{"analyses":[{"groupDescription":"Assuming a binomial distribution, 140 eligible patients per arm were required for 80% power and 1-sided type I error rate of 10% to test the null hypothesis of 2-year progression-free survival (PFS) rate ≤ 85% against the alternative hypothesis of \\> 85% with a binomial test. The arms are not compared to each other; they are each tested separately against the null hypothesis.","groupIds":["OG000"],"nonInferiorityType":"SUPERIORITY","pValue":"0.04","statisticalComment":"One-sided significance level=0.10","statisticalMethod":"binomial"},{"groupDescription":"Assuming a binomial distribution, 140 eligible patients per arm were required for 80% power and 1-sided type I error rate of 10% to test the null hypothesis of 2-year PFS rate ≤ 85% against the alternative hypothesis of \\> 85% with a binomial test. The arms are not compared to each other; they are each tested separately against the null hypothesis.","groupIds":["OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.23","statisticalComment":"One-sided significance level = 0.10","statisticalMethod":"bionmial"}],"classes":[{"categories":[{"measurements":[{"comment":"one-side confidence interval","groupId":"OG000","lowerLimit":"86.6","value":"90.5"},{"comment":"one-side confidence interval","groupId":"OG001","lowerLimit":"83.3","value":"87.6"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"147"},{"groupId":"OG001","value":"145"}],"units":"Participants"}],"description":"Progression is defined as local, regional, or distant disease progression or death due to any cause. Percentage is estimated using the binomial distribution.","dispersionType":"90% Confidence Interval","groups":[{"description":"Cisplatin: 40 mg/m2 IV (intravenously) weekly for 6 weeks\n\nIMRT 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","id":"OG000","title":"IMRT 6 Weeks + Cisplatin (Arm 1)"},{"description":"IMRT 5 weeks: 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":"IMRT 5 Weeks (Arm 2)"}],"paramType":"NUMBER","populationDescription":"Two-year data was available for 147/157 (Arm 1) and 145/149 (Arm 2) randomized and eligible participants.","reportingStatus":"POSTED","timeFrame":"From randomization to 2 years","title":"Percentage of Participants Alive Without Progression at Two Years (Progression-free Survival)","type":"PRIMARY","unitOfMeasure":"percentage of participants"}