{"analyses":[{"ciLowerLimit":"0.346","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.815","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0038","paramType":"Hazard Ratio (HR)","paramValue":"0.531","statisticalMethod":"Log-rank test"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"4.14","upperLimit":"11.01","value":"7.4"},{"groupId":"OG001","lowerLimit":"3.52","upperLimit":"4.86","value":"3.8"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"92"},{"groupId":"OG001","value":"62"}],"units":"Participants"}],"description":"To determine the efficacy of olaparib maintenance monotherapy compared to placebo by PFS. The PFS was defined as the time from randomisation until the date of objective radiological disease progression according to modified RECIST v1.1 or death (by any cause in the absence of disease progression) regardless of whether the patient withdrew from randomized therapy or received another anticancer therapy prior to disease progression.","dispersionType":"95% Confidence Interval","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":"MEDIAN","populationDescription":"Intention to treat (ITT): All randomised patients, Myriad confirmed Breast cancer susceptibility gene mutation (gBRCAm) subgroup.","reportingStatus":"POSTED","timeFrame":"Up to 4 years","title":"Progression-free Survival (PFS) by Blinded Independent Central Review (BICR) Using Modified Response Evaluation Criteria in Solid Tumours. This Study Used Modified RECIST Version (v) 1.1 (RECIST v1.1)","type":"PRIMARY","unitOfMeasure":"Months"}