Methotrexate combined with Peg-L-Asparaginase (K-H)

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Tachycardia Death 2/1/2006 Male 42 lb 2/8/2006 United States
Primary
Secondary
Weight Decreased Other Serious 2/18/2006 14 Female 40 lb 3/2/2006 United States
Primary
Secondary
Respiratory Failure Hospitalization 3/14/2006 Male 251 lb 4/10/2006 United States
Primary
Secondary
Wound Drainage Hospitalization 4/24/2006 Male 21 lb 4/27/2006 United States
Primary
Secondary
Tracheal Haemorrhage Other Serious 3/7/2006 Male 32 lb 3/20/2006 United States
Primary
Secondary
Ventricular Fibrillation Death 5/9/2006 11 Male 176 lb 6/11/2006 United States
Primary
Secondary
Haemorrhage Intracranial Hospitalization 6/7/2006 Female 109 lb 6/16/2006 United States
Primary
Secondary
Tachycardia Hospitalization 6/28/2006 Female 50 lb 7/7/2006 United States
Primary
Secondary
Staphylococcal Infection Hospitalization 5/9/2006 Female 171 lb 7/7/2006 United States
Primary
Secondary
Urosepsis Hospitalization 6/27/2006 Female 176 lb 7/13/2006 United States
Primary
Secondary
Tachycardia Hospitalization 6/28/2006 Female 50 lb 7/27/2006 United States
Primary
Secondary
Concomitant
White Blood Cell Count Increased Hospitalization 6/2/2006 Male 33 lb 8/11/2006 United States
Primary
Secondary
Vomiting Hospitalization 8/14/2006 Female 180 lb 8/15/2006 United States
Primary
Secondary
Concomitant
Pulmonary Embolism Hospitalization 8/23/2006 Male 53 lb 8/24/2006 United States
Primary
Secondary
Therapy Non-responder Hospitalization 8/24/2006 10 Male 117 lb 8/25/2006 United States
Primary
Secondary
Urticaria Generalised Hospitalization 8/25/2006 Female 33 lb 8/29/2006 United States
Primary
Secondary
Concomitant
White Blood Cell Count Increased Hospitalization 6/2/2006 Male 33 lb 8/28/2006 United States
Primary
Secondary
Urticaria Generalised Hospitalization 8/25/2006 Female 33 lb 9/1/2006 United States
Primary
Secondary
Vomiting Hospitalization 8/14/2006 Female 180 lb 9/5/2006 United States
Primary
Secondary
Concomitant
Pulmonary Embolism Hospitalization 8/23/2006 Male 53 lb 9/12/2006 United States
Primary
Secondary
Vomiting Hospitalization 9/15/2006 Male 29 lb 9/15/2006 United States
Primary
Secondary
Concomitant
Liver Disorder Hospitalization 9/1/2006 Female 143 lb 9/15/2006 United States
Primary
Secondary
Septic Shock Hospitalization 8/30/2006 Female 35 lb 9/12/2006 United States
Primary
Secondary
Vomiting Hospitalization 9/12/2006 Male 146 lb 9/18/2006 United States
Primary
Secondary
Septic Shock Hospitalization 9/1/2006 Female 188 lb 9/13/2006 Other Health Professional United States
Primary
Secondary
Therapy Non-responder Hospitalization 9/20/2006 Female 66 lb 9/22/2006 United States
Primary
Secondary
Pyrexia Hospitalization 9/24/2006 Female 154 lb 10/11/2006 United States
Primary
Secondary
Septic Shock Hospitalization 9/1/2006 Female 188 lb 10/26/2006 United States
Primary
Secondary
Vomiting Hospitalization 9/15/2006 Male 29 lb 11/6/2006 United States
Primary
Secondary
Concomitant
Sepsis Hospitalization Female 87 lb 11/9/2006 United States
Primary
Secondary
Concomitant
Venoocclusive Liver Disease Hospitalization 11/23/2006 Female 40 lb 11/27/2006 Other Health Professional United States
Primary
Secondary
Weight Increased Hospitalization 11/23/2006 Female 40 lb 11/30/2006 Other Health Professional United States
Primary
Secondary
Vulval Disorder Hospitalization 11/27/2006 Female 188 lb 12/6/2006 United States
Primary
Secondary
White Blood Cell Count Decreased Hospitalization 10/18/2006 Female 87 lb 12/13/2006 United States
Primary
Secondary
Concomitant
Wheezing Hospitalization 12/1/2006 Male 38 lb 12/14/2006 United States
Primary
Secondary
Vulval Erythema Hospitalization 12/10/2006 Female 138 lb 12/18/2006 United States
Primary
Secondary
Ventricular Tachycardia Hospitalization 12/14/2006 Female 140 lb 12/18/2006 United States
Primary
Secondary
Vomiting Hospitalization 11/23/2006 Female 40 lb 12/18/2006 United States
Primary
Secondary
Vomiting Hospitalization 12/10/2006 Female 100 lb 1/12/2007 United States
Primary
Secondary
Ventricular Tachycardia Hospitalization 12/14/2006 Female 140 lb 1/18/2007 United States
Primary
Secondary
Tracheal Haemorrhage 12/22/2006 Female 43 lb 1/25/2007 United States
Primary
Secondary
Concomitant
Sinusitis Fungal Hospitalization 2/22/2007 Male 227 lb United States
Primary
Secondary
White Blood Cell Count Decreased 3/7/2007 Female 66 lb 3/9/2007 United States
Primary
Secondary
White Blood Cell Count Decreased Female 66 lb 3/20/2007 United States
Primary
Secondary
Vulval Ulceration Hospitalization 11/27/2006 Female 188 lb 3/20/2007 United States
Primary
Secondary
Concomitant
Respiratory Arrest Hospitalization 4/9/2007 Female 30 lb 4/24/2007 United States
Primary
Secondary
Vomiting Hospitalization 9/12/2006 Male 146 lb 5/2/2007 United States
Primary
Secondary
Jaundice Hospitalization 7/5/2007 Female 61 lb 7/6/2007 United States
Primary
Secondary
Tachypnoea Hospitalization 3/15/2007 Female 183 lb 7/20/2007 United States
Primary
Secondary
Vomiting Hospitalization 7/27/2007 Male 28 lb 7/27/2007 United States
Primary
Secondary
Respiratory Distress Hospitalization 8/25/2007 Female 169 lb 8/31/2007 United States
Primary
Secondary
Staphylococcal Infection Hospitalization 10/10/2007 Female 127 lb 10/12/2007 United States
Primary
Secondary
Bladder Perforation Hospitalization 10/13/2007 Female 98 lb 10/16/2007 United States
Primary
Secondary
Pyrexia Hospitalization 9/8/2007 Male 139 lb 10/25/2007 United States
Primary
Secondary
Flatulence Hospitalization 10/13/2007 Female 98 lb 10/29/2007 United States
Primary
Secondary
Renal Tubular Necrosis Hospitalization 8/27/2007 Male 144 lb 11/12/2007 United States
Primary
Secondary
Unresponsive To Stimuli Hospitalization 11/21/2007 Female 45 lb 11/21/2007 United States
Primary
Secondary
Vomiting Hospitalization 8/27/2007 Male 144 lb 12/5/2007 United States
Primary
Secondary
Unresponsive To Stimuli Hospitalization 11/21/2007 Female 45 lb 12/5/2007 United States
Primary
Secondary
Supraventricular Extrasystoles Hospitalization 12/12/2007 Male 139 lb 12/19/2007 United States
Primary
Secondary
Status Epilepticus Hospitalization 12/16/2007 Female 118 lb 12/28/2007 United States
Primary
Secondary
Pain In Extremity Hospitalization 10/15/2007 Female 110 lb 1/4/2008 United States
Primary
Secondary
Thrombosis Hospitalization 12/14/2007 Female 102 lb 1/10/2008 United States
Primary
Secondary
Hemiparesis Hospitalization 2/13/2008 Female 42 lb 2/13/2008 United States
Primary
Secondary
Cerebrovascular Accident Hospitalization 2/13/2008 Female 42 lb 2/26/2008 United States
Primary
Secondary
Pseudomonal Sepsis Hospitalization 2/21/2008 Female 26 lb 2/29/2008 United States
Primary
Secondary
Small Intestinal Perforation Hospitalization 3/5/2008 Female 117 lb 3/10/2008 United States
Primary
Secondary
Concomitant
Vomiting Hospitalization 3/21/2008 Female 267 lb 3/25/2008 Australia
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Hospitalization 2/15/2008 Female 30 lb 4/16/2008 United States
Primary
Secondary
Pneumoperitoneum Hospitalization 4/28/2008 Female 124 lb 4/30/2008 United States
Primary
Secondary
Pneumoperitoneum Hospitalization 4/28/2008 Female 124 lb 6/11/2008 United States
Primary
Secondary
Tachycardia Hospitalization 7/7/2008 Male 249 lb 7/9/2008 United States
Primary
Secondary
Tachycardia Hospitalization 7/7/2008 Male 249 lb 7/15/2008 United States
Primary
Secondary
Thrombocytopenia Hospitalization 7/10/2008 Female 257 lb 7/28/2008 United States
Primary
Secondary
Weight Increased Hospitalization 8/4/2008 Male 340 lb 8/19/2008 United States
Primary
Secondary
Vomiting Hospitalization 10/20/2008 Female 143 lb 10/23/2008 United States
Primary
Secondary
Haematuria Hospitalization 10/28/2008 Male 205 lb 10/31/2008 United States
Primary
Secondary
Pancreatitis Acute Hospitalization 9/10/2008 Male 205 lb 11/4/2008 United States
Primary
Secondary
Concomitant
Thrombocytopenia Hospitalization 10/13/2008 Female 12 lb 11/10/2008 United States
Primary
Secondary
Urticaria Male 205 lb 11/14/2008 Physician United States
Primary
Secondary
Inflammation Hospitalization 11/1/2008 Male 90 lb 11/18/2008 United States
Primary
Secondary
Concomitant
Thrombocytopenia Hospitalization 10/13/2008 Female 12 lb 11/25/2008 United States
Primary
Secondary
Pyrexia Hospitalization 12/6/2008 Female 18 lb 12/8/2008 United States
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Hospitalization 12/11/2008 Female 15 lb 12/16/2008 United States
Primary
Secondary
Pupil Fixed Hospitalization 12/6/2008 Female 18 lb 12/17/2008 United States
Primary
Secondary
Concomitant
Thrombocytopenia Hospitalization 10/13/2008 Female 12 lb 12/24/2008 United States
Primary
Secondary
Vomiting Hospitalization 12/20/2008 Male 146 lb 12/29/2008 United States
Primary
Secondary
Facial Palsy 1/15/2009 Female 33 lb 1/15/2009 United States
Primary
Secondary
Sepsis Hospitalization 12/26/2008 Female 236 lb 1/15/2009 United States
Primary
Secondary
Vaginal Haemorrhage Hospitalization 9/29/2008 Female 269 lb 2/17/2009 United States
Primary
Secondary
No Therapeutic Response Hospitalization 2/8/2009 Male 236 lb 2/23/2009 United States
Primary
Secondary
Concomitant
Muscular Weakness Hospitalization 1/31/2009 Male 144 lb 3/4/2009 United States
Primary
Secondary
Weight Decreased Hospitalization 3/12/2009 Female 182 lb 3/17/2009 United States
Primary
Secondary
Concomitant
Respiratory Disorder Hospitalization 3/11/2009 Male 32 lb 3/30/2009 United States
Primary
Secondary
Pyrexia Hospitalization 3/30/2009 Male 206 lb 4/7/2009 United States
Primary
Secondary
Vomiting Hospitalization 4/17/2009 Male 272 lb 4/22/2009 United States
Primary
Secondary
Urticaria Hospitalization 5/15/2009 Female 159 lb 5/18/2009 United States
Primary
Secondary
Rash Hospitalization 5/11/2009 Male 236 lb 5/14/2009 United States
Primary
Secondary
Pneumoperitoneum Hospitalization 5/25/2009 Male 104 lb 5/29/2009 United States
Primary
Secondary
Pneumoperitoneum Hospitalization 5/25/2009 Male 104 lb 6/9/2009 United States
Primary
Secondary
Stomatitis Hospitalization 9/2/2009 Female 151 lb 9/4/2009 Canada
Primary
Secondary
Stomatitis Hospitalization 9/2/2009 Female 151 lb 9/11/2009 United States
Primary
Secondary
Subclavian Vein Thrombosis Hospitalization 9/10/2009 Female 326 lb 9/11/2009 United States
Primary
Secondary
Vomiting Hospitalization 10/10/2009 Male 142 lb 10/12/2009 United States
Primary
Secondary
Blood Triglycerides Increased 6/19/2009 Male 143 lb 10/16/2009 United States
Primary
Secondary
Febrile Neutropenia Hospitalization 10/14/2009 Male 170 lb 10/15/2009 United States
Primary
Secondary
Concomitant
Rash Hospitalization 10/20/2009 Male 141 lb 10/21/2009 Peru
Primary
Secondary
Rash Hospitalization 10/20/2009 Male 141 lb 10/26/2009 Peru
Primary
Secondary
Wound Necrosis Hospitalization 10/5/2009 Female 348 lb 10/29/2009 United States
Primary
Secondary
Intracranial Venous Sinus Thrombosis Hospitalization 12/3/2009 Male 174 lb 12/4/2009 United States
Primary
Secondary
Vith Nerve Paralysis Hospitalization 12/10/2009 Male 220 lb 12/15/2009 United States
Primary
Secondary
Concomitant
Pulmonary Embolism Hospitalization 12/12/2009 Male 160 lb 12/15/2009 United States
Primary
Secondary
Pyrexia Hospitalization 1/8/2010 Female 179 lb 1/11/2010 United States
Primary
Secondary
Prothrombin Time Prolonged Hospitalization 12/12/2009 Male 160 lb 1/5/2010 United States
Primary
Secondary
Urticaria Hospitalization 1/11/2010 Male 45 lb 1/12/2010 United States
Primary
Secondary
Post Lumbar Puncture Syndrome Hospitalization 1/11/2010 Female 133 lb 1/18/2010 United States
Primary
Secondary
Weight Decreased Hospitalization 1/11/2010 Female 65 lb 1/14/2010 United States
Primary
Secondary
Concomitant
Thrombocytopenia Hospitalization 12/24/2009 Male 115 lb 1/13/2010 United States
Primary
Secondary
Staphylococcal Bacteraemia Hospitalization 12/5/2009 Male 158 lb 2/4/2010 United States
Primary
Secondary
Superior Sagittal Sinus Thrombosis Hospitalization 1/23/2010 Female 125 lb 2/23/2010 United States
Primary
Secondary
Transverse Sinus Thrombosis Hospitalization 2/1/2010 Female 170 lb 2/25/2010 United States
Primary
Secondary
Vomiting Hospitalization 2/25/2010 Male 164 lb 2/26/2010 United States
Primary
Secondary
Superior Sagittal Sinus Thrombosis Hospitalization 12/3/2009 Male 174 lb 3/10/2010 United States
Primary
Secondary
No Therapeutic Response 2/21/2010 Female 51 lb 3/15/2010 United States
Primary
Secondary
Vomiting Hospitalization 2/25/2010 Male 164 lb 3/16/2010 United States
Primary
Secondary
Pyrexia Hospitalization 3/14/2010 Male 180 lb 3/18/2010 United States
Primary
Secondary
Concomitant
Staphylococcal Infection Hospitalization 3/25/2010 23 Male 175 lb 3/26/2010 United States
Primary
Secondary
Superior Sagittal Sinus Thrombosis Hospitalization 4/2/2010 13 Female 112 lb 4/5/2010 United States
Primary
Secondary
Vomiting Hospitalization 4/29/2010 Female 133 lb 5/4/2010 United States
Primary
Secondary
Vomiting 5/19/2010 20 Male 169 lb 5/20/2010 United States
Primary
Secondary
White Blood Cell Count Decreased Hospitalization 4/15/2010 20 Female 159 lb 5/20/2010 United States
Primary
Secondary
Scedosporium Infection Hospitalization 6/11/2010 32 Male 233 lb 6/17/2010 United States
Primary
Secondary
Vomiting Hospitalization 6/18/2010 32 Male 216 lb 7/21/2010 United States
Primary
Secondary
Vomiting Hospitalization 7/30/2010 21 Male 126 lb United States
Primary
Secondary
Pseudomonal Sepsis Hospitalization 8/11/2010 12 Female 101 lb 8/18/2010 Switzerland
Primary
Secondary
Concomitant
Staphylococcal Infection Hospitalization 9/2/2010 31 Male 207 lb 9/14/2010 Physician United States
Primary
Secondary
Convulsion Hospitalization 9/25/2010 21 Male 233 lb 9/29/2010 United States
Primary
Secondary
Pyrexia Hospitalization 9/24/2010 36 Male 142 lb 10/20/2010 United States
Primary
Secondary
Nausea Hospitalization 11/4/2010 20 Male 174 lb 11/16/2010 United States
Primary
Secondary
Systemic Candida Hospitalization 5/1/2010 19 Female 181 lb 11/29/2010 United States
Primary
Secondary
Pancreatitis Hospitalization 10/29/2010 12 Female 112 lb 11/29/2010 United States
Primary
Secondary
Pyrexia Hospitalization 11/26/2010 32 Female 174 lb 12/16/2010 United States
Primary
Secondary
Weaning Failure Hospitalization 12/8/2010 14 Female 151 lb 12/16/2010 United States
Primary
Secondary
Vomiting Hospitalization 8/19/2010 20 Male 304 lb 12/21/2010 United States
Primary
Secondary
Abdominal Pain Hospitalization 3/14/2009 22 Female 128 lb 1/3/2011 Physician United States
Primary
Secondary
Hypoxia Hospitalization 12/27/2010 21 Female 161 lb 12/29/2010 United States
Primary
Secondary
Pneumatosis Hospitalization 1/26/2011 16 Female 132 lb 2/7/2011 United States
Primary
Secondary
Thought Blocking Hospitalization 2/16/2011 22 Male 169 lb 3/8/2011
Primary
Secondary
Concomitant
Haemorrhage Hospitalization 12/21/2010 11 Male 108 lb 3/15/2011
Primary
Secondary
Febrile Neutropenia Hospitalization 3/18/2011 25 Male 174 lb 3/30/2011 Physician United States
Primary
Secondary

Drug Data