| International Normalised Ratio Fluctuation |
Other Serious |
9/1/2005 |
66 |
Male |
200 lb |
1/12/2006 |
Consumer |
United States |
|
| Oedema Peripheral |
Hospitalization |
8/18/2005 |
69 |
Male |
|
2/7/2006 |
Physician |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Urinary Tract Infection |
Hospitalization |
|
77 |
Male |
|
1/31/2006 |
Other Health Professional |
Canada |
|
| Myocardial Infarction |
Other Serious |
10/11/1999 |
78 |
Male |
|
2/17/2006 |
Physician |
Germany |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Urinary Tract Infection |
Hospitalization |
|
77 |
Male |
|
2/10/2006 |
|
Canada |
|
| Hepatic Function Abnormal |
Hospitalization |
8/18/2005 |
69 |
Male |
|
2/24/2006 |
Physician |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Anaphylactic Reaction |
Life Threatening |
10/26/2005 |
84 |
Male |
|
3/3/2006 |
Consumer |
United States |
|
| Hypoglycaemia |
Hospitalization |
2/10/2006 |
66 |
Male |
|
3/10/2006 |
Physician |
Japan |
|
| Prostate Cancer |
Hospitalization |
1/1/2003 |
69 |
Male |
185 lb |
3/29/2006 |
Lawyer |
United States |
|
| Syncope |
Hospitalization |
4/9/2006 |
75 |
Male |
171 lb |
5/19/2006 |
|
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Torsade De Pointes |
Hospitalization |
5/30/2006 |
62 |
Male |
|
6/7/2006 |
Pharmacist |
United States |
|
| Sinus Tachycardia |
Life Threatening |
5/26/2005 |
78 |
Male |
|
6/5/2006 |
Physician |
United States |
|
| Urinary Hesitation |
|
3/13/2006 |
81 |
Male |
|
6/6/2006 |
|
United States |
|
| Ulcer |
Other Serious |
|
82 |
Male |
|
8/2/2006 |
Consumer |
United States |
|
| Heart Rate Increased |
Other Serious |
8/1/2006 |
78 |
Male |
160 lb |
9/11/2006 |
Consumer |
United States |
|
| Weight Decreased |
Disability |
8/30/2006 |
73 |
Male |
138 lb |
9/21/2006 |
Physician |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Weight Increased |
Other Serious |
11/1/2005 |
74 |
Male |
198 lb |
9/22/2006 |
Other Health Professional |
Germany |
|
| Cardiac Death |
Death |
10/10/2006 |
77 |
Male |
247 lb |
10/18/2006 |
Physician |
Canada |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Weight Decreased |
Hospitalization |
8/30/2006 |
73 |
Male |
138 lb |
10/24/2006 |
Physician |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Speech Disorder |
Disability |
1/1/2004 |
64 |
Male |
|
11/10/2006 |
Physician |
Denmark |
|
| Urine Analysis Abnormal |
Other Serious |
5/1/2006 |
90 |
Male |
|
11/13/2006 |
Other Health Professional |
United States |
|
| Torsade De Pointes |
Other Serious |
10/1/2006 |
78 |
Male |
|
11/17/2006 |
Physician |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Urinary Retention |
|
3/13/2006 |
81 |
Male |
|
9/12/2006 |
|
United States |
|
| Torsade De Pointes |
Other Serious |
10/1/2006 |
78 |
Male |
|
12/6/2006 |
Physician |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Sedation |
Life Threatening |
5/29/2006 |
82 |
Male |
|
12/15/2006 |
Pharmacist |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Pulmonary Embolism |
Other Serious |
|
|
Male |
|
12/22/2006 |
Physician |
United States |
|
| Vitreous Floaters |
Other Serious |
10/30/2005 |
90 |
Male |
209 lb |
8/28/2006 |
Other Health Professional |
United States |
|
| Swelling |
Other Serious |
11/9/2006 |
|
Male |
122 lb |
1/24/2007 |
Physician |
Japan |
| Primary |
|
| Concomitant |
|
| Interacting |
|
|
| Memory Impairment |
Required Intervention |
5/25/2006 |
86 |
Male |
|
1/25/2007 |
Consumer |
Canada |
|
| Neurodermatitis |
Other Serious |
|
91 |
Male |
|
|
|
United States |
|
| Influenza |
Other Serious |
|
63 |
Male |
250 lb |
6/14/2005 |
|
United States |
|
| Renal Disorder |
Hospitalization |
12/20/2006 |
85 |
Male |
|
2/12/2007 |
|
Canada |
|
| Syncope |
Hospitalization |
9/29/2006 |
|
Male |
|
2/23/2007 |
Consumer |
United States |
|
| Pulmonary Oedema |
Hospitalization |
1/4/2006 |
|
Male |
194 lb |
3/14/2007 |
Physician |
Canada |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Somnolence |
Other Serious |
|
75 |
Male |
|
3/15/2007 |
Other Health Professional |
United Kingdom |
|
| Interstitial Lung Disease |
Hospitalization |
12/14/2006 |
89 |
Male |
|
3/15/2007 |
Physician |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Pulmonary Oedema |
Hospitalization |
1/4/2006 |
|
Male |
194 lb |
3/16/2007 |
Physician |
Canada |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Tremor |
Hospitalization |
8/1/2004 |
81 |
Male |
|
3/30/2006 |
Other Health Professional |
United States |
|
| Disease Progression |
Required Intervention |
1/22/2004 |
68 |
Male |
207 lb |
3/30/2006 |
|
United States |
|
| Renal Failure |
Death |
6/24/2004 |
62 |
Male |
|
3/27/2007 |
Physician |
United States |
|
| Oedema Peripheral |
|
1/23/2007 |
88 |
Male |
192 lb |
4/2/2007 |
Other Health Professional |
United States |
|
| Renal Disorder |
Hospitalization |
12/20/2006 |
85 |
Male |
|
6/11/2007 |
Consumer |
Canada |
|
| Hot Flush |
|
|
80 |
Male |
210 lb |
6/29/2007 |
Consumer |
United States |
|
| Movement Disorder |
Life Threatening |
7/1/2007 |
85 |
Male |
|
7/13/2007 |
Pharmacist |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Renal Failure |
Hospitalization |
8/21/2006 |
83 |
Male |
|
8/19/2007 |
Pharmacist |
United States |
|
| Seasonal Affective Disorder |
|
3/1/2001 |
|
Male |
|
8/29/2007 |
Consumer |
United States |
|
| Myocardial Infarction |
Other Serious |
3/9/2007 |
79 |
Male |
|
9/10/2007 |
Other Health Professional |
United Kingdom |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Pancreatic Carcinoma |
Other Serious |
|
73 |
Male |
|
9/25/2007 |
|
Japan |
|
| Pulmonary Fibrosis |
Other Serious |
11/28/2005 |
|
Male |
|
10/16/2007 |
Physician |
United States |
|
| Pancreatic Carcinoma |
Other Serious |
|
73 |
Male |
|
10/12/2007 |
Other Health Professional |
Japan |
|
| Pharmaceutical Product Complaint |
Hospitalization |
10/1/2007 |
90 |
Male |
|
10/26/2007 |
Consumer |
United States |
|
| White Blood Cell Count Increased |
Other Serious |
1/1/2006 |
92 |
Male |
|
8/29/2007 |
Other Health Professional |
United States |
|
| Vomiting |
Other Serious |
10/1/2007 |
81 |
Male |
149 lb |
10/29/2007 |
Other Health Professional |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Stevens-johnson Syndrome |
Hospitalization |
10/12/2007 |
66 |
Male |
|
11/9/2007 |
Pharmacist |
Canada |
|
| Incorrect Route Of Drug Administration |
|
11/15/2006 |
|
|
|
12/6/2007 |
Other Health Professional |
United States |
|
| Prostatectomy |
Other Serious |
8/1/2007 |
66 |
Male |
210 lb |
1/14/2008 |
Consumer |
United States |
|
| Vasculitis |
Other Serious |
|
78 |
Male |
|
1/25/2008 |
Physician |
United Kingdom |
|
| Vasculitic Rash |
Hospitalization |
1/13/2008 |
73 |
Male |
168 lb |
2/7/2008 |
Other Health Professional |
United Kingdom |
|
| Radical Prostatectomy |
Other Serious |
7/1/2007 |
66 |
Male |
210 lb |
2/13/2008 |
Physician |
United States |
|
| Staphylococcal Infection |
Other Serious |
2/1/2008 |
84 |
Male |
|
2/19/2008 |
|
Canada |
|
| Renal Failure |
Death |
|
|
Male |
|
3/19/2008 |
Physician |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Middle Insomnia |
|
10/12/2007 |
72 |
Male |
228 lb |
1/30/2008 |
Consumer |
United States |
|
| Stomatitis |
Hospitalization |
3/3/2008 |
77 |
Male |
223 lb |
4/3/2008 |
Other Health Professional |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Paraesthesia |
|
|
|
Male |
|
4/18/2008 |
Pharmacist |
United States |
|
| Myocardial Infarction |
Life Threatening |
2/26/2008 |
|
Male |
|
4/29/2008 |
Other Health Professional |
France |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Platelet Count Decreased |
Hospitalization |
1/16/2008 |
73 |
Male |
157 lb |
6/9/2008 |
Physician |
Japan |
|
| Wound Haemorrhage |
Other Serious |
|
|
Male |
|
6/13/2008 |
Consumer |
Canada |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Platelet Count Decreased |
Hospitalization |
1/16/2008 |
73 |
Male |
157 lb |
6/18/2008 |
Physician |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Platelet Count Decreased |
Hospitalization |
1/16/2008 |
73 |
Male |
157 lb |
7/1/2008 |
Physician |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Palpitations |
Hospitalization |
7/21/2008 |
|
Male |
152 lb |
7/31/2008 |
Pharmacist |
United States |
|
| Speech Disorder |
Other Serious |
7/8/2008 |
73 |
Male |
240 lb |
7/21/2008 |
Consumer |
United States |
|
| Leukocytoclastic Vasculitis |
Hospitalization |
|
77 |
Male |
|
8/5/2008 |
Pharmacist |
Canada |
|
| Palpitations |
Hospitalization |
1/1/2008 |
|
Male |
152 lb |
8/6/2008 |
Pharmacist |
United Kingdom |
|
| Blood Creatinine Increased |
|
1/1/2008 |
84 |
Male |
|
8/15/2008 |
Pharmacist |
United States |
|
| White Blood Cell Count Decreased |
|
7/28/2008 |
|
Male |
151 lb |
8/20/2008 |
|
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Occult Blood Positive |
Hospitalization |
6/10/2008 |
|
Male |
176 lb |
9/19/2008 |
|
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Pyrexia |
Hospitalization |
8/12/2008 |
|
Male |
|
9/26/2008 |
Other Health Professional |
United States |
|
| Occult Blood Positive |
Hospitalization |
6/10/2008 |
|
Male |
176 lb |
9/30/2008 |
|
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Febrile Neutropenia |
Hospitalization |
9/15/2008 |
|
Male |
|
10/3/2008 |
|
Spain |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Cerebrovascular Accident |
Death |
11/4/2008 |
77 |
Male |
|
11/12/2008 |
Other Health Professional |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Tooth Extraction |
Other Serious |
4/1/2004 |
|
Male |
209 lb |
11/26/2008 |
Physician |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Tooth Extraction |
Other Serious |
4/1/2004 |
|
Male |
209 lb |
1/12/2009 |
Physician |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Wound Haemorrhage |
Other Serious |
|
|
Male |
|
1/21/2009 |
Physician |
Canada |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Urinary Tract Infection |
Hospitalization |
1/7/2009 |
71 |
Male |
|
1/28/2009 |
Physician |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Swelling Face |
Hospitalization |
9/1/2006 |
77 |
Male |
|
1/29/2009 |
|
Japan |
|
| Lung Abscess |
Hospitalization |
1/1/2007 |
79 |
Male |
|
2/2/2009 |
|
Japan |
|
| Cerebrovascular Accident |
Death |
11/4/2008 |
77 |
Male |
150 lb |
2/4/2009 |
Other Health Professional |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Tooth Extraction |
Other Serious |
4/1/2004 |
|
Male |
209 lb |
2/5/2009 |
|
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Interstitial Lung Disease |
Life Threatening |
1/3/2009 |
|
Male |
|
2/10/2009 |
Physician |
Japan |
|
| Wound Dehiscence |
Other Serious |
1/1/2004 |
|
Male |
182 lb |
2/16/2009 |
Physician |
United States |
|
| Intestinal Perforation |
Other Serious |
11/4/2008 |
77 |
Male |
150 lb |
2/17/2009 |
Other Health Professional |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Osteonecrosis |
Other Serious |
12/16/2008 |
78 |
Male |
|
2/18/2009 |
Other Health Professional |
United States |
|
| Tooth Extraction |
Other Serious |
4/1/2004 |
|
Male |
209 lb |
2/18/2009 |
|
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Gastric Ulcer |
Life Threatening |
12/11/2008 |
73 |
Male |
|
2/20/2009 |
|
Japan |
|
| Constipation |
Life Threatening |
5/11/2007 |
72 |
Male |
|
2/20/2009 |
|
Japan |
|
| Intestinal Perforation |
Other Serious |
11/4/2008 |
77 |
Male |
150 lb |
2/26/2009 |
Other Health Professional |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Pneumonia |
Death |
3/15/2008 |
81 |
Male |
|
3/5/2009 |
|
Japan |
|
| Wound Dehiscence |
Other Serious |
1/1/2004 |
|
Male |
182 lb |
3/9/2009 |
Physician |
United States |
|
| Interstitial Lung Disease |
Hospitalization |
2/8/2009 |
74 |
Male |
163 lb |
3/9/2009 |
Pharmacist |
Ireland |
|
| Cardiac Arrest |
Death |
7/3/2008 |
|
Male |
|
3/10/2009 |
|
Canada |
|
| Pancreatitis |
Hospitalization |
|
80 |
Male |
175 lb |
3/16/2009 |
|
United States |
|
| Lung Abscess |
Hospitalization |
1/1/2007 |
79 |
Male |
|
3/18/2009 |
|
Japan |
|
| Lumbar Vertebral Fracture |
Other Serious |
5/13/2007 |
104 |
Male |
|
3/19/2009 |
|
Japan |
|
| Bundle Branch Block Left |
Hospitalization |
8/5/2008 |
79 |
Male |
128 lb |
3/23/2009 |
Other Health Professional |
Japan |
|
| Unresponsive To Stimuli |
Hospitalization |
9/2/2008 |
58 |
Male |
|
3/23/2009 |
Pharmacist |
United States |
|
| Gastrointestinal Haemorrhage |
Death |
3/2/2009 |
78 |
Male |
|
3/23/2009 |
Physician |
Switzerland |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Gastric Ulcer |
Life Threatening |
12/11/2008 |
73 |
Male |
|
3/27/2009 |
|
Japan |
|
| Constipation |
Life Threatening |
5/11/2007 |
72 |
Male |
|
3/27/2009 |
|
Japan |
|
| Bundle Branch Block Left |
Hospitalization |
8/5/2008 |
79 |
Male |
128 lb |
3/30/2009 |
Other Health Professional |
Japan |
|
| Myocardial Ischaemia |
Hospitalization |
|
78 |
Male |
|
4/1/2009 |
|
Japan |
|
| Osteonecrosis |
Other Serious |
12/16/2008 |
78 |
Male |
|
4/3/2009 |
Physician |
United States |
|
| Prostate Cancer |
Other Serious |
1/19/2008 |
74 |
Male |
|
4/3/2009 |
|
Japan |
|
| Pneumonia |
Hospitalization |
7/5/2008 |
74 |
Male |
|
4/8/2009 |
|
Japan |
|
| Shock Haemorrhagic |
Death |
3/2/2009 |
78 |
Male |
146 lb |
4/1/2009 |
Physician |
Switzerland |
|
| Tooth Fracture |
Other Serious |
6/1/2008 |
68 |
Male |
194 lb |
4/15/2009 |
Physician |
Switzerland |
|
| Prostatic Specific Antigen Increased |
|
|
80 |
Male |
186 lb |
4/21/2009 |
|
United States |
|
| Limb Discomfort |
|
|
78 |
Male |
|
4/21/2009 |
Other Health Professional |
United States |
|
| Pain |
|
|
58 |
Male |
231 lb |
4/21/2009 |
|
United States |
|
| Victim Of Homicide |
Death |
1/17/2008 |
72 |
Male |
|
4/27/2009 |
|
Japan |
|
| Tooth Repair |
Other Serious |
4/7/2005 |
|
Male |
|
5/6/2009 |
Physician |
United States |
|
| Tooth Extraction |
Other Serious |
4/1/2004 |
|
Male |
209 lb |
5/11/2009 |
Physician |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Death |
Death |
4/19/2009 |
76 |
Male |
|
5/15/2009 |
Other Health Professional |
Germany |
|
| Prostate Cancer |
Hospitalization |
4/30/2008 |
|
Male |
|
5/22/2009 |
|
Japan |
|
| Tricuspid Valve Incompetence |
Hospitalization |
2/8/2009 |
74 |
Male |
187 lb |
6/2/2009 |
Pharmacist |
Ireland |
|
| Subdural Haematoma |
Death |
6/25/2008 |
77 |
Male |
|
6/8/2009 |
|
Japan |
|
| Pneumonia |
Hospitalization |
7/5/2008 |
74 |
Male |
|
6/18/2009 |
|
Japan |
|
| Muscle Contracture |
Disability |
7/24/2006 |
58 |
Male |
|
6/18/2009 |
Physician |
Japan |
|
| Prostate Cancer Metastatic |
Death |
7/10/2007 |
58 |
Male |
|
6/18/2009 |
|
Japan |
|
| Oesophageal Adenocarcinoma Stage Iii |
Other Serious |
4/7/2009 |
74 |
Male |
132 lb |
6/23/2009 |
Other Health Professional |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Prostate Cancer |
Hospitalization |
4/30/2008 |
|
Male |
|
6/23/2009 |
|
Japan |
|
| Streptococcal Infection |
Other Serious |
3/10/2007 |
71 |
Male |
|
4/20/2009 |
Physician |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Tooth Repair |
Other Serious |
4/7/2005 |
|
Male |
|
6/25/2009 |
Other Health Professional |
United States |
|
| Lumbar Vertebral Fracture |
Other Serious |
5/13/2007 |
104 |
Male |
|
6/29/2009 |
|
Japan |
|
| Tooth Extraction |
Other Serious |
4/1/2004 |
|
Male |
209 lb |
7/2/2009 |
Physician |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Muscle Contracture |
Disability |
7/24/2006 |
58 |
Male |
|
7/2/2009 |
Physician |
Japan |
|
| Interstitial Lung Disease |
Life Threatening |
6/8/2009 |
84 |
Male |
|
7/7/2009 |
Physician |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Cerebral Infarction |
Hospitalization |
12/29/2006 |
81 |
Female |
|
7/8/2009 |
|
Japan |
|
| Cerebral Infarction |
Hospitalization |
12/29/2006 |
81 |
Female |
|
7/24/2009 |
|
Japan |
|
| Cerebral Infarction |
Hospitalization |
12/29/2006 |
81 |
Female |
|
7/24/2009 |
|
Japan |
|
| Neutrophil Count Decreased |
Hospitalization |
7/26/2009 |
|
|
|
7/28/2009 |
|
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Neutrophil Count Decreased |
Hospitalization |
7/26/2009 |
|
Male |
215 lb |
7/30/2009 |
|
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Cerebral Infarction |
Hospitalization |
8/31/2007 |
83 |
Male |
|
8/7/2009 |
|
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Aspiration |
Death |
9/17/2007 |
90 |
Male |
|
8/7/2009 |
|
Japan |
|
| Prostate Cancer Stage Iv |
Death |
7/6/2008 |
91 |
Male |
|
8/10/2009 |
|
Japan |
|
| Urinary Tract Infection |
Hospitalization |
7/26/2009 |
|
Male |
215 lb |
8/17/2009 |
|
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Tremor |
|
7/12/2009 |
|
Male |
172 lb |
8/23/2009 |
|
United States |
|
| Flushing |
|
|
|
Male |
|
8/29/2009 |
|
United States |
|
| Prostate Cancer Stage Iv |
Death |
7/6/2008 |
91 |
Male |
|
8/31/2009 |
|
Japan |
|
| Marasmus |
Death |
1/7/2008 |
85 |
Male |
|
9/2/2009 |
|
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Pneumonia |
Hospitalization |
8/22/2008 |
|
Male |
172 lb |
9/8/2009 |
|
United States |
|