Cc-5013 (Lenalidomide) (Capsules) combined with Dexamethasone Tab

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Death Death 7/6/2006 71 Male 150 lb 7/13/2006 Physician Canada
Primary
Secondary
Tachypnoea Life Threatening 6/12/2006 76 Male 189 lb 7/25/2006 Physician United States
Primary
Secondary
Mental Status Changes Hospitalization 2/19/2006 73 Female 132 lb 7/20/2006 Physician United States
Primary
Secondary
Concomitant
Pneumonia Death 7/22/2006 72 Male 187 lb 8/4/2006 Physician Austria
Primary
Concomitant
Renal Failure Chronic Hospitalization 7/18/2006 61 Female 180 lb 8/1/2006 Physician United States
Primary
Secondary
Pulmonary Embolism Hospitalization 6/20/2006 75 Male 172 lb 8/18/2006 Physician United States
Primary
Secondary
White Blood Cell Count Decreased Hospitalization 3/10/2006 56 Female 140 lb 8/21/2006 Physician United States
Primary
Secondary
Concomitant
Syncope Vasovagal Hospitalization 3/19/2006 70 Male 209 lb 8/23/2006 Physician United States
Primary
Secondary
White Blood Cell Count Decreased Hospitalization 5/2/2006 82 Male 8/23/2006 Physician United States
Primary
Secondary
Concomitant
Pneumonia Death 7/6/2006 71 Male 150 lb 8/28/2006 Physician Canada
Primary
Secondary
Weight Decreased Hospitalization 5/1/2006 69 Male 8/25/2006 France
Primary
Concomitant
Partial Seizures Hospitalization 8/15/2006 61 Male 203 lb 8/31/2006 Physician Canada
Primary
Secondary
Concomitant
Skin Necrosis Other Serious 3/28/2006 70 Male 9/7/2006 Physician United States
Primary
Secondary
Concomitant
Circulatory Collapse Death 8/30/2006 53 Male 174 lb 9/7/2006 Physician Canada
Primary
Secondary
Concomitant
Sudden Death Death 7/6/2006 71 Male 150 lb 9/14/2006 Other Health Professional Canada
Primary
Secondary
Concomitant
Multiple Myeloma Death 8/9/2006 77 Male 9/19/2006 Physician France
Primary
Secondary
Concomitant
Vertigo Hospitalization 7/1/2006 83 Female 121 lb 9/25/2006 France
Primary
Secondary
Concomitant
Red Blood Cell Count Decreased Hospitalization 9/18/2006 67 Female 9/20/2006 Physician Canada
Primary
Secondary
Concomitant
Septic Shock Hospitalization 7/13/2006 45 Female 215 lb 9/28/2006 Other Health Professional United States
Primary
Secondary
Pulmonary Oedema Other Serious 9/29/2006 74 Male 10/2/2006 France
Primary
Secondary
Death Death 74 Male 10/3/2006 Physician France
Primary
Secondary
Death Death 81 Male 10/17/2006 France
Primary
Secondary
Death Death 59 Male 10/19/2006 France
Primary
Secondary
Stem Cell Transplant Hospitalization 5/31/2006 57 Female 157 lb 11/1/2006 Other Health Professional United States
Primary
Secondary
Concomitant
Partial Seizures Hospitalization 8/14/2006 61 Male 203 lb 11/15/2006 Other Health Professional Canada
Primary
Secondary
Concomitant
Septic Shock Death 10/19/2006 48 Female 132 lb 11/20/2006 Physician France
Primary
Secondary
Cardiac Arrest Death 12/13/2006 57 Male 165 lb 12/14/2006 Other Health Professional Canada
Primary
Secondary
Thrombocytopenia Hospitalization 12/4/2006 61 Male 212 lb 12/18/2006 Other Health Professional Canada
Primary
Secondary
Pulmonary Alveolar Haemorrhage Death 9/15/2006 49 Female 12/12/2006 Physician France
Primary
Secondary
Concomitant
Renal Failure Hospitalization 7/18/2006 61 Female 180 lb 12/19/2006 United States
Primary
Secondary
Concomitant
Respiratory Arrest Other Serious 75 Male 209 lb 12/19/2006 Physician France
Primary
Secondary
Concomitant
Pulmonary Embolism Other Serious 10/26/2005 64 Male 273 lb 12/28/2006 Other Health Professional United States
Primary
Secondary
Necrotising Fasciitis Death 61 Male 1/2/2007 Physician Netherlands
Primary
Secondary
Concomitant
Septic Shock Hospitalization 7/13/2006 45 Female 215 lb 1/8/2007 Other Health Professional United States
Primary
Secondary
Concomitant
Necrotising Fasciitis Hospitalization 61 Male 1/2/2007 Physician Netherlands
Primary
Secondary
Concomitant
Pneumonia Hospitalization 1/12/2007 69 Male 1/15/2007 Physician Canada
Primary
Secondary
Death Death 71 Male 1/17/2007 Physician France
Primary
Secondary
Pyrexia Other Serious 1/9/2007 65 Female 115 lb 1/17/2007 Physician France
Primary
Secondary
Ventricular Tachycardia Hospitalization 7/31/2006 54 Male 148 lb 1/22/2007 Physician United States
Primary
Secondary
Pulmonary Embolism Hospitalization 6/20/2006 75 Male 172 lb 1/23/2007 Physician United States
Primary
Secondary
Fatigue Hospitalization 7/7/2006 62 Male 223 lb 7/12/2006 Other Health Professional United States
Primary
Secondary
Concomitant
Infection Hospitalization 4/25/2006 69 Male 1/25/2007 Austria
Primary
Concomitant
Septic Shock Hospitalization 7/13/2006 45 Female 215 lb 1/29/2007 Physician United States
Primary
Secondary
Concomitant
Tracheomalacia Hospitalization 7/7/2006 62 Male 223 lb 1/29/2007 Other Health Professional United States
Primary
Secondary
Concomitant
Hepatotoxicity Other Serious 12/14/2005 61 Male 1/31/2007 Physician United Kingdom
Primary
Secondary
Concomitant
Liver Function Test Abnormal Other Serious 12/14/2005 61 Male 175 lb 1/31/2007 Physician United Kingdom
Primary
Concomitant
White Blood Cell Count Decreased Hospitalization 3/22/2006 63 Male 168 lb 2/9/2007 Other Health Professional United States
Primary
Secondary
Respiratory Syncytial Virus Infection Hospitalization 1/21/2007 67 Female 149 lb 2/9/2007 Physician Canada
Primary
Secondary
Concomitant
Thrombocytopenia Hospitalization 4/17/2006 45 Male 192 lb 12/18/2006 Physician United States
Primary
Concomitant
Vomiting Hospitalization 3/26/2006 56 Male 134 lb 12/18/2006 Other Health Professional Canada
Primary
Secondary
Concomitant
Partial Seizures Hospitalization 8/15/2006 61 Male 203 lb 2/8/2007 Other Health Professional Canada
Primary
Secondary
Concomitant
Septic Shock Death 10/14/2006 48 Female 132 lb 2/26/2007 France
Primary
Secondary
Concomitant
Pancytopenia Death 71 Male 3/5/2007 Physician France
Primary
Secondary
Peritonitis Other Serious 8/11/2005 65 Male 198 lb 3/6/2007 Other Health Professional United States
Primary
Secondary
Urinary Tract Infection Other Serious 76 3/5/2007 Physician France
Primary
Secondary
Refusal Of Treatment By Patient Other Serious 12/29/2006 53 Male 3/7/2007 Physician France
Primary
Secondary
Streptococcal Infection Hospitalization 12/26/2006 50 Male 3/8/2007 Physician France
Primary
Secondary
Concomitant
Renal Failure Acute Other Serious 7/31/2006 64 Male 170 lb 3/9/2007 Physician France
Primary
Secondary
Concomitant
Sepsis Life Threatening 34 Male 3/12/2007 Physician Canada
Primary
Secondary
Febrile Bone Marrow Aplasia Required Intervention 7/10/2006 64 Male 176 lb 8/1/2006 France
Primary
Secondary
Skin Disorder Hospitalization 3/15/2006 64 Female 107 lb 3/6/2007 Physician Germany
Primary
Secondary
Concomitant
Death Death 68 Male 3/14/2007 Physician France
Primary
Secondary
Disease Progression Death 12/11/2006 64 Male 150 lb 3/15/2007 Physician Spain
Primary
Secondary
Concomitant
Sigmoiditis Hospitalization 1/25/2007 85 Male 150 lb 3/15/2007 Physician France
Primary
Secondary
Concomitant
Renal Impairment Other Serious 58 Female 3/15/2007 Physician France
Primary
Secondary
Thrombocytopenia Other Serious 12/15/2006 77 Male 165 lb 3/14/2007 Physician Austria
Primary
Secondary
Concomitant
Red Blood Cell Count Decreased Hospitalization 1/30/2007 67 Male 3/17/2007 Other Health Professional Austria
Primary
Secondary
Concomitant
Renal Failure Death 75 Male 3/16/2007 Physician Germany
Primary
Secondary
Pulmonary Embolism Death 3/11/2007 70 Female 4/3/2007 Physician France
Primary
Secondary
White Blood Cell Count Decreased Hospitalization 2/3/2007 79 Male 3/29/2007 Physician Canada
Primary
Secondary
Sigmoiditis Hospitalization 1/25/2007 85 Male 150 lb 4/2/2007 Physician France
Primary
Secondary
Concomitant
Supraventricular Extrasystoles Death 10/16/2006 80 Male 4/5/2007 France
Primary
Secondary
Concomitant
Multiple Myeloma Other Serious 12/10/2006 77 Male 165 lb 4/4/2007 Physician Austria
Primary
Secondary
Concomitant
Somnolence Hospitalization 4/5/2007 62 Female 176 lb 4/5/2007 Other Health Professional Germany
Primary
Secondary
Ventricular Extrasystoles Other Serious 2/1/2007 79 Female 139 lb 4/5/2007 Physician Germany
Primary
Secondary
Supraventricular Tachycardia Hospitalization 4/2/2007 69 Female 4/16/2007 Other Health Professional United Kingdom
Primary
Secondary
Pulmonary Infarction Hospitalization 4/8/2007 57 Male 181 lb 4/13/2007 Physician United Kingdom
Primary
Secondary
Concomitant
Septic Shock Hospitalization 4/8/2007 75 Female 4/16/2007 Physician Spain
Primary
Secondary
Concomitant
Death Death 1/16/2007 79 Male 4/17/2007 Physician France
Primary
Secondary
Somnolence Hospitalization 4/5/2007 62 Female 176 lb 4/17/2007 Physician Germany
Primary
Secondary
Small Intestine Ulcer Other Serious 70 Female 4/20/2007 Physician United Kingdom
Primary
Secondary
Supraventricular Tachycardia Other Serious 4/2/2007 69 Female 4/19/2007 Physician United Kingdom
Primary
Secondary
Concomitant
Thrombocytopenia Death 3/22/2007 71 Male 176 lb 4/25/2007 Physician United Kingdom
Primary
Secondary
Concomitant
Dizziness Hospitalization 4/27/2007 74 Male 241 lb 4/30/2007 Physician Ireland
Primary
Secondary
Unevaluable Event Death 12/11/2006 64 Male 150 lb 5/4/2007 Physician Spain
Primary
Secondary
Concomitant
Oral Candidiasis Hospitalization 5/7/2007 65 Male 206 lb 5/7/2007 Other Health Professional Australia
Primary
Secondary
Pneumonia Hospitalization 1/25/2006 65 Female 190 lb 5/2/2007 Physician United States
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Hospitalization 4/9/2007 71 Male 5/11/2007 Physician Canada
Primary
Secondary
Concomitant
Renal Impairment Hospitalization 3/1/2007 55 Female 5/11/2007 Physician Greece
Primary
Concomitant
Urinary Retention Hospitalization 3/15/2006 64 Female 107 lb 5/23/2007 Physician Germany
Primary
Concomitant
White Blood Cells Urine Positive Required Intervention 7/19/2006 56 Male 222 lb 5/18/2007 Physician United States
Primary
Secondary
Concomitant
Pneumonia Required Intervention 7/19/2005 76 Female 242 lb 5/23/2007 Physician United States
Primary
Secondary
Concomitant
Renal Impairment Life Threatening 3/26/2007 56 Male 5/23/2007 Physician Canada
Primary
Secondary
Concomitant
Thoracic Vertebral Fracture Hospitalization 3/20/2006 59 Male 201 lb 5/25/2007 Physician United States
Primary
Secondary
Concomitant
Hypocalcaemia Hospitalization 5/23/2007 64 Female 5/30/2007 Physician Austria
Primary
Secondary
Respiratory Failure Death 4/16/2007 54 Female 165 lb 6/4/2007 Physician Netherlands
Primary
Concomitant
Stomatitis Other Serious 4/25/2007 Male 5/30/2007 Physician Germany
Primary
Secondary
Concomitant
Shock Other Serious 5/23/2007 52 Male 6/5/2007 Physician New Zealand
Primary
Secondary
Concomitant
Rash Hospitalization 3/6/2006 78 Female 149 lb 6/5/2007 Other Health Professional United States
Primary
Secondary
Concomitant
Thrombosis Other Serious 5/15/2007 43 Female 172 lb 6/11/2007 Physician Netherlands
Primary
Concomitant
Sudden Death Death 12/11/2006 64 Male 150 lb 6/8/2007 Physician Spain
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Other Serious 2/1/2007 79 Female 139 lb 6/12/2007 Physician Germany
Primary
Concomitant
Haemoglobin Decreased Hospitalization 6/4/2007 62 Male 192 lb 6/12/2007 Physician Germany
Primary
Secondary
Renal Failure Hospitalization 12/30/2006 76 Female 6/12/2007 Physician Canada
Primary
Secondary
Concomitant
Renal Impairment Hospitalization 6/12/2007 69 Female 147 lb 6/14/2007 Physician United Kingdom
Primary
Secondary
Hyperglycaemia Hospitalization 6/9/2007 68 Female 6/13/2007 Physician United Kingdom
Primary
Secondary
Sputum Purulent Death 8/29/2006 68 Male 6/19/2007 Physician United Kingdom
Primary
Secondary
Concomitant
Sigmoiditis Hospitalization 1/25/2007 85 Male 150 lb 6/21/2007 Physician France
Primary
Secondary
Concomitant
Osteonecrosis Disability 6/19/2007 59 Male 6/22/2007 Physician United Kingdom
Primary
Secondary
Cholelithiasis Hospitalization 11/19/2006 55 Female 156 lb 6/19/2007 Physician Spain
Primary
Secondary
Platelet Count Decreased Hospitalization 6/20/2007 69 Male 6/22/2007 Physician Canada
Primary
Secondary
Renal Impairment Hospitalization 6/12/2007 69 Female 147 lb 6/27/2007 Other Health Professional United Kingdom
Primary
Secondary
Pain Hospitalization 6/23/2007 84 6/28/2007 Physician Ireland
Primary
Secondary
White Blood Cell Count Decreased Hospitalization 4/17/2007 64 Male 190 lb 6/27/2007 Physician Australia
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Life Threatening 10/28/2006 53 Male 7/5/2007 Physician France
Primary
Secondary
Concomitant
Septic Shock Hospitalization 4/8/2007 75 Female 7/2/2007 Physician Spain
Primary
Secondary
Concomitant
Sigmoiditis Hospitalization 1/25/2007 85 Male 150 lb 7/4/2007 Physician France
Primary
Secondary
Respiratory Failure Hospitalization 2/26/2007 68 Male 154 lb 7/5/2007 Physician France
Primary
Secondary
Concomitant
Palpitations Hospitalization 7/4/2007 56 Male 220 lb 7/5/2007 Other Health Professional Germany
Primary
Secondary
Subileus Hospitalization 6/28/2007 68 Male 177 lb 7/5/2007 Physician Germany
Primary
Secondary
Oral Candidiasis Hospitalization 7/6/2007 81 Male 190 lb 7/6/2007 Physician Australia
Primary
Secondary
Tachycardia Other Serious 10/31/2006 66 Female 121 lb 7/6/2007 Physician France
Primary
Secondary
Concomitant
Pulmonary Embolism Death 3/11/2007 70 Female 7/6/2007 Physician France
Primary
Secondary
Tumour Lysis Syndrome Life Threatening 6/20/2007 78 Female 123 lb 7/6/2007 Physician Germany
Primary
Secondary
Concomitant
Rectal Haemorrhage Hospitalization 5/26/2006 68 Male 170 lb 7/7/2007 Physician United States
Primary
Secondary
Concomitant
Thrombocytopenia Hospitalization 7/8/2007 67 Female 132 lb 7/9/2007 Physician Germany
Primary
Secondary
Thyroid Neoplasm Hospitalization 5/23/2007 69 Male 216 lb 7/10/2007 Physician Germany
Primary
Secondary
Concomitant
Ultrasound Thyroid Abnormal Hospitalization 5/23/2007 69 Male 216 lb 7/10/2007 Physician Germany
Primary
Secondary
Concomitant
Small Intestine Ulcer Other Serious 12/1/2006 70 Female 7/12/2007 Physician United Kingdom
Primary
Secondary
Concomitant
Sigmoiditis Hospitalization 1/25/2007 85 Male 150 lb 7/10/2007 Physician France
Primary
Secondary
Concomitant
Renal Failure Death 11/28/2006 86 Male 7/17/2007 Physician France
Primary
Secondary
Concomitant
Pneumonia Death 7/1/2007 65 Male 168 lb 7/17/2007 Germany
Primary
Secondary
Urinary Tract Infection Other Serious 2/7/2007 76 7/17/2007 Physician France
Primary
Secondary
Subileus Hospitalization 6/28/2007 68 Male 177 lb 7/16/2007 Other Health Professional Germany
Primary
Secondary
Syncope Life Threatening 6/27/2007 69 Male 170 lb 7/19/2007 Other Health Professional Germany
Primary
Secondary
Concomitant
Grand Mal Convulsion Hospitalization 7/17/2007 73 Male 185 lb 7/17/2007 Other Health Professional Germany
Primary
Secondary
Concomitant
Chronic Respiratory Failure Death 6/27/2007 72 Female 7/18/2007 Physician France
Primary
Concomitant
Tumour Lysis Syndrome Life Threatening 6/20/2007 78 Female 123 lb 7/17/2007 Physician Germany
Primary
Secondary
Concomitant
Hypocalcaemia Hospitalization 5/23/2007 64 Female 140 lb 7/16/2007 Physician Austria
Primary
Secondary
Death Death 1/1/2007 69 Female 7/23/2007 Physician France
Primary
Concomitant
Vasculitis Hospitalization 7/8/2007 67 Female 132 lb 7/19/2007 Physician Germany
Primary
Secondary
Somnolence Hospitalization 7/1/2007 69 Male 7/25/2007 Physician Australia
Primary
Secondary
Concomitant
Pleural Fibrosis Hospitalization 7/6/2007 81 Male 190 lb 7/20/2007 Physician Australia
Primary
Secondary
Death Death 1/1/2007 69 Female 7/23/2007 Other Health Professional France
Primary
Concomitant
Pulmonary Embolism Life Threatening 7/19/2007 68 Female 7/24/2007 Physician Germany
Primary
Secondary
White Blood Cell Count Decreased Other Serious 10/10/2006 80 Male 7/25/2007 France
Primary
Concomitant
Renal Failure Other Serious 4/7/2006 58 Female 7/25/2007 Physician France
Primary
Concomitant
Hospitalisation Death 7/26/2007 59 Male 115 lb 7/26/2007 Physician Canada
Primary
Secondary
Multiple Myeloma Death 5/19/2007 69 Female 7/27/2007 Physician France
Primary
Concomitant
Sudden Death Other Serious 7/1/2006 71 Male 150 lb 9/14/2006 Physician Canada
Primary
Secondary
Concomitant

Drug Data