Tyverb combined with Xeloda

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Wound Haemorrhage Other Serious 10/3/2007 66 Female 2/6/2008 Consumer Sweden
Primary
Secondary
Fistula Hospitalization 8/4/2007 52 Female 2/8/2008 Physician France
Primary
Secondary
Death Death 1/13/2008 Female 2/29/2008 Physician Switzerland
Primary
Secondary
Concomitant
Haemorrhage Death 1/13/2008 Female 3/5/2008 Physician Switzerland
Primary
Secondary
Concomitant
Stomatitis Hospitalization 11/30/2007 66 Female 126 lb 3/10/2008 Physician France
Primary
Secondary
Skin Fissures Disability 55 Female 198 lb 3/14/2008 Physician France
Primary
Secondary
Concomitant
Stomatitis Hospitalization 11/30/2007 66 Female 126 lb 4/11/2008 Physician France
Primary
Secondary
Hepatotoxicity Other Serious 1/1/2007 Female 4/11/2008 Physician Switzerland
Primary
Concomitant
Skin Exfoliation Other Serious 40 Female 4/21/2008 Physician Switzerland
Primary
Concomitant
Thrombosis Death Female 4/23/2008 Physician Switzerland
Primary
Secondary
Concomitant
Skin Exfoliation Other Serious 40 Female 176 lb 4/23/2008 Physician Switzerland
Primary
Concomitant
Intracranial Pressure Increased Hospitalization 10/19/2007 67 Female 139 lb 4/25/2008 Physician France
Primary
Secondary
Transient Ischaemic Attack Other Serious 10/1/2007 51 Female 126 lb 4/28/2008 Physician France
Primary
Secondary
Transient Ischaemic Attack Other Serious 10/1/2007 51 Female 126 lb 5/12/2008 Physician France
Primary
Secondary
Ulcer Disability 6/22/2007 53 Female 5/19/2008 Physician France
Primary
Secondary
Nausea Hospitalization 52 Female 5/22/2008 Physician Switzerland
Primary
Concomitant
Rash Pruritic Other Serious 71 Female 6/6/2008 Physician France
Primary
Secondary
Nausea Hospitalization 4/19/2008 52 Female 6/9/2008 Physician Switzerland
Primary
Concomitant
Transient Ischaemic Attack Other Serious 10/1/2007 51 Female 126 lb 6/11/2008 Physician France
Primary
Secondary
Haemorrhagic Disorder Death 48 Female 6/12/2008 Physician France
Primary
Secondary
Hepatotoxicity Other Serious 10/16/2007 Female 148 lb 6/24/2008 Physician Switzerland
Primary
Concomitant
Diarrhoea Disability 52 Female 106 lb 7/7/2008 Physician France
Primary
Secondary
Pseudomembranous Colitis Hospitalization 11/1/2007 75 Female 132 lb 7/14/2008 Physician France
Primary
Secondary
Vomiting Hospitalization 53 Female 214 lb 7/14/2008 Physician France
Primary
Secondary
Concomitant
Treatment Noncompliance Death 6/4/2008 56 Female 8/1/2008 Physician France
Primary
Secondary
Hepatitis Cholestatic Other Serious 6/18/2008 57 Female 110 lb 8/6/2008 Pharmacist France
Primary
Secondary
Skin Toxicity Other Serious 1/1/2008 60 Female 148 lb 8/6/2008 Pharmacist France
Primary
Secondary
Cardiotoxicity Other Serious 76 Female 8/6/2008 Physician France
Primary
Secondary
Jaundice Other Serious 3/11/2008 39 Female 205 lb 8/11/2008 Pharmacist France
Primary
Secondary
Jaundice Other Serious 3/12/2008 49 Female 146 lb 8/11/2008 Pharmacist France
Primary
Secondary
Skin Toxicity Other Serious 1/1/2008 60 Female 148 lb 8/11/2008 Pharmacist France
Primary
Secondary
Death Death 7/1/2008 80 Female 8/26/2008 Physician France
Primary
Secondary
Neoplasm Skin Disability 51 Female 8/29/2008 Physician France
Primary
Secondary
Jaundice Other Serious 3/11/2008 39 Female 205 lb 8/29/2008 Pharmacist France
Primary
Secondary
Jaundice Other Serious 3/12/2008 49 Female 146 lb 8/29/2008 Pharmacist France
Primary
Secondary
Respiratory Failure Hospitalization 8/7/2008 60 Female 118 lb 8/29/2008 Physician Netherlands
Primary
Concomitant
Thrombocytopenia Other Serious 63 Female 9/8/2008 Physician France
Primary
Secondary
Chest Pain Death 80 Male 183 lb 9/9/2008 Physician France
Primary
Secondary
Concomitant
Peripheral Arterial Occlusive Disease Hospitalization 8/4/2008 63 Female 172 lb 9/9/2008 Physician Germany
Primary
Concomitant
Mass Disability 51 Female 9/10/2008 Physician France
Primary
Secondary
Metastases To Central Nervous System Other Serious 6/1/2008 52 Female 161 lb 9/17/2008 Physician France
Primary
Concomitant
Pulmonary Embolism Hospitalization 2/7/2008 66 Female 126 lb 9/29/2008 Physician France
Primary
Secondary
Pruritus Other Serious 6/18/2006 57 Female 110 lb 10/14/2008 Pharmacist France
Primary
Secondary
Aphasia Other Serious 1/1/2008 65 Female 10/31/2008 Physician Germany
Primary
Concomitant
Thyroxine Decreased Hospitalization 8/1/2008 43 Female 11/7/2008 Consumer France
Primary
Secondary
Respiratory Failure Hospitalization 8/7/2008 60 Female 118 lb 11/10/2008 Physician Netherlands
Primary
Concomitant
Respiratory Failure Hospitalization 8/7/2008 60 Female 118 lb 11/13/2008 Physician Netherlands
Primary
Concomitant
Diarrhoea Hospitalization 8/1/2008 Female 11/18/2008 Physician United States
Primary
Secondary
Cardiac Failure Life Threatening 11/1/2008 50 Female 121 lb 12/1/2008 Consumer Austria
Primary
Concomitant
Thyroiditis Hospitalization 8/1/2008 43 Female 12/2/2008 Physician France
Primary
Secondary
Muscle Spasms Hospitalization 10/28/2008 43 Female 12/19/2008 Consumer Hungary
Primary
Concomitant
Jaundice Other Serious 11/27/2008 53 Female 12/29/2008 Other Health Professional France
Primary
Secondary
Diarrhoea Hospitalization 8/1/2008 Female 1/30/2009 Physician United States
Primary
Secondary
Jaundice Other Serious 11/27/2008 53 Female 2/6/2009 Other Health Professional France
Primary
Secondary
Pulmonary Oedema Other Serious 2/3/2009 46 Female 145 lb 2/27/2009 Other Health Professional Belgium
Primary
Concomitant
Neoplasm Malignant Hospitalization Female 2/27/2009 Physician France
Primary
Secondary
Pyrexia Death Female 3/4/2009 Other Health Professional Netherlands
Primary
Concomitant
Vomiting Other Serious 8/30/2008 73 Female 3/5/2009 Other Health Professional Netherlands
Primary
Secondary
Concomitant
Mucosal Inflammation Hospitalization 5/5/2008 67 Female 3/6/2009 Consumer France
Primary
Secondary
Radiation Mucositis Hospitalization 5/29/2008 Female 3/9/2009 Physician France
Primary
Secondary
Skin Exfoliation Disability 11/13/2007 55 Female 104 lb 3/13/2009 Physician France
Primary
Secondary
Pulmonary Oedema Other Serious 2/3/2009 46 Female 145 lb 3/16/2009 Other Health Professional Belgium
Primary
Concomitant
Polyneuropathy Hospitalization 10/29/2008 Female 4/1/2009 Physician Czech Republic
Primary
Concomitant
Pulmonary Oedema Other Serious 1/15/2009 Female 145 lb 4/3/2009 Other Health Professional Belgium
Primary
Concomitant
Rash Other Serious 3/31/2009 Female 4/8/2009 Other Health Professional Ireland
Primary
Secondary
Vomiting Other Serious 12/4/2008 Female 126 lb 4/17/2009 Physician Russian Federation
Primary
Secondary
Pyrexia Hospitalization 5/16/2008 Female 5/8/2009 Physician France
Primary
Secondary
Staphylococcal Infection Other Serious 3/31/2009 Female 5/8/2009 Other Health Professional Ireland
Primary
Secondary
Concomitant
Pyrexia Hospitalization 5/16/2008 Female 5/8/2009 Consumer France
Primary
Secondary
Pneumonia Hospitalization 4/1/2009 Female 137 lb 5/11/2009 Physician Germany
Primary
Secondary
Concomitant
Staphylococcal Infection Other Serious 3/31/2009 Female 127 lb 5/14/2009 Other Health Professional Ireland
Primary
Secondary
Concomitant
Staphylococcal Infection Other Serious 3/31/2009 Female 127 lb 6/15/2009 Other Health Professional Ireland
Primary
Secondary
Concomitant
Septic Shock Hospitalization 5/26/2009 Female 6/16/2009 Physician Netherlands
Primary
Concomitant
Staphylococcal Infection Other Serious 3/31/2009 Female 127 lb 6/17/2009 Other Health Professional Ireland
Primary
Secondary
Concomitant
Interstitial Lung Disease Hospitalization 5/1/2009 38 Female 7/7/2009 Consumer Spain
Primary
Secondary
Tachypnoea Hospitalization 5/1/2009 Female 121 lb 7/9/2009 Physician Germany
Primary
Concomitant
Interstitial Lung Disease Hospitalization 5/1/2009 38 Female 7/13/2009 Other Health Professional Spain
Primary
Secondary
Vomiting Other Serious 53 Female 7/28/2009 Consumer Germany
Primary
Concomitant
Vomiting Hospitalization 7/16/2009 Female 123 lb 8/3/2009 Physician France
Primary
Secondary
Concomitant
Hepatitis Other Serious 1/1/2008 Female 8/3/2009 Physician Switzerland
Primary
Concomitant
Weight Decreased Hospitalization 3/6/2009 74 Female 9/3/2009 Consumer France
Primary
Secondary
Concomitant
Sudden Death Death 5/26/2009 67 Female 128 lb 9/8/2009 Physician Austria
Primary
Secondary
Concomitant
Renal Failure Hospitalization 3/6/2009 74 Female 9/10/2009 Physician France
Primary
Secondary
Concomitant
Vertigo Other Serious 1/1/2008 Female 9/21/2009 Physician France
Primary
Secondary
Jaundice Other Serious 6/1/2009 35 Female 9/25/2009 Physician France
Primary
Concomitant
Hepatitis Other Serious 8/1/2008 Female 165 lb 9/28/2009 Physician Switzerland
Primary
Concomitant
Tooth Disorder Other Serious Female 11/4/2009 Physician France
Primary
Secondary
Stomatitis Death 10/22/2009 Female 11/12/2009 Consumer Italy
Primary
Secondary
Tooth Disorder Other Serious 10/1/2007 Female 11/20/2009 Physician France
Primary
Secondary
Vomiting Other Serious 8/27/2009 Female 12/11/2009 Physician Slovakia (Slovak Republic)
Primary
Concomitant
Stomatitis Death 10/19/2009 Female 12/11/2009 Consumer Italy
Primary
Secondary
Stomatitis Hospitalization 10/22/2009 Female 172 lb 12/14/2009 Other Health Professional Italy
Primary
Secondary
Concomitant
Post Procedural Haemorrhage Hospitalization 10/22/2009 Female 132 lb 12/22/2009 Physician Germany
Primary
Secondary
Concomitant
Drug Toxicity Other Serious Female 152 lb 12/24/2009 Consumer France
Primary
Concomitant
Drug Toxicity Other Serious Female 152 lb 12/29/2009 Physician France
Primary
Concomitant
Palmar-plantar Erythrodysaesthesia Syndrome Other Serious 11/1/2009 Female 1/8/2010 Consumer Italy
Primary
Secondary
Diabetes Mellitus Hospitalization 12/7/2009 49 Female 1/29/2010 Physician Sweden
Primary
Secondary
Concomitant
Mucosal Haemorrhage Other Serious 9/1/2009 Female 2/10/2010 Physician Czech Republic
Primary
Concomitant
Vertigo Hospitalization 1/13/2010 Female 2/11/2010 Other Health Professional Italy
Primary
Secondary
Concomitant
Vertigo Hospitalization 1/13/2010 Female 3/18/2010 Other Health Professional Italy
Primary
Secondary
Concomitant
Fall Hospitalization 11/2/2009 Female 3/23/2010 Physician Czech Republic
Primary
Concomitant
Jaundice Other Serious 39 Female 5/14/2010 Physician Norway
Primary
Secondary
Lipoatrophy Disability Female 121 lb 5/17/2010 Physician Germany
Primary
Secondary
Concomitant
Lipoatrophy Disability Female 121 lb 5/19/2010 Physician Germany
Primary
Secondary
Concomitant
Skin Hyperpigmentation Other Serious Female 6/4/2010 Consumer Italy
Primary
Concomitant
Skin Toxicity Other Serious Female 7/16/2010 Consumer Italy
Primary
Secondary
Concomitant
Renal Failure Hospitalization 7/5/2010 64 Female 8/4/2010 Physician Czech Republic
Primary
Concomitant
Metastases To Skin Other Serious Female 8/26/2010 Physician Germany
Primary
Secondary
Vomiting Other Serious Female 8/30/2010 Physician Norway
Primary
Secondary
Hepatitis Other Serious 12/1/2009 44 Female 9/13/2010 Consumer France
Primary
Secondary
Concomitant
Vomiting Other Serious 61 Female 9/15/2010 Physician Czech Republic
Primary
Secondary
Vomiting Other Serious 45 Female 9/15/2010 Physician Czech Republic
Primary
Secondary
Concomitant
Vomiting Other Serious 47 Female 9/15/2010 Physician Czech Republic
Primary
Secondary
Concomitant
Hyponatraemia Hospitalization 4/12/2010 53 Female 9/21/2010 Consumer Spain
Primary
Secondary
Skin Toxicity Other Serious 10/1/2008 28 Male 9/24/2010 Consumer Czech Republic
Primary
Secondary
Hyponatraemia Death 4/12/2010 53 Female 9/27/2010 Other Health Professional Spain
Primary
Secondary
Skin Disorder Disability 8/1/2010 64 Female 10/1/2010 Consumer France
Primary
Secondary
Pulmonary Embolism Other Serious 4/1/2010 58 Female 157 lb 10/22/2010 Physician Germany
Primary
Concomitant
Hypersensitivity Other Serious Female 10/25/2010 Physician Switzerland
Primary
Concomitant
Malaise Hospitalization 9/14/2010 63 Female 11/4/2010 Pharmacist Ireland
Primary
Secondary
Concomitant
Palmar-plantar Erythrodysaesthesia Syndrome Other Serious 46 Female 11/29/2010 Physician Czech Republic
Primary
Concomitant
Pulmonary Embolism Hospitalization 10/26/2010 46 Female 12/1/2010 Physician Italy
Primary
Concomitant
Thrombosis Death 11/10/2010 Female 12/6/2010 Physician Russian Federation
Primary
Secondary
Concomitant
Thrombosis Death 11/10/2010 Female 12/7/2010 Physician Russian Federation
Primary
Secondary
Concomitant
Thrombosis Death 11/10/2010 51 Female 196 lb 12/10/2010 Physician Russian Federation
Primary
Secondary
Concomitant
Stomatitis Hospitalization 4/12/2010 53 Female 12/27/2010 Other Health Professional Spain
Primary
Secondary
Stomatitis Hospitalization 4/12/2010 53 Female 12/28/2010 Consumer Spain
Primary
Secondary
Diarrhoea Hospitalization 5/5/2008 67 Female 1/3/2011 Consumer France
Primary
Secondary
Stomatitis Death 4/12/2010 53 Female 1/3/2011 Pharmacist Spain
Primary
Secondary
Death Death 1/1/2011 63 Female 1/11/2011 Pharmacist Ireland
Primary
Secondary
Basedow's Disease Other Serious Female 1/13/2011 Consumer Germany
Primary
Concomitant
Drug Interaction Other Serious 12/1/2010 63 Female 1/19/2011 Consumer Germany
Primary
Interacting
Metastases To Liver Death 1/1/2011 63 Female 1/21/2011 Physician Ireland
Primary
Secondary
Yellow Skin Other Serious 49 Female 1/31/2011 Other Health Professional Hungary
Primary
Secondary
General Physical Health Deterioration Other Serious Female 2/7/2011 Physician Austria
Primary
Secondary
Concomitant
Vomiting Hospitalization 12/6/2010 63 Female 184 lb 2/11/2011 Physician Ireland
Primary
Concomitant
Vomiting Hospitalization 12/6/2010 63 Female 184 lb 2/14/2011 Pharmacist Ireland
Primary
Concomitant
Mouth Ulceration Hospitalization 12/6/2010 63 Female 184 lb 2/16/2011 Physician Ireland
Primary
Concomitant
Vomiting Hospitalization 12/6/2010 63 Female 184 lb 2/22/2011 Pharmacist Ireland
Primary
Concomitant
Anaphylactic Shock Death 12/15/2010 65 Female 126 lb 3/1/2011 Physician Germany
Primary
Concomitant
Diarrhoea Hospitalization 2/1/2011 56 Female 3/8/2011 Physician Hungary
Primary
Secondary
Concomitant
Paronychia Other Serious 1/1/2011 44 Female 3/21/2011 Physician Germany
Primary
Secondary
Gamma-glutamyltransferase Increased Other Serious Female 3/31/2011 Physician Austria
Primary
Secondary
Concomitant
Nausea Hospitalization 12/6/2010 63 Female 184 lb 4/1/2011 Physician Ireland
Primary
Concomitant
Skin Fissures Other Serious Female 177 lb 4/19/2011 Physician Ireland
Primary
Concomitant
Back Pain Death 1/1/2011 63 Female 4/20/2011 Pharmacist Ireland
Primary
Secondary
Skin Maceration Other Serious 11/1/2009 34 Female 4/20/2011 Consumer Russian Federation
Primary
Secondary
Back Pain Death 1/1/2011 63 Female 4/27/2011 Pharmacist Ireland
Primary
Secondary
Concomitant
Nausea Hospitalization 12/6/2010 63 Female 184 lb 4/28/2011 Physician Ireland
Primary
Concomitant
Inflammation Hospitalization 1/1/2011 Female 4/28/2011 Physician France
Primary
Secondary

Drug Data