{"analyses":[{"ciLowerLimit":"0.660","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.537","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":"0.989","paramType":"Hazard Ratio (HR)","paramValue":"1.00","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":"6.9","upperLimit":"10.4","value":"8.8"},{"groupId":"OG001","lowerLimit":"6.0","upperLimit":"14.5","value":"8.6"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"145"},{"groupId":"OG001","value":"71"}],"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 hazard ratio (HR) and confidence intervals (CIs) from a stratified Cox proportional hazards model. Analyses were stratified on World Health Organization/ Eastern Cooperative Oncology Group performance status (WHO/ECOG PS) (0 or 1) and number of prior lines of therapy in recurrent or metastatic (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 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 oropharyngeal cancer (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":"Overall Survival (OS) in Human Papillomavirus (HPV)-Unrelated Analysis Set","type":"PRIMARY","unitOfMeasure":"Months"}