Study: NCT00923117

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 44 at risk

Adverse event: Death not associated with CTCAE term: Death NOS
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 44 at risk

Adverse event: Death not associated with CTCAE term: Disease progression NOS
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 44 at risk

Adverse event: Fatigue (asthenia, lethargy, malaise)
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 44 at risk

Adverse event: Pain: Head/Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 44 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 44 at risk

Adverse event: Thrombosis/thrombus/embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 44 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 44 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 44 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 44 at risk

Adverse event: Hemorrhage, CNS
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 44 at risk

Adverse event: Hemorrhage, pulmonary/upper respiratory: Nose
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 44 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 44 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 44 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Notes: (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC \<1.0 x 10e9/L): Lung (pneumonia)
Frequency: 2 affected / 44 at risk

Adverse event: Leukocytes (total WBC)
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 44 at risk

Adverse event: Muscle weakness, generalized or specific area (not due to neuropathy): Extremity-upper
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 44 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 44 at risk

Adverse event: Neurology - other (herniation)
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 44 at risk

Adverse event: Neutrophils/granulocytes (ANC/AGC)
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 44 at risk

Adverse event: Opportunistic infection associated with >=Grade 2 lymphopenia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 44 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 44 at risk

Adverse event: Pyramidal tract dysfunction
Serious: yes
Organ System: Nervous system disorders
Notes: (e.g. increased tone, hyperflexia, positive Babinski, decreased fine motor coordination)
Frequency: 1 affected / 44 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 44 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 44 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 24 affected / 44 at risk

Adverse event: ALT/SGPT (serum glutamic pyruvic transaminase)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 21 affected / 44 at risk

Adverse event: AST/SGOT (serum glutamic oxaloacetic transaminase)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 12 affected / 44 at risk

Adverse event: Albumin, serum-low (hypoalbuminemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 20 affected / 44 at risk

Adverse event: Blood alkaline phosphatase
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 44 at risk

Adverse event: Bilirubin (hyperbilirubinemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 44 at risk

Adverse event: CPK (creatine phosphokinase)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 44 at risk

Adverse event: Cognitive disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 44 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 44 at risk

Adverse event: Blood creatinine
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 44 at risk

Adverse event: Dermatology/Skin-Other (skin tear)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 44 at risk

Adverse event: Dyspnea (shortness of breath)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 44 at risk

Adverse event: Edema: limb
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 44 at risk

Adverse event: Fatigue (asthenia, lethargy, malaise)
Serious: no
Organ System: General disorders
Frequency: 8 affected / 44 at risk

Adverse event: Glucose, serum-high (hypoglycemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 44 at risk

Adverse event: Heartburn/Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 44 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 11 affected / 44 at risk

Adverse event: Hemorrhage, CNS
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 44 at risk

Adverse event: Hemorrhage, pulmonary/upper respiratory: Nose
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 44 at risk

Adverse event: Hiccoughs (hiccups, singultus)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 44 at risk

Adverse event: Hypopigmentation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 44 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils::Lip/perioral
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 44 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils::Upper airway NOS
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 44 at risk

Adverse event: Infection with unknown ANC: Lung (pneumonia)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 44 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 44 at risk

Adverse event: Leukocytes (total WBC)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 25 affected / 44 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 24 affected / 44 at risk

Adverse event: Magnesium, serum-high (hypermagnesemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 44 at risk

Adverse event: Mood alteration: depression
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 44 at risk

Adverse event: Mucositis/stomatitis (clinical exam)::oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 44 at risk

Adverse event: Muscle weakness, generalized or specific area (not due to neuropathy): Extremity-lower
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 44 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 44 at risk

Adverse event: Neutrophils/granulocytes (ANC/AGC)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 16 affected / 44 at risk

Adverse event: Opportunistic infection associated with >=Grade 2 lymphopenia
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 44 at risk

Adverse event: Pain: Head/Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 44 at risk

Adverse event: Pain: Joint
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 44 at risk

Adverse event: Phosphate, serum-low (hypophosphatemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 18 affected / 44 at risk

Adverse event: Platelets
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 30 affected / 44 at risk

Adverse event: Potassium, serum-high (hyperkalemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 44 at risk

Adverse event: Potassium, serum-low (hypokalemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 44 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 44 at risk

Adverse event: Pyramidal tract dysfunction
Serious: no
Organ System: Nervous system disorders
Notes: (e.g. increased tone, hyperflexia, positive Babinski, decreased fine motor coordination)
Frequency: 10 affected / 44 at risk

Adverse event: Rash/Desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 44 at risk

Adverse event: Rash: acne/acneiform
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 44 at risk

Adverse event: Rash: hand-foot skin reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 44 at risk

Adverse event: Seizure
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 44 at risk

Adverse event: Sodium, serum-low (hyponatremia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 44 at risk

Adverse event: Speech impairment (e.g. dysphasia or aphasia)
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 44 at risk

Adverse event: Thyroid function, high (hyperthyroidism, thyrotoxicosis)
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 44 at risk

Adverse event: Thyroid function, low (hypothyroidism)
Serious: no
Organ System: Endocrine disorders
Frequency: 20 affected / 44 at risk

Adverse event: Arthritis (non-septic)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 44 at risk

Adverse event: Edema: head and neck
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 44 at risk

Adverse event: Memory impairment
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 44 at risk

Adverse event: Pain: chest wall
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 44 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils::Mucosa
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 44 at risk

Adverse event: Skin breakdown/decubitus ulcer
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 44 at risk

Adverse event: Voice changes/dysarthia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: (e.g., hoarseness, loss of alteration in voice, laryngitis)
Frequency: 1 affected / 44 at risk

Adverse event: Vision-flashing lights/floaters
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 44 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Notes: (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC \<1.0 x 10e9/L): pancreas
Frequency: 1 affected / 44 at risk

Adverse event: Incontinence, urinary
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 44 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 44 at risk

Adverse event: Ataxia (incoordination)
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 44 at risk

Adverse event: Bruising (in absence of Grade 3 or 4 thrombocytopenia)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 44 at risk

Adverse event: Confusional state
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 44 at risk

Adverse event: Mood alteration: anxiety
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 44 at risk

Adverse event: Neurology Other (quadrantanopsia; sensory loss)
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 44 at risk

Adverse event: Pain: back
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 44 at risk

Adverse event: Pain: neck
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 44 at risk

Adverse event: Pain: oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 44 at risk

Adverse event: Calcium, serum-low (hypocalcemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 44 at risk

Adverse event: Metabolic/Laboratory - Other (high LDH)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 44 at risk

Adverse event: Death not associated with CTCAE term: Death NOS
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 43 at risk

Adverse event: Death not associated with CTCAE term: Disease progression NOS
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 43 at risk

Adverse event: Encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 43 at risk

Adverse event: Fatigue (asthenia, lethargy, malaise)
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 43 at risk

Adverse event: Gastrointestinal-Other (hemorrhoids)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 43 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils::Lung (pneumonia)
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 43 at risk

Adverse event: Pain: Head/Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 43 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 43 at risk

Adverse event: Speech impairment (e.g. dysphasia or aphasia)
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 43 at risk

Adverse event: Supraventricular & nodal arrhythmia: Sinus tachycardia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 43 at risk

Adverse event: Thrombosis/thrombus/embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 43 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 43 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 13 affected / 43 at risk

Adverse event: ALT/SGPT (serum glutamic pyruvic transaminase)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 21 affected / 43 at risk

Adverse event: AST/SGOT (serum glutamic oxaloacetic transaminase)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 10 affected / 43 at risk

Adverse event: Albumin, serum-low (hypoalbuminemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 19 affected / 43 at risk

Adverse event: Blood alkaline phosphatase
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 43 at risk

Adverse event: Bilirubin (hyperbilirubinemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 9 affected / 43 at risk

Adverse event: CPK (creatine phosphokinase)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 43 at risk

Adverse event: Cardiac General - Other (mitral valve disease)
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 43 at risk

Adverse event: Cardiac troponin T (cTnT)
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 43 at risk

Adverse event: Cognitive disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 43 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 43 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 43 at risk

Adverse event: Blood creatinine
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 43 at risk

Adverse event: Cushingoid appearance (e.g. moon face, buffalo hump, centripetal obesity, cutaneous striae)
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 43 at risk

Adverse event: Dyspnea (shortness of breath)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 43 at risk

Adverse event: Edema: limb
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 43 at risk

Adverse event: Extremity-lower (gait/walking)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 43 at risk

Adverse event: Fatigue (asthenia, lethargy, malaise)
Serious: no
Organ System: General disorders
Frequency: 11 affected / 43 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 / 43 at risk

Adverse event: Fracture
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 43 at risk

Adverse event: Gastrointestinal-Other (tongue irritation, soreness)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 43 at risk

Adverse event: Glucose, serum-high (hyperglycemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 43 at risk

Adverse event: Glucose, serum-high (hypoglycemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 43 at risk

Adverse event: Heartburn/Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 43 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 15 affected / 43 at risk

Adverse event: Hemorrhage, CNS
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 43 at risk

Adverse event: Hemorrhage, GI: Anus
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 43 at risk

Adverse event: Hemorrhage, GI: oral cavity
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 43 at risk

Adverse event: Hemorrhage, pulmonary/upper respiratory: Nose
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 43 at risk

Adverse event: Hiccoughs (hiccups, singultus)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 43 at risk

Adverse event: Hypopigmentation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 43 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 43 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils::Bronchus
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 43 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils::Lip/perioral
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 43 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils::Upper airway NOS
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 43 at risk

Adverse event: Infection with unknown ANC: Lung (pneumonia)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 43 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 43 at risk

Adverse event: Left ventricular dysfunction
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 43 at risk

Adverse event: Leukocytes (total WBC)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 37 affected / 43 at risk

Adverse event: Libido
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 43 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 24 affected / 43 at risk

Adverse event: Magnesium, serum-high (hypermagnesemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 43 at risk

Adverse event: Magnesium, serum-low (hypomagnesemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 43 at risk

Adverse event: Metabolic/Laboratory - Other (Elevated LDH; lactate dehidrogenase)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 43 at risk

Adverse event: Mood alteration: agitation
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 43 at risk

Adverse event: Mood alteration: depression
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 43 at risk

Adverse event: Mucositis/stomatitis (clinical exam)::oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 43 at risk

Adverse event: Mucositis/stomatitis (functional/symptomatic)::oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 43 at risk

Adverse event: Muscle weakness, generalized or specific area (not due to neuropathy): Extremity-lower
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 43 at risk

Adverse event: Muscle weakness, generalized or specific area (not due to neuropathy): Left-sided
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 43 at risk

Adverse event: Muscle weakness, generalized or specific area (not due to neuropathy): Right-sided
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 43 at risk

Adverse event: Nail disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 43 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 43 at risk

Adverse event: Neurology - Other (decreased concentration; spatial disorientation)
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 43 at risk

Adverse event: Neuropathy:sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 43 at risk

Adverse event: Neutrophils/granulocytes (ANC/AGC)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 27 affected / 43 at risk

Adverse event: Opportunistic infection associated with >=Grade 2 lymphopenia
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 43 at risk

Adverse event: Pain: Head/Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 43 at risk

Adverse event: Pain: Joint
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 43 at risk

Adverse event: Pain: Pain NOS
Serious: no
Organ System: General disorders
Frequency: 1 affected / 43 at risk

Adverse event: Pain: Throat/pharynx/larynx
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 43 at risk

Adverse event: Phosphate, serum-low (hypophosphatemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 17 affected / 43 at risk

Adverse event: Platelets
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 31 affected / 43 at risk

Adverse event: Potassium, serum-high (hyperkalemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 43 at risk

Adverse event: Potassium, serum-low (hypokalemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 43 at risk

Adverse event: Prolonged QTc interval
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 43 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 43 at risk

Adverse event: Pulmonary/Upper respiratory - Other (right upper lobe cavity mass)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 43 at risk

Adverse event: Pyramidal tract dysfunction
Serious: no
Organ System: Nervous system disorders
Notes: (e.g. increased tone, hyperflexia, positive Babinski, decreased fine motor coordination)
Frequency: 2 affected / 43 at risk

Adverse event: Rash/Desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 43 at risk

Adverse event: Rash: acne/acneiform
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 43 at risk

Adverse event: Rash: erythema multiforme
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis)
Frequency: 1 affected / 43 at risk

Adverse event: Rash: hand-foot skin reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 43 at risk

Adverse event: Seizure
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 43 at risk

Adverse event: Sodium, serum-high (hypernatremia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 43 at risk

Adverse event: Sodium, serum-low (hyponatremia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 43 at risk

Adverse event: Speech impairment (e.g. dysphasia or aphasia)
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 43 at risk

Adverse event: Supraventricular & nodal arrhythmia: Sinus bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 43 at risk

Adverse event: Taste alteration (dysgeusia)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 43 at risk

Adverse event: Thrombosis/thrombus/embolism
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 43 at risk

Adverse event: Thyroid function, high (hyperthyroidism, thyrotoxicosis)
Serious: no
Organ System: Endocrine disorders
Frequency: 6 affected / 43 at risk

Adverse event: Thyroid function, low (hypothyroidism)
Serious: no
Organ System: Endocrine disorders
Frequency: 17 affected / 43 at risk

Adverse event: Ulcer
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 43 at risk

Adverse event: Vision-blurred vision
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 43 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 43 at risk

Adverse event: Weight decreased
Serious: no
Organ System: General disorders
Frequency: 1 affected / 43 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 43 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 / 43 at risk

Adverse event: Dermatology/Skin-Other (hair pigmentation changes)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 43 at risk

Adverse event: Ocular/Visual - Other (color contrast changes, color vision distortion, eisodic wavy vision)
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 43 at risk