Voriconazole (Vfend) Drug Use Investigation (Regulatory Post Marketing Commitment Plan)

Study Overview
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Brief Summary
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To collect the efficacy and safety informations of voriconazole related to their appropriate use in daily practice.

Detailed Description
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All the subjects whom an investigator prescribes the first voriconazole (VFEND) should be registered consecutively until the number of subjects reaches target number in order to extract subjects enrolled into the investigation at random.

Official Title
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Vfend Drug Use Investigation (Regulatory Post Marketing Commitment Plan)

Conditions
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Systemic Mycosis

Intervention / Treatment
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* Drug: Voriconazole


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or Female subjects intend to treat their deep mycosis who are prescribed voriconazole (VFEND) by their Physicians. Exclusion Criteria: Subject who heve been prescribed voriconazole (VFEND) before.
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 |
| --- | --- |
| Voriconazole<br>Subjects who are treated with voriconazole | Drug: Voriconazole<br>* Voriconazole Intravenous Solution 200 mg: Voriconazole is administered by intravenous drip infusion at the dose of 6 mg/kg twice daily on day 1 and 3 mg/kg or 4 mg/kg twice daily from day 2 onward in adults. Voriconazole Tablet 50 mg/ Voriconazole Tablet 200 mg: administration for an adult (weighing 40 kg or more) is voriconazole 300mg orally twice daily between meals for day 1 and then 150 mg or 200 mg twice daily between meals from day 2 onward. Depending on the symptoms or in cases where the effect is insufficient, the dosage may be increased. However, the maximum dose on day 1 must be 400 mg twice daily, and the maximum dose from day 2 onward must be 300 mg twice daily. In patients weighing less than 40 kg, voriconazole 150 mg shall be administered twice daily on day 1, and voriconazole 100 mg shall be administered twice daily from day 2 onward. Depending on the symptoms, the maintenance dose from day 2 onward may be increased to 150 mg twice daily.<br>* Other names: VFEND for Intravenous Use, Voriconazole for Intravenous Use, VFEND Tablets, Voriconazole Tablet;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With the Frequency of Treatment Related Adverse Events. | Adverse events mean all unfavorable events that occur in participants after administration of Voriconazole, irrespective of causal relationship to Voriconazole (including clinically problematic abnormal changes in laboratory test values). Treatment related Adverse Events were evaluated in company with the causal relationship to Voriconazole. | 16 weeks | 
| Number of Participants That Responded to Voriconazole Treatment. | The primary endpoint was the efficacy ratio (number of effective cases/number of evaluable cases for efficacy assessment) among the cohort comprising the subjects for efficacy analysis. | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Unlisted Treatment Related Adverse Events in Japanese Package Insert. | Adverse events mean all unfavorable events that occur in participants after administration of Voriconazole, irrespective of causal relationship to Voriconazole (including clinically problematic abnormal changes in laboratory test values). Number of Treatment Related Adverse Events were evaluated in company with the causal relationship to Voriconazole. Unlisted treatment related adverse events were confirmed with listed adverse drug reaction in Japanese package insert. | 16 weeks | 
| Risk Factors for the Frequency of Treatment Related Adverse Events -Gender. | Number of participants with Treatment Related Adverse Events of Voriconazole to determine whether male or female is significant risk factor. | 16 weeks | 
| Risk Factors for the Frequency of Treatment Related Adverse Events -Severity of Infections. | Number of participants with Treatment Related Adverse Events of Voriconazole to determine whether severity of infections(mild, moderate or severe) is significant risk factor. | 16 weeks | 
| Risk Factors for the Frequency of Treatment Related Adverse Events -Past History. | Number of participants with Treatment Related Adverse Events of Voriconazole to determine whether with or without Past History is significant risk factor. | 16 weeks | 
| Number of Participants That Responded to Voriconazole Treatment -Severity of Infections. | Number of participants that responded to voriconazole to determine whether severity of infections(mild, moderate or severe) is significant risk factor. | 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Systemic Mycosis, Aspergillus infection, Candidiasis, Cryptococcal infections, Japanese, voriconazole, VFEND, Regulatory Post Marketing Commitment Plan.