Cyclosporine combined with Fludara

Reports:


Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Ventricular Dysfunction Other Serious 8/16/2005 61 Male 148 lb 1/26/2006 Other Health Professional Japan
Primary
Secondary
Concomitant
Hepatitis Fulminant Other Serious Unknown 1/31/2006 Germany
Primary
Secondary
Concomitant
Pulmonary Toxicity Other Serious Unknown 1/31/2006 Germany
Primary
Secondary
Concomitant
Cerebral Haemorrhage Death Unknown 1/31/2006 Germany
Primary
Secondary
Concomitant
Virus Urine Test Positive Other Serious 8/16/2005 61 Male 148 lb 2/3/2006 Other Health Professional Japan
Primary
Secondary
Concomitant
Vasculitis Cerebral Other Serious 15 Male 2/10/2006 Canada
Primary
Secondary
Respiratory Failure Required Intervention 55 Female 3/15/2006 France
Primary
Concomitant
Sepsis Life Threatening 4/19/2005 3 Male 3/31/2006 Consumer United States
Primary
Concomitant
Vomiting Hospitalization 1/1/2001 42 Male 3/27/2006 Physician United States
Primary
Secondary
Concomitant
Liver Disorder Life Threatening 6/1/2005 42 Male 159 lb 4/6/2006 Physician Japan
Primary
Secondary
Concomitant
Sepsis Life Threatening 4/19/2005 3 Male 4/14/2006 Consumer United States
Primary
Secondary
Concomitant
Venoocclusive Liver Disease Other Serious 62 Male 4/21/2006 Physician United States
Primary
Secondary
Concomitant
Venoocclusive Liver Disease Other Serious 69 Male 4/21/2006 Physician United States
Primary
Secondary
Concomitant
Venoocclusive Liver Disease Other Serious 47 Male 4/21/2006 Physician United States
Primary
Secondary
Concomitant
Hyperbilirubinaemia Other Serious 59 Male 4/21/2006 Physician United States
Primary
Secondary
Concomitant
Renal Failure Other Serious 51 Male 4/21/2006 Physician United States
Primary
Secondary
Concomitant
Graft Versus Host Disease Other Serious 55 Male 4/21/2006 Physician United States
Primary
Secondary
Concomitant
Viral Vasculitis Other Serious 4/10/2005 34 Male 159 lb 5/3/2006 Physician United States
Primary
Secondary
Concomitant
Viral Vasculitis Other Serious 4/10/2005 34 Male 159 lb 5/3/2006 Physician United States
Primary
Secondary
Concomitant
Unevaluable Event Other Serious 1/1/2004 45 Male 5/15/2006 Physician Japan
Primary
Concomitant
Toxic Epidermal Necrolysis Other Serious 1/1/2004 45 Male 5/24/2006 Physician Japan
Primary
Concomitant
Tachycardia Hospitalization 3/17/2006 61 Male 6/2/2006 Physician United States
Primary
Secondary
Concomitant
Graft Versus Host Disease In Skin Other Serious 61 Female 6/29/2006 Physician United States
Primary
Secondary
Concomitant
Squamous Cell Carcinoma Of Skin Other Serious 62 Male 6/29/2006 Physician United States
Primary
Secondary
Concomitant
Obliterative Bronchiolitis Other Serious 59 Male 6/29/2006 Physician United States
Primary
Secondary
Concomitant
Stem Cell Transplant Other Serious 61 Male 6/29/2006 Physician United States
Primary
Secondary
Concomitant
Stem Cell Transplant Other Serious 53 Male 6/29/2006 Physician United States
Primary
Secondary
Concomitant
Squamous Cell Carcinoma Of Skin Other Serious 45 Male 6/29/2006 Physician United States
Primary
Secondary
Concomitant
Renal Tubular Acidosis Other Serious 5/5/2005 20 Male 8/3/2006 Consumer United States
Primary
Secondary
Concomitant
Renal Tubular Acidosis Other Serious 5/5/2005 20 Male 8/30/2006 Consumer United States
Primary
Secondary
Concomitant
Venoocclusive Liver Disease Life Threatening 4/19/2005 3 Male 9/8/2006 Consumer United States
Primary
Concomitant
Respiratory Failure Hospitalization 6/27/2006 38 Female 9/8/2006 Physician United States
Primary
Secondary
Concomitant
Sepsis Life Threatening 4/19/2005 3 Male 9/20/2006 Consumer United States
Primary
Concomitant
Haemolysis Other Serious Male 11/15/2006 Physician Russian Federation
Primary
Secondary
Transplant Rejection Death 5/16/2006 49 Female 109 lb 4/29/2007 Physician Japan
Primary
Concomitant
Respiratory Failure Death 5/8/2003 13 Female 8/20/2007 Other Health Professional Japan
Primary
Concomitant
Acute Graft Versus Host Disease Other Serious 9/27/2007 Physician Russian Federation
Primary
Secondary
Concomitant
Acute Graft Versus Host Disease Death Female 9/27/2007 Physician Russian Federation
Primary
Secondary
Concomitant
Scleroderma Other Serious 9/27/2007 Physician Russian Federation
Primary
Secondary
Concomitant
Chronic Graft Versus Host Disease Other Serious 9/27/2007 Physician Russian Federation
Primary
Secondary
Concomitant
Sepsis Other Serious 9/27/2007 Physician Russian Federation
Primary
Secondary
Concomitant
Thrombotic Microangiopathy Other Serious 46 Female 10/24/2007 Physician Japan
Primary
Concomitant
Venoocclusive Disease Other Serious 8/27/2002 57 Male 165 lb 10/24/2007 Other Health Professional Germany
Primary
Secondary
Concomitant
Reticulocyte Count Decreased Hospitalization 2/16/2004 54 Male 11/21/2007 Physician Japan
Primary
Secondary
Concomitant
Thrombotic Microangiopathy Hospitalization 2/21/2007 46 Female 12/12/2007 Physician Japan
Primary
Concomitant
Thrombotic Microangiopathy Hospitalization 2/21/2007 46 Female 12/14/2007 Physician Japan
Primary
Concomitant
Reticulocyte Count Decreased Hospitalization 2/16/2004 54 Male 12/18/2007 Other Health Professional Japan
Primary
Secondary
Concomitant
Thrombotic Microangiopathy Other Serious 61 Male 12/18/2007 Physician Japan
Primary
Concomitant
Sepsis Life Threatening 27 Female 2/15/2008 Other Health Professional Mexico
Primary
Secondary
Concomitant
Graft Versus Host Disease Death 33 Male 2/15/2008 Other Health Professional Mexico
Primary
Secondary
Concomitant
Interstitial Lung Disease Death 7/17/2007 65 Male 161 lb 2/29/2008 Physician Japan
Primary
Secondary
Concomitant
Capillary Leak Syndrome Death 11/6/2007 12 Male 4/14/2008 Physician Italy
Primary
Secondary
Concomitant
Thrombotic Microangiopathy Death 55 Male 4/16/2008 Consumer Japan
Primary
Concomitant
Capillary Leak Syndrome Death 11/6/2007 12 Male 4/25/2008 Physician Italy
Primary
Secondary
Concomitant
Cardiac Failure Death 3/8/2008 14 Female 4/25/2008 Physician Italy
Primary
Secondary
Concomitant
Cardiac Failure Death 3/8/2008 13 Female 4/22/2008 Other Health Professional Italy
Primary
Secondary
Concomitant
Venoocclusive Liver Disease Other Serious 11/1/2007 12 Male 5/6/2008 Physician Italy
Primary
Secondary
Concomitant
Cardiac Failure Death 3/8/2008 14 Female 5/6/2008 Physician Italy
Primary
Secondary
Concomitant
Weight Decreased Hospitalization 3/13/2008 47 Male 141 lb 5/14/2008 Physician Japan
Primary
Secondary
Concomitant
Pyrexia Death 7/17/2007 65 Male 161 lb 5/20/2008 Physician Japan
Primary
Secondary
Concomitant
Weight Decreased Hospitalization 3/13/2008 47 Male 141 lb 6/24/2008 Physician Japan
Primary
Secondary
Concomitant
Weight Decreased Hospitalization 3/13/2008 47 Male 141 lb 7/2/2008 Physician Japan
Primary
Secondary
Concomitant
Vomiting Other Serious 4/21/2007 69 Female 82 lb 7/11/2008 Physician Japan
Primary
Concomitant
Vomiting Other Serious 4/21/2007 69 Female 82 lb 9/12/2008 Physician Japan
Primary
Secondary
Concomitant
Vomiting Other Serious 4/21/2007 69 Female 82 lb 11/4/2008 Physician Japan
Primary
Secondary
Concomitant
Viral Haemorrhagic Cystitis Other Serious 10/6/2004 Male 143 lb 12/23/2008 Physician Japan
Primary
Secondary
Concomitant
Viral Haemorrhagic Cystitis Other Serious 10/6/2004 Male 143 lb 1/16/2009 Physician Japan
Primary
Secondary
Concomitant
Toxic Epidermal Necrolysis Death 11/25/2008 62 Female 163 lb 1/23/2009 Consumer France
Primary
Secondary
Concomitant
Toxic Epidermal Necrolysis Death 11/25/2008 62 Female 163 lb 1/27/2009 Consumer France
Primary
Secondary
Concomitant
Interstitial Lung Disease Other Serious 3 Male 1/26/2009 Other Health Professional Japan
Primary
Secondary
Thrombotic Microangiopathy Other Serious 42 Female 1/28/2009 Other Health Professional Japan
Primary
Concomitant
Systemic Candida Other Serious 39 Male 1/28/2009 Other Health Professional Japan
Primary
Concomitant
Toxic Epidermal Necrolysis Death 11/25/2008 Female 163 lb 1/28/2009 Other Health Professional France
Primary
Secondary
Concomitant
Toxic Epidermal Necrolysis Hospitalization 11/1/2008 Female 163 lb 1/28/2009 Other Health Professional France
Primary
Secondary
Concomitant
Toxic Epidermal Necrolysis Other Serious 11/28/2008 Female 163 lb 2/4/2009 Germany
Primary
Secondary
Concomitant
Respiratory Disorder Other Serious 8 Male 2/6/2009 Consumer Japan
Primary
Secondary
Concomitant
Toxic Epidermal Necrolysis Hospitalization 11/25/2008 62 Female 163 lb 1/28/2009 Other Health Professional France
Primary
Concomitant
Toxic Epidermal Necrolysis Other Serious 11/28/2008 Female 163 lb 2/6/2009 Germany
Primary
Secondary
Concomitant
Respiratory Disorder Other Serious 8 Male 2/16/2009 Consumer Japan
Primary
Secondary
Concomitant
Systemic Candida Death 40 Male 2/27/2009 Japan
Primary
Concomitant
Thrombotic Microangiopathy Life Threatening 42 Female 117 lb 3/4/2009 Other Health Professional Japan
Primary
Concomitant
Thrombotic Microangiopathy Life Threatening 42 Female 117 lb 3/16/2009 Other Health Professional Japan
Primary
Concomitant
Venoocclusive Liver Disease Life Threatening 9/1/2008 21 Male 146 lb 3/20/2009 Physician Japan
Primary
Secondary
Concomitant
Viral Haemorrhagic Cystitis Other Serious 6/27/2008 44 Male 148 lb 3/20/2009 Physician Japan
Primary
Concomitant
Thrombotic Microangiopathy Life Threatening 7/30/2008 59 Female 95 lb 3/24/2009 Physician Japan
Primary
Concomitant
Sepsis Life Threatening 6/27/2008 36 Female 97 lb 4/9/2009 Physician Japan
Primary
Concomitant
Engraft Failure Death 11/20/2008 57 Female 104 lb 5/15/2009 Japan
Primary
Concomitant
Pneumonia Life Threatening 10/8/2008 65 Male 132 lb 8/6/2009 Physician Japan
Primary
Secondary
Concomitant
Sepsis Life Threatening 2/9/2009 36 Female 119 lb 8/6/2009 Physician Japan
Primary
Secondary
Concomitant
Viral Haemorrhagic Cystitis Other Serious 6/27/2008 44 Male 148 lb 8/17/2009 Physician Japan
Primary
Concomitant
Renal Impairment Death 12/1/2008 61 Male 115 lb 9/8/2009 Physician Japan
Primary
Concomitant
Nausea Other Serious 10/29/2008 58 Female 106 lb 9/8/2009 Physician Japan
Primary
Secondary
Concomitant
Nausea Other Serious 10/29/2008 58 Female 106 lb 9/15/2009 Physician Japan
Primary
Secondary
Concomitant
Febrile Neutropenia Other Serious 9/24/2008 57 Female 104 lb 9/25/2009 Physician Japan
Primary
Concomitant
Septic Shock Other Serious 54 Male 9/25/2009 Physician Poland
Primary
Secondary
Concomitant
Somnolence Other Serious 9/18/2009 50 Female 10/1/2009 Physician France
Primary
Secondary
Septic Shock Other Serious 54 Male 10/2/2009 Physician United Kingdom
Primary
Secondary
Concomitant
Respiratory Failure Hospitalization 8/18/2009 23 Male 11/5/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Renal Failure Other Serious 9/19/2009 58 Male 181 lb 11/10/2009 Physician France
Primary
Secondary
Concomitant
Renal Failure Other Serious 9/19/2009 58 Male 181 lb 11/11/2009 Physician France
Primary
Secondary
Concomitant
Renal Failure Other Serious 9/19/2009 58 Male 181 lb 11/20/2009 Physician France
Primary
Secondary
Concomitant
Renal Failure Other Serious 9/29/2009 58 Male 11/18/2009 Other Health Professional France
Primary
Concomitant
White Blood Cell Count Decreased Other Serious 9/29/2009 58 Male 11/20/2009 Other Health Professional France
Primary
Concomitant
Renal Failure Other Serious 9/19/2009 58 Male 181 lb 12/7/2009 Physician France
Primary
Secondary
Concomitant
Renal Failure Other Serious 9/19/2009 58 Male 181 lb 12/7/2009 Physician France
Primary
Secondary
Concomitant
Staphylococcal Infection Other Serious 9/29/2009 58 Male 12/16/2009 Other Health Professional France
Primary
Concomitant
Venoocclusive Liver Disease Other Serious 52 Male 12/29/2009 Other Health Professional Japan
Primary
Concomitant
Venoocclusive Liver Disease Other Serious 52 Male 1/19/2010 Other Health Professional Japan
Primary
Concomitant
Venoocclusive Liver Disease Other Serious 52 Male 1/22/2010 Other Health Professional Japan
Primary
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
Renal Impairment Death 12/1/2008 61 Male 115 lb 2/12/2010 Physician Japan
Primary
Concomitant
Venoocclusive Liver Disease Other Serious 52 Male 2/17/2010 Other Health Professional Japan
Primary
Concomitant
Renal Impairment Death 12/1/2008 61 Male 115 lb 2/22/2010 Physician Japan
Primary
Concomitant
Thrombotic Microangiopathy Other Serious 49 Male 2/24/2010 Other Health Professional Japan
Primary
Concomitant
Venoocclusive Liver Disease Other Serious 22 Female 3/3/2010 Other Health Professional Japan
Primary
Concomitant
Epstein-barr Virus Infection Other Serious 7 Male 3/3/2010 Other Health Professional Japan
Primary
Concomitant
Reversible Posterior Leukoencephalopathy Syndrome Other Serious 39 Female 3/5/2010 Other Health Professional Japan
Primary
Concomitant
Reversible Posterior Leukoencephalopathy Syndrome Other Serious 39 Female 3/8/2010 Other Health Professional Japan
Primary
Concomitant
Epstein-barr Virus Infection Other Serious 7 Male 3/8/2010 Other Health Professional Japan
Primary
Concomitant
Venoocclusive Liver Disease Other Serious 22 Female 3/22/2010 Other Health Professional Japan
Primary
Concomitant
Thrombotic Microangiopathy Other Serious 49 Male 4/1/2010 Other Health Professional Japan
Primary
Concomitant
Thrombotic Microangiopathy Other Serious 49 Male 4/6/2010 Other Health Professional Japan
Primary
Concomitant
Febrile Neutropenia Hospitalization 7/17/2004 45 Male 121 lb 8/2/2010 Physician Japan
Primary
Secondary
Concomitant
Pneumonia Death 6/3/2004 57 Male 117 lb 8/2/2010 Physician Japan
Primary
Secondary
Concomitant
Pneumonia Death 9/20/2004 66 Male 121 lb 8/2/2010 Physician Japan
Primary
Secondary
Concomitant
Liver Disorder Hospitalization 4/27/2005 30 Female 110 lb 8/3/2010 Physician Japan
Primary
Secondary
Concomitant
Febrile Neutropenia Hospitalization 7/17/2004 45 Male 121 lb 8/20/2010 Physician Japan
Primary
Secondary
Concomitant
Serum Ferritin Increased Life Threatening 2/16/2009 24 Male 161 lb 9/8/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Sepsis Death 5/17/2006 57 Male 123 lb 9/15/2010 Physician Japan
Primary
Secondary
Concomitant
Liver Disorder Hospitalization 4/27/2005 30 Female 110 lb 9/24/2010 Physician Japan
Primary
Secondary
Concomitant
Unresponsive To Stimuli Other Serious 9/16/2009 22 Male 169 lb 9/28/2010 Physician United States
Primary
Secondary
Concomitant
Therapeutic Response Decreased Other Serious 58 Female 10/6/2010 Physician Japan
Primary
Concomitant
Toxoplasmosis Death 42 Female 10/7/2010 Other Health Professional Germany
Primary
Secondary
Concomitant
Respiratory Failure Other Serious 9 Female 10/8/2010 Other Health Professional Germany
Primary
Secondary
Concomitant
Mycobacterium Avium Complex Infection Other Serious 0 Male 10/14/2010 Physician Germany
Primary
Secondary
Concomitant
Somnolence Hospitalization 6/16/2010 61 Male 10/21/2010 Physician Germany
Primary
Secondary
Concomitant
Pericardial Effusion Other Serious 16 Female 10/29/2010 Physician Germany
Primary
Secondary
Concomitant
Thrombocytopenia Other Serious 56 Female 10/29/2010 Physician Germany
Primary
Secondary
Concomitant
Renal Failure Other Serious 6 Male 10/29/2010 Physician United States
Primary
Secondary
Concomitant
Transplant Rejection Other Serious 5 Male 10/29/2010 Physician United States
Primary
Secondary
Concomitant
Mucosal Inflammation Other Serious 1 Male 10/29/2010 Physician Germany
Primary
Secondary
Concomitant
Skin Toxicity Other Serious 14 Female 10/29/2010 Physician Germany
Primary
Secondary
Concomitant
Renal Failure Other Serious 6 Female 10/29/2010 Physician Germany
Primary
Secondary
Concomitant
Mucosal Inflammation Other Serious 6 Female 10/29/2010 Physician Germany
Primary
Secondary
Concomitant
Mucosal Inflammation Other Serious 1 Male 11/3/2010 Physician United States
Primary
Secondary
Concomitant
Hypotension Hospitalization 10/22/2010 47 Male 11/5/2010 Physician Canada
Primary
Secondary
Concomitant
Venoocclusive Disease Death 11/8/2010 Other Health Professional Germany
Primary
Secondary
Rash Papular Other Serious 7/15/2010 57 Female 11/10/2010 Physician Germany
Primary
Secondary
Concomitant