Fresh Frozen Plasma combined with Novoseven

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Encephalopathy Death 1/1/2005 17 Male 1/3/2006 Physician Japan
Primary
Concomitant
Shock Death 9/1/2005 80 Female 1/3/2006 Physician Japan
Primary
Concomitant
Arterial Thrombosis Limb Hospitalization 3/29/2005 42 Male 150 lb 1/3/2006 Other Health Professional France
Primary
Concomitant
Peripheral Ischaemia Other Serious 65 Male 1/12/2006 Physician United States
Primary
Concomitant
Staphylococcal Sepsis Hospitalization 8/31/2005 75 Male 181 lb 2/13/2006 Other Health Professional United States
Primary
Concomitant
Peripheral Ischaemia Hospitalization 1/18/2005 48 Male 176 lb 2/14/2006 Physician France
Primary
Concomitant
Thrombosis Other Serious 9/15/2001 36 Male 2/14/2006 Physician United States
Primary
Concomitant
Thrombotic Stroke Disability 4/28/2005 45 Male 2/21/2006 Physician France
Primary
Concomitant
Neoplasm Death 11/6/2003 81 Female 2/24/2006 Physician Denmark
Primary
Concomitant
Tachycardia Other Serious 1/15/2006 65 Male 2/24/2006 Physician Germany
Primary
Concomitant
Peripheral Ischaemia Hospitalization 1/18/2005 48 Male 176 lb 2/24/2006 Physician France
Primary
Concomitant
Wound Haemorrhage Other Serious 1/1/2000 16 Male 2/10/2006 Physician United States
Primary
Secondary
Concomitant
Sepsis Other Serious 2/4/2006 31 Female 165 lb 3/16/2006 Physician Turkey
Primary
Concomitant
Transverse Sinus Thrombosis Other Serious 10/5/2005 0 Male 9 lb 3/21/2006 Physician United States
Primary
Concomitant
Therapeutic Response Decreased Hospitalization 1/1/2006 0 Female 7 lb 3/23/2006 United States
Primary
Concomitant
Therapeutic Response Decreased Other Serious 5/5/2004 66 Male 225 lb 4/6/2006 Physician United States
Primary
Concomitant
Death Death 5/1/2004 78 Male 161 lb 4/6/2006 Physician United States
Primary
Concomitant
Cerebral Infarction Death 2/6/2006 62 Female 99 lb 4/10/2006 Other Health Professional United States
Primary
Concomitant
Sepsis Other Serious 2/4/2006 31 Female 165 lb 4/10/2006 Physician Turkey
Primary
Concomitant
Death Death 3/1/2006 44 Male 4/12/2006 Physician United States
Primary
Concomitant
Death Death 3/18/2004 77 Male 207 lb 4/12/2006 Physician United States
Primary
Concomitant
Death Death 4/24/2004 61 Male 181 lb 4/12/2006 Physician United States
Primary
Concomitant
Hypersensitivity Other Serious 1/15/2006 65 Male 4/13/2006 Physician Germany
Primary
Concomitant
Subclavian Vein Thrombosis Death 1/25/2006 Female 4/13/2006 Physician United Kingdom
Primary
Concomitant
Sinusitis Hospitalization 56 Female 216 lb 4/13/2006 Other Health Professional Australia
Primary
Concomitant
Disseminated Intravascular Coagulation Hospitalization 51 Female 198 lb 4/13/2006 Other Health Professional Australia
Primary
Concomitant
Multi-organ Failure Death 4/22/2005 68 Female 227 lb 4/13/2006 Other Health Professional Australia
Primary
Concomitant
Pulmonary Haemorrhage Life Threatening 3/30/2006 2 Female 4/14/2006 Physician Turkey
Primary
Concomitant
Portal Vein Thrombosis Other Serious 12/7/2005 0 Male 4 lb 4/18/2006 Physician United States
Primary
Concomitant
Pulmonary Haemorrhage Life Threatening 3/30/2006 2 Female 29 lb 5/1/2006 Physician Turkey
Primary
Concomitant
Troponin I Increased Hospitalization 8/31/2005 75 Male 181 lb 5/5/2006 Other Health Professional United States
Primary
Concomitant
Septic Shock Hospitalization 1/1/2001 59 Male 198 lb 5/8/2006 Other Health Professional Germany
Primary
Concomitant
Subclavian Vein Thrombosis Hospitalization 1/25/2006 Female 141 lb 5/9/2006 Physician United Kingdom
Primary
Concomitant
Thrombosis Other Serious 65 Male 154 lb 5/16/2006 Other Health Professional Australia
Primary
Concomitant
Respiratory Failure Other Serious 9/14/2004 70 Male 154 lb 5/16/2006 Other Health Professional Australia
Primary
Concomitant
Haemorrhage Hospitalization 3/1/2006 73 Male 5/16/2006 Physician Turkey
Primary
Concomitant
Subclavian Artery Thrombosis Hospitalization 4/1/2005 53 Male 6/23/2006 Other Health Professional
Primary
Concomitant
Transverse Sinus Thrombosis Other Serious 10/5/2005 0 Male 9 lb 6/27/2006 Physician United States
Primary
Concomitant
Venous Thrombosis Life Threatening 2/23/2006 41 Male 353 lb 7/14/2006 Physician Germany
Primary
Concomitant
Hypotension Death 6/27/2006 67 Male 7/21/2006 Physician Turkey
Primary
Concomitant
Catheter Related Complication Hospitalization 4/1/2005 53 Male 8/2/2006 Other Health Professional
Primary
Concomitant
Shock Haemorrhagic Hospitalization 7/8/2006 67 Male 8/3/2006 Physician Turkey
Primary
Concomitant
Death Death 3/1/2006 36 Female 8/11/2006 Physician United Kingdom
Primary
Concomitant
Death Death 8/6/2006 Male 8/14/2006 Physician Israel
Primary
Concomitant
Unevaluable Event Other Serious 8/17/2006 63 Female 139 lb 8/17/2006 Physician
Primary
Concomitant
Unevaluable Event Other Serious 4/11/2006 63 Female 139 lb 8/21/2006 Physician
Primary
Concomitant
Subclavian Vein Thrombosis Other Serious 8/22/2005 67 Female 159 lb 8/21/2006 Australia
Primary
Concomitant
Renal Failure Acute Other Serious 57 Male 8/21/2006 Australia
Primary
Concomitant
Thrombosis Other Serious 82 Male 165 lb 8/21/2006 Australia
Primary
Concomitant
Thalamic Infarction Life Threatening 2/27/2003 13 Female 106 lb 8/30/2006 Other Health Professional Turkey
Primary
Concomitant
Death Death 3/1/2006 36 Female 9/15/2006 Physician United Kingdom
Primary
Concomitant
Therapeutic Response Decreased Hospitalization 1/1/2006 0 Female 7 lb 10/9/2006 United States
Primary
Concomitant
Shock Haemorrhagic Death 10/31/2006 81 Female 11/3/2006 Physician Japan
Primary
Concomitant
Arterial Thrombosis Other Serious 9/29/2005 64 Male 148 lb 11/13/2006 Physician Australia
Primary
Concomitant
Shock Haemorrhagic Death 10/30/2006 66 Male 198 lb 11/14/2006 Physician Croatia (Local Name: Hrvatska)
Primary
Concomitant
Therapeutic Response Decreased Death 11/8/2006 36 Female 154 lb 11/15/2006 Physician Israel
Primary
Concomitant
Drug Ineffective Life Threatening 11/17/2006 56 Male 176 lb 11/27/2006 Physician Israel
Primary
Concomitant
Subdural Haematoma Life Threatening 11/14/2006 Female 177 lb 11/17/2006 Other Health Professional United States
Primary
Concomitant
Concomitant Disease Progression Death 7/16/2006 65 Male 220 lb 11/28/2006 United States
Primary
Concomitant
Death Life Threatening 11/26/2006 27 Female 12/8/2006 Physician Israel
Primary
Concomitant
Pulmonary Embolism Death 1 Male 12/15/2006 Other Health Professional United States
Primary
Concomitant
Haemorrhage Life Threatening 11/26/2006 27 Female 132 lb 12/20/2006 Physician Israel
Primary
Concomitant
Septic Shock Hospitalization 1/1/2001 59 Male 198 lb 1/19/2007 Other Health Professional Germany
Primary
Concomitant
Pulmonary Haemorrhage Death 32 Female 143 lb 3/6/2007 Physician Israel
Primary
Concomitant
Neurological Symptom Other Serious 9/27/2005 Male 251 lb 3/12/2007 Physician United States
Primary
Concomitant
Multi-organ Failure Hospitalization 2/2/2007 80 Male 165 lb 3/12/2007 Physician Israel
Primary
Concomitant
Renal Vein Thrombosis Other Serious 1 Male 18 lb 3/16/2007 Physician Australia
Primary
Concomitant
Jugular Vein Thrombosis Other Serious 32 Male 132 lb 3/26/2007 Physician Israel
Primary
Concomitant
Multi-organ Failure Death 3/1/2007 Male 3/28/2007 Physician Israel
Primary
Concomitant
Sepsis Other Serious 19 Male 165 lb 3/30/2007 Physician Romania
Primary
Concomitant
Concomitant Disease Progression Death 11/2/2006 92 Female 201 lb 4/3/2007 Pharmacist United States
Primary
Concomitant
Sepsis Other Serious 19 Male 165 lb 4/10/2007 Physician Romania
Primary
Concomitant
Sepsis Other Serious 19 Male 165 lb 4/16/2007 Physician Romania
Primary
Concomitant
Multi-organ Failure Death 65 Female 4/17/2007 Physician Israel
Primary
Concomitant
Multi-organ Failure Death 4/2/2007 21 Female 4/17/2007 Physician Israel
Primary
Concomitant
Jugular Vein Thrombosis Other Serious 32 Male 132 lb 4/27/2007 Physician Israel
Primary
Concomitant
Pulmonary Embolism Other Serious 11/19/2005 37 Female 5/2/2007 Physician France
Primary
Concomitant
Shock Haemorrhagic Death 4/14/2007 49 Male 165 lb 5/21/2007 Physician Croatia (Local Name: Hrvatska)
Primary
Concomitant
Drug Ineffective Death 5/19/2007 0 Male 5/29/2007 Physician Israel
Primary
Concomitant
Drug Ineffective Death 5/19/2007 0 Male 5/29/2007 Physician Israel
Primary
Concomitant
Pneumococcal Sepsis Other Serious 67 Male 6/11/2007 Physician Turkey
Primary
Concomitant
Haemorrhage Intracranial Death Male 7/16/2007 Physician Turkey
Primary
Concomitant
Haemorrhage Intracranial Death Male 7/17/2007 Physician Turkey
Primary
Concomitant
Septic Shock Death 7/30/2007 8/24/2007 Physician Croatia (Local Name: Hrvatska)
Primary
Concomitant
Septic Shock Hospitalization 7/21/2007 9/21/2007 Physician Croatia (Local Name: Hrvatska)
Primary
Concomitant
Puncture Site Haemorrhage Death Male 9/24/2007 Physician Turkey
Primary
Concomitant
Renal Failure Other Serious Male 9/24/2007 Physician Turkey
Primary
Concomitant
Multi-organ Failure Other Serious Male 9/27/2007 Physician Turkey
Primary
Concomitant
Multi-organ Failure Death Male 9/27/2007 Physician Turkey
Primary
Concomitant
Hypersensitivity Other Serious 3/26/2004 10/11/2007 Physician Australia
Primary
Concomitant
Pneumococcal Sepsis Other Serious 67 Male 10/19/2007 Physician Turkey
Primary
Concomitant
Ventricular Fibrillation Death 10/26/2007 Physician United States
Primary
Concomitant
Multi-organ Failure Death Male 11/7/2007 Physician Turkey
Primary
Concomitant
Multi-organ Failure Other Serious Male 11/7/2007 Physician Turkey
Primary
Concomitant
Drug Ineffective Death 1/2/2008 Physician United States
Primary
Concomitant
Drug Ineffective Death 1/16/2008 Physician United States
Primary
Concomitant
Drug Ineffective Death 11/22/2007 1/31/2008 Physician Japan
Primary
Concomitant
Acute Myocardial Infarction Death 2/5/2008 Physician Japan
Primary
Concomitant
Drug Ineffective Death 11/22/2007 2/8/2008 Physician Japan
Primary
Concomitant
Cardiogenic Shock Death 2/14/2008 Physician Taiwan, Province Of China
Primary
Concomitant
Multi-organ Failure Other Serious Male 6 lb 3/10/2008 Physician Australia
Primary
Concomitant
Multi-organ Failure Death 1/7/2008 22 Female 163 lb 3/17/2008 Physician Israel
Primary
Concomitant
Oxygen Saturation Decreased Other Serious 2/29/2008 Male 1 lb 3/17/2008 Physician Germany
Primary
Concomitant
Hydrocephalus Other Serious 9/1/2007 61 Male 3/31/2008 Physician Japan
Primary
Concomitant
Sinusitis Life Threatening 2/2/2007 39 Female 107 lb 4/11/2008 Physician Hong Kong
Primary
Concomitant
Death Death 3/5/2008 5 Male 44 lb 5/14/2008 Physician Israel
Primary
Concomitant
Ischaemic Cerebral Infarction Life Threatening 2/20/2003 31 Female 156 lb 5/23/2008 Other Health Professional United States
Primary
Concomitant
Thrombosis Other Serious 4/7/2008 Female 132 lb 5/28/2008 Physician Israel
Primary
Concomitant
Oxygen Saturation Decreased Other Serious 2/29/2008 Male 1 lb 5/30/2008 Physician Germany
Primary
Concomitant
Drug Ineffective Death 6/17/2008 Other Health Professional United States
Primary
Concomitant
Sinusitis Life Threatening 2/2/2007 39 Female 107 lb 6/19/2008 Physician Hong Kong
Primary
Concomitant
Subarachnoid Haemorrhage Other Serious 9/6/2007 33 Male 154 lb 6/24/2008 Physician Australia
Primary
Concomitant
Renal Failure Acute Other Serious 4/15/2007 73 Male 194 lb 6/24/2008 Other Health Professional Australia
Primary
Concomitant
Sinusitis Life Threatening 2/2/2007 39 Female 107 lb 6/26/2008 Physician Hong Kong
Primary
Concomitant
Arterial Thrombosis Limb Other Serious 4/15/2007 73 Male 194 lb 6/27/2008 Other Health Professional Australia
Primary
Concomitant
Haemorrhage Other Serious 6/7/2008 52 Male 154 lb 7/16/2008 Physician United States
Primary
Concomitant
Right Ventricular Failure Life Threatening 79 Female 7/23/2008 Other Health Professional United States
Primary
Secondary
Concomitant
Pelvic Haemorrhage Death 20 Male 8/18/2008 Physician United States
Primary
Concomitant
Multi-organ Failure Death 34 Male 123 lb 8/18/2008 Physician Hungary
Primary
Concomitant
Ischaemic Cerebral Infarction Life Threatening 2/20/2003 Female 156 lb 8/19/2008 Other Health Professional United States
Primary
Concomitant
Subarachnoid Haemorrhage Hospitalization 9/1/2007 33 Male 8/22/2008 Other Health Professional Australia
Primary
Secondary
Concomitant
Subarachnoid Haemorrhage Hospitalization 9/1/2007 33 Male 8/28/2008 Other Health Professional Australia
Primary
Secondary
Concomitant
Multi-organ Failure Life Threatening 11/22/2007 77 Male 110 lb 10/6/2008 Physician Japan
Primary
Concomitant
Multi-organ Failure Death 34 Male 123 lb 10/9/2008 Physician Hungary
Primary
Concomitant
Cerebral Infarction Life Threatening 9/17/2008 48 Male 154 lb 11/4/2008 Physician Japan
Primary
Concomitant
Multi-organ Failure Death 34 Male 123 lb 11/21/2008 Physician Hungary
Primary
Concomitant
Shock Haemorrhagic Death 8/1/2008 39 Male 132 lb 12/1/2008 Physician Japan
Primary
Concomitant
Thrombosis Other Serious 43 Female 12/16/2008 Physician United States
Primary
Concomitant
Proteinuria Other Serious 8/1/2008 Female 12/24/2008 Other Health Professional France
Primary
Secondary
Concomitant
Cerebral Infarction Life Threatening 9/17/2008 48 Male 154 lb 2/12/2009 Physician Japan
Primary
Concomitant
Therapeutic Response Decreased Life Threatening 1/1/2006 0 Female 6 lb 3/17/2009 Other Health Professional United States
Primary
Concomitant
Ischaemic Cerebral Infarction Other Serious 2/20/2003 Female 156 lb 3/17/2009 Other Health Professional United States
Primary
Concomitant
Embolism Death 0 7 lb 4/6/2009 Physician United States
Primary
Concomitant
Proteinuria Other Serious 8/1/2008 Female 4/15/2009 Other Health Professional France
Primary
Concomitant
Peripheral Ischaemia Other Serious 1/27/2009 13 Male 121 lb 5/4/2009 Physician France
Primary
Concomitant
Factor Viii Inhibition Life Threatening 42 Male 179 lb 5/13/2009 Japan
Primary
Concomitant
Dermatitis Exfoliative Other Serious 8/23/2007 72 Female 5/18/2009 Other Health Professional Australia
Primary
Concomitant
Peripheral Ischaemia Hospitalization 1/27/2009 13 Male 121 lb 5/20/2009 Physician France
Primary
Concomitant
Factor Viii Inhibition Life Threatening 42 Male 179 lb 5/22/2009 Japan
Primary
Concomitant
Peripheral Ischaemia Hospitalization 6 Male 57 lb 6/10/2009 Physician Australia
Primary
Concomitant
Multi-organ Failure Hospitalization 6/1/2008 61 Male 196 lb 6/11/2009 Physician Australia
Primary
Concomitant
Hydrocephalus Other Serious 9/1/2007 61 Male 7/6/2009 Physician Japan
Primary
Concomitant
Alkalosis Hospitalization 0 Male 12 lb 10/22/2009 Physician Australia
Primary
Concomitant
Renal Impairment Other Serious 10/25/2009 70 11/5/2009 Physician Japan
Primary
Concomitant
Renal Impairment Other Serious 10/25/2009 70 11/18/2009 Physician Japan
Primary
Concomitant
Drug Ineffective Other Serious 5/8/2007 Female 77 lb 2/15/2010 Physician Japan
Primary
Concomitant
Drug Ineffective Other Serious 10/11/2008 Female 20 lb 2/15/2010 Physician Japan
Primary
Concomitant
Drug Ineffective Other Serious 10/22/2007 Female 10 lb 2/15/2010 Physician Japan
Primary
Concomitant
Embolism Arterial Death 0 7 lb 9/6/2010 Physician United States
Primary
Concomitant
Haematemesis Life Threatening 6/23/2010 8 Male 37 lb 11/15/2010 Physician Thailand
Primary
Secondary
Concomitant

Drug Data