Study: NCT00667342

Adverse event: Hypotension
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 31 at risk

Adverse event: Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 31 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils, Lung (pneumonia)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 31 at risk

Adverse event: Cognitive disorder
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 31 at risk

Adverse event: Encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 31 at risk

Adverse event: Neuropathy: motor
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 31 at risk

Adverse event: Neuropathy: sensory
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 31 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 31 at risk

Adverse event: ALT, SGPT (serum glutamic pyruvic transaminase)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 29 affected / 31 at risk

Adverse event: Albumin, serum-low (hypoalbuminemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 29 affected / 31 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 30 affected / 31 at risk

Adverse event: Leukocytes (total WBC)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 30 affected / 31 at risk

Adverse event: Platelets
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 30 affected / 31 at risk

Adverse event: AST, SGOT (serum glutamic oxaloacetic transaminase)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 29 affected / 31 at risk

Adverse event: Glucose, serum-high (hyperglycemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 13 affected / 31 at risk

Adverse event: Phosphate, serum-low (hypophosphatemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 26 affected / 31 at risk

Adverse event: Mucositis/stomatitis (clinical exam), oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 25 affected / 31 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 24 affected / 31 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 25 affected / 31 at risk

Adverse event: Hemorrhage, pulmonary/upper respiratory, Nose
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 23 affected / 31 at risk

Adverse event: Sodium, serum-low (hyponatremia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 23 affected / 31 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 20 affected / 31 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 22 affected / 31 at risk

Adverse event: Potassium, serum-low (hypokalemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 21 affected / 31 at risk

Adverse event: Calcium, serum-low (hypocalcemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 20 affected / 31 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Infections and infestations
Notes: Fever of unknown origin without clinically or microbiologically documented infection) (ANC \<1.0 x 10e9/L)
Frequency: 20 affected / 31 at risk

Adverse event: Pain, Abdomen NOS
Serious: no
Organ System: General disorders
Frequency: 15 affected / 31 at risk

Adverse event: Weight decreased
Serious: no
Organ System: General disorders
Frequency: 19 affected / 31 at risk

Adverse event: Bilirubin (hyperbilirubinemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 18 affected / 31 at risk

Adverse event: Pain, Head/headache
Serious: no
Organ System: General disorders
Frequency: 16 affected / 31 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 31 at risk

Adverse event: Magnesium, serum-low (hypomagnesemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 16 affected / 31 at risk

Adverse event: Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
Serious: no
Organ System: General disorders
Frequency: 14 affected / 31 at risk

Adverse event: Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)
Serious: no
Organ System: Immune system disorders
Frequency: 6 affected / 31 at risk

Adverse event: Pain, extremity-limb
Serious: no
Organ System: General disorders
Frequency: 4 affected / 31 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 12 affected / 31 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 12 affected / 31 at risk

Adverse event: Allergic reaction/hypersensitivity (including drug fever)
Serious: no
Organ System: Immune system disorders
Frequency: 5 affected / 31 at risk

Adverse event: Fatigue (asthenia, lethargy, malaise)
Serious: no
Organ System: General disorders
Frequency: 13 affected / 31 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 31 at risk

Adverse event: Hearing: patients with/without baseline audiogram and enrolled in a monitoring program
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 14 affected / 31 at risk

Adverse event: Pain, oral cavity
Serious: no
Organ System: General disorders
Frequency: 14 affected / 31 at risk

Adverse event: Pain, throat/pharynx/larynx
Serious: no
Organ System: General disorders
Frequency: 12 affected / 31 at risk

Adverse event: Supraventricular and nodal arrhythmia, sinus tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 9 affected / 31 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 31 at risk

Adverse event: Uric acid, serum-high (hyperuricemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 31 at risk

Adverse event: Pruritus/itching
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 31 at risk

Adverse event: Pain, Back
Serious: no
Organ System: General disorders
Frequency: 3 affected / 31 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 31 at risk

Adverse event: Glucose, serum-low (hypoglycemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 31 at risk

Adverse event: Hair loss/alopecia (scalp or body)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 31 at risk

Adverse event: Dehydration
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 31 at risk

Adverse event: Pain, chest/thorax NOS
Serious: no
Organ System: General disorders
Frequency: 4 affected / 31 at risk

Adverse event: Haemoglobinuria
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 31 at risk

Adverse event: Potassium, serum-high (hyperkalemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 31 at risk

Adverse event: Bicarbonate, serum-low
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 31 at risk

Adverse event: Magnesium, serum-high (hypermagnesemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 31 at risk

Adverse event: Hemorrhage, GI, rectum
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 31 at risk

Adverse event: GGT (gamma-glutamyl transpeptidase)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 31 at risk

Adverse event: Mucositis/stomatitis (functional/symptomatic), oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 31 at risk

Adverse event: Urinary retention (including neurogenic bladder)
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 31 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 31 at risk

Adverse event: Heartburn/dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 31 at risk

Adverse event: Sodium, serum-high (hypernatremia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 31 at risk

Adverse event: Tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 6 affected / 31 at risk

Adverse event: Neuropathy: sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 31 at risk

Adverse event: Blood creatinine
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 31 at risk

Adverse event: Skin breakdown/decubitus ulcer
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 31 at risk

Adverse event: Calcium, serum-high (hypercalcemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 31 at risk

Adverse event: Prolonged QTc interval
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 31 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils, skin (cellulitis)
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 31 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 31 at risk

Adverse event: Pain, esophagus
Serious: no
Organ System: General disorders
Frequency: 5 affected / 31 at risk

Adverse event: Hemorrhage, GU, bladder
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 31 at risk

Adverse event: Blood alkaline phosphatase
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 31 at risk

Adverse event: Left ventricular dysfunction
Serious: no
Organ System: Cardiac disorders
Frequency: 8 affected / 31 at risk

Adverse event: Hemorrhage, GI, lower GI NOS
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 31 at risk

Adverse event: Pain, urethra
Serious: no
Organ System: General disorders
Frequency: 2 affected / 31 at risk

Adverse event: Oesophagitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 31 at risk

Adverse event: Hemorrhage, GI, upper GI NOS
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 31 at risk

Adverse event: Hemorrhage, GU, urinary NOS
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 31 at risk

Adverse event: Pain, joint
Serious: no
Organ System: General disorders
Frequency: 2 affected / 31 at risk

Adverse event: Pain, phantom (pain associated with missing limb)
Serious: no
Organ System: General disorders
Frequency: 2 affected / 31 at risk

Adverse event: Mucositis/stomatitis (functional/symptomatic), esophagus
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 31 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils, catheter-related
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 31 at risk

Adverse event: Glomerular filtration rate
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 31 at risk

Adverse event: Vision-blurred vision
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 31 at risk

Adverse event: Pain, rectum
Serious: no
Organ System: General disorders
Frequency: 3 affected / 31 at risk

Adverse event: Chelitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 31 at risk

Adverse event: Fracture
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 31 at risk

Adverse event: Urinary electrolyte wasting (e.g., Fanconi's syndrome, renal tubular acidosis)
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 31 at risk

Adverse event: Neutrophils/granulocytes (ANC/AGC)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 31 affected / 31 at risk

Adverse event: Conduction abnormality/atrioventricular heart block, conduction abnormality, NOS
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 31 at risk

Adverse event: Mucositis/stomatitis (clinical exam), anus
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 31 at risk

Adverse event: Hemorrhage, GI, anus
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 31 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils, blood
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 31 at risk

Adverse event: Pain, stomach
Serious: no
Organ System: General disorders
Frequency: 2 affected / 31 at risk

Adverse event: Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L), skin (cellulitis)
Serious: no
Organ System: Infections and infestations
Notes: Documented clinically or microbiologically
Frequency: 2 affected / 31 at risk

Adverse event: Confusional state
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 31 at risk

Adverse event: Irregular menses (change from baseline)
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 3 affected / 31 at risk

Adverse event: Pain, pain NOS
Serious: no
Organ System: General disorders
Frequency: 3 affected / 31 at risk

Adverse event: Hemorrhage, GI, oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 31 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils, oral cavity-gums (gingivitis)
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 31 at risk

Adverse event: Rigors/chills
Serious: no
Organ System: General disorders
Frequency: 2 affected / 31 at risk

Adverse event: Colitis, infectious (e.g., Clostridium difficile)
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 31 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils, wound
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 31 at risk

Adverse event: Encephalopathy
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 31 at risk

Adverse event: Pulmonary/upper respiratory - other
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 31 at risk

Adverse event: Pain, pleura
Serious: no
Organ System: General disorders
Frequency: 2 affected / 31 at risk

Adverse event: Mucositis/stomatitis (clinical exam), esophagus
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 31 at risk

Adverse event: Mucositis/stomatitis (clinical exam), rectum
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 31 at risk

Adverse event: Taste alteration (dysgeusia)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 31 at risk

Adverse event: Hemorrhage, pulmonary/upper respiratory, bronchopulmonary NOS
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 31 at risk

Adverse event: Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L), blood
Serious: no
Organ System: Infections and infestations
Notes: Documented clinically or microbiologically.
Frequency: 2 affected / 31 at risk

Adverse event: Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L), oral cavity-gums
Serious: no
Organ System: Infections and infestations
Notes: Documented clinically or microbiologically.
Frequency: 2 affected / 31 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils, mucosa
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 31 at risk

Adverse event: Neuropathy: motor
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 31 at risk

Adverse event: Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L), catheter-related
Serious: no
Organ System: Infections and infestations
Notes: Documented clinically or microbiologically.
Frequency: 2 affected / 31 at risk

Adverse event: Rash: hand-foot skin reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 31 at risk

Adverse event: Mucositis/stomatitis (functional/symptomatic), pharynx
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 31 at risk

Adverse event: Bone age (alteration in bone age)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 31 at risk

Adverse event: Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L), lung (pneumonia)
Serious: no
Organ System: Infections and infestations
Notes: Documented clinically or microbiologically.
Frequency: 1 affected / 31 at risk

Adverse event: Pain, anus
Serious: no
Organ System: General disorders
Frequency: 1 affected / 31 at risk

Adverse event: Hemorrhage/bleeding - other
Serious: no
Organ System: General disorders
Frequency: 1 affected / 31 at risk

Adverse event: ALT, SGPT (serum glutamic pyruvic transaminase)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 10 affected / 11 at risk

Adverse event: Albumin, serum-low (hypoalbuminemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 10 affected / 11 at risk

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

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

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

Adverse event: AST, SGOT (serum glutamic oxaloacetic transaminase)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 10 affected / 11 at risk

Adverse event: Glucose, serum-high (hyperglycemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 11 at risk

Adverse event: Phosphate, serum-low (hypophosphatemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 9 affected / 11 at risk

Adverse event: Mucositis/stomatitis (clinical exam), oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 11 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 11 at risk

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

Adverse event: Hemorrhage, pulmonary/upper respiratory, Nose
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 11 at risk

Adverse event: Sodium, serum-low (hyponatremia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 11 at risk

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

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

Adverse event: Potassium, serum-low (hypokalemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 10 affected / 11 at risk

Adverse event: Calcium, serum-low (hypocalcemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 11 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Infections and infestations
Notes: Fever of unknown origin without clinically or microbiologically documented infection) (ANC \<1.0 x 10e9/L)
Frequency: 8 affected / 11 at risk

Adverse event: Pain, Abdomen NOS
Serious: no
Organ System: General disorders
Frequency: 4 affected / 11 at risk

Adverse event: Weight decreased
Serious: no
Organ System: General disorders
Frequency: 7 affected / 11 at risk

Adverse event: Bilirubin (hyperbilirubinemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 11 at risk

Adverse event: Pain, Head/headache
Serious: no
Organ System: General disorders
Frequency: 6 affected / 11 at risk

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

Adverse event: Magnesium, serum-low (hypomagnesemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 11 at risk

Adverse event: Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
Serious: no
Organ System: General disorders
Frequency: 2 affected / 11 at risk

Adverse event: Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 11 at risk

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

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

Adverse event: Allergic reaction/hypersensitivity (including drug fever)
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 11 at risk

Adverse event: Fatigue (asthenia, lethargy, malaise)
Serious: no
Organ System: General disorders
Frequency: 4 affected / 11 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 11 at risk

Adverse event: Hearing: patients with/without baseline audiogram and enrolled in a monitoring program
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 6 affected / 11 at risk

Adverse event: Pain, oral cavity
Serious: no
Organ System: General disorders
Frequency: 6 affected / 11 at risk

Adverse event: Pain, throat/pharynx/larynx
Serious: no
Organ System: General disorders
Frequency: 5 affected / 11 at risk

Adverse event: Supraventricular and nodal arrhythmia, sinus tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 11 at risk

Adverse event: Uric acid, serum-high (hyperuricemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 11 at risk

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

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 11 at risk

Adverse event: Glucose, serum-low (hypoglycemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 11 at risk

Adverse event: Hair loss/alopecia (scalp or body)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 11 at risk

Adverse event: Dehydration
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 11 at risk

Adverse event: Potassium, serum-high (hyperkalemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 11 at risk

Adverse event: Bicarbonate, serum-low
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 11 at risk

Adverse event: Magnesium, serum-high (hypermagnesemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 11 at risk

Adverse event: Hemorrhage, GI, rectum
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 11 at risk

Adverse event: GGT (gamma-glutamyl transpeptidase)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 11 at risk

Adverse event: Mucositis/stomatitis (functional/symptomatic), oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 11 at risk

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

Adverse event: Sodium, serum-high (hypernatremia)
Serious: no
Organ System: Metabolism and nutrition 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: Blood creatinine
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 11 at risk

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

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

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

Adverse event: Hemorrhage, GU, bladder
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 11 at risk

Adverse event: Blood alkaline phosphatase
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 11 at risk

Adverse event: Left ventricular dysfunction
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 11 at risk

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

Adverse event: Hemorrhage, GI, upper GI NOS
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Hemorrhage, GU, urinary NOS
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 11 at risk

Adverse event: Pain, phantom (pain associated with missing limb)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 11 at risk

Adverse event: Mucositis/stomatitis (functional/symptomatic), esophagus
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 11 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils, catheter-related
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 11 at risk

Adverse event: Glomerular filtration rate
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 11 at risk

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

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

Adverse event: Fracture
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 11 at risk

Adverse event: Urinary electrolyte wasting (e.g., Fanconi's syndrome, renal tubular acidosis)
Serious: no
Organ System: Renal and urinary disorders
Frequency: 5 affected / 11 at risk

Adverse event: Neutrophils/granulocytes (ANC/AGC)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 11 affected / 11 at risk

Adverse event: Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L), skin (cellulitis)
Serious: no
Organ System: Infections and infestations
Notes: Documented clinically or microbiologically
Frequency: 1 affected / 11 at risk

Adverse event: Irregular menses (change from baseline)
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 11 at risk

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

Adverse event: Hemorrhage, GI, oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 11 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils, oral cavity-gums (gingivitis)
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 11 at risk

Adverse event: Mucositis/stomatitis (clinical exam), esophagus
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Mucositis/stomatitis (clinical exam), rectum
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 11 at risk

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

Adverse event: Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L), blood
Serious: no
Organ System: Infections and infestations
Notes: Documented clinically or microbiologically.
Frequency: 1 affected / 11 at risk

Adverse event: Joint-effusion
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 11 at risk

Adverse event: Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L), oral cavity-gums
Serious: no
Organ System: Infections and infestations
Notes: Documented clinically or microbiologically.
Frequency: 2 affected / 11 at risk

Adverse event: Somnolence/depressed level of consciousness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 11 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils, mucosa
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 11 at risk

Adverse event: Neuropathy: motor
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 11 at risk

Adverse event: Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L), catheter-related
Serious: no
Organ System: Infections and infestations
Notes: Documented clinically or microbiologically.
Frequency: 5 affected / 11 at risk

Adverse event: Rash: hand-foot skin reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 11 at risk

Adverse event: Mucositis/stomatitis (functional/symptomatic), pharynx
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 11 at risk

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

Adverse event: Bone age (alteration in bone age)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 11 at risk

Adverse event: Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L), lung (pneumonia)
Serious: no
Organ System: Infections and infestations
Notes: Documented clinically or microbiologically.
Frequency: 1 affected / 11 at risk

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

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

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

Adverse event: Hemorrhage/bleeding - other
Serious: no
Organ System: General disorders
Frequency: 2 affected / 11 at risk

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

Adverse event: Injection site reaction/extravasation changes
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 11 at risk

Adverse event: Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L), conjunctiva
Serious: no
Organ System: Infections and infestations
Notes: Documented clinically or microbiologically)
Frequency: 1 affected / 11 at risk

Adverse event: Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L), eye NOS
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 11 at risk

Adverse event: Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L), mucosa
Serious: no
Organ System: Infections and infestations
Notes: Documented clinically or microbiologically.
Frequency: 1 affected / 11 at risk

Adverse event: Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L), urinary tract NOS
Serious: no
Organ System: Infections and infestations
Notes: Documented clinically or microbiologically.
Frequency: 1 affected / 11 at risk

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

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

Adverse event: Infection (ANC <1.0 x 10e9/L, fever >38.5 degrees C.), blood
Serious: no
Organ System: Infections and infestations
Notes: Documented clinically or microbiologically.
Frequency: 2 affected / 11 at risk

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