{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"48.7","value":"69800"},{"groupId":"OG001","spread":"23.9","value":"56000"},{"groupId":"OG002","spread":"41.1","value":"50800"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"28"}],"units":"Participants"}],"title":"EDO-S101 concentration, Cycle 1 D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"19.5","value":"89600"},{"groupId":"OG001","spread":"58.3","value":"49600"},{"groupId":"OG002","spread":"45.2","value":"53600"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"21"}],"units":"Participants"}],"title":"EDO-S101 concentration, Cycle 1 D15"},{"categories":[{"measurements":[{"comment":"M2 metabolite plasma concentrations were either below the limit of quantification, or a regression line could not be fitted to calculate elimination rate constant due to R square value not meeting acceptance criteria. Therefore clearance could not be derived.","groupId":"OG000","spread":"NA","value":"NA"},{"comment":"M2 metabolite plasma concentrations were either below the limit of quantification, or a regression line could not be fitted to calculate elimination rate constant due to R square value not meeting acceptance criteria. Therefore clearance could not be derived.","groupId":"OG001","spread":"NA","value":"NA"},{"comment":"M2 metabolite plasma concentrations were either below the limit of quantification, or a regression line could not be fitted to calculate elimination rate constant due to R square value not meeting acceptance criteria. Therefore clearance could not be derived.","groupId":"OG002","spread":"NA","value":"NA"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"7"},{"groupId":"OG002","value":"35"}],"units":"Participants"}],"title":"M2 metabolite concentration, Cycle 1 D1"},{"categories":[{"measurements":[{"comment":"M2 metabolite plasma concentrations were either below the limit of quantification, or a regression line could not be fitted to calculate elimination rate constant due to R square value not meeting acceptance criteria. Therefore clearance could not be derived.","groupId":"OG000","spread":"NA","value":"NA"},{"comment":"M2 metabolite plasma concentrations were either below the limit of quantification, or a regression line could not be fitted to calculate elimination rate constant due to R square value not meeting acceptance criteria. Therefore clearance could not be derived.","groupId":"OG001","spread":"NA","value":"NA"},{"comment":"M2 metabolite plasma concentrations were either below the limit of quantification, or a regression line could not be fitted to calculate elimination rate constant due to R square value not meeting acceptance criteria. Therefore clearance could not be derived.","groupId":"OG002","spread":"NA","value":"NA"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"7"},{"groupId":"OG002","value":"35"}],"units":"Participants"}],"title":"M2 metabolite concentration, Cycle 1 D15"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"54.2","value":"2410000"},{"groupId":"OG001","spread":"22.4","value":"2270000"},{"comment":"M8 metabolite plasma concentrations were either below the limit of quantification, or a regression line could not be fitted to calculate elimination rate constant due to R square value not meeting acceptance criteria. Therefore clearance could not be derived.","groupId":"OG002","spread":"NA","value":"NA"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"35"}],"units":"Participants"}],"title":"M8 metabolite concentration, Cycle 1 D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"14.8","value":"1240000"},{"groupId":"OG001","spread":"40.8","value":"1740000"},{"comment":"M8 metabolite plasma concentrations were either below the limit of quantification, or a regression line could not be fitted to calculate elimination rate constant due to R square value not meeting acceptance criteria. Therefore clearance could not be derived.","groupId":"OG002","spread":"NA","value":"NA"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"35"}],"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":"Clearance of Tinostamustine and Metabolites in Phase 2 and Substudies","type":"SECONDARY","unitOfMeasure":"mL/h/m^2"}