{"analyses":[{"ciLowerLimit":"0.447","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.885","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"=0.0054","pValueComment":"Cox regression: HR p=0.0062","paramType":"Hazard Ratio (HR)","paramValue":"0.65","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"1.9","upperLimit":"3.0","value":"2.6"},{"groupId":"OG001","lowerLimit":"1.1","upperLimit":"2.0","value":"1.7"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"171"},{"groupId":"OG001","value":"84"}],"units":"Participants"}],"description":"To compare the efficacy of plitidepsin in combination with dexamethasone vs. dexamethasone alone as measured by progression-free survival (PFS) in patients with relapsed/refractory multiple myeloma (MM).\n\nProgression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions","dispersionType":"95% Confidence Interval","groups":[{"description":"plitidepsin + dexamethasone combination\n\nplitidepsin + dexamethasone: plitidepsin: powder and solvent for concentrate for solution for infusion. 2 mg vial + 4 ml ampoule. 5 mg/m2 intravenously (i.v.) over three hours on Day 1 and 15 every 4 weeks. dexamethasone: 4 mg tablet. 40 mg orally on Day 1, 8, 15 and 22 every four weeks at least one hour before plitidepsin infusion.","id":"OG000","title":"Plitidepsin+Dexamethasone"},{"description":"dexamethasone single agent\n\ndexamethasone: 4 mg tablet. 40 mg orally on Day 1, 8, 15 and 22 every four weeks.","id":"OG001","title":"Dexamethasone"}],"paramType":"MEDIAN","reportingStatus":"POSTED","timeFrame":"From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years","title":"Progression Free Survival (PFS) as Per Intention-to-treat (ITT)","type":"PRIMARY","unitOfMeasure":"months"}