{"analyses":[{"ciLowerLimit":"9.90","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"36.89","estimateComment":"The 95% CI was calculated based on the Wilson Score method.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","pValueComment":"The p-value was calculated based on Cochran-Mantel-Haenszel (CMH) controlling for prior RBC transfusion burden (≤6 versus\\[vs.\\]\\>6 units RBC) \\& international prognostic scoring system (IPSS) risk group (low vs. intermediate-1) applied to randomization.","paramType":"Percentage Difference","paramValue":"24.8","statisticalMethod":"Cochran-Mantel-Haenszel"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"30.93","upperLimit":"49.25","value":"39.8"},{"groupId":"OG001","lowerLimit":"7.10","upperLimit":"26.57","value":"15.0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"118"},{"groupId":"OG001","value":"60"}],"units":"Participants"}],"description":"Percentage of participants without any RBC transfusion during any consecutive 8 weeks (56 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. 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.","id":"OG000","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":"OG001","title":"Phase 3: Placebo"}],"paramType":"NUMBER","populationDescription":"Phase 3: The ITT Analysis Set included all participants randomized into the Phase 3 study.","reportingStatus":"POSTED","timeFrame":"Up to 3.7 years in Phase 3","title":"Phase 3: Percentage of Participants Without Any RBC Transfusion During Any Consecutive 8-Weeks Period","type":"PRIMARY","unitOfMeasure":"percentage of participants"}