N/A
Completed N=692
Non-Interventional Post Marketing Surveillance Study To Observe The Safety And Efficacy Of Vfend® IV
Serious Fungal Infections
Source: ClinicalTrials.gov NCT01073618 ↗
Enrolled (actual)
692
Serious AEs
34.5%
Results posted
Sep 2010
Primary outcomePrimary: Percentage of Participants With Categorical Clinical Response: Cure, Improvement, Failure, or Unevaluable — 12.72; 41.47; 17.92; 27.89 percentage of participants
Summary
This is non-interventional study of voriconazole IV formulation in clinical use, which was mandated by the Korean government agency following the approval of Vfend in the Republic of Korea.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Categorical Clinical Response: Cure, Improvement, Failure, or Unevaluable |
12.72; 41.47; 17.92; 27.89 | — |
| SECONDARY Percentage of Participants With Cultivated Strain Mycological Response: Eradication, Persistence, Superinfection, or Not Evaluable |
64.78; 27.67; 3.77; 3.77 | — |
Eligibility Criteria
Inclusion Criteria
- Invasive aspergillosis and other serious fungal infections.
Exclusion Criteria
- N/A
Data sourced from ClinicalTrials.gov (NCT01073618). 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.