Special Drug Use Investigation for VALTREX (Valaciclovir) (Pediatrics Chickenpox)

Study Overview
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Brief Summary
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The purpose of this post-marketing surveillance study is to collect and assess information on safety and efficacy of valaciclovir in pediatric patients with chickenpox

Official Title
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Special Drug Use Investigation for VALTREX (Valaciclovir) (Pediatrics Chickenpox)

Conditions
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Varicella

Intervention / Treatment
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* Drug: Valaciclovir


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pediatric patients with chickenpox (aged less than 15 years old). Exclusion Criteria: Patients with a history of hypersensitivity to the ingredients of valaciclovir or acyclovir.

Ages Eligible for Study
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Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pediatric patients prescribed valaciclovir<br>Pediatric patients with chickenpox prescribed valaciclovir during study period. | Drug: Valaciclovir<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Any Serious Adverse Event | A serious adverse event is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or results in prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. For a list of all serious adverse events occurring during the course of the study, please see the table entitled Serious Adverse Events in the Adverse Event section of the results record. | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With the Indicated Adverse Drug Reactions | An adverse drug reaction (ADR) is an adverse event whose causal relationship to study drug was not ruled out by the reporting physician. An adverse event is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. For a list of all ADRs occurring during the course of the study, please also see the table entitled Other (non-serious) adverse events in the Adverse Event section of the results record. | 1 month | 
| Number of Participants With Any Unexpected Adverse Drug Reactions | An unexpected adverse drug reaction is an adverse event whose casual relationship to the study drug is not ruled out by the reporting physician and also is not listed in a package insert of the drug. | 1 month | 
| Number of Participants Classified as Effective and Not Effective | The course of symptoms was comprehensively assessed by the investigator on a four-category scale (Improved, Unchanged, Worsen, and Unassessable) before and after the initiation of valaciclovir therapy. Improved was regarded as Effective, and Unchanged and  Worsen were regarded as Not effective. The two participants classifed as Not effective were classified as Unchanged. | 1 month |