Anti-Thymocyte Globulin Nos combined with Fludarabine Phosphate

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Tubulointerstitial Nephritis Other Serious 50 Female 5/28/2008 United States
Primary
Secondary
Pulmonary Toxicity Other Serious 6/12/2008 United States
Primary
Secondary
Concomitant
Post Transplant Lymphoproliferative Disorder Other Serious 7/1/2007 32 Female 128 lb 6/18/2008 Pharmacist Netherlands
Primary
Secondary
Oral Herpes Other Serious 16 Male 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
Oral Herpes Other Serious 5 Male 6/18/2008 Other Health Professional Germany
Primary
Secondary
Concomitant
Pancytopenia Hospitalization 9 Female 6/25/2008 Other Health Professional Germany
Primary
Concomitant
Viral Haemorrhagic Cystitis Other Serious 7/1/2008 Other Health Professional Germany
Primary
Secondary
Concomitant
Transplant Failure Other Serious 39 185 lb 7/2/2008 Other Health Professional Germany
Primary
Secondary
Concomitant
Transplant Failure Other Serious 39 185 lb 7/3/2008 Other Health Professional Germany
Primary
Secondary
Concomitant
Subdural Haematoma Other Serious 7/17/2008 United States
Primary
Secondary
Concomitant
Multi-organ Failure Other Serious 7/23/2008 Germany
Primary
Secondary
Multi-organ Failure Other Serious 5/9/2007 47 Female 115 lb 7/25/2008 Pharmacist United States
Primary
Secondary
Immune Reconstitution Syndrome Hospitalization 31 Female 10/14/2008 Consumer United States
Primary
Secondary
Concomitant
Pyrexia Death 21 Female 10/14/2008 Other Health Professional Taiwan, Province Of China
Primary
Secondary
Concomitant
Evans Syndrome Death 3 10/31/2008 United Kingdom
Primary
Secondary
Epstein-barr Virus Infection Death 2 Female 24 lb 11/8/2008 Other Health Professional Canada
Primary
Concomitant
Evans Syndrome Death 3 11/14/2008 Other Health Professional United Kingdom
Primary
Secondary
Vomiting Life Threatening 3/6/2007 57 Female 11/10/2008 Japan
Primary
Concomitant
Drug Toxicity Death 11/17/2008 France
Primary
Secondary
Concomitant
Evans Syndrome Death 3 11/18/2008 Other Health Professional United Kingdom
Primary
Secondary
Evans Syndrome Death 3 11/21/2008 Other Health Professional United Kingdom
Primary
Secondary
Uveitis Other Serious 18 Female 11/19/2008 Other Health Professional United States
Primary
Secondary
Concomitant
Tachyarrhythmia Other Serious 57 Female 2/12/2009 Other Health Professional Germany
Primary
Concomitant
Subdural Haemorrhage 3 Female 4/20/2009 Germany
Primary
Secondary
Stridor Hospitalization 4/23/2009 Female 159 lb 5/1/2009 Consumer United States
Primary
Secondary
Concomitant
Tracheal Haemorrhage Death 5/2/2009 Male 176 lb 5/4/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Pneumonia Parainfluenzae Viral Death 5/4/2009 Male 187 lb 5/4/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Thrombotic Microangiopathy Other Serious 9 Female 5/8/2009 Other Health Professional Switzerland
Primary
Concomitant
Sepsis Other Serious 5/12/2009 Other Health Professional Russian Federation
Primary
Secondary
Concomitant
Ventricular Extrasystoles Death 6/16/2009 62 Female 190 lb 6/22/2009 Consumer United States
Primary
Secondary
Concomitant
Stem Cell Transplant Other Serious 6 Male 6/26/2009 Canada
Primary
Concomitant
Soft Tissue Infection Other Serious 20 Female 7/2/2009 Other Health Professional Israel
Primary
Concomitant
Stem Cell Transplant Hospitalization 6 Male 6/30/2009 Other Health Professional Canada
Primary
Concomitant
Transplant Rejection Death 32 Male 10/23/2009 Physician Japan
Primary
Concomitant
Transplant Failure Death 1 1/14/2010 Germany
Primary
Concomitant
Sepsis Death 64 Male 2/26/2010 Physician Japan
Primary
Concomitant
Tumour Lysis Syndrome Other Serious 52 Male 4/2/2010 Physician United States
Primary
Concomitant
Renal Failure Other Serious 6/30/2009 15 Male 88 lb 4/7/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Myelodysplastic Syndrome Other Serious 62 Female 4/16/2010 Physician United States
Primary
Concomitant
Renal Failure Acute Other Serious 52 Male 4/16/2010 Physician United States
Primary
Concomitant
Myelodysplastic Syndrome Other Serious 66 Male 4/16/2010 Physician United States
Primary
Concomitant
Myelodysplastic Syndrome Other Serious 60 Female 4/16/2010 Physician United States
Primary
Concomitant
White Blood Cell Count Decreased Other Serious 24 Male 5/6/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Pancreatitis Acute Hospitalization 6/24/2009 15 Male 88 lb 5/3/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Splenomegaly Other Serious 23 Male 7/12/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Vanishing Bile Duct Syndrome Other Serious 8 Male 8/3/2010 Netherlands
Primary
Secondary
Concomitant
Transplant Failure Other Serious 13 Male 8/18/2010 Other Health Professional Turkey
Primary
Secondary
Concomitant
Transplant Failure Other Serious 13 Male 8/20/2010 Other Health Professional Turkey
Primary
Secondary
Cardiac Failure Congestive Hospitalization 8/17/2009 51 Female 8/23/2010 Physician Japan
Primary
Secondary
Respiratory Distress Hospitalization 5/3/2010 2 Male 8/16/2010 Physician United States
Primary
Concomitant
Varicella Virus Test Positive Other Serious 9 Male 8/16/2010 Netherlands
Primary
Secondary
Concomitant
Herpes Zoster Other Serious 10/30/2009 31 Male 8/24/2010 Physician Japan
Primary
Secondary
Concomitant
Cardiac Failure Congestive Hospitalization 8/17/2009 51 Female 8/27/2010 Physician Japan
Primary
Secondary
Rash Other Serious 36 9/7/2010 Physician United States
Primary
Concomitant
Sepsis Death 0 9/7/2010 Physician United States
Primary
Concomitant
Hypercalcaemia Other Serious 0 9/7/2010 Physician United States
Primary
Concomitant
Sepsis Other Serious 28 9/7/2010 Physician United States
Primary
Concomitant
Anaemia Haemolytic Autoimmune Death 4 9/7/2010 Physician United States
Primary
Concomitant
Respiratory Arrest Other Serious 1 9/7/2010 Physician United States
Primary
Concomitant
Hypercalcaemia Other Serious 24 9/7/2010 Physician United States
Primary
Concomitant
Pulmonary Haemorrhage Death 2 9/7/2010 Physician United States
Primary
Concomitant
Transplant Failure Death 0 Male 9/7/2010 Physician United States
Primary
Concomitant
Transplant Failure Other Serious 1 Unknown 9/7/2010 Physician United States
Primary
Concomitant
Hypercalcaemia Other Serious 33 9/7/2010 Physician United States
Primary
Concomitant
Thrombocytopenia Other Serious 21 Female 9/16/2010 Other Health Professional Germany
Primary
Secondary
Concomitant
Transplant Rejection Other Serious 1 Male 9/22/2010 Physician United States
Primary
Concomitant
Malignant Neoplasm Progression Death 9/22/2010 Physician Spain
Primary
Concomitant
Malignant Neoplasm Progression Death 9/22/2010 Physician Spain
Primary
Concomitant
Renal Failure Chronic Other Serious 9/30/2010 Physician United States
Primary
Concomitant
Psychotic Disorder Other Serious 5/28/2004 52 Male 10/19/2010 Physician United States
Primary
Concomitant
Recurrent Cancer Death 5/28/2004 59 Female 10/19/2010 Physician United States
Primary
Concomitant
Neuropathy Peripheral Other Serious 6/5/2006 59 Male 10/19/2010 Physician United States
Primary
Concomitant
Malignant Neoplasm Progression Death 50 Male 10/26/2010 Physician France
Primary
Concomitant
Recurrent Cancer Death 46 Female 10/26/2010 Physician France
Primary
Concomitant
Neoplasm Malignant Death 66 Male 10/26/2010 Physician France
Primary
Concomitant
Neuropathy Peripheral Other Serious 50 Female 10/26/2010 Physician France
Primary
Concomitant
Recurrent Cancer Other Serious 65 Male 10/26/2010 Physician France
Primary
Concomitant
Infection Death 58 Male 10/26/2010 Physician France
Primary
Concomitant
Malignant Neoplasm Progression Other Serious 62 Male 10/26/2010 Physician France
Primary
Concomitant
Post Procedural Sepsis Death 10/26/2010 Physician Germany
Primary
Concomitant
Reversible Posterior Leukoencephalopathy Syndrome Other Serious 12/22/2005 10 Male 61 lb 10/27/2010 Physician Japan
Primary
Secondary
Concomitant
Chronic Graft Versus Host Disease Other Serious 58 Male 11/9/2010 Physician Ireland
Primary
Concomitant
Acute Graft Versus Host Disease Other Serious 59 Male 11/9/2010 Physician Ireland
Primary
Concomitant
Death Death 51 Male 11/12/2010 Physician United Kingdom
Primary
Concomitant
Neuroblastoma Death 8 12/7/2010 Physician France
Primary
Concomitant
Liver Disorder Hospitalization 3/26/2010 54 Female 95 lb 12/28/2010 Physician Japan
Primary
Secondary
Concomitant
Thrombotic Microangiopathy Other Serious 9 Female 12/28/2010 Physician Japan
Primary
Concomitant
Neuropathy Peripheral Other Serious 53 Male 3/31/2011 Consumer Japan
Primary
Secondary
Concomitant
Candida Test Positive Hospitalization 3/12/2010 54 Female 95 lb 5/25/2011 Physician Japan
Primary
Secondary
Concomitant
Liver Disorder Hospitalization 3/26/2010 54 Female 95 lb 6/3/2011 Physician Japan
Primary
Secondary
Concomitant
Pneumonia Herpes Viral Death 46 5/31/2011 Other Health Professional Japan
Primary
Secondary
Concomitant
Idiopathic Pneumonia Syndrome Death 49 5/31/2011 Other Health Professional Japan
Primary
Secondary
Concomitant
Thrombotic Microangiopathy Other Serious 2 Female 6/13/2011 Physician United States
Primary
Secondary
Concomitant
Fungal Infection Death 1/1/2008 5 Male 6/17/2011 Consumer United Kingdom
Primary
Concomitant
White Blood Cell Count Decreased Other Serious 13 Male 97 lb 6/22/2011 Physician Japan
Primary
Concomitant
Orthostatic Hypotension Other Serious 10/9/2008 60 Male 6/22/2011 Physician United States
Primary
Secondary
Concomitant
Epstein-barr Virus Associated Lymphoproliferative Disorder Death 16 7/6/2011 Other Health Professional United States
Primary
Concomitant
Dermatitis Other Serious 9 Female 6/29/2011 Other Health Professional Germany
Primary
Secondary
Concomitant
Neutropenia Other Serious 6/9/2010 10 Female 88 lb 7/18/2011 Physician Japan
Primary
Secondary
Concomitant
Bacterial Test Positive Hospitalization 8/25/2010 1 Male 23 lb 7/12/2011 Other Health Professional Canada
Primary
Concomitant
Epstein-barr Virus Infection Death 59 Female 7/13/2011 Other Health Professional Sweden
Primary
Secondary
Concomitant
Pyrexia Hospitalization 1/29/2011 2 23 lb 7/18/2011 Other Health Professional Canada
Primary
Concomitant
Bronchopulmonary Aspergillosis Other Serious 50 Male 7/19/2011 Physician United States
Primary
Secondary
Concomitant
Renal Impairment Death 11 Male 8/12/2011 Other Health Professional Canada
Primary
Concomitant
Graft Versus Host Disease Hospitalization 7/26/2011 55 Male 119 lb 8/12/2011 United States
Primary
Secondary
Platelet Count Decreased Other Serious 61 Male 8/18/2011 Other Health Professional Sweden
Primary
Concomitant
Cytomegalovirus Infection Death 62 Male 8/11/2011 Other Health Professional Israel
Primary
Secondary
Concomitant
Haemolysis Other Serious 29 Female 9/21/2011 Other Health Professional Germany
Primary
Concomitant
Drug Ineffective Other Serious 61 Male 9/28/2011 Physician Korea, Republic Of
Primary
Secondary
Concomitant
Engraft Failure Death 6/9/2010 10 Female 88 lb 10/13/2011 Physician Japan
Primary
Secondary
Concomitant
Cerebral Toxoplasmosis Other Serious 68 10/14/2011 Physician Germany
Primary
Concomitant
Posterior Reversible Encephalopathy Syndrome Death 16 Female 10/17/2011 Other Health Professional Italy
Primary
Concomitant
Febrile Neutropenia Other Serious 10/19/2011 Physician Japan
Primary
Concomitant
Drug Ineffective Other Serious 10/19/2011 Physician Japan
Primary
Concomitant
Febrile Neutropenia Other Serious 10/19/2011 Physician Japan
Primary
Concomitant
Drug Ineffective Other Serious 10/19/2011 Physician Japan
Primary
Concomitant
Drug Ineffective Other Serious 9 Male 10/19/2011 Physician Japan
Primary
Concomitant
Cerebral Haemorrhage Death 67 Male 10/20/2011 Other Health Professional Germany
Primary
Secondary
Concomitant
Febrile Neutropenia Death 5/6/2010 67 Male 183 lb 10/21/2011 Germany
Primary
Secondary
Concomitant
Febrile Neutropenia Death 5/6/2010 66 Male 183 lb 11/8/2011 Germany
Primary
Secondary
Concomitant
Cerebral Atrophy Other Serious 11/19/2007 24 Female 11/7/2011 Physician Japan
Primary
Concomitant
Blood Bilirubin Increased Hospitalization 51 Female 11/16/2011 Other Health Professional Japan
Primary
Concomitant
Cytomegalovirus Enterocolitis Death 11/21/2011 Physician Korea, Republic Of
Primary
Secondary
Concomitant
Graft Versus Host Disease Death 22 Female 12/12/2011 Physician United States
Primary
Secondary
Concomitant
Graft Versus Host Disease Death 17 Female 12/12/2011 Physician United States
Primary
Secondary
Concomitant
Acute Graft Versus Host Disease Death 19 Male 12/9/2011 Physician Japan
Primary
Concomitant
Chronic Graft Versus Host Disease Other Serious 10 Female 12/12/2011 Physician Japan
Primary
Concomitant
Drug Ineffective Other Serious 18 Female 12/12/2011 Physician Japan
Primary
Concomitant
Drug Ineffective Other Serious 17 Male 12/12/2011 Physician Japan
Primary
Concomitant
Acute Graft Versus Host Disease Other Serious 6 Female 12/12/2011 Physician Japan
Primary
Concomitant
Acute Graft Versus Host Disease Other Serious 13 Male 12/12/2011 Physician Japan
Primary
Concomitant
Herpes Zoster Other Serious 11 Female 12/12/2011 Physician Japan
Primary
Concomitant
Food Allergy Disability 9/1/2010 Male 18 lb 12/12/2011 Physician Japan
Primary
Concomitant
Chronic Graft Versus Host Disease Other Serious 5 Male 12/12/2011 Physician Japan
Primary
Concomitant
Pancreatitis Acute Death 5 Male 12/9/2011 Physician Japan
Primary
Concomitant
Acute Graft Versus Host Disease Other Serious 29 Female 12/13/2011 Physician Japan
Primary
Concomitant
Drug Ineffective Other Serious 3 Male 12/13/2011 Physician Japan
Primary
Concomitant
Pulmonary Arterial Hypertension Other Serious 9 Female 12/15/2011 Switzerland
Primary
Concomitant
Drug Ineffective Other Serious 19 Male 12/12/2011 Physician Japan
Primary
Concomitant
Toxicity To Various Agents Other Serious 12/22/2005 10 Male 61 lb 12/13/2011 Physician Japan
Primary
Secondary
Concomitant
Multi-organ Failure Death 12/9/2010 48 Male 176 lb 1/26/2012 Germany
Primary
Concomitant
Drug Ineffective Other Serious 6/13/2011 3 Male 29 lb 2/7/2012 Physician Japan
Primary
Concomitant
Oedema Peripheral Hospitalization 28 Female 2/24/2012 Other Health Professional United Kingdom
Primary
Secondary
Acute Graft Versus Host Disease Other Serious 12/11/2010 60 Male 2/28/2012 Other Health Professional France
Primary
Concomitant
Platelet Disorder Other Serious 11/5/2010 57 Female 2/28/2012 Other Health Professional France
Primary
Concomitant
Zygomycosis Death 62 Female 3/6/2012 Physician Japan
Primary
Concomitant
Drug Ineffective Other Serious 1 Male 3/8/2012 Physician Japan
Primary
Concomitant
Drug Ineffective Other Serious 58 Male 3/8/2012 Physician Japan
Primary
Concomitant
Drug Ineffective Other Serious 49 Male 3/12/2012 Physician Japan
Primary
Concomitant

Drug Data