Cytarabine combined with Mylotarg

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Sepsis Death 12/7/2005 31 Male 1/23/2006 Other Health Professional Japan
Primary
Secondary
Concomitant
Vomiting Life Threatening 11/7/2005 71 Male 1/26/2006 Other Health Professional Japan
Primary
Secondary
Concomitant
Ventricular Tachycardia Life Threatening 11/27/2005 74 Male 1/30/2006 Japan
Primary
Concomitant
Vomiting Hospitalization 1/16/2006 Male 159 lb 1/30/2006 United States
Primary
Secondary
Weight Increased Life Threatening 6/10/2001 19 Female 2/8/2006 United States
Primary
Secondary
Infection Life Threatening 6/8/2002 38 Male 2/8/2006 United States
Primary
Concomitant
Weight Decreased Other Serious 6/10/2002 56 Male 2/8/2006 United States
Primary
Secondary
Pulmonary Oedema Other Serious 6/26/2002 34 Female 2/8/2006 United States
Primary
Concomitant
Ventricular Dysfunction Other Serious 4/15/2002 59 Female 2/8/2006 United States
Primary
Secondary
Concomitant
Subarachnoid Haemorrhage Life Threatening 1/2/2003 51 Male 2/8/2006 United States
Primary
Concomitant
Thrombosis Death 10/31/2005 77 Male 2/23/2006 Japan
Primary
Concomitant
Transaminases Increased Life Threatening 1/30/2006 61 Female 2/22/2006 United States
Primary
Secondary
Concomitant
International Normalised Ratio Increased Other Serious 12/28/2005 2/23/2006 United States
Primary
Concomitant
Platelet Count Decreased Life Threatening 10/10/2005 43 Female 2/27/2006 Japan
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Life Threatening 11/21/2005 66 Male 3/9/2006 Japan
Primary
Secondary
Concomitant
Pyrexia Other Serious 2/2/2006 49 Female 180 lb 3/9/2006 United States
Primary
Concomitant
Weight Increased Life Threatening 12/30/2005 77 Female 137 lb 3/9/2006 United States
Primary
Concomitant
Pyrexia Other Serious 5/15/2005 82 Male 210 lb 3/13/2006 United States
Primary
Concomitant
Infusion Related Reaction Other Serious 7/23/2004 63 Male 190 lb 3/13/2006 United States
Primary
Concomitant
Staphylococcal Bacteraemia Other Serious 1/30/2004 73 Female 134 lb 3/14/2006 United States
Primary
Concomitant
Infusion Related Reaction Other Serious 12/6/2002 64 Male 146 lb 3/14/2006 United States
Primary
Concomitant
Weight Increased Other Serious 4/24/2004 45 Female 175 lb 3/14/2006 United States
Primary
Concomitant
Wheezing Other Serious 4/22/2004 63 Male 202 lb 3/14/2006 United States
Primary
Concomitant
Pneumonia Fungal Other Serious 10/16/2003 50 Male 183 lb 3/17/2006 United States
Primary
Secondary
Concomitant
Weight Increased Other Serious 2/2/2006 70 Male 167 lb 3/17/2006 United States
Primary
Concomitant
Venoocclusive Liver Disease Hospitalization 9/10/2005 51 Male 205 lb 3/20/2006 United States
Primary
Concomitant
Thrombocytopenia Hospitalization 7/5/2005 43 Male 219 lb 3/20/2006 United States
Primary
Secondary
White Blood Cell Count Decreased Life Threatening 10/10/2005 43 Female 3/20/2006 Japan
Primary
Secondary
Concomitant
Thrombocytopenia Hospitalization 3/17/2005 37 Male 227 lb 3/24/2006 Other Health Professional United States
Primary
Secondary
Ventricular Tachycardia Life Threatening 11/27/2005 74 Male 3/22/2006 Japan
Primary
Concomitant
Thrombosis Other Serious 5/1/2005 28 Female 152 lb 3/23/2006 United States
Primary
Secondary
White Blood Cell Count Decreased Life Threatening 12/30/2005 77 Female 137 lb 4/4/2006 United States
Primary
Concomitant
White Blood Cell Count Decreased Death 10/31/2005 77 Male 4/5/2006 Japan
Primary
Concomitant
Vomiting Life Threatening 11/22/2005 71 Male 4/10/2006 Japan
Primary
Secondary
Concomitant
Staphylococcal Sepsis Death 12/6/2005 31 Male 4/11/2006 Japan
Primary
Secondary
Concomitant
Transaminases Increased Other Serious 5/27/2005 48 Female 152 lb 4/12/2006 United States
Primary
Concomitant
Transaminases Increased Other Serious 5/27/2005 48 Female 152 lb 4/21/2006 United States
Primary
Concomitant
Pyrexia Other Serious 3/20/2006 Female 144 lb 4/25/2006 United States
Primary
Secondary
Ventricular Dysfunction Other Serious 1/18/2006 7 Male 4/25/2006 Japan
Primary
Concomitant
Renal Disorder Death 3/1/2006 63 Male 5/1/2006 Other Health Professional Japan
Primary
Concomitant
Ventricular Tachycardia Life Threatening 11/27/2005 74 Male 5/5/2006 Japan
Primary
Concomitant
Weight Increased Other Serious 2/2/2006 70 Male 167 lb 5/22/2006 United States
Primary
Concomitant
White Blood Cell Count Decreased Hospitalization 11/24/2005 2 Female 5/22/2006 Other Health Professional Japan
Primary
Concomitant
White Blood Cell Count Decreased Life Threatening 11/21/2005 66 Male 6/7/2006 Japan
Primary
Secondary
Concomitant
Nausea Other Serious 4/8/2004 68 Male 196 lb 6/15/2006 United States
Primary
Concomitant
Pulmonary Haemorrhage Death 6/9/2006 Male 216 lb 6/13/2006 United States
Primary
Secondary
Nausea Other Serious 4/8/2004 68 Male 196 lb 6/21/2006 United States
Primary
Concomitant
Pyrexia Other Serious 9/10/2005 76 Female 131 lb 6/26/2006 United States
Primary
Secondary
White Blood Cell Count Decreased Other Serious 9/27/2005 77 Female 131 lb 6/28/2006 United States
Primary
Concomitant
Venoocclusive Liver Disease Other Serious 8/18/2002 51 Female 107 lb 6/29/2006 United States
Primary
Concomitant
Subarachnoid Haemorrhage Death 6/9/2006 55 Male 216 lb 6/23/2006 United States
Primary
Secondary
Pyrexia Other Serious 7/9/2005 53 Female 201 lb 6/30/2006 United States
Primary
Concomitant
Transaminases Increased Other Serious 5/27/2005 48 Female 152 lb 7/11/2006 United States
Primary
Concomitant
Venoocclusive Liver Disease Other Serious 1/1/2006 68 Male 133 lb 8/2/2006 Physician United States
Primary
Concomitant
Weight Increased Life Threatening 12/1/2004 62 Male 160 lb 8/10/2006 United States
Primary
Secondary
White Blood Cell Count Decreased Life Threatening 11/21/2005 66 Male 8/10/2006 Japan
Primary
Secondary
Concomitant
Sepsis Life Threatening 6/11/2006 78 Female 8/11/2006 Japan
Primary
Secondary
Concomitant
Renal Failure Acute Life Threatening 5/13/2006 18 Male 8/18/2006 Japan
Primary
Concomitant
Venoocclusive Liver Disease Life Threatening 2/18/2004 66 Female 196 lb 8/21/2006 United States
Primary
Secondary
Febrile Neutropenia Other Serious 9/27/2005 77 Female 131 lb 8/29/2006 United States
Primary
Concomitant
Pleural Effusion Other Serious 7/9/2005 53 Female 201 lb 9/1/2006 United States
Primary
Concomitant
Febrile Neutropenia Hospitalization 3/14/2004 68 Male 168 lb 9/1/2006 United States
Primary
Secondary
Concomitant
Weight Increased Life Threatening 12/1/2004 62 Male 160 lb 9/8/2006 United States
Primary
Secondary
Concomitant
Prothrombin Time Prolonged Other Serious 12/28/2005 72 Female 153 lb 9/8/2006 Other Health Professional United States
Primary
Concomitant
White Blood Cell Count Decreased Life Threatening 12/30/2005 77 Female 137 lb 9/8/2006 Other Health Professional United States
Primary
Concomitant
Pulmonary Oedema Life Threatening 12/7/2004 68 Female 199 lb 9/8/2006 Other Health Professional United States
Primary
Secondary
Concomitant
Jaundice Death 8/23/2006 76 Male 9/14/2006 Physician United States
Primary
Secondary
White Blood Cell Count Decreased Life Threatening 2/8/2006 63 Male 9/15/2006 Other Health Professional Japan
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Life Threatening 11/21/2005 66 Male 9/28/2006 Japan
Primary
Secondary
Concomitant
Sepsis Life Threatening 6/11/2006 78 Female 10/13/2006 Japan
Primary
Secondary
Concomitant
Ventricular Hypertrophy Hospitalization 3/26/2003 68 Male 174 lb 10/18/2006 Physician United States
Primary
Concomitant
Pleural Effusion Hospitalization 9/9/2006 Female 120 lb 10/25/2006 United States
Primary
Secondary
Staphylococcal Sepsis Death 12/6/2005 31 Male 10/27/2006 Japan
Primary
Secondary
Concomitant
White Blood Cell Count Increased Other Serious 4/10/2006 63 Male 10/30/2006 Other Health Professional Japan
Primary
Secondary
Concomitant
Pleural Effusion Hospitalization 9/1/2006 45 Female 120 lb 11/2/2006 United States
Primary
Secondary
Thrombocytopenia Hospitalization 12/7/2005 46 Male 11/7/2006 Japan
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Life Threatening 9/4/2006 51 Male 11/8/2006 Japan
Primary
Concomitant
White Blood Cell Count Decreased Life Threatening 10/26/2005 47 Male 11/15/2006 Japan
Primary
Concomitant
White Blood Cell Count Decreased Life Threatening 2/8/2006 63 Male 11/15/2006 Japan
Primary
Secondary
Concomitant
Stomatitis Hospitalization 6/10/2006 28 Male 11/15/2006 Japan
Primary
Secondary
Concomitant
Respiratory Syncytial Virus Infection Hospitalization 11/6/2006 Female 17 lb 11/20/2006 United States
Primary
Secondary
Sepsis Life Threatening 5/16/2006 18 Male 11/21/2006 Japan
Primary
Secondary
Concomitant
Ventricular Flutter Life Threatening 2/27/2006 20 Female 11/21/2006 Japan
Primary
Concomitant
Therapy Non-responder Hospitalization 11/6/2006 Female 17 lb 12/5/2006 United States
Primary
Secondary
Thrombocytopenia Hospitalization 8/16/2006 35 Female 187 lb 12/7/2006 Other Health Professional France
Primary
Secondary
Venoocclusive Liver Disease Hospitalization 12/23/2006 Male 157 lb 12/26/2006 United States
Primary
Secondary
Stomatitis Hospitalization 6/10/2006 28 Male 1/2/2007 Japan
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Life Threatening 2/8/2006 63 Male 1/2/2007 Japan
Primary
Secondary
Concomitant
Sepsis Other Serious 8/28/2006 28 Male 1/8/2007 Japan
Primary
Secondary
Concomitant
Renal Failure Other Serious 7/3/2006 71 Male 1/12/2007 Japan
Primary
Secondary
Concomitant
Pneumonia Hospitalization 12/7/2005 46 Male 1/17/2007 Japan
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Life Threatening 6/20/2006 58 Male 1/17/2007 Japan
Primary
Concomitant
Thrombocytopenia Hospitalization 12/7/2005 46 Male 1/19/2007 Japan
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Life Threatening 6/11/2006 78 Female 1/23/2007 Japan
Primary
Secondary
Concomitant
Sepsis Other Serious 6/10/2006 Male 130 lb 1/30/2007 Physician Japan
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Other Serious 6/28/2006 67 Female 1/25/2007 Japan
Primary
Secondary
Concomitant
Stomatitis Other Serious 9/6/2006 Male 150 lb 1/30/2007 Physician Japan
Primary
Concomitant
Ventricular Failure Other Serious 1/19/2006 Male 40 lb 2/5/2007 Physician Japan
Primary
Secondary
Concomitant
Stomatitis Other Serious 8/28/2006 28 Male 2/5/2007 Japan
Primary
Secondary
Concomitant
Thrombocytopenia Other Serious 12/7/2005 Male 2/13/2007 Physician Japan
Primary
Secondary
Concomitant
Pneumonia Other Serious 6/2/2006 Male 141 lb 2/15/2007 Physician Japan
Primary
Concomitant
Thrombocytopenia Hospitalization 8/16/2006 35 Female 187 lb 2/22/2007 Other Health Professional France
Primary
Secondary
Ventricular Flutter Other Serious 2/27/2006 Female 95 lb 3/5/2007 Physician Japan
Primary
Secondary
Concomitant
Neutropenia Other Serious 5/15/2006 83 Female 2/26/2007 Japan
Primary
Secondary
Concomitant
Sepsis Other Serious 1/1/2006 Male 130 lb 3/7/2007 Physician Japan
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Other Serious 6/20/2006 Male 117 lb 3/9/2007 Physician Japan
Primary
Concomitant
White Blood Cell Count Decreased Other Serious 8/11/2006 56 Male 3/9/2007 United States
Primary
Secondary
Concomitant
Stomatitis Other Serious 8/28/2006 28 Male 3/13/2007 Japan
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Other Serious 3/16/2006 20 Female 3/13/2007 Japan
Primary
Secondary
Concomitant
Renal Failure Other Serious 7/3/2006 71 Male 3/15/2007 Japan
Primary
Secondary
Concomitant
Stomatitis Other Serious 9/6/2006 Male 150 lb 3/26/2007 Physician Japan
Primary
Secondary
Concomitant
Pneumonia Other Serious 5/15/2006 83 Female 3/19/2007 Japan
Primary
Secondary
Concomitant
Weight Increased Other Serious 4/1/2006 35 Male 3/26/2007 United States
Primary
Secondary
Concomitant
Stomatitis Other Serious 9/6/2006 Male 150 lb 4/2/2007 Physician Japan
Primary
Secondary
Concomitant
White Blood Cell Count Increased Other Serious 9/21/2006 Male 170 lb 4/2/2007 Physician Japan
Primary
Concomitant
White Blood Cell Count Increased Death 2/2/2007 Male 108 lb 4/4/2007 Physician Japan
Primary
Concomitant
Sepsis Other Serious 5/16/2006 Male 121 lb 4/5/2007 Physician Japan
Primary
Secondary
Concomitant
Stomatitis Other Serious 9/13/2006 51 Male 3/29/2007 Japan
Primary
Secondary
Concomitant
Weight Increased Other Serious 1/19/2006 Male 40 lb 4/5/2007 Physician Japan
Primary
Secondary
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
Sepsis Other Serious 6/10/2006 Male 130 lb 4/17/2007 Physician Japan
Primary
Secondary
Concomitant
Pseudomembranous Colitis Other Serious 10/30/2006 Male 161 lb 4/17/2007 Physician Japan
Primary
Secondary
Concomitant
Stomatitis Other Serious 9/13/2006 51 Male 4/9/2007 Japan
Primary
Secondary
Concomitant
Stomatitis Other Serious 9/6/2006 Male 150 lb 4/18/2007 Physician Japan
Primary
Secondary
Concomitant
Procedural Complication Hospitalization 3/26/2007 Male 213 lb 4/13/2007 United States
Primary
Secondary
Ventricular Dysfunction Other Serious 3/28/2006 7 Male 4/12/2007 United States
Primary
Secondary
Concomitant
Pneumonia Other Serious 6/2/2006 Male 141 lb 4/24/2007 Physician Japan
Primary
Concomitant
Myocardial Infarction Hospitalization 3/26/2007 47 Male 213 lb 4/24/2007 Physician United States
Primary
Secondary
Pneumonia Other Serious 5/15/2006 83 Female 4/13/2007 Japan
Primary
Secondary
Concomitant
Renal Impairment Other Serious 4/1/2006 62 Male 4/17/2007 Japan
Primary
Secondary
Concomitant
Tachypnoea Hospitalization 4/17/2006 Female 56 lb 4/18/2007 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
Stomatitis Other Serious 8/28/2006 28 Male 4/23/2007 Japan
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Other Serious 8/11/2006 56 Male 4/19/2007 Japan
Primary
Secondary
Concomitant
Stomatitis Other Serious 9/13/2006 51 Male 4/25/2007 United States
Primary
Secondary
Concomitant
Tachypnoea Hospitalization 4/17/2007 Female 56 lb 4/26/2007 United States
Primary
Secondary
White Blood Cell Count Increased Other Serious 2/2/2007 Male 108 lb 5/4/2007 Physician Japan
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
Ventricular Fibrillation Hospitalization 4/22/2007 54 Female 158 lb 6/4/2007 Physician United States
Primary
Secondary
Weight Increased Other Serious 7/3/2006 Female 55 lb 6/8/2007 Physician Japan
Primary
Concomitant
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
Pseudomembranous Colitis Other Serious 10/30/2006 Male 161 lb 6/15/2007 Physician Japan
Primary
Secondary
Concomitant
Swelling Hospitalization 6/16/2007 Female 86 lb 6/18/2007 United States
Primary
Secondary
Venoocclusive Liver Disease Hospitalization 5/31/2007 Male 258 lb 6/19/2007 United States
Primary
Secondary

Drug Data