{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.77","upperLimit":"20.81","value":"6"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"32"}],"units":"Participants"}],"description":"Biological activity of bendamustine was defined as achieving a best response of partial response (PR), CRp, or CR. Rate was calculated as follows: number of participants in the primary analysis set achieving a best overall response of PR, CRp, or CR, divided by the number of participants in the primary analysis set. The most positive response for each patient during the study was counted. The 95% CI was calculated using binomial parameter exact method. Response was determined by the investigator, and evaluated per Jeha et al, 2006: A PR had to meet the following criteria: complete disappearance of circulating blasts and an M2 marrow (≥ 5% and ≤ 25% bone marrow blasts) and appearance of normal progenitor cells or an M1 marrow that did not qualify for CR or CRp. See Outcome Measure 2 for full definitions for CRp and CR.","dispersionType":"95% Confidence Interval","groups":[{"description":"Bendamustine 120 mg/m\\^2 administered as an IV infusion over 60 minutes on Days 1 and 2 of each 21-day cycle (Cycles 2 through 12), with delays up to 2 weeks for neutrophil and platelet count recovery, for up to a 35-day cycle.","id":"OG000","title":"Phase 2: Bendamustine 120 mg/m^2"}],"paramType":"NUMBER","populationDescription":"The primary analysis set for efficacy included all participants treated at the RP2D in Phase 2.","reportingStatus":"POSTED","timeFrame":"At each treatment cycle (21 to 35 days), for a maximum of 12 cycles","title":"Best Overall Tumor Response Rate","type":"SECONDARY","unitOfMeasure":"percentage of participants"}