Busulfan combined with Thymoglobulin

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Status Epilepticus Hospitalization 2/1/2006 58 Male 4/13/2006 France
Primary
Concomitant
Transaminases Increased Other Serious 9 Male 41 lb 5/8/2006 Other Health Professional Italy
Primary
Secondary
Concomitant
Septic Shock Life Threatening 7/27/2006 51 Male 181 lb 8/16/2006 Physician United States
Primary
Concomitant
Weight Increased Death 1 Male 10/3/2006 Physician France
Primary
Concomitant
Erythema Multiforme Other Serious 10/11/2006 2 Female 31 lb 10/17/2006 Physician Argentina
Primary
Concomitant
Erythema Multiforme Other Serious 10/11/2006 2 Female 31 lb 10/26/2006 Physician Argentina
Primary
Concomitant
Sputum Culture Positive Life Threatening 10/19/2006 35 Female 294 lb 11/9/2006 Other Health Professional United States
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
Interstitial Lung Disease Other Serious 11/20/2006 41 Female 163 lb 12/20/2006 Physician China
Primary
Concomitant
Restlessness Life Threatening 10/25/2006 63 Male 12/19/2006 Physician United States
Primary
Concomitant
Interstitial Lung Disease Other Serious 11/19/2006 41 Male 165 lb 12/29/2006 Physician China
Primary
Concomitant
Restlessness Life Threatening 10/25/2006 63 Male 1/18/2007 Physician United States
Primary
Concomitant
Lymphoproliferative Disorder Other Serious 10/11/2006 2 Female 31 lb 2/6/2007 Physician Argentina
Primary
Concomitant
Platelet Count Decreased Other Serious 10/11/2006 2 Female 31 lb 4/3/2007 Physician Argentina
Primary
Secondary
Concomitant
Pulmonary Oedema Disability 5/2/2007 1 Male 13 lb 5/8/2007 Physician Taiwan, Province Of China
Primary
Secondary
Shock Life Threatening 5/2/2007 1 Male 13 lb 5/18/2007 Physician Taiwan, Province Of China
Primary
Secondary
Concomitant
Shock Life Threatening 5/2/2007 1 Male 13 lb 5/30/2007 Physician Taiwan, Province Of China
Primary
Secondary
Concomitant
Lymphoproliferative Disorder Other Serious 10/11/2006 2 Female 31 lb 2/8/2007 Physician Argentina
Primary
Secondary
Concomitant
Erythema Multiforme Other Serious 10/11/2006 2 Female 31 lb 10/20/2006 Physician Argentina
Primary
Secondary
Concomitant
Secondary Immunodeficiency Life Threatening 5/4/2007 10 Male 93 lb 7/2/2007 Denmark
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
Paralysis Life Threatening 5/4/2007 10 Male 93 lb 8/29/2007 Denmark
Primary
Concomitant
Neutropenia Other Serious 4 Female 4/14/2008 Other Health Professional Germany
Primary
Secondary
Graft Versus Host Disease Hospitalization 4 Female 4/23/2008 Germany
Primary
Concomitant
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
Venoocclusive Disease Other Serious 8/12/2008 Canada
Primary
Secondary
Concomitant
Septic Shock Other Serious 12/1/2006 40 Female 8/26/2008 Other Health Professional Spain
Primary
Secondary
Myelodysplastic Syndrome Other Serious 1/18/2008 66 Male 172 lb 8/28/2008 Physician United States
Primary
Secondary
Concomitant
Complications Of Bone Marrow Transplant Death 8/29/2008 Germany
Primary
Secondary
Concomitant
Complications Of Bone Marrow Transplant Death 8/29/2008 Germany
Primary
Secondary
Concomitant
Pancytopenia Other Serious 0 Female 10/3/2008 Other Health Professional United States
Primary
Secondary
Concomitant
Sepsis Other Serious 21 Female 11/12/2008 Other Health Professional Austria
Primary
Secondary
Concomitant
Sepsis Other Serious 21 Female 11/20/2008 Other Health Professional Austria
Primary
Secondary
Concomitant
Stem Cell Transplant Other Serious 6 Male 4/30/2009 Canada
Primary
Concomitant
Pain Other Serious 7 Male 6/12/2009 Canada
Primary
Concomitant
Multi-organ Failure Death 2 Male 10/1/2009 Physician Argentina
Primary
Secondary
Multi-organ Failure Death 2 Male 10/23/2009 Physician Argentina
Primary
Secondary
Epstein-barr Virus Associated Lymphoproliferative Disorder Other Serious 59 Female 11/23/2009 Other Health Professional Sweden
Primary
Secondary
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
Transplant Rejection Other Serious 5 Male 11/24/2009 Other Health Professional Italy
Primary
Concomitant
Renal Failure Other Serious 9/19/2009 58 Male 181 lb 12/7/2009 Physician France
Primary
Secondary
Concomitant
Renal Failure Other Serious 9/19/2009 58 Male 181 lb 12/7/2009 Physician France
Primary
Secondary
Concomitant
Staphylococcal Infection Other Serious 9/29/2009 58 Male 12/16/2009 Other Health Professional France
Primary
Concomitant
Hypersensitivity Hospitalization 1/24/2010 Male 200 lb 2/12/2010 Other Health Professional United States
Primary
Concomitant
Encephalopathy Other Serious 6/4/2009 58 Female 121 lb 6/4/2010 Physician Japan
Primary
Concomitant
Multi-organ Failure Death 5/27/2010 63 Male 161 lb 6/30/2010 Physician France
Primary
Secondary
Multi-organ Failure Death 5/27/2010 63 Male 7/8/2010 Other Health Professional France
Primary
Concomitant
Pyrexia Hospitalization 3/12/2010 59 Male 132 lb 7/16/2010 Physician Japan
Primary
Concomitant
Metastasis Death 7/19/2010 Other Health Professional France
Primary
Concomitant
Pyrexia Other Serious 3/12/2010 59 Male 132 lb 7/19/2010 Physician Japan
Primary
Secondary
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
Death Death 7/20/2010 Other Health Professional Canada
Primary
Concomitant
Death Death 7/20/2010 Other Health Professional Canada
Primary
Concomitant
Venoocclusive Disease Other Serious 4/30/2010 31 Female 176 lb 7/21/2010 Other Health Professional United States
Primary
Concomitant
Venoocclusive Disease Hospitalization 4/30/2010 31 Female 7/21/2010 Other Health Professional United States
Primary
Concomitant
Graft Versus Host Disease Other Serious 7/23/2010 Other Health Professional United States
Primary
Concomitant
Graft Versus Host Disease Death 7/23/2010 Other Health Professional United States
Primary
Concomitant
Neurotoxicity Death 7/23/2010 Other Health Professional United States
Primary
Concomitant
Neurotoxicity Death 7/23/2010 Other Health Professional United States
Primary
Concomitant
Septic Shock Other Serious 56 Female 7/28/2010 Other Health Professional France
Primary
Concomitant
Extrasystoles Other Serious 49 7/28/2010 Other Health Professional France
Primary
Concomitant
Circulatory Collapse Other Serious 43 7/28/2010 Other Health Professional France
Primary
Concomitant
Nephropathy Toxic Other Serious 55 Male 7/30/2010 Other Health Professional United States
Primary
Concomitant
Venoocclusive Liver Disease Other Serious 10/20/2009 50 Female 97 lb 8/3/2010 Physician Japan
Primary
Concomitant
Transplant Failure Other Serious 12/1/2009 60 Male 126 lb 8/4/2010 Physician Japan
Primary
Concomitant
Septic Shock Other Serious 56 Female 8/4/2010 Other Health Professional France
Primary
Secondary
Concomitant
Septic Shock Other Serious 56 Female 8/10/2010 Other Health Professional France
Primary
Secondary
Concomitant
Nephrotic Syndrome Other Serious 9/19/2009 69 Female 86 lb 8/13/2010 Physician Japan
Primary
Concomitant
Thrombotic Microangiopathy Hospitalization 1/23/2010 66 Male 130 lb 8/13/2010 Consumer Japan
Primary
Concomitant
Herpes Zoster Other Serious 10/30/2009 31 Male 128 lb 8/16/2010 Physician Japan
Primary
Concomitant
Vomiting Hospitalization 12/19/2009 35 Female 8/10/2010 Other Health Professional France
Primary
Concomitant
Thrombotic Microangiopathy Other Serious 1/23/2010 67 Male 130 lb 8/19/2010 Physician Japan
Primary
Secondary
Concomitant
Thrombotic Microangiopathy Other Serious 1/23/2010 67 Male 130 lb 8/24/2010 Physician Japan
Primary
Secondary
Concomitant
Venoocclusive Disease Hospitalization 4/30/2010 31 Female 9/8/2010 Other Health Professional United States
Primary
Concomitant
Venoocclusive Disease Other Serious 4/30/2010 31 Female 176 lb 9/9/2010 Other Health Professional United States
Primary
Concomitant
Hepatic Enzyme Increased Other Serious 8 Male 9/24/2010 Other Health Professional United States
Primary
Concomitant
Chronic Graft Versus Host Disease Other Serious 64 Male 9/27/2010 Other Health Professional Germany
Primary
Concomitant
Haematopoietic Neoplasm Death 67 Male 9/27/2010 Other Health Professional Germany
Primary
Concomitant
Premature Menopause Other Serious 23 Female 9/30/2010 Other Health Professional France
Primary
Concomitant
Pneumothorax Other Serious 3/23/2010 56 Male 190 lb 10/6/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Pneumothorax Other Serious 3/23/2010 56 Male 190 lb 10/6/2010 Physician United States
Primary
Secondary
Concomitant
Respiratory Failure Other Serious 41 Female 10/14/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Staphylococcal Infection Other Serious 5/11/2009 70 Female 86 lb 10/15/2010 Physician Japan
Primary
Concomitant
Herpes Zoster Other Serious 10/30/2009 31 Male 128 lb 10/20/2010 Physician Japan
Primary
Concomitant
Encephalopathy Other Serious 4/10/2010 35 Male 139 lb 10/20/2010 Physician Japan
Primary
Concomitant
Stenotrophomonas Infection Hospitalization 5/17/2010 59 Male 126 lb 10/21/2010 Physician Japan
Primary
Concomitant
Respiratory Failure Other Serious 10/2/2010 15 Male 115 lb 10/25/2010 Physician Mexico
Primary
Concomitant
Chronic Graft Versus Host Disease Other Serious 64 Male 10/25/2010 Other Health Professional Germany
Primary
Concomitant
Haematopoietic Neoplasm Death 67 Male 10/25/2010 Other Health Professional Germany
Primary
Concomitant
Staphylococcal Sepsis Life Threatening 1/14/2009 67 Male 99 lb 10/26/2010 Consumer Japan
Primary
Concomitant
Stenotrophomonas Infection Hospitalization 5/17/2010 59 Male 126 lb 10/27/2010 Physician Japan
Primary
Concomitant
Transplant Failure Other Serious 12/27/2008 52 Male 152 lb 10/28/2010 Physician Japan
Primary
Secondary
Concomitant
Tachycardia Hospitalization 1/1/2010 57 Female 10/19/2010 Other Health Professional France
Primary
Concomitant
Staphylococcal Infection Hospitalization 5/31/2010 60 Male 10/19/2010 Other Health Professional France
Primary
Concomitant
Parotitis Hospitalization 9/1/2010 57 Female 10/19/2010 Other Health Professional France
Primary
Concomitant
Stem Cell Transplant Hospitalization 7/25/2010 61 Male 10/19/2010 Other Health Professional France
Primary
Concomitant
Respiratory Distress Other Serious 1/1/2010 64 Male 11/2/2010 Other Health Professional France
Primary
Concomitant
Hyperthermia Other Serious 7/3/2010 58 Male 10/19/2010 Other Health Professional France
Primary
Concomitant
Thrombotic Microangiopathy Death 9/21/2009 62 Female 126 lb 11/3/2010 Physician Japan
Primary
Concomitant
Febrile Neutropenia Other Serious 10/23/2009 41 Male 132 lb 11/3/2010 Physician Japan
Primary
Concomitant
Thrombocytopenia Other Serious 56 Female 11/4/2010 Other Health Professional France
Primary
Concomitant
Thrombocytopenia Other Serious 21 Female 11/5/2010 Other Health Professional Germany
Primary
Concomitant
Encephalitis Hospitalization 9/6/2010 38 Female 11/5/2010 Other Health Professional France
Primary
Secondary
Concomitant
Pyrexia Other Serious 1/30/2009 3 Female 31 lb 11/8/2010 Physician Japan
Primary
Concomitant
Encephalitis Other Serious 9/1/2010 38 Female 11/9/2010 Other Health Professional France
Primary
Concomitant
Rash Papular Other Serious 7/15/2010 57 Female 11/10/2010 Physician Germany
Primary
Secondary
Concomitant
Transplant Rejection Other Serious 1 Male 11/11/2010 Other Health Professional United States
Primary
Concomitant
Leukaemia Recurrent Other Serious 57 Male 11/11/2010 Other Health Professional Greece
Primary
Concomitant
Staphylococcal Infection Hospitalization 5/31/2010 60 Male 159 lb 11/3/2010 Other Health Professional France
Primary
Concomitant
Rhinovirus Infection Hospitalization 1/1/2010 60 Male 159 lb 11/12/2010 Physician Germany
Primary
Secondary
Concomitant
Pyrexia Other Serious 1/30/2009 3 Female 31 lb 11/12/2010 Physician Japan
Primary
Secondary
Concomitant
Therapeutic Response Decreased Other Serious 1/1/2010 57 Female 11/3/2010 Other Health Professional France
Primary
Concomitant
Acute Myeloid Leukaemia Other Serious 50 Female 11/22/2010 Other Health Professional Italy
Primary
Concomitant
Weight Increased Other Serious 1/17/2010 Male 168 lb 11/22/2010 Physician Japan
Primary
Concomitant
Thyroid Disorder Other Serious 7/17/2009 28 Male 110 lb 11/23/2010 Physician Japan
Primary
Concomitant
Cytomegalovirus Infection Other Serious 7/17/2009 28 Male 110 lb 11/24/2010 Physician Japan
Primary
Secondary
Concomitant
Pyrexia Life Threatening Male 112 lb 11/24/2010 Physician Japan
Primary
Secondary
Concomitant
Pyrexia Life Threatening Male 112 lb 11/24/2010 Physician Japan
Primary
Concomitant
Febrile Bone Marrow Aplasia Hospitalization 10/1/2010 42 Female 134 lb 11/23/2010 Other Health Professional France
Primary
Concomitant
White Blood Cell Count Decreased Hospitalization 9/1/2010 57 Female 11/23/2010 Other Health Professional France
Primary
Concomitant
Staphylococcal Infection Hospitalization 5/31/2010 60 Male 159 lb 11/23/2010 Other Health Professional France
Primary
Concomitant
Therapeutic Response Decreased Other Serious 1/1/2010 57 Female 11/23/2010 Other Health Professional France
Primary
Concomitant
Stem Cell Transplant Hospitalization 10/1/2010 42 Female 134 lb 11/24/2010 Other Health Professional France
Primary
Concomitant
Staphylococcal Infection Hospitalization 7/25/2010 61 Male 11/23/2010 Other Health Professional France
Primary
Concomitant
Venoocclusive Liver Disease Other Serious 10/20/2009 12/23/2010 Physician Japan
Primary
Concomitant
Pyrexia Hospitalization 12/12/2009 76 Male 119 lb 12/23/2010 Physician Japan
Primary
Secondary
Concomitant
Transplant Failure Other Serious 12/1/2009 60 Male 126 lb 12/23/2010 Physician Japan
Primary
Concomitant
Urinary Tract Infection Bacterial Death 3/25/2010 58 Male 150 lb 12/29/2010 Physician Japan
Primary
Secondary
Concomitant
Pyrexia Life Threatening 12/12/2009 76 Male 119 lb 12/29/2010 Physician Japan
Primary
Concomitant
Pyrexia Death 3/25/2010 58 Male 150 lb 12/29/2010 Physician Japan
Primary
Concomitant
Interstitial Lung Disease Hospitalization 2/23/2010 69 Male 130 lb 12/30/2010 Physician Japan
Primary
Concomitant

Drug Data