{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"15.8","value":"1150"},{"groupId":"OG001","spread":"11.3","value":"1210"},{"groupId":"OG002","spread":"43.3","value":"1620"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"7"},{"groupId":"OG002","value":"35"}],"units":"Participants"}],"title":"EDO-S101 concentration, Cycle 1 D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"38.6","value":"999"},{"groupId":"OG001","spread":"21.2","value":"1040"},{"groupId":"OG002","spread":"41.5","value":"1540"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"6"},{"groupId":"OG002","value":"34"}],"units":"Participants"}],"title":"EDO-S101 concentration, Cycle 1 D15"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"65.4","value":"2.18"},{"groupId":"OG001","spread":"65.5","value":"2.32"},{"groupId":"OG002","spread":"77.9","value":"1.92"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"5"},{"groupId":"OG002","value":"24"}],"units":"Participants"}],"title":"M2 metabolite concentration, Cycle 1 D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"105","value":"2.31"},{"comment":"Not calculated due to insufficient data","groupId":"OG001","spread":"NA","value":"2.91"},{"groupId":"OG002","spread":"63.3","value":"1.98"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"24"}],"units":"Participants"}],"title":"M2 metabolite concentration, Cycle 1 D15"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"17.0","value":"37.4"},{"groupId":"OG001","spread":"36.5","value":"27.0"},{"groupId":"OG002","spread":"50.2","value":"47.7"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"7"},{"groupId":"OG002","value":"35"}],"units":"Participants"}],"title":"M8 metabolite concentration, Cycle 1 D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"46.3","value":"31.2"},{"groupId":"OG001","spread":"33.3","value":"24.6"},{"groupId":"OG002","spread":"43.7","value":"49.8"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"6"},{"groupId":"OG002","value":"34"}],"units":"Participants"}],"title":"M8 metabolite concentration, Cycle 1 D15"}],"denoms":[{"counts":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"7"},{"groupId":"OG002","value":"35"}],"units":"Participants"}],"dispersionType":"Geometric Coefficient of Variation","groups":[{"description":"A dose of 60 mg/m2 administered over 60 minutes on D1 and D15 of 4-week cycles","id":"OG000","title":"Tinostamustine (EDO-S101) - Sub Study 1 (SS1)"},{"description":"A dose of 80 mg/m2 administered over 80 minutes on D1 and D15 of 4-week cycles.","id":"OG001","title":"Tinostamustine (EDO-S101) - Sub Study 2 (SS2)"},{"description":"A dose of 80 mg/m2 administered over 60 minutes on D1 and D15 of 4-week cycles.","id":"OG002","title":"Phase 2 All Cohorts"}],"paramType":"GEOMETRIC_MEAN","populationDescription":"All enrolled subjects in the Safety Population with at least 1 quantifiable pre-dose and 1 quantifiable post-dose PK plasma concentration in Cycle 1 were included in the PK Population. PK analyses were performed using the PK population. 48 subjects of the Safety Population were included in the PK Population.","reportingStatus":"POSTED","timeFrame":"Blood samples were collected over a period of 24hr (phase 2 and sub-study 1) and 30hr (sub-study 2) on Cycle 1 Day 1 and Day 15.","title":"Maximum Plasma Concentration (Cmax) in Phase 2 and Sub Studies","type":"SECONDARY","unitOfMeasure":"nanogram(s)/millilitre"}