{"groups":[{"description":"5 milligram tablets administered orally in an outpatient setting according to the protocol-specified dosing schedule","id":"FG000","title":"Ruxolitinib"},{"description":"Commercially available therapy, oral or parenteral, per manufacturer's instructions and Investigator discretion. BAT included the option of no treatment.","id":"FG001","title":"Best Available Therapy (BAT)"},{"description":"5 milligram tablets administered orally in an outpatient setting according to the protocol-specified dosing schedule","id":"FG002","title":"Ruxolitinib After BAT (Cross-over)"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"12"},{"groupId":"FG001","numSubjects":"4"},{"groupId":"FG002","numSubjects":"0"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"9"},{"groupId":"FG002","numSubjects":"0"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}],"type":"Protocol Violation"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"3"},{"groupId":"FG002","numSubjects":"0"}],"type":"Disease Progression"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}],"type":"Non-compliance with study Medication"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"}],"type":"Non-compliance with study procedures"},{"reasons":[{"groupId":"FG000","numSubjects":"7"},{"groupId":"FG001","numSubjects":"7"},{"groupId":"FG002","numSubjects":"0"}],"type":"Other reasons"},{"reasons":[{"groupId":"FG000","numSubjects":"29"},{"groupId":"FG001","numSubjects":"18"},{"groupId":"FG002","numSubjects":"0"}],"type":"Entered extension phase"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"146"},{"groupId":"FG001","numSubjects":"73"},{"groupId":"FG002","numSubjects":"0"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"91"},{"groupId":"FG001","numSubjects":"31"},{"groupId":"FG002","numSubjects":"0"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"55"},{"groupId":"FG001","numSubjects":"42"},{"groupId":"FG002","numSubjects":"0"}],"type":"NOT COMPLETED"}],"title":"Primary Endpoint Analysis (Interim)"},{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"16"},{"groupId":"FG001","numSubjects":"9"},{"groupId":"FG002","numSubjects":"6"}],"type":"Including stem cell transplantation"},{"reasons":[{"groupId":"FG000","numSubjects":"35"},{"groupId":"FG001","numSubjects":"5"},{"groupId":"FG002","numSubjects":"10"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"10"},{"groupId":"FG001","numSubjects":"9"},{"groupId":"FG002","numSubjects":"0"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"5"}],"type":"Protocol Violation"},{"reasons":[{"groupId":"FG000","numSubjects":"32"},{"groupId":"FG001","numSubjects":"4"},{"groupId":"FG002","numSubjects":"7"}],"type":"Disease progression"},{"reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"}],"type":"Noncompliance with study medication"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"}],"type":"Noncompliance with study procedures"},{"reasons":[{"groupId":"FG000","numSubjects":"8"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"5"}],"type":"Lack of Efficacy"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"146"},{"groupId":"FG001","numSubjects":"28"},{"groupId":"FG002","numSubjects":"45"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"27"}],"type":"Crossed Over After Qualifying Event"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"12"}],"type":"Crossed Over After AMEND 5"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"6"}],"type":"Crossed Over: Other"},{"achievements":[{"groupId":"FG000","numSubjects":"39"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"11"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"107"},{"groupId":"FG001","numSubjects":"28"},{"groupId":"FG002","numSubjects":"34"}],"type":"NOT COMPLETED"}],"title":"Overall Disposition at 5 Year Follow-up"}],"preAssignmentDetails":"219 unique participants were randomized to either ruxolitinib or BAT. Of the 73 participants randomized to BAT, 45 were crossed over to ruxolitinib after a protocol-specified qualifying disease progression event.","recruitmentDetails":"Subjects were recruited from 9 countries located in Europe: Austria, Belgium, France, Germany, Italy, Netherlands, Spain, Sweden, and United Kingdom."}