Iviglob-EX combined with Nplate

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Platelet Count Decreased Other Serious 1/1/2010 11/24/2010 Pharmacist United States
Primary
Concomitant
No Therapeutic Response Other Serious 1/1/2010 12/8/2010 Physician United States
Primary
Secondary
Concomitant
Platelet Count Decreased Other Serious 1/1/2010 12/10/2010 Pharmacist United States
Primary
Concomitant
Injury Death 11/1/2010 12/13/2010 Physician United States
Primary
Concomitant
Thrombosis Death 12/14/2010 Physician United States
Primary
Concomitant
No Therapeutic Response Other Serious 1/1/2010 12/15/2010 Physician United States
Primary
Secondary
Concomitant
Therapeutic Response Decreased Other Serious 1/1/2010 12/17/2010 Pharmacist United States
Primary
Concomitant
Sepsis Death 12/20/2010 Physician United States
Primary
Concomitant
Cardiac Arrest Death 11/3/2010 12/21/2010 Physician United States
Primary
Concomitant
Sepsis Death 12/22/2010 Physician United States
Primary
Concomitant
Platelet Count Abnormal Hospitalization 1/6/2011 Physician United States
Primary
Concomitant
Hyperplasia Other Serious 12/31/2010 1/11/2011 Physician United States
Primary
Concomitant
Pulmonary Embolism Hospitalization 1/11/2011 Physician United States
Primary
Concomitant
Deep Vein Thrombosis Hospitalization 10/14/2010 1/14/2011 Physician United States
Primary
Concomitant
Pleural Effusion Hospitalization 10/1/2010 1/17/2011 Physician United States
Primary
Concomitant
Haemorrhage Intracranial Death 1/17/2011 Physician United States
Primary
Concomitant
Thrombocytosis Other Serious 1/18/2011 Physician Australia
Primary
Concomitant
Hospitalisation Hospitalization 80 Female 1/28/2011 Physician United States
Primary
Concomitant
Drug Ineffective Other Serious 75 Female 2/2/2011 Physician United States
Primary
Concomitant
No Adverse Event 80 Female 2/2/2011 Physician United States
Primary
Concomitant
Death Death Male 2/9/2011 Physician United States
Primary
Concomitant
Bone Marrow Reticulin Fibrosis Other Serious Female 2/11/2011 Physician United States
Primary
Concomitant
Pneumonia Death 79 Female 2/22/2011 Physician United States
Primary
Concomitant
Anaemia Macrocytic Other Serious 7/9/2010 69 Male 2/22/2011 Physician United States
Primary
Concomitant
Infection Other Serious 1/1/2011 5 Male 2/23/2011 Physician United States
Primary
Concomitant
No Adverse Event 80 Female 2/24/2011 Physician United States
Primary
Concomitant
Retinal Artery Occlusion Other Serious 80 Male 2/25/2011 Physician United States
Primary
Concomitant
Ear Infection Other Serious 1/3/2011 5 Male 62 lb 3/2/2011 Other Health Professional United States
Primary
Concomitant
Myelodysplastic Syndrome Other Serious 97 Male 3/4/2011 Physician United States
Primary
Concomitant
Death Death 6/12/2010 63 Male 3/7/2011 Physician United States
Primary
Concomitant
Therapeutic Response Decreased Other Serious 1/1/2010 58 Male 3/7/2011 Physician United States
Primary
Concomitant
Death Death 80 Male 3/7/2011 Physician United States
Primary
Concomitant
Drug Ineffective Other Serious 1/1/2010 58 Male 3/9/2011 Physician United States
Primary
Concomitant
Bone Marrow Reticulin Fibrosis Other Serious 7/9/2010 69 Male 3/10/2011 Physician United States
Primary
Concomitant
Cardiac Death Other Serious 2/14/2011 77 Female 3/11/2011 Physician United States
Primary
Concomitant
Accident At Home Other Serious 80 Male 3/14/2011 Physician United States
Primary
Concomitant
Fungal Infection Death 35 Male 3/17/2011 Physician United States
Primary
Concomitant
Platelet Count Decreased Hospitalization Female 3/17/2011 Physician United States
Primary
Concomitant
Deep Vein Thrombosis Hospitalization 3/8/2011 91 Male 3/18/2011 Physician United States
Primary
Concomitant
Therapeutic Response Delayed Other Serious 4/9/2009 73 Male 3/21/2011 Physician United States
Primary
Concomitant
Primary Mediastinal Large B-cell Lymphoma Other Serious 80 Male 3/21/2011 Physician United States
Primary
Concomitant
Therapeutic Response Delayed Other Serious 4/9/2009 73 Male 3/25/2011 Physician United States
Primary
Concomitant
Rheumatoid Arthritis Other Serious Female 143 lb 3/26/2011 Other Health Professional Ireland
Primary
Concomitant
Arthralgia 12/1/2009 57 Male 203 lb 3/30/2011 Other Health Professional United States
Primary
Concomitant
Non-hodgkin's Lymphoma Other Serious 97 Male 3/31/2011 Physician United States
Primary
Concomitant
Drug Ineffective Other Serious 97 Male 4/4/2011 Physician United States
Primary
Concomitant
Retinal Artery Occlusion Disability 10/14/2010 80 Male 172 lb 4/5/2011 Physician United States
Primary
Concomitant
Thrombocytosis Other Serious Female 4/7/2011 Physician Australia
Primary
Concomitant
Blindness Other Serious 10/13/2010 80 Male 172 lb 4/7/2011 Physician United States
Primary
Concomitant
Cardiac Failure Congestive Hospitalization Female 4/8/2011 Physician United States
Primary
Concomitant
Drug Ineffective Death Female 4/13/2011 Physician United States
Primary
Concomitant
Cardiac Failure Congestive Hospitalization Female 4/15/2011 Physician United States
Primary
Concomitant
Haemorrhage Intracranial Death 51 Male 4/15/2011 Physician United States
Primary
Concomitant
Splenomegaly Hospitalization 2/17/2011 24 Male 4/18/2011 Physician United States
Primary
Concomitant
Embolism Arterial Disability 4/1/2010 80 Male 172 lb 4/18/2011 Physician United States
Primary
Concomitant
Neoplasm Malignant Other Serious Female 101 lb 4/19/2011 Physician United States
Primary
Concomitant
Therapeutic Response Decreased Other Serious Male 4/19/2011 Physician United States
Primary
Concomitant
Ecchymosis Other Serious 1/1/2010 75 Male 167 lb 4/20/2011 Physician United States
Primary
Concomitant
Paroxysmal Nocturnal Haemoglobinuria Other Serious 10/12/2010 6 Male 4/20/2011 Other Health Professional United States
Primary
Concomitant
Drug Ineffective Other Serious 35 Male 4/21/2011 Physician United States
Primary
Concomitant
Mouth Haemorrhage Other Serious 4/1/2010 80 Male 172 lb 4/26/2011 Physician United States
Primary
Concomitant
Haemorrhage Intracranial Death 51 Male 4/27/2011 Physician United States
Primary
Concomitant
Fatigue Other Serious 3/14/2011 71 Female 148 lb 4/27/2011 Other Health Professional United States
Primary
Concomitant
Platelet Count Decreased Other Serious 72 Male 4/28/2011 Physician United States
Primary
Concomitant
Drug Ineffective Other Serious 45 Male 5/3/2011 Physician United States
Primary
Concomitant
Drug Ineffective Other Serious 1/1/2010 33 Female 5/5/2011 Physician United States
Primary
Secondary
Concomitant
Cardiac Failure Congestive Hospitalization 2/1/2011 48 Female 5/11/2011 Other Health Professional United States
Primary
Concomitant
Diabetes Insipidus Other Serious 2/17/2011 24 Male 5/12/2011 Physician United States
Primary
Concomitant
Bone Marrow Reticulin Fibrosis Other Serious 1/1/2005 56 Female 169 lb 5/16/2011 Other Health Professional United States
Primary
Concomitant
Ecchymosis Other Serious 10/22/2010 6 Male 5/17/2011 Physician United States
Primary
Concomitant
Cardiomyopathy Other Serious 2/1/2011 49 Female 5/22/2011 Other Health Professional United States
Primary
Concomitant
Bone Marrow Reticulin Fibrosis Other Serious Female 5/25/2011 Physician United States
Primary
Concomitant
Drug Ineffective Other Serious 67 Male 5/25/2011 Physician United States
Primary
Concomitant
Thrombocytopenia Other Serious 4/12/2010 29 Female 5/25/2011 Physician United States
Primary
Concomitant
Injection Site Pain 44 Female 5/25/2011 Consumer United States
Primary
Concomitant
Platelet Count Abnormal Other Serious 10/6/2010 31 Female 5/25/2011 Physician United States
Primary
Concomitant
Transfusion Other Serious 67 Male 5/26/2011 Physician United States
Primary
Concomitant
Platelet Count Abnormal Other Serious 8/31/2010 30 Female 5/31/2011 Physician United States
Primary
Concomitant
Hospitalisation Hospitalization Male 5/31/2011 Physician United States
Primary
Concomitant
Glioblastoma Death 11/3/2010 73 Male 6/1/2011 Consumer United States
Primary
Concomitant
Cardiomyopathy Hospitalization 2/1/2011 49 Female 6/2/2011 Physician United States
Primary
Concomitant
Thrombocytopenia Other Serious 8/31/2010 30 Female 6/2/2011 Physician United States
Primary
Concomitant
Abdominal Pain Other Serious 9/23/2010 30 Female 6/3/2011 Physician United States
Primary
Concomitant
Leukaemia Recurrent Death Female 120 lb 6/3/2011 Other Health Professional United States
Primary
Secondary
Concomitant
Drug Ineffective Other Serious 3/18/2010 22 Female 6/3/2011 Physician United States
Primary
Concomitant
White Blood Cell Count Increased Death 1/26/2011 77 Female 120 lb 6/8/2011 Other Health Professional United States
Primary
Secondary
Concomitant
Lymphadenopathy Hospitalization 1/1/2011 31 Female 148 lb 6/8/2011 Physician Portugal
Primary
Concomitant
Drug Ineffective Other Serious 3/18/2010 22 Female 183 lb 6/14/2011 Pharmacist United States
Primary
Concomitant
Brain Injury Other Serious 12/9/2010 75 Male 171 lb 6/16/2011 Other Health Professional United States
Primary
Concomitant
Platelet Count Decreased Other Serious 72 Male 6/16/2011 Physician United States
Primary
Concomitant
Multiple Myeloma Death 62 Female 6/17/2011 Physician United States
Primary
Concomitant
Pre-existing Disease Other Serious 50 Male 6/20/2011 Other Health Professional United States
Primary
Concomitant
Chronic Lymphocytic Leukaemia Death 57 Female 6/21/2011 Physician United States
Primary
Concomitant
Lymphoma Other Serious 50 Male 6/22/2011 Other Health Professional United States
Primary
Concomitant
Orthostatic Hypotension Other Serious 10/9/2008 60 Male 6/22/2011 Physician United States
Primary
Secondary
Concomitant
Death Death 88 Male 6/23/2011 Physician United States
Primary
Concomitant
Platelet Count Decreased Other Serious 2/28/2011 55 Female 6/23/2011 Physician United States
Primary
Concomitant
Cardiac Disorder Hospitalization 72 Female 6/24/2011 Physician United States
Primary
Concomitant
Renal Failure Chronic Death 62 Female 98 lb 6/28/2011 Other Health Professional United States
Primary
Concomitant
Brain Injury Death 12/9/2010 75 Male 171 lb 6/28/2011 Physician United States
Primary
Concomitant
Cardiac Disorder Hospitalization 72 Female 126 lb 6/28/2011 Physician United States
Primary
Concomitant
Pulseless Electrical Activity Hospitalization 5/21/2011 90 Male 123 lb 6/29/2011 Physician United States
Primary
Concomitant
Multi-organ Failure Death 57 Male 7/1/2011 Physician United States
Primary
Concomitant
Therapeutic Response Decreased Other Serious Male 7/15/2011 Physician United States
Primary
Concomitant
Medication Error Other Serious 4/12/2010 29 Female 7/19/2011 Physician United States
Primary
Concomitant
Death Death 1/29/2011 88 Male 7/19/2011 Physician United States
Primary
Concomitant
Megakaryocytes Increased Other Serious 12/31/2010 66 Female 7/20/2011 Physician United States
Primary
Concomitant
Neutropenia Other Serious 1/1/2005 56 Female 169 lb 7/25/2011 Other Health Professional United States
Primary
Concomitant
Platelet Count Increased Other Serious 11/1/2010 57 Female 7/25/2011 Physician United States
Primary
Concomitant
Therapeutic Response Decreased Other Serious Male 8/1/2011 Other Health Professional United States
Primary
Concomitant
Subdural Haematoma Hospitalization 12/9/2010 75 Male 171 lb 8/1/2011 Physician United States
Primary
Concomitant
Bronchopulmonary Aspergillosis Death 76 Male 8/1/2011 Physician United States
Primary
Concomitant
Myelodysplastic Syndrome Other Serious 95 Male 8/1/2011 Physician United States
Primary
Concomitant
Drug Ineffective Other Serious 3/1/2011 67 Male 8/2/2011 Physician United States
Primary
Concomitant
Haemorrhage Death 57 Male 8/3/2011 Physician United States
Primary
Concomitant
Nephritis Other Serious Male 8/8/2011 Other Health Professional United States
Primary
Concomitant
Haemorrhage Death 57 Male 8/8/2011 Physician United States
Primary
Concomitant
Thrombocytopenia Other Serious 4/12/2010 29 Female 8/8/2011 Physician United States
Primary
Concomitant
Oesophageal Dilatation Other Serious 12/9/2010 75 Male 171 lb 8/9/2011 Physician United States
Primary
Concomitant
Death Death 4/12/2011 52 Female 8/10/2011 Physician United States
Primary
Concomitant
Death Death 5/4/2011 68 Female 8/10/2011 Physician United States
Primary
Concomitant
Non-hodgkin's Lymphoma Other Serious 76 Male 211 lb 8/10/2011 Physician United States
Primary
Concomitant
Nephritis Hospitalization 7/12/2011 16 Male 8/11/2011 Other Health Professional United States
Primary
Concomitant
Lymphoproliferative Disorder Death 5/4/2011 68 Female 8/15/2011 Physician United States
Primary
Concomitant
Condition Aggravated Other Serious Female 8/17/2011 Physician United States
Primary
Concomitant
Respiratory Failure Hospitalization 1/1/2011 76 Male 211 lb 8/17/2011 Physician United States
Primary
Concomitant
Depression Other Serious 5/4/2011 68 Female 8/18/2011 Physician United States
Primary
Concomitant
Condition Aggravated Other Serious 81 Female 113 lb 8/22/2011 Physician United States
Primary
Concomitant
Type 2 Diabetes Mellitus Hospitalization 60 Male 8/24/2011 Physician United States
Primary
Concomitant
Prostate Cancer Metastatic Death Male 8/25/2011 Physician United States
Primary
Concomitant
Thrombocytopenia Other Serious 4/12/2010 29 Female 8/30/2011 Physician United States
Primary
Concomitant
Drug Ineffective Other Serious 27 Female 8/30/2011 Physician United States
Primary
Concomitant
Adverse Event 14 Female 8/30/2011 Physician United States
Primary
Concomitant
Hospitalisation Other Serious Male 9/1/2011 Physician United States
Primary
Concomitant
Myelodysplastic Syndrome Other Serious 95 Male 9/1/2011 Physician United States
Primary
Concomitant
Drug Ineffective Other Serious 52 Female 9/2/2011 Physician United States
Primary
Concomitant
Haematological Malignancy Other Serious 52 Female 9/2/2011 Physician United States
Primary
Concomitant
Proteinuria Other Serious 7/12/2011 16 Male 9/6/2011 Other Health Professional United States
Primary
Concomitant
Myelodysplastic Syndrome Other Serious 95 Male 9/6/2011 Physician United States
Primary
Concomitant
Non-hodgkin's Lymphoma Death Female 9/6/2011 Physician United States
Primary
Concomitant
Anaemia Hospitalization 60 Male 285 lb 9/7/2011 Physician United States
Primary
Concomitant
Drug Ineffective Death 52 Female 9/7/2011 Physician United States
Primary
Concomitant
Drug Ineffective Hospitalization 52 Female 9/8/2011 Physician United States
Primary
Concomitant
Biopsy Bone Marrow Abnormal Other Serious Male 9/9/2011 Physician United States
Primary
Concomitant
Lymphadenopathy Other Serious 1/1/2011 31 Female 148 lb 9/9/2011 Physician Portugal
Primary
Concomitant
Haematological Malignancy Death 52 Female 9/12/2011 Physician United States
Primary
Concomitant
Lung Neoplasm Malignant Death Female 9/13/2011 Physician United States
Primary
Concomitant
Cardiomyopathy Other Serious 2/1/2011 49 Female 9/14/2011 Other Health Professional United States
Primary
Concomitant
Hypogammaglobulinaemia Other Serious Female 9/15/2011 Physician United States
Primary
Concomitant
Epstein-barr Virus Associated Lymphoproliferative Disorder Hospitalization 7/21/2011 16 Male 9/15/2011 Other Health Professional United States
Primary
Concomitant

Drug Data