{"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":"FG000","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":"FG001","title":"Dexamethasone"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"1"}],"type":"Randomized but not treated"},{"reasons":[{"groupId":"FG000","numSubjects":"15"},{"groupId":"FG001","numSubjects":"8"}],"type":"Adverse Events (treatment-related)"},{"reasons":[{"groupId":"FG000","numSubjects":"9"},{"groupId":"FG001","numSubjects":"6"}],"type":"Physician Decision"},{"reasons":[{"groupId":"FG000","numSubjects":"85"},{"groupId":"FG001","numSubjects":"44"}],"type":"Progressive Disease"},{"reasons":[{"groupId":"FG000","numSubjects":"9"},{"groupId":"FG001","numSubjects":"1"}],"type":"Adverse Events (unrelated to"},{"reasons":[{"groupId":"FG000","numSubjects":"24"},{"groupId":"FG001","numSubjects":"12"}],"type":"Patient Refusal"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}],"type":"Death (due to adverse events"},{"reasons":[{"groupId":"FG000","numSubjects":"19"},{"groupId":"FG001","numSubjects":"8"}],"type":"Death (non-related to the study"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"171"},{"groupId":"FG001","numSubjects":"84"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"3"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"165"},{"groupId":"FG001","numSubjects":"81"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"recruitmentDetails":"A total of 255 patients were enrolled. 171 Group A (Plitidepsin in combination with DXM) and 84 Group B (DXM alone).\n\nEnrolled patients between 29Jun10 and 19May15 (Last randomization). The first dose of the first patient was given on 19May15 and the last dose of the last patient was given on 07Aug17."}