{"analyses":[{"ciLowerLimit":"0.5","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"3.2","estimateComment":"The OR and confidence interval (CI) were calculated using logistic regression, adjusting for visceral metastases and cisplatin eligibility status, with 95% CI calculated by profile likelihood.","groupDescription":"Patients with improvement in fatigue","groupIds":["OG000","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"0.6763","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":"1.2","statisticalMethod":"Regression, Logistic"},{"ciLowerLimit":"0.5","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"3.3","estimateComment":"The OR and confidence interval (CI) were calculated using logistic regression, adjusting for visceral metastases and cisplatin eligibility status, with 95% CI calculated by profile likelihood.","groupDescription":"Patients with improvement in fatigue","groupIds":["OG001","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"0.6539","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":"1.2","statisticalMethod":"Regression, Logistic"},{"ciLowerLimit":"1.2","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"4.0","estimateComment":"The OR and confidence interval (CI) were calculated using logistic regression, adjusting for visceral metastases and cisplatin eligibility status, with 95% CI calculated by profile likelihood","groupDescription":"Patient with deterioration in pain","groupIds":["OG000","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0092","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":"2.2","statisticalMethod":"Regression, Logistic"},{"ciLowerLimit":"1.1","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"3.5","estimateComment":"The OR and confidence interval (CI) were calculated using logistic regression, adjusting for visceral metastases and cisplatin eligibility status, with 95% CI calculated by profile likelihood.","groupDescription":"Patient with deterioration in pain","groupIds":["OG001","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0324","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":"1.9","statisticalMethod":"Regression, Logistic"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"15"},{"groupId":"OG001","value":"13"},{"groupId":"OG002","value":"10"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"55"},{"groupId":"OG001","value":"46"},{"groupId":"OG002","value":"41"}],"units":"Participants"}],"title":"Patients with improvement in fatigue"},{"categories":[{"measurements":[{"groupId":"OG000","value":"64"},{"groupId":"OG001","value":"59"},{"groupId":"OG002","value":"32"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"109"},{"groupId":"OG001","value":"106"},{"groupId":"OG002","value":"81"}],"units":"Participants"}],"title":"Patient with deterioration in pain"}],"denoms":[{"counts":[{"groupId":"OG000","value":"137"},{"groupId":"OG001","value":"137"},{"groupId":"OG002","value":"137"}],"units":"Participants"}],"description":"Fatigue will be based on the question of \"I have a lack of energy\" and pain will be based on the question of \"I have pain\", according to GP1 and GP4 in PWB, respectively.\n\nImprovement in fatigue is defined at least 1 point improvement from baseline using GP1 of FACT-BL.\n\nDeterioration in pain is defined as at least 1 point deterioration from baseline using GP4 of FACT-BL.","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":"COUNT_OF_PARTICIPANTS","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":"At baseline then every 8 weeks until second progression/death, whichever comes first. Assessed up to the data cut-off date (27JAN2020, a maximum of 5 years).","title":"Improvement in Fatigue and Deterioration in Pain Per FACT-BL, PD-L1-Low/Negative Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Mono Therapy vs SoC","type":"SECONDARY","unitOfMeasure":"Participants"}