{"groups":[{"description":"mitoxantrone 12 mg/m\\^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily","id":"FG000","title":"Mitoxantrone + Prednisone"},{"description":"cabazitaxel 25 mg/m\\^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily","id":"FG001","title":"Cabazitaxel + Prednisone"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"267"},{"groupId":"FG001","numSubjects":"180"}],"type":"Disease progression"},{"reasons":[{"groupId":"FG000","numSubjects":"32"},{"groupId":"FG001","numSubjects":"67"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}],"type":"Non-compliance to protocol"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"0"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"17"},{"groupId":"FG001","numSubjects":"8"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"7"}],"type":"Not treated"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"1"}],"type":"Screened failure"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"4"}],"type":"Investigator's decision"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"1"}],"type":"Non-confirmed Disease progression"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}],"type":"Clinical deterioration"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"1"}],"type":"Screening error"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}],"type":"Withdrawal by subject's family"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}],"type":"Patient unable to come to the clinic"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}],"type":"abnormal liver function tests"}],"milestones":[{"achievements":[{"comment":"Randomized patients","groupId":"FG000","numSubjects":"377"},{"comment":"Randomized patients","groupId":"FG001","numSubjects":"378"}],"type":"STARTED"},{"achievements":[{"comment":"Randomized patients","groupId":"FG000","numSubjects":"46"},{"comment":"Randomized patients","groupId":"FG001","numSubjects":"105"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"331"},{"groupId":"FG001","numSubjects":"273"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"preAssignmentDetails":"165 patients signed informed consent but were not randomized and considered as screen failure.\n\nIntention to Treat Population (ITT or randomized patients): 755 patients (377 mitoxantrone, 378 cabazitaxel).\n\nSafety population (treated patients): 742 patients (371 mitoxantrone, 371 cabazitaxel) (Patients not treated: 6 mitoxantrone, 7 cabazitaxel).","recruitmentDetails":"Multicenter study: 146 actives sites from 26 countries in Europe, USA, South America and Asia Pacific region. Study initiation date: January 2nd, 2007; study completion date/study cut off date: September 25th, 2009."}