Blinded Placebo combined with Rituximab

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
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
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
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
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
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
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 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
Febrile Neutropenia Hospitalization 3/13/2008 Male 146 lb 6/18/2008 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
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
Catheter Related Infection Life Threatening 6/30/2008 Male 236 lb 7/18/2008 Physician United States
Primary
Secondary
Concomitant
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
Febrile Neutropenia Hospitalization 7/2/2008 Male 8/1/2008 Consumer United Kingdom
Primary
Secondary
Metabolic Disorder Hospitalization 7/10/2008 Male 8/4/2008 Consumer United States
Primary
Secondary
Concomitant
Septic Shock Life Threatening 3/15/2008 Female 132 lb 8/14/2008 Consumer United Kingdom
Primary
Secondary
Concomitant
Ascites Hospitalization 5/30/2008 Male 8/26/2008 Consumer United Kingdom
Primary
Secondary
Concomitant
Febrile Neutropenia Hospitalization 8/18/2008 Male 9/4/2008 Physician United Kingdom
Primary
Secondary
Catheter Related Infection Life Threatening 6/30/2008 Male 236 lb 9/5/2008 Physician United States
Primary
Secondary
Concomitant
General Physical Health Deterioration Hospitalization 8/4/2008 Male 9/11/2008 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
White Blood Cell Count Decreased Hospitalization 8/18/2008 Male 9/25/2008 Consumer United Kingdom
Primary
Secondary
Febrile Neutropenia Hospitalization 8/18/2008 Male 11/3/2008 Consumer United Kingdom
Primary
Secondary
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 11/12/2008 Female 11/26/2008 Consumer United Kingdom
Primary
Secondary
Concomitant
Ascites Hospitalization 5/30/2008 Male 12/2/2008 Consumer 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
Metabolic Disorder Hospitalization 7/10/2008 Male 12/11/2008 Consumer United States
Primary
Secondary
Concomitant
Proteinuria Other Serious 11/4/2008 12/12/2008 Physician 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
Pneumocystis Jiroveci Infection Hospitalization 9/17/2008 Female 12/29/2008 Physician 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
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
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 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
Cerebrovascular Accident Hospitalization 1/6/2009 Female 2/20/2009 Consumer United Kingdom
Primary
Secondary
Concomitant
Pulmonary Embolism Death 2/13/2009 Female 3/4/2009 Physician United Kingdom
Primary
Secondary
Concomitant
Febrile Neutropenia Hospitalization 1/17/2009 Female 3/6/2009 Consumer 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
Febrile Neutropenia Hospitalization 1/17/2009 Female 3/17/2009 Consumer United Kingdom
Primary
Secondary
Concomitant
Mucosal Inflammation Hospitalization 9/9/2008 Female 3/18/2009 Physician Spain
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
Pyrexia Hospitalization 2/2/2009 Female 3/26/2009 Physician United Kingdom
Primary
Secondary
Concomitant
Febrile Neutropenia Life Threatening 3/7/2009 Male 4/8/2009 Consumer United Kingdom
Primary
Secondary
Febrile Neutropenia Hospitalization 1/17/2009 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
Febrile Neutropenia Hospitalization 1/17/2009 Female 4/23/2009 Consumer Korea, Democratic People's Republic Of
Primary
Secondary
Concomitant
Respiratory Disorder Hospitalization 3/13/2009 Male 5/15/2009 Physician United Kingdom
Primary
Secondary
Concomitant
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
Platelet Count Decreased Hospitalization 3/13/2009 Male 5/22/2009 Physician 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
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
Sepsis Hospitalization 5/29/2009 Male 6/17/2009 Consumer United Kingdom
Primary
Secondary
Concomitant
Febrile Neutropenia Hospitalization 8/18/2008 Male 6/25/2009 Consumer United Kingdom
Primary
Secondary
Amnesia Other Serious 3/23/2009 Female 7/1/2009 Physician United Kingdom
Primary
Secondary
Concomitant
Amnesia Other Serious 3/23/2009 Female 7/10/2009 Physician United Kingdom
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Hospitalization 8/18/2008 Male 7/16/2009 Consumer United Kingdom
Primary
Secondary
Febrile Neutropenia Hospitalization 7/8/2009 Female 7/21/2009 Consumer United Kingdom
Primary
Secondary
Concomitant
Pulmonary Embolism Hospitalization 6/5/2009 Male 7/22/2009 Physician United Kingdom
Primary
Secondary
Stomatitis Hospitalization 5/4/2009 Female 7/23/2009 Consumer United Kingdom
Primary
Secondary
Concomitant
Acute Respiratory Distress Syndrome Death 6/22/2009 Female 7/23/2009 Consumer United Kingdom
Primary
Secondary
Small Intestinal Obstruction Life Threatening 5/11/2009 Male 7/24/2009 Consumer United Kingdom
Primary
Secondary
Concomitant
Febrile Neutropenia Hospitalization 7/8/2009 Female 7/29/2009 Consumer United Kingdom
Primary
Secondary
Concomitant
Small Intestinal Obstruction Hospitalization 5/11/2009 Male 7/31/2009 Consumer United Kingdom
Primary
Secondary
Concomitant
Neutropenic Sepsis Hospitalization 5/29/2009 Male 8/3/2009 Consumer United Kingdom
Primary
Secondary
Concomitant
Neutropenic Sepsis Hospitalization 5/29/2009 Male 8/4/2009 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
Neutropenic Sepsis Hospitalization 5/29/2009 Male 8/11/2009 Consumer United Kingdom
Primary
Secondary
Concomitant
Febrile Neutropenia Hospitalization 7/27/2009 Male 8/18/2009 Physician United Kingdom
Primary
Secondary
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
Dizziness Hospitalization 7/9/2009 Female 8/25/2009 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Febrile Neutropenia Hospitalization 7/8/2009 Female 8/26/2009 Consumer United Kingdom
Primary
Secondary
Concomitant
Neutropenic Sepsis Hospitalization 4/20/2009 Male 8/31/2009 Consumer United Kingdom
Primary
Secondary
Concomitant
Meningitis Hospitalization 7/9/2009 Female 9/3/2009 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Meningitis Hospitalization 7/9/2009 Female 9/9/2009 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Neutropenic Sepsis Hospitalization 4/20/2009 Male 9/9/2009 Consumer United Kingdom
Primary
Secondary
Concomitant
Stomatitis Hospitalization 5/6/2009 Female 9/18/2009 Consumer United Kingdom
Primary
Secondary
Concomitant
Pyrexia Hospitalization 6/5/2009 Male 9/21/2009 Physician United Kingdom
Primary
Secondary
Acute Respiratory Distress Syndrome Hospitalization 6/22/2009 Female 9/24/2009 Consumer United Kingdom
Primary
Secondary
Pyrexia Hospitalization 7/10/2009 Male 141 lb 9/24/2009 Physician United Kingdom
Primary
Secondary
Concomitant
Febrile Neutropenia Hospitalization 1/17/2009 Female 9/29/2009 Consumer Korea, Republic Of
Primary
Secondary
Concomitant
Pyrexia Hospitalization 7/10/2009 Male 141 lb 9/29/2009 Physician United Kingdom
Primary
Secondary
Concomitant
Meningitis Hospitalization 7/9/2009 Female 10/5/2009 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Pyrexia Hospitalization 6/5/2009 Male 179 lb 10/14/2009 Physician United Kingdom
Primary
Secondary
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
Febrile Neutropenia Hospitalization 10/1/2009 10/19/2009 Physician United Kingdom
Primary
Secondary
Meningitis Hospitalization 7/9/2009 Female 10/21/2009 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Pyrexia Hospitalization 6/5/2009 Male 179 lb 10/27/2009 Physician United Kingdom
Primary
Secondary
Hepatitis B Other Serious 10/2/2009 Female 10/28/2009 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
Febrile Neutropenia Hospitalization 10/1/2009 11/11/2009 Physician United Kingdom
Primary
Secondary
Ascites Hospitalization 5/30/2008 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
Hepatitis B Dna Increased Other Serious 10/2/2009 Female 11/13/2009 Consumer 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
Pulmonary Embolism Hospitalization 4/27/2009 Male 11/20/2009 Physician United Kingdom
Primary
Secondary
Concomitant
Pharyngitis Hospitalization 10/1/2009 Male 93 lb 11/25/2009 Physician United Kingdom
Primary
Secondary
Febrile Neutropenia Hospitalization 10/11/2009 Male 134 lb 12/1/2009 Consumer United Kingdom
Primary
Secondary
Concomitant
Leukoencephalopathy Hospitalization 8/30/2009 Male 130 lb 12/2/2009 Consumer United Kingdom
Primary
Secondary
Concomitant
Febrile Neutropenia Hospitalization 10/17/2009 Female 12/2/2009 Consumer United Kingdom
Primary
Secondary
Febrile Neutropenia Hospitalization 10/11/2009 Male 134 lb 12/10/2009 Consumer United Kingdom
Primary
Secondary
Concomitant

Drug Data