Anti-Thymocyte Globulin Nos combined with Methotrexate

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Pulmonary Toxicity Other Serious 6/12/2008 United States
Primary
Secondary
Concomitant
Oral Herpes Other Serious 16 Female 6/18/2008 Other Health Professional Germany
Primary
Secondary
Concomitant
Subdural Haematoma Other Serious 7/17/2008 United States
Primary
Secondary
Concomitant
Vomiting Other Serious 5/19/2008 Male 52 lb 8/15/2008 Other Health Professional Brazil
Primary
Secondary
Concomitant
Sepsis Other Serious 36 Male 10/14/2008 Other Health Professional Taiwan, Province Of China
Primary
Secondary
Concomitant
Pyrexia Other Serious 10 Male 10/14/2008 Other Health Professional Taiwan, Province Of China
Primary
Secondary
Concomitant
Septic Shock Other Serious 29 Female 10/14/2008 Other Health Professional Taiwan, Province Of China
Primary
Secondary
Concomitant
Septic Shock Other Serious 27 Female 10/14/2008 Other Health Professional Taiwan, Province Of China
Primary
Secondary
Concomitant
Pyrexia Other Serious 27 Male 10/14/2008 Other Health Professional Taiwan, Province Of China
Primary
Secondary
Concomitant
Toxic Encephalopathy Other Serious 10 11/1/2008 Other Health Professional United Kingdom
Primary
Secondary
Visual Acuity Reduced Other Serious 4/18/2008 Male 57 lb 11/4/2008 Other Health Professional Brazil
Primary
Concomitant
Toxic Encephalopathy Other Serious 10 11/13/2008 United Kingdom
Primary
Secondary
Vomiting Life Threatening 3/6/2007 57 Female 11/10/2008 Japan
Primary
Concomitant
Sepsis Syndrome Other Serious 14 Male 11/28/2008 Other Health Professional Germany
Primary
Concomitant
Paraesthesia Other Serious 39 Female 2/10/2009 Other Health Professional Canada
Primary
Secondary
Concomitant
Tachyarrhythmia Other Serious 57 Female 2/12/2009 Other Health Professional Germany
Primary
Concomitant
Toxic Encephalopathy Other Serious 1/1/2003 11 Male 3/24/2009 Japan
Primary
Concomitant
Toxic Encephalopathy Other Serious 1/1/2003 11 Female 4/4/2009 Japan
Primary
Concomitant
Sinusitis Fungal Other Serious 8/1/2006 28 Male 4/24/2009 Other Health Professional Italy
Primary
Concomitant
Cytomegalovirus Infection Other Serious 1/1/2008 1 5/5/2009 United Kingdom
Primary
Secondary
Sepsis Other Serious 5/12/2009 Other Health Professional Russian Federation
Primary
Secondary
Concomitant
Subdural Haemorrhage Other Serious 8 Female 5/13/2009 Other Health Professional Italy
Primary
Concomitant
Thrombotic Microangiopathy Other Serious 18 5/25/2009 Other Health Professional Tunisia
Primary
Concomitant
Multi-organ Failure Other Serious 19 5/23/2009 Other Health Professional Tunisia
Primary
Secondary
Concomitant
Transplant Rejection Other Serious 30 5/23/2009 Other Health Professional Tunisia
Primary
Secondary
Concomitant
Serum Ferritin Increased Other Serious 24 5/25/2009 Other Health Professional Tunisia
Primary
Concomitant
Stem Cell Transplant Other Serious 36 5/26/2009 Other Health Professional Tunisia
Primary
Concomitant
Sepsis Life Threatening 1/30/2009 40 Male 110 lb 9/9/2009 Japan
Primary
Concomitant
Sepsis Other Serious 1/30/2009 40 Male 110 lb 9/11/2009 Japan
Primary
Concomitant
Precursor T-lymphoblastic Lymphoma/leukaemia Other Serious 1/1/2009 12 Male 10/23/2009 Other Health Professional Japan
Primary
Concomitant
Pyrexia Death 12 Male 10/23/2009 Japan
Primary
Secondary
Concomitant
Transplant Rejection Death 32 Male 10/23/2009 Physician Japan
Primary
Concomitant
Pyrexia Death 2/3/2009 12 Male 64 lb 11/20/2009 Physician Japan
Primary
Secondary
Concomitant
Precursor T-lymphoblastic Lymphoma/leukaemia Other Serious 2/1/2009 12 Male 12/2/2009 Other Health Professional Japan
Primary
Concomitant
Sepsis Death 1/9/2010 Female 220 lb 1/29/2010 Physician Germany
Primary
Secondary
Vomiting Life Threatening 5/29/2009 Female 2/2/2010 Physician Italy
Primary
Secondary
Concomitant
Renal Failure Other Serious 6/30/2009 15 Male 88 lb 4/7/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Vomiting Other Serious 18 Male 4/19/2010 Other Health Professional Germany
Primary
Secondary
Concomitant
Pyrexia Other Serious 50 Female 4/16/2010 Italy
Primary
Concomitant
Pancreatitis Acute Hospitalization 6/24/2009 15 Male 88 lb 5/3/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Other Serious 1/1/2008 5 Male 5/21/2010 Other Health Professional China
Primary
Concomitant
Splenomegaly Other Serious 23 Male 7/12/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Transplant Failure Other Serious 13 Male 8/18/2010 Other Health Professional Turkey
Primary
Secondary
Concomitant
Respiratory Distress Hospitalization 5/3/2010 2 Male 8/16/2010 Physician United States
Primary
Concomitant
Thrombocytopenia Other Serious 21 Female 9/16/2010 Other Health Professional Germany
Primary
Secondary
Concomitant
Venoocclusive Disease Hospitalization Female 9/24/2010 Other Health Professional Germany
Primary
Secondary
Concomitant
Malignant Neoplasm Progression Death 9/22/2010 Physician Spain
Primary
Concomitant
Malignant Neoplasm Progression Death 9/22/2010 Physician Spain
Primary
Concomitant
Urinary Retention Other Serious 1/29/2009 65 Female 119 lb 9/28/2010 Other Health Professional Germany
Primary
Secondary
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
Oedema Other Serious 8/16/2009 7 Male 66 lb 12/10/2010 Physician Hungary
Primary
Secondary
Concomitant
Engraftment Syndrome Other Serious 8/23/2009 8 Female 71 lb 12/10/2010 Physician Hungary
Primary
Secondary
Concomitant
Multi-organ Failure Other Serious 4/23/2009 7 Female 40 lb 12/13/2010 Physician Hungary
Primary
Secondary
Concomitant
Venoocclusive Disease Other Serious 12/15/2010 Physician United Kingdom
Primary
Secondary
Concomitant
Venoocclusive Liver Disease Other Serious 9 Female 12/22/2010 Physician Japan
Primary
Secondary
Concomitant
Thrombotic Microangiopathy Other Serious 1 Female 12/27/2010 Physician Japan
Primary
Concomitant
Liver Disorder Hospitalization 3/26/2010 54 Female 95 lb 12/28/2010 Physician Japan
Primary
Secondary
Concomitant
Klebsiella Infection Other Serious 17 Female 12/13/2010 Physician United States
Primary
Concomitant
Mucosal Inflammation Other Serious 5 Male 12/12/2010 Physician Italy
Primary
Concomitant
Thrombotic Microangiopathy Other Serious 9 Female 12/28/2010 Physician Japan
Primary
Concomitant
Multi-organ Failure Other Serious 4/23/2009 7 Female 40 lb 12/30/2010 Physician Hungary
Primary
Secondary
Concomitant
Chronic Graft Versus Host Disease Death 1/5/2011 Physician Korea, Republic Of
Primary
Secondary
Concomitant
Epstein-barr Virus Infection Other Serious 19 Male 1/25/2011 Physician Germany
Primary
Secondary
Concomitant
Thrombotic Microangiopathy Hospitalization 9/16/2009 9 Female 1/31/2011 Physician Japan
Primary
Secondary
Concomitant
Chronic Graft Versus Host Disease Other Serious 46 Male 3/9/2011 Physician Japan
Primary
Secondary
Concomitant
Hepatitis Fulminant Other Serious 58 Female 3/9/2011 Physician Japan
Primary
Secondary
Concomitant
Drug Ineffective Other Serious 3 Female 3/18/2011 Physician Japan
Primary
Concomitant
Epstein-barr Virus Test Positive Other Serious 1 Female 3/18/2011 Physician Japan
Primary
Concomitant
Drug Ineffective Other Serious 7 Male 3/18/2011 Physician Japan
Primary
Concomitant
Acute Graft Versus Host Disease In Intestine Other Serious 10 Male 3/21/2011 Other Health Professional Italy
Primary
Secondary
Epstein-barr Virus Associated Lymphoproliferative Disorder Other Serious 33 Male 3/22/2011 Physician Japan
Primary
Concomitant
Skin Erosion Death 12 Male 3/23/2011 Physician Japan
Primary
Secondary
Concomitant
Skin Erosion Death 12 Male 3/23/2011 Physician Japan
Primary
Secondary
Concomitant
Cardio-respiratory Arrest Death 12 Male 3/23/2011 Physician Japan
Primary
Secondary
Concomitant
Cardio-respiratory Arrest Death 12 Male 3/23/2011 Physician Japan
Primary
Secondary
Concomitant
Ileus Paralytic Death 12 Male 3/23/2011 Physician Japan
Primary
Secondary
Concomitant
Drug Ineffective Other Serious Male 3/23/2011 Physician Japan
Primary
Concomitant
Graft Versus Host Disease Other Serious 2 Male 3/24/2011 Physician Sweden
Primary
Secondary
Concomitant
Skin Erosion Death Male 4/1/2011 Other Health Professional Japan
Primary
Secondary
Drug Ineffective Other Serious 7 Male 4/5/2011 Physician Japan
Primary
Concomitant
Enteritis Other Serious 4/6/2011 Other Health Professional Japan
Primary
Secondary
Concomitant
Hepatitis Fulminant Other Serious 58 Female 4/13/2011 Physician Japan
Primary
Secondary
Concomitant
Thrombotic Microangiopathy Life Threatening 12/7/2009 1 Female 22 lb 4/19/2011 Physician Japan
Primary
Secondary
Concomitant
Thrombotic Microangiopathy Life Threatening 12/7/2009 1 Female 22 lb 4/19/2011 Physician Japan
Primary
Secondary
Concomitant
Enteritis Other Serious 4/20/2011 Other Health Professional Japan
Primary
Secondary
Concomitant
Candida Test Positive Hospitalization 3/12/2010 54 Female 95 lb 5/25/2011 Physician Japan
Primary
Secondary
Concomitant
Cystitis Haemorrhagic Other Serious 4/1/2011 Physician United States
Primary
Concomitant
Thrombocytopenia Other Serious 24 Male 4/1/2011 Physician United States
Primary
Concomitant
Osteonecrosis Other Serious 6/1/2011 Other Health Professional France
Primary
Secondary
Concomitant
Osteonecrosis Other Serious 6/1/2011 Other Health Professional France
Primary
Secondary
Concomitant
Osteonecrosis Other Serious 6/1/2011 Other Health Professional France
Primary
Secondary
Concomitant
Osteonecrosis Other Serious 6/1/2011 Other Health Professional France
Primary
Secondary
Concomitant
Osteonecrosis Other Serious 6/1/2011 Other Health Professional France
Primary
Secondary
Concomitant
Osteonecrosis Other Serious 6/1/2011 Other Health Professional France
Primary
Secondary
Concomitant
Osteonecrosis Other Serious 6/1/2011 Other Health Professional France
Primary
Secondary
Concomitant
Osteonecrosis Other Serious 6/1/2011 Other Health Professional France
Primary
Secondary
Concomitant
Osteonecrosis Other Serious 6/1/2011 Other Health Professional France
Primary
Secondary
Concomitant
Osteonecrosis Other Serious 6/1/2011 Other Health Professional France
Primary
Secondary
Concomitant
Liver Disorder Hospitalization 3/26/2010 54 Female 95 lb 6/3/2011 Physician Japan
Primary
Secondary
Concomitant
Acute Myeloid Leukaemia Death 49 6/14/2011 Other Health Professional Germany
Primary
Secondary
Concomitant
Multi-organ Failure Death 54 6/14/2011 Other Health Professional Germany
Primary
Secondary
Multi-organ Failure Death 37 6/14/2011 Other Health Professional Germany
Primary
Secondary
Multi-organ Failure Other Serious 37 6/15/2011 Other Health Professional Germany
Primary
Secondary
Acute Myeloid Leukaemia Other Serious 49 6/15/2011 Other Health Professional Germany
Primary
Secondary
Concomitant
Sepsis Death 54 6/15/2011 Other Health Professional Germany
Primary
Secondary
Orthostatic Hypotension Other Serious 10/9/2008 60 Male 6/22/2011 Physician United States
Primary
Secondary
Concomitant
Hypertension Life Threatening 4/22/2010 13 Male 90 lb 7/5/2011 Physician Japan
Primary
Concomitant
Epstein-barr Virus Associated Lymphoproliferative Disorder Other Serious 22 7/6/2011 Other Health Professional United States
Primary
Secondary
Concomitant
Chronic Graft Versus Host Disease Death 2 7/6/2011 Other Health Professional United States
Primary
Secondary
Concomitant
Human Herpesvirus 6 Infection Other Serious 23 Male 7/6/2011 Physician Japan
Primary
Concomitant
Acute Graft Versus Host Disease Other Serious 2 7/6/2011 Other Health Professional United States
Primary
Secondary
Concomitant
Acute Graft Versus Host Disease Other Serious 22 7/6/2011 Other Health Professional United States
Primary
Secondary
Concomitant
Neutropenia Other Serious 6/9/2010 10 Female 88 lb 7/18/2011 Physician Japan
Primary
Secondary
Concomitant
Death Death 7/18/2011 Other Health Professional France
Primary
Secondary
Concomitant
Subdural Haemorrhage Other Serious 7/18/2011 Other Health Professional France
Primary
Secondary
Concomitant
Bronchopulmonary Aspergillosis Other Serious 50 Male 7/19/2011 Physician United States
Primary
Secondary
Concomitant
Irritability Other Serious 1 Female 7/28/2011 Other Health Professional United States
Primary
Secondary
Concomitant
Irritability Other Serious 1 Female 7/28/2011 Other Health Professional United States
Primary
Secondary
Concomitant
Bk Virus Infection Other Serious 2 Female 8/2/2011 Physician Japan
Primary
Secondary
Concomitant
Human Herpesvirus 6 Infection Other Serious 20 Male 8/2/2011 Physician Japan
Primary
Secondary
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
Hyponatraemia Other Serious 12/4/2010 23 Male 198 lb 8/29/2011 Physician Japan
Primary
Secondary
Concomitant
Human Herpesvirus 6 Infection Disability 12/4/2010 23 Male 198 lb 8/30/2011 Physician Japan
Primary
Secondary
Concomitant
Inappropriate Antidiuretic Hormone Secretion Disability 12/4/2010 23 Male 198 lb 9/12/2011 Physician Japan
Primary
Secondary
Concomitant
Inappropriate Antidiuretic Hormone Secretion Disability 12/4/2010 23 Male 198 lb 9/27/2011 Physician Japan
Primary
Secondary
Concomitant
Hypertension Other Serious 12 Male 10/3/2011 Physician Pakistan
Primary
Secondary
Concomitant
Engraft Failure Death 6/9/2010 10 Female 88 lb 10/13/2011 Physician Japan
Primary
Secondary
Concomitant
Herpes Simplex Death 42 10/14/2011 Physician Germany
Primary
Concomitant
Neurotoxicity Other Serious 17 Male 10/17/2011 Other Health Professional Italy
Primary
Concomitant
Posterior Reversible Encephalopathy Syndrome Death 7 Male 10/17/2011 Other Health Professional Italy
Primary
Concomitant
Posterior Reversible Encephalopathy Syndrome Death 16 Female 10/17/2011 Other Health Professional Italy
Primary
Concomitant
Neurotoxicity Other Serious 7 Male 10/17/2011 Other Health Professional Italy
Primary
Concomitant
Status Epilepticus Other Serious 12 Female 10/17/2011 Other Health Professional Italy
Primary
Concomitant
Status Epilepticus Other Serious 3 Male 10/17/2011 Other Health Professional Italy
Primary
Concomitant
Drug Ineffective Other Serious 9 Male 10/19/2011 Physician Japan
Primary
Concomitant
Cell Death Other Serious 29 Female 10/27/2011 Other Health Professional Taiwan, Province Of China
Primary
Concomitant
Graft Versus Host Disease Other Serious 20 Female 10/28/2011 Physician Thailand
Primary
Concomitant
Sepsis Other Serious 42 11/1/2011 Physician Germany
Primary
Concomitant
Cytomegalovirus Enterocolitis Death 11/21/2011 Physician Korea, Republic Of
Primary
Secondary
Concomitant
Graft Versus Host Disease Death 12/6/2011 Other Health Professional China
Primary
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

Drug Data