N/A
N=89
Vfend Special Investigation For Pediatric - Observational
Pediatric Safety and Effectiveness
Bottom Line
View on ClinicalTrials.gov: NCT02554656 ↗Enrolled (actual)
89
Serious AEs
12.8%
Results posted
Nov 2019
Primary outcome: Primary: Number of Participants With Adverse Reactions — 23; 3 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Sep 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Reactions |
23; 3 | — |
| SECONDARY Number of Participants With Adverse Drug Reactions Not Expected From the LPD (Unknown Adverse Drug Reaction) |
2 | — |
| SECONDARY Incidence of Aadverse Reactions by Diagnosis (Infection) |
35.29; 33.33; 100.00; 0.00; 0.00; 50.00 | — |
| SECONDARY Overall Clinical Response |
80.6 | — |
| SECONDARY Clinical Response Rate by Diagnostic Name (Name of Infection) |
97.0; 75.0; 0.0; 100.0; 100.0; 100.0 | — |
Summary
Examine the safety and effectiveness of Vfend [voriconazole] for pediatric under general clinical practices.
Eligibility Criteria
Inclusion Criteria
- Patients who is under 15 years old and deep mycosis infection.
Exclusion Criteria
- Patients who have been previously enrolled in this study. -
Data sourced from ClinicalTrials.gov (NCT02554656). 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.