Cytarabine 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
Malignant Neoplasm Progression Other Serious 8/1/2006 51 Male 7/6/2009 Other Health Professional United Kingdom
Primary
Secondary
Mucosal Inflammation Other Serious 8/1/2006 51 Male 7/8/2009 Other Health Professional United Kingdom
Primary
Secondary
Thrombotic Thrombocytopenic Purpura Death 5/25/2009 57 Male 219 lb 7/12/2009 Physician United States
Primary
Secondary
Sepsis Other Serious 6/26/2008 57 Male 137 lb 8/12/2009 Physician Japan
Primary
Concomitant
Transplant Failure Other Serious 69 Male 8/17/2009 United States
Primary
Secondary
Thrombocytopenia Life Threatening 5/12/2007 Male 223 lb 8/17/2009 Consumer United States
Primary
Secondary
Concomitant
Thrombocytopenia Life Threatening 5/12/2007 Male 223 lb 8/18/2009 Consumer United States
Primary
Secondary
Concomitant
Gastric Cancer Life Threatening 8/6/2008 52 Male 119 lb 8/25/2009 Physician Japan
Primary
Concomitant
Thrombocytopenia Life Threatening 5/12/2007 Male 223 lb 8/25/2009 Consumer United States
Primary
Secondary
Concomitant
Thrombocytopenia Life Threatening 5/12/2007 Male 223 lb 8/28/2009 Consumer United States
Primary
Secondary
Concomitant
Sepsis Other Serious 6/26/2008 57 Male 137 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
Streptococcal Sepsis Hospitalization 4/5/2009 Male 9/10/2009 Physician United Kingdom
Primary
Secondary
Gastric Cancer Life Threatening 8/6/2008 52 Male 119 lb 9/14/2009 Physician Japan
Primary
Concomitant
Bacterial Infection Death Unknown 12/1/2009 Italy
Primary
Secondary
Concomitant
Drug Toxicity Other Serious 12/1/2009 Physician Italy
Primary
Secondary
Pathogen Resistance Death Unknown 12/14/2009 Croatia (Local Name: Hrvatska)
Primary
Secondary
Multi-organ Failure Death Unknown 12/14/2009 Croatia (Local Name: Hrvatska)
Primary
Secondary
Productive Cough Hospitalization 8/9/2009 61 Male 190 lb 1/26/2010 Physician United States
Primary
Secondary
Concomitant
Agranulocytosis Hospitalization 7/7/2009 Male 1/26/2010 Physician United Kingdom
Primary
Concomitant
Encephalitis Viral Death 3/12/2010 Other Health Professional Italy
Primary
Concomitant
Therapeutic Agent Toxicity Death Unknown 3/16/2010 Brazil
Primary
Secondary
Concomitant
Cardiotoxicity Death Unknown 3/16/2010 Brazil
Primary
Secondary
Concomitant
Pulmonary Alveolar Haemorrhage Death Unknown 3/16/2010 Brazil
Primary
Secondary
Concomitant
Respiratory Failure Death 4/1/2008 45 Male 3/25/2010 Other Health Professional Italy
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
Non-small Cell Lung Cancer Death 6/29/2009 68 Male 4/30/2010 Physician United Kingdom
Primary
Secondary
Progressive Multifocal Leukoencephalopathy Other Serious Male 5/27/2010 Physician United Kingdom
Primary
Concomitant
Sweat Gland Tumour Required Intervention 32 Male 6/2/2010 Physician United Kingdom
Primary
Secondary
Sweat Gland Tumour Other Serious 32 Male 6/11/2010 Other Health Professional United Kingdom
Primary
Secondary
Sweat Gland Tumour Other Serious 32 Female 6/15/2010 Physician United Kingdom
Primary
Secondary
Sweat Gland Tumour Other Serious 32 Male 6/23/2010 Other Health Professional United Kingdom
Primary
Secondary
Myelodysplastic Syndrome Other Serious 4/28/2010 57 Female 199 lb 6/23/2010 Physician United States
Primary
Secondary
Myelodysplastic Syndrome Other Serious 4/28/2010 57 Female 199 lb 6/25/2010 Physician United States
Primary
Secondary
Myelodysplastic Syndrome Other Serious 57 Female 199 lb 6/29/2010 Consumer United States
Primary
Secondary
Myelodysplastic Syndrome Other Serious 4/28/2010 57 Female 199 lb 6/30/2010 Consumer United States
Primary
Secondary
Sweat Gland Tumour Other Serious 6/1/2002 32 Male 7/5/2010 Other Health Professional United Kingdom
Primary
Secondary
Sweat Gland Tumour Other Serious 6/1/2002 32 Male 7/6/2010 Other Health Professional United Kingdom
Primary
Secondary
Pneumonia Klebsiella Other Serious 58 Female 7/12/2010 United Kingdom
Primary
Secondary
Anaemia Haemolytic Autoimmune Other Serious 66 Male 7/12/2010 United Kingdom
Primary
Secondary
Streptococcal Sepsis Other Serious 63 Female 7/12/2010 United Kingdom
Primary
Secondary
Epstein-barr Virus Associated Lymphoproliferative Disorder Death 50 Male 7/12/2010 United Kingdom
Primary
Secondary
Venoocclusive Disease Other Serious 8/26/2010 Korea, Republic Of
Primary
Secondary
Concomitant
Venoocclusive Disease Other Serious 8/26/2010 Korea, Republic Of
Primary
Secondary
Concomitant
Engraftment Syndrome Death Unknown 8/26/2010 Korea, Republic Of
Primary
Secondary
Concomitant
Progressive Multifocal Leukoencephalopathy Other Serious 56 Male 9/10/2010 Consumer United Kingdom
Primary
Secondary
Sebaceous Carcinoma Other Serious 10/1/2009 46 Male 203 lb 9/15/2010 Physician United Kingdom
Primary
Secondary
Concomitant
Renal Failure Other Serious 1/1/2009 62 Female 88 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
Suicide Attempt Hospitalization 9/7/2010 65 Male 209 lb 10/15/2010 Physician United Kingdom
Primary
Secondary
Concomitant
Organ Failure Death 10/7/2010 Canada
Primary
Secondary
Neuropathy Peripheral Hospitalization 9/13/2010 38 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
Pneumonia Life Threatening 8/12/2010 72 Male 10/22/2010 Consumer Japan
Primary
Secondary
Stenotrophomonas Infection Hospitalization 5/17/2010 59 Male 126 lb 10/27/2010 Physician Japan
Primary
Concomitant
Stem Cell Transplant Other Serious 15 Female 10/27/2010 Other Health Professional Japan
Primary
Concomitant
Venoocclusive Liver Disease Hospitalization 9/16/2010 59 Male 206 lb 10/28/2010 Physician United States
Primary
Secondary
Staphylococcal Infection Hospitalization 8/30/2010 64 Female 163 lb 11/4/2010 Physician United States
Primary
Secondary
Concomitant
Pneumonia Life Threatening 8/12/2010 72 Male 11/5/2010 Consumer Japan
Primary
Secondary
Interstitial Lung Disease Death 10/28/2010 Physician Canada
Primary
Secondary
Concomitant
Organ Failure Death 10/28/2010 Physician Canada
Primary
Secondary
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
Stem Cell Transplant Other Serious 15 Female 11/26/2010 Other Health Professional Japan
Primary
Concomitant
Shock Haemorrhagic Other Serious 4/23/2009 54 Female 115 lb 11/12/2010 Physician Japan
Primary
Concomitant
Staphylococcal Sepsis Other Serious 4/20/2010 1 Male 15 lb 12/10/2010 Physician Japan
Primary
Concomitant
Pleural Effusion Other Serious 31 Female 11/30/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Disorientation Death 4/13/2009 52 Male 117 lb 1/10/2011 Physician Japan
Primary
Concomitant
Myelodysplastic Syndrome Other Serious 39 Female 2/28/2011 Other Health Professional Australia
Primary
Secondary
Shock Death 49 Male 2/28/2011 Other Health Professional Spain
Primary
Secondary
Pulmonary Oedema Death 59 Female 2/28/2011 Other Health Professional United States
Primary
Secondary
Concomitant
Geotrichum Infection Death 49 Male 3/17/2011 Other Health Professional Spain
Primary
Secondary
Cardiac Failure Acute Other Serious 1/1/2009 63 Female 3/18/2011 Other Health Professional Japan
Primary
Secondary
Concomitant
Infection Death Unknown 4/6/2011 Other Health Professional France
Primary
Secondary
Bradycardia Hospitalization 59 Female 4/21/2011 Other Health Professional United States
Primary
Secondary
Metapneumovirus Infection Hospitalization 2/14/2011 7 Male 53 lb 5/25/2011 Physician United States
Primary
Secondary
Concomitant
Respiratory Failure Death 10/26/2009 59 Male 121 lb 5/31/2011 Physician Japan
Primary
Secondary
Concomitant
Klebsiella Sepsis Death Unknown 5/24/2011 Other Health Professional Spain
Primary
Secondary
Lymphoma Death Male 6/9/2011 Physician United Kingdom
Primary
Secondary
Disease Recurrence Other Serious 53 Female 6/22/2011 Physician Germany
Primary
Secondary
Cardiac Arrest Hospitalization 59 Female 2/21/2011 United States
Primary
Secondary
Pyrexia Death 49 Female 2/21/2011 Other Health Professional Spain
Primary
Secondary
Herpes Zoster Male 6/23/2011 Physician United Kingdom
Primary
Secondary
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
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
Neutropenia Other Serious 6/9/2010 10 Female 88 lb 7/18/2011 Physician Japan
Primary
Secondary
Concomitant
Toxicity To Various Agents Death 7/18/2011 Physician Denmark
Primary
Secondary
Toxicity To Various Agents Death 7/18/2011 Physician Denmark
Primary
Secondary
Hodgkin's Disease Recurrent Other Serious Male 7/20/2011 Other Health Professional Italy
Primary
Secondary
Bk Virus Infection Hospitalization 2/14/2011 7 Male 53 lb 7/27/2011 Consumer United States
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 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
Pneumonia Bacterial Hospitalization 7/19/2010 32 Female 108 lb 8/10/2011 Physician Japan
Primary
Secondary
Concomitant
Cystitis Haemorrhagic Hospitalization 7/2/2010 62 Female 130 lb 8/12/2011 Physician Japan
Primary
Concomitant
Febrile Bone Marrow Aplasia Death 7/5/2011 65 Male 137 lb 8/12/2011 Physician United Kingdom
Primary
Secondary
Venoocclusive Liver Disease Hospitalization 9/16/2010 59 Male 205 lb 8/17/2011 Other Health Professional United States
Primary
Secondary
Venoocclusive Liver Disease Hospitalization 9/16/2010 59 Male 206 lb 8/18/2011 Consumer United States
Primary
Secondary
Death Death 8/19/2011 Consumer United Kingdom
Primary
Secondary
Septic Shock Other Serious 49 Male 8/23/2011 Physician Portugal
Primary
Secondary
Concomitant
Progressive Multifocal Leukoencephalopathy Hospitalization 5/10/2011 8/31/2011 Consumer Germany
Primary
Secondary
Pancytopenia Other Serious 72 Female 9/7/2011 Other Health Professional United States
Primary
Secondary
Parainfluenzae Virus Infection Death 72 Female 8/31/2011 Other Health Professional United States
Primary
Secondary
Concomitant
Infection Death 9/9/2011 Other Health Professional France
Primary
Secondary
Concomitant
Gastroenteritis Adenovirus Other Serious 72 Female 9/16/2011 Physician United States
Primary
Secondary
Acute Myeloid Leukaemia Recurrent Life Threatening 10/21/2009 22 Female 110 lb 9/19/2011 Physician Japan
Primary
Secondary
Concomitant
Dehydration Other Serious 72 Female 9/9/2011 United States
Primary
Secondary
Epistaxis Death 6/16/2009 67 Female 9/16/2011 Other Health Professional United Kingdom
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
Multi-organ Failure Life Threatening 5/7/2009 50 Female 90 lb 10/6/2011 Physician Japan
Primary
Concomitant
Death Death 75 Male 10/6/2011 Physician United States
Primary
Secondary
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
Leukaemia Monocytic Other Serious 10/12/2011 Physician France
Primary
Secondary
Engraft Failure Death 6/9/2010 10 Female 88 lb 10/13/2011 Physician Japan
Primary
Secondary
Concomitant
Engraft Failure Other Serious 11/1/2010 68 Male 142 lb 11/2/2011 Physician United States
Primary
Secondary
Concomitant
Acute Graft Versus Host Disease In Skin Other Serious 5/31/2009 58 Female 134 lb 11/8/2011 Physician Japan
Primary
Concomitant
Infection Other Serious 10 Male 11/9/2011 Physician Japan
Primary
Concomitant
Lung Neoplasm Death 11/9/2011 Other Health Professional United Kingdom
Primary
Secondary
Engraft Failure Other Serious 11/2/2010 68 Male 141 lb 11/8/2011 Other Health Professional United States
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
Neutropenic Sepsis Death 11/21/2011 Other Health Professional United States
Primary
Secondary
Multi-organ Failure Hospitalization 6/24/2009 15 Male 126 lb 11/23/2011 Physician Japan
Primary
Concomitant
Skin Lesion Other Serious 55 Male 11/25/2011 Other Health Professional Japan
Primary
Secondary
Concomitant
Blast Cell Crisis Other Serious 55 Male 11/25/2011 Other Health Professional Japan
Primary
Secondary
Concomitant
Myelodysplastic Syndrome Other Serious 49 Male 11/28/2011 Other Health Professional Greece
Primary
Secondary
Myelodysplastic Syndrome Other Serious 11 Male 11/28/2011 Other Health Professional Greece
Primary
Secondary
Pneumonia Staphylococcal Death 6/10/2010 33 Female 101 lb 11/29/2011 Physician Japan
Primary
Concomitant
Cytogenetic Abnormality Other Serious 11/30/2011 Greece
Primary
Secondary
Multiple Myeloma Other Serious 49 Male 11/22/2011 Other Health Professional Greece
Primary
Secondary
Cytogenetic Abnormality Other Serious 12/1/2011 Greece
Primary
Secondary
Myelodysplastic Syndrome Other Serious 11 Male 12/6/2011 Physician Greece
Primary
Secondary
Refractory Cytopenia With Multilineage Dysplasia Other Serious 49 Male 12/1/2011 Other Health Professional Greece
Primary
Secondary
Viral Haemorrhagic Cystitis Death 6/24/2010 29 Female 99 lb 12/8/2011 Other Health Professional Japan
Primary
Concomitant
Myelodysplastic Syndrome Other Serious 11 Male 12/12/2011 Physician Greece
Primary
Secondary
Ovarian Failure Other Serious 20 Female 12/12/2011 Physician Japan
Primary
Secondary
Acute Graft Versus Host Disease Other Serious 29 Female 12/13/2011 Physician Japan
Primary
Concomitant

Drug Data