{"analyses":[{"ciLowerLimit":"0.432","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.802","estimateComment":"The OR and confidence interval (CI) were calculated using logistic regression, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status.","groupIds":["OG000","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0008","pValueComment":"P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status.","paramType":"Odds Ratio (OR)","paramValue":"0.59","statisticalMethod":"Regression, Logistic"},{"ciLowerLimit":"0.270","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.512","estimateComment":"The OR and confidence interval (CI) were calculated using logistic regression, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status.","groupIds":["OG001","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 PD-L1 status, visceral metastases and cisplatin eligibility status.","paramType":"Odds Ratio (OR)","paramValue":"0.37","statisticalMethod":"Regression, Logistic"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"38.0"},{"groupId":"OG001","value":"28.0"},{"groupId":"OG002","value":"50.6"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"342"},{"groupId":"OG001","value":"346"},{"groupId":"OG002","value":"344"}],"units":"Participants"}],"description":"Disease control rate (DCR) at 12 months is defined as the percentage of patients who have a best objective response (BoR) of CR or PR, or who have demonstrated SD for a minimum interval of 48 weeks (-7 days, i.e., 329 days), following the start of study treatment.","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":"Full analysis set (FAS) included all randomized participants analyzed on an intent-to-treat (ITT) basis.","reportingStatus":"POSTED","timeFrame":"Tumour scans performed at baseline then every 8 weeks since randomization until confirmed disease progression. Assessed up to 12 months or the data cut-off date (27JAN2020)","title":"Disease Control Rate (DCR) at 12 Months, Full Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Mono Therapy vs SoC","type":"SECONDARY","unitOfMeasure":"percentage of participants"}