{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"1475.82","value":"2858.44"},{"groupId":"OG001","spread":"2056.86","value":"4922.66"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"3"}],"units":"Participants"}],"title":"EDO-S101"},{"categories":[{"measurements":[{"comment":"Mean and Standard Deviation (SD) was not calculated as data were available for only two participants.","groupId":"OG000","spread":"NA","value":"NA"},{"groupId":"OG001","spread":"3.75","value":"6.65"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"3"}],"units":"Participants"}],"title":"M2-EDO-S101"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"20.36","value":"60.42"},{"groupId":"OG001","spread":"20.01","value":"100.75"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"3"}],"units":"Participants"}],"title":"M8-EDO-S101"}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"3"}],"units":"Participants"}],"description":"AUC0-t was defined as area under the concentration-time curve from time zero to the last measurable concentration. Tinostamustine (EDO-S101) and its metabolites included M2-EDO-S101 and M8-EDO-S101.","dispersionType":"Standard Deviation","groups":[{"description":"Participants received single dose of tinostamustine 180 mg/m\\^2 IV injection followed by autologous stem cell transplantation (ASCT) on Day 1.","id":"OG000","title":"Tinostamustine 180 mg/m^2"},{"description":"Participants received single dose of tinostamustine 220 mg/m\\^2 IV injection followed by ASCT on Day 1.","id":"OG001","title":"Tinostamustine 220 mg/m^2"}],"paramType":"MEAN","populationDescription":"PK population included all participants in the safety population with at least one quantifiable pre-dose and one quantifiable post-dose PK plasma concentration. The study was early terminated on 17 April 2019, due to safety signals during Phase 1, participants were not enrolled in Phase 2. Here, number analyzed refers to the number of participants with available data for each specified category.","reportingStatus":"POSTED","timeFrame":"Pre-infusion, 0.50, 0.75, 1, 3, 6, 24, 48 hours post-infusion","title":"Phase 1 and 2: Area Under the Concentration-time Curve From Time Zero to the Last Measurable Concentration (AUC0-t) of Tinostamustine and Its Metabolites","type":"SECONDARY","unitOfMeasure":"hour*nanogram per milliliter (h*ng/mL)"}