Cytarabine combined with Gemtuzumab Ozogamicin

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Venoocclusive Disease Life Threatening 11/23/2005 63 Female 121 lb 1/12/2006 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Skin Discolouration Hospitalization 4/13/2006 Male 196 lb 4/24/2006 United States
Primary
Secondary
Infusion Related Reaction Other Serious 9/15/2005 76 Female 7/6/2006 Other Health Professional United States
Primary
Secondary
Prothrombin Time Prolonged Life Threatening 3/8/2006 73 Male 5/24/2006 Japan
Primary
Concomitant
White Blood Cell Count Increased Life Threatening 3/8/2006 73 Male 7/11/2006 Japan
Primary
Concomitant
Ventricular Tachycardia Life Threatening 1/1/2005 70 Male 7/13/2006 Other Health Professional Germany
Primary
Secondary
Ventricular Tachycardia Life Threatening 11/10/2005 70 Male 7/19/2006 United States
Primary
Secondary
Concomitant
Prothrombin Time Prolonged Life Threatening 3/8/2006 73 Male 7/18/2006 Japan
Primary
Concomitant
Weight Increased Life Threatening 12/21/2004 62 Male 8/17/2006 United States
Primary
Secondary
Febrile Neutropenia Other Serious 5/15/2006 83 Female 9/13/2006 United States
Primary
Secondary
Concomitant
Weight Increased Life Threatening 12/21/2004 62 Male 9/14/2006 United States
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Other Serious 1/16/2006 37 Male 9/21/2006 Japan
Primary
Secondary
Concomitant
Thrombocytopenia Hospitalization 8/20/2006 35 Female 11/20/2006 United States
Primary
Secondary
White Blood Cell Count Decreased Other Serious 11/21/2005 37 Male 11/22/2006 Other Health Professional Japan
Primary
Secondary
Concomitant
Myocardial Infarction Death 6/26/2005 Male 166 lb 2/2/2007 Physician Germany
Primary
Secondary
White Blood Cell Count Decreased Death 4/15/2006 44 Female 103 lb 3/8/2007 Physician Belgium
Primary
Secondary
Concomitant
Respiratory Failure Other Serious 12/20/2005 Female 150 lb 3/20/2007 Physician Netherlands
Primary
Secondary
Concomitant
Hypokalaemia Other Serious 4/26/2004 Female 3/20/2007 Physician Belgium
Primary
Secondary
Concomitant
Lung Infiltration Other Serious 1/5/2004 Female 150 lb 3/26/2007 Physician Netherlands
Primary
Secondary
Concomitant
Respiratory Failure Other Serious 2/1/2005 Female 154 lb 3/26/2007 Physician Italy
Primary
Secondary
Concomitant
Vomiting Hospitalization 3/1/2007 4/5/2007 Physician Italy
Primary
Secondary
Venoocclusive Liver Disease Life Threatening 2/19/2007 49 Male 4/11/2007 Physician France
Primary
Secondary
Concomitant
Vomiting Life Threatening 3/1/2007 203 lb 4/17/2007 Physician Italy
Primary
Secondary
Concomitant
Sepsis Hospitalization 4/8/2007 Male 4/19/2007 Physician United Kingdom
Primary
Concomitant
Myocardial Infarction Death 6/26/2005 Male 166 lb 4/24/2007 Physician Germany
Primary
Secondary
Vomiting Life Threatening 3/1/2007 203 lb 6/12/2007 Physician Italy
Primary
Secondary
Concomitant
Febrile Neutropenia Hospitalization 5/27/2007 Male 148 lb 6/22/2007 Physician Italy
Primary
Secondary
Concomitant
Myocardial Infarction Death 6/26/2005 Male 166 lb 7/3/2007 Physician Germany
Primary
Secondary
Septic Shock Death 6/30/2007 Male 150 lb 7/10/2007 Physician Italy
Primary
Secondary
Concomitant
Respiratory Failure Life Threatening 6/23/2006 74 Male 7/5/2007 Belgium
Primary
Secondary
Concomitant
Pneumonitis Life Threatening 6/23/2006 Male 170 lb 7/17/2007 Physician Belgium
Primary
Secondary
Concomitant
Pneumonitis Life Threatening 6/23/2006 Male 170 lb 7/30/2007 Physician Belgium
Primary
Secondary
Concomitant
Pneumonia Death 2/20/2007 75 Male 7/30/2007 Other Health Professional United Kingdom
Primary
Secondary
Septic Shock Death 6/30/2007 Male 150 lb 8/9/2007 Physician Italy
Primary
Secondary
Concomitant
Sepsis Hospitalization 8/10/2007 8/21/2007 Physician United Kingdom
Primary
Secondary
Neutropenic Sepsis Death 8/13/2007 8/21/2007 Physician United Kingdom
Primary
Secondary
Neutropenic Sepsis Death 8/13/2007 8/21/2007 Physician United Kingdom
Primary
Secondary
Fungal Infection Hospitalization 4/13/2007 9/20/2007 Physician Italy
Primary
Secondary
Concomitant
Fungal Infection Hospitalization 4/13/2007 Male 159 lb 9/21/2007 Physician Italy
Primary
Secondary
Concomitant
Pericardial Effusion Other Serious 9/12/2007 46 Male 204 lb 9/24/2007 Physician Canada
Primary
Concomitant
Venoocclusive Liver Disease Life Threatening 9/23/2007 Male 192 lb 10/17/2007 Physician United Kingdom
Primary
Secondary
Concomitant
Hepatic Failure Death 11/13/2006 Male 168 lb 10/24/2007 Physician Italy
Primary
Secondary
Concomitant
Skin Hyperpigmentation Other Serious 1/1/2007 Male 10/30/2007 Physician United Kingdom
Primary
Secondary
Skin Hyperpigmentation Other Serious 1/1/2007 Male 11/1/2007 Physician United Kingdom
Primary
Secondary
Skin Hyperpigmentation Other Serious 1/1/2007 Male 11/2/2007 Physician United Kingdom
Primary
Secondary
Sepsis Hospitalization 10/30/2007 Female 123 lb 12/4/2007 Physician Italy
Primary
Secondary
Concomitant
Rash Pruritic Hospitalization 11/10/2007 47 Male 197 lb 12/7/2007 Physician Canada
Primary
Secondary
Concomitant
Sepsis Hospitalization 10/30/2007 Female 123 lb 12/14/2007 Physician Italy
Primary
Secondary
Concomitant
Multi-organ Failure Death 11/13/2006 Male 168 lb 12/26/2007 Physician Italy
Primary
Secondary
Concomitant
Cardiac Arrest Hospitalization 5/29/2007 Male 148 lb 1/15/2008 Physician Italy
Primary
Secondary
Concomitant
Rash Pruritic Hospitalization 11/10/2007 47 Male 197 lb 1/18/2008 Physician Canada
Primary
Secondary
Concomitant
Acute Respiratory Distress Syndrome Hospitalization 1/15/2008 58 Female 198 lb 1/22/2008 Physician Canada
Primary
Concomitant
Tumour Lysis Syndrome Other Serious 1/15/2008 58 Female 198 lb 2/1/2008 Physician Canada
Primary
Concomitant
Renal Failure Acute Life Threatening 2/6/2008 Male 2/19/2008 Physician United Kingdom
Primary
Secondary
Respiratory Failure Life Threatening 2/23/2007 Male 170 lb 3/7/2008 Physician Netherlands
Primary
Secondary
Concomitant
Respiratory Disorder Hospitalization 1/1/2008 Male 4/24/2008 Pharmacist United Kingdom
Primary
Concomitant
Pulmonary Haemorrhage Other Serious 5/1/2008 Male 6/12/2008 Physician United Kingdom
Primary
Secondary
Respiratory Failure Life Threatening 1/31/2007 Male 170 lb 6/12/2008 Physician Netherlands
Primary
Secondary
Concomitant
Pulmonary Haemorrhage Other Serious 5/1/2008 Male 6/17/2008 Physician United Kingdom
Primary
Secondary
Sepsis Other Serious 5/1/2008 Female 7/17/2008 Physician Denmark
Primary
Secondary
Renal Failure Other Serious 11/15/2003 Male 7/18/2008 Physician Belgium
Primary
Secondary
Concomitant
Renal Failure Other Serious 11/15/2003 Male 7/21/2008 Physician Belgium
Primary
Secondary
Concomitant
Renal Failure Other Serious 11/15/2003 Male 7/22/2008 Physician Belgium
Primary
Secondary
Concomitant
Respiratory Failure Life Threatening 1/31/2007 Male 170 lb 7/23/2008 Physician Netherlands
Primary
Secondary
Concomitant
Thrombophlebitis Other Serious 7/11/2008 49 Male 179 lb 7/29/2008 Physician Sweden
Primary
Secondary
Respiratory Failure Life Threatening 1/31/2007 Male 170 lb 8/6/2008 Physician Netherlands
Primary
Secondary
Concomitant
Fatigue Other Serious 7/18/2008 25 Male 165 lb 9/11/2008 Physician Sweden
Primary
Secondary
Lung Disorder Life Threatening 5/5/2007 Female 106 lb 10/1/2008 Physician France
Primary
Secondary
Concomitant
Respiratory Failure Hospitalization 8/22/2008 59 Male 267 lb 10/3/2008 Physician Canada
Primary
Secondary
Myocardial Infarction Life Threatening 9/26/2008 10/6/2008 Physician United Kingdom
Primary
Secondary
Pulmonary Haemorrhage Hospitalization 9/25/2008 59 Female 194 lb 10/9/2008 Physician Canada
Primary
Secondary
Tachypnoea Other Serious 9/1/2008 10/9/2008 Physician United Kingdom
Primary
Secondary
Cardiac Arrest Death 9/19/2008 Male 10/10/2008 Physician United Kingdom
Primary
Secondary
Hypoxia Death 7/23/2007 60 Male 247 lb 10/15/2008 Physician Canada
Primary
Secondary
Platelet Count Decreased Other Serious Male 10/17/2008 Other Health Professional Japan
Primary
Concomitant
Liver Disorder Life Threatening 1/26/2008 Female 161 lb 11/12/2008 Physician France
Primary
Concomitant
Jaundice Hospitalization 4/1/2008 Male 11/12/2008 Physician France
Primary
Secondary
Subdural Haemorrhage Life Threatening 8/1/2008 Male 11/12/2008 Physician United Kingdom
Primary
Concomitant
Respiratory Distress Life Threatening 9/24/2008 Male 110 lb 11/12/2008 Physician France
Primary
Secondary
Respiratory Distress Life Threatening 9/24/2008 Male 110 lb 11/14/2008 Physician France
Primary
Secondary
Subdural Haemorrhage Life Threatening 8/1/2008 Male 11/20/2008 Physician United Kingdom
Primary
Concomitant
Fall Other Serious 11/1/2008 Male 165 lb 12/1/2008 Physician France
Primary
Secondary
Fall Other Serious 11/1/2008 Male 165 lb 12/9/2008 Physician France
Primary
Secondary
Tubulointerstitial Nephritis Other Serious 4/19/2007 47 Female 12/22/2008 Physician Denmark
Primary
Secondary
Clostridium Difficile Colitis Hospitalization 10/29/2008 56 Female 247 lb 12/23/2008 Physician United States
Primary
Secondary
Stenotrophomonas Infection Life Threatening 10/1/2008 35 Male 174 lb 1/15/2009 Physician Spain
Primary
Secondary
Stenotrophomonas Infection Life Threatening 10/1/2008 35 Male 174 lb 1/16/2009 Physician Spain
Primary
Secondary
Pneumonitis Hospitalization 1/12/2009 39 Female 199 lb 1/28/2009 Physician Canada
Primary
Secondary
Stenotrophomonas Infection Life Threatening 10/1/2008 35 Male 174 lb 1/29/2009 Physician Spain
Primary
Secondary
Sepsis Hospitalization 2/5/2009 55 Male 182 lb 2/20/2009 Physician Canada
Primary
Secondary
Thrombocytopenia Hospitalization 1/20/2009 Female 132 lb 3/2/2009 Physician France
Primary
Secondary
Sepsis Hospitalization 2/21/2009 Female 116 lb 3/10/2009 United States
Primary
Secondary
Septic Embolus Other Serious 3/1/2009 Female 112 lb 3/26/2009 Physician United Kingdom
Primary
Secondary
Concomitant
Foetal Growth Retardation Other Serious 3/27/2009 Other Health Professional Germany
Primary
Secondary
Concomitant
Unresponsive To Stimuli Life Threatening 3/4/2009 3/31/2009 Physician United Kingdom
Primary
Secondary
Urine Output Decreased Other Serious 5/12/2009 Female 5/26/2009 Physician United Kingdom
Primary
Concomitant
Disease Progression Hospitalization 5/5/2009 60 Female 166 lb 5/28/2009 Physician Canada
Primary
Secondary
Sepsis Hospitalization 10/6/2003 73 Female 203 lb 6/1/2009 Physician Belgium
Primary
Secondary
Concomitant
Venoocclusive Liver Disease Life Threatening 6/27/2009 Female 192 lb 7/17/2009 Physician France
Primary
Secondary
Concomitant
Septic Shock Other Serious 10/25/2009 52 Male 134 lb 10/29/2009 Physician Spain
Primary
Concomitant
Septic Shock Other Serious 10/25/2009 52 Male 134 lb 11/5/2009 Physician Spain
Primary
Secondary
Concomitant
Supraventricular Extrasystoles Required Intervention Male 4 lb 11/16/2009 Physician Germany
Primary
Concomitant
Septic Shock Other Serious 10/25/2009 52 Male 134 lb 12/1/2009 Physician Spain
Primary
Secondary
Concomitant
Venoocclusive Liver Disease Other Serious 12/1/2008 31 Male 12/1/2009 Other Health Professional Japan
Primary
Secondary
Concomitant
Venoocclusive Liver Disease Other Serious 12/1/2008 31 Male 12/1/2009 Other Health Professional Japan
Primary
Secondary
Concomitant
Renal Failure Life Threatening 3/26/2009 55 Male 150 lb 12/7/2009 Physician Spain
Primary
Secondary
Rectal Haemorrhage Life Threatening 12/15/2009 Physician Netherlands
Primary
Secondary
Renal Failure Life Threatening 3/26/2009 55 Male 12/15/2009 Physician Spain
Primary
Secondary
Multi-organ Failure Death 11/13/2006 Male 168 lb 12/15/2009 Physician Italy
Primary
Secondary
Concomitant
Renal Failure Life Threatening 3/26/2009 55 Male 150 lb 1/12/2010 Physician Spain
Primary
Secondary
Vitamin B Complex Deficiency Hospitalization 7/27/2009 Female 144 lb 2/9/2010 United States
Primary
Secondary
Sepsis Life Threatening 3/1/2010 Male 3/4/2010 Physician United Kingdom
Primary
Secondary
Sepsis Life Threatening 2/1/2010 Male 3/16/2010 Physician United Kingdom
Primary
Secondary
Sepsis Life Threatening 2/1/2010 Male 3/17/2010 Physician United Kingdom
Primary
Secondary
Sepsis Life Threatening 2/1/2010 Male 3/18/2010 Physician United Kingdom
Primary
Secondary
Bone Marrow Failure Life Threatening 8/26/2006 71 Male 168 lb 4/28/2010 Physician France
Primary
Secondary
Concomitant
Thrombocytopenia Other Serious 43 Male 4/28/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Multi-organ Failure Hospitalization 4/13/2007 69 Male 159 lb 4/29/2010 Physician Italy
Primary
Secondary
Concomitant
Pancreatitis Life Threatening 6/16/2010 United States
Primary
Secondary
Concomitant
Respiratory Failure Life Threatening 6/16/2010 United States
Primary
Secondary
Concomitant
Hepatic Function Abnormal Life Threatening 6/16/2010 United States
Primary
Secondary
Concomitant
Respiratory Failure Life Threatening 6/17/2010 United States
Primary
Secondary
Concomitant
Pancreatitis Life Threatening 6/17/2010 United States
Primary
Secondary
Concomitant
Death Death 6/14/2010 65 Male 187 lb 6/22/2010 Physician France
Primary
Concomitant
Atrial Fibrillation Other Serious 6/24/2010 United States
Primary
Secondary
Concomitant
Multi-organ Failure Hospitalization 4/13/2007 69 Male 159 lb 6/29/2010 Physician Italy
Primary
Secondary
Concomitant
Hepatotoxicity Life Threatening 7/12/2010 64 Male 170 lb 7/22/2010 Physician France
Primary
Secondary
Concomitant
Thrombocytopenia Hospitalization 7/5/2010 70 Female 121 lb 7/27/2010 Physician France
Primary
Secondary
Concomitant
Hepatotoxicity Life Threatening 7/12/2010 64 Male 170 lb 8/2/2010 Physician France
Primary
Secondary
Concomitant
Tachycardia Other Serious 4/1/2010 73 Female 9/14/2010 Physician United Kingdom
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Other Serious 1/29/2010 49 Male 110 lb 12/13/2010 Physician Japan
Primary
Concomitant
White Blood Cell Count Decreased Other Serious 1/29/2010 49 Male 110 lb 12/13/2010 Physician Japan
Primary
Concomitant
Febrile Neutropenia Hospitalization 11/1/2010 67 Male 176 lb 12/15/2010 Other Health Professional Spain
Primary
Secondary
Concomitant
Hiccups Death 7/30/2010 49 Male 110 lb 12/17/2010 Physician Japan
Primary
Secondary
Concomitant
Neutropenia Other Serious 75 12/22/2010 Physician Japan
Primary
Secondary
Transaminases Increased Other Serious 66 12/22/2010 Physician Japan
Primary
Secondary
Rectal Haemorrhage Life Threatening 1/4/2011 Physician Netherlands
Primary
Secondary
Rectal Haemorrhage Other Serious 5/10/2007 67 Female 140 lb 1/4/2011 Physician Netherlands
Primary
Secondary
Concomitant
Neutropenic Sepsis Death 1/21/2010 68 Male 1/27/2011 Physician United Kingdom
Primary
Secondary
Acute Myeloid Leukaemia Death 9/15/2009 76 Female 1/31/2011 Physician United Kingdom
Primary
Secondary
Staphylococcal Infection Other Serious 8/26/2010 63 Female 1/28/2011 Physician United Kingdom
Primary
Secondary
Concomitant
Thrombocytopenia Death 7/5/2010 70 Female 121 lb 1/31/2011 Physician France
Primary
Secondary
Concomitant
Deep Vein Thrombosis Hospitalization 2/21/2010 64 Female 148 lb 1/31/2011 Physician France
Primary
Secondary
Concomitant
Epilepsy Hospitalization 9/1/2010 70 Female 2/1/2011 Physician United Kingdom
Primary
Secondary
Concomitant
Multi-organ Failure Death 1/25/2010 66 Male 2/1/2011 Physician United Kingdom
Primary
Secondary
Concomitant
Carpal Tunnel Syndrome Disability 11/21/2009 70 Male 2/1/2011 Physician United Kingdom
Primary
Secondary
Ascites Life Threatening 12/6/2008 44 Male 2/1/2011 Physician France
Primary
Secondary
Concomitant
Acute Respiratory Distress Syndrome Death 3/23/2010 62 Female 2/1/2011 Physician United Kingdom
Primary
Secondary
Sepsis Life Threatening 2/1/2010 70 Male 2/1/2011 Physician United Kingdom
Primary
Secondary
Crohn's Disease Life Threatening 7/12/2010 64 Male 170 lb 2/1/2011 Physician France
Primary
Secondary
Concomitant

Drug Data