{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"73.5","upperLimit":"82.3","value":"78.2"},{"groupId":"OG001","lowerLimit":"91.3","upperLimit":"96.4","value":"94.2"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"357"},{"groupId":"OG001","value":"365"}],"units":"Participants"}],"description":"Safety was evaluated throughout trial treatment, including ASCT, and through 30 days after receipt of the last dose of a trial drug. Treatment attribution and grade were based on the NCI CTCAE v4. The Grade 3 or Higher Treatment-Related Non-Hematologic AE Rate is percentage of participants who experienced any grade 3-5 treatment-related (possible, probable or definite attribution) non-hematologic adverse event based on CTCAEv4 as reported on case report forms. The difference in the rate of all grade 3 or higher toxicities was compared between the two groups using Fisher's exact test.","dispersionType":"95% Confidence Interval","groups":[{"description":"All participants received one cycle of Lenalidomide (R), bortezomib (V) and dexamethasone (D) and then were randomized. All participants then received two additional RVD cycles, followed by stem-cell collection. RVD Alone participants received five additional RVD cycles. Maintenance in both arms comprised daily lenalidomide 10 mg, escalated to 15 mg if tolerated, until disease progression, unacceptable toxicity, or withdrawal from treatment or study. After finishing protocol-specified treatment, off-study salvage transplantation was recommended but not mandated for RVD Alone participants at relapse.\n\nRVD cycle duration=21 days R: 25 mg oral on days 1-14 V: 1.3 mg per square meter of body surface area IV or subcutaneous on days 1, 4, 8, and 11 D: 20 mg oral (cycles 1-3) or 10 mg (cycles 4-8) on days 1, 2, 4, 5, 8, 9, 11, and 12","id":"OG000","title":"RVD Alone"},{"description":"All participants received one cycle of Lenalidomide (R), bortezomib (V) and dexamethasone (d) and then were randomized. All participants then received two additional RVD cycles, followed by stem-cell collection. RVD plus autologous stem cell transplant (ASCT) participants received high-dose melphalan (200 mg/m2, adjusted for ideal body weight) ASCT and, upon recovery (\\~day 60), two additional RVD cycles. Maintenance in both arms comprised daily lenalidomide 10 mg, escalated to 15 mg if tolerated, until disease progression, unacceptable toxicity, or withdrawal from treatment or study.\n\nAfter finishing protocol-specified treatment, RVD plus ASCT participants could undergo a second transplant.\n\nRVD cycle duration=21 days R: 25 mg oral on days 1-14 V: 1.3 mg per square meter of body surface area IV or subcutaneous on days 1, 4, 8, and 11 D: 20 mg oral (cycles 1-3) or 10 mg (cycles 4-8) on days 1, 2, 4, 5, 8, 9, 11, and 12","id":"OG001","title":"RVD Plus ASCT"}],"paramType":"NUMBER","populationDescription":"The analysis population comprised of all randomized participants.","reportingStatus":"POSTED","timeFrame":"AEs was assessed every cycle on treatment. Median treatment duration (months) from randomization 28.2 (RVD Alone) and 36.1 (RVD plus ASCT). Maximum treatment duration was 133.5 months in this study cohort.","title":"Grade 3 or Higher Treatment-Related Non-Hematologic Adverse Event (AE) Rate","type":"SECONDARY","unitOfMeasure":"percentage of participants"}