Fludara combined with Melphalan

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Thrombotic Microangiopathy Other Serious 40 Female 10/24/2007 Physician Japan
Primary
Concomitant
Thrombotic Microangiopathy Life Threatening 10/22/2006 40 Female 12/10/2007 Physician Japan
Primary
Concomitant
Serum Sickness Other Serious 13 Male 12/20/2007 Japan
Primary
Concomitant
Serum Sickness Other Serious 13 Male 1/17/2008 Other Health Professional Japan
Primary
Concomitant
Venoocclusive Liver Disease Other Serious 2/14/2008 Other Health Professional Germany
Primary
Secondary
Hepatitis B Other Serious 57 Female 7/9/2008 Other Health Professional Japan
Primary
Concomitant
Hepatitis B Other Serious 57 Female 10/2/2008 Other Health Professional Japan
Primary
Concomitant
Platelet Count Decreased Death 4/14/2008 73 Male 2/6/2009 Physician Japan
Primary
Concomitant
Sepsis Other Serious 8/16/2008 51 Male 97 lb 2/13/2009 Physician Japan
Primary
Secondary
Concomitant
Liver Disorder Other Serious 8/25/2008 18 Male 128 lb 2/18/2009 Physician Japan
Primary
Secondary
Concomitant
Venoocclusive Liver Disease Life Threatening 9/1/2008 21 Male 146 lb 3/20/2009 Physician Japan
Primary
Secondary
Concomitant
Gastric Cancer Other Serious 8/6/2008 52 Male 119 lb 4/6/2009 Physician Japan
Primary
Concomitant
Sepsis Other Serious 6/26/2008 57 Male 137 lb 4/14/2009 Physician Japan
Primary
Concomitant
Venoocclusive Liver Disease Life Threatening 7/21/2008 56 Male 132 lb 4/15/2009 Physician Japan
Primary
Concomitant
Systemic Candida Other Serious 9/29/2008 22 Male 97 lb 5/11/2009 Other Health Professional Japan
Primary
Concomitant
Systemic Candida Other Serious 9/29/2008 22 Male 97 lb 5/12/2009 Other Health Professional Japan
Primary
Concomitant
Pneumonia Other Serious 10/10/2008 56 Male 121 lb 5/20/2009 Japan
Primary
Secondary
Concomitant
Renal Disorder Other Serious 8/14/2008 15 Female 110 lb 5/20/2009 Physician Japan
Primary
Secondary
Concomitant
Pneumonia Other Serious 10/10/2008 56 Male 121 lb 5/21/2009 Japan
Primary
Secondary
Concomitant
Renal Failure Death 12/12/2008 68 Male 101 lb 5/29/2009 Other Health Professional Japan
Primary
Concomitant
Febrile Neutropenia Other Serious 12/26/2008 15 Female 99 lb 6/5/2009 Physician Japan
Primary
Concomitant
Epstein-barr Virus Associated Lymphoproliferative Disorder Other Serious 1/11/2009 1 Male 15 lb 7/30/2009 Physician Japan
Primary
Secondary
Concomitant
Renal Disorder Other Serious 8/14/2008 15 Female 110 lb 8/4/2009 Physician Japan
Primary
Secondary
Concomitant
Renal Failure Acute Death 12/1/2008 68 Male 101 lb 9/21/2009 Other Health Professional Japan
Primary
Concomitant
Venoocclusive Liver Disease Life Threatening 7/11/2008 56 Male 132 lb 9/24/2009 Physician Japan
Primary
Concomitant
Epstein-barr Virus Associated Lymphoproliferative Disorder Other Serious 1/11/2009 1 Male 15 lb 9/25/2009 Physician Japan
Primary
Secondary
Concomitant
Pseudomembranous Colitis Other Serious 8/25/2008 18 Male 128 lb 10/1/2009 Physician Japan
Primary
Secondary
Concomitant
Platelet Count Decreased Death 4/11/2008 73 Male 10/5/2009 Physician Japan
Primary
Concomitant
Sepsis Other Serious 8/8/2008 51 Male 97 lb 10/14/2009 Physician Japan
Primary
Secondary
Concomitant
Thrombotic Thrombocytopenic Purpura Death 10/15/2009 Other Health Professional Japan
Primary
Concomitant
Venoocclusive Liver Disease Other Serious 44 Female 10/20/2009 Other Health Professional Japan
Primary
Concomitant
Pneumocystis Jiroveci Pneumonia Other Serious 11/26/2008 61 Male 10/29/2009 Other Health Professional Japan
Primary
Concomitant
Thrombotic Thrombocytopenic Purpura Death 12/1/2009 Other Health Professional Japan
Primary
Concomitant
Venoocclusive Liver Disease Other Serious 44 Female 12/7/2009 Other Health Professional Japan
Primary
Concomitant
Renal Impairment Death 12/1/2008 61 Male 115 lb 2/22/2010 Physician Japan
Primary
Concomitant
Small Intestinal Haemorrhage Other Serious 60 Male 2/24/2010 Other Health Professional Japan
Primary
Concomitant
Histiocytosis Haematophagic Other Serious 15 Female 3/3/2010 Physician Japan
Primary
Concomitant
Staphylococcal Sepsis Other Serious 1/1/2007 68 Female 3/3/2010 Other Health Professional Japan
Primary
Concomitant
Stomatitis Other Serious 9/25/2008 39 Male 157 lb 3/3/2010 Physician Japan
Primary
Secondary
Concomitant
Thrombotic Microangiopathy Other Serious 18 Male 3/4/2010 Other Health Professional Japan
Primary
Concomitant
Thrombotic Microangiopathy Other Serious 4 Male 3/4/2010 Other Health Professional Japan
Primary
Concomitant
Graft Versus Host Disease Other Serious 39 Female 3/4/2010 Other Health Professional Japan
Primary
Concomitant
Graft Versus Host Disease Other Serious 39 Female 3/8/2010 Other Health Professional Japan
Primary
Concomitant
Thrombotic Microangiopathy Other Serious 4 Male 3/8/2010 Other Health Professional Japan
Primary
Concomitant
Thrombotic Microangiopathy Other Serious 18 Male 3/8/2010 Other Health Professional Japan
Primary
Concomitant
Organising Pneumonia Death 70 Male 6/4/2010 Other Health Professional Japan
Primary
Concomitant
Thrombotic Thrombocytopenic Purpura Death 9/2/2010 Other Health Professional Japan
Primary
Concomitant
Thrombotic Thrombocytopenic Purpura Death 9/8/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Staphylococcal Infection Death 20 Male 1/3/2011 Other Health Professional Japan
Primary
Secondary
Concomitant
Death Death 41 Male 1/3/2011 Other Health Professional Korea, Republic Of
Primary
Secondary
Concomitant
Pneumonia Fungal Death 1/4/2011 Physician United States
Primary
Secondary
Concomitant
Death Death 45 Male 1/4/2011 Consumer Korea, Republic Of
Primary
Secondary
Concomitant
Death Other Serious 39 Female 1/4/2011 Other Health Professional Korea, Republic Of
Primary
Secondary
Concomitant
Death Other Serious 38 Male 1/5/2011 Other Health Professional Korea, Republic Of
Primary
Secondary
Concomitant
Death Death 38 Female 1/5/2011 Consumer Korea, Republic Of
Primary
Secondary
Concomitant
Death Death 46 Female 1/5/2011 Consumer Korea, Republic Of
Primary
Secondary
Concomitant
Death Death 40 Male 1/5/2011 Other Health Professional Korea, Republic Of
Primary
Secondary
Concomitant
Interstitial Lung Disease Death 10/23/2009 62 Male 130 lb 1/7/2011 Physician Japan
Primary
Secondary
Concomitant
Infection Life Threatening 7/4/2010 73 Female 97 lb 1/11/2011 Physician Japan
Primary
Secondary
Concomitant
Respiratory Failure Other Serious 1/1/2009 61 Female 88 lb 1/11/2011 Physician Japan
Primary
Secondary
Concomitant
Cytomegalovirus Test Positive Hospitalization 5/1/2010 54 Female 119 lb 1/11/2011 Physician Japan
Primary
Secondary
Concomitant
Pneumonia Death 10/26/2009 59 Male 121 lb 1/11/2011 Physician Japan
Primary
Secondary
Concomitant
Acute Graft Versus Host Disease In Liver Other Serious 3 Male 1/19/2011 Physician Japan
Primary
Secondary
Concomitant
Respiratory Syncytial Virus Infection Other Serious 1/21/2011 Physician United States
Primary
Secondary
Concomitant
Cystitis Haemorrhagic Other Serious 15 Female 1/24/2011 Physician Japan
Primary
Secondary
Concomitant
Epstein-barr Virus Infection Other Serious 19 Male 1/25/2011 Physician Germany
Primary
Secondary
Concomitant
Acute Graft Versus Host Disease Other Serious 1/26/2011 Physician Korea, Republic Of
Primary
Secondary
Concomitant
Peritonitis Other Serious 47 Male 1/27/2011 Other Health Professional Germany
Primary
Secondary
Concomitant
Pneumonia Respiratory Syncytial Viral Other Serious 42 Male 1/27/2011 Consumer Germany
Primary
Secondary
Concomitant
Adenovirus Infection Other Serious 19 Male 1/27/2011 Physician Germany
Primary
Secondary
Concomitant
Pneumonia Respiratory Syncytial Viral Other Serious 42 Male 1/27/2011 Physician Germany
Primary
Secondary
Concomitant
Cerebral Toxoplasmosis Other Serious 68 Male 1/28/2011 Physician Germany
Primary
Secondary
Concomitant
Acute Graft Versus Host Disease Other Serious 66 Male 1/28/2011 Physician Germany
Primary
Secondary
Concomitant
Cerebral Toxoplasmosis Other Serious 66 Male 1/28/2011 Physician Germany
Primary
Secondary
Concomitant
Bronchopulmonary Aspergillosis Other Serious 12/1/2008 64 Female 1/28/2011 Physician Japan
Primary
Concomitant
Chronic Graft Versus Host Disease Other Serious 47 Male 2/1/2011 Other Health Professional Germany
Primary
Secondary
Concomitant
Respiratory Failure Death 9/27/2010 9 Male 2/4/2011 Other Health Professional United States
Primary
Secondary
Concomitant
Respiratory Failure Death 9/27/2010 9 Male 2/4/2011 Other Health Professional United States
Primary
Secondary
Concomitant
Infection Other Serious 2/7/2011 Physician Germany
Primary
Secondary
Concomitant
Infection Other Serious 2/7/2011 Physician United States
Primary
Secondary
Concomitant
Shock Hospitalization 1/12/2011 5 Female 35 lb 2/8/2011 Other Health Professional Korea, Republic Of
Primary
Secondary
Concomitant
Acute Graft Versus Host Disease Other Serious 68 Male 2/8/2011 Physician Japan
Primary
Concomitant
Drug Ineffective Other Serious 20 Male 2/8/2011 Physician Japan
Primary
Concomitant
Drug Ineffective Other Serious 12/1/2008 64 Female 2/8/2011 Physician Japan
Primary
Concomitant
Subarachnoid Haemorrhage Other Serious 16 Female 2/9/2011 Physician Japan
Primary
Secondary
Concomitant
Acute Graft Versus Host Disease Other Serious 3 Female 2/9/2011 Physician Japan
Primary
Secondary
Concomitant
Acute Graft Versus Host Disease Other Serious 4 Female 2/9/2011 Physician Japan
Primary
Secondary
Concomitant
Acute Graft Versus Host Disease Other Serious 31 Female 2/9/2011 Physician Japan
Primary
Secondary
Concomitant
Subarachnoid Haemorrhage Other Serious 16 Female 2/10/2011 Physician Japan
Primary
Secondary
Concomitant
Chronic Graft Versus Host Disease Other Serious 31 Female 2/10/2011 Physician Japan
Primary
Secondary
Concomitant
Acute Graft Versus Host Disease Other Serious 4 Female 2/10/2011 Physician Japan
Primary
Secondary
Concomitant
Transplant Failure Other Serious 9 Female 2/10/2011 Physician Japan
Primary
Secondary
Concomitant
Acute Graft Versus Host Disease Other Serious 12 Male 2/10/2011 Physician Japan
Primary
Secondary
Concomitant
Acute Graft Versus Host Disease Other Serious 6 Male 2/10/2011 Physician Japan
Primary
Secondary
Concomitant
Acute Graft Versus Host Disease Other Serious 37 Female 2/10/2011 Physician Japan
Primary
Secondary
Concomitant
Chronic Graft Versus Host Disease Other Serious 2 Female 2/10/2011 Physician Japan
Primary
Secondary
Concomitant
Acute Graft Versus Host Disease Other Serious 7 Male 2/10/2011 Physician Japan
Primary
Secondary
Concomitant
Acute Graft Versus Host Disease Other Serious 18 Male 2/10/2011 Physician Japan
Primary
Secondary
Concomitant
Acute Graft Versus Host Disease Other Serious Female 2/11/2011 Physician Japan
Primary
Secondary
Concomitant
Fungal Infection Hospitalization 6/24/2009 15 Male 126 lb 2/14/2011 Consumer Japan
Primary
Concomitant
Bk Virus Infection Other Serious 2 Female 2/17/2011 Physician Japan
Primary
Secondary
Concomitant
Cytokine Release Syndrome Hospitalization 1/12/2011 5 Female 35 lb 2/17/2011 Other Health Professional Korea, Republic Of
Primary
Secondary
Concomitant
Pneumonia Bacterial Other Serious 7/19/2010 32 Female 108 lb 2/18/2011 Physician Japan
Primary
Secondary
Concomitant
Renal Failure Acute Hospitalization 2/3/2011 49 Female 2/21/2011 Consumer United States
Primary
Secondary
Concomitant
Pneumonia Cytomegaloviral Death 10/15/2010 7 Female 42 lb 2/23/2011 Physician Japan
Primary
Secondary
Concomitant
Multi-organ Disorder Death 58 Male 2/23/2011 Physician United States
Primary
Secondary
Concomitant
Pneumonia Cytomegaloviral Death 18 Female 2/23/2011 Physician United States
Primary
Secondary
Concomitant
Neoplasm Malignant Death 27 Male 2/23/2011 Physician United States
Primary
Secondary
Concomitant
Neoplasm Malignant Death 51 Male 2/23/2011 Physician United States
Primary
Secondary
Concomitant
Neoplasm Malignant Death 34 Female 2/23/2011 Physician United States
Primary
Secondary
Concomitant
Respiratory Failure Hospitalization 9/27/2010 9 Male 2/28/2011 Physician United States
Primary
Secondary
Concomitant
Ileus Other Serious 3/1/2011 Physician United States
Primary
Secondary
Concomitant
Acute Graft Versus Host Disease Death Male 3/2/2011 Physician Israel
Primary
Secondary
Concomitant
Pneumocystis Jiroveci Pneumonia Other Serious 3/3/2011 Physician United Kingdom
Primary
Secondary
Concomitant
Bacterial Sepsis Death 3/3/2011 Physician United Kingdom
Primary
Secondary
Concomitant
Bacterial Sepsis Death 3/3/2011 Physician United Kingdom
Primary
Secondary
Concomitant
Bacterial Sepsis Death 3/3/2011 Physician United Kingdom
Primary
Secondary
Concomitant
Fungal Infection Death 3/3/2011 Physician United Kingdom
Primary
Secondary
Concomitant
Fungal Infection Death 3/3/2011 Physician United Kingdom
Primary
Secondary
Concomitant
Pneumonia Adenoviral Death 3/3/2011 Physician United Kingdom
Primary
Secondary
Concomitant
Graft Versus Host Disease Death 3/4/2011 Physician United Kingdom
Primary
Secondary
Concomitant
Graft Versus Host Disease Death 3/4/2011 Physician United Kingdom
Primary
Secondary
Concomitant
Chronic Obstructive Pulmonary Disease Death 3/4/2011 Physician United Kingdom
Primary
Secondary
Concomitant
Encephalopathy Death 3/4/2011 Physician United Kingdom
Primary
Secondary
Concomitant
Pneumonitis Death 3/4/2011 Physician United Kingdom
Primary
Secondary
Concomitant
Pneumonitis Death 3/4/2011 Physician United Kingdom
Primary
Secondary
Concomitant
Infection Death 3/4/2011 Physician Spain
Primary
Secondary
Concomitant
Infection Death 3/7/2011 Physician Spain
Primary
Secondary
Concomitant
Graft Versus Host Disease Death 3/7/2011 Physician Spain
Primary
Secondary
Concomitant
Graft Versus Host Disease Death 3/7/2011 Physician Spain
Primary
Secondary
Concomitant
Infection Death 3/7/2011 Physician Spain
Primary
Secondary
Concomitant
Stem Cell Transplant Death 3/7/2011 Physician Spain
Primary
Secondary
Concomitant
Graft Versus Host Disease Death 3/7/2011 Physician Spain
Primary
Secondary
Concomitant
Infection Death 3/7/2011 Physician Spain
Primary
Secondary
Concomitant
Infection Death 3/7/2011 Physician Spain
Primary
Secondary
Concomitant
Infection Death 3/7/2011 Physician Spain
Primary
Secondary
Concomitant
Infection Death 3/7/2011 Physician Spain
Primary
Secondary
Concomitant
Neurotoxicity Other Serious 3/7/2011 Physician Spain
Primary
Secondary
Concomitant
Seroma Other Serious 1/1/2000 52 Female 140 lb 3/10/2011 Physician United States
Primary
Secondary
Concomitant
Pericardial Effusion Other Serious 16 Female 3/10/2011 Physician Germany
Primary
Secondary
Concomitant
Epstein-barr Virus Associated Lymphoproliferative Disorder Other Serious 6/20/2007 Male 154 lb 3/14/2011 Other Health Professional Germany
Primary
Secondary
Concomitant
Pyrexia Hospitalization 1/12/2011 5 Female 35 lb 3/16/2011 Other Health Professional Korea, Republic Of
Primary
Secondary
Concomitant
Rhesus Antibodies Other Serious 58 Male 3/21/2011 Physician United States
Primary
Secondary
Venoocclusive Liver Disease Other Serious 16 Female 3/21/2011 Other Health Professional Japan
Primary
Concomitant
Blood Pressure Decreased Other Serious 1/12/2011 5 Female 35 lb 3/22/2011 Physician Korea, Republic Of
Primary
Secondary
Concomitant
Drug Ineffective Other Serious 68 Female 3/22/2011 Physician Japan
Primary
Concomitant
Drug Ineffective Other Serious 56 Male 3/22/2011 Physician Japan
Primary
Concomitant
Epstein-barr Virus Associated Lymphoproliferative Disorder Other Serious 3/24/2011 Physician United Kingdom
Primary
Secondary
Concomitant
Herpes Zoster Other Serious 3/24/2011 Physician United Kingdom
Primary
Secondary
Concomitant
Pneumonia Bacterial Other Serious 1/29/2010 52 Male 132 lb 3/24/2011 Physician Japan
Primary
Secondary
Concomitant

Drug Data