{"classes":[{"categories":[{"measurements":[{"comment":"this value could not be calculated due to the limited number of events","groupId":"OG000","lowerLimit":"888.0","upperLimit":"NA","value":"NA"},{"comment":"this value could not be calculated due to the limited number of events","groupId":"OG001","lowerLimit":"982.0","upperLimit":"NA","value":"NA"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"144"},{"groupId":"OG001","value":"19"}],"units":"Participants"}],"description":"Is defined as the time interval from start of treatment to the date of death due to any cause. In the absence of confirmation of death (including subjects lost to follow-up), survival time will be censored at the last date the subject is known to be alive","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 each visit from baseline to end of treatment. After treatment, monthly visit until progression or relapse or until the start of alternative MMY therapy. Further follow up by monthly phone call until the last patient was treated and followed for 1 year","title":"Overall Survival","type":"SECONDARY","unitOfMeasure":"days"}