{"analyses":[{"ciLowerLimit":"12.64","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"34.18","estimateComment":"The 95% CI was calculated based on the Wilson Score method.","groupIds":["OG001","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","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":"24.6","statisticalMethod":"Cochran-Mantel-Haenszel"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"14.13","upperLimit":"37.76","value":"24.6"},{"groupId":"OG001","lowerLimit":"20.10","upperLimit":"36.98","value":"28.0"},{"groupId":"OG002","lowerLimit":"0.41","upperLimit":"11.53","value":"3.3"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"57"},{"groupId":"OG001","value":"118"},{"groupId":"OG002","value":"60"}],"units":"Participants"}],"description":"Percentage of participants without any RBC transfusion during any consecutive 24 weeks (168 days) starting from Study Day 1 until subsequent anti-cancer therapy if any were reported. Study Day 1 is defined as the day of the first dose for participants enrolled in Phase 2 and the day of randomization for participants enrolled in Phase 3. 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. Phase 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 Without Any RBC Transfusion During Any Consecutive 24-Weeks Period","type":"SECONDARY","unitOfMeasure":"percentage of participants"}