{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.250","upperLimit":"0.750","value":"0.750"},{"groupId":"OG001","lowerLimit":"0.750","upperLimit":"1.33","value":"1"},{"groupId":"OG002","lowerLimit":"0.250","upperLimit":"1.25","value":"0.750"}]}],"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","lowerLimit":"0.5","upperLimit":"0.750","value":"0.750"},{"groupId":"OG001","lowerLimit":"0.167","upperLimit":"1.33","value":"0.875"},{"groupId":"OG002","lowerLimit":"0","upperLimit":"1.25","value":"0.750"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"6"},{"groupId":"OG002","value":"35"}],"units":"Participants"}],"title":"EDO-S101 concentration, Cycle 1 D15"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.250","upperLimit":"6","value":"1"},{"groupId":"OG001","lowerLimit":"0.750","upperLimit":"24","value":"1.58"},{"groupId":"OG002","lowerLimit":"0.25","upperLimit":"2.00","value":"1.00"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"5"},{"groupId":"OG002","value":"35"}],"units":"Participants"}],"title":"M2 metabolite concentration, Cycle 1 D1"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.250","upperLimit":"24","value":"1"},{"groupId":"OG001","lowerLimit":"3.50","upperLimit":"3.50","value":"3.50"},{"groupId":"OG002","lowerLimit":"0","upperLimit":"6","value":"1.00"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"35"}],"units":"Participants"}],"title":"M2 metabolite concentration, Cycle 1 D15"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.250","upperLimit":"1","value":"0.750"},{"groupId":"OG001","lowerLimit":"1","upperLimit":"1.33","value":"1"},{"groupId":"OG002","lowerLimit":"0.250","upperLimit":"1.50","value":"0.750"}]}],"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","lowerLimit":"0.500","upperLimit":"0.750","value":"0.750"},{"groupId":"OG001","lowerLimit":"1","upperLimit":"1.33","value":"1.33"},{"groupId":"OG002","lowerLimit":"0","upperLimit":"1.25","value":"0.750"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"6"},{"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":"Full Range","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":"MEDIAN","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 Tmax in in Phase 2 and Sub Studies.","type":"SECONDARY","unitOfMeasure":"hours"}