Study: NCT00128713

Adverse event: Angioedema and Mucositis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 453 at risk

Adverse event: Aphasia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 453 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 453 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 453 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 453 at risk

Adverse event: Fall
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 453 at risk

Adverse event: Haemodynamic instability
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 453 at risk

Adverse event: Hemoptysis and Respiratory Distress
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 453 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 453 at risk

Adverse event: Hypotension
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 453 at risk

Adverse event: Hypotension and Possible Sepsis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 453 at risk

Adverse event: Hypovolaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 453 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 453 at risk

Adverse event: Intracranial Bleed
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 453 at risk

Adverse event: Endotracheal intubation
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 453 at risk

Adverse event: Ischaemia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 453 at risk

Adverse event: Obtunded Level of Consciousness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 453 at risk

Adverse event: Perforated Appendix
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 453 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 453 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 453 at risk

Adverse event: Possible Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 453 at risk

Adverse event: Eyelid ptosis
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 453 at risk

Adverse event: Pulmonary haemorrhage
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 453 at risk

Adverse event: Rectal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 453 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 453 at risk

Adverse event: Respiratory distress
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 453 at risk

Adverse event: Respiratory Distress and Renal Failure
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 453 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 453 at risk

Adverse event: Respiratory Syncytial Virus
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 453 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 453 at risk

Adverse event: Septic shock
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 453 at risk

Adverse event: Septic Shock and Renal Failure
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 453 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 453 at risk

Adverse event: Transfusion Related Acute Lung Injury vs Fluid Overload
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 453 at risk

Adverse event: Veno-Occlusive Disease
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 6 affected / 453 at risk

Adverse event: Allergic Reaction/Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 37 affected / 453 at risk

Adverse event: Sinus bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 453 at risk

Adverse event: Sinus tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 43 affected / 453 at risk

Adverse event: Hypertension
Serious: no
Organ System: General disorders
Frequency: 39 affected / 453 at risk

Adverse event: Hypotension
Serious: no
Organ System: General disorders
Frequency: 32 affected / 453 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 17 affected / 453 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 13 affected / 453 at risk

Adverse event: Wheezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 453 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 453 at risk

Adverse event: Haemolysis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 453 at risk

Adverse event: Rigors, chills
Serious: no
Organ System: General disorders
Frequency: 37 affected / 453 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 153 affected / 453 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 453 at risk

Adverse event: Alveolar Hemorrhage
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 449 at risk

Adverse event: Burkitt's lymphoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 449 at risk

Adverse event: Chest Pain - Probably Due To Chemotherapy Toxicity
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 449 at risk

Adverse event: Coagulopathy
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 449 at risk

Adverse event: Colonic Ischemia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 449 at risk

Adverse event: Fever with Hypoxia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 449 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 449 at risk

Adverse event: Ischaemia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 449 at risk

Adverse event: Myositis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 449 at risk

Adverse event: Obtunded Level of Consciousness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 449 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 449 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 449 at risk

Adverse event: Possible Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 449 at risk

Adverse event: Relapse of Acute Myelogenous Leukemia
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 449 at risk

Adverse event: Respiratory distress
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 449 at risk

Adverse event: Respiratory Distress and Multiorgan Failure
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 449 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 449 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 449 at risk

Adverse event: Subarachnoid haemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 449 at risk

Adverse event: Veno-Occlusive Disease
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 5 affected / 449 at risk

Adverse event: Allergic Reaction/Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 46 affected / 449 at risk

Adverse event: Sinus bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 449 at risk

Adverse event: Sinus tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 41 affected / 449 at risk

Adverse event: Hypertension
Serious: no
Organ System: General disorders
Frequency: 34 affected / 449 at risk

Adverse event: Hypotension
Serious: no
Organ System: General disorders
Frequency: 23 affected / 449 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 20 affected / 449 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 15 affected / 449 at risk

Adverse event: Wheezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 449 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 449 at risk

Adverse event: Haemolysis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 449 at risk

Adverse event: Rigors, chills
Serious: no
Organ System: General disorders
Frequency: 42 affected / 449 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 133 affected / 449 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 449 at risk

Adverse event: Acidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 449 at risk

Adverse event: Anaphylactic reaction
Serious: yes
Organ System: Immune system disorders
Frequency: 2 affected / 449 at risk

Adverse event: Atrial Fibrilation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 449 at risk

Adverse event: Coagulopathy
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 449 at risk

Adverse event: Failed Engraftment
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 449 at risk

Adverse event: Fever, Rigors and Shortness of Breath
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 449 at risk

Adverse event: Graft-Versus-Host Disease
Serious: yes
Organ System: Immune system disorders
Frequency: 3 affected / 449 at risk

Adverse event: Atrioventricular block
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 449 at risk

Adverse event: Haemodynamic instability
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 449 at risk

Adverse event: Hypotension
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 449 at risk

Adverse event: Hypotension and Possible Sepsis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 449 at risk

Adverse event: Hypotension and Hypoxemia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 449 at risk

Adverse event: Hypotension and Cardiac Arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 449 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 449 at risk

Adverse event: Mucosal inflammation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 449 at risk

Adverse event: Multisystem Organ Failure
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 449 at risk

Adverse event: Obtunded Level of Consciousness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 449 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 449 at risk

Adverse event: Possible Toxoplasmosis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 449 at risk

Adverse event: Pulmonary haemorrhage
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 449 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 449 at risk

Adverse event: Respiratory distress
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 449 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 449 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 449 at risk

Adverse event: Sepsis and Multiorgan Failure
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 449 at risk

Adverse event: Subdural haematoma
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 449 at risk

Adverse event: Toxic epidermal necrolysis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 449 at risk

Adverse event: Veno-Occlusive Disease
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 449 at risk

Adverse event: Allergic Reaction/Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 55 affected / 449 at risk

Adverse event: Sinus bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 449 at risk

Adverse event: Sinus tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 35 affected / 449 at risk

Adverse event: Hypertension
Serious: no
Organ System: General disorders
Frequency: 46 affected / 449 at risk

Adverse event: Hypotension
Serious: no
Organ System: General disorders
Frequency: 25 affected / 449 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 18 affected / 449 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 14 affected / 449 at risk

Adverse event: Wheezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 13 affected / 449 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 449 at risk

Adverse event: Haemolysis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 449 at risk

Adverse event: Rigors, chills
Serious: no
Organ System: General disorders
Frequency: 49 affected / 449 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 143 affected / 449 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 449 at risk