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

Completed

• Conditions: Systemic Mycosis
• Interventions: Drug: Voriconazole

• Registration Number: NCT01151085
• Lead Sponsor: Pfizer

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2006-04
• Study First Submitted: 2010-06-24
• Study First Submitted QC: 2010-06-24
• Study First Posted: 2010-06-25
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Status Verified: 2013-05
• Results First Submitted: 2013-05-14
• Results First Submitted QC: 2013-05-14
• Last Update Submitted: 2013-05-14
• Results First Posted: 2013-08-08
• Last Update Posted: 2013-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1002

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Voriconazole	Voriconazole	Subjects who are treated with voriconazole

Primary Outcome Measures

Name	Time	Method
Number of Participants With the Frequency of Treatment Related Adverse Events.	16 weeks	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.
Number of Participants That Responded to Voriconazole Treatment.	16 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Number of Unlisted Treatment Related Adverse Events in Japanese Package Insert.	16 weeks	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.
Risk Factors for the Frequency of Treatment Related Adverse Events -Gender.	16 weeks	Number of participants with Treatment Related Adverse Events of Voriconazole to determine whether male or female is significant risk factor.
Risk Factors for the Frequency of Treatment Related Adverse Events -Severity of Infections.	16 weeks	Number of participants with Treatment Related Adverse Events of Voriconazole to determine whether severity of infections(mild, moderate or severe) is significant risk factor.
Risk Factors for the Frequency of Treatment Related Adverse Events -Past History.	16 weeks	Number of participants with Treatment Related Adverse Events of Voriconazole to determine whether with or without Past History is significant risk factor.
Number of Participants That Responded to Voriconazole Treatment -Severity of Infections.	16 weeks	Number of participants that responded to voriconazole to determine whether severity of infections(mild, moderate or severe) is significant risk factor.