Placebo combined with Prednisolone

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Polymyalgia Rheumatica Other Serious 7/30/2003 75 Female 4/7/2006 Physician Australia
Primary
Secondary
Concomitant
Polymyalgia Rheumatica Other Serious 7/30/2003 75 Female 5/5/2006 Physician Australia
Primary
Secondary
Concomitant
Tuberculosis Hospitalization 5/29/2006 Female 99 lb 6/26/2006 Physician Japan
Primary
Secondary
Concomitant
Tuberculosis Hospitalization 5/29/2006 Female 93 lb 7/11/2006 Physician Japan
Primary
Secondary
Concomitant
White Blood Cell Count Increased Other Serious 2/15/2007 71 Female 161 lb 4/5/2007 Other Health Professional Denmark
Primary
Secondary
Concomitant
Rash Maculo-papular Hospitalization 12/4/2004 Female 132 lb 7/25/2007 Other Health Professional Belgium
Primary
Secondary
Concomitant
Myocardial Ischaemia Death 11/19/2007 Female 183 lb 11/30/2007 Consumer United Kingdom
Primary
Secondary
Concomitant
Myocardial Ischaemia Death 10/31/2007 Female 183 lb 12/12/2007 Consumer United Kingdom
Primary
Secondary
Concomitant
Polyomavirus-associated Nephropathy Hospitalization 3/27/2007 Male 184 lb 1/3/2008 Consumer Sweden
Primary
Secondary
Concomitant
Toxic Epidermal Necrolysis Death 8/6/2004 Male 1/25/2008 Physician Germany
Primary
Secondary
Concomitant
Toxic Epidermal Necrolysis Death 8/6/2004 Male 1/30/2008 Physician Germany
Primary
Secondary
Concomitant
Retinal Detachment Hospitalization 3/26/2008 Male 93 lb 4/11/2008 Physician Japan
Primary
Concomitant
Transaminases Increased Hospitalization 12/12/2001 Male 6/16/2008 Other Health Professional Austria
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
Loss Of Consciousness Hospitalization 2/23/2004 64 Male 12/2/2008 Physician Australia
Primary
Secondary
Concomitant
Retinal Detachment Hospitalization 3/26/2008 Male 93 lb 12/5/2008 Physician Japan
Primary
Concomitant
Meningioma Hospitalization 2/6/2009 Male 198 lb 2/24/2009 Physician Germany
Primary
Secondary
Concomitant
Infection Life Threatening 3/14/2009 77 Male 161 lb 4/20/2009 Physician Finland
Primary
Secondary
Concomitant
Infection Life Threatening 3/14/2009 77 Male 161 lb 4/21/2009 Physician Finland
Primary
Secondary
Concomitant
Tachycardia Hospitalization 3/5/2009 64 Male 4/17/2009 Physician Poland
Primary
Secondary
Concomitant
Infection Life Threatening 3/14/2009 77 Male 161 lb 4/27/2009 Physician Finland
Primary
Secondary
Concomitant
Adenocarcinoma Hospitalization 11/22/2008 Male 192 lb 5/15/2009 Physician Belgium
Primary
Secondary
Concomitant
Pneumonia Hospitalization 4/3/2009 Male 5/15/2009 Physician Australia
Primary
Secondary
Concomitant
Pneumonia Hospitalization 4/10/2009 Male 176 lb 5/20/2009 Physician Australia
Primary
Secondary
Concomitant
Herpes Zoster Hospitalization 5/7/2009 58 Female 5/20/2009 Physician Japan
Primary
Secondary
Concomitant
Ileitis Hospitalization 5/20/2009 45 Male 5/29/2009 Japan
Primary
Secondary
Concomitant
Immune System Disorder Hospitalization 5/7/2009 58 Male 146 lb 5/29/2009 Japan
Primary
Secondary
Concomitant
Ventricular Extrasystoles Hospitalization 3/30/2009 68 Female 118 lb 5/29/2009 Japan
Primary
Secondary
Concomitant
Pleural Effusion Hospitalization 9/9/2008 Female 6/15/2009 Physician Malaysia
Primary
Secondary
Concomitant
Ileitis Hospitalization 5/20/2009 45 Male 127 lb 6/4/2009 Physician Japan
Primary
Secondary
Concomitant
Pleural Effusion Hospitalization 9/9/2008 Female 6/16/2009 Physician Malaysia
Primary
Secondary
Concomitant
Herpes Zoster Hospitalization 5/7/2009 58 146 lb 6/10/2009 Physician Japan
Primary
Secondary
Concomitant
Vomiting Hospitalization 5/28/2009 61 Female 6/11/2009 Physician Japan
Primary
Secondary
Concomitant
Vomiting Hospitalization 5/28/2009 61 Female 111 lb 6/19/2009 Consumer Japan
Primary
Secondary
Concomitant
Pneumonia Hospitalization 3/24/2009 Male 143 lb 7/2/2009 Physician Bulgaria
Primary
Secondary
Concomitant
Duodenal Ulcer Hospitalization 6/19/2009 Female 115 lb 7/9/2009 Physician Japan
Primary
Secondary
Concomitant
Vomiting Hospitalization 5/28/2009 61 Female 111 lb 7/6/2009 Physician Japan
Primary
Secondary
Concomitant
Organising Pneumonia Hospitalization 7/4/2009 Female 137 lb 7/15/2009 Physician Japan
Primary
Secondary
Concomitant
Duodenal Ulcer Hospitalization 6/16/2009 Female 115 lb 7/22/2009 Physician Japan
Primary
Secondary
Concomitant
Urinary Tract Infection Hospitalization 7/24/2009 Female 8/6/2009 Physician Japan
Primary
Secondary
Concomitant
Prinzmetal Angina Hospitalization 7/26/2009 77 Male 117 lb 8/12/2009 Other Health Professional Japan
Primary
Secondary
Concomitant
Renal Impairment Hospitalization 4/22/2008 Female 206 lb 9/3/2009 Physician New Zealand
Primary
Secondary
Concomitant
Urinary Tract Infection Hospitalization 7/24/2009 Female 9/4/2009 Physician Japan
Primary
Secondary
Concomitant
Vascular Rupture Life Threatening 9/2/2009 Male 209 lb 10/9/2009 Other Health Professional Denmark
Primary
Secondary
Concomitant
Staphylococcal Infection Other Serious 7/6/2009 Female 123 lb 10/14/2009 Physician Malaysia
Primary
Secondary
Concomitant
Upper Respiratory Tract Infection Hospitalization 2/8/2009 Female 88 lb 10/16/2009 Physician Malaysia
Primary
Secondary
Concomitant
Vomiting Hospitalization 5/28/2009 61 Female 111 lb 10/20/2009 Physician Japan
Primary
Secondary
Concomitant
Upper Respiratory Tract Infection Hospitalization 2/8/2009 Female 88 lb 11/2/2009 Physician Malaysia
Primary
Secondary
Concomitant
Staphylococcal Infection Other Serious 7/6/2009 Female 123 lb 11/6/2009 Physician Malaysia
Primary
Secondary
Concomitant
Systemic Lupus Erythematosus Other Serious 1/1/2009 Female 198 lb 11/17/2009 Physician Netherlands
Primary
Secondary
Concomitant
Wound Dehiscence Hospitalization 10/15/2009 Female 168 lb 11/20/2009 Physician Finland
Primary
Secondary
Concomitant
Anal Abscess Hospitalization 10/20/2009 Female 114 lb 11/23/2009 Physician Japan
Primary
Secondary
Concomitant
Vascular Rupture Life Threatening 9/2/2009 Male 209 lb 11/24/2009 Other Health Professional Denmark
Primary
Secondary
Concomitant
Retinal Detachment Hospitalization 11/10/2009 Female 143 lb 11/25/2009 Physician United Kingdom
Primary
Secondary
Concomitant
Wound Dehiscence Hospitalization 10/15/2009 Female 168 lb 12/9/2009 Physician Finland
Primary
Secondary
Concomitant
Retinal Detachment Hospitalization 11/10/2009 Female 143 lb 12/9/2009 Physician United Kingdom
Primary
Secondary
Concomitant
Anal Abscess Hospitalization 10/20/2009 Female 114 lb 12/15/2009 Physician Japan
Primary
Secondary
Concomitant
Retinal Detachment Hospitalization 11/10/2009 Female 143 lb 12/17/2009 Physician United Kingdom
Primary
Secondary
Concomitant
Anal Abscess Hospitalization 10/20/2009 Female 114 lb 1/5/2010 Physician Japan
Primary
Secondary
Concomitant
Urinary Tract Infection Hospitalization 12/17/2009 Female 75 lb 1/5/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Pyoderma Gangrenosum Hospitalization 10/20/2009 Female 114 lb 1/8/2010 Physician Japan
Primary
Secondary
Concomitant
Sepsis Hospitalization 12/17/2009 Female 75 lb 1/15/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Lung Neoplasm Other Serious 11/25/2009 Male 196 lb 2/2/2010 Physician United Kingdom
Primary
Secondary
Concomitant
Lung Neoplasm Other Serious 11/1/2009 Male 196 lb 2/12/2010 Physician United Kingdom
Primary
Secondary
Concomitant
Sepsis Hospitalization 12/17/2009 Female 75 lb 2/17/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Spindle Cell Sarcoma Life Threatening 3/13/2008 Female 328 lb 2/17/2010 Physician Australia
Primary
Secondary
Concomitant
Pyoderma Gangrenosum Hospitalization 10/20/2009 Female 114 lb 2/19/2010 Physician Japan
Primary
Secondary
Concomitant
Abscess Intestinal Hospitalization 1/23/2010 Female 249 lb 2/19/2010 Physician Australia
Primary
Secondary
Concomitant
Anal Abscess Hospitalization 10/20/2009 Female 114 lb 2/25/2010 Physician Japan
Primary
Secondary
Concomitant
Colectomy Hospitalization 12/18/2008 Female 3/2/2010 Physician Australia
Primary
Secondary
Concomitant
Lung Neoplasm Other Serious 11/1/2009 Male 196 lb 3/3/2010 Physician United Kingdom
Primary
Secondary
Concomitant
Spindle Cell Sarcoma Life Threatening 3/13/2008 Female 328 lb 3/12/2010 Physician Australia
Primary
Secondary
Concomitant
Spinal Compression Fracture Hospitalization 6/18/2009 67 Male 159 lb 3/12/2010 Physician Japan
Primary
Secondary
Concomitant
Abscess Intestinal Hospitalization 1/23/2010 Female 249 lb 3/16/2010 Physician Australia
Primary
Secondary
Concomitant
Abscess Intestinal Hospitalization 1/23/2010 Female 249 lb 3/26/2010 Physician Australia
Primary
Secondary
Concomitant
Sepsis Hospitalization 12/17/2009 Female 75 lb 3/31/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Tuberculous Pleurisy Hospitalization 10/19/2009 62 Female 178 lb 4/5/2010 Physician Singapore
Primary
Secondary
Concomitant
Spinal Compression Fracture Hospitalization 6/18/2009 67 Male 159 lb 4/8/2010 Physician Japan
Primary
Secondary
Concomitant
Sepsis Hospitalization 12/17/2009 66 Female 75 lb 4/9/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Anal Abscess Hospitalization 10/20/2009 28 Female 114 lb 4/9/2010 Physician Japan
Primary
Secondary
Concomitant
Basal Cell Carcinoma Other Serious 2/14/2009 37 Female 4/13/2010 Physician South Africa
Primary
Secondary
Concomitant
Otitis Externa Hospitalization 4/4/2010 26 Female 243 lb 4/15/2010 Physician Germany
Primary
Secondary
Concomitant
Anal Abscess Hospitalization 10/20/2009 28 Female 114 lb 4/15/2010 Physician Japan
Primary
Secondary
Concomitant
Renal Failure Acute Hospitalization 7/19/2008 76 Male 199 lb 4/21/2010 Physician United States
Primary
Secondary
Concomitant
Sepsis Hospitalization 12/17/2009 66 Female 75 lb 4/23/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Sepsis Hospitalization 12/17/2009 66 Female 75 lb 4/30/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Tuberculous Pleurisy Hospitalization 10/19/2009 62 Female 178 lb 4/30/2010 Physician Singapore
Primary
Secondary
Concomitant
Anal Abscess Hospitalization 11/8/2009 28 Female 114 lb 4/30/2010 Physician Japan
Primary
Secondary
Concomitant
Sepsis Hospitalization 7/13/2008 76 Male 199 lb 5/3/2010 Physician United States
Primary
Secondary
Concomitant
Prostate Cancer Death Male 5/4/2010 Physician United Kingdom
Primary
Secondary
Concomitant
Sepsis Hospitalization 12/17/2009 66 Female 75 lb 5/7/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Hepatic Enzyme Increased Other Serious 1/8/2009 78 Male 173 lb 5/7/2010 Physician United Kingdom
Primary
Secondary
Concomitant
Lung Squamous Cell Carcinoma Stage I Other Serious 1/18/2010 60 Male 196 lb 5/11/2010 Physician United Kingdom
Primary
Secondary
Concomitant
Renal Failure Acute Hospitalization 7/13/2008 76 Male 156 lb 5/14/2010 Physician United States
Primary
Secondary
Concomitant
Renal Failure Acute Hospitalization 7/13/2008 76 Male 156 lb 5/18/2010 Physician United States
Primary
Secondary
Concomitant
Sepsis Hospitalization 12/17/2009 66 Female 75 lb 5/21/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Disseminated Tuberculosis Hospitalization 4/22/2010 67 Female 115 lb 5/21/2010 Physician Korea, Republic Of
Primary
Secondary
Concomitant
Cerebral Infarction Other Serious 3/14/2009 77 Male 161 lb 5/25/2010 Physician Finland
Primary
Secondary
Concomitant
Disseminated Tuberculosis Hospitalization 4/22/2010 67 Female 115 lb 5/27/2010 Physician Korea, Republic Of
Primary
Secondary
Concomitant
Anal Abscess Hospitalization 11/8/2009 28 Female 114 lb 5/27/2010 Physician Japan
Primary
Secondary
Concomitant
Renal Failure Acute Hospitalization 7/13/2008 76 Male 156 lb 6/8/2010 Physician United States
Primary
Secondary
Concomitant
Cerebral Infarction Other Serious 3/14/2009 77 Male 161 lb 6/10/2010 Physician Finland
Primary
Secondary
Concomitant
Pneumonia Hospitalization 4/6/2010 60 Female 175 lb 6/11/2010 Physician Ukraine
Primary
Secondary
Concomitant
Sepsis Hospitalization 12/17/2009 66 Female 75 lb 6/15/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Disseminated Tuberculosis Hospitalization 4/22/2010 67 Female 115 lb 6/18/2010 Physician Korea, Republic Of
Primary
Secondary
Concomitant
Renal Impairment Hospitalization 4/22/2008 39 Female 206 lb 6/22/2010 Physician New Zealand
Primary
Secondary
Concomitant
Sepsis Hospitalization 2/12/2010 56 Male 227 lb 6/25/2010 Physician Germany
Primary
Secondary
Concomitant
Renal Failure Acute Hospitalization 7/13/2008 76 Male 156 lb 7/1/2010 Physician United States
Primary
Secondary
Concomitant
Hepatic Enzyme Increased Other Serious 1/8/2009 78 Male 173 lb 7/6/2010 Physician United Kingdom
Primary
Secondary
Concomitant
Septic Shock Hospitalization 4/22/2010 67 Female 115 lb 7/7/2010 Physician Korea, Republic Of
Primary
Secondary
Concomitant
Pneumonia Hospitalization 3/24/2009 60 Male 143 lb 7/9/2010 Physician Bulgaria
Primary
Secondary
Concomitant
Sepsis Hospitalization 2/12/2010 56 Male 227 lb 7/12/2010 Physician Germany
Primary
Secondary
Concomitant
Septic Shock Hospitalization 4/22/2010 67 Female 115 lb 7/16/2010 Physician Korea, Republic Of
Primary
Secondary
Concomitant
Lung Squamous Cell Carcinoma Stage I Other Serious 1/18/2010 60 Male 196 lb 7/22/2010 Physician France
Primary
Secondary
Concomitant
Pleural Disorder Hospitalization 3/6/2010 31 Female 7/23/2010 Physician United Kingdom
Primary
Secondary
Concomitant
Pleuritic Pain Hospitalization 3/6/2010 31 Female 8/4/2010 Physician United Kingdom
Primary
Secondary
Concomitant
Iron Deficiency Anaemia Hospitalization 6/24/2010 35 Female 110 lb 8/9/2010 Physician Japan
Primary
Secondary
Concomitant
Pleuritic Pain Hospitalization 3/6/2010 32 Female 8/20/2010 Physician United Kingdom
Primary
Secondary
Concomitant
Interstitial Lung Disease Hospitalization 8/13/2010 57 Female 106 lb 8/25/2010 Physician Japan
Primary
Secondary
Concomitant
Pleuritic Pain Hospitalization 3/6/2010 32 Female 152 lb 9/2/2010 Physician United Kingdom
Primary
Secondary
Concomitant
Interstitial Lung Disease Hospitalization 8/8/2010 57 Female 108 lb 9/10/2010 Physician Japan
Primary
Secondary
Concomitant
Rectal Abscess Hospitalization 8/30/2010 51 Male 143 lb 9/13/2010 Physician Ukraine
Primary
Secondary
Concomitant
Sepsis Life Threatening 2/12/2010 56 Male 227 lb 9/24/2010 Physician Germany
Primary
Secondary
Concomitant
Pneumonia Hospitalization 9/8/2010 20 Male 10/8/2010 Physician Germany
Primary
Secondary
Concomitant
Lymphopenia Other Serious 6/18/2008 69 Male 182 lb 10/11/2010 Physician United States
Primary
Secondary
Concomitant
Malignant Melanoma Other Serious 9/27/2010 61 Female 163 lb 10/12/2010 Physician Australia
Primary
Secondary
Concomitant
Interstitial Lung Disease Hospitalization 8/8/2010 57 Female 108 lb 10/13/2010 Physician Japan
Primary
Secondary
Concomitant
Cellulitis Other Serious 9/2/2010 58 Female 168 lb 10/18/2010 Physician Japan
Primary
Secondary
Concomitant
Lymphopenia Other Serious 6/18/2008 69 Male 182 lb 10/19/2010 Physician United States
Primary
Concomitant
Interstitial Lung Disease Hospitalization 8/8/2010 57 Female 108 lb 10/21/2010 Physician Japan
Primary
Secondary
Concomitant
Intervertebral Discitis Other Serious 7/26/2010 69 Female 126 lb 10/25/2010 Physician Japan
Primary
Secondary
Concomitant
Rectal Abscess Hospitalization 8/30/2010 51 Male 143 lb 10/27/2010 Physician Ukraine
Primary
Secondary
Concomitant
Urinary Tract Infection Hospitalization 7/13/2010 67 Male 164 lb 10/29/2010 Physician United Kingdom
Primary
Concomitant
Vomiting Hospitalization 12/23/2008 67 Male 11/1/2010 United Kingdom
Primary
Secondary
Concomitant
Respiratory Tract Infection Life Threatening 4/8/2009 63 Male 11/1/2010
Primary
Secondary
Concomitant
Syncope Hospitalization 3/17/2009 78 Male 11/1/2010 Physician Germany
Primary
Secondary
Concomitant
Dyspnoea Hospitalization 1/6/2009 70 Male 11/1/2010 Physician Germany
Primary
Secondary
Concomitant
Rectal Haemorrhage Hospitalization 1/25/2009 77 Male 11/1/2010 Physician United Kingdom
Primary
Secondary
Concomitant
Hepatic Enzyme Increased Other Serious 1/8/2009 78 Male 173 lb 11/2/2010 Physician United Kingdom
Primary
Secondary
Concomitant
Pneumonia Life Threatening 9/1/2010 78 Male 194 lb 11/3/2010 Consumer United Kingdom
Primary
Secondary
Concomitant
Rectal Haemorrhage Hospitalization 4/1/2010 64 Male 11/5/2010 Physician France
Primary
Secondary
Herpes Zoster Hospitalization 11/29/2008 69 Male 11/5/2010 Physician Germany
Primary
Secondary
Concomitant
Bone Pain Hospitalization 9/12/2008 67 Male 11/5/2010 Physician United Kingdom
Primary
Secondary
Concomitant
Venous Pressure Jugular Increased Hospitalization 12/15/2008 65 Male 11/5/2010 Physician Ireland
Primary
Secondary
Concomitant
Pneumonia Hospitalization 9/8/2010 19 Male 11/5/2010 Physician Germany
Primary
Secondary
Concomitant
Pneumonia Hospitalization 9/8/2010 19 Male 11/8/2010 Physician Germany
Primary
Secondary
Concomitant
Hypoxia Other Serious 9/28/2010 66 Male 150 lb 11/10/2010 Other Health Professional Korea, Republic Of
Primary
Secondary
Concomitant
Pneumonia Life Threatening 9/28/2010 78 Male 194 lb 11/10/2010 Consumer United Kingdom
Primary
Secondary
Concomitant
Rectal Abscess Hospitalization 8/30/2010 51 Male 143 lb 11/11/2010 Physician Ukraine
Primary
Secondary
Concomitant

Drug Data