{"analyses":[{"ciLowerLimit":"0.274","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.154","estimateComment":"The analysis was performed using a logistic regression model, with treatment as a covariate and adjusting for WHO/ECOG PS, and number of lines of prior therapy in the R/M setting with 95% CI calculated by profile likelihood.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.115","paramType":"Odds Ratio (OR)","paramValue":"0.56","statisticalComment":"P-value is based on twice the change in log-likelihood resulting from the addition of a treatment factor to the model.","statisticalMethod":"Regression, Logistic"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.274","upperLimit":"1.154","value":"15.2"},{"groupId":"OG001","value":"23.9"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"145"},{"groupId":"OG001","value":"71"}],"units":"Participants"}],"description":"The OR is defined as the percentage of participants with at least one confirmed investigator-assessed response of complete response (CR) or partial response (PR) as assessed by RECIST 1.1 guidelines. The CR is defined as disappearance of all TLs and NTLs, any pathological lymph nodes (target and non-target) must have reduction in short axis \\< 10 mm, and no new lesions. The PR is defined as at least a 30% decrease in the sum of the diameters (SoD) of TLs (compared to baseline) and no new lesions. Confirmation of CR and PR is required by a repeat, consecutive assessment no less than 4 weeks from the date of first documentation. Percentage of participants with OR is reported. Participants who had measurable disease at baseline per the site investigator were analyzed for this outcome.","groups":[{"description":"Participants received IV monalizumab 750 mg Q2W and IV cetuximab 400 mg/m\\^2 initial dose followed by 250 mg/m\\^2 Q1W until disease progression, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.","id":"OG000","title":"Monalizumab 750 mg Q2W + Cetuximab 400 mg/m^2"},{"description":"Participants receieved IV placebo matched to monalizumab Q2W and IV cetuximab 400 mg/m\\^2 initial dose followed by 250 mg/m\\^2 Q1W until disease progression, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.","id":"OG001","title":"Placebo Q2W + Cetuximab 400 mg/m^2"}],"paramType":"NUMBER","populationDescription":"The HPV-unrelated analysis set included all participants who were randomized at least 2 months before the 11May2022 DCO (i.e. on or before 11Mar2022) and were either OPC HPV negative or non OPC regardless of the HPV status. Participants who had measurable disease at baseline per the site investigator were analyzed for this outcome.","reportingStatus":"POSTED","timeFrame":"Baseline (-28 to -1) through 17.5 months (maximum observed duration)","title":"Percentage of Participants With Objective Response (OR) Per RECIST 1.1 in HPV-unrelated Analysis Set","type":"SECONDARY","unitOfMeasure":"Percentage of Participants"}