{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.9","upperLimit":"58.2","value":"16.7"},{"groupId":"OG001","lowerLimit":"0","upperLimit":"34.8","value":"0"}]}],"title":"Objective Response Rate (CR+PR) (%)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"15.3","upperLimit":"84.7","value":"50.0"},{"groupId":"OG001","lowerLimit":"0.7","upperLimit":"52.1","value":"14.3"}]}],"title":"Clinical Benefit Response Rate (CR+PR+durable SD) %"}],"denoms":[{"counts":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"7"}],"units":"Participants"}],"description":"To determine the objective response rate (ORR) and the clinical benefit rate (CBR \\[Complete Response (CR), Partial Response (PR) plus durable Stable Disease (SD)\\]) in Sub Studies.\n\nSD was regarded as durable if, after observing SD, the first observation of PD was at least 84 days after the start of study treatment.","dispersionType":"90% Confidence Interval","groups":[{"description":"To determine the objective response rate (ORR) (complete response \\[CR\\] plus partial response \\[PR\\]) of any duration, plus the rate of subjects with stable disease (SD) of at least 12-week duration at a dose of 60 mg/m2 administered over 1 hour.","id":"OG000","title":"Tinostamustine (EDO-S101) - Sub Study 1 (SS1)"},{"description":"To determine the objective response rate (ORR) (complete response \\[CR\\] plus partial response \\[PR\\]) of any duration, plus the rate of subjects with stable disease (SD) of at least 12-week duration at a dose of 80 mg/m2 administered over 80 minutes.","id":"OG001","title":"Tinostamustine (EDO-S101) - Sub Study 2 (SS2)"}],"paramType":"NUMBER","populationDescription":"All subjects who received at least 1 dose of study treatment were included in the Full Analysis (FA) Population. Efficacy analyses were performed on data from all subjects in the FA Population","reportingStatus":"POSTED","timeFrame":"From start of treatment, assessed every 2 cycles, until first documented complete CR, PR or SD, up to 6 months. If SD, assessment continued every 2 cycles until CR/PR/death (up to 6 months)","title":"Objective Response Rate (ORR) and the Clinical Benefit Rate (CBR) That Persists for at Least Four (4) Months in Selected Solid Tumor Cohorts on Sub Studies","type":"SECONDARY","unitOfMeasure":"percentage of participants"}