{"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0002","statisticalMethod":"Normal approximation"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"19.1","upperLimit":"33.7","value":"26.4"},{"groupId":"OG001","lowerLimit":"1.9","upperLimit":"14.3","value":"8.1"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"171"},{"groupId":"OG001","value":"84"}],"units":"Participants"}],"description":"The secondary study analysis was based on Investigator's assessment PFS data in the ITT efficacy population, defined as all patients randomized to either treatment arm. PFS was calculated from randomization to the first evidence of PD or death due to any cause. Progression 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 If the patient received further antitumor therapy before PD and within the timeframe expected for first follow-up, PFS was censored on the date of the last disease assessment prior to the administration of this antitumor therapy.","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 date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months","title":"Percentage of Participants With Progression-free Survival (Investigator Assessment) at 6 Months","type":"SECONDARY","unitOfMeasure":"percentage of participants"}