Elplat combined with Leucovorin Calcium

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Venoocclusive Liver Disease Other Serious 8/29/2006 57 Male 8/9/2007 Physician Japan
Primary
Concomitant
Thrombocytopenia Life Threatening 10/11/2007 64 Male 12/6/2007 Other Health Professional Japan
Primary
Concomitant
Thrombocytopenia Life Threatening 10/10/2007 Male 12/27/2007 Other Health Professional Japan
Primary
Concomitant
Monoplegia Disability 1/20/2008 77 Male 2/6/2008 Physician Japan
Primary
Concomitant
Neutropenia Other Serious 55 Female 108 lb 4/1/2008 Other Health Professional Japan
Primary
Secondary
Concomitant
Hypoxic Encephalopathy Life Threatening 3/26/2008 Male 119 lb 6/3/2008 Physician Japan
Primary
Secondary
Concomitant
Stomatitis Hospitalization 9/2/2007 Female 6/20/2008 Physician Japan
Primary
Secondary
Concomitant
Neutropenia Other Serious 4/30/2008 Female 99 lb 6/24/2008 Other Health Professional Japan
Primary
Secondary
Concomitant
Palmar-plantar Erythrodysaesthesia Syndrome Other Serious 3/21/2008 Male 139 lb 7/24/2008 Physician Japan
Primary
Secondary
Concomitant
Nausea Life Threatening 6/25/2008 Female 118 lb 7/28/2008 Physician Japan
Primary
Secondary
Concomitant
Sepsis Hospitalization 7/14/2008 58 Male 8/7/2008 Physician Japan
Primary
Secondary
Small Intestinal Perforation Life Threatening 8/4/2008 62 Male 115 lb 8/14/2008 Physician Japan
Primary
Secondary
Interstitial Lung Disease Death 8/8/2007 70 Male 8/18/2008 Physician Japan
Primary
Concomitant
Small Intestinal Perforation Life Threatening 8/1/2008 Male 115 lb 8/20/2008 Physician Japan
Primary
Secondary
Upper Gastrointestinal Haemorrhage Other Serious 10/29/2007 Female 124 lb 8/20/2008 Physician Japan
Primary
Secondary
Concomitant
Peritonitis Life Threatening 4/10/2007 Female 159 lb 8/21/2008 Other Health Professional Japan
Primary
Secondary
Concomitant
Tumour Haemorrhage Hospitalization 5/26/2008 28 Male 121 lb 8/25/2008 Physician Japan
Primary
Secondary
Concomitant
Cerebral Infarction Other Serious 8/10/2008 81 Male 154 lb 8/26/2008 Physician Japan
Primary
Secondary
Concomitant
Small Intestinal Perforation Life Threatening 7/1/2008 Male 115 lb 8/26/2008 Physician Japan
Primary
Secondary
Bone Marrow Failure Life Threatening 1/4/2008 Female 133 lb 8/27/2008 Other Health Professional Japan
Primary
Secondary
Concomitant
Intervertebral Discitis Hospitalization 4/2/2008 Male 9/4/2008 Physician Japan
Primary
Secondary
Concomitant
Gastrointestinal Perforation Hospitalization 8/27/2008 Female 100 lb 9/15/2008 Physician Japan
Primary
Secondary
Haemorrhage Subcutaneous Hospitalization 1/9/2008 Male 9/16/2008 Physician Japan
Primary
Secondary
Ileal Perforation Life Threatening 8/1/2008 Male 115 lb 9/16/2008 Physician Japan
Primary
Secondary
Anaphylactic Shock Other Serious 9/1/2008 67 Female 9/17/2008 Physician United Kingdom
Primary
Secondary
Interstitial Lung Disease Hospitalization 4/16/2008 Male 9/22/2008 Physician Japan
Primary
Secondary
Ileal Perforation Death 8/1/2008 Male 121 lb 9/24/2008 Physician Japan
Primary
Secondary
Small Intestinal Perforation Death 7/1/2008 62 Male 9/25/2008 Physician Japan
Primary
Secondary
Concomitant
Mucosal Haemorrhage Hospitalization 12/9/2007 Male 157 lb 9/30/2008 Physician Japan
Primary
Secondary
Concomitant
Interstitial Lung Disease Life Threatening 9/5/2008 Male 10/1/2008 Physician Japan
Primary
Concomitant
Loss Of Consciousness Hospitalization 9/22/2008 60 Male 10/6/2008 Physician Japan
Primary
Secondary
Ileal Perforation Death 8/1/2008 Male 121 lb 10/6/2008 Physician Japan
Primary
Secondary
General Physical Health Deterioration Death 9/24/2008 Male 120 lb 10/17/2008 Physician Japan
Primary
Secondary
Interstitial Lung Disease Death 8/8/2007 Male 146 lb 10/21/2008 Physician Japan
Primary
Secondary
Concomitant
Interstitial Lung Disease Death 9/29/2008 Male 10/22/2008 Other Health Professional Japan
Primary
Concomitant
Duodenal Ulcer Perforation Hospitalization 9/18/2008 61 Female 10/27/2008 Physician Japan
Primary
Secondary
Concomitant
Gastrointestinal Necrosis Death 11/20/2007 Male 108 lb 10/28/2008 Physician Japan
Primary
Secondary
Concomitant
Neutrophil Count Decreased Hospitalization 7/30/2007 Male 10/29/2008 Physician Japan
Primary
Secondary
Concomitant
Neutrophil Count Decreased Other Serious 7/26/2007 Female 118 lb 10/31/2008 Physician Japan
Primary
Secondary
Concomitant
Neutrophil Count Decreased Other Serious 1/11/2008 Male 106 lb 10/31/2008 Consumer United Kingdom
Primary
Secondary
Concomitant
Ileal Perforation Disability 12/6/2007 Male 117 lb 11/3/2008 Physician Japan
Primary
Secondary
Concomitant
Disease Progression Hospitalization 8/29/2007 Male 11/3/2008 Physician Japan
Primary
Secondary
Concomitant
Duodenal Ulcer Perforation Hospitalization 9/18/2008 61 Female 11/4/2008 Physician Japan
Primary
Secondary
Concomitant
Drug Eruption Hospitalization 6/16/2008 Female 11/4/2008 Consumer Japan
Primary
Secondary
Concomitant
Disease Progression Death 6/12/2008 Female 100 lb 11/5/2008 Physician Japan
Primary
Secondary
Concomitant
Pneumothorax Life Threatening Male 11/7/2008 Physician Japan
Primary
Secondary
Disease Progression Death 5/8/2008 Female 157 lb 11/10/2008 Physician Japan
Primary
Secondary
Concomitant
Death Death 1/1/2008 Male 131 lb 11/11/2008 Consumer United Kingdom
Primary
Concomitant
Cardiac Arrest Life Threatening 11/6/2008 50 Male 11/18/2008 Other Health Professional Japan
Primary
Concomitant
Shock Life Threatening 11/6/2008 59 Male 11/19/2008 Physician United Kingdom
Primary
Concomitant
Ileal Perforation Disability 12/6/2007 Male 117 lb 11/19/2008 Physician Japan
Primary
Secondary
Anaphylactic Shock Hospitalization 9/1/2008 Female 11/20/2008 Consumer United Kingdom
Primary
Secondary
Concomitant
Convulsion Hospitalization 11/1/2008 63 Female 11/21/2008 Physician United Kingdom
Primary
Secondary
Peritonitis Hospitalization 11/11/2008 Female 108 lb 11/25/2008 Physician United Kingdom
Primary
Concomitant
Shock Other Serious 9/1/2008 Male 121 lb 12/2/2008 Physician Japan
Primary
Secondary
Small Intestinal Perforation Death 7/1/2008 Male 12/2/2008 Physician Japan
Primary
Secondary
Concomitant
Hallucination Hospitalization 11/15/2008 Female 93 lb 12/2/2008 Consumer United Kingdom
Primary
Concomitant
Bone Marrow Failure Other Serious 52 Female 12/5/2008 Physician Japan
Primary
Concomitant
Platelet Count Decreased Hospitalization 11/25/2008 Male 146 lb 12/10/2008 Physician Japan
Primary
Secondary
Concomitant
Duodenal Ulcer Perforation Hospitalization 9/18/2008 Female 86 lb 12/11/2008 Physician Japan
Primary
Secondary
Concomitant
Disease Progression Life Threatening 9/5/2008 Male 12/12/2008 Consumer United Kingdom
Primary
Secondary
Concomitant
Spinal Cord Infarction Hospitalization 11/27/2008 12/12/2008 Physician Japan
Primary
Secondary
Sudden Death Death 10/31/2008 67 Male 12/15/2008 Physician Japan
Primary
Secondary
Varices Oesophageal Other Serious 8/20/2008 Male 12/16/2008 Physician United Kingdom
Primary
Secondary
Concomitant
Spinal Cord Infarction Hospitalization 11/27/2008 12/19/2008 Physician Japan
Primary
Secondary
Cardio-respiratory Arrest Death 11/6/2008 Male 165 lb 12/19/2008 Other Health Professional Japan
Primary
Secondary
Concomitant
Anaphylactic Shock Hospitalization 9/1/2008 Female 12/23/2008 Consumer United Kingdom
Primary
Secondary
Concomitant
Ulcer Other Serious 6/4/2008 Female 12/24/2008 Consumer Japan
Primary
Secondary
Pyrexia Other Serious 12/17/2008 59 Female 12/30/2008 Consumer United Kingdom
Primary
Concomitant
Leukoencephalopathy Other Serious 12/8/2008 56 Male 1/7/2009 Other Health Professional Japan
Primary
Secondary
Concomitant
Interstitial Lung Disease Death 9/29/2008 Male 106 lb 1/19/2009 Other Health Professional Japan
Primary
Secondary
Concomitant
Illusion Other Serious 63 Male 2/5/2009 Other Health Professional Japan
Primary
Secondary
Concomitant
Jejunal Perforation Life Threatening 3/13/2008 Female 105 lb 2/12/2009 Other Health Professional Japan
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Death 11/6/2008 Male 165 lb 2/13/2009 Other Health Professional Japan
Primary
Secondary
Concomitant
Bone Marrow Failure Other Serious 10/1/2006 52 Female 2/27/2009 Physician Japan
Primary
Concomitant
Shock Life Threatening 2/19/2009 Female 3/4/2009 Other Health Professional Japan
Primary
Secondary
Anaphylactic Shock Other Serious 9/1/2008 Male 121 lb 3/24/2009 Physician Japan
Primary
Secondary
Concomitant
Shock Other Serious 11/1/2007 66 Male 4/6/2009 Other Health Professional Japan
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Death 11/6/2008 Male 165 lb 4/27/2009 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Convulsion Hospitalization 11/2/2008 Female 5/1/2009 Physician United Kingdom
Primary
Secondary
Concomitant
Multi-organ Failure Other Serious 4/1/2009 Female 5/4/2009 Other Health Professional Japan
Primary
Secondary
Gastrointestinal Perforation Hospitalization 11/5/2008 Male 5/5/2009 Physician Japan
Primary
Secondary
Concomitant
Multi-organ Failure Other Serious 4/17/2009 Female 5/5/2009 Consumer United Kingdom
Primary
Secondary
Interstitial Lung Disease Hospitalization 4/15/2009 65 Male 5/7/2009 Consumer United Kingdom
Primary
Secondary
Concomitant
Anaphylactic Reaction Other Serious 52 5/7/2009 Consumer Japan
Primary
Concomitant
Anaphylactoid Reaction Hospitalization 70 Female 5/19/2009 Consumer United Kingdom
Primary
Concomitant
Shock Other Serious 11/1/2007 66 Male 5/21/2009 Other Health Professional Japan
Primary
Secondary
Concomitant
Speech Disorder Other Serious 6/2/2009 6/17/2009 Physician United Kingdom
Primary
Secondary
Concomitant
Speech Disorder Other Serious 6/2/2009 9/1/2009 Physician United Kingdom
Primary
Secondary
Concomitant
Hyperammonaemia Disability 6/19/2009 Male 117 lb 9/7/2009 Physician Japan
Primary
Secondary
Concomitant
Anaphylactic Shock Life Threatening 7/7/2009 Male 179 lb 9/17/2009 Physician Japan
Primary
Secondary
Concomitant
Reversible Posterior Leukoencephalopathy Syndrome Other Serious 7/28/2008 35 Female 110 lb 9/17/2009 Physician Japan
Primary
Concomitant
Neutrophil Count Decreased Hospitalization 7/30/2007 Male 10/20/2009 Physician Japan
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Death 11/6/2008 Male 165 lb 11/4/2009 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Stomatitis Other Serious 1/12/2010 59 Male 4/12/2010 Physician Japan
Primary
Secondary
Concomitant
Vomiting Other Serious 9/20/2007 47 Female 141 lb 4/19/2010 Physician Japan
Primary
Secondary
Concomitant
Small Intestinal Perforation Other Serious 9/8/2009 70 Female 95 lb 4/26/2010 Physician Japan
Primary
Concomitant
Anaphylactic Shock Life Threatening 4/15/2010 69 Male 4/27/2010 Physician Japan
Primary
Secondary
Concomitant
Ventricular Tachycardia Death 7/7/2009 70 Male 134 lb 5/13/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Dyschezia Other Serious 1/1/2009 64 Male 5/19/2010 Physician Japan
Primary
Concomitant
Stomatitis Other Serious 1/1/2009 48 Male 88 lb 5/27/2010 Physician Japan
Primary
Concomitant
Small Intestinal Perforation Other Serious 9/8/2009 70 Female 95 lb 5/28/2010 Physician Japan
Primary
Concomitant
Photosensitivity Reaction Hospitalization 4/27/2010 68 Male 5/28/2010 Physician Japan
Primary
Secondary
Concomitant
Neuropathy Peripheral Life Threatening 12/17/2009 69 Male 128 lb 6/1/2010 Physician Japan
Primary
Secondary
Concomitant
Small Intestinal Perforation Other Serious 11/1/2008 60 Male 119 lb 6/8/2010 Physician Japan
Primary
Secondary
Concomitant
Throat Irritation Other Serious 4/1/2010 68 Male 112 lb 6/17/2010 Physician Japan
Primary
Secondary
Concomitant
Vomiting Other Serious 1/1/2010 52 Female 6/17/2010 Physician Japan
Primary
Secondary
Urinary Tract Infection Other Serious 6/1/2009 70 Female 104 lb 6/18/2010 Physician Japan
Primary
Secondary
Concomitant
Septic Shock Other Serious 1/1/2009 76 Female 6/21/2010 Physician Japan
Primary
Concomitant
Pyrexia Hospitalization 1/13/2010 72 Male 126 lb 6/22/2010 Physician Japan
Primary
Secondary
Concomitant
Interstitial Lung Disease Hospitalization 3/31/2009 79 Male 115 lb 8/4/2010 Physician Japan
Primary
Secondary
Concomitant
Pyrexia Other Serious 7/1/2010 81 Male 112 lb 8/4/2010 Physician Japan
Primary
Secondary
Concomitant
Ventricular Fibrillation Other Serious 1/1/2009 62 Male 148 lb 8/11/2010 Physician Japan
Primary
Secondary
Concomitant
Thrombocytopenia Other Serious 77 Male 8/11/2010 Physician Japan
Primary
Secondary
Concomitant
Postoperative Wound Infection Other Serious 9/26/2009 67 Male 137 lb 8/13/2010 Physician Japan
Primary
Concomitant
Interstitial Lung Disease Hospitalization 7/6/2010 69 Male 172 lb 8/13/2010 Physician Japan
Primary
Secondary
Concomitant
Liver Abscess Hospitalization 2/11/2010 81 Male 141 lb 8/19/2010 Physician Japan
Primary
Secondary
Concomitant
Pyrexia Other Serious 1/1/2010 53 Male 106 lb 8/26/2010 Physician Japan
Primary
Secondary
Concomitant
Large Intestine Perforation Life Threatening 1/1/2010 81 Female 71 lb 8/30/2010 Physician Japan
Primary
Secondary
Concomitant
Wound Infection Other Serious 8/10/2010 66 Male 104 lb 9/1/2010 Other Health Professional Japan
Primary
Concomitant
Large Intestine Perforation Life Threatening 1/1/2010 81 Female 71 lb 9/2/2010 Physician Japan
Primary
Secondary
Concomitant
Pyrexia Hospitalization 1/13/2010 72 Male 126 lb 9/4/2010 Physician Japan
Primary
Secondary
Concomitant
Neuropathy Peripheral Other Serious 71 Female 9/7/2010 Pharmacist Japan
Primary
Concomitant
Renal Tubular Acidosis Hospitalization 12/1/2009 67 Female 99 lb 9/8/2010 Physician Japan
Primary
Concomitant
Small Intestinal Perforation Other Serious 5/6/2010 62 Male 141 lb 9/8/2010 Physician Japan
Primary
Concomitant
Pyrexia Hospitalization 7/1/2010 81 Male 112 lb 9/8/2010 Physician Japan
Primary
Secondary
Concomitant
Ovarian Torsion Other Serious 10/2/2008 41 Female 119 lb 9/9/2010 Physician Japan
Primary
Secondary
Concomitant
Anaphylactic Shock Other Serious 8/2/2010 60 Female 86 lb 9/10/2010 Pharmacist Japan
Primary
Concomitant
White Blood Cell Count Decreased Other Serious 1/1/2010 60 Female 75 lb 9/15/2010 Physician Japan
Primary
Concomitant
Anaphylactic Shock Other Serious 8/2/2010 60 Female 86 lb 9/16/2010 Pharmacist Japan
Primary
Secondary
Concomitant
Anaphylactic Shock Other Serious 8/2/2010 60 Female 86 lb 9/21/2010 Pharmacist Japan
Primary
Secondary
Concomitant
Peripheral Coldness Death 8/20/2010 66 Female 66 lb 9/21/2010 Physician Japan
Primary
Concomitant
Hyperammonaemia Hospitalization 9/8/2010 67 Male 9/21/2010 Physician Japan
Primary
Concomitant
Atrioventricular Block Complete Hospitalization 7/21/2010 70 Male 9/23/2010 Pharmacist Japan
Primary
Concomitant
Small Intestine Ulcer Other Serious 7/28/2010 55 Male 115 lb 9/24/2010 Physician Japan
Primary
Concomitant
Atrioventricular Block Complete Hospitalization 7/21/2010 70 Male 9/24/2010 Physician Japan
Primary
Concomitant
Subarachnoid Haemorrhage Death 9/3/2010 62 Female 110 lb 9/27/2010 Physician Japan
Primary
Concomitant
Testis Cancer Other Serious 60 Male 9/29/2010 Pharmacist Japan
Primary
Concomitant
Pyrexia Other Serious 6/23/2010 54 Male 106 lb 9/30/2010 Physician Japan
Primary
Secondary
Concomitant
Visual Impairment Other Serious 11/1/2009 77 Female 10/4/2010 Physician Japan
Primary
Concomitant
Sepsis Life Threatening 4/1/2010 71 Male 115 lb 10/7/2010 Physician Japan
Primary
Concomitant
Toxic Skin Eruption Other Serious 7/30/2010 79 Male 123 lb 10/7/2010 Physician Japan
Primary
Secondary
Concomitant
Peritonitis Other Serious 60 Female 10/13/2010 Physician Japan
Primary
Concomitant
Peritonitis Hospitalization 10/4/2010 10/14/2010 Physician Japan
Primary
Secondary
Hyperammonaemia Hospitalization 9/9/2010 67 Male 10/15/2010 Physician Japan
Primary
Secondary
Concomitant
Intestinal Obstruction Hospitalization 6/4/2010 52 Female 101 lb 10/18/2010 Physician Japan
Primary
Secondary
Polymyositis Hospitalization 5/1/2009 58 Male 10/19/2010 Physician Japan
Primary
Secondary
Concomitant
Ventricular Fibrillation Life Threatening 10/6/2010 72 Male 10/19/2010 Physician Japan
Primary
Secondary
Peritonitis Hospitalization 7/16/2010 68 Female 10/28/2010 Physician Japan
Primary
Secondary
Femoral Neck Fracture Other Serious 10/10/2010 69 Male 116 lb 11/4/2010 Physician Japan
Primary
Concomitant

Drug Data