Asparaginase combined with Vincristine

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Hypotension Life Threatening 12/5/2005 9 Female 66 lb 1/6/2006 Consumer United States
Primary
Secondary
Malaise Hospitalization 10/15/2005 4 Female 1/5/2006 Other Health Professional France
Primary
Secondary
Concomitant
Respiratory Disorder Other Serious 17 Male 2/2/2006 Other Health Professional Ireland
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
Intussusception Hospitalization 7 Female 10/20/2006 Other Health Professional United Kingdom
Primary
Secondary
Neuropathy Hospitalization 7/15/2006 15 Male 128 lb 10/25/2006
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 Other Serious 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
Hepatotoxicity Other Serious 52 Male 1/19/2007 Other Health Professional 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
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
Pulmonary Embolism Life Threatening 5/19/2005 34 Male 5/2/2007 Switzerland
Primary
Secondary
Concomitant
Renal Failure Acute Life Threatening 3/4/2005 69 Male 5/18/2007 Switzerland
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
Malignant Melanoma In Situ Other Serious Male 6/12/2007 United States
Primary
Secondary
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
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
Pancreatitis Acute Hospitalization 6/1/2007 Male 7/27/2007 France
Primary
Secondary
Retinal Vein Thrombosis Hospitalization 4/21/2007 8 8/15/2007 Physician United States
Primary
Concomitant
Pancreatitis Acute Hospitalization 7/10/2007 12 Female 8/13/2007 Italy
Primary
Secondary
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
Nervous System Disorder Death 12 Male 11/21/2007 Physician Germany
Primary
Secondary
Respiratory Failure Death 12/1/2006 53 176 lb 12/13/2007 Physician Italy
Primary
Concomitant
Wound Infection Pseudomonas Other Serious 21 Male 12/8/2007 Greece
Primary
Secondary
Concomitant
Staphylococcal Infection Death 21 Male 12/5/2007 Physician Greece
Primary
Secondary
Concomitant
Multi-organ Failure Death 9/30/2007 Female 165 lb 12/21/2007 Physician France
Primary
Secondary
Concomitant
Staphylococcal Infection Other Serious 17 Male 12/29/2007 Physician Germany
Primary
Secondary
Staphylococcal Infection Other Serious 21 Male 1/11/2008 Greece
Primary
Secondary
Concomitant
Hyperlipidaemia 5 Male 2/8/2008 United Kingdom
Primary
Secondary
Concomitant
Hyperlipidaemia Other Serious 12/1/2007 5 Male 44 lb 2/20/2008 United Kingdom
Primary
Secondary
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
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
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
Stomatitis Other Serious 16 Male 5/24/2008 Physician Turkey
Primary
Secondary
Thrombocytopenia Other Serious 15 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
Trichosporon Infection Hospitalization 5/1/2005 11 Male 6/21/2008 Physician Canada
Primary
Secondary
Concomitant
Renal Failure Hospitalization Male 7/8/2008 Other Health Professional United Kingdom
Primary
Secondary
Chronic Myeloid Leukaemia Life Threatening 54 Male 7/15/2008 United Kingdom
Primary
Secondary
Renal Tubular Necrosis Death 11 Male 176 lb 7/15/2008 Other Health Professional United States
Primary
Secondary
Concomitant
Staphylococcal Infection Hospitalization 1 Male 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
Staphylococcal Infection Hospitalization 2 Male 7/19/2008 Other Health Professional United Kingdom
Primary
Secondary
Promyelocyte Count Increased Life Threatening 54 Male 7/22/2008 Other Health Professional United Kingdom
Primary
Secondary
Hepatic Encephalopathy Hospitalization 2 Male 8/8/2008 Physician United Kingdom
Primary
Secondary
Staphylococcal Infection Hospitalization 2 Male 8/11/2008 United Kingdom
Primary
Secondary
Chronic Myeloid Leukaemia Life Threatening 54 Male 8/18/2008 Other Health Professional United Kingdom
Primary
Secondary
Systemic Candida Other Serious 2 Male 8/18/2008 Other Health Professional United Kingdom
Primary
Secondary
Viral Infection Other Serious 2 Male 9/18/2008 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
Renal Tubular Necrosis Death 11 Male 176 lb 10/16/2008 Other Health Professional United States
Primary
Secondary
Concomitant
Renal Failure Hospitalization 2 Male 10/21/2008 Physician United Kingdom
Primary
Secondary
Hypotension Hospitalization 12/2/2007 Female 10/24/2008 Other Health Professional France
Primary
Secondary
Concomitant
Reversible Posterior Leukoencephalopathy Syndrome Other Serious 4 Male 11/10/2008 Italy
Primary
Secondary
Reversible Posterior Leukoencephalopathy Syndrome Other Serious 5 Female 11/10/2008 Italy
Primary
Secondary
Systemic Candida Other Serious 2 Male 12/2/2008
Primary
Secondary
Tumour Lysis Syndrome Other Serious 30 Male 12/9/2008 Other Health Professional Taiwan, Province Of China
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
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
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
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
Superior Sagittal Sinus Thrombosis Hospitalization 1/1/2008 73 Male 6/4/2009 United Kingdom
Primary
Secondary
Syncope Hospitalization 1/23/2009 14 Female 5/28/2009 Netherlands
Primary
Secondary
Concomitant
Superior Sagittal Sinus Thrombosis Hospitalization 73 Male 5/29/2009 Physician United Kingdom
Primary
Secondary
Concomitant
Venous Thrombosis 7/22/2009 United Kingdom
Primary
Secondary
Renal Vein Thrombosis Male 7/22/2009 United Kingdom
Primary
Secondary
Renal Vein Thrombosis Male 7/22/2009 United Kingdom
Primary
Secondary
Intracranial Venous Sinus Thrombosis Male 7/22/2009 United Kingdom
Primary
Secondary
Renal Vein Thrombosis Male 7/22/2009 United Kingdom
Primary
Secondary
Renal Vein Thrombosis Male 7/22/2009 United Kingdom
Primary
Secondary
Venous Thrombosis Male 7/22/2009 United Kingdom
Primary
Secondary
Renal Vein Thrombosis Male 7/22/2009 Physician United Kingdom
Primary
Secondary
Venous Thrombosis Male 7/22/2009 Physician United Kingdom
Primary
Secondary
Venous Thrombosis Female 7/22/2009 United Kingdom
Primary
Secondary
Venous Thrombosis Female 7/22/2009 United Kingdom
Primary
Secondary
Venous Thrombosis Female 7/22/2009 United Kingdom
Primary
Secondary
Venous Thrombosis Female 7/22/2009 United Kingdom
Primary
Secondary
Venous Thrombosis Female 7/22/2009 United Kingdom
Primary
Secondary
Renal Vein Thrombosis Female 7/22/2009 United Kingdom
Primary
Secondary
Venous Thrombosis Male 7/22/2009 United Kingdom
Primary
Secondary
Renal Vein Thrombosis Female 7/22/2009 United Kingdom
Primary
Secondary
Renal Vein Thrombosis Male 7/22/2009 United Kingdom
Primary
Secondary
Renal Vein Thrombosis 7/22/2009 United Kingdom
Primary
Secondary
Renal Vein Thrombosis 7/22/2009 United Kingdom
Primary
Secondary
Renal Vein Thrombosis Female 7/22/2009 United Kingdom
Primary
Secondary
Renal Vein Thrombosis Male 7/22/2009 United Kingdom
Primary
Secondary
Renal Vein Thrombosis Male 7/22/2009 United Kingdom
Primary
Secondary
Renal Vein Thrombosis Male 7/22/2009 United Kingdom
Primary
Secondary
Renal Vein Thrombosis Male 7/22/2009 United Kingdom
Primary
Secondary
Renal Vein Thrombosis Male 7/22/2009 United Kingdom
Primary
Secondary

Drug Data