{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"63.92","upperLimit":"95.46","value":"84.0"},{"groupId":"OG001","lowerLimit":"34.91","upperLimit":"96.81","value":"75.0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"25"},{"groupId":"OG001","value":"8"}],"units":"Participants"}],"description":"An adverse event (AE) was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body, or worsening of a pre-existing condition, temporally associated with the use of a product whether or not considered related to the use of the product. A TEAE was defined per protocol as any AE with onset after the administration of study medication through the end of the study (i.e., study discharge).","dispersionType":"95% Confidence Interval","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":"NUMBER","populationDescription":"Safety population included all participants who received at least one (1) dose of VGX-3100 (with or without EP).","reportingStatus":"POSTED","timeFrame":"7 days following each dose: Day 0 (Days 0 to 7), Week 4 (Days 22 to 28), Week 12 (Days 78 to 84), Week 24 (Days 162 to 168), and Week 52 (Days 358 to 364)","title":"Percentage of Participants With at Least One Local and Systemic Treatment-emergent Adverse Event (TEAE) During 7 Days Following Each Dose","type":"SECONDARY","unitOfMeasure":"percentage of participants"}