Gemcitabine combined with Xeloda

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Death Death 4/3/2006 58 Female 90 lb 4/4/2006 Other Health Professional United States
Primary
Secondary
Concomitant
Vomiting Death 4/3/2006 58 Female 4/13/2006 Physician United States
Primary
Secondary
Concomitant
Chest Discomfort Hospitalization 4/19/2006 67 Female 143 lb 4/19/2006 Other Health Professional United States
Primary
Secondary
Pain Hospitalization 6/2/2006 55 Male 281 lb 6/16/2006 Other Health Professional United States
Primary
Secondary
Concomitant
Haematocrit Decreased Hospitalization 71 Male 5/31/2006 Physician United States
Primary
Concomitant
Neutropenia Other Serious 4/24/2006 72 Male 213 lb 6/30/2006 Other Health Professional United States
Primary
Secondary
White Blood Cell Count Decreased Life Threatening 59 Female 9/21/2006 Other Health Professional United States
Primary
Secondary
Concomitant
Gallbladder Perforation Hospitalization 10/27/2006 65 Female 164 lb 11/7/2006 United States
Primary
Secondary
Thrombosis Other Serious 66 Male 11/17/2006 Physician Finland
Primary
Secondary
Concomitant
Swollen Tongue Hospitalization 9/30/2006 59 Female 133 lb 11/27/2006 Physician United States
Primary
Secondary
Concomitant
Osteonecrosis Disability 6/1/2006 57 Female 12/20/2006 Physician Belgium
Primary
Secondary
Concomitant
Swollen Tongue Hospitalization 9/30/2006 59 Female 133 lb 12/22/2006 Other Health Professional United States
Primary
Secondary
Concomitant
Cardiac Arrest Death 12/24/2006 Male 2/8/2007 Physician Sweden
Primary
Secondary
Wound Treatment Other Serious 1/1/1998 57 Female 150 lb 3/17/2007 Lawyer United States
Primary
Secondary
Concomitant
Mixed Hepatocellular Cholangiocarcinoma Hospitalization 11/1/2006 Male 209 lb 3/23/2007 Physician Germany
Primary
Concomitant
Pulmonary Hypertension Other Serious Female 5/18/2007 Physician United States
Primary
Concomitant
Neutropenia Other Serious 4/24/2006 72 Male 213 lb 6/29/2007 Other Health Professional United States
Primary
Secondary
Neutrophil Count Decreased Other Serious 4/28/2006 70 Female 160 lb 6/29/2007 Other Health Professional United States
Primary
Secondary
Diarrhoea Hospitalization 4/26/2006 76 Male 7/24/2007 Pharmacist United States
Primary
Concomitant
Sepsis Death 10/11/2007 Male 11/22/2007 Other Health Professional Switzerland
Primary
Secondary
Concomitant
Gastrointestinal Haemorrhage Life Threatening 5/1/2007 Male 203 lb 4/14/2008 Consumer Ireland
Primary
Concomitant
Osteonecrosis Other Serious 1/1/2007 Female 4/24/2008 Physician Germany
Primary
Concomitant
Renal Impairment Hospitalization 3/31/2008 53 Male 4/24/2008 United Kingdom
Primary
Secondary
Deep Vein Thrombosis Other Serious 5/9/2008 Physician United States
Primary
Secondary
Deep Vein Thrombosis Other Serious 5/9/2008 Physician United States
Primary
Secondary
Pyrexia Hospitalization 3/9/2007 71 Male 5/9/2008 Physician United States
Primary
Secondary
Cerebral Infarction Death 4/17/2008 Male 141 lb 5/19/2008 Physician Korea, Republic Of
Primary
Secondary
Venous Thrombosis Other Serious 59 Male 5/20/2008 Physician United States
Primary
Secondary
Concomitant
Aspiration Death 5/21/2008 Female 5/28/2008 Other Health Professional Switzerland
Primary
Secondary
Concomitant
Disease Progression Hospitalization 5/9/2008 Male 5/29/2008 Physician Switzerland
Primary
Secondary
Concomitant
Disease Progression Hospitalization 5/9/2008 Male 5/30/2008 Physician Switzerland
Primary
Secondary
Concomitant
Gastrointestinal Haemorrhage Hospitalization 60 Female 6/29/2008 United States
Primary
Secondary
Concomitant
Gastrointestinal Haemorrhage Hospitalization 7/1/2007 60 Female 7/29/2008 Consumer United States
Primary
Concomitant
Interacting
Skin Reaction Other Serious 5/1/2007 76 Female 11/3/2008 Consumer Finland
Primary
Concomitant
Prothrombin Time Prolonged Other Serious 70 Female 1/19/2009 Other Health Professional United States
Primary
Interacting
Vomiting Hospitalization 12/1/2008 60 Female 125 lb 3/20/2009 Physician United States
Primary
Secondary
Vomiting Hospitalization 12/24/2008 53 Female 140 lb 4/9/2009 Physician United States
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Hospitalization 12/1/2008 60 Female 125 lb 4/10/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Oedema Other Serious 1/1/2006 70 Female 7/2/2009 Other Health Professional United States
Primary
Secondary
White Blood Cell Count Decreased Other Serious 7/1/2009 Female 8/25/2009 Physician United States
Primary
Secondary
Concomitant
Disease Progression Other Serious 2/1/2009 30 Male 12/10/2009 Physician Finland
Primary
Concomitant
Weight Fluctuation Other Serious Male 145 lb 12/21/2009 Consumer United States
Primary
Secondary
Concomitant
Weight Fluctuation Other Serious 68 Male 145 lb 1/4/2010 United States
Primary
Secondary
Concomitant
Weight Fluctuation Other Serious 68 Male 145 lb 1/19/2010 United States
Primary
Secondary
Concomitant
Thrombocytopenia Hospitalization 1/8/2010 49 Female 142 lb 1/27/2010 Physician United States
Primary
Secondary
Concomitant
Toothache Other Serious 4/14/2005 Female 127 lb 3/12/2010 Physician United States
Primary
Concomitant
Wound Infection Staphylococcal Other Serious 1/1/2003 56 Female 155 lb 8/2/2010 United States
Primary
Secondary
Concomitant
Vaginal Haemorrhage Other Serious 10/3/2003 46 Female 128 lb 8/24/2010 United States
Primary
Concomitant
Vaginal Haemorrhage Other Serious 10/3/2003 46 Female 128 lb 8/31/2010 United States
Primary
Concomitant
Wound Infection Staphylococcal Other Serious 1/1/2003 56 Female 155 lb 9/30/2010 United States
Primary
Secondary
Concomitant
Weight Decreased Other Serious 8/8/2000 25 Female 10/4/2010 Physician United States
Primary
Secondary
Concomitant
Weight Decreased Other Serious 8/8/2000 25 Female 10/12/2010 Physician United States
Primary
Secondary
Concomitant
Platelet Disorder Death 9/13/2010 57 Male 11/10/2010 Other Health Professional Italy
Primary
Concomitant
Vulvovaginal Pruritus Other Serious 6/28/2002 Female 11/10/2010 United States
Primary
Concomitant
Vulvovaginal Pruritus Other Serious 6/28/2002 Female 11/10/2010 United States
Primary
Concomitant
Pyrexia Other Serious 9/1/2010 50 Female 11/18/2010 Consumer Mexico
Primary
Secondary
Concomitant
Vulvovaginal Pruritus Other Serious 6/28/2002 Female 11/18/2010 United States
Primary
Concomitant
White Blood Cell Count Increased Other Serious 1/1/2002 50 Female 188 lb 11/24/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Weight Decreased Other Serious 8/8/2000 25 Female 11/24/2010 Physician United States
Primary
Secondary
Concomitant
Vulvovaginal Pruritus Other Serious 6/28/2002 45 Female 11/25/2010 United States
Primary
Concomitant
White Blood Cell Count Increased Other Serious 1/1/2002 50 Female 188 lb 12/6/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Weight Decreased Other Serious 8/8/2000 25 Female 12/14/2010 Physician United States
Primary
Secondary
Concomitant
Tumour Marker Increased Other Serious 11/10/2010 74 Male 153 lb 12/17/2010 Consumer France
Primary
Secondary
Concomitant
Wound Dehiscence Other Serious 8/26/1999 74 Female 192 lb 12/22/2010 United States
Primary
Secondary
Concomitant
White Blood Cell Count Increased Other Serious 1/1/2002 50 Female 188 lb 12/22/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Bone Lesion Hospitalization 8/8/2000 25 Female 1/11/2011 United States
Primary
Secondary
Concomitant
Vaginal Haemorrhage Other Serious 8/8/2000 25 Female 1/19/2011 Other Health Professional United States
Primary
Secondary
Concomitant
Thoracic Outlet Syndrome Death 1/1/2003 51 Female 154 lb 1/26/2011 Physician United States
Primary
Secondary
Concomitant
Osteolysis Death 1/1/2003 51 Female 154 lb 2/15/2011 Lawyer United States
Primary
Secondary
Concomitant
Vulval Abscess Hospitalization 1/1/2003 51 Female 154 lb 2/17/2011 Other Health Professional United States
Primary
Secondary
Concomitant
Staphylococcal Skin Infection Other Serious 10/3/2003 46 Female 128 lb 3/9/2011 Other Health Professional United States
Primary
Concomitant
Cardiac Failure Hospitalization Male 3/17/2011 Consumer United States
Primary
Secondary
White Blood Cell Count Decreased Other Serious 9/16/2010 64 Female 128 lb 3/24/2011 Physician Japan
Primary
Secondary
Concomitant
Bronchitis Other Serious 8/8/2000 25 Female 4/5/2011 Physician United States
Primary
Secondary
Concomitant
Hypercalcaemia Hospitalization 10/3/2003 46 Female 128 lb 4/5/2011 United States
Primary
Concomitant
White Blood Cell Count Decreased Other Serious 9/16/2010 64 Female 128 lb 4/15/2011 Physician Japan
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Other Serious 1/14/2011 44 Female 115 lb 4/20/2011 Physician Japan
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Other Serious 1/14/2011 44 Female 115 lb 4/28/2011 Physician Japan
Primary
Secondary
Concomitant
Colitis Ulcerative Hospitalization 1/1/2003 51 Female 154 lb 5/3/2011 Physician United States
Primary
Secondary
Concomitant
Calcification Metastatic Other Serious 1/1/2002 50 Female 188 lb 5/4/2011 Physician United States
Primary
Secondary
Concomitant
Sciatica Hospitalization 1/1/2002 50 Female 188 lb 5/26/2011 Other Health Professional United States
Primary
Secondary
Concomitant
Cerebrovascular Disorder Other Serious 1/1/2002 50 Female 188 lb 6/22/2011 Lawyer United States
Primary
Secondary
Concomitant
Lichenoid Keratosis Other Serious 1/1/2003 56 Female 155 lb 7/7/2011 Pharmacist United States
Primary
Secondary
Concomitant
Urticaria Hospitalization 1/1/2002 50 Female 188 lb 7/8/2011 Lawyer United States
Primary
Secondary
Concomitant
Alopecia Other Serious 10/7/2002 77 Female 192 lb 7/8/2011 Other Health Professional United States
Primary
Secondary
Concomitant
Ankle Fracture Hospitalization 10/3/2003 46 Female 128 lb 7/20/2011 Physician United States
Primary
Concomitant
Hypokalaemia Other Serious 10/23/2004 55 Female 133 lb 7/26/2011 Lawyer United States
Primary
Secondary
Concomitant
Excessive Granulation Tissue Hospitalization 1/1/2003 56 Female 155 lb 8/4/2011 Other Health Professional United States
Primary
Secondary
Concomitant
Dysplastic Naevus Other Serious 1/1/2003 56 Female 155 lb 8/11/2011 United States
Primary
Secondary
Concomitant
Fatigue Other Serious 1/1/2003 56 Female 155 lb 8/20/2011 Consumer United States
Primary
Secondary
Concomitant
Dyspnoea Death 10/23/2004 55 Female 133 lb 8/26/2011 Physician United States
Primary
Secondary
Concomitant
Tendon Disorder Other Serious 1/1/2003 56 Female 155 lb 8/26/2011 Other Health Professional United States
Primary
Secondary
Concomitant
Abdominal Distension Hospitalization 8/13/2011 62 Male 219 lb 8/30/2011 Physician United States
Primary
Secondary
Concomitant
Atelectasis Other Serious 10/23/2004 55 Female 133 lb 9/4/2011 Lawyer United States
Primary
Secondary
Concomitant
Disease Progression Other Serious Female 9/13/2011 Physician Australia
Primary
Secondary
Concomitant
Decreased Appetite Hospitalization 8/13/2011 62 Male 219 lb 9/14/2011 Physician United States
Primary
Secondary
Concomitant
Metastases To Skin Hospitalization 8/1/2011 Female 9/21/2011 Physician China
Primary
Secondary
Concomitant
Dizziness Hospitalization 7/28/2011 37 Female 222 lb 9/23/2011 Physician United States
Primary
Secondary
Concomitant
Deafness Other Serious 10/23/2004 55 Female 133 lb 11/1/2011 Physician United States
Primary
Secondary
Concomitant
Disease Progression Death 54 Female 11/3/2011 Physician Japan
Primary
Secondary
Concomitant
Pain In Extremity Hospitalization 2/9/2004 47 Female 11/17/2011 Physician United States
Primary
Concomitant
Inflammation Other Serious 12/14/2011 Physician Brazil
Primary
Secondary
Concomitant
Iron Deficiency Anaemia Hospitalization 10/23/2004 55 Female 133 lb 1/1/2012 Lawyer United States
Primary
Secondary
Concomitant
Tinnitus Hospitalization 1/1/2003 56 Female 155 lb 1/5/2012 Pharmacist United States
Primary
Secondary
Concomitant
Deafness Death 10/23/2004 55 Female 133 lb 1/13/2012 Physician United States
Primary
Secondary
Concomitant
Pain In Jaw Other Serious 1/1/2003 56 Female 155 lb 1/14/2012 Consumer United States
Primary
Secondary
Concomitant
Death Death 11/30/2011 69 Male 1/25/2012 Consumer Canada
Primary
Concomitant
Hand Fracture Other Serious 1/1/2003 56 Female 155 lb 2/8/2012 Other Health Professional United States
Primary
Secondary
Concomitant
Disease Progression Other Serious Female 2/22/2012 Consumer India
Primary
Secondary
Concomitant
Oedema Hospitalization 2/9/2004 47 Female 6/5/2012 Other Health Professional United States
Primary
Concomitant
Stress Cardiomyopathy Other Serious 5/9/2012 Female 6/8/2012 Physician Spain
Primary
Secondary
Concomitant
Lymphadenectomy Other Serious 70 Female 6/12/2012 Other Health Professional Canada
Primary
Secondary
Stress Cardiomyopathy Other Serious 5/9/2012 Female 6/13/2012 Physician Spain
Primary
Secondary
Concomitant
Stress Cardiomyopathy Other Serious 5/9/2012 59 Female 6/14/2012 Physician Spain
Primary
Secondary
Concomitant
Nausea Hospitalization 12/1/2008 48 Male 7/20/2012 Physician Germany
Primary
Secondary
Concomitant
Vomiting Death Male 157 lb 12/19/2012 Other Health Professional Us
Primary
Concomitant
Small Intestinal Obstruction Death 8/23/2011 77 Female 209 lb 9/14/2012 Physician Us
Primary
Secondary
Drug Ineffective Death Male 9/24/2012 Physician Us
Primary
Concomitant
Pleural Effusion Hospitalization 9/2006 Female 9/26/2012 Physician Us
Primary
Secondary
Concomitant
Vomiting Other Serious 4/24/2006 45 Female 9/26/2012 Physician Us
Primary
Secondary
Concomitant
Vomiting Other Serious 5/2011 62 Female 117 lb 9/27/2012 Physician Be
Primary
Secondary
Metastases To Bone Other Serious Female 9/27/2012 Physician Us
Primary
Secondary
Concomitant
Toxicity To Various Agents Hospitalization 4/4/2005 54 Female 9/27/2012 Physician Us
Primary
Secondary
Concomitant
Metastases To Central Nervous System Other Serious Female 9/28/2012 Physician Us
Primary
Secondary
Concomitant
Vomiting Other Serious 10/1/2012 Physician Country Not Specified
Primary
Secondary
Vomiting Other Serious 57 Female 10/17/2012 Other Health Professional Us
Primary
Secondary
Concomitant
Thrombocytopenia Death 9/2008 Female 11/9/2012 Physician Us
Primary
Secondary
Concomitant
Blood Disorder Death Male 10/18/2012 Physician Us
Primary
Concomitant
Nausea Other Serious Male 10/19/2012 Other Health Professional Us
Primary
Concomitant
Weight Decreased Death Female 10/22/2012 Physician Us
Primary
Secondary
Concomitant
Disease Progression Other Serious Female 143 lb 3/22/2013 Physician Au
Primary
Secondary
Concomitant
Drug Ineffective Other Serious 2/2011 68 Female 119 lb 11/20/2012 Physician Be
Primary
Secondary
Concomitant
Vomiting Other Serious Female 132 lb 12/10/2012 Physician Be
Primary
Secondary
Haemolysis Other Serious 6/2012 Male 1/16/2013 Consumer De
Primary
Secondary
Haemolysis Other Serious 6/2012 Male 1/21/2013 Consumer De
Primary
Secondary
Disease Progression Other Serious Female 12/26/2012 Physician Au
Primary
Secondary
Concomitant
Disease Progression Other Serious Male 12/31/2012 Physician Dk
Primary
Secondary
Rash Other Serious 3/19/2010 44 Female 3/12/2013 Consumer Dk
Primary
Secondary
Concomitant
Metastases To Liver Other Serious Male 1/8/2013 Physician Dk
Primary
Secondary
Metastases To Skin Other Serious 10/2005 Female 1/9/2013 Physician Dk
Primary
Secondary
Concomitant
Disease Progression Other Serious Male 1/18/2013 Physician Dk
Primary
Secondary
Second Primary Malignancy Other Serious 10/2005 64 Female 1/23/2013 Physician Dk
Primary
Secondary
Concomitant
Drug Effect Decreased Other Serious 42 Female 1/22/2013 Other Health Professional Country Not Specified
Primary
Secondary
Metastases To Skin Other Serious 10/2005 Female 1/21/2013 Physician Dk
Primary
Secondary
Concomitant
Liver Disorder Other Serious 7/2012 Female 176 lb 2/18/2013 Physician Dk
Primary
Secondary
Concomitant
Cellulitis Other Serious 9/18/2010 Female 130 lb 2/1/2013 Physician Jp
Primary
Secondary
Concomitant
Liver Disorder Other Serious Female 176 lb 2/25/2013 Other Health Professional Dk
Primary
Secondary
Concomitant
Liver Disorder Other Serious 7/2012 Female 176 lb 3/1/2013 Physician Dk
Primary
Secondary
Concomitant
Wound Other Serious 10/3/2003 47 Female 128 lb 11/7/2012 Consumer Country Not Specified
Primary
Concomitant
Wound Infection Staphylococcal Hospitalization 2003 Female 155 lb 10/10/2012 Consumer Us
Primary
Secondary
Concomitant

Drug Data