{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.431","upperLimit":"0.628","value":"0.52"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"100"}],"units":"Participants"}],"description":"Progression-free-survival at 6 months: is the proportion of patients alive and progression-free at 6 months after start of regimen. This proportion will be estimated using the binomial point estimator and the binomial 95% confidence interval estimated. Progression is defined as at least a 25% increase in product of perpendicular diameters of contrast enhancement or mass or unequivocal increase in size of contrast enhancement or increase in mass effect as agreed upon independently by primary physician and quality control physicians or appearance of new lesions.","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 6 months","title":"Progression-free-survival at 6 Months (Phase II)","type":"SECONDARY","unitOfMeasure":"proportion of participants"}