Placebo combined with Prednisone

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Respiratory Failure Life Threatening 5/24/2005 64 Male 2/22/2006 Other Health Professional Peru
Primary
Secondary
Concomitant
Pneumonia Primary Atypical Hospitalization 3/6/2006 33 Male 154 lb 4/20/2006 Consumer Japan
Primary
Secondary
Respiratory Arrest Death 5/24/2006 Female 152 lb 6/22/2006 Other Health Professional United States
Primary
Secondary
Concomitant
Splenectomy Hospitalization 9/26/1999 Male 130 lb 2/5/2007 Physician Sweden
Primary
Secondary
Concomitant
Immune Reconstitution Syndrome Hospitalization 7/18/2006 Female 158 lb 2/13/2007 Physician Poland
Primary
Secondary
Concomitant
Immune Reconstitution Syndrome Hospitalization 7/18/2006 Female 158 lb 3/5/2007 Physician Poland
Primary
Secondary
Concomitant
Pulmonary Mycosis Hospitalization 11/4/2006 Male 3/9/2007 Germany
Primary
Secondary
Concomitant
Sinusitis Other Serious 8/18/2006 Male 117 lb 3/26/2007 Physician Brazil
Primary
Secondary
Concomitant
Abdominal Pain Hospitalization 6/18/2007 Male 108 lb 7/2/2007 Physician Canada
Primary
Secondary
Concomitant
Death Death 9/13/2007 Male 170 lb 10/12/2007 Physician United States
Primary
Secondary
Concomitant
Disseminated Tuberculosis Hospitalization 2/17/2007 23 Female 128 lb 11/2/2007 Physician China
Primary
Secondary
Concomitant
Myocardial Ischaemia Death 10/31/2007 Female 183 lb 12/12/2007 Consumer United Kingdom
Primary
Secondary
Concomitant
Sepsis Life Threatening 6/2/2007 56 Male 2/20/2008 Physician United States
Primary
Secondary
Concomitant
Sudden Death Death 4/13/2008 77 Female 5/1/2008 Other Health Professional Canada
Primary
Secondary
Concomitant
Acute Myocardial Infarction Death 2/4/2008 65 Male 225 lb 5/7/2008 Other Health Professional Australia
Primary
Secondary
Concomitant
Bleeding Varicose Vein Death 8/8/2005 Female 187 lb 6/24/2008 Physician Denmark
Primary
Secondary
Concomitant
Lymphoma Life Threatening 2/17/1997 Male 10/3/2008 Physician United States
Primary
Secondary
Concomitant
Death Death 10/12/2008 Female 10/31/2008 Physician United Kingdom
Primary
Secondary
Concomitant
Central Nervous System Lymphoma Hospitalization 8/25/2008 Male 10/31/2008 Consumer United Kingdom
Primary
Secondary
Hypokalaemia Hospitalization 11/30/2008 Male 12/29/2008 Physician
Primary
Secondary
Concomitant
Sepsis Hospitalization 11/28/2008 64 Male 2/26/2009 Consumer United States
Primary
Secondary
Concomitant
Female Genital Tract Fistula Other Serious 11/19/2008 59 Female 121 lb 3/3/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Sepsis Hospitalization 11/28/2008 64 Male 3/4/2009 Consumer United States
Primary
Secondary
Concomitant
Thrombosis Other Serious 1/27/2009 Male 3/5/2009 Physician
Primary
Secondary
Concomitant
Rheumatoid Arthritis Hospitalization 2/23/2009 33 Female 3/11/2009 Other Health Professional South Africa
Primary
Secondary
Concomitant
Thrombosis Other Serious 1/27/2009 Male 3/23/2009 Physician
Primary
Secondary
Concomitant
Intervertebral Discitis Hospitalization 3/23/2009 Female 159 lb 4/29/2009 Physician Argentina
Primary
Secondary
Concomitant
Cardiac Disorder Death 10/4/2008 78 Male 5/4/2009 Other Health Professional Canada
Primary
Secondary
Concomitant
Uterine Haemorrhage Hospitalization 1/8/2009 Female 161 lb 5/6/2009 Physician Mexico
Primary
Secondary
Concomitant
Cellulitis Hospitalization 3/24/2009 Female 192 lb 5/6/2009 Physician Chile
Primary
Secondary
Concomitant
Infection Hospitalization 4/6/2009 Male 163 lb 5/19/2009 Physician France
Primary
Secondary
Concomitant
Infection Hospitalization 4/6/2009 Male 163 lb 5/19/2009 Physician France
Primary
Secondary
Concomitant
Infection Hospitalization 4/6/2009 Male 163 lb 5/21/2009 Physician France
Primary
Secondary
Concomitant
Malaise Hospitalization 4/28/2009 Male 183 lb 5/21/2009 Physician Australia
Primary
Secondary
Concomitant
Sepsis Hospitalization 5/6/2009 Female 196 lb 5/22/2009 Physician United States
Primary
Secondary
Concomitant
Infection Hospitalization 4/6/2009 Male 163 lb 5/28/2009 Physician France
Primary
Secondary
Concomitant
Respiratory Failure Hospitalization 3/10/2009 Female 271 lb 5/29/2009 Physician United States
Primary
Secondary
Concomitant
Swollen Tongue Other Serious 5/16/2009 Female 5/29/2009 Physician
Primary
Secondary
Concomitant
Lower Limb Fracture Hospitalization 11/30/2007 Female 137 lb 6/3/2009 Physician United States
Primary
Secondary
Concomitant
Urinary Tract Infection Hospitalization 5/1/2009 Female 246 lb 6/5/2009 Physician United States
Primary
Secondary
Concomitant
Malaise Hospitalization 4/28/2009 Male 183 lb 6/8/2009 Physician Australia
Primary
Secondary
Concomitant
Swollen Tongue Other Serious 5/16/2009 Female 6/10/2009 Physician
Primary
Secondary
Concomitant
Lower Limb Fracture Hospitalization 11/30/2007 Female 137 lb 6/25/2009 Physician United States
Primary
Secondary
Concomitant
Influenza Hospitalization 6/14/2009 Male 7/6/2009 Physician Canada
Primary
Secondary
Concomitant
White Blood Cell Count Increased Hospitalization 1/27/2009 65 Male 7/1/2009 United States
Primary
Secondary
Concomitant
Pneumonia Hospitalization 7/7/2009 Female 151 lb 7/22/2009 Physician Argentina
Primary
Secondary
Concomitant
Lymphoma Hospitalization 6/14/2009 Male 254 lb 7/27/2009 Physician Canada
Primary
Secondary
Concomitant
Pneumonia Hospitalization 7/7/2009 Female 151 lb 7/30/2009 Physician Argentina
Primary
Secondary
Concomitant
Gastroenteritis Hospitalization 9/6/2008 Male 161 lb 7/30/2009 Physician Israel
Primary
Secondary
Concomitant
Sepsis Hospitalization 5/6/2009 Female 196 lb 8/7/2009 Physician United States
Primary
Secondary
Concomitant
Encephalitis Hospitalization 5/21/2009 Male 8/12/2009 Physician United Kingdom
Primary
Secondary
Concomitant
Lymphoma Hospitalization 6/14/2009 Male 254 lb 8/18/2009 Physician Canada
Primary
Secondary
Concomitant
Upper Respiratory Tract Infection Hospitalization 10/13/2008 Female 254 lb 8/18/2009 Physician United States
Primary
Secondary
Concomitant
Urinary Tract Infection Hospitalization 7/27/2009 67 Female 166 lb 8/11/2009 Physician Germany
Primary
Secondary
Concomitant
Osteomyelitis Hospitalization 8/7/2009 Female 105 lb 8/28/2009 Physician Philippines
Primary
Secondary
Concomitant
Respiratory Tract Infection Life Threatening 8/21/2009 Female 9/2/2009 Physician Argentina
Primary
Secondary
Concomitant
Cellulitis Hospitalization 8/1/2009 71 Male 9/2/2009 Physician United States
Primary
Secondary
Concomitant
Rheumatoid Arthritis Hospitalization 6/12/2009 Female 9/11/2009 Physician Japan
Primary
Secondary
Concomitant
Rectal Haemorrhage Hospitalization 9/9/2009 Male 190 lb 9/18/2009 Physician Australia
Primary
Secondary
Concomitant
Respiratory Tract Infection Life Threatening 8/21/2009 Female 9/22/2009 Physician Argentina
Primary
Secondary
Concomitant
Lymphoproliferative Disorder Hospitalization 6/14/2009 Male 254 lb 9/24/2009 Physician Canada
Primary
Secondary
Concomitant
Drug Interaction Other Serious 4/1/2009 Female 112 lb 10/1/2009 Physician Denmark
Primary
Concomitant
Interacting
Breast Cancer Other Serious 9/10/2009 Female 159 lb 10/8/2009 Physician United States
Primary
Secondary
Concomitant
Rheumatoid Nodule Other Serious 11/26/2007 Female 166 lb 10/9/2009 Physician Germany
Primary
Secondary
Concomitant
Pneumonia Hospitalization 9/17/2009 77 Female 172 lb 10/2/2009 United States
Primary
Secondary
Concomitant
Osteomyelitis Hospitalization 8/7/2009 Female 105 lb 10/12/2009 Physician Philippines
Primary
Secondary
Concomitant
Urinary Tract Infection Hospitalization 7/27/2009 67 Female 166 lb 10/6/2009 Other Health Professional Germany
Primary
Secondary
Concomitant
Pneumonia Hospitalization 6/14/2009 Male 254 lb 10/14/2009 Physician Canada
Primary
Secondary
Concomitant
Pancreatitis Other Serious 9/26/2009 23 Female 97 lb 10/9/2009 Physician United States
Primary
Secondary
Concomitant
Myocarditis Hospitalization 10/6/2009 34 Female 101 lb 10/20/2009 Consumer Taiwan, Province Of China
Primary
Secondary
Respiratory Failure Life Threatening 9/9/2009 Male 10/20/2009 Physician United Kingdom
Primary
Secondary
Drug Interaction Other Serious 4/1/2009 Female 112 lb 10/23/2009 Physician Denmark
Primary
Concomitant
Interacting
Swelling Face Hospitalization 6/14/2009 Male 254 lb 10/23/2009 Physician Canada
Primary
Secondary
Concomitant
Respiratory Tract Infection Life Threatening 8/21/2009 Female 10/23/2009 Physician Argentina
Primary
Secondary
Concomitant
Myocarditis Hospitalization 10/6/2009 34 Female 101 lb 10/23/2009 Consumer Taiwan, Province Of China
Primary
Secondary
Tongue Neoplasm Malignant Stage Unspecified Other Serious 7/9/2009 Female 189 lb 10/26/2009 Physician United States
Primary
Secondary
Concomitant
Osteomyelitis Hospitalization 8/7/2009 Female 105 lb 10/30/2009 Physician Philippines
Primary
Secondary
Concomitant
Pneumonia Hospitalization 6/14/2009 Male 254 lb 10/30/2009 Physician Canada
Primary
Secondary
Concomitant
Rheumatoid Arthritis Hospitalization 6/12/2009 Female 11/5/2009 Physician Japan
Primary
Secondary
Concomitant
Generalised Oedema Life Threatening 6/23/2009 Female 316 lb 11/6/2009 Physician United States
Primary
Secondary
Concomitant
Vertigo Other Serious 9/18/2009 34 Female 101 lb 11/11/2009 Consumer Taiwan, Province Of China
Primary
Secondary
Malaise Hospitalization 4/28/2009 Male 183 lb 11/12/2009 Physician Australia
Primary
Secondary
Concomitant
Viral Infection Hospitalization 9/21/2009 Female 132 lb 11/16/2009 Physician United States
Primary
Secondary
Concomitant
Pneumonia Hospitalization 10/31/2009 Male 254 lb 11/16/2009 Physician Canada
Primary
Secondary
Concomitant
Breast Cancer Other Serious 9/10/2009 Female 159 lb 11/17/2009 Physician United States
Primary
Secondary
Concomitant
Colitis Ulcerative Hospitalization 9/9/2009 Male 190 lb 11/19/2009 Physician Australia
Primary
Secondary
Concomitant
Tachycardia Life Threatening 9/4/2009 Female 157 lb 11/23/2009 Physician United States
Primary
Secondary
Concomitant
Pneumonia Hospitalization 6/14/2009 Male 254 lb 11/23/2009 Physician Canada
Primary
Secondary
Concomitant
Gastroenteritis Viral Hospitalization 4/28/2009 Male 183 lb 11/24/2009 Physician Australia
Primary
Secondary
Concomitant
Pneumonia Hospitalization 10/31/2009 Male 254 lb 11/25/2009 Physician Canada
Primary
Secondary
Concomitant
Bacteraemia Hospitalization 9/18/2009 Female 132 lb 12/1/2009 Physician United States
Primary
Secondary
Concomitant
Pneumonia Hospitalization 10/31/2009 Male 254 lb 12/3/2009 Physician Canada
Primary
Secondary
Concomitant
Pyrexia Hospitalization 9/18/2009 Female 132 lb 12/11/2009 Physician United States
Primary
Secondary
Concomitant
Liver Transplant Rejection Other Serious 9/30/2009 Male 12/17/2009 Physician
Primary
Secondary
Concomitant
Generalised Oedema Life Threatening 6/23/2009 Female 316 lb 12/23/2009 Physician United States
Primary
Secondary
Concomitant
Herpes Zoster Hospitalization 12/7/2009 12/23/2009 Physician Slovakia (Slovak Republic)
Primary
Secondary
Concomitant
Herpes Zoster Hospitalization 12/7/2009 12/30/2009 Physician Slovakia (Slovak Republic)
Primary
Secondary
Concomitant
Spinal Fracture Life Threatening 12/15/2009 Male 152 lb 12/31/2009 Physician Chile
Primary
Secondary
Concomitant
Oesophageal Candidiasis Hospitalization 12/12/2009 Male 1/4/2010 Other Health Professional United States
Primary
Secondary
Suicidal Ideation Hospitalization 12/2/2009 Female 173 lb 1/6/2010 Physician United States
Primary
Secondary
Concomitant
Herpes Zoster Hospitalization 12/22/2009 Female 1/8/2010 Physician Argentina
Primary
Secondary
Concomitant
Pyrexia Hospitalization 9/18/2009 Female 132 lb 1/8/2010 Physician United States
Primary
Secondary
Concomitant
Large Intestine Perforation Life Threatening 9/4/2009 Female 157 lb 1/8/2010 Physician United States
Primary
Secondary
Concomitant
Sudden Death Death 10/27/2009 72 Male 192 lb 1/11/2010 Physician Argentina
Primary
Secondary
Concomitant
Sudden Death Death 10/27/2009 72 Male 192 lb 1/11/2010 Physician Argentina
Primary
Secondary
Concomitant
Sudden Death Death 10/27/2009 72 Male 192 lb 1/11/2010 Physician Argentina
Primary
Secondary
Concomitant
Suicidal Ideation Hospitalization 12/2/2009 Female 173 lb 1/12/2010 Physician United States
Primary
Secondary
Concomitant
Herpes Zoster Hospitalization 12/22/2009 Female 183 lb 1/14/2010 Physician Argentina
Primary
Secondary
Concomitant
Colitis Ulcerative Hospitalization 12/14/2009 Female 132 lb 1/14/2010 Physician United States
Primary
Secondary
Concomitant
Calculus Urinary Hospitalization 3/1/2007 Female 159 lb 1/21/2010 Physician Argentina
Primary
Secondary
Concomitant
Pyrexia Hospitalization 9/18/2009 Female 132 lb 1/26/2010 Physician United States
Primary
Secondary
Concomitant
Calculus Urinary Hospitalization 3/1/2007 Female 159 lb 1/27/2010 Physician Argentina
Primary
Secondary
Concomitant
Herpes Zoster Hospitalization 12/26/2009 Female 183 lb 1/28/2010 Physician Argentina
Primary
Secondary
Concomitant
Interstitial Lung Disease Life Threatening 6/21/2009 72 Female 1/28/2010 Other Health Professional Argentina
Primary
Secondary
Concomitant
Pyrexia Hospitalization 9/18/2009 Female 132 lb 1/29/2010 Physician United States
Primary
Secondary
Concomitant
Meningioma Hospitalization 9/1/2007 Male 185 lb 2/2/2010 Other Health Professional France
Primary
Secondary
Concomitant
Breast Cancer Other Serious 9/10/2009 Female 159 lb 2/5/2010 Physician United States
Primary
Secondary
Concomitant
Colitis Ulcerative Hospitalization 12/14/2009 Female 132 lb 2/8/2010 Physician United States
Primary
Secondary
Concomitant
Gastrointestinal Haemorrhage Hospitalization 1/25/2010 Male 162 lb 2/9/2010 Physician United States
Primary
Secondary
Concomitant
Sepsis Life Threatening 3/10/2008 Female 106 lb 2/11/2010 Pharmacist Philippines
Primary
Secondary
Concomitant
Suicidal Ideation Hospitalization 12/2/2009 Female 173 lb 2/11/2010 Physician United States
Primary
Secondary
Concomitant
Procedural Pain Hospitalization 6/4/2009 Female 133 lb 2/12/2010 Physician United States
Primary
Secondary
Concomitant
Colitis Ulcerative Hospitalization 12/14/2009 Female 132 lb 2/18/2010 Physician United States
Primary
Secondary
Concomitant
Gastrointestinal Haemorrhage Hospitalization 1/25/2010 Male 162 lb 2/19/2010 Physician United States
Primary
Secondary
Concomitant
Calculus Urinary Hospitalization 3/1/2007 Female 159 lb 2/25/2010 Physician Argentina
Primary
Secondary
Concomitant
Herpes Zoster Hospitalization 12/7/2009 Female 3/5/2010 Physician Slovakia (Slovak Republic)
Primary
Secondary
Concomitant
Basal Cell Carcinoma 12/30/2009 3/5/2010 Physician United States
Primary
Secondary
Concomitant
Vomiting Other Serious 10/9/2009 Male 3/5/2010 Physician United States
Primary
Secondary
Concomitant
Spinal Fracture Life Threatening 12/15/2009 Male 152 lb 3/8/2010 Physician Chile
Primary
Secondary
Concomitant
Pneumonia Hospitalization 6/14/2009 Male 254 lb 3/9/2010 Physician Canada
Primary
Secondary
Concomitant
Herpes Zoster Hospitalization 12/7/2009 Female 3/10/2010 Physician Slovakia (Slovak Republic)
Primary
Secondary
Concomitant
Procedural Pain Hospitalization 6/4/2009 Female 131 lb 3/19/2010 Physician United States
Primary
Secondary
Concomitant
Herpes Zoster Hospitalization 12/26/2009 Female 183 lb 3/23/2010 Physician Argentina
Primary
Secondary
Concomitant
Urinary Tract Infection Hospitalization 5/15/2009 50 Female 246 lb 4/1/2010 Physician United States
Primary
Secondary
Concomitant
Vomiting Hospitalization 10/9/2009 66 Male 4/1/2010 Physician United States
Primary
Secondary
Concomitant
Pneumonia Primary Atypical Hospitalization 3/24/2010 67 Female 115 lb 4/26/2010 Physician Korea, Republic Of
Primary
Secondary
Concomitant
Tibia Fracture Hospitalization 9/2/2009 76 Female 141 lb 4/29/2010 Physician Panama
Primary
Secondary
Concomitant
Colitis Ulcerative Other Serious 10/10/2007 20 Male 141 lb 4/30/2010 Physician United States
Primary
Secondary
Concomitant
Confusional State Hospitalization 3/11/2010 59 Female 280 lb 4/30/2010 Physician United States
Primary
Secondary
Concomitant
Sepsis Hospitalization 6/14/2009 63 Male 254 lb 5/3/2010 Physician Canada
Primary
Secondary
Concomitant
Narcotic Intoxication Other Serious 12/29/2009 81 Male 150 lb 5/4/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Narcotic Intoxication Other Serious 12/29/2009 81 Male 150 lb 5/7/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Sudden Death Death 4/14/2010 79 Male 185 lb 5/7/2010 Physician Brazil
Primary
Secondary
Concomitant
H1n1 Influenza Other Serious 7/2/2009 53 Female 148 lb 5/13/2010 Other Health Professional Chile
Primary
Secondary
Concomitant
Breast Calcifications Other Serious 4/30/2010 54 Female 143 lb 5/18/2010 Physician Chile
Primary
Secondary
Concomitant
Narcotic Intoxication Other Serious 12/29/2009 81 Male 150 lb 5/19/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Suicidal Ideation Other Serious 12/2/2009 51 Female 173 lb 5/25/2010 Physician United States
Primary
Secondary
Concomitant
Breast Cancer Other Serious 4/30/2010 54 Female 143 lb 5/26/2010 Physician Chile
Primary
Secondary
Concomitant
Myocardial Ischaemia Life Threatening 9/15/2008 78 Male 6/2/2010 Consumer Canada
Primary
Secondary
Concomitant
Myocardial Ischaemia Life Threatening 9/15/2008 78 Male 6/4/2010 Consumer Canada
Primary
Secondary
Concomitant

Drug Data