{"analyses":[{"ciLowerLimit":"0.315","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.634","groupDescription":"Statistical Analysis for Time to Symptomatic Progression","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.0001","paramType":"Hazard Ratio (HR)","paramValue":"0.447","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"comment":"NA signifies: median and upper limit of CI were NA. Median was NA as KM curve did not drop to 0.5 or below. Upper limit was NA as upper limit of CI for survivor function was above 0.5 using log(-log) transformation (default of SAS Proc Lifetest).","groupId":"OG000","lowerLimit":"36.83","upperLimit":"NA","value":"NA"},{"comment":"The median was not estimable(NA) as Kaplan-Meier(KM) curve did not drop to 0.5 or below. The lower or upper limit was NA as lower or upper limit of CI for survivor function was above 0.5 using log(-log) transformation (default of SAS Proc Lifetest).","groupId":"OG001","lowerLimit":"NA","upperLimit":"NA","value":"NA"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"401"},{"groupId":"OG001","value":"806"}],"units":"Participants"}],"description":"Time to symptomatic progression was defined as the time from randomization to documentation in the CRF of any of the following (whichever occurred earlier): a) development of a skeletal-related event (pathologic fracture, spinal cord compression, or need for surgical intervention or radiation therapy to the bone); b) pain progression or worsening of disease-related symptoms requiring initiation of a new systemic anti-cancer therapy; or c) development of clinically significant symptoms due to loco-regional tumor progression requiring surgical intervention or radiation therapy.","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 Symptomatic Progression","type":"SECONDARY","unitOfMeasure":"Months"}