{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"3.71","spread":"3.71","upperLimit":"6.47","value":"4.76"},{"comment":"Upper limit was beyond the timeframe of the analysis.","groupId":"OG001","lowerLimit":"2.79","spread":"23.486","upperLimit":"NA","value":"3.91"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"277"},{"groupId":"OG001","value":"139"}],"units":"Participants"}],"description":"The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) contains 30 items. These include a global health status/QoL scale, five functional scales, three symptom scales, and six single items. Global health status / QoL scale (QL), consisting of 2 questions each scored from 1 (very poor) to 7 (excellent), and with possible scores ranging from 2 to 14. Higher score indicates better functioning. Definitive deterioration by at least 10% is defined as a decrease in score by at least 10% compared to baseline, with no increase above this threshold observed during the course of the study. A single measure reporting a decrease of at least 10% is considered definitive only if it is the last one available for the patient. Time to definitive deterioration is the number of days between the date of randomization and date of assessment at which definitive deterioration is seen.","dispersionType":"95% Confidence Interval","groups":[{"description":"The study drugs were self administered by the patients. Patients were instructed to take the study drug as specified in the protocol. Patients were instructed to take two tablets (5 mg each) by mouth every day. Tablets were to be taken one tablet after another with a glass of water, at the same time each day in a fasting state or with a light fat-free meal. If disease progression occurred at data cutoff of 28Feb2008, patients were unblinded and if they were receiving RAD001, they would discontinue the study. Otherwise, they would be given the option to continue in the extension open label phase of 2 tablets of RAD001 5mg by mouth every day.","id":"OG000","title":"RAD001 +BSC"},{"description":"Patients received matching placebo of RAD001 tablets twice a day along with Best Supportive Care. With the documented disease progression at data cutoff of 28Feb2008, the investigator could unblind the patient. If unblinded patient was receiving placebo treatment, they were given the option to continue in the extension open label phase of 2 tablets of RAD001 5mg by mouth every day.","id":"OG001","title":"Placebo + BSC"}],"paramType":"MEDIAN","populationDescription":"Full Analysis Set was performed on the intent-to-treat population which consisted of all randomized patients.","reportingStatus":"POSTED","timeFrame":"Baseline and every 28 days under treatment and at discontinuation from RAD001\" until 28Feb2008 cutoff date","title":"Analysis of Time to Definitive Deterioration of the Global Health Status/QoL Scale(QL) Scores of the EORTC QLQ-30 Questionnaire by at Least 10 Percent Using Kaplan Meier Method, by Treatment.","type":"SECONDARY","unitOfMeasure":"months"}