Study: NCT00070564

Adverse event: Blood/Bone Marrow-Other
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 654 at risk

Adverse event: DIC (disseminated intravascular coagulation)
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 654 at risk

Adverse event: Left ventricular dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 654 at risk

Adverse event: Left ventricular dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 654 at risk

Adverse event: Ventricular arrhythmia - PVCs
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 654 at risk

Adverse event: Death - Multi-organ failure
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 654 at risk

Adverse event: Liver dysfunction/failure (clinical)
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 654 at risk

Adverse event: Inf (clin/microbio) w/Gr 3-4 neuts - Lung
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 654 at risk

Adverse event: Inf w/normal ANC or Gr 1-2 neutrophils - Blood
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 654 at risk

Adverse event: Secondary Malignancy-poss rel to cancer Tx
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 654 at risk

Adverse event: Adult respiratory distress syndrome (ARDS)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 654 at risk

Adverse event: Pulmonary/Upper Respiratory-Other
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 654 at risk

Adverse event: Thrombosis/thrombus/embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 654 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 49 affected / 654 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 87 affected / 654 at risk

Adverse event: Mucositis/stomatitis (clinical exam) - Oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 654 at risk

Adverse event: Mucositis/stomatitis (functional/symp) - Oral cav
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 654 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 50 affected / 654 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 31 affected / 654 at risk

Adverse event: Fatigue (asthenia, lethargy, malaise)
Serious: no
Organ System: General disorders
Frequency: 77 affected / 654 at risk

Adverse event: Leukocytes (total WBC)
Serious: no
Organ System: Investigations
Frequency: 128 affected / 654 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Investigations
Frequency: 24 affected / 654 at risk

Adverse event: Neutrophils/granulocytes (ANC/AGC)
Serious: no
Organ System: Investigations
Frequency: 174 affected / 654 at risk

Adverse event: Pain - Bone
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 10 affected / 654 at risk

Adverse event: Pain - Joint
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 39 affected / 654 at risk

Adverse event: Pain - Muscle
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 42 affected / 654 at risk

Adverse event: Neuropathy: sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 107 affected / 654 at risk

Adverse event: Rash: hand-foot skin reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 19 affected / 654 at risk

Adverse event: Constitutional Symptoms-Other
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 663 at risk

Adverse event: Inf (clin/microbio) w/Gr 3-4 neuts - Lung
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 663 at risk

Adverse event: Thrombosis/embolism (vascular access-related)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 663 at risk

Adverse event: Myelodysplastic syndrome
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 663 at risk

Adverse event: Secondary Malignancy-poss rel to cancer Tx
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 663 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 663 at risk

Adverse event: Pleural effusion (non-malignant)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 663 at risk

Adverse event: Pulmonary/Upper Respiratory-Other
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 663 at risk

Adverse event: Thrombosis/thrombus/embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 663 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 9 affected / 663 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 48 affected / 663 at risk

Adverse event: Mucositis/stomatitis (clinical exam) - Oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 56 affected / 663 at risk

Adverse event: Mucositis/stomatitis (functional/symp) - Oral cav
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 38 affected / 663 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 40 affected / 663 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 29 affected / 663 at risk

Adverse event: Fatigue (asthenia, lethargy, malaise)
Serious: no
Organ System: General disorders
Frequency: 59 affected / 663 at risk

Adverse event: Leukocytes (total WBC)
Serious: no
Organ System: Investigations
Frequency: 98 affected / 663 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Investigations
Frequency: 31 affected / 663 at risk

Adverse event: Neutrophils/granulocytes (ANC/AGC)
Serious: no
Organ System: Investigations
Frequency: 156 affected / 663 at risk

Adverse event: Pain - Bone
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 36 affected / 663 at risk

Adverse event: Pain - Joint
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 40 affected / 663 at risk

Adverse event: Pain - Muscle
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 48 affected / 663 at risk

Adverse event: Neuropathy: sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 101 affected / 663 at risk

Adverse event: Rash: hand-foot skin reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 95 affected / 663 at risk

Adverse event: Cardiac-ischemia/infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 674 at risk

Adverse event: Conduction abnormality - Asystole
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 674 at risk

Adverse event: Left ventricular dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 674 at risk

Adverse event: Myocarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 674 at risk

Adverse event: Death - Multi-organ failure
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 674 at risk

Adverse event: Liver dysfunction/failure (clinical)
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 674 at risk

Adverse event: Inf w/normal ANC or Gr 1-2 neutrophils - Soft tiss
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 674 at risk

Adverse event: ALT, SGPT (serum glutamic pyruvic transaminase)
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 674 at risk

Adverse event: AST, SGOT
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 674 at risk

Adverse event: Bilirubin (hyperbilirubinemia)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 674 at risk

Adverse event: Cardiac troponin I (cTnI)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 674 at risk

Adverse event: Neutrophils/granulocytes (ANC/AGC)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 674 at risk

Adverse event: Myelodysplastic syndrome
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 674 at risk

Adverse event: Secondary Malignancy-poss rel to cancer Tx
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 4 affected / 674 at risk

Adverse event: Dyspnea (shortness of breath)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 674 at risk

Adverse event: Pneumonitis/pulmonary infiltrates
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 674 at risk

Adverse event: Pulmonary/Upper Respiratory-Other
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 674 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 674 at risk

Adverse event: Thrombosis/thrombus/embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 674 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 38 affected / 674 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 101 affected / 674 at risk

Adverse event: Mucositis/stomatitis (clinical exam) - Oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 23 affected / 674 at risk

Adverse event: Mucositis/stomatitis (functional/symp) - Oral cav
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 28 affected / 674 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 53 affected / 674 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 38 affected / 674 at risk

Adverse event: Fatigue (asthenia, lethargy, malaise)
Serious: no
Organ System: General disorders
Frequency: 87 affected / 674 at risk

Adverse event: Leukocytes (total WBC)
Serious: no
Organ System: Investigations
Frequency: 157 affected / 674 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Investigations
Frequency: 26 affected / 674 at risk

Adverse event: Neutrophils/granulocytes (ANC/AGC)
Serious: no
Organ System: Investigations
Frequency: 217 affected / 674 at risk

Adverse event: Pain - Bone
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 15 affected / 674 at risk

Adverse event: Pain - Joint
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 21 affected / 674 at risk

Adverse event: Pain - Muscle
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 21 affected / 674 at risk

Adverse event: Neuropathy: sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 76 affected / 674 at risk

Adverse event: Rash: hand-foot skin reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 16 affected / 674 at risk

Adverse event: Death not associated with CTCAE term - Death NOS
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 624 at risk

Adverse event: Inf (clin/microbio) w/Gr 3-4 neuts - Lung
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 624 at risk

Adverse event: Inf w/normal ANC or Gr 1-2 neutrophils - Lung
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 624 at risk

Adverse event: Secondary Malignancy-poss rel to cancer Tx
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 3 affected / 624 at risk

Adverse event: CNS cerebrovascular ischemia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 624 at risk

Adverse event: Thrombosis/thrombus/embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 624 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 20 affected / 624 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 47 affected / 624 at risk

Adverse event: Mucositis/stomatitis (clinical exam) - Oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 57 affected / 624 at risk

Adverse event: Mucositis/stomatitis (functional/symp) - Oral cav
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 40 affected / 624 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 33 affected / 624 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 624 at risk

Adverse event: Fatigue (asthenia, lethargy, malaise)
Serious: no
Organ System: General disorders
Frequency: 65 affected / 624 at risk

Adverse event: Leukocytes (total WBC)
Serious: no
Organ System: Investigations
Frequency: 128 affected / 624 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Investigations
Frequency: 32 affected / 624 at risk

Adverse event: Neutrophils/granulocytes (ANC/AGC)
Serious: no
Organ System: Investigations
Frequency: 201 affected / 624 at risk

Adverse event: Pain - Bone
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 9 affected / 624 at risk

Adverse event: Pain - Joint
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 12 affected / 624 at risk

Adverse event: Pain - Muscle
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 11 affected / 624 at risk

Adverse event: Neuropathy: sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 56 affected / 624 at risk

Adverse event: Rash: hand-foot skin reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 94 affected / 624 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 275 at risk

Adverse event: Left ventricular dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 275 at risk

Adverse event: Neutrophils/granulocytes (ANC/AGC)
Serious: yes
Organ System: Investigations
Frequency: 3 affected / 275 at risk

Adverse event: Secondary Malignancy-poss rel to cancer Tx
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 275 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 15 affected / 275 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 21 affected / 275 at risk

Adverse event: Mucositis/stomatitis (clinical exam) - Oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 275 at risk

Adverse event: Mucositis/stomatitis (functional/symp) - Oral cav
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 275 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 275 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 275 at risk

Adverse event: Fatigue (asthenia, lethargy, malaise)
Serious: no
Organ System: General disorders
Frequency: 20 affected / 275 at risk

Adverse event: Leukocytes (total WBC)
Serious: no
Organ System: Investigations
Frequency: 38 affected / 275 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Investigations
Frequency: 15 affected / 275 at risk

Adverse event: Neutrophils/granulocytes (ANC/AGC)
Serious: no
Organ System: Investigations
Frequency: 54 affected / 275 at risk

Adverse event: Pain - Bone
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 15 affected / 275 at risk

Adverse event: Pain - Joint
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 11 affected / 275 at risk

Adverse event: Pain - Muscle
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 10 affected / 275 at risk

Adverse event: Neuropathy: sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 45 affected / 275 at risk

Adverse event: Rash: hand-foot skin reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 275 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 291 at risk

Adverse event: Pericardial effusion (non-malignant)
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 291 at risk

Adverse event: Death not associated with CTCAE term - Death NOS
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 291 at risk

Adverse event: Infection with unknown ANC - Blood
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 291 at risk

Adverse event: Infection with unknown ANC - Skin (cellulitis)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 291 at risk

Adverse event: Potassium, serum-low (hypokalemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 291 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 291 at risk

Adverse event: Somnolence/depressed level of consciousness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 291 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 12 affected / 291 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 19 affected / 291 at risk

Adverse event: Mucositis/stomatitis (clinical exam) - Oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 291 at risk

Adverse event: Mucositis/stomatitis (functional/symp) - Oral cav
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 291 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 291 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 291 at risk

Adverse event: Fatigue (asthenia, lethargy, malaise)
Serious: no
Organ System: General disorders
Frequency: 14 affected / 291 at risk

Adverse event: Leukocytes (total WBC)
Serious: no
Organ System: Investigations
Frequency: 34 affected / 291 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Investigations
Frequency: 18 affected / 291 at risk

Adverse event: Neutrophils/granulocytes (ANC/AGC)
Serious: no
Organ System: Investigations
Frequency: 65 affected / 291 at risk

Adverse event: Pain - Bone
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 291 at risk

Adverse event: Pain - Joint
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 291 at risk

Adverse event: Pain - Muscle
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 291 at risk

Adverse event: Neuropathy: sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 25 affected / 291 at risk

Adverse event: Rash: hand-foot skin reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 291 at risk