Study: NCT00393029

Adverse event: BLOOD/BONE MARROW-Hemoglobin decreased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 2 at risk

Adverse event: BLOOD/BONE MARROW - Leukocyte count decreased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 2 at risk

Adverse event: BLOOD/BONE MARROW-Lymphocyte count decreased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 2 at risk

Adverse event: BLOOD/BONE MARROW-Neutrophil count decreased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 2 at risk

Adverse event: BLOOD/BONE MARROW -Platelet count decreased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 2 at risk

Adverse event: CARDIAC GENERAL - Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 2 at risk

Adverse event: COAGULATION - Activated partial thromboplastin time prolonged
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 2 at risk

Adverse event: CONSTITUTIONAL SYMPTOMS- Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 2 at risk

Adverse event: CONSTITUTIONAL SYMPTOMS - Fever
Serious: no
Organ System: General disorders
Frequency: 1 affected / 2 at risk

Adverse event: DERMATOLOGY/SKIN-Rash desquamating
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 2 at risk

Adverse event: GASTROINTESTINAL - Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 2 at risk

Adverse event: GASTROINTESTINAL - Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2 at risk

Adverse event: HEMORRHAGE/BLEEDING - Hemorrhage nasal
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 2 at risk

Adverse event: HEMORRHAGE/BLEEDING-Respiratory tract hemorrhage
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 2 at risk

Adverse event: METABOLIC/LABORATORY-Serum albumin decreased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 2 at risk

Adverse event: METABOLIC/LABORATORY - Serum calcium decreased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 2 at risk

Adverse event: METABOLIC/LABORATORY-Serum phosphate decreased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 2 at risk

Adverse event: METABOLIC/LABORATORY - Serum potassium decreased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 2 at risk

Adverse event: METABOLIC/LABORATORY - Serum sodium decreased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 2 at risk

Adverse event: NEUROLOGY - Confusion
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 2 at risk

Adverse event: PAIN - Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 2 at risk

Adverse event: VASCULAR-Capillary leak syndrome
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 2 at risk

Adverse event: BLOOD/BONE MARROW-Hemoglobin decreased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 9 at risk

Adverse event: BLOOD/BONE MARROW - Leukocyte count decreased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 9 affected / 9 at risk

Adverse event: BLOOD/BONE MARROW-Lymphocyte count decreased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 9 affected / 9 at risk

Adverse event: BLOOD/BONE MARROW-Neutrophil count decreased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 9 affected / 9 at risk

Adverse event: BLOOD/BONE MARROW -Platelet count decreased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 9 affected / 9 at risk

Adverse event: CARDIAC GENERAL - Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 9 at risk

Adverse event: COAGULATION - Activated partial thromboplastin time prolonged
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 9 at risk

Adverse event: CONSTITUTIONAL SYMPTOMS- Fatigue
Serious: no
Organ System: General disorders
Frequency: 4 affected / 9 at risk

Adverse event: CONSTITUTIONAL SYMPTOMS - Fever
Serious: no
Organ System: General disorders
Frequency: 4 affected / 9 at risk

Adverse event: DERMATOLOGY/SKIN-Rash desquamating
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 9 at risk

Adverse event: GASTROINTESTINAL - Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 9 at risk

Adverse event: GASTROINTESTINAL - Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 9 at risk

Adverse event: HEMORRHAGE/BLEEDING-Respiratory tract hemorrhage
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: METABOLIC/LABORATORY-Serum albumin decreased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 9 at risk

Adverse event: METABOLIC/LABORATORY - Serum calcium decreased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 9 at risk

Adverse event: METABOLIC/LABORATORY-Serum phosphate decreased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 9 at risk

Adverse event: METABOLIC/LABORATORY - Serum potassium decreased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 9 at risk

Adverse event: METABOLIC/LABORATORY - Serum sodium decreased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 9 at risk

Adverse event: NEUROLOGY - Confusion
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 9 at risk

Adverse event: PAIN - Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 9 at risk

Adverse event: VASCULAR-Capillary leak syndrome
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 9 at risk

Adverse event: CARDIAC ARRHYTHMIA - Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 9 at risk

Adverse event: CONSTITUTIONAL SYMPTOMS-General symptom
Serious: no
Organ System: General disorders
Frequency: 1 affected / 9 at risk

Adverse event: GASTROINTESTINAL- Anorexia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 9 at risk

Adverse event: GASTROINTESTINAL-Diarrhea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: GASTROINTESTINAL- Ear, nose and throat examination abnormal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: GASTROINTESTINAL - Mucositis oral
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: HEMORRHAGE/BLEEDING- Petechiae
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 9 at risk

Adverse event: INFECTION - Febrile neutropenia
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 9 at risk

Adverse event: INFECTION- Sepsis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 9 at risk

Adverse event: INFECTION -Vaginal infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 9 at risk

Adverse event: NEUROLOGY -Mini mental status examination abnormal
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 9 at risk

Adverse event: NEUROLOGY- Anxiety
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 9 at risk

Adverse event: PAIN - Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 9 at risk

Adverse event: PAIN - Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 9 at risk

Adverse event: PAIN - Breast pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 9 at risk

Adverse event: PAIN- Joint pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 9 at risk

Adverse event: PAIN-Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 9 at risk

Adverse event: PAIN -Neuralgia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 9 at risk

Adverse event: PAIN - Oral pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: PAIN-Tumor pain
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 9 at risk

Adverse event: PULMONARY/UPPER RESPIRATORY - Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: PULMONARY/UPPER RESPIRATORY- Dyspnea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: SECONDARY MALIGNANCY - Treatment related secondary malignancy
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 9 at risk