{"groups":[{"description":"Imetelstat sodium administered intravenously (IV), at a starting dose of 7.5 milligrams per kilogram (mg/kg), every 4 weeks (on a 28-day cycle) until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first. Dose escalation to 9.4 mg/kg was allowed before Protocol Amendment 2.","id":"FG000","title":"Phase 2: Imetelstat Sodium"},{"description":"Imetelstat sodium administered IV, at a starting dose of 7.5 mg/kg, every 4 weeks (on a 28-day cycle) until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first.","id":"FG001","title":"Phase 3: Imetelstat Sodium"},{"description":"Imetelstat sodium-matching placebo administered IV, every 4 weeks (on a 28-day cycle), until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first.","id":"FG002","title":"Phase 3: Placebo"},{"description":"Imetelstat sodium administered IV, at a starting dose of 7.5 mg/kg, every 4 weeks (on a 28-day cycle) until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first.","id":"FG003","title":"QTc Substudy: Imetelstat Sodium"},{"description":"Imetelstat sodium-matching placebo administered IV, every 4 weeks (on a 28-day cycle), until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first. If after a minimum of 2 treatment cycles a participant has no significant change to pRBC transfusion burden or evidence of clinical benefit per Investigator, after discussion with the Sponsor the participant, he/she may be permitted to start treatment with imetelstat sodium.","id":"FG004","title":"QTc Substudy: Placebo"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"27"},{"groupId":"FG001","numSubjects":"34"},{"groupId":"FG002","numSubjects":"14"},{"groupId":"FG003","numSubjects":"1"},{"groupId":"FG004","numSubjects":"0"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"3"},{"groupId":"FG002","numSubjects":"2"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"13"},{"groupId":"FG001","numSubjects":"24"},{"groupId":"FG002","numSubjects":"14"},{"groupId":"FG003","numSubjects":"1"},{"groupId":"FG004","numSubjects":"1"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"1"}],"type":"Randomized, Never Treated"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"57"},{"groupId":"FG001","numSubjects":"118"},{"groupId":"FG002","numSubjects":"60"},{"groupId":"FG003","numSubjects":"35"},{"groupId":"FG004","numSubjects":"19"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"14"}],"type":"Crossover to Imetelstat"},{"achievements":[{"groupId":"FG000","numSubjects":"38"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"}],"comment":"The Target Population included the participants without prior hypomethylating agent (HMA) or lenalidomide use and non del(5q) in karyotype at baseline.","type":"Target Population"},{"achievements":[{"groupId":"FG000","numSubjects":"15"},{"groupId":"FG001","numSubjects":"57"},{"groupId":"FG002","numSubjects":"29"},{"groupId":"FG003","numSubjects":"33"},{"groupId":"FG004","numSubjects":"17"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"42"},{"groupId":"FG001","numSubjects":"61"},{"groupId":"FG002","numSubjects":"31"},{"groupId":"FG003","numSubjects":"2"},{"groupId":"FG004","numSubjects":"2"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"preAssignmentDetails":"57 participants with MDS received Imetelstat Sodium in Phase 2, followed by Phase 3 where 178 participants were randomized to receive either Imetelstat Sodium or Imetelstat sodium-matching placebo. 54 participants enrolled in QTc Substudy to receive either Imetelstat Sodium or Imetelstat sodium-matching placebo.","recruitmentDetails":"Participants were enrolled in Phase 2 at 48 study sites and in the Phase 3 Study at 77 study sites. Data is reported for the Phase 2, Phase 3 and QTc substudy up to the primary completion date (PCD) of 13 October 2023. Enrolment in Extension phase started after October 2023 and analyses for the participants in extension phase is still ongoing, hence data for extension phase will be reported at study completion date in 2026."}