{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.553","upperLimit":"0.741","value":"0.64"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"100"}],"units":"Participants"}],"description":"The primary endpoint is overall survival at 12 months (OS12) after entry into this study. The proportion of successes will be estimated using the binomial point estimator (number of successes divided by the total number of evaluable patients) and the binomial 95% confidence interval estimated. A patient who is evaluable and survive more than 12 months (i.e. 365 days or more) after start of therapy will be classified as a \"success\". Patients who die within 12 months after start of therapy will be considered to have \"failed\".","dispersionType":"95% Confidence Interval","groups":[{"description":"Cycle 1: Everolimus 70 mg days 1, 8, and weekly through radiation therapy (RT). Starting between day 8 and 15 RT was 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Everolimus. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Everolimus 70 mg/week (Days 1, 8, 15 and 22 for each cycle, until progression). Prophylaxis for pneumocystis carinii pneumonia (PCP) was required starting cycle 1 day1.","id":"OG000","title":"Phase II"}],"paramType":"NUMBER","reportingStatus":"POSTED","timeFrame":"at 12 months","title":"Overall Survival at 12 Months (Phase II)","type":"PRIMARY","unitOfMeasure":"proportion of participants"}