{"groups":[{"description":"Participants received AG-120 500 mg, tablet, orally, once daily (QD) in each 28-day treatment cycle, until occurrence of disease progression, unacceptable toxicity, confirmed pregnancy, death, subject withdrawal, lost to follow-up, or the sponsor ended the study for up to approximately 45 months.","id":"FG000","title":"AG-120"},{"description":"Participants received AG-120 matched placebo, orally, QD in each 28-day treatment cycle, until occurrence of disease progression, unacceptable toxicity, confirmed pregnancy, death, subject withdrawal, lost to follow-up or the sponsor ended the study for up to approximately 7 months. Participants who experienced disease progression and received placebo were allowed to cross over and receive AG-120.","id":"FG001","title":"Placebo"},{"description":"Participants who experienced disease progression and received placebo were allowed to cross over to receive AG-120 500 mg, tablet, orally, QD in each 28-day treatment cycle for up to approximately 32 months.","id":"FG002","title":"After Crossover to AG-120"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"0"}],"type":"Not Treated"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"126"},{"groupId":"FG001","numSubjects":"61"},{"groupId":"FG002","numSubjects":"0"}],"type":"STARTED"},{"achievements":[{"comment":"Completed = Participants who completed the protocol defined treatment.","groupId":"FG000","numSubjects":"123"},{"comment":"Completed = Participants who completed the protocol defined treatment.","groupId":"FG001","numSubjects":"59"},{"groupId":"FG002","numSubjects":"0"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"0"}],"type":"NOT COMPLETED"}],"title":"Randomization Phase"},{"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"comment":"Participants who had experienced disease progression and received placebo were allowed to cross over to receive AG-120.","groupId":"FG002","numSubjects":"43"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"comment":"Completed = Participants who completed the protocol defined treatment.","groupId":"FG002","numSubjects":"43"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}],"type":"NOT COMPLETED"}],"title":"Cross Over Phase"}],"preAssignmentDetails":"The final analysis of progression-free survival (PFS) occurred once 131 PFS events had been determined by Investigator assessment. Two participants were randomized in the study after the data cutoff date (31 January 2019) for the final analysis of PFS.","recruitmentDetails":"Participants took part in the study at 49 study sites in France, Italy, Spain, South Korea, the United States, and the United Kingdom from 20 February 2017 to 17 May 2021."}