| Unevaluable Event |
Hospitalization |
1/1/1999 |
49 |
Male |
185 lb |
1/12/2006 |
Lawyer |
United States |
|
| Death |
Death |
12/25/2005 |
57 |
Male |
235 lb |
1/13/2006 |
Other Health Professional |
United States |
|
| Deep Vein Thrombosis |
Hospitalization |
1/1/2002 |
52 |
Female |
190 lb |
1/23/2006 |
Lawyer |
United States |
|
| Pulmonary Embolism |
Life Threatening |
12/29/2005 |
77 |
Female |
|
1/27/2006 |
Physician |
United States |
|
| Pain In Extremity |
Disability |
|
|
Female |
|
3/2/2006 |
|
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Pulmonary Hypertension |
Life Threatening |
9/27/2005 |
69 |
Male |
212 lb |
2/14/2006 |
Physician |
United States |
|
| Palpitations |
|
2/20/2006 |
59 |
Female |
182 lb |
4/17/2006 |
Consumer |
United States |
|
| Headache |
|
3/1/2006 |
|
Male |
|
5/23/2006 |
Consumer |
United States |
|
| Weight Decreased |
Life Threatening |
12/15/2005 |
73 |
Female |
113 lb |
6/15/2006 |
Physician |
United States |
|
| Malaise |
|
1/1/2003 |
|
Female |
174 lb |
8/9/2006 |
Other Health Professional |
United States |
|
| Infection |
Hospitalization |
8/27/2005 |
58 |
Female |
172 lb |
9/25/2006 |
Other Health Professional |
United States |
|
| Sensory Loss |
Required Intervention |
10/28/2006 |
52 |
Male |
197 lb |
12/4/2006 |
Physician |
United States |
|
| Tumour Haemorrhage |
Required Intervention |
1/20/2007 |
74 |
Male |
206 lb |
3/13/2007 |
Physician |
United States |
|
| Blood Creatinine Increased |
Hospitalization |
5/3/2007 |
|
Male |
147 lb |
5/21/2007 |
Physician |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Blood Creatinine Increased |
Hospitalization |
5/3/2007 |
|
Male |
147 lb |
6/11/2007 |
Physician |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Transitional Cell Carcinoma |
Required Intervention |
1/20/2007 |
74 |
Male |
206 lb |
6/26/2007 |
Physician |
United States |
|
| White Blood Cells Urine Positive |
Required Intervention |
1/20/2007 |
74 |
Male |
206 lb |
7/5/2007 |
Physician |
United States |
|
| Blood Creatinine Increased |
Life Threatening |
5/3/2007 |
|
Male |
147 lb |
9/11/2007 |
Physician |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Syncope |
Other Serious |
1/7/2007 |
39 |
Male |
224 lb |
9/7/2007 |
Pharmacist |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Diabetes Mellitus |
Hospitalization |
4/18/2003 |
45 |
Male |
287 lb |
9/17/2007 |
Other Health Professional |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Back Pain |
|
4/26/2007 |
70 |
Female |
223 lb |
9/20/2007 |
Consumer |
United States |
|
| Somnolence |
Hospitalization |
6/13/2006 |
64 |
Male |
269 lb |
11/16/2007 |
Other Health Professional |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Somnolence |
Hospitalization |
6/13/2006 |
64 |
Male |
269 lb |
11/21/2007 |
Other Health Professional |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Blood Creatinine Increased |
Life Threatening |
5/3/2007 |
|
Male |
147 lb |
12/3/2007 |
Physician |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Blood Creatinine Increased |
Life Threatening |
5/3/2007 |
|
Male |
147 lb |
2/15/2008 |
Physician |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Somnolence |
Hospitalization |
6/13/2006 |
63 |
Male |
269 lb |
5/27/2008 |
|
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Skin Discolouration |
Life Threatening |
3/1/2008 |
62 |
Male |
|
6/16/2008 |
Physician |
United States |
|
| Somnolence |
Other Serious |
6/13/2006 |
63 |
Male |
269 lb |
7/1/2008 |
|
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Unresponsive To Stimuli |
Life Threatening |
3/1/2008 |
62 |
Male |
170 lb |
7/2/2008 |
Physician |
United States |
|
| Abdominal Pain |
Hospitalization |
11/4/2008 |
|
Male |
176 lb |
11/18/2008 |
Physician |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Large Intestine Perforation |
Hospitalization |
11/4/2008 |
|
Male |
176 lb |
12/16/2008 |
Physician |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Flushing |
|
12/1/2007 |
|
Male |
160 lb |
1/26/2009 |
Consumer |
United States |
|
| Platelet Count Decreased |
Hospitalization |
2/26/2009 |
63 |
Male |
|
3/12/2009 |
Consumer |
United States |
|
| Breast Cancer |
Hospitalization |
9/1/2008 |
|
Female |
|
3/25/2009 |
Consumer |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Type 2 Diabetes Mellitus |
Other Serious |
9/7/2004 |
47 |
Female |
147 lb |
4/8/2009 |
Other Health Professional |
United States |
|
| Subdural Haemorrhage |
Death |
2/17/2009 |
76 |
Male |
181 lb |
4/14/2009 |
Physician |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| White Blood Cell Count Decreased |
Hospitalization |
4/30/2009 |
35 |
Female |
241 lb |
5/1/2009 |
Other Health Professional |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Skin Tightness |
Other Serious |
1/1/2006 |
54 |
Male |
335 lb |
5/12/2009 |
Lawyer |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Skin Tightness |
Other Serious |
1/1/2006 |
54 |
Male |
335 lb |
5/13/2009 |
Lawyer |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Vulvovaginal Pruritus |
Other Serious |
12/1/2003 |
43 |
Female |
134 lb |
5/20/2009 |
|
United States |
|
| Type 1 Diabetes Mellitus |
Other Serious |
11/4/2002 |
59 |
Female |
141 lb |
6/3/2009 |
|
United States |
|
| Type 2 Diabetes Mellitus |
Other Serious |
5/27/2002 |
37 |
Female |
164 lb |
6/15/2009 |
|
United States |
|
| Skin Tightness |
Other Serious |
1/1/2006 |
54 |
Male |
335 lb |
6/17/2009 |
Other Health Professional |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Type 1 Diabetes Mellitus |
Other Serious |
5/1/2003 |
57 |
Female |
209 lb |
6/19/2009 |
|
United States |
|
| Weight Increased |
Hospitalization |
1/1/1999 |
35 |
Female |
220 lb |
7/27/2009 |
|
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Wheezing |
Hospitalization |
|
45 |
Male |
|
8/25/2009 |
|
United States |
|
| Tardive Dyskinesia |
Other Serious |
1/1/2002 |
45 |
Male |
260 lb |
9/23/2009 |
|
United States |
|
| Type 2 Diabetes Mellitus |
Other Serious |
6/21/2004 |
46 |
Male |
350 lb |
9/23/2009 |
|
United States |
|
| Weight Increased |
Hospitalization |
1/1/1999 |
35 |
Female |
220 lb |
9/23/2009 |
|
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Tricuspid Valve Incompetence |
Hospitalization |
|
52 |
Female |
|
10/12/2009 |
|
United States |
|
| Urinary Tract Infection |
Hospitalization |
11/24/2009 |
64 |
Male |
|
1/21/2010 |
Physician |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Weight Decreased |
Other Serious |
1/1/2005 |
|
Female |
|
2/23/2010 |
Other Health Professional |
United States |
|
| Pyrexia |
Other Serious |
11/1/2007 |
62 |
Female |
143 lb |
3/4/2010 |
Lawyer |
United States |
|
| Weight Decreased |
Other Serious |
1/1/2005 |
|
Female |
|
3/8/2010 |
Other Health Professional |
United States |
|
| Weight Decreased |
Other Serious |
1/1/2005 |
|
Female |
|
3/18/2010 |
Other Health Professional |
United States |
|
| Weight Decreased |
Hospitalization |
|
75 |
Female |
|
4/8/2010 |
|
United States |
|
| Weight Decreased |
Hospitalization |
|
75 |
Female |
|
4/21/2010 |
Lawyer |
United States |
|
| Dry Mouth |
|
|
|
Female |
|
5/5/2010 |
Physician |
United States |
|
| Vein Disorder |
Other Serious |
|
|
Female |
|
5/20/2010 |
|
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Weight Decreased |
Other Serious |
1/30/2008 |
67 |
Female |
|
5/20/2010 |
|
United States |
|
| Pyrexia |
Other Serious |
6/1/2006 |
62 |
Female |
143 lb |
5/27/2010 |
Other Health Professional |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Swelling |
Other Serious |
5/1/2010 |
61 |
Male |
212 lb |
6/21/2010 |
|
United States |
|
| Type 2 Diabetes Mellitus |
Other Serious |
9/7/2004 |
47 |
Female |
147 lb |
6/23/2010 |
|
United States |
|
| Skin Tightness |
Other Serious |
1/1/2006 |
54 |
Male |
335 lb |
6/24/2010 |
Other Health Professional |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Myocardial Infarction |
Death |
|
52 |
Male |
|
6/24/2010 |
Pharmacist |
United States |
|
| Skin Tightness |
Other Serious |
1/1/2006 |
54 |
Male |
335 lb |
6/25/2010 |
Other Health Professional |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Expired Drug Administered |
|
2/12/2010 |
64 |
Female |
210 lb |
6/30/2010 |
Other Health Professional |
United States |
|
| Weight Decreased |
Other Serious |
1/1/2005 |
32 |
Female |
|
7/6/2010 |
Other Health Professional |
United States |
|
| Diabetic Retinopathy |
Other Serious |
5/28/1998 |
39 |
Female |
280 lb |
7/30/2010 |
|
United States |
|
| Diabetic Retinopathy |
Other Serious |
5/28/1998 |
39 |
Female |
280 lb |
8/5/2010 |
|
United States |
|
| Pneumonia |
Hospitalization |
6/6/2010 |
74 |
Female |
|
8/5/2010 |
Physician |
United States |
|
| Renal Failure Chronic |
Hospitalization |
1/9/2008 |
79 |
Female |
165 lb |
8/5/2010 |
Lawyer |
United States |
|
| Septic Shock |
Other Serious |
1/1/2008 |
55 |
Female |
|
8/9/2010 |
Other Health Professional |
United States |
|
| Pneumonia |
Hospitalization |
6/6/2010 |
74 |
Female |
|
8/13/2010 |
Physician |
United States |
|
| Ventricular Hypertrophy |
Other Serious |
12/8/2000 |
72 |
Male |
260 lb |
8/10/2010 |
|
United States |
|
| Diabetes Mellitus |
Other Serious |
8/6/2010 |
53 |
Male |
391 lb |
8/23/2010 |
Consumer |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Stomatitis |
Hospitalization |
|
72 |
Male |
|
8/24/2010 |
Consumer |
United States |
|
| Incorrect Drug Administration Duration |
Other Serious |
1/1/2009 |
53 |
Male |
391 lb |
8/25/2010 |
Consumer |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Tremor |
|
|
83 |
Male |
161 lb |
8/25/2010 |
Consumer |
United States |
|
| Type 2 Diabetes Mellitus |
Other Serious |
5/28/1998 |
39 |
Female |
210 lb |
8/26/2010 |
|
United States |
|
| Type 2 Diabetes Mellitus |
Hospitalization |
1/30/2002 |
33 |
Male |
290 lb |
8/26/2010 |
|
United States |
|
| Type 2 Diabetes Mellitus |
Other Serious |
5/1/2002 |
41 |
Male |
240 lb |
9/3/2010 |
|
United States |
|
| Skin Tightness |
Other Serious |
1/1/2006 |
54 |
Male |
335 lb |
9/9/2010 |
Other Health Professional |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Diabetes Mellitus |
Hospitalization |
4/18/2003 |
45 |
Male |
286 lb |
9/20/2010 |
|
United States |
|
| Vomiting |
Other Serious |
11/7/2007 |
65 |
Male |
262 lb |
10/7/2010 |
Lawyer |
United States |
|
| Weight Increased |
Other Serious |
6/1/2006 |
47 |
Female |
|
10/19/2010 |
Other Health Professional |
United States |
|
| Failure To Thrive |
Hospitalization |
9/28/2010 |
66 |
Male |
315 lb |
10/8/2010 |
Physician |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Type 2 Diabetes Mellitus |
Other Serious |
9/8/2004 |
53 |
Male |
|
10/22/2010 |
|
United States |
|
| Dry Mouth |
|
|
|
Female |
|
11/10/2010 |
Physician |
United States |
|
| Hyperammonaemia |
Required Intervention |
8/17/2010 |
48 |
Male |
180 lb |
11/5/2010 |
Pharmacist |
United States |
|
| Urinary Retention |
Hospitalization |
3/17/2006 |
61 |
Male |
171 lb |
11/11/2010 |
Consumer |
United States |
|
| Vomiting |
Other Serious |
11/7/2007 |
65 |
Male |
262 lb |
12/2/2010 |
Other Health Professional |
United States |
|
| Death |
Death |
11/16/2010 |
65 |
Female |
|
10/24/2010 |
Other Health Professional |
United States |
|
| Vomiting |
Other Serious |
1/1/2008 |
55 |
Female |
|
12/29/2010 |
Lawyer |
United States |
|
| Vomiting |
Other Serious |
10/14/2010 |
55 |
Female |
|
1/5/2011 |
|
United States |
|
| Multi-organ Failure |
Hospitalization |
|
|
Female |
|
1/11/2011 |
Physician |
United States |
|
| Diarrhoea |
Other Serious |
11/7/2007 |
65 |
Male |
262 lb |
1/31/2011 |
Other Health Professional |
United States |
|
| Pneumonia |
Hospitalization |
11/1/2010 |
66 |
Male |
|
2/28/2011 |
Consumer |
United States |
|
| Abnormal Dreams |
Other Serious |
9/1/2007 |
45 |
Female |
|
3/1/2011 |
Lawyer |
United States |
|
| Pain In Jaw |
Death |
1/1/2007 |
76 |
Female |
166 lb |
3/31/2011 |
|
United States |
|
| Cardiomyopathy |
Hospitalization |
2/20/2008 |
48 |
Female |
180 lb |
3/17/2011 |
|
United States |
|
| Acute Sinusitis |
Hospitalization |
6/1/2006 |
47 |
Female |
|
4/6/2011 |
Lawyer |
United States |
|
| Vomiting |
Other Serious |
1/1/2008 |
55 |
Female |
254 lb |
4/11/2011 |
Lawyer |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Osteolysis |
Other Serious |
1/1/2007 |
76 |
Female |
166 lb |
4/19/2011 |
Other Health Professional |
United States |
|
| Systemic Lupus Erythematosus |
Hospitalization |
|
|
Male |
|
5/6/2011 |
|
United States |
|
| Muscle Spasms |
Other Serious |
|
|
Male |
203 lb |
5/6/2011 |
Physician |
United States |
|
| Paraesthesia |
|
2/12/2011 |
88 |
Female |
|
5/6/2011 |
Consumer |
United States |
|
| Neck Pain |
Other Serious |
1/30/2008 |
67 |
Female |
|
5/23/2011 |
|
United States |
|
| Off Label Use |
Other Serious |
9/1/2007 |
50 |
Female |
224 lb |
6/6/2011 |
Physician |
United States |
|
| Pain |
Hospitalization |
1/1/2005 |
59 |
Male |
|
7/12/2011 |
Physician |
United States |
|
| Cardiovascular Disorder |
Other Serious |
|
|
Female |
119 lb |
7/20/2011 |
Other Health Professional |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Hyperlipidaemia |
Disability |
1/1/2005 |
44 |
Male |
196 lb |
8/2/2011 |
Consumer |
United States |
|
| Abasia |
Other Serious |
7/1/2006 |
66 |
Male |
200 lb |
8/2/2011 |
Other Health Professional |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Myocardial Infarction |
Other Serious |
|
|
Female |
100 lb |
8/5/2011 |
Lawyer |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Rash |
Disability |
|
55 |
Female |
292 lb |
8/3/2011 |
Physician |
United States |
|
| Vomiting |
Hospitalization |
|
|
Female |
|
9/6/2011 |
Lawyer |
United States |
|
| Blood Glucose Increased |
Other Serious |
7/1/2010 |
72 |
Female |
111 lb |
8/31/2011 |
Lawyer |
United States |
|
| Renal Impairment |
Other Serious |
1/1/2009 |
81 |
Female |
161 lb |
9/8/2011 |
Consumer |
United States |
|
| Hypercholesterolaemia |
Disability |
|
|
Female |
|
9/13/2011 |
Physician |
United States |
|
| Weight Increased |
Hospitalization |
1/1/1999 |
35 |
Female |
209 lb |
9/22/2011 |
Consumer |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Anxiety |
Hospitalization |
1/1/2005 |
59 |
Male |
246 lb |
9/27/2011 |
Other Health Professional |
United States |
|
| Anhedonia |
Hospitalization |
1/1/2005 |
59 |
Male |
246 lb |
9/27/2011 |
Consumer |
United States |
|
| Abasia |
Other Serious |
5/1/2006 |
66 |
Male |
200 lb |
10/20/2011 |
Other Health Professional |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Bone Pain |
Hospitalization |
|
|
Female |
|
11/3/2011 |
Physician |
United States |
|
| Blood Potassium Increased |
Death |
|
64 |
Male |
214 lb |
11/9/2011 |
Lawyer |
United States |
|
| Retching |
Other Serious |
8/28/2011 |
62 |
Female |
180 lb |
11/9/2011 |
Physician |
United States |
|
| Arthralgia |
|
11/1/2011 |
79 |
Male |
|
11/28/2011 |
Consumer |
United States |
|
| Impaired Gastric Emptying |
Hospitalization |
11/27/2008 |
61 |
Female |
174 lb |
11/21/2011 |
Lawyer |
United States |
|
| Injury |
Hospitalization |
1/1/2005 |
59 |
Male |
246 lb |
11/28/2011 |
Other Health Professional |
United States |
|
| Androgen Deficiency |
Disability |
|
45 |
Male |
253 lb |
11/23/2011 |
Lawyer |
United States |
|
| Dyspnoea |
Life Threatening |
8/28/2011 |
62 |
Female |
180 lb |
11/11/2011 |
Physician |
United States |
|
| Gastric Ulcer Haemorrhage |
Other Serious |
3/16/2011 |
66 |
Female |
101 lb |
12/9/2011 |
Physician |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Bone Pain |
Disability |
|
|
Female |
|
12/12/2011 |
Lawyer |
United States |
|
| Oedema Peripheral |
Other Serious |
|
|
Female |
|
12/20/2011 |
Lawyer |
United States |
|
| Muscle Strain |
|
4/1/2011 |
73 |
Male |
|
12/21/2011 |
Consumer |
United States |
|
| Nausea |
|
|
|
Female |
|
12/28/2011 |
Consumer |
United States |
|
| Death |
Death |
|
|
Female |
|
12/30/2011 |
Pharmacist |
United States |
|
| Speech Disorder |
|
1/7/2012 |
51 |
Female |
125 lb |
1/17/2012 |
Consumer |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Venous Thrombosis |
Hospitalization |
2/19/2010 |
39 |
Female |
230 lb |
1/18/2012 |
Lawyer |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Anaemia |
Disability |
|
|
Female |
|
1/18/2012 |
Physician |
United States |
|
| Drug Effect Decreased |
|
1/1/2009 |
48 |
Female |
125 lb |
1/18/2012 |
Consumer |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Cholelithiasis |
Other Serious |
11/1/2010 |
50 |
Female |
125 lb |
1/19/2012 |
Consumer |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Drug Ineffective |
Other Serious |
10/22/2008 |
63 |
Male |
|
1/19/2012 |
Consumer |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Neoplasm Malignant |
Death |
|
|
Female |
|
1/19/2012 |
Physician |
United States |
|
| Tooth Extraction |
Other Serious |
3/21/2011 |
78 |
Male |
|
1/28/2012 |
Consumer |
United States |
|
| Crohn's Disease |
Hospitalization |
11/1/2011 |
54 |
Male |
|
1/29/2012 |
Consumer |
United States |
|
| Chest Discomfort |
Hospitalization |
1/15/2012 |
66 |
Female |
185 lb |
1/31/2012 |
|
United States |
|
| Melaena |
Hospitalization |
3/16/2011 |
66 |
Female |
101 lb |
2/6/2012 |
Physician |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Blood Pressure Decreased |
Other Serious |
1/1/2008 |
55 |
Female |
254 lb |
2/9/2012 |
Lawyer |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Diarrhoea |
Hospitalization |
7/3/2011 |
63 |
Female |
|
2/15/2012 |
Consumer |
United States |
|