Daunorubicin Hcl combined with Gemtuzumab Ozogamicin

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Skin Hyperpigmentation Other Serious 1/1/2007 Male 10/30/2007 Physician United Kingdom
Primary
Secondary
Rash Pruritic Hospitalization 11/10/2007 47 Male 197 lb 12/7/2007 Physician Canada
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
Pneumonia Hospitalization 5/20/2007 Male 2/12/2008 Physician United Kingdom
Primary
Secondary
Pneumonia Hospitalization 5/20/2007 Male 2/14/2008 Physician United Kingdom
Primary
Secondary
Pneumonia Hospitalization 5/20/2007 Male 2/28/2008 Physician United Kingdom
Primary
Secondary
Nodule Other Serious 4/1/2008 Male 5/6/2008 Physician United Kingdom
Primary
Secondary
Pulmonary Haemorrhage Other Serious 5/1/2008 Male 6/12/2008 Physician United Kingdom
Primary
Secondary
Pulmonary Haemorrhage Other Serious 5/1/2008 Male 6/17/2008 Physician United Kingdom
Primary
Secondary
Jaundice Hospitalization 4/1/2008 Male 7/11/2008 Physician France
Primary
Secondary
Sepsis Other Serious 5/1/2008 Female 7/17/2008 Physician Denmark
Primary
Secondary
Thrombophlebitis Other Serious 7/11/2008 49 Male 179 lb 7/29/2008 Physician Sweden
Primary
Secondary
Sepsis Other Serious 1/1/2008 Male 7/30/2008 Physician United Kingdom
Primary
Secondary
Pancytopenia Hospitalization 6/18/2008 Male 8/21/2008 Physician United Kingdom
Primary
Secondary
Pancytopenia Hospitalization 6/18/2008 Male 8/21/2008 Physician United Kingdom
Primary
Secondary
Fatigue Other Serious 7/18/2008 25 Male 165 lb 9/11/2008 Physician Sweden
Primary
Secondary
Sepsis Life Threatening 9/11/2008 Female 9/16/2008 Physician United Kingdom
Primary
Secondary
Sepsis Life Threatening 9/11/2008 Female 9/24/2008 Physician United Kingdom
Primary
Secondary
Tachypnoea Other Serious 9/1/2008 10/2/2008 Physician United Kingdom
Primary
Secondary
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
Tachypnoea Other Serious 9/1/2008 10/9/2008 Physician United Kingdom
Primary
Secondary
Hypoxia Death 7/23/2007 60 Male 247 lb 10/15/2008 Physician Canada
Primary
Secondary
Sepsis Other Serious 9/1/2008 Female 10/16/2008 Physician United Kingdom
Primary
Secondary
Cholecystitis Other Serious 9/26/2008 10/16/2008 Physician United Kingdom
Primary
Concomitant
Ventricular Hypokinesia Other Serious 9/1/2008 Female 10/27/2008 Physician United Kingdom
Primary
Secondary
Ventricular Hypokinesia Other Serious 9/1/2008 Female 10/27/2008 Physician United Kingdom
Primary
Secondary
Pulmonary Oedema Other Serious 9/26/2008 10/30/2008 Physician United Kingdom
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
Tumour Lysis Syndrome Life Threatening 11/13/2008 Male 11/18/2008 Physician United Kingdom
Primary
Secondary
Tumour Lysis Syndrome Life Threatening 11/13/2008 Male 11/19/2008 Physician United Kingdom
Primary
Secondary
Tumour Lysis Syndrome Life Threatening 11/1/2008 Male 1/9/2009 Physician United Kingdom
Primary
Secondary
Concomitant
Tumour Lysis Syndrome Life Threatening 11/1/2008 Male 1/9/2009 Physician United Kingdom
Primary
Secondary
Concomitant
Subdural Haematoma Other Serious 12/31/2008 Male 2/6/2009 Physician United Kingdom
Primary
Secondary
Concomitant
Pulmonary Oedema Other Serious 9/26/2008 2/10/2009 Physician United Kingdom
Primary
Concomitant
Sepsis Hospitalization 2/5/2009 55 Male 182 lb 2/20/2009 Physician Canada
Primary
Secondary
Syncope Other Serious 12/31/2008 Male 2/20/2009 Physician United Kingdom
Primary
Secondary
Concomitant
Syncope Other Serious 12/31/2008 Male 2/20/2009 Physician United Kingdom
Primary
Secondary
Concomitant
Thrombocytopenia Hospitalization 1/20/2009 Female 132 lb 3/2/2009 Physician France
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
Venoocclusive Liver Disease Life Threatening 6/27/2009 Female 192 lb 7/17/2009 Physician France
Primary
Secondary
Concomitant
Pulmonary Haemorrhage Hospitalization 7/21/2009 Male 8/24/2009 Physician United Kingdom
Primary
Concomitant
Shock Life Threatening 8/13/2009 Female 8/25/2009 Physician Denmark
Primary
Secondary
Shock Life Threatening 8/13/2009 Female 8/26/2009 Physician Denmark
Primary
Secondary
Pneumonia Other Serious 6/19/2009 52 Male 141 lb 8/28/2009 Physician Canada
Primary
Secondary
Concomitant
Shock Life Threatening 8/13/2009 Female 9/1/2009 Physician Denmark
Primary
Secondary
Concomitant
Shock Life Threatening 8/13/2009 Female 9/3/2009 Physician Denmark
Primary
Secondary
Concomitant
Graft Versus Host Disease Death 9/9/2008 Male 9/3/2009 Physician United Kingdom
Primary
Concomitant
Neutropenic Sepsis Hospitalization 1/1/2009 Male 9/4/2009 Physician United Kingdom
Primary
Secondary
Concomitant
Pneumonia Other Serious 6/19/2009 52 Male 141 lb 9/8/2009 Physician Canada
Primary
Secondary
Concomitant
Graft Versus Host Disease Death 9/9/2008 Male 168 lb 9/9/2009 Physician United Kingdom
Primary
Concomitant
Neutropenic Sepsis Hospitalization 1/1/2009 Male 9/10/2009 Physician United Kingdom
Primary
Secondary
Concomitant
Shock Life Threatening 8/13/2009 Female 9/11/2009 Physician Denmark
Primary
Secondary
Concomitant
Neutropenic Sepsis Hospitalization 7/12/2009 Male 9/21/2009 Physician United Kingdom
Primary
Secondary
Concomitant
Lower Respiratory Tract Infection Hospitalization 8/17/2009 Male 9/28/2009 Physician United Kingdom
Primary
Secondary
Lower Respiratory Tract Infection Hospitalization 8/17/2009 Male 9/29/2009 Physician United Kingdom
Primary
Secondary
Subarachnoid Haemorrhage Life Threatening 1/1/2009 Female 10/9/2009 Physician Denmark
Primary
Concomitant
Interacting
Subarachnoid Haemorrhage Life Threatening 1/1/2009 Female 10/13/2009 Physician Denmark
Primary
Concomitant
Interacting
Subarachnoid Haemorrhage Life Threatening 1/1/2009 Female 10/14/2009 Physician Denmark
Primary
Concomitant
Interacting
Megacolon Life Threatening 10/4/2009 Male 10/14/2009 Physician United Kingdom
Primary
Secondary
Megacolon Life Threatening 10/4/2009 Male 10/28/2009 Physician United Kingdom
Primary
Secondary
Sepsis Life Threatening 10/24/2009 Female 10/30/2009 Physician United Kingdom
Primary
Secondary
Sepsis Hospitalization 10/22/2009 Female 11/3/2009 Physician United Kingdom
Primary
Secondary
Concomitant
Sepsis Hospitalization 10/22/2009 Female 11/4/2009 Physician United Kingdom
Primary
Secondary
Concomitant
Sepsis Life Threatening 10/24/2009 Female 11/6/2009 Physician United Kingdom
Primary
Secondary
Concomitant
Neutropenic Sepsis Life Threatening 1/21/2010 Male 1/26/2010 Physician United Kingdom
Primary
Secondary
Disease Progression Death 9/15/2009 Female 1/27/2010 Physician United Kingdom
Primary
Secondary
Neutropenic Sepsis Death 1/1/2010 Male 2/2/2010 Physician United Kingdom
Primary
Concomitant
Pulmonary Haemorrhage Hospitalization 7/21/2009 Male 2/2/2010 Physician United Kingdom
Primary
Concomitant
Pneumonia Death 1/1/2010 Male 187 lb 2/19/2010 Physician United Kingdom
Primary
Concomitant
Pneumonia Death 1/1/2010 Male 187 lb 2/19/2010 Physician United Kingdom
Primary
Concomitant
Tenosynovitis Disability 11/21/2009 Male 3/2/2010 Physician United Kingdom
Primary
Secondary
Tenosynovitis Disability 11/21/2009 Male 3/4/2010 Physician United Kingdom
Primary
Secondary
Lobar Pneumonia Hospitalization 2/3/2010 Male 181 lb 3/4/2010 Physician United Kingdom
Primary
Secondary
Concomitant
Tenosynovitis Disability 11/21/2009 Male 3/15/2010 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
Neutropenic Sepsis Hospitalization 3/23/2010 62 Female 4/2/2010 Physician United Kingdom
Primary
Secondary
Pneumonia Hospitalization 1/1/2010 67 Male 4/23/2010 Physician United Kingdom
Primary
Concomitant
Thrombocytopenia Other Serious 43 Male 4/28/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Pneumonia Hospitalization 1/18/2010 67 Male 4/28/2010 Physician United Kingdom
Primary
Concomitant
Pneumonia Hospitalization 1/18/2010 67 Male 188 lb 4/29/2010 Physician United Kingdom
Primary
Concomitant
Multi-organ Failure Hospitalization 4/13/2007 69 Male 159 lb 4/29/2010 Physician Italy
Primary
Secondary
Concomitant
Cerebral Haemorrhage Death 4/3/2010 68 Female 5/10/2010 Physician Denmark
Primary
Secondary
Death Death 6/14/2010 65 Male 187 lb 6/22/2010 Physician France
Primary
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
Neutropenic Sepsis Hospitalization 3/23/2010 62 Female 8/16/2010 Physician United Kingdom
Primary
Secondary
Neutropenic Sepsis Hospitalization 3/23/2010 62 Female 8/18/2010 Physician United Kingdom
Primary
Secondary
Staphylococcal Infection Hospitalization 1/25/2010 66 Male 9/7/2010 Physician United Kingdom
Primary
Secondary
Staphylococcal Infection Other Serious 8/26/2010 63 Female 9/14/2010 Physician United Kingdom
Primary
Secondary
Concomitant
Tachycardia Other Serious 4/1/2010 73 Female 9/14/2010 Physician United Kingdom
Primary
Secondary
Concomitant
Staphylococcal Infection Hospitalization 1/25/2010 66 Male 9/15/2010 Physician United Kingdom
Primary
Secondary
Concomitant
Deep Vein Thrombosis Hospitalization 2/21/2010 64 Female 148 lb 9/21/2010 Physician France
Primary
Secondary
Concomitant
Conduction Disorder Death 6/14/2010 65 Male 187 lb 9/27/2010 Physician France
Primary
Concomitant
Staphylococcal Infection Hospitalization 1/25/2010 66 Male 9/27/2010 Physician United Kingdom
Primary
Secondary
Concomitant
Tenosynovitis Disability 11/21/2009 70 Male 10/6/2010 Physician United Kingdom
Primary
Secondary
Tremor Hospitalization 10/1/2010 50 Female 10/16/2010 Physician France
Primary
Secondary
Neutropenic Sepsis Death 1/21/2010 68 Male 1/27/2011 Physician United Kingdom
Primary
Secondary
Tenosynovitis Disability 11/21/2009 70 Male 2/9/2011 Physician United Kingdom
Primary
Secondary
Disease Progression Death 3/12/2011 56 Male 4/1/2011 Physician United Kingdom
Primary
Secondary
Concomitant
Neutropenic Sepsis Hospitalization 2/21/2011 58 Female 4/1/2011 Physician United Kingdom
Primary
Secondary
Concomitant
Disease Progression Death 3/12/2011 56 Male 4/7/2011 Physician United Kingdom
Primary
Secondary
Concomitant
Disease Progression Hospitalization 2/21/2011 58 Female 4/8/2011 Physician United Kingdom
Primary
Secondary
Concomitant
Acute Myeloid Leukaemia Death 3/12/2011 56 Male 4/19/2011 Physician United Kingdom
Primary
Secondary
Concomitant
Lung Infiltration Life Threatening 4/12/2011 57 Female 4/19/2011 Physician United Kingdom
Primary
Secondary
Concomitant
Disease Progression Death 3/12/2011 56 Male 4/28/2011 Physician United Kingdom
Primary
Secondary
Concomitant
Disease Progression Death 4/12/2011 57 Female 4/29/2011 Physician United Kingdom
Primary
Secondary
Concomitant
Hepatotoxicity Other Serious 4/8/2011 21 Female 5/13/2011 Physician United Kingdom
Primary
Secondary
Concomitant
Hypokalaemia Life Threatening 5/2/2011 66 Male 5/13/2011 Physician United Kingdom
Primary
Secondary
Concomitant
Respiratory Failure Death 49 Female 5/18/2011 Physician United Kingdom
Primary
Secondary
Concomitant
Renal Failure Other Serious 2/12/2011 57 Male 5/20/2011 Physician United Kingdom
Primary
Secondary
Concomitant
Hypokalaemia Life Threatening 5/2/2011 66 Male 5/20/2011 Physician United Kingdom
Primary
Secondary
Concomitant
Disease Progression Hospitalization 2/21/2011 58 Female 5/24/2011 Physician United Kingdom
Primary
Secondary
Concomitant
Neutropenic Sepsis Death 1/19/2010 58 5/27/2011 Physician United Kingdom
Primary
Secondary
Colitis Death 5/20/2011 56 Male 5/27/2011 Physician United Kingdom
Primary
Secondary
Concomitant
Caecitis Death 49 Female 5/31/2011 Physician United Kingdom
Primary
Secondary
Concomitant
Neutropenia Death 1/19/2010 58 6/2/2011 Physician United Kingdom
Primary
Secondary
Concomitant
Renal Failure Other Serious 2/12/2011 57 Male 6/6/2011 Physician United Kingdom
Primary
Secondary
Concomitant
Colitis Death 5/20/2011 56 Male 6/8/2011 Physician United Kingdom
Primary
Secondary
Concomitant
Duodenal Ulcer Haemorrhage Death 1/25/2011 18 Female 6/27/2011 Physician United Kingdom
Primary
Secondary
Necrotising Fasciitis Hospitalization 12/26/2010 52 Female 6/27/2011 Physician United Kingdom
Primary
Secondary
Deep Vein Thrombosis Hospitalization 12/17/2010 41 Female 6/28/2011 Physician Denmark
Primary
Secondary
Concomitant
Clostridial Infection Other Serious 2/7/2011 59 Male 6/29/2011 Physician United Kingdom
Primary
Secondary
Concomitant
Blood Albumin Decreased Other Serious 12/30/2010 35 Female 6/29/2011 Physician United Kingdom
Primary
Secondary
Concomitant
Hypokalaemia Other Serious 12/29/2010 35 Female 6/30/2011 Physician United Kingdom
Primary
Secondary
Concomitant
Exfoliative Rash Other Serious 1/15/2011 59 Female 6/30/2011 Physician United Kingdom
Primary
Secondary
Concomitant
Gamma-glutamyltransferase Increased Other Serious 1/5/2011 58 Male 7/11/2011 Physician United Kingdom
Primary
Secondary
Concomitant
Blood Albumin Decreased Other Serious 12/30/2010 35 Female 7/28/2011 Consumer United States
Primary
Secondary
Concomitant
Catheter Site Cellulitis Other Serious 8/21/2010 59 Male 8/1/2011 Physician United Kingdom
Primary
Secondary
Pneumonia Death 50 Male 8/2/2011 Physician United Kingdom
Primary
Secondary
Concomitant
Drug Interaction Death 7/31/2011 60 Male 8/5/2011 Physician United Kingdom
Primary
Secondary
Concomitant
Drug Interaction Hospitalization 2/22/2011 57 Male 8/5/2011 Physician United States
Primary
Secondary
Interacting
Necrosis Other Serious 8/21/2010 59 Male 8/8/2011 Physician United Kingdom
Primary
Secondary
Obstructive Airways Disorder Death 6/8/2011 2 Male 8/10/2011 Physician United Kingdom
Primary
Secondary
Concomitant
Convulsion Hospitalization 8/6/2011 48 Male 8/17/2011 Physician United Kingdom
Primary
Secondary
Obstructive Airways Disorder Life Threatening 6/8/2011 2 Male 8/17/2011 Physician United Kingdom
Primary
Secondary
Concomitant
Neutropenic Sepsis Death 8/2/2011 61 Male 8/23/2011 Physician United Kingdom
Primary
Secondary
Concomitant
Neutropenic Sepsis Death 8/2/2011 61 Male 9/1/2011 Physician United Kingdom
Primary
Secondary
Concomitant
Convulsion Hospitalization 8/6/2011 48 Male 9/1/2011 Physician United Kingdom
Primary
Secondary

Drug Data