Fludarabine Phosphate combined with Melphalan Hydrochloride

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Myelopathy Other Serious 15 Male 1/29/2009 Other Health Professional United States
Primary
Secondary
Unresponsive To Stimuli Other Serious 14 Male 1/29/2009 Other Health Professional United States
Primary
Secondary
Hypotension Hospitalization 5/11/2009 55 Male 207 lb 6/22/2009 Physician United States
Primary
Secondary
Concomitant
Drug Toxicity Other Serious 6/23/2009 Consumer Thailand
Primary
Secondary
Febrile Neutropenia Other Serious 40 Male 165 lb 6/25/2009 Physician Spain
Primary
Secondary
Concomitant
Strongyloidiasis Other Serious 63 Male 8/14/2009 Physician United States
Primary
Secondary
Drug Intolerance Hospitalization 7/25/2009 32 Male 8/14/2009 Other Health Professional Spain
Primary
Concomitant
Vomiting Other Serious 11/1/2004 44 Male 8/28/2009 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Vomiting Other Serious 7/1/2006 64 Male 8/28/2009 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Graft Versus Host Disease Death 9/9/2008 Male 168 lb 9/9/2009 Physician United Kingdom
Primary
Concomitant
Weight Increased Other Serious 44 Female 9/11/2009 Other Health Professional Japan
Primary
Concomitant
Thrombocytopenic Purpura Death 10/23/2009 Japan
Primary
Concomitant
Ultrasound Kidney Abnormal Other Serious 10/8/2009 50 Female 164 lb 10/29/2009 Physician United States
Primary
Secondary
Renal Atrophy Other Serious 10/8/2009 50 Female 164 lb 11/8/2009 Physician United States
Primary
Secondary
Renal Failure Other Serious 59 Female 11/11/2009 United States
Primary
Secondary
Viral Infection Hospitalization 11/5/2009 50 Female 163 lb 11/17/2009 Physician United States
Primary
Secondary
Thrombotic Microangiopathy Other Serious 50 Female 12/7/2009 Japan
Primary
Secondary
Concomitant
Sepsis Death Unknown 12/14/2009 United States
Primary
Secondary
Concomitant
Toxoplasmosis Hospitalization 12/21/2009 Male 121 lb 12/23/2009 Consumer United States
Primary
Secondary
Concomitant
Transaminases Increased Hospitalization 1/5/2010 55 Male 151 lb 1/13/2010 Consumer United States
Primary
Secondary
Concomitant
Rash Generalised Life Threatening 4/1/2008 55 Male 126 lb 1/22/2010 Physician Japan
Primary
Secondary
Concomitant
Serum Ferritin Increased Life Threatening 59 Male 2/24/2010 Physician Japan
Primary
Concomitant
Respiratory Failure Other Serious 70 Male 2/26/2010 Physician Japan
Primary
Concomitant
Lymphocytosis Other Serious 54 Male 3/17/2010 Physician United Kingdom
Primary
Secondary
Concomitant
Epstein-barr Virus Associated Lymphoproliferative Disorder Other Serious 3/22/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Respiratory Disorder Other Serious 16 Male 3/23/2010 Physician Japan
Primary
Concomitant
White Blood Cell Count Increased Other Serious 50 Male 3/23/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Organising Pneumonia Hospitalization 4/16/2009 Male 3/25/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Klebsiella Sepsis Death 22 Male 3/29/2010 Consumer United Kingdom
Primary
Secondary
Concomitant
Thrombotic Microangiopathy Other Serious 3/30/2010 Consumer United States
Primary
Secondary
Renal Failure Other Serious 3/30/2010 Consumer United States
Primary
Secondary
Thrombotic Microangiopathy Other Serious 3/30/2010 Consumer United States
Primary
Secondary
Thrombotic Microangiopathy Other Serious 3/30/2010 Consumer United States
Primary
Secondary
Thrombotic Microangiopathy Other Serious 3/30/2010 Consumer United States
Primary
Secondary
Wound Treatment Other Serious 1/1/2000 Female 140 lb 3/30/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Respiratory Failure Hospitalization 12/16/2008 73 Male 117 lb 3/24/2010 Physician Japan
Primary
Concomitant
Quality Of Life Decreased Death 22 Male 3/26/2010 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Nephropathy Toxic Other Serious 4/1/2010 United States
Primary
Secondary
Concomitant
Pulmonary Alveolar Haemorrhage Death 3/29/2010 United States
Primary
Secondary
Drug Toxicity Death 3/29/2010 United States
Primary
Secondary
Drug Toxicity Other Serious 3/29/2010 United States
Primary
Secondary
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
Klebsiella Sepsis Death 22 Male 4/6/2010 Consumer United Kingdom
Primary
Secondary
Concomitant
Thrombotic Microangiopathy Other Serious 40 Female 4/2/2010 Physician Japan
Primary
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
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
Infection Hospitalization 3 Male 29 lb 4/23/2010 Consumer Colombia
Primary
Concomitant
Thrombocytopenia Other Serious 22 Female 4/26/2010 Physician Germany
Primary
Concomitant
Pancreatitis Acute Hospitalization 6/24/2009 15 Male 88 lb 5/3/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Weight Increased Required Intervention 44 Female 5/14/2010 Japan
Primary
Secondary
Concomitant
Venoocclusive Liver Disease Required Intervention 44 Female 5/25/2010 Physician Japan
Primary
Concomitant
Sweat Gland Tumour Other Serious 32 Female 6/15/2010 Physician United Kingdom
Primary
Secondary
Sweat Gland Tumour Required Intervention 28 Male 6/17/2010 Consumer United Kingdom
Primary
Secondary
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
Acute Myeloid Leukaemia Death 66 Male 9/28/2010 Physician Japan
Primary
Concomitant
Acute Myeloid Leukaemia Death 61 Female 9/28/2010 Physician Japan
Primary
Concomitant
Multi-organ Failure Death 67 Female 9/28/2010 Physician Japan
Primary
Concomitant
Acute Myeloid Leukaemia Death 61 Female 9/30/2010 Physician Japan
Primary
Concomitant
Acute Myeloid Leukaemia Death 57 Female 9/30/2010 Physician Japan
Primary
Concomitant
Thrombotic Microangiopathy Death 1/1/2009 48 Female 88 lb 8/18/2010 Physician Japan
Primary
Concomitant
Renal Failure Chronic Other Serious 9/30/2010 Physician United States
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
Venoocclusive Disease Other Serious 10/13/2010 Physician Japan
Primary
Concomitant
Leukaemia Recurrent Other Serious 35 Male 10/13/2010 Physician Japan
Primary
Concomitant
Myocarditis Death 54 Male 10/13/2010 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
Varicella Virus Test Positive Other Serious 24 Female 154 lb 10/25/2010 Other Health Professional Japan
Primary
Concomitant
Stenotrophomonas Infection Hospitalization 5/17/2010 59 Male 126 lb 10/27/2010 Physician Japan
Primary
Concomitant
Pneumonia Herpes Viral Other Serious 7/19/2006 59 Male 10/19/2010 Physician United States
Primary
Concomitant
Psychotic Disorder Other Serious 5/28/2004 52 Male 10/19/2010 Physician United States
Primary
Concomitant
Recurrent Cancer Death 5/28/2004 59 Female 10/19/2010 Physician United States
Primary
Concomitant
Neuropathy Peripheral Other Serious 6/5/2006 59 Male 10/19/2010 Physician United States
Primary
Concomitant
Respiratory Failure Other Serious 62 Male 10/30/2010 Other Health Professional Israel
Primary
Secondary
Concomitant
Thrombotic Microangiopathy Death 9/21/2009 62 Female 126 lb 11/3/2010 Physician Japan
Primary
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
White Blood Cell Count Increased Other Serious 25 Female 11/9/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Pyrexia Other Serious 20 Female 11/9/2010 Other Health Professional 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
Tumour Lysis Syndrome Death 11/15/2009 58 Male 108 lb 11/15/2010 Physician Japan
Primary
Concomitant
Thrombotic Microangiopathy Other Serious 25 Female 11/15/2010 Physician Japan
Primary
Concomitant
Pyrexia Other Serious 2/11/2009 54 Male 152 lb 11/23/2010 Consumer Japan
Primary
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
Rash Other Serious 5/14/2010 2 Female 24 lb 11/29/2010 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
Venoocclusive Liver Disease Life Threatening 9/7/2009 4 Female 12/2/2010 Physician Japan
Primary
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
Syncope Other Serious 4/27/2011 42 Female 188 lb 5/13/2011 Consumer United States
Primary
Secondary
Concomitant
Acute Graft Versus Host Disease In Intestine Hospitalization 4/9/2011 42 Female 197 lb 5/15/2011 Physician United States
Primary
Secondary
Concomitant
Microangiopathy Hospitalization 5/1/2011 46 Female 162 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
Acute Graft Versus Host Disease Hospitalization 5/14/2010 2 Female 24 lb 5/20/2011 Physician Japan
Primary
Concomitant
Upper Respiratory Tract Infection Hospitalization 5/5/2011 44 Male 163 lb 5/27/2011 Consumer United States
Primary
Secondary
Concomitant
Idiopathic Pneumonia Syndrome Death 49 6/2/2011 Other Health Professional Japan
Primary
Secondary
Idiopathic Pneumonia Syndrome Death 49 6/2/2011 Other Health Professional Japan
Primary
Secondary
Idiopathic Pneumonia Syndrome Death 49 6/2/2011 Other Health Professional Japan
Primary
Secondary
Idiopathic Pneumonia Syndrome Death 49 6/2/2011 Other Health Professional Japan
Primary
Secondary
Idiopathic Pneumonia Syndrome Death 46 6/3/2011 Other Health Professional Japan
Primary
Secondary
Pneumonia Herpes Viral Death 46 6/3/2011 Other Health Professional Japan
Primary
Secondary
Pneumonia Herpes Viral Death 46 6/3/2011 Other Health Professional Japan
Primary
Secondary
Pneumonia Herpes Viral Death 46 6/3/2011 Other Health Professional Japan
Primary
Secondary
Idiopathic Pneumonia Syndrome Death 49 6/3/2011 Other Health Professional Japan
Primary
Secondary
Idiopathic Pneumonia Syndrome Death 49 6/3/2011 Other Health Professional Japan
Primary
Secondary
Idiopathic Pneumonia Syndrome Death 49 6/3/2011 Other Health Professional Japan
Primary
Secondary
Idiopathic Pneumonia Syndrome Death 49 6/3/2011 Other Health Professional Japan
Primary
Secondary
Pneumonia Herpes Viral Death 46 5/31/2011 Other Health Professional Japan
Primary
Secondary
Concomitant
Idiopathic Pneumonia Syndrome Death 49 5/31/2011 Other Health Professional Japan
Primary
Secondary
Concomitant
Multi-organ Failure Death 7 Male 6/10/2011 Physician United States
Primary
Secondary
Concomitant
Thrombotic Microangiopathy Other Serious 2 Female 6/13/2011 Physician United States
Primary
Secondary
Concomitant
Thrombocytopenia Other Serious 1/1/1991 16 Female 6/14/2011 Other Health Professional United States
Primary
Secondary
Concomitant
Infection Life Threatening 4/27/2011 42 Female 188 lb 6/16/2011 Consumer United States
Primary
Secondary
Concomitant
Graft Versus Host Disease Other Serious 16 Female 6/22/2011 Other Health Professional Japan
Primary
Concomitant
Acute Graft Versus Host Disease Death 5 6/23/2011 Other Health Professional Korea, Republic Of
Primary
Concomitant
Rash Other Serious 5/20/2010 7 Male 42 lb 6/24/2011 Physician Japan
Primary
Concomitant
Anaemia Of Chronic Disease Other Serious 3/17/2004 56 Female 140 lb 6/24/2011 Other Health Professional United States
Primary
Secondary
Concomitant
Neoplasm Malignant Death 5 6/25/2011 Other Health Professional Korea, Republic Of
Primary
Concomitant
Renal Haemorrhage Other Serious 1/1/2007 63 Female 6/30/2011 Other Health Professional Japan
Primary
Concomitant
Memory Impairment Hospitalization 2/10/2010 23 Male 117 lb 7/6/2011 Other Health Professional Japan
Primary
Secondary
Concomitant
Fatigue Other Serious 7/12/2011 Other Health Professional United States
Primary
Concomitant
Neutropenia Other Serious 6/9/2010 10 Female 88 lb 7/18/2011 Physician Japan
Primary
Secondary
Concomitant
Pleural Effusion Death 3/17/2004 56 Female 140 lb 7/25/2011 Other Health Professional United States
Primary
Secondary
Concomitant
Epstein-barr Virus Test Positive Other Serious 9/13/2009 7 Female 44 lb 8/1/2011 Physician Japan
Primary
Concomitant
Febrile Neutropenia Hospitalization 11/10/2010 49 Female 97 lb 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
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
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
Renal Impairment Death 11 Male 8/12/2011 Other Health Professional Canada
Primary
Concomitant
Disease Progression Hospitalization 2/10/2009 57 Female 4/16/2011 Other Health Professional Japan
Primary
Concomitant
Acute Graft Versus Host Disease Other Serious 8 Male 9/12/2011 Physician Japan
Primary
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
Haemolysis Other Serious 29 Female 9/21/2011 Other Health Professional Germany
Primary
Concomitant
Acute Graft Versus Host Disease Other Serious 9/7/2011 26 Male 148 lb 9/22/2011 Other Health Professional United States
Primary
Secondary
Concomitant
Epstein-barr Virus Infection Other Serious Male 9/26/2011 Other Health Professional Germany
Primary
Concomitant
Drug Ineffective Other Serious 61 Male 9/28/2011 Physician Korea, Republic Of
Primary
Secondary
Concomitant

Drug Data