{"analyses":[{"ciLowerLimit":"0.88","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.32","estimateComment":"Reference arm = RT + cisplatin","groupDescription":"A total of 945 patients were required (900 analyzable) to test for a 25% reduction in the hazard associated with progression-free survival with 84% statistical power using a one-sided log-rank test at the 0.025 significance level (0.0238 after 3 interim analyses).","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.76","paramType":"Hazard Ratio (HR)","paramValue":"1.08","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"56.7","upperLimit":"65.8","value":"61.2"},{"groupId":"OG001","lowerLimit":"54.2","upperLimit":"63.6","value":"58.9"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"447"},{"groupId":"OG001","value":"444"}],"units":"Participants"}],"description":"Progression-free survival (PFS) is defined as time from randomization to date of local, regional, or distant disease progression, or death from any cause. Patients last known to be alive without progression are censored at the date of last contact. Three-year rates were estimated by the Kaplan-Meier method. Local or regional progression is defined as an estimated increase in the size of the tumor (product of the perpendicular diameters of the two largest dimensions) of greater than 25%, taking as reference the smallest value of all previous measurements or appearance of new areas of malignant disease. Distant progression is defined as clear evidence of distant metastases.","dispersionType":"95% Confidence Interval","groups":[{"description":"Radiation therapy (RT) as accelerated fractionation by concomitant boost (AFX-CB) or intensity-modulated radiation therapy (IMRT) plus cisplatin","id":"OG000","title":"RT + Cisplatin"},{"description":"Radiation therapy (RT) as accelerated fractionation by concomitant boost (AFX-CB) or intensity-modulated radiation therapy (IMRT) plus cisplatin plus cetuximab","id":"OG001","title":"RT + Cisplatin + Cetuximab"}],"paramType":"NUMBER","populationDescription":"Randomized eligible patients with follow-up data","reportingStatus":"POSTED","timeFrame":"From randomization until 434 failures have occurred, approximately 5 years from start of study. (Patients are followed until death or study termination, whichever occurs first.)","title":"Progression-free Survival (PFS) (3-year Rate Reported)","type":"PRIMARY","unitOfMeasure":"percentage of participants"}