{"analyses":[{"ciLowerLimit":"-4.10","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"27.56","estimateComment":"95% CI was calculated based on the Wilson Score Method.","groupIds":["OG001","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"0.112","pValueComment":"The p-value was calculated based on CMH controlling for prior RBC transfusion burden (≤ 6 vs. \\> 6 units RBC) and IPSS risk group (low vs. intermediate-1) applied to randomization.","paramType":"Percentage Difference","paramValue":"11.9","statisticalMethod":"Cochran-Mantel-Haenszel"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"47.57","upperLimit":"74.00","value":"61.4"},{"groupId":"OG001","lowerLimit":"54.20","upperLimit":"72.22","value":"63.6"},{"groupId":"OG002","lowerLimit":"38.39","upperLimit":"64.77","value":"51.7"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"57"},{"groupId":"OG001","value":"118"},{"groupId":"OG002","value":"60"}],"units":"Participants"}],"description":"As per IWG Response Criteria 2006: HI-E was defined as a hemoglobin (Hb) increase by greater than or equal to (≥)1.5 grams per deciliter (g/dL) relevant reduction of units of RBC transfusions by an absolute number of at least 4 RBC transfusion units/8 weeks compared with the pretreatment transfusion number in the previous 8 weeks. Only RBC transfusions given for a Hb of less than or equal to (≤)9 g/dL pretreatment were counted in the RBC transfusion response evaluation. The 95% CI was calculated using Clopper-Pearson method. Percentages were rounded off to the nearest single decimal place.","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":"NUMBER","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 5 years in Phase 2 and up to 3.7 years in Phase 3","title":"Phase 2 and Phase 3: Percentage of Participants With Hematologic Improvement Including Erythroid Response (HI-E) as Per International Working Group (IWG) Response Criteria 2006","type":"SECONDARY","unitOfMeasure":"percentage of participants"}