{"denoms":[{"counts":[{"groupId":"BG000","value":"301"},{"groupId":"BG001","value":"281"},{"groupId":"BG002","value":"300"},{"groupId":"BG003","value":"882"}],"units":"Participants"}],"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). Qualified participants who received the first course of pembrolizumab but continued to experience disease progression may have, at the investigator's discretion, initiated a second course of pembrolizumab at the same dose and schedule of 200 mg IV on Day 1 of each 3-week cycle for up to 17 cycles (up to \\~1 year).","id":"BG000","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\\]). Qualified participants who received the first course of pembrolizumab but continued to experience disease progression may have, at the investigator's discretion, initiated a second course of pembrolizumab at the same dose and schedule of 200 mg IV on Day 1 of each 3-week cycle for up to 17 cycles (up to \\~1 year).","id":"BG001","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":"BG002","title":"Cetuximab + Chemotherapy (Control)"},{"description":"Total of all reporting groups","id":"BG003","title":"Total"}],"measures":[{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","spread":"9.4","value":"61.2"},{"groupId":"BG001","spread":"9.8","value":"60.7"},{"groupId":"BG002","spread":"10.0","value":"61.0"},{"groupId":"BG003","spread":"9.7","value":"61.0"}]}]}],"dispersionType":"STANDARD_DEVIATION","paramType":"MEAN","title":"Age, Continuous","unitOfMeasure":"Years"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"51"},{"groupId":"BG001","value":"57"},{"groupId":"BG002","value":"39"},{"groupId":"BG003","value":"147"}],"title":"Female"},{"measurements":[{"groupId":"BG000","value":"250"},{"groupId":"BG001","value":"224"},{"groupId":"BG002","value":"261"},{"groupId":"BG003","value":"735"}],"title":"Male"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Sex: Female, Male","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"46"},{"groupId":"BG001","value":"45"},{"groupId":"BG002","value":"44"},{"groupId":"BG003","value":"135"}],"title":"Hispanic or Latino"},{"measurements":[{"groupId":"BG000","value":"233"},{"groupId":"BG001","value":"213"},{"groupId":"BG002","value":"231"},{"groupId":"BG003","value":"677"}],"title":"Not Hispanic or Latino"},{"measurements":[{"groupId":"BG000","value":"22"},{"groupId":"BG001","value":"23"},{"groupId":"BG002","value":"25"},{"groupId":"BG003","value":"70"}],"title":"Unknown or Not Reported"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Ethnicity (NIH/OMB)","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"5"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"6"},{"groupId":"BG003","value":"14"}],"title":"American Indian or Alaska Native"},{"measurements":[{"groupId":"BG000","value":"58"},{"groupId":"BG001","value":"60"},{"groupId":"BG002","value":"54"},{"groupId":"BG003","value":"172"}],"title":"Asian"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}],"title":"Native Hawaiian or Other Pacific Islander"},{"measurements":[{"groupId":"BG000","value":"4"},{"groupId":"BG001","value":"11"},{"groupId":"BG002","value":"6"},{"groupId":"BG003","value":"21"}],"title":"Black or African American"},{"measurements":[{"groupId":"BG000","value":"219"},{"groupId":"BG001","value":"203"},{"groupId":"BG002","value":"224"},{"groupId":"BG003","value":"646"}],"title":"White"},{"measurements":[{"groupId":"BG000","value":"12"},{"groupId":"BG001","value":"4"},{"groupId":"BG002","value":"9"},{"groupId":"BG003","value":"25"}],"title":"More than one race"},{"measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"1"},{"groupId":"BG003","value":"4"}],"title":"Unknown or Not Reported"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Race (NIH/OMB)","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"118"},{"groupId":"BG001","value":"110"},{"groupId":"BG002","value":"117"},{"groupId":"BG003","value":"345"}],"title":"ECOG = 0"},{"measurements":[{"groupId":"BG000","value":"183"},{"groupId":"BG001","value":"171"},{"groupId":"BG002","value":"183"},{"groupId":"BG003","value":"537"}],"title":"ECOG = 1"}]}],"description":"An ECOG Performance Status of 0 (Fully active, able to carry on all pre-disease performance without restriction) or 1 (Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature) was required for inclusion in the trial.","paramType":"COUNT_OF_PARTICIPANTS","title":"Eastern Cooperative Group (ECOG) Performance Status","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"63"},{"groupId":"BG001","value":"60"},{"groupId":"BG002","value":"67"},{"groupId":"BG003","value":"190"}],"title":"HPV Positive"},{"measurements":[{"groupId":"BG000","value":"238"},{"groupId":"BG001","value":"221"},{"groupId":"BG002","value":"233"},{"groupId":"BG003","value":"692"}],"title":"HPV Negative"}]}],"description":"HPV status for oropharynx cancer as determined by p16 immunohistochemistry (IHC) (positive vs. negative); HPV status for participants without oropharynx cancer was considered HPV negative.","paramType":"COUNT_OF_PARTICIPANTS","title":"Human Papillomavirus (HPV) Status","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"67"},{"groupId":"BG001","value":"66"},{"groupId":"BG002","value":"66"},{"groupId":"BG003","value":"199"}],"title":"Strongly Positive"},{"measurements":[{"groupId":"BG000","value":"234"},{"groupId":"BG001","value":"215"},{"groupId":"BG002","value":"234"},{"groupId":"BG003","value":"683"}],"title":"Not Strongly Positive"}]}],"description":"The Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) Status indicates the degree by which participants tumors stain positive for PD-L1 by IHC staining (i.e. strongly positive or not strongly positive). 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":"PD-L1 TPS Status","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"44"},{"groupId":"BG001","value":"39"},{"groupId":"BG002","value":"45"},{"groupId":"BG003","value":"128"}],"title":"CPS<1"},{"measurements":[{"groupId":"BG000","value":"257"},{"groupId":"BG001","value":"242"},{"groupId":"BG002","value":"255"},{"groupId":"BG003","value":"754"}],"title":"CPS ≥1"}]}],"description":"The PD-L1 Combined Positive Score (CPS) Status indicates tumor PD-L1 positivity using both tumor cells and inflammatory cells that are positive for PD-L1 by IHC. The number of participants with CPS\\<1 and CPS≥1 at baseline is presented. Participants with a CPS\\<1 were classified as PD-L1 negative and participants with a CPS≥1 were classified as PD-L1 positive.","paramType":"COUNT_OF_PARTICIPANTS","title":"PD-L1 CPS ≥1 Status","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"167"},{"groupId":"BG001","value":"154"},{"groupId":"BG002","value":"175"},{"groupId":"BG003","value":"496"}],"title":"CPS <20"},{"measurements":[{"groupId":"BG000","value":"133"},{"groupId":"BG001","value":"126"},{"groupId":"BG002","value":"122"},{"groupId":"BG003","value":"381"}],"title":"CPS ≥20"},{"measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"3"},{"groupId":"BG003","value":"5"}],"title":"Missing"}]}],"description":"The PD-L1 CPS Status indicates tumor PD-L1 positivity using both tumor cells and inflammatory cells that are positive for PD-L1 by IHC. The number of participants with CPS\\<20 and CPS ≥20 at baseline is presented.","paramType":"COUNT_OF_PARTICIPANTS","title":"PD-L1 CPS ≥20 Status","unitOfMeasure":"Participants"}]}