N/A
N=692
Non-Interventional Post Marketing Surveillance Study To Observe The Safety And Efficacy Of Vfend® IV
Serious Fungal Infections
Bottom Line
View on ClinicalTrials.gov: NCT01073618 ↗Enrolled (actual)
692
Serious AEs
34.5%
Results posted
Sep 2010
Primary outcome: Primary: Percentage of Participants With Categorical Clinical Response: Cure, Improvement, Failure, or Unevaluable — 12.72; 41.47; 17.92; 27.89 percentage of participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- voriconazole IV (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Oct 2009
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 | — |
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.
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.