{"analyses":[{"ciLowerLimit":"0.238","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.356","groupDescription":"Statistical Analysis for PFS by BICR (US Regulatory)","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.0001","paramType":"Hazard Ratio (HR)","paramValue":"0.291","statisticalMethod":"Log Rank"},{"ciLowerLimit":"0.247","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.364","groupDescription":"Statistical Analysis for PFS by BICR (EX-US Regulatory)","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.0001","paramType":"Hazard Ratio (HR)","paramValue":"0.300","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"14.49","upperLimit":"18.37","value":"14.72"},{"comment":"NA signifies: lower and upper limit of CI was not estimable (NA) as lower, or upper, or both limits of CI for survivor function were above 0.5 using log(-log) transformation (default of SAS Proc Lifetest).","groupId":"OG001","lowerLimit":"NA","upperLimit":"NA","value":"40.51"}]}],"title":"US Regulatory"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"11.27","upperLimit":"17.97","value":"14.65"},{"groupId":"OG001","lowerLimit":"29.40","upperLimit":"40.51","value":"40.51"}]}],"title":"EX-US Regulatory"}],"denoms":[{"counts":[{"groupId":"OG000","value":"401"},{"groupId":"OG001","value":"806"}],"units":"Participants"}],"description":"PFS defined as time from randomization to first documentation of BICR-confirmed radiographic progressive disease (PD) (development of distant/local/regional metastasis)/death due to any cause whichever occurred first. PFS data for participants without loco-regional disease were performed for US/ex-US regulatory purposes. Radiographic scans (bone scans and CT/MRI of chest,abdomen,pelvis) performed for detection of metastasis throughout study. PD based on RECIST v1.1; Subjects with one measurable lesion, At least 20% increase in sum of diameters of target lesions taking as reference smallest sum on study. In addition, sum must demonstrate an absolute increase of at least 5 millimeter(mm). Also, appearance of one/more new lesions was also considered PD. Subjects with non-measurable disease as per CT/MRI scans, unequivocal progression/appearance of one or more new lesions was considered PD. For new bone lesions detected on bone scans, second imaging (CT/MRI) was required to confirm PD.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants received apalutamide matched placebo tablets orally on a continuous once daily dosing regimen along with androgen deprivation therapy (ADT) until disease progression, withdrawal of consent or unacceptable toxicity or death.","id":"OG000","title":"Placebo"},{"description":"Participants received apalutamide orally at a starting dose of 240 milligram (mg) (8 x 30 mg capsules then 4 x 60 mg tablets) in a continuous treatment cycles (each treatment cycle is of 28 days) once daily dosing regimen along with androgen deprivation therapy (ADT) until disease progression, withdrawal of consent or unacceptable toxicity or death.","id":"OG001","title":"Apalutamide"}],"paramType":"MEDIAN","populationDescription":"ITT population included all participants who were randomized into the study, with study drug assignments designated according to initial randomization, regardless of whether participants received what was assigned.","reportingStatus":"POSTED","timeFrame":"Up to approximately 43 Months","title":"Progression-free Survival (PFS)","type":"SECONDARY","unitOfMeasure":"Months"}