{"analyses":[{"ciLowerLimit":"0.576","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.094","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.1563","paramType":"Hazard Ratio (HR)","paramValue":"0.794","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"comment":"Here NA signifies that the median and upper limit of CI was 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 chronic opioid use was defined as the time from date of randomization to the first date of confirmed chronic opioid use. For participants entering the study without receiving opioids, chronic opioid use was defined as administration of opioid analgesics lasting for greater than or equal to (\\>=) 3 weeks for oral or \\>=7 days for non-oral formulations. For participants entering the study already receiving opioids, chronic opioid use was defined as a \\>=30 percent (%) increase in total daily dose of the opioid analgesics lasting for \\>= 3 weeks for oral or \\>= 7 days for non-oral formulation.","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 Chronic Opioid Use","type":"SECONDARY","unitOfMeasure":"months"}