Cyclophosphamide combined with Mabthera (Rituximab) Conc For Solution For Infusion

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Anaphylactic Shock Other Serious 10/25/2005 39 Female 1/2/2006 Physician France
Primary
Secondary
Neutropenia Other Serious 8/1/2005 55 Female 12/22/2005 Physician France
Primary
Concomitant
Neutropenia Other Serious 70 Female 1/2/2006 Other Health Professional Australia
Primary
Concomitant
Sudden Death Death 58 Female 123 lb 1/2/2006 Physician Poland
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Life Threatening 5/23/2004 72 Female 12/22/2005 Other Health Professional Australia
Primary
Secondary
Pulmonary Oedema Other Serious 9/1/2005 63 Female 196 lb 1/5/2006 Physician Germany
Primary
Concomitant
Paresis Other Serious 6/27/2005 Male 143 lb 1/5/2006 Switzerland
Primary
Secondary
Concomitant
Red Blood Cell Count Decreased Hospitalization 12/29/2005 40 Male 170 lb 1/12/2006 Physician Australia
Primary
Secondary
Concomitant
Sudden Death Death 58 Female 123 lb 1/13/2006 Other Health Professional Poland
Primary
Secondary
Concomitant
Deafness Hospitalization 12/2/2005 57 Female 1/17/2006 France
Primary
Secondary
Sudden Death Death 8/9/2005 58 Female 123 lb 1/19/2006 Physician Poland
Primary
Secondary
Concomitant
Premature Baby Hospitalization 4/22/2004 Male 5 lb 1/20/2006 Australia
Primary
Secondary
Concomitant
Viral Infection Hospitalization 9/9/2005 40 Female 119 lb 1/20/2006 Physician Germany
Primary
Secondary
Hepatitis Other Serious 10/25/2005 56 Male 1/24/2006 Sweden
Primary
Concomitant
Leukopenia Other Serious 33 Female 1/27/2006 Physician Taiwan, Province Of China
Primary
Secondary
Tremor Hospitalization 1/1/2006 56 207 lb 2/2/2006 Physician Czech Republic
Primary
Secondary
Agranulocytosis Other Serious Unknown 2/6/2006 Physician Germany
Primary
Concomitant
Pyrexia Hospitalization 1/12/2006 64 Female 148 lb 2/3/2006 France
Primary
Secondary
Shift To The Left Other Serious 1/23/2006 68 Male 198 lb 2/8/2006 Physician Australia
Primary
Concomitant
Febrile Neutropenia Hospitalization 1/26/2006 58 Female 2/13/2006 Physician Australia
Primary
Secondary
Red Blood Cell Count Decreased Hospitalization 12/29/2005 40 Male 170 lb 2/14/2006 Physician Australia
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Other Serious 11/17/2005 43 2/15/2006 Physician Germany
Primary
Concomitant
Cerebral Haemorrhage Death 2/21/2006 Physician Spain
Primary
Secondary
White Blood Cell Count Decreased Hospitalization 5/23/2004 72 Female 2/22/2006 Other Health Professional Australia
Primary
Secondary
Hepatic Failure Death Male 2/22/2006 Other Health Professional Australia
Primary
Secondary
Concomitant
Progressive Multifocal Leukoencephalopathy Hospitalization 67 Female 2/27/2006 Physician France
Primary
Concomitant
Tachycardia Life Threatening Male 2/27/2006 Physician Germany
Primary
Concomitant
Subarachnoid Haemorrhage Death 2/7/2006 62 Unknown 121 lb 2/27/2006 Physician Spain
Primary
Secondary
Concomitant
Coma Death 12/13/2005 50 Female 128 lb 3/2/2006 Physician Spain
Primary
Concomitant
Febrile Neutropenia Death Male 3/2/2006 Physician Australia
Primary
Concomitant
Subarachnoid Haemorrhage Death 2/7/2006 62 Unknown 121 lb 3/3/2006 Physician Spain
Primary
Secondary
Concomitant
Pneumocystis Jiroveci Pneumonia Other Serious 60 Female 3/7/2006 Physician France
Primary
Concomitant
Hepatitis Other Serious 47 Male 3/7/2006 Physician France
Primary
Concomitant
Pneumocystis Jiroveci Pneumonia Other Serious 60 Male 3/13/2006 Physician France
Primary
Concomitant
Carditis Death 24 Female 3/10/2006 Other Health Professional United Kingdom
Primary
Secondary
Rash Pustular Hospitalization 2/24/2006 78 Male 199 lb 3/10/2006 Other Health Professional Australia
Primary
Secondary
Concomitant
Skin Exfoliation Hospitalization 12/15/2005 61 Male 3/15/2006 Physician Netherlands
Primary
Secondary
Concomitant
Sputum Culture Positive Hospitalization 1/25/2006 73 Male 130 lb 3/17/2006 Other Health Professional Thailand
Primary
Secondary
Pyrexia Death 32 Female 3/24/2006 Physician South Africa
Primary
Secondary
Gamma-glutamyltransferase Increased Other Serious 65 Male 3/27/2006 Physician France
Primary
Concomitant
Shock Life Threatening 8/3/2005 69 Male 154 lb 3/27/2006 Other Health Professional Germany
Primary
Secondary
Concomitant
Gamma-glutamyltransferase Increased Other Serious 65 Male 3/29/2006 Physician France
Primary
Concomitant
Pain Life Threatening 3/8/2006 62 Female 184 lb 3/29/2006 Physician Australia
Primary
Secondary
Concomitant
Sepsis Hospitalization 2/6/2006 59 Male 128 lb 4/5/2006 Physician Germany
Primary
Secondary
Concomitant
Haematuria Hospitalization 3/23/2006 78 Female 4/6/2006 Physician France
Primary
Secondary
Superinfection Hospitalization Male 4/7/2006 Physician France
Primary
Concomitant
Thrombosis Other Serious 2/15/2006 53 Male 172 lb 4/7/2006 Other Health Professional France
Primary
Secondary
Pneumocystis Jiroveci Pneumonia Hospitalization 3/24/2006 69 Male 4/10/2006 Physician Netherlands
Primary
Secondary
Thrombocytopenia Hospitalization 9/13/2004 77 Female 4/12/2006 Other Health Professional Germany
Primary
Secondary
Renal Cell Carcinoma Stage Unspecified Other Serious 4/14/2006 Physician Australia
Primary
Concomitant
Pregnancy Other Serious 1/30/2006 38 Female 151 lb 4/17/2006 Physician Ireland
Primary
Secondary
Vomiting Hospitalization 2/6/2006 59 Male 128 lb 4/18/2006 Other Health Professional Germany
Primary
Secondary
Concomitant
Fluid Overload Hospitalization 1/11/2006 61 Female 132 lb 4/19/2006 Physician New Zealand
Primary
Secondary
Deep Vein Thrombosis Hospitalization 1/29/2006 69 Male 4/19/2006 Physician Germany
Primary
Concomitant
Septic Shock Death 4/7/2006 58 Male 183 lb 4/24/2006 Other Health Professional Belgium
Primary
Secondary
Concomitant
Weight Decreased Hospitalization 10/1/2005 61 Male 5/1/2006 Physician Netherlands
Primary
Concomitant
Respiratory Failure Hospitalization 7/1/2005 Unknown 5/1/2006 Physician Netherlands
Primary
Concomitant
Hepatotoxicity Hospitalization 4/4/2006 57 Male 192 lb 5/1/2006 Physician Denmark
Primary
Secondary
Concomitant
T-cell Lymphoma Death 66 Male 5/5/2006 Other Health Professional United Kingdom
Primary
Secondary
Staphylococcal Sepsis Death 75 Female 5/9/2006 Other Health Professional Australia
Primary
Secondary
Coronary Artery Stenosis Hospitalization 4/7/2006 66 Female 5/8/2006 France
Primary
Secondary
Septic Shock Life Threatening 2/7/2006 40 Female 209 lb 5/15/2006 Physician France
Primary
Secondary
Concomitant
Neutropenia Hospitalization 2/1/2006 63 Male 187 lb 5/16/2006 Physician Germany
Primary
Secondary
Concomitant
Viraemia Death 4/7/2006 58 Male 183 lb 5/17/2006 Physician Belgium
Primary
Secondary
Concomitant
Anaphylactic Reaction Hospitalization Male 5/25/2006 Other Health Professional New Zealand
Primary
Concomitant
Neutropenia Other Serious 70 Female 5/25/2006 Other Health Professional Australia
Primary
Concomitant
Hepatitis Other Serious 47 Male 5/25/2006 Physician France
Primary
Concomitant
Staphylococcal Bacteraemia Hospitalization 10/1/2005 61 Male 5/25/2006 Physician Netherlands
Primary
Concomitant
Respiratory Failure Hospitalization 7/1/2005 Unknown 5/25/2006 Physician Netherlands
Primary
Concomitant
Jc Virus Infection Hospitalization 67 Female 5/25/2006 Physician France
Primary
Concomitant
General Physical Health Deterioration Hospitalization 11/5/2005 40 Female 154 lb 5/25/2006 France
Primary
Secondary
Pneumocystis Jiroveci Pneumonia Other Serious 60 Female 5/25/2006 Physician France
Primary
Concomitant
Subcutaneous Abscess Hospitalization 2/1/2006 63 Male 187 lb 5/31/2006 Physician Germany
Primary
Secondary
Concomitant
Staphylococcal Bacteraemia Death 8/21/2005 67 Female 159 lb 6/1/2006 Physician Spain
Primary
Secondary
Concomitant
Soft Tissue Necrosis Hospitalization 2/1/2006 63 Male 187 lb 6/2/2006 Physician Germany
Primary
Secondary
Concomitant
Immunodeficiency Life Threatening 11/23/2005 6/2/2006 Physician Spain
Primary
Secondary
Coronary Artery Disease Life Threatening 12/14/2004 61 Female 198 lb 6/2/2006 Other Health Professional South Africa
Primary
Secondary
Concomitant
Respiratory Failure Death 9/7/2005 73 Male 171 lb 6/5/2006 Spain
Primary
Secondary
Concomitant
Agranulocytosis Hospitalization 11/22/2005 42 Female 6/5/2006 Physician Spain
Primary
Secondary
Febrile Neutropenia Hospitalization 3/27/2005 66 Female 153 lb 6/5/2006 Physician Spain
Primary
Secondary
Sinusitis Hospitalization 68 Male 196 lb 6/5/2006 Physician Germany
Primary
Secondary
Concomitant
Tumour Lysis Syndrome Death 3/16/2006 Male 6/6/2006 Physician Poland
Primary
Secondary
Neutropenia Hospitalization 4/20/2006 63 Female 6/8/2006 Spain
Primary
Secondary
Febrile Neutropenia Hospitalization 4/18/2005 65 Female 159 lb 6/12/2006 Other Health Professional Spain
Primary
Secondary
Aplasia Hospitalization 5/27/2006 68 Female 159 lb 6/12/2006 Physician United States
Primary
Secondary
Subcutaneous Abscess Hospitalization 2/1/2006 63 Male 187 lb 6/12/2006 Physician Germany
Primary
Secondary
Concomitant
Guillain-barre Syndrome Other Serious 5/30/2006 Male 6/14/2006 Pharmacist United Kingdom
Primary
Concomitant
Oral Infection Other Serious 4/18/2005 58 Female 168 lb 6/20/2006 Germany
Primary
Secondary
Concomitant
Septic Shock Life Threatening 8/12/2005 65 Male 6/20/2006 Other Health Professional France
Primary
Secondary
Concomitant
Tachycardia Life Threatening 6/1/2005 69 Male 154 lb 6/20/2006 Other Health Professional Germany
Primary
Secondary
Concomitant
Recurrent Cancer Other Serious 6/6/2005 64 Male 182 lb 6/20/2006 Physician Australia
Primary
Concomitant
Sepsis Life Threatening 5/19/2005 69 Male 154 lb 6/20/2006 Physician Germany
Primary
Secondary
Concomitant
Post Procedural Complication Hospitalization 2/11/2006 62 Male 126 lb 6/27/2006 Other Health Professional Australia
Primary
Secondary
Concomitant
Hepatitis Toxic Hospitalization 2/24/2006 31 Male 6/27/2006 Physician France
Primary
Secondary
Concomitant
Leukocyturia Hospitalization 5/27/2006 68 Female 159 lb 6/27/2006 Other Health Professional France
Primary
Secondary
Vomiting Hospitalization 8/12/2003 63 Female 165 lb 6/28/2006 Other Health Professional South Africa
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Hospitalization 2/11/2006 62 Male 126 lb 6/30/2006 Other Health Professional Australia
Primary
Secondary
Concomitant
Pancytopenia Death 5/10/2006 49 Female 216 lb 6/30/2006 France
Primary
Secondary
Papilloedema Other Serious Male 7/6/2006 Physician Sweden
Primary
Concomitant
Haemolysis Hospitalization 5/15/2005 69 Female 123 lb 7/6/2006 Physician Germany
Primary
Secondary
Concomitant
Platelet Count Decreased Hospitalization 4/18/2005 65 Female 159 lb 7/10/2006 Other Health Professional Spain
Primary
Secondary
Staphylococcal Infection Death 8/8/2005 67 Female 159 lb 7/10/2006 Other Health Professional Spain
Primary
Secondary
Concomitant
Neutropenia Other Serious 5/19/2006 57 Male 128 lb 7/13/2006 Other Health Professional India
Primary
Secondary
Agranulocytosis Hospitalization 3/11/2006 63 Male 7/13/2006 Other Health Professional Australia
Primary
Secondary
Pneumocystis Jiroveci Pneumonia Hospitalization 2/15/2006 71 Male 7/17/2006 Other Health Professional Belgium
Primary
Secondary
Concomitant
Pain In Extremity Hospitalization 3/8/2006 73 Male 148 lb 7/26/2006 Other Health Professional Australia
Primary
Secondary
Concomitant
Pain Life Threatening 3/8/2006 62 Female 184 lb 8/1/2006 Physician Australia
Primary
Secondary
Concomitant
Weight Decreased Hospitalization 12/30/2004 75 Male 8/2/2006 Physician France
Primary
Secondary
Concomitant
Premature Baby Hospitalization 4/22/2004 Male 5 lb 8/2/2006 Australia
Primary
Secondary
Concomitant
Pneumocystis Jiroveci Pneumonia Hospitalization 9/1/2005 Male 220 lb 8/8/2006 Physician Germany
Primary
Secondary
White Blood Cell Count Decreased Hospitalization 7/14/2005 54 Female 181 lb 8/14/2006 Other Health Professional Germany
Primary
Secondary
Acute Leukaemia Life Threatening 6/15/2006 69 Female 8/14/2006 Physician France
Primary
Secondary
Staphylococcal Bacteraemia Death 8/8/2005 67 Female 159 lb 8/14/2006 Other Health Professional Spain
Primary
Secondary
Concomitant
Hepatitis B Hospitalization 4/4/2006 57 Male 192 lb 8/15/2006 Other Health Professional Denmark
Primary
Secondary
Concomitant
Pain Hospitalization 2/24/2006 78 Male 199 lb 8/16/2006 Physician Australia
Primary
Secondary
Concomitant
Platelet Count Decreased Hospitalization 9/19/2005 74 Female 123 lb 8/16/2006 Physician Belgium
Primary
Secondary
Concomitant
Pyrexia Other Serious 5/23/2006 49 Female 106 lb 8/22/2006 Physician Spain
Primary
Secondary
Concomitant
Thrombocytopenia Hospitalization 9/1/2005 Male 220 lb 8/25/2006 Physician Germany
Primary
Secondary
Concomitant
Thrombocytopenia Hospitalization 9/1/2005 Male 220 lb 8/30/2006 Other Health Professional Germany
Primary
Secondary
Anaphylactic Reaction Life Threatening 8/28/2006 48 Female 9/5/2006 Australia
Primary
Secondary
T-cell Lymphoma Life Threatening 66 Male 9/12/2006 Other Health Professional United Kingdom
Primary
Secondary
Stevens-johnson Syndrome Other Serious 9/13/2006 Physician Netherlands
Primary
Concomitant
Pancytopenia Other Serious Female 9/18/2006 Other Health Professional Ireland
Primary
Secondary
Neutropenia Hospitalization 8/20/2006 65 Male 209 lb 9/18/2006 Physician Finland
Primary
Secondary
Concomitant
Febrile Neutropenia Hospitalization 6/17/2006 40 Male 137 lb 9/18/2006 Physician Spain
Primary
Secondary
Concomitant
Oral Intake Reduced Hospitalization 7/1/2006 Female 143 lb 9/22/2006 Other Health Professional Germany
Primary
Secondary
Concomitant
Subcutaneous Abscess Hospitalization 2/1/2006 63 Male 187 lb 9/25/2006 Physician Germany
Primary
Secondary
Concomitant
Hepatitis B Life Threatening 6/17/2005 66 Male 165 lb 9/25/2006 Physician France
Primary
Secondary
Sinus Bradycardia Hospitalization 3/22/2006 67 Female 148 lb 9/28/2006 Other Health Professional Italy
Primary
Secondary
Concomitant
Thrombocytopenia Life Threatening 9/1/2006 69 Female 9/27/2006 Other Health Professional Spain
Primary
Secondary
Injection Site Necrosis Hospitalization 8/21/2006 74 Male 220 lb 10/20/2006 Physician France
Primary
Secondary
Concomitant
Streptococcal Infection Hospitalization 8/18/2006 49 Male 176 lb 10/24/2006 Physician Australia
Primary
Secondary
Concomitant
Stevens-johnson Syndrome Other Serious Unknown 10/26/2006 Physician Netherlands
Primary
Concomitant
Cerebrovascular Accident Hospitalization 70 Female 11/7/2006 Pharmacist United Kingdom
Primary
Secondary
Respiratory Failure Required Intervention 1/1/2006 Female 11/21/2006 Physician Netherlands
Primary
Secondary
Pulmonary Fibrosis Hospitalization 50 Female 12/4/2006 Physician France
Primary
Concomitant
Jaundice Cholestatic Other Serious 71 Female 11/30/2006 Physician France
Primary
Concomitant
Tumour Lysis Syndrome Life Threatening 11/17/2006 67 Male 180 lb 12/12/2006 Physician Austria
Primary
Secondary
Concomitant
White Blood Cell Count Increased Hospitalization 3/10/2005 62 Female 110 lb 12/20/2006 Physician Germany
Primary
Secondary
Concomitant
Nausea Hospitalization 4/1/2006 57 Male 12/21/2006 Lawyer Denmark
Primary
Secondary
Concomitant
Sudden Death Death 10/9/2006 53 Male 163 lb 12/21/2006 Czech Republic
Primary
Secondary
Concomitant
Tumour Lysis Syndrome Life Threatening 12/15/2006 67 Male 180 lb 12/22/2006 Physician Austria
Primary
Secondary
Concomitant
Vomiting Hospitalization 5/4/2006 56 Female 200 lb 12/22/2006 Other Health Professional Argentina
Primary
Secondary
Syncope Vasovagal Hospitalization 9/19/2005 74 Female 123 lb 12/28/2006 Physician Belgium
Primary
Secondary
Concomitant
Stenotrophomonas Infection Other Serious 6/11/2006 77 Female 1/11/2007 Physician Thailand
Primary
Secondary
Liver Function Test Abnormal Other Serious 12/3/2006 67 Male 150 lb 1/18/2007 Physician Egypt
Primary
Concomitant
Psychotic Disorder Hospitalization 11/25/2006 75 1/24/2007 Other Health Professional Germany
Primary
Secondary
Pulmonary Oedema Hospitalization 11/12/2006 70 Female 1/22/2007 Physician France
Primary
Secondary
Paresis Other Serious 6/27/2005 Male 143 lb 1/23/2007 Switzerland
Primary
Secondary
Concomitant
Pyrexia Hospitalization 12/30/2005 64 Female 148 lb 1/23/2007 France
Primary
Secondary
Concomitant

Drug Data