{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"41.9","value":"938"},{"groupId":"OG001","spread":"22.6","value":"1680"},{"groupId":"OG002","spread":"40.9","value":"1490"}]}],"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":"53.7","value":"943"},{"groupId":"OG001","spread":"28.7","value":"1390"},{"groupId":"OG002","spread":"41.7","value":"1520"}]}],"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":"420","value":"5.19"},{"groupId":"OG001","spread":"1430","value":"12.4"},{"groupId":"OG002","spread":"248","value":"0.865"}]}],"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":"9060","value":"2.32"},{"comment":"Not calculated due to insufficient data","groupId":"OG001","spread":"NA","value":"48.6"},{"groupId":"OG002","spread":"163","value":"1.32"}]}],"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":"80.5","value":"36.0"},{"groupId":"OG001","spread":"61.2","value":"54.4"},{"groupId":"OG002","spread":"48.3","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":"94.1","value":"40.9"},{"groupId":"OG001","spread":"33.7","value":"35.2"},{"groupId":"OG002","spread":"44.8","value":"53.3"}]}],"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":"Area Under the Curve [AUC(0-t)] in Phase 2 and Sub Studies.","type":"SECONDARY","unitOfMeasure":"ng.h/mL"}