{"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.08","statisticalComment":"Two-sided significance level = 0.05","statisticalMethod":"Fisher Exact"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"114"},{"groupId":"OG001","value":"6"}],"title":"HPV DNA Negative"},{"measurements":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"2"}],"title":"HPV DNA Positive"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"120"},{"groupId":"OG001","value":"8"}],"units":"Participants"}],"description":"Local-regional failure is defined as local or regional progression, salvage surgery of the primary tumor with tumor present/unknown, salvage neck dissection with tumor present/unknown \\> 20 weeks after the end of radiation therapy, death due to study cancer without documented progression, or death due to unknown causes without documented progression. 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":"Local-regional 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":"Local-regional Failure at 2 Years = Yes"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Eligible participants with post-treatment HPV DNA value and two-year local-regional failure 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 Local-regional Failure Status","type":"SECONDARY","unitOfMeasure":"Participants"}