{"analyses":[{"ciLowerLimit":"0.297","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.231","estimateComment":"The analysis was performed using a logistic regression model, with treatment as a covariate and adjusting for HPV Status, 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":"0.162","paramType":"Odds Ratio (OR)","paramValue":"0.60","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":"0.297","upperLimit":"1.231","value":"13.1"},{"groupId":"OG001","value":"19.1"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"175"},{"groupId":"OG001","value":"89"}],"units":"Participants"}],"description":"The OR is defined as the percentage of participants with at least one confirmed investigator-assessed response of CR or 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 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 FAS included all participants randomized at least 2 months before the DCO 11May2022 (i.e. on or before 11Mar2022). 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 OR Per RECIST 1.1 in FAS","type":"SECONDARY","unitOfMeasure":"Percentage of Participants"}