{"analyses":[{"ciLowerLimit":"1.09","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.53","groupDescription":"PFS in all participants of the pembro mono arm was compared to PFS in all participants of the control arm to address the third primary hypothesis. The comparison was based on a Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG, HPV status and PD-L1 status.","groupIds":["OG000","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"0.99830","pValueComment":"One-sided p-value based on log-rank test stratified by ECOG, HPV status and PD-L1 status.","paramType":"Hazard Ratio (HR)","paramValue":"1.29","statisticalMethod":"Regression, Cox"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"2.2","upperLimit":"3.3","value":"2.3"},{"groupId":"OG002","lowerLimit":"4.9","upperLimit":"6.1","value":"5.2"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"301"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"300"}],"units":"Participants"}],"description":"PFS was defined as the time from randomization to the first documented PD per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum had to demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD.\n\nPer protocol, PFS in the pembro mono arm was compared to the control arm as a pre-specified primary analysis of the ITT population. PFS is reported here for the first course of treatment, for all participants in the pembro mono arm and control arm. Per protocol, PFS was compared separately between all participants of the pembro combo arm and control arm and is presented earlier in the record.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle for up to 35 cycles (up to \\~2 years).","id":"OG000","title":"Pembrolizumab Monotherapy (Pembro Mono)"},{"description":"Participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for up to 35 cycles (up to \\~2 years); plus cisplatin 100 mg/m\\^2 IV or carboplatin at a target area under the curve of 5 (AUC 5) IV, per Investigator's choice, on Day 1 of each 3-week cycle (6 cycle maximum \\[up to \\~4 months\\]); plus 5-Fluorouracil (5-FU) 1000 mg/m\\^2/day IV continuous from Day 1-4 of each 3-week cycle (6 cycle maximum \\[up to \\~4 months\\]).","id":"OG001","title":"Pembrolizumab + Chemotherapy (Pembro Combo)"},{"description":"Participants received cetuximab on Day 1 at a dose of 400 mg/m\\^2 IV, and then 250 mg/m\\^2 IV on Day 1 of each subsequent week until disease progression or unacceptable toxicity; plus cisplatin 100 mg/m\\^2 IV or carboplatin AUC 5 IV (Investigator's choice) on Day 1 of each 3-week cycle (6 cycle maximum \\[up to \\~4 months\\] for platinum-based therapy); plus 5-FU 1000 mg/m\\^2/day IV continuous from Day 1-4 of each 3-week cycle (6 cycle maximum \\[up to \\~4 months\\]).","id":"OG002","title":"Cetuximab + Chemotherapy (Control)"}],"paramType":"MEDIAN","populationDescription":"All participants in the ITT population randomized to either the pembro mono arm or control arm during active enrollment were analyzed. Per protocol, pembro combo arm was compared to control arm separately and not included in this analysis.","reportingStatus":"POSTED","timeFrame":"Up to approximately 47 months","title":"Pembro Mono vs Control: PFS Per RECIST 1.1 by BICR in All Participants","type":"PRIMARY","unitOfMeasure":"Months"}