{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"1.6","upperLimit":"4.7","value":"2.8"},{"comment":"The confidence interval could not be determined as only 1 patient was analysed.","groupId":"OG001","lowerLimit":"NA","upperLimit":"NA","value":"6.7"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"14"},{"groupId":"OG001","value":"1"}],"units":"Participants"}],"title":"OR"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"1.4","upperLimit":"3.0","value":"2.4"},{"groupId":"OG001","lowerLimit":"2.8","upperLimit":"6.1","value":"2.8"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"22"},{"groupId":"OG001","value":"3"}],"units":"Participants"}],"title":"CBR"}],"denoms":[{"counts":[{"groupId":"OG000","value":"22"},{"groupId":"OG001","value":"3"}],"units":"Participants"}],"description":"Time to first OR was defined as the time from the date of the first dose of study drug (overall reference start date) to the date of the first occurrence of PR or better (first of 2 consecutive assessments-confirmed response). Time to first CBR was defined as the time from the date of the first dose of study drug (overall reference start date) to the date of the first occurrence of MR or better (first of 2 consecutive assessments-confirmed response). Time to disease response was estimated using Kaplan-Meier statistics.","dispersionType":"95% Confidence Interval","groups":[{"description":"Patients were treated with 40 mg melflufen as IV infusion on Day 1 and 40 mg dexamethasone oral tablet or IV infusion on Days 1, 8 and 15 of each 21-day or 28-day treatment cycle. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator. In Protocol amendment 4, the cycle of melflufen was increased from 21 to 28 days. For any patients on the 28-day treatment schedule, an additional dose of 40 mg dexamethasone was administered on Day 22 of each cycle.","id":"OG000","title":"Phase I + II: Melflufen 40 mg + Dexamethasone"},{"description":"Patients were treated with 40 mg melflufen as IV infusion on Day 1 of each 28-day treatment cycle. Dexamethasone was not administered as an antitumor compound. However, all patients were treated with 8 mg dexamethasone as an antiemetic on Days 1 and 2, and an optional 4 mg dexamethasone as an antiemetic on Days 3 and 4 of the same 28-day cycle, unless the Investigator decided to switch a patient to a combination regimen. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator.","id":"OG001","title":"Phase II: Melflufen 40 mg (Single Agent)"}],"paramType":"MEDIAN","populationDescription":"The mITT Analysis Set included all patients considered to be valid for the Safety Analysis Set and who received at least 1 dose of study drug at the MTD as the initial dose. Only patients who had achieved OR and CBR were evaluated, for each respective time to response parameter.","reportingStatus":"POSTED","timeFrame":"Baseline and every cycle from Cycle 2 onwards until confirmed disease progression. Assessed until EOT date of 29 October 2019; up to a maximum of approximately 76 months.","title":"Time to Disease Response in Patients Who Achieved OR and CBR","type":"SECONDARY","unitOfMeasure":"months"}