{"analyses":[{"ciLowerLimit":"0.12","ciPctValue":"95","ciUpperLimit":"0.66","groupDescription":"Participants who did not start cytotoxic chemotherapy were censored at the date of the last assessment indicating no evidence of cytotoxic chemotherapy usage. Hazard ratio calculated using unstratified Cox Proportional Hazards model with treatment as the only covariate for enzalutamide group versus placebo group.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.0020","pValueComment":"P-value is based on an unstratified log-rank test.","paramType":"Hazard Ratio (HR)","paramValue":"0.28","statisticalMethod":"Unstratified log-rank test"}],"classes":[{"categories":[{"measurements":[{"comment":"Could not be estimated due to the low number of events","groupId":"OG000","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"comment":"Could not be estimated due to the low number of events","groupId":"OG001","lowerLimit":"NA","upperLimit":"NA","value":"13.93"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"198"},{"groupId":"OG001","value":"190"}],"units":"Participants"}],"description":"Time to initiation of cytotoxic chemotherapy was defined as the time from randomization to initiation of cytotoxic chemotherapy. It included only therapies for prostate cancer. When multiple cytotoxic chemotherapies were initiated, the first chemotherapy was used to determine the time to event. Participants who did not start cytotoxic chemotherapy at the time of analysis data cutoff were censored at the date of their last assessment indicating no evidence of cytotoxic chemotherapy usage.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants received 160 mg of enzalutamide orally once a day during double blind period until PSA progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer (up to 29.4 months). Eligible participants who received enzalutamide during double blind and who provided consent to take part in open-label period continued to receive 160 mg of enzalutamide in open-label period orally once a day until PSA progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer (up to 54.3 months).","id":"OG000","title":"Enzalutamide"},{"description":"Participants received enzalutamide matching placebo orally once a day during double-blind period until PSA progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer (up to 18.6 months).","id":"OG001","title":"Placebo"}],"paramType":"MEDIAN","populationDescription":"ITT population with available data.","reportingStatus":"POSTED","timeFrame":"From the date of randomization to initiation of cytotoxic chemotherapy median follow-up time is 7.39 months for enzalutamide and 5.19 months for placebo","title":"Time to Initiation of Cytotoxic Chemotherapy","type":"SECONDARY","unitOfMeasure":"Months"}