Frequency: 1 affected / 4 at risk

Adverse event: Oesophagitis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 4 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: (asthenia, lethargy, malaise)
Frequency: 1 affected / 4 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: (in the absence of neutropenia, where neutropenia is defined as ANC \<1.0 x 10e9/L)
Frequency: 1 affected / 4 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Notes: (including bile reflux gastritis)
Frequency: 1 affected / 4 at risk

Adverse event: Glucose, serum-high
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: (hyperglycemia)
Frequency: 3 affected / 4 at risk

Adverse event: Glucose, serum-low
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: (hypoglycemia)
Frequency: 2 affected / 4 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: (gender based)
Frequency: 4 affected / 4 at risk

Adverse event: Hypotension
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 4 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils
Serious: no
Organ System: Infections and infestations
Notes: Lip/perioral
Frequency: 1 affected / 4 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils
Serious: no
Organ System: Infections and infestations
Notes: Skin (cellulitis)
Frequency: 1 affected / 4 at risk

Adverse event: Infection with unknown ANC
Serious: no
Organ System: Infections and infestations
Notes: Lung (pneumonia)
Frequency: 1 affected / 4 at risk

Adverse event: Leukocytes
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: (total WBC) (4.8-10.8)
Frequency: 4 affected / 4 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: (1-5.1)
Frequency: 4 affected / 4 at risk

Adverse event: Magnesium, serum-high
Serious: no
Organ System: Renal and urinary disorders
Notes: (hypermagnesemia)
Frequency: 2 affected / 4 at risk

Adverse event: Magnesium, serum-low
Serious: no
Organ System: Renal and urinary disorders
Notes: (hypomagnesemia)
Frequency: 2 affected / 4 at risk

Adverse event: Mucositis/stomatitis (clinical exam)
Serious: no
Organ System: General disorders
Notes: Larynx
Frequency: 1 affected / 4 at risk

Adverse event: Mucositis/stomatitis (clinical exam)
Serious: no
Organ System: General disorders
Notes: Oral cavity
Frequency: 2 affected / 4 at risk

Adverse event: Neutrophils/granulocytes
Serious: no
Organ System: Immune system disorders
Notes: (ANC/AGC) 1.6-7.3
Frequency: 1 affected / 4 at risk

Adverse event: Pain: Abdomen NOS
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 4 at risk

Adverse event: Pain: Chest/thorax NOS
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: Pain: Eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 4 at risk

Adverse event: Pain: Head/headache
Serious: no
Organ System: General disorders
Frequency: 2 affected / 4 at risk

Adverse event: Pain: Neck
Serious: no
Organ System: General disorders
Frequency: 1 affected / 4 at risk

Adverse event: Pain: Scalp
Serious: no
Organ System: General disorders
Frequency: 1 affected / 4 at risk

Adverse event: Pain: Stomach
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: Pain: Throat/pharynx/larynx
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 4 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 4 at risk

Adverse event: Phosphate, serum-low
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: (hypophosphatemia)
Frequency: 2 affected / 4 at risk

Adverse event: Platelets
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: (160-360)
Frequency: 2 affected / 4 at risk

Adverse event: Potassium, serum-high (hyperkalemia) (3.5-5.3)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 4 at risk

Adverse event: Potassium, serum-low (hypokalemia) (3.5-5.3)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 4 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 4 at risk

Adverse event: Rash: acne/acneiform
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 4 at risk

Adverse event: Rash: dermatitis associated with radiation: Chemoradiation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 4 at risk

Adverse event: Sodium, serum-low
Serious: no
Organ System: Renal and urinary disorders
Notes: (hyponatremia) (135-146)
Frequency: 4 affected / 4 at risk

Adverse event: Supraventricular and nodal arrhythmia: Atrial tachycardia/Paroxysmal Atrial Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 4 at risk

Adverse event: Supraventricular and nodal arrhythmia: Sinus bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 4 at risk

Adverse event: Supraventricular and nodal arrhythmia: Sinus tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 4 at risk

Adverse event: Trismus (difficulty, restriction or pain when opening mouth)
Serious: no
Organ System: General disorders
Frequency: 2 affected / 4 at risk

Adverse event: Voice changes/dysarthria (e.g., hoarseness, loss or alteration in voice, laryngitis)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: Weight decreased
Serious: no
Organ System: General disorders
Frequency: 1 affected / 4 at risk

Adverse event: Aspiration
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 4 at risk

Adverse event: Atelectasis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: Bone
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: spine-scoliosis
Frequency: 1 affected / 4 at risk

Adverse event: Distension/bloating, abdominal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: (shortness of breath)
Frequency: 4 affected / 4 at risk

Adverse event: Edema: limb
Serious: no
Organ System: General disorders
Frequency: 1 affected / 4 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: Hair loss/alopecia (scalp or body)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 4 at risk

Adverse event: Heartburn/dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: Hemorrhage, pulmonary/upper respiratory: Pharynx
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: Hemorrhage, pulmonary/upper respiratory: Respiratory tract NOS
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: Hemorrhage, pulmonary/upper respiratory: Stoma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: Hemorrhage, pulmonary/upper respiratory: Trachea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: Hemorrhage/Bleeding - Other
Serious: no
Organ System: General disorders
Frequency: 1 affected / 4 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils: Conjunctiva
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 4 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils: Trachea
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 4 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils: Vagina
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 4 at risk

Adverse event: Infection with unknown ANC: Conjunctiva
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 4 at risk

Adverse event: Infection with unknown ANC: Lip/perioral
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 4 at risk

Adverse event: Infection with unknown ANC: Skin (cellulitis)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 4 at risk

Adverse event: Infection with unknown ANC: Vagina
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 4 at risk

Adverse event: Muscle weakness, generalized or specific area (not due to neuropathy): Whole body/generalized
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 4 at risk

Adverse event: Partial Thromboplastin Time
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 4 at risk

Adverse event: Pain: Back
Serious: no
Organ System: General disorders
Frequency: 1 affected / 4 at risk

Adverse event: Pain: Cardiac/heart
Serious: no
Organ System: General disorders
Frequency: 1 affected / 4 at risk

Adverse event: Pain: Chest wall
Serious: no
Organ System: General disorders
Frequency: 1 affected / 4 at risk

Adverse event: Pain: External ear
Serious: no
Organ System: General disorders
Frequency: 1 affected / 4 at risk

Adverse event: Pain: Face
Serious: no
Organ System: General disorders
Frequency: 1 affected / 4 at risk

Adverse event: Pain: Joint
Serious: no
Organ System: General disorders
Frequency: 1 affected / 4 at risk

Adverse event: Pain: Middle ear
Serious: no
Organ System: General disorders
Frequency: 1 affected / 4 at risk

Adverse event: Pain: Pleura
Serious: no
Organ System: General disorders
Frequency: 1 affected / 4 at risk

Adverse event: Pain: Skin
Serious: no
Organ System: General disorders
Frequency: 2 affected / 4 at risk

Adverse event: Pain: Tumor pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 4 at risk

Adverse event: Pleural effusion (non-malignant)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: Salivary gland changes/saliva
Serious: no
Organ System: General disorders
Frequency: 1 affected / 4 at risk

Adverse event: Tumour flare
Serious: no
Organ System: General disorders
Frequency: 1 affected / 4 at risk

Adverse event: Urinary frequency/urgency
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 4 at risk

Adverse event: Vessel injury-vein: Extremity-upper
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 4 at risk

Adverse event: Vessel injury-vein: IVC
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 4 at risk

Adverse event: Proteinuria (neg, trace)
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 4 at risk

Adverse event: Pruritus/itching
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 4 at risk

Adverse event: Neutrophils/granulocytes
Serious: yes
Organ System: Immune system disorders
Notes: (ANC/AGC) 1.6-7.3
Frequency: 1 affected / 6 at risk

Adverse event: Blood creatine phosphokinase
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: creatine phosphokinase
Frequency: 1 affected / 6 at risk

Adverse event: Calcium, serum-low
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: hypocalcemia
Frequency: 1 affected / 6 at risk

Adverse event: Cardiac ischemia/infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 6 at risk

Adverse event: Troponin I
Serious: yes
Organ System: Cardiac disorders
Notes: cTnI
Frequency: 1 affected / 6 at risk

Adverse event: Cardiopulmonary arrest, cause unknown
Serious: yes
Organ System: Cardiac disorders
Notes: non-fatal
Frequency: 1 affected / 6 at risk

Adverse event: Leukocytes
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: (total WBC) (4.8-10.8)
Frequency: 1 affected / 6 at risk

Adverse event: Pain
Serious: yes
Organ System: Cardiac disorders
Notes: Cardiac/heart
Frequency: 1 affected / 6 at risk

Adverse event: ALT, SGPT
Serious: no
Organ System: Hepatobiliary disorders
Notes: (serum glutamic pyruvic transaminase) ((2 -50)
Frequency: 4 affected / 6 at risk

Adverse event: AST, SGOT
Serious: no
Organ System: Hepatobiliary disorders
Notes: (serum glutamic oxaloacetic transaminase) (5-40)
Frequency: 4 affected / 6 at risk

Adverse event: Albumin, serum-low
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: (hypoalbuminemia) (3.5-5.0)
Frequency: 6 affected / 6 at risk

Adverse event: Blood alkaline phosphatase
Serious: no
Organ System: General disorders
Notes: (25-125)
Frequency: 3 affected / 6 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 6 at risk

Adverse event: Blood bilirubin
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: (hyperbilirubinemia) (0.1-1.2)
Frequency: 4 affected / 6 at risk

Adverse event: Calcium, serum-low
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: (hypocalcemia)
Frequency: 4 affected / 6 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 6 at risk

Adverse event: Cough
Serious: no
Organ System: General disorders
Frequency: 3 affected / 6 at risk

Adverse event: Blood creatinine
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: (0.5-1.5)
Frequency: 2 affected / 6 at risk

Adverse event: Dehydration
Serious: no
Organ System: General disorders
Frequency: 2 affected / 6 at risk

Adverse event: Dermatology/Skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 6 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 6 at risk

Adverse event: Dry mouth/salivary gland
Serious: no
Organ System: General disorders
Notes: (xerostomia)
Frequency: 2 affected / 6 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 6 at risk

Adverse event: Dysphagia
Serious: no
Organ System: General disorders
Notes: (difficulty swallowing)
Frequency: 1 affected / 6 at risk

Adverse event: Oedema
Serious: no
Organ System: General disorders
Notes: head and neck
Frequency: 1 affected / 6 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: (asthenia, lethargy, malaise)
Frequency: 3 affected / 6 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: (in the absence of neutropenia, where neutropenia is defined as ANC \<1.0 x 10e9/L)
Frequency: 3 affected / 6 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Notes: (including bile reflux gastritis)
Frequency: 1 affected / 6 at risk

Adverse event: Glucose, serum-high
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: (hyperglycemia)
Frequency: 5 affected / 6 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: (gender based)
Frequency: 6 affected / 6 at risk

Adverse event: Hemorrhage, pulmonary/upper respiratory
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Hypotension
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 6 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils
Serious: no
Organ System: Infections and infestations
Notes: Skin (cellulitis)
Frequency: 2 affected / 6 at risk

Adverse event: Leukocytes
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: (total WBC) (4.8-10.8)
Frequency: 4 affected / 6 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: (1-5.1)
Frequency: 6 affected / 6 at risk

Adverse event: Magnesium, serum-high
Serious: no
Organ System: Renal and urinary disorders
Notes: (hypermagnesemia)
Frequency: 3 affected / 6 at risk

Adverse event: Magnesium, serum-low
Serious: no
Organ System: Renal and urinary disorders
Notes: (hypomagnesemia)
Frequency: 3 affected / 6 at risk

Adverse event: Mood alteration
Serious: no
Organ System: Nervous system disorders
Notes: Anxiety
Frequency: 1 affected / 6 at risk

Adverse event: Mucositis/stomatitis (clinical exam)
Serious: no
Organ System: General disorders
Notes: Oral cavity
Frequency: 3 affected / 6 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 6 at risk

Adverse event: Neutrophils/granulocytes
Serious: no
Organ System: Immune system disorders
Notes: (ANC/AGC) 1.6-7.3
Frequency: 3 affected / 6 at risk

Adverse event: Pain: Chest/thorax NOS
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Pain: Neck
Serious: no
Organ System: General disorders
Frequency: 3 affected / 6 at risk

Adverse event: Pain: Oral cavity
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Pain: Throat/pharynx/larynx
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 6 at risk

Adverse event: Phosphate, serum-low
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: (hypophosphatemia)
Frequency: 1 affected / 6 at risk

Adverse event: Platelets
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: (160-360)
Frequency: 4 affected / 6 at risk

Adverse event: Potassium, serum-high (hyperkalemia) (3.5-5.3)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 6 at risk

Adverse event: Potassium, serum-low (hypokalemia) (3.5-5.3)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 6 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 6 at risk

Adverse event: Rash: acne/acneiform
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 6 at risk

Adverse event: Rash: dermatitis associated with radiation: Chemoradiation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 6 at risk

Adverse event: Rash: dermatitis associated with radiation: Radiation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 6 at risk

Adverse event: Sodium, serum-low
Serious: no
Organ System: Renal and urinary disorders
Notes: (hyponatremia) (135-146)
Frequency: 4 affected / 6 at risk

Adverse event: Supraventricular and nodal arrhythmia: Sinus bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 6 at risk

Adverse event: Supraventricular and nodal arrhythmia: Sinus tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 6 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 6 at risk

Adverse event: Weight decreased
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Aspiration
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Atelectasis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Distension/bloating, abdominal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 6 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: (shortness of breath)
Frequency: 1 affected / 6 at risk

Adverse event: Edema: limb
Serious: no
Organ System: General disorders
Frequency: 2 affected / 6 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 6 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils: Conjunctiva
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 6 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils: Trachea
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 6 at risk

Adverse event: Muscle weakness, generalized or specific area (not due to neuropathy): Whole body/generalized
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 6 at risk

Adverse event: Partial Thromboplastin Time
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 6 at risk

Adverse event: Pain: Back
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Pain: Skin
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Pleural effusion (non-malignant)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Salivary gland changes/saliva
Serious: no
Organ System: General disorders
Frequency: 3 affected / 6 at risk

Adverse event: Urinary frequency/urgency
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 6 at risk

Adverse event: Alkalosis (metabolic or respiratory) (7.35-7.45)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 6 at risk

Adverse event: Calcium, ionized-low (hypocalcemia)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 6 at risk

Adverse event: Cholesterol, serum-high (hypercholesteremia) (<200)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 6 at risk

Adverse event: Confusional state
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Gamma-Glutamyl transpeptidase
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 6 at risk

Adverse event: Glomerular filtration rate
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 6 at risk

Adverse event: Hemorrhage, GI: Lower GI NOS
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Hemorrhage, GU: Stoma
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Hemorrhage, pulmonary/upper respiratory: Bronchus
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Infection (Doc.) with Grade 3/4 ANC: Eye NOS
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 6 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils: Wound
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 6 at risk

Adverse event: Left ventricular dysfunction
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 6 at risk

Adverse event: Mood alteration: Agitation
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Neuropathy: sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 6 at risk

Adverse event: Pain - Other
Serious: no
Organ System: General disorders
Frequency: 2 affected / 6 at risk

Adverse event: Pain: Bone
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Pain: Extremity-limb
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Pain: Pain NOS
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Pericardial effusion (non-malignant)
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 6 at risk

Adverse event: Psychosis (hallucinations/delusions)
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 6 at risk

Adverse event: Taste alteration (dysgeusia)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Triglyceride, serum-high (hypertriglyceridemia)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 6 at risk

Adverse event: Ventricular arrhythmia: Ventricular tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 6 at risk

Adverse event: Wound complication, non-infectious
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Proteinuria (neg, trace)
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 6 at risk

Adverse event: Pruritus/itching
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 6 at risk

Adverse event: Neutrophils/granulocytes
Serious: yes
Organ System: Immune system disorders
Notes: (ANC/AGC) 1.6-7.3
Frequency: 1 affected / 5 at risk

Adverse event: Leukocytes
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: (total WBC) (4.8-10.8)
Frequency: 1 affected / 5 at risk

Adverse event: Acidosis
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: (metabolic or respiratory) (7.35-7.45)
Frequency: 1 affected / 5 at risk

Adverse event: Gastrointestinal
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Other
Frequency: 1 affected / 5 at risk

Adverse event: Haemoglobin
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: (gender based)
Frequency: 1 affected / 5 at risk

Adverse event: Lymphopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: (1-5.1)
Frequency: 1 affected / 5 at risk

Adverse event: ALT, SGPT
Serious: no
Organ System: Hepatobiliary disorders
Notes: (serum glutamic pyruvic transaminase) ((2 -50)
Frequency: 3 affected / 5 at risk

Adverse event: AST, SGOT
Serious: no
Organ System: Hepatobiliary disorders
Notes: (serum glutamic oxaloacetic transaminase) (5-40)
Frequency: 4 affected / 5 at risk

Adverse event: Albumin, serum-low
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: (hypoalbuminemia) (3.5-5.0)
Frequency: 5 affected / 5 at risk

Adverse event: Blood alkaline phosphatase
Serious: no
Organ System: General disorders
Notes: (25-125)
Frequency: 1 affected / 5 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 5 at risk

Adverse event: Blood bilirubin
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: (hyperbilirubinemia) (0.1-1.2)
Frequency: 3 affected / 5 at risk

Adverse event: Calcium, serum-low
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: (hypocalcemia)
Frequency: 5 affected / 5 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 5 at risk

Adverse event: Cough
Serious: no
Organ System: General disorders
Frequency: 1 affected / 5 at risk

Adverse event: Blood creatinine
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: (0.5-1.5)
Frequency: 2 affected / 5 at risk

Adverse event: Dehydration
Serious: no
Organ System: General disorders
Frequency: 3 affected / 5 at risk

Adverse event: Dermatology/Skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 5 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 5 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 5 at risk

Adverse event: Dysphagia
Serious: no
Organ System: General disorders
Notes: (difficulty swallowing)
Frequency: 2 affected / 5 at risk

Adverse event: Oedema
Serious: no
Organ System: General disorders
Notes: head and neck
Frequency: 1 affected / 5 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: (asthenia, lethargy, malaise)
Frequency: 4 affected / 5 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: (fever of unknown origin without clinically or microbiologically documented infection)(ANC \<1.0 x 10e9/L, fever \>=38.5 degrees C)
Frequency: 1 affected / 5 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: (in the absence of neutropenia, where neutropenia is defined as ANC \<1.0 x 10e9/L)
Frequency: 2 affected / 5 at risk

Adverse event: Gastrointestinal - Other
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 5 at risk

Adverse event: Glucose, serum-high
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: (hyperglycemia)
Frequency: 4 affected / 5 at risk

Adverse event: Glucose, serum-low
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: (hypoglycemia)
Frequency: 1 affected / 5 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: (gender based)
Frequency: 4 affected / 5 at risk

Adverse event: Hypotension
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 5 at risk

Adverse event: Infection with unknown ANC
Serious: no
Organ System: Infections and infestations
Notes: Lung (pneumonia)
Frequency: 1 affected / 5 at risk

Adverse event: Leukocytes
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: (total WBC) (4.8-10.8)
Frequency: 4 affected / 5 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: (1-5.1)
Frequency: 4 affected / 5 at risk

Adverse event: Magnesium, serum-high
Serious: no
Organ System: Renal and urinary disorders
Notes: (hypermagnesemia)
Frequency: 1 affected / 5 at risk

Adverse event: Magnesium, serum-low
Serious: no
Organ System: Renal and urinary disorders
Notes: (hypomagnesemia)
Frequency: 3 affected / 5 at risk

Adverse event: Mood alteration
Serious: no
Organ System: Nervous system disorders
Notes: Anxiety
Frequency: 1 affected / 5 at risk

Adverse event: Mucositis/stomatitis (clinical exam)
Serious: no
Organ System: General disorders
Notes: Oral cavity
Frequency: 1 affected / 5 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 5 at risk

Adverse event: Neutrophils/granulocytes
Serious: no
Organ System: Immune system disorders
Notes: (ANC/AGC) 1.6-7.3
Frequency: 3 affected / 5 at risk

Adverse event: Pain: Abdomen NOS
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 5 at risk

Adverse event: Pain: Neck
Serious: no
Organ System: General disorders
Frequency: 1 affected / 5 at risk

Adverse event: Pain: Oral cavity
Serious: no
Organ System: General disorders
Frequency: 1 affected / 5 at risk

Adverse event: Phosphate, serum-low
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: (hypophosphatemia)
Frequency: 2 affected / 5 at risk

Adverse event: Platelets
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: (160-360)
Frequency: 3 affected / 5 at risk

Adverse event: Potassium, serum-high (hyperkalemia) (3.5-5.3)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 5 at risk

Adverse event: Potassium, serum-low (hypokalemia) (3.5-5.3)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 5 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 5 at risk

Adverse event: Rash: acne/acneiform
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 5 at risk

Adverse event: Rash: dermatitis associated with radiation: Chemoradiation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 5 at risk

Adverse event: Rash: dermatitis associated with radiation: Radiation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 5 at risk

Adverse event: Skin breakdown/decubitus ulcer
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 5 at risk

Adverse event: Sodium, serum-high
Serious: no
Organ System: Renal and urinary disorders
Notes: (hypernatremia) (135-146)
Frequency: 1 affected / 5 at risk

Adverse event: Sodium, serum-low
Serious: no
Organ System: Renal and urinary disorders
Notes: (hyponatremia) (135-146)
Frequency: 2 affected / 5 at risk

Adverse event: Voice changes/dysarthria (e.g., hoarseness, loss or alteration in voice, laryngitis)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 5 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 5 at risk

Adverse event: Aspiration
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 5 at risk

Adverse event: Atelectasis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 5 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: (shortness of breath)
Frequency: 2 affected / 5 at risk

Adverse event: Edema: limb
Serious: no
Organ System: General disorders
Frequency: 1 affected / 5 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 5 at risk

Adverse event: Muscle weakness, generalized or specific area (not due to neuropathy): Whole body/generalized
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 5 at risk

Adverse event: Pain: Joint
Serious: no
Organ System: General disorders
Frequency: 2 affected / 5 at risk

Adverse event: Pain: Tumor pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 5 at risk

Adverse event: Pleural effusion (non-malignant)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 5 at risk

Adverse event: Alkalosis (metabolic or respiratory) (7.35-7.45)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 5 at risk

Adverse event: Confusional state
Serious: no
Organ System: General disorders
Frequency: 1 affected / 5 at risk

Adverse event: Glomerular filtration rate
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 5 at risk

Adverse event: Mood alteration: Agitation
Serious: no
Organ System: General disorders
Frequency: 1 affected / 5 at risk

Adverse event: Bicarbonate, serum-low
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 5 at risk

Adverse event: Bruising (in absence of Grade 3 or 4 thrombocytopenia)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 5 at risk

Adverse event: Cardiac ischemia/infarction
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 5 at risk

Adverse event: Haemorrhoids
Serious: no
Organ System: General disorders
Frequency: 1 affected / 5 at risk

Adverse event: Ileus, GI
Serious: no
Organ System: Gastrointestinal disorders
Notes: functional obstruction of bowel, i.e., neuroconstipation
Frequency: 1 affected / 5 at risk

Adverse event: Somnolence/depressed level of consciousness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 5 at risk

Adverse event: Proteinuria (neg, trace)
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 5 at risk

Adverse event: Pruritus/itching
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 5 at risk

Adverse event: Fracture
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 5 at risk

Adverse event: Lymphatics
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 5 at risk

Adverse event: Ocular/Visual - Other
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 5 at risk

Adverse event: Neutrophils/granulocytes
Serious: yes
Organ System: Immune system disorders
Notes: (ANC/AGC) 1.6-7.3
Frequency: 1 affected / 11 at risk

Adverse event: Leukocytes
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: (total WBC) (4.8-10.8)
Frequency: 1 affected / 11 at risk

Adverse event: Haemoglobin
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: (gender based)
Frequency: 1 affected / 11 at risk

Adverse event: Lymphopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: (1-5.1)
Frequency: 1 affected / 11 at risk

Adverse event: Hemorrhage, pulmonary/upper respiratory
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Bronchopulmonary NOS
Frequency: 1 affected / 11 at risk

Adverse event: ALT, SGPT
Serious: no
Organ System: Hepatobiliary disorders
Notes: (serum glutamic pyruvic transaminase) ((2 -50)
Frequency: 3 affected / 11 at risk

Adverse event: AST, SGOT
Serious: no
Organ System: Hepatobiliary disorders
Notes: (serum glutamic oxaloacetic transaminase) (5-40)
Frequency: 4 affected / 11 at risk

Adverse event: Albumin, serum-low
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: (hypoalbuminemia) (3.5-5.0)
Frequency: 8 affected / 11 at risk

Adverse event: Blood alkaline phosphatase
Serious: no
Organ System: General disorders
Notes: (25-125)
Frequency: 3 affected / 11 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Immune system disorders
Notes: (including sneezing, nasal stuffiness, postnasal drip)
Frequency: 1 affected / 11 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 11 at risk

Adverse event: Arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: (non-septic)
Frequency: 1 affected / 11 at risk

Adverse event: Blood bilirubin
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: (hyperbilirubinemia) (0.1-1.2)
Frequency: 5 affected / 11 at risk

Adverse event: Calcium, serum-low
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: (hypocalcemia)
Frequency: 9 affected / 11 at risk

Adverse event: Cardiac General
Serious: no
Organ System: Cardiac disorders
Notes: Other
Frequency: 1 affected / 11 at risk

Adverse event: Cervical spine
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: range of motion
Frequency: 1 affected / 11 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 11 at risk

Adverse event: Cough
Serious: no
Organ System: General disorders
Frequency: 4 affected / 11 at risk

Adverse event: Blood creatinine
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: (0.5-1.5)
Frequency: 2 affected / 11 at risk

Adverse event: Dehydration
Serious: no
Organ System: General disorders
Frequency: 6 affected / 11 at risk

Adverse event: Dermatology/Skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 11 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 11 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 2 affected / 11 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 11 at risk

Adverse event: Dry mouth/salivary gland
Serious: no
Organ System: General disorders
Notes: (xerostomia)
Frequency: 1 affected / 11 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 11 at risk

Adverse event: Dysphagia
Serious: no
Organ System: General disorders
Notes: (difficulty swallowing)
Frequency: 7 affected / 11 at risk

Adverse event: Oedema
Serious: no
Organ System: General disorders
Notes: head and neck
Frequency: 1 affected / 11 at risk

Adverse event: Oesophagitis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 11 at risk

Adverse event: Eyelid dysfunction
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 11 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: (asthenia, lethargy, malaise)
Frequency: 8 affected / 11 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: (fever of unknown origin without clinically or microbiologically documented infection)(ANC \<1.0 x 10e9/L, fever \>=38.5 degrees C)
Frequency: 1 affected / 11 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: (in the absence of neutropenia, where neutropenia is defined as ANC \<1.0 x 10e9/L)
Frequency: 1 affected / 11 at risk

Adverse event: Fistula, GI
Serious: no
Organ System: Gastrointestinal disorders
Notes: Pharynx
Frequency: 1 affected / 11 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Notes: (including bile reflux gastritis)
Frequency: 2 affected / 11 at risk

Adverse event: Gastrointestinal - Other
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 11 at risk

Adverse event: Glucose, serum-high
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: (hyperglycemia)
Frequency: 10 affected / 11 at risk

Adverse event: Glucose, serum-low
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: (hypoglycemia)
Frequency: 3 affected / 11 at risk

Adverse event: Hearing
Serious: no
Organ System: Ear and labyrinth disorders
Notes: patients without baseline audiogram and not enrolled in a monitoring program
Frequency: 1 affected / 11 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: (gender based)
Frequency: 10 affected / 11 at risk

Adverse event: Hemorrhage, pulmonary/upper respiratory
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Hypertension
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 11 at risk

Adverse event: Hypotension
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 11 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils
Serious: no
Organ System: Infections and infestations
Notes: Lip/perioral
Frequency: 1 affected / 11 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils
Serious: no
Organ System: Infections and infestations
Notes: Middle ear (otitis media)
Frequency: 1 affected / 11 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils
Serious: no
Organ System: Infections and infestations
Notes: Skin (cellulitis)
Frequency: 2 affected / 11 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils
Serious: no
Organ System: Infections and infestations
Notes: Urinary tract NOS
Frequency: 1 affected / 11 at risk

Adverse event: Infection with unknown ANC
Serious: no
Organ System: Infections and infestations
Notes: Foreign body (e.g., graft, implant, prosthesis, stent)
Frequency: 1 affected / 11 at risk

Adverse event: Infection with unknown ANC
Serious: no
Organ System: Infections and infestations
Notes: Lung (pneumonia)
Frequency: 2 affected / 11 at risk

Adverse event: Infection with unknown ANC
Serious: no
Organ System: Infections and infestations
Notes: Neck NOS
Frequency: 1 affected / 11 at risk

Adverse event: Infection with unknown ANC
Serious: no
Organ System: Infections and infestations
Notes: Upper airway NOS
Frequency: 2 affected / 11 at risk

Adverse event: Insomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 11 at risk

Adverse event: Leukocytes
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: (total WBC) (4.8-10.8)
Frequency: 10 affected / 11 at risk

Adverse event: Lymphedema-related fibrosis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 11 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: (1-5.1)
Frequency: 10 affected / 11 at risk

Adverse event: Magnesium, serum-high
Serious: no
Organ System: Renal and urinary disorders
Notes: (hypermagnesemia)
Frequency: 3 affected / 11 at risk

Adverse event: Magnesium, serum-low
Serious: no
Organ System: Renal and urinary disorders
Notes: (hypomagnesemia)
Frequency: 5 affected / 11 at risk

Adverse event: Mood alteration
Serious: no
Organ System: Nervous system disorders
Notes: Anxiety
Frequency: 3 affected / 11 at risk

Adverse event: Mood alteration
Serious: no
Organ System: Nervous system disorders
Notes: Depression
Frequency: 2 affected / 11 at risk

Adverse event: Mucositis/stomatitis (clinical exam)
Serious: no
Organ System: General disorders
Notes: Larynx
Frequency: 2 affected / 11 at risk

Adverse event: Mucositis/stomatitis (clinical exam)
Serious: no
Organ System: General disorders
Notes: Oral cavity
Frequency: 9 affected / 11 at risk

Adverse event: Musculoskeletal/Soft Tissue - Other
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 11 at risk

Adverse event: Nasal cavity/paranasal sinus reactions
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 11 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 11 at risk

Adverse event: Neutrophils/granulocytes
Serious: no
Organ System: Immune system disorders
Notes: (ANC/AGC) 1.6-7.3
Frequency: 5 affected / 11 at risk

Adverse event: Pain: Abdomen NOS
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 11 at risk

Adverse event: Pain: Chest/thorax NOS
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 11 at risk

Adverse event: Pain: Eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 11 at risk

Adverse event: Pain: Head/headache
Serious: no
Organ System: General disorders
Frequency: 2 affected / 11 at risk

Adverse event: Pain: Neck
Serious: no
Organ System: General disorders
Frequency: 2 affected / 11 at risk

Adverse event: Pain: Oral cavity
Serious: no
Organ System: General disorders
Frequency: 3 affected / 11 at risk

Adverse event: Pain: Oral-gums
Serious: no
Organ System: General disorders
Frequency: 1 affected / 11 at risk

Adverse event: Pain: Scalp
Serious: no
Organ System: General disorders
Frequency: 1 affected / 11 at risk

Adverse event: Pain: Stomach
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Pain: Throat/pharynx/larynx
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 11 at risk

Adverse event: Phosphate, serum-low
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: (hypophosphatemia)
Frequency: 1 affected / 11 at risk

Adverse event: Platelets
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: (160-360)
Frequency: 7 affected / 11 at risk

Adverse event: Potassium, serum-high (hyperkalemia) (3.5-5.3)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 11 at risk

Adverse event: Potassium, serum-low (hypokalemia) (3.5-5.3)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 11 at risk

Adverse event: Pulmonary/Upper Respiratory - Other
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 11 at risk

Adverse event: Rash: acne/acneiform
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 11 at risk

Adverse event: Rash: dermatitis associated with radiation: Chemoradiation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 11 at risk

Adverse event: Rash: dermatitis associated with radiation: Radiation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 11 at risk

Adverse event: Rigors/chills
Serious: no
Organ System: General disorders
Frequency: 1 affected / 11 at risk

Adverse event: Skin breakdown/decubitus ulcer
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 11 at risk

Adverse event: Sodium, serum-high
Serious: no
Organ System: Renal and urinary disorders
Notes: (hypernatremia) (135-146)
Frequency: 3 affected / 11 at risk

Adverse event: Sodium, serum-low
Serious: no
Organ System: Renal and urinary disorders
Notes: (hyponatremia) (135-146)
Frequency: 7 affected / 11 at risk

Adverse event: Supraventricular and nodal arrhythmia: Atrial tachycardia/Paroxysmal Atrial Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 11 at risk

Adverse event: Supraventricular and nodal arrhythmia: Sinus bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 11 at risk

Adverse event: Supraventricular and nodal arrhythmia: Sinus tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 11 at risk

Adverse event: Sweating (diaphoresis)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 11 at risk

Adverse event: Tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 11 at risk

Adverse event: Trismus (difficulty, restriction or pain when opening mouth)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 11 at risk

Adverse event: Vision-flashing lights/floaters
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 11 at risk

Adverse event: Voice changes/dysarthria (e.g., hoarseness, loss or alteration in voice, laryngitis)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 11 at risk

Adverse event: Weight decreased
Serious: no
Organ System: General disorders
Frequency: 2 affected / 11 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 11 at risk