{"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.3","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"2.1","upperLimit":"8.4","value":"3.1"},{"groupId":"OG001","lowerLimit":"4.0","upperLimit":"8.0","value":"5.5"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"31"},{"groupId":"OG001","value":"32"}],"units":"Participants"}],"description":"PFS is defined as the time from randomization to documented progression or death without progression. PFS is censored at the date of last disease evaluation. The study was closed for futility in 2021 after the 2021 Spring DSMC meeting, which found that the boundary for futility had been met (ie, temozolomide and capecitabine did not appear to be superior to platinum and etoposide chemotherapy). As the interim analysis finding led to the conclusion of the study, no PFS stratified logrank test was conducted with the data extracted on April 23rd, 2025 for the final analysis, that was presented here.","dispersionType":"95% Confidence Interval","groups":[{"description":"Patients receive capecitabine PO BID on days 1-14 and temozolomide PO QD on days 10-14. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.","id":"OG000","title":"Arm A (Capecitabine, Temozolomide)"},{"description":"Patients receive cisplatin IV on days 1-3 or carboplatin IV on day 1. Patients also receive etoposide IV on days 1-3. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.","id":"OG001","title":"Arm B (Cisplatin, Carboplatin, Etoposide)"}],"paramType":"MEDIAN","populationDescription":"All eligible patients","reportingStatus":"POSTED","timeFrame":"assessed at baseline, every 8 weeks until treatment completion, then every 3 months within 2 years and every 6 months within 3-5 years from randomization until disease progression, up to 5 years from study registration","title":"Progression-free Survival (PFS)","type":"PRIMARY","unitOfMeasure":"months"}