{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"90"},{"groupId":"OG001","value":"74"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"370"},{"groupId":"OG001","value":"370"}],"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 to 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 AE. The number of participants that discontinued any study drug due to an AE was reported for each treatment arm.","groups":[{"description":"Participants received pembrolizumab 200 mg IV Q3W plus SOC chemotherapy with cisplatin 80 mg/m\\^2 IV Q3W and 5-FU 800 mg/m\\^2/day continuous IV infusion on Days 1 to 5 (120 hours) Q3W. All treatments were administered on an outpatient basis beginning on Day 1 of each 3-week dosing cycle.","id":"OG000","title":"Pembrolizumab + SOC"},{"description":"Participants received placebo to pembrolizumab (saline) IV Q3W plus SOC chemotherapy with cisplatin 80 mg/m\\^2 IV Q3W and 5-FU 800 mg/m\\^2/day continuous IV infusion on Days 1 to 5 (120 hours) Q3W. All treatments were administered on an outpatient basis beginning on Day 1 of each 3-week dosing cycle.","id":"OG001","title":"Placebo + SOC"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"All randomized participants who received at least one dose of study treatment were analyzed.","reportingStatus":"POSTED","timeFrame":"Up to approximately 27 months","title":"Number of Participants Discontinuing Study Treatment Due to an AE","type":"SECONDARY","unitOfMeasure":"Participants"}