Daunorubicin Hcl combined with Mylotarg

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Weight Increased Life Threatening 6/10/2001 19 Female 2/8/2006 United States
Primary
Secondary
Weight Decreased Other Serious 6/10/2002 56 Male 2/8/2006 United States
Primary
Secondary
White Blood Cell Count Decreased Life Threatening 11/21/2005 66 Male 3/9/2006 Japan
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Life Threatening 11/21/2005 66 Male 6/7/2006 Japan
Primary
Secondary
Concomitant
Pulmonary Haemorrhage Death 6/9/2006 Male 216 lb 6/13/2006 United States
Primary
Secondary
Subarachnoid Haemorrhage Death 6/9/2006 55 Male 216 lb 6/23/2006 United States
Primary
Secondary
White Blood Cell Count Decreased Life Threatening 11/21/2005 66 Male 8/10/2006 Japan
Primary
Secondary
Concomitant
Pulmonary Oedema Life Threatening 12/7/2004 68 Female 199 lb 9/8/2006 Other Health Professional United States
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Life Threatening 11/21/2005 66 Male 9/28/2006 Japan
Primary
Secondary
Concomitant
Pleural Effusion Hospitalization 9/9/2006 Female 120 lb 10/25/2006 United States
Primary
Secondary
Pleural Effusion Hospitalization 9/1/2006 45 Female 120 lb 11/2/2006 United States
Primary
Secondary
Respiratory Syncytial Virus Infection Hospitalization 11/6/2006 Female 17 lb 11/20/2006 United States
Primary
Secondary
Therapy Non-responder Hospitalization 11/6/2006 Female 17 lb 12/5/2006 United States
Primary
Secondary
Venoocclusive Liver Disease Hospitalization 12/23/2006 Male 157 lb 12/26/2006 United States
Primary
Secondary
White Blood Cell Count Increased Death 2/2/2007 Male 108 lb 4/4/2007 Physician Japan
Primary
Concomitant
General Physical Health Deterioration 10/8/2006 Female 349 lb 4/5/2007 United States
Primary
Secondary
White Blood Cell Count Increased Other Serious 10/1/2006 38 Female 159 lb 4/12/2007 Physician United States
Primary
Secondary
Procedural Complication Hospitalization 3/26/2007 Male 213 lb 4/13/2007 United States
Primary
Secondary
Myocardial Infarction Hospitalization 3/26/2007 47 Male 213 lb 4/24/2007 Physician United States
Primary
Secondary
White Blood Cell Disorder Other Serious 4/8/2007 59 Male 145 lb 4/27/2007 Physician United States
Primary
Secondary
White Blood Cell Count Increased Other Serious 2/2/2007 Male 108 lb 5/4/2007 Physician Japan
Primary
Concomitant
Neutropenia Required Intervention 1/14/2007 79 Male 4/26/2007 Other Health Professional United Kingdom
Primary
Concomitant
Post Procedural Haemorrhage Hospitalization 4/13/2007 Male 145 lb 4/26/2007 United States
Primary
Secondary
White Blood Cell Disorder Other Serious 4/1/2007 59 Male 145 lb 5/10/2007 Physician United States
Primary
Secondary
Post Procedural Complication Hospitalization 4/13/2007 Male 145 lb 5/2/2007 United States
Primary
Secondary
Myocardial Infarction Hospitalization 3/26/2007 47 Male 213 lb 5/15/2007 Physician United States
Primary
Secondary
Concomitant
Ventricular Fibrillation Hospitalization 4/22/2007 Female 158 lb 5/23/2007 United States
Primary
Secondary
Pyrexia Life Threatening 4/29/2007 61 5/29/2007 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Ventricular Fibrillation Hospitalization 4/22/2007 54 Female 158 lb 6/4/2007 Physician United States
Primary
Secondary
Staphylococcal Infection Hospitalization 5/15/2007 Male 183 lb 6/7/2007 United States
Primary
Secondary
Venoocclusive Liver Disease Hospitalization 5/31/2007 Male 258 lb 6/6/2007 United States
Primary
Secondary
Venoocclusive Liver Disease Hospitalization 5/31/2007 Male 258 lb 6/19/2007 United States
Primary
Secondary
Oral Intake Reduced 5/19/2007 Female 130 lb 6/28/2007 United States
Primary
Secondary
Ventricular Fibrillation Hospitalization 4/22/2007 Female 158 lb 7/11/2007 Physician United States
Primary
Secondary
Concomitant
Thrombocytopenia Hospitalization 2/7/2007 Male 234 lb 7/5/2007 United States
Primary
Secondary
Small Intestinal Obstruction Hospitalization 6/1/2007 Male 163 lb 7/11/2007 United States
Primary
Secondary
Pleural Effusion Hospitalization 5/1/2007 43 Male 163 lb 7/23/2007 Physician United States
Primary
Secondary
White Blood Cell Disorder Hospitalization 7/7/2007 39 Female 127 lb 7/26/2007 Physician United States
Primary
Secondary
Transfusion-related Acute Lung Injury Hospitalization 7/16/2007 Female 127 lb 7/18/2007 United States
Primary
Secondary
Pancreatitis Hospitalization 6/27/2007 Female 153 lb 7/23/2007 United States
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Hospitalization 7/23/2007 Female 127 lb 7/23/2007 United States
Primary
Secondary
Sinus Tachycardia Hospitalization 7/19/2007 Female 126 lb 7/20/2007 United States
Primary
Secondary
Renal Failure 4/27/2007 Male 272 lb 7/27/2007 United States
Primary
Secondary
Sinus Tachycardia Hospitalization 7/19/2007 Female 126 lb 8/14/2007 United States
Primary
Secondary
Venoocclusive Liver Disease 8/11/2007 Female 115 lb 8/30/2007 United States
Primary
Secondary
Venoocclusive Liver Disease 8/11/2007 Female 115 lb 8/31/2007 United States
Primary
Secondary
Renal Failure 4/27/2007 Male 272 lb 9/24/2007 United States
Primary
Secondary
White Blood Cell Count Decreased Other Serious 9/12/2006 Female 108 lb 11/6/2007 Physician Japan
Primary
Concomitant
Skin Inflammation Hospitalization 11/10/2007 Male 197 lb 11/28/2007 United States
Primary
Secondary
Concomitant
Swelling Hospitalization 11/10/2007 Male 197 lb 1/11/2008 United States
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Hospitalization 1/15/2008 Female 198 lb 1/15/2008 United States
Primary
Secondary
Respiratory Failure Hospitalization 3/2/2008 48 Male 227 lb 3/7/2008 Physician United States
Primary
Concomitant
Respiratory Failure Hospitalization 5/16/2008 36 Female 138 lb 5/22/2008 Physician United States
Primary
Secondary
Thrombocytopenia Hospitalization 5/16/2008 36 Female 138 lb 6/9/2008 Physician United States
Primary
Secondary
Renal Failure Hospitalization 5/19/2008 Female 31 lb 6/2/2008 United States
Primary
Secondary
Concomitant
Renal Failure Hospitalization 5/19/2008 Female 31 lb 6/9/2008 United States
Primary
Secondary
Concomitant
Platelet Count Decreased Other Serious 2/19/2007 Male 117 lb 6/17/2008 Physician Japan
Primary
Concomitant
Unresponsive To Stimuli Hospitalization 6/9/2008 Male 72 lb 6/12/2008 United States
Primary
Secondary
Unresponsive To Stimuli Hospitalization 6/9/2008 Male 72 lb 6/18/2008 United States
Primary
Secondary
White Blood Cell Count Decreased Other Serious 3/19/2007 Male 165 lb 6/26/2008 Physician Japan
Primary
Secondary
Concomitant
Tumour Lysis Syndrome Life Threatening 11/13/2008 Male 11/21/2008 Other Health Professional United Kingdom
Primary
Concomitant
Urinary Tract Infection Fungal Hospitalization 1/9/2009 Female 37 lb 1/14/2009 United States
Primary
Secondary
Hypercholesterolaemia Hospitalization 2/12/2009 30 Female 212 lb 2/18/2009 Physician United States
Primary
Secondary
Hypercholesterolaemia Hospitalization 2/12/2009 30 Female 212 lb 3/3/2009 Physician United States
Primary
Secondary
Shock Hospitalization 3/1/2009 Female 118 lb 3/2/2009 United States
Primary
Secondary
Concomitant
Leukaemia Death 12/25/2008 63 Male 3/12/2009 United Kingdom
Primary
Secondary
Tumour Lysis Syndrome Hospitalization 3/31/2009 Male 63 lb 4/23/2009 United States
Primary
Secondary
Thrombocytopenia Hospitalization 3/31/2009 Male 63 lb 5/18/2009 United States
Primary
Secondary
Urinary Bladder Haemorrhage Hospitalization 3/28/2009 57 Female 122 lb 6/9/2009 Other Health Professional United States
Primary
Secondary
Xanthochromia Hospitalization 3/31/2009 Male 63 lb 8/6/2009 United States
Primary
Secondary
Septic Shock Hospitalization 8/5/2009 Female 234 lb 8/6/2009 United States
Primary
Secondary
Pneumonia Staphylococcal Other Serious 9/1/2009 56 Male 9/8/2009 Physician United States
Primary
Secondary
Tumour Lysis Syndrome Life Threatening 11/13/2008 Male 9/4/2009 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Acute Respiratory Distress Syndrome Hospitalization 7/20/2009 51 Female 218 lb 10/9/2009 Physician United States
Primary
Secondary
Shock Hospitalization 10/6/2009 Female 200 lb 10/6/2009 United States
Primary
Secondary
Shock Hospitalization 10/6/2009 Female 200 lb 10/13/2009 United States
Primary
Secondary
Tumour Lysis Syndrome Life Threatening 11/13/2008 Male 12/3/2009 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Other Serious 10/22/2009 75 Female 12/18/2009 Physician United Kingdom
Primary
Secondary
Concomitant
Pancytopenia Hospitalization 12/14/2007 65 Male 12/28/2009 Other Health Professional United Kingdom
Primary
Secondary
Renal Tubular Disorder Other Serious 10/16/2009 67 Male 1/12/2010 Physician United States
Primary
Secondary
Vomiting Other Serious 9/14/2009 66 Female 110 lb 1/29/2010 Physician United Kingdom
Primary
Secondary
Concomitant
Thrombocytopenia Other Serious 12/29/2009 Male 2/11/2010 Other Health Professional United Kingdom
Primary
Secondary
Streptococcal Infection Hospitalization 7/3/2009 66 Female 141 lb 2/5/2010 Physician United Kingdom
Primary
Secondary
Concomitant
Thrombocytopenia Other Serious 12/29/2009 Male 2/22/2010 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Vomiting Hospitalization 1/11/2010 Female 2/25/2010 Physician United Kingdom
Primary
Concomitant
Renal Tubular Disorder Other Serious 10/16/2009 67 Male 3/1/2010 Physician United Kingdom
Primary
Secondary
Vomiting Hospitalization 1/11/2010 Female 3/15/2010 Physician United Kingdom
Primary
Concomitant
Thrombocytopenia Other Serious 12/27/2009 Male 3/16/2010 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Vomiting Hospitalization 1/11/2010 63 Female 4/1/2010 Physician United Kingdom
Primary
Concomitant
Subclavian Vein Thrombosis Life Threatening 2/7/2008 66 4/5/2010 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Thrombocytopenia Other Serious 12/27/2009 46 Male 4/9/2010 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Thrombocytopenia Other Serious 12/29/2009 75 Male 4/12/2010 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Vomiting Hospitalization 1/11/2010 63 Female 166 lb 4/13/2010 Physician United Kingdom
Primary
Concomitant
Thrombocytopenia Other Serious 12/29/2009 75 Male 5/4/2010 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Vomiting Hospitalization 1/11/2010 63 Female 166 lb 5/5/2010 Physician United Kingdom
Primary
Concomitant
Thrombocytopenia Other Serious 2/23/2010 61 Male 5/24/2010 Physician United Kingdom
Primary
Secondary
Thrombocytopenia Other Serious 12/27/2009 46 Male 6/8/2010 Other Health Professional United Kingdom
Primary
Concomitant
Interacting
Vaginal Discharge Other Serious 11/2/2009 63 Female 6/16/2010 Physician United Kingdom
Primary
Secondary
Concomitant
Interacting
Thrombocytopenia Other Serious 4/10/2010 61 Male 6/24/2010 Physician United Kingdom
Primary
Secondary
Thrombocytopenia Other Serious 12/29/2009 75 Male 7/7/2010 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Haemoptysis Hospitalization 3/31/2010 7/7/2010 Physician United Kingdom
Primary
Secondary
Thrombocytopenia Other Serious 4/10/2010 61 Male 7/8/2010 Physician United Kingdom
Primary
Secondary
Thrombocytopenia Other Serious 12/27/2009 46 Male 7/16/2010 Other Health Professional United Kingdom
Primary
Concomitant
Interacting
Haemoptysis Hospitalization 3/31/2010 25 Male 7/22/2010 Physician United Kingdom
Primary
Secondary
Thrombocytopenia Other Serious 12/29/2009 75 Male 7/29/2010 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Pneumonia Hospitalization 4/13/2010 72 Female 7/30/2010 Other Health Professional United Kingdom
Primary
Secondary
Vaginal Discharge Other Serious 11/2/2009 63 Female 7/30/2010 Physician United Kingdom
Primary
Secondary
Concomitant
Interacting
Thrombocytopenia Other Serious 12/27/2009 46 Male 9/9/2010 Other Health Professional United Kingdom
Primary
Concomitant
Interacting
Ulcer Other Serious 8/21/2010 59 Male 9/22/2010 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Thrombocytopenia Other Serious 12/16/2009 62 Female 9/21/2010 Physician United Kingdom
Primary
Concomitant
Interacting
Septic Shock Other Serious 10/11/2010 43 Female 10/22/2010 Physician United Kingdom
Primary
Concomitant
Septic Shock Other Serious 10/11/2010 43 Female 10/29/2010 Physician United Kingdom
Primary
Concomitant
Pseudomonas Test Positive Other Serious 8/21/2010 59 Male 11/10/2010 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Tremor Hospitalization 10/8/2010 55 Female 130 lb 11/17/2010 Pharmacist France
Primary
Secondary
Concomitant
Tremor Hospitalization 10/1/2010 50 Female 11/17/2010 Pharmacist France
Primary
Secondary
Tremor Hospitalization 10/8/2010 55 Female 130 lb 11/17/2010 Pharmacist France
Primary
Secondary
Concomitant
Acute Myeloid Leukaemia Recurrent Death 1/20/2011 60 Female 134 lb 4/22/2011 Consumer United Kingdom
Primary
Secondary
Hypokalaemia Life Threatening 5/2/2011 66 Male 5/23/2011 Consumer United Kingdom
Primary
Secondary
Concomitant
Hypokalaemia Life Threatening 5/2/2011 66 Male 5/25/2011 United Kingdom
Primary
Secondary
Concomitant
Lung Infiltration Hospitalization 4/12/2011 57 Female 5/27/2011 Consumer United States
Primary
Secondary
Concomitant
Colitis Life Threatening 4/8/2011 59 Male 6/6/2011 Consumer United States
Primary
Secondary
Acute Myeloid Leukaemia Recurrent Death 5/11/2011 52 Female 6/10/2011 Other Health Professional United Kingdom
Primary
Secondary
Petechiae Other Serious 5/2/2011 66 Male 6/13/2011 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Hypokalaemia Life Threatening 5/2/2011 66 Male 6/14/2011 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Toxicity To Various Agents Hospitalization 4/12/2011 57 Female 6/15/2011 Other Health Professional United States
Primary
Secondary
Concomitant
Neutropenia Life Threatening 5/2/2011 66 Male 6/24/2011 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Myelodysplastic Syndrome Hospitalization 4/12/2011 57 Female 6/24/2011 Consumer United States
Primary
Secondary
Concomitant
Infection Hospitalization 8/21/2010 59 Male 8/3/2011 Consumer United Kingdom
Primary
Secondary
Concomitant
Hypokalaemia Other Serious 12/29/2010 35 Female 8/4/2011 Consumer United States
Primary
Secondary
Concomitant
Neutropenic Sepsis Hospitalization 1/1/2011 39 Female 8/4/2011 Other Health Professional United States
Primary
Secondary
Concomitant
Acute Myeloid Leukaemia Recurrent Death 5/11/2011 52 Female 8/9/2011 Physician United Kingdom
Primary
Secondary
Concomitant
Hepatobiliary Disease Death 8/6/2011 29 Female 8/30/2011 Physician United Kingdom
Primary
Secondary
Cardiac Arrest Hospitalization 2/1/2008 69 Female 10/12/2011 Other Health Professional United Kingdom
Primary
Secondary
Fungal Infection Death 10/26/2007 69 Male 10/12/2011 Physician United Kingdom
Primary
Secondary
Gamma-glutamyltransferase Increased Other Serious 4/18/2007 64 Male 10/14/2011 Consumer United Kingdom
Primary
Secondary
Pancytopenia Other Serious 4/18/2008 76 Male 10/14/2011 Physician United Kingdom
Primary
Secondary
Pyrexia Other Serious 6/16/2007 64 Male 10/14/2011 Consumer United Kingdom
Primary
Secondary
Local Swelling Hospitalization 2/7/2008 66 Female 10/12/2011 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Pancytopenia Life Threatening 4/29/2007 61 Female 10/12/2011 Physician United Kingdom
Primary
Secondary
Concomitant
Blood Creatinine Increased Life Threatening 10/8/2007 69 Female 10/12/2011 Other Health Professional United Kingdom
Primary
Secondary
Neutropenic Sepsis Death 12/8/2008 72 Female 10/24/2011 Physician Denmark
Primary
Secondary
Pulmonary Necrosis Hospitalization 6/18/2008 58 Male 10/24/2011 Other Health Professional United Kingdom
Primary
Secondary
Gamma-glutamyltransferase Increased Other Serious 4/18/2007 64 Male 11/14/2011 Consumer United Kingdom
Primary
Secondary
Platelet Count Increased Other Serious 9/10/2011 46 Female 11/11/2011 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Pulmonary Necrosis Death 6/18/2008 58 Male 11/9/2011 Other Health Professional United Kingdom
Primary
Secondary
Renal Tubular Disorder Other Serious 10/16/2009 67 Male 11/11/2011 Other Health Professional United Kingdom
Primary
Secondary
Pneumonia Life Threatening 55 Male 1/12/2012 Other Health Professional France
Primary
Secondary
Pyrexia Other Serious 64 Female 1/12/2012 Other Health Professional France
Primary
Secondary
Hepatotoxicity Other Serious 60 Male 1/12/2012 Other Health Professional France
Primary
Secondary
Bacteraemia Other Serious 64 1/12/2012 Other Health Professional France
Primary
Secondary

Drug Data