Apixaban combined with Placebo

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Sudden Death Death 7/7/2008 79 Female 7/14/2008 Consumer Mexico
Primary
Secondary
Concomitant
Sudden Death Death 7/7/2008 79 Female 7/22/2008 Consumer Mexico
Primary
Secondary
Concomitant
Pneumonia Hospitalization 7/15/2008 67 Male 161 lb 7/29/2008 Other Health Professional United States
Primary
Secondary
Concomitant
Syncope Hospitalization 5/10/2008 Female 9/2/2008 Other Health Professional United States
Primary
Secondary
Concomitant
Syncope Hospitalization 5/10/2008 Female 9/2/2008 Other Health Professional United States
Primary
Secondary
Concomitant
Arthralgia Hospitalization 8/27/2007 64 Male 9/24/2008 Consumer Australia
Primary
Secondary
Concomitant
Pulmonary Haemorrhage Hospitalization 9/17/2008 79 Male 11/3/2008 Consumer United Kingdom
Primary
Secondary
Concomitant
Upper Gastrointestinal Haemorrhage Life Threatening 9/17/2008 79 Male 11/12/2008 Consumer United Kingdom
Primary
Secondary
Concomitant
Upper Gastrointestinal Haemorrhage Hospitalization 9/17/2008 79 Male 11/21/2008 Consumer United Kingdom
Primary
Secondary
Concomitant
Atrial Fibrillation Hospitalization 4/22/2008 Male 11/24/2008 Other Health Professional United States
Primary
Secondary
Mental Status Changes Hospitalization 9/22/2008 Male 2/4/2009 Physician United States
Primary
Secondary
Atrial Fibrillation Hospitalization 4/22/2008 Male 2/6/2009 Other Health Professional United States
Primary
Secondary
Ischaemic Stroke Life Threatening 12/28/2008 73 Male 179 lb 2/24/2009 Other Health Professional Brazil
Primary
Secondary
Concomitant
Transient Ischaemic Attack Other Serious 3/19/2009 67 Male 4/1/2009 Consumer United States
Primary
Secondary
Concomitant
Weight Increased Other Serious 3/31/2009 77 Female 126 lb 4/23/2009 Consumer United States
Primary
Secondary
Concomitant
Aortic Dissection Rupture Life Threatening 5/21/2009 67 Male 5/29/2009 Consumer United Kingdom
Primary
Secondary
Concomitant
Cerebral Infarction Life Threatening 4/20/2009 78 Female 6/1/2009 Consumer United Kingdom
Primary
Secondary
Concomitant
Cerebral Infarction Life Threatening 4/20/2009 78 Female 6/3/2009 Consumer United Kingdom
Primary
Secondary
Concomitant
Ureteric Stenosis Other Serious 5/15/2009 68 Female 6/4/2009 Consumer United Kingdom
Primary
Secondary
Concomitant
Pneumonia Life Threatening 5/21/2009 67 Male 6/5/2009 Consumer United Kingdom
Primary
Secondary
Concomitant
Haematuria Other Serious 5/15/2009 68 Female 6/11/2009 Consumer United Kingdom
Primary
Secondary
Concomitant
Haematuria Other Serious 5/15/2009 68 Female 6/19/2009 Consumer United Kingdom
Primary
Secondary
Concomitant
Haematuria Other Serious 5/15/2009 68 Female 6/25/2009 Consumer United Kingdom
Primary
Secondary
Concomitant
Throat Tightness Other Serious 4/1/2008 Male 6/29/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Haematuria Other Serious 5/15/2009 68 Female 6/30/2009 Consumer United Kingdom
Primary
Secondary
Concomitant
Sepsis Other Serious 3/1/2009 77 Female 126 lb 7/2/2009 Consumer United States
Primary
Secondary
Concomitant
Ischaemic Stroke Life Threatening 12/27/2008 73 Male 179 lb 7/9/2009 Consumer United States
Primary
Secondary
Concomitant
Hypovolaemic Shock Hospitalization 6/5/2009 78 Male 7/9/2009 Other Health Professional Argentina
Primary
Secondary
Concomitant
Ischaemic Stroke Other Serious 7/1/2009 61 Male 231 lb 7/17/2009 Consumer Brazil
Primary
Secondary
Concomitant
Ischaemic Stroke Other Serious 7/1/2009 61 Male 231 lb 7/23/2009 Consumer Brazil
Primary
Secondary
Concomitant
Ischaemic Stroke Hospitalization 5/28/2009 71 Female 7/24/2009 Consumer United States
Primary
Secondary
Concomitant
Ischaemic Stroke Hospitalization 5/28/2009 71 Female 7/30/2009 Consumer United States
Primary
Secondary
Concomitant
Hypovolaemia Hospitalization 6/18/2009 83 Male 7/30/2009 Consumer United States
Primary
Secondary
Concomitant
Pneumonia Life Threatening 5/21/2009 67 Male 8/6/2009 Consumer United Kingdom
Primary
Secondary
Concomitant
Sepsis Other Serious 3/1/2009 77 Female 126 lb 8/10/2009 Consumer United States
Primary
Secondary
Concomitant
Hepatitis Acute Other Serious 7/22/2009 63 Male 8/20/2009 Consumer Mexico
Primary
Secondary
Concomitant
Convulsion Other Serious 3/19/2009 67 Male 8/24/2009 Consumer United States
Primary
Secondary
Concomitant
Transient Ischaemic Attack Other Serious 3/17/2009 67 Male 9/15/2009 Consumer United States
Primary
Secondary
Concomitant
Aortic Aneurysm Hospitalization 9/4/2009 64 Male 9/18/2009 Consumer United States
Primary
Secondary
Concomitant
Metabolic Encephalopathy Hospitalization 8/14/2009 Female 10/7/2009 Physician United States
Primary
Secondary
Sepsis Other Serious 3/1/2009 77 Female 126 lb 10/12/2009 Consumer United States
Primary
Secondary
Concomitant
Upper Gastrointestinal Haemorrhage Life Threatening 9/17/2008 79 Male 10/15/2009 Consumer United Kingdom
Primary
Secondary
Concomitant
Vascular Pseudoaneurysm Hospitalization 9/4/2009 64 Male 10/15/2009 Consumer United States
Primary
Secondary
Concomitant
Vascular Pseudoaneurysm Hospitalization 9/4/2009 64 Male 10/19/2009 Consumer United States
Primary
Secondary
Concomitant
Cerebral Infarction Life Threatening 4/20/2009 78 Female 10/26/2009 Consumer United Kingdom
Primary
Secondary
Concomitant
Paralysis Other Serious 9/16/2009 75 Male 10/30/2009 Consumer United Kingdom
Primary
Secondary
Renal Failure Acute Life Threatening 5/21/2009 67 Male 11/9/2009 Consumer United Kingdom
Primary
Secondary
Concomitant
Pneumonia Life Threatening 5/21/2009 67 Male 11/12/2009 Consumer United Kingdom
Primary
Secondary
Concomitant
Throat Tightness Other Serious 4/1/2008 Male 11/24/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Arthropathy Hospitalization 10/26/2009 56 Male 12/11/2009 Physician United States
Primary
Secondary
Concomitant
Haemoglobin Decreased Life Threatening 10/13/2009 Female 12/23/2009 Physician Hungary
Primary
Secondary
Concomitant
Mental Status Changes Hospitalization 11/1/2009 Male 12/31/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Therapeutic Agent Toxicity Life Threatening 10/8/2009 66 Female 1/4/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Ischaemic Stroke Hospitalization 12/5/2009 71 Male 1/8/2010 Consumer United States
Primary
Secondary
Concomitant
Ischaemic Stroke Hospitalization 12/5/2009 71 Male 1/14/2010 Consumer United States
Primary
Secondary
Concomitant
Aortic Aneurysm Rupture Death 1/9/2010 90 Female 1/15/2010 Consumer United Kingdom
Primary
Secondary
Concomitant
Large Intestinal Ulcer Hospitalization 11/18/2009 65 Female 1/15/2010 Consumer United States
Primary
Secondary
Concomitant
Aortic Aneurysm Rupture Death 1/9/2010 90 Female 1/22/2010 Consumer United Kingdom
Primary
Secondary
Concomitant
Visual Impairment Other Serious 10/30/2009 Female 1/23/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Ischaemic Stroke Hospitalization 12/5/2009 71 Male 1/26/2010 Consumer United States
Primary
Secondary
Concomitant
Drug Withdrawal Syndrome Hospitalization 1/19/2010 Male 2/10/2010 Physician
Primary
Secondary
Concomitant
Drug Withdrawal Syndrome Hospitalization 1/19/2010 Male 2/18/2010 Physician
Primary
Secondary
Concomitant
Viral Infection Other Serious 1/9/2010 70 Female 2/19/2010 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Electrocardiogram Qt Prolonged Other Serious 1/19/2010 Male 2/22/2010 Physician
Primary
Secondary
Concomitant
Haemoglobin Decreased Life Threatening 10/13/2009 Female 3/2/2010 Physician Hungary
Primary
Secondary
Concomitant
Pneumonia Life Threatening 5/21/2009 67 Male 3/2/2010 Consumer United Kingdom
Primary
Secondary
Concomitant
Viral Infection Other Serious 1/9/2010 70 Female 3/3/2010 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Neuropathy Peripheral Other Serious 1/31/2010 84 Male 3/9/2010 Other Health Professional Mexico
Primary
Secondary
Concomitant
Viral Infection Other Serious 1/9/2010 70 Female 3/18/2010 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Pneumonia Life Threatening 12/27/2008 73 Male 179 lb 3/25/2010 Consumer United States
Primary
Secondary
Concomitant
Upper Gastrointestinal Haemorrhage Life Threatening 9/17/2008 79 Male 3/26/2010 Consumer United Kingdom
Primary
Secondary
Concomitant
Pneumonia Life Threatening 12/27/2008 73 Male 179 lb 4/1/2010 Consumer United States
Primary
Secondary
Concomitant
Electrocardiogram Qt Prolonged Other Serious 1/19/2010 65 Male 4/6/2010 Physician
Primary
Secondary
Concomitant
Upper Gastrointestinal Haemorrhage Hospitalization 3/13/2010 65 Male 4/28/2010 Consumer United Kingdom
Primary
Secondary
Concomitant
Synovial Rupture Other Serious 3/23/2010 81 Male 4/30/2010 Consumer United Kingdom
Primary
Secondary
Concomitant
Upper Gastrointestinal Haemorrhage Hospitalization 3/13/2010 65 Male 5/5/2010 Consumer United Kingdom
Primary
Secondary
Concomitant
Syncope Hospitalization 1/24/2010 88 Female 5/6/2010 Other Health Professional United States
Primary
Secondary
Thoracic Haemorrhage Life Threatening 5/21/2009 67 Male 5/6/2010 Consumer United Kingdom
Primary
Secondary
Concomitant
Psoriasis Hospitalization 4/27/2010 71 Male 5/11/2010 Consumer United Kingdom
Primary
Secondary
Somnolence Hospitalization 11/1/2009 69 Male 5/11/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Electrocardiogram Qt Prolonged Other Serious 1/19/2010 65 Male 5/24/2010 Physician
Primary
Secondary
Concomitant
Cerebral Infarction Life Threatening 4/20/2009 78 Female 5/27/2010 Consumer United Kingdom
Primary
Secondary
Concomitant
Pneumonia Life Threatening 5/21/2009 67 Male 5/27/2010 Consumer United Kingdom
Primary
Secondary
Concomitant
Haematuria Other Serious 5/15/2009 68 Female 6/1/2010 Consumer United Kingdom
Primary
Secondary
Concomitant
Syncope Hospitalization 1/24/2010 88 Female 6/2/2010 Other Health Professional United States
Primary
Secondary
Limb Discomfort Hospitalization Female 6/2/2010 Physician United States
Primary
Secondary
Concomitant
Orthostatic Hypotension Hospitalization Female 6/3/2010 Physician United States
Primary
Secondary
Concomitant
Urinary Tract Infection Hospitalization 6/20/2009 78 Male 6/3/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Urinary Tract Infection Hospitalization 6/20/2009 78 Male 6/3/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Mental Status Changes Hospitalization 11/1/2009 69 Male 6/15/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Psoriasis Hospitalization 4/27/2010 71 Male 6/16/2010 Consumer United Kingdom
Primary
Secondary
Electrocardiogram Qt Prolonged Other Serious 1/19/2010 65 Male 6/30/2010 Physician
Primary
Secondary
Concomitant
Tubulointerstitial Nephritis Other Serious 9/24/2009 65 Male 6/30/2010 Consumer United Kingdom
Primary
Secondary
Concomitant
Transient Ischaemic Attack Other Serious 3/17/2009 67 Male 7/2/2010 Consumer United States
Primary
Secondary
Concomitant
Mesenteric Artery Embolism Hospitalization 3/1/2010 77 Male 7/9/2010 Consumer United Kingdom
Primary
Secondary
Concomitant
Psoriasis Hospitalization 4/27/2010 71 Male 7/12/2010 Consumer United Kingdom
Primary
Secondary
Concomitant
Mesenteric Artery Embolism Hospitalization 3/1/2010 77 Male 7/16/2010 Consumer United Kingdom
Primary
Secondary
Concomitant
Electrocardiogram Qt Prolonged Other Serious 1/19/2010 65 Male 7/23/2010 Physician
Primary
Secondary
Concomitant
Mesenteric Artery Embolism Hospitalization 3/1/2010 77 Male 7/26/2010 Consumer United Kingdom
Primary
Secondary
Concomitant
Gilbert's Syndrome Other Serious 7/27/2010 70 Male 207 lb 8/12/2010 Consumer United Kingdom
Primary
Secondary
Concomitant
Aortic Aneurysm Rupture Life Threatening 8/12/2010 80 Male 8/16/2010 Consumer United Kingdom
Primary
Secondary
Concomitant
Renal Failure Acute Life Threatening 8/1/2010 56 Male 8/23/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Aortic Aneurysm Rupture Life Threatening 8/12/2010 80 Male 8/23/2010 Consumer United Kingdom
Primary
Secondary
Concomitant
Spinal Compression Fracture Hospitalization 7/2/2010 79 Female 88 lb 8/24/2010 Consumer United Kingdom
Primary
Secondary
Concomitant
Tremor Hospitalization 11/1/2009 69 Male 9/10/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Mesenteric Artery Embolism Hospitalization 3/1/2010 77 Male 9/15/2010 Consumer United Kingdom
Primary
Secondary
Concomitant
Akathisia Hospitalization 6/25/2010 41 Female 9/17/2010 Other Health Professional United States
Primary
Secondary
Therapeutic Agent Toxicity Hospitalization 2/21/2010 88 Female 9/22/2010 Physician Spain
Primary
Secondary
Concomitant
Vascular Dementia Hospitalization 11/1/2009 69 Male 10/1/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Visual Impairment Other Serious 10/30/2009 84 Female 10/25/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Urticaria Other Serious 8/21/2010 70 Male 11/8/2010 Other Health Professional Italy
Primary
Secondary
Urinary Tract Infection Other Serious 9/24/2009 65 Male 11/22/2010 Consumer United Kingdom
Primary
Secondary
Concomitant
Unresponsive To Stimuli Life Threatening 8/1/2010 56 Male 11/29/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Wrong Technique In Drug Usage Process Life Threatening 8/1/2010 56 Male 11/29/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Tremor Hospitalization 10/24/2010 85 Male 12/1/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Tremor Hospitalization 10/24/2010 85 Male 12/2/2010 Physician United States
Primary
Secondary
Concomitant
Tremor Hospitalization 10/24/2010 85 Male 12/3/2010 Physician United States
Primary
Secondary
Concomitant
Gilbert's Syndrome Other Serious 7/27/2010 70 Male 207 lb 12/8/2010 Consumer United Kingdom
Primary
Secondary
Concomitant
Vomiting Life Threatening 9/17/2008 79 Male 12/10/2010 Consumer United Kingdom
Primary
Secondary
Concomitant
Aortic Aneurysm Rupture Life Threatening 8/12/2010 80 Male 12/13/2010 Consumer United Kingdom
Primary
Secondary
Concomitant
Hepatic Function Abnormal Hospitalization 58 Male 12/16/2010 Consumer United States
Primary
Secondary
Hepatic Function Abnormal Hospitalization 58 Male 12/19/2010 Consumer United States
Primary
Secondary
Visual Impairment Hospitalization 12/2/2009 42 Male 12/22/2010 Other Health Professional Philippines
Primary
Secondary
Concomitant
Gilbert's Syndrome Other Serious 7/27/2010 70 Male 207 lb 12/23/2010 Consumer United Kingdom
Primary
Secondary
Concomitant
Visual Impairment Hospitalization 12/2/2009 12/27/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Visual Impairment Hospitalization 12/2/2009 42 Male 12/27/2010 Other Health Professional Philippines
Primary
Secondary
Concomitant
Renal Failure Acute Life Threatening 8/1/2010 56 Male 12/30/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Presyncope Hospitalization 12/2/2009 42 Male 1/3/2011 Other Health Professional Philippines
Primary
Secondary
Concomitant
Urinary Tract Infection Hospitalization 6/11/2010 82 Female 12/20/2010 India
Primary
Secondary
Concomitant
Hiccups Hospitalization 9/25/2010 86 Male 1/5/2011 Physician United States
Primary
Secondary
Concomitant
Diabetes Mellitus Other Serious 8/21/2010 70 Male 1/11/2011 Other Health Professional Italy
Primary
Secondary
Tremor Hospitalization 9/25/2010 85 Male 1/25/2011 Physician United States
Primary
Secondary
Concomitant
Hypotension Hospitalization 11/2/2010 86 Male 1/17/2011 Other Health Professional Canada
Primary
Secondary
Concomitant
Liver Function Test Abnormal Hospitalization 12/23/2010 75 Female 1/27/2011 Other Health Professional United States
Primary
Secondary
Concomitant
Tremor Hospitalization 10/24/2010 86 Male 1/27/2011 Physician United States
Primary
Secondary
Concomitant
Cardiac Arrest Death 12/2/2010 1/27/2011 Other Health Professional United States
Primary
Secondary
Intentional Drug Misuse Life Threatening 8/1/2010 56 Male 1/31/2011 Other Health Professional United States
Primary
Secondary
Concomitant
Urticaria Hospitalization 8/21/2010 70 Male 2/2/2011 Other Health Professional Italy
Primary
Secondary
Concomitant
Cellulitis Hospitalization 12/23/2010 74 Female 2/2/2011 Physician United States
Primary
Secondary
Concomitant
Psychiatric Decompensation Required Intervention 10/22/2010 29 1/27/2011 France
Primary
Secondary
Concomitant
Urticaria Hospitalization 8/21/2010 70 Male 2/3/2011 Other Health Professional Italy
Primary
Secondary
Concomitant
Urinary Tract Infection Bacterial Hospitalization 12/23/2010 75 Female 2/9/2011 Other Health Professional United States
Primary
Secondary
Concomitant
Cholelithiasis Hospitalization 12/23/2010 75 Female 2/16/2011 Other Health Professional United States
Primary
Secondary
Concomitant
Hypotension Other Serious 1/13/2011 43 Female 2/16/2011 Consumer United States
Primary
Secondary
Concomitant
Visual Impairment Hospitalization 12/2/2009 42 Male 2/16/2011 Other Health Professional Philippines
Primary
Secondary
Concomitant
Overdose Hospitalization 11/25/2010 79 Female 2/18/2011 Other Health Professional United States
Primary
Secondary
Renal Failure Acute Life Threatening 8/1/2010 56 Male 2/24/2011 Other Health Professional United States
Primary
Secondary
Concomitant
Toxicity To Various Agents Hospitalization 10/16/2010 62 Female 2/24/2011 Physician United States
Primary
Secondary
Concomitant
Hypoxia Life Threatening 1/13/2011 43 Female 2/24/2011 Consumer United States
Primary
Secondary
Concomitant
Cholelithiasis Hospitalization 12/23/2010 74 Female 2/28/2011 Other Health Professional Israel
Primary
Secondary
Concomitant

Drug Data