Liver Function Test Abnormal |
Other Serious |
3/10/2005 |
17 |
Female |
|
4/10/2006 |
|
Japan |
|
Nausea |
Other Serious |
8/17/2005 |
33 |
Female |
97 lb |
5/31/2006 |
|
Japan |
|
Weight Increased |
Other Serious |
6/28/2005 |
57 |
Female |
77 lb |
7/10/2006 |
Physician |
Japan |
|
Subileus |
Hospitalization |
4/27/2006 |
53 |
Female |
90 lb |
8/23/2006 |
|
Japan |
|
Vomiting |
Other Serious |
7/1/2006 |
44 |
Female |
|
8/29/2006 |
Physician |
Japan |
|
Vomiting |
Other Serious |
3/27/2006 |
44 |
Female |
99 lb |
9/19/2006 |
Physician |
Japan |
Primary |
|
Secondary |
|
Concomitant |
|
|
Pulmonary Hypertension |
Death |
12/26/2005 |
82 |
Female |
|
11/30/2006 |
Physician |
Japan |
|
Pulmonary Vein Stenosis |
Hospitalization |
4/2/2006 |
53 |
Female |
100 lb |
11/30/2006 |
Physician |
Japan |
Primary |
|
Secondary |
|
Concomitant |
|
|
Subileus |
Hospitalization |
4/27/2006 |
54 |
Female |
90 lb |
12/6/2006 |
|
Japan |
|
Venous Pressure Jugular Increased |
Other Serious |
3/20/2006 |
67 |
Female |
|
1/3/2007 |
Physician |
United States |
|
Right Ventricular Failure |
Hospitalization |
10/2/2006 |
47 |
Female |
117 lb |
1/22/2007 |
|
Japan |
|
White Blood Cell Count Increased |
Hospitalization |
4/27/2006 |
54 |
Female |
90 lb |
2/21/2007 |
|
Japan |
|
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 |
|
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 |
|
Breast Mass |
Other Serious |
6/1/2007 |
40 |
Female |
121 lb |
7/19/2007 |
Physician |
United States |
|
Right Ventricular Failure |
Other Serious |
11/18/2007 |
75 |
Female |
134 lb |
1/4/2008 |
Physician |
Netherlands |
|
Right Ventricular Failure |
Other Serious |
7/18/2006 |
31 |
Female |
|
1/5/2008 |
Other Health Professional |
United Kingdom |
|
Vaginal Haemorrhage |
Other Serious |
1/5/2006 |
42 |
Female |
90 lb |
1/21/2008 |
|
Japan |
|
White Blood Cell Count Decreased |
Life Threatening |
2/26/2007 |
43 |
Female |
77 lb |
3/11/2008 |
Physician |
Japan |
|
Vaginal Haemorrhage |
Other Serious |
1/5/2006 |
42 |
Female |
90 lb |
3/19/2008 |
Physician |
Japan |
|
Interstitial Lung Disease |
Hospitalization |
|
|
Female |
|
7/7/2008 |
Physician |
Japan |
|
Liver Function Test Abnormal |
Other Serious |
2/1/2008 |
61 |
Male |
|
7/30/2008 |
Consumer |
Japan |
|
Liver Function Test Abnormal |
Other Serious |
2/1/2008 |
61 |
Male |
|
7/30/2008 |
|
Japan |
|
Pulmonary Haemorrhage |
Hospitalization |
9/10/2007 |
32 |
Female |
123 lb |
10/31/2008 |
Physician |
Japan |
Primary |
|
Secondary |
|
Concomitant |
|
|
White Blood Cell Count Decreased |
Other Serious |
2/26/2007 |
43 |
Female |
77 lb |
10/31/2008 |
Physician |
Japan |
|
Shock |
Other Serious |
11/29/2006 |
25 |
Male |
|
11/4/2008 |
Physician |
Japan |
|
White Blood Cell Count Increased |
Life Threatening |
6/9/2006 |
23 |
Male |
121 lb |
11/3/2008 |
Physician |
Japan |
Primary |
|
Secondary |
|
Concomitant |
|
|
Respiratory Tract Haemorrhage |
Other Serious |
|
24 |
Female |
|
11/5/2008 |
|
Japan |
|
Vocal Cord Paralysis |
Hospitalization |
|
34 |
Female |
|
11/20/2008 |
Consumer |
Japan |
|
Shock |
Other Serious |
11/29/2006 |
25 |
Male |
|
11/20/2008 |
Consumer |
Japan |
|
Vocal Cord Paralysis |
Other Serious |
|
34 |
Female |
|
12/3/2008 |
Physician |
Japan |
|
Weight Decreased |
Other Serious |
3/15/2006 |
7 |
Male |
40 lb |
12/11/2008 |
Physician |
Japan |
|
Operative Haemorrhage |
Death |
10/5/2008 |
48 |
Female |
110 lb |
12/19/2008 |
Physician |
Netherlands |
|
Blood Bilirubin Increased |
Hospitalization |
1/16/2009 |
30 |
Female |
|
2/11/2009 |
Physician |
Japan |
|
Weight Decreased |
Other Serious |
3/15/2006 |
7 |
Male |
40 lb |
2/20/2009 |
Physician |
Japan |
Primary |
|
Secondary |
|
Concomitant |
|
|
Pulmonary Alveolar Haemorrhage |
Other Serious |
|
17 |
Male |
|
3/6/2009 |
Other Health Professional |
Japan |
|
Hepatosplenomegaly |
Other Serious |
1/16/2009 |
30 |
Female |
95 lb |
3/23/2009 |
Physician |
Japan |
|
Ileus |
Death |
|
|
Male |
|
7/28/2009 |
Other Health Professional |
Japan |
|
Vomiting |
Other Serious |
6/1/2009 |
39 |
Female |
|
8/3/2009 |
Physician |
United States |
|
Swelling |
Other Serious |
5/26/2009 |
26 |
Female |
131 lb |
8/7/2009 |
Pharmacist |
United States |
Primary |
|
Secondary |
|
Concomitant |
|
|
Organ Transplant |
Other Serious |
|
60 |
Female |
130 lb |
11/30/2009 |
Other Health Professional |
Belgium |
|
Sudden Death |
Death |
|
41 |
Male |
|
12/3/2009 |
|
France |
|
Pulmonary Arterial Hypertension |
Other Serious |
10/31/2003 |
60 |
Female |
130 lb |
12/11/2009 |
Other Health Professional |
Belgium |
|
Pulmonary Haemorrhage |
Hospitalization |
10/23/2008 |
24 |
Female |
99 lb |
12/17/2009 |
|
Japan |
|
Right Ventricular Failure |
Other Serious |
6/27/2008 |
1 |
Male |
|
4/12/2010 |
|
Japan |
|
Ventricular Septal Defect |
Other Serious |
5/26/2008 |
1 |
Male |
9 lb |
4/30/2010 |
|
Japan |
Primary |
|
Secondary |
|
Concomitant |
|
|
Pyrexia |
Hospitalization |
5/23/2010 |
39 |
Female |
101 lb |
6/8/2010 |
|
Japan |
|
Vomiting |
Other Serious |
1/1/2004 |
72 |
Female |
|
8/6/2010 |
Physician |
United States |
Primary |
|
Secondary |
|
Concomitant |
|
|
Haemoptysis |
Death |
|
21 |
Female |
|
8/10/2010 |
Physician |
Japan |
|
Haemoptysis |
Death |
|
21 |
Female |
|
8/27/2010 |
Physician |
Japan |
|
International Normalised Ratio Decreased |
Hospitalization |
7/4/2005 |
42 |
Female |
108 lb |
9/7/2010 |
|
Japan |
Primary |
|
Secondary |
|
Concomitant |
|
|
No Adverse Event |
|
|
39 |
Female |
101 lb |
9/8/2010 |
|
Japan |
|
Torsade De Pointes |
Life Threatening |
9/10/2010 |
|
Female |
|
9/20/2010 |
|
Japan |
|
Ventricular Tachycardia |
Life Threatening |
9/9/2010 |
23 |
Female |
75 lb |
10/5/2010 |
Physician |
Japan |
Primary |
|
Secondary |
|
Concomitant |
|
|
Ventricular Tachycardia |
Life Threatening |
9/9/2010 |
23 |
Female |
75 lb |
10/18/2010 |
Physician |
Japan |
Primary |
|
Secondary |
|
Concomitant |
|
|
Ventricular Tachycardia |
Life Threatening |
9/9/2010 |
23 |
Female |
75 lb |
11/8/2010 |
Physician |
Japan |
Primary |
|
Secondary |
|
Concomitant |
|
|
Tachycardia |
Other Serious |
|
0 |
Male |
|
11/16/2010 |
Physician |
Japan |
Primary |
|
Secondary |
|
Concomitant |
|
|
White Blood Cell Count Increased |
Hospitalization |
11/7/2010 |
|
|
|
11/17/2010 |
Other Health Professional |
United States |
Primary |
|
Secondary |
|
Concomitant |
|
|
Device Malfunction |
Hospitalization |
8/4/2010 |
43 |
Female |
|
10/19/2010 |
Physician |
United States |
|
Pancreatic Carcinoma Metastatic |
Death |
|
77 |
Female |
|
11/23/2010 |
Physician |
Japan |
|
Death |
Death |
5/1/2003 |
52 |
Female |
|
12/6/2010 |
Consumer |
Italy |
|
White Blood Cell Count Decreased |
Death |
1/1/2009 |
44 |
Female |
|
12/6/2010 |
Physician |
Japan |
|
White Blood Cell Count Decreased |
Other Serious |
10/24/2005 |
54 |
Female |
115 lb |
12/6/2010 |
Physician |
Japan |
Primary |
|
Secondary |
|
Concomitant |
|
|
Death |
Death |
9/3/2010 |
66 |
Female |
|
12/9/2010 |
Pharmacist |
United States |
|
Hepatic Function Abnormal |
Hospitalization |
7/4/2005 |
42 |
Female |
108 lb |
12/16/2010 |
Physician |
Japan |
Primary |
|
Secondary |
|
Concomitant |
|
|
Catheter Site Pruritus |
Other Serious |
|
36 |
Female |
|
1/4/2011 |
Physician |
Japan |
Primary |
|
Secondary |
|
Concomitant |
|
|
Packed Red Blood Cell Transfusion |
Hospitalization |
1/1/2009 |
|
|
|
1/15/2011 |
Physician |
United States |
Primary |
|
Secondary |
|
Concomitant |
|
|
Gamma-glutamyltransferase Increased |
Hospitalization |
1/11/2010 |
33 |
Female |
|
2/7/2011 |
Physician |
Japan |
Primary |
|
Secondary |
|
Concomitant |
|
|
Respiratory Failure |
Hospitalization |
1/30/2011 |
|
|
|
2/13/2011 |
Pharmacist |
United States |
|
Diarrhoea Haemorrhagic |
Hospitalization |
12/22/2010 |
64 |
Male |
230 lb |
1/25/2011 |
Physician |
United States |
|
Death |
Death |
12/1/2010 |
|
Female |
|
1/23/2011 |
Physician |
United States |
|
Lung Infiltration |
Other Serious |
12/1/2010 |
13 |
Female |
|
1/21/2011 |
Physician |
United States |
|
Vomiting |
Required Intervention |
1/1/2009 |
57 |
Female |
143 lb |
1/21/2011 |
Other Health Professional |
United States |
Primary |
|
Secondary |
|
Concomitant |
|
|
Electrocardiogram Qt Prolonged |
Life Threatening |
9/9/2010 |
23 |
Female |
75 lb |
3/16/2011 |
Physician |
Japan |
Primary |
|
Secondary |
|
Concomitant |
|
|
Fatigue |
Life Threatening |
3/1/2009 |
43 |
Female |
|
3/16/2011 |
Physician |
Japan |
|
Pulmonary Arterial Hypertension |
Death |
|
59 |
Female |
|
3/21/2011 |
Physician |
Israel |
|
Asthenia |
Hospitalization |
1/31/2011 |
37 |
Female |
|
3/11/2011 |
Pharmacist |
United States |
Primary |
|
Secondary |
|
Concomitant |
|
|
Condition Aggravated |
Other Serious |
5/1/2010 |
75 |
Male |
|
3/25/2011 |
Physician |
Japan |
|
International Normalised Ratio Increased |
Hospitalization |
3/6/2011 |
|
|
|
4/7/2011 |
Other Health Professional |
United States |
Primary |
|
Secondary |
|
Concomitant |
|
|
Alanine Aminotransferase Increased |
Hospitalization |
11/18/2009 |
20 |
Female |
110 lb |
4/11/2011 |
Physician |
Japan |
Primary |
|
Secondary |
|
Concomitant |
|
|
Pericardial Effusion |
Death |
3/15/2006 |
7 |
Male |
40 lb |
4/12/2011 |
Physician |
Japan |
Primary |
|
Secondary |
|
Concomitant |
|
|
Isolated Adrenocorticotropic Hormone Deficiency |
Life Threatening |
3/1/2009 |
43 |
Female |
|
4/21/2011 |
Physician |
Japan |
|
Chills |
Death |
3/6/2011 |
|
|
|
4/29/2011 |
Physician |
United States |
Primary |
|
Secondary |
|
Concomitant |
|
|
Nausea |
Death |
5/1/2011 |
|
|
|
5/6/2011 |
Pharmacist |
United States |
|
Death |
Death |
5/3/2011 |
|
|
|
5/9/2011 |
Physician |
United States |
Primary |
|
Secondary |
|
Concomitant |
|
|
Death |
Death |
5/4/2011 |
|
|
|
5/9/2011 |
Pharmacist |
United States |
|
Blood Potassium Decreased |
Life Threatening |
3/1/2010 |
|
|
|
5/10/2011 |
Physician |
United States |
Primary |
|
Secondary |
|
Concomitant |
|
|
Cardiac Failure Congestive |
Death |
5/4/2011 |
|
|
|
5/13/2011 |
Pharmacist |
United States |
|
Nausea |
Death |
5/2/2011 |
|
|
|
5/13/2011 |
Physician |
United States |
|
Death |
Death |
5/9/2011 |
|
|
|
5/14/2011 |
Physician |
United States |
Primary |
|
Secondary |
|
Concomitant |
|
|
Pulmonary Oedema |
Hospitalization |
|
35 |
Female |
|
5/16/2011 |
Physician |
Germany |
|
Dysarthria |
Death |
5/8/2011 |
|
|
|
5/17/2011 |
Pharmacist |
United States |
Primary |
|
Secondary |
|
Concomitant |
|
|
Death |
Death |
5/11/2011 |
|
|
|
5/17/2011 |
Physician |
United States |
Primary |
|
Secondary |
|
Concomitant |
|
|
Death |
Death |
5/11/2011 |
|
|
|
5/20/2011 |
Other Health Professional |
United States |
Primary |
|
Secondary |
|
Concomitant |
|
|
Viith Nerve Paralysis |
Hospitalization |
4/30/2011 |
|
|
|
5/24/2011 |
Other Health Professional |
United States |
Primary |
|
Secondary |
|
Concomitant |
|
|
Abdominal Pain Upper |
Hospitalization |
3/6/2011 |
|
|
|
5/25/2011 |
Other Health Professional |
United States |
|
Disease Progression |
Death |
4/12/2011 |
|
|
|
5/26/2011 |
Pharmacist |
United States |
|
Atrial Fibrillation |
Hospitalization |
3/30/2011 |
|
|
|
5/31/2011 |
Consumer |
United States |
|
Nausea |
Hospitalization |
4/16/2011 |
|
|
|
5/31/2011 |
Pharmacist |
United States |
|
Nausea |
Death |
5/2/2011 |
|
|
|
6/1/2011 |
Consumer |
United States |
|
Concomitant Disease Aggravated |
Death |
10/1/2010 |
77 |
Female |
|
6/2/2011 |
Physician |
Japan |
|
Diarrhoea |
Hospitalization |
3/6/2011 |
|
|
|
6/2/2011 |
Physician |
United States |
Primary |
|
Secondary |
|
Concomitant |
|
|
Resuscitation |
Hospitalization |
3/6/2011 |
|
|
|
6/2/2011 |
Other Health Professional |
United States |
Primary |
|
Secondary |
|
Concomitant |
|
|
Disease Progression |
Hospitalization |
2/18/2011 |
|
|
|
6/6/2011 |
Pharmacist |
United States |
|
Pneumonia |
Hospitalization |
5/8/2011 |
|
|
|
6/7/2011 |
Pharmacist |
United States |
|
Haemoptysis |
Hospitalization |
5/1/2011 |
|
|
|
6/10/2011 |
Pharmacist |
United States |
Primary |
|
Secondary |
|
Concomitant |
|
|
Autoimmune Disorder |
Hospitalization |
3/23/2011 |
|
|
|
6/13/2011 |
Other Health Professional |
United States |
|
Respiratory Failure |
Hospitalization |
5/11/2011 |
|
|
|
6/13/2011 |
Pharmacist |
United States |
|
Diarrhoea |
Hospitalization |
3/6/2011 |
|
|
|
6/15/2011 |
Physician |
United States |
Primary |
|
Secondary |
|
Concomitant |
|
|
Vomiting |
Hospitalization |
3/6/2011 |
|
|
|
6/15/2011 |
Other Health Professional |
United States |
Primary |
|
Secondary |
|
Concomitant |
|
|
Road Traffic Accident |
Death |
3/18/2011 |
31 |
Male |
|
6/16/2011 |
Physician |
Japan |
|
Blood Bilirubin Increased |
Other Serious |
1/1/2011 |
|
|
|
6/20/2011 |
Pharmacist |
United States |
Primary |
|
Secondary |
|
Concomitant |
|
|
Anaemia |
Death |
12/25/2007 |
22 |
Female |
106 lb |
6/21/2011 |
Physician |
Japan |
Primary |
|
Secondary |
|
Concomitant |
|
|
Dyspnoea |
Death |
4/15/2011 |
|
|
|
6/29/2011 |
Pharmacist |
United States |
Primary |
|
Secondary |
|
Concomitant |
|
|
Cardiac Disorder |
Hospitalization |
6/17/2011 |
|
|
|
6/29/2011 |
Pharmacist |
United States |
|
Aspartate Aminotransferase Increased |
Other Serious |
1/1/2011 |
|
|
|
8/2/2011 |
Consumer |
United States |
Primary |
|
Secondary |
|
Concomitant |
|
|
Pain |
Hospitalization |
7/1/2011 |
|
|
|
8/9/2011 |
Physician |
United States |
|
Tachycardia |
Hospitalization |
1/1/2011 |
|
|
|
8/11/2011 |
Other Health Professional |
United States |
Primary |
|
Secondary |
|
Concomitant |
|
|
Supraventricular Tachycardia |
Hospitalization |
8/3/2011 |
|
|
|
8/16/2011 |
Physician |
United States |
|
Blood Potassium Increased |
Hospitalization |
8/1/2011 |
|
|
|
8/16/2011 |
Physician |
United States |
|
Condition Aggravated |
Death |
1/1/2011 |
|
|
|
8/19/2011 |
Consumer |
United States |
Primary |
|
Secondary |
|
Concomitant |
|
|
Death |
Hospitalization |
7/21/2011 |
|
|
|
8/26/2011 |
Pharmacist |
United States |
Primary |
|
Secondary |
|
Concomitant |
|
|
Pulmonary Arterial Hypertension |
Life Threatening |
7/21/2011 |
|
|
|
9/6/2011 |
Physician |
United States |
Primary |
|
Secondary |
|
Concomitant |
|
|
Torsade De Pointes |
Life Threatening |
9/9/2010 |
23 |
Female |
75 lb |
9/7/2011 |
Physician |
Japan |
Primary |
|
Secondary |
|
Concomitant |
|
|
Renal Failure |
Hospitalization |
8/1/2011 |
|
|
|
9/7/2011 |
Pharmacist |
United States |
|
Supraventricular Tachycardia |
Hospitalization |
8/3/2011 |
|
|
|
9/8/2011 |
Other Health Professional |
United States |
|
Breast Cancer |
Other Serious |
7/1/2011 |
|
|
|
9/8/2011 |
Pharmacist |
United States |
|
Death |
Death |
9/1/2011 |
|
|
|
9/8/2011 |
Pharmacist |
United States |
|
Device Related Infection |
Hospitalization |
9/3/2011 |
|
|
|
9/12/2011 |
Physician |
United States |
Primary |
|
Secondary |
|
Concomitant |
|
|
Death |
Death |
9/1/2011 |
|
|
|
9/12/2011 |
Other Health Professional |
United States |
|
Diarrhoea |
Hospitalization |
9/1/2011 |
|
|
|
9/15/2011 |
Physician |
United States |
Primary |
|
Secondary |
|
Concomitant |
|
|
Right Ventricular Failure |
Hospitalization |
8/3/2011 |
|
|
|
9/16/2011 |
Other Health Professional |
United States |
|
Right Ventricular Failure |
Hospitalization |
8/3/2011 |
|
|
|
9/16/2011 |
Other Health Professional |
United States |
|
Device Related Infection |
Hospitalization |
9/3/2011 |
|
|
|
9/22/2011 |
Physician |
United States |
Primary |
|
Secondary |
|
Concomitant |
|
|
Skin Discolouration |
|
7/1/2011 |
|
|
|
9/22/2011 |
Pharmacist |
United States |
|
Diarrhoea |
Hospitalization |
9/1/2011 |
|
|
|
9/22/2011 |
Pharmacist |
United States |
Primary |
|
Secondary |
|
Concomitant |
|
|
Death |
Hospitalization |
9/1/2011 |
|
|
|
9/27/2011 |
Physician |
United States |
Primary |
|
Secondary |
|
Concomitant |
|
|
Mental Disorder |
Hospitalization |
6/1/2011 |
|
|
|
9/29/2011 |
Pharmacist |
United States |
Primary |
|
Secondary |
|
Concomitant |
|
|
Infection |
Hospitalization |
9/1/2011 |
|
|
|
9/29/2011 |
Physician |
United States |
|
Device Damage |
Hospitalization |
9/1/2011 |
|
|
|
10/4/2011 |
Physician |
United States |
Primary |
|
Secondary |
|
Concomitant |
|
|
Right Ventricular Failure |
Death |
8/3/2011 |
|
|
|
10/4/2011 |
Pharmacist |
United States |
|
Food Poisoning |
Hospitalization |
4/16/2011 |
|
|
|
10/11/2011 |
Physician |
United States |
Primary |
|
Secondary |
|
Concomitant |
|
|
Medical Device Complication |
Hospitalization |
8/23/2011 |
|
|
|
10/12/2011 |
Physician |
United States |
Primary |
|
Secondary |
|
Concomitant |
|
|
Mental Disorder |
Hospitalization |
6/1/2011 |
|
|
|
10/12/2011 |
Pharmacist |
United States |
Primary |
|
Secondary |
|
Concomitant |
|
|
Transfusion |
Hospitalization |
9/21/2011 |
|
|
|
10/13/2011 |
Other Health Professional |
United States |
Primary |
|
Secondary |
|
Concomitant |
|
|
Pleural Effusion |
Hospitalization |
1/1/2011 |
22 |
Male |
130 lb |
10/17/2011 |
Physician |
United States |
|
Diarrhoea |
Hospitalization |
4/16/2011 |
|
|
|
10/18/2011 |
Pharmacist |
United States |
Primary |
|
Secondary |
|
Concomitant |
|
|
Panic Attack |
Hospitalization |
10/1/2011 |
|
|
|
10/19/2011 |
Physician |
United States |
|