{"groups":[{"description":"Participants randomized to receive zoledronic acid 4 mg intravenously plus placebo to denosumab subcutaneously (SC) once every 4 weeks (Q4W) in the double-blind treatment phase. In the open-label treatment phase, remaining participants received denosumab 120 mg SC Q4W.","id":"FG000","title":"Zoledronic Acid"},{"description":"Participants randomized to receive denosumab 120 mg subcutaneously (SC) plus placebo to zoledronic acid intravenously once every 4 weeks (Q4W) in the double-blind treatment phase. In the open-label treatment phase, remaining participants received denosumab 120 mg SC Q4W.","id":"FG001","title":"Denosumab"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"147"},{"groupId":"FG001","numSubjects":"137"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"103"},{"groupId":"FG001","numSubjects":"112"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"21"},{"groupId":"FG001","numSubjects":"9"}],"type":"Completed Survival Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"12"},{"groupId":"FG001","numSubjects":"10"}],"type":"Disease Progression"},{"reasons":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"13"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"10"},{"groupId":"FG001","numSubjects":"8"}],"type":"Administrative Decision"},{"reasons":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"3"}],"type":"Noncompliance"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"6"}],"type":"Ineligibility Determined"},{"reasons":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"0"}],"type":"Protocol Deviation"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"3"}],"type":"Other, Not Specified"},{"reasons":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"3"}],"type":"Lost to Follow-up"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"859"},{"groupId":"FG001","numSubjects":"859"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"852"},{"groupId":"FG001","numSubjects":"850"}],"type":"Received Treatment"},{"achievements":[{"groupId":"FG000","numSubjects":"541"},{"groupId":"FG001","numSubjects":"555"}],"comment":"Still on-study as of blinded treatment analysis cutoff date of 05 January 2017","type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"318"},{"groupId":"FG001","numSubjects":"304"}],"type":"NOT COMPLETED"}],"title":"Blinded Treatment Phase"},{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"49"},{"groupId":"FG001","numSubjects":"48"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"49"},{"groupId":"FG001","numSubjects":"47"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"30"},{"groupId":"FG001","numSubjects":"51"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"30"},{"groupId":"FG001","numSubjects":"15"}],"type":"Administrative Decision"},{"reasons":[{"groupId":"FG000","numSubjects":"17"},{"groupId":"FG001","numSubjects":"18"}],"type":"Disease Progression"},{"reasons":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"4"}],"type":"Noncompliance"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"2"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}],"type":"Pregnancy"},{"reasons":[{"groupId":"FG000","numSubjects":"9"},{"groupId":"FG001","numSubjects":"7"}],"type":"Other, Not Specified"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}],"type":"Protocol Violation"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"418"},{"groupId":"FG001","numSubjects":"426"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"227"},{"groupId":"FG001","numSubjects":"233"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"191"},{"groupId":"FG001","numSubjects":"193"}],"type":"NOT COMPLETED"}],"title":"Open Label Treatment Phase"}],"preAssignmentDetails":"Randomization was stratified according to:\n\n* intent to undergo autologous peripheral blood stem cell (PBSC) transplantation\n* the antimyeloma agent being utilized/planned to be utilized in first-line therapy\n* stage (International Staging System \\[ISS\\]) at diagnosis\n* previous SRE (yes or no)\n* region (Japan yes or no)","recruitmentDetails":"This study was conducted at 259 centers across 29 countries in Europe, North America, Asia, Australia/New Zealand, and Japan. Participants were enrolled from 17 May 2012 to 29 March 2016."}