Alemtuzumab combined with Fludarabine

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Weight Decreased Other Serious 25 Male 1/8/2008 Other Health Professional United Kingdom
Primary
Secondary
Graft Versus Host Disease Death 53 Male 2/18/2008 Other Health Professional Mexico
Primary
Secondary
Concomitant
Chronic Graft Versus Host Disease Death 15 Male 2/18/2008 Other Health Professional Mexico
Primary
Secondary
Concomitant
Graft Versus Host Disease Death 27 Female 2/18/2008 Other Health Professional Mexico
Primary
Secondary
Concomitant
No Therapeutic Response Death 33 Male 2/19/2008 Other Health Professional Mexico
Primary
Secondary
Concomitant
Stenotrophomonas Infection Other Serious 2/19/2008 United States
Primary
Secondary
Chronic Graft Versus Host Disease Death 15 Male 2/20/2008 Other Health Professional Mexico
Primary
Secondary
Concomitant
Graft Versus Host Disease Death 53 Male 2/20/2008 Other Health Professional Mexico
Primary
Secondary
Concomitant
Graft Versus Host Disease Death 27 Female 2/20/2008 Other Health Professional Mexico
Primary
Secondary
Concomitant
Chronic Myeloid Leukaemia Death 57 Male 2/20/2008 Other Health Professional Mexico
Primary
Secondary
Concomitant
Drug Eruption Hospitalization 1/2/2008 58 Male 174 lb 2/28/2008 Physician Germany
Primary
Secondary
Concomitant
Disease Progression Death 3/21/2008 United Kingdom
Primary
Secondary
Concomitant
Progressive Multifocal Leukoencephalopathy Other Serious Male 3/27/2008 Other Health Professional Germany
Primary
Secondary
Progressive Multifocal Leukoencephalopathy Other Serious Male 3/31/2008 Other Health Professional Germany
Primary
Secondary
Progressive Multifocal Leukoencephalopathy Death Male 4/2/2008 Germany
Primary
Secondary
Weight Decreased Hospitalization 2/1/2008 74 Female 4/3/2008 Physician Germany
Primary
Secondary
Concomitant
Venoocclusive Liver Disease Death 4/16/2008 United States
Primary
Secondary
Concomitant
Human Herpesvirus 6 Infection Other Serious 11 Female 4/16/2008 Physician Austria
Primary
Secondary
Respiratory Distress Other Serious 1 Male 7/25/2008 United States
Primary
Secondary
Concomitant
Vomiting Other Serious 31 Female 8/7/2008 United Kingdom
Primary
Secondary
Vomiting Other Serious 31 Female 8/11/2008 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Immune Reconstitution Syndrome Hospitalization 31 Female 8/13/2008 Consumer United States
Primary
Secondary
Concomitant
Vomiting Other Serious 31 Female 8/13/2008 United Kingdom
Primary
Secondary
Concomitant
Vomiting Other Serious 31 Female 8/21/2008 United Kingdom
Primary
Secondary
Concomitant
Vomiting Other Serious 31 Female 8/22/2008 United Kingdom
Primary
Secondary
Vomiting Hospitalization 31 Female 8/28/2008 United Kingdom
Primary
Secondary
Concomitant
Vomiting Hospitalization 31 Female 9/2/2008 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Human Herpesvirus 6 Infection Other Serious 7/9/2002 11 Female 9/2/2008 Other Health Professional Austria
Primary
Secondary
Concomitant
Pneumonia Viral Other Serious Male 10/15/2008 Other Health Professional Denmark
Primary
Secondary
Concomitant
Oropharyngeal Pain Other Serious 5/1/2008 68 Male 161 lb 10/22/2008 Physician Germany
Primary
Secondary
Concomitant
Rheumatoid Factor Positive Other Serious 1/1/2005 36 Female 1/21/2009 Consumer United Kingdom
Primary
Secondary
B-cell Lymphoma Hospitalization 59 Male 1/27/2009 Germany
Primary
Secondary
Concomitant
B-cell Lymphoma Death 63 Female 1/27/2009 Germany
Primary
Secondary
Concomitant
Proteinuria Hospitalization 12/1/2007 63 Male 150 lb 4/22/2009 Physician Germany
Primary
Secondary
Concomitant
Encephalitis Viral Death 11/17/2006 63 7/7/2009 Other Health Professional Germany
Primary
Concomitant
Vomiting Other Serious 11/1/2004 44 9/11/2009 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Graft Versus Host Disease Other Serious 2/1/2006 45 Female 9/16/2009 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Vomiting Other Serious 7/1/2007 56 Female 9/16/2009 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Vomiting Other Serious 9/1/2006 52 Male 9/16/2009 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Stem Cell Transplant Other Serious 11/1/2006 34 Male 9/15/2009 United Kingdom
Primary
Secondary
Concomitant
Stem Cell Transplant Other Serious 9/1/2006 52 Male 9/15/2009 United Kingdom
Primary
Secondary
Concomitant
Graft Versus Host Disease In Lung Other Serious 2/1/2006 45 Female 9/14/2009 United Kingdom
Primary
Secondary
Concomitant
Stem Cell Transplant Death 7/1/2006 64 Male 9/15/2009 United Kingdom
Primary
Secondary
Concomitant
Vomiting Other Serious 4/1/2006 18 Male 9/15/2009 United Kingdom
Primary
Secondary
Concomitant
Epstein-barr Virus Associated Lymphoproliferative Disorder Death 53 Male 9/28/2009 Italy
Primary
Secondary
Gene Mutation Other Serious 7/25/2007 52 Male 12/29/2009 Czech Republic
Primary
Concomitant
Progressive Multifocal Leukoencephalopathy Life Threatening 10/1/2009 Male 198 lb 12/31/2009 Physician United Kingdom
Primary
Secondary
Skin Lesion Other Serious 45 Female 1/11/2010 United Kingdom
Primary
Secondary
Pemphigoid Other Serious 51 Male 2/3/2010 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Progressive Multifocal Leukoencephalopathy Death 5/1/2008 Male 172 lb 2/4/2010 Other Health Professional United States
Primary
Concomitant
Pemphigoid Other Serious 51 Male 2/4/2010 United Kingdom
Primary
Secondary
Pemphigoid Other Serious 51 Male 2/12/2010 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Pemphigoid Other Serious 51 Male 2/12/2010 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Vomiting Hospitalization 31 Female 2/25/2010 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Vomiting Other Serious 31 Female 2/26/2010 United Kingdom
Primary
Secondary
Concomitant
Progressive Multifocal Leukoencephalopathy Other Serious 3/1/2005 79 Male 4/5/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Vertigo Hospitalization 3/20/2010 60 Male 192 lb 4/9/2010 Physician Netherlands
Primary
Secondary
Concomitant
Vertigo Hospitalization 3/20/2010 60 Male 192 lb 4/15/2010 Physician Netherlands
Primary
Secondary
Concomitant
Epstein-barr Virus Associated Lymphoproliferative Disorder Other Serious 4/20/2010 Other Health Professional Germany
Primary
Secondary
Concomitant
Epstein-barr Virus Associated Lymphoproliferative Disorder Other Serious 4/20/2010 Other Health Professional Germany
Primary
Secondary
Concomitant
Sepsis Other Serious 4/20/2010 Other Health Professional Germany
Primary
Secondary
Concomitant
Sepsis Other Serious 4/20/2010 Other Health Professional Germany
Primary
Secondary
Concomitant
Sepsis Other Serious 4/20/2010 Other Health Professional Germany
Primary
Secondary
Concomitant
Pancytopenia Other Serious 4/20/2010 Other Health Professional Germany
Primary
Secondary
Concomitant
Vertigo Hospitalization 3/20/2010 60 Male 192 lb 4/21/2010 Physician Sweden
Primary
Secondary
Concomitant
Vertigo Hospitalization 3/20/2010 60 Male 192 lb 4/22/2010 Physician Sweden
Primary
Secondary
Concomitant
Tonsillar Hypertrophy Disability 60 Female 4/22/2010 Consumer France
Primary
Concomitant
T-lymphocyte Count Decreased Other Serious 1 Female 4/23/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Vertigo Hospitalization 3/20/2010 60 Male 192 lb 4/27/2010 Physician Sweden
Primary
Secondary
Concomitant
Pseudomonas Infection Other Serious 1 Female 4/30/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Pyrexia Hospitalization 62 Male 5/17/2010 Physician United Kingdom
Primary
Secondary
Concomitant
Hyponatraemia Death 6/4/2010 United States
Primary
Secondary
Concomitant
Hyponatraemia Death 6/8/2010 United States
Primary
Secondary
Concomitant
Venoocclusive Liver Disease Death 6/17/2010 United Kingdom
Primary
Secondary
Concomitant
Hepatotoxicity Other Serious 6/17/2010 United States
Primary
Secondary
Concomitant
Cytomegalovirus Infection Other Serious 6/22/2010 United Kingdom
Primary
Secondary
Varicella Virus Test Positive Other Serious 9 Male 6/23/2010 Other Health Professional Netherlands
Primary
Secondary
Concomitant
Epstein-barr Virus Associated Lymphoproliferative Disorder Death 6/24/2010 United Kingdom
Primary
Secondary
Concomitant
Pulmonary Haemorrhage Death 6/24/2010 United Kingdom
Primary
Secondary
Concomitant
Squamous Cell Carcinoma Other Serious 12/26/2009 64 Male 198 lb 7/9/2010 Physician Norway
Primary
Secondary
Concomitant
Pneumonia Other Serious 4 Male 8/4/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Pneumocystis Jiroveci Pneumonia Other Serious 8/17/2010 United States
Primary
Secondary
Concomitant
Infection Other Serious 8/17/2010 United States
Primary
Secondary
Concomitant
Renal Failure Acute Other Serious 8/17/2010 United States
Primary
Secondary
Concomitant
Encephalopathy Death 8/20/2010 United Kingdom
Primary
Secondary
Staphylococcal Skin Infection Other Serious 9 Male 8/20/2010 Other Health Professional Netherlands
Primary
Concomitant
Pneumocystis Jiroveci Pneumonia Other Serious 8/23/2010 United States
Primary
Secondary
Concomitant
Renal Failure Acute Other Serious 8/23/2010 United States
Primary
Secondary
Concomitant
Encephalopathy Death 8/24/2010 United Kingdom
Primary
Secondary
Infection Other Serious 8/24/2010 United States
Primary
Secondary
Concomitant
Transplant Failure Other Serious 7 Male 8/27/2010 Other Health Professional Jordan
Primary
Secondary
Concomitant
Graft Versus Host Disease Other Serious Male 9/8/2010 Physician United Kingdom
Primary
Concomitant
Respiratory Tract Infection Other Serious 12/1/2008 59 Male 9/14/2010 Other Health Professional France
Primary
Secondary
Cytomegalovirus Infection Other Serious Female 9/8/2010 Physician United Kingdom
Primary
Concomitant
Myeloproliferative Disorder Other Serious Female 9/8/2010 Physician United Kingdom
Primary
Concomitant
Myeloproliferative Disorder Other Serious Male 9/8/2010 Physician United Kingdom
Primary
Concomitant
Respiratory Tract Infection Other Serious 12/1/2008 59 Male 9/15/2010 Other Health Professional France
Primary
Secondary
Respiratory Tract Infection Bacterial Other Serious 12/1/2008 59 Male 9/20/2010 Other Health Professional France
Primary
Secondary
Encephalitis Viral Death 11/17/2006 63 10/8/2010 Germany
Primary
Concomitant
Cytomegalovirus Infection Other Serious 11/10/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Pneumonia Cytomegaloviral Death 11/10/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Cytomegalovirus Infection Other Serious 11/10/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Cytomegalovirus Infection Other Serious 11/10/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Cytomegalovirus Infection Other Serious 11/10/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Cytomegalovirus Infection Other Serious 11/10/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Cytomegalovirus Infection Other Serious 11/11/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Transplant Rejection Other Serious 1 Male 11/11/2010 Other Health Professional United States
Primary
Concomitant
Chronic Lymphocytic Leukaemia Transformation Other Serious 67 Male 12/22/2010 Consumer United Kingdom
Primary
Secondary
Off Label Use Death 9/12/2012 Other Health Professional Ca
Primary
Secondary
Concomitant
Venoocclusive Disease Death 9/13/2012 Other Health Professional Ca
Primary
Secondary
Concomitant
Viral Infection Death 11 Male 8/31/2012 Other Health Professional Hk
Primary
Secondary
Concomitant
Respiratory Moniliasis Death Female 9/4/2012 Other Health Professional Se
Primary
Secondary
Off Label Use Death 9/13/2012 Other Health Professional Ca
Primary
Secondary
Concomitant
Viral Infection Other Serious 1 Male 9/5/2012 Other Health Professional Hk
Primary
Secondary
Concomitant
Fungal Sepsis Death 9/6/2012 Other Health Professional Ie
Primary
Concomitant
Bacterial Sepsis Death 9/13/2012 Other Health Professional Ie
Primary
Concomitant
Drug Ineffective Death 2 Male 9/26/2012 Us
Primary
Concomitant
Staphylococcal Infection Hospitalization 10/31/2011 61 Male 212 lb 12/5/2012 Consumer Nl
Primary
Secondary
Concomitant
Hodgkin's Disease Other Serious 57 Male 10/14/2012 Physician Fr
Primary
Secondary
Concomitant
Pneumocystis Jiroveci Pneumonia Other Serious 61 Female 10/10/2012 Other Health Professional Kr
Primary
Secondary
Concomitant
Pneumocystis Jiroveci Pneumonia Other Serious 22 Female 10/10/2012 Other Health Professional Kr
Primary
Secondary
Concomitant
Pneumocystis Jiroveci Pneumonia Other Serious 48 Female 10/10/2012 Other Health Professional Kr
Primary
Secondary
Infection Death 20 10/22/2012 Other Health Professional Gr
Primary
Secondary
Concomitant
Acute Graft Versus Host Disease In Liver Death 58 10/22/2012 Other Health Professional Gr
Primary
Secondary
Concomitant
Graft Versus Host Disease In Lung Death 20 10/22/2012 Other Health Professional Gr
Primary
Secondary
Concomitant
Infection Death 28 10/22/2012 Other Health Professional Gr
Primary
Secondary
Concomitant
Hodgkin's Disease Other Serious 57 Male 10/22/2012 Country Not Specified
Primary
Secondary
Sepsis Death 55 Male 10/29/2012 Physician Us
Primary
Concomitant
Lymphoma Transformation Other Serious 11/23/2012 Other Health Professional Gb
Primary
Secondary
Lymphoma Transformation Other Serious 11/23/2012 Other Health Professional Gb
Primary
Secondary
Infection In An Immunocompromised Host Other Serious 1 Male 12/26/2012 Other Health Professional Hk
Primary
Secondary
Concomitant
Septic Shock Death NotSpecified 1/11/2013 Other Health Professional De
Primary
Secondary
Autoimmune Haemolytic Anaemia Death NotSpecified 1/9/2013 Other Health Professional De
Primary
Secondary
Autoimmune Haemolytic Anaemia Other Serious NotSpecified 1/9/2013 Other Health Professional De
Primary
Secondary
Cytomegalovirus Infection Death NotSpecified 1/9/2013 Other Health Professional De
Primary
Secondary
Cytomegalovirus Infection Death NotSpecified 1/9/2013 Other Health Professional De
Primary
Secondary
Pneumonia Other Serious NotSpecified 1/9/2013 Other Health Professional De
Primary
Secondary
Graft Versus Host Disease Other Serious 54 Male 1/23/2013 Other Health Professional Country Not Specified
Primary
Secondary
Graft Versus Host Disease Other Serious 67 Male 1/23/2013 Other Health Professional Country Not Specified
Primary
Secondary
Respiration Abnormal Life Threatening 55 Male 5/31/2013 Other Health Professional Pt
Primary
Concomitant
Rash Generalised Other Serious 2 NotSpecified 6/20/2013 Other Health Professional Gb
Primary
Concomitant
Pneumonia Cytomegaloviral Other Serious NotSpecified 6/27/2013 Physician De
Primary
Secondary
Concomitant
Sepsis Other Serious NotSpecified 6/27/2013 Physician De
Primary
Secondary
Concomitant
Cytomegalovirus Enteritis Other Serious NotSpecified 6/27/2013 Physician De
Primary
Secondary
Concomitant
Pancytopenia Death NotSpecified 6/27/2013 Physician De
Primary
Secondary
Concomitant
Tuberculosis Other Serious NotSpecified 6/27/2013 Physician De
Primary
Secondary
Concomitant
Post Transplant Lymphoproliferative Disorder Death NotSpecified 6/27/2013 Physician De
Primary
Secondary
Concomitant
Pneumocystis Jirovecii Pneumonia Other Serious 48 Female 6/19/2013 Other Health Professional Kr
Primary
Secondary
Concomitant
Venoocclusive Liver Disease Other Serious 54 Male 10/28/2013 Physician Us
Primary
Secondary
Acute Graft Versus Host Disease 1 NotSpecified 3/28/2013 Us
Primary
Secondary
Concomitant

Drug Data