{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"43.0","upperLimit":"58.0","value":"43.0"},{"comment":"It is not possible to estimate the median time to first response or upper limit for the CI. This is because of the 19 subjects only 6 have an event, the majority is censored.","groupId":"OG001","lowerLimit":"152.0","upperLimit":"NA","value":"NA"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"144"},{"groupId":"OG001","value":"19"}],"units":"Participants"}],"description":"Time from start of treatment to the date of the first documentation of a confirmed response. Estimated using the Kaplan-Meier method. Response was assessed using the International Myeloma Working Group (IMWG) Uniform Response Criteria and validated by an Independent Monitoring Committee.","dispersionType":"95% Confidence Interval","groups":[{"description":"Complete, very good partial or partial response after 4 cycles bortezomib + dexamethasone: bortezomib 1.3 mg/m2 IV bolus on Day 1, 4, 8, 11 in combination with dexamethasone 20 mg orally daily, on Days 1, 2, 4, 5, 8, 9, 11, 12 for cycle 5 to 8","id":"OG000","title":"Complete to Partial Response: Bortezomib + Dexamethasone"},{"description":"Patients were treated with bortezomib 1.3 mg/m2 IV bolus on day 1, 4, 8 and 11 in combination with dexamethasone 20 mg orally on days 1, 2, 4, 5, 8, 9, 11, 12 for cycle 1 to 4. Patients with stable disease after these 4 cycles, were randomized at the start of cycle 5 and received either bortezomib 1.3 mg/m2 IV bolus on day 1, 4, 8 and 11 in combination with dexamethasone 20 mg orally, on days 1, 2, 4, 5, 8, 9, 11, 12 alone or in combination with cyclophosphamide 500 mg orally on days 1, 8 and 15 or lenalidomide 10 mg orally daily from day 1 to day 14 for cycle 5 to 8","id":"OG001","title":"Stable Disease After 4 Cycles: VD, VDC, VDL"}],"paramType":"MEDIAN","populationDescription":"mITT: All patients with at least 1 dose and 1 post baseline assessment. The non- randomized CR/PR group, n=144 for Time to First confirmed Response. Low powered study because necessary sample size for the randomized part could not be reached. Thus, data were analyzed and reported by combining the randomized groups with SD, (n=19).","reportingStatus":"POSTED","timeFrame":"At Day 1 of each treatment cycle, at the End of Treatment visit until there is evidence of Progressive Disease or relapse from Complete Response (CR), up to 168 days","title":"Median Time to First Confirmed Response","type":"SECONDARY","unitOfMeasure":"days"}