{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"5.82","upperLimit":"23.49","value":"9.26"},{"comment":"Data not estimable. At the final data cut the upper limit CI was not reached at the previous data cut due to too few events","groupId":"OG001","lowerLimit":"4.63","upperLimit":"NA","value":"10.58"},{"comment":"Data not estimable due to an insufficient number of events. Only one patient had a best response of confirmed MR or better.","groupId":"OG002","lowerLimit":"NA","upperLimit":"NA","value":"NA"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"11"},{"groupId":"OG001","value":"8"},{"groupId":"OG002","value":"1"}],"units":"Participants"}],"description":"Duration of clinical benefit (DOCB) was calculated as time in months from the first evidence of confirmed assessment of stringent complete response (sCR), complete response (CR), very good partial response (VGPR), partial response (PR), or minimal response (MR) to first confirmed disease progression, or to death due to any cause. DOCB was defined only for patients with a confirmed MR or better. DOCB was summarized using the Kaplan-Meier (K-M) method. The median DOCB was estimated from the 50th percentile of the corresponding K-M estimates. The 95% confidence interval for median DOCB was constructed using the method of Brookmeyer (Brookmeyer, 1982).","dispersionType":"95% Confidence Interval","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":"MEDIAN","populationDescription":"This analysis included patients who achieved a best response of MR or better.","reportingStatus":"POSTED","timeFrame":"Patients were assessed from the first measure of a confirmed MR or better until confirmed progression, death, or initiation of subsequent therapy (maximum duration 127.1 weeks).","title":"Duration of Clinical Benefit","type":"SECONDARY","unitOfMeasure":"months"}