{"analyses":[{"ciLowerLimit":"0.71","ciNumSides":"TWO_SIDED","ciPctValue":"90","ciUpperLimit":"1.13","estimateComment":"Reference level = High Fatigue group","groupDescription":"Four hundred evaluable patients provide at least 90% power to detect a HR of 0.70 between low and high fatigue groups using a baseline FACIT-F score cut point of 30, with a 1-sided alpha of 0.05.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.21","pValueComment":"One-sided significance level = 0.05","paramType":"Hazard Ratio (HR)","paramValue":"0.89","statisticalMethod":"Log Rank"}],"anticipatedPostingDate":"2025-12","classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"44.3","upperLimit":"64.0","value":"54.1"},{"groupId":"OG001","lowerLimit":"53.7","upperLimit":"62.6","value":"58.1"}]}],"title":"Two years"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"13.0","upperLimit":"29.5","value":"21.1"},{"groupId":"OG001","lowerLimit":"21.1","upperLimit":"29.1","value":"25.1"}]}],"title":"Five years"}],"denoms":[{"counts":[{"groupId":"OG000","value":"71"},{"groupId":"OG001","value":"352"}],"units":"Participants"}],"description":"Overall survival is estimated by the Kaplan-Meier method. Survival time is measured from enrollment (step 1) to date of death from any cause or last known follow-up (censored). Baseline fatigue is measured by Functional Assessment of Chronic Illness Therapy-Fatigue (FACT-F) questionnaire which has a range of 0 to 52 with a higher score indicating less fatigue. Combining treatment arms, patients with low fatigue at baseline (FACIT-F score \\> 30) will be compared to patients with high fatigue at baseline (FACIT-F scores ≤ 30).","dispersionType":"90% Confidence Interval","groups":[{"description":"Participants from both treatment arms with FACIT-F score ≤ 30.","id":"OG000","title":"High Fatigue"},{"description":"Participants from both treatment arms with FACIT-F score \\> 30.","id":"OG001","title":"Low Fatigue"}],"paramType":"NUMBER","populationDescription":"Eligible participants enrolled at step 1 who consented to the quality of life study component and have baseline FACT-F data.","reportingStatus":"POSTED","timeFrame":"From enrollment (step 1) to death or last follow-up. Maximum follow-up at time of the phase III analysis was 13.2 years, measured from enrollment. Two- and five-year rates are reported here.","title":"Overall Survival (Percentage of Participants Alive) by Baseline Fatigue Group","type":"SECONDARY","unitOfMeasure":"Percentage of participants"}