{"analyses":[{"ciLowerLimit":"0.704","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.528","estimateComment":"HR and CIs were calculated using a stratified Cox proportional hazards model, adjusted for HPV status, WHO/ECOG PS, and number of lines of prior therapy in R/M setting.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.891","paramType":"Hazard Ratio (HR)","paramValue":"1.03","statisticalComment":"P-value was calculated using stratified log-rank test, adjusted for HPV status, 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":"6.9","upperLimit":"10.8","value":"8.8"},{"groupId":"OG001","lowerLimit":"6.0","upperLimit":"15.1","value":"8.9"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"175"},{"groupId":"OG001","value":"89"}],"units":"Participants"}],"description":"The OS is defined as time from the date of randomization until death due to any cause regardless of whether the participant withdraws from randomized therapy or receives another anti-cancer therapy (i.e. date of death or censoring - date of randomization + 1). The OS was analyzed using Kaplan-Meier technique. Statistical analysis was performed using P-value from a stratified log-rank test and HR and CIs from a stratified Cox proportional hazards model. Analyses were stratified on HPV status (OPC HPV positive or HPV-unrelated), WHO/ECOG PS (0 or 1) and number of prior lines of therapy in R/M setting (1 or 2).","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 FAS included all participants randomized at least 2 months before the DCO 11May2022 (i.e. on or before 11Mar2022).","reportingStatus":"POSTED","timeFrame":"Baseline (-28 to -1) through 17.5 months (maximum observed duration)","title":"Overall Survival in Full Analysis Set (FAS)","type":"SECONDARY","unitOfMeasure":"Months"}