Placebo combined with Prednisone Tab

Reports:


Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Appendicitis Hospitalization 4/25/2006 Female 139 lb 5/9/2006 Physician Canada
Primary
Secondary
Concomitant
Splenectomy Hospitalization 9/26/1999 Male 130 lb 5/18/2006 Physician Sweden
Primary
Secondary
Concomitant
Therapy Non-responder Life Threatening 5/24/2005 64 Male 7/11/2006 Other Health Professional Peru
Primary
Secondary
Concomitant
Bacterial Infection Hospitalization 6/21/2005 57 Female 7/13/2006 Other Health Professional Zaire
Primary
Secondary
Concomitant
Rectal Cancer Other Serious 7/13/2005 51 Female 8/7/2006 Other Health Professional Brazil
Primary
Secondary
Concomitant
Bacterial Infection Hospitalization 6/21/2005 57 Female 8/7/2006 Other Health Professional Zaire
Primary
Secondary
Concomitant
Respiratory Arrest Death 5/24/2006 Female 152 lb 6/22/2006 Other Health Professional United States
Primary
Secondary
Concomitant
Therapy Non-responder Hospitalization 11/18/2000 Male 11/2/2006 Physician United States
Primary
Secondary
Concomitant
Sarcoidosis Life Threatening 6/9/2004 Female 147 lb 11/22/2006 Physician United States
Primary
Concomitant
Immune Reconstitution Syndrome Hospitalization 7/18/2006 Female 158 lb 4/25/2007 Ireland
Primary
Concomitant
Hyperkalaemia Hospitalization 4/6/2007 Female 112 lb 4/27/2007 United States
Primary
Secondary
Concomitant
Sinusitis Other Serious 1/30/2007 Female 5/24/2007 Physician United States
Primary
Secondary
Concomitant
Myocardial Ischaemia Death 11/19/2007 Female 183 lb 11/30/2007 Consumer United Kingdom
Primary
Secondary
Concomitant
Angina Pectoris Death 2/4/2008 65 Male 225 lb 2/21/2008 Other Health Professional Australia
Primary
Secondary
Concomitant
Acute Myocardial Infarction Death 2/4/2008 65 Male 225 lb 2/28/2008 Other Health Professional Australia
Primary
Secondary
Concomitant
Oedema Peripheral Other Serious 12/15/2004 65 Female 136 lb 6/23/2008 Other Health Professional United States
Primary
Secondary
Concomitant
Pulmonary Embolism Hospitalization 8/18/2006 51 Female 8/7/2008 Other Health Professional Italy
Primary
Secondary
Concomitant
Pneumonia Other Serious 1/24/2007 60 Female 190 lb 9/10/2008 Physician Finland
Primary
Secondary
Concomitant
Pyrexia Other Serious 1/24/2007 60 Female 190 lb 9/12/2008 Other Health Professional Finland
Primary
Secondary
Concomitant
Death Death 9/20/2008 Female 10/7/2008 Consumer United Kingdom
Primary
Secondary
Concomitant
Cardiac Failure Death 9/20/2008 Female 10/15/2008 Consumer United Kingdom
Primary
Secondary
Concomitant
Inguinal Hernia Other Serious 8/28/2008 Male 10/23/2008 Physician
Primary
Secondary
Concomitant
Inguinal Hernia Other Serious 8/28/2008 Male 11/6/2008 Physician
Primary
Secondary
Concomitant
Renal Failure Life Threatening 10/4/2008 63 Male 245 lb 11/17/2008 Other Health Professional United States
Primary
Secondary
Concomitant
Febrile Neutropenia Hospitalization 10/24/2008 Male 12/3/2008 Consumer United Kingdom
Primary
Secondary
Febrile Neutropenia Hospitalization 7/2/2008 Male 12/3/2008 Consumer United Kingdom
Primary
Secondary
Acute Myocardial Infarction Death 2/4/2008 65 Male 225 lb 12/8/2008 Other Health Professional Australia
Primary
Secondary
Concomitant
Febrile Neutropenia Hospitalization 7/2/2008 Male 12/12/2008 Consumer United Kingdom
Primary
Secondary
Febrile Neutropenia Hospitalization 10/24/2008 Male 12/12/2008 Consumer United Kingdom
Primary
Secondary
Renal Failure Life Threatening 10/4/2008 63 Male 245 lb 12/17/2008 Other Health Professional United States
Primary
Secondary
Concomitant
Urinary Tract Infection Hospitalization 12/22/2008 Male 194 lb 1/12/2009 Other Health Professional
Primary
Secondary
Concomitant
Intestinal Functional Disorder Hospitalization 11/30/2008 Male 161 lb 1/12/2009 Physician
Primary
Secondary
Concomitant
Pyrexia Hospitalization 11/28/2008 64 Male 2/20/2009 Consumer United States
Primary
Secondary
Concomitant
Tongue Neoplasm Malignant Stage Unspecified Other Serious 4/21/2009 Female 189 lb 6/19/2009 Physician United States
Primary
Secondary
Concomitant
Thrombosis Other Serious 1/27/2009 Male 6/22/2009 Physician
Primary
Secondary
Concomitant
Lymphoma Hospitalization 6/14/2009 Male 254 lb 7/10/2009 Physician Canada
Primary
Secondary
Concomitant
Uterine Haemorrhage Hospitalization 1/8/2009 Female 161 lb 7/16/2009 Physician Mexico
Primary
Secondary
Concomitant
Generalised Oedema Hospitalization 6/23/2009 Female 316 lb 7/21/2009 Physician United States
Primary
Secondary
Concomitant
Subileus Hospitalization 4/7/2009 Male 163 lb 7/24/2009 Physician France
Primary
Secondary
Concomitant
Generalised Oedema Life Threatening 6/23/2009 Female 316 lb 7/24/2009 Physician United States
Primary
Secondary
Concomitant
Generalised Oedema Life Threatening 6/23/2009 Female 316 lb 7/31/2009 Physician United States
Primary
Secondary
Concomitant
Tongue Neoplasm Malignant Stage Unspecified Other Serious 6/9/2009 Female 189 lb 8/10/2009 Physician United States
Primary
Secondary
Concomitant
Lymphoma Hospitalization 6/14/2009 Male 254 lb 8/26/2009 Physician Canada
Primary
Secondary
Concomitant
Osteonecrosis Disability 10/2/2008 Female 144 lb 9/4/2009 Physician Argentina
Primary
Secondary
Concomitant
White Blood Cell Count Increased Hospitalization 8/24/2009 52 Male 182 lb 9/8/2009 Physician Canada
Primary
Secondary
Concomitant
Metastases To Peritoneum Other Serious 4/1/2009 Female 112 lb 9/23/2009 Physician Denmark
Primary
Secondary
Concomitant
Interacting
Breast Cancer Other Serious 9/10/2009 Female 159 lb 9/24/2009 Physician United States
Primary
Secondary
Concomitant
Generalised Oedema Life Threatening 6/23/2009 Female 316 lb 9/25/2009 Physician United States
Primary
Secondary
Concomitant
Drug Interaction Life Threatening 4/1/2009 Female 112 lb 9/25/2009 Physician Denmark
Primary
Concomitant
Interacting
Tongue Neoplasm Malignant Stage Unspecified Other Serious 7/9/2009 Female 189 lb 9/29/2009 Physician United States
Primary
Secondary
Concomitant
Respiratory Tract Infection Life Threatening 8/21/2009 Female 9/30/2009 Physician Argentina
Primary
Secondary
Concomitant
Viral Infection Hospitalization 9/21/2009 Female 132 lb 10/5/2009 Physician United States
Primary
Secondary
Concomitant
Drug Interaction Other Serious Female 112 lb 10/19/2009 Physician Denmark
Primary
Secondary
Concomitant
Interacting
Urine Odour Abnormal Hospitalization 9/17/2009 77 Female 172 lb 10/13/2009 United States
Primary
Secondary
Concomitant
Rheumatoid Arthritis Hospitalization 6/12/2009 Female 10/21/2009 Physician Japan
Primary
Secondary
Concomitant
Respiratory Failure Life Threatening 9/9/2009 Male 10/26/2009 Physician United Kingdom
Primary
Secondary
Respiratory Failure Life Threatening 9/9/2009 Male 11/25/2009 Physician United Kingdom
Primary
Secondary
Urinary Tract Infection Life Threatening 10/23/2008 76 Female 1/28/2010 Consumer Argentina
Primary
Secondary
Concomitant
Pneumonia Necrotising Death 8/13/2008 49 Male 1/28/2010 Other Health Professional Mexico
Primary
Secondary
Concomitant
Narcotic Intoxication Other Serious 12/29/2009 Male 150 lb 2/12/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Pneumonia Hospitalization 6/14/2009 Male 254 lb 3/15/2010 Physician Canada
Primary
Secondary
Concomitant
Death Death 11/7/2009 Female 238 lb 3/15/2010 Physician United States
Primary
Secondary
Concomitant
Confusional State Hospitalization 3/11/2010 Female 280 lb 3/23/2010 Physician United States
Primary
Secondary
Concomitant
Colitis Ulcerative Other Serious 10/24/2007 20 Male 141 lb 4/7/2010 Physician United States
Primary
Secondary
Concomitant
Surgical Failure Hospitalization 6/4/2009 49 Female 131 lb 4/12/2010 Physician United States
Primary
Secondary
Concomitant
Sudden Death Death 4/15/2010 79 Male 185 lb 4/22/2010 Physician Brazil
Primary
Secondary
Concomitant
Myocardial Infarction Death 11/7/2009 32 Female 238 lb 5/3/2010 Physician United States
Primary
Secondary
Concomitant
Surgical Failure Hospitalization 6/4/2009 49 Female 131 lb 5/4/2010 Physician United States
Primary
Secondary
Concomitant
Mental Status Changes Hospitalization 3/9/2009 77 Male 141 lb 5/7/2010 Physician United States
Primary
Secondary
Concomitant
Fistula Hospitalization 5/1/2010 57 Male 193 lb 5/14/2010 Physician United States
Primary
Secondary
Concomitant
Myocardial Infarction Death 4/14/2010 79 Male 185 lb 5/17/2010 Physician Brazil
Primary
Secondary
Concomitant
Lower Respiratory Tract Infection Hospitalization 5/12/2010 49 Male 236 lb 5/21/2010 Physician Australia
Primary
Secondary
Concomitant
Polyp Other Serious 3/20/2010 74 Male 5/21/2010 Physician United States
Primary
Secondary
Concomitant
Sepsis Hospitalization 6/1/2009 63 Male 254 lb 5/28/2010 Physician Canada
Primary
Secondary
Concomitant
Breast Calcifications Other Serious 5/7/2010 54 Female 143 lb 6/1/2010 Physician Chile
Primary
Secondary
Concomitant
Respiratory Tract Infection Hospitalization 5/24/2010 64 Male 151 lb 6/18/2010 Physician Spain
Primary
Secondary
Concomitant
Enterocutaneous Fistula Hospitalization 5/1/2010 57 Male 193 lb 7/2/2010 Physician United States
Primary
Secondary
Concomitant
Ureteric Obstruction Other Serious 8/10/2009 66 Male 7/2/2010 Physician
Primary
Secondary
Concomitant
Acute Hepatic Failure Death 7/19/2010 63 Female 150 lb 9/24/2010 Physician Poland
Primary
Secondary
Concomitant
Respiratory Tract Infection Hospitalization 5/24/2010 64 Male 151 lb 10/5/2010 Physician Spain
Primary
Secondary
Concomitant
Gastroenteritis Viral Other Serious 12/2/2009 51 Female 173 lb 2/15/2011 Physician United States
Primary
Secondary
Concomitant
Cholelithiasis Hospitalization 12/23/2010 75 Female 2/16/2011 Other Health Professional United States
Primary
Secondary
Concomitant
Pneumonia Hospitalization 4/24/2008 73 Male 137 lb 3/8/2011 Physician France
Primary
Secondary
Prostate Cancer Stage Ii Life Threatening 5/24/2010 68 Male 155 lb 3/9/2011 Physician United States
Primary
Secondary
Concomitant
Staphylococcal Abscess Hospitalization 2/9/2011 64 Female 238 lb 3/11/2011 Physician United States
Primary
Secondary
Concomitant
Pneumonia Hospitalization 12/17/2009 58 Male 150 lb 3/17/2011 Physician Spain
Primary
Secondary
Concomitant
Pyrexia Hospitalization 6/5/2009 77 Male 179 lb 5/6/2011 Consumer United Kingdom
Primary
Secondary
Ascites Hospitalization 4/10/2008 67 Male 197 lb 5/18/2011 Consumer United Kingdom
Primary
Secondary
Concomitant
Rectal Ulcer Hospitalization 9/12/2009 63 Female 92 lb 5/20/2011 Consumer United Kingdom
Primary
Secondary
Concomitant
Neutropenic Sepsis Hospitalization 8/10/2009 76 Male 141 lb 5/20/2011 Physician United Kingdom
Primary
Secondary
Concomitant
Wheezing Hospitalization 6/21/2006 82 Male 174 lb 5/25/2011 Physician United States
Primary
Secondary
Concomitant
Traumatic Lung Injury Hospitalization 6/30/2010 61 Male 155 lb 5/31/2011 Consumer United Kingdom
Primary
Secondary
Concomitant
Angina Pectoris Hospitalization 1/27/2009 70 Female 6/1/2011 Consumer United Kingdom
Primary
Secondary
Concomitant
Urinary Tract Infection Death 5/20/2010 67 Female 174 lb 6/8/2011 Physician United Kingdom
Primary
Secondary
Concomitant
Febrile Neutropenia Death 4/4/2009 73 Female 146 lb 7/12/2011 Consumer United Kingdom
Primary
Secondary
Concomitant
Proteinuria Other Serious 9/4/2008 67 Female 146 lb 8/16/2011 Consumer United Kingdom
Primary
Secondary
Concomitant
Myelodysplastic Syndrome Life Threatening 3/3/2010 77 Female 11/18/2011 Other Health Professional Czech Republic
Primary
Secondary
Concomitant
Actinic Keratosis Other Serious 6/23/2011 78 Male 11/18/2011 Physician Australia
Primary
Secondary
Concomitant
Shock Death 10/15/2011 77 Female 125 lb 11/18/2011 Spain
Primary
Secondary
Concomitant
Post Procedural Complication Hospitalization 9/15/2011 25 Female 165 lb 11/28/2011 Physician United States
Primary
Secondary
Concomitant
Lung Neoplasm Other Serious 8/9/2011 55 Female 146 lb 12/7/2011 Physician Argentina
Primary
Secondary
Concomitant
Squamous Cell Carcinoma Of Skin Other Serious 1/1/2011 94 Female 12/22/2011 Physician Australia
Primary
Secondary
Chronic Obstructive Pulmonary Disease Other Serious 10/10/2011 72 Female 12/22/2011 Physician United States
Primary
Secondary
Concomitant
Shock Death 10/15/2011 77 Female 125 lb 12/27/2011 Spain
Primary
Secondary
Concomitant
Breast Cancer Female Hospitalization 9/10/2009 42 Female 159 lb 1/5/2012 Physician United States
Primary
Secondary
Concomitant
Atrial Fibrillation Hospitalization 11/22/2011 65 Male 187 lb 1/6/2012 Other Health Professional United States
Primary
Secondary
Concomitant
Constipation Other Serious 78 Male 167 lb 1/26/2012 Consumer United States
Primary
Secondary
Concomitant
General Physical Health Deterioration Hospitalization 3/19/2009 69 Male 1/26/2012 Physician France
Primary
Secondary
Febrile Infection Hospitalization 4/28/2009 76 Male 146 lb 1/27/2012 Physician Finland
Primary
Secondary
Concomitant
Urinary Tract Infection Hospitalization 1/28/2009 61 Male 176 lb 1/27/2012 Physician Poland
Primary
Secondary
Concomitant
Death Death 6/12/2009 80 Male 163 lb 1/27/2012 Other Health Professional Spain
Primary
Secondary
Concomitant
Polyneuropathy In Malignant Disease Hospitalization 9/21/2009 64 Male 216 lb 1/27/2012 Other Health Professional Israel
Primary
Secondary
Concomitant
Breast Cancer Hospitalization 1/1/2012 53 Female 220 lb 1/30/2012 Physician United States
Primary
Secondary
Concomitant
Basal Cell Carcinoma Other Serious 1/1/2011 94 Female 1/30/2012 Physician Australia
Primary
Secondary
Metastases To Bone Hospitalization 6/14/2010 68 Male 156 lb 1/30/2012 Physician United States
Primary
Secondary
Concomitant
Neoplasm Progression Hospitalization 9/22/2009 81 Male 146 lb 1/31/2012 Physician United States
Primary
Secondary
Concomitant
Pneumonia Hospitalization 8/18/2010 63 Male 1/31/2012 Physician United States
Primary
Secondary
Concomitant
Disseminated Intravascular Coagulation Hospitalization 8/18/2010 62 Male 171 lb 1/31/2012 Other Health Professional United States
Primary
Secondary
Concomitant
Hyponatraemia Hospitalization 10/12/2009 65 Male 195 lb 1/31/2012 Physician Canada
Primary
Secondary
Concomitant
Muscular Weakness Hospitalization 4/16/2010 68 Male 159 lb 2/2/2012 Physician United States
Primary
Secondary
Concomitant
Cellulitis Hospitalization 1/24/2012 53 Female 151 lb 2/13/2012 Other Health Professional Chile
Primary
Secondary
Concomitant
Paraplegia Hospitalization 6/29/2010 43 Male 3/5/2012 Physician Poland
Primary
Secondary
Concomitant
Infusion Related Reaction Hospitalization 6/11/2007 22 Male 135 lb 3/9/2012 Physician Germany
Primary
Concomitant
Paraplegia Hospitalization 6/29/2010 43 Male 3/9/2012 Physician Poland
Primary
Secondary
Concomitant
Cellulitis Hospitalization 1/24/2012 53 Female 151 lb 3/15/2012 Other Health Professional Chile
Primary
Secondary
Concomitant
Squamous Cell Carcinoma Other Serious 8/16/2010 70 Female 203 lb 3/23/2012 Physician United States
Primary
Secondary
Concomitant
Squamous Cell Carcinoma 8/16/2010 70 Female 203 lb 3/23/2012 Physician United States
Primary
Secondary
Concomitant
Infusion Related Reaction Hospitalization 6/11/2007 22 Male 135 lb 3/23/2012 Physician Germany
Primary
Concomitant
Escherichia Urinary Tract Infection Hospitalization 4/11/2010 83 Male 183 lb 3/26/2012 Physician Belgium
Primary
Secondary
Concomitant
Haemorrhagic Stroke Death 12/6/2009 75 Male 192 lb 3/29/2012 Physician France
Primary
Secondary
Concomitant
Ischaemic Stroke Other Serious 9/21/2008 55 Male 161 lb 3/29/2012 Consumer Portugal
Primary
Secondary
Concomitant
Cerebral Ischaemia Hospitalization 8/7/2010 64 Male 201 lb 3/29/2012 Physician Chile
Primary
Secondary
Concomitant
Ischaemic Stroke Hospitalization 7/29/2009 76 Male 203 lb 3/30/2012 Physician Hungary
Primary
Secondary
Concomitant
Squamous Cell Carcinoma 8/16/2010 70 Female 203 lb 4/2/2012 Other Health Professional United States
Primary
Secondary
Concomitant
Pelvic Pain Death 10/15/2011 77 Female 125 lb 4/2/2012 Physician Spain
Primary
Secondary
Concomitant
Brucellosis Hospitalization 4/5/2007 55 Male 4/2/2012 Other Health Professional United States
Primary
Secondary
Concomitant
Basal Cell Carcinoma Other Serious 1/1/2011 94 Female 4/16/2012 Physician Australia
Primary
Secondary
Coronary Artery Disease Other Serious 3/9/2011 67 Female 188 lb 4/16/2012 Physician United States
Primary
Secondary
Chills Hospitalization 4/10/2012 35 Female 284 lb 6/8/2012 Physician United States
Primary
Secondary
Concomitant
Nephrotic Syndrome Hospitalization 4/30/2012 65 Male 181 lb 6/12/2012 Physician Chile
Primary
Secondary
Concomitant
Nephrotic Syndrome Hospitalization 4/30/2012 65 Male 181 lb 6/22/2012 Other Health Professional Chile
Primary
Secondary
Concomitant
Nausea Death 1/25/2010 76 Male 381 lb 7/23/2012 Physician Germany
Primary
Secondary
Concomitant
Restlessness Other Serious 7/3/2012 58 Male 8/9/2012 Other Health Professional United States
Primary
Secondary
Concomitant
Cholangitis Hospitalization 7/29/2012 34 Male 228 lb 8/13/2012 Physician United States
Primary
Secondary
Concomitant
Hyperhidrosis Hospitalization 6/18/2012 58 Male 8/15/2012 Other Health Professional United States
Primary
Secondary
Concomitant
Transplant Rejection Hospitalization 7/9/2012 36 Male 182 lb 8/16/2012 Pharmacist United States
Primary
Concomitant
Microcytosis Other Serious 7/2/2012 66 Male 8/17/2012 Physician United States
Primary
Secondary
Concomitant
Squamous Cell Carcinoma Of Skin Other Serious 1/1/2011 94 Female 8/20/2012 Physician Australia
Primary
Secondary
Jc Virus Infection Other Serious 8/9/2012 52 Female 150 lb 8/21/2012 Physician Argentina
Primary
Secondary
Concomitant
Platelet Count Decreased Life Threatening 8/1/2012 8/16/2012 Physician United States
Primary
Secondary