Fludara combined with Melphalan Hydrochloride

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Sepsis Other Serious 6/26/2008 57 Male 137 lb 8/12/2009 Physician Japan
Primary
Concomitant
Gastric Cancer Life Threatening 8/6/2008 52 Male 119 lb 8/25/2009 Physician Japan
Primary
Concomitant
Hypertension Other Serious 12/16/2008 15 Female 99 lb 8/27/2009 Physician Japan
Primary
Secondary
Concomitant
Sepsis Other Serious 8/8/2008 51 Male 97 lb 9/3/2009 Physician Japan
Primary
Secondary
Concomitant
Sepsis Other Serious 6/26/2008 57 Male 137 lb 9/8/2009 Physician Japan
Primary
Concomitant
Renal Impairment Death 12/1/2008 61 Male 115 lb 9/8/2009 Physician Japan
Primary
Concomitant
Gastric Cancer Life Threatening 8/6/2008 52 Male 119 lb 9/8/2009 Physician Japan
Primary
Concomitant
Gastric Cancer Life Threatening 8/6/2008 52 Male 119 lb 9/14/2009 Physician Japan
Primary
Concomitant
Pneumonia Other Serious 10/3/2008 56 Male 121 lb 9/15/2009 Japan
Primary
Secondary
Concomitant
Tonsillitis Hospitalization 5/1/2007 55 Male 1/15/2010 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Epstein-barr Virus Infection Death 7/2/2007 62 Male 1/15/2010 Other Health Professional United Kingdom
Primary
Secondary
Epstein-barr Virus Associated Lymphoproliferative Disorder Death 7/2/2007 62 Male 1/25/2010 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Swelling Face Other Serious 8/1/2009 Male 2/10/2010 Consumer France
Primary
Concomitant
Renal Impairment Death 12/1/2008 61 Male 115 lb 2/12/2010 Physician Japan
Primary
Concomitant
Small Intestinal Haemorrhage Other Serious 60 Male 3/19/2010 Other Health Professional Japan
Primary
Concomitant
Venoocclusive Liver Disease Other Serious 1/1/2008 44 Female 4/20/2010 Other Health Professional Japan
Primary
Concomitant
Alanine Aminotransferase Increased Other Serious 5/20/2010 6/8/2010 Pharmacist United Kingdom
Primary
Secondary
Concomitant
Organising Pneumonia Death 70 Male 6/8/2010 Other Health Professional Japan
Primary
Concomitant
Alanine Aminotransferase Increased Other Serious 5/20/2010 6/9/2010 Pharmacist United Kingdom
Primary
Secondary
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
Staphylococcal Sepsis Other Serious 4/21/2007 68 Female 6/15/2010 Other Health Professional Japan
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
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
Mycobacterium Avium Complex Infection Other Serious 0 Male 10/14/2010 Physician Germany
Primary
Secondary
Concomitant
Pericardial Effusion Other Serious 16 Female 10/29/2010 Physician Germany
Primary
Secondary
Concomitant
Respiratory Failure Other Serious 62 Male 10/29/2010 Physician Germany
Primary
Secondary
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
Idiopathic Pneumonia Syndrome Other Serious 6/29/2010 57 Female 99 lb 11/22/2010 Physician Japan
Primary
Secondary
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
Neoplasm Malignant Other Serious 3/1/2009 54 Male 152 lb 11/24/2010 Physician Japan
Primary
Secondary
Concomitant
Shock Haemorrhagic Other Serious 4/23/2009 54 Female 115 lb 11/12/2010 Physician Japan
Primary
Concomitant
Sepsis Other Serious 15 Male 12/13/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Death Other Serious 50 Female 12/15/2010 Physician Japan
Primary
Secondary
Venoocclusive Disease Other Serious 12/15/2010 Physician United Kingdom
Primary
Secondary
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
Myelodysplastic Syndrome Other Serious 39 Female 2/28/2011 Other Health Professional Australia
Primary
Secondary
Chronic Graft Versus Host Disease Death 20 Female 3/2/2011 Other Health Professional Japan
Primary
Secondary
Concomitant
Thrombotic Microangiopathy Other Serious 28 Female 3/2/2011 Other Health Professional 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 4 Male 3/18/2011 Physician Japan
Primary
Concomitant
Encephalopathy Other Serious 55 Male 3/18/2011 Physician Japan
Primary
Concomitant
Acute Graft Versus Host Disease Other Serious 65 4/13/2011 Physician Japan
Primary
Secondary
Concomitant
Acute Graft Versus Host Disease In Intestine Other Serious 31 4/13/2011 Physician Japan
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
Death Death 37 4/15/2011 Physician United States
Primary
Secondary
Acute Graft Versus Host Disease In Intestine Death 58 4/15/2011 Physician United States
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
Epstein-barr Virus Test Positive Life Threatening 5/14/2010 2 Female 24 lb 5/20/2011 Physician Japan
Primary
Secondary
Concomitant
Intestinal T-cell Lymphoma Death 5/23/2011 Physician Netherlands
Primary
Secondary
Intestinal T-cell Lymphoma Death 5/23/2011 Physician Netherlands
Primary
Secondary
Intestinal T-cell Lymphoma Death 5/23/2011 Physician Netherlands
Primary
Secondary
Respiratory Failure Death 10/26/2009 59 Male 121 lb 5/31/2011 Physician Japan
Primary
Secondary
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
Pneumonia Adenoviral Death 6/7/2011 Physician United Kingdom
Primary
Secondary
Concomitant
Encephalopathy Death 6/7/2011 Physician United Kingdom
Primary
Secondary
Concomitant
Neuroblastoma Recurrent Other Serious 7 Female 6/10/2011 Other Health Professional Germany
Primary
Secondary
Concomitant
Pancreatitis Acute Other Serious 9 Male 6/13/2011 Other Health Professional Germany
Primary
Secondary
Concomitant
Pancytopenia Other Serious 5/1/2007 Female 6/13/2011 Physician United States
Primary
Secondary
Concomitant
Cytomegalovirus Infection Other Serious 7 Male 6/13/2011 Other Health Professional Germany
Primary
Secondary
Concomitant
Acute Lymphocytic Leukaemia Recurrent Death 10 Male 6/13/2011 Other Health Professional Germany
Primary
Secondary
Concomitant
Cholestasis Other Serious 1 Male 6/13/2011 Other Health Professional Germany
Primary
Secondary
Concomitant
Cystitis Viral Other Serious 14 Female 6/13/2011 Physician Germany
Primary
Secondary
Concomitant
Myelodysplastic Syndrome Other Serious 14 Female 6/13/2011 Other Health Professional Germany
Primary
Secondary
Concomitant
Pyrexia Other Serious 10 Male 6/13/2011 Other Health Professional Germany
Primary
Secondary
Concomitant
Epstein-barr Virus Infection Other Serious 8 Female 6/14/2011 Other Health Professional Germany
Primary
Secondary
Concomitant
Chronic Graft Versus Host Disease Other Serious 14 Female 6/14/2011 Other Health Professional Germany
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
Disease Recurrence Other Serious 53 Female 6/22/2011 Physician Germany
Primary
Secondary
Graft Versus Host Disease Hospitalization 5/25/2010 23 Female 73 lb 6/23/2011 Physician Japan
Primary
Secondary
Concomitant
Cytomegalovirus Test Positive Other Serious 5/20/2010 7 Male 42 lb 6/24/2011 Physician Japan
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
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
Acute Graft Versus Host Disease In Intestine Other Serious 15 Female 7/1/2011 Physician Japan
Primary
Secondary
Concomitant
Hypertension Life Threatening 4/22/2010 13 Male 90 lb 7/5/2011 Physician Japan
Primary
Concomitant
Toxoplasmosis Other Serious 56 Male 7/8/2011 Physician Germany
Primary
Secondary
Concomitant
Engraftment Syndrome Other Serious 65 Female 7/11/2011 Other Health Professional Germany
Primary
Secondary
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
Guillain-barre Syndrome Hospitalization 58 Male 6/30/2011 Other Health Professional United States
Primary
Secondary
Concomitant
Abscess Bacterial Hospitalization 11/25/2009 61 Male 141 lb 7/18/2011 Physician Japan
Primary
Secondary
Concomitant
Pyrexia Life Threatening 6/14/2011 18 Male 141 lb 7/20/2011 Physician Brazil
Primary
Secondary
Concomitant
Acute Lymphocytic Leukaemia Recurrent Other Serious 7 Male 7/22/2011 Other Health Professional Germany
Primary
Secondary
Concomitant
Acute Lymphocytic Leukaemia Recurrent Death 10 Male 7/22/2011 Other Health Professional Germany
Primary
Secondary
Concomitant
Acute Graft Versus Host Disease Other Serious 14 Female 7/22/2011 Physician Germany
Primary
Secondary
Concomitant
Myelodysplastic Syndrome Other Serious 14 Female 7/22/2011 Other Health Professional Germany
Primary
Secondary
Concomitant
Neuroblastoma Recurrent Other Serious 7 Female 7/22/2011 Other Health Professional Germany
Primary
Secondary
Concomitant
Gastrointestinal Disorder Other Serious 10 Male 7/22/2011 Other Health Professional Germany
Primary
Secondary
Concomitant
Chronic Graft Versus Host Disease Death 8 Female 7/22/2011 Other Health Professional Germany
Primary
Secondary
Concomitant
Colitis Other Serious 9 Male 7/22/2011 Other Health Professional Germany
Primary
Secondary
Concomitant
Cholestasis Other Serious 1 Male 7/22/2011 Other Health Professional Germany
Primary
Secondary
Concomitant
Chronic Graft Versus Host Disease Other Serious 14 Female 7/22/2011 Other Health Professional Germany
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
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
Subarachnoid Haemorrhage Other Serious 16 Female 8/1/2011 Physician Japan
Primary
Secondary
Concomitant
Acute Graft Versus Host Disease Other Serious 4 Female 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 6 Male 8/2/2011 Physician Japan
Primary
Secondary
Concomitant
Acute Graft Versus Host Disease Other Serious 18 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 31 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
Chronic Graft Versus Host Disease Other Serious 20 Female 8/8/2011 Physician Japan
Primary
Secondary
Concomitant
Pneumonia Bacterial Hospitalization 7/19/2010 32 Female 108 lb 8/10/2011 Physician Japan
Primary
Secondary
Concomitant
Septic Shock Other Serious 49 Male 8/23/2011 Physician Portugal
Primary
Secondary
Concomitant
Cerebral Haemorrhage Death 9/2/2011 Physician Japan
Primary
Secondary
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
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
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
Pseudomonal Sepsis Other Serious 10/21/2009 22 Female 104 lb 10/11/2011 Physician Japan
Primary
Secondary
Concomitant
Pneumonia Cytomegaloviral Other Serious 6/9/2010 10 Female 88 lb 10/12/2011 Physician Japan
Primary
Secondary
Concomitant
Candidiasis Death 19 Male 10/14/2011 Physician Germany
Primary
Concomitant
Death Death 42 10/14/2011 Physician Germany
Primary
Concomitant
Death Other Serious 19 Male 10/17/2011 Physician Germany
Primary
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
Pyrexia Death 7/2/2007 62 Male 10/31/2011 Physician United Kingdom
Primary
Secondary
Concomitant
Sinus Congestion Other Serious 1/1/2007 62 Male 11/2/2011 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Staphylococcal Sepsis Life Threatening 2/2/2010 44 Male 159 lb 11/8/2011 Physician Japan
Primary
Concomitant

Drug Data