Calcium Levofolinate combined with Irinotecan Hydrochloride

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Platelet Count Decreased Life Threatening 10/2/2007 Female 3/10/2008 Physician Japan
Primary
Secondary
Concomitant
Interstitial Lung Disease Other Serious 1/5/2009 69 Male 1/23/2009 Physician United Kingdom
Primary
Secondary
Peritonitis Life Threatening 10/6/2008 Female 2/3/2009 Physician United Kingdom
Primary
Concomitant
Interstitial Lung Disease Other Serious 1/5/2009 69 Male 2/4/2009 Physician United Kingdom
Primary
Secondary
Concomitant
Hypertension Life Threatening 11/25/2008 Male 146 lb 2/4/2009 Physician Japan
Primary
Secondary
Concomitant
Pyrexia Hospitalization 8/14/2007 Female 2/17/2009 Physician United Kingdom
Primary
Secondary
Concomitant
Interstitial Lung Disease Other Serious 1/5/2009 Male 2/18/2009 Physician United Kingdom
Primary
Secondary
Concomitant
Interstitial Lung Disease Other Serious 10/8/2008 Male 132 lb 2/19/2009 Consumer Japan
Primary
Secondary
Concomitant
Gastrointestinal Perforation Hospitalization 1/20/2009 60 Male 2/20/2009 Physician Japan
Primary
Secondary
Convulsion Other Serious 5/20/2008 Male 123 lb 2/24/2009 Consumer Japan
Primary
Secondary
Concomitant
Interstitial Lung Disease Other Serious 12/8/2008 Male 101 lb 2/27/2009 Consumer United Kingdom
Primary
Secondary
Concomitant
Interstitial Lung Disease Other Serious 12/8/2008 Male 101 lb 3/11/2009 Consumer United Kingdom
Primary
Secondary
Concomitant
Stomatitis Hospitalization 10/27/2008 Female 128 lb 3/13/2009 Physician Japan
Primary
Secondary
Concomitant
Arteriosclerosis Hospitalization 1/28/2009 Male 120 lb 3/13/2009 Consumer Japan
Primary
Concomitant
Hypertension Life Threatening 11/25/2008 Male 146 lb 3/17/2009 Physician Japan
Primary
Secondary
Concomitant
Pyrexia Hospitalization 2/28/2009 59 Male 154 lb 3/20/2009 Consumer Japan
Primary
Concomitant
Neutrophil Count Decreased Other Serious 11/7/2007 Male 3/21/2009 Other Health Professional Japan
Primary
Secondary
Duodenal Ulcer Perforation Hospitalization 1/20/2009 Male 3/25/2009 Physician Japan
Primary
Secondary
Concomitant
Death Death 3/23/2009 72 Male 4/16/2009 Consumer United Kingdom
Primary
Secondary
Pyrexia Hospitalization 2/27/2009 Male 154 lb 4/21/2009 Consumer Japan
Primary
Secondary
Concomitant
Gastric Ulcer Hospitalization 2/26/2009 Male 207 lb 5/22/2009 Consumer United Kingdom
Primary
Concomitant
Gastric Ulcer Hospitalization 2/26/2009 Male 207 lb 6/12/2009 Consumer United Kingdom
Primary
Concomitant
Pyrexia Hospitalization 6/5/2009 55 Female 6/29/2009 Physician Japan
Primary
Concomitant
Hepatitis Other Serious 6/11/2008 Female 135 lb 7/1/2009 Consumer Japan
Primary
Secondary
Concomitant
Pyrexia Hospitalization 6/5/2009 55 Female 7/20/2009 Physician Japan
Primary
Secondary
Concomitant
Myocardial Infarction Death 3/12/2009 Male 8/5/2009 Consumer United Kingdom
Primary
Concomitant
Leukoencephalopathy Hospitalization 9/14/2009 9/30/2009 Physician United Kingdom
Primary
Secondary
Pyrexia Other Serious 7/1/2009 Male 119 lb 10/8/2009 Pharmacist Japan
Primary
Concomitant
Hepatitis Other Serious 6/11/2008 Female 135 lb 10/9/2009 Consumer Japan
Primary
Secondary
Concomitant
Melaena Other Serious 63 Male 11/5/2009 Consumer Japan
Primary
Secondary
Pyrexia Other Serious 7/1/2009 Male 119 lb 12/4/2009 Pharmacist Japan
Primary
Concomitant
Interstitial Lung Disease Hospitalization 1/1/2008 64 Female 2/4/2010 Physician Japan
Primary
Secondary
Concomitant
Leukoencephalopathy Hospitalization 9/14/2009 Male 2/17/2010 Physician Japan
Primary
Secondary
Concomitant
Arteriosclerosis Obliterans Hospitalization 1/28/2009 Male 121 lb 3/1/2010 Physician Japan
Primary
Concomitant
Vomiting Hospitalization 2/15/2010 69 Male 104 lb 4/13/2010 Physician Japan
Primary
Concomitant
Paraesthesia Hospitalization 12/1/2009 61 Male 4/14/2010 Other Health Professional France
Primary
Secondary
Concomitant
Hepatitis Cholestatic Hospitalization 8/21/2009 60 Male 4/16/2010 Other Health Professional France
Primary
Secondary
Concomitant
Renal Impairment Other Serious 12/2/2008 71 Male 143 lb 4/19/2010 Physician Japan
Primary
Secondary
Concomitant
Hepatitis Cholestatic Hospitalization 8/21/2009 60 Male 4/27/2010 Other Health Professional France
Primary
Secondary
Concomitant
Renal Failure Acute Hospitalization 4/27/2010 Female 5/3/2010 Physician Japan
Primary
Secondary
Concomitant
Wound Decomposition Other Serious 9/27/2007 58 Male 5/6/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Septic Shock Other Serious 2/18/2010 64 Female 115 lb 6/22/2010 Physician Japan
Primary
Secondary
Concomitant
Urinary Tract Infection Other Serious 6/1/2009 71 Female 6/22/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Renal Failure Acute Hospitalization 4/27/2010 Female 6/29/2010 Physician Japan
Primary
Secondary
Concomitant
Pyrexia Hospitalization 8/28/2009 74 Male 93 lb 7/6/2010 Physician Japan
Primary
Secondary
Concomitant
Septic Shock Other Serious 2/18/2010 64 Female 115 lb 7/8/2010 Physician Japan
Primary
Secondary
Concomitant
Pyrexia Other Serious 11/27/2009 67 Female 7/14/2010 Physician Italy
Primary
Secondary
Necrotising Fasciitis Hospitalization 70 Male 7/16/2010 Physician Japan
Primary
Secondary
Ventricular Fibrillation Other Serious 1/1/2009 Male 8/16/2010 Consumer Japan
Primary
Secondary
Concomitant
Gastrointestinal Inflammation Hospitalization 8/12/2010 46 Male 8/24/2010 Physician Japan
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Hospitalization 8/1/2010 63 Male 8/26/2010 Physician Japan
Primary
Concomitant
Vomiting Hospitalization 8/14/2010 45 Female 8/27/2010 Physician Japan
Primary
Concomitant
Blepharitis Other Serious 8/30/2010 67 Male 9/13/2010 Physician Japan
Primary
Concomitant
Stomatitis Other Serious 7/22/2010 75 Female 99 lb 9/15/2010 Physician Japan
Primary
Secondary
Concomitant
Vomiting Hospitalization 8/14/2010 45 Female 119 lb 10/7/2010 Physician Japan
Primary
Secondary
White Blood Cell Count Decreased Hospitalization 8/12/2010 63 Male 126 lb 10/7/2010 Physician Japan
Primary
Secondary
Concomitant
Respiratory Failure Other Serious 7/28/2010 55 Male 115 lb 10/15/2010 Physician Japan
Primary
Concomitant
Reversible Posterior Leukoencephalopathy Syndrome Other Serious 9/14/2009 52 Male 10/15/2010 Physician Japan
Primary
Secondary
Concomitant
Blood Urea Increased Other Serious 69 Male 10/21/2010 Pharmacist Japan
Primary
Secondary
Pneumonia Death 8/4/2010 10/22/2010 Physician Japan
Primary
Concomitant
Colorectal Cancer Death 9/24/2010 10/26/2010 Other Health Professional Japan
Primary
Concomitant
Rash Hospitalization 8/13/2010 10/27/2010 Other Health Professional Japan
Primary
Concomitant
Interstitial Lung Disease Hospitalization 8/24/2010 10/27/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Herpes Zoster Hospitalization 3/9/2007 76 Male 10/27/2010 Physician Italy
Primary
Secondary
Concomitant
Necrotising Fasciitis Disability 9/21/2010 60 Male 126 lb 10/27/2010 Physician Japan
Primary
Concomitant
Sepsis Other Serious 10/16/2010 60 Male 10/28/2010 Physician Japan
Primary
Concomitant
White Blood Cell Count Decreased Hospitalization 8/12/2010 63 Male 126 lb 10/29/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Hospitalization 8/12/2010 10/29/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Stomatitis Hospitalization 7/23/2010 10/29/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Hypomagnesaemia Other Serious 7/13/2010 10/29/2010 Other Health Professional Japan
Primary
Concomitant
Sepsis Other Serious 10/16/2010 10/29/2010 Other Health Professional Japan
Primary
Concomitant
Sepsis Other Serious 10/16/2010 60 Male 10/29/2010 Physician Japan
Primary
Concomitant
Interstitial Lung Disease Hospitalization 8/24/2010 11/2/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Hepatic Encephalopathy Death 6/25/2010 11/2/2010 Other Health Professional Japan
Primary
Concomitant
Small Intestinal Ulcer Haemorrhage Other Serious 7/28/2010 55 Male 115 lb 11/4/2010 Pharmacist Japan
Primary
Concomitant
Stomatitis Death 6/25/2010 11/8/2010 Other Health Professional Japan
Primary
Concomitant
Dermatitis Acneiform Other Serious 7/13/2010 11/9/2010 Physician Japan
Primary
Concomitant
Stomatitis Disability 10/19/2010 11/11/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Ventricular Arrhythmia Other Serious 10/20/2010 11/12/2010 Other Health Professional Japan
Primary
Concomitant
Shock Other Serious 70 Male 11/15/2010 Other Health Professional Japan
Primary
Secondary
Blood Urea Increased Other Serious 69 Male 11/15/2010 Pharmacist Japan
Primary
Secondary
Rash Hospitalization 8/13/2010 11/19/2010 Physician Japan
Primary
Concomitant
Stomatitis Other Serious 7/22/2010 11/19/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Death 11/2/2010 11/24/2010 Physician Japan
Primary
Secondary
Weight Decreased Disability 9/21/2010 11/24/2010 Physician Japan
Primary
Concomitant
Weight Decreased Disability 9/21/2010 60 Male 126 lb 11/25/2010 Physician Japan
Primary
Concomitant
Dermatitis Acneiform Hospitalization 9/9/2010 11/26/2010 Physician Japan
Primary
Secondary
Concomitant
Gastric Ulcer Haemorrhage Hospitalization 9/25/2010 11/30/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Stomatitis Other Serious 7/22/2010 12/3/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Stomatitis Hospitalization 7/23/2010 12/6/2010 Physician Japan
Primary
Secondary
Concomitant
Stomatitis Other Serious 9/15/2010 12/7/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Hospitalization 8/12/2010 12/8/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Hypomagnesaemia Life Threatening 12/1/2010 12/9/2010 Physician Japan
Primary
Concomitant
White Blood Cell Count Decreased Other Serious 7/5/2010 12/10/2010 Physician Japan
Primary
Secondary
Concomitant
Dermatitis Acneiform Other Serious 7/13/2010 12/10/2010 Physician Japan
Primary
Concomitant
Stomatitis Other Serious 7/22/2010 12/10/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Stomatitis Other Serious 9/30/2010 12/15/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Hepatic Function Abnormal Other Serious 2/1/2009 12/20/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Vomiting Hospitalization 8/14/2010 12/21/2010 Pharmacist Japan
Primary
Secondary
Concomitant
Blood Potassium Decreased Other Serious Female 12/22/2010 Pharmacist Japan
Primary
Concomitant
Nausea Other Serious 9/7/2010 12/22/2010 Other Health Professional Japan
Primary
Concomitant
Rash Hospitalization 10/18/2010 12/22/2010 Other Health Professional Japan
Primary
Concomitant
Paronychia Hospitalization 9/28/2010 12/24/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Blood Potassium Decreased Other Serious Female 12/27/2010 Pharmacist Japan
Primary
Concomitant
Stomatitis Other Serious 9/15/2010 12/28/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Stomatitis Life Threatening 7/6/2010 12/28/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Stomatitis Other Serious 7/22/2010 12/29/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Vomiting Other Serious 10/17/2010 12/30/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Hypomagnesaemia Life Threatening 11/12/2010 12/30/2010 Other Health Professional Japan
Primary
Concomitant
Pyrexia Other Serious 9/9/2010 12/30/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Arthralgia Other Serious 3/24/2010 48 Male 209 lb 1/4/2011 Physician Japan
Primary
Secondary
Concomitant
Hypoaesthesia Other Serious 9/1/2009 75 Male 1/5/2011 Physician Japan
Primary
Secondary
Concomitant
Pruritus Hospitalization 10/8/2010 1/5/2011 Physician Japan
Primary
Secondary
Concomitant
Pleural Effusion Other Serious 10/1/2010 1/7/2011 Other Health Professional Japan
Primary
Concomitant
Pneumonia Aspiration Life Threatening 9/15/2010 1/10/2011 Physician Japan
Primary
Secondary
Concomitant
Hypomagnesaemia Hospitalization 7/2/2010 1/10/2011 Physician Japan
Primary
Concomitant
Paronychia Disability 10/19/2010 1/10/2011 Physician Japan
Primary
Secondary
Concomitant
Hypocalcaemia Other Serious 9/13/2010 1/10/2011 Physician Japan
Primary
Secondary
Concomitant
Dermatitis Acneiform Other Serious 7/29/2010 1/11/2011 Physician Japan
Primary
Secondary
Concomitant
Dermatitis Acneiform Hospitalization 8/30/2010 1/12/2011 Physician Japan
Primary
Secondary
Concomitant
Urinary Retention Hospitalization 6/28/2010 1/12/2011 Other Health Professional Japan
Primary
Secondary
Concomitant
Febrile Neutropenia Hospitalization 9/7/2010 1/13/2011 Physician Japan
Primary
Secondary
Concomitant
Colorectal Cancer Death 9/30/2010 1/13/2011 Other Health Professional Japan
Primary
Concomitant
Duodenal Obstruction Death 8/5/2010 1/14/2011 Physician Japan
Primary
Concomitant
Decreased Appetite Other Serious 10/13/2010 1/20/2011 Physician Japan
Primary
Secondary
Concomitant
Colorectal Cancer Other Serious 10/1/2010 1/21/2011 Other Health Professional Japan
Primary
Secondary
Concomitant
Rash Other Serious 10/21/2010 71 Female 104 lb 1/24/2011 Physician Japan
Primary
Secondary
Concomitant
Pulmonary Embolism Other Serious 10/15/2010 72 Male 159 lb 1/24/2011 Other Health Professional Japan
Primary
Secondary
Dermatitis Acneiform Hospitalization 8/14/2010 45 Female 119 lb 1/26/2011 Pharmacist Japan
Primary
Secondary
Concomitant
Loss Of Consciousness Hospitalization 9/7/2010 76 Male 152 lb 1/27/2011 Other Health Professional Japan
Primary
Concomitant
Neutrophil Count Decreased Death 7/22/2010 75 Female 99 lb 1/28/2011 Physician Japan
Primary
Secondary
Concomitant
Gastric Ulcer Haemorrhage Hospitalization 9/25/2010 64 Male 90 lb 1/28/2011 Physician Japan
Primary
Secondary
Concomitant
Paronychia Hospitalization 9/28/2010 70 Male 141 lb 1/28/2011 Physician Japan
Primary
Secondary
Concomitant
Neoplasm Malignant Life Threatening 10/1/2010 18 Male 106 lb 1/28/2011 Physician Japan
Primary
Concomitant
Hepatic Function Abnormal Other Serious 7/27/2010 45 Male 212 lb 1/28/2011 Other Health Professional Japan
Primary
Secondary
Concomitant
Acne Hospitalization 11/25/2010 73 Female 143 lb 1/31/2011 Physician Japan
Primary
Concomitant
Ventricular Fibrillation Death 10/20/2010 67 Male 139 lb 1/31/2011 Physician Japan
Primary
Concomitant
Stomatitis Hospitalization 11/11/2010 58 Male 121 lb 2/2/2011 Other Health Professional Japan
Primary
Secondary
Concomitant
Febrile Neutropenia Hospitalization 11/22/2010 70 Female 82 lb 2/2/2011 Physician Japan
Primary
Secondary
Concomitant
Malaise Hospitalization 8/30/2010 75 Female 117 lb 2/3/2011 Physician Japan
Primary
Concomitant
Paronychia Hospitalization 10/1/2010 18 Male 106 lb 2/4/2011 Physician Japan
Primary
Concomitant
Stomatitis Other Serious 10/15/2010 72 Male 159 lb 2/4/2011 Physician Japan
Primary
Secondary
Jaundice Hospitalization 9/30/2010 56 Male 137 lb 2/4/2011 Physician Japan
Primary
Concomitant
Renal Failure Acute Hospitalization 12/7/2010 67 Male 110 lb 2/7/2011 Other Health Professional Japan
Primary
Secondary
Concomitant
Paronychia Hospitalization 10/1/2010 18 Male 106 lb 2/8/2011 Other Health Professional Japan
Primary
Concomitant
Hypoaesthesia Other Serious 9/1/2009 75 Male 2/8/2011 Physician Japan
Primary
Secondary
Concomitant
Dermatitis Acneiform Life Threatening 7/6/2010 64 Male 165 lb 2/8/2011 Physician Japan
Primary
Concomitant
Acne Other Serious 7/5/2010 53 Male 139 lb 2/8/2011 Physician Japan
Primary
Concomitant
Diarrhoea Other Serious 10/17/2010 77 Female 130 lb 2/8/2011 Physician Japan
Primary
Secondary
Concomitant
Metastases To Central Nervous System Hospitalization 8/30/2010 49 Male 143 lb 2/8/2011 Physician Japan
Primary
Secondary
Concomitant

Drug Data