Fludarabine Phosphate combined with Thiotepa

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Septic Shock Death 12/28/2005 64 Male 1/30/2006 Germany
Primary
Concomitant
Renal Impairment Other Serious 8/15/2005 21 Male 88 lb 3/10/2006 Japan
Primary
Concomitant
Cryptogenic Organising Pneumonia Hospitalization 7/28/2007 Female 121 lb 7/30/2007 Other Health Professional United States
Primary
Secondary
Vomiting Death 2/25/2007 13 Female 8/1/2007 Japan
Primary
Concomitant
Fatigue Death 8/2/2007 Female 8/3/2007 Other Health Professional United States
Primary
Secondary
Tachycardia Hospitalization 8/16/2007 Female 160 lb 8/21/2007 Other Health Professional United States
Primary
Secondary
Pulmonary Oedema Death 11/21/2007 Female 195 lb 11/21/2007 Other Health Professional United States
Primary
Secondary
Pulmonary Embolism Hospitalization 11/19/2007 Female 195 lb 11/21/2007 Other Health Professional United States
Primary
Secondary
Death Other Serious 4/17/2008 Germany
Primary
Secondary
Pulmonary Oedema Life Threatening 4/16/2008 Male 4/17/2008 Other Health Professional United States
Primary
Secondary
Concomitant
Tuberculosis Hospitalization 4/17/2008 Male 4/24/2008 Other Health Professional United States
Primary
Secondary
Concomitant
Renal Failure Death 4/26/2008 Male 143 lb 4/28/2008 Other Health Professional United States
Primary
Secondary
Concomitant
Thrombotic Microangiopathy Other Serious 5/22/2008 Japan
Primary
Secondary
Concomitant
Tubulointerstitial Nephritis Other Serious 50 Female 5/28/2008 United States
Primary
Secondary
Unresponsive To Stimuli Life Threatening 6/5/2008 Male 6/13/2008 Other Health Professional United States
Primary
Secondary
Concomitant
Oral Herpes Other Serious 16 Female 6/18/2008 Other Health Professional Germany
Primary
Secondary
Concomitant
Viral Haemorrhagic Cystitis Other Serious 7/1/2008 Other Health Professional Germany
Primary
Secondary
Concomitant
Pseudomonas Infection Other Serious 7/3/2008 Italy
Primary
Secondary
Concomitant
Renal Failure Death 6/22/2008 Male 132 lb 6/23/2008 Other Health Professional United States
Primary
Secondary
Concomitant
Pulmonary Sepsis Life Threatening 6/1/2004 51 Male 7/7/2008 Other Health Professional Italy
Primary
Secondary
Concomitant
Pyrexia Hospitalization 6/30/2008 45 Male 163 lb 7/16/2008 Physician Spain
Primary
Secondary
Concomitant
Venoocclusive Liver Disease Death 7/11/2008 Male 180 lb 7/14/2008 Other Health Professional United States
Primary
Secondary
Pyrexia Hospitalization 6/30/2008 45 Male 163 lb 7/22/2008 Physician Spain
Primary
Secondary
Concomitant
Fungal Infection Other Serious 9/10/2008 Other Health Professional Italy
Primary
Secondary
Stomatitis Other Serious 9/11/2008 Germany
Primary
Secondary
Sepsis Other Serious 17 Male 9/11/2008 Other Health Professional Germany
Primary
Secondary
Progressive Multifocal Leukoencephalopathy Other Serious 9/12/2008 Germany
Primary
Secondary
Stomatitis Other Serious 9/12/2008 Germany
Primary
Secondary
Stomatitis Other Serious 9/12/2008 Germany
Primary
Secondary
Infection Other Serious 44 Male 181 lb 9/15/2008 United States
Primary
Concomitant
Stomatitis Other Serious 9/15/2008 Germany
Primary
Secondary
Progressive Multifocal Leukoencephalopathy Other Serious 9/15/2008 Germany
Primary
Secondary
Rash Hospitalization 6/30/2008 45 Male 163 lb 9/17/2008 Physician Spain
Primary
Secondary
Concomitant
Thrombocytopenia Other Serious 8/1/2008 43 Male 10/8/2008 Other Health Professional Spain
Primary
Concomitant
Thrombocytopenia Hospitalization 9/9/2008 43 Male 10/30/2008 Other Health Professional Spain
Primary
Concomitant
Haemoglobin Decreased Hospitalization 11/5/2008 63 Male 11/20/2008 Other Health Professional Spain
Primary
Concomitant
Surgical Procedure Repeated Other Serious 15 Male 11/27/2008 Physician United States
Primary
Secondary
Concomitant
Unresponsive To Stimuli Other Serious 14 Male 11/27/2008 Physician United States
Primary
Secondary
Concomitant
Nervous System Disorder Other Serious 12 Female 11/27/2008 Physician United States
Primary
Secondary
Staphylococcal Infection Other Serious 11/5/2008 63 Male 12/4/2008 Other Health Professional Spain
Primary
Concomitant
Stem Cell Transplant Other Serious 12 Female 12/2/2008 Physician United States
Primary
Secondary
Rash Papular Other Serious 17 Female 12/15/2008 Other Health Professional United States
Primary
Secondary
Treatment Failure Other Serious 15 Male 12/23/2008 Other Health Professional United States
Primary
Secondary
Renal Impairment Life Threatening 12/23/2008 Male 176 lb 12/29/2008 Other Health Professional United States
Primary
Secondary
Concomitant
Spinal Disorder Other Serious 12 Female 1/6/2009 Other Health Professional United States
Primary
Secondary
Stem Cell Transplant Other Serious 12 Female 1/6/2009 Physician United States
Primary
Secondary
Myelitis Transverse Other Serious 14 Male 1/9/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Myelitis Transverse Other Serious 15 Male 1/9/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Spinal Disorder Other Serious 12 Female 1/9/2009 United States
Primary
Secondary
Spinal Cord Disorder Other Serious 12 Female 1/14/2009 Other Health Professional United States
Primary
Secondary
Neuropathy Peripheral Other Serious 12 Female 1/22/2009 United States
Primary
Secondary
Neuropathy Peripheral Other Serious 12 Female 1/28/2009 United States
Primary
Secondary
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
Staphylococcal Infection Other Serious 11/5/2008 63 Male 1/26/2009 Other Health Professional Spain
Primary
Concomitant
Death 6/18/2008 Germany
Primary
Secondary
Pneumonia Cytomegaloviral Death 3/5/2009 Other Health Professional United States
Primary
Concomitant
Renal Failure Other Serious 1/27/2009 59 Male 2/25/2009 Other Health Professional Spain
Primary
Concomitant
Neuropathy Peripheral Hospitalization 1/1/2008 12 Female 3/6/2009 Other Health Professional United States
Primary
Secondary
Thrombocytopenia Other Serious 1/27/2009 60 Male 163 lb 3/18/2009 Physician Spain
Primary
Secondary
Concomitant
Neutropenia Other Serious 3/9/2009 3/24/2009 Physician Spain
Primary
Secondary
Neutropenic Colitis Life Threatening 3/22/2009 Male 187 lb 3/23/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Staphylococcal Infection Other Serious 2/1/2009 59 Male 3/26/2009 Other Health Professional Spain
Primary
Concomitant
Sepsis Life Threatening 1/2/2009 Male 4/9/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Respiratory Distress Hospitalization 4/23/2009 Male 187 lb 4/23/2009 Consumer United States
Primary
Secondary
Concomitant
Tracheal Haemorrhage Death 5/2/2009 Male 176 lb 5/4/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Pneumonia Parainfluenzae Viral Death 5/4/2009 Male 187 lb 5/4/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Drug Toxicity Other Serious 6/23/2009 Consumer Thailand
Primary
Secondary
Tuberculosis Other Serious 12/1/2007 19 Male 7/3/2009 Other Health Professional Brazil
Primary
Secondary
Concomitant
Tuberculosis Other Serious 12/1/2007 19 Male 7/7/2009 Consumer United Kingdom
Primary
Secondary
Concomitant
Thrombotic Microangiopathy Death Unknown 9/9/2009 Germany
Primary
Secondary
Concomitant
Respiratory Failure Death 12/8/2009 29 Female 1/13/2010 Physician Italy
Primary
Secondary
Transplant Failure Death 1 1/14/2010 Germany
Primary
Concomitant
Vitritis Other Serious 0 Female 3/26/2010 Austria
Primary
Secondary
Concomitant
Nephropathy Toxic Other Serious 4/1/2010 United States
Primary
Secondary
Concomitant
Nephropathy Toxic Other Serious 4/6/2010 United States
Primary
Secondary
Concomitant
Pancytopenia Other Serious 3 Male 4/26/2010 Israel
Primary
Concomitant
Intracranial Hypotension Hospitalization 2/23/2010 51 Male 5/12/2010 Physician United States
Primary
Secondary
Concomitant
Pancytopenia Other Serious 3 Male 5/14/2010 Israel
Primary
Concomitant
Venoocclusive Liver Disease Other Serious 8/30/2010 Physician Italy
Primary
Concomitant
Unevaluable Event Other Serious Male 8/30/2010 Physician Italy
Primary
Concomitant
Malignant Neoplasm Progression Death 9/22/2010 Physician Spain
Primary
Concomitant
Malignant Neoplasm Progression Death 9/22/2010 Physician Spain
Primary
Concomitant
Mucosal Inflammation Other Serious 9 Female 9/30/2010 Physician Italy
Primary
Concomitant
Graft Versus Host Disease Death 10/20/2010 Physician Italy
Primary
Concomitant
Vulvovaginitis Other Serious 10/20/2010 Physician Italy
Primary
Concomitant
Sepsis Other Serious 14 Male 10/20/2010 Physician Italy
Primary
Concomitant
Ureteric Stenosis Death 10/20/2010 Physician Italy
Primary
Concomitant
Death Death Female 11/16/2010 Physician Italy
Primary
Concomitant
Venoocclusive Liver Disease Other Serious 10/21/2010 6 Female 12/8/2010 Physician United States
Primary
Concomitant
Enterococcal Sepsis Death 11 Female 12/17/2010 Physician Italy
Primary
Secondary
Concomitant
Pancytopenia Death 11 Female 12/21/2010 United States
Primary
Secondary
Concomitant
Venoocclusive Liver Disease Death 3/1/2007 22 Female 99 lb 12/29/2010 Physician Japan
Primary
Secondary
Concomitant
Staphylococcal Sepsis Death 3/1/2007 22 Female 99 lb 1/17/2011 Physician Japan
Primary
Secondary
Concomitant
Circulatory Collapse Death 3/1/2007 22 Female 99 lb 2/16/2011 Physician Japan
Primary
Secondary
Concomitant
Venoocclusive Liver Disease Death 3/1/2007 22 Female 99 lb 4/28/2011 Physician Japan
Primary
Secondary
Concomitant
Thrombocytopenia Hospitalization 9/9/2009 19 Female 4/29/2011 Physician United States
Primary
Concomitant
Neoplasm Malignant Death 5 6/25/2011 Other Health Professional Korea, Republic Of
Primary
Concomitant
Stem Cell Transplant Death 5/8/2009 18 Female 115 lb 7/15/2011 Physician Japan
Primary
Concomitant
Multi-organ Failure Death 3/1/2007 22 Female 99 lb 8/18/2011 Physician Japan
Primary
Secondary
Concomitant
Haemolysis Other Serious 29 Female 9/21/2011 Other Health Professional Germany
Primary
Concomitant
Posterior Reversible Encephalopathy Syndrome Death 16 Female 10/17/2011 Other Health Professional Italy
Primary
Concomitant
Infection Other Serious 10 Male 11/9/2011 Physician Japan
Primary
Concomitant
Graft Versus Host Disease Death 17 Female 12/12/2011 Physician United States
Primary
Secondary
Concomitant
Pancreatitis Acute Death 5 Male 12/9/2011 Physician Japan
Primary
Concomitant
Graft Versus Host Disease Death 17 Female 12/8/2011 Physician United States
Primary
Secondary
Concomitant
Leukaemia Recurrent Death 22 Female 12/8/2011 Physician United States
Primary
Secondary
Concomitant
Pyrexia Other Serious 8 Male 1/24/2012 Other Health Professional Italy
Primary
Concomitant
Respiratory Distress Other Serious 1 Male 2/1/2012 Other Health Professional France
Primary
Concomitant
Pleural Effusion Other Serious 4 Male 2/7/2012 Other Health Professional Israel
Primary
Concomitant
Chronic Graft Versus Host Disease Other Serious Male 2/21/2012 Physician Japan
Primary
Concomitant
Hepatitis Other Serious 6 Male 2/21/2012 Physician Japan
Primary
Concomitant
Radiculopathy Hospitalization 55 Male 3/14/2012 Other Health Professional United Kingdom
Primary
Concomitant
Death Death 54 Male 3/19/2012 Other Health Professional United Kingdom
Primary
Concomitant
Cytomegalovirus Infection Death 30 Female 3/19/2012 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
General Physical Health Deterioration Death 65 Male 3/21/2012 Other Health Professional United Kingdom
Primary
Concomitant
Encephalitis Cytomegalovirus Death 65 Male 3/29/2012 Other Health Professional United States
Primary
Secondary
Lymphatic Disorder Other Serious 34 Female 4/12/2012 Spain
Primary
Concomitant
Lymphatic Disorder Other Serious 24 Female 4/12/2012 Other Health Professional Spain
Primary
Concomitant
Cns Ventriculitis Death 65 Male 4/16/2012 Physician United States
Primary
Secondary
Confusional State Death 55 Male 5/9/2012 Other Health Professional United Kingdom
Primary
Concomitant
Acute Myeloid Leukaemia Recurrent Death 15 Male 5/16/2012 Other Health Professional Uruguay
Primary
Concomitant
Acute Graft Versus Host Disease Death 1 Male 5/16/2012 Other Health Professional Uruguay
Primary
Concomitant
Pneumonia Cytomegaloviral Death 9 Male 5/16/2012 Other Health Professional Uruguay
Primary
Concomitant
Acute Lymphocytic Leukaemia Recurrent Death 5 Female 5/16/2012 Other Health Professional Uruguay
Primary
Concomitant
Chronic Graft Versus Host Disease Other Serious 17 Female 5/16/2012 Other Health Professional Uruguay
Primary
Concomitant
Acute Lymphocytic Leukaemia Recurrent Other Serious 5 Male 5/16/2012 Other Health Professional Uruguay
Primary
Concomitant
Transplant Rejection Death 5 Male 5/16/2012 Other Health Professional Uruguay
Primary
Concomitant
Acute Graft Versus Host Disease Death 1 Male 5/16/2012 Other Health Professional Uruguay
Primary
Concomitant
Transplant Rejection Death 5 Male 5/16/2012 Other Health Professional Uruguay
Primary
Concomitant
Sepsis Other Serious 5/21/2012 Other Health Professional Germany
Primary
Concomitant
Stupor Other Serious 5/21/2012 Other Health Professional Germany
Primary
Concomitant
Sepsis Other Serious 5/21/2012 Other Health Professional Germany
Primary
Concomitant
Stupor Death 5/21/2012 Other Health Professional Germany
Primary
Concomitant
Graft Versus Host Disease In Intestine Death 5/24/2012 Other Health Professional Germany
Primary
Concomitant
Graft Versus Host Disease In Intestine Death Male 5/24/2012 Other Health Professional Germany
Primary
Concomitant
Neurological Symptom Other Serious 5/24/2012 Other Health Professional Germany
Primary
Concomitant
Disease Progression Death Male 5/24/2012 Other Health Professional Germany
Primary
Concomitant
Graft Versus Host Disease In Intestine Death 5/24/2012 Other Health Professional Germany
Primary
Concomitant
Infection Death Unknown 5/14/2012 Other Health Professional United States
Primary
Secondary
Pancreatitis Acute Other Serious Unknown 5/14/2012 Other Health Professional United States
Primary
Secondary
Dialysis Required Intervention Male 5/14/2012 Consumer United States
Primary
Secondary
Decerebration Death 18 Male 6/13/2012 Other Health Professional Italy
Primary
Concomitant
Graft Versus Host Disease In Skin Other Serious 18 Male 6/13/2012 Other Health Professional Italy
Primary
Concomitant
Generalised Oedema Other Serious 4 Male 6/13/2012 Physician Israel
Primary
Secondary
Locked-in Syndrome Life Threatening 58 Female 7/2/2012 Other Health Professional United States
Primary
Concomitant
Brain Oedema Death 1 Male 7/10/2012 Other Health Professional Italy
Primary
Concomitant
Status Epilepticus Death 16 Female 7/11/2012 Other Health Professional Italy
Primary
Concomitant
Status Epilepticus Other Serious 1 Male 7/16/2012 Physician Italy
Primary
Secondary
Concomitant
Pericarditis Hospitalization 9 Female 7/24/2012 Physician Israel
Primary
Secondary
Concomitant

Drug Data