Vfend Special Investigation For Pediatric - Observational

Study Overview
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Brief Summary
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Examine the safety and effectiveness of Vfend [voriconazole] for pediatric under general clinical practices.

Official Title
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VFEND SPECIAL INVESTIGATION- INVESTIGATION FOR TREATMENT OF INVASIVE FUNGAL INFECTIONS IN PEDIATRIC PATIENTS -

Conditions
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Pediatric Safety and Effectiveness

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who is under 15 years old and deep mycosis infection. Exclusion Criteria: Patients who have been previously enrolled in this study. -

Ages Eligible for Study
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Minimum Age: 0 Years
Maximum Age: 15 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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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Adverse Reactions | An adverse drug reaction (ADR) was any untoward medical occurrence attributed to VFEND in a participant who received VFEND. A serious ADR was an ADR resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. Relatedness to VFEND was assessed by the physician. | 16 weeks at maximum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Adverse Drug Reactions Not Expected From the LPD (Unknown Adverse Drug Reaction) | An adverse drug reaction (ADR) was any untoward medical occurrence attributed to VFEND in a participant who received VFEND. Expectedness of the adverse event was determined according to the Japanese package insert. Relatedness to VFEND was assessed by the physician. | 16 weeks at maximum | 
| Incidence of Aadverse Reactions by Diagnosis (Infection) | An ADR was any untoward medical occurrence attributed to VFEND in a participant who received VFEND. Relatedness to VFEND was assessed by the physician. Participants with ADRs were counted by diagnosis (infection) to assess whether it was a risk factor for the occurrence of ADRs. | 16 weeks at maximum | 
| Overall Clinical Response | Clinical effectiveness rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of assessable effectiveness analysis population, was presented along with the corresponding 2-sided 95% CI. Overall clinical effectiveness of VFEND was assessed as effective, not effective, or indeterminate by the physician based on the clinical course at the end of the observation period or at the time of treatment discontinuation. | 16 weeks at maximum | 
| Clinical Response Rate by Diagnostic Name (Name of Infection) | Clinical effectiveness rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of assessable effectiveness analysis population, was presented along with the corresponding 2-sided 95% CI. Overall clinical effectiveness of VFEND was assessed as effective, not effective, or indeterminate by the physician based on the clinical course at the end of the observation period or at the time of treatment discontinuation. Overall effectiveness of VFEND was determined by the physician based on the clinical course. Participants achieved clinical effectiveness by Diagnosis (Infection) were counted to assess whether it contributes to the clinical effectiveness. | 16 weeks at maximum |