{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"92"},{"groupId":"OG001","value":"5"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"101"},{"groupId":"OG001","value":"6"}],"units":"Participants"}],"description":"An adverse event (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE was defined as either an AE reported for the first time or a worsening of a pre-existing event after the first dose of study drug until 90 days after the last dose of study drug. An AE with onset on/after starting a new anticancer therapy was not summarized as a TEAE.","groups":[{"description":"Participants with recurrent, advanced locoregional disease or distant metastatic disease who did not receive any prior chemotherapy received retifanlimab 500 milligrams (mg), administered by intravenous (IV) infusion over 60 minutes on Day 1 of each 28-day cycle (Q4W).","id":"OG000","title":"Chemotherapy: Naïve"},{"description":"Participants with disease not responding to prior chemotherapy received retifanlimab 500 mg, administered by IV infusion over 60 minutes on Day 1 Q4W.","id":"OG001","title":"Chemotherapy: Refractory"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Safety Evaluable Population","reportingStatus":"POSTED","timeFrame":"up to 846 days (up to approximately 2.3 years)","title":"Number of Participants With Any Treatment-emergent Adverse Event (TEAE)","type":"SECONDARY","unitOfMeasure":"Participants"}