{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"3.6","upperLimit":"30.3","value":"13.1"},{"groupId":"OG001","lowerLimit":"0.4","upperLimit":"22.1","value":"2.6"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"23"},{"groupId":"OG001","value":"38"}],"units":"Participants"}],"description":"Tumor response was evaluated via Response Evaluation Criteria In Solid Tumors (RECIST) v1.0, and response rate was defined as the proportion of patients with a complete response or partial response among all eligible and treated patients. Complete response was defined as disappearance of all tumor lesions. Partial response was defined as at least a 30% decrease in the sum of the longest diameters of target lesions.","dispersionType":"90% Confidence Interval","groups":[{"description":"Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11 and irinotecan hydrochloride IV over 90 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.","id":"OG000","title":"Arm I (Bortezomib+Irinotecan)"},{"description":"Patients receive bortezomib (PS-341) 1.3 mg/m2 IV over 3-5 seconds twice weekly on days 1, 4, 8 and 11 followed by one week of rest. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Upon disease progression, patients may cross over to arm I (bortezomib + irinotecan).","id":"OG001","title":"Arm II (Bortezomib)"}],"paramType":"NUMBER","populationDescription":"61 eligible and treated patients were included in the analysis","reportingStatus":"POSTED","timeFrame":"Tumor response was assessed every 2 cycles until progression or intolerable toxicity with maximum of 3 years","title":"Response Rate on Step 1","type":"PRIMARY","unitOfMeasure":"percentage of participants"}