Busulfan combined with Methotrexate

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Weight Increased Required Intervention 12/15/2005 Female 117 lb 12/28/2005 United States
Primary
Secondary
Pneumonia Hospitalization 7/5/2005 58 Male 1/20/2006 Physician Japan
Primary
Secondary
Concomitant
Venous Thrombosis Required Intervention 1/27/2006 Male 247 lb 1/30/2006 United States
Primary
Secondary
Thrombotic Microangiopathy Other Serious 38 Female 3/4/2006 Physician United States
Primary
Concomitant
Visual Field Defect Other Serious 1/1/2005 49 Female 3/14/2006 Japan
Primary
Secondary
Concomitant
Venoocclusive Liver Disease Other Serious 14 Male 3/14/2006 Japan
Primary
Secondary
Transplant Rejection Other Serious 1 Male 3/15/2006 Japan
Primary
Secondary
Concomitant
Transplant Rejection Other Serious 6/27/2005 1 Male 19 lb 3/17/2006 Japan
Primary
Secondary
Concomitant
White Blood Cell Count Increased Other Serious 7/1/2005 14 Male 3/21/2006 Japan
Primary
Secondary
Spinal Myelogram Abnormal Other Serious 34 Female 3/21/2006 Physician Japan
Primary
Concomitant
Cytomegalovirus Viraemia Life Threatening 4/21/2004 1 Male 18 lb 3/23/2006 Physician Japan
Primary
Secondary
Concomitant
Stem Cell Transplant Hospitalization 53 Male 3/20/2006
Primary
Secondary
Shoulder Pain Hospitalization 53 Male 3/20/2006
Primary
Secondary
Vomiting Disability 11/4/2005 9 Male 53 lb 3/29/2006 Physician Japan
Primary
Concomitant
Vomiting Hospitalization 53 Male 3/20/2006
Primary
Secondary
Shoulder Pain Hospitalization 53 Male 3/20/2006
Primary
Secondary
White Blood Cell Count Decreased Other Serious 20 Male 4/3/2006 Other Health Professional United States
Primary
Secondary
Concomitant
Visual Field Defect Other Serious 1/1/2005 49 Female 4/11/2006 Japan
Primary
Secondary
Concomitant
Stem Cell Transplant Other Serious 3/19/2006 Male 141 lb 4/11/2006 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
Septic Shock Life Threatening 7/27/2006 51 Male 181 lb 8/16/2006 Physician United States
Primary
Concomitant
Stem Cell Transplant Hospitalization 8/25/2006 Male 138 lb 9/7/2006 United States
Primary
Secondary
Transplant Other Serious 36 Male 9/23/2006 Physician United States
Primary
Concomitant
Histiocytosis Haematophagic Other Serious 4 Female 10/9/2006 Japan
Primary
Concomitant
Serum Ferritin Increased Other Serious 4 Female 10/17/2006 Japan
Primary
Secondary
Concomitant
Viral Dna Test Positive Other Serious 1/1/2006 64 Female 10/17/2006 Japan
Primary
Concomitant
Serum Ferritin Increased Other Serious 4 Female 10/23/2006 Japan
Primary
Secondary
Concomitant
Skin Exfoliation Other Serious 31 Female 10/31/2006 Other Health Professional United States
Primary
Secondary
Concomitant
Viral Dna Test Positive Other Serious 1/1/2006 64 Female 11/1/2006 Japan
Primary
Concomitant
Pulmonary Fibrosis Hospitalization 8/25/2006 Male 138 lb 11/15/2006 United States
Primary
Secondary
Thrombophlebitis Other Serious 1/1/2003 34 Female 11/21/2006 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
Weight Increased Hospitalization 56 Female 12/9/2006 Other Health Professional Japan
Primary
Secondary
Concomitant
Lymphoproliferative Disorder Death Unknown 12/1/2006 Physician Japan
Primary
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
Thrombophlebitis Other Serious 1/1/2003 34 Female 1/5/2007 Japan
Primary
Secondary
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
Pyrexia Other Serious 12/1/2004 49 Male 2/8/2007 Japan
Primary
Concomitant
Venoocclusive Disease Hospitalization Female 2/10/2007 Other Health Professional Germany
Primary
Secondary
Concomitant
Venoocclusive Disease Hospitalization Female 2/10/2007 Other Health Professional Germany
Primary
Secondary
Concomitant
Weight Decreased Other Serious 12/1/2004 49 Male 2/10/2007 Japan
Primary
Concomitant
Chronic Graft Versus Host Disease Other Serious 48 Male 3/3/2007 Japan
Primary
Concomitant
Weight Decreased Other Serious 48 Male 3/10/2007 Japan
Primary
Secondary
Concomitant
Thrombotic Microangiopathy Other Serious 44 Male 3/14/2007 Japan
Primary
Concomitant
Ureteric Stenosis Other Serious 35 Male 3/14/2007 Japan
Primary
Secondary
Concomitant
Pneumonia Other Serious 32 Female 3/17/2007 Japan
Primary
Secondary
Ureteric Stenosis Other Serious 35 Male 3/28/2007 Japan
Primary
Secondary
Concomitant
Thrombocytopenia Other Serious 52 Male 4/4/2007 Other Health Professional United States
Primary
Secondary
Pneumonia Other Serious 32 Female 4/10/2007 Japan
Primary
Secondary
Thrombocytopenia Death 13 Female 4/16/2007 Other Health Professional India
Primary
Secondary
Concomitant
Viral Pharyngitis Other Serious 8/26/2005 19 Male 5/11/2007 Poland
Primary
Secondary
Concomitant
Thrombotic Microangiopathy Other Serious 10 Male 5/29/2007 Japan
Primary
Secondary
Concomitant
Pleural Effusion Other Serious 46 Male 6/24/2007 Japan
Primary
Concomitant
Pleural Effusion Other Serious 46 Male 7/6/2007 Japan
Primary
Concomitant
Thrombotic Microangiopathy Other Serious 10 Male 7/6/2007 Japan
Primary
Secondary
Concomitant
Thrombotic Microangiopathy Other Serious 10 Male 7/6/2007 Japan
Primary
Secondary
Concomitant
Weight Increased Life Threatening 4/5/2007 51 Female 7/16/2007 Other Health Professional Japan
Primary
Concomitant
Respiratory Failure Death 5/8/2003 13 Female 8/20/2007 Other Health Professional Japan
Primary
Concomitant
Epstein-barr Virus Infection Hospitalization 5/2/2006 62 Male 218 lb 1/15/2007 Other Health Professional United States
Primary
Concomitant
Cystitis Hospitalization 8/27/2006 44 Female 173 lb 1/15/2007 Other Health Professional United States
Primary
Concomitant
Stomatitis Hospitalization 4/8/2007 55 Male 9/4/2007 Other Health Professional Japan
Primary
Concomitant
Reticulocyte Count Decreased Other Serious 54 Male 10/25/2007 Physician Japan
Primary
Secondary
Concomitant
Urine Analysis Abnormal Other Serious 53 Male 11/13/2007 Other Health Professional Portugal
Primary
Secondary
Concomitant
Reticulocyte Count Decreased Hospitalization 2/16/2004 54 Male 11/21/2007 Physician Japan
Primary
Secondary
Concomitant
Subdural Haematoma Other Serious 7 Female 11/23/2007 Other Health Professional Turkey
Primary
Concomitant
Renal Tubular Necrosis Other Serious 53 Male 12/6/2007 Other Health Professional Portugal
Primary
Secondary
Renal Tubular Necrosis Other Serious 53 Male 12/12/2007 Other Health Professional Portugal
Primary
Secondary
Vaginal Disorder Other Serious 28 Female 12/13/2007 Other Health Professional Greece
Primary
Secondary
Reticulocyte Count Decreased Hospitalization 2/16/2004 54 Male 12/18/2007 Other Health Professional Japan
Primary
Secondary
Concomitant
Polyp Other Serious 8 Male 1/11/2008 United States
Primary
Concomitant
Oesophagitis Other Serious 26 Female 1/23/2008 Other Health Professional Spain
Primary
Secondary
Oesophagitis Other Serious 26 Female 1/29/2008 Other Health Professional Spain
Primary
Secondary
Sepsis Other Serious 1 Male 2/7/2008 Japan
Primary
Concomitant
Vulvovaginal Dryness Other Serious 2/1/2001 28 Female 2/12/2008
Primary
Secondary
Concomitant
Infection Death 2/19/2008 Other Health Professional Canada
Primary
Secondary
Concomitant
Subarachnoid Haemorrhage Disability 6/10/2006 52 Female 132 lb 2/19/2008 Physician Slovakia (Slovak Republic)
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
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
Subarachnoid Haemorrhage Disability 6/10/2006 52 Female 2/26/2008 Consumer United States
Primary
Secondary
Concomitant
Speech Rehabilitation Other Serious 1 Female 2/25/2008 Other Health Professional Japan
Primary
Concomitant
Weight Decreased Hospitalization 42 Male 2/26/2008 Other Health Professional Spain
Primary
Concomitant
Rash Papular Hospitalization 10/1/2005 26 Female 2/27/2008
Primary
Secondary
Concomitant
Nocardiosis Other Serious Female 3/13/2008 Physician United States
Primary
Concomitant
Venous Occlusion Life Threatening 5 Female 3/18/2008 Consumer United States
Primary
Secondary
Venous Occlusion Life Threatening 5 Female 3/24/2008 Consumer United States
Primary
Secondary
Swelling Other Serious 22 Male 3/21/2008 Other Health Professional Pakistan
Primary
Secondary
Concomitant
Drug Toxicity Death 3/28/2008 Russian Federation
Primary
Secondary
Concomitant
Subcutaneous Nodule Other Serious 4 Female 4/3/2008 Japan
Primary
Secondary
Concomitant
Venoocclusive Liver Disease Other Serious 4/4/2008 Physician Germany
Primary
Concomitant
Graft Versus Host Disease Other Serious 14 Male 4/14/2008 Other Health Professional Germany
Primary
Secondary
Neutropenia Other Serious 4 Female 4/14/2008 Other Health Professional Germany
Primary
Secondary
Viral Haemorrhagic Cystitis Other Serious 4/25/2007 Physician United States
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
Venoocclusive Disease Other Serious 42 Male 6/4/2008 Other Health Professional Spain
Primary
Secondary
Renal Impairment Other Serious 6/6/2008 United States
Primary
Secondary
Concomitant
Venoocclusive Disease Other Serious 42 Male 6/9/2008 Other Health Professional Spain
Primary
Secondary
Renal Impairment Other Serious 6/9/2008 United States
Primary
Secondary
Concomitant
Pulmonary Toxicity Other Serious 6/12/2008 United States
Primary
Secondary
Concomitant
Renal Failure Chronic Other Serious 5/1/2006 43 Male 6/18/2008 Other Health Professional United States
Primary
Secondary
Concomitant
Vomiting Hospitalization 23 Male 7/3/2008
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
Thrombotic Microangiopathy Other Serious 7/21/2008 Other Health Professional Japan
Primary
Concomitant
Cystitis Haemorrhagic Other Serious 7/25/2008 Other Health Professional Japan
Primary
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
Guillain-barre Syndrome Other Serious 42 Male 8/5/2008 Other Health Professional United States
Primary
Secondary
Thrombotic Microangiopathy Other Serious 50 Female 8/7/2008 Physician Japan
Primary
Secondary
Concomitant
Venoocclusive Disease Other Serious 8/12/2008 Canada
Primary
Secondary
Concomitant
Transplant Rejection Hospitalization 8/13/2008 Other Health Professional Denmark
Primary
Concomitant
Weight Increased Other Serious 5/16/2008 Female 8/15/2008 Other Health Professional Brazil
Primary
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
Venoocclusive Disease Other Serious 9/29/2008 Korea, Republic Of
Primary
Secondary
Concomitant
Sepsis Other Serious 2/12/2008 Canada
Primary
Secondary
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
Viral Infection Hospitalization 46 Male 10/3/2008 Other Health Professional Spain
Primary
Secondary
Concomitant
Sepsis Other Serious 36 Male 10/14/2008 Other Health Professional Taiwan, Province Of China
Primary
Secondary
Concomitant
Pyrexia Other Serious 34 Male 10/14/2008 Other Health Professional Taiwan, Province Of China
Primary
Secondary
Concomitant
Obliterative Bronchiolitis Other Serious 5 Female 10/14/2008 Other Health Professional Korea, Republic Of
Primary
Concomitant
Thrombotic Microangiopathy Other Serious 5 Male 10/14/2008 Other Health Professional Korea, Republic Of
Primary
Concomitant
Venoocclusive Liver Disease Other Serious 12 Male 10/13/2008 Other Health Professional Turkey
Primary
Secondary
Thrombotic Microangiopathy Other Serious 14 Female 10/14/2008 Other Health Professional Korea, Republic Of
Primary
Concomitant
Cytomegalovirus Infection Other Serious 2 Female 10/13/2008 Other Health Professional Korea, Republic Of
Primary
Concomitant
Weight Increased Other Serious 5/16/2008 Female 10/16/2008 Other Health Professional Brazil
Primary
Concomitant
Venoocclusive Liver Disease Other Serious 12 Male 10/17/2008 Other Health Professional Turkey
Primary
Secondary

Drug Data