{"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.02","pValueComment":"Two-sided significance level = 0.05","statisticalMethod":"Fisher Exact"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"112"},{"groupId":"OG001","value":"8"}],"title":"HPV DNA Negative"},{"measurements":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"3"}],"title":"HPV DNA Positive"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"117"},{"groupId":"OG001","value":"11"}],"units":"Participants"}],"description":"Progression-free survival (PFS) failure is defined as local, regional, or distant disease progression or death due to any cause. Positive HPV DNA status is defined as 5 or more HPV DNA fragments per mL of blood plasma, assessed by tumor-tissue modified viral (TTMV) testing.","groups":[{"description":"Treatment arms are combined:\n\nMRT 6 Weeks + Cisplatin arm: Cisplatin: 40 mg/m2 IV (intravenously) weekly for 6 weeks; Intensity-modulated radiation therapy (IMRT), 30 fractions over 6 weeks, 5 fractions per week, 2 Gray per fraction to total dose of 60 Gy.\n\nIMRT 5 weeks arm: Intensity-modulated radiation therapy (IMRT), 30 fractions over 5 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 60 Gy","id":"OG000","title":"PFS Failure at 2 Years = No"},{"description":"Treatment arms are combined:\n\nMRT 6 Weeks + Cisplatin arm: Cisplatin: 40 mg/m2 IV (intravenously) weekly for 6 weeks; Intensity-modulated radiation therapy (IMRT), 30 fractions over 6 weeks, 5 fractions per week, 2 Gray per fraction to total dose of 60 Gy.\n\nIMRT 5 weeks arm: Intensity-modulated radiation therapy (IMRT), 30 fractions over 5 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 60 Gy","id":"OG001","title":"PFS Failure at 2 Years = Yes"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Eligible participants with post-treatment HPV DNA value and two-year progression-free survival data (i.e. not censored)","reportingStatus":"POSTED","timeFrame":"From end of treatment (approximate 6 weeks) to 2 years","title":"HPV DNA Status by 2-year Progression-free Survival Status","type":"SECONDARY","unitOfMeasure":"Participants"}