Blinded Placebo combined with Prednisone

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Urticaria Other Serious 9/6/2006 Female 242 lb 7/2/2007 Physician United States
Primary
Secondary
Concomitant
Febrile Neutropenia Hospitalization Female 123 lb 9/20/2007 Consumer United Kingdom
Primary
Secondary
Pneumonia Hospitalization 8/19/2007 Female 123 lb 10/15/2007 Consumer United Kingdom
Primary
Secondary
Febrile Neutropenia Hospitalization 10/26/2007 Male 201 lb 11/16/2007 Consumer United Kingdom
Primary
Secondary
Concomitant
Febrile Neutropenia Hospitalization 10/26/2007 Male 201 lb 11/29/2007 Consumer United Kingdom
Primary
Secondary
Concomitant
Mouth Ulceration Hospitalization 11/22/2007 Male 169 lb 12/10/2007 Consumer United Kingdom
Primary
Secondary
Febrile Neutropenia Hospitalization 10/26/2007 Male 174 lb 12/12/2007 Consumer United Kingdom
Primary
Secondary
Concomitant
Febrile Neutropenia Hospitalization 11/22/2007 Male 169 lb 12/18/2007 Consumer United Kingdom
Primary
Secondary
Electrocardiogram Abnormal Other Serious Female 12/27/2007 Physician United States
Primary
Secondary
Concomitant
Febrile Neutropenia Hospitalization 10/26/2007 Male 174 lb 1/9/2008 Consumer United Kingdom
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
Febrile Neutropenia Hospitalization 10/26/2007 Male 174 lb 4/4/2008 Consumer United Kingdom
Primary
Secondary
Concomitant
Fungal Oesophagitis Hospitalization 2/22/2008 Female 126 lb 4/7/2008 Physician United Kingdom
Primary
Secondary
Mucosal Inflammation Hospitalization 11/8/2007 Female 120 lb 4/11/2008 Consumer United Kingdom
Primary
Secondary
Concomitant
Febrile Neutropenia Hospitalization 12/21/2007 Female 265 lb 4/11/2008 Consumer United Kingdom
Primary
Secondary
Concomitant
Pneumonia Hospitalization 8/19/2007 Female 122 lb 4/14/2008 Consumer United Kingdom
Primary
Secondary
Febrile Neutropenia Life Threatening 3/15/2008 Female 132 lb 4/16/2008 Consumer United Kingdom
Primary
Secondary
Concomitant
Head Injury Hospitalization 3/13/2008 Female 104 lb 4/16/2008 Physician 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
White Blood Cell Count Decreased Hospitalization 4/24/2008 Female 122 lb 5/9/2008 Consumer United Kingdom
Primary
Secondary
Concomitant
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
Dehydration Hospitalization 4/25/2008 Female 110 lb 5/19/2008 Physician United Kingdom
Primary
Secondary
Concomitant
Dehydration Hospitalization 4/25/2008 Female 110 lb 5/23/2008 Physician United Kingdom
Primary
Secondary
Febrile Neutropenia Life Threatening 4/17/2008 Female 143 lb 5/27/2008 Consumer United Kingdom
Primary
Secondary
Dehydration Hospitalization 4/25/2008 Female 110 lb 6/27/2008 Physician 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 7/2/2008 Male 7/15/2008 Consumer United Kingdom
Primary
Secondary
Febrile Neutropenia Hospitalization 3/13/2008 Male 146 lb 7/16/2008 Consumer United Kingdom
Primary
Secondary
Thrombocytopenia Hospitalization 7/4/2008 Male 7/18/2008 Consumer United Kingdom
Primary
Secondary
Concomitant
Septic Shock Life Threatening 3/15/2008 Female 132 lb 7/18/2008 Consumer United Kingdom
Primary
Secondary
Concomitant
Febrile Neutropenia Hospitalization 7/12/2008 Female 7/29/2008 Consumer United Kingdom
Primary
Secondary
Concomitant
Febrile Neutropenia Hospitalization 6/19/2008 Male 7/30/2008 Physician Austria
Primary
Secondary
Febrile Neutropenia Hospitalization 7/2/2008 Male 8/1/2008 Consumer United Kingdom
Primary
Secondary
Febrile Neutropenia Hospitalization 8/18/2008 Male 9/4/2008 Physician United Kingdom
Primary
Secondary
Syncope Hospitalization 7/28/2008 Female 9/19/2008 Consumer United Kingdom
Primary
Secondary
Febrile Neutropenia Hospitalization 7/12/2008 Female 9/23/2008 Consumer Spain
Primary
Secondary
Concomitant
Respiratory Syncytial Virus Infection Hospitalization 8/2/2008 Male 9/24/2008 Consumer United Kingdom
Primary
Secondary
Concomitant
Febrile Neutropenia Hospitalization 9/14/2008 Male 9/25/2008 Physician United Kingdom
Primary
Secondary
White Blood Cell Count Decreased Hospitalization 8/18/2008 Male 9/25/2008 Consumer United Kingdom
Primary
Secondary
Pyrexia Hospitalization 7/2/2008 Female 9/30/2008 Consumer United Kingdom
Primary
Secondary
Febrile Neutropenia Hospitalization 9/25/2008 Female 10/10/2008 Consumer United Kingdom
Primary
Secondary
Concomitant
Stomatitis Hospitalization 9/14/2008 Female 10/17/2008 Consumer United Kingdom
Primary
Secondary
Concomitant
Febrile Neutropenia Hospitalization 9/14/2008 Male 10/17/2008 Physician United Kingdom
Primary
Secondary
Febrile Neutropenia Hospitalization 7/12/2008 Female 10/23/2008 Consumer Spain
Primary
Secondary
Concomitant
Febrile Neutropenia Hospitalization 9/25/2008 Female 10/24/2008 Consumer United Kingdom
Primary
Secondary
Concomitant
Febrile Neutropenia Hospitalization 10/11/2008 Male 10/30/2008 Consumer United Kingdom
Primary
Secondary
Sleep Apnoea Syndrome Death 9/13/2008 68 Male 221 lb 10/31/2008 Physician United States
Primary
Secondary
Concomitant
Thrombosis Hospitalization 9/3/2008 Male 10/31/2008 Consumer United Kingdom
Primary
Secondary
Febrile Neutropenia Hospitalization 8/18/2008 Male 11/3/2008 Consumer United Kingdom
Primary
Secondary
Febrile Neutropenia Hospitalization 10/29/2008 Female 12/22/2008 Consumer United Kingdom
Primary
Secondary
Concomitant
Pneumonia Other Serious 11/6/2008 Female 12/29/2008 Physician United Kingdom
Primary
Secondary
Pneumocystis Jiroveci Infection Hospitalization 9/17/2008 Female 12/29/2008 Physician Spain
Primary
Secondary
Concomitant
Respiratory Failure Hospitalization 7/12/2008 Female 12/29/2008 Consumer Spain
Primary
Secondary
Concomitant
Mucosal Inflammation Hospitalization 9/9/2008 Female 12/29/2008 Physician Spain
Primary
Secondary
Concomitant
Febrile Neutropenia Hospitalization 12/24/2008 Female 1/7/2009 Consumer United Kingdom
Primary
Secondary
Febrile Neutropenia Hospitalization 12/24/2008 Female 1/16/2009 Consumer United Kingdom
Primary
Secondary
Tricuspid Valve Incompetence Life Threatening 9/17/2008 Female 139 lb 1/20/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Febrile Neutropenia Hospitalization 12/26/2008 Female 1/22/2009 Physician United Kingdom
Primary
Secondary
Concomitant
Febrile Neutropenia Hospitalization 12/24/2008 Female 1/23/2009 Consumer United Kingdom
Primary
Secondary
Febrile Neutropenia Hospitalization 9/14/2008 Male 1/23/2009 Consumer United Kingdom
Primary
Secondary
Febrile Neutropenia Hospitalization 1/17/2009 Female 1/29/2009 Consumer United Kingdom
Primary
Secondary
Concomitant
Pneumocystis Jiroveci Pneumonia Hospitalization 9/9/2008 Female 1/30/2009 Physician Spain
Primary
Secondary
Concomitant
Febrile Neutropenia Life Threatening 12/28/2008 Male 2/2/2009 Consumer United Kingdom
Primary
Secondary
Concomitant
Rectal Ulcer Hospitalization 10/20/2008 Female 2/6/2009 Consumer United Kingdom
Primary
Secondary
Concomitant
Febrile Neutropenia Hospitalization 10/29/2008 Female 2/6/2009 Consumer United Kingdom
Primary
Secondary
Concomitant
Pneumonia Hospitalization 11/9/2008 Female 2/6/2009 Consumer United Kingdom
Primary
Secondary
Concomitant
Blood Sodium Decreased Hospitalization 1/21/2009 Female 2/6/2009 Physician United Kingdom
Primary
Secondary
Concomitant
Pneumonia Hospitalization 11/9/2008 Female 2/13/2009 Consumer United Kingdom
Primary
Secondary
Concomitant
Haematoma Life Threatening 1/22/2009 Female 2/13/2009 Consumer United Kingdom
Primary
Secondary
Concomitant
Febrile Neutropenia Hospitalization 12/26/2008 Female 2/26/2009 Physician United Kingdom
Primary
Secondary
Concomitant
Febrile Neutropenia Life Threatening 2/12/2009 Female 2/27/2009 Consumer United Kingdom
Primary
Secondary
Concomitant
Febrile Neutropenia Hospitalization 10/29/2008 Female 3/3/2009 Consumer United Kingdom
Primary
Secondary
Concomitant
Rectal Ulcer Hospitalization 10/20/2008 Female 3/3/2009 Consumer United Kingdom
Primary
Secondary
Concomitant
Pulmonary Embolism Death 2/13/2009 Female 3/4/2009 Physician United Kingdom
Primary
Secondary
Concomitant
Pulmonary Embolism Death 2/13/2009 Female 3/12/2009 Physician United Kingdom
Primary
Secondary
Concomitant
Febrile Neutropenia Hospitalization 2/19/2009 Male 3/12/2009 Physician United Kingdom
Primary
Secondary
Concomitant
Breast Cancer Life Threatening 1/26/2009 Female 3/19/2009 Consumer United Kingdom
Primary
Secondary
Concomitant
Febrile Neutropenia Hospitalization 10/29/2008 Female 3/20/2009 Consumer United Kingdom
Primary
Secondary
Concomitant
Rectal Ulcer Hospitalization 10/20/2008 Female 3/20/2009 Consumer United Kingdom
Primary
Secondary
Concomitant
Febrile Neutropenia Hospitalization 2/19/2009 Male 3/24/2009 Physician United Kingdom
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Life Threatening 3/7/2009 Male 3/25/2009 Consumer United Kingdom
Primary
Secondary
Breast Cancer Life Threatening 1/26/2009 Female 3/26/2009 Consumer United Kingdom
Primary
Secondary
Concomitant
Pyrexia Hospitalization 2/2/2009 Female 3/26/2009 Physician United Kingdom
Primary
Secondary
Concomitant
Pneumonia Hospitalization 11/9/2008 Female 3/27/2009 Consumer United Kingdom
Primary
Secondary
Concomitant
Lymphopenia Other Serious 3/1/2009 Female 3/27/2009 Consumer United Kingdom
Primary
Secondary
Concomitant
Vertigo Hospitalization 3/13/2009 53 Female 170 lb 3/31/2009 Physician United States
Primary
Secondary
Concomitant
Pulmonary Embolism Other Serious 5/21/2008 Female 122 lb 4/3/2009 Consumer United Kingdom
Primary
Secondary
Concomitant
Febrile Neutropenia Hospitalization 10/29/2008 Female 4/15/2009 Consumer United Kingdom
Primary
Secondary
Concomitant
Lymphopenia Other Serious 3/1/2009 Female 4/17/2009 Consumer United Kingdom
Primary
Secondary
Concomitant
Sepsis Life Threatening 3/7/2009 Male 4/17/2009 Consumer United Kingdom
Primary
Secondary
Respiratory Disorder Hospitalization 3/13/2009 Male 4/20/2009 Physician United Kingdom
Primary
Secondary
Concomitant
Febrile Neutropenia Hospitalization 11/12/2008 Female 4/22/2009 Consumer United Kingdom
Primary
Secondary
Concomitant
Multi-organ Failure Hospitalization 4/4/2009 Female 4/29/2009 Consumer United Kingdom
Primary
Secondary
Concomitant
Vertigo Hospitalization 3/13/2009 Female 170 lb 4/30/2009 Physician United States
Primary
Secondary
Concomitant
Arrhythmia Death 3/28/2009 Male 248 lb 5/5/2009 Physician United States
Primary
Secondary
Concomitant
Febrile Neutropenia Life Threatening 12/28/2008 Male 5/6/2009 Consumer United Kingdom
Primary
Secondary
Concomitant
Febrile Neutropenia Life Threatening 2/12/2009 Female 5/6/2009 Consumer United Kingdom
Primary
Secondary
Concomitant
Febrile Neutropenia Hospitalization 3/21/2009 Female 5/8/2009 Physician United Kingdom
Primary
Secondary
Respiratory Disorder Hospitalization 3/13/2009 Male 5/15/2009 Physician United Kingdom
Primary
Secondary
Concomitant
Mucosal Inflammation Hospitalization 4/30/2009 Female 5/21/2009 Consumer United Kingdom
Primary
Secondary
Viral Infection Hospitalization 2/22/2009 Male 5/21/2009 Physician United Kingdom
Primary
Secondary
Concomitant
Platelet Count Decreased Hospitalization 3/13/2009 Male 5/22/2009 Physician United Kingdom
Primary
Secondary
Concomitant
Blood Sodium Decreased Hospitalization 1/21/2009 Female 6/4/2009 Physician United Kingdom
Primary
Secondary
Concomitant
Rectal Ulcer Hospitalization 10/20/2008 Female 6/4/2009 Consumer United Kingdom
Primary
Secondary
Concomitant
Febrile Neutropenia Hospitalization 10/29/2008 Female 6/4/2009 Consumer United Kingdom
Primary
Secondary
Concomitant
Visual Impairment Hospitalization 5/21/2009 Male 6/9/2009 Physician United Kingdom
Primary
Secondary
Concomitant
Sepsis Hospitalization 5/29/2009 Male 6/17/2009 Consumer United Kingdom
Primary
Secondary
Concomitant
Dehydration Hospitalization 5/20/2009 Male 6/18/2009 Consumer United Kingdom
Primary
Secondary
Concomitant
Febrile Neutropenia Hospitalization 6/4/2009 Female 6/19/2009 Consumer United Kingdom
Primary
Secondary
Blood Sodium Decreased Hospitalization 1/21/2009 Female 6/24/2009 Physician United Kingdom
Primary
Secondary
Concomitant
Rectal Ulcer Hospitalization 10/20/2008 Female 6/24/2009 Consumer United Kingdom
Primary
Secondary
Concomitant
Febrile Neutropenia Hospitalization 10/29/2008 Female 6/24/2009 Consumer United Kingdom
Primary
Secondary
Concomitant
Febrile Neutropenia Hospitalization 8/18/2008 Male 6/25/2009 Consumer United Kingdom
Primary
Secondary
Pyrexia Hospitalization 6/15/2009 Female 7/1/2009 Consumer United Kingdom
Primary
Secondary
Concomitant
Febrile Neutropenia Hospitalization 6/1/2009 Female 7/8/2009 Consumer United Kingdom
Primary
Secondary
Atrioventricular Block Complete Hospitalization 7/15/2006 Male 7/9/2009 Physician United States
Primary
Secondary
Febrile Neutropenia Hospitalization 6/1/2009 Female 7/14/2009 Consumer United Kingdom
Primary
Secondary
Febrile Neutropenia Hospitalization 7/8/2009 Female 7/29/2009 Consumer United Kingdom
Primary
Secondary
Concomitant
Acute Respiratory Distress Syndrome Hospitalization 6/22/2009 Female 8/5/2009 Consumer United Kingdom
Primary
Secondary
Febrile Neutropenia Hospitalization 7/8/2009 Female 8/5/2009 Consumer United Kingdom
Primary
Secondary
Concomitant
Lung Disorder Disability 7/17/2009 Male 8/6/2009 Consumer United Kingdom
Primary
Secondary
Febrile Neutropenia Hospitalization 7/10/2009 Female 8/7/2009 Physician United Kingdom
Primary
Secondary
Concomitant
Febrile Neutropenia Hospitalization 7/20/2009 Female 8/11/2009 Physician United Kingdom
Primary
Secondary
Concomitant
Neutropenic Sepsis Hospitalization 5/29/2009 Male 8/11/2009 Consumer United Kingdom
Primary
Secondary
Concomitant
Panic Attack Other Serious Male 8/11/2009 Other Health Professional Germany
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Hospitalization 7/10/2009 Female 8/12/2009 Physician United Kingdom
Primary
Secondary
Concomitant
Osteomyelitis Hospitalization 7/10/2009 Female 8/17/2009 Physician United States
Primary
Secondary
Concomitant
Febrile Neutropenia Hospitalization 7/27/2009 Male 8/18/2009 Physician United Kingdom
Primary
Secondary
Respiratory Failure Life Threatening 8/3/2009 Male 8/18/2009 Consumer United Kingdom
Primary
Secondary
Concomitant
Febrile Neutropenia Hospitalization 7/8/2009 Female 8/19/2009 Consumer United Kingdom
Primary
Secondary
Concomitant
Febrile Neutropenia Hospitalization 7/8/2009 Female 8/20/2009 Consumer United Kingdom
Primary
Secondary
Concomitant
Respiratory Failure Life Threatening 8/3/2009 Male 8/20/2009 Consumer United Kingdom
Primary
Secondary
Concomitant
Rectal Ulcer Hospitalization 10/20/2008 Female 8/21/2009 Consumer United Kingdom
Primary
Secondary
Concomitant
Oral Candidiasis Hospitalization 6/1/2009 Female 8/21/2009 Consumer United Kingdom
Primary
Secondary
Febrile Neutropenia Hospitalization 10/29/2008 Female 8/24/2009 Consumer United Kingdom
Primary
Secondary
Concomitant
Pyrexia Hospitalization 6/15/2009 Female 8/26/2009 Consumer United Kingdom
Primary
Secondary
Concomitant

Drug Data