{"groups":[{"description":"Patients with moderate renal impairment (eGFR ≥30 to \\<45 mL/min/1.73m²) and a starting dose of melflufen of 40 mg.","id":"FG000","title":"Cohort 1a, Melflufen 40 mg"},{"description":"Patients with moderate renal impairment (eGFR ≥30 to \\<45 mL/min/1.73m²) and a starting dose of melflufen of 30 mg.","id":"FG001","title":"Cohort 1b, Melflufen 30 mg"},{"description":"Patients with severe renal impairment (eGFR ≥15 to \\<30 mL/min/1.73m²) and a starting dose of melflufen of 20 mg.","id":"FG002","title":"Cohort 2a, Melflufen 20 mg"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"7"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"}],"type":"Physician Decision"},{"reasons":[{"groupId":"FG000","numSubjects":"8"},{"groupId":"FG001","numSubjects":"5"},{"groupId":"FG002","numSubjects":"3"}],"type":"Disease progression"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"1"}],"type":"Study terminated by sponsor"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"0"}],"type":"Patient request to stop treatment"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"21"},{"groupId":"FG001","numSubjects":"10"},{"groupId":"FG002","numSubjects":"4"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"21"},{"groupId":"FG001","numSubjects":"10"},{"groupId":"FG002","numSubjects":"4"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"preAssignmentDetails":"All enrolled patients received study treatment and were included in the Safety Analysis Set.","recruitmentDetails":"The first patient (in Cohort 1a) received their first dose of study drug on 17 September 2018. The last patient (in Cohort 2a) received their first dose of study drug on 29 June 2021."}