{"groups":[{"description":"All participants in this study received both study drugs and were therefore analysed together as a single treatment arm.\n\nParticipants receiving the different regimens were not analysed separately by regimen, as the study was designed to assess the safety of the combination study treatment.\n\nThe study included N=161 participants who received both acalabrutinib and pembrolizumab and are summarized together (from First stage safety lead-in and Second stage expansion). Stage 3 (additional expansion in subjects with Myelofibrosis) was planned but not conducted.","id":"FG000","title":"Acalabrutinib + Pembrolizumab"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"67"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"3"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"1"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"1"}],"type":"Physician Decision"},{"reasons":[{"groupId":"FG000","numSubjects":"10"}],"type":"Subject started another cancer therapy"},{"reasons":[{"groupId":"FG000","numSubjects":"45"}],"type":"Study terminated by sponsor"},{"reasons":[{"groupId":"FG000","numSubjects":"2"}],"type":"Decision by subject not related to AE/SAE"},{"reasons":[{"groupId":"FG000","numSubjects":"1"}],"type":"Decision by PI not related to AE/SAE"},{"reasons":[{"groupId":"FG000","numSubjects":"11"}],"type":"Disease progression"},{"reasons":[{"groupId":"FG000","numSubjects":"20"}],"type":"Withdrawal by Subject"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"161"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"161"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"preAssignmentDetails":"For the ACE-LY-005 program, Study Terminated by Sponsor refers to the following: Patients receiving treatment benefits will continue to be provided with study medication in the Post Final Analysis Management of the trial. No further data collection for analysis and reporting will be completed after the final Analysis"}