Busulfan combined with Melphalan

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Venoocclusive Liver Disease Other Serious 14 Male 3/14/2006 Japan
Primary
Secondary
Urinary Retention Hospitalization 3/1/2006 Male 223 lb 5/8/2006 Physician United States
Primary
Concomitant
Blood Bilirubin Increased Other Serious 1/7/2005 3 Female 5/24/2006 Spain
Primary
Concomitant
Enterocolitis Haemorrhagic Other Serious 7/3/2006 Consumer Spain
Primary
Secondary
Concomitant
Enterocolitis Haemorrhagic Other Serious 7/3/2006 Consumer Spain
Primary
Secondary
Concomitant
Systemic Candida Other Serious 7/3/2006 Consumer Spain
Primary
Secondary
Concomitant
Status Epilepticus Other Serious 10 Female 9/1/2006 Spain
Primary
Concomitant
Prostatic Specific Antigen Increased Other Serious 8/1/2006 73 Male 152 lb 10/16/2006 Physician France
Primary
Secondary
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
Malignant Neoplasm Progression Other Serious 4 Female 1/19/2007 Other Health Professional Belgium
Primary
Secondary
Tenderness Other Serious 4 Female 1/26/2007
Primary
Secondary
Stem Cell Transplant Death 4 Female 1/26/2007 Belgium
Primary
Secondary
Stem Cell Transplant Death 4 Female 2/7/2007 Belgium
Primary
Secondary
Interstitial Lung Disease Other Serious 9 Female 5/29/2007 Japan
Primary
Secondary
Concomitant
Pain In Extremity Other Serious 9 Female 6/7/2007 Japan
Primary
Secondary
Concomitant
Pleural Fibrosis Disability 3/1/2006 39 Female 6/27/2007 Consumer United States
Primary
Secondary
Concomitant
Renal Impairment Other Serious 4/1/2005 9 Female 7/6/2007 Japan
Primary
Secondary
Concomitant
Renal Impairment Other Serious 4/1/2005 9 Female 7/6/2007 Japan
Primary
Secondary
Concomitant
Vomiting Hospitalization 1/1/2007 Female 104 lb 7/17/2007 Physician France
Primary
Secondary
Concomitant
Polyp Other Serious 8 Male 1/11/2008 United States
Primary
Concomitant
Venoocclusive Liver Disease Other Serious 4 Male 2/15/2008 Japan
Primary
Secondary
Concomitant
Venoocclusive Liver Disease Other Serious 4 Male 3/7/2008 Other Health Professional Japan
Primary
Secondary
Infection Other Serious 4/3/2008 Physician United States
Primary
Secondary
Infection Death 4/4/2008 Israel
Primary
Secondary
Thyroid Cancer Other Serious 6 Female 4/11/2008 Other Health Professional Japan
Primary
Secondary
Parkinson's Disease Other Serious 12 Female 4/10/2008 Other Health Professional Germany
Primary
Secondary
Parkinson's Disease Other Serious 12 Female 4/14/2008 Other Health Professional Germany
Primary
Secondary
Thyroid Cancer Other Serious 6 Female 4/14/2008 Other Health Professional Japan
Primary
Secondary
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
Toxoplasmosis Hospitalization 14 Male 4/23/2008 Germany
Primary
Concomitant
Graft Versus Host Disease Hospitalization 4 Female 4/23/2008 Germany
Primary
Concomitant
Toxoplasmosis Hospitalization 14 Male 5/5/2008 Germany
Primary
Concomitant
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
Post Procedural Complication Other Serious 57 Male 6/19/2008 United States
Primary
Secondary
Viraemia Other Serious 6/20/2008 South Africa
Primary
Secondary
Concomitant
Myelodysplastic Syndrome Other Serious 57 Male 6/23/2008 Other Health Professional United States
Primary
Secondary
Viraemia Other Serious 6/23/2008 South Africa
Primary
Secondary
Concomitant
Stem Cell Transplant Death 57 Male 6/24/2008 United States
Primary
Secondary
Thrombotic Microangiopathy Other Serious 7/21/2008 Other Health Professional Japan
Primary
Concomitant
Guillain-barre Syndrome Other Serious 1/1/2006 61 Male 7/23/2008 Other Health Professional United States
Primary
Secondary
Vomiting Hospitalization 1/1/2007 19 Female 104 lb 8/1/2008 Physician France
Primary
Secondary
Concomitant
Thrombotic Microangiopathy Other Serious 50 Female 8/1/2008 Consumer Japan
Primary
Secondary
Concomitant
Thrombotic Microangiopathy Other Serious 50 Female 8/7/2008 Physician Japan
Primary
Secondary
Concomitant
Nephritis Interstitial Other Serious 9 Male 9/30/2008 Other Health Professional Germany
Primary
Secondary
Tubulointerstitial Nephritis Other Serious 9 Male 10/3/2008 Other Health Professional Germany
Primary
Secondary
Sepsis Syndrome Other Serious 14 Male 11/28/2008 Other Health Professional Germany
Primary
Concomitant
Thrombotic Microangiopathy Other Serious 54 Male 1/15/2009 Physician Japan
Primary
Secondary
Thrombotic Microangiopathy Other Serious 11/1/2007 54 Male 1/20/2009 Physician Japan
Primary
Secondary
Thrombotic Microangiopathy Other Serious 11/17/2007 54 Male 2/2/2009 Physician Japan
Primary
Secondary
Concomitant
Febrile Neutropenia Other Serious 4/14/2009 Consumer United Kingdom
Primary
Secondary
Acute Promyelocytic Leukaemia Other Serious 25 Female 4/23/2009 Other Health Professional France
Primary
Secondary
Febrile Neutropenia Other Serious 4/27/2009 Consumer United Kingdom
Primary
Secondary
Renal Failure Death 12/12/2008 68 Male 101 lb 5/29/2009 Other Health Professional Japan
Primary
Concomitant
Febrile Neutropenia Other Serious 12/26/2008 15 Female 99 lb 6/5/2009 Physician Japan
Primary
Concomitant
Stem Cell Transplant Other Serious 1 Female 9/10/2009 United Kingdom
Primary
Secondary
Vomiting Other Serious 12 Male 9/18/2009 Other Health Professional Japan
Primary
Secondary
Concomitant
Vomiting Other Serious 12 Male 9/18/2009 Other Health Professional Japan
Primary
Secondary
Concomitant
Graft Versus Host Disease Death 5 Female 9/25/2009 United Kingdom
Primary
Secondary
Renal Failure Acute Other Serious 10/9/2009 Iceland
Primary
Secondary
Concomitant
Graft Versus Host Disease Death 5 Male 10/12/2009 Other Health Professional United Kingdom
Primary
Secondary
Thrombotic Thrombocytopenic Purpura Death 10/15/2009 Other Health Professional Japan
Primary
Concomitant
Venoocclusive Disease Other Serious 2 Male 10/19/2009 Other Health Professional United Kingdom
Primary
Secondary
Graft Versus Host Disease Other Serious 2 Female 10/21/2009 Other Health Professional United Kingdom
Primary
Secondary
Graft Versus Host Disease Other Serious 2 Female 10/21/2009 Other Health Professional United Kingdom
Primary
Secondary
Respiratory Syncytial Virus Infection Other Serious 2 Male 10/21/2009 Other Health Professional United Kingdom
Primary
Secondary
Graft Versus Host Disease Other Serious 4 Male 10/21/2009 Other Health Professional United Kingdom
Primary
Secondary
Graft Versus Host Disease Other Serious 6 Female 10/21/2009 Other Health Professional United Kingdom
Primary
Secondary
Graft Versus Host Disease Other Serious 2 Female 10/21/2009 Other Health Professional United Kingdom
Primary
Secondary
Renal Impairment Death 2 Female 10/21/2009 Other Health Professional United Kingdom
Primary
Secondary
Renal Impairment Other Serious 2 Female 11/27/2009 Other Health Professional United Kingdom
Primary
Secondary
Renal Impairment Other Serious 2 Female 11/30/2009 Other Health Professional United Kingdom
Primary
Secondary
Thrombotic Thrombocytopenic Purpura Death 12/1/2009 Other Health Professional Japan
Primary
Concomitant
Stem Cell Transplant Other Serious 2 Female 11/24/2009 United Kingdom
Primary
Secondary
Concomitant
Renal Impairment Other Serious 1 Female 11/30/2009 United Kingdom
Primary
Secondary
Renal Impairment Other Serious 2 Female 12/2/2009 United Kingdom
Primary
Secondary
Weight Increased Other Serious 1/1/1995 57 Male 7/19/2010 United States
Primary
Secondary
Concomitant
Weight Increased Other Serious 1/1/1995 57 Male 8/6/2010 United States
Primary
Secondary
Concomitant
Pneumonia Other Serious 4 Male 8/4/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Thrombotic Thrombocytopenic Purpura Death 9/2/2010 Other Health Professional Japan
Primary
Concomitant
Thrombotic Thrombocytopenic Purpura Death 9/8/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Pyrexia Other Serious 18 Female 12/27/2010 Other Health Professional Japan
Primary
Concomitant
Interstitial Lung Disease Hospitalization 2/23/2010 69 Male 130 lb 12/30/2010 Physician Japan
Primary
Concomitant
Bacterial Infection Death 8/20/2009 46 Male 161 lb 1/3/2011 Other Health Professional Japan
Primary
Concomitant
Interstitial Lung Disease Death 10/23/2009 62 Male 130 lb 1/6/2011 Physician Japan
Primary
Concomitant
Interstitial Lung Disease Death 10/23/2009 62 Male 130 lb 1/7/2011 Physician Japan
Primary
Secondary
Concomitant
Cytomegalovirus Test Positive Death 5/1/2010 54 Female 119 lb 1/10/2011 Physician Japan
Primary
Concomitant
Infection Life Threatening 7/4/2010 73 Female 97 lb 1/10/2011 Physician Japan
Primary
Concomitant
Cystitis Haemorrhagic Hospitalization 5/17/2010 43 Female 1/10/2011 Physician Japan
Primary
Concomitant
Cardiac Failure Death 8/6/2010 35 Female 71 lb 1/10/2011 Physician Japan
Primary
Concomitant
Infection Life Threatening 7/4/2010 73 Female 97 lb 1/11/2011 Physician Japan
Primary
Secondary
Concomitant
Cytomegalovirus Test Positive Hospitalization 5/1/2010 54 Female 119 lb 1/11/2011 Physician Japan
Primary
Secondary
Concomitant
Infection Life Threatening 7/4/2010 73 Female 97 lb 1/13/2011 Physician Japan
Primary
Secondary
Concomitant
Cardiac Failure Other Serious 8/6/2010 35 Female 71 lb 1/14/2011 Physician Japan
Primary
Secondary
Concomitant
Thrombotic Microangiopathy Death 9/21/2009 62 Female 126 lb 1/26/2011 Physician Japan
Primary
Concomitant
Progressive Multifocal Leukoencephalopathy Hospitalization 5/17/2010 43 Female 119 lb 1/26/2011 Physician Japan
Primary
Concomitant
Bronchopulmonary Aspergillosis Other Serious 12/1/2008 64 Female 1/28/2011 Physician Japan
Primary
Concomitant
Candidiasis Other Serious 27 Male 2/7/2011 Physician France
Primary
Secondary
Concomitant
Drug Ineffective Other Serious 12/1/2008 64 Female 2/8/2011 Physician Japan
Primary
Concomitant
Pneumonia Cytomegaloviral Death 10/15/2010 7 Female 42 lb 2/23/2011 Physician Japan
Primary
Secondary
Concomitant
Ileus Other Serious 3/1/2011 Physician United States
Primary
Secondary
Concomitant
Acute Graft Versus Host Disease Death Male 3/2/2011 Physician Israel
Primary
Secondary
Concomitant
Cystitis Haemorrhagic Hospitalization 5/17/2010 43 Female 119 lb 3/10/2011 Physician Japan
Primary
Concomitant
Toxicity To Various Agents Other Serious 3/3/2011 Spain
Primary
Secondary
Obliterative Bronchiolitis Death 55 Male 3/21/2011 Consumer Japan
Primary
Secondary
Obliterative Bronchiolitis Death 55 Male 3/22/2011 Consumer Japan
Primary
Secondary
Drug Ineffective Other Serious Female 3/23/2011 Physician Japan
Primary
Concomitant
Cystitis Haemorrhagic Hospitalization 5/17/2010 43 Female 119 lb 3/25/2011 Physician Japan
Primary
Concomitant
Hypomagnesaemia Other Serious 1/1/1995 57 Male 3/28/2011 Lawyer United States
Primary
Secondary
Concomitant
Venoocclusive Disease Other Serious 1 Male 3/31/2011 Other Health Professional Japan
Primary
Concomitant
Engraftment Syndrome Other Serious 4/4/2011 Physician Spain
Primary
Secondary
Concomitant
Engraftment Syndrome Other Serious 4/4/2011 Physician Spain
Primary
Secondary
Concomitant
Engraftment Syndrome Other Serious 4/4/2011 Physician Spain
Primary
Secondary
Concomitant
Engraftment Syndrome Other Serious 4/4/2011 Physician Spain
Primary
Secondary
Concomitant
Engraftment Syndrome Other Serious 4/4/2011 Physician Spain
Primary
Secondary
Concomitant
Engraftment Syndrome Other Serious 4/4/2011 Physician Spain
Primary
Secondary
Concomitant
Venoocclusive Disease Life Threatening 9/6/2010 1 Male 4/5/2011 Other Health Professional Japan
Primary
Concomitant
Hypogammaglobulinaemia Other Serious 10 Female 4/8/2011 Physician United States
Primary
Secondary
Hypogammaglobulinaemia Other Serious 10 Female 4/10/2011 Physician United States
Primary
Secondary
Concomitant
Staphylococcal Sepsis Death 5/21/2011 3 Male 26 lb 9/8/2011 Physician Japan
Primary
Concomitant
Spinal Disorder Hospitalization 8/2000 Female 11/26/2012 Consumer Fr
Primary
Secondary
Concomitant
Pseudomonal Sepsis Other Serious 10/21/2009 23 Female 104 lb 4/15/2013 Physician Jp
Primary
Secondary
Concomitant
Systemic Candida Life Threatening 5/9/2010 73 Male 119 lb 12/6/2012 Physician Jp
Primary
Secondary
Concomitant
Staphylococcal Sepsis Other Serious 5/21/2011 6 Male 40 lb 6/3/2013 Physician Jp
Primary
Secondary
Concomitant
Viral Haemorrhagic Cystitis Hospitalization 6 Male 9/19/2012 Physician Jp
Primary
Concomitant
Sepsis Death 1/13/2012 7 Female 55 lb 6/14/2013 Physician Us
Primary
Secondary
Concomitant
Viral Infection Other Serious 1 Female 8/31/2012 Other Health Professional Hk
Primary
Secondary
Concomitant
Toxic Skin Eruption Other Serious 1999 28 Female 11/22/2012 Physician Fr
Primary
Secondary
Concomitant
Venoocclusive Liver Disease Hospitalization 10/4/2012 Male 32 lb 10/8/2012 Other Health Professional Us
Primary
Secondary
Death Death 10/19/2012 Other Health Professional Au
Primary
Secondary
Premature Labour Other Serious Female 11/26/2012 Physician It
Primary
Secondary
Premature Baby Other Serious 11/26/2012 Physician It
Primary
Secondary
Death Death 10/24/2012 Other Health Professional Country Not Specified
Primary
Secondary
Sepsis Other Serious 11/2/2012 Physician Us
Primary
Concomitant
Viraemia Hospitalization 4/2/2011 6 Female 40 lb 3/19/2013 Physician Jp
Primary
Concomitant
Malignant Neoplasm Progression Other Serious 45 Female 12/26/2012 Other Health Professional It
Primary
Secondary
Concomitant
Urethral Stenosis Other Serious 20 Male 12/26/2012 Other Health Professional Hu
Primary
Secondary
Thrombocytopenia Other Serious 3 Male 12/19/2012 Other Health Professional It
Primary
Secondary
Respiratory Failure Other Serious 6 Male 1/7/2013 Other Health Professional Us
Primary
Secondary
Concomitant
Respiratory Failure Other Serious 6 Male 44 lb 1/8/2013 Consumer Us
Primary
Secondary
Concomitant
Staphylococcal Infection Other Serious 1 Male 12/24/2012 Other Health Professional Hk
Primary
Secondary
Concomitant
Graft Versus Host Disease Other Serious 14 Male 1/16/2013 Physician Jp
Primary
Concomitant
Drug Ineffective Other Serious Male 3/15/2013 Physician Jp
Primary
Concomitant
Drug Ineffective Other Serious 26 Female 3/15/2013 Physician Jp
Primary
Concomitant
Guillain-barre Syndrome Other Serious 9/11/2012 Other Health Professional Country Not Specified
Primary
Secondary
Concomitant
Drug Ineffective Other Serious 64 Male 3/19/2013 Physician Jp
Primary
Concomitant
Off Label Use Life Threatening 5/2010 12 Female 3/21/2013 Other Health Professional Jp
Primary
Secondary

Drug Data