{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"4.30","upperLimit":"14.52","value":"8.61"},{"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":"6.24","upperLimit":"NA","value":"7.66"},{"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":"OG002","lowerLimit":"0.95","upperLimit":"NA","value":"3.43"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"21"},{"groupId":"OG001","value":"10"},{"groupId":"OG002","value":"4"}],"units":"Participants"}],"description":"Progression-free survival (PFS) was defined as the time from the date of first study drug (the earliest of melflufen and dexamethasone start date) initiation to the date of first documentation of confirmed PD or death due to any cause, whichever occurred first. Participants were deemed 'progressed' in case of i) unconfirmed progressive disease (PD) as the final response assessment, ii) death after at least one response assessment or PD based on at least two consecutive response assessments at any time, or iii) death before the first response assessment. The distribution of PFS was summarized using the Kaplan-Meier (K-M) method. The median PFS was estimated from the 50th percentile of the corresponding K-M estimates. The 95% confidence interval for median PFS 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 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 from the initiation of therapy until documented disease progression or initiation of new therapy (maximum duration 127.1 weeks).","title":"Progression-free Survival","type":"SECONDARY","unitOfMeasure":"months"}