{"analyses":[{"ciLowerLimit":"0.50","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.10","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.073","paramType":"Hazard Ratio (HR)","paramValue":"0.74","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"9.33","upperLimit":"24.80","value":"13.01"},{"groupId":"OG001","lowerLimit":"5.52","upperLimit":"28.62","value":"9.23"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"205"},{"groupId":"OG001","value":"97"}],"units":"Participants"}],"description":"FACT-G is a self-assessed health-related quality of life questionnaire. The questionnaire is comprised of 27 questions examining physical, social/family, emotional, and functional well-being. Participants responded to the items on a five-point scale, ranging from 0: \"Not at all\" to 4: \"Very much.\" The total score ranges from 0 to 108, with higher scores indicating a better patient-reported outcome/quality of life.\n\nDefinitive deterioration is defined as a decrease in the total score by at least 7 points compared to baseline with no further improvement.\n\nDeath was considered as worsening of the FACT-G total score if it occurred close to the last available assessment, where \"close\" was defined as twice the planned period between two assessments. Patients without definitive worsening prior to analysis cut-off or prior to start of another anticancer therapy were censored at the date of their last assessment.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants received everolimus 10 mg once daily BSC throughout the study","id":"OG000","title":"Everolimus + BSC"},{"description":"Participants received matching placebo once daily plus BSC during the blinded period. Participants were allowed to crossover to treatment with everolimus 10mg once daily plus BSC during the open-label period","id":"OG001","title":"Placebo + BSC"}],"paramType":"MEDIAN","populationDescription":"The full analysis set (FAS) consists of all randomized patients. Following the intent-to-treat principle, patients were analyzed according to the treatment arm and stratification factors they were assigned to at randomization.","reportingStatus":"POSTED","timeFrame":"From randomization to definitive deterioration of FACT-G total score, assessed up to approximately 3 years","title":"Time to Definitive Deterioration in Functional Assessment of Cancer Therapy - General (FACT-G) Questionnaire Total Score","type":"SECONDARY","unitOfMeasure":"Months"}