Melphalan combined with Methotrexate

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Venoocclusive Liver Disease Other Serious 14 Male 3/14/2006 Japan
Primary
Secondary
Rash Generalised Hospitalization 1/13/2006 59 Female 3/28/2006 Other Health Professional France
Primary
Secondary
Concomitant
Stem Cell Transplant Hospitalization 1/13/2006 59 Female 4/18/2006 Other Health Professional France
Primary
Secondary
Concomitant
Streptococcal Infection Hospitalization 6/7/2006 Male 135 lb 6/8/2006 United States
Primary
Secondary
Concomitant
Thrombotic Thrombocytopenic Purpura Other Serious 7/3/2006 Consumer United States
Primary
Secondary
Concomitant
Septic Shock Death 10/2/2006 Consumer France
Primary
Secondary
Concomitant
Neurotoxicity Other Serious 10/2/2006 Consumer France
Primary
Secondary
Concomitant
Stomatitis Other Serious 7/1/2006 Female 165 lb 10/9/2006 Physician Belgium
Primary
Concomitant
Viral Dna Test Positive Other Serious 1/1/2006 64 Female 10/17/2006 Japan
Primary
Concomitant
Viral Dna Test Positive Other Serious 1/1/2006 64 Female 11/1/2006 Japan
Primary
Concomitant
Stomatitis Other Serious 7/12/2006 Female 165 lb 12/12/2006 Physician Belgium
Primary
Concomitant
Toxic Epidermal Necrolysis Other Serious Female 1/23/2007 Other Health Professional Germany
Primary
Secondary
Concomitant
Viral Dna Test Positive Other Serious 7/11/2004 15 Male 73 lb 1/30/2007 Japan
Primary
Concomitant
Viral Dna Test Positive Other Serious 7/11/2004 15 Male 73 lb 2/8/2007 Japan
Primary
Concomitant
Viral Dna Test Positive Other Serious 7/11/2004 15 Male 73 lb 2/8/2007 Japan
Primary
Concomitant
Neutropenic Sepsis Death 2/20/2007 Consumer Australia
Primary
Secondary
Thrombocytopenia Other Serious 2/20/2007 Consumer Australia
Primary
Secondary
Renal Impairment Other Serious 56 Female 2/22/2007 Consumer Finland
Primary
Secondary
Concomitant
Somnolence Other Serious 56 Female 2/23/2007 Other Health Professional Germany
Primary
Secondary
Concomitant
Somnolence Death 56 Female 2/16/2007 Germany
Primary
Secondary
Concomitant
White Blood Cell Count Increased Death 56 Female 2/20/2007 Germany
Primary
Secondary
Concomitant
Somnolence Other Serious 56 Female 3/2/2007
Primary
Secondary
Pruritus Hospitalization 10/1/2005 Female 183 lb 3/19/2007 Netherlands
Primary
Secondary
Concomitant
Sepsis Other Serious 59 Female 5/10/2007 Other Health Professional India
Primary
Secondary
Spherocytic Anaemia Other Serious 41 Female 5/21/2007 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Autoimmune Thrombocytopenia Other Serious 41 Female 5/21/2007 Other Health Professional United Kingdom
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
Viral Dna Test Positive Other Serious 7/11/2004 15 Male 73 lb 6/22/2007 Japan
Primary
Secondary
Concomitant
Viral Dna Test Positive Other Serious 7/11/2004 15 Male 73 lb 6/22/2007 Japan
Primary
Secondary
Concomitant
Transplant Failure 2/5/2007 47 Male 7/13/2007 Japan
Primary
Concomitant
Renal Tubular Disorder Other Serious 7 Female 8/14/2007 Physician Italy
Primary
Secondary
Concomitant
Stomatitis Other Serious 12 Male 9/26/2007 Japan
Primary
Secondary
Concomitant
Sepsis Hospitalization 8/7/2007 Male 183 lb 9/28/2007 Pharmacist Australia
Primary
Concomitant
Stomatitis Other Serious 6/1/2006 12 Male 10/5/2007 Japan
Primary
Secondary
Concomitant
Sepsis Hospitalization 8/7/2007 Male 183 lb 10/10/2007 Pharmacist Australia
Primary
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
Ureaplasma Infection Hospitalization 28 Male 10/11/2007 Switzerland
Primary
Secondary
Hypersensitivity Other Serious 16 Female 11/20/2007 Other Health Professional Australia
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
Viith Nerve Paralysis Other Serious 39 Female 12/28/2007 Other Health Professional Japan
Primary
Secondary
Polyp Other Serious 8 Male 1/11/2008 United States
Primary
Concomitant
Renal Failure Other Serious 12 Male 1/17/2008 Physician Germany
Primary
Secondary
Pancytopenia Other Serious Male 2/7/2008 Consumer United Kingdom
Primary
Concomitant
Vomiting Other Serious 39 Female 2/21/2008
Primary
Secondary
Renal Failure Other Serious 2/22/2008 Other Health Professional United States
Primary
Secondary
Renal Disorder Other Serious 2/29/2008 Other Health Professional United States
Primary
Secondary
Pulmonary Alveolar Haemorrhage Other Serious 39 Female 3/6/2008 Other Health Professional Japan
Primary
Concomitant
Serositis Death 1 3/6/2008 Consumer Japan
Primary
Concomitant
Cystitis Haemorrhagic Other Serious 11 3/11/2008 Consumer Japan
Primary
Concomitant
Venoocclusive Disease Other Serious 13 3/11/2008 Consumer Japan
Primary
Concomitant
Inappropriate Antidiuretic Hormone Secretion Other Serious 14 3/11/2008 Consumer Japan
Primary
Concomitant
Cytomegalovirus Enteritis Other Serious 12 3/11/2008 Consumer Japan
Primary
Concomitant
Sepsis Other Serious 8/1/2005 51 Male 3/13/2008 Japan
Primary
Secondary
Concomitant
Serositis Death 1 3/24/2008 Physician Japan
Primary
Concomitant
Cystitis Haemorrhagic Other Serious 11 3/24/2008 Physician Japan
Primary
Concomitant
Venoocclusive Disease Other Serious 13 3/24/2008 Physician Japan
Primary
Concomitant
Inappropriate Antidiuretic Hormone Secretion Other Serious 14 3/24/2008 Physician Japan
Primary
Concomitant
Cytomegalovirus Enteritis Other Serious 12 3/24/2008 Physician Japan
Primary
Concomitant
Pancytopenia Other Serious Male 4/11/2008 Other Health Professional Greece
Primary
Concomitant
Graft Versus Host Disease Other Serious 14 Male 4/14/2008 Other Health Professional Germany
Primary
Secondary
Neutropenia Other Serious 4 Female 4/14/2008 Other Health Professional Germany
Primary
Secondary
Graft Versus Host Disease Other Serious 12 Male 4/15/2008 Other Health Professional Germany
Primary
Secondary
Drug Toxicity Other Serious 4/9/2008 Germany
Primary
Secondary
Renal Failure Acute Other Serious 5/29/2008 Iceland
Primary
Secondary
Concomitant
Renal Failure Acute Other Serious 6/2/2008 Iceland
Primary
Secondary
Concomitant
Streptococcal Sepsis Other Serious 6/5/2008 Germany
Primary
Secondary
Concomitant
Streptococcal Sepsis Other Serious 6/9/2008 Germany
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
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
Thrombotic Microangiopathy Other Serious 7/21/2008 Other Health Professional Japan
Primary
Concomitant
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
Vomiting Hospitalization 39 Male 7/28/2008 Other Health Professional Germany
Primary
Secondary
Thrombotic Microangiopathy Other Serious 50 Female 8/1/2008 Consumer Japan
Primary
Secondary
Concomitant
Vasculitis Hospitalization 1/13/2006 59 Female 8/5/2008 France
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
Caecitis Hospitalization 8/13/2008 Male 9/4/2008 Physician United States
Primary
Concomitant
Caecitis Hospitalization 8/13/2008 Male 9/9/2008 Physician United States
Primary
Concomitant
Infection Other Serious 44 Male 181 lb 9/15/2008 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
Pneumonia Cytomegaloviral Death 9 10/31/2008 Other Health Professional United States
Primary
Concomitant
Vascular Occlusion Other Serious 10/6/2008 40 Female 10/28/2008 Other Health Professional France
Primary
Concomitant
Weight Increased Other Serious 43 Female 11/11/2008 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
Weight Increased Other Serious 11/26/2007 43 Female 11/26/2008 Other Health Professional Japan
Primary
Secondary
Concomitant
Bone Sarcoma Other Serious 8 Male 12/1/2008 Consumer Japan
Primary
Secondary
Bone Sarcoma Other Serious 8 Male 12/1/2008 Other Health Professional Japan
Primary
Secondary
Concomitant
Sepsis Syndrome Other Serious 14 Male 11/28/2008 Other Health Professional Germany
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
Bone Sarcoma Other Serious 8 Male 12/2/2008 Other Health Professional Japan
Primary
Secondary
Concomitant
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
Neuropathy Peripheral Other Serious 15 Male 12/29/2008 Other Health Professional United States
Primary
Secondary
Pseudomembranous Colitis Other Serious 43 Male 12/30/2008 Other Health Professional Japan
Primary
Secondary
Immune System Disorder Other Serious 65 Female 12/22/2008 Physician United States
Primary
Secondary
Concomitant
Myelopathy Other Serious 15 Male 1/2/2009 United States
Primary
Secondary
Bone Sarcoma Life Threatening 5/1/2007 7 Male 1/5/2009 Other Health Professional Japan
Primary
Secondary
Basal Cell Carcinoma Other Serious 1/1/2004 4 Female 1/7/2009 Italy
Primary
Secondary
Squamous Cell Carcinoma Death 4/1/2002 6 Male 1/7/2009 Italy
Primary
Secondary
Progressive Multifocal Leukoencephalopathy Other Serious 15 Male 1/5/2009 Other Health Professional United States
Primary
Secondary
Sudden Death Hospitalization 14 Male 1/5/2009 Other Health Professional 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
Influenza Other Serious 3/1/2007 39 Male 1/23/2009 Other Health Professional Japan
Primary
Concomitant
Myelodysplastic Syndrome Other Serious 1/1/2006 49 Male 1/29/2009 Other Health Professional Japan
Primary
Concomitant
Rash Other Serious 8 Male 2/3/2009 Other Health Professional Japan
Primary
Secondary
Concomitant
Sepsis Other Serious 8/16/2008 51 Male 97 lb 2/13/2009 Physician Japan
Primary
Secondary
Concomitant
Liver Disorder Other Serious 8/25/2008 18 Male 128 lb 2/18/2009 Physician Japan
Primary
Secondary
Concomitant
Hypocalcaemia Hospitalization 8/10/2008 Male 2/18/2009 Physician United Kingdom
Primary
Secondary
Concomitant
Rash Other Serious 8 Male 2/19/2009 Other Health Professional Japan
Primary
Secondary
Concomitant
Immune System Disorder Other Serious 1/1/2008 43 Female 3/6/2009 Other Health Professional Japan
Primary
Secondary
Concomitant
Nervous System Disorder Death 54 Male 3/9/2009 Consumer United States
Primary
Secondary
Concomitant
Septic Shock Other Serious 12/21/2008 45 Male 3/18/2009 Other Health Professional Spain
Primary
Concomitant
Neutropenia Other Serious 3/9/2009 52 Male 165 lb 3/30/2009 Physician Spain
Primary
Secondary
Concomitant
Immune System Disorder Other Serious 1/1/2008 43 Female 101 lb 4/3/2009 Other Health Professional Japan
Primary
Secondary
Concomitant
Pneumonia Other Serious 3/9/2009 51 Male 4/1/2009 Other Health Professional Spain
Primary
Concomitant
Immune System Disorder Other Serious 1/1/2008 43 Female 101 lb 4/8/2009 Other Health Professional Japan
Primary
Secondary
Concomitant
Febrile Neutropenia Other Serious 4/14/2009 Consumer United Kingdom
Primary
Secondary
Venoocclusive Liver Disease Life Threatening 7/21/2008 56 Male 132 lb 4/15/2009 Physician Japan
Primary
Concomitant
Immune System Disorder Death 1/15/2008 43 Female 101 lb 4/22/2009 Other Health Professional Japan
Primary
Secondary
Concomitant
Bladder Cancer Other Serious 1/1/2008 67 Male 4/21/2009 Other Health Professional France
Primary
Concomitant
Sinusitis Fungal Other Serious 8/1/2006 28 Male 4/24/2009 Other Health Professional Italy
Primary
Concomitant
Febrile Neutropenia Other Serious 4/27/2009 Consumer United Kingdom
Primary
Secondary
Nervous System Disorder Other Serious 1/1/2008 67 Male 5/12/2009 Other Health Professional France
Primary
Concomitant
Pneumonia Other Serious 10/10/2008 56 Male 121 lb 5/20/2009 Japan
Primary
Secondary
Concomitant
Clostridial Infection Death 67 Female 5/20/2009 Germany
Primary
Secondary
Renal Disorder Other Serious 8/14/2008 15 Female 110 lb 5/20/2009 Physician Japan
Primary
Secondary
Concomitant
Pneumonia Other Serious 10/10/2008 56 Male 121 lb 5/21/2009 Japan
Primary
Secondary
Concomitant
Leukopenia Other Serious 67 Female 5/26/2009 Other Health Professional Germany
Primary
Secondary
Multi-organ Failure Death 56 5/23/2009 Other Health Professional Tunisia
Primary
Secondary
Concomitant

Drug Data