{"analyses":[{"ciLowerLimit":"0.73","ciNumSides":"TWO_SIDED","ciPctValue":"95.67","ciUpperLimit":"1.03","estimateComment":"The 95.67% confidence interval were derived based upon the exact number of OS events for each comparison using the Lan and DeMets approach that approximates the O'Brien Fleming spending function.","groupDescription":"The analysis was performed using a Cox proportional hazards model adjusting for treatment, etiology of liver disease (HBV versus HCV versus others), ECOG (0 versus 1), and macro-vascular invasion (yes versus no). Values of the variables used for adjustment were obtained from IVRS.","groupIds":["OG000","OG003"],"nonInferiorityComment":"Non-interiority for the comparison of arm Durva 1500 mg vs Sora 400 mg is declared if the upper limit of the two-sided alpha adjusted CI for HR is less than the NI margin of 1.08.","nonInferiorityType":"NON_INFERIORITY","paramType":"Hazard Ratio (HR)","paramValue":"0.86","statisticalMethod":"Regression, Cox"},{"groupDescription":"The analysis was performed using stratified log-rank test adjusting for treatment, etiology of liver disease (HBV versus HCV versus others), ECOG (0 versus 1), and macro-vascular invasion (yes versus no). The values of the stratification factors were obtained from IVRS.","groupIds":["OG000","OG003"],"nonInferiorityComment":"Superiority was tested sequentially per protocol as non-inferiority was satisfied.","nonInferiorityType":"SUPERIORITY","pValue":"0.0674","pValueComment":"The adjusted alpha levels (0.0433) for the two-sided superiority test were derived based upon the exact number of OS events for each comparison using the Lan and DeMets approach that approximates the O'Brien Fleming spending function.","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"14.06","upperLimit":"19.12","value":"16.56"},{"groupId":"OG001","lowerLimit":"14.16","upperLimit":"19.58","value":"16.43"},{"groupId":"OG002","lowerLimit":"12.39","upperLimit":"19.65","value":"16.36"},{"groupId":"OG003","lowerLimit":"12.25","upperLimit":"16.13","value":"13.77"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"389"},{"groupId":"OG001","value":"389"},{"groupId":"OG002","value":"153"},{"groupId":"OG003","value":"389"}],"units":"Participants"}],"description":"OS was defined as the time from the date of randomization until death due to any cause, regardless of whether the participant withdrew from randomized therapy or received another anticancer therapy. Any participant not known to have died at the DCO date was censored based on the last recorded date on which the participant was known to be alive. If the last known date alive or if the date of death was after the DCO date, participants were censored at the DCO date. This secondary outcome measure presents OS analysis of Durva 1500 mg vs Sora 400 mg at the time of the final analysis DCO (27Aug2021).","dispersionType":"95% Confidence Interval","groups":[{"description":"Durvalumab 1500 mg every 4 weeks (Q4W)","id":"OG000","title":"Durva 1500 mg"},{"description":"Tremelimumab 300 mg × 1 dose + durvalumab 1500 mg Q4W","id":"OG001","title":"Treme 300 mg x1 Dose + Durva 1500 mg"},{"description":"Tremelimumab 75 mg Q4W × 4 doses + durvalumab 1500 mg Q4W","id":"OG002","title":"Treme 75 mg x4 Doses + Durva 1500 mg"},{"description":"Sorafenib 400 mg twice daily (BID)","id":"OG003","title":"Sora 400 mg"}],"paramType":"MEDIAN","populationDescription":"The FAS included all participants who were randomized. T75+D arm was closed during study.","reportingStatus":"POSTED","timeFrame":"From the date of randomization until death due to any cause, assessed up to the data cut-off date (27Aug2021, to a maximum of approximately 46 months).","title":"Overall Survival (OS) - Durva 1500 mg vs Sora 400 mg","type":"SECONDARY","unitOfMeasure":"months"}