Study: NCT00119366

Adverse event: Febrile neutropenia (fever of unknown origin without clinically or microbiologically documented infe
Serious: yes
Organ System: Infections and infestations
Notes: Neutropenic fever
Frequency: 1 affected / 1 at risk

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

Adverse event: Extremity/Limb (Left shoulder)
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1 at risk

Adverse event: Acute respiratory distress syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Acute Respiratory Distress Syndrome
Frequency: 1 affected / 1 at risk

Adverse event: Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 2 at risk

Adverse event: Dysphagia
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Difficulty swallowing
Frequency: 1 affected / 2 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2 at risk

Adverse event: Febrile neutropenia (fever of unknown origin without clinically or microbiologically documented infe
Serious: yes
Organ System: Infections and infestations
Notes: Neutropenic fever
Frequency: 2 affected / 2 at risk

Adverse event: Supraventricular and nodal arrhythmia
Serious: yes
Organ System: Cardiac disorders
Notes: Atrial Fibrillation
Frequency: 1 affected / 3 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Cardiac disorders
Notes: Low blood pressure
Frequency: 1 affected / 3 at risk

Adverse event: Bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3 at risk

Adverse event: Mucosal inflammation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 3 at risk

Adverse event: Stomatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3 at risk

Adverse event: Neurology- Other (altered mental status)
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3 at risk

Adverse event: Deafness
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Hearing loss
Frequency: 1 affected / 3 at risk

Adverse event: Supraventricular and nodal arrhythmia
Serious: yes
Organ System: Cardiac disorders
Notes: Atrial Fibrillation
Frequency: 1 affected / 2 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Cardiac disorders
Notes: Low blood pressure
Frequency: 1 affected / 2 at risk

Adverse event: Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 2 at risk

Adverse event: Rigors/Chills
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 2 at risk

Adverse event: Febrile neutropenia (fever of unknown origin without clinically or microbiologically documented infe
Serious: yes
Organ System: Infections and infestations
Notes: Neutropenic fever
Frequency: 1 affected / 2 at risk

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

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Notes: Hypertension
Frequency: 1 affected / 2 at risk

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

Adverse event: Edema: limb
Serious: no
Organ System: Vascular disorders
Notes: Lower Extremity Edema
Frequency: 1 affected / 2 at risk

Adverse event: Bilirubin (hyperbilirubinemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Bilirubin (hyperbilirubinemia)
Frequency: 1 affected / 2 at risk

Adverse event: Potassium, serum-low (hypokalemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Hypokalemia
Frequency: 1 affected / 2 at risk

Adverse event: Keratitis
Serious: no
Organ System: Eye disorders
Notes: Corneal inflammation
Frequency: 1 affected / 2 at risk

Adverse event: Engraftment syndrome
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 8 at risk

Adverse event: Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 8 at risk

Adverse event: Rigors/Chills
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 8 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 8 at risk

Adverse event: Febrile neutropenia (fever of unknown origin without clinically or microbiologically documented infe
Serious: yes
Organ System: Infections and infestations
Notes: Neutropenic fever
Frequency: 2 affected / 8 at risk

Adverse event: Infection - Other (C. Difficile)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 8 at risk

Adverse event: Pain Extremity-limb
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 8 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Pneumonitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Allergic reaction/hypersensitivity (including drug fever)
Serious: no
Organ System: Immune system disorders
Notes: Allergic reaction/hypersensitivity (including drug fever)
Frequency: 2 affected / 8 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Notes: Anorexia
Frequency: 2 affected / 8 at risk

Adverse event: Leukocytes (total WBC)
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Leukocytes (total WBC)
Frequency: 1 affected / 8 at risk

Adverse event: Neutrophils/granulocytes (ANC/AGC)
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Neutrophils/granulocytes (ANC/AGC)
Frequency: 1 affected / 8 at risk

Adverse event: Platelets
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Platelets
Frequency: 2 affected / 8 at risk

Adverse event: White blood cell count
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: WBC
Frequency: 1 affected / 8 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Notes: Hypertension
Frequency: 1 affected / 8 at risk

Adverse event: Pericardial effusion
Serious: no
Organ System: Cardiac disorders
Notes: Pericardial effusion
Frequency: 1 affected / 8 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Fatigue
Frequency: 1 affected / 8 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Fever
Frequency: 1 affected / 8 at risk

Adverse event: Rigors/chills
Serious: no
Organ System: General disorders
Notes: Rigors/chills
Frequency: 2 affected / 8 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Rash/desquamation
Frequency: 2 affected / 8 at risk

Adverse event: Hot flashes/flushes
Serious: no
Organ System: Endocrine disorders
Notes: Hot flashes/flushes
Frequency: 1 affected / 8 at risk

Adverse event: Thyroid function, high (hyperthyroidism, thyrotoxicosis)
Serious: no
Organ System: Endocrine disorders
Notes: Thyroid function, high (hyperthyroidism, thyrotoxicosis)
Frequency: 1 affected / 8 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Diarrhea
Frequency: 2 affected / 8 at risk

Adverse event: Dysguesia
Serious: no
Organ System: Gastrointestinal disorders
Notes: Dysguesia
Frequency: 1 affected / 8 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Mucositis
Frequency: 1 affected / 8 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Nausea
Frequency: 1 affected / 8 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Vomiting
Frequency: 1 affected / 8 at risk

Adverse event: Hemorrhage, GU Vagina
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Hemorrhage, GU Vagina
Frequency: 1 affected / 8 at risk

Adverse event: Bacteraemia
Serious: no
Organ System: Infections and infestations
Notes: Bacteremia
Frequency: 1 affected / 8 at risk

Adverse event: Blood infection - Ralstonia pickettii
Serious: no
Organ System: Infections and infestations
Notes: Blood infection - Ralstonia pickettii
Frequency: 1 affected / 8 at risk

Adverse event: Febrile neutropenia (fever of unknown origin without clinically or microbiologically documented infe
Serious: no
Organ System: Infections and infestations
Notes: Febrile neutropenia (fever of unknown origin without clinically or microbiologically documented infection)(ANC \<1.0 x 10e9/L, fever \>=38.5 degrees C)
Frequency: 1 affected / 8 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils Blood
Serious: no
Organ System: Infections and infestations
Notes: Infection with normal ANC or Grade 1 or 2 neutrophils Blood
Frequency: 1 affected / 8 at risk

Adverse event: Coagulase negative staph
Serious: no
Organ System: Infections and infestations
Notes: Coagulase negative staph
Frequency: 1 affected / 8 at risk

Adverse event: Infection with unknown ANC Oral cavity-gums (gingivitis)
Serious: no
Organ System: Infections and infestations
Notes: Thrush/candida
Frequency: 1 affected / 8 at risk

Adverse event: Infection with unknown ANC Upper airway NOS
Serious: no
Organ System: Infections and infestations
Notes: Rhinovirus
Frequency: 1 affected / 8 at risk

Adverse event: Infection with unknown ANC Upper airway NOS
Serious: no
Organ System: Infections and infestations
Notes: Infection with unknown ANC Upper airway NOS
Frequency: 2 affected / 8 at risk

Adverse event: Infection with unknown ANC Upper airway NOS
Serious: no
Organ System: Infections and infestations
Notes: Rhinorrhea
Frequency: 1 affected / 8 at risk

Adverse event: Lymphatics - Other (Fluid overload)
Serious: no
Organ System: Vascular disorders
Notes: Fluid overload
Frequency: 1 affected / 8 at risk

Adverse event: Bilirubin (hyperbilirubinemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Bilirubin (hyperbilirubinemia)
Frequency: 1 affected / 8 at risk

Adverse event: Blood creatinine
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Creatinine
Frequency: 2 affected / 8 at risk

Adverse event: Magnesium, serum-low (hypomagnesemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Hypomagnesemia
Frequency: 1 affected / 8 at risk

Adverse event: Sodium, serum-low (hyponatremia)
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Hyponatremia
Frequency: 1 affected / 8 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Muscle weakness
Frequency: 1 affected / 8 at risk

Adverse event: Anxiety
Serious: no
Organ System: Nervous system disorders
Notes: Anxiety
Frequency: 1 affected / 8 at risk

Adverse event: Depression
Serious: no
Organ System: Nervous system disorders
Notes: Depression
Frequency: 2 affected / 8 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: Dizziness
Frequency: 2 affected / 8 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Notes: Dry eyes
Frequency: 1 affected / 8 at risk

Adverse event: Pain Chest/thorax NOS
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Pain Chest/thorax NOS
Frequency: 1 affected / 8 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Notes: Headache
Frequency: 2 affected / 8 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Muscle pain
Frequency: 1 affected / 8 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Cough
Frequency: 2 affected / 8 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Shortness of breath
Frequency: 1 affected / 8 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Hypoxia
Frequency: 1 affected / 8 at risk

Adverse event: Pleural effusion (non-malignant)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Pleural effusion (non-malignant)
Frequency: 1 affected / 8 at risk