{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}],"title":"Stringent complete response (sCR)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"0"}]}],"title":"Complete response (CR)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"0"}]}],"title":"Very good partial response (VGPR)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"4"},{"groupId":"OG002","value":"1"}]}],"title":"Partial response (PR)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"0"}]}],"title":"Minimal response (MR)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"0"}]}],"title":"Stable disease (SD)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"3"}]}],"title":"Progressive disease (PD)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}],"title":"Non-evaluable"}],"denoms":[{"counts":[{"groupId":"OG000","value":"21"},{"groupId":"OG001","value":"10"},{"groupId":"OG002","value":"4"}],"units":"Participants"}],"description":"Best confirmed response required 2 consecutive assessments with the same response result made at any time. In case at the second consecutive assessment (made at any time) the response is higher than the previous one, then confirmed response (linked to the first assessment visit) will be the first one (e.g., PR - VGPR consecutive pair will lead to a PR confirmed response at the first visit). In case the second consecutive response is lower than the first one, then confirmed response (linked to the first assessment visit) will be the second one (e.g. CR-VGPR consecutive pair will lead to a VGPR confirmed response at the first visit).","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":"OG000","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":"OG001","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":"OG002","title":"Cohort 2a, Melflufen 20 mg"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"This analysis was performed in the Safety Analysis Set, which is defined as all patients who received at least 1 or partial dose of melflufen or dexamethasone.","reportingStatus":"POSTED","timeFrame":"Patients were assessed for response after each cycle. After discontinuation of therapy, patients continued to be assessed until documented progression (confirmed on 2 consecutive assessments) or initiation of subsequent therapy (max duration 127.1 weeks).","title":"Best Confirmed Response","type":"SECONDARY","unitOfMeasure":"Participants"}