{"analyses":[{"ciLowerLimit":"0.7","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"3.4","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":"0.2473","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":"1.6","statisticalMethod":"Regression, Logistic"},{"ciLowerLimit":"0.8","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"3.8","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":"0.0148","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":"1.7","statisticalMethod":"Regression, Logistic"},{"ciLowerLimit":"1.2","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"3.0","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":"0.0090","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"},{"ciLowerLimit":"0.9","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"2.3","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":"Patient with deterioration in pain","groupIds":["OG001","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"0.1510","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":"1.4","statisticalMethod":"Regression, Logistic"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"23"},{"groupId":"OG001","value":"24"},{"groupId":"OG002","value":"14"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"86"},{"groupId":"OG001","value":"83"},{"groupId":"OG002","value":"74"}],"units":"Participants"}],"title":"Patients with improvement in fatigue"},{"categories":[{"measurements":[{"groupId":"OG000","value":"78"},{"groupId":"OG001","value":"71"},{"groupId":"OG002","value":"51"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"156"},{"groupId":"OG001","value":"164"},{"groupId":"OG002","value":"145"}],"units":"Participants"}],"title":"Patient with deterioration in pain"}],"denoms":[{"counts":[{"groupId":"OG000","value":"205"},{"groupId":"OG001","value":"209"},{"groupId":"OG002","value":"207"}],"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-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":"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-High Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Mono Therapy vs SoC","type":"SECONDARY","unitOfMeasure":"Participants"}