{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"101"},{"groupId":"OG001","value":"6"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"123"},{"groupId":"OG001","value":"19"}],"units":"Participants"}],"description":"Overall Best Confirmed Response is the best Overall Response Rate with borezomib-dexamathasone (+/-cyclophosphamide or lenalidomide) recorded between baseline and end of treatment. Response was assessed using the International Myeloma working Group (IMWG) Uniform Response Criteria and validated by an Independent Monitoring Committee.","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":"NUMBER","populationDescription":"mITT: All patients with at least 1 dose and 1 post baseline assessment. 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). Data are missing for 21 patients in the non-randomized CR/PR group, n=123.","reportingStatus":"POSTED","timeFrame":"Prior to treatment at day 1 of each cycle and at the end of treatment (day 21 of cycle 8), up to 168 days","title":"Overall Best Confirmed Response","type":"PRIMARY","unitOfMeasure":"number of participants"}