Melphalan Hydrochloride combined with Thymoglobulin

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Thrombotic Thrombocytopenic Purpura Death 5/25/2009 57 Male 219 lb 7/12/2009 Physician United States
Primary
Secondary
Respiratory Disorder Other Serious 16 Male 3/23/2010 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
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
Pulmonary Alveolar Haemorrhage Death 4/30/2010 United States
Primary
Secondary
Concomitant
Trichosporon Infection Death 12/10/2008 54 Male 132 lb 6/18/2010 Physician Japan
Primary
Concomitant
Viral Myocarditis Other Serious 55 Male 7/16/2010 Physician Japan
Primary
Concomitant
Multi-organ Failure Hospitalization 6/24/2009 15 Male 126 lb 9/23/2010 Physician Japan
Primary
Concomitant
Guillain-barre Syndrome Other Serious 51 Female 9/29/2010 Other Health Professional Italy
Primary
Concomitant
Renal Failure Other Serious 1/1/2009 62 Female 88 lb 8/18/2010 Physician Japan
Primary
Concomitant
Stem Cell Transplant Death 5/19/2009 53 Female 101 lb 8/18/2010 Physician Japan
Primary
Concomitant
Thrombotic Microangiopathy Death 1/1/2009 48 Female 88 lb 8/18/2010 Physician Japan
Primary
Concomitant
Disease Progression Death 1/1/2009 52 Male 115 lb 8/18/2010 Physician Japan
Primary
Concomitant
Malignant Neoplasm Progression Death 1/1/2009 50 Female 99 lb 8/18/2010 Physician Japan
Primary
Concomitant
White Blood Cell Count Decreased Other Serious 4/10/2009 4 Female 31 lb 10/8/2010 Physician Japan
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Other Serious 4/10/2009 4 Female 31 lb 10/11/2010 Physician Japan
Primary
Secondary
Concomitant
Pruritus Hospitalization 9/30/2009 18 Female 137 lb 10/18/2010 Physician Japan
Primary
Concomitant
Pneumonia Hospitalization 7/2/2010 62 Male 130 lb 10/21/2010 Physician Japan
Primary
Concomitant
Stenotrophomonas Infection Hospitalization 5/17/2010 59 Male 126 lb 10/21/2010 Physician Japan
Primary
Concomitant
Myeloproliferative Disorder Other Serious 9/13/2005 55 Male 176 lb 10/26/2010 Other Health Professional United States
Primary
Concomitant
Myeloproliferative Disorder Other Serious 7/11/2006 51 Female 154 lb 10/26/2010 Other Health Professional United States
Primary
Concomitant
Stenotrophomonas Infection Hospitalization 5/17/2010 59 Male 126 lb 10/27/2010 Physician Japan
Primary
Concomitant
Myeloproliferative Disorder Other Serious 9/13/2007 57 Male 176 lb 10/28/2010 Other Health Professional United States
Primary
Concomitant
Thrombotic Microangiopathy Death 9/21/2009 62 Female 126 lb 11/3/2010 Physician Japan
Primary
Concomitant
Oedema Life Threatening 1/29/2010 59 Male 176 lb 11/3/2010 Physician Japan
Primary
Secondary
Concomitant
Tumour Lysis Syndrome Death 11/15/2009 58 Male 108 lb 11/15/2010 Physician Japan
Primary
Concomitant
Colitis Other Serious 33 Female 11/16/2010 Other Health Professional Czech Republic
Primary
Concomitant
Idiopathic Pneumonia Syndrome Other Serious 6/29/2010 57 Female 99 lb 11/22/2010 Physician Japan
Primary
Secondary
Concomitant
Multi-organ Failure Hospitalization 6/24/2009 15 Male 126 lb 11/23/2010 Physician Japan
Primary
Concomitant
Pyrexia Other Serious 2/11/2009 54 Male 152 lb 11/23/2010 Consumer Japan
Primary
Concomitant
Rash Other Serious 6/10/2010 2 Female 24 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
Venoocclusive Liver Disease Hospitalization 5/26/2010 Male 18 lb 11/24/2010 Physician Japan
Primary
Concomitant
Neoplasm Malignant Other Serious 3/1/2009 54 Male 152 lb 11/24/2010 Physician Japan
Primary
Secondary
Concomitant
Rash Other Serious 5/14/2010 2 Female 24 lb 11/29/2010 Physician Japan
Primary
Concomitant
Fall Other Serious 12/9/2009 11/29/2010 Physician Japan
Primary
Concomitant
Shock Haemorrhagic Other Serious 4/23/2009 54 Female 115 lb 11/12/2010 Physician Japan
Primary
Concomitant
Sepsis Other Serious 15 Male 12/10/2010 Other Health Professional Japan
Primary
Concomitant
Staphylococcal Sepsis Other Serious 4/20/2010 1 Male 15 lb 12/10/2010 Physician Japan
Primary
Concomitant
Sepsis Other Serious 15 Male 12/13/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Urine Output Decreased Death 3/16/2009 8 Female 51 lb 12/6/2010 Physician Japan
Primary
Concomitant
Pseudomonal Sepsis Life Threatening 11/7/2010 49 Female 97 lb 12/30/2010 Physician Japan
Primary
Secondary
Concomitant
Disorientation Death 4/13/2009 52 Male 117 lb 1/10/2011 Physician Japan
Primary
Concomitant
Cardiac Failure Congestive Other Serious 4/22/2009 62 Female 88 lb 1/11/2011 Physician Japan
Primary
Concomitant
Acute Graft Versus Host Disease Other Serious 3 Female 2/10/2011 Physician Japan
Primary
Secondary
Concomitant
Renal Impairment Other Serious 12 Female 2/25/2011 Physician United States
Primary
Secondary
Concomitant
Renal Failure Death 12/10/2008 54 Male 132 lb 2/28/2011 Physician Japan
Primary
Concomitant
Acute Graft Versus Host Disease In Intestine Other Serious 31 4/13/2011 Physician Japan
Primary
Secondary
Concomitant
Febrile Neutropenia Death 4/15/2011 Physician Saudi Arabia
Primary
Secondary
Concomitant
Venoocclusive Disease Other Serious 5/16/2011 Physician Serbia
Primary
Secondary
Concomitant
Venoocclusive Disease Other Serious 5/16/2011 Physician Serbia
Primary
Secondary
Concomitant
Haemolysis Other Serious Male 5/17/2011 Pharmacist United States
Primary
Concomitant
Haemolysis Other Serious 18 Male 5/17/2011 Physician United States
Primary
Concomitant
Acute Graft Versus Host Disease Hospitalization 5/14/2010 2 Female 24 lb 5/20/2011 Physician Japan
Primary
Concomitant
Epstein-barr Virus Test Positive Life Threatening 5/14/2010 2 Female 24 lb 5/20/2011 Physician Japan
Primary
Secondary
Concomitant
Haemolysis Hospitalization 3/11/2011 18 Male 230 lb 5/20/2011 Pharmacist United States
Primary
Concomitant
Haemolysis Hospitalization 4/18/2011 60 Male 170 lb 5/20/2011 Physician United States
Primary
Concomitant
Respiratory Failure Death 10/26/2009 59 Male 121 lb 5/31/2011 Physician Japan
Primary
Secondary
Concomitant
Pneumonitis Other Serious 1 Male 5/31/2011 Other Health Professional Hungary
Primary
Concomitant
Engraft Failure Life Threatening 8/9/2010 Female 33 lb 6/1/2011 Physician Japan
Primary
Concomitant
Epstein-barr Virus Infection Other Serious 45 Male 6/6/2011 Other Health Professional United States
Primary
Secondary
Concomitant
Pulmonary Mycosis Other Serious 3/2/2010 63 Male 130 lb 6/7/2011 Physician Japan
Primary
Secondary
Concomitant
Pericardial Effusion Death 10/15/2010 7 Female 42 lb 6/15/2011 Physician Japan
Primary
Secondary
Concomitant
Staphylococcal Sepsis Life Threatening 1/29/2010 52 Male 132 lb 6/20/2011 Physician Japan
Primary
Secondary
Concomitant
Febrile Neutropenia Life Threatening 7/18/2010 61 Female 110 lb 6/21/2011 Physician Japan
Primary
Secondary
Concomitant
Graft Versus Host Disease Hospitalization 5/25/2010 23 Female 73 lb 6/23/2011 Physician Japan
Primary
Secondary
Concomitant
Thrombotic Microangiopathy Other Serious 3/5/2010 6/24/2011 Physician Japan
Primary
Secondary
Concomitant
Rash Other Serious 5/20/2010 7 Male 42 lb 6/24/2011 Physician Japan
Primary
Concomitant
Cytomegalovirus Test Positive Other Serious 5/20/2010 7 Male 42 lb 6/24/2011 Physician Japan
Primary
Secondary
Concomitant
Pulmonary Haemorrhage Death 3/9/2010 55 Male 152 lb 6/30/2011 Physician Japan
Primary
Secondary
Concomitant
Pancreatitis Other Serious 2/10/2010 23 Male 117 lb 6/30/2011 Physician Japan
Primary
Secondary
Concomitant
Encephalitis Cytomegalovirus Other Serious 29 Female 7/5/2011 Physician United States
Primary
Concomitant
Hypertension Life Threatening 4/22/2010 13 Male 90 lb 7/5/2011 Physician Japan
Primary
Concomitant
Memory Impairment Hospitalization 2/10/2010 23 Male 117 lb 7/6/2011 Other Health Professional Japan
Primary
Secondary
Concomitant
Abdominal Pain Other Serious 6/14/2010 7 Female 31 lb 7/8/2011 Physician Japan
Primary
Concomitant
Pyrexia Life Threatening 6/14/2011 18 Male 141 lb 7/12/2011 Pharmacist Brazil
Primary
Secondary
Concomitant
Engraft Failure Other Serious 6/9/2010 10 Female 88 lb 7/15/2011 Physician Japan
Primary
Secondary
Concomitant
Acute Graft Versus Host Disease In Intestine Death 4/7/2010 54 Male 110 lb 7/15/2011 Physician Japan
Primary
Secondary
Concomitant
Congestive Cardiomyopathy Hospitalization 4 Female 6/29/2011 Physician United States
Primary
Secondary
Concomitant
Abscess Bacterial Hospitalization 11/25/2009 61 Male 141 lb 7/18/2011 Physician Japan
Primary
Secondary
Concomitant
Acute Graft Versus Host Disease In Skin Death 12/10/2009 7 Male 53 lb 7/19/2011 Physician Japan
Primary
Concomitant
Pyrexia Life Threatening 6/14/2011 18 Male 141 lb 7/20/2011 Physician Brazil
Primary
Secondary
Concomitant
Thrombotic Thrombocytopenic Purpura Death 11/20/2009 34 Male 130 lb 7/22/2011 Physician Japan
Primary
Secondary
Concomitant
Pseudomonal Sepsis Death 9/1/2010 52 Male 154 lb 7/22/2011 Physician Japan
Primary
Secondary
Concomitant
Epstein-barr Virus Test Positive Other Serious 9/13/2009 7 Female 44 lb 8/1/2011 Physician Japan
Primary
Concomitant
Subarachnoid Haemorrhage Other Serious 16 Female 8/1/2011 Physician Japan
Primary
Secondary
Concomitant
Febrile Neutropenia Hospitalization 11/10/2010 49 Female 97 lb 8/2/2011 Physician Japan
Primary
Secondary
Concomitant
Acute Graft Versus Host Disease Other Serious 6 Male 8/2/2011 Physician Japan
Primary
Secondary
Concomitant
Acute Graft Versus Host Disease Other Serious 37 Female 8/2/2011 Physician Japan
Primary
Secondary
Concomitant
Acute Graft Versus Host Disease Other Serious 3 Female 8/2/2011 Physician Japan
Primary
Secondary
Concomitant
Acute Graft Versus Host Disease Other Serious 12 Male 8/3/2011 Physician Japan
Primary
Secondary
Concomitant
Acute Graft Versus Host Disease Other Serious Female 8/3/2011 Physician Japan
Primary
Secondary
Concomitant
Acute Graft Versus Host Disease Other Serious 9 Female 8/3/2011 Physician Japan
Primary
Secondary
Concomitant
Febrile Neutropenia Death 11/10/2010 49 Female 97 lb 8/3/2011 Physician Japan
Primary
Secondary
Concomitant
Pyrexia Other Serious 2/11/2009 54 Male 152 lb 8/5/2011 Physician Japan
Primary
Secondary
Concomitant
Neutropenia Life Threatening 1/17/2011 27 Female 95 lb 8/5/2011 Physician Japan
Primary
Concomitant
Insomnia Other Serious 11/23/2010 62 Female 108 lb 8/8/2011 Physician Japan
Primary
Concomitant
Pneumonia Bacterial Hospitalization 7/19/2010 32 Female 108 lb 8/10/2011 Physician Japan
Primary
Secondary
Concomitant
Cytomegalovirus Gastroenteritis Other Serious 2/11/2009 54 Male 152 lb 8/11/2011 Physician Japan
Primary
Concomitant
Graft Versus Host Disease Disability 4/20/2011 58 Male 119 lb 8/11/2011 Physician Japan
Primary
Concomitant
Cystitis Haemorrhagic Hospitalization 7/2/2010 62 Female 130 lb 8/12/2011 Physician Japan
Primary
Concomitant
Enterococcal Bacteraemia Other Serious 2 Male 8/18/2011 Physician United States
Primary
Concomitant
Septic Shock Other Serious 49 Male 8/23/2011 Physician Portugal
Primary
Secondary
Concomitant
Trichosporon Infection Death 12/10/2008 54 Male 132 lb 8/15/2011 Physician Japan
Primary
Concomitant
Headache Other Serious 2/4/2011 13 Female 86 lb 9/16/2011 Physician Japan
Primary
Concomitant
Acute Myeloid Leukaemia Recurrent Life Threatening 10/21/2009 22 Female 110 lb 9/19/2011 Physician Japan
Primary
Secondary
Concomitant
Haemolytic Anaemia Hospitalization 2/3/2010 6 Male 35 lb 9/19/2011 Physician Japan
Primary
Concomitant
Idiopathic Thrombocytopenic Purpura Death 11/17/2009 6 Male 33 lb 9/19/2011 Physician Japan
Primary
Concomitant
Epstein-barr Virus Associated Lymphoproliferative Disorder Death 5/19/2009 10 Male 49 lb 9/19/2011 Physician Japan
Primary
Concomitant
Septic Shock Hospitalization 3/26/2011 56 Male 183 lb 9/20/2011 Other Health Professional Australia
Primary
Secondary
Concomitant
Acute Graft Versus Host Disease In Skin Life Threatening 10/21/2009 22 Female 104 lb 9/26/2011 Physician Japan
Primary
Secondary
Concomitant
Acute Graft Versus Host Disease In Skin Other Serious 10/21/2009 22 Female 104 lb 9/26/2011 Physician Japan
Primary
Secondary
Concomitant
Acute Graft Versus Host Disease In Intestine Death 73 Male 119 lb 9/29/2011 Physician Japan
Primary
Concomitant
Thrombocytopenia Other Serious 3/11/2009 23 Female 97 lb 9/29/2011 Physician Japan
Primary
Concomitant
Enterococcal Infection Hospitalization 2/10/2010 23 Male 117 lb 10/3/2011 Physician Japan
Primary
Secondary
Concomitant
Multi-organ Failure Life Threatening 5/7/2009 50 Female 90 lb 10/6/2011 Physician Japan
Primary
Concomitant
Cytomegalovirus Test Positive Death 12/15/2010 52 Male 150 lb 10/7/2011 Physician Japan
Primary
Concomitant
Acute Myeloid Leukaemia Recurrent Other Serious 10/10/2011 Other Health Professional Japan
Primary
Concomitant
Pseudomonal Sepsis Other Serious 10/21/2009 22 Female 104 lb 10/11/2011 Physician Japan
Primary
Secondary
Concomitant
Pyrexia Hospitalization 8/9/2010 6 Female 33 lb 10/12/2011 Physician Japan
Primary
Concomitant
Pneumonia Cytomegaloviral Other Serious 6/9/2010 10 Female 88 lb 10/12/2011 Physician Japan
Primary
Secondary
Concomitant
Herpes Zoster Hospitalization 10/24/2010 19 Male 97 lb 10/21/2011 Physician Japan
Primary
Concomitant
Thrombotic Microangiopathy Other Serious 3/24/2011 74 Female 101 lb 10/28/2011 Physician Japan
Primary
Concomitant
Liver Disorder Hospitalization 4/5/2011 8 Female 53 lb 11/2/2011 Physician Japan
Primary
Concomitant
Acute Graft Versus Host Disease Hospitalization 3/23/2011 49 lb 11/3/2011 Physician Japan
Primary
Concomitant
Staphylococcal Sepsis Life Threatening 2/2/2010 44 Male 159 lb 11/8/2011 Physician Japan
Primary
Concomitant
Acute Graft Versus Host Disease In Skin Other Serious 5/31/2009 58 Female 134 lb 11/8/2011 Physician Japan
Primary
Concomitant
Acute Graft Versus Host Disease In Intestine Disability 1/4/2010 1 57 lb 11/10/2011 Physician Japan
Primary
Concomitant
Abscess Bacterial Hospitalization 11/25/2009 61 Male 141 lb 11/17/2011 Physician Japan
Primary
Secondary
Concomitant
Pseudomonal Sepsis Death 9/1/2010 52 Male 154 lb 11/17/2011 Physician Japan
Primary
Secondary
Concomitant
Graft Versus Host Disease In Skin Other Serious 4/7/2010 54 Male 110 lb 11/18/2011 Physician Japan
Primary
Secondary
Concomitant
Hepatomegaly Hospitalization 5/10/2010 56 Male 132 lb 11/22/2011 Physician Japan
Primary
Concomitant
Hyperglycaemia Life Threatening 3/14/2011 55 Male 141 lb 11/23/2011 Physician Japan
Primary
Concomitant
Multi-organ Failure Hospitalization 6/24/2009 15 Male 126 lb 11/23/2011 Physician Japan
Primary
Concomitant
Neutropenia Hospitalization 3/2/2011 1 Male 24 lb 11/29/2011 Physician Japan
Primary
Concomitant
Neutropenia Death 6/1/2011 10 Female 60 lb 11/29/2011 Physician Japan
Primary
Concomitant
Pneumonia Staphylococcal Death 6/10/2010 33 Female 101 lb 11/29/2011 Physician Japan
Primary
Concomitant
Enterococcal Infection Hospitalization 2/10/2010 23 Male 117 lb 12/8/2011 Physician Japan
Primary
Secondary
Concomitant
Viral Haemorrhagic Cystitis Death 6/24/2010 29 Female 99 lb 12/8/2011 Other Health Professional Japan
Primary
Concomitant
Cytomegalovirus Viraemia Death 3/26/2011 62 Male 128 lb 12/12/2011 Physician Japan
Primary
Concomitant
Cytomegalovirus Hepatitis Hospitalization 2/25/2011 2 Male 33 lb 12/12/2011 Physician Japan
Primary
Concomitant
Venoocclusive Liver Disease Death 2/7/2009 57 Male 139 lb 12/14/2011 Physician Japan
Primary
Concomitant
Cytomegalovirus Test Positive Life Threatening 5/23/2010 73 Male 119 lb 12/16/2011 Physician Japan
Primary
Concomitant
Cerebral Haemorrhage Death 5/10/2010 29 Female 64 lb 12/19/2011 Physician Japan
Primary
Concomitant
Graft Versus Host Disease In Skin Life Threatening 5/31/2011 9 Male 79 lb 12/19/2011 Physician Japan
Primary
Concomitant

Drug Data