{"analyses":[{"ciLowerLimit":"0.14","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.94","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.39","paramType":"Odds Ratio (OR)","paramValue":"0.53","statisticalMethod":"Regression, Logistic"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"7","upperLimit":"37","value":"19"},{"groupId":"OG001","lowerLimit":"16","upperLimit":"50","value":"31"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"31"},{"groupId":"OG001","value":"32"}],"units":"Participants"}],"description":"ORR is defined as the proportion of patients with complete response (CR) or partial response (PR). Response is evaluated using the RECIST 1.1 criteria. CR is defined as disappearance of all lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\< 10 mm. PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.","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":"NUMBER","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, up to 5 years from registration; the best response among all assessments was considered as objective response","title":"Objective Response Rate (ORR)","type":"SECONDARY","unitOfMeasure":"percentage of participants"}