{"classes":[{"categories":[{"measurements":[{"comment":"upper limit was not estimable due to few participants with events","groupId":"OG000","lowerLimit":"0.7","upperLimit":"NA","value":"2.7"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"8"}],"units":"Participants"}],"description":"Event-free survival (EFS) was defined as the time, in months, from the date of first drug administration to the date of onset of the first drug-related event leading to treatment discontinuation, documented PD or death. The censoring rules defined above for PFS were used for EFS","dispersionType":"95% Confidence Interval","groups":[{"description":"Plitidepsin was to be administered as a 3-hour (h) intravenous (i.v.) infusion at a dose of 5 mg/m2, on Day (D) 1 and 15, every four weeks (q4wk); BTZ was to be administered as a subcutaneous (s.c.) injection at a dose of 1.3 mg/m2 on D1, 4, 8 and 11, q4wk and DXM was to be taken orally at a dose of 40 mg/day on D1, 8, 15 and 22, q4wk. A cycle was defined as 28 days, plus any additional days required for dosing delays due to any reason. Treatment cycles were repeated q4wk.","id":"OG000","title":"Experimental"}],"paramType":"MEDIAN","populationDescription":"1 died without any valid tumor assessment done\n\n1 discontinued treatment-related AEs","reportingStatus":"POSTED","timeFrame":"From the date of first drug administration to the date of onset of the first drug-related event leading to treatment discontinuation, documented PD or death, up to 100 weeks","title":"Event-free Survival","type":"SECONDARY","unitOfMeasure":"months"}