{"analyses":[{"ciLowerLimit":"0.219","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.335","groupDescription":"Statistical Analysis for TTM by BICR (US Regulatory)","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.0001","paramType":"Hazard Ratio (HR)","paramValue":"0.271","statisticalMethod":"Log Rank"},{"ciLowerLimit":"0.227","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.342","groupDescription":"Statistical Analysis for TTM by BICR (Ex-US Regulatory)","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.0001","paramType":"Hazard Ratio (HR)","paramValue":"0.279","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"14.59","upperLimit":"18.46","value":"16.59"},{"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":"14.55","upperLimit":"18.40","value":"15.70"},{"groupId":"OG001","lowerLimit":"31.15","upperLimit":"40.51","value":"40.51"}]}],"title":"EX-US Regulatory"}],"denoms":[{"counts":[{"groupId":"OG000","value":"401"},{"groupId":"OG001","value":"806"}],"units":"Participants"}],"description":"Time to metastasis (TTM) was defined as the time from randomization to the time of the scan that showed first evidence of BICR-confirmed radiographically detected bone or soft tissue distant metastasis. The TTM data for participants without metastasis were performed for US or ex-US regulatory purposes. Radiographic scans (bone scans and CT or 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":"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":"Time to Metastasis (TTM)","type":"SECONDARY","unitOfMeasure":"Months"}