{"analyses":[{"ciLowerLimit":"0.62","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.06","estimateComment":"Cox regression model with treatment as a covariate stratified by ECOG PS (0 vs. 1), HPV status (Positive vs. Negative) \\& PD-L1 status (Strongly Positive, Not Strongly Positive)","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.05851","pValueComment":"p-value stratified by ECOG PS (0 vs. 1), HPV status (Positive vs. Negative) \\& PD-L1 status (Strongly Positive, Not Strongly Positive)","paramType":"Hazard Ratio (HR)","paramValue":"0.81","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"2.1","upperLimit":"3.5","value":"2.7"},{"groupId":"OG001","lowerLimit":"2.1","upperLimit":"3.4","value":"2.3"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"196"},{"groupId":"OG001","value":"191"}],"units":"Participants"}],"description":"TTP was defined as the time from randomization to the first documented disease progression based on assessments by the blinded central imaging vendor review per RECIST 1.1. Per RECIST 1.1, progressive disease was defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of at least 5 mm. Note: The appearance of one or more new lesions was also considered progression. The TTP per RECIST 1.1 for all participants with PD-L1 ≥1% CPS is presented. These efficacy results were reported after complete acquisition of all outstanding survival data using a 15-May-2017 data cut-off date with a database update date of 13-Oct-2017.","dispersionType":"Full Range","groups":[{"description":"Participants received pembrolizumab 200 mg intravenous (IV) on Day 1 of each 3-week cycle. Eligible participants who stopped the initial course of pembrolizumab with Stable Disease (SD) or better but progressed after discontinuation may have been able to initiate a second course of pembrolizumab for up to 17 cycles (up to approximately 1 additional year) at the investigator's discretion.","id":"OG000","title":"Pembrolizumab"},{"description":"Participants received standard treatment of either methotrexate 40 mg/m\\^2 IV (could be escalated to 60 mg/m\\^2 maximum dose) on Days 1, 8, and 15 of each 3-week cycle; or docetaxel 75 mg/m\\^2 IV on Day 1 of each 3- week cycle; or cetuximab 400 mg/m\\^2 IV loading dose on Day 1 and 250 mg/m\\^2 IV on Days 8 and 15 of Cycle 1, followed by cetuximab 250 mg/m\\^2 on Days 1, 8, and 15 of each subsequent 3-week cycle.","id":"OG001","title":"Standard Treatment"}],"paramType":"MEDIAN","populationDescription":"The efficacy population consisted of all randomized participants with PD-L1 ≥1% CPS. Participants are included in the treatment group to which they were randomized.","reportingStatus":"POSTED","timeFrame":"Up to approximately 2 years","title":"TTP Per RECIST 1.1 in Participants With PD-L1 ≥1% CPS","type":"SECONDARY","unitOfMeasure":"Months"}