Dactinomycin combined with Vincristine Sulfate

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Treatment Related Secondary Malignancy Other Serious 15 Female 8/3/2006 Consumer United States
Primary
Secondary
Treatment Related Secondary Malignancy Death 6 Female 8/3/2006 Consumer United States
Primary
Secondary
Treatment Related Secondary Malignancy Death 5 Male 8/3/2006 Consumer United States
Primary
Secondary
Treatment Related Secondary Malignancy Death 10 Male 8/3/2006 Consumer United States
Primary
Secondary
Treatment Related Secondary Malignancy Other Serious 13 Female 8/3/2006 Consumer United States
Primary
Secondary
Treatment Related Secondary Malignancy Death 2 Female 8/3/2006 Consumer United States
Primary
Secondary
Treatment Related Secondary Malignancy Death 2 Male 8/3/2006 Consumer United States
Primary
Secondary
Treatment Related Secondary Malignancy Death 2 Female 8/3/2006 Consumer United States
Primary
Secondary
Recurrent Cancer Other Serious 4 Female 8/1/2006 Other Health Professional Japan
Primary
Secondary
Thymus Enlargement Other Serious 3 Female 8/17/2006 Other Health Professional Morocco
Primary
Secondary
Thymus Enlargement Other Serious 3 Female 8/30/2006 Other Health Professional Morocco
Primary
Secondary
Oedema Peripheral Hospitalization 7/14/2006 2 Male 9/19/2006 Physician France
Primary
Secondary
Venoocclusive Disease Death 10/6/2006 Physician Germany
Primary
Secondary
Venoocclusive Disease Death 10/6/2006 Physician Germany
Primary
Secondary
Venoocclusive Disease Death 10/6/2006 Physician Germany
Primary
Secondary
Staphylococcal Infection Hospitalization 9/4/2006 12 Male 11/28/2006 Physician United States
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Hospitalization 9/4/2006 12 Male 12/18/2006 Physician United States
Primary
Secondary
Concomitant
Respiratory Failure Death 10 Male 1/15/2007 Physician United States
Primary
Secondary
Interstitial Lung Disease Hospitalization Female 2/14/2007 Consumer United States
Primary
Secondary
Respiratory Failure Hospitalization 6 Female 4/13/2007 Physician United Kingdom
Primary
Secondary
Concomitant
Respiratory Failure Other Serious 3 Male 4/30/2007 Other Health Professional United Kingdom
Primary
Secondary
Interstitial Lung Disease Death 3 Male 5/9/2007 United Kingdom
Primary
Secondary
Concomitant
Respiratory Failure Other Serious 3 Male 6/1/2007 United Kingdom
Primary
Secondary
Concomitant
Respiratory Failure Death 3 Male 5/25/2007 United Kingdom
Primary
Secondary
Stomatitis Hospitalization 5/26/2007 2 Male 5/31/2007 Other Health Professional France
Primary
Secondary
Respiratory Failure Other Serious 3 Male 6/14/2007 Other Health Professional United Kingdom
Primary
Secondary
Respiratory Failure Other Serious 3 Male 6/19/2007 United Kingdom
Primary
Secondary
Concomitant
Respiratory Failure Hospitalization 3 Male 6/26/2007 Other Health Professional United Kingdom
Primary
Secondary
Skin Reaction Death 3 Male 6/20/2007 United Kingdom
Primary
Secondary
Respiratory Failure Hospitalization 3 Male 6/29/2007 United Kingdom
Primary
Secondary
Concomitant
Weaning Failure Hospitalization 3 Male 7/6/2007 Other Health Professional United Kingdom
Primary
Secondary
Respiratory Failure Hospitalization 3 Male 7/13/2007 Other Health Professional United Kingdom
Primary
Secondary
Respiratory Failure Hospitalization 3 Male 8/1/2007 United Kingdom
Primary
Secondary
Concomitant
Stress Fracture Hospitalization 12/1/2002 33 Female 8/17/2007 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Respiratory Failure Hospitalization 6 Female 9/24/2007 Physician United Kingdom
Primary
Secondary
Concomitant
Pneumonitis Hospitalization 6 Female 9/27/2007 Physician United Kingdom
Primary
Concomitant
Soft Tissue Necrosis Hospitalization 10/27/2007 Female 99 lb 11/2/2007 United States
Primary
Secondary
Concomitant
Vulval Disorder Hospitalization 10/27/2007 Female 99 lb 11/15/2007 Canada
Primary
Secondary
Pneumonitis Hospitalization 6 Female 11/28/2007 Physician United Kingdom
Primary
Secondary
Concomitant
Febrile Neutropenia Life Threatening 11/30/2006 16 Female 1/2/2008 Physician United States
Primary
Secondary
Concomitant
Troponin Increased Hospitalization 1/23/2008 Female 114 lb 1/28/2008 United States
Primary
Secondary
Troponin Increased Hospitalization 1/23/2008 Female 114 lb 2/5/2008 United States
Primary
Secondary
Vomiting Hospitalization 1/23/2008 Female 114 lb 1/30/2008 Canada
Primary
Secondary
Respiratory Failure Hospitalization 3 Male 2/8/2008 Other Health Professional United Kingdom
Primary
Secondary
Vomiting Hospitalization 1/23/2008 Female 114 lb 2/7/2008 Canada
Primary
Secondary
Troponin Increased Hospitalization 1/23/2008 Female 114 lb 2/11/2008 United States
Primary
Secondary
Respiratory Failure Hospitalization 3 Male 2/21/2008 United Kingdom
Primary
Secondary
Concomitant
Neuropathy Peripheral Other Serious 10 Male 3/6/2008 Other Health Professional Turkey
Primary
Secondary
Neuropathy Peripheral Other Serious 10 Male 3/7/2008 Other Health Professional Turkey
Primary
Secondary
White Blood Cell Count Decreased Hospitalization 2/29/2008 Female 29 lb 3/13/2008 United States
Primary
Secondary
Concomitant
Weight Decreased Hospitalization 3/30/2008 Male 203 lb 4/7/2008 United States
Primary
Secondary
Stridor Hospitalization 6 Female 4/14/2008 United Kingdom
Primary
Secondary
Concomitant
Weight Decreased Hospitalization 3/30/2008 Male 203 lb 4/10/2008 United States
Primary
Secondary
Vomiting 3/18/2008 Female 30 lb 5/23/2008 United States
Primary
Secondary
Venous Pressure Jugular Increased Hospitalization 24 Male 6/2/2008 United States
Primary
Secondary
Vomiting Hospitalization 3/30/2008 Male 203 lb 6/9/2008 United States
Primary
Secondary
Cardiomyopathy Death 2 Female 6/24/2008 Japan
Primary
Secondary
Therapeutic Agent Toxicity Hospitalization 6/13/2008 Female 141 lb 6/19/2008 United States
Primary
Secondary
Stomatitis Hospitalization 6/13/2008 Female 141 lb 7/7/2008 United States
Primary
Secondary
Breast Cancer Other Serious 1/1/2004 24 Female 7/28/2008 Consumer United States
Primary
Secondary
Deafness Unilateral Other Serious 11 Male 8/13/2008 Other Health Professional Brazil
Primary
Secondary
Ear Infection Other Serious 5 Female 8/13/2008 Other Health Professional Brazil
Primary
Secondary
Deafness Bilateral Other Serious 15 Female 8/13/2008 Other Health Professional Brazil
Primary
Secondary
Tinnitus Other Serious 19 Female 8/13/2008 Other Health Professional Brazil
Primary
Secondary
Pruritus Other Serious 10 Female 8/13/2008 Other Health Professional Brazil
Primary
Secondary
Tinnitus Other Serious 27 Male 8/13/2008 Other Health Professional Brazil
Primary
Secondary
Tinnitus Other Serious 20 Female 8/13/2008 Other Health Professional Brazil
Primary
Secondary
Ear Pain Other Serious 19 Female 8/13/2008 Other Health Professional Brazil
Primary
Secondary
Focal Nodular Hyperplasia Other Serious 8 Male 10/1/2008 Physician Japan
Primary
Secondary
Bone Sarcoma Other Serious 10/1/2007 12 Male 11/10/2008 Physician Japan
Primary
Secondary
Bone Sarcoma Other Serious 10/1/2007 12 Male 11/12/2008 Japan
Primary
Secondary
Bone Sarcoma Other Serious 10/1/2007 12 Male 11/19/2008 Physician Japan
Primary
Secondary
Interstitial Lung Disease Other Serious 11 Female 12/2/2008 Other Health Professional Japan
Primary
Secondary
Concomitant
Bone Sarcoma Other Serious 10/1/2007 12 Male 12/2/2008 Japan
Primary
Secondary
Thyroid Cancer Other Serious 7 Male 1/6/2009 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Thyroid Cancer Other Serious 7 Male 1/8/2009 Other Health Professional United Kingdom
Primary
Secondary
Thyroid Cancer Other Serious 7 Male 1/12/2009 Other Health Professional United Kingdom
Primary
Secondary
Thyroid Cancer Other Serious 7 Male 1/20/2009 Other Health Professional United Kingdom
Primary
Secondary
Thyroid Cancer Other Serious 7 Male 1/22/2009 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Thyroid Cancer Other Serious 7 Male 1/14/2009 Other Health Professional United Kingdom
Primary
Secondary
Sweat Gland Disorder Hospitalization 12 Female 2/2/2009 Other Health Professional United States
Primary
Secondary
Thyroid Cancer Other Serious 7 Male 1/26/2009 Other Health Professional United Kingdom
Primary
Secondary
Thyroid Cancer Other Serious 2/9/2009 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Skin Plaque Other Serious 12 Female 2/5/2009 Physician United States
Primary
Concomitant
Weight Increased Required Intervention 2 Male 2/11/2009 Other Health Professional Taiwan, Province Of China
Primary
Secondary
Concomitant
Cardiomyopathy Death 2 Female 2/19/2009 Japan
Primary
Secondary
Thyroid Cancer Other Serious 7 Male 2/24/2009 Other Health Professional United Kingdom
Primary
Secondary
Thyroid Cancer Other Serious 7 Male 3/13/2009 Other Health Professional United Kingdom
Primary
Secondary
Weight Increased Hospitalization 3/12/2009 Male 31 lb 3/23/2009 United States
Primary
Secondary
Concomitant
Weight Increased Hospitalization 3/12/2009 Male 31 lb 3/30/2009 United States
Primary
Secondary
Concomitant
Ileus Paralytic Other Serious 5 Female 5/29/2009 Consumer Australia
Primary
Secondary
Spinal Cord Disorder Hospitalization 12/3/2009 Male 39 lb 12/11/2009 United States
Primary
Secondary
Spinal Cord Disorder Hospitalization 12/3/2009 Male 39 lb 12/22/2009 United States
Primary
Secondary
Weight Decreased Other Serious 10 Female 5/17/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Uterine Perforation Hospitalization 25 Female 6/17/2010 Other Health Professional Switzerland
Primary
Secondary
Vomiting Hospitalization 2/25/2010 9 Female 35 lb 11/19/2010 Other Health Professional Norway
Primary
Secondary
Concomitant
Oesophagitis Life Threatening 17 Female 1/21/2011 Physician United States
Primary
Secondary
Concomitant
Fanconi Syndrome Other Serious 1 2/23/2011 Physician France
Primary
Secondary
Fanconi Syndrome Other Serious 2 2/23/2011 Other Health Professional France
Primary
Secondary
Fanconi Syndrome Other Serious 1 2/23/2011 Other Health Professional France
Primary
Secondary
Fanconi Syndrome Other Serious 2 2/23/2011 Physician France
Primary
Secondary
Blood Human Chorionic Gonadotropin Increased Hospitalization 1/1/2008 36 Female 3/21/2011 Other Health Professional United Kingdom
Primary
Secondary
Ascites Hospitalization 3/16/2011 3 Female 37 lb 3/17/2011 United States
Primary
Secondary
Liver Function Test Abnormal Hospitalization 3/16/2011 3 Female 37 lb 4/4/2011 Other Health Professional New Zealand
Primary
Secondary
Pyrexia Hospitalization 4/6/2011 5 Male 41 lb 4/11/2011 Other Health Professional United States
Primary
Secondary
Thyroid Cancer Other Serious 7 Male 6/28/2011 Other Health Professional United Kingdom
Primary
Secondary
Neoplasm Malignant Other Serious 7 Male 6/29/2011 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Pregnancy Other Serious Female 7/14/2011 Other Health Professional India
Primary
Secondary
Lymphocyte Count Decreased Hospitalization 7/12/2011 3 Female 34 lb 7/19/2011 United States
Primary
Secondary
Concomitant
Rhabdomyolysis Other Serious 15 Female 8/12/2011 Other Health Professional Japan
Primary
Secondary
Maternal Exposure During Pregnancy Other Serious 28 Female 9/7/2011 Other Health Professional United States
Primary
Secondary
Small For Dates Baby Other Serious Female 9/7/2011 Other Health Professional United States
Primary
Secondary
Swelling Face Hospitalization 9/15/2011 5 Male 40 lb 9/20/2011 Physician United States
Primary
Secondary
Concomitant
Anaemia Hospitalization 10/7/2011 4 Female 37 lb 10/10/2011 Physician Australia
Primary
Secondary
Febrile Bone Marrow Aplasia Hospitalization 3/3/2010 6 Male 64 lb 10/26/2011 Consumer United Kingdom
Primary
Secondary
Fungaemia Hospitalization 7/15/2011 3 Female 24 lb 10/27/2011 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Hypertension Other Serious 16 Male 10/24/2011 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Blood Potassium Decreased Hospitalization 10/21/2011 6 Female 53 lb 10/24/2011 Physician United States
Primary
Secondary
Febrile Neutropenia Hospitalization 3/18/2010 13 Male 119 lb 10/31/2011 Consumer United Kingdom
Primary
Secondary
Concomitant
Tumour Lysis Syndrome Other Serious 36 Female 11/25/2011 Other Health Professional Japan
Primary
Secondary
Fluid Intake Reduced Hospitalization 11/21/2011 2 Male 22 lb 12/12/2011 Consumer United Kingdom
Primary
Secondary
Concomitant
Febrile Neutropenia Hospitalization 7/15/2011 3 Female 26 lb 12/12/2011 Consumer United Kingdom
Primary
Secondary
Concomitant
Febrile Neutropenia Other Serious 18 Female 12/12/2011 Physician United States
Primary
Secondary
Concomitant
Premature Baby Other Serious Female 12/12/2011 Physician United States
Primary
Secondary
Ascites Hospitalization 1/3/2011 1 Female 27 lb 1/9/2012 Physician United States
Primary
Secondary
Concomitant
Hepatic Function Abnormal Hospitalization 1/3/2012 2 Female 27 lb 1/16/2012 United States
Primary
Secondary
Concomitant
Staphylococcal Infection Hospitalization 15 Female 2/28/2012 Physician Sweden
Primary
Secondary
Caecitis Hospitalization 15 Female 2/28/2012 Physician Sweden
Primary
Secondary
Chest Pain Hospitalization 3/23/2012 4 Male 38 lb 3/27/2012 Physician United States
Primary
Secondary
Venoocclusive Liver Disease Hospitalization 1/3/2012 2 Female 27 lb 4/25/2012 Physician United States
Primary
Secondary
Concomitant
Acute Lymphocytic Leukaemia Other Serious 19 Male 7/3/2012 Other Health Professional Turkey
Primary
Secondary
Concomitant
Oral Candidiasis Hospitalization 3/18/2010 13 Male 119 lb 6/24/2013 Physician Nl
Primary
Secondary
Concomitant
Vomiting Hospitalization 9/9/2012 Female 37 lb Other Health Professional Country Not Specified
Primary
Secondary
Concomitant
Febrile Neutropenia Hospitalization 6/30/2012 1 Male 19 lb 10/16/2012 Other Health Professional Pe
Primary
Secondary
Concomitant
Haematuria Hospitalization 6/6/2012 5 Male 40 lb 11/12/2012 Physician It
Primary
Secondary
Concomitant
Hypophagia Hospitalization 7/23/2012 5 Male 34 lb 2/1/2013 Gb
Primary
Secondary
Concomitant
Presyncope Hospitalization 7/25/2010 16 Female 146 lb 11/29/2012 Physician Gb
Primary
Secondary
Concomitant
Vomiting Hospitalization 12/10/2012 Female 91 lb 12/10/2012 Physician Us
Primary
Secondary
Gastrointestinal Haemorrhage Hospitalization 11/29/2012 Male 28 lb 12/6/2012 Other Health Professional Us
Primary
Secondary
Radiation Injury Hospitalization 11/29/2012 Male 28 lb 12/11/2012 Physician Us
Primary
Secondary
Mucosal Inflammation Hospitalization 8/4/2012 3 Male 32 lb 1/28/2013 Physician Pl
Primary
Secondary
Concomitant
Off Label Use Death Female 12/19/2012 Other Health Professional Cn
Primary
Secondary
Rhabdomyoma Other Serious 21 Male 12/26/2012 Other Health Professional Us
Primary
Secondary
Haematotoxicity Hospitalization 1/5/2013 10 Male 70 lb 1/18/2013 Physician Gb
Primary
Secondary
Concomitant
Pyrexia Hospitalization 5/24/2012 3 Male 33 lb 2/22/2013 Physician Kr
Primary
Secondary
Concomitant
Tachycardia Hospitalization 4/22/2013 3 Female 24 lb 4/25/2013 Physician Country Not Specified
Primary
Secondary
Venoocclusive Liver Disease Hospitalization 5/1/2013 4 Female 30 lb 5/7/2013 Country Not Specified
Primary
Secondary
Weight Decreased Hospitalization 5/1/2013 4 Female 30 lb 5/7/2013 Physician Country Not Specified
Primary
Secondary
Weight Increased Hospitalization 5/16/2013 6 Male 48 lb 5/20/2013 Consumer Us
Primary
Secondary
Hypophagia Hospitalization 7/23/2012 5 Male 34 lb 6/3/2013 Physician Gb
Primary
Secondary
Concomitant

Drug Data