Vfend Drug Use Investigation (Regulatory Post Marketing Commitment Plan)
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Pfizer
- Enrollment
- 1,002
- Primary Endpoint
- Number of Participants With the Frequency of Treatment Related Adverse Events.
Overview
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 Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Voriconazole
Subjects who are treated with voriconazole
Intervention: Voriconazole (Drug)
Outcomes
Primary Outcomes
Number of Participants With the Frequency of Treatment Related Adverse Events.
Time Frame: 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.
Time Frame: 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 Outcomes
- Number of Unlisted Treatment Related Adverse Events in Japanese Package Insert.(16 weeks)
- Risk Factors for the Frequency of Treatment Related Adverse Events -Gender.(16 weeks)
- Risk Factors for the Frequency of Treatment Related Adverse Events -Severity of Infections.(16 weeks)
- Risk Factors for the Frequency of Treatment Related Adverse Events -Past History.(16 weeks)
- Number of Participants That Responded to Voriconazole Treatment -Severity of Infections.(16 weeks)