{"groups":[{"description":"Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery.\n\nAdjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks).","id":"FG000","title":"Pembrolizumab + Standard of Care (SOC)"},{"description":"Adjuvant treatment: Following surgical resection, participants received investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks).","id":"FG001","title":"Standard of Care (SOC)"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"109"},{"groupId":"FG001","numSubjects":"127"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"3"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"12"},{"groupId":"FG001","numSubjects":"16"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"240"},{"groupId":"FG001","numSubjects":"205"}],"type":"Participants Ongoing"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"363"},{"groupId":"FG001","numSubjects":"351"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"360"},{"groupId":"FG001","numSubjects":"316"}],"type":"Treated"},{"achievements":[{"groupId":"FG000","numSubjects":"361"},{"groupId":"FG001","numSubjects":"315"}],"comment":"All participants who received ≥1 dose of study treatment: 1 participant in the SOC arm received neoadjuvant treatment, which was a protocol deviation, and this participant was continued in the Pembrolizumab + SOC arm in the study.","type":"Safety Analysis Population"},{"achievements":[{"groupId":"FG000","numSubjects":"363"},{"groupId":"FG001","numSubjects":"351"}],"comment":"All randomized participants: 2 participants in the SOC arm received neoadjuvant treatment in error (protocol deviations) and were included in the SOC arm for efficacy analysis.","type":"Efficacy Analysis Population"},{"achievements":[{"groupId":"FG000","numSubjects":"354"},{"groupId":"FG001","numSubjects":"0"}],"type":"Neoadjuvant Treatment Period: Participants Who Took EORTCQLQ-C30 GHS/QoL (Items 29 & 30) Assessment"},{"achievements":[{"groupId":"FG000","numSubjects":"356"},{"groupId":"FG001","numSubjects":"306"}],"type":"Adjuvant Treatment Period: Participants Who Took EORTCQLQ-C30 GHS/QoL (Items 29 and 30) Assessment"},{"achievements":[{"groupId":"FG000","numSubjects":"354"},{"groupId":"FG001","numSubjects":"0"}],"type":"Neoadjuvant Treatment Period: Participants Who Took EORTCQLQ-C30 (Items 1-5) Assessment"},{"achievements":[{"groupId":"FG000","numSubjects":"356"},{"groupId":"FG001","numSubjects":"306"}],"type":"Adjuvant Treatment Period: Participants Who Took EORTCQLQ-C30 (Items 1-5) Assessment"},{"achievements":[{"groupId":"FG000","numSubjects":"354"},{"groupId":"FG001","numSubjects":"0"}],"type":"Neoadjuvant Treatment Period: Participants Who Took EORTCQLQ-H&N35 (Items 35-38) Assessment"},{"achievements":[{"groupId":"FG000","numSubjects":"356"},{"groupId":"FG001","numSubjects":"306"}],"type":"Adjuvant Treatment Period: Participants Who Took EORTCQLQ-H&N35 (Items 35-38) Assessment"},{"achievements":[{"groupId":"FG000","numSubjects":"354"},{"groupId":"FG001","numSubjects":"0"}],"type":"Neoadjuvant Treatment Period: Participants Who Took EORTCQLQ-H&N35 (Items 46, 53-54) Assessment"},{"achievements":[{"groupId":"FG000","numSubjects":"356"},{"groupId":"FG001","numSubjects":"306"}],"type":"Adjuvant Treatment Period: Participants Who Took EORTCQLQ-H&N35 (Items 46, 53-54) Assessment"},{"achievements":[{"groupId":"FG000","numSubjects":"354"},{"groupId":"FG001","numSubjects":"0"}],"type":"Neoadjuvant Treatment Period: Participants Who Took EORTCQLQ-H&N35 (Items 31-34) Assessment"},{"achievements":[{"groupId":"FG000","numSubjects":"356"},{"groupId":"FG001","numSubjects":"306"}],"type":"Adjuvant Treatment Period: Participants Who Took EORTCQLQ-H&N35 (Items 31-34) Assessment"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"363"},{"groupId":"FG001","numSubjects":"351"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"preAssignmentDetails":"Two participants in the SOC arm received neoadjuvant treatment in error (protocol deviations). One of the participants (who received one cycle of neoadjuvant treatment) was included in the SOC arm for the efficacy and safety analyses per protocol. The other participant (who received 2 cycles of neoadjuvant treatment) was included in the SOC arm for efficacy analysis and in the Pembrolizumab + SOC arm for the safety analysis per protocol.","recruitmentDetails":"Per protocol, patient-reported outcome (PRO) measures (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 \\[EORTC QLQ-C30\\] Global Health Status \\[GHS\\]/Quality of Life \\[QoL\\]\\[Items 29 and 30\\], EORTC QLQ-C30 \\[Items 1-5\\], EORTC QLQ-Head and Neck Module 35 \\[H\\&N35\\] \\[Items 35-38\\], EORTC QLQ-H\\&N35 \\[Items 46, 53-54\\], and EORTC QLQ-H\\&N35 \\[Items 31-34\\] were reported separately for neoadjuvant and adjuvant treatment periods."}