{"analyses":[{"ciLowerLimit":"0.53","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.71","estimateComment":"Stratified by Region and RPA Class.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.0001","pValueComment":"Stratified by Region and RPA Class.","paramType":"Hazard Ratio (HR)","paramValue":"0.61","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"7.9","upperLimit":"9.7","value":"8.4"},{"groupId":"OG001","lowerLimit":"4.1","upperLimit":"5.1","value":"4.3"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"458"},{"groupId":"OG001","value":"463"}],"units":"Participants"}],"description":"An Independent Review Facility reviewed the MRI scans used by investigator to evaluate radiological tumor response. PFS is defined as time from randomization to PD or death. PD was assessed using adapted Macdonald response (modified WHO) criteria based on 3 components: radiological tumor assessments using MRI scans, neurological assessment and changes in corticosteroid use. PD is assessed as \\>=25% increase in sum of products of the longest diameters of all index lesions (enhancing, measurable) compared with the smallest recorded sum (nadir); or unequivocal PD of existing non-index lesions (non-enhancing and enhancing, non-measurable); or unequivocal appearance of new lesions); or neurological worsening (if corticosteroid dose is stable or increased) compared to neurological evaluation at previous disease assessment with no need for a confirmatory scan. Participants without a PFS event were censored at last disease assessment.","dispersionType":"95% Confidence Interval","groups":[{"description":"In the Concurrent Phase participants received RT in daily fractions of 2 Gy given 5 days per weeks for 6 weeks (for a total of 60 Gy) and temozolomide 75 mg/m\\^2 daily from the first day to the last day of radiotherapy (for a maximum of 49 days in case of delay to the end of radiation therapy) and bevacizumab 10 mg/kg IV every 2 weeks for 6 weeks. There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of bevacizumab 10 mg/kg IV every 2 weeks and temozolomide 150 to 200 mg/m\\^2 daily in the first 5 days of each cycle. The participants then entered the Monotherapy Phase where they received bevacizumab 15 mg/kg IV every 3 weeks until disease progression/unacceptable toxicity.","id":"OG000","title":"Bevacizumab + RT +Temozolomide"},{"description":"In the Concurrent Phase participants received radiotherapy in daily fractions of 2 Gy given 5 days per week for 6 weeks (for a total of 60 Gy) and temozolomide 75 mg/m\\^2 daily from the first day to the last day of radiotherapy (for a maximum of 49 days in case of delay to the end of radiation therapy) and placebo IV every 2 weeks for 6 weeks. There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of placebo IV every 2 weeks and temozolomide 150 to 200 mg/m\\^2 daily in the first 5 days of each cycle. The participants then entered the Monotherapy Phase where they received placebo IV every 3 weeks until disease progression/unacceptable toxicity. Participants then entered the last period: After Primary Overall Survival Analysis, in which participants were followed up for safety.","id":"OG001","title":"Placebo + RT + Temozolomide"}],"paramType":"MEDIAN","populationDescription":"Intent to treat population.","reportingStatus":"POSTED","timeFrame":"Randomization until PFS Event (Until data cutoff= 31 March 2012 [up to 29.5 months])","title":"PFS as Assessed by an Independent Review Facility","type":"SECONDARY","unitOfMeasure":"Months"}