N/A
N=543
Non-Interventional Post Marketing Surveillance Study To Observe The Safety And Efficacy Of Vfend® Tablet In Korea
Serious Fungal Infections
Bottom Line
View on ClinicalTrials.gov: NCT01073631 ↗Enrolled (actual)
543
Serious AEs
21.9%
Results posted
Sep 2010
Primary outcome: Primary: Percentage of Participants With Categorical Clinical Response: Cure, Improvement, Failure, or Unevaluable — 36.83; 26.52; 16.94; 19.71 Percentage of participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- voriconazole tablet (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 |
36.83; 26.52; 16.94; 19.71 | — |
| SECONDARY Percentage of Participants With Cultivated Strain Mycological Response: Eradication, Persistence, Superinfection, or Not Evaluable |
71.59; 23.86; 2.27; 2.27 | — |
Summary
This is a non-interventional study of voriconazole tablet in Korea which is mandated by the Korean government agency.
Eligibility Criteria
Inclusion Criteria
- Patients who are indicated for voriconazole table according to the drug package insert.
Exclusion Criteria
- None.
Data sourced from ClinicalTrials.gov (NCT01073631). 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.