Blinded Placebo combined with Cyclophosphamide

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Chest Pain Hospitalization 5/12/2007 Female 5/17/2007 Physician United Kingdom
Primary
Secondary
Chest Pain Hospitalization 5/12/2007 Female 5/21/2007 Physician United Kingdom
Primary
Secondary
Chest Pain Hospitalization 5/12/2007 Female 5/24/2007 Physician United Kingdom
Primary
Secondary
Concomitant
Febrile Neutropenia Hospitalization Female 123 lb 9/20/2007 Consumer United Kingdom
Primary
Secondary
Osteonecrosis Other Serious 8/21/2007 Female 10/1/2007 Consumer Australia
Primary
Secondary
Concomitant
Left Ventricular Dysfunction Hospitalization 7/5/2007 Female 137 lb 10/12/2007 Physician Norway
Primary
Secondary
Pneumonia Hospitalization 8/19/2007 Female 123 lb 10/15/2007 Consumer United Kingdom
Primary
Secondary
Osteonecrosis Other Serious 8/21/2007 Female 10/24/2007 Consumer Australia
Primary
Secondary
Concomitant
Left Ventricular Dysfunction Hospitalization 7/5/2007 Female 137 lb 11/16/2007 Physician Norway
Primary
Secondary
Concomitant
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
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 11/28/2007 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
Febrile Neutropenia Hospitalization 3/13/2008 Male 146 lb 5/30/2008 Consumer United Kingdom
Primary
Secondary
Febrile Neutropenia Hospitalization 4/24/2008 Female 122 lb 6/3/2008 Consumer United Kingdom
Primary
Secondary
Concomitant
Pulmonary Embolism Other Serious 5/21/2008 Female 122 lb 6/6/2008 Consumer United Kingdom
Primary
Secondary
Concomitant
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
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
Ascites Hospitalization 5/30/2008 Male 7/30/2008 Consumer United Kingdom
Primary
Secondary
Concomitant
Febrile Neutropenia Hospitalization 7/2/2008 Male 8/1/2008 Consumer United Kingdom
Primary
Secondary
White Blood Cell Count Decreased Hospitalization 2/11/2008 Female 8/6/2008 Consumer United Kingdom
Primary
Secondary
Concomitant
Febrile Neutropenia Hospitalization 7/12/2008 Female 8/13/2008 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
Febrile Neutropenia Hospitalization 8/2/2008 Male 8/15/2008 Consumer United Kingdom
Primary
Secondary
Concomitant
Febrile Neutropenia Hospitalization 8/2/2008 Male 8/21/2008 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 8/18/2008 Male 9/4/2008 Physician United Kingdom
Primary
Secondary
Sinus Tachycardia Hospitalization 8/14/2008 Female 9/5/2008 Consumer United Kingdom
Primary
Secondary
Concomitant
Septic Shock Other Serious 8/25/2008 Female 9/11/2008 Physician United Kingdom
Primary
Secondary
General Physical Health Deterioration Hospitalization 8/4/2008 Male 9/11/2008 Physician United Kingdom
Primary
Secondary
Septic Shock Other Serious 8/25/2008 Female 9/15/2008 Physician United Kingdom
Primary
Secondary
Cavernous Sinus Thrombosis Hospitalization 8/25/2008 Male 9/15/2008 Consumer United Kingdom
Primary
Secondary
Febrile Neutropenia Hospitalization 10/26/2007 Male 174 lb 9/15/2008 Consumer United Kingdom
Primary
Secondary
Concomitant
General Physical Health Deterioration Hospitalization 8/4/2008 Male 9/17/2008 Physician United Kingdom
Primary
Secondary
Thrombosis Hospitalization 9/3/2008 Male 9/17/2008 Consumer United Kingdom
Primary
Secondary
Septic Shock Other Serious 8/25/2008 Female 9/18/2008 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
Pyrexia Hospitalization 6/1/2007 9/30/2008 Physician Singapore
Primary
Secondary
Septic Shock Death 9/19/2008 Male 10/7/2008 Physician United Kingdom
Primary
Secondary
Concomitant
Stomatitis Hospitalization 9/14/2008 Female 10/8/2008 Consumer United Kingdom
Primary
Secondary
Concomitant
Febrile Neutropenia Hospitalization 9/14/2008 Male 10/9/2008 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 Bone Marrow Aplasia Hospitalization 3/15/2008 Female 108 lb 10/22/2008 Consumer United Kingdom
Primary
Secondary
Concomitant
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
Pyrexia Hospitalization 6/1/2007 134 lb 10/29/2008 Physician Singapore
Primary
Secondary
Febrile Neutropenia Hospitalization 10/11/2008 Male 10/30/2008 Consumer United Kingdom
Primary
Secondary
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
Left Ventricular Dysfunction 7/5/2007 Female 137 lb 11/4/2008 Physician Norway
Primary
Secondary
Concomitant
Febrile Neutropenia Hospitalization 11/6/2008 Female 11/21/2008 Physician United Kingdom
Primary
Secondary
Febrile Neutropenia Other Serious 11/9/2008 Female 11/25/2008 Physician United Kingdom
Primary
Secondary
Concomitant
Cerebrovascular Accident Hospitalization 10/21/2008 Female 11/25/2008 Physician United Kingdom
Primary
Secondary
Concomitant
Febrile Neutropenia Hospitalization 7/2/2008 Male 11/26/2008 Consumer United Kingdom
Primary
Secondary
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
Febrile Neutropenia Hospitalization 10/24/2008 Male 11/26/2008 Consumer United Kingdom
Primary
Secondary
Febrile Neutropenia Hospitalization 11/9/2008 Female 12/1/2008 Consumer United Kingdom
Primary
Secondary
Concomitant
Febrile Neutropenia Hospitalization 11/6/2008 Female 12/1/2008 Physician 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
Mucosal Inflammation Hospitalization 9/9/2008 Female 12/8/2008 Physician Spain
Primary
Secondary
Concomitant
Proteinuria Other Serious 11/4/2008 12/12/2008 Physician United Kingdom
Primary
Secondary
Concomitant
Pneumonia Hospitalization 11/9/2008 Female 12/16/2008 Consumer United Kingdom
Primary
Secondary
Concomitant
Fall Hospitalization 11/26/2008 Female 12/17/2008 Consumer United Kingdom
Primary
Secondary
Concomitant
Mucosal Inflammation Hospitalization 9/9/2008 Female 12/18/2008 Physician Spain
Primary
Secondary
Concomitant
Pneumocystis Jiroveci Infection Hospitalization 9/17/2008 Female 12/18/2008 Physician Spain
Primary
Secondary
Concomitant
Pneumonia Other Serious 11/6/2008 Female 12/18/2008 Physician United Kingdom
Primary
Secondary
Febrile Neutropenia Hospitalization 11/6/2008 Female 12/18/2008 Physician United Kingdom
Primary
Secondary
Panic Attack Other Serious Male 12/22/2008 Consumer United Kingdom
Primary
Secondary
Concomitant
Febrile Neutropenia Hospitalization 10/29/2008 Female 12/22/2008 Consumer United Kingdom
Primary
Secondary
Concomitant
Rectal Ulcer Hospitalization 10/20/2008 Female 12/23/2008 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
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
Rectal Ulcer Hospitalization 10/20/2008 Female 12/31/2008 Consumer United Kingdom
Primary
Secondary
Concomitant
Febrile Neutropenia Hospitalization 10/29/2008 Female 12/31/2008 Consumer 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
Febrile Neutropenia Hospitalization 12/24/2008 Female 1/7/2009 Consumer United Kingdom
Primary
Secondary
Febrile Neutropenia Life Threatening 12/28/2008 Male 1/13/2009 Consumer United Kingdom
Primary
Secondary
Concomitant
Platelet Count Decreased Hospitalization 11/17/2008 Male 1/13/2009 Consumer United Kingdom
Primary
Secondary
Concomitant
Lethargy Hospitalization 10/21/2008 Female 1/14/2009 Physician United Kingdom
Primary
Secondary
Concomitant
Febrile Neutropenia Hospitalization 12/24/2008 Female 1/16/2009 Consumer United Kingdom
Primary
Secondary
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
Urinary Tract Infection Death 12/4/2008 Female 2/4/2009 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

Drug Data