Fludara combined with Methylprednisolone Sodium Succinate

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Precursor T-lymphoblastic Lymphoma/leukaemia Other Serious 2/1/2009 12 Male 12/2/2009 Other Health Professional Japan
Primary
Concomitant
Serum Ferritin Increased Life Threatening 2/16/2009 24 Male 161 lb 9/8/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Transplant Failure Other Serious 12/27/2008 52 Male 152 lb 10/28/2010 Physician Japan
Primary
Secondary
Concomitant
Oedema Life Threatening 1/29/2010 59 Male 176 lb 11/3/2010 Physician Japan
Primary
Secondary
Concomitant
Sepsis Other Serious 5/26/2009 7 Female 29 lb 11/11/2010 Physician Japan
Primary
Secondary
Concomitant
Idiopathic Pneumonia Syndrome Other Serious 6/29/2010 57 Female 99 lb 11/22/2010 Physician Japan
Primary
Secondary
Concomitant
Staphylococcal Bacteraemia Other Serious 8/3/2009 62 Female 110 lb 11/24/2010 Physician Japan
Primary
Secondary
Concomitant
Cytomegalovirus Infection Other Serious 7/17/2009 28 Male 110 lb 11/24/2010 Physician Japan
Primary
Secondary
Concomitant
Staphylococcal Sepsis Other Serious 8/18/2009 13 Male 97 lb 12/10/2010 Physician Japan
Primary
Secondary
Concomitant
Hiccups Death 7/30/2010 49 Male 110 lb 12/17/2010 Physician Japan
Primary
Secondary
Concomitant
Vomiting Other Serious 3/15/2010 54 Female 95 lb 12/22/2010 Physician Japan
Primary
Secondary
Concomitant
Pyrexia Hospitalization 12/12/2009 76 Male 119 lb 12/23/2010 Physician Japan
Primary
Secondary
Concomitant
Urinary Tract Infection Bacterial Death 3/25/2010 58 Male 150 lb 12/29/2010 Physician Japan
Primary
Secondary
Concomitant
Staphylococcal Bacteraemia Other Serious 11/28/2009 73 Male 112 lb 12/29/2010 Physician Japan
Primary
Secondary
Concomitant
Pseudomonal Sepsis Life Threatening 11/7/2010 49 Female 97 lb 12/30/2010 Physician Japan
Primary
Secondary
Concomitant
Interstitial Lung Disease Death 10/23/2009 62 Male 130 lb 1/7/2011 Physician Japan
Primary
Secondary
Concomitant
Febrile Neutropenia Death 5/5/2010 48 Male 137 lb 1/7/2011 Physician Japan
Primary
Secondary
Concomitant
Acute Myeloid Leukaemia Death 5/12/2009 56 Male 139 lb 1/10/2011 Physician Japan
Primary
Secondary
Concomitant
Blood Pressure Increased Other Serious 8/9/2009 48 Female 115 lb 1/10/2011 Physician Japan
Primary
Secondary
Concomitant
Infection Life Threatening 7/4/2010 73 Female 97 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
Viral Haemorrhagic Cystitis Life Threatening 11/7/2009 66 Male 128 lb 1/11/2011 Physician Japan
Primary
Secondary
Concomitant
Acute Graft Versus Host Disease In Skin Hospitalization 2/26/2010 56 Male 134 lb 1/11/2011 Physician Japan
Primary
Secondary
Concomitant
Adult T-cell Lymphoma/leukaemia Death Female 126 lb 1/13/2011 Physician Japan
Primary
Secondary
Concomitant
Fungal Infection Hospitalization 6/24/2009 15 Male 126 lb 2/14/2011 Consumer Japan
Primary
Concomitant
Acute Graft Versus Host Disease In Liver Other Serious 9/22/2010 46 Female 64 lb 2/18/2011 Physician Japan
Primary
Secondary
Concomitant
Pneumonia Cytomegaloviral Death 10/15/2010 7 Female 42 lb 2/23/2011 Physician Japan
Primary
Secondary
Concomitant
Epstein-barr Virus Associated Lymphoproliferative Disorder Death 5/6/2010 59 Female 99 lb 3/3/2011 Physician Japan
Primary
Secondary
Concomitant
Pneumonia Bacterial Other Serious 1/29/2010 52 Male 132 lb 3/24/2011 Physician Japan
Primary
Secondary
Concomitant
Rash Hospitalization 3/15/2010 54 Female 95 lb 4/20/2011 Physician Japan
Primary
Secondary
Concomitant
Abscess Bacterial Death 11/25/2009 61 Male 141 lb 4/25/2011 Physician Japan
Primary
Secondary
Concomitant
Cardiac Failure Congestive Other Serious 6/29/2010 57 Female 99 lb 5/2/2011 Consumer Japan
Primary
Secondary
Concomitant
Diarrhoea Hospitalization 3/12/2010 54 Female 95 lb 5/19/2011 Physician Japan
Primary
Secondary
Concomitant
Disseminated Intravascular Coagulation Death 7/30/2010 49 Male 110 lb 5/20/2011 Physician Japan
Primary
Secondary
Concomitant
Pulmonary Mycosis Other Serious 3/2/2010 63 Male 130 lb 6/7/2011 Physician Japan
Primary
Secondary
Concomitant
Pericardial Effusion Death 10/15/2010 7 Female 42 lb 6/15/2011 Physician Japan
Primary
Secondary
Concomitant
Serum Sickness Death 7/16/2010 68 Male 121 lb 6/16/2011 Physician Japan
Primary
Secondary
Concomitant
Disseminated Intravascular Coagulation Death 7/30/2010 49 Male 110 lb 6/16/2011 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
Bronchopulmonary Aspergillosis Death 9/2/2010 2 Female 18 lb 6/21/2011 Physician Japan
Primary
Secondary
Concomitant
Acute Lymphocytic Leukaemia Recurrent Hospitalization 9/25/2009 10 Male 6/22/2011 Physician Germany
Primary
Secondary
Concomitant
Graft Versus Host Disease Hospitalization 5/25/2010 23 Female 73 lb 6/23/2011 Physician Japan
Primary
Secondary
Concomitant
Pulmonary Haemorrhage Death 3/9/2010 55 Male 152 lb 6/30/2011 Physician Japan
Primary
Secondary
Concomitant
Sepsis Life Threatening 11/19/2008 55 Female 99 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 Skin Other Serious 7/21/2010 7/5/2011 Physician Japan
Primary
Secondary
Concomitant
Hypertension Life Threatening 4/22/2010 13 Male 90 lb 7/5/2011 Physician Japan
Primary
Concomitant
Febrile Neutropenia Death 2/18/2009 56 Female 128 lb 7/7/2011 Physician Japan
Primary
Secondary
Concomitant
Drug Effect Decreased Death 2/1/2009 12 Male 7/8/2011 Physician Japan
Primary
Secondary
Concomitant
Febrile Neutropenia Life Threatening 11/7/2009 66 Male 128 lb 7/11/2011 Physician Japan
Primary
Secondary
Concomitant
Human Herpesvirus 6 Infection Hospitalization 3/27/2010 23 Male 117 lb 7/14/2011 Physician Japan
Primary
Secondary
Concomitant
Engraft Failure Other Serious 6/9/2010 10 Female 88 lb 7/15/2011 Physician Japan
Primary
Secondary
Concomitant
Abscess Bacterial Hospitalization 11/25/2009 61 Male 141 lb 7/18/2011 Physician Japan
Primary
Secondary
Concomitant
Cytomegalovirus Infection Other Serious 6/18/2010 39 Female 110 lb 7/22/2011 Physician Japan
Primary
Secondary
Concomitant
Diarrhoea Hospitalization 6/8/2010 57 Male 126 lb 7/27/2011 Physician Japan
Primary
Secondary
Concomitant
Transaminases Increased Other Serious 6/18/2011 1 Male 24 lb 8/1/2011 Physician Japan
Primary
Concomitant
Febrile Neutropenia Death 11/10/2010 49 Female 97 lb 8/3/2011 Physician Japan
Primary
Secondary
Concomitant
Rash Hospitalization 3/15/2010 54 Female 95 lb 8/4/2011 Physician Japan
Primary
Secondary
Concomitant
Aspartate Aminotransferase Abnormal Hospitalization 10/1/2008 18 Male 95 lb 8/17/2011 Physician Japan
Primary
Secondary
Concomitant
Acute Graft Versus Host Disease Death 1/24/2011 58 Male 141 lb 8/22/2011 Physician Japan
Primary
Secondary
Concomitant
Dizziness Hospitalization 9/27/2010 8/22/2011 Physician Japan
Primary
Concomitant
Pneumonia Hospitalization 5/17/2010 57 Female 134 lb 8/22/2011 Physician Japan
Primary
Secondary
Concomitant
Acute Graft Versus Host Disease In Intestine Other Serious 3/19/2011 10 Male 73 lb 8/31/2011 Physician Japan
Primary
Concomitant
Gastritis Hospitalization 11/14/2010 12 Female 106 lb 9/1/2011 Physician Japan
Primary
Concomitant
Staphylococcal Sepsis Death 5/21/2011 3 Male 26 lb 9/8/2011 Physician Japan
Primary
Concomitant
Headache Other Serious 2/4/2011 13 Female 86 lb 9/16/2011 Physician Japan
Primary
Concomitant
Enterococcal Infection Hospitalization 2/10/2010 23 Male 117 lb 10/3/2011 Physician Japan
Primary
Secondary
Concomitant
Cytomegalovirus Test Positive Death 12/15/2010 52 Male 150 lb 10/7/2011 Physician Japan
Primary
Concomitant
Pneumonia Cytomegaloviral Other Serious 6/9/2010 10 Female 88 lb 10/12/2011 Physician Japan
Primary
Secondary
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
Oedema Other Serious 5/26/2009 7 Female 29 lb 11/4/2011 Physician Japan
Primary
Secondary
Concomitant
Insomnia Life Threatening 8/21/2009 13 Male 97 lb 11/4/2011 Physician Japan
Primary
Secondary
Concomitant
Staphylococcal Sepsis Life Threatening 2/2/2010 44 Male 159 lb 11/8/2011 Physician Japan
Primary
Concomitant
Urinary Tract Infection Pseudomonal Life Threatening 6/9/2010 73 Female 128 lb 11/9/2011 Physician Japan
Primary
Concomitant
Thrombosis Hospitalization 2/27/2011 39 Male 137 lb 11/17/2011 Physician Japan
Primary
Concomitant
Abscess Bacterial Hospitalization 11/25/2009 61 Male 141 lb 11/17/2011 Physician Japan
Primary
Secondary
Concomitant
Cardiomyopathy Death Male 33 lb 11/18/2011 Physician Japan
Primary
Secondary
Concomitant
Acute Graft Versus Host Disease In Skin Other Serious 3/29/2011 36 Male 148 lb 11/21/2011 Physician Japan
Primary
Concomitant
Cardiomyopathy Death Male 33 lb 11/22/2011 Physician Japan
Primary
Secondary
Concomitant
Thyroid Cancer Other Serious 3/8/2010 74 Female 99 lb 11/25/2011 Physician Japan
Primary
Concomitant
Chronic Graft Versus Host Disease Other Serious 11/14/2010 12 Female 106 lb 11/30/2011 Physician Japan
Primary
Concomitant
Vomiting Other Serious 4/4/2009 28 Female 115 lb 11/30/2011 Physician Japan
Primary
Concomitant
Acute Graft Versus Host Disease In Skin Other Serious 3/8/2010 74 Female 99 lb 12/1/2011 Physician Japan
Primary
Concomitant
Cytomegalovirus Infection Life Threatening 5/20/2011 34 Female 132 lb 12/6/2011 Physician Japan
Primary
Secondary
Concomitant
Enterococcal Infection Hospitalization 2/10/2010 23 Male 117 lb 12/8/2011 Physician Japan
Primary
Secondary
Concomitant
Acute Graft Versus Host Disease Hospitalization 1/24/2011 58 Male 141 lb 12/9/2011 Physician Japan
Primary
Secondary
Concomitant
Cytomegalovirus Viraemia Death 3/26/2011 62 Male 128 lb 12/12/2011 Physician Japan
Primary
Concomitant
Graft Versus Host Disease Death 1/26/2010 58 Male 123 lb 12/19/2011 Physician Japan
Primary
Secondary
Concomitant
Neutropenia Death 11/22/2010 66 Male 132 lb 12/20/2011 Physician Japan
Primary
Secondary
Concomitant
Histiocytosis Haematophagic Other Serious 9/30/2010 56 Male 150 lb 12/21/2011 Physician Japan
Primary
Concomitant
Staphylococcal Infection Hospitalization 10/13/2010 60 Male 132 lb 12/23/2011 Physician Japan
Primary
Secondary
Concomitant
Respiratory Failure Other Serious 5/21/2011 3 Male 26 lb 12/23/2011 Physician Japan
Primary
Concomitant
Multi-organ Failure Death 7/17/2011 58 Female 12/23/2011 Physician Japan
Primary
Concomitant
Dialysis Other Serious 2/21/2011 43 Male 157 lb 12/23/2011 Physician Japan
Primary
Concomitant
Cerebral Haemorrhage Death 12/28/2010 25 Male 104 lb 12/23/2011 Physician Japan
Primary
Concomitant
Diarrhoea Other Serious 2/4/2011 13 Female 86 lb 12/30/2011 Physician Japan
Primary
Concomitant
Graft Versus Host Disease In Skin Other Serious 4/22/2010 13 Male 90 lb 1/9/2012 Physician Japan
Primary
Concomitant
Disseminated Intravascular Coagulation Other Serious 8/21/2009 13 Male 97 lb 2/6/2012 Physician Japan
Primary
Secondary
Concomitant
Infection Hospitalization 1/29/2009 3 Female 35 lb 2/10/2012 Physician Japan
Primary
Concomitant
Blood Pressure Increased Other Serious 6/18/2010 39 Female 110 lb 2/15/2012 Physician Japan
Primary
Secondary
Concomitant
Acute Graft Versus Host Disease Other Serious 3/26/2011 62 Male 128 lb 2/27/2012 Physician Japan
Primary
Concomitant
Multi-organ Failure Life Threatening 12/15/2010 52 Male 150 lb 2/29/2012 Physician Japan
Primary
Concomitant
Neutropenia Hospitalization 1/17/2010 55 Male 168 lb 3/7/2012 Other Health Professional Japan
Primary
Secondary
Concomitant
Dizziness Hospitalization 9/27/2010 60 Male 151 lb 3/8/2012 Physician Japan
Primary
Concomitant
Acute Graft Versus Host Disease In Skin Other Serious 3/29/2011 36 Male 148 lb 3/9/2012 Physician Japan
Primary
Concomitant
Acute Lymphocytic Leukaemia Recurrent Death 10/24/2010 19 Male 97 lb 3/16/2012 Physician Japan
Primary
Concomitant
Diarrhoea Life Threatening 7/18/2010 61 Female 110 lb 3/19/2012 Physician Japan
Primary
Secondary
Concomitant
Insomnia Life Threatening 11/23/2010 62 Female 108 lb 3/19/2012 Physician Japan
Primary
Secondary
Concomitant
Neutropenia Other Serious 4/30/2010 23 Female 73 lb 3/19/2012 Physician Japan
Primary
Secondary
Concomitant
Pneumonia Death 2/10/2010 23 Male 117 lb 3/20/2012 Physician Japan
Primary
Secondary
Concomitant
Melaena Hospitalization 2/10/2010 23 Male 117 lb 3/20/2012 Physician Japan
Primary
Secondary
Concomitant
Post Transplant Lymphoproliferative Disorder Life Threatening 3/28/2011 10 Female 75 lb 3/21/2012 Physician Japan
Primary
Secondary
Concomitant
Thrombosis Hospitalization 2/27/2011 39 Male 137 lb 3/22/2012 Physician Japan
Primary
Concomitant
Rhinitis Allergic Other Serious 11/14/2010 12 Female 106 lb 3/23/2012 Physician Japan
Primary
Secondary
Concomitant
Graft Versus Host Disease In Skin Death 4/20/2010 13 Male 90 lb 3/26/2012 Physician Japan
Primary
Concomitant
Cytomegalovirus Viraemia Hospitalization 6/29/2011 16 Male 112 lb 3/29/2012 Physician Japan
Primary
Secondary
Concomitant
Thrombotic Microangiopathy Life Threatening 7/17/2011 58 Female 82 lb 3/30/2012 Physician Japan
Primary
Concomitant
Neutropenia Life Threatening 11/22/2010 66 Male 132 lb 4/18/2012 Physician Japan
Primary
Secondary
Concomitant
Febrile Neutropenia Death 10/16/2009 38 Female 110 lb 4/27/2012 Physician Japan
Primary
Secondary
Concomitant
Renal Impairment Other Serious 5/23/2010 73 Male 119 lb 4/27/2012 Physician Japan
Primary
Secondary
Concomitant
Renal Impairment Other Serious 4/6/2011 12 Male 97 lb 5/15/2012 Physician Japan
Primary
Secondary
Concomitant
Oxygen Saturation Decreased Other Serious 9/18/2011 1 Male 24 lb 5/15/2012 Physician Japan
Primary
Secondary
Concomitant
Staphylococcal Sepsis Hospitalization 11/1/2010 6 Female 42 lb 5/17/2012 Physician Japan
Primary
Secondary
Concomitant
Hyperglycaemia Other Serious 8/19/2010 13 Male 97 lb 5/18/2012 Physician Japan
Primary
Concomitant
Graft Versus Host Disease In Skin Death 4/20/2010 13 Male 90 lb 6/1/2012 Physician Japan
Primary
Secondary
Concomitant
Hypertension Life Threatening 11/20/2009 62 Female 108 lb 6/7/2012 Physician Japan
Primary
Secondary
Concomitant
Staphylococcal Sepsis Death 2/11/2011 55 Female 123 lb 6/8/2012 Physician Japan
Primary
Secondary
Concomitant
Febrile Neutropenia Death 1/10/2011 60 Female 90 lb 7/6/2012 Physician Japan
Primary
Secondary
Concomitant
Platelet Count Decreased Hospitalization 7/21/2010 7/9/2012 Physician Japan
Primary
Secondary
Concomitant
Candida Pneumonia Death 11/17/2011 Male 13 lb 7/27/2012 Physician Japan
Primary
Secondary
Concomitant
Graft Versus Host Disease In Skin Death 2/11/2011 55 Female 123 lb 7/31/2012 Physician Japan
Primary
Secondary
Concomitant
Antithrombin Iii Decreased Life Threatening 9/22/2011 20 Female 106 lb 8/13/2012 Physician Japan
Primary
Secondary
Concomitant
Bk Virus Infection Other Serious 4/2/2011 27 Female 112 lb 8/14/2012 Physician Japan
Primary
Secondary
Concomitant
Thrombotic Microangiopathy Death 7/17/2011 58 Female 82 lb 8/15/2012 Physician Japan
Primary
Concomitant
Cytomegalovirus Infection Other Serious 4/11/2011 3 Male 29 lb 8/17/2012 Physician Japan
Primary
Concomitant
Bacterial Infection Hospitalization 4/15/2011 3 Female 29 lb 8/17/2012 Physician Japan
Primary
Secondary
Concomitant
Chronic Myeloid Leukaemia Hospitalization 8/18/2009 18 Female 108 lb 8/23/2012 Physician Japan
Primary
Secondary
Concomitant
Urinary Retention Death 2/10/2010 23 Male 117 lb 11/2/2012 Physician Jp
Primary
Secondary
Concomitant
Transaminases Increased Other Serious 6/18/2011 2 Male 24 lb 9/14/2012 Physician Jp
Primary
Concomitant
Viral Infection Death 1/10/2011 60 Female 90 lb 8/31/2012 Physician Jp
Primary
Secondary
Concomitant
Thrombotic Microangiopathy Other Serious 7/17/2011 59 Female 82 lb 9/20/2012 Physician Jp
Primary
Concomitant
Stomatitis Life Threatening 9/27/2010 60 Male 151 lb 9/12/2012 Physician Jp
Primary
Concomitant
Systemic Candida Life Threatening 5/9/2010 73 Male 119 lb 12/6/2012 Physician Jp
Primary
Secondary
Concomitant
Pyrexia Death 10/16/2009 38 Female 110 lb 12/6/2012 Physician Jp
Primary
Secondary
Concomitant
Staphylococcal Sepsis Life Threatening 2/2/2010 45 Male 159 lb 11/5/2012 Physician Jp
Primary
Concomitant
Sepsis Death 4/25/2009 61 Male 159 lb 11/2/2012 Consumer Jp
Primary
Concomitant
White Blood Cell Count Decreased Life Threatening 2/11/2011 55 Female 123 lb 9/6/2012 Physician Jp
Primary
Secondary
Concomitant
Staphylococcal Sepsis Life Threatening 5/20/2011 34 Female 132 lb 9/13/2012 Physician Jp
Primary
Secondary
Concomitant

Drug Data