Fludara combined with Thymoglobulin

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Status Epilepticus Hospitalization 2/1/2006 58 Male 4/13/2006 France
Primary
Concomitant
Pyrexia Death 12/24/2006 29 Female 112 lb 1/11/2007 Israel
Primary
Concomitant
Haemolytic Anaemia Other Serious 1 Male 11/8/2007 Pharmacist Canada
Primary
Secondary
Concomitant
Renal Failure Life Threatening 1/21/2008 24 Female 4/8/2008 Other Health Professional France
Primary
Secondary
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
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
Complications Of Bone Marrow Transplant Death 8/29/2008 Germany
Primary
Secondary
Concomitant
Complications Of Bone Marrow Transplant Death 8/29/2008 Germany
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
Subarachnoid Haemorrhage Hospitalization 11/1/2008 56 Female 1/28/2009 Consumer France
Primary
Secondary
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 Hospitalization 11/25/2008 62 Female 163 lb 1/28/2009 Other Health Professional France
Primary
Concomitant
Subarachnoid Haemorrhage Hospitalization 11/1/2008 56 Female 2/9/2009 Consumer France
Primary
Secondary
Epstein-barr Virus Associated Lymphoproliferative Disorder Other Serious 1/11/2009 1 Male 15 lb 7/30/2009 Physician Japan
Primary
Secondary
Concomitant
Epstein-barr Virus Associated Lymphoproliferative Disorder Other Serious 1/11/2009 1 Male 15 lb 9/25/2009 Physician Japan
Primary
Secondary
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
Hepatitis Fulminant Other Serious 58 Female 12/7/2009 Other Health Professional Japan
Primary
Secondary
Concomitant
Staphylococcal Infection Other Serious 9/29/2009 58 Male 12/16/2009 Other Health Professional France
Primary
Concomitant
Hepatitis Fulminant Other Serious 58 Female 2/9/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Pyrexia Hospitalization 3/12/2010 59 Male 132 lb 7/16/2010 Physician Japan
Primary
Concomitant
Pyrexia Other Serious 3/12/2010 59 Male 132 lb 7/19/2010 Physician Japan
Primary
Secondary
Concomitant
Hepatitis Fulminant Other Serious 58 Female 7/27/2010 Other Health Professional 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
Stem Cell Transplant Death 5/1/2009 18 Female 110 lb 8/18/2010 Physician Japan
Primary
Concomitant
Renal Failure Other Serious 1/1/2009 62 Female 88 lb 8/18/2010 Physician Japan
Primary
Concomitant
Stem Cell Transplant Death 5/19/2009 53 Female 101 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
Therapeutic Response Decreased Other Serious 58 Female 10/6/2010 Physician Japan
Primary
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
Rash Papular Other Serious 7/15/2010 57 Female 11/10/2010 Physician Germany
Primary
Secondary
Concomitant
Sepsis Other Serious 5/26/2009 7 Female 29 lb 11/11/2010 Physician Japan
Primary
Secondary
Concomitant
Rhinovirus Infection Hospitalization 1/1/2010 60 Male 159 lb 11/12/2010 Physician Germany
Primary
Secondary
Concomitant
Pyrexia Other Serious 1/30/2009 3 Female 31 lb 11/12/2010 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
Cytomegalovirus Infection Other Serious 7/17/2009 28 Male 110 lb 11/24/2010 Physician Japan
Primary
Secondary
Concomitant
Rash Other Serious 6/10/2010 2 Female 24 lb 11/24/2010 Physician Japan
Primary
Secondary
Concomitant
Pyrexia Life Threatening Male 112 lb 11/24/2010 Physician Japan
Primary
Secondary
Concomitant
Neoplasm Malignant Other Serious 3/1/2009 54 Male 152 lb 11/24/2010 Physician Japan
Primary
Secondary
Concomitant
Shock Haemorrhagic Other Serious 4/23/2009 54 Female 115 lb 11/12/2010 Physician Japan
Primary
Concomitant
Mouth Haemorrhage Death 4/25/2009 4 Female 32 lb 12/8/2010 Physician Japan
Primary
Secondary
Concomitant
Hyperbilirubinaemia Other Serious 4/20/2010 24 Male 12/9/2010 Other Health Professional Spain
Primary
Secondary
Staphylococcal Sepsis Other Serious 8/18/2009 13 Male 97 lb 12/10/2010 Physician Japan
Primary
Secondary
Concomitant
Transplant Failure Other Serious 16 Female 12/13/2010 Other Health Professional Russian Federation
Primary
Secondary
Concomitant
Transplant Failure Other Serious 12 Male 12/13/2010 Other Health Professional Russian Federation
Primary
Secondary
Concomitant
Sepsis Other Serious 15 Male 12/13/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Enterocolitis Other Serious 12 Male 12/13/2010 Other Health Professional Russian Federation
Primary
Secondary
Concomitant
Histiocytosis Haematophagic Other Serious 11 Male 12/13/2010 Other Health Professional Russian Federation
Primary
Secondary
Concomitant
Hiccups Death 7/30/2010 49 Male 110 lb 12/17/2010 Physician Japan
Primary
Secondary
Concomitant
Graft Versus Host Disease Other Serious 16 Female 12/20/2010 Other Health Professional Russian Federation
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 Recurrent Death 8/6/2010 67 Female 110 lb 1/7/2011 Physician Japan
Primary
Secondary
Concomitant
Acute Graft Versus Host Disease In Intestine Death 1/1/2010 52 Female 143 lb 1/10/2011 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
Respiratory Failure Other Serious 1/1/2009 61 Female 88 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
Pneumonia Death 10/26/2009 59 Male 121 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
Blood Bilirubin Increased Other Serious 11/29/2010 46 Female 1/21/2011 Other Health Professional France
Primary
Secondary
Concomitant
Infection Death 4/25/2009 4 Female 32 lb 1/24/2011 Physician Japan
Primary
Secondary
Concomitant
Disorientation Death 4/13/2009 52 Male 117 lb 1/10/2011 Physician Japan
Primary
Concomitant
Cardiac Failure Congestive Other Serious 4/22/2009 62 Female 88 lb 1/11/2011 Physician Japan
Primary
Concomitant
Pancreatitis Acute Other Serious 12/3/2010 46 Female 1/25/2011 Other Health Professional France
Primary
Secondary
Concomitant
Pancreatitis Acute Other Serious 12/3/2010 46 Female 1/26/2011 Physician France
Primary
Secondary
Concomitant
Sepsis Death 8/27/2010 57 Male 130 lb 1/31/2011 Physician Japan
Primary
Secondary
Concomitant
Haematological Malignancy Death 2/7/2011 Physician France
Primary
Secondary
Concomitant
Epstein-barr Virus Associated Lymphoproliferative Disorder Death 2/7/2011 Physician United States
Primary
Secondary
Infection Other Serious 2/7/2011 Physician Germany
Primary
Secondary
Concomitant
Shock Hospitalization 1/12/2011 5 Female 35 lb 2/8/2011 Other Health Professional Korea, Republic Of
Primary
Secondary
Concomitant
Acute Graft Versus Host Disease Other Serious 19 Female 2/9/2011 Physician Sweden
Primary
Secondary
Concomitant
Subarachnoid Haemorrhage Other Serious 16 Female 2/9/2011 Physician Japan
Primary
Secondary
Concomitant
Acute Graft Versus Host Disease Other Serious 3 Female 2/9/2011 Physician Japan
Primary
Secondary
Concomitant
Acute Graft Versus Host Disease Other Serious 18 Male 2/9/2011 Physician Sweden
Primary
Secondary
Concomitant
Toxicity To Various Agents Death 12 Male 2/10/2011 Physician Japan
Primary
Secondary
Concomitant
Subarachnoid Haemorrhage Other Serious 16 Female 2/10/2011 Physician Japan
Primary
Secondary
Concomitant
Acute Graft Versus Host Disease Other Serious 3 Female 2/10/2011 Physician Japan
Primary
Secondary
Concomitant
Transplant Failure Other Serious 9 Female 2/10/2011 Physician Japan
Primary
Secondary
Concomitant
Acute Graft Versus Host Disease Other Serious 19 Male 2/10/2011 Physician Japan
Primary
Secondary
Concomitant
Acute Graft Versus Host Disease Other Serious 12 Male 2/10/2011 Physician Japan
Primary
Secondary
Concomitant
Acute Graft Versus Host Disease Other Serious 6 Male 2/10/2011 Physician Japan
Primary
Secondary
Concomitant
Acute Graft Versus Host Disease Other Serious 37 Female 2/10/2011 Physician Japan
Primary
Secondary
Concomitant
Transplant Failure Other Serious 24 Male 2/11/2011 Physician United States
Primary
Secondary
Concomitant
Acute Graft Versus Host Disease Other Serious Female 2/11/2011 Physician Japan
Primary
Secondary
Concomitant
Venoocclusive Liver Disease Other Serious 2/11/2011 Physician Australia
Primary
Secondary
Concomitant
Fungal Infection Hospitalization 6/24/2009 15 Male 126 lb 2/14/2011 Consumer Japan
Primary
Concomitant
Human Herpesvirus 6 Infection Hospitalization 3/27/2010 23 Male 117 lb 2/14/2011 Physician Japan
Primary
Secondary
Concomitant
Infection Other Serious 2/16/2011 Physician United States
Primary
Secondary
Cytokine Release Syndrome Hospitalization 1/12/2011 5 Female 35 lb 2/17/2011 Other Health Professional Korea, Republic Of
Primary
Secondary
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
Transplant Failure Other Serious 2/18/2011 Physician United States
Primary
Secondary
Concomitant
Chronic Graft Versus Host Disease Other Serious 72 Male 2/18/2011 Physician Brazil
Primary
Secondary
Concomitant
Cytomegalovirus Test Positive Hospitalization Female 66 lb 2/18/2011 Physician Japan
Primary
Secondary
Concomitant
Chronic Graft Versus Host Disease Other Serious 29 Female 2/18/2011 Physician Brazil
Primary
Secondary
Concomitant
Pneumonia Bacterial Other Serious 7/19/2010 32 Female 108 lb 2/18/2011 Physician Japan
Primary
Secondary
Concomitant
Multi-organ Failure Death Female 2/22/2011 Physician United States
Primary
Secondary
Epstein-barr Virus Associated Lymphoproliferative Disorder Other Serious 8 Male 2/22/2011 Physician Canada
Primary
Secondary
Concomitant
Neoplasm Malignant Death 8 Female 2/22/2011 Physician Canada
Primary
Secondary
Concomitant
Chronic Graft Versus Host Disease Other Serious 2/22/2011 Physician Tunisia
Primary
Secondary
Concomitant
Neoplasm Malignant Death 6 Male 2/22/2011 Physician Canada
Primary
Secondary
Concomitant
Neoplasm Malignant Death 1 Male 2/22/2011 Physician Canada
Primary
Secondary
Concomitant
Cytomegalovirus Infection Death 9 Male 2/22/2011 Physician Canada
Primary
Secondary
Concomitant
Hypotension Life Threatening 1/22/2011 2/22/2011 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Neoplasm Malignant Death 18 Male 2/22/2011 Physician Canada
Primary
Secondary
Concomitant
Pneumonia Cytomegaloviral Death 10/15/2010 7 Female 42 lb 2/23/2011 Physician Japan
Primary
Secondary
Concomitant
Hepatitis Acute Other Serious 2/14/2011 2/23/2011 Physician France
Primary
Secondary
Concomitant
Neoplasm Malignant Death 27 Male 2/23/2011 Physician United States
Primary
Secondary
Concomitant
Neoplasm Malignant Death 34 Female 2/23/2011 Physician United States
Primary
Secondary
Concomitant
Renal Impairment Other Serious 12 Female 2/25/2011 Physician United States
Primary
Secondary
Concomitant
Renal Failure Acute Hospitalization 1/16/2011 18 Female 2/28/2011 Other Health Professional Switzerland
Primary
Secondary
Concomitant
Thrombocytopenia Other Serious 21 Female 3/1/2011 Other Health Professional Germany
Primary
Concomitant
Granulocytopenia Other Serious 2 Female 3/1/2011 Other Health Professional Germany
Primary
Secondary
Concomitant
Acute Graft Versus Host Disease Death Male 3/2/2011 Physician Israel
Primary
Secondary
Concomitant
Herpes Simplex Hepatitis Other Serious 9/1/2007 49 Male 3/3/2011 Other Health Professional Germany
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
Multi-organ Failure Death 3/4/2011 Physician Lebanon
Primary
Secondary
Concomitant
Sepsis Death 3/4/2011 Physician Lebanon
Primary
Secondary
Concomitant
Disease Recurrence Death 3/4/2011 Physician Lebanon
Primary
Secondary
Concomitant
Acute Graft Versus Host Disease Other Serious 3/4/2011 Physician Lebanon
Primary
Secondary
Concomitant
Graft Versus Host Disease Death 3/4/2011 Physician Lebanon
Primary
Secondary
Concomitant
Graft Versus Host Disease Death 3/7/2011 Physician Canada
Primary
Secondary
Concomitant
Acute Respiratory Distress Syndrome Death 3/7/2011 Physician Canada
Primary
Secondary
Concomitant
Graft Versus Host Disease Death 3/7/2011 Physician Canada
Primary
Secondary
Concomitant
Pneumonia Death 3/7/2011 Physician Canada
Primary
Secondary
Concomitant
Graft Versus Host Disease Death 3/7/2011 Physician Canada
Primary
Secondary
Concomitant
Graft Versus Host Disease Death 3/7/2011 Physician Canada
Primary
Secondary
Concomitant
Cardiac Arrest Death 3/7/2011 Physician Canada
Primary
Secondary
Concomitant
Graft Versus Host Disease Death 3/7/2011 Physician Canada
Primary
Secondary
Concomitant
Graft Versus Host Disease Death 3/7/2011 Physician Canada
Primary
Secondary
Concomitant
Haemolytic Anaemia Death 3/7/2011 Physician Canada
Primary
Secondary
Concomitant
Graft Versus Host Disease Death 3/7/2011 Physician Canada
Primary
Secondary
Concomitant
Venoocclusive Disease Death 3/7/2011 Physician Canada
Primary
Secondary
Concomitant
Sudden Death Death 3/7/2011 Physician Canada
Primary
Secondary
Concomitant
Haemolytic Uraemic Syndrome Death 3/7/2011 Physician Canada
Primary
Secondary
Concomitant
Parainfluenzae Virus Infection Death 3/7/2011 Physician Canada
Primary
Secondary
Concomitant

Drug Data