{"analyses":[{"ciLowerLimit":"0.700","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.076","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.1966","paramType":"Hazard Ratio (HR)","paramValue":"0.868","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"comment":"Here NA signifies that the median and upper limit of CI were not estimable due to lesser number of events.","groupId":"OG000","lowerLimit":"51.32","upperLimit":"NA","value":"NA"},{"comment":"Here NA signifies that the median, lower limit and upper limit of CI were not estimable due to lesser number of events.","groupId":"OG001","lowerLimit":"NA","upperLimit":"NA","value":"NA"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"527"},{"groupId":"OG001","value":"525"}],"units":"Participants"}],"description":"Time to pain progression was defined as the time from the date of randomization to the date of the first observation of pain progression. Pain progression was defined as an average increase by 2 points from baseline to greater than (\\>) 4 on the Brief Pain Inventory - Short Form (BPI-SF) worst pain intensity (item 3) with no decrease in opioids confirmed greater than equal to (\\>=) 3 weeks apart or initiation of chronic opioids, whichever occurred first. BPI-SF is a self-administered questionnaire developed to assess severity of pain and impact of pain on daily functions. Item 3 (worst pain intensity) asks participants to rate worst pain in prior 7-days on a 0-10 numeric rating scale, where \"0\" indicates \"No pain\" and \"10\" indicates \"Pain as bad as you can imagine.\" A lower score is better.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants received matching placebo (4 tablets) orally once daily (qd) along with ADT (gonadotropin releasing hormone analog \\[GnRHa\\] or surgical castration) as standard of care therapy in each 28-day treatment cycle. The choice of the GnRHa (agonist or antagonist) was at discretion of the investigator. In the event of a positive result at interim or final analysis participants in treatment phase had opportunity to receive Apalutamide +ADT. Participants received treatment until radiographic progression or unequivocal clinical progression, unacceptable toxicity, or death.","id":"OG000","title":"Placebo + Androgen Deprivation Therapy (ADT)"},{"description":"Participants received JNJ-56021927 (apalutamide) 240 milligrams (mg) (4\\*60 mg tablets) orally qd along with ADT (gonadotropin releasing hormone analog \\[GnRHa\\] or surgical castration) as standard of care therapy in each 28-day treatment cycle. The choice of the GnRHa (agonist or antagonist) was at discretion of the investigator. Participants received treatment until radiographic progression or unequivocal clinical progression, unacceptable toxicity, or death.","id":"OG001","title":"Apalutamide + ADT"}],"paramType":"MEDIAN","populationDescription":"ITT population included all randomized participants classified according to their assigned treatment group, regardless of the actual treatment received.","reportingStatus":"POSTED","timeFrame":"Up to 57 months","title":"Time to Pain Progression","type":"SECONDARY","unitOfMeasure":"months"}