{"analyses":[{"groupDescription":"RTOG 93-10 reported a pre-irradiation chemotherapy complete response rate of 59%. A chi-square test with a 0.20 one-sided significance level provides 81% power to detect the difference between a null hypothesis complete response rate of 59% and the alternative rate of 71% (a 20% increase) for the planned sample size of 52 patients.","groupIds":["OG000"],"nonInferiorityType":"OTHER","pValue":"0.82","statisticalComment":"One-sample test of proportions","statisticalMethod":"Chi-squared"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"18"}]}],"title":"Complete Response"},{"categories":[{"measurements":[{"groupId":"OG000","value":"12"}]}],"title":"Partial Response"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"}]}],"title":"Progressive Disease"},{"categories":[{"measurements":[{"groupId":"OG000","value":"3"}]}],"title":"Not evaluable"}],"denoms":[{"counts":[{"groupId":"OG000","value":"35"}],"units":"Participants"}],"description":"Tumor response was centrally reviewed. Complete response: Disappearance of all enhancing tumor, the patient must be off steroid therapy and neurologically stable or improved; partial response: ≥ 50% decrease in enhancing tumor; progressive disease: ≥ 25% increase in a lesion, progressive or newly emergent meningeal or ocular disease. (Please note that this outcome measure is considered a secondary endpoint for the Phase II component of the study, but that the patients from Phase I that were treated at the same dose level are included, as indicated in the treatment arm descriptions. )","groups":[{"description":"Phase I: Temozolomide 100mg and Phase II: Temozolomide 100 mg","id":"OG000","title":"Combined Temozolomide 100mg Arms"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Eligible patients on Temozolomide 100 mg arms who started study treatment and have scans for central review","reportingStatus":"POSTED","timeFrame":"From start of treatment to 10 weeks if RT received, to 15 weeks if not.","title":"Phase II: Pre-irradiation Chemotherapy Tumor Response Rate (Including Phase I Patients at Same Dose)","type":"SECONDARY","unitOfMeasure":"Participants"}