{"analyses":[{"ciLowerLimit":"0.526","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.823","estimateComment":"Hazard ratio and 95% CI were calculated from the Cox proportional hazard model, stratified by prior RBC transfusion burden (≤6 vs. \\>6 units RBC) and IPSS risk group (low vs. intermediate-1), with treatment as the only covariate.","groupIds":["OG001","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"0.949","pValueComment":"P value (two-sided) for superiority of imetelstat sodium versus placebo in hazard ratio was calculated using stratified log-rank test.","paramType":"Hazard Ratio (HR)","paramValue":"0.98","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"comment":"Upper limit of 95% CI was not estimable due to low number of participants with events.","groupId":"OG000","lowerLimit":"39.16","upperLimit":"NA","value":"55.3"},{"comment":"Upper limit of 95% CI was not estimable due to low number of participants with events.","groupId":"OG001","lowerLimit":"37.06","upperLimit":"NA","value":"40.4"},{"comment":"Median and upper limit of 95% CI were not estimable due to low number of participants with events.","groupId":"OG002","lowerLimit":"32.16","upperLimit":"NA","value":"NA"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"57"},{"groupId":"OG001","value":"118"},{"groupId":"OG002","value":"60"}],"units":"Participants"}],"description":"OS was defined as the interval from Study Day 1 to death from any cause. Survival time of living participants was censored on the last date a participant is known to be alive or lost to follow-up. The Kaplan-Meier method was used to estimate overall survival.","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: Overall Survival (OS)","type":"SECONDARY","unitOfMeasure":"months"}