Aspirin combined with Blinded Therapy

Reports:

---

Reaction	Outcome	Event Date	Age	Sex	Weight	Reported	Reporter	Country	Treatment
									Role	Name
Vasculitis	Required Intervention	6/29/2006	64	Male	189 lb	8/8/2006	Physician	United States	Primary Concomitant
Thrombocytopenic Purpura	Hospitalization	4/18/2007	66	Male	185 lb	6/18/2007	Physician	United States	Primary Concomitant
Amnesia	Disability	1/15/2007	56	Male		3/4/2008		United Kingdom	Primary Secondary Concomitant
Duodenal Ulcer Perforation	Hospitalization	8/2/2005	69	Female		3/31/2008		Denmark	Primary Secondary Concomitant
Duodenal Ulcer Perforation	Hospitalization	8/2/2005	69	Female		4/9/2008	Physician	Denmark	Primary Secondary Concomitant
Dyspnoea	Hospitalization	7/19/2008	56	Female	454 lb	10/6/2008	Other Health Professional	United States	Primary Secondary Concomitant
Dyspnoea	Hospitalization	7/19/2008	56	Female	454 lb	10/10/2008	Other Health Professional	United States	Primary Secondary Concomitant
Dyspnoea	Hospitalization	7/19/2008	56	Female	453 lb	12/11/2008	Physician	United States	Primary Secondary Concomitant
Dyspnoea	Hospitalization	7/19/2008		Female	453 lb	3/19/2009	Other Health Professional	United States	Primary Secondary Concomitant
Urinary Tract Infection	Hospitalization	8/12/2009	69	Male	236 lb	11/16/2009	Physician	United States	Primary Secondary Concomitant
Haemoptysis	Hospitalization	10/2/2009	62	Female	142 lb	11/24/2009	Consumer	Belgium	Primary Secondary Concomitant
Hyponatraemia	Hospitalization	8/21/2009	74	Male		11/30/2009	Consumer	United States	Primary Secondary Concomitant
Mallory-weiss Syndrome	Hospitalization	8/1/2009	73	Male	134 lb	12/4/2009	Physician	Japan	Primary Secondary Concomitant
Weight Decreased	Hospitalization	10/19/2009	69	Male	166 lb	12/7/2009		United States	Primary Secondary Concomitant
Pneumonia	Hospitalization	9/26/2009	66	Male	136 lb	12/8/2009	Consumer	Korea, Republic Of	Primary Secondary Concomitant
Urosepsis	Hospitalization	3/1/2005	75	Male	176 lb	12/14/2009	Physician	Taiwan, Province Of China	Primary Concomitant
Vomiting	Hospitalization	10/31/2007	78	Female	181 lb	12/14/2009	Physician	Canada	Primary Concomitant
Vaginal Haemorrhage	Life Threatening	1/29/2005	65	Female	180 lb	12/14/2009	Physician	Canada	Primary Concomitant
Upper Gastrointestinal Haemorrhage	Other Serious	4/25/2005	90	Male	146 lb	12/14/2009	Physician	Hong Kong	Primary Concomitant
Gastrointestinal Haemorrhage	Life Threatening	7/28/2006	85	Female	141 lb	12/14/2009	Physician	Spain	Primary Concomitant
Haemorrhage	Other Serious	10/26/2006	86	Male	159 lb	12/14/2009	Physician	United Kingdom	Primary Concomitant
Therapeutic Agent Toxicity	Life Threatening	10/6/2009	66	Female		12/7/2009		Canada	Primary Secondary Concomitant
Off Label Use	Hospitalization	8/21/2009	74	Male		12/17/2009	Consumer	United States	Primary Secondary Concomitant
Therapeutic Agent Toxicity	Life Threatening	10/6/2009	66	Female		11/12/2009		Canada	Primary Secondary Concomitant
Pulmonary Embolism	Life Threatening	11/2/2009	71	Male	201 lb	12/22/2009	Physician	Canada	Primary Secondary Concomitant
Normochromic Normocytic Anaemia	Hospitalization	10/26/2009	72	Male	385 lb	12/22/2009	Physician	United States	Primary Secondary Concomitant
Urinary Bladder Polyp	Other Serious	12/7/2009	69	Male		12/23/2009	Physician	Argentina	Primary Secondary Concomitant
Renal Failure	Hospitalization	9/30/2009		Male	210 lb	1/12/2010	Physician	United States	Primary Secondary Concomitant
Suicide Attempt	Life Threatening	12/26/2009	60	Male		1/13/2010	Physician	Denmark	Primary Secondary Concomitant
Renal Failure	Hospitalization	9/29/2009		Male	210 lb	1/15/2010	Physician	United States	Primary Secondary Concomitant
Hypokalaemia	Life Threatening	11/24/2009	66	Female	209 lb	1/25/2010	Consumer	United States	Primary Secondary Concomitant
Nephrogenic Anaemia	Other Serious	1/20/2009	76	Female		1/21/2010		United States	Primary Secondary
Coronary Artery Restenosis	Other Serious	1/14/2010	68	Male		1/27/2010	Physician	Japan	Primary Secondary Concomitant
Death	Other Serious	10/1/2009	66	Male		2/4/2010	Consumer	Canada	Primary Secondary Concomitant
Ventricular Fibrillation	Other Serious	10/1/2009	66	Male		2/9/2010	Consumer	Canada	Primary Secondary Concomitant
Hypokalaemia	Life Threatening	11/24/2009	66	Female	209 lb	2/10/2010	Consumer	United States	Primary Secondary Concomitant
Suicide Attempt	Life Threatening	12/26/2009	60	Male		2/10/2010	Physician	Denmark	Primary Secondary Concomitant
Mallory-weiss Syndrome	Hospitalization	8/1/2009	73	Male	134 lb	2/11/2010	Physician	Japan	Primary Secondary Concomitant
Sepsis	Hospitalization	11/24/2009	66	Female	209 lb	2/23/2010	Consumer	United States	Primary Secondary Concomitant
Nasopharyngitis	Hospitalization	1/22/2010	64	Male		3/1/2010	Physician	United States	Primary Secondary Concomitant
Musculoskeletal Chest Pain	Hospitalization	11/24/2009		Male	200 lb	3/3/2010	Physician	United States	Primary Secondary Concomitant
Withdrawal Syndrome	Hospitalization	9/29/2009		Male	210 lb	3/4/2010	Consumer	United States	Primary Secondary Concomitant
Pulmonary Embolism	Hospitalization	2/13/2010		Male	131 lb	3/3/2010	Physician	Japan	Primary Secondary Concomitant
Rectosigmoid Cancer Stage Iii	Other Serious	6/1/2009	70	Male		3/24/2010	Physician	United Kingdom	Primary Secondary Concomitant
Splenomegaly	Other Serious	11/2/2009	82	Female		3/25/2010	Other Health Professional	United States	Primary Secondary Concomitant
Rectosigmoid Cancer Stage Iii	Other Serious	6/1/2009	70	Male		4/6/2010	Physician	United Kingdom	Primary Secondary Concomitant
Renal Failure	Hospitalization	8/7/2008	77	Male	198 lb	4/7/2010	Consumer	Poland	Primary Secondary Concomitant
Pulmonary Embolism	Hospitalization	2/13/2010	69	Male	131 lb	4/20/2010	Physician	Japan	Primary Secondary Concomitant
Pericardial Effusion	Other Serious	11/1/2009	71	Male	200 lb	4/22/2010	Physician	United States	Primary Secondary Concomitant
Pneumonia	Hospitalization	2/13/2010	69	Male	131 lb	4/26/2010	Physician	Japan	Primary Secondary Concomitant
Upper Gastrointestinal Haemorrhage	Hospitalization	9/20/2009	56	Male		4/27/2010	Physician	United States	Primary Secondary Concomitant
Pericardial Effusion	Other Serious	11/1/2009	71	Male	200 lb	4/27/2010	Physician	United States	Primary Secondary Concomitant
Gastric Ulcer	Other Serious	11/28/2009	80	Male	123 lb	4/28/2010	Physician	Japan	Primary Secondary Concomitant
Non-small Cell Lung Cancer	Other Serious	2/15/2010	70	Male		4/29/2010	Physician	Croatia (Local Name: Hrvatska)	Primary Secondary Concomitant
Rectosigmoid Cancer Stage Iii	Other Serious	6/1/2009	70	Male	157 lb	5/4/2010	Physician	United Kingdom	Primary Secondary Concomitant
Parkinson's Disease	Other Serious	3/1/2010	78	Male	170 lb	5/11/2010	Physician	United States	Primary Secondary Concomitant
Non-small Cell Lung Cancer	Other Serious	2/15/2010	70	Male		5/12/2010	Physician	Croatia (Local Name: Hrvatska)	Primary Secondary Concomitant
Parkinson's Disease	Other Serious	3/11/2010	78	Male	170 lb	5/14/2010	Physician	United States	Primary Secondary Concomitant
Parkinson's Disease	Other Serious	3/11/2010	78	Male	170 lb	5/18/2010	Physician	United States	Primary Secondary Concomitant
Pulmonary Embolism	Life Threatening	11/2/2009	71	Male	201 lb	5/21/2010	Physician	Canada	Primary Secondary Concomitant
Stomatitis	Hospitalization	5/22/2010	68	Male	187 lb	6/21/2010	Physician	United States	Primary Secondary Concomitant
Stomatitis	Hospitalization	5/22/2010	68	Male	187 lb	6/28/2010	Physician	United States	Primary Secondary Concomitant
White Blood Cell Count Increased	Hospitalization	4/30/2010	65	Female		6/24/2010		Japan	Primary Secondary Concomitant
Urinary Tract Infection	Hospitalization	5/31/2010	76	Female	172 lb	7/13/2010	Physician	Germany	Primary Secondary Concomitant
Gastric Ulcer	Hospitalization	6/18/2010	62	Male	227 lb	7/28/2010	Physician	United States	Primary Secondary Concomitant
Small Intestinal Obstruction	Hospitalization	7/12/2010	66	Male		8/4/2010	Physician	United States	Primary Secondary Concomitant
Small Intestinal Obstruction	Hospitalization	7/12/2010	66	Male		8/11/2010	Physician	United States	Primary Secondary Concomitant
Wound Infection Staphylococcal	Hospitalization	6/18/2010	62	Male	227 lb	8/27/2010	Physician	United States	Primary Secondary Concomitant
Small Intestinal Obstruction	Hospitalization	7/12/2010	66	Male		9/8/2010	Physician	United States	Primary Secondary Concomitant
Lung Neoplasm Malignant	Hospitalization	2/2/2010	88	Male	130 lb	9/20/2010	Physician	Japan	Primary Secondary Concomitant
Wound Infection Staphylococcal	Hospitalization	6/18/2010	62	Male	227 lb	9/21/2010	Physician	United States	Primary Secondary Concomitant
Pulmonary Embolism	Other Serious	9/7/2010	80	Female	183 lb	9/24/2010	Physician	Canada	Primary Secondary Concomitant
In-stent Coronary Artery Restenosis	Other Serious	1/14/2010	68	Male	150 lb	9/28/2010	Physician	Japan	Primary Secondary Concomitant
Urosepsis	Hospitalization	8/12/2009	67	Male	236 lb	9/29/2010	Physician	United States	Primary Secondary Concomitant
Cerebral Ischaemia	Hospitalization	8/7/2010	64	Male	201 lb	10/4/2010	Physician	Chile	Primary Secondary Concomitant
Urinary Bladder Polyp	Other Serious	12/7/2009	69	Male		10/4/2010	Physician	Argentina	Primary Secondary Concomitant
Multi-organ Failure	Death	10/4/2009	69	Male	193 lb	10/5/2010	Physician	United States	Primary Secondary Concomitant
Haemoglobin Decreased	Hospitalization	9/29/2010	72	Female	106 lb	10/13/2010	Physician	United States	Primary Secondary Concomitant
Coronary Artery Disease	Life Threatening	8/30/2010	67	Male		10/22/2010	Physician	United States	Primary Secondary Concomitant
Syncope	Hospitalization	8/28/2010	70	Female	150 lb	10/29/2010	Physician	Canada	Primary Secondary Concomitant
Syncope	Hospitalization	8/28/2010	70	Female	150 lb	11/5/2010	Physician	Canada	Primary Secondary Concomitant
Angioedema	Other Serious	8/26/2010	69	Male		11/8/2010		Canada	Primary Secondary Concomitant
Tumour Lysis Syndrome	Life Threatening	2/23/2010	59	Male		11/25/2010	Physician	United States	Primary Secondary Concomitant
Angina Unstable	Hospitalization	10/28/2010	60	Male	154 lb	12/1/2010	Physician	Brazil	Primary Secondary Concomitant
Coronary Artery Disease	Hospitalization	8/26/2010	69	Male		11/19/2010	Physician	Canada	Primary Secondary Concomitant
Acute Respiratory Failure	Hospitalization	11/3/2010	86	Female	158 lb	12/7/2010	Physician	United States	Primary Secondary Concomitant
Protrusion Tongue	Other Serious	8/26/2010	69	Male		11/29/2010	Physician	Canada	Primary Secondary Concomitant
Cerebral Ischaemia	Hospitalization	8/7/2010	64	Male	201 lb	1/4/2011	Physician	Chile	Primary Secondary Concomitant
Multi-organ Failure	Life Threatening	1/6/2011	79	Male	150 lb	1/18/2011	Physician	Chile	Primary Secondary Concomitant
Aphasia	Hospitalization	11/13/2006	55	Male		2/7/2011	Other Health Professional	Germany	Primary Secondary Concomitant
Liver Function Test Abnormal	Hospitalization	5/6/2010		Female	104 lb	2/10/2011	Other Health Professional	United States	Primary Secondary Concomitant
Death	Death	1/1/2010	49	Female	170 lb	2/16/2011	Physician	United States	Primary Secondary Concomitant
Acute Pulmonary Oedema	Hospitalization	9/20/2010	78	Male	194 lb	2/24/2011	Physician	Italy	Primary Secondary Concomitant
Hypomania	Other Serious	1/10/2005	67	Female		3/3/2011	Consumer	Canada	Primary Secondary Concomitant
Ventricular Fibrillation	Life Threatening	2/9/2011	65	Female	161 lb	3/7/2011	Other Health Professional	Colombia	Primary Secondary Concomitant
Femoral Neck Fracture	Hospitalization	10/12/2009	88	Female		2/28/2011		United States	Primary Secondary Concomitant
Disorientation	Other Serious	11/13/2006	55	Male		3/10/2011	Other Health Professional	Germany	Primary Secondary Concomitant
Gastroenteritis	Hospitalization	10/27/2008	64	Male		3/10/2011	Physician	Ireland	Primary Secondary Concomitant
Pulmonary Embolism	Hospitalization	11/2/2009	71	Male	201 lb	3/11/2011	Physician	Canada	Primary Concomitant
Squamous Cell Carcinoma	Other Serious	2/18/2011	64	Male		3/14/2011	Physician	United States	Primary Secondary Concomitant
Hypoglycaemia	Hospitalization	10/27/2008	64	Male		3/17/2011	Physician	Ireland	Primary Secondary Concomitant
Angina Pectoris	Hospitalization	1/6/2011	76	Male	117 lb	3/18/2011	Physician	Japan	Primary Secondary
Pericardial Effusion	Other Serious	11/1/2009	71	Male	200 lb	4/8/2011	Consumer	United States	Primary Secondary Concomitant
Angina Pectoris	Other Serious	1/12/2011	71	Male	147 lb	4/14/2011	Physician	United States	Primary Secondary Concomitant
Syncope	Hospitalization	8/28/2010	70	Female	150 lb	4/26/2011	Physician	Canada	Primary Secondary Concomitant
Renal Failure Acute	Hospitalization	1/7/2011	46	Female		5/2/2011	Other Health Professional		Primary Secondary Concomitant
Systemic Inflammatory Response Syndrome	Hospitalization	12/8/2010	70	Male		5/13/2011	Physician	United States	Primary Secondary Concomitant
Gastroenteritis Viral	Hospitalization	1/7/2011	46	Female		5/6/2011		Netherlands	Primary Secondary Concomitant
Small Intestinal Obstruction	Hospitalization	7/12/2010	66	Male		5/19/2011	Consumer	United States	Primary Secondary Concomitant
Vascular Pseudoaneurysm	Hospitalization	4/30/2011	70	Male	187 lb	5/23/2011	Physician	Poland	Primary Secondary Concomitant
Haemoglobin Decreased	Hospitalization	5/11/2011	74	Male	154 lb	5/27/2011	Physician	Portugal	Primary Secondary
Cardiac Failure Congestive	Other Serious	1/1/2010	76	Male		5/31/2011	Physician	United States	Primary Secondary Concomitant
Renal Failure	Other Serious	3/4/2010	89	Male	186 lb	5/19/2011		United States	Primary Secondary Concomitant
Musculoskeletal Chest Pain	Other Serious	11/1/2009	71	Male	200 lb	6/1/2011	Consumer	United States	Primary Secondary Concomitant
Drug Eruption	Hospitalization	5/10/2011	72	Male	154 lb	6/3/2011	Physician	Japan	Primary Secondary
Haemoglobin Decreased	Hospitalization	5/11/2011	74	Male	154 lb	6/3/2011	Physician	Portugal	Primary Secondary
Atrial Flutter	Hospitalization	5/21/2011	60	Male	281 lb	6/6/2011	Physician	United States	Primary Secondary Concomitant
Loss Of Consciousness	Hospitalization	4/8/2011	59	Male		6/6/2011	Physician	Spain	Primary Secondary Concomitant
Hypotension	Hospitalization	12/8/2010	70	Male		6/9/2011	Physician	United States	Primary Secondary Concomitant
Post Procedural Complication	Hospitalization	5/21/2011	60	Male	281 lb	6/14/2011	Physician	United States	Primary Secondary Concomitant
Death	Death	5/16/2011	73	Male	197 lb	6/14/2011	Physician	Russian Federation	Primary Secondary Concomitant
Atrial Fibrillation	Hospitalization	5/21/2011	60	Male	281 lb	6/16/2011	Physician	United States	Primary Secondary Concomitant
Atrial Fibrillation	Hospitalization	5/21/2011	60	Male	281 lb	6/24/2011	Physician	United States	Primary Secondary Concomitant
Hallucination	Other Serious	1/14/2011	65	Male	179 lb	6/29/2011	Physician	United States	Primary Secondary Concomitant
Arrhythmia Supraventricular	Hospitalization	4/29/2010	57	Male	236 lb	7/5/2011	Physician	Canada	Primary Secondary Concomitant
Dehydration	Hospitalization	5/6/2010	89	Female	104 lb	7/5/2011	Other Health Professional	United States	Primary Secondary Concomitant
Tumour Lysis Syndrome	Life Threatening	3/23/2011	64	Male	189 lb	7/8/2011	Physician	United States	Primary Secondary Concomitant
Cardiac Failure	Other Serious			Female		7/18/2011	Physician	Canada	Primary Secondary Concomitant
Dyspnoea	Hospitalization	6/12/2011	54	Male	258 lb	7/19/2011	Physician	United States	Primary Secondary Concomitant
Dyspnoea	Hospitalization	6/12/2011	54	Male	258 lb	7/21/2011	Physician	United States	Primary Secondary Concomitant
Dyspnoea	Hospitalization	6/12/2011	54	Male	258 lb	7/27/2011	Physician	United States	Primary Secondary Concomitant
Dyspepsia	Hospitalization	8/22/2011	60	Male	99 lb	9/7/2011	Physician	Thailand	Primary Secondary Concomitant
Hallucination	Hospitalization	1/14/2011	65	Male	179 lb	9/8/2011	Physician	United States	Primary Secondary Concomitant
Non-cardiac Chest Pain	Other Serious	6/3/2010	58	Male	251 lb	9/22/2011	Physician	Canada	Primary Secondary Concomitant
Eosinophilia	Other Serious	9/3/2011	78	Female	139 lb	9/26/2011	Physician	Sweden	Primary Secondary Concomitant
Anxiety	Other Serious	6/3/2010	58	Male	251 lb	10/12/2011	Physician	Canada	Primary Secondary Concomitant
Vascular Pseudoaneurysm	Hospitalization	10/11/2011	63	Male	205 lb	10/19/2011	Physician	Chile	Primary Secondary Concomitant
Acute Pulmonary Oedema	Life Threatening	10/13/2011	72	Male	128 lb	10/20/2011	Physician	Taiwan, Province Of China	Primary Secondary Concomitant
Dilatation Ventricular	Death	7/2/2011	60	Male		10/21/2011	Other Health Professional		Primary Secondary Concomitant
Eosinophilia	Other Serious	9/3/2011	78	Female	139 lb	10/26/2011	Physician	Sweden	Primary Secondary Concomitant
Eosinophilia	Other Serious	9/3/2011	78	Female	139 lb	10/26/2011	Physician	Sweden	Primary Secondary Concomitant
Vascular Pseudoaneurysm	Hospitalization	10/11/2011	63	Male	205 lb	10/26/2011	Physician	Chile	Primary Secondary Concomitant
Jaundice	Hospitalization	1/1/2011	75	Male		10/27/2011	Physician	Argentina	Primary Secondary Concomitant
Hepatic Enzyme Increased	Hospitalization	6/1/2011	58	Male		10/28/2011	Physician	Israel	Primary Secondary Concomitant
Thrombocytopenia	Disability	10/13/2011	72	Male	128 lb	10/30/2011	Physician	Taiwan, Province Of China	Primary Secondary Concomitant
Multi-organ Failure	Life Threatening	10/13/2011	72	Male	128 lb	10/31/2011	Physician	Taiwan, Province Of China	Primary Secondary Concomitant
Mitral Valve Incompetence	Hospitalization	9/3/2011	78	Female	139 lb	11/3/2011	Physician	Sweden	Primary Secondary Concomitant
Renal Failure Acute	Hospitalization	1/7/2011	46	Female		11/2/2011			Primary Secondary Concomitant
Renal Failure Acute	Hospitalization	1/7/2011	46	Female		11/2/2011	Physician	Netherlands	Primary Secondary Concomitant
Vascular Pseudoaneurysm	Hospitalization	10/11/2011	63	Male	205 lb	11/18/2011	Physician	Chile	Primary Secondary Concomitant