{"analyses":[{"ciLowerLimit":"0.65","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.61","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.539","paramType":"Hazard Ratio (HR)","paramValue":"1.02","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"comment":"NA. Not evaluable due to the low number of participants with an event of interest.","groupId":"OG000","lowerLimit":"17.05","upperLimit":"NA","value":"24.08"},{"comment":"NA. Not evaluable due to the low number of participants with an event of interest.","groupId":"OG001","lowerLimit":"8.31","upperLimit":"NA","value":"24.15"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"205"},{"groupId":"OG001","value":"97"}],"units":"Participants"}],"description":"WHO PS is a scale rated from 0 (fully active) to 5 (death) by a healthcare professional to assess the overall status of a patient: a lower score represents a higher ability to perform daily tasks. Deterioration is defined as an increase of at least one point compared to baseline. Deterioration is considered definitive if no improvements in the WHO PS status is observed at a subsequent time of measurement during the treatment period following the time point where the deterioration is observed. Death was considered as worsening of the WHO PS 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 WHO performance status, assessed up to approximately 3 years","title":"Time to Definitive Deterioration in World Health Organization (WHO) Performance Status (PS) Change","type":"SECONDARY","unitOfMeasure":"Months"}