Fludarabine combined with Methotrexate

Reports:


Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Transaminases Increased Other Serious 47 Male 1/19/2006 Physician United States
Primary
Concomitant
Trichosporon Infection Other Serious 1/1/2004 30 Male 3/29/2006 Japan
Primary
Secondary
Concomitant
Visual Field Defect Other Serious 1/1/2005 49 Female 4/11/2006 Japan
Primary
Secondary
Concomitant
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
Thrombotic Microangiopathy Other Serious 2/22/2003 61 Male 95 lb 5/16/2006 Physician Japan
Primary
Secondary
Concomitant
Streptococcal Infection Hospitalization 6/7/2006 Male 135 lb 6/8/2006 United States
Primary
Secondary
Concomitant
Thrombotic Thrombocytopenic Purpura Other Serious 7/3/2006 Consumer United States
Primary
Secondary
Concomitant
Squamous Cell Carcinoma Of Skin Other Serious 61 Male 7/17/2006 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
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
White Blood Cell Count Increased Other Serious 42 Female 10/27/2006 Physician Turkey
Primary
Secondary
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
Weight Increased Hospitalization 56 Female 12/9/2006 Other Health Professional Japan
Primary
Secondary
Concomitant
Mucous Stools Other Serious 4 Female 12/14/2006 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
Mucous Stools Other Serious 4 Female 1/3/2007 Japan
Primary
Concomitant
Restlessness Life Threatening 10/25/2006 63 Male 12/19/2006 Physician United States
Primary
Concomitant
Toxic Epidermal Necrolysis Other Serious Female 1/23/2007 Other Health Professional Germany
Primary
Secondary
Concomitant
Restlessness Life Threatening 10/25/2006 63 Male 1/18/2007 Physician United States
Primary
Concomitant
Viral Dna Test Positive Other Serious 7/11/2004 15 Male 73 lb 1/30/2007 Japan
Primary
Concomitant
Vasculitis Death 15 Male 2/6/2007 Physician Canada
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
Vasculitis Death 15 Male 2/12/2007 Physician Canada
Primary
Secondary
Concomitant
Viral Myocarditis Other Serious 56 Male 2/22/2007 Other Health Professional Japan
Primary
Secondary
Concomitant
Renal Impairment Other Serious 56 Female 2/22/2007 Consumer Finland
Primary
Secondary
Concomitant
Ventricular Tachycardia Hospitalization 56 Male 2/26/2007
Primary
Secondary
Somnolence Other Serious 56 Female 2/23/2007 Other Health Professional Germany
Primary
Secondary
Concomitant
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
Sepsis Other Serious 25 Male 3/7/2007 Australia
Primary
Secondary
Concomitant
Sepsis Death 25 Male 3/22/2007 Australia
Primary
Secondary
Spinal Cord Disorder Other Serious 25 Male 4/4/2007 Other Health Professional Australia
Primary
Secondary
White Blood Cell Morphology Abnormal Other Serious 51 Female 3/29/2007 Other Health Professional Sweden
Primary
Secondary
Concomitant
Spinal Cord Disorder Other Serious 25 Male 4/10/2007 Other Health Professional Australia
Primary
Secondary
Spinal Cord Disorder Hospitalization 25 Male 4/11/2007 Australia
Primary
Secondary
Sepsis Death 25 Male 4/11/2007
Primary
Secondary
Spinal Cord Disorder Other Serious 25 Male 4/13/2007 Consumer United States
Primary
Secondary
Viral Dna Test Positive Other Serious 7/11/2004 15 Male 73 lb 6/22/2007 Japan
Primary
Secondary
Concomitant
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
Stomatitis Other Serious 6 Male 12/23/2007 Japan
Primary
Concomitant
Lichenification Other Serious 61 Male 2/7/2008 Other Health Professional Sweden
Primary
Concomitant
Lichenification Other Serious 61 Male 2/7/2008 Other Health Professional Sweden
Primary
Concomitant
Graft Versus Host Disease Death 53 Male 2/18/2008 Other Health Professional Mexico
Primary
Secondary
Concomitant
Chronic Graft Versus Host Disease Death 15 Male 2/18/2008 Other Health Professional Mexico
Primary
Secondary
Concomitant
Graft Versus Host Disease Death 27 Female 2/18/2008 Other Health Professional Mexico
Primary
Secondary
Concomitant
No Therapeutic Response Death 33 Male 2/19/2008 Other Health Professional Mexico
Primary
Secondary
Concomitant
Infection Death 2/19/2008 Other Health Professional Canada
Primary
Secondary
Concomitant
Chronic Graft Versus Host Disease Death 15 Male 2/20/2008 Other Health Professional Mexico
Primary
Secondary
Concomitant
Graft Versus Host Disease Death 53 Male 2/20/2008 Other Health Professional Mexico
Primary
Secondary
Concomitant
Graft Versus Host Disease Death 27 Female 2/20/2008 Other Health Professional Mexico
Primary
Secondary
Concomitant
Chronic Myeloid Leukaemia Death 57 Male 2/20/2008 Other Health Professional Mexico
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
Renal Failure Other Serious 2/22/2008 Other Health Professional United States
Primary
Secondary
Reversible Posterior Leukoencephalopathy Syndrome Other Serious Female 2/21/2008 Physician United States
Primary
Secondary
Concomitant
Transplant Failure Death 2/28/2008 Netherlands
Primary
Secondary
Concomitant
Transplant Failure Death 2/28/2008 Netherlands
Primary
Secondary
Concomitant
Transplant Failure Death 2/28/2008 Netherlands
Primary
Secondary
Concomitant
Transplant Failure Death 2/28/2008 Netherlands
Primary
Secondary
Concomitant
Transplant Failure Death 2/28/2008 Netherlands
Primary
Secondary
Concomitant
Transplant Failure Death 2/28/2008 Netherlands
Primary
Secondary
Concomitant
Transplant Failure Death 2/28/2008 Netherlands
Primary
Secondary
Concomitant
Transplant Failure Death 2/28/2008 Netherlands
Primary
Secondary
Concomitant
Renal Disorder Other Serious 2/29/2008 Other Health Professional United States
Primary
Secondary
Rash Other Serious 56 Male 3/9/2008 Japan
Primary
Secondary
Concomitant
Rash Other Serious 12/1/2006 56 Male 3/11/2008 Japan
Primary
Secondary
Concomitant
Oedema Mucosal Hospitalization 27 Female 3/12/2008 Japan
Primary
Secondary
Concomitant
Weight Increased Other Serious 11/1/2005 55 Male 3/13/2008 Japan
Primary
Concomitant
Nocardiosis Other Serious Female 3/13/2008 Physician United States
Primary
Concomitant
Pneumonia Fungal Life Threatening 3/25/2008 India
Primary
Secondary
Concomitant
Pneumonia Fungal Life Threatening 3/26/2008 India
Primary
Secondary
Concomitant
Drug Toxicity Death 3/28/2008 Russian Federation
Primary
Secondary
Concomitant
Oedema Mucosal Hospitalization 27 Female 4/16/2008 Japan
Primary
Secondary
Concomitant
Acute Graft Versus Host Disease Other Serious 21 Male 6/24/2008 Other Health Professional Germany
Primary
Secondary
Concomitant
Vomiting Hospitalization 39 Male 7/28/2008 Other Health Professional Germany
Primary
Secondary
Venoocclusive Disease Other Serious 8/12/2008 Canada
Primary
Secondary
Concomitant
Stomatitis Other Serious 8/21/2008 Japan
Primary
Secondary
Concomitant
Cytomegalovirus Colitis Other Serious 42 Male 9/2/2008 Other Health Professional Japan
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
Neuropathy Peripheral Other Serious 15 Male 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
Tuberculosis Other Serious 32 Male 1/16/2009 Other Health Professional China
Primary
Secondary
Concomitant
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
Paraesthesia Other Serious 39 Female 2/10/2009 Other Health Professional Canada
Primary
Secondary
Concomitant
Pneumonia Other Serious 3/9/2009 51 Male 4/1/2009 Other Health Professional Spain
Primary
Concomitant
Weight Increased Other Serious 49 Female 110 lb 7/18/2009 Other Health Professional China
Primary
Concomitant
Weight Decreased Death 9/4/2009 Female 123 lb 9/15/2009 Other Health Professional United States
Primary
Concomitant
Ataxia Other Serious Male 9/23/2009 Pharmacist United States
Primary
Secondary
Concomitant
Weight Decreased Death 9/4/2009 Female 123 lb 9/16/2009 Other Health Professional United States
Primary
Concomitant
Pyrexia Hospitalization 8/20/2009 Female 120 lb 9/16/2009 Other Health Professional United States
Primary
Concomitant
Transplant Rejection Other Serious 1/1/2007 30 Female 9/28/2009
Primary
Secondary
Concomitant
Renal Failure Acute Other Serious 10/9/2009 Iceland
Primary
Secondary
Concomitant
Cholelithiasis Hospitalization 12/25/2007 30 Male 145 lb 10/12/2009 Physician Japan
Primary
Secondary
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
Ataxia Other Serious 63 Male 10/26/2009 Pharmacist United States
Primary
Secondary
Concomitant
Somnolence Life Threatening 9/16/2009 Male 120 lb 11/2/2009 Physician Netherlands
Primary
Concomitant
Axonal Neuropathy Other Serious 9/13/2009 Male 11/2/2009 Pharmacist United States
Primary
Secondary
Concomitant
Thrombotic Microangiopathy Other Serious 58 Male 10/27/2009 Physician Japan
Primary
Concomitant
Somnolence Life Threatening 9/15/2009 Male 120 lb 11/11/2009 Physician Netherlands
Primary
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
Acute Graft Versus Host Disease In Skin Other Serious 10/28/2009 56 Female 11/25/2009 Other Health Professional Spain
Primary
Concomitant
Septic Shock Life Threatening 4/6/2009 Male 12/3/2009 Physician Germany
Primary
Secondary
Concomitant
Gastrointestinal Toxicity Other Serious 17 Female 1/29/2010 Physician United States
Primary
Concomitant
Sepsis Death 1/9/2010 Female 220 lb 1/29/2010 Physician Germany
Primary
Secondary
Hypersensitivity Hospitalization 1/24/2010 Male 200 lb 2/12/2010 Other Health Professional United States
Primary
Concomitant
Klebsiella Sepsis Death 22 Male 3/17/2010 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Intracranial Hypotension Hospitalization 2/23/2010 51 Male 3/17/2010 Physician Italy
Primary
Secondary
Concomitant
Paraparesis Other Serious 28 Male 3/18/2010 Other Health Professional Italy
Primary
Secondary
Concomitant
Klebsiella Sepsis Death 22 Male 3/19/2010 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Intracranial Hypotension Hospitalization 2/23/2010 51 Male 3/19/2010 Physician Italy
Primary
Secondary
Concomitant
Overdose Other Serious 52 Female 3/19/2010 Other Health Professional United States
Primary
Concomitant
Wernicke's Encephalopathy Disability 5/9/2008 4/13/2010 Physician United States
Primary
Secondary
Wernicke's Encephalopathy Disability 5/9/2008 4/20/2010 Physician United States
Primary
Secondary
Staphylococcal Sepsis Other Serious 24 Female 4/20/2010 Other Health Professional Japan
Primary
Concomitant
Pyrexia Life Threatening 4/7/2010 68 Male 157 lb 4/15/2010 Other Health Professional United States
Primary
Concomitant
Staphylococcal Sepsis Other Serious 24 Female 5/18/2010 Other Health Professional Japan
Primary
Concomitant
White Blood Cell Count Decreased Other Serious 3 Female 5/21/2010 Other Health Professional China
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Other Serious 1/1/2008 5 Male 5/21/2010 Other Health Professional China
Primary
Concomitant
Paraparesis Other Serious 28 Male 6/16/2010 Other Health Professional Italy
Primary
Secondary
Concomitant
Mucosal Inflammation Other Serious 6/16/2010 Spain
Primary
Secondary
Concomitant