| Visual Field Defect |
Other Serious |
10/1/2005 |
77 |
Male |
|
12/28/2005 |
|
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Respiratory Arrest |
Hospitalization |
11/16/2005 |
81 |
Male |
|
12/29/2005 |
|
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Myocardial Infarction |
Hospitalization |
1/4/2006 |
75 |
Male |
|
1/23/2006 |
|
Japan |
|
| Myocardial Infarction |
Hospitalization |
1/4/2006 |
75 |
Male |
|
2/3/2006 |
|
Japan |
|
| Urinary Casts |
Disability |
8/30/2005 |
76 |
Male |
|
3/7/2006 |
|
Japan |
|
| Lymphocyte Stimulation Test Positive |
Death |
2/10/2006 |
88 |
Male |
|
3/7/2006 |
Other Health Professional |
Japan |
|
| Interstitial Lung Disease |
Death |
2/12/2006 |
74 |
Male |
|
3/9/2006 |
|
Japan |
|
| Therapy Non-responder |
Death |
2/8/2006 |
88 |
Male |
|
3/9/2006 |
|
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Jaundice |
Hospitalization |
2/9/2006 |
85 |
Male |
|
3/16/2006 |
|
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Therapy Non-responder |
Death |
2/8/2006 |
88 |
Male |
|
3/31/2006 |
|
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Pleural Effusion |
Hospitalization |
2/9/2006 |
85 |
Male |
|
4/13/2006 |
|
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Pleural Effusion |
Death |
2/12/2006 |
74 |
Male |
|
5/2/2006 |
|
Japan |
|
| Therapeutic Product Ineffective |
Hospitalization |
1/23/2006 |
73 |
Male |
|
6/5/2006 |
|
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Pleural Effusion |
Hospitalization |
3/11/2006 |
85 |
Male |
|
6/26/2006 |
|
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Respiratory Failure |
Hospitalization |
11/16/2005 |
81 |
Male |
|
6/30/2006 |
|
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Visual Field Defect |
Other Serious |
10/1/2005 |
77 |
Male |
|
8/10/2006 |
|
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Cryptogenic Organising Pneumonia |
Hospitalization |
3/1/2006 |
70 |
Male |
|
8/23/2006 |
|
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Visual Pathway Disorder |
Other Serious |
10/1/2005 |
77 |
Male |
|
9/6/2006 |
|
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Interstitial Lung Disease |
Hospitalization |
3/1/2006 |
90 |
Male |
|
10/2/2006 |
|
Japan |
|
| Muscular Weakness |
Hospitalization |
8/27/2006 |
76 |
Male |
|
10/12/2006 |
Other Health Professional |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Cryptogenic Organising Pneumonia |
Hospitalization |
10/11/2005 |
72 |
Male |
|
10/20/2006 |
|
Japan |
|
| Renal Failure |
Life Threatening |
11/7/2006 |
80 |
Male |
|
11/10/2006 |
|
Japan |
|
| Tremor |
Life Threatening |
11/4/2006 |
80 |
Male |
|
11/15/2006 |
|
Japan |
|
| Pleural Effusion |
Hospitalization |
3/11/2006 |
85 |
Male |
|
11/22/2006 |
Physician |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Suicidal Ideation |
|
9/28/2006 |
|
Male |
182 lb |
11/29/2006 |
|
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Renal Failure Acute |
Life Threatening |
3/15/2006 |
79 |
Male |
|
12/1/2006 |
|
Japan |
|
| Tremor |
Life Threatening |
11/4/2006 |
80 |
Male |
|
11/29/2006 |
|
Japan |
|
| Pneumonia |
Hospitalization |
7/10/2006 |
76 |
Male |
|
12/21/2006 |
Physician |
Japan |
|
| Hepatic Function Abnormal |
Hospitalization |
2/1/2004 |
53 |
Male |
|
12/28/2006 |
Physician |
Japan |
|
| Urinary Retention |
Hospitalization |
12/6/2006 |
86 |
Male |
|
1/3/2007 |
|
France |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Peliosis Hepatis |
Hospitalization |
12/28/2006 |
72 |
Male |
|
1/25/2007 |
Physician |
Japan |
|
| Eosinophilic Pneumonia |
Hospitalization |
5/1/2006 |
|
Male |
|
1/29/2007 |
Physician |
Japan |
|
| Hypotension |
Other Serious |
9/15/2006 |
65 |
Male |
141 lb |
2/6/2007 |
Physician |
Japan |
|
| Peliosis Hepatis |
Hospitalization |
11/1/2006 |
73 |
Male |
150 lb |
2/13/2007 |
Physician |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Injection Site Nodule |
Other Serious |
1/1/2006 |
86 |
Male |
|
2/12/2007 |
|
Japan |
|
| Peliosis Hepatis |
Hospitalization |
11/1/2006 |
73 |
Male |
150 lb |
2/22/2007 |
Physician |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Road Traffic Accident |
|
1/30/2007 |
|
Male |
185 lb |
2/15/2007 |
|
United States |
|
| Peliosis Hepatis |
Hospitalization |
11/1/2006 |
73 |
Male |
150 lb |
2/26/2007 |
Physician |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Pancreatitis Acute |
Hospitalization |
7/16/2006 |
79 |
Male |
|
3/1/2007 |
|
Japan |
|
| Renal Impairment |
Hospitalization |
9/24/2006 |
76 |
Male |
|
3/6/2007 |
|
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Gastrointestinal Carcinoma |
Death |
6/7/2006 |
83 |
Male |
|
3/7/2007 |
|
Japan |
|
| Urinary Retention |
Hospitalization |
12/6/2006 |
86 |
Male |
|
3/15/2007 |
Other Health Professional |
France |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Spleen Disorder |
Hospitalization |
9/28/2006 |
73 |
Male |
150 lb |
3/22/2007 |
Physician |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Cerebrovascular Disorder |
Hospitalization |
11/23/2006 |
81 |
Male |
|
3/21/2007 |
|
Japan |
|
| Interstitial Lung Disease |
Hospitalization |
9/18/2006 |
77 |
Male |
|
3/21/2007 |
|
Japan |
|
| Respiratory Failure |
Life Threatening |
10/24/2005 |
81 |
Male |
|
3/22/2007 |
|
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Renal Impairment |
Hospitalization |
9/24/2006 |
76 |
Male |
|
3/23/2007 |
|
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Cerebrovascular Disorder |
Hospitalization |
11/23/2006 |
81 |
Male |
|
4/3/2007 |
|
Japan |
|
| Pancreatitis Acute |
Hospitalization |
7/16/2006 |
79 |
Male |
|
4/4/2007 |
|
Japan |
|
| Urinary Retention |
|
4/10/2007 |
|
Male |
207 lb |
4/13/2007 |
|
United States |
|
| Interstitial Lung Disease |
Hospitalization |
9/18/2006 |
77 |
Male |
|
4/24/2007 |
|
Japan |
|
| Weight Increased |
Other Serious |
2/9/2007 |
72 |
Male |
220 lb |
5/31/2007 |
Physician |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Stevens-johnson Syndrome |
Other Serious |
5/23/2007 |
70 |
Male |
|
6/4/2007 |
Physician |
Japan |
|
| Pulmonary Alveolar Haemorrhage |
Life Threatening |
5/6/2007 |
68 |
Male |
|
6/14/2007 |
|
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Cataract |
Other Serious |
3/5/2007 |
72 |
Male |
|
6/14/2007 |
|
Japan |
|
| Renal Impairment |
Hospitalization |
9/24/2006 |
76 |
Male |
|
6/14/2007 |
|
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Metastases To Lung |
Death |
5/19/2006 |
74 |
Male |
|
6/21/2007 |
|
Japan |
|
| No Therapeutic Response |
Hospitalization |
9/18/2006 |
77 |
Male |
|
6/26/2007 |
|
Japan |
|
| Cataract |
Other Serious |
3/5/2007 |
72 |
Male |
|
7/6/2007 |
|
Japan |
|
| Prostate Cancer |
Death |
5/19/2006 |
74 |
Male |
|
7/11/2007 |
Physician |
Japan |
|
| White Blood Cell Count Decreased |
Hospitalization |
6/30/2007 |
|
Male |
192 lb |
7/26/2007 |
|
United States |
|
| Lung Neoplasm Malignant |
Death |
2/27/2007 |
78 |
Male |
|
7/26/2007 |
|
Japan |
|
| Obesity |
Disability |
|
73 |
Male |
|
7/27/2007 |
|
Japan |
|
| Pleural Effusion |
Death |
2/27/2007 |
78 |
Male |
|
8/1/2007 |
|
Japan |
|
| Mood Altered |
Other Serious |
|
|
Male |
|
9/12/2007 |
Physician |
Japan |
|
| Mood Altered |
Other Serious |
|
|
Male |
|
9/13/2007 |
Physician |
Japan |
|
| Pneumonia |
Hospitalization |
9/24/2006 |
76 |
Male |
|
9/10/2007 |
|
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Weight Decreased |
Hospitalization |
7/30/2007 |
73 |
Male |
|
9/7/2007 |
|
France |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Respiratory Tract Infection |
Life Threatening |
3/14/2006 |
79 |
Male |
|
9/7/2007 |
|
Japan |
|
| Bradycardia |
Other Serious |
5/17/2007 |
80 |
Male |
|
9/24/2007 |
Physician |
Japan |
|
| Injection Site Induration |
Other Serious |
6/29/2007 |
69 |
Male |
161 lb |
9/26/2007 |
Physician |
Japan |
|
| Injection Site Induration |
Other Serious |
6/29/2007 |
69 |
Male |
161 lb |
9/27/2007 |
Physician |
Japan |
|
| Pancreatic Carcinoma |
Other Serious |
|
73 |
Male |
|
9/25/2007 |
|
Japan |
|
| Pancreatic Carcinoma |
Other Serious |
|
73 |
Male |
|
10/12/2007 |
Other Health Professional |
Japan |
|
| Pneumonia |
Hospitalization |
9/24/2006 |
76 |
Male |
|
10/15/2007 |
|
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Sudden Death |
Death |
9/27/2007 |
81 |
Male |
|
10/12/2007 |
|
Japan |
|
| Disease Progression |
Hospitalization |
8/6/2006 |
80 |
Male |
|
10/12/2007 |
Other Health Professional |
Japan |
|
| Renal Failure |
Hospitalization |
6/1/2007 |
61 |
Male |
|
10/22/2007 |
Pharmacist |
Spain |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Pulmonary Infarction |
Death |
6/29/2007 |
80 |
Male |
|
10/16/2007 |
|
Japan |
|
| Prostatic Specific Antigen Increased |
Death |
6/26/2007 |
67 |
Male |
|
10/23/2007 |
|
Japan |
|
| Pancreatic Carcinoma |
Life Threatening |
2/28/2007 |
75 |
Male |
|
10/16/2007 |
|
Japan |
|
| Mood Altered |
|
|
|
Male |
|
11/14/2007 |
Physician |
Japan |
|
| Mood Altered |
|
|
|
Male |
|
11/14/2007 |
Physician |
Japan |
|
| Restlessness |
Hospitalization |
8/6/2006 |
80 |
Male |
|
11/7/2007 |
|
Japan |
|
| Deep Vein Thrombosis |
Other Serious |
10/14/2007 |
80 |
Male |
|
11/27/2007 |
Physician |
Japan |
|
| Malaise |
Hospitalization |
9/18/2007 |
74 |
Male |
|
12/3/2007 |
Physician |
Japan |
|
| Pancreatic Carcinoma |
Life Threatening |
2/28/2007 |
75 |
Male |
|
11/26/2007 |
|
Japan |
|
| Urge Incontinence |
Death |
4/27/2007 |
75 |
Male |
|
11/26/2007 |
|
Japan |
|
| Pneumonia |
Hospitalization |
9/24/2006 |
76 |
Male |
|
12/4/2007 |
|
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Tongue Neoplasm Malignant Stage Unspecified |
Life Threatening |
4/17/2007 |
76 |
Male |
|
12/5/2007 |
|
Japan |
|
| Pulmonary Mycosis |
Life Threatening |
5/6/2007 |
68 |
Male |
|
12/26/2007 |
|
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Hepatic Function Abnormal |
Hospitalization |
12/12/2007 |
74 |
Male |
170 lb |
1/7/2008 |
Physician |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Hepatic Function Abnormal |
Hospitalization |
12/12/2007 |
74 |
Male |
170 lb |
1/22/2008 |
Physician |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Cardiac Failure |
Hospitalization |
1/15/2008 |
52 |
Male |
|
2/1/2008 |
Physician |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Interstitial Lung Disease |
Death |
11/24/2007 |
81 |
Male |
154 lb |
2/7/2008 |
Physician |
Japan |
|
| Cardiac Failure |
Hospitalization |
1/15/2008 |
52 |
Male |
|
2/20/2008 |
Physician |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Interstitial Lung Disease |
Hospitalization |
|
76 |
Male |
|
2/25/2008 |
Physician |
Japan |
|
| Cardiac Failure |
Hospitalization |
1/23/2008 |
72 |
Male |
|
2/25/2008 |
Physician |
Japan |
|
| Surfactant Protein Increased |
Other Serious |
1/7/2008 |
79 |
Male |
|
2/22/2008 |
|
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Hepatic Function Abnormal |
Hospitalization |
12/12/2007 |
74 |
Male |
170 lb |
2/28/2008 |
Physician |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Myocardial Infarction |
Death |
7/1/2007 |
94 |
Male |
121 lb |
2/25/2008 |
Other Health Professional |
Japan |
|
| Cardiac Failure |
Hospitalization |
1/23/2008 |
72 |
Male |
|
3/4/2008 |
Physician |
Japan |
|
| Hypothermia |
Hospitalization |
2/14/2008 |
80 |
Male |
|
3/7/2008 |
Pharmacist |
Japan |
|
| Hepatic Function Abnormal |
Other Serious |
11/28/2007 |
70 |
Male |
|
3/13/2008 |
Physician |
Japan |
|
| Gastric Cancer |
Death |
|
82 |
Male |
|
3/10/2008 |
|
Japan |
|
| Hypothermia |
Hospitalization |
|
|
Male |
|
3/6/2008 |
|
Japan |
|
| Tongue Neoplasm Malignant Stage Unspecified |
Life Threatening |
4/19/2007 |
76 |
Male |
176 lb |
3/6/2008 |
|
Japan |
|
| Hypothermia |
Hospitalization |
|
|
Male |
|
3/6/2008 |
|
Japan |
|
| Cardiac Failure |
Life Threatening |
2/14/2008 |
72 |
Male |
97 lb |
3/17/2008 |
Physician |
Japan |
|
| Post Procedural Complication |
Hospitalization |
1/1/2007 |
77 |
Male |
150 lb |
3/10/2008 |
Other Health Professional |
Japan |
|
| Renal Failure |
Death |
|
|
Male |
|
3/19/2008 |
Physician |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Respiratory Failure |
Other Serious |
1/7/2008 |
79 |
Male |
|
3/12/2008 |
|
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Cardiac Failure |
Hospitalization |
1/15/2008 |
52 |
Male |
|
3/21/2008 |
Physician |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Cardiac Failure |
Life Threatening |
2/14/2008 |
72 |
Male |
97 lb |
3/28/2008 |
Physician |
Japan |
|
| Post Procedural Complication |
Hospitalization |
6/1/2007 |
77 |
Male |
152 lb |
3/24/2008 |
Physician |
Japan |
|
| Hypothermia |
Hospitalization |
2/14/2008 |
80 |
Male |
|
4/7/2008 |
Pharmacist |
Japan |
|
| Prostatic Specific Antigen Increased |
|
9/10/2007 |
|
Male |
|
4/18/2008 |
Physician |
United States |
|
| Pancreatic Enzymes Increased |
Hospitalization |
3/11/2008 |
63 |
Male |
174 lb |
4/30/2008 |
Other Health Professional |
France |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Pulmonary Infarction |
Death |
6/29/2007 |
80 |
Male |
|
5/19/2008 |
|
Japan |
|
| Aplastic Anaemia |
Disability |
2/1/2008 |
60 |
Male |
|
5/29/2008 |
Physician |
Japan |
|
| Pancreatic Enzymes Increased |
Hospitalization |
3/11/2008 |
63 |
Male |
174 lb |
6/2/2008 |
Other Health Professional |
France |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Pyrexia |
Hospitalization |
3/11/2008 |
63 |
Male |
174 lb |
5/22/2008 |
|
France |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Cerebral Infarction |
Death |
2/18/2007 |
81 |
Male |
132 lb |
5/23/2008 |
|
Japan |
|
| Pancreatic Enzymes Increased |
Hospitalization |
3/11/2008 |
63 |
Male |
|
5/30/2008 |
|
France |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Pancreatic Enzymes Increased |
Hospitalization |
3/11/2008 |
63 |
Male |
174 lb |
6/19/2008 |
Other Health Professional |
France |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| White Blood Cell Count Decreased |
Other Serious |
|
|
Male |
|
7/14/2008 |
Physician |
Japan |
|
| Diplopia |
Other Serious |
5/27/2008 |
80 |
Male |
141 lb |
7/31/2008 |
Other Health Professional |
Japan |
|
| Rectal Haemorrhage |
Hospitalization |
4/14/2008 |
88 |
Male |
|
8/5/2008 |
Physician |
France |
| Primary |
|
| Concomitant |
|
| Interacting |
|
|
| Rectal Haemorrhage |
Hospitalization |
4/14/2008 |
|
Male |
|
8/8/2008 |
Other Health Professional |
France |
| Primary |
|
| Concomitant |
|
| Interacting |
|
|
| Rectal Haemorrhage |
Hospitalization |
4/11/2008 |
87 |
Male |
|
8/7/2008 |
Other Health Professional |
Germany |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Renal Failure Acute |
Hospitalization |
7/8/2008 |
71 |
Male |
|
8/15/2008 |
Other Health Professional |
United States |
|
| White Blood Cell Count Decreased |
|
7/28/2008 |
|
Male |
151 lb |
8/20/2008 |
|
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Transient Ischaemic Attack |
Hospitalization |
8/15/2008 |
|
Male |
177 lb |
8/19/2008 |
|
United States |
|
| Transient Ischaemic Attack |
Hospitalization |
8/15/2008 |
|
Male |
177 lb |
9/8/2008 |
|
United States |
|
| Neutrophil Count Increased |
|
9/2/2008 |
|
Male |
201 lb |
9/12/2008 |
|
United States |
|
| Occult Blood Positive |
Hospitalization |
6/10/2008 |
|
Male |
176 lb |
9/19/2008 |
|
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Occult Blood Positive |
Hospitalization |
6/10/2008 |
|
Male |
176 lb |
9/30/2008 |
|
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Renal Impairment |
Other Serious |
3/1/2007 |
|
Male |
|
10/15/2008 |
|
Japan |
|
| Transaminases Increased |
Other Serious |
|
|
Male |
|
10/29/2008 |
Physician |
Italy |
|
| Tooth Extraction |
Other Serious |
3/1/2006 |
|
Male |
|
11/7/2008 |
|
France |
|
| Ventricular Hypokinesia |
Hospitalization |
3/9/2008 |
|
Male |
213 lb |
11/19/2008 |
|
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Myocardial Infarction |
Hospitalization |
11/17/2008 |
|
Male |
192 lb |
11/19/2008 |
|
United States |
|
| Renal Failure |
Hospitalization |
6/1/2007 |
61 |
Male |
|
12/2/2008 |
Pharmacist |
Spain |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Iron Deficiency Anaemia |
Hospitalization |
7/2/2007 |
85 |
Male |
|
12/23/2008 |
|
Japan |
|
| Ill-defined Disorder |
Hospitalization |
12/22/2007 |
76 |
Male |
119 lb |
12/23/2008 |
|
Japan |
|
| Interstitial Lung Disease |
Hospitalization |
10/30/2008 |
|
Male |
|
12/26/2008 |
Physician |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Sepsis |
Hospitalization |
8/14/2007 |
80 |
Male |
|
12/29/2008 |
|
Japan |
|
| Myelodysplastic Syndrome |
Other Serious |
4/23/2007 |
83 |
Male |
|
12/29/2008 |
|
Japan |
|
| Lung Neoplasm Malignant |
Death |
8/8/2005 |
76 |
Male |
|
12/29/2008 |
|
Japan |
|
| Gastroenteritis |
Hospitalization |
1/3/2007 |
79 |
Male |
179 lb |
12/29/2008 |
|
Japan |
|