Study: NCT00271609

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 32 at risk

Adverse event: Hemorrhage, CNS
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 32 at risk

Adverse event: Hemorrhage, pulmonary/upper respiratory: nose
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 32 at risk

Adverse event: Thrombosis/thrombus/embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 32 at risk

Adverse event: Aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 32 at risk

Adverse event: Infection (documented clinically or microbiologically) with grade 3 or 4 neutrophils
Serious: yes
Organ System: Infections and infestations
Notes: (ANC\<1.0x10e9/L): Lung (pneumonia)
Frequency: 1 affected / 32 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 / 32 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 32 at risk

Adverse event: Rash/desquamation
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 32 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 32 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 32 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 9 affected / 32 at risk

Adverse event: Fatigue (asthenia, lethargy, malaise)
Serious: no
Organ System: General disorders
Frequency: 11 affected / 32 at risk

Adverse event: ALT, SGPT (serum glutamic pyruvic transaminase)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 32 at risk

Adverse event: AST, SGOT (serum glutamic oxaloacetic transaminase)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 11 affected / 32 at risk

Adverse event: Albumin, serum-low (hypoalbuminemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 32 at risk

Adverse event: Blood alkaline phosphatase
Serious: no
Organ System: Investigations
Frequency: 1 affected / 32 at risk

Adverse event: Allergic reaction/hypersensitivity (including drug fever)
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 32 at risk

Adverse event: Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 32 at risk

Adverse event: Ataxia (incoordination)
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 32 at risk

Adverse event: Bilirubin (hyperbilirubinemia)
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 9 affected / 32 at risk

Adverse event: Calcium, serum-low (hypocalcemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 32 at risk

Adverse event: Cognitive disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 32 at risk

Adverse event: Confusional state
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 32 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 32 at risk

Adverse event: Constitutional symptoms-other (Specify-orthostasis, "dizzines" when standing x minutes, self limited
Serious: no
Organ System: General disorders
Frequency: 1 affected / 32 at risk

Adverse event: Blood creatinine
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 32 at risk

Adverse event: Cushingoid appearance (e.g. moon face, buffalo hump, centripetal obesity, cutaneous striae)
Serious: no
Organ System: Endocrine disorders
Frequency: 2 affected / 32 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 32 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 32 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 32 at risk

Adverse event: Dyspnea (shortness of breath)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 32 at risk

Adverse event: Edema: limb
Serious: no
Organ System: General disorders
Frequency: 3 affected / 32 at risk

Adverse event: Encephalopathy
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 32 at risk

Adverse event: Extremity-lower (gait/walking)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 32 at risk

Adverse event: Gastrointestinal-Other (Specify-new urgency of bowel and bladder habits)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 32 at risk

Adverse event: Glucose, serum-high (hyperglycemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 32 at risk

Adverse event: Heartburn/dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 32 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 32 at risk

Adverse event: Haemoglobinuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 32 at risk

Adverse event: Hemorrhage, GI: Anus
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 32 at risk

Adverse event: Hemorrhage, GI: Rectum
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 32 at risk

Adverse event: Hemorrhage, pulmonary/upper respiratory: nose
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 32 at risk

Adverse event: Hiccoughs (hiccups, singultus)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 32 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 32 at risk

Adverse event: Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC<1.0x10e9/L
Serious: no
Organ System: Infections and infestations
Notes: oral cavity-gums (gingivitis)
Frequency: 1 affected / 32 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 / 32 at risk

Adverse event: Infection with normal ANC Grade 1 or 2 neutrophils: nerve-peripheral
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 32 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils: pharynx
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 32 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils: sinus
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 32 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils: skin (cellulitis)
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 32 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils: upper aerodigestive NOS
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 32 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: 4 affected / 32 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: 4 affected / 32 at risk

Adverse event: Infection with unknown ANC: colon
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 32 at risk

Adverse event: Infection with unknown ANC: pharynx
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 32 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 32 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Investigations
Frequency: 8 affected / 32 at risk

Adverse event: Magnesium, serum-high (hypermagnesemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 32 at risk

Adverse event: Magnesium, serum-low (hypomagnesemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 32 at risk

Adverse event: Memory impairment
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 32 at risk

Adverse event: Mood alteration: depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 32 at risk

Adverse event: Muscle weakness, generalized or specific area (not due to neuropathy)L extremity-lower
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 32 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 32 at risk

Adverse event: PTT (Partial thromboplastin Time)
Serious: no
Organ System: Investigations
Frequency: 1 affected / 32 at risk

Adverse event: Pain Other (Specify-pain-extremity-limb)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 32 at risk

Adverse event: Pain: Head/headache
Serious: no
Organ System: Nervous system disorders
Frequency: 15 affected / 32 at risk

Adverse event: Pain: joint
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 32 at risk

Adverse event: Pain: muscle
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 32 at risk

Adverse event: Pain: Neuralgia/peripheral nerve
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 32 at risk

Adverse event: Pain: Throat/pharynx/larynx
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 32 at risk

Adverse event: Pancreatic endocrine: glucose intolerance
Serious: no
Organ System: Investigations
Frequency: 1 affected / 32 at risk

Adverse event: Petechiae/purpura (hemorrhage/bleeding into skin or mucosa)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 32 at risk

Adverse event: Phosphate, serum-low (hypophosphatemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 32 at risk

Adverse event: Platelets
Serious: no
Organ System: Investigations
Frequency: 10 affected / 32 at risk

Adverse event: Potassium, serum-high (hyperkalemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 32 at risk

Adverse event: Potassium, serum-low (hypokalemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 32 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 10 affected / 32 at risk

Adverse event: Psychosis (hallucinations/delusions)
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 32 at risk

Adverse event: Pulmonary/upper respiratory-Other (Specify-mild dry nasal mucosa)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 32 at risk

Adverse event: Pyramidal tract dysfunction
Serious: no
Organ System: Nervous system disorders
Notes: (e.g. increased tone, hyperreflexia, positive Babinski, decreased fine coordination)
Frequency: 10 affected / 32 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 32 at risk

Adverse event: Rash: acne/acneiform
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 32 at risk

Adverse event: Rash: Hand/foot skin reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 32 at risk

Adverse event: Retinopathy
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 32 at risk

Adverse event: Seizure
Serious: no
Organ System: Vascular disorders
Frequency: 5 affected / 32 at risk

Adverse event: Skin breakdown/decubitus ulcer
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 32 at risk

Adverse event: Sodium, serum-high (hypernatremia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 32 at risk

Adverse event: Sodium, serum-low (hyponatremia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 32 at risk

Adverse event: Speech impairment (e.g. dysphasia or aphasia)
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 32 at risk

Adverse event: Supraventricular and nodal arrhythmia: sinus bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 32 at risk

Adverse event: Syncope (fainting)
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 32 at risk

Adverse event: Thrombosis/thrombus/embolism
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 32 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 32 at risk

Adverse event: Uric acid, serum-high (hyperuricemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 32 at risk

Adverse event: Urinary frequency/urgency
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 32 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 32 at risk

Adverse event: Calcium, serum-high (hypercalcemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 32 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 32 at risk

Adverse event: Hemorrhage, pulmonary/upper respiratory: Bronchus
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 32 at risk

Adverse event: Dermatology/Skin-Other (Specify-psoriasis)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 32 at risk

Adverse event: Oesophagitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 32 at risk

Adverse event: Mucositis/stomatitis (clinical exam): oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 32 at risk

Adverse event: Neuropathy: Cranial-CN II vision
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 32 at risk

Adverse event: Somnolence/depressed level of consciousness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 32 at risk

Adverse event: Sweating (diaphoresis)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 32 at risk

Adverse event: Neurology-Other (Specify-worsening L-sided Parethesia, now clumsiness/?BCNU-related)
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 32 at risk

Adverse event: Fever ( in the absence of neutropenia, where neutropenia is defined as ANC <1.0x10e9/L)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 32 at risk

Adverse event: Atelectasis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 32 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: 1 affected / 32 at risk

Adverse event: Pain: oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 32 at risk

Adverse event: Wound complication, non-infectious
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 32 at risk

Adverse event: Rigors/chills
Serious: no
Organ System: General disorders
Frequency: 1 affected / 32 at risk

Adverse event: Infection with unknown ANC: Upper airway NOS
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 32 at risk

Adverse event: Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils
Serious: no
Organ System: Infections and infestations
Notes: (ANC\<1.0x10e9/L): mucosa
Frequency: 1 affected / 32 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 32 at risk

Adverse event: Pulmonary/Upper Respiratory-Other (Specify)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 32 at risk

Adverse event: Hemorrhage, Central nervous system (CNS)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 32 at risk

Adverse event: Glucose, serum-high (hyperglycemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 32 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 56 at risk

Adverse event: Proteinuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 56 at risk

Adverse event: Hemorrhage, CNS
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 56 at risk

Adverse event: Thrombosis/thrombus/embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 7 affected / 56 at risk

Adverse event: CNS cerebrovascular ischemia
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 56 at risk

Adverse event: Death not associated with CTCAE term: death NOS
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 56 at risk

Adverse event: Death not associated with CTCAE term: disease progression NOS
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 56 at risk

Adverse event: Death not associated with CTCAE term: sudden death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 56 at risk

Adverse event: Hydrocephalus
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 56 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 56 at risk

Adverse event: Infection with normal ANC Grade 1 or 2 neutrophils: joint
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 56 at risk

Adverse event: Infection with unknown ANC: skin (cellulitis)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 56 at risk

Adverse event: Leak, cerebrospinal fluid (CSF)
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 56 at risk

Adverse event: Left ventricular dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 56 at risk

Adverse event: Leukocytes (total WBC)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 56 at risk

Adverse event: Lymphopenia
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 56 at risk

Adverse event: Musculoskeletal/soft tissue-other (specify-injury to the first index fingers & nail bed)
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 56 at risk

Adverse event: Necrosis, GI:gallbladder
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 56 at risk

Adverse event: Neutrophils/granulocytes (ANC/AGC)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 56 at risk

Adverse event: Opportunistic infection associated with >=Grade 2 lymphopenia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 56 at risk

Adverse event: Pain:headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 56 at risk

Adverse event: Pain:muscle
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 56 at risk

Adverse event: Pain:neck
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 56 at risk

Adverse event: Perforation, GI: small bowel NOS
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 56 at risk

Adverse event: Platelets
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 56 at risk

Adverse event: Somnolence/depressed level of consciousness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 56 at risk

Adverse event: Thrombosis/embolism (vascular access-related)
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 56 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 / 56 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 5 affected / 56 at risk

Adverse event: Fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 56 at risk

Adverse event: Ataxia (incoordination)
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 56 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 56 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 11 affected / 56 at risk

Adverse event: Fatigue (asthenia, lethargy, malaise)
Serious: no
Organ System: General disorders
Frequency: 11 affected / 56 at risk

Adverse event: ALT, SGPT (serum glutamic pyruvic transaminase)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 56 at risk

Adverse event: AST, SGOT (serum glutamic oxaloacetic transaminase)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 18 affected / 56 at risk

Adverse event: Albumin, serum-low (hypoalbuminemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 10 affected / 56 at risk

Adverse event: Blood alkaline phosphatase
Serious: no
Organ System: Investigations
Frequency: 6 affected / 56 at risk

Adverse event: Allergic reaction/hypersensitivity (including drug fever)
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 56 at risk

Adverse event: Ataxia (incoordination)
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 56 at risk

Adverse event: Bilirubin (hyperbilirubinemia)
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 16 affected / 56 at risk

Adverse event: Calcium, serum-low (hypocalcemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 56 at risk

Adverse event: Confusional state
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 56 at risk

Adverse event: Blood creatinine
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 56 at risk

Adverse event: Cushingoid appearance (e.g. moon face, buffalo hump, centripetal obesity, cutaneous striae)
Serious: no
Organ System: Endocrine disorders
Frequency: 2 affected / 56 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 56 at risk

Adverse event: Dyspnea (shortness of breath)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 56 at risk

Adverse event: Edema: limb
Serious: no
Organ System: General disorders
Frequency: 3 affected / 56 at risk

Adverse event: Extremity-lower (gait/walking)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 56 at risk

Adverse event: Glucose, serum-high (hyperglycemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 56 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 10 affected / 56 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 56 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils: skin (cellulitis)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 56 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 / 56 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: 2 affected / 56 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 56 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Investigations
Frequency: 21 affected / 56 at risk

Adverse event: Magnesium, serum-high (hypermagnesemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 17 affected / 56 at risk

Adverse event: Magnesium, serum-low (hypomagnesemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 56 at risk

Adverse event: Memory impairment
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 56 at risk

Adverse event: Mood alteration: depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 56 at risk

Adverse event: PTT (Partial thromboplastin Time)
Serious: no
Organ System: Investigations
Frequency: 5 affected / 56 at risk

Adverse event: Pain Other (Specify-pain-extremity-limb)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 56 at risk

Adverse event: Pain: Head/headache
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 56 at risk

Adverse event: Pain: joint
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 56 at risk

Adverse event: Pain: Throat/pharynx/larynx
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 56 at risk

Adverse event: Pancreatic endocrine: glucose intolerance
Serious: no
Organ System: Investigations
Frequency: 1 affected / 56 at risk

Adverse event: Petechiae/purpura (hemorrhage/bleeding into skin or mucosa)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 56 at risk

Adverse event: Phosphate, serum-low (hypophosphatemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 19 affected / 56 at risk

Adverse event: Platelets
Serious: no
Organ System: Investigations
Frequency: 17 affected / 56 at risk

Adverse event: Potassium, serum-high (hyperkalemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 56 at risk

Adverse event: Potassium, serum-low (hypokalemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 56 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 24 affected / 56 at risk

Adverse event: Psychosis (hallucinations/delusions)
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 56 at risk

Adverse event: Pyramidal tract dysfunction
Serious: no
Organ System: Nervous system disorders
Notes: (e.g. increased tone, hyperreflexia, positive Babinski, decreased fine coordination)
Frequency: 5 affected / 56 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 56 at risk

Adverse event: Rash: acne/acneiform
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 56 at risk

Adverse event: Retinopathy
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 56 at risk

Adverse event: Seizure
Serious: no
Organ System: Vascular disorders
Frequency: 13 affected / 56 at risk

Adverse event: Sodium, serum-high (hypernatremia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 56 at risk

Adverse event: Sodium, serum-low (hyponatremia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 10 affected / 56 at risk

Adverse event: Speech impairment (e.g. dysphasia or aphasia)
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 56 at risk

Adverse event: Thrombosis/thrombus/embolism
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 56 at risk

Adverse event: Uric acid, serum-high (hyperuricemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 56 at risk

Adverse event: Urinary frequency/urgency
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 56 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 56 at risk

Adverse event: Calcium, serum-high (hypercalcemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 56 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 56 at risk

Adverse event: Oesophagitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 56 at risk

Adverse event: Hemorrhage, pulmonary/upper respiratory: nose
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 56 at risk

Adverse event: Mucositis/stomatitis (clinical exam): oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 56 at risk

Adverse event: Sweating (diaphoresis)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 56 at risk

Adverse event: Cholesterol, serum-high (hypercholesteremia)
Serious: no
Organ System: Investigations
Frequency: 1 affected / 56 at risk

Adverse event: Dermatology/skin-Other (Specify-tinea, requiring med. intervention)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 56 at risk

Adverse event: Erectile dysfunction
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 56 at risk

Adverse event: Extremity-upper (function)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 56 at risk

Adverse event: Eyelid dysfunction
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 56 at risk

Adverse event: Hair loss/alopecia (scalp or body)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 56 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 56 at risk

Adverse event: Incontinence, anal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 56 at risk

Adverse event: Hydrocephalus
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 56 at risk

Adverse event: Incontinence, urinary
Serious: no
Organ System: Renal and urinary disorders
Frequency: 5 affected / 56 at risk

Adverse event: Mucositis/stomatitis (functional/symptomatic): anus
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 56 at risk

Adverse event: Neurology-Other (Specify-visual field cut)
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 56 at risk

Adverse event: Neurology: motor
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 56 at risk

Adverse event: Pain: Other
Serious: no
Organ System: General disorders
Notes: (Specify-during visit patient bent over to pick something up and had pain in L side in the lower rib area)
Frequency: 1 affected / 56 at risk

Adverse event: Pain: Abdomen NOS
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 56 at risk

Adverse event: Pain : Back
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 56 at risk

Adverse event: Prolonged QTc Interval
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 56 at risk

Adverse event: Rash: erythema multiforme (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 56 at risk

Adverse event: Supraventricular and nodal arrhythmia: atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 56 at risk

Adverse event: Taste alteration (dysgeusia)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 56 at risk

Adverse event: Thyroid function, low (hypothyroidism)
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 56 at risk

Adverse event: Ulcer
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 56 at risk

Adverse event: Urinary retention (including neurogenic bladder)
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 56 at risk

Adverse event: Voice changes/dysarthria (e.g. hoarseness, loss or alteration in voice, laryngitis)
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 56 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 / 56 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 / 56 at risk

Adverse event: Leukocytes (total WBC)
Serious: no
Organ System: Investigations
Frequency: 8 affected / 56 at risk

Adverse event: Fever ( in the absence of neutropenia, where neutropenia is defined as ANC <1.0x10e9/L)
Serious: no
Organ System: General disorders
Frequency: 2 affected / 56 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 56 at risk

Adverse event: Bicarbonate, serum low
Serious: no
Organ System: Investigations
Frequency: 3 affected / 56 at risk

Adverse event: Bruising (in absence of Grade 3 or 4 thrombocytopenia)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 56 at risk

Adverse event: Hemorrhage, GU: urinary NOS
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 56 at risk

Adverse event: Infection-Other (Specify- fungal infection with normal ANC)
Serious: no
Organ System: Infections and infestations
Notes: UTI (urinary tract infection) Whitish exudate on his tongue appeared to be thrush
Frequency: 4 affected / 56 at risk

Adverse event: Infection with unknown ANC: Upper airway NOS
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 56 at risk

Adverse event: Infection with unknown ANC: Urinary tract NOS
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 56 at risk

Adverse event: Mood alteration: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 56 at risk

Adverse event: Muscle weakness, generalized or specific area (not due to neuropathy): extreme-lower
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 56 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 / 56 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: 2 affected / 56 at risk

Adverse event: Neutrophils/granulocytes (ANC/AGC)
Serious: no
Organ System: Investigations
Frequency: 3 affected / 56 at risk

Adverse event: Pain: neck
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 56 at risk

Adverse event: Pruritis/itching
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 56 at risk

Adverse event: Vision-blurred vision
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 56 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 56 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 56 at risk

Adverse event: Neuropathy-motor
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 56 at risk

Adverse event: Retinopathy
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 56 at risk