N/A
Completed N=1,002
Voriconazole (Vfend) Drug Use Investigation (Regulatory Post Marketing Commitment Plan)
Systemic Mycosis
Source: ClinicalTrials.gov NCT01151085 ↗
Enrolled (actual)
1,002
Serious AEs
2.5%
Results posted
Aug 2013
Primary outcomePrimary: Number of Participants With the Frequency of Treatment Related Adverse Events. — 220 participants
Summary
To collect the efficacy and safety informations of voriconazole related to their appropriate use in daily practice.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With the Frequency of Treatment Related Adverse Events. |
220 | — |
| PRIMARY Number of Participants That Responded to Voriconazole Treatment. |
405 | — |
| SECONDARY Number of Unlisted Treatment Related Adverse Events in Japanese Package Insert. |
19 | — |
| SECONDARY Risk Factors for the Frequency of Treatment Related Adverse Events -Gender. |
156; 64 | =0.030 sig |
| SECONDARY Risk Factors for the Frequency of Treatment Related Adverse Events -Severity of Infections. |
60; 115; 45 | <0.001 sig |
| SECONDARY Risk Factors for the Frequency of Treatment Related Adverse Events -Past History. |
77; 142 | =0.017 sig |
| SECONDARY Number of Participants That Responded to Voriconazole Treatment -Severity of Infections. |
106; 202; 97 | <0.001 sig |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01151085). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.