Study: NCT00085709

Adverse event: DIC (disseminated intravascular coagulation)
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 293 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 293 at risk

Adverse event: Haemoglobin
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 293 at risk

Adverse event: Cardiac-ischemia/infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 293 at risk

Adverse event: Pericardial effusion (non-malignant)
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 293 at risk

Adverse event: Pericarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 293 at risk

Adverse event: Typhlitis (cecal inflammation)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 293 at risk

Adverse event: Death not associated with CTCAE term - Multi-organ failure
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 293 at risk

Adverse event: Fatigue (asthenia, lethargy, malaise)
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 293 at risk

Adverse event: Hepatobiliary/Pancreas-Other (Specify)
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 293 at risk

Adverse event: Liver dysfunction/failure (clinical)
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 4 affected / 293 at risk

Adverse event: Portal vein flow
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 293 at risk

Adverse event: Allergic reaction/hypersensitivity (including drug fever)
Serious: yes
Organ System: Immune system disorders
Frequency: 2 affected / 293 at risk

Adverse event: Colitis, infectious (e.g., Clostridium difficile)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 293 at risk

Adverse event: Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Blood
Serious: yes
Organ System: Infections and infestations
Frequency: 8 affected / 293 at risk

Adverse event: Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Colon
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 293 at risk

Adverse event: Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Heart (endoca
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 293 at risk

Adverse event: Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Lung (pneumon
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 293 at risk

Adverse event: Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Pelvis NOS
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 293 at risk

Adverse event: Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Skin (celluli
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 293 at risk

Adverse event: ALT, SGPT (serum glutamic pyruvic transaminase)
Serious: yes
Organ System: Investigations
Frequency: 5 affected / 293 at risk

Adverse event: AST, SGOT (serum glutamic oxaloacetic transaminase)
Serious: yes
Organ System: Investigations
Frequency: 4 affected / 293 at risk

Adverse event: Bilirubin (hyperbilirubinemia)
Serious: yes
Organ System: Investigations
Frequency: 3 affected / 293 at risk

Adverse event: Blood creatinine
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 293 at risk

Adverse event: Leukocytes (total WBC)
Serious: yes
Organ System: Investigations
Frequency: 5 affected / 293 at risk

Adverse event: Neutrophils/granulocytes (ANC/AGC)
Serious: yes
Organ System: Investigations
Frequency: 3 affected / 293 at risk

Adverse event: Platelets
Serious: yes
Organ System: Investigations
Frequency: 9 affected / 293 at risk

Adverse event: Calcium, serum-low (hypocalcemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 293 at risk

Adverse event: Glucose, serum-low (hypoglycemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 293 at risk

Adverse event: Pancreatic endocrine: glucose intolerance
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 293 at risk

Adverse event: Potassium, serum-low (hypokalemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 293 at risk

Adverse event: Uric acid, serum-high (hyperuricemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 293 at risk

Adverse event: Pain - Joint
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 293 at risk

Adverse event: Hemorrhage, CNS
Serious: yes
Organ System: Nervous system disorders
Frequency: 5 affected / 293 at risk

Adverse event: Neurology-Other (Specify)
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 293 at risk

Adverse event: Hemorrhage, GU - Bladder
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 293 at risk

Adverse event: Hemorrhage, GU - Kidney
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 293 at risk

Adverse event: Adult respiratory distress syndrome (ARDS)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 293 at risk

Adverse event: Dyspnea (shortness of breath)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 293 at risk

Adverse event: Hemorrhage, pulmonary/upper respiratory - Lung
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 293 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 293 at risk

Adverse event: Pleural effusion (non-malignant)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 293 at risk

Adverse event: Pneumonitis/pulmonary infiltrates
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 293 at risk

Adverse event: Rash/desquamation
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 293 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 293 at risk

Adverse event: Phlebitis (including superficial thrombosis)
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 293 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 172 affected / 293 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 116 affected / 293 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 36 affected / 293 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 115 affected / 293 at risk

Adverse event: Mucositis/stomatitis (clinical exam) - Oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 76 affected / 293 at risk

Adverse event: Mucositis/stomatitis (functional/symptomatic) - Oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 33 affected / 293 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 165 affected / 293 at risk

Adverse event: Pain - Abdomen NOS
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 51 affected / 293 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 93 affected / 293 at risk

Adverse event: Edema: limb
Serious: no
Organ System: General disorders
Frequency: 38 affected / 293 at risk

Adverse event: Fatigue (asthenia, lethargy, malaise)
Serious: no
Organ System: General disorders
Frequency: 140 affected / 293 at risk

Adverse event: Fever (in the absence of neutropenia, where neutropenia is defined as ANC lt1.0 x 10e9/L)
Serious: no
Organ System: General disorders
Frequency: 56 affected / 293 at risk

Adverse event: Rigors/chills
Serious: no
Organ System: General disorders
Frequency: 71 affected / 293 at risk

Adverse event: Allergic reaction/hypersensitivity (including drug fever)
Serious: no
Organ System: Immune system disorders
Frequency: 15 affected / 293 at risk

Adverse event: Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Blood
Serious: no
Organ System: Infections and infestations
Frequency: 23 affected / 293 at risk

Adverse event: Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Lung (pneumon
Serious: no
Organ System: Infections and infestations
Frequency: 22 affected / 293 at risk

Adverse event: ALT, SGPT (serum glutamic pyruvic transaminase)
Serious: no
Organ System: Investigations
Frequency: 124 affected / 293 at risk

Adverse event: AST, SGOT (serum glutamic oxaloacetic transaminase)
Serious: no
Organ System: Investigations
Frequency: 126 affected / 293 at risk

Adverse event: Blood alkaline phosphatase
Serious: no
Organ System: Investigations
Frequency: 79 affected / 293 at risk

Adverse event: Bilirubin (hyperbilirubinemia)
Serious: no
Organ System: Investigations
Frequency: 51 affected / 293 at risk

Adverse event: Blood creatinine
Serious: no
Organ System: Investigations
Frequency: 34 affected / 293 at risk

Adverse event: Leukocytes (total WBC)
Serious: no
Organ System: Investigations
Frequency: 101 affected / 293 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Investigations
Frequency: 32 affected / 293 at risk

Adverse event: Metabolic/Laboratory-Other (Specify)
Serious: no
Organ System: Investigations
Frequency: 16 affected / 293 at risk

Adverse event: Neutrophils/granulocytes (ANC/AGC)
Serious: no
Organ System: Investigations
Frequency: 109 affected / 293 at risk

Adverse event: Platelets
Serious: no
Organ System: Investigations
Frequency: 136 affected / 293 at risk

Adverse event: Albumin, serum-low (hypoalbuminemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 69 affected / 293 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 85 affected / 293 at risk

Adverse event: Calcium, serum-low (hypocalcemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 44 affected / 293 at risk

Adverse event: Glucose, serum-high (hyperglycemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 79 affected / 293 at risk

Adverse event: Magnesium, serum-low (hypomagnesemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 17 affected / 293 at risk

Adverse event: Phosphate, serum-low (hypophosphatemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 17 affected / 293 at risk

Adverse event: Potassium, serum-high (hyperkalemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 20 affected / 293 at risk

Adverse event: Potassium, serum-low (hypokalemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 55 affected / 293 at risk

Adverse event: Sodium, serum-low (hyponatremia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 42 affected / 293 at risk

Adverse event: Pain - Head/headache
Serious: no
Organ System: Nervous system disorders
Frequency: 72 affected / 293 at risk

Adverse event: Taste alteration (dysgeusia)
Serious: no
Organ System: Nervous system disorders
Frequency: 18 affected / 293 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 15 affected / 293 at risk

Adverse event: Dyspnea (shortness of breath)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 33 affected / 293 at risk

Adverse event: Hemorrhage, pulmonary/upper respiratory - Nose
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 37 affected / 293 at risk

Adverse event: Hair loss/Alopecia (scalp or body)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 76 affected / 293 at risk

Adverse event: Petechiae/purpura (hemorrhage/bleeding into skin or mucosa)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 53 affected / 293 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 51 affected / 293 at risk

Adverse event: Hemorrhage/Bleeding-Other (Specify)
Serious: no
Organ System: Vascular disorders
Frequency: 27 affected / 293 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 21 affected / 293 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 17 affected / 293 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 293 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 293 at risk

Adverse event: Perforation, GI - Colon
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 293 at risk

Adverse event: Typhlitis (cecal inflammation)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 293 at risk

Adverse event: Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Blood
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 293 at risk

Adverse event: Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Lung (pneumon
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 293 at risk

Adverse event: Platelets
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 293 at risk

Adverse event: Potassium, serum-low (hypokalemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 293 at risk

Adverse event: Hemorrhage, CNS
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 293 at risk

Adverse event: Neurology-Other (Specify)
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 293 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 194 affected / 293 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 109 affected / 293 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 32 affected / 293 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 130 affected / 293 at risk

Adverse event: Heartburn/dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 25 affected / 293 at risk

Adverse event: Mucositis/stomatitis (clinical exam) - Oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 64 affected / 293 at risk

Adverse event: Mucositis/stomatitis (functional/symptomatic) - Oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 37 affected / 293 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 159 affected / 293 at risk

Adverse event: Pain - Abdomen NOS
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 35 affected / 293 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 75 affected / 293 at risk

Adverse event: Edema: limb
Serious: no
Organ System: General disorders
Frequency: 24 affected / 293 at risk

Adverse event: Fatigue (asthenia, lethargy, malaise)
Serious: no
Organ System: General disorders
Frequency: 142 affected / 293 at risk

Adverse event: Fever (in the absence of neutropenia, where neutropenia is defined as ANC lt1.0 x 10e9/L)
Serious: no
Organ System: General disorders
Frequency: 55 affected / 293 at risk

Adverse event: Rigors/chills
Serious: no
Organ System: General disorders
Frequency: 55 affected / 293 at risk

Adverse event: Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Blood
Serious: no
Organ System: Infections and infestations
Frequency: 24 affected / 293 at risk

Adverse event: Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Lung (pneumon
Serious: no
Organ System: Infections and infestations
Frequency: 26 affected / 293 at risk

Adverse event: ALT, SGPT (serum glutamic pyruvic transaminase)
Serious: no
Organ System: Investigations
Frequency: 90 affected / 293 at risk

Adverse event: AST, SGOT (serum glutamic oxaloacetic transaminase)
Serious: no
Organ System: Investigations
Frequency: 92 affected / 293 at risk

Adverse event: Blood alkaline phosphatase
Serious: no
Organ System: Investigations
Frequency: 60 affected / 293 at risk

Adverse event: Bilirubin (hyperbilirubinemia)
Serious: no
Organ System: Investigations
Frequency: 63 affected / 293 at risk

Adverse event: Blood creatinine
Serious: no
Organ System: Investigations
Frequency: 19 affected / 293 at risk

Adverse event: Leukocytes (total WBC)
Serious: no
Organ System: Investigations
Frequency: 97 affected / 293 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Investigations
Frequency: 27 affected / 293 at risk

Adverse event: Neutrophils/granulocytes (ANC/AGC)
Serious: no
Organ System: Investigations
Frequency: 111 affected / 293 at risk

Adverse event: Platelets
Serious: no
Organ System: Investigations
Frequency: 130 affected / 293 at risk

Adverse event: Albumin, serum-low (hypoalbuminemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 53 affected / 293 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 75 affected / 293 at risk

Adverse event: Calcium, serum-low (hypocalcemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 53 affected / 293 at risk

Adverse event: Glucose, serum-high (hyperglycemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 71 affected / 293 at risk

Adverse event: Phosphate, serum-low (hypophosphatemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 18 affected / 293 at risk

Adverse event: Potassium, serum-low (hypokalemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 44 affected / 293 at risk

Adverse event: Sodium, serum-low (hyponatremia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 41 affected / 293 at risk

Adverse event: Pain - Bone
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 15 affected / 293 at risk

Adverse event: Pain - Head/headache
Serious: no
Organ System: Nervous system disorders
Frequency: 48 affected / 293 at risk

Adverse event: Taste alteration (dysgeusia)
Serious: no
Organ System: Nervous system disorders
Frequency: 16 affected / 293 at risk

Adverse event: Dyspnea (shortness of breath)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 20 affected / 293 at risk

Adverse event: Hemorrhage, pulmonary/upper respiratory - Nose
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 24 affected / 293 at risk

Adverse event: Hair loss/Alopecia (scalp or body)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 98 affected / 293 at risk

Adverse event: Petechiae/purpura (hemorrhage/bleeding into skin or mucosa)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 45 affected / 293 at risk

Adverse event: Pruritus/itching
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 15 affected / 293 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 64 affected / 293 at risk

Adverse event: Hemorrhage/Bleeding-Other (Specify)
Serious: no
Organ System: Vascular disorders
Frequency: 15 affected / 293 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 15 affected / 293 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 375 at risk

Adverse event: Syndromes-Other (Specify)
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 375 at risk

Adverse event: Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Blood
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 375 at risk

Adverse event: Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Lung (pneumon
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 375 at risk

Adverse event: ALT, SGPT (serum glutamic pyruvic transaminase)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 375 at risk

Adverse event: AST, SGOT (serum glutamic oxaloacetic transaminase)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 375 at risk

Adverse event: Blood alkaline phosphatase
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 375 at risk

Adverse event: Leukocytes (total WBC)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 375 at risk

Adverse event: Metabolic/Laboratory-Other (Specify)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 375 at risk

Adverse event: Neutrophils/granulocytes (ANC/AGC)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 375 at risk

Adverse event: Platelets
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 375 at risk

Adverse event: Leukoencephalopathy (radiolographic findings)
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 375 at risk

Adverse event: Adult respiratory distress syndrome (ARDS)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 375 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 375 at risk

Adverse event: Pneumonitis/pulmonary infiltrates
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 375 at risk

Adverse event: Pulmonary/Upper Respiratory-Other (Specify)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 375 at risk

Adverse event: Hemorrhage/Bleeding-Other (Specify)
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 375 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 375 at risk

Adverse event: Thrombosis/thrombus/embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 375 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 178 affected / 375 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 201 affected / 375 at risk

Adverse event: Vision-blurred vision
Serious: no
Organ System: Eye disorders
Frequency: 19 affected / 375 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 46 affected / 375 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 76 affected / 375 at risk

Adverse event: Heartburn/dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 20 affected / 375 at risk

Adverse event: Hemorrhage, GI - Oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 19 affected / 375 at risk

Adverse event: Mucositis/stomatitis (clinical exam) - Oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 63 affected / 375 at risk

Adverse event: Mucositis/stomatitis (functional/symptomatic) - Oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 35 affected / 375 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 182 affected / 375 at risk

Adverse event: Pain - Abdomen NOS
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 31 affected / 375 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 97 affected / 375 at risk

Adverse event: Edema: limb
Serious: no
Organ System: General disorders
Frequency: 27 affected / 375 at risk

Adverse event: Fatigue (asthenia, lethargy, malaise)
Serious: no
Organ System: General disorders
Frequency: 210 affected / 375 at risk

Adverse event: Fever (in the absence of neutropenia, where neutropenia is defined as ANC lt1.0 x 10e9/L)
Serious: no
Organ System: General disorders
Frequency: 97 affected / 375 at risk

Adverse event: Rigors/chills
Serious: no
Organ System: General disorders
Frequency: 56 affected / 375 at risk

Adverse event: Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Blood
Serious: no
Organ System: Infections and infestations
Frequency: 47 affected / 375 at risk

Adverse event: Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Lung (pneumon
Serious: no
Organ System: Infections and infestations
Frequency: 23 affected / 375 at risk

Adverse event: ALT, SGPT (serum glutamic pyruvic transaminase)
Serious: no
Organ System: Investigations
Frequency: 137 affected / 375 at risk

Adverse event: AST, SGOT (serum glutamic oxaloacetic transaminase)
Serious: no
Organ System: Investigations
Frequency: 121 affected / 375 at risk

Adverse event: Blood alkaline phosphatase
Serious: no
Organ System: Investigations
Frequency: 84 affected / 375 at risk

Adverse event: Bilirubin (hyperbilirubinemia)
Serious: no
Organ System: Investigations
Frequency: 75 affected / 375 at risk

Adverse event: Blood creatinine
Serious: no
Organ System: Investigations
Frequency: 23 affected / 375 at risk

Adverse event: Leukocytes (total WBC)
Serious: no
Organ System: Investigations
Frequency: 152 affected / 375 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Investigations
Frequency: 50 affected / 375 at risk

Adverse event: Metabolic/Laboratory-Other (Specify)
Serious: no
Organ System: Investigations
Frequency: 21 affected / 375 at risk

Adverse event: Neutrophils/granulocytes (ANC/AGC)
Serious: no
Organ System: Investigations
Frequency: 195 affected / 375 at risk

Adverse event: Platelets
Serious: no
Organ System: Investigations
Frequency: 227 affected / 375 at risk

Adverse event: Albumin, serum-low (hypoalbuminemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 81 affected / 375 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 76 affected / 375 at risk

Adverse event: Calcium, serum-low (hypocalcemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 44 affected / 375 at risk

Adverse event: Glucose, serum-high (hyperglycemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 97 affected / 375 at risk

Adverse event: Magnesium, serum-low (hypomagnesemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 25 affected / 375 at risk

Adverse event: Potassium, serum-low (hypokalemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 61 affected / 375 at risk

Adverse event: Sodium, serum-low (hyponatremia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 39 affected / 375 at risk

Adverse event: Uric acid, serum-high (hyperuricemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 20 affected / 375 at risk

Adverse event: Pain - Bone
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 40 affected / 375 at risk

Adverse event: Pain - Joint
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 21 affected / 375 at risk

Adverse event: Pain - Muscle
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 19 affected / 375 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 42 affected / 375 at risk

Adverse event: Pain - Head/headache
Serious: no
Organ System: Nervous system disorders
Frequency: 94 affected / 375 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 25 affected / 375 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 20 affected / 375 at risk

Adverse event: Dyspnea (shortness of breath)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 59 affected / 375 at risk

Adverse event: Hemorrhage, pulmonary/upper respiratory - Nose
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 26 affected / 375 at risk

Adverse event: Hair loss/Alopecia (scalp or body)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 118 affected / 375 at risk

Adverse event: Petechiae/purpura (hemorrhage/bleeding into skin or mucosa)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 85 affected / 375 at risk

Adverse event: Pruritus/itching
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 20 affected / 375 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 62 affected / 375 at risk

Adverse event: Hemorrhage/Bleeding-Other (Specify)
Serious: no
Organ System: Vascular disorders
Frequency: 29 affected / 375 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 28 affected / 375 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 9 affected / 78 at risk

Adverse event: Mucositis/stomatitis (clinical exam) - Oral cavity
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 78 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 78 at risk

Adverse event: Pain - Rectum
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 78 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 78 at risk

Adverse event: Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Blood
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 78 at risk

Adverse event: Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Skin (celluli
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 78 at risk

Adverse event: Infection-Other (Specify)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 78 at risk

Adverse event: ALT, SGPT (serum glutamic pyruvic transaminase)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 78 at risk

Adverse event: AST, SGOT (serum glutamic oxaloacetic transaminase)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 78 at risk

Adverse event: Leukocytes (total WBC)
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 78 at risk

Adverse event: Neutrophils/granulocytes (ANC/AGC)
Serious: yes
Organ System: Investigations
Frequency: 5 affected / 78 at risk

Adverse event: Platelets
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 78 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 78 at risk

Adverse event: Glucose, serum-high (hyperglycemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 78 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 14 affected / 78 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 27 affected / 78 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 78 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 78 at risk

Adverse event: Mucositis/stomatitis (clinical exam) - Oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 78 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 40 affected / 78 at risk

Adverse event: Pain - Abdomen NOS
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 78 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 22 affected / 78 at risk

Adverse event: Fatigue (asthenia, lethargy, malaise)
Serious: no
Organ System: General disorders
Frequency: 41 affected / 78 at risk

Adverse event: Fever (in the absence of neutropenia, where neutropenia is defined as ANC lt1.0 x 10e9/L)
Serious: no
Organ System: General disorders
Frequency: 14 affected / 78 at risk

Adverse event: Rigors/chills
Serious: no
Organ System: General disorders
Frequency: 8 affected / 78 at risk

Adverse event: ALT, SGPT (serum glutamic pyruvic transaminase)
Serious: no
Organ System: Investigations
Frequency: 34 affected / 78 at risk

Adverse event: AST, SGOT (serum glutamic oxaloacetic transaminase)
Serious: no
Organ System: Investigations
Frequency: 33 affected / 78 at risk

Adverse event: Blood alkaline phosphatase
Serious: no
Organ System: Investigations
Frequency: 22 affected / 78 at risk

Adverse event: Leukocytes (total WBC)
Serious: no
Organ System: Investigations
Frequency: 40 affected / 78 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Investigations
Frequency: 10 affected / 78 at risk

Adverse event: Neutrophils/granulocytes (ANC/AGC)
Serious: no
Organ System: Investigations
Frequency: 40 affected / 78 at risk

Adverse event: Platelets
Serious: no
Organ System: Investigations
Frequency: 49 affected / 78 at risk

Adverse event: Albumin, serum-low (hypoalbuminemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 78 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 9 affected / 78 at risk

Adverse event: Calcium, serum-low (hypocalcemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 78 at risk

Adverse event: Glucose, serum-high (hyperglycemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 21 affected / 78 at risk

Adverse event: Potassium, serum-low (hypokalemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 12 affected / 78 at risk

Adverse event: Sodium, serum-low (hyponatremia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 78 at risk

Adverse event: Muscle weakness, generalized or specific area (not due to neuropathy) - Whole body/generalized
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 78 at risk

Adverse event: Pain - Bone
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 78 at risk

Adverse event: Pain - Joint
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 78 at risk

Adverse event: Pain - Head/headache
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 78 at risk

Adverse event: Hemorrhage, pulmonary/upper respiratory - Nose
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 78 at risk

Adverse event: Hair loss/Alopecia (scalp or body)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 78 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 78 at risk