{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.00","upperLimit":"14.50","value":"0.150"},{"groupId":"OG001","lowerLimit":"0.00","upperLimit":"3.35","value":"1.250"}]}],"title":"Baseline"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.00","upperLimit":"18.70","value":"0.000"},{"groupId":"OG001","lowerLimit":"0.00","upperLimit":"7.70","value":"0.000"}]}],"title":"Change from Baseline at Week 27"}],"denoms":[{"counts":[{"groupId":"OG000","value":"22"},{"groupId":"OG001","value":"7"}],"units":"Participants"}],"description":"Assessment of cellular immune activity was measured using the application of flow cytometry for the purpose of performing a Lytic Granule Loading Assay. The Lytic Granule Loading Assay examines the following external cellular markers: cluster of differentiation 3 (CD3), CD4, CD8 (T-cell identification), CD137, CD38, and CD69 (T-cell activation markers) as well as PD-1 (exhaustion/activation marker). Here, a change from baseline in CD8+/CD137+ PBMCs expressing Perforin+ was reported.","dispersionType":"Full Range","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"}],"paramType":"MEDIAN","populationDescription":"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.","reportingStatus":"POSTED","timeFrame":"Baseline; Week 27","title":"Change From Baseline in Flow Cytometry Response Magnitude","type":"SECONDARY","unitOfMeasure":"SFU/10^6 PBMC"}