{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"2"}]}],"title":"PR"},{"categories":[{"measurements":[{"groupId":"OG000","value":"6"}]}],"title":"SD"},{"categories":[{"measurements":[{"groupId":"OG000","value":"14"}]}],"title":"NA"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}],"title":"CR"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}],"title":"VGPR"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}],"title":"sCR"}],"denoms":[{"counts":[{"groupId":"OG000","value":"22"}],"units":"Participants"}],"description":"Responses will be summarized by simple descriptive summary statistics delineating complete and partial responses as well as stable and progressive disease in this patient population. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Exact binomial 95% confidence intervals for the true success proportion will be calculated.","groups":[{"description":"6 MTD and 16 phase II accruals","id":"OG000","title":"Phase II and MTD"}],"paramType":"COUNT_OF_PARTICIPANTS","reportingStatus":"POSTED","timeFrame":"Up to 6 months","title":"Rate of Confirmed Response, Defined as a Patient Who Has Achieved a Stringent Complete Response (sCR), Complete Response (CR), Very Good Partial Response (VGPR), or Partial Response (PR) on Two Consecutive Evaluations (Phase II)","type":"PRIMARY","unitOfMeasure":"Participants"}