Fludarabine combined with Melphalan

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Weight Decreased Hospitalization 1/16/2006 Male 148 lb 1/20/2006 Other Health Professional United States
Primary
Secondary
Transfusion Reaction Life Threatening 10/12/2005 61 Female 176 lb 2/27/2006 Physician United States
Primary
Concomitant
Urinary Tract Infection Enterococcal 56 Female 3/9/2006 United States
Primary
Secondary
Concomitant
Nephropathy Toxic Other Serious 65 Male 4/12/2006 Other Health Professional Japan
Primary
Secondary
Concomitant
Venoocclusive Liver Disease Other Serious 9/24/2005 65 Male 5/16/2006 Other Health Professional Japan
Primary
Secondary
Concomitant
Venoocclusive Liver Disease Death 65 Male 6/2/2006 Physician Japan
Primary
Secondary
Concomitant
Pneumonia Aspergillus Other Serious Male 6/14/2006 Consumer Germany
Primary
Secondary
Concomitant
Pneumonia Aspergillus Other Serious Male 6/14/2006 Consumer Germany
Primary
Secondary
Concomitant
Streptococcal Infection Hospitalization 6/7/2006 Male 135 lb 6/8/2006 United States
Primary
Secondary
Concomitant
Stem Cell Transplant Death 6/9/2006 Female 245 lb 6/13/2006 Other Health Professional United States
Primary
Secondary
Concomitant
Vomiting Death 6/20/2006 Male 125 lb 6/20/2006 Other Health Professional United States
Primary
Secondary
Concomitant
Thrombotic Thrombocytopenic Purpura Other Serious 7/3/2006 Consumer United States
Primary
Secondary
Concomitant
Lower Respiratory Tract Infection Fungal Hospitalization 7/11/2006 41 Female 108 lb 7/20/2006 Other Health Professional United States
Primary
Secondary
Necrosis Death 7/24/2006 Female 108 lb 7/27/2006 Other Health Professional United States
Primary
Secondary
Concomitant
Respiratory Distress Hospitalization 8/10/2006 Female 154 lb 8/10/2006 Other Health Professional United States
Primary
Secondary
Rash Hospitalization 9/23/2006 Female 141 lb 9/26/2006 Other Health Professional United States
Primary
Secondary
Concomitant
Septic Shock Death 9/20/2006 Physician Japan
Primary
Concomitant
Osteomyelitis Hospitalization 10/4/2006 Male 161 lb 10/10/2006 Other Health Professional United States
Primary
Secondary
Concomitant
Vomiting Hospitalization 9/25/2006 Male 287 lb 10/10/2006 Other Health Professional United States
Primary
Secondary
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
White Blood Cell Count Decreased Hospitalization 10/26/2006 Female 121 lb 10/31/2006 Other Health Professional United States
Primary
Secondary
Pyrexia Hospitalization 11/6/2006 Male 231 lb 11/7/2006 Other Health Professional United States
Primary
Secondary
Culture Urine Positive Hospitalization 11/6/2006 Male 358 lb 11/13/2006 Other Health Professional United States
Primary
Secondary
Concomitant
Constipation Hospitalization 11/25/2006 Male 163 lb 11/28/2006 Other Health Professional United States
Primary
Secondary
Concomitant
Vomiting Hospitalization 8 Male 12/12/2006 Physician Sweden
Primary
Concomitant
Toxic Epidermal Necrolysis Other Serious Female 1/23/2007 Other Health Professional Germany
Primary
Secondary
Concomitant
Viral Dna Test Positive Other Serious 7/11/2004 15 Male 73 lb 1/30/2007 Japan
Primary
Concomitant
Post Procedural Complication Hospitalization 1/26/2007 Male 196 lb 1/29/2007 Other Health Professional United States
Primary
Secondary
Concomitant
Viral Dna Test Positive Other Serious 7/11/2004 15 Male 73 lb 2/8/2007 Japan
Primary
Concomitant
Viral Dna Test Positive Other Serious 7/11/2004 15 Male 73 lb 2/8/2007 Japan
Primary
Concomitant
Viral Infection Hospitalization 2/8/2007 Male 268 lb 2/19/2007 Other Health Professional United States
Primary
Secondary
Renal Impairment Other Serious 56 Female 2/22/2007 Consumer Finland
Primary
Secondary
Concomitant
Somnolence Other Serious 56 Female 2/23/2007 Other Health Professional Germany
Primary
Secondary
Concomitant
Pulmonary Oedema Death 2/18/2004 Female 190 lb 2/21/2007 Other Health Professional United States
Primary
Secondary
White Blood Cell Count Increased Death 56 Female 2/20/2007 Germany
Primary
Secondary
Concomitant
Somnolence Other Serious 56 Female 3/2/2007
Primary
Secondary
Systemic Candida Other Serious 45 Female 3/5/2007 Japan
Primary
Concomitant
Neurotoxicity Other Serious 56 Female 3/22/2007 United States
Primary
Concomitant
Interacting
Encephalitis Herpes Other Serious 58 Female 4/27/2007 Physician United States
Primary
Concomitant
Viral Dna Test Positive Other Serious 7/11/2004 15 Male 73 lb 6/22/2007 Japan
Primary
Secondary
Concomitant
Pancreatitis Other Serious 5/30/2007 Female 31 lb 9/17/2007 Pharmacist
Primary
Concomitant
Weight Decreased Other Serious 25 Male 1/8/2008 Other Health Professional United Kingdom
Primary
Secondary
Renal Failure Other Serious 2/22/2008 Other Health Professional United States
Primary
Secondary
Renal Disorder Other Serious 2/29/2008 Other Health Professional United States
Primary
Secondary
Pregnancy Other Serious 36 Female 3/25/2008 Brazil
Primary
Secondary
Venoocclusive Disease Other Serious 3/26/2008 Spain
Primary
Secondary
Stomatitis Other Serious 3/28/2008 Germany
Primary
Secondary
Venoocclusive Disease Other Serious 3/27/2008 Spain
Primary
Secondary
Respiratory Failure Other Serious 4/1/2008 United States
Primary
Secondary
Multi-organ Failure Other Serious 4/2/2008 United States
Primary
Secondary
Concomitant
Hodgkin's Disease Recurrent Other Serious 36 Female 4/2/2008 Brazil
Primary
Secondary
Infection Other Serious 4/3/2008 Physician United States
Primary
Secondary
Infection Death 4/4/2008 Israel
Primary
Secondary
Human Herpesvirus 6 Infection Other Serious 11 Female 4/16/2008 Physician Austria
Primary
Secondary
Myelodysplastic Syndrome Other Serious 57 Male 6/23/2008 Other Health Professional United States
Primary
Secondary
Respiratory Distress Other Serious 1 Male 7/25/2008 United States
Primary
Secondary
Concomitant
Vomiting Hospitalization 39 Male 7/28/2008 Other Health Professional Germany
Primary
Secondary
Thrombotic Thrombocytopenic Purpura Hospitalization 59 Female 8/8/2008 Other Health Professional Italy
Primary
Concomitant
Venoocclusive Liver Disease Other Serious Male 8/20/2008 Other Health Professional Germany
Primary
Secondary
Concomitant
Venoocclusive Liver Disease Other Serious Male 8/22/2008 Other Health Professional Germany
Primary
Secondary
Concomitant
Graft Versus Host Disease Hospitalization 8/9/2008 43 Male 8/28/2008 Physician Spain
Primary
Secondary
Concomitant
Respiratory Distress Other Serious 9/2/2008 Other Health Professional Iran (Islamic Republic Of)
Primary
Secondary
Human Herpesvirus 6 Infection Other Serious 7/9/2002 11 Female 9/2/2008 Other Health Professional Austria
Primary
Secondary
Concomitant
Neuropathy Peripheral Other Serious 15 Male 12/29/2008 Other Health Professional United States
Primary
Secondary
Neuropathy Peripheral Other Serious 12 Female 12/29/2008 Other Health Professional United States
Primary
Secondary
Progressive Multifocal Leukoencephalopathy Other Serious 15 Male 1/5/2009 Other Health Professional United States
Primary
Secondary
Sudden Death Hospitalization 14 Male 1/5/2009 Other Health Professional United States
Primary
Secondary
Influenza Other Serious 3/1/2007 39 Male 1/23/2009 Other Health Professional Japan
Primary
Concomitant
Myelodysplastic Syndrome Other Serious 1/1/2006 49 Male 1/29/2009 Other Health Professional Japan
Primary
Concomitant
Deafness Hospitalization 9/11/2008 Male 2/2/2009 Physician France
Primary
Secondary
Concomitant
Renal Failure Chronic Hospitalization 3/18/2009 59 Male 4/1/2009 Other Health Professional Spain
Primary
Concomitant
Pneumonia Other Serious 3/9/2009 51 Male 4/1/2009 Other Health Professional Spain
Primary
Concomitant
Encephalitis Viral Death 11/17/2006 63 7/7/2009 Other Health Professional Germany
Primary
Concomitant
Vomiting Other Serious 11/1/2004 44 9/11/2009 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Vomiting Other Serious 9/1/2006 52 Male 9/16/2009 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Respiratory Failure Hospitalization 8/27/2009 58 Male 9/21/2009 Physician Spain
Primary
Secondary
Concomitant
Respiratory Failure Hospitalization 8/27/2009 58 Male 9/23/2009 Physician Spain
Primary
Secondary
Concomitant
Stem Cell Transplant Other Serious 9/1/2006 52 Male 9/15/2009 United Kingdom
Primary
Secondary
Concomitant
Graft Versus Host Disease In Lung Other Serious 2/1/2006 45 Female 9/14/2009 United Kingdom
Primary
Secondary
Concomitant
Stem Cell Transplant Death 7/1/2006 64 Male 9/15/2009 United Kingdom
Primary
Secondary
Concomitant
Vomiting Other Serious 4/1/2006 18 Male 9/15/2009 United Kingdom
Primary
Secondary
Concomitant
Tumour Lysis Syndrome Other Serious 60 Male 9/18/2009 Japan
Primary
Concomitant
Chronic Graft Versus Host Disease Other Serious 55 Female 9/18/2009 Physician Japan
Primary
Concomitant
Tumour Lysis Syndrome Other Serious 9/18/2009 Physician Japan
Primary
Concomitant
Respiratory Failure Hospitalization 8/27/2009 58 Male 9/28/2009 Physician Spain
Primary
Secondary
Concomitant
Renal Failure Acute Other Serious 10/9/2009 Iceland
Primary
Secondary
Concomitant
Weight Increased Other Serious 44 Female 10/20/2009 Other Health Professional Japan
Primary
Concomitant
Rash Other Serious 41 Female 10/23/2009 Other Health Professional Italy
Primary
Concomitant
Rash Life Threatening 2/27/2009 57 Male 126 lb 10/26/2009 Physician Japan
Primary
Secondary
Concomitant
Thrombotic Microangiopathy Other Serious 58 Male 10/27/2009 Physician Japan
Primary
Concomitant
Lymphopenia Other Serious 9 Male 11/6/2009 Other Health Professional Hong Kong
Primary
Secondary
Concomitant
Weight Increased Other Serious 55 Female 11/9/2009 Other Health Professional Japan
Primary
Concomitant
Venoocclusive Liver Disease Other Serious 31 Male 11/9/2009 Other Health Professional Japan
Primary
Concomitant
Acute Graft Versus Host Disease Other Serious 42 Male 11/25/2009 Other Health Professional France
Primary
Secondary
Concomitant
Acute Graft Versus Host Disease Other Serious 57 Male 11/25/2009 Other Health Professional France
Primary
Secondary
Concomitant
Cytomegalovirus Infection Other Serious 51 Female 11/25/2009 Other Health Professional France
Primary
Secondary
Concomitant
Acute Graft Versus Host Disease Other Serious 47 Female 11/27/2009 Other Health Professional France
Primary
Secondary
Concomitant
Weight Increased Other Serious 12/1/2008 55 Female 12/1/2009 Other Health Professional Japan
Primary
Secondary
Concomitant
Venoocclusive Liver Disease Other Serious 12/1/2008 31 Male 12/1/2009 Other Health Professional Japan
Primary
Secondary
Concomitant
Venoocclusive Liver Disease Other Serious 12/1/2008 31 Male 12/1/2009 Other Health Professional Japan
Primary
Secondary
Concomitant
Weight Increased Other Serious 12/1/2008 55 Female 12/1/2009 Other Health Professional Japan
Primary
Secondary
Concomitant
Venoocclusive Liver Disease Other Serious 1/1/2008 31 Male 12/2/2009 Other Health Professional Japan
Primary
Secondary
Concomitant
Transaminases Increased Other Serious 1/1/2008 31 Male 12/2/2009 Other Health Professional Japan
Primary
Secondary
Concomitant
Weight Increased Other Serious 1/1/2008 55 Female 12/2/2009 Other Health Professional Japan
Primary
Secondary
Concomitant
Acute Graft Versus Host Disease In Skin Other Serious 10/28/2009 56 Female 11/25/2009 Other Health Professional Spain
Primary
Concomitant
Acute Graft Versus Host Disease In Intestine Hospitalization 7/25/2009 32 Male 12/1/2009 Other Health Professional Spain
Primary
Concomitant
Weight Increased Other Serious 1/1/2008 55 Female 12/23/2009 Other Health Professional Japan
Primary
Secondary
Concomitant
Venoocclusive Liver Disease Other Serious 1/1/2008 31 Male 12/23/2009 Other Health Professional Japan
Primary
Secondary
Concomitant
Transaminases Increased Other Serious 1/1/2008 31 Male 12/23/2009 Other Health Professional Japan
Primary
Secondary
Concomitant
Neuropathy Peripheral Other Serious 14 Male 12/29/2009 Other Health Professional United States
Primary
Secondary
Death Death 12/30/2009 Consumer Italy
Primary
Secondary
Multi-organ Failure Death 2/22/2010 Germany
Primary
Secondary
Concomitant
Sinusitis Hospitalization 2/15/2010 Female 3/1/2010 Physician United States
Primary
Secondary
Transplant Rejection Other Serious 3 Male 3/4/2010 Other Health Professional Poland
Primary
Secondary
Concomitant
Pulmonary Alveolar Haemorrhage Death 3/4/2010 United States
Primary
Secondary
Concomitant
Wound Treatment Other Serious 1/1/2000 Female 140 lb 3/5/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Stomatitis 8/13/2009 Germany
Primary
Secondary
Transplant Rejection Other Serious 3 Male 3/5/2010 Other Health Professional Poland
Primary
Secondary
Concomitant
Pulmonary Alveolar Haemorrhage Death 3/8/2010 United States
Primary
Secondary
Concomitant
White Blood Cell Count Increased Other Serious 12/1/2008 50 Male 3/14/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Klebsiella Sepsis Death 22 Male 3/17/2010 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Epstein-barr Virus Associated Lymphoproliferative Disorder Other Serious 3/17/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Viral Upper Respiratory Tract Infection Other Serious 31 Female 6/4/2010 United States
Primary
Secondary
Concomitant
Vomiting Other Serious 9/1/2009 4 Male 6/8/2010 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Renal Impairment Other Serious 42 Male 6/8/2010 Other Health Professional Pakistan
Primary
Secondary
Concomitant
Sweat Gland Tumour Other Serious 6/1/2002 32 Male 8/4/2010 Other Health Professional United Kingdom
Primary
Secondary
Myelodysplastic Syndrome Other Serious Male 8/4/2010 Other Health Professional United States
Primary
Concomitant
Staphylococcal Infection Other Serious 49 Female 8/6/2010 Other Health Professional Switzerland
Primary
Secondary
Concomitant
Prostatic Intraepithelial Neoplasia Other Serious 6/29/2007 8/9/2010 Consumer United States
Primary
Secondary
Concomitant
Septic Shock Other Serious 59 Male 8/11/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Pneumonia Other Serious 4 Male 8/4/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Septic Shock Other Serious 59 Male 8/17/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Encephalopathy Death 8/20/2010 United Kingdom
Primary
Secondary
Staphylococcal Skin Infection Other Serious 9 Male 8/20/2010 Other Health Professional Netherlands
Primary
Concomitant
Encephalopathy Death 8/24/2010 United Kingdom
Primary
Secondary
Sweat Gland Tumour Other Serious 6/1/2002 32 Male 8/26/2010 Other Health Professional United Kingdom
Primary
Secondary
White Blood Cell Count Increased Hospitalization 46 Male 9/10/2010 Consumer Czech Republic
Primary
Concomitant
Venoocclusive Liver Disease Other Serious 9 Female 12/22/2010 Physician Japan
Primary
Secondary
Concomitant
Graft Versus Host Disease Other Serious 1/20/2011 Physician United States
Primary
Secondary
Concomitant
Influenza Other Serious 46 Female 1/21/2011 Other Health Professional United States
Primary
Concomitant
Human Herpesvirus 6 Infection Other Serious 1/26/2011 Physician United States
Primary
Secondary
Concomitant
Bronchopulmonary Aspergillosis Death 68 Male 1/27/2011 Physician Germany
Primary
Secondary
Concomitant
Thrombotic Microangiopathy Hospitalization 9/16/2009 9 Female 1/31/2011 Physician Japan
Primary
Secondary
Concomitant
Infection Death 59 3/22/2011 Other Health Professional United States
Primary
Secondary
Concomitant
Infection Death 19 3/22/2011 Other Health Professional United States
Primary
Secondary
Concomitant
Infection Death 35 3/22/2011 Other Health Professional United States
Primary
Secondary
Concomitant
Infection Death 35 3/22/2011 Other Health Professional United States
Primary
Secondary
Concomitant
Memory Impairment Death 59 Male 3/23/2011 Other Health Professional Japan
Primary
Concomitant
Drug Ineffective Other Serious Female 3/23/2011 Physician Japan
Primary
Concomitant

Drug Data