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This post-marketing surveillance study of CLAVAMOX® was designed to collect and assess the information on proper use, such as safety and efficacy, under actual use conditions, targeting pediatric Japanese patients with diseases (superficial skin infection, deep skin infection, lymphangitis, lymphadenitis, chronic pyoderma, pharyngitis, laryngitis, tonsillitis, acute bronchitis, cystitis, pyelonephritis) other than otitis media.
("CLAVAMOX" is a trademark of the GlaxoSmithKline group of companies.)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pediatrics patients prescribed amoxicillin and clavulanate | Pediatrics patients prescribed amoxicillin and clavulanate for treatment of diseases other than otitis media during study period |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amoxicillin and clavulanate | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| The number of incidence of adverse events in Japanese pediatric patients, with diseases other than otitis media, treated with amoxicillin and clavulanate based on prescribing information | 2 months | |
| Clinical symptoms after treatment with amoxicillin and clavulanate | 2 months |
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Inclusion Criteria:
Exclusion Criteria:
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Japanese pediatric patients who have superficial skin infection, deep skin infection, lymphangitis, lymphadenitis, chronic pyoderma, pharyngitis, laryngitis, tonsillitis, acute bronchitis, cystitis, pyelonephritis other than otitis media, and treated with amoxicillin and clavulanate
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
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| ID | Term |
|---|---|
| D000658 | Amoxicillin |
| D019818 | Clavulanic Acid |
| ID | Term |
|---|---|
| D000667 | Ampicillin |
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D047090 | beta-Lactams |
| D007769 |
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| Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D002969 | Clavulanic Acids |