{"analyses":[{"ciLowerLimit":"0.135","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.406","estimateComment":"The OR and confidence interval (CI) were calculated using logistic regression, adjusting for visceral metastases and cisplatin eligibility status.","groupIds":["OG000","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.0001","pValueComment":"P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for visceral metastases and cisplatin eligibility status.","paramType":"Odds Ratio (OR)","paramValue":"0.24","statisticalMethod":"Regression, Logistic"},{"ciLowerLimit":"0.469","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.566","estimateComment":"The OR and confidence interval (CI) were calculated using logistic regression, adjusting for visceral metastases and cisplatin eligibility status.","groupDescription":"monotherapy as reference.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.6195","pValueComment":"P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for visceral metastases and cisplatin eligibility status.","paramType":"Odds Ratio (OR)","paramValue":"0.86","statisticalMethod":"Regression, Logistic"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"20.4"},{"groupId":"OG001","value":"22.6"},{"groupId":"OG002","value":"50.4"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"137"},{"groupId":"OG001","value":"137"},{"groupId":"OG002","value":"137"}],"units":"Participants"}],"description":"Objective response rate ORR (per RECIST 1.1 as assessed by investigator) is defined as the number (%) of patients with at least 1 visit response of CR or PR.","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":"NUMBER","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":"Objective Response Rate (ORR), PD-L1-Low/Negative Analysis Set -Durvalumab + Tremelimumab Combination Therapy Versus SoC and Durvalumab + Tremelimumab Combination Therapy Versus Durvalumab Monotherapy","type":"SECONDARY","unitOfMeasure":"percentage of participants"}