Dysphagia |
Other Serious |
12/19/2005 |
8 |
Female |
57 lb |
1/20/2006 |
Physician |
Japan |
|
Delirium |
Hospitalization |
12/15/2005 |
9 |
Female |
46 lb |
1/20/2006 |
Physician |
Japan |
|
Hallucination |
Hospitalization |
1/8/2006 |
6 |
|
|
1/30/2006 |
Physician |
Japan |
|
Upper Respiratory Tract Inflammation |
Other Serious |
12/19/2005 |
8 |
Female |
57 lb |
2/1/2006 |
Physician |
Japan |
|
Urinary Incontinence |
Other Serious |
12/21/2005 |
8 |
Male |
53 lb |
2/2/2006 |
Physician |
Japan |
|
Speech Disorder |
Hospitalization |
12/15/2005 |
9 |
Female |
46 lb |
2/9/2006 |
Physician |
Japan |
|
Vomiting |
Hospitalization |
11/30/2004 |
6 |
Male |
49 lb |
2/10/2006 |
Physician |
Japan |
|
Mental Disorder |
Life Threatening |
1/26/2005 |
6 |
Male |
|
2/13/2006 |
Physician |
Japan |
|
Abnormal Behaviour |
Other Serious |
12/21/2005 |
8 |
Male |
53 lb |
2/14/2006 |
Physician |
Japan |
|
Hallucination |
Life Threatening |
1/24/2006 |
6 |
Female |
|
2/17/2006 |
Physician |
Japan |
|
Hallucination |
Life Threatening |
1/26/2006 |
6 |
Male |
53 lb |
2/24/2006 |
Physician |
Japan |
|
Urine Ketone Body Present |
Other Serious |
1/9/2006 |
6 |
Male |
33 lb |
2/24/2006 |
Physician |
Japan |
|
Urinary Incontinence |
Other Serious |
12/21/2005 |
8 |
Male |
55 lb |
3/1/2006 |
Physician |
Japan |
|
Dysphagia |
Other Serious |
12/19/2005 |
8 |
Female |
57 lb |
3/1/2006 |
Physician |
Japan |
|
Haematuria |
Other Serious |
1/21/2006 |
2 |
Female |
|
3/2/2006 |
Physician |
Japan |
Primary |
|
Secondary |
|
Concomitant |
|
|
Unresponsive To Verbal Stimuli |
Hospitalization |
12/26/2005 |
8 |
Male |
55 lb |
3/10/2006 |
Physician |
Japan |
|
Sleep Disorder |
Other Serious |
2/6/2006 |
5 |
Female |
37 lb |
3/10/2006 |
Physician |
Japan |
|
Hallucination, Visual |
Other Serious |
2/6/2006 |
5 |
Female |
37 lb |
3/13/2006 |
Physician |
Japan |
|
Hepatic Function Abnormal |
Other Serious |
1/13/2006 |
1 |
Male |
22 lb |
2/16/2006 |
|
Japan |
|
White Blood Cell Count Decreased |
Other Serious |
2/6/2006 |
12 |
Male |
106 lb |
3/15/2006 |
Physician |
Japan |
|
Somnolence |
Hospitalization |
1/9/2006 |
6 |
Male |
33 lb |
3/17/2006 |
Physician |
Japan |
|
Neutrophil Count Decreased |
Other Serious |
2/6/2006 |
12 |
Male |
106 lb |
3/24/2006 |
Physician |
Japan |
|
Haematuria |
Other Serious |
1/21/2006 |
2 |
Female |
31 lb |
3/27/2006 |
Physician |
Japan |
Primary |
|
Secondary |
|
Concomitant |
|
|
Dysphagia |
Other Serious |
12/19/2005 |
8 |
Female |
57 lb |
3/28/2006 |
Physician |
Japan |
|
Hepatic Function Abnormal |
Other Serious |
1/13/2006 |
1 |
Male |
22 lb |
3/24/2006 |
|
Japan |
|
Toxic Induced Encephalopathy |
Hospitalization |
11/30/2004 |
6 |
Male |
49 lb |
4/12/2006 |
Physician |
Japan |
|
Hallucinations, Mixed |
Life Threatening |
1/26/2006 |
6 |
Male |
53 lb |
4/20/2006 |
Physician |
Japan |
|
Electroencephalogram Abnormal |
Hospitalization |
1/16/2006 |
8 |
Male |
66 lb |
4/21/2006 |
Physician |
Japan |
|
Haematuria |
Other Serious |
1/21/2006 |
2 |
Female |
31 lb |
4/24/2006 |
Physician |
Japan |
Primary |
|
Secondary |
|
Concomitant |
|
|
Encephalopathy |
Other Serious |
1/5/2006 |
2 |
Female |
26 lb |
4/25/2006 |
Physician |
Japan |
Primary |
|
Secondary |
|
Concomitant |
|
|
Head Banging |
Other Serious |
4/1/2006 |
3 |
Male |
31 lb |
5/5/2006 |
Physician |
Japan |
|
Delirium |
Hospitalization |
12/26/2005 |
8 |
Male |
55 lb |
6/7/2006 |
Physician |
Japan |
|
Restlessness |
Other Serious |
12/19/2005 |
6 |
Female |
42 lb |
6/21/2006 |
Physician |
Japan |
|
Stridor |
Other Serious |
4/9/2006 |
2 |
Male |
|
8/8/2006 |
Physician |
Japan |
Primary |
|
Secondary |
|
Concomitant |
|
|
Delirium |
Other Serious |
12/19/2005 |
6 |
Female |
37 lb |
8/11/2006 |
Physician |
Japan |
|
Stridor |
Other Serious |
4/9/2006 |
2 |
Male |
|
8/21/2006 |
Physician |
Japan |
Primary |
|
Secondary |
|
Concomitant |
|
|
Stridor |
Other Serious |
4/9/2006 |
2 |
Male |
|
9/5/2006 |
Physician |
Japan |
Primary |
|
Secondary |
|
Concomitant |
|
|
White Blood Cell Count Decreased |
Hospitalization |
9/8/2006 |
7 |
Female |
|
11/9/2006 |
Physician |
Japan |
Primary |
|
Secondary |
|
Concomitant |
|
|
Quadriparesis |
Other Serious |
1/5/2006 |
2 |
Female |
26 lb |
12/27/2006 |
Physician |
Japan |
Primary |
|
Secondary |
|
Concomitant |
|
|
Nephrotic Syndrome |
Hospitalization |
3/8/2005 |
4 |
Male |
40 lb |
1/4/2007 |
Physician |
Japan |
|
Nephrotic Syndrome |
Hospitalization |
3/8/2005 |
4 |
Male |
40 lb |
1/30/2007 |
Physician |
Japan |
|
Ocular Hyperaemia |
Other Serious |
|
|
|
|
2/6/2007 |
Pharmacist |
Japan |
|
Ocular Hyperaemia |
Other Serious |
|
|
|
|
2/6/2007 |
Pharmacist |
Japan |
|
Ocular Hyperaemia |
Other Serious |
1/24/2007 |
1 |
Female |
|
2/15/2007 |
Physician |
Japan |
|
Ocular Hyperaemia |
Other Serious |
1/24/2007 |
1 |
Male |
|
2/15/2007 |
Physician |
Japan |
|
Fear |
Other Serious |
2/27/2007 |
6 |
Male |
|
3/12/2007 |
Physician |
Japan |
|
Restlessness |
Other Serious |
2/27/2007 |
6 |
Male |
60 lb |
3/20/2007 |
Physician |
Japan |
|
Hallucination |
Other Serious |
3/16/2007 |
9 |
Female |
|
4/2/2007 |
Physician |
Japan |
|
Restlessness |
Other Serious |
2/27/2007 |
6 |
Male |
60 lb |
4/3/2007 |
Physician |
Japan |
|
Visual Disturbance |
Hospitalization |
3/3/2007 |
4 |
Male |
40 lb |
4/3/2007 |
Physician |
Japan |
|
Hypothermia |
Other Serious |
1/24/2006 |
10 |
Female |
|
4/13/2007 |
Pharmacist |
Japan |
|
Restlessness |
Other Serious |
3/16/2007 |
9 |
Female |
77 lb |
4/16/2007 |
Physician |
Japan |
|
Delirium |
Other Serious |
12/19/2005 |
6 |
Female |
37 lb |
4/25/2007 |
Physician |
Japan |
|
Delirium |
Life Threatening |
3/9/2007 |
11 |
Male |
66 lb |
4/26/2007 |
Physician |
Japan |
|
Agitation |
Other Serious |
3/4/2007 |
11 |
Female |
35 lb |
4/26/2007 |
Physician |
Japan |
|
Depressed Level Of Consciousness |
Other Serious |
3/19/2007 |
5 |
Female |
40 lb |
4/27/2007 |
Physician |
Japan |
|
Urinary Incontinence |
Other Serious |
12/21/2005 |
8 |
Male |
55 lb |
4/30/2007 |
Physician |
Japan |
|
Hallucination |
Other Serious |
1/24/2006 |
6 |
Female |
|
5/1/2007 |
Physician |
Japan |
|
Visual Disturbance |
Hospitalization |
3/1/2007 |
4 |
Male |
40 lb |
5/1/2007 |
Physician |
Japan |
|
Delirium |
Hospitalization |
12/15/2005 |
9 |
Female |
46 lb |
5/1/2007 |
Physician |
Japan |
|
Abnormal Behaviour |
Other Serious |
2/28/2007 |
4 |
Male |
35 lb |
5/1/2007 |
Physician |
Japan |
|
Delirium |
Hospitalization |
12/15/2005 |
9 |
Female |
46 lb |
5/1/2007 |
Physician |
Japan |
|
Visual Disturbance |
Hospitalization |
3/1/2007 |
4 |
Male |
40 lb |
5/1/2007 |
Physician |
Japan |
|
Depressed Level Of Consciousness |
Other Serious |
4/1/2006 |
3 |
Male |
31 lb |
5/3/2007 |
Physician |
Japan |
|
Suicidal Ideation |
Other Serious |
3/5/2007 |
10 |
Female |
75 lb |
5/3/2007 |
Physician |
Japan |
|
Abnormal Behaviour |
Other Serious |
3/19/2007 |
7 |
Female |
55 lb |
5/3/2007 |
Physician |
Japan |
|
Agitation |
Other Serious |
3/4/2007 |
11 |
Female |
35 lb |
5/3/2007 |
Physician |
Japan |
|
Depressed Level Of Consciousness |
Other Serious |
3/19/2007 |
5 |
Female |
40 lb |
5/4/2007 |
Physician |
Japan |
|
Abnormal Behaviour |
Other Serious |
2/24/2007 |
5 |
Female |
40 lb |
5/4/2007 |
Physician |
Japan |
|
Convulsion |
Other Serious |
3/13/2007 |
8 |
Female |
60 lb |
5/7/2007 |
Physician |
Japan |
|
Liver Disorder |
Other Serious |
2/18/2007 |
|
Male |
20 lb |
5/9/2007 |
Physician |
Japan |
|
Convulsion |
Other Serious |
3/23/2007 |
4 |
Female |
33 lb |
5/9/2007 |
Physician |
Japan |
|
Vomiting |
Other Serious |
3/17/2007 |
4 |
Male |
35 lb |
5/21/2007 |
Physician |
Japan |
|
Abnormal Behaviour |
Other Serious |
3/19/2007 |
7 |
Female |
55 lb |
5/23/2007 |
Physician |
Japan |
|
Liver Disorder |
Other Serious |
2/18/2007 |
1 |
Male |
20 lb |
5/25/2007 |
Physician |
Japan |
|
Restlessness |
Other Serious |
5/9/2007 |
10 |
Female |
51 lb |
5/30/2007 |
Physician |
Japan |
|
Somnolence |
Hospitalization |
1/9/2006 |
6 |
Male |
33 lb |
6/1/2007 |
Physician |
Japan |
|
Rash |
Hospitalization |
4/30/2007 |
6 |
Male |
|
6/5/2007 |
Physician |
Japan |
|
Disorientation |
Other Serious |
5/23/2007 |
|
Male |
32 lb |
6/5/2007 |
Physician |
Japan |
|
Abnormal Behaviour |
Other Serious |
3/12/2007 |
7 |
Male |
66 lb |
6/8/2007 |
Physician |
Japan |
|
Pyrexia |
Hospitalization |
5/26/2007 |
1 |
|
|
6/8/2007 |
Physician |
Japan |
|
Convulsion |
Other Serious |
4/12/2007 |
4 |
Female |
33 lb |
6/11/2007 |
Physician |
Japan |
|
Convulsion |
Other Serious |
3/13/2007 |
8 |
Female |
60 lb |
6/14/2007 |
Physician |
Japan |
|
Pyrexia |
Hospitalization |
5/26/2007 |
1 |
|
19 lb |
6/21/2007 |
Physician |
Japan |
Primary |
|
Secondary |
|
Concomitant |
|
|
Convulsion |
Other Serious |
3/23/2007 |
4 |
Female |
33 lb |
6/28/2007 |
Physician |
Japan |
|
Ventricular Extrasystoles |
Other Serious |
6/7/2007 |
|
Female |
37 lb |
7/3/2007 |
Physician |
Japan |
Primary |
|
Concomitant |
|
Interacting |
|
|
Convulsion |
Other Serious |
3/13/2007 |
8 |
Female |
60 lb |
7/11/2007 |
Physician |
Japan |
|
Pyrexia |
Hospitalization |
5/26/2007 |
1 |
|
19 lb |
7/26/2007 |
Physician |
Japan |
|
Liver Disorder |
Other Serious |
2/18/2007 |
1 |
Male |
20 lb |
8/23/2007 |
Physician |
Japan |
|
Loss Of Consciousness |
Other Serious |
3/26/2007 |
7 |
Male |
53 lb |
9/10/2007 |
Physician |
Japan |
Primary |
|
Secondary |
|
Concomitant |
|
|
Erythema Multiforme |
Other Serious |
8/10/2007 |
1 |
Female |
22 lb |
9/21/2007 |
Physician |
Japan |
Primary |
|
Secondary |
|
Concomitant |
|
|
Pneumonia |
Other Serious |
8/29/2002 |
1 |
Male |
|
9/22/2007 |
|
Japan |
|
Loss Of Consciousness |
Other Serious |
3/26/2007 |
7 |
Male |
53 lb |
9/28/2007 |
Physician |
Japan |
Primary |
|
Secondary |
|
Concomitant |
|
|
Erythema Multiforme |
Other Serious |
8/10/2007 |
2 |
Female |
22 lb |
10/16/2007 |
Physician |
Japan |
Primary |
|
Secondary |
|
Concomitant |
|
|
Toxic Epidermal Necrolysis |
Other Serious |
7/21/2007 |
0 |
Male |
|
10/22/2007 |
Physician |
Japan |
|
Streptococcal Infection |
Other Serious |
2/6/2007 |
2 |
Female |
24 lb |
10/29/2007 |
Pharmacist |
Japan |
|
Body Temperature Decreased |
Other Serious |
10/11/2007 |
2 |
Female |
26 lb |
11/6/2007 |
Physician |
Japan |
|
Hypothermia |
Other Serious |
10/11/2007 |
2 |
Female |
26 lb |
11/15/2007 |
Physician |
Japan |
|
Sudden Death |
Death |
12/30/2002 |
2 |
Male |
30 lb |
11/19/2007 |
Physician |
Japan |
Primary |
|
Secondary |
|
Concomitant |
|
|
Hallucination |
Other Serious |
11/18/2007 |
8 |
Male |
|
11/27/2007 |
Physician |
Japan |
|
Speech Disorder |
Other Serious |
11/18/2007 |
8 |
Male |
54 lb |
12/13/2007 |
Physician |
Japan |
|
Convulsion |
Other Serious |
12/13/2007 |
8 |
Female |
60 lb |
12/21/2007 |
Physician |
Japan |
|
Haemoptysis |
Other Serious |
|
1 |
Male |
|
12/21/2007 |
Physician |
Japan |
|
Hepatitis Fulminant |
Other Serious |
10/30/2004 |
|
Female |
|
12/27/2007 |
Physician |
Japan |
|
Haematemesis |
Other Serious |
12/12/2007 |
|
Male |
|
1/8/2008 |
Physician |
Japan |
|
Hallucination, Auditory |
Hospitalization |
12/31/2007 |
5 |
Female |
|
1/11/2008 |
Pharmacist |
Japan |
|
Screaming |
Other Serious |
12/21/2007 |
7 |
Female |
44 lb |
1/14/2008 |
Physician |
Japan |
|
Hepatitis Fulminant |
Death |
10/30/2004 |
|
Female |
|
1/10/2008 |
Physician |
Japan |
|
Pyrexia |
Other Serious |
12/13/2007 |
8 |
Female |
60 lb |
1/16/2008 |
Physician |
Japan |
|
Convulsion |
Other Serious |
12/14/2007 |
5 |
Male |
|
1/17/2008 |
Physician |
Japan |
|
Vomiting |
Other Serious |
12/11/2007 |
|
Male |
|
1/18/2008 |
Physician |
Japan |
|
Screaming |
Other Serious |
12/21/2007 |
7 |
Female |
44 lb |
1/22/2008 |
Physician |
Japan |
|
Cyanosis |
Other Serious |
12/1/2007 |
1 |
Male |
20 lb |
1/29/2008 |
Physician |
Japan |
|
Insomnia |
Other Serious |
1/7/2008 |
4 |
Male |
33 lb |
1/30/2008 |
Physician |
Japan |
Primary |
|
Secondary |
|
Concomitant |
|
|
Hallucination, Auditory |
Other Serious |
12/31/2007 |
5 |
Female |
|
2/4/2008 |
Physician |
Japan |
|
Hepatitis Fulminant |
Death |
10/30/2004 |
|
Male |
|
1/27/2008 |
Physician |
Japan |
|
Delirium |
Other Serious |
12/25/2007 |
4 |
Female |
|
2/8/2008 |
Physician |
Japan |
|
Tremor |
Other Serious |
1/21/2008 |
6 |
Female |
|
2/8/2008 |
Physician |
Japan |
|
Pyrexia |
Other Serious |
12/13/2007 |
8 |
Female |
60 lb |
2/12/2008 |
Physician |
Japan |
|
Abnormal Behaviour |
Other Serious |
1/15/2008 |
10 |
Male |
66 lb |
2/12/2008 |
Physician |
Japan |
|
Nasopharyngitis |
Other Serious |
12/1/2007 |
1 |
Male |
20 lb |
2/14/2008 |
Physician |
Japan |
|
Loss Of Consciousness |
Other Serious |
1/24/2008 |
6 |
Male |
|
2/14/2008 |
Physician |
Japan |
|
Nasopharyngitis |
Other Serious |
12/5/2007 |
1 |
Male |
20 lb |
2/20/2008 |
Physician |
Japan |
|
Rhabdomyolysis |
Hospitalization |
12/4/2007 |
|
Female |
21 lb |
2/21/2008 |
Physician |
Japan |
|
Abnormal Behaviour |
Other Serious |
11/13/2007 |
5 |
Male |
40 lb |
2/22/2008 |
Physician |
Japan |
|
Delirium |
Other Serious |
12/25/2007 |
4 |
Female |
|
2/26/2008 |
Physician |
Japan |
|
Rhabdomyolysis |
Hospitalization |
12/4/2007 |
|
Female |
21 lb |
2/27/2008 |
Physician |
Japan |
|
Tremor |
Other Serious |
1/21/2008 |
6 |
Female |
44 lb |
2/28/2008 |
Physician |
Japan |
|
Blood Corticotrophin Decreased |
Other Serious |
2/5/2008 |
1 |
Female |
22 lb |
2/28/2008 |
Physician |
Japan |
|
Delirium |
Other Serious |
1/28/2008 |
9 |
Male |
53 lb |
2/29/2008 |
Physician |
Japan |
|
Abnormal Behaviour |
Other Serious |
1/14/2008 |
6 |
Female |
49 lb |
2/29/2008 |
Physician |
Japan |
|
Multi-organ Failure |
Life Threatening |
10/30/2004 |
|
Male |
|
2/28/2008 |
Physician |
Japan |
|
Loss Of Consciousness |
Other Serious |
1/24/2008 |
6 |
Male |
45 lb |
3/6/2008 |
Physician |
Japan |
Primary |
|
Secondary |
|
Concomitant |
|
|
Delirium |
Other Serious |
1/18/2008 |
7 |
Male |
71 lb |
3/6/2008 |
Physician |
Japan |
|
Convulsion |
Other Serious |
2/7/2008 |
3 |
Male |
33 lb |
3/17/2008 |
Physician |
Japan |
|
Hepatitis Fulminant |
Death |
10/30/2004 |
|
Male |
|
3/31/2008 |
Physician |
Japan |
|
Tremor |
Other Serious |
1/21/2008 |
6 |
Female |
44 lb |
4/11/2008 |
Physician |
Japan |
|
Convulsion |
Other Serious |
2/15/2008 |
7 |
Male |
51 lb |
4/29/2008 |
Other Health Professional |
Japan |
|
Oedema |
Hospitalization |
3/11/2008 |
29 |
Female |
|
5/12/2008 |
Physician |
Japan |
Primary |
|
Secondary |
|
Concomitant |
|
|
Abnormal Behaviour |
Other Serious |
2/15/2008 |
|
Male |
51 lb |
5/28/2008 |
Other Health Professional |
Japan |
|
Abnormal Behaviour |
Other Serious |
2/15/2008 |
|
Male |
51 lb |
5/30/2008 |
Other Health Professional |
Japan |
|
Oedema |
Hospitalization |
3/11/2008 |
29 |
Female |
|
6/13/2008 |
Physician |
Japan |
Primary |
|
Secondary |
|
Concomitant |
|
|
Hepatic Function Abnormal |
Other Serious |
5/13/2008 |
2 |
Female |
24 lb |
6/23/2008 |
Physician |
Japan |
Primary |
|
Secondary |
|
Concomitant |
|
|
Hepatic Function Abnormal |
|
5/13/2008 |
2 |
Female |
24 lb |
6/25/2008 |
Physician |
Japan |
Primary |
|
Secondary |
|
Concomitant |
|
|
Somnolence |
Other Serious |
6/14/2008 |
5 |
Male |
44 lb |
7/10/2008 |
Physician |
Japan |
Primary |
|
Secondary |
|
Concomitant |
|
|
Vomiting |
Other Serious |
|
2 |
Male |
|
7/10/2008 |
Physician |
Japan |
Primary |
|
Secondary |
|
Concomitant |
|
|
Somnolence |
Other Serious |
6/14/2008 |
5 |
Male |
44 lb |
7/16/2008 |
Physician |
Japan |
Primary |
|
Secondary |
|
Concomitant |
|
|
Vomiting |
Other Serious |
6/18/2008 |
2 |
Male |
|
7/18/2008 |
Physician |
Japan |
Primary |
|
Secondary |
|
Concomitant |
|
|
Blood Corticotrophin Decreased |
Other Serious |
2/5/2008 |
1 |
Female |
22 lb |
7/31/2008 |
Physician |
Japan |
|
Neutropenia |
Hospitalization |
7/22/2008 |
1 |
Male |
|
8/8/2008 |
Physician |
Japan |
|