{"denoms":[{"counts":[{"groupId":"BG000","value":"247"},{"groupId":"BG001","value":"248"},{"groupId":"BG002","value":"495"}],"units":"Participants"}],"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":"BG000","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":"BG001","title":"Standard Treatment"},{"description":"Total of all reporting groups","id":"BG002","title":"Total"}],"measures":[{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","spread":"9.8","value":"60.3"},{"groupId":"BG001","spread":"8.6","value":"60.2"},{"groupId":"BG002","spread":"9.2","value":"60.2"}]}]}],"dispersionType":"STANDARD_DEVIATION","paramType":"MEAN","title":"Age, Continuous","unitOfMeasure":"Years"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"40"},{"groupId":"BG001","value":"43"},{"groupId":"BG002","value":"83"}],"title":"Female"},{"measurements":[{"groupId":"BG000","value":"207"},{"groupId":"BG001","value":"205"},{"groupId":"BG002","value":"412"}],"title":"Male"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Sex: Female, Male","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"21"},{"groupId":"BG001","value":"12"},{"groupId":"BG002","value":"33"}],"title":"Hispanic or Latino"},{"measurements":[{"groupId":"BG000","value":"182"},{"groupId":"BG001","value":"195"},{"groupId":"BG002","value":"377"}],"title":"Not Hispanic or Latino"},{"measurements":[{"groupId":"BG000","value":"44"},{"groupId":"BG001","value":"41"},{"groupId":"BG002","value":"85"}],"title":"Unknown or Not Reported"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Ethnicity (NIH/OMB)","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"2"}],"title":"American Indian or Alaska Native"},{"measurements":[{"groupId":"BG000","value":"15"},{"groupId":"BG001","value":"16"},{"groupId":"BG002","value":"31"}],"title":"Asian"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}],"title":"Native Hawaiian or Other Pacific Islander"},{"measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"7"},{"groupId":"BG002","value":"10"}],"title":"Black or African American"},{"measurements":[{"groupId":"BG000","value":"206"},{"groupId":"BG001","value":"207"},{"groupId":"BG002","value":"413"}],"title":"White"},{"measurements":[{"groupId":"BG000","value":"4"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"7"}],"title":"More than one race"},{"measurements":[{"groupId":"BG000","value":"17"},{"groupId":"BG001","value":"15"},{"groupId":"BG002","value":"32"}],"title":"Unknown or Not Reported"}]}],"description":"The race of participants is presented.","paramType":"COUNT_OF_PARTICIPANTS","title":"Race (NIH/OMB)","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"103"},{"groupId":"BG001","value":"93"},{"groupId":"BG002","value":"196"}],"title":"TPS = 0%"},{"measurements":[{"groupId":"BG000","value":"79"},{"groupId":"BG001","value":"87"},{"groupId":"BG002","value":"166"}],"title":"1% ≤ TPS <50%"},{"measurements":[{"groupId":"BG000","value":"64"},{"groupId":"BG001","value":"65"},{"groupId":"BG002","value":"129"}],"title":"TPS ≥ 50%"},{"measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"4"}],"title":"Missing"}]}],"description":"Participants were assessed for their PD-L1 tumor expression level by immunohistochemistry assay using tumor tissue from a newly obtained biopsy. Participants with a TPS ≥50% were classified as PD-L1 strongly positive and participants with a TPS \\<50% were classified as not strongly positive.","paramType":"COUNT_OF_PARTICIPANTS","title":"Programmed Cell Death-Ligand 1 (PD-L1) Expression Level: Tumor Proportion Score (TPS)","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"71"},{"groupId":"BG001","value":"68"},{"groupId":"BG002","value":"139"}],"title":"EGOG PS=0"},{"measurements":[{"groupId":"BG000","value":"176"},{"groupId":"BG001","value":"179"},{"groupId":"BG002","value":"355"}],"title":"ECOG PS=1"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"1"}],"title":"ECOG PS=2"}]}],"description":"Participants were assessed for ECOG PS: Grade 0: Fully active, able to carry on all pre-disease performance without restriction; Grade 1: Restricted in physically strenuous activity but ambulatory \\& able to carry out work of a light or sedentary nature; Grade 2: Ambulatory \\& capable of all selfcare but unable to carry out any work activities, up \\& about more than 50% of waking hours; Grade 3: Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours; Grade 4: Completely disabled, cannot carry on any selfcare, totally confined to bed or chair or Grade 5: Dead.","paramType":"COUNT_OF_PARTICIPANTS","title":"Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"61"},{"groupId":"BG001","value":"57"},{"groupId":"BG002","value":"118"}],"title":"Positive HPV Status"},{"measurements":[{"groupId":"BG000","value":"186"},{"groupId":"BG001","value":"191"},{"groupId":"BG002","value":"377"}],"title":"Negative HPV Status"}]}],"description":"Participants were assessed for the presence or absence of HPV in their tumors.","paramType":"COUNT_OF_PARTICIPANTS","title":"Human Papillomavirus (HPV) Tumor Status","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"50"},{"groupId":"BG001","value":"54"},{"groupId":"BG002","value":"104"}],"title":"PD-L1 CPS <1"},{"measurements":[{"groupId":"BG000","value":"196"},{"groupId":"BG001","value":"191"},{"groupId":"BG002","value":"387"}],"title":"PD-L1 CPS ≥1"},{"measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"4"}],"title":"Missing"}]}],"description":"Participants were assessed for their PD-L1 tumor expression level by immunohistochemistry assay using tumor tissue from a newly obtained biopsy. Participants with a CPS ≥1 were classified as PD-L1 positive and participants with a CPS \\<1 were classified as PD-L1 negative.","paramType":"COUNT_OF_PARTICIPANTS","title":"PD-L1 Combined Positive Score (CPS) Status","unitOfMeasure":"Participants"}]}