| Delirium |
Other Serious |
2/27/2004 |
8 |
Male |
66 lb |
1/6/2006 |
Physician |
Japan |
|
| Sudden Death |
Life Threatening |
12/16/2005 |
7 |
Male |
42 lb |
1/9/2006 |
Physician |
Japan |
|
| Vascular Purpura |
Hospitalization |
12/30/2004 |
2 |
Female |
|
1/18/2006 |
Pharmacist |
Japan |
|
| 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 |
|
| Intestinal Ischaemia |
Hospitalization |
12/23/2005 |
25 |
Female |
|
1/26/2006 |
Physician |
Japan |
|
| Hallucination |
Hospitalization |
1/8/2006 |
6 |
|
|
1/30/2006 |
Physician |
Japan |
|
| Sudden Death |
Life Threatening |
12/16/2005 |
7 |
Male |
42 lb |
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 |
|
| Vascular Purpura |
Hospitalization |
12/30/2004 |
2 |
Female |
26 lb |
2/3/2006 |
Pharmacist |
Japan |
|
| Nausea |
Other Serious |
1/26/2006 |
29 |
Female |
|
2/8/2006 |
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 |
|
| Nausea |
Other Serious |
1/26/2006 |
29 |
Female |
110 lb |
2/16/2006 |
Physician |
Japan |
|
| Hallucination |
Life Threatening |
1/24/2006 |
6 |
Female |
|
2/17/2006 |
Physician |
Japan |
|
| Haemorrhagic Diathesis |
Hospitalization |
2/6/2006 |
9 |
Male |
|
2/20/2006 |
Physician |
Japan |
|
| Hallucination |
Life Threatening |
1/26/2006 |
6 |
Male |
53 lb |
2/24/2006 |
Physician |
Japan |
|
| Pyrexia |
Other Serious |
1/16/2006 |
10 |
Male |
60 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 |
|
|
| Encephalopathy |
Other Serious |
1/19/2006 |
8 |
Female |
|
3/2/2006 |
Physician |
Japan |
|
| Henoch-schonlein Purpura |
Hospitalization |
12/29/2004 |
2 |
Female |
29 lb |
3/3/2006 |
Physician |
Japan |
|
| Jaundice |
Hospitalization |
1/28/2006 |
62 |
Male |
|
3/6/2006 |
Physician |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Abnormal Behaviour |
Hospitalization |
2/21/2006 |
5 |
Male |
|
3/7/2006 |
Physician |
Japan |
|
| Abnormal Behaviour |
Hospitalization |
12/25/2005 |
8 |
Male |
57 lb |
3/9/2006 |
Physician |
Japan |
|
| 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 |
|
| Laryngeal Oedema |
Life Threatening |
2/4/2006 |
50 |
Female |
119 lb |
3/14/2006 |
Physician |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Psychiatric Symptom |
Other Serious |
1/19/2006 |
8 |
Female |
|
3/14/2006 |
Physician |
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 |
|
| Vascular Purpura |
Hospitalization |
12/29/2004 |
2 |
Female |
29 lb |
3/21/2006 |
Physician |
Japan |
|
| Upper Gastrointestinal Haemorrhage |
Hospitalization |
2/15/2006 |
5 |
Female |
40 lb |
3/21/2006 |
Physician |
Japan |
|
| Neutrophil Count Decreased |
Other Serious |
2/6/2006 |
12 |
Male |
106 lb |
3/24/2006 |
Physician |
Japan |
|
| Jaundice |
Hospitalization |
1/28/2006 |
62 |
Male |
157 lb |
3/24/2006 |
Physician |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| 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 |
|
| Tracheal Stenosis |
Life Threatening |
2/4/2006 |
54 |
Female |
119 lb |
3/28/2006 |
Physician |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Therapy Non-responder |
Life Threatening |
2/4/2006 |
54 |
Female |
119 lb |
4/7/2006 |
Physician |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| 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 |
|
| Upper Gastrointestinal Haemorrhage |
Hospitalization |
2/15/2006 |
5 |
Female |
40 lb |
4/21/2006 |
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 |
|
| Respiratory Arrest |
Life Threatening |
3/27/2005 |
1 |
Male |
|
6/5/2006 |
Physician |
Japan |
|
| Delirium |
Hospitalization |
12/26/2005 |
8 |
Male |
55 lb |
6/7/2006 |
Physician |
Japan |
|
| Restlessness |
Hospitalization |
12/25/2005 |
8 |
Male |
57 lb |
6/7/2006 |
Physician |
Japan |
|
| Restlessness |
Other Serious |
12/19/2005 |
6 |
Female |
42 lb |
6/21/2006 |
Physician |
Japan |
|
| Vision Blurred |
Other Serious |
7/5/2006 |
14 |
Male |
|
7/25/2006 |
Physician |
Japan |
|
| Respiratory Arrest |
Life Threatening |
3/27/2005 |
1 |
Male |
|
7/31/2006 |
Physician |
Japan |
|
| Vision Blurred |
Other Serious |
7/5/2006 |
14 |
Male |
126 lb |
8/4/2006 |
Physician |
Japan |
|
| Delirium |
Other Serious |
12/19/2005 |
6 |
Female |
37 lb |
8/11/2006 |
Physician |
Japan |
|
| Vascular Purpura |
Hospitalization |
12/29/2004 |
2 |
Female |
29 lb |
10/24/2006 |
Physician |
Japan |
|
| Speech Disorder |
Other Serious |
1/13/2006 |
4 |
Male |
|
11/15/2006 |
Pharmacist |
Japan |
|
| 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 |
|
| Suicide Attempt |
Life Threatening |
2/18/2007 |
15 |
Male |
128 lb |
3/14/2007 |
Physician |
Japan |
|
| Suicide Attempt |
Life Threatening |
2/18/2007 |
15 |
Male |
128 lb |
3/27/2007 |
Physician |
Japan |
|
| Cardio-respiratory Arrest |
Death |
2/12/2006 |
1 |
Female |
20 lb |
3/29/2007 |
Physician |
Japan |
|
| Loss Of Consciousness |
Hospitalization |
2/28/2007 |
13 |
Female |
95 lb |
3/30/2007 |
Physician |
Japan |
|
| Visual Disturbance |
Hospitalization |
3/3/2007 |
4 |
Male |
40 lb |
4/3/2007 |
Physician |
Japan |
|
| Suicide Attempt |
Life Threatening |
2/18/2007 |
15 |
Male |
128 lb |
4/5/2007 |
Physician |
Japan |
|
| Depressed Level Of Consciousness |
Hospitalization |
2/27/2007 |
6 |
Female |
51 lb |
4/13/2007 |
Physician |
Japan |
|
| Loss Of Consciousness |
Hospitalization |
2/28/2007 |
13 |
Female |
95 lb |
4/13/2007 |
Physician |
Japan |
|
| Hypothermia |
Other Serious |
1/24/2006 |
10 |
Female |
|
4/13/2007 |
Pharmacist |
Japan |
|
| Febrile Convulsion |
Other Serious |
4/2/2007 |
3 |
Male |
|
4/13/2007 |
Physician |
Japan |
|
| Tachypnoea |
Other Serious |
3/30/2007 |
4 |
Female |
35 lb |
4/20/2007 |
Physician |
Japan |
|
| Enterocolitis Haemorrhagic |
Other Serious |
2/26/2007 |
57 |
Female |
161 lb |
4/23/2007 |
Physician |
Japan |
|
| Delirium |
Other Serious |
12/19/2005 |
6 |
Female |
37 lb |
4/25/2007 |
Physician |
Japan |
|
| Abnormal Behaviour |
Hospitalization |
3/30/2007 |
5 |
Male |
|
4/26/2007 |
Physician |
Japan |
|
| Delirium |
Life Threatening |
3/9/2007 |
11 |
Male |
66 lb |
4/26/2007 |
Physician |
Japan |
|
| Speech Disorder |
Life Threatening |
2/28/2007 |
45 |
Male |
|
4/26/2007 |
Physician |
Japan |
|
| Agitation |
Other Serious |
3/4/2007 |
11 |
Female |
35 lb |
4/26/2007 |
Physician |
Japan |
|
| Abnormal Behaviour |
Other Serious |
3/30/2007 |
9 |
Female |
55 lb |
4/27/2007 |
Physician |
Japan |
|
| Abnormal Behaviour |
Other Serious |
2/20/2007 |
5 |
Female |
37 lb |
4/27/2007 |
Physician |
Japan |
|
| Depressed Level Of Consciousness |
Other Serious |
3/19/2007 |
5 |
Female |
40 lb |
4/27/2007 |
Physician |
Japan |
|
| Psychiatric Symptom |
Other Serious |
2/23/2007 |
13 |
Male |
88 lb |
4/27/2007 |
Physician |
Japan |
|
| Delirium |
Other Serious |
1/21/2004 |
13 |
Male |
|
4/30/2007 |
Physician |
Japan |
|
| Delirium |
Other Serious |
1/21/2004 |
13 |
Male |
|
4/30/2007 |
Physician |
Japan |
|
| Urinary Incontinence |
Other Serious |
12/21/2005 |
8 |
Male |
55 lb |
4/30/2007 |
Physician |
Japan |
|
| Agitation |
Other Serious |
3/15/2005 |
1 |
Female |
|
4/30/2007 |
Physician |
Japan |
|
| Agitation |
Other Serious |
3/15/2005 |
1 |
Female |
|
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 |
1/16/2006 |
10 |
Male |
60 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 |
|
| Abnormal Behaviour |
Other Serious |
1/16/2006 |
10 |
Male |
60 lb |
5/1/2007 |
Physician |
Japan |
|
| Depressed Level Of Consciousness |
Hospitalization |
2/27/2007 |
6 |
Female |
51 lb |
5/2/2007 |
Physician |
Japan |
|
| Delirium |
Life Threatening |
3/2/2005 |
14 |
Female |
104 lb |
5/3/2007 |
Physician |
Japan |
|
| Abnormal Behaviour |
Hospitalization |
3/1/2005 |
5 |
Male |
|
5/3/2007 |
Physician |
Japan |
|
| Depressed Level Of Consciousness |
Other Serious |
4/1/2006 |
3 |
Male |
31 lb |
5/3/2007 |
Physician |
Japan |
|
| Convulsion |
Other Serious |
2/23/2007 |
12 |
Female |
86 lb |
5/3/2007 |
Physician |
Japan |
|
| Suicide Attempt |
Other Serious |
2/18/2007 |
15 |
Male |
128 lb |
5/3/2007 |
Physician |
Japan |
|
| Suicidal Ideation |
Other Serious |
3/5/2007 |
10 |
Female |
75 lb |
5/3/2007 |
Physician |
Japan |
|
| Cardio-respiratory Arrest |
Death |
2/12/2006 |
2 |
Female |
20 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 |
|
| Agitation |
Hospitalization |
3/6/2007 |
2 |
Female |
20 lb |
5/4/2007 |
Physician |
Japan |
|
| Depressed Level Of Consciousness |
Other Serious |
3/19/2007 |
5 |
Female |
40 lb |
5/4/2007 |
Physician |
Japan |
|
| Abnormal Behaviour |
Hospitalization |
12/25/2005 |
8 |
Male |
57 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 |
|
| Loss Of Consciousness |
Hospitalization |
2/28/2007 |
13 |
Female |
95 lb |
5/8/2007 |
Physician |
Japan |
|
| Enterocolitis Haemorrhagic |
Other Serious |
2/26/2007 |
57 |
Female |
161 lb |
5/8/2007 |
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 |
|
| Febrile Convulsion |
Other Serious |
4/2/2007 |
5 |
Male |
40 lb |
5/9/2007 |
Physician |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Abnormal Behaviour |
Other Serious |
3/15/2007 |
13 |
Male |
|
5/18/2007 |
Physician |
Japan |
|
| Delirium |
Other Serious |
3/20/2007 |
13 |
Male |
117 lb |
5/21/2007 |
Physician |
Japan |
|
| Vomiting |
Other Serious |
3/17/2007 |
4 |
Male |
35 lb |
5/21/2007 |
Physician |
Japan |
|
| Abnormal Behaviour |
Other Serious |
2/20/2007 |
5 |
Female |
37 lb |
5/22/2007 |
Physician |
Japan |
|
| Abnormal Behaviour |
Other Serious |
3/19/2007 |
7 |
Female |
55 lb |
5/23/2007 |
Physician |
Japan |
|
| Hallucination |
Hospitalization |
3/30/2007 |
5 |
Male |
44 lb |
5/24/2007 |
Physician |
Japan |
|
| Liver Disorder |
Other Serious |
2/18/2007 |
1 |
Male |
20 lb |
5/25/2007 |
Physician |
Japan |
|
| Hallucination, Visual |
Life Threatening |
3/15/2007 |
13 |
Male |
119 lb |
5/29/2007 |
Physician |
Japan |
|
| Convulsion |
Other Serious |
2/23/2007 |
12 |
Female |
86 lb |
5/30/2007 |
Physician |
Japan |
|
| Tonic Convulsion |
Other Serious |
2/27/2007 |
6 |
Female |
|
5/30/2007 |
Pharmacist |
Japan |
|
| Hallucination |
Hospitalization |
3/30/2007 |
5 |
Male |
44 lb |
6/1/2007 |
Physician |
Japan |
|
| Somnolence |
Hospitalization |
1/9/2006 |
6 |
Male |
33 lb |
6/1/2007 |
Physician |
Japan |
|
| Abnormal Behaviour |
Other Serious |
3/12/2007 |
7 |
Male |
66 lb |
6/8/2007 |
Physician |
Japan |
|
| Delirium |
Other Serious |
3/20/2007 |
13 |
Male |
117 lb |
6/8/2007 |
Physician |
Japan |
|
| Delirium |
Hospitalization |
3/1/2005 |
5 |
Male |
|
6/8/2007 |
Physician |
Japan |
|
| Hallucination, Visual |
Life Threatening |
3/15/2007 |
13 |
Male |
119 lb |
6/11/2007 |
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 |
|
| Fear |
Hospitalization |
3/20/2007 |
4 |
Female |
31 lb |
6/18/2007 |
Physician |
Japan |
|
| Shock Haemorrhagic |
Death |
1/31/2006 |
8 |
Male |
35 lb |
6/18/2007 |
Physician |
Japan |
|
| Convulsion |
Other Serious |
4/2/2007 |
5 |
Male |
40 lb |
6/25/2007 |
Physician |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Convulsion |
Other Serious |
3/23/2007 |
4 |
Female |
33 lb |
6/28/2007 |
Physician |
Japan |
|
| Convulsion |
Other Serious |
3/13/2007 |
8 |
Female |
60 lb |
7/11/2007 |
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 |
|
|
| Abnormal Behaviour |
Life Threatening |
3/20/2007 |
10 |
Male |
73 lb |
9/10/2007 |
Physician |
Japan |
|
| Psychiatric Symptom |
Other Serious |
3/14/2007 |
10 |
Male |
104 lb |
9/26/2007 |
Physician |
Japan |
|
| Abnormal Behaviour |
Other Serious |
2/24/2007 |
8 |
Male |
90 lb |
9/26/2007 |
Physician |
Japan |
|
| Loss Of Consciousness |
Other Serious |
3/26/2007 |
7 |
Male |
53 lb |
9/28/2007 |
Physician |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Sudden Death |
Death |
12/30/2002 |
2 |
Male |
30 lb |
11/19/2007 |
Physician |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Sudden Death |
Life Threatening |
12/16/2005 |
7 |
Male |
42 lb |
11/19/2007 |
Physician |
Japan |
|