Abiraterone Acetate combined with Prednisolone

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Prostate Cancer Death Male 5/4/2010 Physician United Kingdom
Primary
Secondary
Concomitant
Hepatic Enzyme Increased Other Serious 1/8/2009 78 Male 173 lb 5/7/2010 Physician United Kingdom
Primary
Secondary
Concomitant
Hepatic Enzyme Increased Other Serious 1/8/2009 78 Male 173 lb 7/6/2010 Physician United Kingdom
Primary
Secondary
Concomitant
Pneumonia Hospitalization 3/31/2009 81 Male 11/1/2010 Austria
Primary
Secondary
Concomitant
Pneumonia Hospitalization 3/24/2009 58 Male 11/1/2010 United Kingdom
Primary
Secondary
Concomitant
Musculoskeletal Pain Hospitalization 6/20/2009 71 Male 11/1/2010 Physician United Kingdom
Primary
Secondary
Concomitant
Spinal Cord Compression Other Serious 9/23/2009 60 Male 172 lb 11/1/2010 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Acute Myocardial Infarction Other Serious 8/28/2009 82 Male 11/1/2010 Physician Australia
Primary
Secondary
Concomitant
Pneumonia Hospitalization 6/29/2009 83 Male 11/1/2010 Physician United Kingdom
Primary
Secondary
Concomitant
Prostate Cancer Metastatic Hospitalization 4/4/2009 83 Male 11/2/2010 Belgium
Primary
Secondary
Concomitant
Hepatic Enzyme Increased Other Serious 1/8/2009 78 Male 173 lb 11/2/2010 Physician United Kingdom
Primary
Secondary
Concomitant
Diverticulitis Hospitalization 1/3/2009 84 Male 11/5/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Hypophosphataemia Life Threatening 9/16/2010 77 Male 11/17/2010 Physician Hungary
Primary
Secondary
Concomitant
Hypophosphataemia Life Threatening 9/16/2010 77 Male 12/23/2010 Physician Hungary
Primary
Secondary
Concomitant
Anaemia Hospitalization 11/3/2010 75 Male 12/23/2010 Physician Germany
Primary
Secondary
Concomitant
Neoplasm Malignant Hospitalization 11/3/2010 75 Male 1/20/2011 Physician Germany
Primary
Secondary
Concomitant
Neoplasm Malignant Hospitalization 11/3/2010 75 Male 2/10/2011 Physician Germany
Primary
Secondary
Concomitant
Hypophosphataemia Life Threatening 9/16/2010 77 Male 4/13/2011 Physician Hungary
Primary
Secondary
Concomitant
Neoplasm Malignant Life Threatening 11/3/2010 75 Male 4/19/2011 Physician Germany
Primary
Secondary
Concomitant
Dehydration Hospitalization 5/5/2011 79 Male 130 lb 5/17/2011 Physician Singapore
Primary
Secondary
Face Oedema Hospitalization 4/8/2011 84 Male 168 lb 5/18/2011 Physician France
Primary
Secondary
Concomitant
Liver Function Test Abnormal Other Serious 4/28/2011 65 Male 176 lb 5/25/2011 Physician Norway
Primary
Secondary
Concomitant
Cytolytic Hepatitis Other Serious 5/13/2011 75 Male 172 lb 5/31/2011 Physician France
Primary
Secondary
Concomitant
Pulmonary Embolism Hospitalization 4/26/2011 59 Male 192 lb 6/7/2011 Other Health Professional Italy
Primary
Secondary
Concomitant
Hypophosphataemia Life Threatening 9/16/2010 77 Male 6/9/2011 Physician Hungary
Primary
Secondary
Concomitant
Thrombocytopenia Other Serious 5/2/2011 53 Male 150 lb 6/10/2011 Physician France
Primary
Secondary
Concomitant
Pain Hospitalization 5/27/2011 72 Male 144 lb 6/15/2011 Physician Australia
Primary
Secondary
Concomitant
Drug Ineffective Disability 4/8/2011 84 Male 168 lb 6/17/2011 Physician France
Primary
Secondary
Concomitant
Anaemia Hospitalization 6/9/2011 72 Male 143 lb 6/21/2011 Physician Greece
Primary
Secondary
Spinal Fracture Other Serious 4/28/2011 74 Male 202 lb 6/24/2011 Physician Ireland
Primary
Secondary
Concomitant
Blood Alkaline Phosphatase Increased Other Serious 6/1/2011 72 Male 218 lb 6/27/2011 Physician Ireland
Primary
Secondary
Concomitant
General Physical Health Deterioration Hospitalization 4/28/2011 67 Male 143 lb 6/27/2011 Physician France
Primary
Secondary
Concomitant
Renal Failure Hospitalization 4/13/2011 70 Male 205 lb 6/28/2011 Physician Netherlands
Primary
Secondary
Concomitant
Bone Pain Death 4/28/2011 67 Male 143 lb 7/5/2011 Physician France
Primary
Secondary
Concomitant
Urinary Tract Infection Hospitalization 6/9/2011 72 Male 137 lb 7/5/2011 Physician Greece
Primary
Secondary
Concomitant
General Physical Health Deterioration Hospitalization 4/28/2011 67 Male 143 lb 7/6/2011 Physician France
Primary
Secondary
Concomitant
Cerebrovascular Accident Life Threatening 6/30/2011 80 Male 146 lb 7/11/2011 Physician United States
Primary
Secondary
Concomitant
Pulmonary Embolism Hospitalization 4/26/2011 59 Male 192 lb 7/14/2011 Other Health Professional Italy
Primary
Secondary
Concomitant
Hypophosphataemia Life Threatening 9/16/2010 77 Male 7/19/2011 Physician Hungary
Primary
Secondary
Concomitant
Blood Alkaline Phosphatase Increased Other Serious 6/1/2011 72 Male 218 lb 7/26/2011 Physician Ireland
Primary
Secondary
Concomitant
Spinal Cord Compression Hospitalization 4/28/2011 74 Male 202 lb 7/28/2011 Physician Ireland
Primary
Secondary
Concomitant
Blood Alkaline Phosphatase Increased Other Serious 6/1/2011 72 Male 218 lb 8/1/2011 Physician Ireland
Primary
Secondary
Concomitant
Abasia Hospitalization 7/15/2011 72 Male 160 lb 8/1/2011 Physician United Kingdom
Primary
Secondary
Concomitant
Hypophosphataemia Life Threatening 9/16/2010 77 Male 8/8/2011 Physician Hungary
Primary
Secondary
Concomitant
Blood Creatinine Increased Life Threatening 4/13/2011 70 Male 205 lb 8/11/2011 Physician Netherlands
Primary
Secondary
Concomitant
Thrombocytopenia Hospitalization 8/1/2011 70 Male 8/12/2011 Physician Austria
Primary
Secondary
Concomitant
Thrombocytopenia Other Serious 5/2/2011 53 Male 150 lb 8/12/2011 Physician France
Primary
Secondary
Concomitant
Coma Hospitalization 6/13/2011 80 Male 132 lb 8/12/2011 Physician France
Primary
Secondary
Concomitant
Pneumonia Hospitalization 2/20/2011 80 Male 185 lb 8/16/2011 Physician United Kingdom
Primary
Secondary
Concomitant
Prostatic Specific Antigen Increased Hospitalization 4/28/2011 74 Male 202 lb 8/18/2011 Physician Ireland
Primary
Secondary
Concomitant
General Physical Health Deterioration Hospitalization 6/13/2011 80 Male 132 lb 8/22/2011 Physician France
Primary
Secondary
Concomitant
Thrombocytopenia Hospitalization 8/1/2011 70 Male 8/23/2011 Physician Austria
Primary
Secondary
Concomitant
Thrombocytopenia Hospitalization 8/1/2011 70 Male 8/26/2011 Physician Austria
Primary
Secondary
Concomitant
Dermatitis Bullous Hospitalization 8/11/2011 78 Male 8/26/2011 Physician France
Primary
Secondary
Hypophosphataemia Life Threatening 9/16/2010 77 Male 9/15/2011 Physician Hungary
Primary
Secondary
Concomitant
Pain In Extremity Hospitalization 6/13/2011 54 Male 132 lb 9/16/2011 Other Health Professional France
Primary
Secondary
Concomitant
Blood Creatinine Increased Hospitalization 4/13/2011 70 Male 205 lb 9/22/2011 Physician Netherlands
Primary
Secondary
Concomitant
Concussion Hospitalization 6/18/2011 63 Male 9/22/2011 Physician Austria
Primary
Secondary
Concomitant
Constipation Other Serious 8/11/2011 88 Male 170 lb 9/23/2011 Physician Austria
Primary
Secondary
Concomitant
Renal Failure Life Threatening 4/13/2011 70 Male 205 lb 9/26/2011 Physician Netherlands
Primary
Secondary
Concomitant
Vomiting Hospitalization 8/1/2011 72 Male 9/26/2011 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Asthenia Hospitalization 6/13/2011 54 Male 132 lb 9/26/2011 Other Health Professional France
Primary
Secondary
Concomitant
Spinal Fracture Other Serious 4/28/2011 74 Male 202 lb 10/4/2011 Physician Ireland
Primary
Secondary
Concomitant
Renal Failure Life Threatening 4/13/2011 70 Male 205 lb 10/6/2011 Physician Netherlands
Primary
Secondary
Concomitant
Constipation Death 8/11/2011 88 Male 170 lb 10/6/2011 Physician Austria
Primary
Secondary
Concomitant
Concussion Hospitalization 6/18/2011 63 Male 10/10/2011 Physician Austria
Primary
Secondary
Concomitant
Muscular Weakness Hospitalization 6/13/2011 54 Male 132 lb 10/11/2011 Other Health Professional France
Primary
Secondary
Concomitant
Cerebrovascular Accident Death 6/30/2011 80 Male 147 lb 10/13/2011 Physician United States
Primary
Secondary
Concomitant
Blood Creatinine Increased Death 4/13/2011 70 Male 205 lb 10/13/2011 Physician Netherlands
Primary
Secondary
Concomitant
Thrombocytopenia Other Serious Male 10/17/2011 Physician Netherlands
Primary
Secondary
Concomitant
Vomiting Hospitalization 10/5/2011 84 Male 126 lb 10/17/2011 Physician Australia
Primary
Secondary
Concomitant
Myopathy Hospitalization 10/3/2011 58 Male 187 lb 10/18/2011 Physician Australia
Primary
Secondary
Concomitant
Cerebrovascular Accident Hospitalization 6/30/2011 80 Male 147 lb 10/21/2011 Other Health Professional United States
Primary
Secondary
Concomitant
Thrombocytopenia Hospitalization 8/1/2011 70 Male 10/27/2011 Physician Austria
Primary
Secondary
Concomitant
Confusional State Hospitalization 10/5/2011 84 Male 126 lb 11/1/2011 Physician Australia
Primary
Secondary
Concomitant
Bone Pain Hospitalization 10/24/2011 67 Male 184 lb 11/14/2011 Physician Australia
Primary
Secondary
Concomitant
Haematuria Hospitalization 10/29/2011 54 Male 227 lb 11/14/2011 Physician Denmark
Primary
Secondary
Concomitant
Diverticulitis Hospitalization 1/3/2009 84 Male 11/15/2011 Other Health Professional United States
Primary
Secondary
Concomitant
Myelodysplastic Syndrome Hospitalization 8/1/2011 70 Male 11/16/2011 Physician Austria
Primary
Secondary
Concomitant
Transaminases Increased Other Serious 8/25/2011 66 Male 198 lb 11/21/2011 Physician Germany
Primary
Secondary
Concomitant
Metastases To Liver Hospitalization Male 11/24/2011 Physician Germany
Primary
Concomitant
Urinary Tract Infection Hospitalization 10/29/2011 54 Male 227 lb 11/24/2011 Physician Denmark
Primary
Secondary
Concomitant
Neoplasm Progression Death 4/13/2011 70 Male 205 lb 12/1/2011 Physician Netherlands
Primary
Secondary
Concomitant
Dehydration Hospitalization 5/5/2011 79 Male 130 lb 12/5/2011 Physician Singapore
Primary
Secondary
Concomitant
Deep Vein Thrombosis Hospitalization 11/7/2011 68 Male 209 lb 12/19/2011 Physician Finland
Primary
Secondary
Concomitant
Cardiovascular Insufficiency Hospitalization Male 12/22/2011 Physician Germany
Primary
Concomitant
Hepatic Function Abnormal Death 11/3/2011 74 Male 181 lb 12/22/2011 Physician Ireland
Primary
Secondary
Headache Hospitalization 11/16/2011 63 Male 244 lb 12/23/2011 Physician Australia
Primary
Secondary
Concomitant
Vomiting Hospitalization 12/9/2011 62 Male 186 lb 12/27/2011 Physician Australia
Primary
Secondary
General Physical Condition Abnormal Hospitalization 7/25/2011 67 Male 1/3/2012 Physician Norway
Primary
Secondary
Concomitant
Renal Failure Disability 7/25/2011 67 Male 1/6/2012 Physician Norway
Primary
Secondary
Concomitant
Vomiting Hospitalization 11/2/2011 67 Male 181 lb 1/6/2012 Physician Australia
Primary
Secondary
Concomitant
General Physical Condition Abnormal Disability 7/25/2011 67 Male 1/6/2012 Physician Norway
Primary
Secondary
Concomitant
Tumour Flare Hospitalization 11/19/2011 73 Male 203 lb 1/9/2012 Physician Australia
Primary
Secondary
Concomitant
Dermatitis Bullous Hospitalization 8/12/2011 78 Male 198 lb 1/10/2012 Physician France
Primary
Secondary
Concomitant
Back Pain Hospitalization 11/2/2011 67 Male 181 lb 1/12/2012 Physician Australia
Primary
Secondary
Concomitant
Disease Progression Death Male 187 lb 1/13/2012 Physician Russian Federation
Primary
Secondary
Hepatic Function Abnormal Hospitalization 1/5/2012 80 Male 126 lb 1/16/2012 Physician Japan
Primary
Secondary
Tumour Flare Hospitalization 11/19/2011 73 Male 190 lb 1/16/2012 Physician Australia
Primary
Secondary
Concomitant
Dizziness Hospitalization 11/16/2011 63 Male 223 lb 1/17/2012 Physician Australia
Primary
Secondary
Concomitant
Back Pain Hospitalization 11/2/2011 67 Male 168 lb 1/18/2012 Physician Australia
Primary
Secondary
Concomitant
Alanine Aminotransferase Increased Hospitalization 1/5/2012 80 Male 126 lb 1/19/2012 Physician Japan
Primary
Secondary
Concomitant
Disease Progression Death Male 187 lb 1/19/2012 Physician Russian Federation
Primary
Secondary
Haematocrit Decreased Other Serious 4/12/2011 73 Male 181 lb 1/19/2012 Consumer United Kingdom
Primary
Secondary
Spinal Column Stenosis Death 4/12/2011 73 Male 181 lb 1/19/2012 Consumer United Kingdom
Primary
Secondary
Hyperkalaemia Hospitalization 11/2/2011 67 Male 168 lb 1/25/2012 Physician Australia
Primary
Secondary
Concomitant
Bone Pain Hospitalization 11/19/2011 73 Male 190 lb 1/25/2012 Physician Australia
Primary
Secondary
Concomitant
Disease Progression Death Male 187 lb 1/26/2012 Physician Russian Federation
Primary
Secondary
Abdominal Pain Hospitalization 1/13/2012 65 Male 247 lb 1/26/2012 Physician Australia
Primary
Secondary
Dyspnoea Hospitalization 1/18/2012 55 Male 141 lb 1/27/2012 Physician Australia
Primary
Secondary
Concomitant
Abdominal Pain Upper Hospitalization 1/13/2012 65 Male 241 lb 1/31/2012 Physician Australia
Primary
Secondary
Concomitant
Dyspnoea Hospitalization 1/18/2012 55 Male 141 lb 1/31/2012 Physician Australia
Primary
Secondary
Concomitant
Abdominal Pain Upper Hospitalization 1/13/2012 65 Male 247 lb 1/31/2012 Physician Australia
Primary
Secondary
Concomitant
Renal Failure Hospitalization 4/13/2011 70 Male 205 lb 1/31/2012 Physician Netherlands
Primary
Secondary
Concomitant
Impaired Gastric Emptying Hospitalization 1/19/2012 73 Male 147 lb 2/7/2012 Physician Malaysia
Primary
Secondary
Blood Creatinine Increased 72 Male 2/10/2012 Physician Germany
Primary
Concomitant
Vomiting Hospitalization 11/2/2011 67 Male 168 lb 2/13/2012 Physician Australia
Primary
Secondary
Concomitant
Hepatic Function Abnormal Death 11/3/2011 74 Male 181 lb 2/14/2012 Physician Ireland
Primary
Secondary
Subendocardial Ischaemia Hospitalization 1/5/2012 63 Male 187 lb 2/15/2012 Physician Russian Federation
Primary
Secondary
Prostate Cancer Metastatic Death 7/15/2011 72 Male 160 lb 2/15/2012 Physician United Kingdom
Primary
Secondary
Concomitant
Abdominal Pain Hospitalization 1/13/2012 65 Male 241 lb 2/17/2012 Physician Australia
Primary
Secondary
Concomitant
Back Pain Hospitalization 11/2/2011 67 Male 168 lb 2/21/2012 Physician Australia
Primary
Secondary
Concomitant
Hypokalaemia Life Threatening 10/3/2011 58 Male 187 lb 2/24/2012 Physician Australia
Primary
Secondary
Concomitant
Haematuria Death 10/9/2011 58 Male 187 lb 3/2/2012 Physician Australia
Primary
Secondary
Concomitant
Confusional State Hospitalization 10/5/2011 84 Male 120 lb 3/13/2012 Physician Australia
Primary
Secondary
Concomitant
Abdominal Pain Upper Hospitalization 1/13/2012 65 Male 241 lb 3/13/2012 Physician Australia
Primary
Secondary
Concomitant
Intestinal Ischaemia Hospitalization 3/5/2010 82 Male 154 lb 3/14/2012 Physician France
Primary
Secondary
Concomitant
Vomiting Hospitalization 12/4/2011 73 Male 161 lb 3/14/2012 Physician Turkey
Primary
Secondary
Concomitant
Prostate Cancer Metastatic Death 3/18/2010 78 Male 3/15/2012 Physician United Kingdom
Primary
Secondary
Concomitant
Hyponatraemia Hospitalization 11/26/2009 80 Male 174 lb 3/15/2012 Physician Greece
Primary
Secondary
Concomitant
Hypoacusis Hospitalization 10/4/2010 68 Male 174 lb 3/15/2012 Physician Germany
Primary
Secondary
Concomitant
Metastases To Central Nervous System Disability 4/26/2010 78 Male 172 lb 3/15/2012 Physician Germany
Primary
Secondary
Concomitant
Ischaemic Cardiomyopathy Hospitalization 8/25/2010 81 Male 3/15/2012 Physician Germany
Primary
Secondary
Concomitant
Atrial Fibrillation Hospitalization 12/10/2010 65 Male 3/15/2012 Physician United Kingdom
Primary
Secondary
Concomitant
Eastern Cooperative Oncology Group Performance Status Worsened Hospitalization 11/9/2010 60 Male 163 lb 3/15/2012 Physician Germany
Primary
Secondary
Concomitant
Tachyarrhythmia Hospitalization 7/19/2010 75 Male 3/15/2012 Physician Germany
Primary
Secondary
Concomitant
Infected Skin Ulcer Hospitalization 1/25/2011 85 Male 3/16/2012 Physician United Kingdom
Primary
Secondary
Concomitant
Dehydration Hospitalization 5/6/2011 80 Male 3/16/2012 Physician United Kingdom
Primary
Secondary
Concomitant
Confusional State Other Serious 12/30/2011 63 Male 160 lb 3/23/2012 Other Health Professional United Kingdom
Primary
Concomitant
Alanine Aminotransferase Increased Other Serious 8/25/2011 66 Male 198 lb 3/23/2012 Physician Germany
Primary
Secondary
Concomitant
Abdominal Pain Upper Hospitalization 10/5/2011 84 Male 120 lb 3/26/2012 Physician Australia
Primary
Secondary
Concomitant
Hyponatraemia Hospitalization 11/26/2009 80 Male 174 lb 3/27/2012 Physician Greece
Primary
Secondary
Concomitant
Eastern Cooperative Oncology Group Performance Status Worsened Disability 11/9/2010 60 Male 163 lb 3/27/2012 Physician Germany
Primary
Secondary
Concomitant
Gastroenteritis Hospitalization 12/4/2011 73 Male 161 lb 3/30/2012 Physician Turkey
Primary
Secondary
Concomitant
Hypokalaemia 10/9/2011 58 Male 187 lb 4/10/2012 Physician Australia
Primary
Secondary
Concomitant
Disease Progression Death Male 187 lb 4/12/2012 Physician Russian Federation
Primary
Secondary
Prostate Cancer Metastatic Hospitalization 11/2/2011 67 Male 168 lb 4/12/2012 Physician Australia
Primary
Secondary
Concomitant
Dehydration Hospitalization 3/30/2012 72 Male 4/30/2012 Physician Australia
Primary
Secondary
Concomitant
Dyspnoea Hospitalization 4/19/2012 83 Male 139 lb 5/11/2012 Physician Korea, Republic Of
Primary
Secondary
Hypoglycaemia Hospitalization 4/21/2012 60 Male 149 lb 5/11/2012 Physician Malaysia
Primary
Secondary
Concomitant

Drug Data