Blinded *NO Subject Drug combined with Prednisone

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Drug Toxicity Hospitalization 5/3/2009 68 6/29/2009 Other Health Professional Spain
Primary
Secondary
Concomitant
Urinary Tract Infection Hospitalization 80 7/8/2009 Physician Spain
Primary
Secondary
Concomitant
General Physical Health Deterioration Hospitalization 3/19/2009 69 7/14/2009 Physician France
Primary
Secondary
Urinary Tract Infection Hospitalization 80 7/20/2009 Physician Spain
Primary
Secondary
Concomitant
Facial Palsy Hospitalization 7/6/2009 81 7/28/2009 Other Health Professional Spain
Primary
Secondary
Concomitant
Myocardial Infarction Life Threatening 6/12/2008 73 7/28/2009 Physician Peru
Primary
Secondary
Concomitant
Subcutaneous Abscess Hospitalization 7/6/2009 81 8/4/2009 Other Health Professional Spain
Primary
Secondary
Concomitant
General Physical Health Deterioration Hospitalization 7/23/2009 68 8/4/2009 Physician France
Primary
Secondary
Concomitant
Upper Gastrointestinal Haemorrhage Other Serious 4/1/2008 64 8/14/2009 Physician Philippines
Primary
Secondary
Concomitant
Subcutaneous Abscess Hospitalization 7/6/2009 81 8/21/2009 Other Health Professional Spain
Primary
Secondary
Concomitant
Renal Failure Acute Hospitalization 8/13/2009 Male 275 lb 8/27/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Intestinal Ischaemia Other Serious 11/25/2008 Male 195 lb 8/31/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Performance Status Decreased Hospitalization 8/14/2009 65 9/1/2009 Other Health Professional Belgium
Primary
Secondary
Concomitant
Sudden Cardiac Death Death 5/19/2009 66 9/2/2009 Other Health Professional Poland
Primary
Secondary
Concomitant
Myocardial Infarction Life Threatening 8/22/2009 73 9/4/2009 Physician Israel
Primary
Secondary
Liver Function Test Abnormal Hospitalization 7/23/2009 68 9/18/2009 Physician France
Primary
Secondary
Concomitant
Urinary Tract Infection Hospitalization 8/7/2009 69 9/18/2009 Physician Israel
Primary
Secondary
Concomitant
Acute Myocardial Infarction Life Threatening 8/22/2009 73 9/18/2009 Physician Israel
Primary
Secondary
Concomitant
Haemorrhage Life Threatening 9/10/2009 43 9/23/2009 Other Health Professional Germany
Primary
Secondary
Concomitant
Hypophosphataemia Hospitalization 9/15/2009 69 9/28/2009 Physician Israel
Primary
Secondary
Concomitant
Mental Status Changes Hospitalization 9/22/2009 Male 140 lb 10/6/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Hypophosphataemia Hospitalization 9/15/2009 69 10/12/2009 Physician Israel
Primary
Secondary
Concomitant
Urinary Tract Infection Hospitalization 8/7/2009 69 10/13/2009 Physician Israel
Primary
Secondary
Concomitant
Pneumonia Hospitalization 9/21/2009 78 10/19/2009 Physician China
Primary
Secondary
Mental Status Changes Hospitalization 9/22/2009 Male 140 lb 10/19/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Mental Status Changes Hospitalization 12/16/2008 Male 197 lb 10/20/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Pneumonia Hospitalization 9/21/2009 78 10/21/2009 Physician China
Primary
Secondary
Renal Failure Acute Hospitalization 8/13/2009 Male 275 lb 10/22/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Cerebrovascular Accident Other Serious 10/7/2009 69 10/27/2009 Other Health Professional Canada
Primary
Secondary
Concomitant
Polyneuropathy In Malignant Disease Hospitalization 9/21/2009 64 10/29/2009 Physician Israel
Primary
Secondary
Concomitant
Drug Toxicity Hospitalization 5/2/2009 68 10/30/2009 Other Health Professional Spain
Primary
Secondary
Concomitant
Hyponatraemia Hospitalization 10/12/2009 65 Male 195 lb 11/2/2009 Other Health Professional Canada
Primary
Secondary
Concomitant
Dehydration Hospitalization 8/10/2009 Male 275 lb 11/4/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Cerebral Ischaemia Disability 10/28/2009 69 Male 192 lb 11/9/2009 Other Health Professional Canada
Primary
Secondary
Concomitant
Gastroenteritis Hospitalization 9/1/2009 Male 148 lb 11/11/2009 Physician United States
Primary
Secondary
Concomitant
Gastrointestinal Haemorrhage Life Threatening 10/8/2009 53 Male 148 lb 11/11/2009 Other Health Professional Germany
Primary
Secondary
Concomitant
Confusional State Hospitalization 9/22/2009 Male 140 lb 11/11/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Intestinal Obstruction Hospitalization 10/31/2009 61 Male 187 lb 11/17/2009 Other Health Professional Belgium
Primary
Secondary
Concomitant
Cerebrovascular Accident Hospitalization 10/7/2009 69 Male 204 lb 11/16/2009 Other Health Professional Canada
Primary
Secondary
Concomitant
Subcutaneous Haematoma Hospitalization 10/24/2009 Male 182 lb 11/18/2009 Physician United States
Primary
Secondary
Concomitant
Fall Hospitalization 10/24/2009 Male 182 lb 11/30/2009 Physician United States
Primary
Secondary
Concomitant
Hypotension Hospitalization 11/16/2009 Male 240 lb 11/30/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Gastroenteritis Hospitalization 9/1/2009 Male 148 lb 12/3/2009 Physician United States
Primary
Secondary
Concomitant
Cerebral Ischaemia Disability 10/28/2009 69 Male 192 lb 12/3/2009 Other Health Professional Canada
Primary
Secondary
Concomitant
Sepsis Death 11/26/2009 Male 218 lb 12/4/2009 Physician United States
Primary
Secondary
Concomitant
Death Death 12/2/2009 Male 196 lb 12/4/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Diverticular Perforation Hospitalization 11/25/2009 80 Male 152 lb 12/4/2009 Other Health Professional Canada
Primary
Secondary
Concomitant
Drug Toxicity Hospitalization 5/2/2009 68 Male 12/11/2009 Other Health Professional Spain
Primary
Secondary
Concomitant
Confusional State Hospitalization 9/22/2009 Male 140 lb 12/11/2009 Other Health Professional United States
Primary
Secondary
Concomitant
General Physical Health Deterioration Hospitalization 12/2/2009 69 Male 170 lb 12/14/2009 Physician Italy
Primary
Secondary
Concomitant
Transient Ischaemic Attack Hospitalization 11/26/2009 Male 196 lb 12/14/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Sepsis Death 11/26/2009 Male 218 lb 12/17/2009 Physician United States
Primary
Secondary
Concomitant
Fall Hospitalization 12/3/2009 Male 12/17/2009 Physician United States
Primary
Secondary
Concomitant
Pyrexia Hospitalization 10/24/2009 77 Male 385 lb 12/18/2009 Physician United Kingdom
Primary
Secondary
Concomitant
Diverticular Perforation Hospitalization 11/25/2009 80 12/21/2009 Other Health Professional Canada
Primary
Secondary
Concomitant
Polyneuropathy In Malignant Disease Hospitalization 9/21/2009 Male 216 lb 12/23/2009 Other Health Professional Israel
Primary
Secondary
Concomitant
Cerebral Ischaemia Hospitalization 10/28/2009 69 12/22/2009 Other Health Professional Canada
Primary
Secondary
Concomitant
Intestinal Obstruction Hospitalization 10/31/2009 61 12/22/2009 Other Health Professional Belgium
Primary
Secondary
Concomitant
Prostate Cancer Hospitalization 9/22/2009 Male 140 lb 12/29/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Gastric Ulcer Hospitalization 11/8/2009 90 Male 128 lb 12/30/2009 Physician Slovakia (Slovak Republic)
Primary
Secondary
Concomitant
Narcotic Intoxication Hospitalization 12/30/2009 81 Male 150 lb 1/11/2010 Physician Germany
Primary
Secondary
Concomitant
Anal Abscess Hospitalization 12/27/2009 62 Male 1/11/2010 Other Health Professional Spain
Primary
Secondary
Concomitant
Thrombocytopenia Life Threatening 9/10/2009 43 Male 159 lb 1/11/2010 Other Health Professional Germany
Primary
Secondary
Concomitant
Prostate Cancer Hospitalization 12/2/2009 69 Male 170 lb 1/12/2010 Physician Italy
Primary
Secondary
Drug Toxicity Hospitalization 5/2/2009 68 Male 1/14/2010 Other Health Professional Spain
Primary
Secondary
Concomitant
Gastrointestinal Haemorrhage Life Threatening 10/7/2009 53 Male 148 lb 1/19/2010 Other Health Professional Germany
Primary
Secondary
Concomitant
Cerebral Ischaemia Hospitalization 10/28/2009 69 Male 192 lb 1/25/2010 Other Health Professional Canada
Primary
Secondary
Concomitant
Diverticular Perforation Hospitalization 11/25/2009 80 Male 152 lb 1/27/2010 Other Health Professional Canada
Primary
Secondary
Concomitant
Cholecystitis Acute Hospitalization 3/11/2009 61 Male 1/29/2010 Other Health Professional Canada
Primary
Secondary
Concomitant
Fracture Hospitalization 11/24/2009 Male 2/1/2010 Physician United States
Primary
Secondary
Concomitant
Urinary Tract Infection Hospitalization 1/28/2009 61 Male 176 lb 2/2/2010 Physician Poland
Primary
Secondary
Concomitant
Acute Myocardial Infarction Life Threatening 8/22/2009 73 Male 141 lb 2/2/2010 Physician Israel
Primary
Secondary
Concomitant
Pyrexia Hospitalization 10/24/2009 77 Male 385 lb 2/2/2010 Physician United Kingdom
Primary
Secondary
Concomitant
Vertigo Hospitalization 6/24/2009 68 Male 126 lb 2/2/2010 Physician Israel
Primary
Secondary
Concomitant
Sepsis Hospitalization 11/24/2009 Male 220 lb 2/2/2010 Physician United States
Primary
Secondary
Concomitant
Transient Ischaemic Attack Hospitalization 11/26/2009 Male 196 lb 2/3/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Mental Status Changes Hospitalization 12/16/2008 Male 197 lb 2/3/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Death Death 6/12/2009 80 Male 163 lb 2/3/2010 Other Health Professional Spain
Primary
Secondary
Concomitant
Cholecystitis Acute Hospitalization 3/11/2009 61 Male 2/4/2010 Other Health Professional Canada
Primary
Secondary
Concomitant
Haemorrhage Intracranial Hospitalization 12/28/2009 Male 210 lb 2/8/2010 Physician United States
Primary
Secondary
Concomitant
Anal Abscess Hospitalization 12/27/2009 62 Male 2/11/2010 Other Health Professional Spain
Primary
Secondary
Concomitant
Vomiting Hospitalization 1/27/2010 Male 143 lb 2/15/2010 Physician United States
Primary
Secondary
Concomitant
Haematuria Hospitalization 12/7/2009 63 Male 183 lb 2/16/2010 Physician France
Primary
Secondary
Concomitant
Convulsion Life Threatening 12/4/2009 Male 210 lb 2/15/2010 Physician United States
Primary
Secondary
Concomitant
Sepsis Hospitalization 11/24/2009 Male 220 lb 2/15/2010 Physician United States
Primary
Secondary
Concomitant
Acute Myocardial Infarction Life Threatening 8/22/2009 73 Male 141 lb 2/16/2010 Physician Israel
Primary
Secondary
Concomitant
Drug Toxicity Hospitalization 5/2/2009 68 Male 2/17/2010 Other Health Professional Spain
Primary
Secondary
Concomitant
Haemorrhage Life Threatening 9/10/2009 43 Male 159 lb 2/18/2010 Other Health Professional Germany
Primary
Secondary
Concomitant
Vomiting Hospitalization 1/27/2010 Male 143 lb 2/23/2010 Physician United States
Primary
Secondary
Concomitant
Acute Myocardial Infarction Life Threatening 8/22/2009 73 Male 141 lb 2/23/2010 Physician Israel
Primary
Secondary
Concomitant
Diverticular Perforation Hospitalization 11/25/2009 80 Male 152 lb 2/25/2010 Other Health Professional Canada
Primary
Secondary
Concomitant
Upper Gastrointestinal Haemorrhage Other Serious 4/1/2008 64 Female 121 lb 2/24/2010 Physician Philippines
Primary
Secondary
Concomitant
Myocardial Infarction Life Threatening 6/12/2008 73 Female 163 lb 3/3/2010 Physician Peru
Primary
Secondary
Concomitant
Ischaemic Stroke Hospitalization 2/20/2010 73 Male 180 lb 3/5/2010 Other Health Professional Spain
Primary
Secondary
Concomitant
Gastrointestinal Haemorrhage Life Threatening 2/8/2010 72 Male 214 lb 3/10/2010 Physician Germany
Primary
Secondary
Concomitant
Drug Toxicity Hospitalization 5/2/2009 68 Male 3/12/2010 Other Health Professional Spain
Primary
Secondary
Concomitant
Death Death 3/8/2010 70 Male 255 lb 3/12/2010 Physician Poland
Primary
Secondary
Concomitant
Urine Output Decreased Hospitalization 1/27/2010 Male 143 lb 3/15/2010 Physician United States
Primary
Secondary
Concomitant
Cholecystitis Acute Hospitalization 3/11/2009 61 Male 3/17/2010 Other Health Professional Canada
Primary
Secondary
Concomitant
Chest Pain Hospitalization 3/8/2010 Male 213 lb 3/23/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Gastrointestinal Haemorrhage Life Threatening 2/8/2010 72 Male 214 lb 3/30/2010 Physician Germany
Primary
Secondary
Concomitant
Cerebral Ischaemia Hospitalization 10/28/2009 69 Male 192 lb 3/30/2010 Other Health Professional Canada
Primary
Secondary
Concomitant
Anaemia Hospitalization 2/17/2010 53 Male 201 lb 3/31/2010 Physician Belgium
Primary
Secondary
Concomitant
Death Death 3/8/2010 70 Male 255 lb 4/1/2010 Physician Poland
Primary
Secondary
Concomitant
Diverticular Perforation Hospitalization 11/25/2009 80 Male 152 lb 4/9/2010 Other Health Professional Canada
Primary
Secondary
Concomitant
Prostate Cancer Hospitalization 12/30/2009 81 Male 150 lb 4/20/2010 Physician Germany
Primary
Secondary
Concomitant
Hyponatraemia Hospitalization 3/21/2010 81 Male 142 lb 4/26/2010 Other Health Professional Canada
Primary
Secondary
Concomitant
Nervous System Disorder Hospitalization 4/21/2010 76 Male 187 lb 5/3/2010 Physician Germany
Primary
Secondary
Concomitant
Gastrointestinal Haemorrhage Life Threatening 2/8/2010 72 Male 214 lb 5/5/2010 Physician Germany
Primary
Secondary
Concomitant
Prothrombin Time Prolonged Hospitalization 4/15/2010 59 Male 115 lb 5/5/2010 Physician Germany
Primary
Secondary
Concomitant
Ischaemic Stroke Hospitalization 2/20/2010 73 Male 180 lb 5/6/2010 Other Health Professional Spain
Primary
Secondary
Concomitant
Transient Ischaemic Attack Hospitalization 11/26/2009 84 Male 196 lb 5/24/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Death Death 12/2/2009 84 Male 196 lb 5/24/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Acute Coronary Syndrome Hospitalization 3/10/2010 78 Male 185 lb 5/31/2010 Other Health Professional Spain
Primary
Secondary
Concomitant
Prothrombin Time Prolonged Hospitalization 4/15/2010 59 Male 115 lb 6/1/2010 Other Health Professional Germany
Primary
Secondary
Concomitant
Proctitis Other Serious 5/13/2010 65 Male 148 lb 6/1/2010 Physician Peru
Primary
Secondary
Concomitant
General Physical Health Deterioration Death 5/20/2010 77 Male 6/1/2010 Physician France
Primary
Secondary
Concomitant
Gastroenteritis Hospitalization 5/20/2010 79 Male 172 lb 6/3/2010 Physician Brazil
Primary
Secondary
Concomitant
Anal Abscess Hospitalization 12/27/2009 62 Male 6/8/2010 Other Health Professional Spain
Primary
Secondary
Concomitant
Hyponatraemia Hospitalization 3/21/2010 81 Male 142 lb 6/8/2010 Other Health Professional Canada
Primary
Secondary
Concomitant
General Physical Health Deterioration Death 5/20/2010 77 Male 6/14/2010 Physician France
Primary
Secondary
Concomitant
Urine Output Decreased Hospitalization 1/27/2010 64 Male 143 lb 6/16/2010 Physician United States
Primary
Secondary
Concomitant
Pyrexia Hospitalization 6/13/2010 76 Male 171 lb 6/29/2010 Physician United States
Primary
Secondary
Concomitant
Acute Myocardial Infarction Life Threatening 8/22/2009 73 Male 141 lb 6/29/2010 Physician Israel
Primary
Secondary
Concomitant
Cholecystitis Acute Hospitalization 5/31/2010 76 Male 6/29/2010 Other Health Professional Spain
Primary
Secondary
Concomitant
Transient Ischaemic Attack Hospitalization 11/26/2009 84 Male 196 lb 7/1/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Pneumonia Hospitalization 6/7/2010 70 Male 153 lb 7/8/2010 Other Health Professional Canada
Primary
Secondary
Concomitant
Pyrexia Hospitalization 6/13/2010 76 Male 171 lb 7/8/2010 Physician United States
Primary
Secondary
Concomitant
Drug Toxicity Hospitalization 5/2/2009 68 Male 7/9/2010 Other Health Professional Spain
Primary
Secondary
Concomitant
Acute Myocardial Infarction Life Threatening 8/22/2009 73 Male 141 lb 7/9/2010 Physician Israel
Primary
Secondary
Concomitant
Peptic Ulcer Hospitalization 4/17/2010 72 Male 139 lb 7/9/2010 Physician Israel
Primary
Secondary
Concomitant
Transient Ischaemic Attack Hospitalization 11/26/2009 84 Male 196 lb 7/14/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Optic Ischaemic Neuropathy Hospitalization 6/24/2010 63 Male 201 lb 7/26/2010 Physician Germany
Primary
Secondary
Concomitant
Intestinal Haemorrhage Hospitalization 6/10/2010 74 Male 183 lb 7/27/2010 Other Health Professional Spain
Primary
Secondary
Concomitant
Diverticulitis Other Serious 5/16/2010 78 Male 202 lb 7/28/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Drug Toxicity Hospitalization 5/2/2009 68 Male 8/2/2010 Other Health Professional Spain
Primary
Secondary
Concomitant
Transient Ischaemic Attack Hospitalization 11/26/2009 84 Male 196 lb 8/12/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Optic Ischaemic Neuropathy Hospitalization 6/24/2010 63 Male 201 lb 8/18/2010 Physician Germany
Primary
Secondary
Concomitant
Death Death 12/2/2009 84 Male 196 lb 8/20/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Death Death 8/2/2010 53 Male 187 lb 8/23/2010 Physician Poland
Primary
Secondary
Concomitant
Disseminated Intravascular Coagulation Hospitalization 8/18/2010 62 Male 171 lb 8/31/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Pneumonia Hospitalization 8/18/2010 63 Male 9/2/2010 Physician United States
Primary
Secondary
Concomitant
Optic Ischaemic Neuropathy Hospitalization 6/24/2010 63 Male 201 lb 9/7/2010 Physician Germany
Primary
Secondary
Concomitant
Transient Ischaemic Attack Hospitalization 11/26/2009 84 Male 196 lb 9/21/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Disseminated Intravascular Coagulation Hospitalization 8/18/2010 62 Male 171 lb 9/22/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Vascular Stent Insertion Other Serious 2/1/2008 64 Male 185 lb 9/22/2010 Physician Canada
Primary
Secondary
Concomitant
Pneumonia Other Serious 2/1/2008 64 Male 185 lb 9/29/2010 Physician Canada
Primary
Secondary
Concomitant
Urinary Tract Infection Hospitalization 10/24/2009 77 Male 385 lb 10/4/2010 Physician United Kingdom
Primary
Secondary
Concomitant
Upper Gastrointestinal Haemorrhage Other Serious 4/1/2008 64 Female 121 lb 10/7/2010 Physician Philippines
Primary
Secondary
Concomitant
Oesophagitis Hospitalization 3/25/2009 72 Male 159 lb 10/18/2010 Other Health Professional Canada
Primary
Secondary
Concomitant

Drug Data