Study: NCT00134056

Adverse event: DIC (disseminated intravascular coagulation)
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 486 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 9 affected / 486 at risk

Adverse event: Haemoglobin
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 10 affected / 486 at risk

Adverse event: Cardiac General-Other
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 486 at risk

Adverse event: Cardiac-ischemia/infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 486 at risk

Adverse event: Left ventricular dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 486 at risk

Adverse event: Left ventricular dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 486 at risk

Adverse event: Myocarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 486 at risk

Adverse event: SVT and nodal arrhythmia - Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 8 affected / 486 at risk

Adverse event: SVT and nodal arrhythmia - Atrial flutter
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 486 at risk

Adverse event: SVT and nodal arrhythmia - Sinus bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 486 at risk

Adverse event: Ventricular arrhythmia - PVCs
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 486 at risk

Adverse event: Ventricular arrhythmia - Ventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 486 at risk

Adverse event: Otitis, middle ear (non-infectious)
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 486 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 486 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 486 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 486 at risk

Adverse event: Distention/bloating, abdominal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 486 at risk

Adverse event: Dry mouth/salivary gland (xerostomia)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 486 at risk

Adverse event: Dysphagia (difficulty swallowing)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 486 at risk

Adverse event: Gastrointestinal-Other
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 486 at risk

Adverse event: Hemorrhage, GI - Abdomen NOS
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 486 at risk

Adverse event: Hemorrhage, GI - Colon
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 486 at risk

Adverse event: Hemorrhage, GI - Duodenum
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 486 at risk

Adverse event: Hemorrhage, GI - Rectum
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 486 at risk

Adverse event: Hemorrhage, GI - Stomach
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 486 at risk

Adverse event: Hemorrhage, GI - Upper GI NOS
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 486 at risk

Adverse event: Ileus, GI (functional obstruction of bowel)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 486 at risk

Adverse event: Mucositis/stomatitis (clinical exam) - Oral cavity
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 486 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 486 at risk

Adverse event: Obstruction, GI - Small bowel NOS
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 486 at risk

Adverse event: Pain - Abdomen NOS
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 486 at risk

Adverse event: Perforation, GI - Colon
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 486 at risk

Adverse event: Stricture/stenosis (including anastomotic), GI - A
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 486 at risk

Adverse event: Ulcer, GI - Duodenum
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 486 at risk

Adverse event: Ulcer, GI - Rectum
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 486 at risk

Adverse event: Ulcer, GI - Stomach
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 486 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 486 at risk

Adverse event: Death - Multi-organ failure
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 486 at risk

Adverse event: Death not associated with CTCAE term - Death NOS
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 486 at risk

Adverse event: Edema: limb
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 486 at risk

Adverse event: Fatigue (asthenia, lethargy, malaise)
Serious: yes
Organ System: General disorders
Frequency: 14 affected / 486 at risk

Adverse event: Pain - Chest/thorax NOS
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 486 at risk

Adverse event: Pain-Other
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 486 at risk

Adverse event: Sudden death
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 486 at risk

Adverse event: Inf (clin/microbio) w/Gr 3-4 neuts - Bladder
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 486 at risk

Adverse event: Inf (clin/microbio) w/Gr 3-4 neuts - Blood
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 486 at risk

Adverse event: Inf (clin/microbio) w/Gr 3-4 neuts - Colon
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 486 at risk

Adverse event: Inf (clin/microbio) w/Gr 3-4 neuts - Eye NOS
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 486 at risk

Adverse event: Inf (clin/microbio) w/Gr 3-4 neuts - Lung
Serious: yes
Organ System: Infections and infestations
Frequency: 14 affected / 486 at risk

Adverse event: Inf (clin/microbio) w/Gr 3-4 neuts - Nerve-periph
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 486 at risk

Adverse event: Inf (clin/microbio) w/Gr 3-4 neuts - Nose
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 486 at risk

Adverse event: Inf (clin/microbio) w/Gr 3-4 neuts - Pharynx
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 486 at risk

Adverse event: Inf (clin/microbio) w/Gr 3-4 neuts - UTI
Serious: yes
Organ System: Infections and infestations
Frequency: 7 affected / 486 at risk

Adverse event: Inf w/normal ANC or Gr 1-2 neutrophils - Ab NOS
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 486 at risk

Adverse event: Inf w/normal ANC or Gr 1-2 neutrophils - Blood
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 486 at risk

Adverse event: Inf w/normal ANC or Gr 1-2 neutrophils - Catheter
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 486 at risk

Adverse event: Inf w/normal ANC or Gr 1-2 neutrophils - Colon
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 486 at risk

Adverse event: Inf w/normal ANC or Gr 1-2 neutrophils - Liver
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 486 at risk

Adverse event: Inf w/normal ANC or Gr 1-2 neutrophils - Lung
Serious: yes
Organ System: Infections and infestations
Frequency: 12 affected / 486 at risk

Adverse event: Inf w/normal ANC or Gr 1-2 neutrophils - Muscle
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 486 at risk

Adverse event: Inf w/normal ANC or Gr 1-2 neutrophils - Skin
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 486 at risk

Adverse event: Inf w/normal ANC or Gr 1-2 neutrophils - Trachea
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 486 at risk

Adverse event: Inf w/normal ANC or Gr 1-2 neutrophils - UTI
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 486 at risk

Adverse event: Infection (documented clinically or microbiologica
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 486 at risk

Adverse event: Infection with unknown ANC - Lung (pneumonia)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 486 at risk

Adverse event: Infection with unknown ANC - Wound
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 486 at risk

Adverse event: Infection-Other
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 486 at risk

Adverse event: Fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 5 affected / 486 at risk

Adverse event: AST, SGOT
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 486 at risk

Adverse event: Blood alkaline phosphatase
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 486 at risk

Adverse event: Bilirubin (hyperbilirubinemia)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 486 at risk

Adverse event: CPK (creatine phosphokinase)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 486 at risk

Adverse event: Cardiac troponin I (cTnI)
Serious: yes
Organ System: Investigations
Frequency: 5 affected / 486 at risk

Adverse event: Cardiac troponin T (cTnT)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 486 at risk

Adverse event: Blood creatinine
Serious: yes
Organ System: Investigations
Frequency: 6 affected / 486 at risk

Adverse event: Blood fibrinogen
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 486 at risk

Adverse event: INR (of prothrombin time)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 486 at risk

Adverse event: Leukocytes (total WBC)
Serious: yes
Organ System: Investigations
Frequency: 8 affected / 486 at risk

Adverse event: Lymphopenia
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 486 at risk

Adverse event: Neutrophils/granulocytes (ANC/AGC)
Serious: yes
Organ System: Investigations
Frequency: 15 affected / 486 at risk

Adverse event: Platelets
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 486 at risk

Adverse event: Prolonged QTc interval
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 486 at risk

Adverse event: Weight decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 486 at risk

Adverse event: Acidosis (metabolic or respiratory)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 486 at risk

Adverse event: Albumin, serum-low (hypoalbuminemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 486 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 486 at risk

Adverse event: Calcium, serum-low (hypocalcemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 486 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 13 affected / 486 at risk

Adverse event: Glucose, serum-high (hyperglycemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 486 at risk

Adverse event: Glucose, serum-low (hypoglycemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 486 at risk

Adverse event: Magnesium, serum-high (hypermagnesemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 486 at risk

Adverse event: Phosphate, serum-low (hypophosphatemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 486 at risk

Adverse event: Potassium, serum-low (hypokalemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 486 at risk

Adverse event: Sodium, serum-low (hyponatremia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 486 at risk

Adverse event: Joint-effusion
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 486 at risk

Adverse event: Muscle weakness, not d/t neuropathy - Extrem-lower
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 486 at risk

Adverse event: Muscle weakness, not d/t neuropathy - body/general
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 486 at risk

Adverse event: Musculoskeletal/Soft Tissue-Other
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 486 at risk

Adverse event: Pain - Back
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 486 at risk

Adverse event: Pain - Bone
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 486 at risk

Adverse event: Pain - Extremity-limb
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 486 at risk

Adverse event: Pain - Joint
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 486 at risk

Adverse event: Pain - Muscle
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 486 at risk

Adverse event: Death - Disease progression NOS
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 10 affected / 486 at risk

Adverse event: Pain - Tumor pain
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 486 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 486 at risk

Adverse event: Hemorrhage, CNS
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 486 at risk

Adverse event: Neuropathy: motor
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 486 at risk

Adverse event: Somnolence/depressed level of consciousness
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 486 at risk

Adverse event: Syncope (fainting)
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 486 at risk

Adverse event: Taste alteration (dysgeusia)
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 486 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Psychiatric disorders
Frequency: 4 affected / 486 at risk

Adverse event: Hemorrhage, GU - Urinary NOS
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 486 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 8 affected / 486 at risk

Adverse event: Renal/Genitourinary-Other
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 486 at risk

Adverse event: Urinary retention (including neurogenic bladder)
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 486 at risk

Adverse event: Adult respiratory distress syndrome (ARDS)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 486 at risk

Adverse event: Dyspnea (shortness of breath)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 25 affected / 486 at risk

Adverse event: Hemorrhage, pulmonary/upper respiratory - Lung
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 486 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 486 at risk

Adverse event: Pleural effusion (non-malignant)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 486 at risk

Adverse event: Pneumonitis/pulmonary infiltrates
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 486 at risk

Adverse event: Hyperpigmentation
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 486 at risk

Adverse event: Induration/fibrosis (skin and subcutaneous tissue)
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 486 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 486 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 13 affected / 486 at risk

Adverse event: Thrombosis/thrombus/embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 12 affected / 486 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 350 affected / 486 at risk

Adverse event: Vision-blurred vision
Serious: no
Organ System: Eye disorders
Frequency: 26 affected / 486 at risk

Adverse event: Watery eye (epiphora, tearing)
Serious: no
Organ System: Eye disorders
Frequency: 37 affected / 486 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 185 affected / 486 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 143 affected / 486 at risk

Adverse event: Dry mouth/salivary gland (xerostomia)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 33 affected / 486 at risk

Adverse event: Heartburn/dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 36 affected / 486 at risk

Adverse event: Mucositis/stomatitis (clinical exam) - Oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 39 affected / 486 at risk

Adverse event: Mucositis/stomatitis (functional/symp) - Oral cav
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 30 affected / 486 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 201 affected / 486 at risk

Adverse event: Pain - Abdomen NOS
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 29 affected / 486 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 78 affected / 486 at risk

Adverse event: Edema: limb
Serious: no
Organ System: General disorders
Frequency: 284 affected / 486 at risk

Adverse event: Fatigue (asthenia, lethargy, malaise)
Serious: no
Organ System: General disorders
Frequency: 357 affected / 486 at risk

Adverse event: Fever in absence of neutropenia, ANC lt1.0x10e9/L
Serious: no
Organ System: General disorders
Frequency: 43 affected / 486 at risk

Adverse event: Pain-Other
Serious: no
Organ System: General disorders
Frequency: 32 affected / 486 at risk

Adverse event: Bruising (in absence of Gr 3-4 thrombocytopenia)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 27 affected / 486 at risk

Adverse event: ALT, SGPT (serum glutamic pyruvic transaminase)
Serious: no
Organ System: Investigations
Frequency: 33 affected / 486 at risk

Adverse event: AST, SGOT
Serious: no
Organ System: Investigations
Frequency: 71 affected / 486 at risk

Adverse event: Blood alkaline phosphatase
Serious: no
Organ System: Investigations
Frequency: 106 affected / 486 at risk

Adverse event: Blood creatinine
Serious: no
Organ System: Investigations
Frequency: 79 affected / 486 at risk

Adverse event: Leukocytes (total WBC)
Serious: no
Organ System: Investigations
Frequency: 165 affected / 486 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Investigations
Frequency: 76 affected / 486 at risk

Adverse event: Metabolic/Laboratory-Other
Serious: no
Organ System: Investigations
Frequency: 23 affected / 486 at risk

Adverse event: Neutrophils/granulocytes (ANC/AGC)
Serious: no
Organ System: Investigations
Frequency: 179 affected / 486 at risk

Adverse event: Platelets
Serious: no
Organ System: Investigations
Frequency: 71 affected / 486 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 49 affected / 486 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 39 affected / 486 at risk

Adverse event: Albumin, serum-low (hypoalbuminemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 91 affected / 486 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 112 affected / 486 at risk

Adverse event: Calcium, serum-low (hypocalcemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 109 affected / 486 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 27 affected / 486 at risk

Adverse event: Glucose, serum-high (hyperglycemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 191 affected / 486 at risk

Adverse event: Potassium, serum-high (hyperkalemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 36 affected / 486 at risk

Adverse event: Potassium, serum-low (hypokalemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 59 affected / 486 at risk

Adverse event: Sodium, serum-low (hyponatremia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 75 affected / 486 at risk

Adverse event: Muscle weakness, not d/t neuropathy - body/general
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 39 affected / 486 at risk

Adverse event: Pain - Back
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 85 affected / 486 at risk

Adverse event: Pain - Bone
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 138 affected / 486 at risk

Adverse event: Pain - Extremity-limb
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 41 affected / 486 at risk

Adverse event: Pain - Joint
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 112 affected / 486 at risk

Adverse event: Pain - Muscle
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 119 affected / 486 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 91 affected / 486 at risk

Adverse event: Neuropathy: motor
Serious: no
Organ System: Nervous system disorders
Frequency: 25 affected / 486 at risk

Adverse event: Neuropathy: sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 202 affected / 486 at risk

Adverse event: Pain - Head/headache
Serious: no
Organ System: Nervous system disorders
Frequency: 70 affected / 486 at risk

Adverse event: Taste alteration (dysgeusia)
Serious: no
Organ System: Nervous system disorders
Frequency: 158 affected / 486 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 74 affected / 486 at risk

Adverse event: Mood alteration - anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 20 affected / 486 at risk

Adverse event: Mood alteration - depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 37 affected / 486 at risk

Adverse event: Urinary frequency/urgency
Serious: no
Organ System: Renal and urinary disorders
Frequency: 48 affected / 486 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 78 affected / 486 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 92 affected / 486 at risk

Adverse event: Dyspnea (shortness of breath)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 197 affected / 486 at risk

Adverse event: Hemorrhage, pulmonary/upper respiratory - Nose
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 17 affected / 486 at risk

Adverse event: Nasal cavity/paranasal sinus reactions
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 40 affected / 486 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 28 affected / 486 at risk

Adverse event: Hair loss/Alopecia (scalp or body)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 201 affected / 486 at risk

Adverse event: Nail disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 97 affected / 486 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 45 affected / 486 at risk

Adverse event: Hot flashes/flushes
Serious: no
Organ System: Vascular disorders
Frequency: 65 affected / 486 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 14 affected / 486 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 69 affected / 486 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 9 affected / 492 at risk

Adverse event: Haemoglobin
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 492 at risk

Adverse event: Cardiac-ischemia/infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 492 at risk

Adverse event: Cardiopulmonary arrest, cause unknown (non-fatal)
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 492 at risk

Adverse event: Left ventricular dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 492 at risk

Adverse event: Right ventricular dysfunction (cor pulmonale)
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 492 at risk

Adverse event: SVT and nodal arrhythmia - Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 492 at risk

Adverse event: SVT and nodal arrhythmia - Atrial flutter
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 492 at risk

Adverse event: Ventricular arrhythmia - Ventricular fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 492 at risk

Adverse event: Vision-blurred vision
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 492 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 492 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 492 at risk

Adverse event: Dysphagia (difficulty swallowing)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 492 at risk

Adverse event: Oesophagitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 492 at risk

Adverse event: Hemorrhage, GI - Colon
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 492 at risk

Adverse event: Hemorrhage, GI - Duodenum
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 492 at risk

Adverse event: Hemorrhage, GI - Lower GI NOS
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 492 at risk

Adverse event: Hemorrhage, GI - Rectum
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 492 at risk

Adverse event: Hemorrhage, GI - Upper GI NOS
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 492 at risk

Adverse event: Mucositis/stomatitis (clinical exam) - Esophagus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 492 at risk

Adverse event: Mucositis/stomatitis (clinical exam) - Oral cavity
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 492 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 492 at risk

Adverse event: Obstruction, GI - Colon
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 492 at risk

Adverse event: Obstruction, GI - Small bowel NOS
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 492 at risk

Adverse event: Pain - Abdomen NOS
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 492 at risk

Adverse event: Perforation, GI - Duodenum
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 492 at risk

Adverse event: Perforation, GI - Small bowel NOS
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 492 at risk

Adverse event: Proctitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 492 at risk

Adverse event: Ulcer, GI - Duodenum
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 492 at risk

Adverse event: Ulcer, GI - Stomach
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 492 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 492 at risk

Adverse event: Death not associated with CTCAE term - Death NOS
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 492 at risk

Adverse event: Edema: head and neck
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 492 at risk

Adverse event: Fatigue (asthenia, lethargy, malaise)
Serious: yes
Organ System: General disorders
Frequency: 6 affected / 492 at risk

Adverse event: Fever in absence of neutropenia, ANC lt1.0x10e9/L
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 492 at risk

Adverse event: Pain - Chest/thorax NOS
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 492 at risk

Adverse event: Pain - Pain NOS
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 492 at risk

Adverse event: Pain-Other
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 492 at risk

Adverse event: Sudden death
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 492 at risk

Adverse event: Inf (clin/microbio) w/Gr 3-4 neuts - Appendix
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 492 at risk

Adverse event: Inf (clin/microbio) w/Gr 3-4 neuts - Bladder
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 492 at risk

Adverse event: Inf (clin/microbio) w/Gr 3-4 neuts - Blood
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 492 at risk

Adverse event: Inf (clin/microbio) w/Gr 3-4 neuts - Lung
Serious: yes
Organ System: Infections and infestations
Frequency: 8 affected / 492 at risk

Adverse event: Inf (clin/microbio) w/Gr 3-4 neuts - UTI
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 492 at risk

Adverse event: Inf (clin/microbio) w/Gr 3-4 neuts - Upper airway
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 492 at risk

Adverse event: Inf w/normal ANC or Gr 1-2 neutrophils - Bladder
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 492 at risk

Adverse event: Inf w/normal ANC or Gr 1-2 neutrophils - Bronchus
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 492 at risk

Adverse event: Inf w/normal ANC or Gr 1-2 neutrophils - Lung
Serious: yes
Organ System: Infections and infestations
Frequency: 9 affected / 492 at risk

Adverse event: Inf w/normal ANC or Gr 1-2 neutrophils - Mid ear
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 492 at risk

Adverse event: Inf w/normal ANC or Gr 1-2 neutrophils - Scrotum
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 492 at risk

Adverse event: Inf w/normal ANC or Gr 1-2 neutrophils - Skin
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 492 at risk

Adverse event: Inf w/normal ANC or Gr 1-2 neutrophils - UTI
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 492 at risk

Adverse event: Inf w/normal ANC or Gr 1-2 neutrophils - Wound
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 492 at risk

Adverse event: Inf w/normal ANC or Gr 1-2 neutrophils -Nerve-peri
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 492 at risk

Adverse event: Inf w/unknown ANC - Middle ear (otitis media)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 492 at risk

Adverse event: Inf w/unknown ANC - Upper aerodigestive NOS
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 492 at risk

Adverse event: Infection with unknown ANC - Blood
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 492 at risk

Adverse event: Infection with unknown ANC - Rectum
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 492 at risk

Adverse event: Infection with unknown ANC - Upper airway NOS
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 492 at risk

Adverse event: Infection with unknown ANC - Urinary tract NOS
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 492 at risk

Adverse event: Infection-Other
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 492 at risk

Adverse event: Perforation, GI - Appendix
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 492 at risk

Adverse event: Fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 492 at risk

Adverse event: Thrombosis/embolism (vascular access-related)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 492 at risk

Adverse event: ALT, SGPT (serum glutamic pyruvic transaminase)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 492 at risk

Adverse event: AST, SGOT
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 492 at risk

Adverse event: Blood alkaline phosphatase
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 492 at risk

Adverse event: Cardiac troponin I (cTnI)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 492 at risk

Adverse event: Blood creatinine
Serious: yes
Organ System: Investigations
Frequency: 4 affected / 492 at risk

Adverse event: INR (of prothrombin time)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 492 at risk

Adverse event: Leukocytes (total WBC)
Serious: yes
Organ System: Investigations
Frequency: 8 affected / 492 at risk

Adverse event: Lymphopenia
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 492 at risk

Adverse event: Metabolic/Laboratory-Other
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 492 at risk

Adverse event: Neutrophils/granulocytes (ANC/AGC)
Serious: yes
Organ System: Investigations
Frequency: 11 affected / 492 at risk

Adverse event: Acidosis (metabolic or respiratory)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 492 at risk

Adverse event: Albumin, serum-low (hypoalbuminemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 492 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 492 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 492 at risk

Adverse event: Glucose, serum-high (hyperglycemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 492 at risk

Adverse event: Potassium, serum-high (hyperkalemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 492 at risk

Adverse event: Sodium, serum-low (hyponatremia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 492 at risk

Adverse event: Muscle weakness, not d/t neuropathy - Extrem-lower
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 492 at risk

Adverse event: Muscle weakness, not d/t neuropathy - body/general
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 492 at risk

Adverse event: Osteonecrosis (avascular necrosis)
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 492 at risk

Adverse event: Pain - Back
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 492 at risk

Adverse event: Pain - Bone
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 492 at risk

Adverse event: Pain - Chest wall
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 492 at risk

Adverse event: Pain - Extremity-limb
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 492 at risk

Adverse event: Death - Disease progression NOS
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 11 affected / 492 at risk

Adverse event: CNS cerebrovascular ischemia
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 492 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 492 at risk

Adverse event: Hemorrhage, CNS
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 492 at risk

Adverse event: Mental status
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 492 at risk

Adverse event: Neurology-Other
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 492 at risk

Adverse event: Neuropathy: CN III Pupil, eyelid, xtra ocular mvmt
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 492 at risk

Adverse event: Neuropathy: CN VII Motor-face; Sensory-taste
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 492 at risk

Adverse event: Neuropathy: cranial - CN VI Lateral deviation of e
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 492 at risk

Adverse event: Neuropathy: motor
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 492 at risk

Adverse event: Pain - Head/headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 492 at risk

Adverse event: Speech impairment (e.g., dysphasia or aphasia)
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 492 at risk

Adverse event: Vasovagal episode
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 492 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Psychiatric disorders
Frequency: 4 affected / 492 at risk

Adverse event: Mood alteration - depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 492 at risk

Adverse event: Personality/behavioral
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 492 at risk

Adverse event: Psychosis (hallucinations/delusions)
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 492 at risk

Adverse event: Hemorrhage, GU - Bladder
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 492 at risk

Adverse event: Hemorrhage, GU - Urinary NOS
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 492 at risk

Adverse event: Obstruction, GU - Ureter
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 492 at risk

Adverse event: Obstruction, GU - Urethra
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 492 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 7 affected / 492 at risk

Adverse event: Urinary retention (including neurogenic bladder)
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 492 at risk

Adverse event: Pain - Testicle
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 492 at risk

Adverse event: Adult respiratory distress syndrome (ARDS)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 492 at risk

Adverse event: Aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 492 at risk

Adverse event: Dyspnea (shortness of breath)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 492 at risk

Adverse event: Edema, larynx
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 492 at risk

Adverse event: Hemorrhage, Respiratory tract NOS
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 492 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 492 at risk

Adverse event: Pneumonitis/pulmonary infiltrates
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 492 at risk

Adverse event: Pulmonary fibrosis (radiographic changes)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 492 at risk

Adverse event: Dermatology/Skin-Other
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 492 at risk

Adverse event: Pain - Scalp
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 492 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 492 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 492 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 7 affected / 492 at risk

Adverse event: Thrombosis/thrombus/embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 17 affected / 492 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 331 affected / 492 at risk

Adverse event: Vision-blurred vision
Serious: no
Organ System: Eye disorders
Frequency: 14 affected / 492 at risk

Adverse event: Watery eye (epiphora, tearing)
Serious: no
Organ System: Eye disorders
Frequency: 41 affected / 492 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 176 affected / 492 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 149 affected / 492 at risk

Adverse event: Dry mouth/salivary gland (xerostomia)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 23 affected / 492 at risk

Adverse event: Heartburn/dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 43 affected / 492 at risk

Adverse event: Mucositis/stomatitis (clinical exam) - Oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 27 affected / 492 at risk

Adverse event: Mucositis/stomatitis (functional/symp) - Oral cav
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 46 affected / 492 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 188 affected / 492 at risk

Adverse event: Pain - Abdomen NOS
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 46 affected / 492 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 62 affected / 492 at risk

Adverse event: Edema: limb
Serious: no
Organ System: General disorders
Frequency: 178 affected / 492 at risk

Adverse event: Fatigue (asthenia, lethargy, malaise)
Serious: no
Organ System: General disorders
Frequency: 346 affected / 492 at risk

Adverse event: Fever in absence of neutropenia, ANC lt1.0x10e9/L
Serious: no
Organ System: General disorders
Frequency: 30 affected / 492 at risk

Adverse event: Pain-Other
Serious: no
Organ System: General disorders
Frequency: 34 affected / 492 at risk

Adverse event: Bruising (in absence of Gr 3-4 thrombocytopenia)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 21 affected / 492 at risk

Adverse event: ALT, SGPT (serum glutamic pyruvic transaminase)
Serious: no
Organ System: Investigations
Frequency: 36 affected / 492 at risk

Adverse event: AST, SGOT
Serious: no
Organ System: Investigations
Frequency: 80 affected / 492 at risk

Adverse event: Blood alkaline phosphatase
Serious: no
Organ System: Investigations
Frequency: 113 affected / 492 at risk

Adverse event: Blood creatinine
Serious: no
Organ System: Investigations
Frequency: 71 affected / 492 at risk

Adverse event: Leukocytes (total WBC)
Serious: no
Organ System: Investigations
Frequency: 165 affected / 492 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Investigations
Frequency: 72 affected / 492 at risk

Adverse event: Metabolic/Laboratory-Other
Serious: no
Organ System: Investigations
Frequency: 27 affected / 492 at risk

Adverse event: Neutrophils/granulocytes (ANC/AGC)
Serious: no
Organ System: Investigations
Frequency: 180 affected / 492 at risk

Adverse event: Platelets
Serious: no
Organ System: Investigations
Frequency: 47 affected / 492 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 36 affected / 492 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 36 affected / 492 at risk

Adverse event: Albumin, serum-low (hypoalbuminemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 90 affected / 492 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 106 affected / 492 at risk

Adverse event: Calcium, serum-low (hypocalcemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 75 affected / 492 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 29 affected / 492 at risk

Adverse event: Glucose, serum-high (hyperglycemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 202 affected / 492 at risk

Adverse event: Potassium, serum-high (hyperkalemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 33 affected / 492 at risk

Adverse event: Potassium, serum-low (hypokalemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 47 affected / 492 at risk

Adverse event: Sodium, serum-low (hyponatremia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 61 affected / 492 at risk

Adverse event: Muscle weakness, not d/t neuropathy - body/general
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 44 affected / 492 at risk

Adverse event: Pain - Back
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 86 affected / 492 at risk

Adverse event: Pain - Bone
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 156 affected / 492 at risk

Adverse event: Pain - Extremity-limb
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 45 affected / 492 at risk

Adverse event: Pain - Joint
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 119 affected / 492 at risk

Adverse event: Pain - Muscle
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 104 affected / 492 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 96 affected / 492 at risk

Adverse event: Neuropathy: motor
Serious: no
Organ System: Nervous system disorders
Frequency: 43 affected / 492 at risk

Adverse event: Neuropathy: sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 223 affected / 492 at risk

Adverse event: Pain - Head/headache
Serious: no
Organ System: Nervous system disorders
Frequency: 45 affected / 492 at risk

Adverse event: Taste alteration (dysgeusia)
Serious: no
Organ System: Nervous system disorders
Frequency: 132 affected / 492 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 80 affected / 492 at risk

Adverse event: Mood alteration - anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 27 affected / 492 at risk

Adverse event: Mood alteration - depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 28 affected / 492 at risk

Adverse event: Urinary frequency/urgency
Serious: no
Organ System: Renal and urinary disorders
Frequency: 58 affected / 492 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 50 affected / 492 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 80 affected / 492 at risk

Adverse event: Dyspnea (shortness of breath)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 156 affected / 492 at risk

Adverse event: Hemorrhage, pulmonary/upper respiratory - Nose
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 29 affected / 492 at risk

Adverse event: Nasal cavity/paranasal sinus reactions
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 30 affected / 492 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 33 affected / 492 at risk

Adverse event: Hair loss/Alopecia (scalp or body)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 192 affected / 492 at risk

Adverse event: Nail disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 149 affected / 492 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 70 affected / 492 at risk

Adverse event: Hot flashes/flushes
Serious: no
Organ System: Vascular disorders
Frequency: 71 affected / 492 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 35 affected / 492 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 42 affected / 492 at risk