Fludarabine Phosphate combined with Thymoglobulin

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Hepatitis Fulminant Other Serious 5/31/2006 64 Male 1/29/2007 France
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
Subdural Haemorrhage Life Threatening 6/24/2006 51 Female 124 lb 1/15/2007 United States
Primary
Concomitant
Cystitis Hospitalization 8/27/2006 44 Female 173 lb 1/15/2007 Other Health Professional United States
Primary
Concomitant
Staphylococcal Infection Death 12/1/2001 56 Female 168 lb 1/15/2007 Physician United States
Primary
Concomitant
Weight Increased Other Serious 7/15/2007 64 Male 198 lb 1/16/2008 France
Primary
Secondary
Concomitant
Interacting
Therapeutic Agent Toxicity Other Serious 5/12/2008 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
Pneumonia Cytomegaloviral Life Threatening 2/28/2008 61 Male 183 lb 6/19/2008 Physician Netherlands
Primary
Secondary
Renal Failure Death 6/22/2008 Male 132 lb 6/23/2008 Other Health Professional United States
Primary
Secondary
Concomitant
Thrombosis Other Serious 64 Female 7/16/2008 Other Health Professional France
Primary
Concomitant
Vomiting Other Serious 7/23/2008 Poland
Primary
Secondary
Concomitant
Vomiting Hospitalization 39 Male 7/25/2008 Other Health Professional Germany
Primary
Secondary
Aspergillosis Other Serious 9 Female 3/18/2008 Other Health Professional Pakistan
Primary
Secondary
Fungal Rhinitis Other Serious 41 Male 7/8/2008 Other Health Professional Italy
Primary
Secondary
Concomitant
Weight Increased Other Serious 5/29/2008 Female 114 lb 10/10/2008 Other Health Professional Brazil
Primary
Concomitant
Miller Fisher Syndrome Other Serious 9 Female 10/24/2008 Physician Italy
Primary
Secondary
Vomiting Life Threatening 3/6/2007 57 Female 11/10/2008 Japan
Primary
Concomitant
Sepsis Other Serious 21 Female 11/20/2008 Other Health Professional Austria
Primary
Secondary
Concomitant
Staphylococcal Infection Other Serious 5 Male 11/25/2008 Other Health Professional Israel
Primary
Secondary
Concomitant
Insomnia Required Intervention 8/23/2008 42 Male 370 lb 12/2/2008 Physician United Kingdom
Primary
Concomitant
Staphylococcal Infection Death 12/1/2001 56 Female 168 lb 1/15/2007 Other Health Professional United States
Primary
Concomitant
Rash Other Serious 12/27/2007 Female 44 lb 12/5/2008 Physician Japan
Primary
Secondary
Concomitant
Evans Syndrome Death 2 12/17/2008 Other Health Professional United Kingdom
Primary
Secondary
Venoocclusive Liver Disease Death 12/28/2008 62 Male 1/2/2009 Physician United States
Primary
Secondary
Meningorrhagia Other Serious 11/1/2008 56 Female 12/29/2008 Pharmacist France
Primary
Concomitant
Headache Other Serious 11/21/2008 52 Female 12/29/2008 Pharmacist France
Primary
Concomitant
Venoocclusive Liver Disease Death 12/28/2008 62 Male 1/14/2009 Consumer United States
Primary
Secondary
Venoocclusive Liver Disease Death 62 Male 1/22/2009 Physician United States
Primary
Secondary
Headache Other Serious 11/21/2008 52 Female 1/22/2009 Pharmacist France
Primary
Concomitant
Subarachnoid Haemorrhage Other Serious 11/1/2008 56 Female 1/21/2009 Pharmacist France
Primary
Concomitant
Evans Syndrome Death 2 1/23/2009 Other Health Professional United Kingdom
Primary
Secondary
Venoocclusive Liver Disease Life Threatening 12/28/2008 62 Male 2/9/2009 Physician United States
Primary
Secondary
Concomitant
Herpes Zoster 20 Male 2/20/2009 Korea, Republic Of
Primary
Concomitant
Stem Cell Transplant 48 Female 2/20/2009 Korea, Republic Of
Primary
Concomitant
Herpes Zoster 22 Female 2/20/2009 Korea, Republic Of
Primary
Concomitant
Stem Cell Transplant 24 Male 2/20/2009 Korea, Republic Of
Primary
Concomitant
Stem Cell Transplant Death 34 Male 2/20/2009 Korea, Republic Of
Primary
Concomitant
Stem Cell Transplant Death 16 Male 2/20/2009 Korea, Republic Of
Primary
Concomitant
Stem Cell Transplant 25 Male 2/20/2009 Korea, Republic Of
Primary
Concomitant
Stem Cell Transplant 69 Male 2/20/2009 Korea, Republic Of
Primary
Concomitant
Sepsis Death 40 Male 2/20/2009 Korea, Republic Of
Primary
Concomitant
Stenotrophomonas Sepsis Death 50 Female 2/20/2009 Korea, Republic Of
Primary
Concomitant
Stem Cell Transplant 31 Male 2/20/2009 Korea, Republic Of
Primary
Concomitant
Treatment Failure 50 Male 2/20/2009 Korea, Republic Of
Primary
Concomitant
Stem Cell Transplant Death 27 Male 2/20/2009 Korea, Republic Of
Primary
Concomitant
Stem Cell Transplant 38 Female 2/20/2009 Korea, Republic Of
Primary
Concomitant
Stem Cell Transplant 65 Female 2/20/2009 Korea, Republic Of
Primary
Concomitant
White Blood Cell Count Decreased Death 1/1/2008 54 Male 132 lb 2/12/2009 Physician Japan
Primary
Concomitant
Weight Decreased Death 28 Male 2/20/2009 Korea, Republic Of
Primary
Concomitant
Disease Recurrence Death 36 Male 2/20/2009 Korea, Republic Of
Primary
Concomitant
Herpes Zoster Death 26 Female 2/20/2009 Physician Korea, Republic Of
Primary
Concomitant
Stem Cell Transplant Death 36 Female 2/20/2009 Physician Korea, Republic Of
Primary
Concomitant
Stem Cell Transplant 45 Male 2/20/2009 Physician Korea, Republic Of
Primary
Concomitant
Pseudomembranous Colitis 22 Male 2/20/2009 Korea, Republic Of
Primary
Concomitant
Stenotrophomonas Sepsis Death 48 Male 2/20/2009 Physician Korea, Republic Of
Primary
Concomitant
Disease Recurrence Death 16 Male 2/20/2009 Korea, Republic Of
Primary
Concomitant
Stem Cell Transplant 23 Male 2/20/2009 Korea, Republic Of
Primary
Concomitant
Stem Cell Transplant Death 43 Female 2/20/2009 Korea, Republic Of
Primary
Concomitant
Stem Cell Transplant Death 19 Female 2/20/2009 Korea, Republic Of
Primary
Concomitant
Chronic Graft Versus Host Disease 34 Male 2/20/2009 Korea, Republic Of
Primary
Concomitant
Stem Cell Transplant 52 Female 2/20/2009 Korea, Republic Of
Primary
Concomitant
Venoocclusive Liver Disease Other Serious 12/20/2008 62 Male 2/23/2009 Physician United States
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Death 12/3/2008 55 Male 158 lb 2/24/2009 Physician United States
Primary
Secondary
Concomitant
Epstein-barr Virus Associated Lymphoproliferative Disorder Death 37 Male 3/11/2009 Consumer United Kingdom
Primary
Secondary
Graft Versus Host Disease Death 3/16/2009 Physician United States
Primary
Secondary
Subarachnoid Haemorrhage Other Serious 11/1/2008 56 Female 3/18/2009 Pharmacist France
Primary
Concomitant
Shock Life Threatening 2/17/2009 1 Male 18 lb 3/13/2009 Physician Japan
Primary
Concomitant
Epstein-barr Virus Associated Lymphoproliferative Disorder Death 37 Male 3/20/2009 Consumer United Kingdom
Primary
Secondary
Shock Life Threatening 2/17/2009 1 Male 18 lb 3/25/2009 Physician Japan
Primary
Concomitant
Transplant Other Serious 4/6/2009 Physician United States
Primary
Secondary
Concomitant
Thrombotic Microangiopathy Other Serious 16 Female 4/3/2009 Physician Japan
Primary
Concomitant
Tachycardia Other Serious 3/29/2009 43 Male 110 lb 4/7/2009 Physician Japan
Primary
Concomitant
Stem Cell Transplant Other Serious 6 Male 4/30/2009 Canada
Primary
Concomitant
Pseudomonal Sepsis Other Serious 3/28/2009 60 Male 137 lb 4/20/2009 Physician Japan
Primary
Concomitant
Tachycardia Other Serious 3/29/2009 43 Male 110 lb 4/29/2009 Physician Japan
Primary
Concomitant
White Blood Cell Count Decreased Death 1/1/2008 54 Male 132 lb 5/8/2009 Physician Japan
Primary
Concomitant
Epstein-barr Virus Infection Other Serious 1/13/2009 52 Male 134 lb 5/14/2009 Physician Japan
Primary
Concomitant
Renal Failure Death 1/1/2008 54 Male 132 lb 5/20/2009 Physician Japan
Primary
Concomitant
White Blood Cell Count Decreased Death 1/1/2008 54 Male 132 lb 5/19/2009 Physician Japan
Primary
Concomitant
Pseudomonal Sepsis Other Serious 3/28/2009 60 Male 150 lb 5/26/2009 Physician Japan
Primary
Concomitant
Virus Serology Test Positive Death 4/17/2009 58 Female 97 lb 6/2/2009 Physician Japan
Primary
Concomitant
Pain Other Serious 7 Male 6/12/2009 Canada
Primary
Concomitant
Pseudomonal Sepsis Other Serious 3/4/2009 60 Male 150 lb 6/15/2009 Physician Japan
Primary
Concomitant
Virus Serology Test Positive Death 4/17/2009 58 Female 97 lb 7/10/2009 Physician Japan
Primary
Concomitant
Thyroiditis Other Serious 46 Female 7/17/2009 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Thyroiditis Other Serious 39 Male 7/17/2009 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Cytokine Release Syndrome Other Serious 3/29/2009 43 Female 110 lb 8/26/2009 Physician Japan
Primary
Concomitant
Tachypnoea Death 2/12/2009 Male 9/17/2009 Physician Japan
Primary
Secondary
Concomitant
Multi-organ Failure Death 2 Male 10/1/2009 Physician Argentina
Primary
Concomitant
Multi-organ Failure Death 2 Male 10/2/2009 Physician Argentina
Primary
Concomitant
Cerebral Haemorrhage Death 9/1/2009 24 Female 99 lb 10/20/2009 Physician Japan
Primary
Concomitant
Splenomegaly Other Serious 12 Male 10/29/2009 Physician Italy
Primary
Concomitant
Upper Gastrointestinal Haemorrhage Other Serious 9/24/2009 58 Female 118 lb 11/18/2009 Other Health Professional United States
Primary
Concomitant
Encephalitis Herpes Death 6/4/2009 58 Female 121 lb 11/24/2009 Physician Japan
Primary
Concomitant
Pseudomonal Sepsis Other Serious 3/4/2009 60 Male 150 lb 11/24/2009 Physician Japan
Primary
Concomitant
Renal Failure Other Serious 10/22/2009 4 Male 33 lb 12/8/2009 Pharmacist France
Primary
Concomitant
Stem Cell Transplant Death 9/16/2009 24 Female 126 lb 12/31/2009 Physician Japan
Primary
Concomitant
Pyrexia Other Serious 59 Male 121 lb 12/31/2009 Physician Japan
Primary
Concomitant
Renal Failure Other Serious 8/19/2009 63 Male 188 lb 1/11/2010 Physician United States
Primary
Concomitant
Renal Failure Other Serious 10/2/2009 64 Male 188 lb 1/5/2010 Physician United States
Primary
Concomitant
Pyrexia Other Serious 3/22/2009 15 Male 110 lb 2/26/2010 Physician Japan
Primary
Concomitant
Upper Gastrointestinal Haemorrhage Other Serious 6/26/2009 58 Female 118 lb 2/16/2010 Other Health Professional United States
Primary
Concomitant
Pseudomembranous Colitis Life Threatening 8/17/2009 59 Male 121 lb 1/29/2010 Physician Japan
Primary
Concomitant
Engraft Failure Hospitalization 9/2/2009 73 Female 126 lb 1/29/2010 Physician Japan
Primary
Concomitant
Pyrexia Other Serious 2/16/2009 Male 161 lb 3/4/2010 Physician Japan
Primary
Concomitant
Respiratory Disorder Other Serious 16 Male 3/23/2010 Physician Japan
Primary
Concomitant
Hepatic Function Abnormal Life Threatening 6/28/2009 Male 3/30/2010 Physician Japan
Primary
Concomitant
Nephropathy Toxic Other Serious 4/1/2010 United States
Primary
Secondary
Concomitant
Respiratory Disorder Other Serious 7/6/2009 16 Male 110 lb 4/5/2010 Physician Japan
Primary
Concomitant
Nephropathy Toxic Other Serious 4/6/2010 United States
Primary
Secondary
Concomitant
Pyrexia Life Threatening 8/17/2009 59 Male 121 lb 4/2/2010 Physician Japan
Primary
Concomitant
Renal Failure Other Serious 9/22/2009 64 Male 188 lb 3/31/2010 Physician United States
Primary
Concomitant
Pulmonary Haemorrhage Death 7/28/2009 57 Male 137 lb 4/12/2010 Physician Japan
Primary
Concomitant
Fungal Sepsis Death 4/2/2009 62 Male 157 lb 4/12/2010 Physician Japan
Primary
Concomitant
Viraemia Death 7/19/2009 58 Male 121 lb 4/12/2010 Physician Japan
Primary
Concomitant
Respiratory Arrest Death 11/30/2009 27 Female 220 lb 4/9/2010 Physician Japan
Primary
Concomitant
Infection Other Serious 8/19/2009 63 Male 188 lb 4/22/2010 Physician United States
Primary
Concomitant
Pseudomonas Infection Other Serious 8 Female 13 lb 4/26/2010 Other Health Professional United States
Primary
Concomitant
White Blood Cell Count Decreased Other Serious 1 Female 13 lb 4/29/2010 United States
Primary
Concomitant
Staphylococcal Infection Life Threatening 5/1/2007 65 Male 99 lb 5/26/2010 Consumer Japan
Primary
Concomitant
Tachypnoea Life Threatening 2/12/2009 1 Male 5/26/2010 Physician Japan
Primary
Secondary
Visual Impairment Disability 3/11/2009 48 Female 84 lb 4/29/2010 Physician Japan
Primary
Concomitant
Splenomegaly Required Intervention 4/24/2006 10 Male 33 lb 4/20/2010 Physician Italy
Primary
Concomitant
Stem Cell Transplant Other Serious 8/19/2009 63 Male 188 lb 4/20/2010 Physician United States
Primary
Concomitant
Encephalopathy Other Serious 6/4/2009 58 Female 121 lb 6/4/2010 Physician Japan
Primary
Concomitant
Pancytopenia Other Serious 12/27/2008 52 Male 152 lb 5/27/2010 Physician Japan
Primary
Concomitant
Mucosal Inflammation Other Serious 6/16/2010 Spain
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Hospitalization 10/19/2009 54 Male 132 lb 6/21/2010 Other Health Professional Japan
Primary
Concomitant
Staphylococcal Infection Other Serious 4/14/2010 60 Male 110 lb 6/25/2010 Physician Japan
Primary
Concomitant
Pyrexia Life Threatening 8/17/2009 59 Male 121 lb 6/8/2010 Physician Japan
Primary
Concomitant
Trichosporon Infection Death 12/10/2008 54 Male 132 lb 6/18/2010 Physician Japan
Primary
Concomitant
Multi-organ Failure Death 5/27/2010 63 Male 7/8/2010 Other Health Professional France
Primary
Concomitant
Metastasis Death 7/19/2010 Other Health Professional France
Primary
Concomitant
Transplant Failure Other Serious 7/19/2010 Other Health Professional United Kingdom
Primary
Concomitant
Death Death 7/20/2010 Other Health Professional Canada
Primary
Concomitant
Death Death 7/20/2010 Other Health Professional Canada
Primary
Concomitant
Acute Lymphocytic Leukaemia Recurrent Death 7/20/2010 Other Health Professional Canada
Primary
Concomitant
Death Death 7/20/2010 Other Health Professional Canada
Primary
Concomitant
Acute Lymphocytic Leukaemia Recurrent Death 7/20/2010 Other Health Professional Canada
Primary
Concomitant
Death Death 7/20/2010 Other Health Professional Canada
Primary
Concomitant
Acute Lymphocytic Leukaemia Recurrent Death 7/20/2010 Other Health Professional Canada
Primary
Concomitant
Death Death 7/20/2010 Other Health Professional Canada
Primary
Concomitant
Acute Lymphocytic Leukaemia Recurrent Death 7/20/2010 Other Health Professional Canada
Primary
Concomitant
Death Death 7/20/2010 Other Health Professional Canada
Primary
Concomitant
Acute Lymphocytic Leukaemia Recurrent Death 7/20/2010 Other Health Professional Canada
Primary
Concomitant
Acute Lymphocytic Leukaemia Recurrent Death 7/20/2010 Other Health Professional Canada
Primary
Concomitant
Death Death 7/20/2010 Other Health Professional Canada
Primary
Concomitant

Drug Data