{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"1.2","upperLimit":"7.3","value":"1.6"},{"groupId":"OG001","lowerLimit":"1.4","upperLimit":"2.7","value":"1.5"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"23"},{"groupId":"OG001","value":"38"}],"units":"Participants"}],"description":"Progression-free survival was defined as time from registration to step 1 to disease recurrence or death from any cause, whichever occurred first. Disease progression was measured by Response Evaluation Criteria In Solid Tumors (RECIST) v1.0, and defined as at least a 20% increase in the sum of the longest diameters of target lesions.","dispersionType":"95% 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":"MEDIAN","populationDescription":"61 eligible and treated patients were included in the analysis","reportingStatus":"POSTED","timeFrame":"Every 3 months for first 2 years from protocol entry, then every 6 months until 3 years from study entry","title":"Progression-free Survival on Step 1","type":"SECONDARY","unitOfMeasure":"months"}