{"analyses":[{"ciLowerLimit":"0.227","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.346","groupDescription":"Statistical Analysis for MFS by BICR (US Regulatory)","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.0001","paramType":"Hazard Ratio (HR)","paramValue":"0.280","statisticalMethod":"Log Rank"},{"ciLowerLimit":"0.244","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.362","groupDescription":"Statistical Analysis for MFS by BICR (Ex-US Regulatory)","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.0001","paramType":"Hazard Ratio (HR)","paramValue":"0.297","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"14.59","upperLimit":"18.40","value":"16.20"},{"comment":"NA signifies: lower and upper limit of Confidence Interval(CI) was not estimable as lower, or upper, or both limits of CI for survivor function were above 0.5 using log(-log) transformation (default of Statistical Analysis System\\[SAS\\] Proc Lifetest).","groupId":"OG001","lowerLimit":"NA","upperLimit":"NA","value":"40.51"}]}],"title":"US Regulatory"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"14.55","upperLimit":"18.40","value":"15.70"},{"groupId":"OG001","lowerLimit":"29.70","upperLimit":"40.51","value":"40.51"}]}],"title":"Ex-US Regulatory"}],"denoms":[{"counts":[{"groupId":"OG000","value":"401"},{"groupId":"OG001","value":"806"}],"units":"Participants"}],"description":"MFS was defined as the time from randomization to the time of first evidence of BICR-confirmed bone or soft tissue distant metastasis or death due to any cause, whichever occurred first. The MFS data for participants without metastasis or death were performed for US or ex-US regulatory purposes. Radiographic scans (bone scans and computerized tomography \\[CT\\] or magnetic resonance imaging \\[MRI\\] of the chest, abdomen, and pelvis) were performed for detection of metastasis throughout the study.","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":"Intent-to-Treat (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":"Metastasis-Free Survival (MFS) by Blinded Independent Central Review (BICR)","type":"PRIMARY","unitOfMeasure":"Months"}