{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"38","value":"0.919"},{"groupId":"OG001","spread":"185","value":"2.14"},{"groupId":"OG002","spread":"54","value":"0.70"}]}],"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":"45.8","value":"0.678"},{"groupId":"OG001","spread":"2150","value":"4.03"},{"groupId":"OG002","spread":"51.2","value":"0.704"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"20"}],"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":"30.2","value":"0.602"},{"groupId":"OG001","spread":"96.8","value":"1.22"},{"groupId":"OG002","spread":"49","value":"0.414"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"7"},{"groupId":"OG002","value":"17"}],"units":"Participants"}],"title":"M8 metabolite concentration, Cycle 1 D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"153","value":"2.30"},{"groupId":"OG001","spread":"99.7","value":"2.48"},{"groupId":"OG002","spread":"553","value":"4.43"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"7"},{"groupId":"OG002","value":"7"}],"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":"Summary of Half-life of Tinostamustine in Phase 2 and Substudies.","type":"SECONDARY","unitOfMeasure":"hour"}