Pregnancy |
Other Serious |
|
25 |
Female |
|
1/18/2006 |
Physician |
United States |
|
Rash Papular |
Hospitalization |
9/16/2005 |
59 |
Female |
105 lb |
1/25/2006 |
Physician |
Japan |
|
Vomiting |
Hospitalization |
|
33 |
Female |
|
1/25/2006 |
Physician |
United States |
Primary |
|
Secondary |
|
Concomitant |
|
|
Weight Increased |
Hospitalization |
1/6/2006 |
79 |
Male |
|
2/1/2006 |
|
United States |
|
Renal Impairment |
Required Intervention |
3/1/2005 |
49 |
Female |
|
2/1/2006 |
Physician |
United States |
|
Respiratory Failure |
Other Serious |
|
25 |
Female |
|
2/1/2006 |
Physician |
United States |
|
Vomiting |
Required Intervention |
11/24/2005 |
25 |
Female |
|
2/8/2006 |
Physician |
United States |
|
Malaise |
Hospitalization |
11/17/2005 |
59 |
Female |
106 lb |
2/8/2006 |
Physician |
Japan |
Primary |
|
Secondary |
|
Concomitant |
|
|
Condition Aggravated |
Other Serious |
6/1/2004 |
77 |
Female |
|
2/8/2006 |
|
France |
|
Gamma-glutamyltransferase Increased |
Hospitalization |
9/5/2005 |
52 |
Female |
101 lb |
2/9/2006 |
Physician |
Japan |
|
Lipase Increased |
Other Serious |
3/31/2004 |
19 |
Female |
93 lb |
2/13/2006 |
Physician |
United States |
|
Hepatic Function Abnormal |
Hospitalization |
8/1/2005 |
54 |
Female |
119 lb |
2/15/2006 |
Physician |
Japan |
|
Aspartate Aminotransferase Increased |
Other Serious |
|
0 |
Female |
|
2/17/2006 |
|
Japan |
|
Rhinorrhoea |
Other Serious |
11/28/2005 |
72 |
Female |
198 lb |
2/21/2006 |
Physician |
United States |
Primary |
|
Secondary |
|
Concomitant |
|
|
Vein Disorder |
Other Serious |
9/7/2005 |
20 |
Female |
121 lb |
2/27/2006 |
Physician |
United States |
|
Ventricular Dysfunction |
Required Intervention |
10/12/2004 |
14 |
Female |
108 lb |
3/9/2006 |
Physician |
United States |
|
White Blood Cell Count Increased |
Hospitalization |
12/5/2005 |
1 |
Female |
15 lb |
3/13/2006 |
Physician |
United States |
|
Liver Disorder |
Hospitalization |
1/6/2006 |
63 |
Female |
115 lb |
3/24/2006 |
Physician |
Japan |
|
Vomiting |
Other Serious |
1/24/2006 |
76 |
Female |
|
3/24/2006 |
Physician |
Japan |
|
Liver Disorder |
Hospitalization |
1/6/2006 |
63 |
Female |
110 lb |
4/3/2006 |
Physician |
Japan |
|
Influenza |
Other Serious |
10/24/2005 |
24 |
Male |
128 lb |
4/17/2006 |
Physician |
Japan |
Primary |
|
Secondary |
|
Concomitant |
|
|
Palpitations |
Other Serious |
2/26/2006 |
17 |
Female |
87 lb |
4/24/2006 |
|
Japan |
|
Pulmonary Congestion |
Other Serious |
2/26/2006 |
17 |
Female |
87 lb |
5/10/2006 |
|
Japan |
|
Liver Disorder |
|
8/27/2005 |
67 |
Female |
|
5/18/2006 |
|
Japan |
|
Rash |
Other Serious |
1/5/2006 |
59 |
Female |
106 lb |
5/23/2006 |
|
Japan |
|
Blood Alkaline Phosphatase Increased |
Other Serious |
5/5/2006 |
77 |
Female |
|
5/23/2006 |
|
Japan |
|
Liver Function Test Abnormal |
Hospitalization |
9/5/2005 |
52 |
Female |
101 lb |
5/25/2006 |
Physician |
Japan |
|
Malaise |
Hospitalization |
11/17/2005 |
59 |
Female |
99 lb |
5/25/2006 |
Physician |
Japan |
Primary |
|
Secondary |
|
Concomitant |
|
|
Pneumonia Bacterial |
Hospitalization |
3/7/2003 |
75 |
Male |
|
6/7/2006 |
Physician |
United States |
|
Vomiting |
Other Serious |
2/27/2006 |
36 |
Female |
119 lb |
6/7/2006 |
Physician |
Japan |
|
Transaminases Increased |
Other Serious |
5/19/2006 |
|
Female |
|
6/7/2006 |
Physician |
Japan |
|
Vestibular Disorder |
Hospitalization |
12/1/2004 |
56 |
Female |
|
6/13/2006 |
Physician |
Germany |
|
Sudden Death |
Other Serious |
4/18/2006 |
75 |
Female |
137 lb |
6/23/2006 |
Physician |
Belgium |
|
White Blood Cell Count Decreased |
Required Intervention |
2/1/2005 |
73 |
Female |
100 lb |
6/27/2006 |
Physician |
United States |
|
Vomiting |
Other Serious |
3/30/2006 |
59 |
Female |
|
6/28/2006 |
Physician |
United States |
Primary |
|
Secondary |
|
Concomitant |
|
|
Palpitations |
Other Serious |
2/16/2006 |
80 |
Female |
158 lb |
6/28/2006 |
Physician |
United States |
|
Rash Generalised |
Hospitalization |
9/16/2005 |
59 |
Female |
105 lb |
6/30/2006 |
Physician |
Japan |
|
Liver Disorder |
Other Serious |
3/30/2006 |
39 |
Female |
115 lb |
7/5/2006 |
Physician |
Japan |
Primary |
|
Secondary |
|
Concomitant |
|
|
Pancytopenia |
Other Serious |
6/1/2006 |
77 |
Female |
160 lb |
7/5/2006 |
Physician |
United States |
|
Viral Infection |
Hospitalization |
6/1/2006 |
20 |
Female |
176 lb |
7/10/2006 |
Physician |
United States |
|
Pulmonary Vein Stenosis |
Hospitalization |
1/15/2004 |
51 |
Female |
100 lb |
7/13/2006 |
Physician |
Japan |
Primary |
|
Secondary |
|
Concomitant |
|
|
Vomiting |
Hospitalization |
6/20/2006 |
43 |
Female |
|
7/25/2006 |
Physician |
United States |
|
Pulmonary Hypertension |
Other Serious |
2/26/2006 |
17 |
Female |
87 lb |
7/25/2006 |
|
Japan |
|
Fall |
Hospitalization |
7/1/2006 |
71 |
Female |
|
7/27/2006 |
Physician |
United States |
|
Po2 Decreased |
Hospitalization |
5/5/2006 |
77 |
Female |
101 lb |
7/27/2006 |
|
Japan |
|
Prothrombin Time Prolonged |
Hospitalization |
2/21/2006 |
58 |
Female |
93 lb |
8/7/2006 |
Physician |
Japan |
Primary |
|
Secondary |
|
Concomitant |
|
|
Skin Ulcer |
Hospitalization |
6/29/2006 |
80 |
Male |
|
8/7/2006 |
Physician |
France |
|
Liver Disorder |
Other Serious |
3/1/2006 |
39 |
Female |
115 lb |
8/7/2006 |
|
Japan |
Primary |
|
Secondary |
|
Concomitant |
|
|
Liver Disorder |
Hospitalization |
1/19/2006 |
45 |
Female |
|
8/10/2006 |
Physician |
Japan |
Primary |
|
Secondary |
|
Concomitant |
|
|
Weight Decreased |
Life Threatening |
5/1/2006 |
60 |
Female |
170 lb |
8/29/2006 |
Physician |
Austria |
|
Respiratory Distress |
Hospitalization |
7/4/2006 |
73 |
Male |
|
9/1/2006 |
|
United States |
|
Aspartate Aminotransferase Increased |
Other Serious |
4/13/2006 |
14 |
Female |
97 lb |
9/6/2006 |
Physician |
Japan |
|
Platelet Count Decreased |
Hospitalization |
9/7/2006 |
74 |
Male |
121 lb |
9/21/2006 |
|
Japan |
|
Platelet Count Decreased |
Hospitalization |
9/7/2006 |
74 |
Male |
121 lb |
10/3/2006 |
Physician |
Japan |
|
Systemic Sclerosis |
Hospitalization |
1/5/2005 |
79 |
Female |
|
10/6/2006 |
|
Germany |
|
Pneumonia |
Other Serious |
2/27/2006 |
62 |
Female |
101 lb |
10/6/2006 |
|
Japan |
|
Liver Disorder |
Hospitalization |
8/7/2006 |
81 |
Female |
150 lb |
10/6/2006 |
|
Japan |
|
Lymphoma |
Death |
6/10/2006 |
66 |
Female |
126 lb |
10/6/2006 |
Physician |
Japan |
|
Portal Vein Thrombosis |
Death |
6/10/2006 |
66 |
Female |
126 lb |
10/18/2006 |
Physician |
Japan |
|
Platelet Count Decreased |
Other Serious |
6/2/2006 |
25 |
Female |
141 lb |
10/23/2006 |
Physician |
Japan |
|
Weight Decreased |
Life Threatening |
5/1/2006 |
69 |
Female |
170 lb |
10/18/2006 |
|
Austria |
|
Hepatic Function Abnormal |
Hospitalization |
9/30/2006 |
48 |
Female |
95 lb |
11/28/2006 |
|
Japan |
|
Condition Aggravated |
Hospitalization |
11/13/2004 |
25 |
Female |
99 lb |
11/30/2006 |
Physician |
Japan |
|
Right Ventricular Failure |
Death |
10/27/2004 |
58 |
Female |
|
12/15/2006 |
Physician |
United States |
|
Ventricular Hypertrophy |
Hospitalization |
4/23/2006 |
63 |
Female |
119 lb |
12/22/2006 |
Other Health Professional |
United States |
|
Gamma-glutamyltransferase Increased |
Hospitalization |
11/20/2006 |
48 |
Female |
86 lb |
1/11/2007 |
|
Japan |
|
Right Ventricular Failure |
Hospitalization |
10/2/2006 |
47 |
Female |
117 lb |
1/22/2007 |
|
Japan |
|
Postoperative Renal Failure |
Hospitalization |
12/20/2006 |
77 |
Female |
|
1/26/2007 |
|
Germany |
|
Uterus Evacuation |
Other Serious |
7/27/2006 |
37 |
Female |
|
1/26/2007 |
|
Japan |
Primary |
|
Secondary |
|
Concomitant |
|
|
Liver Function Test Abnormal |
Other Serious |
4/13/2006 |
14 |
Female |
97 lb |
2/6/2007 |
Other Health Professional |
Japan |
|
White Blood Cell Count Increased |
Hospitalization |
4/27/2006 |
54 |
Female |
90 lb |
2/21/2007 |
|
Japan |
|
Hepatic Function Abnormal |
Life Threatening |
11/30/2006 |
82 |
Female |
97 lb |
2/23/2007 |
|
Japan |
|
Vomiting |
Required Intervention |
6/23/2005 |
36 |
Female |
90 lb |
3/20/2007 |
Physician |
Japan |
Primary |
|
Secondary |
|
Concomitant |
|
|
Pulmonary Hypertension |
Life Threatening |
9/10/2005 |
72 |
Female |
112 lb |
3/20/2007 |
Physician |
Japan |
|
Pulmonary Hypertension |
Life Threatening |
9/10/2005 |
72 |
Female |
112 lb |
3/27/2007 |
|
Japan |
|
Pericarditis |
Hospitalization |
3/12/2007 |
37 |
Male |
|
3/23/2007 |
Physician |
United States |
|
Pulmonary Hypertension |
Hospitalization |
1/1/2006 |
52 |
Female |
194 lb |
4/3/2007 |
Physician |
United States |
|
Pulmonary Vascular Resistance Abnormality |
Other Serious |
2/9/2006 |
1 |
Male |
15 lb |
4/20/2007 |
Physician |
Japan |
Primary |
|
Secondary |
|
Concomitant |
|
|
Thrombocytopenia |
Hospitalization |
3/3/2007 |
46 |
Female |
|
5/24/2007 |
Physician |
Japan |
|
Pneumonia |
Hospitalization |
11/25/2006 |
42 |
Female |
148 lb |
5/24/2007 |
Other Health Professional |
Japan |
|
Vomiting |
Required Intervention |
6/23/2005 |
36 |
Female |
90 lb |
6/4/2007 |
Physician |
Japan |
Primary |
|
Secondary |
|
Concomitant |
|
|
Pulmonary Hypertension |
Hospitalization |
6/4/2006 |
51 |
Female |
97 lb |
6/19/2007 |
|
Japan |
|
Ventricular Hypokinesia |
Hospitalization |
4/23/2006 |
63 |
Female |
119 lb |
6/23/2007 |
Other Health Professional |
United States |
|
Sinusitis |
Other Serious |
5/21/2007 |
69 |
Female |
293 lb |
6/22/2007 |
Physician |
United States |
|
Throat Tightness |
Other Serious |
5/5/2007 |
37 |
Female |
392 lb |
7/3/2007 |
Physician |
United States |
|
Breast Mass |
Other Serious |
6/1/2007 |
40 |
Female |
121 lb |
7/19/2007 |
Physician |
United States |
|
Hypoaesthesia |
Other Serious |
|
59 |
Female |
|
7/25/2007 |
Physician |
Greece |
|
Right Ventricular Failure |
Other Serious |
7/21/2005 |
44 |
Male |
143 lb |
7/26/2007 |
|
Japan |
Primary |
|
Secondary |
|
Concomitant |
|
|
Dysphoria |
Other Serious |
5/23/2007 |
78 |
Female |
104 lb |
8/23/2007 |
Physician |
Japan |
Primary |
|
Secondary |
|
Concomitant |
|
|
Interstitial Lung Disease |
Death |
7/25/2007 |
60 |
Female |
|
8/27/2007 |
Physician |
Japan |
|
Pain In Jaw |
Other Serious |
7/1/2006 |
66 |
Female |
162 lb |
9/12/2007 |
Physician |
United States |
Primary |
|
Secondary |
|
Concomitant |
|
|
Right Ventricular Failure |
Hospitalization |
1/19/2006 |
45 |
Female |
|
9/12/2007 |
Physician |
Japan |
Primary |
|
Secondary |
|
Concomitant |
|
|
Pleural Effusion |
Hospitalization |
3/8/2007 |
54 |
Male |
|
9/19/2007 |
Physician |
United States |
|
Renal Impairment |
Other Serious |
3/29/2007 |
69 |
Male |
135 lb |
9/21/2007 |
Other Health Professional |
Japan |
|
Respiratory Failure |
Hospitalization |
|
71 |
Female |
264 lb |
10/11/2007 |
Physician |
United States |
|
Pulmonary Hypertension |
Hospitalization |
4/1/2007 |
60 |
Female |
99 lb |
10/16/2007 |
|
Japan |
|
Respiratory Failure |
Required Intervention |
7/17/2007 |
74 |
Female |
228 lb |
11/2/2007 |
Physician |
United States |
|
Sudden Death |
Death |
9/22/2007 |
77 |
Male |
|
11/8/2007 |
Other Health Professional |
Belgium |
|
Dyspnoea |
Death |
1/1/2007 |
65 |
Female |
86 lb |
11/14/2007 |
Physician |
Japan |
|
White Blood Cell Count Decreased |
Other Serious |
11/4/2006 |
58 |
Female |
95 lb |
11/14/2007 |
Physician |
Japan |
Primary |
|
Secondary |
|
Concomitant |
|
|
Sudden Cardiac Death |
Hospitalization |
9/16/2005 |
59 |
Female |
105 lb |
11/19/2007 |
Physician |
Japan |
|
Right Ventricular Failure |
Hospitalization |
8/1/2007 |
75 |
Female |
|
11/20/2007 |
Physician |
United States |
|
Subileus |
Other Serious |
5/23/2007 |
78 |
Female |
104 lb |
11/29/2007 |
Other Health Professional |
Japan |
Primary |
|
Secondary |
|
Concomitant |
|
|
Cardiac Arrest |
Other Serious |
1/4/2007 |
76 |
Male |
117 lb |
12/7/2007 |
|
Japan |
|
Dyspnoea |
Death |
1/1/2007 |
65 |
Female |
86 lb |
12/11/2007 |
Physician |
Japan |
|
Pericardial Effusion Malignant |
Death |
9/10/2005 |
76 |
Female |
84 lb |
12/11/2007 |
|
Japan |
|
Pancytopenia |
Hospitalization |
6/8/2007 |
59 |
Female |
|
12/14/2007 |
Other Health Professional |
Japan |
Primary |
|
Secondary |
|
Concomitant |
|
|
Vaginal Haemorrhage |
Other Serious |
1/5/2006 |
42 |
Female |
90 lb |
1/21/2008 |
|
Japan |
|
Pleural Effusion |
Hospitalization |
6/6/2007 |
59 |
Female |
|
2/5/2008 |
Physician |
Japan |
Primary |
|
Secondary |
|
Concomitant |
|
|
Hyperthyroidism |
Other Serious |
1/5/2008 |
42 |
Female |
90 lb |
2/8/2008 |
Consumer |
Japan |
|
Pancytopenia |
Other Serious |
11/4/2006 |
58 |
Female |
95 lb |
2/11/2008 |
|
Japan |
Primary |
|
Secondary |
|
Concomitant |
|
|
Vascular Pseudoaneurysm |
Hospitalization |
1/15/2007 |
18 |
Female |
86 lb |
2/15/2008 |
Consumer |
Japan |
Primary |
|
Secondary |
|
Concomitant |
|
|
White Blood Cell Count Decreased |
Other Serious |
6/1/2006 |
51 |
Female |
148 lb |
3/14/2008 |
|
Germany |
|
Ileus Paralytic |
Hospitalization |
1/24/2008 |
4 |
Female |
|
3/14/2008 |
|
Japan |
|
Renal Failure |
Other Serious |
11/5/2007 |
45 |
Male |
|
3/19/2008 |
Physician |
Spain |
|
Vaginal Haemorrhage |
Other Serious |
1/5/2006 |
42 |
Female |
90 lb |
3/19/2008 |
Physician |
Japan |
|
Pulmonary Mass |
Other Serious |
9/22/2006 |
37 |
Male |
|
4/14/2008 |
Other Health Professional |
Japan |
Primary |
|
Secondary |
|
Concomitant |
|
|
Renal Failure |
Other Serious |
11/5/2007 |
45 |
Male |
|
4/25/2008 |
|
Spain |
|
White Blood Cell Count Decreased |
Other Serious |
6/1/2006 |
51 |
Female |
148 lb |
5/15/2008 |
Physician |
Germany |
|
Pulmonary Hypertension |
Other Serious |
4/13/2006 |
14 |
Female |
97 lb |
5/15/2008 |
Physician |
Japan |
|
Pneumonia |
Other Serious |
4/1/2008 |
61 |
Female |
|
5/27/2008 |
Physician |
Canada |
|
Liver Disorder |
Other Serious |
11/30/2005 |
86 |
Female |
104 lb |
5/30/2008 |
Consumer |
Japan |
|
Red Blood Cell Count Decreased |
Other Serious |
3/1/2008 |
78 |
Female |
175 lb |
6/13/2008 |
Physician |
United States |
|
Ventricular Dysfunction |
Required Intervention |
10/12/2004 |
14 |
Female |
108 lb |
6/26/2008 |
Physician |
United States |
|
Pulmonary Haemorrhage |
Other Serious |
1/15/2007 |
18 |
Female |
86 lb |
6/26/2008 |
|
Japan |
Primary |
|
Secondary |
|
Concomitant |
|
|
White Blood Cell Count Increased |
Other Serious |
11/30/2005 |
86 |
Female |
104 lb |
7/2/2008 |
|
Japan |
|
Systemic Lupus Erythematosus |
Other Serious |
3/1/2008 |
78 |
Female |
180 lb |
7/7/2008 |
Physician |
United States |
|
Rash |
Required Intervention |
3/6/2008 |
68 |
Female |
162 lb |
7/14/2008 |
Other Health Professional |
United States |
|
No Therapeutic Response |
Other Serious |
|
79 |
Female |
|
7/14/2008 |
Physician |
United States |
|
Off Label Use |
Other Serious |
3/1/2008 |
78 |
Female |
180 lb |
7/24/2008 |
Physician |
United States |
|
Pulmonary Hypertension |
Other Serious |
4/13/2006 |
14 |
Female |
97 lb |
7/30/2008 |
Physician |
Japan |
|
Respiratory Failure |
Death |
|
76 |
Female |
|
8/6/2008 |
Consumer |
Japan |
|
Systemic Lupus Erythematosus |
Other Serious |
6/9/2008 |
72 |
Female |
158 lb |
8/12/2008 |
Physician |
United States |
|
Vomiting |
Hospitalization |
6/30/2008 |
74 |
Female |
192 lb |
8/14/2008 |
Physician |
United States |
Primary |
|
Secondary |
|
Concomitant |
|
|
Pulmonary Fibrosis |
Other Serious |
10/17/2006 |
84 |
Female |
195 lb |
8/20/2008 |
Other Health Professional |
United States |
|
Shock |
Death |
8/1/2008 |
75 |
Female |
|
8/27/2008 |
|
Japan |
|
Vomiting |
Hospitalization |
6/30/2008 |
74 |
Female |
192 lb |
9/4/2008 |
Physician |
United States |
Primary |
|
Secondary |
|
Concomitant |
|
|
Therapeutic Agent Toxicity |
Hospitalization |
6/30/2008 |
74 |
Female |
192 lb |
9/15/2008 |
Physician |
United States |
Primary |
|
Secondary |
|
Concomitant |
|
|
Shock |
Death |
8/1/2008 |
75 |
Female |
82 lb |
9/25/2008 |
|
Japan |
|
Systemic Lupus Erythematosus |
Other Serious |
2/1/2008 |
55 |
Female |
|
10/1/2008 |
Physician |
United States |
Primary |
|
Secondary |
|
Concomitant |
|
|
Nephrolithiasis |
Other Serious |
10/17/2006 |
84 |
Female |
195 lb |
10/15/2008 |
Physician |
United States |
|
Respiratory Depression |
Death |
8/1/2008 |
75 |
Female |
82 lb |
10/15/2008 |
|
Japan |
|
Pancytopenia |
Life Threatening |
8/6/2008 |
60 |
Female |
90 lb |
10/17/2008 |
|
Japan |
|
Pulmonary Hypertension |
Hospitalization |
6/4/2006 |
51 |
Female |
97 lb |
10/22/2008 |
Consumer |
Japan |
|
Pulmonary Haemorrhage |
Hospitalization |
9/10/2007 |
32 |
Female |
123 lb |
10/31/2008 |
Physician |
Japan |
Primary |
|
Secondary |
|
Concomitant |
|
|
White Blood Cell Count Increased |
Life Threatening |
6/9/2006 |
23 |
Male |
121 lb |
11/3/2008 |
Physician |
Japan |
Primary |
|
Secondary |
|
Concomitant |
|
|
Pulmonary Arterial Hypertension |
Death |
1/4/2008 |
68 |
Female |
159 lb |
11/7/2008 |
Physician |
Japan |
Primary |
|
Secondary |
|
Concomitant |
|
|
Pulmonary Arterial Hypertension |
Death |
8/20/2006 |
66 |
Female |
159 lb |
12/3/2008 |
Physician |
Japan |
Primary |
|
Secondary |
|
Concomitant |
|
|
Weight Decreased |
Other Serious |
3/15/2006 |
7 |
Male |
40 lb |
12/11/2008 |
Physician |
Japan |
|
Pancytopenia |
Life Threatening |
8/6/2008 |
60 |
Female |
90 lb |
12/18/2008 |
Physician |
Japan |
|