{"analyses":[{"ciLowerLimit":"0.668","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"3.610","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.3273","paramType":"Odds Ratio (OR)","paramValue":"1.520","statisticalMethod":"Regression, Logistic"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"22"},{"groupId":"OG001","value":"11"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"72"},{"groupId":"OG001","value":"49"}],"units":"Participants"}],"description":"To determine efficacy by assessment of objective response rate according to modified RECIST 1.1 of olaparib maintenance monotherapy compared to placebo. The ORR is defined as the number of with a BoR of CR and PR according to the BICR data divided by the number of patients in the treatment group with measurable disease at baseline.","groups":[{"description":"Randomised participants received orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.","id":"OG000","title":"Olaparib 300 mg Twice Daily (bd)"},{"description":"Randomised participants received placebo tablets orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.","id":"OG001","title":"Placebo"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"All randomised patients with measurable disease at baseline.","reportingStatus":"POSTED","timeFrame":"Up to 4 years","title":"Number of Participants With Objective Response Rate (ORR) by BICR Using Modified RECIST 1.1","type":"SECONDARY","unitOfMeasure":"Participants"}