{"analyses":[{"ciLowerLimit":"0.790","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.568","estimateComment":"HR and CIs were calculated using a stratified Cox proportional hazards model, adjusted for WHO/ECOG PS, and number of lines of prior therapy in R/M setting.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.574","paramType":"Hazard Ratio (HR)","paramValue":"1.11","statisticalComment":"P-value was calculated using stratified log-rank test, adjusted for WHO/ECOG PS (0/1) and number of prior lines of therapy in R/M setting.","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"3.1","upperLimit":"3.7","value":"3.6"},{"groupId":"OG001","lowerLimit":"2.4","upperLimit":"4.9","value":"3.8"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"145"},{"groupId":"OG001","value":"71"}],"units":"Participants"}],"description":"PFS per RECIST 1.1 as assessed by the investigator is defined as time from randomization until date of RECIST 1.1-defined radiological progressive disease (PD) or death regardless of whether participant withdraws from therapy or received subsequent anticancer therapy prior to progression. PD: at least 20% increase in sum of diameters of target lesions (TLs), taking as reference the smallest sum on study (nadir) and sum must demonstrate an absolute increase of at least 5 mm from nadir or unequivocal progression of existing non-TLs (NTLs) or appearance of new lesions. PFS was analyzed using Kaplan-Meier technique. Statistical analysis was performed using P-value from stratified log-rank test and HR and CIs from a stratified Cox proportional hazards model. Analyses were stratified on WHO/ECOG PS (0/1) and no. of prior lines of therapy in R/M setting.","dispersionType":"95% Confidence Interval","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":"MEDIAN","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.","reportingStatus":"POSTED","timeFrame":"Baseline (-28 to -1) through 17.5 months (maximum observed duration)","title":"Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by Investigator Assessment in HPV-unrelated Analysis Set","type":"SECONDARY","unitOfMeasure":"Months"}