{"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.0001","statisticalMethod":"Fisher Exact"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"16.8","upperLimit":"29.8","value":"22.8"},{"groupId":"OG001","lowerLimit":"0.7","upperLimit":"10.1","value":"3.6"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"171"},{"groupId":"OG001","value":"84"}],"units":"Participants"}],"description":"Overall response rate including sCR, CR, VGPR, PR and MR. Very good partial response (VGPR) serum and urine M-protein detectable but not electrophoresis or \\>90% reduction in serum M-protein and urine M-protein \\<100 mg/24h Partial response (PR) ≥50% reduction in serum M-protein and 90% reduction in 24h urine M-protein or to \\<200 mg/24h. 50% reduction in size of any soft tissue plasmacytomas Minor response (MR) 25%-49% reduction of serum M-protein and 50-89% reduction of 24h urine M-protein. 25-49% reduction in size of soft tissue plasmacytomas. No increase in size or number of bone 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":"NUMBER","reportingStatus":"POSTED","timeFrame":"From the date of first documentation of response to the date of disease progression or death, assessed up to 5 years","title":"Overall Response Rate (Independent Review Committee)","type":"SECONDARY","unitOfMeasure":"percentage of participants"}