{"analyses":[{"ciLowerLimit":"0.6136","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.4231","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.7522","pValueComment":"Stratification factors: • Age (at induction therapy): 55 to 64 years and ≥ 65 years • Prior history of MDS: yes/no • Cytogenetic risk (at induction therapy): intermediate-risk/poor-risk • Received consolidation therapy following induction: yes/no","paramType":"Hazard Ratio (HR)","paramValue":"0.9345","statisticalMethod":"Regression, Cox"}],"classes":[{"categories":[{"measurements":[{"comment":"Not estimable because the survival curve does not drop to or below 0.5, i.e. the cumulative probability of developing clinically meaningful deterioration does not reach or exceed 50%, during the observation period","groupId":"OG000","lowerLimit":"135.1","upperLimit":"NA","value":"NA"},{"comment":"Not estimable because the survival curve does not drop to or below 0.5, i.e. the cumulative probability of developing clinically meaningful deterioration does not reach or exceed 50%, during the observation period","groupId":"OG001","lowerLimit":"122.9","upperLimit":"NA","value":"NA"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"225"},{"groupId":"OG001","value":"217"}],"units":"Participants"}],"description":"Clinically meaningful deterioration was defined at least 0.10 point of deterioration from baseline for at least 2 consecutive visits for the EQ-5D Health Utility Index. The EQ-5D-3L is a self-administered questionnaire consisting of 5 questions, pertaining to specific health dimensions (ie, mobility, self-care, pain, usual activities, and anxiety/depression) and a health status scale. Each question has 3 levels of severity, corresponding to no problems, moderate problems and severe problems. Canadian population sample weights were used to derive health utility scores. A higher utility score represents a better health state. A clinically meaningful improvement or worsening was defined as at least 0.08 points of improvement or 0.10 points of worsening from baseline, respectively, for the EQ-5D-3L Health Utility Index. The EQ-5D-3L is scored using the UK index ranges from -0.594 to 1, where 0 equates to death and 1 equates to full health; -0.594 is considered 'worse than death'.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants received 300 mg azacitidine tablets once a day (QD) for the first 14 days of each 28-day treatment cycle until discontinuation, which includes the following reasons: disease relapse, withdrawal of consent, adverse events, participant became eligible for allogeneic bone marrow or stem cell transplantation during the treatment period, death, lost to follow-up, or protocol violation or until the end of the study.","id":"OG000","title":"Oral Azacitidine Plus Best Supportive Care"},{"description":"Participants received identically matching placebo tablets QD for the first 14 days of each 28-day treatment cycle until no longer receiving benefit, withdrawal of consent, disease relapse, adverse events, participant became eligible for allogeneic bone marrow or stem cell transplantation during the treatment period, lost to follow-up, or protocol violation or until the end of the study.","id":"OG001","title":"Placebo Plus Best Supportive Care"}],"paramType":"MEDIAN","populationDescription":"The Health Related Quality of Life (HRQoL) evaluable population was defined as the ITT participants with a non-missing EQ-5D-3L score at baseline (C1D1) and at least one post-baseline visit. Results are presented for each post-baseline visit with sample size ≥ 25 in both arms. Death was censored at the date of the last HRQoL assessment visit.","reportingStatus":"POSTED","timeFrame":"From day 1 (randomization) up to data cut off date of 15 July 2019; approximately 74 months","title":"Time to Definitive Clinically Meaningful Deterioration for ≥ 2 Consecutive Visits as Measured Using the EQ-5D HRQoL Scale","type":"SECONDARY","unitOfMeasure":"Weeks"}