{"analyses":[{"ciLowerLimit":"0.105","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.586","estimateComment":"Hazard ratio and 95% CI were calculated using 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":"<0.001","pValueComment":"The p-value (2-sided) was calculated using the stratified log-rank test for superiority of imetelstat sodium versus placebo in hazard ratio.","paramType":"Hazard Ratio (HR)","paramValue":"0.25","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"17.00","upperLimit":"92.43","value":"69.6"},{"groupId":"OG001","lowerLimit":"26.86","upperLimit":"80.43","value":"51.6"},{"groupId":"OG002","lowerLimit":"8.00","upperLimit":"24.86","value":"13.3"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"21"},{"groupId":"OG001","value":"47"},{"groupId":"OG002","value":"9"}],"units":"Participants"}],"description":"Duration of RBC TI was defined as the first day of the longest RBC TI period to the date of the first RBC transfusion after the TI period started. The 95% CI was based on Kaplan-Meier product limit estimates.","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 8-week TI Responder Analysis Set included participants in the All Treated Analysis Set who achieved 8-week RBC TI.\n\nPhase 3: ITT 8-week TI Responder Analysis Set included all participants in the ITT Analysis Set who achieved 8-week RBC TI.","reportingStatus":"POSTED","timeFrame":"Up to 5 years in Phase 2 and up to 3.7 years in Phase 3","title":"Phase 2 and Phase 3: Duration of RBC TI","type":"SECONDARY","unitOfMeasure":"weeks"}