{"analyses":[{"ciLowerLimit":"1.177","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.990","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":"0.0014","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":"1.53","statisticalMethod":"Log Rank"},{"ciLowerLimit":"0.729","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.209","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.","groupDescription":"monotherapy as reference.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.6236","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":"0.94","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"1.9","upperLimit":"3.6","value":"2.0"},{"groupId":"OG001","lowerLimit":"1.9","upperLimit":"3.5","value":"2.0"},{"groupId":"OG002","lowerLimit":"5.7","upperLimit":"7.5","value":"7.2"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"137"},{"groupId":"OG001","value":"137"},{"groupId":"OG002","value":"137"}],"units":"Participants"}],"description":"Progression free survival (PFS) (per RECIST 1.1, as assessed by investigator) was defined as the time from the date of randomization until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the patient withdraws from randomized therapy or receives another anticancer therapy prior to progression.\n\nMedian PFS 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-Low/Negative analysis set will include the subset of patients in the FAS whose PD-L1 status is PD-L1-Low/negative 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 AND \\<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 confirmed disease progression. Assessed up to the data cut-off date (27JAN2020, a maximum of 5 years).","title":"PFS, PD-L1-Low/Negative Analysis Set -Durvalumab + Tremelimumab Combination Therapy Versus SoC and Durvalumab + Tremelimumab Combination Therapy Versus Durvalumab Monotherapy","type":"SECONDARY","unitOfMeasure":"Months"}