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not receive treatment"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"0"},{"groupId":"FG006","numSubjects":"49"},{"groupId":"FG007","numSubjects":"62"},{"groupId":"FG008","numSubjects":"20"},{"groupId":"FG009","numSubjects":"33"},{"groupId":"FG010","numSubjects":"17"},{"groupId":"FG011","numSubjects":"24"},{"groupId":"FG012","numSubjects":"18"},{"groupId":"FG013","numSubjects":"20"},{"groupId":"FG014","numSubjects":"22"}],"comment":"Only the Dose Expansion Phase is being presented.","type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"0"},{"groupId":"FG006","numSubjects":"1"},{"groupId":"FG007","numSubjects":"1"},{"groupId":"FG008","numSubjects":"0"},{"groupId":"FG009","numSubjects":"0"},{"groupId":"FG010","numSubjects":"0"},{"groupId":"FG011","numSubjects":"0"},{"groupId":"FG012","numSubjects":"0"},{"groupId":"FG013","numSubjects":"0"},{"groupId":"FG014","numSubjects":"1"}],"type":"Enrolled, But Not Dosed"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"0"},{"groupId":"FG006","numSubjects":"0"},{"groupId":"FG007","numSubjects":"0"},{"groupId":"FG008","numSubjects":"0"},{"groupId":"FG009","numSubjects":"0"},{"groupId":"FG010","numSubjects":"0"},{"groupId":"FG011","numSubjects":"0"},{"groupId":"FG012","numSubjects":"0"},{"groupId":"FG013","numSubjects":"0"},{"groupId":"FG014","numSubjects":"0"}],"comment":"Data from Ongoing and Discontinued participants are presented as of data cutoff on 01 February 2019.","type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"0"},{"groupId":"FG006","numSubjects":"49"},{"groupId":"FG007","numSubjects":"62"},{"groupId":"FG008","numSubjects":"20"},{"groupId":"FG009","numSubjects":"33"},{"groupId":"FG010","numSubjects":"17"},{"groupId":"FG011","numSubjects":"24"},{"groupId":"FG012","numSubjects":"18"},{"groupId":"FG013","numSubjects":"20"},{"groupId":"FG014","numSubjects":"22"}],"type":"NOT COMPLETED"}],"title":"Dose Expansion"}],"preAssignmentDetails":"The Dose Escalation was intended to identify the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) of DS-8201a with at least 3 participants evaluable for assessment of dose-limiting toxicity per dose level. Since the MTD was not reached, doses of 5.4 mg/kg and 6.4 mg/kg were chosen for evaluation in the Dose Expansion phase.","recruitmentDetails":"A total of 292 participants who met all inclusion and no exclusion criteria were enrolled at 8 centers in the US and 6 centers in Japan. A total of 27 participants started the Dose Escalation phase and a total of 265 participants in the Dose Expansion phase."}