Melphalan Hydrochloride combined with Thiotepa

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
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
Thrombotic Microangiopathy Hospitalization 5/28/2009 Male 27 lb 6/5/2009 United States
Primary
Secondary
Stem Cell Transplant Other Serious 4/22/2009 2 Male 6/18/2009 Physician United States
Primary
Secondary
Drug Toxicity Other Serious 6/23/2009 Consumer Thailand
Primary
Secondary
Bone Sarcoma Other Serious 11 Male 8/14/2009 Consumer Japan
Primary
Secondary
Gastric Cancer Life Threatening 8/6/2008 52 Male 119 lb 8/25/2009 Physician Japan
Primary
Concomitant
Transaminases Increased Other Serious 0 Female 8/27/2009 Other Health Professional Italy
Primary
Secondary
Gastric Cancer Life Threatening 8/6/2008 52 Male 119 lb 9/8/2009 Physician Japan
Primary
Concomitant
Gastric Cancer Life Threatening 8/6/2008 52 Male 119 lb 9/14/2009 Physician Japan
Primary
Concomitant
Venoocclusive Liver Disease Other Serious Unknown 10/2/2009 Korea, Republic Of
Primary
Secondary
Capillary Leak Syndrome Death Unknown 12/14/2009 Italy
Primary
Secondary
Disease Progression Death 1/19/2010 Physician United States
Primary
Secondary
Leukaemia Recurrent Death 1/19/2010 Physician United States
Primary
Secondary
Stem Cell Transplant Death 1/19/2010 Physician United States
Primary
Secondary
Stem Cell Transplant Death 1/19/2010 Physician United States
Primary
Secondary
Therapeutic Agent Toxicity Death 1/19/2010 Physician United States
Primary
Secondary
Weight Increased Hospitalization 7/21/2009 Male 48 lb 2/24/2010 United States
Primary
Secondary
Concomitant
Venoocclusive Liver Disease Required Intervention 4 Male 3/10/2010 Physician United States
Primary
Secondary
Concomitant
Acute Graft Versus Host Disease Death 3/25/2010 Italy
Primary
Secondary
Concomitant
Nephropathy Toxic Other Serious 4/1/2010 United States
Primary
Secondary
Concomitant
Thrombotic Microangiopathy Other Serious 13 Male 3/30/2010 Physician Japan
Primary
Concomitant
Nephropathy Toxic Other Serious 4/6/2010 United States
Primary
Secondary
Concomitant
Respiratory Failure Life Threatening 6 Male 4/13/2010 Japan
Primary
Concomitant
Pyrexia Other Serious 9 Unknown 5/4/2010 United States
Primary
Secondary
Concomitant
Sepsis Other Serious 5 Unknown 5/4/2010 United States
Primary
Secondary
Concomitant
Urinary Tract Infection Other Serious 9 Unknown 5/4/2010 United States
Primary
Secondary
Concomitant
Sepsis Other Serious 11 Unknown 5/4/2010 United States
Primary
Secondary
Concomitant
Sepsis Other Serious 11 Unknown 5/4/2010 United States
Primary
Secondary
Concomitant
Pyrexia Other Serious 5 Unknown 5/4/2010 United States
Primary
Secondary
Concomitant
Venoocclusive Disease Death 13 Unknown 5/4/2010 United States
Primary
Secondary
Concomitant
Venoocclusive Disease Death 1 Unknown 5/4/2010 United States
Primary
Secondary
Concomitant
Sepsis Death 7 5/4/2010 United States
Primary
Secondary
Concomitant
Pyrexia Other Serious 2 5/4/2010 Physician United States
Primary
Secondary
Concomitant
Mucosal Inflammation Other Serious 44 Female 5/6/2010 Korea, Republic Of
Primary
Secondary
Concomitant
Mucosal Inflammation Other Serious 43 Female 5/6/2010 Korea, Republic Of
Primary
Secondary
Concomitant
Venoocclusive Disease Other Serious 39 Female 5/7/2010 Korea, Democratic People's Republic Of
Primary
Concomitant
Mucosal Inflammation Other Serious 57 Male 5/7/2010 Korea, Republic Of
Primary
Concomitant
Venoocclusive Disease Other Serious 36 Female 5/7/2010 Korea, Republic Of
Primary
Concomitant
Venoocclusive Disease Other Serious 52 Female 5/7/2010 Korea, Republic Of
Primary
Concomitant
Mucosal Inflammation Other Serious 43 Female 5/7/2010 Korea, Republic Of
Primary
Concomitant
Venoocclusive Disease Other Serious 39 Female 5/10/2010 Korea, Democratic People's Republic Of
Primary
Secondary
Mucosal Inflammation Other Serious 57 Male 5/10/2010 Korea, Democratic People's Republic Of
Primary
Secondary
Mucosal Inflammation Other Serious 29 Female 5/10/2010 Korea, Democratic People's Republic Of
Primary
Secondary
Hepatotoxicity Other Serious 58 Male 5/10/2010 Korea, Democratic People's Republic Of
Primary
Secondary
Concomitant
Venoocclusive Disease Other Serious 36 Female 5/10/2010 Korea, Republic Of
Primary
Secondary
Concomitant
Mucosal Inflammation Other Serious 52 Female 5/10/2010 Korea, Republic Of
Primary
Secondary
Concomitant
Venoocclusive Disease Death 60 Female 5/10/2010 Korea, Republic Of
Primary
Secondary
Concomitant
Venoocclusive Disease Other Serious 52 Female 5/10/2010 Korea, Republic Of
Primary
Secondary
Concomitant
Venoocclusive Disease Other Serious 39 Male 5/10/2010 Korea, Democratic People's Republic Of
Primary
Secondary
Concomitant
Renal Failure Hospitalization 4/25/2010 43 Male 5/17/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Tracheomalacia Other Serious 5/7/2009 1 Male 5/14/2010 Physician United States
Primary
Secondary
Concomitant
Graft Versus Host Disease Death 1 Male 5/14/2010 Physician United States
Primary
Secondary
Tracheomalacia Other Serious 5/7/2009 1 Male 5/18/2010 Physician United States
Primary
Secondary
Concomitant
Stem Cell Transplant Death 5/18/2010 Physician United States
Primary
Secondary
Stem Cell Transplant Death Male 5/18/2010 Physician United States
Primary
Secondary
Pyrexia Other Serious 5/19/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Pyrexia Other Serious 5/19/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Sepsis Other Serious 5/19/2010 Physician United States
Primary
Secondary
Concomitant
Sepsis Other Serious 5/19/2010 Physician United States
Primary
Secondary
Concomitant
Urinary Tract Infection Other Serious 5/19/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Pyrexia Other Serious 5/19/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Sepsis Death Unknown 5/19/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Venoocclusive Liver Disease Life Threatening 7/12/2007 39 Male 5/20/2010 Physician United States
Primary
Secondary
Concomitant
Stem Cell Transplant Hospitalization 6 Male 5/25/2010 Japan
Primary
Secondary
Viral Test Positive Other Serious 5/7/2009 1 Male 6/1/2010 Physician United States
Primary
Secondary
Concomitant
Renal Failure Hospitalization 4/25/2010 43 Male 6/7/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Urinary Tract Infection Other Serious 7/1/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Herpes Zoster Other Serious 7/1/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Pleural Effusion Other Serious 7/1/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Sepsis Death 7/1/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Sepsis Death 7/1/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Venoocclusive Disease Death 7/1/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Sepsis Other Serious 7/1/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Venoocclusive Disease Death 7/1/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Tracheomalacia Other Serious 5/7/2009 1 Male 8/13/2010 Physician United States
Primary
Secondary
Concomitant
Skin Toxicity Other Serious 0 Female 9/29/2010 Other Health Professional Germany
Primary
Secondary
Concomitant
Transplant Failure Other Serious 7/30/2010 56 Male 10/4/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Mucosal Inflammation Other Serious 57 Male 10/12/2010 Physician Korea, Democratic People's Republic Of
Primary
Concomitant
Mucosal Inflammation Other Serious 43 Female 10/12/2010 Physician Korea, Democratic People's Republic Of
Primary
Concomitant
Venoocclusive Liver Disease Other Serious 39 Female 10/12/2010 Physician Korea, Democratic People's Republic Of
Primary
Concomitant
Mucosal Inflammation Other Serious 52 Female 10/12/2010 Physician Korea, Democratic People's Republic Of
Primary
Concomitant
Venoocclusive Disease Other Serious 36 Female 10/12/2010 Physician Korea, Democratic People's Republic Of
Primary
Concomitant
Venoocclusive Disease Other Serious 60 Female 10/12/2010 Physician Korea, Democratic People's Republic Of
Primary
Concomitant
Venoocclusive Disease Other Serious 39 Male 10/12/2010 Physician Korea, Democratic People's Republic Of
Primary
Concomitant
Venoocclusive Disease Other Serious 47 Male 10/12/2010 Physician Korea, Democratic People's Republic Of
Primary
Concomitant
Recurrent Cancer Other Serious 58 Male 10/12/2010 Physician Korea, Democratic People's Republic Of
Primary
Concomitant
T-cell Lymphoma Other Serious 29 Female 10/12/2010 Physician Korea, Democratic People's Republic Of
Primary
Concomitant
Mucosal Inflammation Other Serious 60 Female 10/12/2010 Physician Korea, Democratic People's Republic Of
Primary
Concomitant
Venoocclusive Liver Disease Life Threatening 10/21/2010 6 Female 11/9/2010 Physician United States
Primary
Concomitant
Pneumonia Hospitalization 11 Male 1/27/2011 Other Health Professional Japan
Primary
Secondary
Acute Lymphocytic Leukaemia Recurrent Death Male 2/4/2011 Physician United States
Primary
Secondary
Concomitant
Multi-organ Failure Death 4/25/2010 43 Male 168 lb 4/13/2011 Other Health Professional United States
Primary
Secondary
Concomitant
Acute Respiratory Distress Syndrome Other Serious 11/16/2010 58 Female 4/15/2011 Physician United States
Primary
Secondary
Hypoxia Other Serious 2/21/2011 7 Male 4/15/2011 Physician United States
Primary
Secondary
Concomitant
Influenza Other Serious 5/7/2009 1 Male 29 lb 4/12/2011 Physician United States
Primary
Secondary
Concomitant
Lymphopenia Death 10 Female 4/11/2011 Physician United States
Primary
Secondary
Concomitant
Venoocclusive Disease Other Serious 4/25/2010 56 Male 168 lb 5/11/2011 Physician United States
Primary
Secondary
Hyperbilirubinaemia Other Serious 11/16/2010 58 Female 117 lb 5/13/2011 Consumer United States
Primary
Secondary
Concomitant
Venoocclusive Disease Other Serious 5/16/2011 Physician Serbia
Primary
Secondary
Concomitant
Venoocclusive Disease Other Serious 5/16/2011 Physician Serbia
Primary
Secondary
Concomitant
Metapneumovirus Infection Hospitalization 2/14/2011 7 Male 53 lb 5/25/2011 Physician United States
Primary
Secondary
Concomitant
Venoocclusive Liver Disease Death 4/25/2010 Male 168 lb 6/8/2011 Physician United States
Primary
Secondary
Concomitant
Neoplasm Malignant Death 5 6/25/2011 Other Health Professional Korea, Republic Of
Primary
Concomitant
Acute Graft Versus Host Disease Death 3 6/25/2011 Other Health Professional Korea, Republic Of
Primary
Concomitant
Renal Failure Hospitalization 10 Female 6/23/2011 Physician United States
Primary
Secondary
Concomitant
Hypogammaglobulinaemia Death 10 Female 6/28/2011 Other Health Professional United States
Primary
Secondary
Concomitant
Acute Leukaemia Other Serious 7/26/2011 Physician United States
Primary
Secondary
Concomitant
Acute Leukaemia Death 7/26/2011 Physician United States
Primary
Secondary
Concomitant
Acute Leukaemia Death 7/26/2011 Physician United States
Primary
Secondary
Concomitant
Acute Leukaemia Death 7/26/2011 Physician United States
Primary
Secondary
Concomitant
Bk Virus Infection Hospitalization 2/14/2011 7 Male 53 lb 7/27/2011 Consumer United States
Primary
Secondary
Concomitant
Thrombocytopenia Life Threatening 11/16/2010 58 Female 117 lb 8/1/2011 Physician United States
Primary
Secondary
Concomitant
Transient Ischaemic Attack Other Serious 14 Female 8/12/2011 Other Health Professional Canada
Primary
Concomitant
Haemolysis Other Serious 29 Female 9/21/2011 Other Health Professional Germany
Primary
Concomitant
Hypoxia Death 9/9/2010 67 Male 9/28/2011 Consumer United States
Primary
Secondary
Acute Leukaemia Death 10/14/2011 Physician United States
Primary
Secondary
Concomitant
Acute Leukaemia Death Male 10/18/2011 Physician United States
Primary
Secondary
Concomitant
Infection Other Serious 10 Male 11/9/2011 Physician Japan
Primary
Concomitant
Acute Respiratory Failure Other Serious 11/16/2010 58 Female 117 lb 12/2/2011 Physician United States
Primary
Secondary
Concomitant
Graft Versus Host Disease Death 17 Female 12/12/2011 Physician United States
Primary
Secondary
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
Neoplasm Progression Other Serious 6 Male 1/3/2012 Other Health Professional Japan
Primary
Secondary
Metastases To Central Nervous System Other Serious 6 Male 1/3/2012 Other Health Professional Japan
Primary
Secondary
Metastases To Central Nervous System Life Threatening 6 Male 1/3/2012 Other Health Professional Japan
Primary
Secondary
Disease Progression Death 1/17/2012 2/1/2012 Other Health Professional United States
Primary
Concomitant
Respiratory Distress Other Serious 1 Male 2/1/2012 Other Health Professional France
Primary
Concomitant
Pleural Effusion Death 12/12/2011 6 Male 2/17/2012 Other Health Professional United States
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
Adenovirus Infection Death 12/12/2011 6 Male 47 lb 2/22/2012 Other Health Professional United States
Primary
Concomitant
Ascites Hospitalization 10/19/2011 6 Male 47 lb 3/5/2012 Other Health Professional United States
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
Stem Cell Transplant Death 4/10/2012 Other Health Professional France
Primary
Secondary
Transplant Failure Other Serious 29 Female 5/2/2012 Other Health Professional Germany
Primary
Secondary
Concomitant
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
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

Drug Data