Fludarabine Phosphate combined with Melphalan

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Oxygen Saturation Decreased Hospitalization 2/27/2006 Male 187 lb 3/8/2006 Other Health Professional United States
Primary
Secondary
Concomitant
Pneumonia Required Intervention 64 Male 6/16/2006 Physician Germany
Primary
Concomitant
Somnolence Death 56 Female 2/16/2007 Germany
Primary
Secondary
Concomitant
Vomiting Death Female 5/4/2007 Other Health Professional United States
Primary
Secondary
Concomitant
Renal Tubular Disorder Death 7 Female 5/24/2007 Physician Italy
Primary
Secondary
Concomitant
Renal Tubular Disorder Other Serious 7 Female 5/30/2007 Physician Italy
Primary
Secondary
Concomitant
Respiratory Disorder Female 110 lb 6/5/2007 Other Health Professional United States
Primary
Secondary
Concomitant
Pericardial Effusion Hospitalization 5/30/2007 Male 199 lb 6/8/2007 Other Health Professional United States
Primary
Secondary
Concomitant
Viral Dna Test Positive Other Serious 7/11/2004 15 Male 73 lb 6/22/2007 Japan
Primary
Secondary
Concomitant
Wrong Technique In Drug Usage Process Other Serious 5/30/2007 Female 31 lb 6/28/2007 Pharmacist United States
Primary
Concomitant
Reversible Posterior Leukoencephalopathy Syndrome Hospitalization 39 Female 7/10/2007 Other Health Professional United States
Primary
Concomitant
Pyrexia Life Threatening 7/8/2007 Male 183 lb 7/12/2007 United States
Primary
Secondary
Concomitant
Ejection Fraction Decreased Hospitalization 7/9/2007 45 Male 152 lb 7/16/2007 Pharmacist United States
Primary
Secondary
Pyrexia Hospitalization 8/3/2007 Female 133 lb 8/6/2007 Other Health Professional United States
Primary
Secondary
Renal Tubular Disorder Other Serious 7 Female 8/14/2007 Physician Italy
Primary
Secondary
Concomitant
Pulmonary Embolism Death Male 178 lb 9/5/2007 Other Health Professional United States
Primary
Secondary
Concomitant
Supraventricular Tachycardia Death 9/8/2007 47 Female 150 lb 9/12/2007 Other Health Professional United States
Primary
Secondary
Concomitant
Viraemia Other Serious 12 Male 9/21/2007 Physician United Kingdom
Primary
Secondary
Concomitant
Pneumonia Parainfluenzae Viral Hospitalization 5/30/2007 45 Male 9/18/2007 Japan
Primary
Concomitant
Stomatitis Other Serious 12 Male 9/26/2007 Japan
Primary
Secondary
Concomitant
Stomatitis Other Serious 6/1/2006 12 Male 10/5/2007 Japan
Primary
Secondary
Concomitant
Renal Failure Acute Other Serious 28 Male 10/15/2007 Consumer Switzerland
Primary
Secondary
Ureaplasma Infection Other Serious 28 Male 10/15/2007 Switzerland
Primary
Secondary
Concomitant
Renal Failure Acute Other Serious 28 Male 10/17/2007
Primary
Secondary
Concomitant
Stem Cell Transplant Life Threatening 10/14/2007 Female 88 lb 10/16/2007 United States
Primary
Secondary
Concomitant
Ureaplasma Infection Hospitalization 28 Male 10/11/2007 Switzerland
Primary
Secondary
Respiratory Failure Death 10/19/2007 Female 110 lb 10/23/2007 Other Health Professional United States
Primary
Secondary
Concomitant
Sepsis Other Serious 58 Female 10/30/2007 Physician United States
Primary
Concomitant
Stem Cell Transplant Death 7/28/2007 65 Male 10/26/2007 Japan
Primary
Concomitant
Febrile Neutropenia Death 10/28/2007 Male 10/30/2007 Other Health Professional United States
Primary
Secondary
Venoocclusive Liver Disease Life Threatening 6/24/2007 14 Female 11/16/2007 Japan
Primary
Concomitant
Ureaplasma Infection Other Serious 28 Male 11/23/2007 Physician Switzerland
Primary
Secondary
Concomitant
Weight Decreased Death 25 Male 11/13/2007 United Kingdom
Primary
Secondary
White Blood Cell Count Decreased Life Threatening 11/24/2007 Female 148 lb 11/27/2007 Other Health Professional United States
Primary
Secondary
Concomitant
Obliterative Bronchiolitis Death 25 Male 12/7/2007 Physician United Kingdom
Primary
Secondary
Weight Decreased Other Serious 25 Male 12/11/2007 Other Health Professional United Kingdom
Primary
Secondary
Stomatitis Other Serious 7/13/2007 32 Female 1/3/2008 Japan
Primary
Concomitant
Vomiting Hospitalization 12/28/2007 Female 197 lb 1/8/2008 United States
Primary
Secondary
Renal Failure Other Serious 12 Male 1/17/2008 Physician Germany
Primary
Secondary
Venoocclusive Disease Other Serious 11 Male 3/5/2008 Japan
Primary
Concomitant
Pulmonary Alveolar Haemorrhage Other Serious 39 Female 3/6/2008 Other Health Professional Japan
Primary
Concomitant
Death Other Serious 4/17/2008 Germany
Primary
Secondary
Respiratory Moniliasis Death 55 Female 4/25/2008 Physician United Kingdom
Primary
Secondary
Drug Toxicity Other Serious 4/9/2008 Germany
Primary
Secondary
Thrombotic Microangiopathy Other Serious 5/22/2008 Japan
Primary
Secondary
Concomitant
Renal Failure Acute Other Serious 5/29/2008 Iceland
Primary
Secondary
Concomitant
Treatment Related Secondary Malignancy Death 5/30/2008 United Kingdom
Primary
Secondary
Concomitant
Renal Failure Acute Other Serious 6/2/2008 Iceland
Primary
Secondary
Concomitant
Treatment Related Secondary Malignancy Death 6/2/2008 United Kingdom
Primary
Secondary
Concomitant
Pyrexia Hospitalization 5/22/2008 58 Male 177 lb 6/4/2008 Other Health Professional United States
Primary
Secondary
Thrombocytopenia Other Serious 6/17/2008 Consumer Czech Republic
Primary
Secondary
Concomitant
Pneumatosis Other Serious 17 Female 6/19/2008 United States
Primary
Secondary
Concomitant
Infection Other Serious 9 Female 6/19/2008 United States
Primary
Secondary
Concomitant
Post Procedural Complication Other Serious 57 Male 6/19/2008 United States
Primary
Secondary
Pneumatosis Other Serious 17 Female 6/19/2008 United States
Primary
Secondary
Concomitant
Infection Other Serious 9 Female 6/19/2008 United States
Primary
Secondary
Concomitant
Chronic Graft Versus Host Disease Other Serious 57 6/26/2008 Other Health Professional Australia
Primary
Secondary
Concomitant
Infection Death 6/26/2008 Spain
Primary
Secondary
Concomitant
Stem Cell Transplant Death 57 Male 6/24/2008 United States
Primary
Secondary
Transplant Failure Other Serious 63 Male 7/1/2008 Japan
Primary
Secondary
Concomitant
Staphylococcal Bacteraemia Other Serious 63 Female 7/1/2008 Japan
Primary
Secondary
Concomitant
Transplant Failure Other Serious 61 Male 7/1/2008 Japan
Primary
Secondary
Concomitant
Transplant Failure Other Serious 59 Female 7/1/2008 Japan
Primary
Secondary
Concomitant
Multi-organ Failure Other Serious 57 Female 7/1/2008 Japan
Primary
Secondary
Concomitant
Pulmonary Toxicity Other Serious 7/3/2008 Germany
Primary
Secondary
Neurotoxicity Death 7/3/2008 Germany
Primary
Secondary
Sepsis Other Serious 7/3/2008 Germany
Primary
Secondary
Venoocclusive Disease Other Serious 7/3/2008 Germany
Primary
Secondary
Pulmonary Toxicity Other Serious 7/7/2008 Germany
Primary
Secondary
Retinal Haemorrhage Other Serious 26 Female 7/11/2008 Other Health Professional Japan
Primary
Secondary
Concomitant
Pyrexia Hospitalization 6/30/2008 45 Male 163 lb 7/16/2008 Physician Spain
Primary
Secondary
Concomitant
Thrombotic Microangiopathy Other Serious 7/21/2008 Other Health Professional Japan
Primary
Concomitant
Visual Acuity Reduced Other Serious 26 Female 7/22/2008 Other Health Professional Japan
Primary
Secondary
Concomitant
Pyrexia Hospitalization 6/30/2008 45 Male 163 lb 7/22/2008 Physician Spain
Primary
Secondary
Concomitant
Guillain-barre Syndrome Other Serious 1/1/2006 61 Male 7/23/2008 Other Health Professional United States
Primary
Secondary
Venoocclusive Disease Other Serious 3 Female 7/24/2008 United States
Primary
Secondary
Concomitant
Pneumonia Cytomegaloviral Other Serious 38 Male 7/24/2008 Other Health Professional Spain
Primary
Secondary
Concomitant
Vomiting Hospitalization 39 Male 7/25/2008 Other Health Professional Germany
Primary
Secondary
Thrombotic Microangiopathy Other Serious 50 Female 8/1/2008 Consumer Japan
Primary
Secondary
Concomitant
Multi-organ Failure Other Serious 57 Female 8/7/2008 Japan
Primary
Secondary
Concomitant
Staphylococcal Bacteraemia Other Serious 63 Female 8/7/2008 Japan
Primary
Secondary
Concomitant
Transplant Failure Other Serious 59 Female 8/7/2008 Japan
Primary
Secondary
Concomitant
Transplant Failure Other Serious 63 Male 8/7/2008 Japan
Primary
Secondary
Concomitant
Transplant Failure Other Serious 61 Male 8/7/2008 Japan
Primary
Secondary
Concomitant
Thrombotic Microangiopathy Other Serious 50 Female 8/7/2008 Physician Japan
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
Sinus Disorder Other Serious 62 Male 9/23/2008 Other Health Professional United Kingdom
Primary
Concomitant
Sepsis Other Serious 45 Male 9/26/2008 Other Health Professional United States
Primary
Concomitant
Infection Death 51 6/14/2008 Other Health Professional Australia
Primary
Secondary
Concomitant
Renal Failure Other Serious 12 Male 9/27/2008 Physician United States
Primary
Secondary
Concomitant
Renal Failure Other Serious 29 Female 9/27/2008 Physician United States
Primary
Secondary
Concomitant
Ventricular Dysfunction Hospitalization 9/28/2008 Male 200 lb 10/6/2008 Consumer United States
Primary
Secondary
Concomitant
Obstructive Airways Disorder Death 62 Male 10/10/2008 Consumer United Kingdom
Primary
Secondary
Thrombocytopenia Other Serious 8/1/2008 43 Male 10/8/2008 Other Health Professional Spain
Primary
Concomitant
Septic Shock Other Serious 8/1/2008 58 Male 123 lb 10/16/2008 Physician Spain
Primary
Secondary
Concomitant
Septic Shock Other Serious 8/1/2008 58 Male 123 lb 10/17/2008 Physician Spain
Primary
Secondary
Concomitant
Thrombocytopenia Other Serious 0 Male 10/21/2008 Other Health Professional Poland
Primary
Concomitant
Tachycardia Other Serious 8/1/2008 Male 10/22/2008 Other Health Professional Spain
Primary
Concomitant
Thrombocytopenia Other Serious 0 Male 10/31/2008 Other Health Professional Poland
Primary
Concomitant
Pneumonia Cytomegaloviral Death 9 10/31/2008 Other Health Professional United States
Primary
Concomitant
Renal Failure Life Threatening 17 Female 11/3/2008 Other Health Professional Austria
Primary
Secondary
Concomitant
Thrombocytopenia Hospitalization 9/9/2008 43 Male 10/30/2008 Other Health Professional Spain
Primary
Concomitant
Weight Increased Other Serious 43 Female 11/11/2008 Other Health Professional Japan
Primary
Secondary
Concomitant
Visual Acuity Reduced Other Serious 6/1/2007 26 Female 11/18/2008 Other Health Professional Japan
Primary
Concomitant
Visual Acuity Reduced Other Serious 6/1/2007 26 Female 11/18/2008 Other Health Professional Japan
Primary
Concomitant
Splenectomy Hospitalization 7 Female 11/24/2008
Primary
Secondary
Concomitant
Vomiting Hospitalization 10/31/2008 Male 165 lb 11/14/2008 Other Health Professional United States
Primary
Secondary
Concomitant
Weight Increased Other Serious 11/26/2007 43 Female 11/26/2008 Other Health Professional Japan
Primary
Secondary
Concomitant
Weight Increased Other Serious 11/26/2007 43 Female 11/26/2008 Other Health Professional Japan
Primary
Secondary
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
Reversible Posterior Leukoencephalopathy Syndrome Other Serious 4 Female 12/2/2008 Other Health Professional Japan
Primary
Concomitant
Respiratory Disorder Death 43 Female 12/2/2008 Japan
Primary
Concomitant
Myelodysplastic Syndrome Other Serious 53 Female 12/10/2008 Other Health Professional Australia
Primary
Secondary
Concomitant
Staphylococcal Infection Other Serious 11/5/2008 63 Male 12/4/2008 Other Health Professional Spain
Primary
Concomitant
Rash Papular Other Serious 17 Female 12/15/2008 Other Health Professional United States
Primary
Secondary
Sinusitis Hospitalization 1/1/2007 60 Male 143 lb 12/16/2008 Physician Spain
Primary
Secondary
Concomitant
Sinusitis Hospitalization 1/1/2007 60 Male 143 lb 12/19/2008 Physician Spain
Primary
Secondary
Concomitant
Pseudomembranous Colitis Other Serious 43 Male 12/22/2008 Other Health Professional Japan
Primary
Secondary
Thrombotic Microangiopathy Hospitalization 70 Male 12/30/2008 Other Health Professional Japan
Primary
Secondary
Concomitant
Pseudomembranous Colitis Other Serious 43 Male 12/30/2008 Other Health Professional Japan
Primary
Secondary
Respiratory Failure Life Threatening 7/2/2008 60 Female 174 lb 12/31/2008 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Immune System Disorder Other Serious 65 Female 12/22/2008 Physician United States
Primary
Secondary
Concomitant
Meningoencephalitis Herpetic Other Serious 4 Male 1/5/2009 Other Health Professional Japan
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
Thrombotic Microangiopathy Other Serious 54 Male 1/15/2009 Physician Japan
Primary
Secondary
Thrombotic Microangiopathy Other Serious 11/1/2007 54 Male 1/20/2009 Physician Japan
Primary
Secondary
Neuropathy Peripheral Other Serious 12 Female 1/22/2009 United States
Primary
Secondary
Thrombotic Microangiopathy Other Serious 70 Male 1/26/2009 Other Health Professional Japan
Primary
Secondary
Concomitant
Neuropathy Peripheral Other Serious 12 Female 1/28/2009 United States
Primary
Secondary
Staphylococcal Infection Other Serious 11/5/2008 63 Male 1/26/2009 Other Health Professional Spain
Primary
Concomitant
Thrombotic Microangiopathy Other Serious 11/17/2007 54 Male 2/2/2009 Physician Japan
Primary
Secondary
Concomitant
Death 6/18/2008 Germany
Primary
Secondary
Septic Shock Other Serious 8/18/2008 58 Male 132 lb 3/3/2009 Physician Spain
Primary
Secondary
Concomitant

Drug Data