Study: NCT00110214

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 25 affected / 505 at risk

Adverse event: Haemoglobin
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 17 affected / 505 at risk

Adverse event: Cardiac Arrhythmia - Other
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 505 at risk

Adverse event: Cardiac General - Other
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 505 at risk

Adverse event: Cardiac ischemia/infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 12 affected / 505 at risk

Adverse event: Cardiopulmonary arrest cause unknown (non-fatal)
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 505 at risk

Adverse event: Left ventricular dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 505 at risk

Adverse event: Supraventricular and nodal arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 8 affected / 505 at risk

Adverse event: Ventricular arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 505 at risk

Adverse event: Watery eye (epiphora tearing)
Serious: yes
Organ System: Eye disorders
Frequency: 2 affected / 505 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 505 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 505 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 505 at risk

Adverse event: Enteritis (inflammation of the small bowel)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 505 at risk

Adverse event: Oesophagitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 505 at risk

Adverse event: Fistula, GI
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 505 at risk

Adverse event: Gastritis (including bile reflux gastritis)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 505 at risk

Adverse event: Gastrointestinal - Other
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 505 at risk

Adverse event: Heartburn/dyspepsia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 505 at risk

Adverse event: Hemorrhage, GI
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 38 affected / 505 at risk

Adverse event: Mucositis/stomatitis (clinical exam)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 505 at risk

Adverse event: Mucositis/stomatitis (functional/symptomatic)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 505 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 505 at risk

Adverse event: Obstruction GI
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 505 at risk

Adverse event: Perforation, GI
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 19 affected / 505 at risk

Adverse event: Ulcer GI
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 505 at risk

Adverse event: Ulcer, GI
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 505 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 505 at risk

Adverse event: Death not associated with CTCAE term
Serious: yes
Organ System: General disorders
Frequency: 10 affected / 505 at risk

Adverse event: Edema: limb
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 505 at risk

Adverse event: Fatigue (asthenia, lethargy, malaise)
Serious: yes
Organ System: General disorders
Frequency: 39 affected / 505 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 43 affected / 505 at risk

Adverse event: Injection site reaction/extravasation changes
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 505 at risk

Adverse event: Pain - Other
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 505 at risk

Adverse event: Rigors/chills
Serious: yes
Organ System: General disorders
Frequency: 13 affected / 505 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 3 affected / 505 at risk

Adverse event: Necrosis GI
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 505 at risk

Adverse event: Necrosis, GI
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 505 at risk

Adverse event: Obstruction, GI
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 505 at risk

Adverse event: Allergic reaction/hypersensitivity (including drug fever)
Serious: yes
Organ System: Immune system disorders
Frequency: 3 affected / 505 at risk

Adverse event: Colitis, infectious (e.g., Clostridium difficile)
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 505 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 35 affected / 505 at risk

Adverse event: Infection - Other
Serious: yes
Organ System: Infections and infestations
Frequency: 14 affected / 505 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils
Serious: yes
Organ System: Infections and infestations
Frequency: 18 affected / 505 at risk

Adverse event: Infection with unknown ANC
Serious: yes
Organ System: Infections and infestations
Frequency: 13 affected / 505 at risk

Adverse event: Infection without neutropenia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 505 at risk

Adverse event: Opportunistic infection associated with >=Grade 2 Lymphopenia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 505 at risk

Adverse event: Fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 505 at risk

Adverse event: Thrombosis/embolism (vascular access-related)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 505 at risk

Adverse event: Wound complication non-infectious
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 505 at risk

Adverse event: ALT, SGPT (serum glutamic pyruvic transaminase)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 505 at risk

Adverse event: AST, SGOT(serum glutamic oxaloacetic transaminase)
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 505 at risk

Adverse event: Blood alkaline phosphatase
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 505 at risk

Adverse event: Bilirubin (hyperbilirubinemia)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 505 at risk

Adverse event: Cardiac troponin I (cTnI)
Serious: yes
Organ System: Investigations
Frequency: 4 affected / 505 at risk

Adverse event: Cardiac troponin T (cTnT)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 505 at risk

Adverse event: Coagulation - Other
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 505 at risk

Adverse event: Blood creatinine
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 505 at risk

Adverse event: Blood fibrinogen
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 505 at risk

Adverse event: Leukocytes (total WBC)
Serious: yes
Organ System: Investigations
Frequency: 39 affected / 505 at risk

Adverse event: Lymphopenia
Serious: yes
Organ System: Investigations
Frequency: 11 affected / 505 at risk

Adverse event: Neutrophils/granulocytes (ANC/AGC)
Serious: yes
Organ System: Investigations
Frequency: 67 affected / 505 at risk

Adverse event: PTT (Partial Thromboplastin Time)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 505 at risk

Adverse event: Platelets
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 505 at risk

Adverse event: Weight increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 505 at risk

Adverse event: Weight decreased
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 505 at risk

Adverse event: Acidosis (metabolic or respiratory)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 505 at risk

Adverse event: Albumin, serum-low (hypoalbuminemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 505 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 14 affected / 505 at risk

Adverse event: Calcium serum-high (hypercalcemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 505 at risk

Adverse event: Calcium serum-low (hypocalcemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 505 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 27 affected / 505 at risk

Adverse event: Glucose serum-high (hyperglycemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 11 affected / 505 at risk

Adverse event: Glucose serum-low (hypoglycemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 505 at risk

Adverse event: Phosphate serum-low (hypophosphatemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 505 at risk

Adverse event: Potassium serum-high (hyperkalemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 505 at risk

Adverse event: Potassium serum-low (hypokalemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 505 at risk

Adverse event: Sodium serum-low (hyponatremia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 10 affected / 505 at risk

Adverse event: Muscle weakness, generalized or specific area (not due to neuropathy)
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 11 affected / 505 at risk

Adverse event: Musculoskeletal/Soft Tissue - Other
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 505 at risk

Adverse event: Osteonecrosis (avascular necrosis)
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 505 at risk

Adverse event: Trismus (difficulty, restriction or pain when opening mouth)
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 505 at risk

Adverse event: Ataxia (incoordination)
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 505 at risk

Adverse event: CNS cerebrovascular ischemia
Serious: yes
Organ System: Nervous system disorders
Frequency: 5 affected / 505 at risk

Adverse event: Cognitive disorder
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 505 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 505 at risk

Adverse event: Encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 505 at risk

Adverse event: Neurology - Other
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 505 at risk

Adverse event: Neuropathy: motor
Serious: yes
Organ System: Nervous system disorders
Frequency: 5 affected / 505 at risk

Adverse event: Neuropathy: sensory
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 505 at risk

Adverse event: Pain
Serious: yes
Organ System: Nervous system disorders
Frequency: 25 affected / 505 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 505 at risk

Adverse event: Somnolence/depressed level of consciousness
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 505 at risk

Adverse event: Speech impairment (e.g., dysphasia or aphasia)
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 505 at risk

Adverse event: Syncope (fainting)
Serious: yes
Organ System: Nervous system disorders
Frequency: 9 affected / 505 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 505 at risk

Adverse event: Mood alteration
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 505 at risk

Adverse event: Psychosis (hallucinations/delusions)
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 505 at risk

Adverse event: Cystitis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 505 at risk

Adverse event: Fistula, GU
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 505 at risk

Adverse event: Haemoglobinuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 505 at risk

Adverse event: Hemorrhage GU
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 6 affected / 505 at risk

Adverse event: Incontinence, urinary
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 505 at risk

Adverse event: Obstruction, GU
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 505 at risk

Adverse event: Proteinuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 22 affected / 505 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 505 at risk

Adverse event: Urinary retention (including neurogenic bladder)
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 505 at risk

Adverse event: Adult Respiratory Distress Syndrome (ARDS)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 505 at risk

Adverse event: Aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 505 at risk

Adverse event: Bronchospasm wheezing
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 505 at risk

Adverse event: Cough
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 505 at risk

Adverse event: Dyspnea (shortness of breath)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 15 affected / 505 at risk

Adverse event: Hemorrhage pulmonary/upper respiratory
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 23 affected / 505 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 505 at risk

Adverse event: Pleural effusion (non-malignant)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 505 at risk

Adverse event: Pneumonitis/pulmonary infiltrates
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 505 at risk

Adverse event: Pulmonary/Upper Respiratory - Other
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 505 at risk

Adverse event: Voice changes/dysarthria (e.g. hoarseness loss or alteration in voice laryngitis)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 505 at risk

Adverse event: Rash/desquamation
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 505 at risk

Adverse event: Rash: hand-foot skin reaction
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 505 at risk

Adverse event: Skin breakdown/decubitus ulcer
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 505 at risk

Adverse event: Urticaria (hives welts wheals)
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 505 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 24 affected / 505 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 11 affected / 505 at risk

Adverse event: Thrombosis/thrombus/embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 17 affected / 505 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 15 affected / 505 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 12 affected / 505 at risk

Adverse event: Cardiac Arrhythmia - Other
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 505 at risk

Adverse event: Cardiac General - Other
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 505 at risk

Adverse event: Cardiac ischemia/infarction
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 505 at risk

Adverse event: Supraventricular and nodal arrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 505 at risk

Adverse event: Cataract
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 505 at risk

Adverse event: Vision-blurred vision
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 505 at risk

Adverse event: Watery eye (epiphora tearing)
Serious: no
Organ System: Eye disorders
Frequency: 10 affected / 505 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 505 at risk

Adverse event: Dental: periodontal disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 505 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 505 at risk

Adverse event: Dry mouth/salivary gland (xerostomia)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 505 at risk

Adverse event: Dysphagia (difficulty swallowing)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 505 at risk

Adverse event: Oesophagitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 505 at risk

Adverse event: Fistula, GI
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 505 at risk

Adverse event: Gastrointestinal - Other
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 505 at risk

Adverse event: Heartburn/dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 505 at risk

Adverse event: Hemorrhage, GI
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 33 affected / 505 at risk

Adverse event: Haemorrhoids
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 505 at risk

Adverse event: Ileus GI (functional obstruction of bowel i.e. neuroconstipation)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 505 at risk

Adverse event: Mucositis/stomatitis (clinical exam)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 505 at risk

Adverse event: Mucositis/stomatitis (functional/symptomatic)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 505 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 505 at risk

Adverse event: Perforation, GI
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 505 at risk

Adverse event: Rectal bleeding/hematochezia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 505 at risk

Adverse event: Ulcer, GI
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 505 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 505 at risk

Adverse event: Death not associated with CTCAE term
Serious: no
Organ System: General disorders
Frequency: 1 affected / 505 at risk

Adverse event: Edema: limb
Serious: no
Organ System: General disorders
Frequency: 1 affected / 505 at risk

Adverse event: Extremity-lower (gait/walking)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 505 at risk

Adverse event: Fatigue (asthenia, lethargy, malaise)
Serious: no
Organ System: General disorders
Frequency: 90 affected / 505 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 77 affected / 505 at risk

Adverse event: Pain - Other
Serious: no
Organ System: General disorders
Frequency: 4 affected / 505 at risk

Adverse event: Rigors/chills
Serious: no
Organ System: General disorders
Frequency: 42 affected / 505 at risk

Adverse event: Syndromes - Other
Serious: no
Organ System: General disorders
Frequency: 1 affected / 505 at risk

Adverse event: Allergic reaction/hypersensitivity (including drug fever)
Serious: no
Organ System: Immune system disorders
Frequency: 20 affected / 505 at risk

Adverse event: Colitis, infectious (e.g., Clostridium difficile)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 505 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 29 affected / 505 at risk

Adverse event: Infection - Other
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 505 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils
Serious: no
Organ System: Infections and infestations
Frequency: 36 affected / 505 at risk

Adverse event: Infection with unknown ANC
Serious: no
Organ System: Infections and infestations
Frequency: 25 affected / 505 at risk

Adverse event: Vessel injury-artery
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 505 at risk

Adverse event: ALT, SGPT (serum glutamic pyruvic transaminase)
Serious: no
Organ System: Investigations
Frequency: 3 affected / 505 at risk

Adverse event: AST, SGOT(serum glutamic oxaloacetic transaminase)
Serious: no
Organ System: Investigations
Frequency: 2 affected / 505 at risk

Adverse event: Blood alkaline phosphatase
Serious: no
Organ System: Investigations
Frequency: 12 affected / 505 at risk

Adverse event: CD4 count
Serious: no
Organ System: Investigations
Frequency: 1 affected / 505 at risk

Adverse event: Cholesterol serum-high (hypercholesteremia)
Serious: no
Organ System: Investigations
Frequency: 1 affected / 505 at risk

Adverse event: GGT (gamma-Glutamyl transpeptidase)
Serious: no
Organ System: Investigations
Frequency: 2 affected / 505 at risk

Adverse event: Leukocytes (total WBC)
Serious: no
Organ System: Investigations
Frequency: 56 affected / 505 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Investigations
Frequency: 18 affected / 505 at risk

Adverse event: Metabolic/Laboratory - Other
Serious: no
Organ System: Investigations
Frequency: 4 affected / 505 at risk

Adverse event: Neutrophils/granulocytes (ANC/AGC)
Serious: no
Organ System: Investigations
Frequency: 110 affected / 505 at risk

Adverse event: PTT (Partial Thromboplastin Time)
Serious: no
Organ System: Investigations
Frequency: 1 affected / 505 at risk

Adverse event: Platelets
Serious: no
Organ System: Investigations
Frequency: 2 affected / 505 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 505 at risk

Adverse event: Albumin, serum-low (hypoalbuminemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 505 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 14 affected / 505 at risk

Adverse event: Calcium serum-low (hypocalcemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 505 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 505 at risk

Adverse event: Glucose serum-high (hyperglycemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 48 affected / 505 at risk

Adverse event: Pancreatic endocrine: glucose intolerance
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 505 at risk

Adverse event: Phosphate serum-low (hypophosphatemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 505 at risk

Adverse event: Potassium serum-low (hypokalemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 505 at risk

Adverse event: Sodium serum-low (hyponatremia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 9 affected / 505 at risk

Adverse event: Muscle weakness, generalized or specific area (not due to neuropathy)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 505 at risk

Adverse event: Osteonecrosis (avascular necrosis)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 505 at risk

Adverse event: Ataxia (incoordination)
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 505 at risk

Adverse event: CNS cerebrovascular ischemia
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 505 at risk

Adverse event: Cognitive disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 505 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 505 at risk

Adverse event: Encephalopathy
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 505 at risk

Adverse event: Extrapyramidal/involuntary movement/restlessness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 505 at risk

Adverse event: Hemorrhage CNS
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 505 at risk

Adverse event: Neurology - Other
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 505 at risk

Adverse event: Neuropathy: cranial
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 505 at risk

Adverse event: Neuropathy: motor
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 505 at risk

Adverse event: Neuropathy: sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 33 affected / 505 at risk

Adverse event: Pain
Serious: no
Organ System: Nervous system disorders
Frequency: 44 affected / 505 at risk

Adverse event: Pyramidal tract dysfunction
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 505 at risk

Adverse event: Syncope (fainting)
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 505 at risk

Adverse event: Taste alteration (dysgeusia)
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 505 at risk

Adverse event: Vasovagal episode
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 505 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 505 at risk

Adverse event: Mood alteration
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 505 at risk

Adverse event: Personality/behavioral
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 505 at risk

Adverse event: Bladder spasms
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 505 at risk

Adverse event: Cystitis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 505 at risk

Adverse event: Fistula, GU
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 505 at risk

Adverse event: Hemorrhage GU
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 505 at risk

Adverse event: Incontinence, urinary
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 505 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 89 affected / 505 at risk

Adverse event: Renal/Genitourinary - Other
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 505 at risk

Adverse event: Urinary frequency/urgency
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 505 at risk

Adverse event: Urinary retention (including neurogenic bladder)
Serious: no
Organ System: Renal and urinary disorders
Frequency: 5 affected / 505 at risk

Adverse event: Allergic rhinitis (including sneezing nasal stuffiness postnasal drip)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 505 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 505 at risk

Adverse event: Dyspnea (shortness of breath)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 505 at risk

Adverse event: Hemorrhage pulmonary/upper respiratory
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 153 affected / 505 at risk

Adverse event: Nasal cavity/paranasal sinus reactions
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 505 at risk

Adverse event: Pneumonitis/pulmonary infiltrates
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 505 at risk

Adverse event: Pulmonary/Upper Respiratory - Other
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 505 at risk

Adverse event: Voice changes/dysarthria (e.g. hoarseness loss or alteration in voice laryngitis)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 505 at risk

Adverse event: Dermatology/Skin - Other
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 505 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 505 at risk

Adverse event: Hair loss/alopecia (scalp or body)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 505 at risk

Adverse event: Nail disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 505 at risk

Adverse event: Photosensitivity reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 505 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 69 affected / 505 at risk

Adverse event: Rash: hand-foot skin reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 505 at risk

Adverse event: Sweating (diaphoresis)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 505 at risk

Adverse event: Ulcer
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 505 at risk

Adverse event: Urticaria (hives welts wheals)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 10 affected / 505 at risk

Adverse event: Dermal change lymphedema phlebolymphedema
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 505 at risk

Adverse event: Flushing
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 505 at risk

Adverse event: Hot flashes/flushes
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 505 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 156 affected / 505 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 505 at risk

Adverse event: Thrombosis/thrombus/embolism
Serious: no
Organ System: Vascular disorders
Frequency: 7 affected / 505 at risk

Adverse event: DIC (disseminated intravascular coagulation)
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 504 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 19 affected / 504 at risk

Adverse event: Haemoglobin
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 14 affected / 504 at risk

Adverse event: Lymphatics - Other
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 504 at risk

Adverse event: Cardiac Arrhythmia - Other
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 504 at risk

Adverse event: Cardiac General - Other
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 504 at risk

Adverse event: Cardiac ischemia/infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 504 at risk

Adverse event: Conduction abnormality/atrioventricular heart block
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 504 at risk

Adverse event: Left ventricular dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 504 at risk

Adverse event: Left ventricular dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 504 at risk

Adverse event: Supraventricular and nodal arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 10 affected / 504 at risk

Adverse event: Ventricular arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 504 at risk

Adverse event: Thyroid function high (hyperthyroidism thyrotoxicosis)
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 504 at risk

Adverse event: Ocular/Visual - Other
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 504 at risk

Adverse event: Vision-blurred vision
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 504 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 504 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 504 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 504 at risk

Adverse event: Fistula, GI
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 504 at risk

Adverse event: Gastrointestinal - Other
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 504 at risk

Adverse event: Hemorrhage, GI
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 504 at risk

Adverse event: Mucositis/stomatitis (clinical exam)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 504 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 504 at risk

Adverse event: Obstruction GI
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 504 at risk

Adverse event: Perforation, GI
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 504 at risk

Adverse event: Proctitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 504 at risk

Adverse event: Ulcer GI
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 504 at risk

Adverse event: Ulcer, GI
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 504 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 504 at risk

Adverse event: Death not associated with CTCAE term
Serious: yes
Organ System: General disorders
Frequency: 10 affected / 504 at risk

Adverse event: Edema: limb
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 504 at risk

Adverse event: Fatigue (asthenia, lethargy, malaise)
Serious: yes
Organ System: General disorders
Frequency: 22 affected / 504 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 32 affected / 504 at risk

Adverse event: Pain - Other
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 504 at risk

Adverse event: Rigors/chills
Serious: yes
Organ System: General disorders
Frequency: 17 affected / 504 at risk

Adverse event: Allergic reaction/hypersensitivity (including drug fever)
Serious: yes
Organ System: Immune system disorders
Frequency: 3 affected / 504 at risk

Adverse event: Colitis, infectious (e.g., Clostridium difficile)
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 504 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 27 affected / 504 at risk

Adverse event: Infection - Other
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 504 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils
Serious: yes
Organ System: Infections and infestations
Frequency: 11 affected / 504 at risk

Adverse event: Infection with unknown ANC
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 504 at risk

Adverse event: Opportunistic infection associated with >=Grade 2 Lymphopenia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 504 at risk

Adverse event: Fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 504 at risk

Adverse event: AST, SGOT(serum glutamic oxaloacetic transaminase)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 504 at risk

Adverse event: Blood alkaline phosphatase
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 504 at risk

Adverse event: Cardiac troponin I (cTnI)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 504 at risk

Adverse event: Blood creatinine
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 504 at risk

Adverse event: INR (International Normalized Ratio of prothrombin time)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 504 at risk

Adverse event: Leukocytes (total WBC)
Serious: yes
Organ System: Investigations
Frequency: 25 affected / 504 at risk

Adverse event: Lymphopenia
Serious: yes
Organ System: Investigations
Frequency: 11 affected / 504 at risk

Adverse event: Metabolic/Laboratory - Other
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 504 at risk

Adverse event: Neutrophils/granulocytes (ANC/AGC)
Serious: yes
Organ System: Investigations
Frequency: 46 affected / 504 at risk

Adverse event: Neutrophils/granulocytes (ANC/AGC) for BMT studies if specified in the protocol.
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 504 at risk

Adverse event: PTT (Partial Thromboplastin Time)
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 504 at risk

Adverse event: Albumin, serum-low (hypoalbuminemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 504 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 504 at risk

Adverse event: Calcium serum-low (hypocalcemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 504 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 14 affected / 504 at risk

Adverse event: Glucose serum-high (hyperglycemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 504 at risk

Adverse event: Glucose serum-low (hypoglycemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 504 at risk

Adverse event: Phosphate serum-low (hypophosphatemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 504 at risk

Adverse event: Potassium serum-high (hyperkalemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 504 at risk

Adverse event: Potassium serum-low (hypokalemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 504 at risk

Adverse event: Sodium serum-low (hyponatremia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 504 at risk

Adverse event: Muscle weakness, generalized or specific area (not due to neuropathy)
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 504 at risk

Adverse event: Musculoskeletal/Soft Tissue - Other
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 504 at risk

Adverse event: Osteonecrosis (avascular necrosis)
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 504 at risk

Adverse event: Ataxia (incoordination)
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 504 at risk

Adverse event: CNS cerebrovascular ischemia
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 504 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 7 affected / 504 at risk

Adverse event: Hemorrhage CNS
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 504 at risk

Adverse event: Neurology - Other
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 504 at risk

Adverse event: Neuropathy: motor
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 504 at risk

Adverse event: Neuropathy: sensory
Serious: yes
Organ System: Nervous system disorders
Frequency: 7 affected / 504 at risk

Adverse event: Pain
Serious: yes
Organ System: Nervous system disorders
Frequency: 19 affected / 504 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 504 at risk

Adverse event: Somnolence/depressed level of consciousness
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 504 at risk

Adverse event: Syncope (fainting)
Serious: yes
Organ System: Nervous system disorders
Frequency: 7 affected / 504 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Psychiatric disorders
Frequency: 5 affected / 504 at risk

Adverse event: Bladder spasms
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 504 at risk

Adverse event: Cystitis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 504 at risk

Adverse event: Hematuria (in the absence of vaginal bleeding)
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 504 at risk

Adverse event: Hemorrhage GU
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 9 affected / 504 at risk

Adverse event: Obstruction, GU
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 5 affected / 504 at risk

Adverse event: Perforation GU
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 504 at risk

Adverse event: Proteinuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 19 affected / 504 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 5 affected / 504 at risk

Adverse event: Stricture/stenosis (including anastomotic), GU
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 504 at risk

Adverse event: Dyspnea (shortness of breath)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 12 affected / 504 at risk

Adverse event: Hemorrhage pulmonary/upper respiratory
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 504 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 504 at risk

Adverse event: Pleural effusion (non-malignant)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 504 at risk

Adverse event: Pneumonitis/pulmonary infiltrates
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 504 at risk

Adverse event: Hair loss/alopecia (scalp or body)
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 504 at risk

Adverse event: Rash/desquamation
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 10 affected / 504 at risk

Adverse event: Ulcer
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 504 at risk

Adverse event: Hot flashes/flushes
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 504 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 6 affected / 504 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 6 affected / 504 at risk

Adverse event: Thrombosis/thrombus/embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 28 affected / 504 at risk

Adverse event: Vascular - Other
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 504 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 504 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 9 affected / 504 at risk

Adverse event: Hemolysis (e.g. immune hemolytic anemia drug-related hemolysis)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 504 at risk

Adverse event: Lymphatics - Other
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 504 at risk

Adverse event: Cardiac General - Other
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 504 at risk

Adverse event: Cardiac ischemia/infarction
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 504 at risk

Adverse event: Oedema
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 504 at risk

Adverse event: Supraventricular and nodal arrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 504 at risk

Adverse event: Hearing: patients without baseline audiogram and not enrolled in a monitoring program
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 504 at risk

Adverse event: Otitis middle ear (non-infectious)
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 504 at risk

Adverse event: Cataract
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 504 at risk

Adverse event: Vision-blurred vision
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 504 at risk

Adverse event: Watery eye (epiphora tearing)
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 504 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 504 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 504 at risk

Adverse event: Hemorrhage, GI
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 504 at risk

Adverse event: Incontinence anal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 504 at risk

Adverse event: Mucositis/stomatitis (functional/symptomatic)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 504 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 504 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 504 at risk

Adverse event: Death not associated with CTCAE term
Serious: no
Organ System: General disorders
Frequency: 2 affected / 504 at risk

Adverse event: Edema: limb
Serious: no
Organ System: General disorders
Frequency: 5 affected / 504 at risk

Adverse event: Edema: trunk/genital
Serious: no
Organ System: General disorders
Frequency: 1 affected / 504 at risk

Adverse event: Fatigue (asthenia, lethargy, malaise)
Serious: no
Organ System: General disorders
Frequency: 51 affected / 504 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 50 affected / 504 at risk

Adverse event: Pain - Other
Serious: no
Organ System: General disorders
Frequency: 6 affected / 504 at risk

Adverse event: Rigors/chills
Serious: no
Organ System: General disorders
Frequency: 33 affected / 504 at risk

Adverse event: Allergic reaction/hypersensitivity (including drug fever)
Serious: no
Organ System: Immune system disorders
Frequency: 26 affected / 504 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 15 affected / 504 at risk

Adverse event: Infection - Other
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 504 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils
Serious: no
Organ System: Infections and infestations
Frequency: 21 affected / 504 at risk

Adverse event: Infection with unknown ANC
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 504 at risk

Adverse event: Infection without neutropenia
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 504 at risk

Adverse event: Fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 504 at risk

Adverse event: AST, SGOT(serum glutamic oxaloacetic transaminase)
Serious: no
Organ System: Investigations
Frequency: 2 affected / 504 at risk

Adverse event: Blood alkaline phosphatase
Serious: no
Organ System: Investigations
Frequency: 12 affected / 504 at risk

Adverse event: Blood creatinine
Serious: no
Organ System: Investigations
Frequency: 1 affected / 504 at risk

Adverse event: INR (International Normalized Ratio of prothrombin time)
Serious: no
Organ System: Investigations
Frequency: 3 affected / 504 at risk

Adverse event: Leukocytes (total WBC)
Serious: no
Organ System: Investigations
Frequency: 50 affected / 504 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Investigations
Frequency: 31 affected / 504 at risk

Adverse event: Metabolic/Laboratory - Other
Serious: no
Organ System: Investigations
Frequency: 1 affected / 504 at risk

Adverse event: Neutrophils/granulocytes (ANC/AGC)
Serious: no
Organ System: Investigations
Frequency: 97 affected / 504 at risk

Adverse event: PTT (Partial Thromboplastin Time)
Serious: no
Organ System: Investigations
Frequency: 1 affected / 504 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 504 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 504 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 504 at risk

Adverse event: Calcium serum-low (hypocalcemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 504 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 504 at risk

Adverse event: Glucose serum-high (hyperglycemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 40 affected / 504 at risk

Adverse event: Magnesium serum-low (hypomagnesemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 504 at risk

Adverse event: Pancreatic endocrine: glucose intolerance
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 504 at risk

Adverse event: Phosphate serum-low (hypophosphatemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 504 at risk

Adverse event: Potassium serum-high (hyperkalemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 504 at risk

Adverse event: Potassium serum-low (hypokalemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 504 at risk

Adverse event: Sodium serum-low (hyponatremia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 504 at risk

Adverse event: Arthritis (non-septic)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 504 at risk

Adverse event: Muscle weakness, generalized or specific area (not due to neuropathy)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 10 affected / 504 at risk

Adverse event: Musculoskeletal/Soft Tissue - Other
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 504 at risk

Adverse event: Osteonecrosis (avascular necrosis)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 504 at risk

Adverse event: Secondary Malignancy - possibly related to cancer treatment
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 504 at risk

Adverse event: CNS cerebrovascular ischemia
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 504 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 504 at risk

Adverse event: Hemorrhage CNS
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 504 at risk

Adverse event: Neuropathy: motor
Serious: no
Organ System: Nervous system disorders
Frequency: 17 affected / 504 at risk

Adverse event: Neuropathy: sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 33 affected / 504 at risk

Adverse event: Pain
Serious: no
Organ System: Nervous system disorders
Frequency: 34 affected / 504 at risk

Adverse event: Syncope (fainting)
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 504 at risk

Adverse event: Taste alteration (dysgeusia)
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 504 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 504 at risk

Adverse event: Mood alteration
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 504 at risk

Adverse event: Hematuria (in the absence of vaginal bleeding)
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 504 at risk

Adverse event: Haemoglobinuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 504 at risk

Adverse event: Hemorrhage GU
Serious: no
Organ System: Renal and urinary disorders
Frequency: 6 affected / 504 at risk

Adverse event: Incontinence, urinary
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 504 at risk

Adverse event: Obstruction, GU
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 504 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 70 affected / 504 at risk

Adverse event: Stricture/stenosis (including anastomotic), GU
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 504 at risk

Adverse event: Urinary frequency/urgency
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 504 at risk

Adverse event: Urinary retention (including neurogenic bladder)
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 504 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 504 at risk

Adverse event: Dyspnea (shortness of breath)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 504 at risk

Adverse event: Hemorrhage pulmonary/upper respiratory
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 54 affected / 504 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 504 at risk

Adverse event: Pneumonitis/pulmonary infiltrates
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 504 at risk

Adverse event: Hair loss/alopecia (scalp or body)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 504 at risk

Adverse event: Nail disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 504 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 56 affected / 504 at risk

Adverse event: Rash: hand-foot skin reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 504 at risk

Adverse event: Urticaria (hives welts wheals)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 504 at risk

Adverse event: Hemorrhage/Bleeding - Other
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 504 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 82 affected / 504 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 504 at risk

Adverse event: Thrombosis/thrombus/embolism
Serious: no
Organ System: Vascular disorders
Frequency: 20 affected / 504 at risk