{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"29"},{"groupId":"OG001","value":"85"},{"groupId":"OG002","value":"58"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"254"},{"groupId":"OG001","value":"250"},{"groupId":"OG002","value":"244"}],"units":"Participants"}],"description":"An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that was temporally associated with the use of the Sponsor's product was also an adverse event. The number of participants who discontinued study treatment due to an AE was reported for each arm according to the treatment received.","groups":[{"description":"Participants received pembrolizumab 200 mg IV Q3W.","id":"OG000","title":"Pembrolizumab Monotherapy (Pembro Mono)"},{"description":"Participants received pembrolizumab 200 mg Q3W plus cisplatin 80 mg/m\\^2 Q3W plus 5-FU 800 mg/m\\^2/day IV infusion on Days 1-5 Q3W. Capecitabine 1000 mg/m\\^2 twice a day (BID) on Days 1-14 Q3W could be substituted for 5-FU per local guidelines.","id":"OG001","title":"Pembrolizumab + SOC Chemotherapy (Pembro Combo)"},{"description":"Participants received placebo IV Q3W plus cisplatin 80 mg/m\\^2 Q3W plus 5-FU 800 mg/m\\^2/day IV infusion on Days 1-5 Q3W. Capecitabine 1000 mg/m\\^2 BID on Days 1-14 Q3W could be substituted for 5-FU per local guidelines.","id":"OG002","title":"Placebo + SOC Chemotherapy (SOC)"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"All randomized participants who received at least 1 dose of trial treatment were analyzed.","reportingStatus":"POSTED","timeFrame":"Up to approximately 30 months","title":"Number of Participants Discontinuing Study Treatment Due to an AE","type":"SECONDARY","unitOfMeasure":"Participants"}