{"analyses":[{"ciLowerLimit":"0.549","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.901","estimateComment":"The HR and confidence interval (CI) were calculated using a stratified Cox proportional hazards model, adjusting for visceral metastases and cisplatin eligibility status with ties handled by the Breslow approach.","groupIds":["OG000","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0053","pValueComment":"The 2-sided p-value was calculated using a stratified log-rank test adjusting for visceral metastases and cisplatin eligibility status.","paramType":"Hazard Ratio (HR)","paramValue":"0.70","statisticalMethod":"Log Rank"},{"ciLowerLimit":"0.651","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.059","estimateComment":"The HR and confidence interval (CI) were calculated using a stratified Cox proportional hazards model, adjusting for visceral metastases and cisplatin eligibility status with ties handled by the Breslow approach.","groupIds":["OG001","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"0.1336","pValueComment":"The 2-sided p-value was calculated using a stratified log-rank test adjusting for visceral metastases and cisplatin eligibility status.","paramType":"Hazard Ratio (HR)","paramValue":"0.83","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"12.1","upperLimit":"24.8","value":"17.2"},{"groupId":"OG001","lowerLimit":"9.7","upperLimit":"17.5","value":"13.4"},{"groupId":"OG002","lowerLimit":"8.9","upperLimit":"14.3","value":"11.3"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"205"},{"groupId":"OG001","value":"209"},{"groupId":"OG002","value":"207"}],"units":"Participants"}],"description":"Time from randomization to second progression or death (PFS2) was defined as the time from the date of randomization to the earliest of the progression event subsequent to first subsequent therapy or death (ie, date of PFS2 event or censoring - date of randomization +1).\n\nMedian PFS2 was calculated using the Kaplan-Meier technique.","dispersionType":"95% Confidence Interval","groups":[{"description":"MEDI4736 (Durvalumab) + Tremelimumab","id":"OG000","title":"Combination Therapy"},{"description":"MEDI4736 (Durvalumab)","id":"OG001","title":"Monotherapy"},{"description":"Standard of Care Chemotherapy Treatment","id":"OG002","title":"Standard of Care"}],"paramType":"MEDIAN","populationDescription":"The PD-L1-High analysis set will include the subset of patients in the FAS whose PD-L1 status is PD-L1-High as defined by an Immunohistochemistry (IHC) assay developed by Ventana as:\n\n≥25% tumor cell membrane positivity for PD-L1 at any intensity above background staining as noted on the corresponding negative control OR ≥25% tumor associated immune cell positivity for PD-L1 at any intensity above background staining as noted on the corresponding negative control","reportingStatus":"POSTED","timeFrame":"Tumour scans performed at baseline then every 8 weeks since randomization until first confirmed disease progression, disease then assessed per local practice until 2nd progression. Assessed up to the data cut-off date (27JAN2020, a maximum of 5 years).","title":"PFS2, PD-L1-High Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Monotherapy vs SoC","type":"SECONDARY","unitOfMeasure":"Months"}