Study: NCT00740636

Adverse event: Death not assoc w CTCAE term- Death NOS
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 25 at risk

Adverse event: Death not assoc w CTCAE term-Disease prog NOS
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 25 at risk

Adverse event: Dehydration
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 25 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 25 at risk

Adverse event: Dyspnea (shortness of breath)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 25 at risk

Adverse event: Fatigue (asthenia, lethargy, malaise)
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 25 at risk

Adverse event: Infection w/ Gr 3/4 neut, Lung (pneumonia)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 25 at risk

Adverse event: Pain
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 25 at risk

Adverse event: Pleural effusion (non-malignant)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 25 at risk

Adverse event: Pneumonitis/pulmonary infiltrates
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 25 at risk

Adverse event: Sodium, low (hyponatremia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 25 at risk

Adverse event: Somnolence/depressed level of conscious
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 25 at risk

Adverse event: Thrombosis/thrombus/embolism
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 25 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 25 at risk

Adverse event: Dyspnea (shortness of breath)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 25 at risk

Adverse event: Fatigue (asthenia, lethargy, malaise)
Serious: no
Organ System: General disorders
Frequency: 6 affected / 25 at risk

Adverse event: Glucose, high (hyperglycemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 25 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 25 at risk

Adverse event: Leukocytes (total WBC)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 25 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 25 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 2 affected / 25 at risk

Adverse event: Neutrophils/granulocytes (ANC/AGC)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 25 at risk

Adverse event: Pain - Head/headache
Serious: no
Organ System: General disorders
Frequency: 2 affected / 25 at risk

Adverse event: Pain - Other
Serious: no
Organ System: General disorders
Frequency: 2 affected / 25 at risk

Adverse event: Phosphate, low (hypophosphatemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 25 at risk

Adverse event: Platelets
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 25 at risk

Adverse event: Sodium, low (hyponatremia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 25 at risk

Adverse event: Vomiting
Serious: no
Organ System: General disorders
Frequency: 2 affected / 25 at risk

Adverse event: Death not assoc w CTCAE term-Disease prog NOS
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 67 at risk

Adverse event: Dyspnea (shortness of breath)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 67 at risk

Adverse event: Fatigue (asthenia, lethargy, malaise)
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 67 at risk

Adverse event: Pain
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 67 at risk

Adverse event: Pleural effusion (non-malignant)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 67 at risk

Adverse event: Sodium, low (hyponatremia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 67 at risk

Adverse event: AST, SGOT
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 67 at risk

Adverse event: Ataxia (incoordination)
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 67 at risk

Adverse event: Bilirubin (hyperbilirubinemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 67 at risk

Adverse event: Cognitive disorder
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 67 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 67 at risk

Adverse event: Edema: limb
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 67 at risk

Adverse event: Fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 67 at risk

Adverse event: Glucose, high (hyperglycemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 67 at risk

Adverse event: Hemorrhage/Bleeding, other
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 67 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 67 at risk

Adverse event: Inf norm ANC/gr1/2 neut-Pneumonia(lung)
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 67 at risk

Adverse event: Infection unknown ANC-UTI NOS
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 67 at risk

Adverse event: Left ventricular dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 67 at risk

Adverse event: Neurology - Other
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 67 at risk

Adverse event: Potassium, low (hypokalemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 67 at risk

Adverse event: Secondary malignancy possibly related to treatment
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 67 at risk

Adverse event: Secondary malig-poss related to ca txt specify
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 67 at risk

Adverse event: Syncope (fainting)
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 67 at risk

Adverse event: Muscle weakness - Whole body/general
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 67 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 67 at risk

Adverse event: Dyspnea (shortness of breath)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 67 at risk

Adverse event: ALT, SGPT
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 67 at risk

Adverse event: AST, SGOT
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 67 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 67 at risk

Adverse event: Fatigue (asthenia, lethargy, malaise)
Serious: no
Organ System: General disorders
Frequency: 21 affected / 67 at risk

Adverse event: Glucose, high (hyperglycemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 14 affected / 67 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 17 affected / 67 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 26 affected / 67 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 9 affected / 67 at risk

Adverse event: Platelets
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 67 at risk

Adverse event: Sodium, low (hyponatremia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 67 at risk