Asparaginase combined with Methotrexate

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Malaise Hospitalization 10/15/2005 4 Female 1/5/2006 Other Health Professional France
Primary
Secondary
Concomitant
Subarachnoid Haemorrhage Other Serious Female 1/30/2006 Other Health Professional France
Primary
Secondary
Respiratory Disorder Other Serious 17 Male 2/2/2006 Other Health Professional Ireland
Primary
Secondary
Therapy Non-responder Death Female 1/27/2006 United Kingdom
Primary
Secondary
Vomiting Death Female 1/31/2006 Other Health Professional United Kingdom
Primary
Secondary
Pseudobulbar Palsy Other Serious 17 Male 2/3/2006 Other Health Professional Ireland
Primary
Secondary
Concomitant
Peripheral Motor Neuropathy Other Serious 1/4/2006 5 Female 35 lb 2/3/2006 Physician United States
Primary
Secondary
Concomitant
Visual Disturbance Hospitalization 10/15/2005 4 Female 2/14/2006 France
Primary
Secondary
Concomitant
Pseudobulbar Palsy Other Serious 17 Male 3/1/2006 Physician Ireland
Primary
Concomitant
Visual Disturbance Other Serious 2/20/2006 Male 134 lb 3/8/2006 Consumer United States
Primary
Secondary
Concomitant
Oral Intake Reduced Hospitalization 7 Female 10/13/2006 Other Health Professional United Kingdom
Primary
Secondary
Necrotising Colitis Hospitalization 7 Female 10/24/2006 Consumer United Kingdom
Primary
Secondary
Vomiting Hospitalization 7 Female 10/26/2006 United Kingdom
Primary
Secondary
Prothrombin Time Prolonged Other Serious 10/25/2004 7 Male 11/13/2006
Primary
Secondary
Hyperglycaemia Other Serious 11/13/2006 46 Female 12/15/2006 Pharmacist United Kingdom
Primary
Concomitant
Hepatotoxicity Other Serious 52 Male 1/19/2007 Other Health Professional Israel
Primary
Secondary
Concomitant
Hepatotoxicity Other Serious 47 Female 1/19/2007 Other Health Professional Israel
Primary
Secondary
Concomitant
Jaundice Cholestatic 52 Male 1/26/2007 Israel
Primary
Secondary
Concomitant
Hepatotoxicity 47 Female 1/26/2007 Israel
Primary
Secondary
Concomitant
Liver Disorder Other Serious 52 Male 2/7/2007 Israel
Primary
Secondary
Jaundice Cholestatic Other Serious 52 Male 2/23/2007
Primary
Secondary
Hepatotoxicity Other Serious 47 Female 2/23/2007
Primary
Secondary
Somnolence Other Serious 56 Female 3/2/2007
Primary
Secondary
Metastasis Death 11 Male 3/5/2007
Primary
Secondary
Metastasis Death 15 Female 3/5/2007
Primary
Secondary
Metastasis Death 13 Female 3/5/2007
Primary
Secondary
Metastasis Death 12 Male 3/5/2007
Primary
Secondary
Metastasis Death 15 Male 3/5/2007
Primary
Secondary
Glioma Other Serious 2 Male 3/9/2007 Consumer Finland
Primary
Secondary
Glioma Other Serious 2 Female 3/9/2007 Other Health Professional Finland
Primary
Secondary
Glioma Other Serious 4 Male 3/9/2007 Consumer Finland
Primary
Secondary
Glioma Other Serious 3 Female 3/9/2007 Consumer Finland
Primary
Secondary
Glioma Other Serious 5 Male 3/9/2007 Consumer Finland
Primary
Secondary
Convulsion Other Serious 11 Male 3/9/2007 Other Health Professional India
Primary
Secondary
Glioma Other Serious 2 Male 3/9/2007 Consumer Finland
Primary
Secondary
Glioma Other Serious 2 Female 3/9/2007 Other Health Professional Finland
Primary
Secondary
Glioma Other Serious 3 Female 3/9/2007 Consumer Finland
Primary
Secondary
Glioma Other Serious 4 Male 3/9/2007 Consumer Finland
Primary
Secondary
Glioma Other Serious 5 Male 3/12/2007 Consumer Finland
Primary
Secondary
Treatment Related Secondary Malignancy Death 11 Male 3/1/2007 Germany
Primary
Secondary
Treatment Related Secondary Malignancy Death 15 Male 3/1/2007 Germany
Primary
Secondary
Concomitant
Treatment Related Secondary Malignancy Death 15 Female 3/1/2007 Germany
Primary
Secondary
Treatment Related Secondary Malignancy Death 12 Male 3/1/2007 Germany
Primary
Secondary
Glioma Death 13 Female 3/1/2007 Germany
Primary
Secondary
Concomitant
Treatment Related Secondary Malignancy Death 15 Male 3/16/2007 Germany
Primary
Secondary
Treatment Related Secondary Malignancy Death 15 Female 3/16/2007 Germany
Primary
Secondary
Treatment Related Secondary Malignancy Death 12 Male 3/16/2007 Germany
Primary
Secondary
Glioma Death 13 Female 3/20/2007 Germany
Primary
Secondary
Glioma Death 11 Male 3/20/2007 Germany
Primary
Secondary
Neoplasm Malignant Death 15 Female 3/30/2007 Germany
Primary
Secondary
Concomitant
Neoplasm Malignant Death 13 Female 3/30/2007 Germany
Primary
Secondary
Concomitant
Neoplasm Malignant Death 11 Male 3/30/2007 Germany
Primary
Secondary
Concomitant
Neoplasm Malignant Death 15 Male 3/30/2007 Germany
Primary
Secondary
Concomitant
Neoplasm Malignant Death 12 Male 3/30/2007 Germany
Primary
Secondary
Concomitant
Malignant Melanoma Other Serious 22 Male 6/8/2007 Other Health Professional United States
Primary
Secondary
Cardiomyopathy Hospitalization 4/17/2007 8 Male 57 lb 6/11/2007 Other Health Professional France
Primary
Secondary
Concomitant
Malignant Melanoma In Situ Other Serious 22 Male 6/12/2007
Primary
Secondary
Hypertrophic Cardiomyopathy Hospitalization 4/17/2007 8 Male 5/31/2007 France
Primary
Secondary
Concomitant
Polyneuropathy Other Serious Female 6/22/2007
Primary
Secondary
Polyneuropathy Other Serious Male 6/22/2007
Primary
Secondary
Pleural Fibrosis Disability 2/1/1994 29 Male 79 lb 6/26/2007 Other Health Professional France
Primary
Secondary
Concomitant
Respiratory Tract Infection Viral Other Serious 8 Male 6/28/2007 Other Health Professional Australia
Primary
Secondary
Pleural Fibrosis Disability 2/1/1994 29 Male 79 lb 6/29/2007 Consumer United States
Primary
Secondary
Concomitant
Polyneuropathy Other Serious Female 7/5/2007
Primary
Secondary
Polyneuropathy Other Serious Male 7/5/2007
Primary
Secondary
Trichostasis Spinulosa Other Serious 6 Male 6/30/2007 Physician Australia
Primary
Secondary
Malignant Melanoma In Situ Other Serious Male 7/16/2007 United States
Primary
Secondary
Retinal Vein Thrombosis Hospitalization 4/21/2007 8 8/15/2007 Physician United States
Primary
Concomitant
Precocious Puberty Other Serious Female 9/14/2007 Other Health Professional United States
Primary
Secondary
Concomitant
Retinal Vein Thrombosis Hospitalization 4/21/2007 8 Male 9/19/2007 Physician United States
Primary
Concomitant
Reversible Posterior Leukoencephalopathy Syndrome Other Serious 4 Female 10/11/2007 Other Health Professional United States
Primary
Secondary
Reversible Posterior Leukoencephalopathy Syndrome Other Serious 13 Male 10/11/2007 Other Health Professional United States
Primary
Secondary
Reversible Posterior Leukoencephalopathy Syndrome Hospitalization 4 Female 10/3/2007 Other Health Professional United States
Primary
Secondary
Reversible Posterior Leukoencephalopathy Syndrome Other Serious 13 Male 10/4/2007 Other Health Professional United States
Primary
Secondary
Glioblastoma Other Serious 10 Male 11/19/2007 Other Health Professional India
Primary
Secondary
Malignant Neoplasm Progression Other Serious 4 Female 11/19/2007 Other Health Professional India
Primary
Secondary
Glioblastoma Other Serious 6 Male 11/20/2007 Other Health Professional India
Primary
Secondary
Malignant Neoplasm Progression Other Serious 4 Female 11/26/2007 Other Health Professional India
Primary
Secondary
Nervous System Disorder Death 12 Male 11/21/2007 Physician Germany
Primary
Secondary
Staphylococcal Bacteraemia Other Serious 17 Male 12/6/2007 Other Health Professional Germany
Primary
Secondary
Staphylococcal Bacteraemia Other Serious 17 Male 12/11/2007 Other Health Professional Germany
Primary
Secondary
Bacteraemia Hospitalization 54 Male 12/13/2007 Other Health Professional Saudi Arabia
Primary
Secondary
Bacteraemia Hospitalization 54 Male 12/18/2007 Other Health Professional Saudi Arabia
Primary
Secondary
Staphylococcal Infection Other Serious 17 Male 12/29/2007 Physician Germany
Primary
Secondary
Ewing's Sarcoma Other Serious 16 Male 2/13/2008 Other Health Professional Japan
Primary
Secondary
Dysthymic Disorder Hospitalization 6/19/2007 Male 2/22/2008 Physician France
Primary
Secondary
Concomitant
Hyperlipidaemia Other Serious 5 Male 44 lb 2/27/2008
Primary
Secondary
Concomitant
Neuropathy Peripheral Other Serious 10 Female 3/7/2008 Other Health Professional Korea, Republic Of
Primary
Secondary
Concomitant
Thrombocytopenia Other Serious 60 Male 3/11/2008 Other Health Professional Belgium
Primary
Secondary
Respiratory Disorder Other Serious 10 Female 3/8/2008 Korea, Republic Of
Primary
Secondary
Concomitant
Lymphoproliferative Disorder Other Serious 4 Female 3/20/2008 United States
Primary
Secondary
Splenomegaly Death 4 Female 3/24/2008 Other Health Professional United States
Primary
Secondary
Quadriparesis Other Serious 10 Female 3/19/2008 Physician Korea, Republic Of
Primary
Secondary
Concomitant
Sinusitis Fungal Other Serious Female 3/31/2008 Physician United States
Primary
Secondary
Bradycardia Other Serious 3/1/2008 7 Male 50 lb 5/2/2008 United Kingdom
Primary
Concomitant
Vomiting Other Serious 29 Female 5/12/2008 Other Health Professional Turkey
Primary
Secondary
Vomiting Other Serious 29 Female 5/14/2008 Other Health Professional Turkey
Primary
Secondary
Trichosporon Infection Other Serious 11 Male 5/23/2008 Other Health Professional Canada
Primary
Secondary
Trichosporon Infection Other Serious 11 Male 5/28/2008 Other Health Professional Canada
Primary
Secondary
Stomatitis Other Serious 16 Male 5/24/2008 Physician Turkey
Primary
Secondary
Reversible Posterior Leukoencephalopathy Syndrome Hospitalization 6 Female 6/3/2008 Spain
Primary
Secondary
Reversible Posterior Leukoencephalopathy Syndrome Hospitalization 4/20/2008 Female 6/3/2008 Other Health Professional France
Primary
Secondary
Renal Failure Other Serious 6/3/2008 Consumer United States
Primary
Secondary
Concomitant
Urogenital Infection Fungal Hospitalization 5/1/2005 11 Male 6/6/2008 Physician Canada
Primary
Secondary
Reversible Posterior Leukoencephalopathy Syndrome Hospitalization 6 Female 6/13/2008 Spain
Primary
Secondary
Toxic Skin Eruption Hospitalization 5/1/2008 14 Male 143 lb 6/19/2008 Consumer United States
Primary
Secondary
Concomitant
Calculus Urinary Other Serious 11 Male 6/25/2008 Other Health Professional Japan
Primary
Secondary
Reversible Posterior Leukoencephalopathy Syndrome Other Serious 11 Female 6/26/2008 Other Health Professional India
Primary
Secondary
Trichosporon Infection Hospitalization 5/1/2005 11 Male 6/21/2008 Physician Canada
Primary
Secondary
Concomitant
Visual Disturbance Other Serious 9 Male 6/30/2008 Other Health Professional India
Primary
Secondary
Reversible Posterior Leukoencephalopathy Syndrome Other Serious 11 Female 6/30/2008 Other Health Professional India
Primary
Secondary
Calculus Urinary Other Serious 11 Male 6/30/2008 Other Health Professional Japan
Primary
Secondary
Subarachnoid Haemorrhage Death 0 Female 7/14/2008 United Kingdom
Primary
Secondary
Chronic Myeloid Leukaemia Life Threatening 54 Male 7/15/2008 United Kingdom
Primary
Secondary
Vomiting Other Serious 0 Female 7/17/2008 Consumer United States
Primary
Secondary
Subarachnoid Haemorrhage Death 0 Female 7/24/2008 Other Health Professional United Kingdom
Primary
Secondary
Chronic Myeloid Leukaemia Life Threatening 54 Male 7/24/2008 Other Health Professional United Kingdom
Primary
Secondary
Chronic Myeloid Leukaemia Life Threatening 54 Male 7/28/2008 United Kingdom
Primary
Secondary
Promyelocyte Count Increased Life Threatening 54 Male 7/22/2008 Other Health Professional United Kingdom
Primary
Secondary
Leukaemia Other Serious 39 Female 8/5/2008 United States
Primary
Secondary
Guillain-barre Syndrome Other Serious 39 Female 8/5/2008 Other Health Professional United States
Primary
Secondary
Vomiting Other Serious 0 Female 8/12/2008 Consumer United States
Primary
Secondary
Chronic Myeloid Leukaemia Life Threatening 54 Male 8/18/2008 Other Health Professional United Kingdom
Primary
Secondary
Subarachnoid Haemorrhage Death 0 Female 8/18/2008 Other Health Professional United Kingdom
Primary
Secondary
Stevens-johnson Syndrome Hospitalization 1/1/2008 14 Male 143 lb 9/26/2008 Consumer United States
Primary
Secondary
Concomitant
Hypotension Hospitalization 12/2/2007 Female 10/24/2008 Other Health Professional France
Primary
Secondary
Concomitant
Cardiac Failure Congestive Other Serious Female 1/12/2009 Other Health Professional United States
Primary
Secondary
Gamma-glutamyltransferase Increased Hospitalization 12/21/2008 4 Male 44 lb 1/7/2009 Physician Germany
Primary
Secondary
Concomitant
Venoocclusive Liver Disease Death 51 Female 1/20/2009 Greece
Primary
Secondary
Puncture Site Infection Hospitalization 12/21/2008 4 Male 44 lb 1/22/2009 Physician Germany
Primary
Secondary
Concomitant
Urticaria Other Serious 12/11/2008 17 Female 1/27/2009 Consumer France
Primary
Secondary
Concomitant
Venous Occlusion Death 51 Female 2/2/2009 Other Health Professional Greece
Primary
Secondary
Transaminases Increased Hospitalization 12/21/2008 4 Male 44 lb 2/2/2009 Physician Germany
Primary
Secondary
Concomitant
Chronic Graft Versus Host Disease Other Serious 21 Male 3/10/2009 Physician United Kingdom
Primary
Secondary
Bone Marrow Disorder Death 17 Female 3/10/2009 Physician United Kingdom
Primary
Secondary
Rhabdomyolysis Other Serious 10/24/2008 2 Male 27 lb 3/18/2009 Physician Japan
Primary
Concomitant
Febrile Neutropenia Other Serious 4/14/2009 Consumer United Kingdom
Primary
Secondary
Febrile Neutropenia Other Serious 4/27/2009 Consumer United Kingdom
Primary
Secondary
Vomiting Hospitalization 2/3/2009 20 Male 4/28/2009 Consumer France
Primary
Secondary
Influenza Like Illness Required Intervention 2/16/2009 58 Male 192 lb 3/5/2009 Pharmacist United States
Primary
Concomitant
Respiratory Arrest Hospitalization 5 Male 5/18/2009 Physician Japan
Primary
Concomitant
Neutropenia Required Intervention 9 Female 5/20/2009 Pharmacist France
Primary
Secondary
Concomitant
Stevens-johnson Syndrome Hospitalization 1/1/2008 14 Male 205 lb 5/29/2009 Other Health Professional France
Primary
Secondary
Concomitant
Toxic Skin Eruption Hospitalization 5/1/2008 Male 205 lb 6/2/2009 Other Health Professional France
Primary
Secondary
Concomitant
Urosepsis Hospitalization 8/27/2009 Female 10/8/2009 Physician United Kingdom
Primary
Secondary
Insulin-like Growth Factor Decreased Other Serious 12 Female 11/17/2009 Other Health Professional United States
Primary
Secondary
Epiphysiolysis Other Serious 15 Male 11/17/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Pancreatitis Other Serious 17 Male 12/9/2009
Primary
Secondary
Concomitant
Neurotoxicity Hospitalization 17 Male 12/16/2009 Physician United States
Primary
Concomitant
Sepsis Other Serious 55 Female 12/17/2009 Consumer United Kingdom
Primary
Secondary

Drug Data