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Study to investigate the safety and efficacy of AlesionĀ® Dry Syrup under the proper use in daily clinical practice in Japanese paediatric patients with urticaria
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| paediatric patients with urticaria |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AlesionĀ® | Drug | Dry Syrup |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse drug reactions | classified by Medical Dictionary for Regulatory Activities (MedDRA) | up to 2 years |
| Incidence of adverse drug reactions classified by patient's background/treatment factors | up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall assessment of efficacy by investigator on a 3-point scale | after 1 week |
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Inclusion Criteria:
All the patients who:
Exclusion Criteria:
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Patients with urticaria and without experience in treatment with epinastine are selected by physicians at medical institutions
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| ID | Term |
|---|---|
| D014581 | Urticaria |
| ID | Term |
|---|---|
| D017445 | Skin Diseases, Vascular |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D006969 | Hypersensitivity, Immediate |
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| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |