{"groups":[{"description":"Ruxolitinib at a starting dose of 10 mg twice a day (bid). Dose was adjusted based on efficacy and safety parameters up to a maximum dose of 25 mg bid","id":"FG000","title":"Ruxolitinib"},{"description":"Best Available Therapy as selected by the investigator from: Hydroxyurea, Pegylated-Interferon (IFN/PEG-IFN), pipobroman, anagrelide, IMIDs, or observation. Participants randomized to BAT who did not respond by Week 28 were eligible to crossover and start treatment with ruxolitinib","id":"FG001","title":"Best Available Therapy (BAT)"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"7"},{"groupId":"FG001","numSubjects":"7"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"1"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"2"}],"type":"Disease progression"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"1"}],"type":"Physician Decision"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}],"type":"Subject/guardian decision"},{"reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"1"}],"type":"Withdrawal by Subject"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"74"},{"groupId":"FG001","numSubjects":"75"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"74"},{"groupId":"FG001","numSubjects":"75"}],"comment":"comprised of all patients to whom study treatment was assigned by randomization.","type":"Full Analysis Set"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"58"}],"comment":"consisted of all patients randomized to the BAT arm, who crossed over and received at least one dose of ruxolitinib.","type":"Crossover Set"},{"achievements":[{"groupId":"FG000","numSubjects":"59"},{"groupId":"FG001","numSubjects":"61"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"15"},{"groupId":"FG001","numSubjects":"14"}],"type":"NOT COMPLETED"}],"title":"Core Study"},{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"3"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"9"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"2"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"3"}],"type":"Disease progression"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"2"}],"type":"Physician Decision"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"comment":"58 participants were eligible to crossover to the ruxolitinib arm","groupId":"FG001","numSubjects":"58"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"38"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"20"}],"type":"NOT COMPLETED"}],"title":"Crossover Period"}],"preAssignmentDetails":"Participants were randomized in a 1:1 ratio either to Ruxolitinib or Best available Therapy (BAT). Randomization was stratified by patients who were resistant to or intolerant of Hydroxyurea (HU).","recruitmentDetails":"Participants were randomized in 48 centers across 12 countries: Australia (1), Belgium (2), Canada (1), France (7), Germany (9), Hungary (3), India (2), Israel (3), Italy (7), South Korea (2), Spain (9) and Turkey (2)"}