Dactinomycin combined with Vincristine

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Haemorrhagic Cerebral Infarction Hospitalization 4 Female 5/12/2006 Other Health Professional Turkey
Primary
Concomitant
Treatment Related Secondary Malignancy Other Serious 9 Female 7/6/2006 Other Health Professional United States
Primary
Secondary
Renal Cell Carcinoma Stage Unspecified Other Serious 9 Female 6/26/2006 Other Health Professional United States
Primary
Secondary
Stem Cell Transplant Other Serious 4 Female 7/14/2006 Other Health Professional Japan
Primary
Secondary
Renal Cell Carcinoma Stage Unspecified Other Serious 9 Female 7/13/2006 United States
Primary
Secondary
Mucoepidermoid Carcinoma Other Serious 13 Female 7/25/2006 Physician Turkey
Primary
Secondary
Primitive Neuroectodermal Tumour Death 10 Male 7/25/2006 Physician Turkey
Primary
Secondary
Acute Myeloid Leukaemia Death 2 Female 8/2/2006 Other Health Professional Turkey
Primary
Secondary
Acute Myeloid Leukaemia Death 2 Female 8/8/2006 Other Health Professional Turkey
Primary
Secondary
Treatment Related Secondary Malignancy Death 2 Female 8/8/2006 Turkey
Primary
Secondary
Solitary Kidney Secondary Other Serious 9 Female 8/14/2006 Physician United States
Primary
Secondary
Hypomania Other Serious 16 Male 9/1/2006 Other Health Professional
Primary
Secondary
Concomitant
Tuberculosis Other Serious 2 Female 9/29/2006 Morocco
Primary
Secondary
Oedema Peripheral Hospitalization 7/14/2006 2 Male 10/9/2006 United Kingdom
Primary
Secondary
Respiratory Failure Required Intervention 31 Female 10/23/2006 Japan
Primary
Secondary
Concomitant
Pyrexia Hospitalization 2 Male 10/23/2006 Physician France
Primary
Concomitant
Respiratory Failure Required Intervention 6/25/2004 31 Female 11/3/2006 Physician Japan
Primary
Secondary
Concomitant
Respiratory Failure Other Serious 6/25/2004 31 Female 11/3/2006 Japan
Primary
Secondary
Concomitant
Pyrexia Other Serious 6 Male 11/15/2006 Physician United States
Primary
Secondary
Vomiting Hospitalization 11/1/2005 Female 11/30/2006 Physician United States
Primary
Secondary
Concomitant
Respiratory Failure Hospitalization 10 Male 1/11/2007 Physician United States
Primary
Secondary
Respiratory Failure Death 10 Male 1/30/2007 United States
Primary
Secondary
Surgery Other Serious 1/1/2001 66 Male 4/6/2007 Physician United States
Primary
Concomitant
Weight Decreased Other Serious 1 Male 4/5/2007 United Kingdom
Primary
Secondary
Concomitant
Pneumonitis Death 3 Male 4/13/2007 Other Health Professional United Kingdom
Primary
Secondary
Stridor Death 6 Female 4/13/2007 Other Health Professional United Kingdom
Primary
Secondary
Renal Tubular Disorder Other Serious 4/27/2007 Other Health Professional Germany
Primary
Secondary
Concomitant
Sputum Culture Positive Death 6 Female 5/1/2007 United Kingdom
Primary
Secondary
Weaning Failure Death 2 Male 5/8/2007 Physician United Kingdom
Primary
Secondary
Concomitant
Stridor Death 6 Female 5/8/2007 Physician United Kingdom
Primary
Secondary
Concomitant
Weaning Failure Death 3 Male 5/4/2007 United Kingdom
Primary
Secondary
Weight Decreased Other Serious 1 Male 5/25/2007 Physician United Kingdom
Primary
Secondary
Concomitant
Weight Decreased Other Serious 1 Male 5/25/2007 Physician United Kingdom
Primary
Secondary
Concomitant
Peliosis Hepatis Hospitalization 4/1/2007 2 Female 5/29/2007 France
Primary
Secondary
Respiratory Failure Hospitalization 3 Male 6/4/2007 United Kingdom
Primary
Secondary
Streptococcal Infection Death 6 Female 7/3/2007 United Kingdom
Primary
Secondary
Ototoxicity Death 3 Male 7/17/2007 United Kingdom
Primary
Secondary
Ulcer Other Serious 1/1/2000 14 Male 7/13/2007 Physician United States
Primary
Secondary
Concomitant
Stridor Death 6 Female 7/10/2007 Physician United Kingdom
Primary
Secondary
Concomitant
Pneumonitis Hospitalization 6 Female 7/24/2007 United Kingdom
Primary
Secondary
Pneumonitis Hospitalization 6 Female 8/7/2007 United Kingdom
Primary
Secondary
Mucoepidermoid Carcinoma Other Serious 16 Female 8/9/2007 Other Health Professional United States
Primary
Secondary
Respiratory Failure Death 10 Male 8/7/2007 Physician United States
Primary
Secondary
Myelodysplastic Syndrome Other Serious 9/14/2007 Other Health Professional United States
Primary
Secondary
Osteomalacia Hospitalization 12/1/2002 33 Female 9/17/2007 Consumer United States
Primary
Secondary
Concomitant
Osteomalacia Hospitalization 12/1/2002 33 Female 9/20/2007 Consumer United States
Primary
Secondary
Concomitant
Venoocclusive Liver Disease Life Threatening 10/3/2007 Male 30 lb 10/9/2007 Pharmacist United States
Primary
Concomitant
Mechanical Ileus Death 1 10/9/2007 Other Health Professional Japan
Primary
Secondary
Testis Cancer Other Serious 30 Male 12/12/2007 Physician United States
Primary
Secondary
Concomitant
Death Death 4/15/1982 12 Female 12/6/2007 Consumer Canada
Primary
Concomitant
Venoocclusive Liver Disease Death 8/7/2006 4 Male 28 lb 1/29/2008 Physician Japan
Primary
Secondary
Concomitant
Venoocclusive Disease Hospitalization 1/23/2008 Female 121 lb 1/25/2008 United States
Primary
Secondary
Venous Occlusion Other Serious 2 Male 2/22/2008 Other Health Professional Turkey
Primary
Secondary
Pneumonitis Hospitalization 6 Female 3/5/2008 United Kingdom
Primary
Secondary
Exsanguination Life Threatening 10/23/1986 23 Male 154 lb 3/31/2008 Physician United Kingdom
Primary
Concomitant
Venoocclusive Disease Hospitalization 2 Male 3/31/2008
Primary
Secondary
Concomitant
Stridor Hospitalization 6 Female 4/14/2008 United Kingdom
Primary
Secondary
Concomitant
Pneumonitis Hospitalization 6 Female 4/24/2008 Consumer United States
Primary
Secondary
Concomitant
Sputum Culture Positive Hospitalization 6 Female 4/25/2008 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Pneumonitis Hospitalization 6 Female 5/5/2008 United Kingdom
Primary
Secondary
Nephrogenic Systemic Fibrosis Other Serious 1/1/2004 5/6/2008 Other Health Professional Germany
Primary
Secondary
Concomitant
Venous Pressure Jugular Increased Hospitalization 24 Male 6/2/2008 United States
Primary
Secondary
Nephrogenic Systemic Fibrosis Other Serious 1/1/2004 8/19/2008 Other Health Professional United States
Primary
Secondary
Concomitant
Nephrogenic Systemic Fibrosis Other Serious 1/1/2004 8/22/2008 Other Health Professional United States
Primary
Secondary
Concomitant
Thrombocytopenia Other Serious 27 Female 12/30/2008 Physician Germany
Primary
Secondary
Concomitant
Vomiting Other Serious 11/18/2008 14 Male 93 lb 1/5/2009 Poland
Primary
Secondary
Concomitant
Xerosis Other Serious 1/1/2000 11 Male 77 lb 12/3/2008 United States
Primary
Secondary
Concomitant
Xerosis Other Serious 1/1/2000 11 Male 77 lb 12/3/2008 United States
Primary
Secondary
Concomitant
Thyroid Cancer Other Serious 7 Male 1/9/2009 United Kingdom
Primary
Secondary
Viral Upper Respiratory Tract Infection Hospitalization 12/12/2008 Male 1/14/2009 Consumer United Kingdom
Primary
Secondary
Thyroid Cancer Other Serious 7 Male 1/11/2009 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Pyrexia Other Serious Male 1/21/2009 Consumer United Kingdom
Primary
Secondary
Thyroid Cancer Other Serious 7 Male 1/15/2009 United Kingdom
Primary
Secondary
Pyrexia Other Serious 1/11/2009 Male 1/26/2009 Consumer United Kingdom
Primary
Secondary
Rash Macular 5/17/2008 53 Male 2/4/2009 Consumer United States
Primary
Secondary
Concomitant
Pyrexia Other Serious 1/11/2009 Male 2/5/2009 Consumer United Kingdom
Primary
Secondary
Acute Lymphocytic Leukaemia Other Serious 34 Male 2/19/2009 United States
Primary
Secondary
Nuclear Magnetic Resonance Imaging Brain Abnormal Other Serious 16 Male 2/17/2009 Physician United States
Primary
Concomitant
Agranulocytosis Other Serious 32 Male 2/26/2009 Consumer Japan
Primary
Concomitant
Febrile Neutropenia Hospitalization 12/26/2008 Female 2/26/2009 Physician United Kingdom
Primary
Secondary
Concomitant
Pneumonia Hospitalization 11/26/2008 Female 2/27/2009 Consumer United Kingdom
Primary
Secondary
Concomitant
Vomiting Other Serious 11/18/2008 14 Male 93 lb 2/27/2009 Poland
Primary
Secondary
Venoocclusive Liver Disease Other Serious 2 Male 3/18/2009 Other Health Professional Taiwan, Province Of China
Primary
Secondary
Hepatic Vein Occlusion Other Serious 21 Male 3/18/2009 Taiwan, Province Of China
Primary
Secondary
Venoocclusive Liver Disease Other Serious 2 Male 3/25/2009 Other Health Professional Taiwan, Province Of China
Primary
Secondary
Vomiting Death 5 Female 5/29/2009 Physician Japan
Primary
Secondary
Concomitant
Thrombocytopenia Hospitalization 1 Male 6/10/2009 Physician Japan
Primary
Concomitant
Sudden Death Death 5 Female 6/19/2009 Physician Japan
Primary
Secondary
Concomitant
Respiratory Failure Other Serious 2 Female 24 lb 7/1/2009 Other Health Professional Italy
Primary
Secondary
Respiratory Failure Other Serious 2 Female 24 lb 7/1/2009 Other Health Professional Italy
Primary
Secondary
Tremor Life Threatening 20 Female 24 lb 6/26/2009 Other Health Professional Italy
Primary
Concomitant
Hepatic Encephalopathy Hospitalization 1/1/2008 2 Female 24 lb 7/8/2009 Other Health Professional Italy
Primary
Concomitant
Off Label Use Death 8/10/2009 Other Health Professional United Kingdom
Primary
Secondary
Febrile Bone Marrow Aplasia Hospitalization 8/11/2009 Female 55 lb 9/16/2009 Physician United Kingdom
Primary
Secondary
Venoocclusive Liver Disease Hospitalization 8/1/2009 Male 9/28/2009 Other Health Professional France
Primary
Secondary
Febrile Bone Marrow Aplasia Hospitalization 8/11/2009 Female 55 lb 10/20/2009 Physician United Kingdom
Primary
Secondary
Concomitant
Toxic Epidermal Necrolysis Hospitalization 1/1/2007 62 Female 11/4/2009 Other Health Professional United Kingdom
Primary
Secondary
Toxic Epidermal Necrolysis Death 62 Female 11/6/2009 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Treatment Failure Other Serious Unknown 11/16/2009 India
Primary
Secondary
Concomitant
Treatment Failure Hospitalization Unknown 11/16/2009 India
Primary
Secondary
Concomitant
Treatment Failure Hospitalization Unknown 11/16/2009 India
Primary
Secondary
Concomitant
Venous Thrombosis Other Serious 30 Female 12/8/2009 Other Health Professional India
Primary
Secondary
Concomitant
Capillary Leak Syndrome Death Unknown 12/14/2009 Italy
Primary
Secondary
Myelitis Other Serious 13 1/11/2010 Physician United States
Primary
Secondary
Concomitant
Myelitis Other Serious 16 1/11/2010 Physician United States
Primary
Secondary
Concomitant
Myelitis Other Serious 13 Female 1/11/2010 Physician United States
Primary
Secondary
Hepatitis B Other Serious 35 Female 2/18/2010 Turkey
Primary
Secondary
Hepatitis B Other Serious 35 Male 2/28/2010 Other Health Professional Turkey
Primary
Secondary
Hepatitis B Other Serious 35 Female 3/8/2010 Turkey
Primary
Secondary
Uterine Perforation Hospitalization 25 Female 6/30/2010 Physician Switzerland
Primary
Secondary
Uterine Perforation Hospitalization 25 Female 6/30/2010 Physician Switzerland
Primary
Secondary
Venoocclusive Liver Disease Hospitalization 1 Male 8/12/2010 Physician Italy
Primary
Secondary
Toxic Epidermal Necrolysis Other Serious 8/31/2010 9 Male 72 lb 12/2/2010 Physician France
Primary
Secondary
Concomitant
Tumour Lysis Syndrome Other Serious 17 Female 11/26/2010 United States
Primary
Secondary
Febrile Bone Marrow Aplasia Hospitalization 12/23/2010 9 Male 41 lb 1/10/2011 Physician France
Primary
Secondary
Concomitant
Mucosal Inflammation Hospitalization 12/23/2010 9 Male 42 lb 1/27/2011 Physician France
Primary
Secondary
Concomitant
Tumour Lysis Syndrome Other Serious 17 Female 2/8/2011 Physician United States
Primary
Secondary
Concomitant
Febrile Bone Marrow Aplasia Hospitalization 12/23/2010 9 Male 42 lb 3/4/2011 Physician France
Primary
Secondary
Concomitant
Tuberculosis Of Central Nervous System Hospitalization 36 Female 3/7/2011 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Tuberculosis Hospitalization 36 Female 3/7/2011 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Hormone Level Abnormal Hospitalization 36 Female 3/7/2011 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Tuberculosis Hospitalization 36 Female 3/7/2011 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Blood Gonadotrophin Abnormal Hospitalization 36 Female 3/9/2011 Physician United Kingdom
Primary
Secondary
Blood Human Chorionic Gonadotropin Positive Other Serious 36 Female 3/11/2011 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Neutropenia Hospitalization 36 Female 3/18/2011 Consumer United Kingdom
Primary
Secondary
Concomitant
Meningism Hospitalization 36 Female 3/21/2011 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Fanconi Syndrome Other Serious 4 Male 3/21/2011 Physician United Kingdom
Primary
Secondary
Tuberculosis Hospitalization 36 Female 3/10/2011 Other Health Professional United Kingdom
Primary
Secondary
Encephalitis Viral Hospitalization 36 Female 3/24/2011 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Faecal Incontinence Disability 13 Female 3/28/2011 Other Health Professional United States
Primary
Concomitant
Paraplegia Hospitalization 16 Male 3/28/2011 Other Health Professional United States
Primary
Concomitant
Blood Human Chorionic Gonadotropin Increased Hospitalization 36 Female 3/30/2011 Physician United Kingdom
Primary
Concomitant
Mucosal Inflammation Hospitalization 11/7/2010 9 Male 42 lb 4/14/2011 Physician France
Primary
Secondary
Concomitant
Febrile Bone Marrow Aplasia Hospitalization 4/29/2011 17 Female 101 lb 5/6/2011 Physician France
Primary
Secondary
Mucosal Inflammation Other Serious 3/12/2011 14 Female 88 lb 5/10/2011 Physician France
Primary
Secondary
Concomitant
Febrile Bone Marrow Aplasia Hospitalization 4/29/2011 17 Female 101 lb 5/17/2011 Physician France
Primary
Secondary
Peripheral Sensorimotor Neuropathy Other Serious 8/31/2010 9 Male 69 lb 5/24/2011 Other Health Professional France
Primary
Secondary
Concomitant
Febrile Neutropenia Other Serious 3/12/2011 14 Female 88 lb 5/24/2011 Physician France
Primary
Secondary
Concomitant
Mucosal Inflammation Other Serious 3/12/2011 14 Female 86 lb 6/3/2011 Physician France
Primary
Secondary
Concomitant
Mucosal Inflammation Other Serious 3/12/2011 14 Female 80 lb 6/17/2011 Physician France
Primary
Secondary
Concomitant
Febrile Bone Marrow Aplasia Hospitalization 4/29/2011 17 Female 101 lb 6/23/2011 Physician France
Primary
Secondary
Febrile Bone Marrow Aplasia Hospitalization 8/31/2010 9 Male 77 lb 6/23/2011 Other Health Professional France
Primary
Secondary
Concomitant
Hyperthyroidism Hospitalization 17 Female 6/23/2011 Physician United States
Primary
Secondary
Mucosal Inflammation Hospitalization 3/12/2011 14 Female 80 lb 6/24/2011 Physician France
Primary
Secondary
Concomitant
Deep Vein Thrombosis Hospitalization 17 Female 6/27/2011 Physician United States
Primary
Secondary
Oesophagitis Hospitalization 17 Female 6/27/2011 Physician United States
Primary
Secondary
Fungaemia Hospitalization 17 Female 6/27/2011 Physician United States
Primary
Secondary
Ejection Fraction Decreased Hospitalization 17 Female 6/28/2011 Other Health Professional United States
Primary
Secondary
Cardiac Failure Congestive Other Serious 17 Female 6/29/2011 Other Health Professional United States
Primary
Secondary
Vomiting Other Serious 3/12/2011 14 Female 80 lb 7/5/2011 Physician France
Primary
Secondary
Concomitant

Drug Data