Blinded Placebo combined with Prednisolone

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Mouth Ulceration Hospitalization 11/22/2007 Male 169 lb 12/10/2007 Consumer United Kingdom
Primary
Secondary
Febrile Neutropenia Hospitalization 11/22/2007 Male 169 lb 12/18/2007 Consumer United Kingdom
Primary
Secondary
Polyomavirus-associated Nephropathy Hospitalization 3/27/2007 Male 184 lb 12/21/2007 Consumer Sweden
Primary
Secondary
Concomitant
Polyomavirus-associated Nephropathy Hospitalization 5/15/2007 Male 192 lb 12/21/2007 Consumer Sweden
Primary
Secondary
Concomitant
Febrile Neutropenia Life Threatening 11/1/2007 Male 146 lb 2/15/2008 Consumer United Kingdom
Primary
Secondary
Concomitant
Febrile Neutropenia Hospitalization 2/11/2008 Female 2/29/2008 Consumer United Kingdom
Primary
Secondary
Concomitant
Acute Pulmonary Oedema Death 2/3/2008 Female 149 lb 3/4/2008 Consumer United Kingdom
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Hospitalization 3/13/2008 Male 146 lb 3/25/2008 Consumer United Kingdom
Primary
Secondary
White Blood Cell Count Decreased Hospitalization 11/8/2007 Female 120 lb 3/25/2008 Consumer United Kingdom
Primary
Secondary
Concomitant
Mucosal Inflammation Hospitalization 11/28/2007 Female 120 lb 3/25/2008 Consumer United Kingdom
Primary
Secondary
Concomitant
Febrile Neutropenia Life Threatening 3/15/2008 Female 132 lb 3/28/2008 Consumer United Kingdom
Primary
Secondary
Concomitant
Mucosal Inflammation Hospitalization 11/8/2007 Female 120 lb 4/11/2008 Consumer United Kingdom
Primary
Secondary
Concomitant
Febrile Neutropenia Hospitalization 11/28/2007 Female 120 lb 4/11/2008 Consumer United Kingdom
Primary
Secondary
Concomitant
Febrile Neutropenia Life Threatening 3/15/2008 Female 132 lb 4/16/2008 Consumer United Kingdom
Primary
Secondary
Concomitant
Stomatitis Hospitalization 11/8/2007 Female 120 lb 4/25/2008 Consumer United Kingdom
Primary
Secondary
Concomitant
Febrile Neutropenia Life Threatening 11/1/2007 Male 146 lb 4/29/2008 Consumer United Kingdom
Primary
Secondary
Concomitant
Deep Vein Thrombosis Other Serious 4/10/2008 Male 268 lb 5/2/2008 Consumer United Kingdom
Primary
Secondary
Concomitant
Febrile Neutropenia Life Threatening 4/17/2008 Female 143 lb 5/2/2008 Consumer United Kingdom
Primary
Secondary
Septic Shock Life Threatening 3/15/2008 Female 132 lb 5/12/2008 Consumer United Kingdom
Primary
Secondary
Concomitant
Deep Vein Thrombosis Other Serious 4/4/2008 Male 268 lb 5/12/2008 Consumer United Kingdom
Primary
Secondary
Concomitant
Acute Pulmonary Oedema Death 2/3/2008 Female 149 lb 5/12/2008 Consumer United Kingdom
Primary
Secondary
Concomitant
Febrile Neutropenia Life Threatening 4/17/2008 Female 143 lb 5/27/2008 Consumer United Kingdom
Primary
Secondary
Appendicitis Other Serious 5/28/2008 Physician United Kingdom
Primary
Secondary
Palpitations Other Serious 5/28/2008 Physician United Kingdom
Primary
Secondary
Febrile Neutropenia Hospitalization 3/13/2008 Male 146 lb 5/30/2008 Consumer United Kingdom
Primary
Secondary
Febrile Neutropenia Hospitalization 3/13/2008 Male 146 lb 6/18/2008 Consumer United Kingdom
Primary
Secondary
Acute Pulmonary Oedema Hospitalization 2/3/2008 Female 149 lb 6/24/2008 Consumer United Kingdom
Primary
Secondary
Concomitant
Febrile Neutropenia Hospitalization 11/8/2007 Female 120 lb 7/2/2008 Consumer United Kingdom
Primary
Secondary
Concomitant
Ascites Hospitalization 5/30/2008 Male 7/7/2008 Consumer United Kingdom
Primary
Secondary
Concomitant
Deep Vein Thrombosis Other Serious 4/4/2008 Male 268 lb 7/9/2008 Consumer United Kingdom
Primary
Secondary
Concomitant
Pulmonary Embolism Other Serious 5/21/2008 Female 122 lb 7/10/2008 Consumer United Kingdom
Primary
Secondary
Concomitant
Febrile Neutropenia Hospitalization 3/13/2008 Male 146 lb 7/16/2008 Consumer United Kingdom
Primary
Secondary
Septic Shock Life Threatening 3/15/2008 Female 132 lb 7/18/2008 Consumer United Kingdom
Primary
Secondary
Concomitant
Ascites Hospitalization 5/30/2008 Male 7/30/2008 Consumer United Kingdom
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Hospitalization 2/11/2008 Female 8/6/2008 Consumer United Kingdom
Primary
Secondary
Concomitant
Acute Pulmonary Oedema Hospitalization 2/3/2008 Female 149 lb 8/14/2008 Consumer United Kingdom
Primary
Secondary
Concomitant
Septic Shock Life Threatening 3/15/2008 Female 132 lb 8/14/2008 Consumer United Kingdom
Primary
Secondary
Concomitant
Febrile Neutropenia Hospitalization 11/28/2007 Female 120 lb 8/15/2008 Consumer United Kingdom
Primary
Secondary
Concomitant
Ascites Hospitalization 5/30/2008 Male 8/26/2008 Consumer United Kingdom
Primary
Secondary
Concomitant
Gastric Perforation Life Threatening 7/19/2008 Male 9/4/2008 Physician United Kingdom
Primary
Secondary
Concomitant
Febrile Neutropenia Hospitalization 9/25/2008 Female 10/24/2008 Consumer United Kingdom
Primary
Secondary
Concomitant
Cerebrovascular Accident Hospitalization 10/21/2008 Female 11/25/2008 Physician United Kingdom
Primary
Secondary
Concomitant
Febrile Neutropenia Hospitalization 9/25/2008 Female 11/26/2008 Consumer United Kingdom
Primary
Secondary
Concomitant
Febrile Neutropenia Hospitalization 11/12/2008 Female 11/26/2008 Consumer United Kingdom
Primary
Secondary
Concomitant
Serum Sickness Other Serious 12/2/2008 Consumer United Kingdom
Primary
Secondary
Ascites Hospitalization 5/30/2008 Male 12/2/2008 Consumer United Kingdom
Primary
Secondary
Concomitant
Gastric Perforation Life Threatening 7/19/2008 Male 12/2/2008 Physician United Kingdom
Primary
Secondary
Concomitant
Melaena Other Serious 11/16/2008 Female 12/3/2008 Physician United Kingdom
Primary
Secondary
Febrile Neutropenia Hospitalization 11/20/2008 Male 12/8/2008 Consumer United Kingdom
Primary
Secondary
Concomitant
Proteinuria Other Serious 11/4/2008 12/12/2008 Physician United Kingdom
Primary
Secondary
Concomitant
Fall Hospitalization 11/26/2008 Female 12/17/2008 Consumer United Kingdom
Primary
Secondary
Concomitant
Melaena Other Serious 11/16/2008 Female 12/29/2008 Physician United Kingdom
Primary
Secondary
Gastric Perforation Life Threatening 7/19/2008 Male 12/30/2008 Physician United Kingdom
Primary
Secondary
Concomitant
Febrile Neutropenia Hospitalization 12/15/2008 Male 12/31/2008 Consumer United Kingdom
Primary
Secondary
Ascites Hospitalization 5/30/2008 Male 12/31/2008 Consumer United Kingdom
Primary
Secondary
Concomitant
Deep Vein Thrombosis Other Serious 4/4/2008 Male 268 lb 1/6/2009 Consumer United Kingdom
Primary
Secondary
Concomitant
Lethargy Hospitalization 10/21/2008 Female 1/14/2009 Physician United Kingdom
Primary
Secondary
Concomitant
Febrile Neutropenia Hospitalization 1/17/2009 Female 1/29/2009 Consumer United Kingdom
Primary
Secondary
Concomitant
Pneumonia Hospitalization 11/26/2008 Female 2/27/2009 Consumer United Kingdom
Primary
Secondary
Concomitant
Febrile Neutropenia Life Threatening 12/15/2008 Male 2/28/2009 Consumer United Kingdom
Primary
Secondary
Concomitant
Aspartate Aminotransferase Increased Hospitalization 2/18/2009 Male 3/6/2009 Consumer United Kingdom
Primary
Secondary
Concomitant
Angina Pectoris Hospitalization 1/27/2009 Female 3/6/2009 Consumer United Kingdom
Primary
Secondary
Concomitant
Aspartate Aminotransferase Increased Hospitalization 2/18/2009 Male 3/6/2009 Consumer United Kingdom
Primary
Secondary
Concomitant
Cardiac Failure Hospitalization 2/10/2009 Male 3/6/2009 Consumer United Kingdom
Primary
Secondary
Concomitant
Febrile Neutropenia Hospitalization 1/17/2009 Female 3/6/2009 Consumer United Kingdom
Primary
Secondary
Concomitant
Febrile Neutropenia Hospitalization 1/17/2009 Female 3/17/2009 Consumer United Kingdom
Primary
Secondary
Concomitant
Aspartate Aminotransferase Increased Hospitalization 2/18/2009 Male 3/17/2009 Consumer United Kingdom
Primary
Secondary
Concomitant
Febrile Neutropenia Hospitalization 2/18/2009 Male 4/1/2009 Consumer United Kingdom
Primary
Secondary
Concomitant
Febrile Neutropenia Hospitalization 1/17/2009 Female 4/17/2009 Consumer United Kingdom
Primary
Secondary
Concomitant
Febrile Neutropenia Hospitalization 11/12/2008 Female 4/22/2009 Consumer United Kingdom
Primary
Secondary
Concomitant
Febrile Neutropenia Hospitalization 1/17/2009 Female 4/23/2009 Consumer Korea, Democratic People's Republic Of
Primary
Secondary
Concomitant
Mucosal Inflammation Hospitalization 4/19/2009 Female 5/14/2009 Physician United Kingdom
Primary
Secondary
Pulmonary Embolism Hospitalization 4/27/2009 Male 5/19/2009 Physician United Kingdom
Primary
Secondary
Concomitant
Febrile Neutropenia Hospitalization 1/17/2009 Female 5/19/2009 Consumer Korea, Republic Of
Primary
Secondary
Concomitant
Stomatitis Hospitalization 5/4/2009 Female 5/20/2009 Consumer United Kingdom
Primary
Secondary
Concomitant
Cardiac Failure Acute Hospitalization 2/10/2009 Male 5/26/2009 Consumer United Kingdom
Primary
Secondary
Concomitant
Gastrointestinal Obstruction Life Threatening 5/11/2009 Male 5/27/2009 Consumer United Kingdom
Primary
Secondary
Concomitant
Ascites Hospitalization 5/30/2008 Male 6/2/2009 Consumer United Kingdom
Primary
Secondary
Concomitant
Gastric Perforation Life Threatening 7/19/2008 Male 6/2/2009 Physician United Kingdom
Primary
Secondary
Concomitant
Splenomegaly Other Serious 4/4/2008 Male 268 lb 6/2/2009 Consumer United Kingdom
Primary
Secondary
Concomitant
Febrile Neutropenia Hospitalization 1/17/2009 Female 6/5/2009 Consumer Korea, Republic Of
Primary
Secondary
Concomitant
Febrile Neutropenia Hospitalization 5/29/2009 Female 6/9/2009 Consumer United Kingdom
Primary
Secondary
Febrile Neutropenia Hospitalization 1/17/2009 Female 6/10/2009 Consumer Korea, Republic Of
Primary
Secondary
Concomitant
Hypertensive Crisis Life Threatening 5/7/2009 Female 6/12/2009 Physician United Kingdom
Primary
Secondary
Amnesia Other Serious 3/23/2009 Female 7/1/2009 Physician United Kingdom
Primary
Secondary
Concomitant
Mucosal Inflammation Hospitalization 4/19/2009 Female 7/7/2009 Physician Czech Republic
Primary
Secondary
Concomitant
Amnesia Other Serious 3/23/2009 Female 7/10/2009 Physician United Kingdom
Primary
Secondary
Concomitant
Febrile Neutropenia Hospitalization 7/1/2009 Male 7/15/2009 Physician United Kingdom
Primary
Secondary
Concomitant
Febrile Neutropenia Hospitalization 6/25/2009 Female 7/22/2009 Consumer United Kingdom
Primary
Secondary
Concomitant
Stomatitis Hospitalization 5/4/2009 Female 7/23/2009 Consumer United Kingdom
Primary
Secondary
Concomitant
Small Intestinal Obstruction Life Threatening 5/11/2009 Male 7/24/2009 Consumer United Kingdom
Primary
Secondary
Concomitant
Small Intestinal Obstruction Hospitalization 5/11/2009 Male 7/31/2009 Consumer United Kingdom
Primary
Secondary
Concomitant
Pyrexia Other Serious 4/14/2009 Female 154 lb 8/6/2009 Consumer United Kingdom
Primary
Secondary
Concomitant
Febrile Neutropenia Hospitalization 8/6/2009 Female 8/20/2009 Consumer United Kingdom
Primary
Secondary
Concomitant
Lymphopenia Hospitalization 6/25/2009 Female 8/27/2009 Consumer United Kingdom
Primary
Secondary
Concomitant
Thrombocytopenia Other Serious 8/6/2009 Female 8/31/2009 Consumer United Kingdom
Primary
Secondary
Concomitant
Rash Hospitalization 1/27/2009 Female 9/17/2009 Consumer United Kingdom
Primary
Secondary
Concomitant
Stomatitis Hospitalization 5/6/2009 Female 9/18/2009 Consumer United Kingdom
Primary
Secondary
Concomitant
Thrombocytopenia Other Serious 8/6/2009 Female 9/24/2009 Consumer United Kingdom
Primary
Secondary
Concomitant
Febrile Neutropenia Hospitalization 7/1/2009 Male 9/29/2009 Consumer United Kingdom
Primary
Secondary
Concomitant
Febrile Neutropenia Hospitalization 1/17/2009 Female 9/29/2009 Consumer Korea, Republic Of
Primary
Secondary
Concomitant
Neutropenia Hospitalization 6/25/2009 Female 10/7/2009 Consumer United Kingdom
Primary
Secondary
Concomitant
Pyrexia Hospitalization 7/10/2009 Male 143 lb 10/14/2009 Physician United Kingdom
Primary
Secondary
Concomitant
Abscess Hospitalization 9/23/2009 Male 10/15/2009 Physician United Kingdom
Primary
Secondary
Rash Hospitalization 1/27/2009 Female 10/27/2009 Consumer United Kingdom
Primary
Secondary
Concomitant
Thrombocytopenia Other Serious 8/6/2009 Female 10/28/2009 Consumer United Kingdom
Primary
Secondary
Concomitant
Febrile Neutropenia Hospitalization 7/1/2009 Male 11/6/2009 Consumer United Kingdom
Primary
Secondary
Concomitant
Febrile Neutropenia Hospitalization 10/17/2009 Female 11/6/2009 Consumer United Kingdom
Primary
Secondary
Abscess Hospitalization 9/23/2009 Male 11/6/2009 Physician United Kingdom
Primary
Secondary
Splenomegaly Other Serious 4/4/2008 Male 268 lb 11/10/2009 Consumer United Kingdom
Primary
Secondary
Concomitant
Ascites Hospitalization 5/30/2008 Male 11/12/2009 Consumer United Kingdom
Primary
Secondary
Concomitant
Gastric Perforation Life Threatening 7/19/2008 Male 11/12/2009 Consumer United Kingdom
Primary
Secondary
Concomitant
Ascites Hospitalization 5/30/2008 Male 11/12/2009 Physician United Kingdom
Primary
Secondary
Concomitant
Neutropenia Hospitalization 6/25/2009 Female 11/12/2009 Consumer United Kingdom
Primary
Secondary
Concomitant
Thrombocytopenia Other Serious 8/6/2009 Female 11/13/2009 Consumer United Kingdom
Primary
Secondary
Concomitant
Pancytopenia Life Threatening 8/7/2009 Female 103 lb 11/13/2009 Physician United Kingdom
Primary
Secondary
Concomitant
Pancytopenia Life Threatening 8/7/2009 Female 103 lb 11/13/2009 Physician United Kingdom
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Hospitalization 7/10/2009 Male 143 lb 11/18/2009 Physician United Kingdom
Primary
Secondary
Concomitant
Pancytopenia Life Threatening 8/7/2009 Female 103 lb 11/20/2009 Physician United Kingdom
Primary
Secondary
Concomitant
Pulmonary Embolism Hospitalization 4/27/2009 Male 11/20/2009 Physician United Kingdom
Primary
Secondary
Concomitant
Aplasia Hospitalization 11/6/2009 Female 132 lb 11/25/2009 Consumer United Kingdom
Primary
Secondary
Concomitant
Febrile Neutropenia Hospitalization 10/17/2009 Female 12/2/2009 Consumer United Kingdom
Primary
Secondary
Cardiovascular Disorder Death 11/23/2009 Female 168 lb 12/11/2009 Physician United Kingdom
Primary
Secondary
Febrile Neutropenia Hospitalization 10/17/2009 Female 119 lb 12/14/2009 Consumer United Kingdom
Primary
Secondary
Influenza Hospitalization 7/1/2009 Male 12/17/2009 Consumer United Kingdom
Primary
Secondary
Concomitant
Cardiac Disorder Death 12/15/2009 Male 185 lb 12/29/2009 Physician United Kingdom
Primary
Secondary
Febrile Neutropenia Life Threatening 12/15/2008 Male 12/31/2009 Consumer United Kingdom
Primary
Secondary
Concomitant
Febrile Neutropenia Hospitalization 12/11/2009 Female 182 lb 1/20/2010 Physician United Kingdom
Primary
Secondary
Febrile Neutropenia Life Threatening 12/15/2008 Male 123 lb 1/26/2010 Consumer United Kingdom
Primary
Secondary
Concomitant
Neutropenia Hospitalization 6/25/2009 Female 110 lb 2/11/2010 Consumer United Kingdom
Primary
Secondary
Concomitant
Subdural Haematoma Life Threatening 1/28/2010 Female 108 lb 2/11/2010 Consumer United Kingdom
Primary
Secondary
Concomitant
Subdural Haematoma Life Threatening 11/5/2009 Female 108 lb 2/18/2010 Consumer United Kingdom
Primary
Secondary
Concomitant
Neutropenia Hospitalization 1/22/2010 Male 243 lb 3/18/2010 Consumer United Kingdom
Primary
Secondary
Concomitant
Neutropenia Hospitalization 6/25/2009 68 Female 110 lb 4/20/2010 Consumer United Kingdom
Primary
Secondary
Concomitant
Influenza Hospitalization 7/1/2009 65 Male 136 lb 4/26/2010 Consumer United Kingdom
Primary
Secondary
Concomitant
Convulsion Other Serious 4/19/2010 74 Female 110 lb 4/28/2010 Physician United Kingdom
Primary
Secondary
Proteinuria Other Serious 11/4/2008 67 Female 146 lb 4/30/2010 Physician United Kingdom
Primary
Secondary
Concomitant
Pyrexia Hospitalization 1/15/2010 74 Female 110 lb 5/6/2010 Physician United Kingdom
Primary
Secondary
Convulsion Other Serious 4/19/2010 74 Female 110 lb 5/7/2010 Physician United Kingdom
Primary
Secondary
Investigation Other Serious 7/14/2009 53 Female 202 lb 5/13/2010 Consumer United Kingdom
Primary
Secondary
Concomitant
Investigation Other Serious 7/14/2009 53 Female 202 lb 5/20/2010 Consumer United Kingdom
Primary
Secondary
Concomitant
Septic Shock Hospitalization 3/15/2008 80 Female 132 lb 6/9/2010 Consumer United Kingdom
Primary
Secondary
Concomitant
Acute Myeloid Leukaemia Hospitalization 6/15/2010 59 Male 269 lb 7/15/2010 Consumer United Kingdom
Primary
Secondary
Concomitant
Acute Myeloid Leukaemia Hospitalization 6/15/2010 59 Male 269 lb 7/23/2010 Consumer United Kingdom
Primary
Secondary
Concomitant
Traumatic Lung Injury Hospitalization 6/30/2010 61 Male 155 lb 7/27/2010 Consumer United Kingdom
Primary
Secondary
Concomitant
Subdural Haematoma Disability 11/5/2009 53 Female 108 lb 7/27/2010 Consumer United Kingdom
Primary
Secondary
Concomitant
Acute Myeloid Leukaemia Hospitalization 6/15/2010 59 Male 269 lb 8/19/2010 Consumer United Kingdom
Primary
Secondary
Concomitant
Subdural Haematoma Disability 11/5/2009 53 Female 108 lb 8/20/2010 Consumer United Kingdom
Primary
Secondary
Concomitant
Traumatic Lung Injury Hospitalization 6/30/2010 61 Male 155 lb 9/17/2010 Consumer United Kingdom
Primary
Secondary
Concomitant
Traumatic Lung Injury Hospitalization 6/30/2010 61 Male 155 lb 10/15/2010 Consumer United Kingdom
Primary
Secondary
Concomitant

Drug Data