TriangleNCT03180684 · OUTCOME
Percent Change From Baseline in the Cumulative Surface Area of the Acetowhite Vulvar Lesion(s)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- percent change in surface area
- Interval / dispersion
- Standard Deviation
- Time frame
- From baseline to Week 48
What was measured
Lesion(s), defined as areas that stain acetowhite were assessed. Analysis of qualifying lesions was defined as the change in total surface area of only lesions with both baseline and Week 48 measurements. Percent change in the cumulative surface area of the acetowhite vulvar lesion(s) was determined by the quantitative analysis of standardized prebiopsy photographic imaging of qualifying lesion(s) at Week 48 compared to baseline.
Analysis population: mITT population included all participants who received at least 1 dose of VGX-3100 + EP (with or without imiquimod) and had an analysis endpoint of interest. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis.
Groups in this outcome
VGX-3100 + EP
Participants with histologically confirmed vulvar HSIL associated with HPV-16 and/or 18, received four doses of 6 mg VGX-3100 as an IM injection on Day 0, Week 4, Week 12, and Week 24 followed by EP using the CELLECTRA™ 2000 device. Participants with vulvar HSIL who had a reduction in lesion size or no increase in lesion size at Week 48, received a fifth dose of VGX-3100 at Week 52.
VGX-3100 + EP + Imiquimod
Participants with histologically confirmed vulvar HSIL associated with HPV-16 and/or 18, received four doses of 6 mg VGX-3100 as an IM injection on Day 0, Week 4, Week 12, and Week 24 followed by EP using the CELLECTRA™ 2000 device. Participants with vulvar HSIL who had a reduction in lesion size or no increase in lesion size at Week 48, received a fifth dose of VGX-3100 at Week 52. In addition, participants applied imiquimod 5% cream to the vulvar lesion three times per week for 20 weeks.
| Group | Source count |
|---|---|
| VGX-3100 + EP | 19 |
| VGX-3100 + EP + Imiquimod | 7 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| VGX-3100 + EP | 47.7 | 249.62 | Not reported | Not reported | Not reported |
| VGX-3100 + EP + Imiquimod | 10.5 | 117.95 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 249.62
- value
- 47.7
- group Id
- OG001
- spread
- 117.95
- value
- 10.5
- denoms
- counts
- group Id
- OG000
- value
- 19
- group Id
- OG001
- value
- 7
- units
- Participants
- description
- Lesion(s), defined as areas that stain acetowhite were assessed. Analysis of qualifying lesions was defined as the change in total surface area of only lesions with both baseline and Week 48 measurements. Percent change in the cumulative surface area of the acetowhite vulvar lesion(s) was determined by the quantitative analysis of standardized prebiopsy photographic imaging of qualifying lesion(s) at Week 48 compared to baseline.
- dispersion Type
- Standard Deviation
- groups
- description
- Participants with histologically confirmed vulvar HSIL associated with HPV-16 and/or 18, received four doses of 6 mg VGX-3100 as an IM injection on Day 0, Week 4, Week 12, and Week 24 followed by EP using the CELLECTRA™ 2000 device. Participants with vulvar HSIL who had a reduction in lesion size or no increase in lesion size at Week 48, received a fifth dose of VGX-3100 at Week 52.
- id
- OG000
- title
- VGX-3100 + EP
- description
- Participants with histologically confirmed vulvar HSIL associated with HPV-16 and/or 18, received four doses of 6 mg VGX-3100 as an IM injection on Day 0, Week 4, Week 12, and Week 24 followed by EP using the CELLECTRA™ 2000 device. Participants with vulvar HSIL who had a reduction in lesion size or no increase in lesion size at Week 48, received a fifth dose of VGX-3100 at Week 52. In addition, participants applied imiquimod 5% cream to the vulvar lesion three times per week for 20 weeks.
- id
- OG001
- title
- VGX-3100 + EP + Imiquimod
- param Type
- MEAN
- population Description
- mITT population included all participants who received at least 1 dose of VGX-3100 + EP (with or without imiquimod) and had an analysis endpoint of interest. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis.
- reporting Status
- POSTED
- time Frame
- From baseline to Week 48
- title
- Percent Change From Baseline in the Cumulative Surface Area of the Acetowhite Vulvar Lesion(s)
- type
- SECONDARY
- unit Of Measure
- percent change in surface area
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice