{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"323"},{"groupId":"OG001","value":"319"}]}],"title":"Treatment-emergent adverse event"},{"categories":[{"measurements":[{"groupId":"OG000","value":"160"},{"groupId":"OG001","value":"128"}]}],"title":"Serious adverse events"}],"denoms":[{"counts":[{"groupId":"OG000","value":"324"},{"groupId":"OG001","value":"321"}],"units":"Participants"}],"description":"An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drugs, whether related to study drugs or not.\n\nAn SAE is any untoward medical occurrence that, at any dose met any of the following criteria:\n\n* Resulted in death\n* Was life-threatening\n* Required hospitalization or prolongation of existing hospitalization\n* Resulted in disability/incapacity\n* Was a congenital anomaly/birth defect\n* Was considered a significant medical AE by the Investigator based on medical judgement.","groups":[{"description":"Participants received tislelizumab 200 mg administered IV on Day 1 of each 3-week treatment cycle together with an investigator-chosen chemotherapy doublet until unacceptable toxicity, disease progression or withdrawal for other reasons.","id":"OG000","title":"Tislelizumab + Chemotherapy"},{"description":"Participants received placebo administered IV on Day 1 of each 3-week treatment cycle together with an investigator-chosen chemotherapy doublet until unacceptable toxicity, disease progression or withdrawal for other reasons.","id":"OG001","title":"Placebo + Chemotherapy"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Safety analysis set included all participants who received at least 1 dose of study drug","reportingStatus":"POSTED","timeFrame":"From first dose of study drug up to 30 days after last dose; maximum time on treatment was 63.5 months.","title":"Number of Participants Experiencing Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)","type":"SECONDARY","unitOfMeasure":"Participants"}