{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"4"}]}],"title":"Hypertension"},{"categories":[{"measurements":[{"groupId":"OG000","value":"11"},{"groupId":"OG001","value":"3"}]}],"title":"Hypotension"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"}]}],"title":"Hypoxia"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"}]}],"title":"Hyperpyrexia"},{"categories":[{"measurements":[{"groupId":"OG000","value":"18"},{"groupId":"OG001","value":"10"}]}],"title":"Pyrexia"}],"denoms":[{"counts":[{"groupId":"OG000","value":"246"},{"groupId":"OG001","value":"122"}],"units":"Participants"}],"description":"Participants with abnormal vital signs (heart rate, blood pressure, temperature, and respiratory rate) reported as TEAEs are reported. TEAEs included events from the first dose of study drug, up to 90 days after the last dose of study drug received or up to the start date of any subsequent anticancer therapy following discontinuation of study drug, or the final safety DCO date of 01Sep2022, whichever occurred first.","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":"COUNT_OF_PARTICIPANTS","populationDescription":"The Safety Analysis Set included all participants randomized at least 2 months before the DCO 01Sep2022 (i.e. on or before 01Jul2022).","reportingStatus":"POSTED","timeFrame":"Day 1 through 21.4 months (maximum observed duration)","title":"Number of Participants With Abnormal Vital Signs Reported as TEAEs","type":"SECONDARY","unitOfMeasure":"Participants"}