{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"25.10","upperLimit":"39.29","value":"34.2"},{"comment":"Median and upper limit of 95% CI were not estimable due to low number of participants with events.","groupId":"OG001","lowerLimit":"29.24","upperLimit":"NA","value":"NA"},{"comment":"Median and upper limit of 95% CI were not estimable due to low number of participants with events.","groupId":"OG002","lowerLimit":"16.72","upperLimit":"NA","value":"NA"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"57"},{"groupId":"OG001","value":"118"},{"groupId":"OG002","value":"60"}],"units":"Participants"}],"description":"Progression free survival was defined as the time interval from study Day 1 to the first date of disease progression or death from any cause, whichever occurs first. Disease progression as per IWG criteria was defined as: at least one of the following: at least 50 % decrement from maximum response levels in granulocytes or platelets; reduction in hemoglobin by ≥1.5 g/dL; transfusion dependence.","dispersionType":"95% Confidence Interval","groups":[{"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. Dose escalation to 9.4 mg/kg was allowed before Protocol Amendment 2.","id":"OG000","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":"OG001","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":"OG002","title":"Phase 3: Placebo"}],"paramType":"MEDIAN","populationDescription":"Phase 2: All Treated Analysis Set included all participants who received at least one dose of study drug.\n\nPhase 3: ITT Analysis Set included all participants randomized into the Phase 3 study.","reportingStatus":"POSTED","timeFrame":"Up to 6.6 years in Phase 2 and up to 4 years in Phase 3","title":"Phase 2 and Phase 3: Progression Free Survival (PFS)","type":"SECONDARY","unitOfMeasure":"months"}