Busulfan combined with Fludarabine

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Visual Field Defect Other Serious 1/1/2005 49 Female 4/11/2006 Japan
Primary
Secondary
Concomitant
White Blood Cell Count Increased Death 4/15/2006 Male 144 lb 4/17/2006 Other Health Professional United States
Primary
Secondary
Vomiting Hospitalization 4/10/2006 Male 144 lb 4/17/2006 Other Health Professional United States
Primary
Secondary
Graft Versus Host Disease Other Serious 40 Male 5/5/2006 Other Health Professional Switzerland
Primary
Concomitant
Granulocytopenia Required Intervention 59 Male 5/11/2006 Other Health Professional United States
Primary
Concomitant
Ill-defined Disorder Life Threatening 5/24/2006 Female 148 lb 5/26/2006 Other Health Professional United States
Primary
Secondary
Concomitant
Thrombotic Thrombocytopenic Purpura Other Serious Female 6/14/2006 Consumer Germany
Primary
Secondary
Concomitant
Sepsis Death 7/10/2006 Female 214 lb 7/10/2006 Other Health Professional United States
Primary
Secondary
Concomitant
Tachycardia Hospitalization 7/9/2006 Female 163 lb 7/28/2006 Other Health Professional United States
Primary
Secondary
Respiratory Distress Death 8/10/2006 Female 154 lb 8/10/2006 Other Health Professional United States
Primary
Secondary
Staphylococcal Infection Hospitalization 8/7/2006 Male 104 lb 8/10/2006 Other Health Professional United States
Primary
Secondary
Concomitant
Septic Shock Life Threatening 7/27/2006 51 Male 181 lb 8/16/2006 Physician United States
Primary
Concomitant
Delirium Hospitalization 8/24/2006 Female 124 lb 9/8/2006 Other Health Professional United States
Primary
Secondary
Concomitant
Transplant Other Serious 36 Male 9/23/2006 Physician United States
Primary
Concomitant
Viral Dna Test Positive Other Serious 1/1/2006 64 Female 10/17/2006 Japan
Primary
Concomitant
Viral Dna Test Positive Other Serious 1/1/2006 64 Female 11/1/2006 Japan
Primary
Concomitant
Sputum Culture Positive Life Threatening 10/19/2006 35 Female 294 lb 11/9/2006 Other Health Professional United States
Primary
Concomitant
Pyrexia Hospitalization 11/24/2006 Male 141 lb 11/27/2006 Other Health Professional United States
Primary
Secondary
Weight Increased Hospitalization 56 Female 12/9/2006 Other Health Professional Japan
Primary
Secondary
Concomitant
Sputum Culture Positive Life Threatening 10/19/2006 35 Female 294 lb 12/6/2006 Other Health Professional United States
Primary
Concomitant
Tachypnoea Life Threatening 10/25/2006 63 Male 12/13/2006 Other Health Professional United States
Primary
Concomitant
Restlessness Life Threatening 10/25/2006 63 Male 12/19/2006 Physician United States
Primary
Concomitant
Restlessness Life Threatening 10/25/2006 63 Male 1/18/2007 Physician United States
Primary
Concomitant
White Blood Cell Count Decreased Other Serious 15 Female 3/15/2007 Japan
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Other Serious 15 Female 3/24/2007 Japan
Primary
Secondary
Concomitant
Viral Infection Hospitalization 4/5/2007 Male 207 lb 4/5/2007 Other Health Professional United States
Primary
Secondary
Urine Analysis Abnormal Other Serious 53 Male 11/13/2007 Other Health Professional Portugal
Primary
Secondary
Concomitant
Renal Tubular Necrosis Other Serious 53 Male 12/12/2007 Other Health Professional Portugal
Primary
Secondary
Thrombocytopenic Purpura Other Serious 1 Female 2/7/2008 Japan
Primary
Concomitant
Infection Death 2/19/2008 Other Health Professional Canada
Primary
Secondary
Concomitant
Infection Death 2/21/2008 Germany
Primary
Secondary
Concomitant
Graft Versus Host Disease Death 2/21/2008 Germany
Primary
Secondary
Concomitant
Adenocarcinoma Death 2/21/2008 Canada
Primary
Secondary
Concomitant
Sepsis Other Serious 2/21/2008 Other Health Professional Canada
Primary
Secondary
Concomitant
Sepsis Other Serious 2/21/2008 Other Health Professional Canada
Primary
Secondary
Concomitant
Sepsis Other Serious 2/21/2008 Other Health Professional Canada
Primary
Secondary
Concomitant
Infection Other Serious 2/21/2008 Other Health Professional Canada
Primary
Secondary
Concomitant
Infection Other Serious 2/21/2008 Other Health Professional Canada
Primary
Secondary
Concomitant
Infection Other Serious 2/21/2008 Other Health Professional Canada
Primary
Secondary
Concomitant
Graft Versus Host Disease Death 2/21/2008 Other Health Professional Canada
Primary
Secondary
Concomitant
Graft Versus Host Disease Death 2/21/2008 Other Health Professional Canada
Primary
Secondary
Concomitant
Graft Versus Host Disease Death 2/21/2008 Other Health Professional Canada
Primary
Secondary
Concomitant
Infection Death 2/21/2008 Other Health Professional Canada
Primary
Secondary
Concomitant
Infection Death 2/21/2008 Other Health Professional Canada
Primary
Secondary
Concomitant
Drug Toxicity Death 2/22/2008 France
Primary
Secondary
Concomitant
Lymphoproliferative Disorder Death 2/22/2008 Other Health Professional Canada
Primary
Secondary
Concomitant
Infection Death 2/22/2008 Other Health Professional Canada
Primary
Secondary
Concomitant
Arrhythmia Death 2/22/2008 Other Health Professional Canada
Primary
Secondary
Concomitant
Lymphoproliferative Disorder Death 2/22/2008 Other Health Professional Canada
Primary
Secondary
Concomitant
Encephalopathy Death 2/22/2008 Other Health Professional Canada
Primary
Secondary
Concomitant
Interstitial Lung Disease Death 2/22/2008 Canada
Primary
Secondary
Concomitant
Cerebral Haemorrhage Death 2/22/2008 Other Health Professional Canada
Primary
Secondary
Concomitant
Vaginal Inflammation Hospitalization 21 Female 2/25/2008 Other Health Professional United States
Primary
Secondary
Concomitant
Inflammation Other Serious 12 2/25/2008 Other Health Professional United States
Primary
Concomitant
Multi-organ Failure Other Serious 4 Female 2/26/2008 United States
Primary
Secondary
Concomitant
Nocardiosis Other Serious Female 3/13/2008 Physician United States
Primary
Concomitant
Progressive Multifocal Leukoencephalopathy Other Serious Male 3/27/2008 Other Health Professional Germany
Primary
Secondary
Drug Toxicity Death 3/28/2008 Russian Federation
Primary
Secondary
Concomitant
Progressive Multifocal Leukoencephalopathy Other Serious Male 3/31/2008 Other Health Professional Germany
Primary
Secondary
Drug Toxicity Death 4/1/2008 United States
Primary
Secondary
Concomitant
Therapeutic Agent Toxicity Death 4/2/2008 Germany
Primary
Secondary
Progressive Multifocal Leukoencephalopathy Death Male 4/2/2008 Germany
Primary
Secondary
Infection Other Serious 4/3/2008 Physician United States
Primary
Secondary
Infection Death 4/4/2008 Israel
Primary
Secondary
Viral Infection Death 4/8/2008 United States
Primary
Secondary
Venoocclusive Liver Disease Death 4/16/2008 United States
Primary
Secondary
Concomitant
Therapeutic Agent Toxicity Other Serious 5/16/2008 United States
Primary
Secondary
Concomitant
Myelodysplastic Syndrome Other Serious 57 Male 6/23/2008 Other Health Professional United States
Primary
Secondary
Vomiting Other Serious 31 Female 8/7/2008 United Kingdom
Primary
Secondary
Vomiting Other Serious 31 Female 8/11/2008 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Venoocclusive Disease Other Serious 8/12/2008 Canada
Primary
Secondary
Concomitant
Immune Reconstitution Syndrome Hospitalization 31 Female 8/13/2008 Consumer United States
Primary
Secondary
Concomitant
Vomiting Other Serious 31 Female 8/13/2008 United Kingdom
Primary
Secondary
Concomitant
Venoocclusive Liver Disease Other Serious 8/15/2008 Germany
Primary
Secondary
Concomitant
Rash Maculo-papular Other Serious 31 Male 8/20/2008 Other Health Professional Brazil
Primary
Secondary
Vomiting Other Serious 31 Female 8/21/2008 United Kingdom
Primary
Secondary
Concomitant
Vomiting Other Serious 31 Female 8/22/2008 United Kingdom
Primary
Secondary
Septic Shock Other Serious 12/1/2006 40 Female 8/26/2008 Other Health Professional Spain
Primary
Secondary
Myelodysplastic Syndrome Other Serious 1/18/2008 66 Male 172 lb 8/28/2008 Physician United States
Primary
Secondary
Concomitant
Vomiting Hospitalization 31 Female 8/28/2008 United Kingdom
Primary
Secondary
Concomitant
Venoocclusive Disease Other Serious 9/2/2008 France
Primary
Secondary
Concomitant
Vomiting Hospitalization 31 Female 9/2/2008 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Sepsis Other Serious 2/12/2008 Canada
Primary
Secondary
Concomitant
Staphylococcal Sepsis Other Serious 5 Male 10/28/2008 Other Health Professional Japan
Primary
Secondary
Concomitant
Sepsis Other Serious 21 Female 11/12/2008 Other Health Professional Austria
Primary
Secondary
Concomitant
Tuberculosis Other Serious 32 Male 1/16/2009 Other Health Professional China
Primary
Secondary
Concomitant
Nuclear Magnetic Resonance Imaging Brain Abnormal Hospitalization 1/23/2009 Female 141 lb 1/27/2009 Other Health Professional United States
Primary
Secondary
Pneumonia Bacterial Other Serious Female 1/29/2009 Other Health Professional Japan
Primary
Concomitant
Respiratory Failure Other Serious 3 Male 2/2/2009 Other Health Professional Japan
Primary
Secondary
Paraesthesia Other Serious 39 Female 2/10/2009 Other Health Professional Canada
Primary
Secondary
Concomitant
Weight Increased Other Serious 49 Female 110 lb 7/18/2009 Other Health Professional China
Primary
Concomitant
Transplant Rejection Other Serious 1/1/2007 30 Female 9/28/2009
Primary
Secondary
Concomitant
Multi-organ Failure Death 2 Male 10/1/2009 Physician Argentina
Primary
Secondary
Renal Failure Acute Other Serious 10/9/2009 Iceland
Primary
Secondary
Concomitant
Multi-organ Failure Death 2 Male 10/23/2009 Physician Argentina
Primary
Secondary
Epstein-barr Virus Associated Lymphoproliferative Disorder Other Serious 59 Female 11/23/2009 Other Health Professional Sweden
Primary
Secondary
Concomitant
Systemic Mycosis Hospitalization 7/1/2006 50 Female 11/24/2009 Other Health Professional Italy
Primary
Secondary
Concomitant
Transplant Rejection Other Serious 10 Female 11/24/2009 Other Health Professional Italy
Primary
Concomitant
Transplant Rejection Other Serious 8 Male 11/24/2009 Other Health Professional Italy
Primary
Concomitant
Transplant Rejection Other Serious 13 Male 11/24/2009 Other Health Professional Italy
Primary
Concomitant
Skin Lesion Other Serious 45 Female 1/11/2010 United Kingdom
Primary
Secondary
Pemphigoid Other Serious 51 Male 2/3/2010 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Haemorrhage Intracranial Death 2/5/2010 United States
Primary
Secondary
Pemphigoid Other Serious 51 Male 2/4/2010 United Kingdom
Primary
Secondary
Pemphigoid Other Serious 51 Male 2/12/2010 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Haemorrhage Intracranial Death 2/12/2010 United States
Primary
Secondary
Hypersensitivity Hospitalization 1/24/2010 Male 200 lb 2/12/2010 Other Health Professional United States
Primary
Concomitant
Pemphigoid Other Serious 51 Male 2/12/2010 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Systemic Candida Other Serious 3 Male 2/19/2010 Other Health Professional Brazil
Primary
Secondary
Concomitant
Sepsis Death 17 Male 2/23/2010 Other Health Professional Italy
Primary
Secondary
Concomitant
Non-hodgkin's Lymphoma Death 13 Female 2/23/2010 Other Health Professional Italy
Primary
Secondary
Concomitant
Sepsis Other Serious 1/1/2009 Female 2/25/2010 Physician United States
Primary
Concomitant
Vomiting Hospitalization 31 Female 2/25/2010 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Vomiting Other Serious 31 Female 2/26/2010 United Kingdom
Primary
Secondary
Concomitant
Meningoencephalitis Herpetic Other Serious 55 Male 6/29/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Multi-organ Failure Death 5/27/2010 63 Male 161 lb 6/30/2010 Physician France
Primary
Secondary
Toxic Encephalopathy Other Serious 4/1/2010 49 Female 7/9/2010 Other Health Professional Belgium
Primary
Secondary
Concomitant
Nephropathy Toxic Other Serious 55 Male 7/30/2010 Other Health Professional United States
Primary
Concomitant
Vasoplegia Syndrome Other Serious 36 Male 8/4/2010 Other Health Professional France
Primary
Secondary
Vasoplegia Syndrome Other Serious 51 Male 8/4/2010 Other Health Professional France
Primary
Secondary
Septic Shock Other Serious 56 Female 8/4/2010 Other Health Professional France
Primary
Secondary
Concomitant
Septic Shock Other Serious 56 Female 8/10/2010 Other Health Professional France
Primary
Secondary
Concomitant
Pneumonia Other Serious 4 Male 8/4/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Vomiting Hospitalization 12/19/2009 35 Female 8/10/2010 Other Health Professional France
Primary
Concomitant
Thrombotic Microangiopathy Other Serious 1/23/2010 67 Male 130 lb 8/19/2010 Physician Japan
Primary
Secondary
Concomitant
Thrombotic Microangiopathy Other Serious 1/23/2010 67 Male 130 lb 8/24/2010 Physician Japan
Primary
Secondary
Concomitant
Transplant Failure Other Serious 7 Male 8/27/2010 Other Health Professional Jordan
Primary
Secondary
Concomitant
Venoocclusive Disease Hospitalization 4/30/2010 31 Female 9/8/2010 Other Health Professional United States
Primary
Concomitant
Venoocclusive Disease Other Serious 4/30/2010 31 Female 176 lb 9/9/2010 Other Health Professional United States
Primary
Concomitant
Weight Decreased Death 55 Male 9/15/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Toxoplasmosis Other Serious 42 Female 9/17/2010 Other Health Professional Greece
Primary
Secondary
Concomitant
Thrombotic Microangiopathy Other Serious 70 Male 9/20/2010 Physician Japan
Primary
Concomitant
Toxoplasmosis Other Serious 42 Female 9/22/2010 Other Health Professional Greece
Primary
Secondary
Concomitant
Chronic Graft Versus Host Disease Other Serious 64 Male 9/27/2010 Other Health Professional Germany
Primary
Concomitant
Haematopoietic Neoplasm Death 67 Male 9/27/2010 Other Health Professional Germany
Primary
Concomitant
Venoocclusive Disease Other Serious 1 Male 9/30/2010 Other Health Professional Germany
Primary
Secondary
Thrombotic Microangiopathy Other Serious 70 Male 10/4/2010 Physician Japan
Primary
Concomitant
Pneumothorax Other Serious 3/23/2010 56 Male 190 lb 10/6/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Pneumothorax Other Serious 3/23/2010 56 Male 190 lb 10/6/2010 Physician United States
Primary
Secondary
Concomitant
Chronic Graft Versus Host Disease Other Serious 64 Male 10/25/2010 Other Health Professional Germany
Primary
Concomitant
Haematopoietic Neoplasm Death 67 Male 10/25/2010 Other Health Professional Germany
Primary
Concomitant
Leukaemia Recurrent Other Serious 13 10/20/2010 Physician United States
Primary
Concomitant
Tachycardia Hospitalization 1/1/2010 57 Female 10/19/2010 Other Health Professional France
Primary
Concomitant
Staphylococcal Infection Hospitalization 5/31/2010 60 Male 10/19/2010 Other Health Professional France
Primary
Concomitant
Stem Cell Transplant Hospitalization 7/25/2010 61 Male 10/19/2010 Other Health Professional France
Primary
Concomitant
Respiratory Distress Other Serious 1/1/2010 64 Male 11/2/2010 Other Health Professional France
Primary
Concomitant
Sepsis Other Serious 10/1/2010 47 Male 11/2/2010 Other Health Professional Canada
Primary
Concomitant
Febrile Neutropenia Other Serious 10/23/2009 41 Male 132 lb 11/3/2010 Physician Japan
Primary
Concomitant
Thrombocytopenia Other Serious 56 Female 11/4/2010 Other Health Professional France
Primary
Concomitant
Thrombocytopenia Other Serious 21 Female 11/5/2010 Other Health Professional Germany
Primary
Concomitant

Drug Data