{"analyses":[{"groupIds":["OG000"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"1.0000","pValueComment":"1-sided p-value is calculated against the null hypothesis of a response rate of 5%.","statisticalMethod":"binomial parameter exact method","testedNonInferiority":false}],"classes":[{"categories":[{"measurements":[{"comment":"1-sided 95% confidence interval","groupId":"OG000","lowerLimit":"0.00","upperLimit":"NA","value":"0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"32"}],"units":"Participants"}],"description":"ORR was calculated as follows: number of participants in the primary analysis set achieving a best overall response of complete remission without platelet recovery (CRp) or complete remission (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 CR required no evidence of circulating blasts or extramedullary disease, an M1 marrow (≤ 5% bone marrow blasts), and recovery of peripheral counts (platelets ≥ 100 × 10\\^9/L and absolute neutrophil count ≥ 1.0 × 10\\^9/L). A CR without platelet recovery (CRp) required all of the criteria for a CR with the exception of platelet recovery.","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":"Assessed at each treatment cycle (21 to 35 days), for a maximum of 12 cycles","title":"Overall Response Rate (ORR)","type":"PRIMARY","unitOfMeasure":"percentage of participants"}