N/A
N=241
Vfend Special Investigation For Prophylaxis
Fungal Infection
Bottom Line
View on ClinicalTrials.gov: NCT02674685 ↗Enrolled (actual)
241
Serious AEs
25.8%
Results posted
Jul 2020
Primary outcome: Primary: Number of Participants With Adverse Drug Reactions — 62; 5 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Pediatric, Adult, Older Adult · 0+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Jul 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Drug Reactions |
62; 5 | — |
| SECONDARY Number of Participants With Adverse Drug Reactions Not Expected From the Approved Local Product Document (Unknown Adverse Drug Reactions) |
6 | — |
| SECONDARY Proportion of Participants With Adverse Drug Reactions by Age |
20.25; 29.87 | — |
| SECONDARY Proportion of Participants With Adverse Drug Reactions by Reason for Use |
26.39; 31.25; 0.00 | — |
| SECONDARY Proportion of Participants With Adverse Drug Reactions by Long-term Use |
24.56; 32.26 | — |
| SECONDARY Proportion of Participants Who Developed Invasive Fungal Infections (IFI Rate) |
1.5 | — |
| SECONDARY Proportion of Participants Who Developed Invasive Fungal Infections (IFI Rate) by Age |
1.5; 1.5 | — |
| SECONDARY Proportion of Participants Who Developed Invasive Fungal Infections (IFI Rate) by Reason for Use |
1.1; 7.1 | — |
| SECONDARY Proportion of Participants With Successful Prophylaxis of Invasive Fungal Infections (Success Rate) |
97.5 | — |
| SECONDARY Proportion of Participants With Successful Prophylaxis of Invasive Fungal Infections (Success Rate) by Age |
98.5; 96.9 | — |
| SECONDARY Proportion of Participants With Successful Prophylaxis of Invasive Fungal Infections (Success Rate) by Reason for Use |
97.8; 92.9 | — |
Summary
Examine the safety and effectiveness of Vfend [voriconazole] for prophylaxix use under general clinical practices.
Eligibility Criteria
Inclusion Criteria
- Patients undergoing HSCT (Hematopoietic Stem Cell Transplantation).
Exclusion Criteria
- Patients who have been previously enrolled in this study.
Data sourced from ClinicalTrials.gov (NCT02674685). 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.