{"analyses":[{"ciLowerLimit":"0.426","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.020","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0613","paramType":"Hazard Ratio (HR)","paramValue":"0.659","statisticalMethod":"Log-rank test"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"8.21","upperLimit":"23.85","value":"16.9"},{"groupId":"OG001","lowerLimit":"8.15","upperLimit":"13.54","value":"9.3"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"92"},{"groupId":"OG001","value":"62"}],"units":"Participants"}],"description":"To determine efficacy by assessment of PFS2 of olaparib maintenance monotherapy compared to placebo. The PFS2 was defined as the time from the date of randomisation to the earliest of the progression event subsequent to that used for the primary variable PFS or death.","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":"Time From Randomisation to Second Progression (PFS2)","type":"SECONDARY","unitOfMeasure":"Months"}