Busulfan combined with Fludarabine Phosphate

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Pneumonia Hospitalization 7/5/2005 58 Male 1/20/2006 Physician Japan
Primary
Secondary
Concomitant
Unresponsive To Verbal Stimuli Hospitalization 1/19/2006 Female 150 lb 1/23/2006 Other Health Professional United States
Primary
Secondary
Unresponsive To Pain Stimuli Death 2/1/2006 Female 2/1/2006 Other Health Professional United States
Primary
Secondary
Venous Thrombosis Required Intervention 1/27/2006 Male 247 lb 1/30/2006 United States
Primary
Secondary
Toxic Epidermal Necrolysis Other Serious 45 Male 2/25/2006 Japan
Primary
Concomitant
Venoocclusive Liver Disease Hospitalization 2/22/2006 Male 195 lb 2/27/2006 Other Health Professional United States
Primary
Secondary
Toxic Epidermal Necrolysis Other Serious 45 Male 3/9/2006 Japan
Primary
Concomitant
Visual Field Defect Other Serious 1/1/2005 49 Female 3/14/2006 Japan
Primary
Secondary
Concomitant
Toxic Epidermal Necrolysis Life Threatening 11/26/2004 45 Male 161 lb 4/4/2006 Japan
Primary
Secondary
Concomitant
Stem Cell Transplant Other Serious 3/19/2006 Male 141 lb 4/11/2006 United States
Primary
Secondary
Toxic Epidermal Necrolysis Life Threatening 11/26/2004 45 Male 161 lb 5/31/2006 Japan
Primary
Secondary
Concomitant
Sinusitis Hospitalization 5/18/2006 Female 161 lb 8/14/2006 United States
Primary
Secondary
Stem Cell Transplant Hospitalization 8/25/2006 Male 138 lb 9/7/2006 United States
Primary
Secondary
Pulmonary Fibrosis Hospitalization 8/25/2006 Male 138 lb 11/15/2006 United States
Primary
Secondary
Graft Versus Host Disease Death 57 Male 3/20/2007 Consumer United States
Primary
Secondary
Pelvic Fluid Collection Hospitalization 4/8/2007 Male 200 lb 4/10/2007 Other Health Professional United States
Primary
Secondary
Pyrexia Hospitalization 4/21/2007 Female 114 lb 4/24/2007 Other Health Professional United States
Primary
Secondary
Venoocclusive Liver Disease Hospitalization 4/8/2007 Male 4/24/2007 Other Health Professional United States
Primary
Secondary
White Blood Cell Count Decreased Hospitalization 5/3/2007 Male 280 lb 5/4/2007 Other Health Professional United States
Primary
Secondary
White Blood Cell Count Decreased Hospitalization 5/3/2007 Male 280 lb 5/8/2007 Other Health Professional United States
Primary
Secondary
White Blood Cell Count Decreased Hospitalization 5/3/2007 Male 280 lb 5/8/2007 Other Health Professional United States
Primary
Secondary
Pyrexia Death 5/8/2007 Female 5/9/2007 Other Health Professional United States
Primary
Secondary
White Blood Cell Count Decreased Death 5/11/2007 Male 5/14/2007 Other Health Professional United States
Primary
Secondary
Venoocclusive Liver Disease Life Threatening 5/14/2007 55 Male 6/11/2007 Other Health Professional Japan
Primary
Concomitant
Visual Disturbance Hospitalization 7/5/2007 Male 168 lb 7/6/2007 Other Health Professional United States
Primary
Secondary
Concomitant
Progressive Multifocal Leukoencephalopathy Death 8/11/2007 Male 8/13/2007 Other Health Professional United States
Primary
Secondary
Epstein-barr Virus Infection Hospitalization 5/2/2006 62 Male 218 lb 1/15/2007 Other Health Professional United States
Primary
Concomitant
Subdural Haemorrhage Life Threatening 6/24/2006 51 Female 124 lb 1/15/2007 United States
Primary
Concomitant
Cystitis Hospitalization 8/27/2006 44 Female 173 lb 1/15/2007 Other Health Professional United States
Primary
Concomitant
Mucosal Exfoliation Other Serious 27 Male 8/28/2007 Israel
Primary
Secondary
Stem Cell Transplant Hospitalization 7/28/2007 Male 9/5/2007 Other Health Professional United States
Primary
Secondary
Pleural Effusion Death 9/16/2007 Male 132 lb 9/18/2007 Other Health Professional United States
Primary
Secondary
Concomitant
Stem Cell Transplant Hospitalization 7/28/2007 Male 9/20/2007 Physician United States
Primary
Secondary
Concomitant
Mental Status Changes Hospitalization 7/28/2007 Male 9/28/2007 Physician United States
Primary
Secondary
Concomitant
Thrombocytopenia Other Serious 1/1/2005 60 Male 10/16/2007 Physician Japan
Primary
Secondary
Concomitant
Reticulocyte Count Decreased Other Serious 54 Male 10/25/2007 Physician Japan
Primary
Secondary
Concomitant
Thrombocytopenia Other Serious 1/1/2005 60 Male 11/5/2007 Physician Japan
Primary
Secondary
Concomitant
Inappropriate Antidiuretic Hormone Secretion Hospitalization 51 Female 11/8/2007 Physician Japan
Primary
Secondary
Urinary Tract Infection Enterococcal Death 11/23/2007 Male 209 lb 11/27/2007 Other Health Professional United States
Primary
Secondary
Concomitant
Stem Cell Transplant Other Serious 10/1/2007 46 Female 11/30/2007 Physician United States
Primary
Secondary
Concomitant
Renal Tubular Necrosis Other Serious 53 Male 12/6/2007 Other Health Professional Portugal
Primary
Secondary
Psychotic Disorder Other Serious 10/1/2007 46 Female 117 lb 12/12/2007 Physician United States
Primary
Secondary
Concomitant
Therapeutic Agent Toxicity Other Serious 5/12/2008 United States
Primary
Secondary
Concomitant
Vertigo Death Male 5/2/2008 Germany
Primary
Concomitant
Progressive Multifocal Leukoencephalopathy Hospitalization 1/1/2004 Male 5/15/2008 Other Health Professional Germany
Primary
Secondary
Thrombotic Microangiopathy Other Serious 5/22/2008 Japan
Primary
Secondary
Concomitant
Renal Failure Acute Other Serious 5/29/2008 Iceland
Primary
Secondary
Concomitant
Renal Failure Acute Other Serious 6/2/2008 Iceland
Primary
Secondary
Concomitant
Cytomegalovirus Colitis Other Serious 56 Male 6/6/2008 Other Health Professional Japan
Primary
Secondary
Concomitant
Renal Impairment Other Serious 6/6/2008 United States
Primary
Secondary
Concomitant
Renal Impairment Other Serious 6/9/2008 United States
Primary
Secondary
Concomitant
Pulmonary Toxicity Other Serious 6/12/2008 United States
Primary
Secondary
Concomitant
Drug Rash With Eosinophilia And Systemic Symptoms Other Serious 9 Female 6/13/2008 Germany
Primary
Secondary
Post Procedural Complication Other Serious 57 Male 6/19/2008 United States
Primary
Secondary
Vomiting Other Serious 1 Male 6/26/2008 United States
Primary
Secondary
Stem Cell Transplant Death 57 Male 6/24/2008 United States
Primary
Secondary
Pancytopenia Hospitalization 9 Female 6/25/2008 Other Health Professional Germany
Primary
Concomitant
Respiratory Failure Death 6/21/2008 Female 148 lb 7/3/2008 Other Health Professional United States
Primary
Secondary
Concomitant
Venoocclusive Disease Other Serious 7/16/2008 Korea, Republic Of
Primary
Secondary
Concomitant
Thrombosis Other Serious 53 Male 7/16/2008 Other Health Professional Portugal
Primary
Secondary
Concomitant
Subdural Haematoma Other Serious 7/17/2008 United States
Primary
Secondary
Concomitant
Venoocclusive Disease Other Serious 7/18/2008 Korea, Republic Of
Primary
Secondary
Concomitant
Thrombotic Microangiopathy Other Serious 7/21/2008 Other Health Professional Japan
Primary
Concomitant
Leukaemia Recurrent Death 47 Female 7/21/2008 Other Health Professional Japan
Primary
Concomitant
Tuberculosis Other Serious 31 Female 7/22/2008 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Guillain-barre Syndrome Other Serious 1/1/2006 61 Male 7/23/2008 Other Health Professional United States
Primary
Secondary
Multi-organ Failure Other Serious 5/9/2007 47 Female 115 lb 7/25/2008 Pharmacist United States
Primary
Secondary
Cystitis Haemorrhagic Other Serious 7/25/2008 Other Health Professional Japan
Primary
Concomitant
Hepatic Infection Fungal Death Male 7/24/2008 Other Health Professional United States
Primary
Secondary
Concomitant
Thrombotic Microangiopathy Other Serious 50 Female 8/1/2008 Consumer Japan
Primary
Secondary
Concomitant
Cystitis Haemorrhagic Other Serious 56 Male 8/1/2008 Consumer Japan
Primary
Secondary
Concomitant
Immune System Disorder Other Serious 49 Female 8/4/2008 Other Health Professional Japan
Primary
Secondary
Concomitant
Therapeutic Agent Toxicity Death 8/7/2008 Germany
Primary
Secondary
Concomitant
Thrombotic Microangiopathy Other Serious 50 Female 8/7/2008 Physician Japan
Primary
Secondary
Concomitant
Graft Versus Host Disease Other Serious 58 Male 8/28/2008 Other Health Professional Japan
Primary
Secondary
Respiratory Distress Other Serious 58 Male 9/8/2008 Other Health Professional Japan
Primary
Secondary
Respiratory Distress Other Serious 58 Male 9/8/2008 Other Health Professional Japan
Primary
Secondary
Pyrexia Life Threatening 9/14/2008 Female 181 lb 9/16/2008 Other Health Professional United States
Primary
Secondary
Concomitant
Hepatitis Hospitalization Female 9/12/2008 Other Health Professional
Primary
Concomitant
Venoocclusive Disease Other Serious 9/29/2008 Korea, Republic Of
Primary
Secondary
Concomitant
Supraventricular Extrasystoles Other Serious 11 Male 51 lb 4/8/2008 Other Health Professional China
Primary
Secondary
Concomitant
Sepsis Other Serious 8/1/2005 31 Male 1/18/2008 Other Health Professional Japan
Primary
Concomitant
Staphylococcal Sepsis Other Serious 5 Male 10/1/2008 Other Health Professional Japan
Primary
Secondary
Concomitant
Streptococcal Sepsis Other Serious 12/19/2001 5 Male 10/1/2008 Other Health Professional Japan
Primary
Secondary
Concomitant
Immune Reconstitution Syndrome Hospitalization 31 Female 10/14/2008 Consumer United States
Primary
Secondary
Concomitant
Transplant Failure Hospitalization 10/30/2008 Male 249 lb 11/5/2008 United States
Primary
Secondary
Visual Acuity Reduced Other Serious 36 Female 11/17/2008 Other Health Professional Korea, Republic Of
Primary
Secondary
Concomitant
Visual Acuity Reduced Other Serious 32 Female 11/17/2008 Other Health Professional Korea, Republic Of
Primary
Secondary
Concomitant
Drug Toxicity Death 11/17/2008 France
Primary
Secondary
Concomitant
Visual Acuity Reduced Other Serious 25 Female 11/18/2008 Other Health Professional Korea, Republic Of
Primary
Secondary
Concomitant
Sepsis Other Serious 21 Female 11/20/2008 Other Health Professional Austria
Primary
Secondary
Concomitant
Uveitis Other Serious 18 Female 11/19/2008 Other Health Professional United States
Primary
Secondary
Concomitant
Toxic Encephalopathy Other Serious 3/1/2006 13 Female 11/24/2008 Other Health Professional Japan
Primary
Concomitant
Toxic Encephalopathy Other Serious 3/1/2006 13 Female 11/26/2008 Other Health Professional Japan
Primary
Secondary
Concomitant
Toxic Encephalopathy Other Serious 3/1/2006 13 Female 11/26/2008 Other Health Professional Japan
Primary
Secondary
Concomitant
Graft Versus Host Disease Other Serious 0 Male 12/15/2008 Other Health Professional United States
Primary
Secondary
Concomitant
Respiratory Failure Death 59 Male 12/22/2008 Japan
Primary
Secondary
Concomitant
Thrombotic Microangiopathy Other Serious 54 Male 1/15/2009 Physician Japan
Primary
Secondary
Myelodysplastic Syndrome Other Serious 1/19/2009 United States
Primary
Secondary
Thrombotic Microangiopathy Other Serious 11/1/2007 54 Male 1/20/2009 Physician Japan
Primary
Secondary
Pneumonia Bacterial Other Serious Female 1/26/2009 Other Health Professional Japan
Primary
Concomitant
Thrombotic Microangiopathy Other Serious 11/17/2007 54 Male 2/2/2009 Physician Japan
Primary
Secondary
Concomitant
Interstitial Lung Disease Death 3 Male 2/6/2009 Consumer Japan
Primary
Secondary
Concomitant
Interstitial Lung Disease Death 3 Male 2/16/2009 Consumer Japan
Primary
Secondary
Concomitant
Staphylococcal Sepsis Other Serious 55 Female 2/19/2009 Other Health Professional Japan
Primary
Concomitant
Haemolysis Hospitalization 1/20/2009 Male 201 lb 2/19/2009 United States
Primary
Secondary
Subdural Haematoma Hospitalization 2/24/2009 Male 191 lb 3/11/2009 United States
Primary
Secondary
Venoocclusive Liver Disease Other Serious 56 3/23/2009 Other Health Professional Germany
Primary
Secondary
Concomitant
Febrile Neutropenia Other Serious 4/14/2009 Consumer United Kingdom
Primary
Secondary
Respiratory Distress Other Serious 58 Male 4/20/2009 Japan
Primary
Secondary
Concomitant
Staphylococcal Sepsis Other Serious 12/1/2006 55 Female 4/20/2009 Other Health Professional Japan
Primary
Concomitant
Renal Failure Acute Hospitalization 2/24/2009 Male 191 lb 4/21/2009 United States
Primary
Secondary
Febrile Neutropenia Other Serious 4/27/2009 Consumer United Kingdom
Primary
Secondary
Viral Infection Other Serious 59 Male 4/30/2009 Other Health Professional Japan
Primary
Secondary
Concomitant
Stem Cell Transplant Other Serious 6 Male 4/30/2009 Canada
Primary
Concomitant
Sputum Abnormal Other Serious 58 Male 5/4/2009 Other Health Professional Japan
Primary
Secondary
Respiratory Distress Other Serious 58 Male 5/4/2009 Japan
Primary
Secondary
Concomitant
Respiratory Syncytial Virus Infection Other Serious 1/1/2009 Male 24 lb 5/21/2009 Physician United States
Primary
Concomitant
Rhabdomyolysis Hospitalization 54 Male 5/18/2009 Other Health Professional Spain
Primary
Secondary
Concomitant
Non-hodgkin's Lymphoma Recurrent Other Serious 5/26/2009 Physician United Kingdom
Primary
Secondary
Systemic Mycosis Hospitalization 7/1/2006 50 Female 5/29/2009 Other Health Professional Italy
Primary
Secondary
Concomitant
Respiratory Syncytial Virus Infection Hospitalization 1/1/2009 Male 24 lb 6/1/2009 Physician United States
Primary
Concomitant
Vomiting Other Serious 1/29/2009 35 Female 6/6/2009 Other Health Professional France
Primary
Secondary
Concomitant
Interacting
Reversible Posterior Leukoencephalopathy Syndrome Disability 4/29/2008 58 Male 6/8/2009 Physician Japan
Primary
Secondary
Concomitant
No Therapeutic Response Death 6/6/2009 Female 141 lb 6/8/2009 Other Health Professional United States
Primary
Secondary
Pain Other Serious 7 Male 6/12/2009 Canada
Primary
Concomitant
Drug Toxicity Other Serious 6/23/2009 Consumer Thailand
Primary
Secondary
Vomiting Other Serious 1/29/2009 35 Female 6/27/2009 Other Health Professional France
Primary
Secondary
Concomitant
Interacting
Suicidal Ideation Other Serious 17 Male 6/29/2009 Physician United States
Primary
Secondary
Concomitant
Suicidal Ideation Other Serious 17 Male 7/2/2009 Physician United States
Primary
Secondary
Concomitant
Suicidal Ideation Other Serious 17 Male 7/2/2009 Physician United Kingdom
Primary
Secondary
Concomitant
Sudden Death Other Serious 7/6/2009 Other Health Professional United States
Primary
Concomitant
Encephalopathy Other Serious 6/4/2009 58 Female 121 lb 6/4/2010 Physician Japan
Primary
Concomitant
Staphylococcus Test Positive 6/6/2010 67 Female 203 lb 7/2/2010 United States
Primary
Secondary
Deep Vein Thrombosis Hospitalization 6/26/2010 53 Male 7/12/2010 Physician United States
Primary
Concomitant
Multi-organ Failure Death 5/27/2010 63 Male 7/8/2010 Other Health Professional France
Primary
Concomitant
Toxic Encephalopathy Other Serious 4/1/2010 49 Female 7/15/2010 Other Health Professional Belgium
Primary
Secondary
Concomitant
Metastasis Death 7/19/2010 Other Health Professional France
Primary
Concomitant
Transplant Failure Other Serious 7/19/2010 Other Health Professional United Kingdom
Primary
Concomitant
Death Death 7/20/2010 Other Health Professional Canada
Primary
Concomitant
Death Death 7/20/2010 Other Health Professional Canada
Primary
Concomitant
Acute Lymphocytic Leukaemia Recurrent Death 7/20/2010 Other Health Professional Canada
Primary
Concomitant
Death Death 7/20/2010 Other Health Professional Canada
Primary
Concomitant
Acute Lymphocytic Leukaemia Recurrent Death 7/20/2010 Other Health Professional Canada
Primary
Concomitant
Death Death 7/20/2010 Other Health Professional Canada
Primary
Concomitant
Acute Lymphocytic Leukaemia Recurrent Death 7/20/2010 Other Health Professional Canada
Primary
Concomitant
Death Death 7/20/2010 Other Health Professional Canada
Primary
Concomitant
Acute Lymphocytic Leukaemia Recurrent Death 7/20/2010 Other Health Professional Canada
Primary
Concomitant
Death Death 7/20/2010 Other Health Professional Canada
Primary
Concomitant
Acute Lymphocytic Leukaemia Recurrent Death 7/20/2010 Other Health Professional Canada
Primary
Concomitant

Drug Data