Fludarabine Phosphate combined with Methotrexate

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Scab Hospitalization 6/21/2004 11 Female 90 lb 12/30/2005 Physician Japan
Primary
Secondary
Productive Cough Other Serious 10/18/2004 Male 183 lb 1/13/2006 United States
Primary
Secondary
Respiratory Syncytial Virus Infection Other Serious 12/16/2005 Male 160 lb 1/13/2006 United States
Primary
Secondary
Concomitant
Pneumonia Hospitalization 7/5/2005 58 Male 1/20/2006 Physician Japan
Primary
Secondary
Concomitant
Vomiting Other Serious 8/17/2004 Female 132 lb 1/17/2006 United States
Primary
Secondary
Pyrexia Other Serious 10/2/2005 Male 160 lb 1/18/2006 United States
Primary
Secondary
Concomitant
Weight Decreased Death 6 Male 1/27/2006 United States
Primary
Secondary
Concomitant
Venous Thrombosis Required Intervention 1/27/2006 Male 247 lb 1/30/2006 United States
Primary
Secondary
Trichosporon Infection Other Serious 1/1/2004 30 Male 3/9/2006 Japan
Primary
Concomitant
Visual Field Defect Other Serious 1/1/2005 49 Female 3/14/2006 Japan
Primary
Secondary
Concomitant
Serum Ferritin Increased Other Serious 57 Male 3/6/2006 Physician Japan
Primary
Concomitant
Serum Ferritin Increased Other Serious 57 Male 3/15/2006 Physician Japan
Primary
Concomitant
Stem Cell Transplant Other Serious 3/19/2006 Male 141 lb 4/11/2006 United States
Primary
Secondary
Mucous Membrane Disorder Hospitalization 8/26/2004 8 Male 51 lb 7/21/2006 Physician Japan
Primary
Concomitant
Squamous Cell Carcinoma Of Skin Other Serious 61 Male 7/15/2006 Physician United States
Primary
Secondary
Concomitant
Urine Output Decreased Hospitalization 3 Female 8/1/2006 Physician Japan
Primary
Concomitant
Troponin I Increased Hospitalization 8/1/2006 Male 181 lb 8/1/2006 United States
Primary
Secondary
Stem Cell Transplant Hospitalization 8/25/2006 Male 138 lb 9/7/2006 United States
Primary
Secondary
Thrombotic Microangiopathy Hospitalization 28 Male 10/6/2006 Physician Japan
Primary
Concomitant
Renal Failure Life Threatening 1/28/2005 54 Female 106 lb 11/9/2006 Physician Japan
Primary
Concomitant
Venoocclusive Liver Disease Other Serious 69 Male 11/2/2006 Physician Japan
Primary
Concomitant
Pulmonary Fibrosis Hospitalization 8/25/2006 Male 138 lb 11/15/2006 United States
Primary
Secondary
Retroperitoneal Neoplasm Life Threatening 1/28/2005 54 Female 106 lb 11/20/2006 Physician Japan
Primary
Concomitant
Encephalopathy Death 53 Female 11/17/2006 Physician Japan
Primary
Concomitant
Ventricular Tachycardia Hospitalization 56 Male 2/19/2007 Physician Japan
Primary
Secondary
Pneumothorax Other Serious 5/31/2006 54 Male 123 lb 2/26/2007 Physician Japan
Primary
Secondary
Concomitant
Renal Impairment Death 56 Female 2/16/2007 Germany
Primary
Secondary
Concomitant
Somnolence Death 56 Female 2/16/2007 Germany
Primary
Secondary
Concomitant
Renal Impairment Other Serious 56 Female 2/28/2007 Physician Germany
Primary
Secondary
Concomitant
Sepsis Other Serious 25 Male 4/6/2007 Other Health Professional Australia
Primary
Secondary
Toxic Epidermal Necrolysis Other Serious Unknown 4/16/2007 Germany
Primary
Secondary
Stem Cell Transplant Other Serious 51 Female 5/8/2007 Other Health Professional Sweden
Primary
Secondary
Concomitant
Squamous Cell Carcinoma Of Skin Death 61 Male 5/15/2007 Physician United States
Primary
Secondary
Concomitant
Renal Tubular Disorder Death 7 Female 5/24/2007 Physician Italy
Primary
Secondary
Concomitant
Renal Tubular Disorder Other Serious 7 Female 5/30/2007 Physician Italy
Primary
Secondary
Concomitant
Squamous Cell Carcinoma Death 61 Male 5/29/2007 Physician United States
Primary
Secondary
Concomitant
Stem Cell Transplant Other Serious 25 Male 6/14/2007 Physician Australia
Primary
Secondary
Concomitant
Miller Fisher Syndrome Other Serious 9 Female 6/19/2007 Other Health Professional Italy
Primary
Secondary
Concomitant
Miller Fisher Syndrome Other Serious 9 Female 6/19/2007 Other Health Professional Italy
Primary
Secondary
Mucous Membrane Disorder Other Serious 57 Female 6/13/2007 Japan
Primary
Secondary
Concomitant
Drug Toxicity Death 64 Male 6/16/2007 Italy
Primary
Secondary
Concomitant
Reticulocyte Count Decreased Other Serious Male 6/23/2007 Japan
Primary
Secondary
Concomitant
Miller Fisher Syndrome Other Serious 9 Female 6/25/2007 Other Health Professional Italy
Primary
Secondary
Viral Dna Test Positive Other Serious 7/11/2004 15 Male 73 lb 6/22/2007 Japan
Primary
Secondary
Concomitant
Upper Gastrointestinal Haemorrhage Other Serious Male 6/18/2007 Physician Japan
Primary
Concomitant
Treatment Failure Disability 9 Female 6/25/2007 Italy
Primary
Secondary
Concomitant
Zygomycosis Other Serious 63 Male 7/3/2007 Other Health Professional United States
Primary
Secondary
Concomitant
Miller Fisher Syndrome Other Serious 9 Female 7/5/2007
Primary
Secondary
Miller Fisher Syndrome Other Serious 9 Female 6/25/2007 Italy
Primary
Secondary
Vomiting Life Threatening 1/28/2007 34 Female 7/16/2007 Japan
Primary
Concomitant
Stomatitis Life Threatening 12/6/2006 50 Female 7/16/2007 Other Health Professional Japan
Primary
Secondary
Concomitant
Vomiting Death 2/25/2007 13 Female 8/1/2007 Japan
Primary
Concomitant
Renal Tubular Disorder Other Serious 7 Female 8/14/2007 Physician Italy
Primary
Secondary
Concomitant
Lymphoproliferative Disorder Death 5/6/2004 38 Female 128 lb 2/28/2005 Other Health Professional Poland
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
Splenomegaly Other Serious 46 Male 9/5/2007 Physician United States
Primary
Concomitant
Zygomycosis Other Serious 63 Male 9/5/2007 Physician United States
Primary
Concomitant
Stomatitis Life Threatening 5/6/2007 56 Female 9/18/2007 Japan
Primary
Secondary
Concomitant
Stenotrophomonas Infection Death 4/12/2007 33 Male 9/18/2007 Japan
Primary
Concomitant
Stomatitis Other Serious 12 Male 9/26/2007 Japan
Primary
Secondary
Concomitant
Transplant Rejection Life Threatening 5/23/2007 60 Male 9/20/2007 Other Health Professional Japan
Primary
Concomitant
Stomatitis Other Serious 6/1/2006 12 Male 10/5/2007 Japan
Primary
Secondary
Concomitant
Renal Failure Acute Other Serious 28 Male 10/15/2007 Consumer Switzerland
Primary
Secondary
Ureaplasma Infection Other Serious 28 Male 10/15/2007 Switzerland
Primary
Secondary
Concomitant
Renal Failure Acute Other Serious 28 Male 10/17/2007
Primary
Secondary
Concomitant
Ureaplasma Infection Hospitalization 28 Male 10/11/2007 Switzerland
Primary
Secondary
Vomiting Life Threatening 1/28/2007 34 Female 10/22/2007 Japan
Primary
Concomitant
Vomiting Life Threatening 12/6/2006 50 Female 10/22/2007 Japan
Primary
Secondary
Concomitant
Reticulocyte Count Decreased Other Serious 54 Male 10/25/2007 Physician Japan
Primary
Secondary
Concomitant
Thrombotic Microangiopathy Other Serious 2/5/2007 46 Female 10/27/2007 Japan
Primary
Secondary
Concomitant
Thrombotic Microangiopathy Other Serious 2/5/2007 46 Female 10/27/2007 Japan
Primary
Secondary
Concomitant
Stomatitis 6/10/2007 21 Female 10/26/2007 Japan
Primary
Concomitant
Vasculitis Other Serious 15 Male 11/5/2007 Other Health Professional Canada
Primary
Secondary
Concomitant
Reticulocyte Count Decreased Other Serious Male 11/7/2007 Japan
Primary
Secondary
Concomitant
Reticulocyte Count Decreased Other Serious Male 11/7/2007 Japan
Primary
Secondary
Concomitant
Systemic Candida Other Serious 26 Male 11/8/2007 Other Health Professional Germany
Primary
Secondary
Ureaplasma Infection Other Serious 28 Male 11/5/2007 Switzerland
Primary
Secondary
Concomitant
Vomiting Hospitalization 6/3/2007 60 Male 11/16/2007 Japan
Primary
Secondary
Concomitant
Venoocclusive Liver Disease Life Threatening 6/24/2007 14 Female 11/16/2007 Japan
Primary
Concomitant
Streptococcal Sepsis Other Serious 5/3/2007 54 Female 11/16/2007 Japan
Primary
Concomitant
Ureaplasma Infection Other Serious 28 Male 11/23/2007 Physician Switzerland
Primary
Secondary
Concomitant
Squamous Cell Carcinoma Other Serious 65 Female 11/26/2007 Other Health Professional United States
Primary
Secondary
Systemic Candida Hospitalization 26 Male 11/15/2007 Germany
Primary
Secondary
Concomitant
Virus Serology Test Positive Other Serious 56 Male 11/20/2007 Japan
Primary
Secondary
Systemic Candida Hospitalization 26 Male 11/21/2007 Germany
Primary
Secondary
Concomitant
Stem Cell Transplant Other Serious 1/1/2005 65 Female 11/20/2007 Consumer United States
Primary
Secondary
Oral Herpes Other Serious 1/1/2005 65 Female 11/29/2007 Consumer
Primary
Secondary
Renal Tubular Necrosis Other Serious 53 Male 12/6/2007 Other Health Professional Portugal
Primary
Secondary
Thrombotic Thrombocytopenic Purpura Other Serious 2/1/2001 52 Male 12/10/2007 Japan
Primary
Concomitant
Cytomegalovirus Viraemia Hospitalization 6/11/2007 60 Male 12/10/2007 Japan
Primary
Secondary
Concomitant
Venous Thrombosis Other Serious 53 Male 12/7/2007 Physician Portugal
Primary
Secondary
Concomitant
Thrombotic Thrombocytopenic Purpura Other Serious 2/1/2001 52 Male 12/21/2007 Japan
Primary
Concomitant
Venoocclusive Liver Disease Life Threatening 11/1/2006 53 Male 12/19/2007 Other Health Professional Japan
Primary
Concomitant
Systemic Candida Hospitalization 26 Male 12/19/2007 Germany
Primary
Secondary
Skin Papilloma Other Serious 17 Male 12/21/2007 Physician Japan
Primary
Concomitant
Stomatitis Other Serious 5/1/2007 6 Male 1/3/2008 Japan
Primary
Concomitant
Vomiting Hospitalization 1/29/2005 49 Male 366 lb 1/11/2008 Physician Japan
Primary
Concomitant
Sepsis Life Threatening 9/27/2004 70 Female 117 lb 1/14/2008 Physician Japan
Primary
Concomitant
Renal Failure Death 12 Male 1/9/2008 Germany
Primary
Secondary
Squamous Cell Carcinoma Other Serious 1/1/2005 65 Female 1/15/2008 Consumer United States
Primary
Secondary
Renal Failure Other Serious 12 Male 1/17/2008 Physician Germany
Primary
Secondary
Stem Cell Transplant Other Serious 25 Male 1/15/2008 Australia
Primary
Secondary
Pneumothorax Other Serious 5/31/2006 54 Male 123 lb 2/29/2008 Physician Japan
Primary
Secondary
Concomitant
Pulmonary Alveolar Haemorrhage Other Serious 39 Female 3/6/2008 Other Health Professional Japan
Primary
Concomitant
Vomiting Hospitalization 10/31/2007 65 Female 3/6/2008 Japan
Primary
Concomitant
Pulmonary Alveolar Haemorrhage Other Serious 39 Female 3/17/2008 Japan
Primary
Concomitant
Venoocclusive Liver Disease Other Serious 36 Female 3/28/2008 Other Health Professional United States
Primary
Secondary
Concomitant
Respiratory Distress Hospitalization 17 Male 3/28/2008 Consumer United States
Primary
Secondary
Concomitant
Ureteral Stent Insertion Hospitalization 7/9/2007 56 Male 4/2/2008 Japan
Primary
Secondary
Concomitant
Vomiting Hospitalization 7/14/2007 40 Female 4/2/2008 Japan
Primary
Secondary
Concomitant
Quadriplegia Life Threatening 11/18/2007 18 Male 165 lb 4/18/2008 Consumer Denmark
Primary
Secondary
Concomitant
Spinal Cord Neoplasm Life Threatening 11/18/2007 18 Male 165 lb 4/22/2008 Consumer Denmark
Primary
Secondary
Concomitant
Ventricular Extrasystoles Life Threatening 10/7/2007 57 Male 4/30/2008 Japan
Primary
Concomitant
Vomiting Hospitalization 10/26/2007 65 Female 4/30/2008 Japan
Primary
Concomitant
Stomatitis Life Threatening 7/3/2007 51 Female 4/30/2008 Japan
Primary
Concomitant
Stomatitis Life Threatening 6/12/2007 52 Female 4/30/2008 Japan
Primary
Concomitant
Thrombotic Microangiopathy Life Threatening 2/6/2007 23 Male 4/30/2008 Japan
Primary
Concomitant
Tumour Associated Fever Hospitalization 11/13/2006 58 Male 4/30/2008 Japan
Primary
Secondary
Concomitant
Vomiting Life Threatening 10/28/2007 58 Male 4/30/2008 Japan
Primary
Concomitant
Vomiting Life Threatening 5/28/2007 25 Male 4/30/2008 Japan
Primary
Concomitant
Pneumothorax Other Serious 5/31/2006 54 Male 123 lb 5/9/2008 Physician Japan
Primary
Secondary
Concomitant
Pneumonia Bacterial Other Serious 4/9/2008 Other Health Professional Australia
Primary
Secondary
Concomitant
Hepatic Failure Other Serious 4/9/2008 Other Health Professional Australia
Primary
Secondary
Concomitant
Drug Toxicity Other Serious 4/9/2008 Germany
Primary
Secondary
White Blood Cell Count Increased Life Threatening 10/21/2007 46 Male 5/15/2008 Physician Japan
Primary
Secondary
Concomitant
Vomiting Other Serious 9/30/2007 67 Female 5/15/2008 Physician Japan
Primary
Concomitant
Tumour Flare Life Threatening 10/30/2007 34 Male 5/15/2008 Physician Japan
Primary
Concomitant
Vertigo Hospitalization 5/7/2007 60 Male 5/15/2008 Other Health Professional 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
Venoocclusive Liver Disease Other Serious 6/2/2008 Israel
Primary
Secondary
Concomitant
Venoocclusive Liver Disease Other Serious 6/3/2008 Israel
Primary
Secondary
Concomitant
Renal Impairment Other Serious 6/6/2008 United States
Primary
Secondary
Concomitant
Renal Impairment Other Serious 6/9/2008 United States
Primary
Secondary
Concomitant
Pulmonary Toxicity Other Serious 6/12/2008 United States
Primary
Secondary
Concomitant
Thrombotic Microangiopathy Death 51 Male 6/6/2008 France
Primary
Concomitant
Thrombotic Microangiopathy Death 44 Female 6/6/2008 France
Primary
Concomitant
Thrombotic Microangiopathy Hospitalization 44 Male 6/6/2008 Korea, Republic Of
Primary
Concomitant
Stomatitis Hospitalization 3/1/2007 62 Female 6/9/2008 Physician Japan
Primary
Concomitant
Vomiting 9/1/2007 18 Female 6/9/2008 Other Health Professional Japan
Primary
Concomitant
Herpes Simplex Other Serious 18 Female 6/18/2008 Other Health Professional Germany
Primary
Secondary
Concomitant
Oral Herpes Other Serious 16 Female 6/18/2008 Other Health Professional Germany
Primary
Secondary
Concomitant
Vomiting Life Threatening 5/1/2008 17 Male 6/18/2008 Japan
Primary
Concomitant
Chronic Graft Versus Host Disease Other Serious 57 6/26/2008 Other Health Professional Australia
Primary
Secondary
Concomitant
Infection Death 6/26/2008 Spain
Primary
Secondary
Concomitant
Transplant Failure Other Serious 63 Male 7/1/2008 Japan
Primary
Secondary
Concomitant
Vomiting Life Threatening 7/9/2007 50 Female 6/27/2008 Other Health Professional Japan
Primary
Concomitant
Bone Marrow Transplant Rejection Life Threatening 4/15/2008 2 Male 6/27/2008 Other Health Professional Japan
Primary
Concomitant
Pneumonia Disability 10/3/2007 37 Male 6/27/2008 Other Health Professional Japan
Primary
Concomitant

Drug Data