Calcium Levofolinate combined with Fluorouracil

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Gastrointestinal Perforation Other Serious 53 Male 104 lb 1/3/2006 Other Health Professional Japan
Primary
Secondary
Epilepsy Other Serious 1/1/2005 Female 1/10/2006 Physician
Primary
Concomitant
Oedema Other Serious 6/3/2005 Female 1/13/2006 Other Health Professional Japan
Primary
Secondary
Thrombocytopenia Death 10/26/2005 Male 128 lb 1/19/2006 Other Health Professional Japan
Primary
Secondary
Concomitant
Cholecystitis Infective Other Serious 12/27/2005 Male 1/20/2006 Other Health Professional Japan
Primary
Secondary
Thrombocytopenia Other Serious 7/19/2005 Male 115 lb 1/23/2006 Other Health Professional Japan
Primary
Secondary
Concomitant
Pulmonary Fibrosis Other Serious 7/6/2005 Male 97 lb 1/26/2006 Other Health Professional Japan
Primary
Secondary
Myocardial Infarction Death 1/12/2006 Male 1/26/2006 Other Health Professional Japan
Primary
Secondary
Thrombocytopenia Other Serious 6/29/2005 Male 139 lb 1/26/2006 Other Health Professional Japan
Primary
Secondary
Asthma Other Serious 1/16/2006 Female 1/30/2006 Other Health Professional Japan
Primary
Secondary
Vomiting Death 10/12/2005 59 Female 99 lb 2/2/2006 Other Health Professional Japan
Primary
Secondary
Concomitant
Gastric Ulcer Other Serious 8/12/2005 67 Male 143 lb 2/2/2006 Other Health Professional Japan
Primary
Secondary
Syncope Other Serious 7/23/2005 80 Female 108 lb 2/2/2006 Other Health Professional Japan
Primary
Secondary
Pulmonary Infarction Other Serious 9/6/2005 68 Male 143 lb 2/7/2006 Other Health Professional Japan
Primary
Secondary
Acute Myocardial Infarction Death 2/1/2006 56 Male 2/8/2006 Other Health Professional Japan
Primary
Secondary
Septic Shock Life Threatening 9/14/2005 44 Female 2/1/2006 France
Primary
Secondary
Concomitant
Nausea Other Serious 10/6/2005 Male 93 lb 2/10/2006 Other Health Professional Japan
Primary
Secondary
Cardiac Arrest Death 11/24/2005 Male 99 lb 2/15/2006 Other Health Professional Japan
Primary
Secondary
Metastases To Bone Other Serious 11/12/2005 Male 119 lb 2/15/2006 Other Health Professional Japan
Primary
Secondary
Concomitant
Leukopenia Death Male 2/16/2006 Other Health Professional Japan
Primary
Secondary
Laryngospasm Other Serious Female 2/20/2006 Physician France
Primary
Concomitant
Stomatitis Other Serious 1/1/2005 64 Male 2/23/2006 Physician France
Primary
Concomitant
Thrombocytopenia Other Serious 10/26/2005 Male 128 lb 2/23/2006 Other Health Professional Japan
Primary
Secondary
Concomitant
Thrombocytopenia Disability 5/22/2005 50 Male 2/23/2006 Other Health Professional Japan
Primary
Secondary
Concomitant
Neutropenia Death 12/8/2005 Male 110 lb 2/23/2006 Other Health Professional Japan
Primary
Secondary
Status Asthmaticus Life Threatening 1/16/2006 Female 128 lb 2/24/2006 Other Health Professional Japan
Primary
Secondary
Concomitant
Intestinal Obstruction Death 2/14/2006 82 Male 2/27/2006 Other Health Professional Japan
Primary
Secondary
Concomitant
Stomatitis Death 5/27/2005 Female 130 lb 3/2/2006 Other Health Professional Japan
Primary
Secondary
Concomitant
Prothrombin Time Prolonged Other Serious 10/2/2005 64 Male 134 lb 3/2/2006 Other Health Professional Japan
Primary
Secondary
Rectal Perforation Other Serious 5/12/2005 Male 128 lb 3/6/2006 Other Health Professional Japan
Primary
Secondary
Concomitant
Pulmonary Embolism Death 7/16/2005 Male 192 lb 3/6/2006 Other Health Professional Japan
Primary
Secondary
Concomitant
Respiratory Failure Life Threatening 9/14/2005 Male 126 lb 3/6/2006 Other Health Professional Japan
Primary
Secondary
Thrombocytopenia Other Serious 11/28/2005 Male 3/6/2006 Other Health Professional Japan
Primary
Secondary
Concomitant
Ventricular Fibrillation Death 2/1/2006 Male 115 lb 3/7/2006 Other Health Professional Japan
Primary
Secondary
Cerebral Haemorrhage Life Threatening 2/22/2006 57 Male 3/8/2006 Other Health Professional Japan
Primary
Concomitant
Sepsis Hospitalization 12/27/2005 Male 101 lb 3/8/2006 Other Health Professional Japan
Primary
Secondary
Concomitant
Thrombocytopenia Life Threatening 9/14/2005 Male 126 lb 3/9/2006 Other Health Professional Japan
Primary
Secondary
Thrombocytopenia Other Serious 11/8/2005 Female 108 lb 3/13/2006 Other Health Professional Japan
Primary
Secondary
Pneumonia Other Serious 9/6/2005 Female 117 lb 3/14/2006 Other Health Professional Japan
Primary
Secondary
Loss Of Consciousness Life Threatening 8/11/2005 Male 132 lb 3/15/2006 Other Health Professional Japan
Primary
Secondary
White Blood Cell Count Increased Hospitalization 7/14/2005 Female 108 lb 3/17/2006 Other Health Professional Japan
Primary
Secondary
Concomitant
Cerebral Haemorrhage Death 2/22/2006 Male 106 lb 3/24/2006 Other Health Professional Japan
Primary
Concomitant
Pneumonia Other Serious 8/17/2005 Female 97 lb 3/27/2006 Other Health Professional Japan
Primary
Secondary
Pulmonary Tuberculosis Hospitalization 55 Male 3/27/2006 Physician Japan
Primary
Secondary
Performance Status Decreased Hospitalization 6/14/2005 Female 137 lb 3/29/2006 Other Health Professional Japan
Primary
Secondary
Staphylococcal Infection Life Threatening 5/12/2005 Male 128 lb 3/31/2006 Other Health Professional Japan
Primary
Secondary
Concomitant
Generalised Oedema Life Threatening 9/14/2005 Male 132 lb 3/31/2006 Other Health Professional Japan
Primary
Secondary
Pyrexia Other Serious 9/29/2005 Female 97 lb 3/24/2006 Physician Japan
Primary
Secondary
Concomitant
Thrombocytopenia Life Threatening 9/14/2005 Male 126 lb 4/6/2006 Other Health Professional Japan
Primary
Secondary
Thrombocytopenia Other Serious 11/8/2005 Female 108 lb 4/7/2006 Other Health Professional Japan
Primary
Secondary
Concomitant
Respiratory Arrest Death 2/14/2006 82 Male 123 lb 4/7/2006 Other Health Professional Japan
Primary
Secondary
Concomitant
Cystitis Other Serious 7/28/2005 Male 4/10/2006 Other Health Professional Japan
Primary
Secondary
Rash Life Threatening 10/6/2005 Male 159 lb 4/12/2006 Other Health Professional Japan
Primary
Secondary
Concomitant
Thrombocytopenia Death 9/2/2005 Female 99 lb 4/13/2006 Physician Japan
Primary
Secondary
Respiratory Arrest Death 2/14/2006 82 Male 123 lb 4/13/2006 Other Health Professional Japan
Primary
Secondary
Concomitant
Hepatic Steatosis Other Serious 9/21/2005 Female 97 lb 4/13/2006 Other Health Professional Japan
Primary
Secondary
Shock Life Threatening 1/12/2006 Female 99 lb 5/3/2006 Other Health Professional Japan
Primary
Secondary
Vomiting Hospitalization 11/26/2005 52 Female 97 lb 5/3/2006 Physician Japan
Primary
Secondary
Concomitant
Thrombocytopenia Other Serious 7/11/2005 Female 110 lb 5/16/2006 Other Health Professional Japan
Primary
Secondary
Interstitial Lung Disease Death 3/31/2006 76 Male 5/18/2006 Other Health Professional Japan
Primary
Secondary
Blood Creatine Phosphokinase Increased Hospitalization 4/1/2006 58 Male 5/18/2006 Other Health Professional Japan
Primary
Secondary
Vascular Pseudoaneurysm Hospitalization 10/16/2005 Male 106 lb 5/19/2006 Other Health Professional Japan
Primary
Secondary
Stomatitis Other Serious 8/17/2005 Female 97 lb 5/19/2006 Other Health Professional Japan
Primary
Secondary
Meningitis Other Serious 11/21/2005 Female 97 lb 5/26/2006 Physician
Primary
Concomitant
Vomiting Hospitalization 4/23/2006 40 Male 5/26/2006 Physician
Primary
Concomitant
Urosepsis Other Serious 11/24/2005 Male 110 lb 6/1/2006 Other Health Professional Japan
Primary
Secondary
Stomatitis Other Serious 8/17/2005 Female 97 lb 6/1/2006 Other Health Professional Japan
Primary
Secondary
Thrombocytopenia Death 2/2/2006 Male 6/6/2006 Other Health Professional Japan
Primary
Secondary
Concomitant
Pneumonia Life Threatening 9/6/2005 Female 117 lb 6/15/2006 Other Health Professional Japan
Primary
Secondary
Pulmonary Tuberculosis Hospitalization 3/1/2006 Male 119 lb 6/16/2006 Physician Japan
Primary
Secondary
Sepsis Hospitalization 12/27/2005 Male 101 lb 6/19/2006 Other Health Professional Japan
Primary
Secondary
Concomitant
Vomiting Hospitalization 4/23/2006 Male 146 lb 6/19/2006 Physician
Primary
Concomitant
Rhabdomyolysis Life Threatening 4/20/2006 Male 6/20/2006 Other Health Professional Japan
Primary
Secondary
Epilepsy Life Threatening 6/13/2006 70 Male 6/26/2006 Japan
Primary
Secondary
Rhabdomyolysis Life Threatening 4/20/2006 Male 6/26/2006 Other Health Professional Japan
Primary
Secondary
Shock Other Serious 12/15/2005 Male 110 lb 6/30/2006 Physician Japan
Primary
Secondary
Sudden Death Death 5/30/2006 Male 141 lb 7/3/2006 Physician France
Primary
Concomitant
Vomiting Other Serious 10/25/2005 Female 110 lb 7/6/2006 Other Health Professional Japan
Primary
Secondary
White Blood Cell Count Decreased Life Threatening 4/24/2006 76 Male 119 lb 6/28/2006 Physician Japan
Primary
Concomitant
Vascular Pseudoaneurysm Hospitalization 10/16/2005 Male 106 lb 7/7/2006 Other Health Professional Japan
Primary
Secondary
Renal Disorder Hospitalization 2/17/2006 Female 104 lb 7/7/2006 Other Health Professional Japan
Primary
Secondary
Concomitant
Road Traffic Accident Life Threatening 4/24/2006 76 Male 119 lb 6/28/2006 Physician Japan
Primary
Concomitant
Leukopenia Death 3/22/2006 66 Female 117 lb 7/10/2006 Other Health Professional Japan
Primary
Secondary
Concomitant
Cerebral Haemorrhage Life Threatening 6/24/2006 Male 7/10/2006 Physician Japan
Primary
Secondary
Pulmonary Infarction Other Serious 9/6/2005 68 Male 143 lb 7/11/2006 Other Health Professional Japan
Primary
Secondary
Ileal Perforation Life Threatening 7/7/2006 Male 148 lb 7/20/2006 Other Health Professional Japan
Primary
Secondary
Concomitant
Renal Failure Acute Disability 10/11/2005 Female 172 lb 7/21/2006 Other Health Professional Japan
Primary
Secondary
Gastrointestinal Perforation Life Threatening 7/7/2006 Male 148 lb 7/24/2006 Other Health Professional Japan
Primary
Secondary
Concomitant
Throat Tightness Life Threatening 4/20/2006 Male 7/24/2006 Other Health Professional Japan
Primary
Secondary
Concomitant
Neutropenia Other Serious 9/20/2005 Female 106 lb 7/10/2006 Other Health Professional Japan
Primary
Secondary
Pupillary Reflex Impaired Death 10/31/2005 Male 106 lb 8/8/2006 Other Health Professional Japan
Primary
Secondary
Concomitant
Epilepsy Life Threatening 6/13/2006 Male 121 lb 8/8/2006 Physician Japan
Primary
Secondary
Concomitant
Renal Impairment Life Threatening 6/1/2006 Female 8/8/2006 Other Health Professional Australia
Primary
Secondary
Concomitant
Interstitial Lung Disease Death 5/10/2006 Male 148 lb 8/8/2006 Physician Japan
Primary
Secondary
Concomitant
Thrombocytopenia Life Threatening 5/26/2006 77 Male 117 lb 8/8/2006 Other Health Professional Japan
Primary
Secondary
Concomitant
Renal Impairment Hospitalization 2/17/2006 Female 104 lb 8/8/2006 Other Health Professional Japan
Primary
Secondary
Concomitant
Gastrointestinal Perforation Life Threatening 7/7/2006 Male 8/11/2006 Physician Japan
Primary
Secondary
Hepatic Failure Life Threatening 1/12/2006 Female 99 lb 8/15/2006 Other Health Professional Japan
Primary
Secondary
Sepsis Other Serious 10/6/2005 Female 8/29/2006 Other Health Professional Japan
Primary
Secondary
Myocardial Infarction Death 1/12/2006 Male 9/1/2006 Other Health Professional Japan
Primary
Secondary
Concomitant
Vomiting Other Serious 10/25/2005 Female 110 lb 9/12/2006 Other Health Professional Japan
Primary
Secondary
Peritonitis Life Threatening 7/7/2006 Male 9/12/2006 Physician Japan
Primary
Secondary
Depressed Level Of Consciousness Other Serious 9/1/2006 78 Male 9/14/2006 Physician Japan
Primary
Secondary
Sepsis Death 10/24/2005 Male 128 lb 9/25/2006 Other Health Professional Japan
Primary
Secondary
White Blood Cell Count Increased Hospitalization 1/24/2006 Male 137 lb 9/28/2006 Physician Japan
Primary
Secondary
Concomitant
Blood Potassium Increased Other Serious 10/6/2005 82 Female 88 lb 10/10/2006 Other Health Professional Japan
Primary
Secondary
Concomitant
Hyperthermia Death 6/20/2003 Male 10/19/2006 Other Health Professional France
Primary
Secondary
Paraesthesia Death 6/20/2003 Male 10/25/2006 Other Health Professional France
Primary
Secondary
Thrombocytopenia Life Threatening 11/24/2005 58 Male 121 lb 10/26/2006 Other Health Professional Japan
Primary
Secondary
Concomitant
Sepsis Death 6/20/2003 Male 11/2/2006 Other Health Professional France
Primary
Secondary
Hepatic Failure Death 10/6/2006 50 Female 11/7/2006 Other Health Professional Japan
Primary
Secondary
Enterocutaneous Fistula Other Serious 9/23/2007 Female 10/29/2007 Physician Japan
Primary
Secondary
Concomitant
Leukopenia Life Threatening 8/27/2005 Male 132 lb 11/5/2007 Other Health Professional Japan
Primary
Secondary
Cyanosis Other Serious 10/23/2007 67 Male 11/9/2007 Physician Japan
Primary
Concomitant
Pruritus Life Threatening 11/5/2007 Male 132 lb 11/12/2007 Pharmacist Brazil
Primary
Concomitant
Pruritus Life Threatening 11/5/2007 Male 132 lb 11/13/2007 Pharmacist Portugal
Primary
Concomitant
Guillain-barre Syndrome Disability 5/22/2007 68 Male 11/14/2007 Physician Japan
Primary
Concomitant
Brain Stem Infarction Disability 10/25/2007 Male 11/14/2007 Physician Japan
Primary
Secondary
Aortic Dissection Other Serious 10/29/2007 Male 11/29/2007 Physician Japan
Primary
Secondary
Concomitant
Thrombocytopenia Hospitalization 12/26/2005 Male 101 lb 11/30/2007 Other Health Professional Japan
Primary
Secondary
Pruritus Life Threatening 11/5/2007 Male 132 lb 11/30/2007 Pharmacist Portugal
Primary
Concomitant
Enterocutaneous Fistula Other Serious 9/23/2007 Female 12/10/2007 Physician Japan
Primary
Secondary
Concomitant
Pyrexia Hospitalization 11/22/2007 66 Female 12/3/2007 Belgium
Primary
Secondary
Concomitant
Guillain-barre Syndrome Disability 5/23/2007 Male 106 lb 12/26/2007 Physician Japan
Primary
Concomitant
Fungal Infection Hospitalization 1/8/2008 Female 123 lb 1/17/2008 Physician Belgium
Primary
Secondary
Psychomotor Skills Impaired Hospitalization 9/13/2007 Female 1/17/2008 Physician United Kingdom
Primary
Secondary
Acute Respiratory Distress Syndrome Death 12/29/2007 Male 1/17/2008 Physician Japan
Primary
Secondary
Tumour Perforation Life Threatening 12/6/2007 54 Female 1/18/2008 Physician Japan
Primary
Secondary
Pruritus Life Threatening 11/5/2007 Male 132 lb 1/23/2008 Pharmacist Portugal
Primary
Concomitant
Aortic Aneurysm Rupture Death 1/21/2008 Male 1/30/2008 Physician Japan
Primary
Secondary
Thrombocytopenia Other Serious 12/7/2005 Male 101 lb 2/4/2008 Other Health Professional Japan
Primary
Secondary
Aortic Aneurysm Rupture Death 1/21/2008 Male 2/11/2008 Physician Japan
Primary
Secondary
Stomatitis Other Serious 12/1/2007 Male 2/14/2008 Physician Japan
Primary
Secondary
Concomitant
Acute Respiratory Distress Syndrome Life Threatening 1/5/2008 Male 2/15/2008 Physician Japan
Primary
Secondary
Concomitant
Interstitial Lung Disease Other Serious 12/19/2007 Female 2/27/2008 Physician Italy
Primary
Secondary
Concomitant
Enterocutaneous Fistula Other Serious 9/23/2007 Female 2/29/2008 Physician Japan
Primary
Secondary
Concomitant
Gastrointestinal Perforation Life Threatening Female 3/3/2008 Physician Japan
Primary
Secondary
Small Intestinal Perforation Life Threatening 1/25/2008 Male 3/10/2008 Physician Japan
Primary
Secondary
Concomitant
Platelet Count Decreased Life Threatening 10/2/2007 Female 3/10/2008 Physician Japan
Primary
Secondary
Concomitant
Small Intestinal Perforation Life Threatening 1/25/2008 Male 3/21/2008 Physician Japan
Primary
Secondary
Concomitant
Hiccups Hospitalization 2/28/2008 Male 164 lb 3/21/2008 Japan
Primary
Secondary
Concomitant
Oesophageal Varices Haemorrhage Hospitalization 11/21/2007 Female 4/2/2008 Physician France
Primary
Concomitant
Hiccups Hospitalization 2/28/2008 Male 164 lb 4/8/2008 Japan
Primary
Secondary
Concomitant
Hiccups Hospitalization 2/28/2008 Male 164 lb 4/10/2008 Japan
Primary
Secondary
Concomitant
Oesophageal Varices Haemorrhage Hospitalization 11/21/2007 Female 4/11/2008 Physician France
Primary
Concomitant
Small Intestinal Perforation Life Threatening 1/25/2008 Male 4/18/2008 Physician Japan
Primary
Secondary
Concomitant
Hiccups Hospitalization 2/28/2008 Male 164 lb 4/30/2008 Japan
Primary
Secondary
Concomitant
Rash Generalised Other Serious 2/28/2008 Male 5/14/2008 Physician United Kingdom
Primary
Secondary
Concomitant
Acute Myeloid Leukaemia Death 1/1/2007 47 Female 5/16/2008 Other Health Professional Japan
Primary
Concomitant
Acute Myeloid Leukaemia Death 1/1/2007 47 Female 5/19/2008 Other Health Professional Japan
Primary
Concomitant

Drug Data