{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"495"},{"groupId":"OG001","value":"486"}]}],"title":"Any TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"211"},{"groupId":"OG001","value":"179"}]}],"title":"Any SAE"}],"denoms":[{"counts":[{"groupId":"OG000","value":"498"},{"groupId":"OG001","value":"494"}],"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 200 mg of tislelizumab intravenously with investigator's choice of chemotherapy once every 3 weeks for up to six treatment cycles. Thereafter, participants continued treatment with 200 mg tislelizumab, with optional maintenance capecitabine (only permitted for participants who initially received capecitabine and oxaliplatin) once every 3 weeks until disease progression or unacceptable toxicity.","id":"OG000","title":"Tislelizumab + Chemotherapy"},{"description":"Participants received placebo intravenously with investigator's choice of chemotherapy once every 3 weeks for up to six treatment cycles. Thereafter, participants continued treatment with placebo with optional maintenance capecitabine (only permitted for participants who initially received capecitabine and oxaliplatin) once every 3 weeks until disease progression or unacceptable toxicity.","id":"OG001","title":"Placebo + Chemotherapy"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"The Safety Analysis Set included all participants who received ≥ 1 dose of study drug","reportingStatus":"POSTED","timeFrame":"From first dose of study drug to 30 days after last dose or the initiation of a new anticancer therapy, whichever occurred first, up to the end of study; maximum treatment duration was 59.3 months in Tislelizumab and 56.8 months in the Placebo group.","title":"Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)","type":"SECONDARY","unitOfMeasure":"Participants"}