Melphalan Hydrochloride combined with Methotrexate

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Leukopenia Death 67 Female 6/23/2009 Other Health Professional Germany
Primary
Secondary
Osteonecrosis Other Serious 75 Female 7/9/2009 Other Health Professional Italy
Primary
Concomitant
Bone Sarcoma Other Serious 11 Male 8/14/2009 Consumer Japan
Primary
Secondary
Renal Impairment Other Serious 1 Female 8/24/2009 United Kingdom
Primary
Secondary
Venoocclusive Disease Other Serious 2 Male 8/25/2009 United Kingdom
Primary
Secondary
Sepsis Other Serious 8/8/2008 51 Male 97 lb 9/3/2009 Physician Japan
Primary
Secondary
Concomitant
Renal Impairment Death 12/1/2008 61 Male 115 lb 9/8/2009 Physician Japan
Primary
Concomitant
Pneumonia Other Serious 10/3/2008 56 Male 121 lb 9/15/2009 Japan
Primary
Secondary
Concomitant
Graft Versus Host Disease Other Serious 2 Female 9/25/2009 United Kingdom
Primary
Secondary
Graft Versus Host Disease Required Intervention 1 Female 9/25/2009 United Kingdom
Primary
Secondary
Graft Versus Host Disease Required Intervention 2 Female 9/25/2009 United Kingdom
Primary
Secondary
Venoocclusive Disease Other Serious 2 Male 9/25/2009 Other Health Professional United Kingdom
Primary
Secondary
Renal Impairment Other Serious 1 Female 11/3/2009 Other Health Professional United Kingdom
Primary
Secondary
Thrombotic Microangiopathy Other Serious 50 Female 12/7/2009 Japan
Primary
Secondary
Concomitant
Rash Generalised Life Threatening 4/1/2008 55 Male 126 lb 1/22/2010 Physician Japan
Primary
Secondary
Concomitant
Agranulocytosis Hospitalization 7/7/2009 Male 1/26/2010 Physician United Kingdom
Primary
Concomitant
Varicose Vein Hospitalization 12/1/2008 Male 220 lb 2/3/2010 Germany
Primary
Concomitant
Renal Impairment Death 12/1/2008 61 Male 115 lb 2/12/2010 Physician Japan
Primary
Concomitant
Respiratory Failure Other Serious 70 Male 2/26/2010 Physician Japan
Primary
Concomitant
Klebsiella Sepsis Death 22 Male 3/19/2010 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Small Intestinal Haemorrhage Other Serious 60 Male 3/19/2010 Other Health Professional Japan
Primary
Concomitant
Respiratory Disorder Other Serious 16 Male 3/23/2010 Physician Japan
Primary
Concomitant
Organising Pneumonia Hospitalization 4/16/2009 Male 3/25/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Respiratory Failure Death 4/1/2008 45 Male 3/25/2010 Other Health Professional Italy
Primary
Secondary
Concomitant
Klebsiella Sepsis Death 22 Male 3/29/2010 Consumer United Kingdom
Primary
Secondary
Concomitant
Respiratory Failure Hospitalization 12/16/2008 73 Male 117 lb 3/24/2010 Physician Japan
Primary
Concomitant
Acute Graft Versus Host Disease Death 3/25/2010 Italy
Primary
Secondary
Concomitant
Quality Of Life Decreased Death 22 Male 3/26/2010 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Respiratory Disorder Other Serious 7/6/2009 16 Male 110 lb 4/5/2010 Physician Japan
Primary
Concomitant
Thrombotic Microangiopathy Other Serious 13 Male 3/30/2010 Physician Japan
Primary
Concomitant
Klebsiella Sepsis Death 22 Male 4/6/2010 Consumer United Kingdom
Primary
Secondary
Concomitant
Renal Failure Other Serious 6/30/2009 15 Male 88 lb 4/5/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Renal Failure Other Serious 6/30/2009 15 Male 88 lb 4/7/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Staphylococcal Sepsis Other Serious 24 Female 4/20/2010 Other Health Professional Japan
Primary
Concomitant
Pancreatitis Acute Hospitalization 6/24/2009 15 Male 88 lb 5/3/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Renal Failure Hospitalization 4/25/2010 43 Male 5/17/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Staphylococcal Sepsis Other Serious 24 Female 5/18/2010 Other Health Professional Japan
Primary
Concomitant
Tracheomalacia Other Serious 5/7/2009 1 Male 5/14/2010 Physician United States
Primary
Secondary
Concomitant
Tracheomalacia Other Serious 5/7/2009 1 Male 5/18/2010 Physician United States
Primary
Secondary
Concomitant
Viral Test Positive Other Serious 5/7/2009 1 Male 6/1/2010 Physician United States
Primary
Secondary
Concomitant
Renal Failure Hospitalization 4/25/2010 43 Male 6/7/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Organising Pneumonia Death 70 Male 6/8/2010 Other Health Professional Japan
Primary
Concomitant
Histiocytosis Haematophagic Death 2/25/2009 15 Female 6/9/2010 Physician Japan
Primary
Concomitant
Thrombotic Microangiopathy Death 7/31/2008 4 Male 6/9/2010 Other Health Professional Japan
Primary
Concomitant
Histiocytosis Haematophagic Death 10/20/2008 18 Male 6/9/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Trichosporon Infection Death 12/10/2008 54 Male 132 lb 6/18/2010 Physician Japan
Primary
Concomitant
Venoocclusive Liver Disease Death 8/5/2010 Other Health Professional Spain
Primary
Secondary
Concomitant
Tracheomalacia Other Serious 5/7/2009 1 Male 8/13/2010 Physician United States
Primary
Secondary
Concomitant
Guillain-barre Syndrome Other Serious 51 Female 9/29/2010 Other Health Professional Italy
Primary
Concomitant
Aspiration Other Serious 1 Male 9/29/2010 Other Health Professional United States
Primary
Secondary
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
Varicella Virus Test Positive Other Serious 24 Female 154 lb 10/25/2010 Other Health Professional Japan
Primary
Concomitant
Oedema Life Threatening 1/29/2010 59 Male 176 lb 11/3/2010 Physician Japan
Primary
Secondary
Concomitant
Mucosal Inflammation Other Serious 1 Male 11/3/2010 Physician United States
Primary
Secondary
Concomitant
Mucosal Inflammation Other Serious 1 Male 11/3/2010 Physician Germany
Primary
Secondary
Concomitant
Venoocclusive Liver Disease Life Threatening 9/7/2009 4 Female 10/26/2010 Physician Japan
Primary
Concomitant
Varicella Virus Test Positive Other Serious 10/1/2007 21 Female 154 lb 11/12/2010 Other Health Professional Japan
Primary
Concomitant
Idiopathic Pneumonia Syndrome Other Serious 6/29/2010 57 Female 99 lb 11/22/2010 Physician Japan
Primary
Secondary
Concomitant
Venoocclusive Liver Disease Hospitalization 5/26/2010 Male 18 lb 11/24/2010 Physician Japan
Primary
Concomitant
Aplasia Pure Red Cell Other Serious 47 Female 11/23/2010 Physician Brazil
Primary
Concomitant
Sepsis Other Serious 15 Male 12/10/2010 Other Health Professional Japan
Primary
Concomitant
Sepsis Other Serious 15 Male 12/13/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Venoocclusive Disease Other Serious 12/15/2010 Physician United Kingdom
Primary
Secondary
Concomitant
Venoocclusive Liver Disease Life Threatening 9/7/2009 4 Female 12/2/2010 Physician Japan
Primary
Concomitant
Pseudomonal Sepsis Life Threatening 11/7/2010 49 Female 97 lb 12/30/2010 Physician Japan
Primary
Secondary
Concomitant
Inappropriate Antidiuretic Hormone Secretion Disability 15 Male 12/29/2010 Other Health Professional Japan
Primary
Concomitant
Pneumonia Hospitalization 11 Male 1/27/2011 Other Health Professional Japan
Primary
Secondary
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
Venoocclusive Disease Other Serious 1 Male 3/18/2011 Other Health Professional Japan
Primary
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
Multi-organ Failure Death 4/25/2010 43 Male 168 lb 4/13/2011 Other Health Professional United States
Primary
Secondary
Concomitant
Acute Graft Versus Host Disease In Skin Other Serious 3 Male 4/15/2011 Physician Japan
Primary
Secondary
Concomitant
Multi-organ Failure Death 66 4/15/2011 Physician United States
Primary
Secondary
Concomitant
Acute Graft Versus Host Disease In Intestine Death 58 4/15/2011 Physician United States
Primary
Secondary
Concomitant
Influenza Other Serious 5/7/2009 1 Male 29 lb 4/12/2011 Physician United States
Primary
Secondary
Concomitant
Atrophy Other Serious Female 4/21/2011 Consumer Canada
Primary
Concomitant
Pain Other Serious 1/1/2009 68 Female 5/11/2011 Consumer United States
Primary
Concomitant
Deep Vein Thrombosis Hospitalization 4/4/2011 47 Female 183 lb 5/11/2011 Physician United Kingdom
Primary
Concomitant
Pain In Extremity 8/15/2010 50 Female 176 lb 5/11/2011 Other Health Professional United States
Primary
Concomitant
Erythema 62 Male 186 lb 5/11/2011 Consumer United States
Primary
Secondary
Concomitant
Injection Site Erythema 8/1/2010 45 Female 137 lb 5/11/2011 Consumer United States
Primary
Concomitant
Chest Pain Other Serious 3/15/2011 51 Female 206 lb 5/13/2011 Physician United States
Primary
Concomitant
Transfusion Reaction Life Threatening 3/31/2010 15 Male 105 lb 5/13/2011 Physician United States
Primary
Secondary
Concomitant
Hyperbilirubinaemia Other Serious 11/16/2010 58 Female 117 lb 5/13/2011 Consumer United States
Primary
Secondary
Concomitant
Colon Cancer Hospitalization 9/14/2009 71 Male 200 lb 5/16/2011 Physician United States
Primary
Concomitant
Breast Cancer Female Other Serious 5/4/2011 49 Female 231 lb 5/16/2011 Physician Canada
Primary
Concomitant
Nervousness Hospitalization 1/1/2008 66 Female 135 lb 5/17/2011 Physician United States
Primary
Concomitant
Injection Site Reaction 6/19/2010 53 Female 96 lb 5/17/2011 Consumer United States
Primary
Concomitant
Injection Site Swelling 4/20/2010 58 Female 170 lb 5/17/2011 Consumer United States
Primary
Secondary
Concomitant
Diarrhoea Disability 11/16/2001 2 Female 19 lb 5/4/2011 Japan
Primary
Secondary
Concomitant
Myocardial Infarction Death 7/27/2008 74 Male 172 lb 5/20/2011 Physician United States
Primary
Secondary
Concomitant
Crohn's Disease Other Serious 3/17/2011 57 Male 143 lb 5/20/2011 Physician Belgium
Primary
Concomitant
Fall Hospitalization 12/1/2010 51 Female 5/20/2011 Other Health Professional France
Primary
Secondary
Concomitant
Cystitis Haemorrhagic Other Serious 4/1/2011 Physician United States
Primary
Concomitant
Pulmonary Mycosis Other Serious 3/2/2010 63 Male 130 lb 6/7/2011 Physician Japan
Primary
Secondary
Concomitant
Thrombocytopenia Other Serious 1/1/1991 16 Female 6/14/2011 Other Health Professional United States
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 Other Serious 16 Female 6/22/2011 Other Health Professional Japan
Primary
Concomitant
Graft Versus Host Disease Hospitalization 5/25/2010 23 Female 73 lb 6/23/2011 Physician Japan
Primary
Secondary
Concomitant
Neoplasm Malignant Death 5 6/25/2011 Other Health Professional Korea, Republic Of
Primary
Concomitant
Acute Graft Versus Host Disease Death 3 6/25/2011 Other Health Professional Korea, Republic Of
Primary
Concomitant
Abscess Other Serious 63 Female 6/27/2011 Other Health Professional Germany
Primary
Secondary
Concomitant
Chronic Graft Versus Host Disease Other Serious 4/1/2010 47 Male 201 lb 6/30/2011 Other Health Professional Japan
Primary
Secondary
Concomitant
Renal Haemorrhage Other Serious 1/1/2007 63 Female 6/30/2011 Other Health Professional Japan
Primary
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
Engraft Failure Other Serious 6/9/2010 10 Female 88 lb 7/15/2011 Physician Japan
Primary
Secondary
Concomitant
Congestive Cardiomyopathy Hospitalization 4 Female 6/29/2011 Physician United States
Primary
Secondary
Concomitant
Neutropenia Other Serious 6/9/2010 10 Female 88 lb 7/18/2011 Physician Japan
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
Cerebral Haemorrhage Death 1 Female 7/25/2011 Physician Japan
Primary
Secondary
Concomitant
Acute Graft Versus Host Disease In Liver Other Serious 3 Male 7/26/2011 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
Thrombocytopenia Life Threatening 11/16/2010 58 Female 117 lb 8/1/2011 Physician United States
Primary
Secondary
Concomitant
Febrile Neutropenia Hospitalization 11/10/2010 49 Female 97 lb 8/2/2011 Physician Japan
Primary
Secondary
Concomitant
Bk Virus Infection Other Serious 2 Female 8/2/2011 Physician Japan
Primary
Secondary
Concomitant
Acute Graft Versus Host Disease Other Serious 7 Male 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
Myelodysplastic Syndrome Other Serious 1/1/2006 Female 8/3/2011 Other Health Professional United States
Primary
Secondary
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
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
Toxicity To Various Agents Death Unknown 8/2/2011 Japan
Primary
Secondary
Concomitant
Trichosporon Infection Death 12/10/2008 54 Male 132 lb 8/15/2011 Physician Japan
Primary
Concomitant
Cerebral Haemorrhage Death 9/2/2011 Physician Japan
Primary
Secondary
Concomitant
Infection Death 9/9/2011 Other Health Professional France
Primary
Secondary
Concomitant
Acute Graft Versus Host Disease Other Serious 8 Male 9/12/2011 Physician Japan
Primary
Concomitant
Headache Other Serious 2/4/2011 13 Female 86 lb 9/16/2011 Physician Japan
Primary
Concomitant
Osteonecrosis Of Jaw Other Serious 63 Female 9/6/2011 Other Health Professional Germany
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
Exposed Bone In Jaw Other Serious 1/1/2006 50 Male 9/20/2011 Other Health Professional United States
Primary
Concomitant
Pneumonia Other Serious Male 10/3/2011 Other Health Professional Germany
Primary
Concomitant
Enterococcal Infection Hospitalization 2/10/2010 23 Male 117 lb 10/3/2011 Physician Japan
Primary
Secondary
Concomitant
Sinusitis Other Serious Male 10/6/2011 Other Health Professional United States
Primary
Concomitant
Acute Myeloid Leukaemia Recurrent Other Serious 10/10/2011 Other Health Professional Japan
Primary
Concomitant

Drug Data