{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"36"},{"groupId":"OG001","value":"90"},{"groupId":"OG002","value":"79"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"300"},{"groupId":"OG001","value":"276"},{"groupId":"OG002","value":"287"}],"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 study drug due to an AE, for the first course of treatment, was reported for each arm.","groups":[{"description":"Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle for up to 35 cycles (up to \\~2 years).","id":"OG000","title":"Pembrolizumab Monotherapy (Pembro Mono)"},{"description":"Participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for up to 35 cycles (up to \\~2 years); plus cisplatin 100 mg/m\\^2 IV or carboplatin at a target area under the curve of 5 (AUC 5) IV, per Investigator's choice, on Day 1 of each 3-week cycle (6 cycle maximum \\[up to \\~4 months\\]); plus 5-Fluorouracil (5-FU) 1000 mg/m\\^2/day IV continuous from Day 1-4 of each 3-week cycle (6 cycle maximum \\[up to \\~4 months\\]).","id":"OG001","title":"Pembrolizumab + Chemotherapy (Pembro Combo)"},{"description":"Participants received cetuximab on Day 1 at a dose of 400 mg/m\\^2 IV, and then 250 mg/m\\^2 IV on Day 1 of each subsequent week until disease progression or unacceptable toxicity; plus cisplatin 100 mg/m\\^2 IV or carboplatin AUC 5 IV (Investigator's choice) on Day 1 of each 3-week cycle (6 cycle maximum \\[up to \\~4 months\\] for platinum-based therapy); plus 5-FU 1000 mg/m\\^2/day IV continuous from Day 1-4 of each 3-week cycle (6 cycle maximum \\[up to \\~4 months\\]).","id":"OG002","title":"Cetuximab + Chemotherapy (Control)"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"All randomized participants who received ≥1 dose of study drug.","reportingStatus":"POSTED","timeFrame":"Up to approximately 47 months","title":"Number of Participants Who Discontinued Study Drug Due to an AE","type":"SECONDARY","unitOfMeasure":"Participants"}