{"groups":[{"description":"Participants received intravenous (IV) monalizumab 750 mg every two weeks (Q2W) and IV cetuximab 400 mg/m\\^2 initial dose followed by 250 mg/m\\^2 every 1 week (Q1W) until disease progression, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.","id":"FG000","title":"Monalizumab 750 mg Q2W + Cetuximab 400 mg/m^2"},{"description":"Participants receieved IV placebo matched to monalizumab Q2W and IV cetuximab 400 mg/m\\^2 initial dose followed by 250 mg/m\\^2 Q1W until disease progression, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.","id":"FG001","title":"Placebo Q2W + Cetuximab 400 mg/m^2"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"118"},{"groupId":"FG001","numSubjects":"59"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"1"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}],"type":"Progressive disease"},{"reasons":[{"groupId":"FG000","numSubjects":"103"},{"groupId":"FG001","numSubjects":"50"}],"type":"Study terminated by sponsor"},{"reasons":[{"groupId":"FG000","numSubjects":"15"},{"groupId":"FG001","numSubjects":"8"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"9"},{"groupId":"FG001","numSubjects":"4"}],"type":"Ongoing at data cut-off"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}],"type":"Screen failure"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"247"},{"groupId":"FG001","numSubjects":"123"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"246"},{"groupId":"FG001","numSubjects":"122"}],"type":"Treated"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"247"},{"groupId":"FG001","numSubjects":"123"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"preAssignmentDetails":"A total of 370 participants were randomized (All randomized participants \\[ARP\\] set) in this study of which 368 participants received treatment. The analyses presented in this report are based on a clinical efficacy data cut-off (DCO) date of 11May2022, and clinical safety DCO date of 01Sep2022.","recruitmentDetails":"The study was conducted at study sites located in Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, France, Germany, Greece, Italy, Japan, Netherlands, Philippines, Poland, Portugal, Republic of Korea, Russia, Spain, Switzerland, Taiwan, United Kingdom, and United States of America."}