Blinded Therapy combined with Prednisone

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Unresponsive To Stimuli Other Serious 2/13/2008 Male 165 lb 4/29/2008 Consumer United States
Primary
Secondary
Concomitant
Incorrect Dose Administered Death 6/20/2008 Male 11/11/2008 Other Health Professional Netherlands
Primary
Secondary
Concomitant
Syncope Hospitalization 9/28/2009 86 Male 148 lb 11/23/2009 Other Health Professional United States
Primary
Secondary
Concomitant
White Blood Cell Count Increased Other Serious 6/24/2009 75 Male 11/24/2009 Consumer United States
Primary
Secondary
Concomitant
Hyponatraemia Hospitalization 8/21/2009 74 Male 11/30/2009 Consumer United States
Primary
Secondary
Concomitant
Generalised Oedema Hospitalization 10/12/2009 Male 265 lb 12/2/2009 Physician United States
Primary
Secondary
Concomitant
Gastroenteritis Viral Hospitalization 9/9/2009 Female 241 lb 12/2/2009 Physician United States
Primary
Secondary
Concomitant
White Blood Cell Count Increased Hospitalization 7/7/2009 67 Male 12/2/2009 Consumer India
Primary
Secondary
Concomitant
Oropharyngeal Pain Hospitalization 7/7/2009 67 Male 12/3/2009 Consumer India
Primary
Secondary
Concomitant
Cerebrovascular Accident Life Threatening 12/6/2009 75 Male 192 lb 12/14/2009 Physician France
Primary
Secondary
Concomitant
Off Label Use Hospitalization 8/21/2009 74 Male 12/17/2009 Consumer United States
Primary
Secondary
Concomitant
Leukoencephalopathy Hospitalization 9/7/2009 71 Male 139 lb 12/23/2009 Consumer Argentina
Primary
Secondary
Concomitant
Faecalith Hospitalization 12/21/2009 76 Male 163 lb 1/5/2010 Physician France
Primary
Secondary
Concomitant
Troponin Life Threatening 11/29/2009 61 Male 221 lb 1/8/2010 Physician United States
Primary
Secondary
Death Death 10/4/2009 69 Male 193 lb 1/12/2010 Physician United States
Primary
Secondary
Tumour Pain Other Serious 12/30/2009 59 Male 209 lb 1/14/2010 Physician United States
Primary
Secondary
Tumour Pain Other Serious 12/30/2009 59 Male 209 lb 1/15/2010 Physician United States
Primary
Secondary
Rectourethral Fistula Hospitalization 12/26/2009 63 Male 238 lb 1/19/2010 Physician United States
Primary
Secondary
Tumour Pain Other Serious 12/30/2009 59 Male 209 lb 1/21/2010 Physician United States
Primary
Secondary
Syncope Hospitalization 9/28/2009 86 Male 148 lb 1/27/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Hypertensive Crisis Hospitalization 1/13/2010 78 Male 132 lb 1/29/2010 Physician Hungary
Primary
Secondary
Concomitant
Cerebrovascular Accident Life Threatening 12/6/2009 75 Male 192 lb 2/2/2010 Physician France
Primary
Secondary
Concomitant
Pleural Effusion Other Serious 1/4/2010 82 Male 132 lb 2/10/2010 Consumer Taiwan, Province Of China
Primary
Secondary
Concomitant
Hypertensive Crisis Hospitalization 1/13/2010 78 Male 132 lb 2/16/2010 Physician Hungary
Primary
Secondary
Concomitant
Sepsis Life Threatening 1/13/2010 72 Male 249 lb 2/16/2010 Physician United States
Primary
Secondary
Concomitant
Gastrointestinal Haemorrhage Death 1/29/2010 73 Male 2/22/2010 Consumer United States
Primary
Secondary
Sepsis Hospitalization 1/15/2010 65 Male 320 lb 2/25/2010 Physician United States
Primary
Secondary
Gastrointestinal Haemorrhage Death 1/29/2010 73 Male 3/1/2010 Consumer United States
Primary
Secondary
Troponin Hospitalization 2/26/2010 77 Male 210 lb 3/8/2010 Physician United States
Primary
Secondary
Troponin Hospitalization 2/26/2010 77 Male 210 lb 3/11/2010 Physician United States
Primary
Secondary
Concomitant
Renal Failure Life Threatening 2/16/2010 80 Male 3/11/2010 Physician United States
Primary
Secondary
Ischaemic Stroke Hospitalization 7/29/2009 76 Male 203 lb 3/11/2010 Consumer Hungary
Primary
Secondary
Concomitant
Faecalith Hospitalization 12/21/2009 76 Male 163 lb 3/12/2010 Physician France
Primary
Secondary
Concomitant
Oesophageal Ulcer Hospitalization 1/16/2010 70 Male 146 lb 3/12/2010 Physician United States
Primary
Secondary
Concomitant
Troponin Hospitalization 2/26/2010 77 Male 210 lb 3/17/2010 Physician United States
Primary
Secondary
Concomitant
Sepsis Hospitalization 1/15/2010 65 Male 320 lb 3/18/2010 Physician United States
Primary
Secondary
Generalised Oedema Hospitalization 10/12/2009 Male 251 lb 3/23/2010 Physician United States
Primary
Secondary
Concomitant
Sepsis Other Serious 6/19/2009 75 Male 3/24/2010 Consumer United States
Primary
Secondary
Concomitant
Sepsis Other Serious 6/19/2009 75 Male 3/25/2010 Consumer United States
Primary
Secondary
Concomitant
Renal Failure Life Threatening 2/16/2010 80 Male 3/31/2010 Physician United States
Primary
Secondary
Parkinson's Disease Other Serious 3/1/2010 78 Male 170 lb 5/11/2010 Physician United States
Primary
Secondary
Concomitant
Subdural Haematoma Hospitalization 4/12/2010 76 Male 5/14/2010 Physician United States
Primary
Secondary
Hypocalcaemia Hospitalization 4/16/2010 41 Male 5/14/2010 Physician India
Primary
Secondary
Ischaemic Stroke Hospitalization 7/29/2009 76 Male 203 lb 5/17/2010 Consumer Hungary
Primary
Secondary
Concomitant
Parkinson's Disease Other Serious 3/11/2010 78 Male 170 lb 5/18/2010 Physician United States
Primary
Secondary
Concomitant
Fatigue Other Serious 4/20/2010 82 Male 157 lb 5/18/2010 Physician United States
Primary
Secondary
Vomiting Hospitalization 2/14/2010 76 Male 6/7/2010 Physician Australia
Primary
Secondary
Concomitant
Febrile Neutropenia Hospitalization 5/17/2010 66 Male 6/8/2010 Physician United States
Primary
Secondary
Concomitant
Multi-organ Failure Hospitalization 4/11/2010 83 Male 183 lb 6/10/2010 Physician Belgium
Primary
Secondary
Concomitant
Tumour Lysis Syndrome Hospitalization 2/23/2010 59 Male 6/16/2010 Physician United States
Primary
Secondary
Concomitant
Stomatitis Hospitalization 5/22/2010 68 Male 187 lb 6/21/2010 Physician United States
Primary
Secondary
Concomitant
Cough Disability 12/23/2009 53 Male 165 lb 6/24/2010 Physician South Africa
Primary
Secondary
Concomitant
Gastric Ulcer Hospitalization 4/29/2010 78 Male 191 lb 6/25/2010 Physician Australia
Primary
Secondary
Concomitant
Pneumonia Hospitalization 6/18/2010 87 Male 197 lb 6/25/2010 Physician United States
Primary
Secondary
Large Intestinal Haemorrhage Hospitalization 1/26/2010 66 Male 219 lb 6/28/2010 Physician United States
Primary
Secondary
Concomitant
Stomatitis Hospitalization 5/22/2010 68 Male 187 lb 6/28/2010 Physician United States
Primary
Secondary
Concomitant
Respiratory Failure Life Threatening 6/1/2010 82 Male 6/28/2010 Physician Argentina
Primary
Secondary
Ventricular Arrhythmia Hospitalization 6/28/2010 Male 239 lb 7/13/2010 Physician United States
Primary
Secondary
Concomitant
Pulmonary Hypertension Hospitalization 5/11/2010 69 Male 7/16/2010 Physician Norway
Primary
Secondary
Respiratory Failure Hospitalization 5/31/2010 81 Male 7/22/2010 Physician Australia
Primary
Secondary
Concomitant
Respiratory Failure Life Threatening 6/1/2010 82 Male 7/26/2010 Physician Argentina
Primary
Secondary
Gastric Ulcer Hospitalization 6/18/2010 62 Male 227 lb 7/28/2010 Physician United States
Primary
Secondary
Concomitant
Respiratory Failure Life Threatening 6/1/2010 82 Male 7/28/2010 Physician Argentina
Primary
Secondary
Haemorrhagic Stroke Death 12/6/2009 75 Male 192 lb 8/2/2010 Physician France
Primary
Secondary
Concomitant
Respiratory Failure Life Threatening 6/1/2010 82 Male 8/5/2010 Physician Argentina
Primary
Secondary
Sepsis Hospitalization 7/13/2010 70 Male 157 lb 8/16/2010 Physician United States
Primary
Secondary
Wound Infection Staphylococcal Hospitalization 6/18/2010 62 Male 227 lb 8/27/2010 Physician United States
Primary
Secondary
Concomitant
Anal Fistula Hospitalization 7/25/2008 78 Male 186 lb 8/30/2010 Physician France
Primary
Secondary
Concomitant
Gastric Ulcer Hospitalization 4/29/2010 78 Male 191 lb 8/30/2010 Physician Australia
Primary
Secondary
Concomitant
Urinary Retention Hospitalization 7/30/2010 67 Male 8/30/2010 Physician United States
Primary
Secondary
Multi-organ Failure Hospitalization 4/11/2010 83 Male 183 lb 9/9/2010 Physician Belgium
Primary
Secondary
Concomitant
Diarrhoea Death 8/12/2010 72 Male 9/13/2010 Consumer United States
Primary
Secondary
Concomitant
Septic Shock Hospitalization 7/24/2010 84 Male 9/17/2010 Physician Brazil
Primary
Secondary
Concomitant
Wound Infection Staphylococcal Hospitalization 6/18/2010 62 Male 227 lb 9/21/2010 Physician United States
Primary
Secondary
Concomitant
Convulsion Hospitalization 4/12/2009 59 Male 160 lb 10/1/2010 Consumer Brazil
Primary
Secondary
Concomitant
Rectal Ulcer Hospitalization 12/7/2009 Male 183 lb 10/4/2010 Physician France
Primary
Secondary
Concomitant
Cerebral Ischaemia Hospitalization 8/7/2010 64 Male 201 lb 10/4/2010 Physician Chile
Primary
Secondary
Concomitant
Reversible Posterior Leukoencephalopathy Syndrome Other Serious 5/11/2009 59 Male 168 lb 10/5/2010 Physician Brazil
Primary
Secondary
Concomitant
Multi-organ Failure Death 10/4/2009 69 Male 193 lb 10/5/2010 Physician United States
Primary
Secondary
Concomitant
Pulmonary Embolism Hospitalization 9/8/2010 81 Male 10/15/2010 Physician Spain
Primary
Secondary
Concomitant
Vomiting Hospitalization 2/14/2010 76 Male 10/18/2010 Physician Australia
Primary
Secondary
Concomitant
Urinary Retention Hospitalization 9/10/2010 79 Male 10/20/2010 Physician Spain
Primary
Secondary
Concomitant
Fall Other Serious 9/14/2010 63 Female 10/29/2010 Physician United States
Primary
Concomitant
Malaise Hospitalization 10/7/2010 75 Male 228 lb 11/2/2010 Physician United Kingdom
Primary
Secondary
Concomitant
Sudden Death Death 11/17/2010 70 Male 185 lb 11/22/2010 Physician United States
Primary
Secondary
Tumour Lysis Syndrome Life Threatening 2/23/2010 59 Male 11/25/2010 Physician United States
Primary
Secondary
Concomitant
Urinary Retention Hospitalization 7/30/2010 67 Male 11/25/2010 Physician United States
Primary
Secondary
Pneumonitis Hospitalization 9/28/2010 77 Male 12/1/2010 Physician United States
Primary
Secondary
Concomitant
Thrombocytopenia Life Threatening 2/17/2010 80 Male 12/2/2010 Physician United States
Primary
Secondary
Cerebral Haemorrhage Hospitalization 11/8/2010 63 Male 12/3/2010 Physician Peru
Primary
Secondary
Urinary Retention Hospitalization 11/5/2010 67 Male 12/3/2010 Physician Ireland
Primary
Secondary
Concomitant
Cerebral Haemorrhage Hospitalization 11/8/2010 63 Male 12/13/2010 Physician Peru
Primary
Secondary
Tricuspid Valve Incompetence Hospitalization 8/7/2010 67 Female 150 lb 12/13/2010 Physician United States
Primary
Concomitant
Cerebral Ischaemia Hospitalization 8/7/2010 64 Male 201 lb 1/4/2011 Physician Chile
Primary
Secondary
Concomitant
Peripheral Ischaemia Hospitalization 11/29/2010 54 Male 227 lb 1/5/2011 Physician Poland
Primary
Secondary
Diarrhoea Other Serious 12/16/2010 74 Male 1/13/2011 Physician Ireland
Primary
Secondary
Concomitant
Musculoskeletal Pain Hospitalization 12/16/2010 74 Male 1/21/2011 Physician Ireland
Primary
Secondary
Concomitant
Gastric Ulcer Hospitalization 4/29/2010 78 Male 191 lb 1/24/2011 Physician Australia
Primary
Secondary
Concomitant
Gait Disturbance Hospitalization 10/7/2010 75 Male 228 lb 2/2/2011 Physician United Kingdom
Primary
Secondary
Concomitant
Neutropenia Hospitalization 1/1/2011 82 Male 2/10/2011 Physician Spain
Primary
Secondary
Concomitant
Diarrhoea Hospitalization 12/16/2010 74 Male 2/17/2011 Physician Ireland
Primary
Secondary
Concomitant
Dyspnoea Hospitalization 1/28/2011 80 Male 190 lb 3/3/2011 Physician United Kingdom
Primary
Secondary
Peripheral Ischaemia Hospitalization 11/29/2010 54 Male 227 lb 3/4/2011 Physician Poland
Primary
Secondary
Concomitant
Squamous Cell Carcinoma Other Serious 2/18/2011 64 Male 3/14/2011 Physician United States
Primary
Secondary
Concomitant
Pulmonary Embolism Hospitalization 12/25/2010 78 Male 3/22/2011 Physician Canada
Primary
Secondary
Concomitant
Pathological Fracture Other Serious 10/20/2010 63 Male 3/23/2011 Physician Canada
Primary
Secondary
Concomitant
Lower Respiratory Tract Infection Death 1/28/2011 80 Male 190 lb 3/23/2011 Physician United Kingdom
Primary
Secondary
Concomitant
Neutropenia Hospitalization 10/3/2010 75 Male 3/24/2011 Physician United Kingdom
Primary
Secondary
Pneumonitis Hospitalization 1/16/2011 76 Male 3/30/2011 Physician India
Primary
Secondary
Dehydration Hospitalization 7/24/2010 84 Male 4/6/2011 Physician Brazil
Primary
Secondary
Concomitant
Death Death 12/14/2010 78 Male 176 lb 4/14/2011 Physician Netherlands
Primary
Secondary
Concomitant
Pain In Extremity Hospitalization 3/16/2010 68 Male 4/19/2011 Physician United States
Primary
Secondary
Concomitant
Back Pain Hospitalization 2/10/2011 70 Male 152 lb 4/19/2011 Physician Australia
Primary
Secondary
Concomitant
Multi-organ Failure Death 4/11/2010 83 Male 183 lb 4/22/2011 Physician Belgium
Primary
Secondary
Concomitant
Transient Ischaemic Attack Other Serious 1/27/2011 68 Male 168 lb 5/6/2011 Physician Sweden
Primary
Secondary
Concomitant
Rectal Ulcer Hospitalization 12/7/2009 56 Male 183 lb 5/11/2011 Physician France
Primary
Secondary
Concomitant
Escherichia Urinary Tract Infection Hospitalization 4/11/2010 83 Male 183 lb 5/12/2011 Physician Belgium
Primary
Secondary
Concomitant
Anal Fistula Hospitalization 7/25/2008 78 Male 186 lb 5/12/2011 Physician France
Primary
Secondary
Concomitant
Confusional State Disability 10/8/2010 75 Male 5/12/2011 Physician United Kingdom
Primary
Secondary
Lower Respiratory Tract Infection Death 1/28/2011 80 Male 190 lb 5/13/2011 Physician United Kingdom
Primary
Secondary
Concomitant
Decreased Appetite Death 12/14/2010 78 Male 176 lb 5/23/2011 Physician Netherlands
Primary
Secondary
Concomitant
Cerebrovascular Accident Hospitalization 11/19/2010 69 Male 159 lb 5/24/2011 Physician South Africa
Primary
Secondary
Concomitant
Pulmonary Embolism Death 1/28/2011 80 Male 190 lb 5/26/2011 Physician United Kingdom
Primary
Secondary
Concomitant
Lower Respiratory Tract Infection Hospitalization 3/28/2011 70 Male 5/30/2011 Physician India
Primary
Secondary
Cardiac Failure Congestive Other Serious 1/1/2010 76 Male 5/31/2011 Physician United States
Primary
Secondary
Concomitant
Cerebrovascular Accident Hospitalization 11/19/2010 69 Male 159 lb 6/3/2011 Physician South Africa
Primary
Secondary
Concomitant
Hypocalcaemia Hospitalization 1/13/2011 70 Male 152 lb 6/3/2011 Physician Australia
Primary
Secondary
Concomitant
Rash Hospitalization 5/9/2011 73 Male 6/7/2011 Physician United Kingdom
Primary
Secondary
Concomitant
Carbon Dioxide Decreased Hospitalization 9/14/2010 63 Female 172 lb 6/8/2011 Physician United States
Primary
Concomitant
Death Death 5/16/2011 73 Male 197 lb 6/14/2011 Physician Russian Federation
Primary
Secondary
Concomitant
Decreased Appetite Death 12/14/2010 78 Male 176 lb 6/23/2011 Physician Netherlands
Primary
Secondary
Concomitant
Fall Hospitalization 5/18/2011 75 Male 6/24/2011 Physician United Kingdom
Primary
Secondary
Ischaemic Stroke Death 11/19/2010 69 Male 159 lb 6/29/2011 Physician South Africa
Primary
Secondary
Concomitant
Diarrhoea Hospitalization 2/18/2010 72 Male 6/24/2011 Korea, Republic Of
Primary
Secondary
Concomitant
Abdominal Pain Hospitalization 11/6/2010 63 Male 7/20/2011 Physician Peru
Primary
Secondary
General Physical Health Deterioration Death 12/14/2010 78 Male 176 lb 7/27/2011 Physician Netherlands
Primary
Secondary
Concomitant
Ischaemic Stroke Disability 11/19/2010 69 Male 159 lb 8/8/2011 Physician South Africa
Primary
Secondary
Concomitant
Prostate Cancer Metastatic Hospitalization 1/28/2011 80 Male 190 lb 8/23/2011 Physician United Kingdom
Primary
Secondary
Concomitant
Pathological Fracture Other Serious 10/20/2010 63 Male 8/26/2011 Physician Canada
Primary
Secondary
Concomitant
Anaemia Hospitalization 5/18/2011 75 Male 8/31/2011 Physician United Kingdom
Primary
Secondary
Cutaneous Lupus Erythematosus Other Serious 3/3/2010 52 Male 9/26/2011 Consumer France
Primary
Secondary
Concomitant
Transient Ischaemic Attack Hospitalization 8/23/2011 80 Male 165 lb 10/14/2011 Physician Italy
Primary
Secondary
Concomitant
Rash Hospitalization 5/11/2011 73 Male 10/17/2011 Physician United Kingdom
Primary
Secondary
Concomitant
Haemorrhagic Stroke Death 12/6/2009 75 Male 192 lb 10/24/2011 Physician France
Primary
Secondary
Concomitant
Dyspnoea Death 1/28/2011 Male 190 lb 11/30/2011 Physician United Kingdom
Primary
Secondary
Concomitant
Squamous Cell Carcinoma Other Serious 2/18/2011 64 Male 12/20/2011 Physician United States
Primary
Secondary
Concomitant
Pathological Fracture Other Serious 10/20/2010 63 Male 12/20/2011 Physician Canada
Primary
Secondary
Concomitant
Prostate Cancer Metastatic Hospitalization 11/12/2010 80 Male 190 lb 2/21/2012 Consumer United Kingdom
Primary
Secondary
Concomitant
Prostate Cancer Metastatic Hospitalization 11/12/2010 80 Male 190 lb 3/21/2012 Physician United Kingdom
Primary
Secondary
Concomitant
Pulmonary Embolism Death 11/12/2010 80 Male 190 lb 3/26/2012 Physician United Kingdom
Primary
Secondary
Concomitant

Drug Data