{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"2"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"12"}],"units":"Participants"}],"description":"DLTs were defined as:\n\nHematological Toxicity\n\n* Grade 3/4 neutropenia associated with fever or lasting\\>7 days related to the study treatment\n* Grade 3/4 thrombocytopenia accompanied by grade 3/4 hemorrhage\n* Extensive bone marrow (BM) infiltration, DLT was defined as grade 4 thrombocytopenia with grade 3/4 hemorrhage or grade 4 neutropenia lasting \\>7 days or with fever Non-hematological Toxicity\n* Grade 3/4 nausea and vomiting refractory to antiemetic therapy\n* Grade≥3 muscular Adverse events (AE) (myalgia, muscular weakness, muscle cramps, myopathy)\n* Grade≥3 alanine aminotransferase (ALT)/Aspartate aminotransferase (AST) lasting more than 1 week\n* Grade≥3 bilirubin increase\n* Grade≥3 creatine phosphokinase (CPK) increase\n* Cardiac toxicity\n\n  * Symptomatic or treatment-requiring grade ≥1 cardiac arrhythmia related to plitidepsin\n  * Grade≥1 left ventricular systolic dysfunction related to plitidepsin\n* Neuropathic pain and peripheral sensory neuropathy related to BTZ","groups":[{"description":"Patients received plitidepsin 4 mg/m2 and BTZ 1 mg/m2 and DXM 40 mg. DXM was administered at least one hour before the start of plitidepsin infusion, and BTZ was administered one minute after the end of the plitidepsin infusion. Patients received a maximum of eight treatment cycles","id":"OG000","title":"Plitidepsin (4 mg/m2)+BTZ (1 mg/m2)+DXM (40 mg)"},{"description":"Patients received plitidepsin 4 mg/m2 and BTZ 1.3 mg/m2 and DXM 40 mg. DXM was administered at least one hour before the start of plitidepsin infusion, and BTZ was administered one minute after the end of the plitidepsin infusion. Patients received a maximum of eight treatment cycles","id":"OG001","title":"Plitidepsin (4 mg/m2)+BTZ (1.3 mg/m2)+DXM (40 mg)"},{"description":"Patients received plitidepsin 5 mg/m2 and BTZ 1.3 mg/m2 and DXM 40 mg. DXM was administered at least one hour before the start of plitidepsin infusion, and BTZ was administered one minute after the end of the plitidepsin infusion. Patients received a maximum of eight treatment cycles","id":"OG002","title":"Plitidepsin (5 mg/m2)+BTZ (1.3 mg/m2)+DXM (40 mg)"}],"paramType":"COUNT_OF_PARTICIPANTS","reportingStatus":"POSTED","timeFrame":"After 28-day cycle","title":"Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)","type":"PRIMARY","unitOfMeasure":"Participants"}