{"analyses":[{"ciLowerLimit":"-0.6","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"4.36","groupDescription":"NFBLSI- 18 score (Average overall visits)","groupIds":["OG000","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"0.1373","pValueComment":"MMRM model included patient, treatment, cisplatin eligibility and visceral metastasis, visit and treatment by visit interaction as explanatory variables, and the appropriate baseline FACT-BL value as a covariate.","paramType":"Mean Difference (Final Values)","paramValue":"1.9","statisticalMethod":"Mixed Models Analysis"},{"ciLowerLimit":"1.26","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"6.27","groupDescription":"NFBLSI- 18 score (Average overall visits)","groupIds":["OG001","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0034","pValueComment":"MMRM model included patient, treatment, cisplatin eligibility and visceral metastasis, visit and treatment by visit interaction as explanatory variables, and the appropriate baseline FACT-BL value as a covariate.","paramType":"Mean Difference (Final Values)","paramValue":"3.8","statisticalMethod":"Mixed Models Analysis"},{"ciLowerLimit":"-1.00","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"5.39","groupDescription":"FACT-BL TOI (Average overall visits)","groupIds":["OG000","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"0.1774","pValueComment":"MMRM model included patient, treatment, cisplatin eligibility and visceral metastasis, visit and treatment by visit interaction as explanatory variables, and the appropriate baseline FACT-BL value as a covariate.","paramType":"Mean Difference (Final Values)","paramValue":"2.2","statisticalMethod":"Mixed Models Analysis"},{"ciLowerLimit":"2.19","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"8.65","groupDescription":"FACT-BL TOI (Average overall visits)","groupIds":["OG001","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0011","pValueComment":"MMRM model included patient, treatment, cisplatin eligibility and visceral metastasis, visit and treatment by visit interaction as explanatory variables, and the appropriate baseline FACT-BL value as a covariate.","paramType":"Mean Difference (Final Values)","paramValue":"5.4","statisticalMethod":"Mixed Models Analysis"},{"ciLowerLimit":"-2.27","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"6.38","groupDescription":"FACT-BL Total score (Average overall visits)","groupIds":["OG000","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"0.3494","pValueComment":"MMRM model included patient, treatment, cisplatin eligibility and visceral metastasis, visit and treatment by visit interaction as explanatory variables, and the appropriate baseline FACT-BL value as a covariate.","paramType":"Mean Difference (Final Values)","paramValue":"2.1","statisticalMethod":"Mixed Models Analysis"},{"ciLowerLimit":"2.96","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"11.71","groupDescription":"FACT-BL Total score (Average overall visits)","groupIds":["OG001","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0011","pValueComment":"MMRM model included patient, treatment, cisplatin eligibility and visceral metastasis, visit and treatment by visit interaction as explanatory variables, and the appropriate baseline FACT-BL value as a covariate.","paramType":"Mean Difference (Final Values)","paramValue":"7.3","statisticalMethod":"Mixed Models Analysis"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.85","value":"-3.9"},{"groupId":"OG001","spread":"0.87","value":"-2.0"},{"groupId":"OG002","spread":"0.95","value":"-5.7"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"129"},{"groupId":"OG001","value":"131"},{"groupId":"OG002","value":"119"}],"units":"Participants"}],"title":"NFBLSI - 18 Score (Average overall visits)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"1.09","value":"-5.8"},{"groupId":"OG001","spread":"1.11","value":"-2.6"},{"groupId":"OG002","spread":"1.22","value":"-8.0"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"129"},{"groupId":"OG001","value":"131"},{"groupId":"OG002","value":"119"}],"units":"Participants"}],"title":"FACT-BL TOI (Average overall visits)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"1.47","value":"-8.0"},{"groupId":"OG001","spread":"1.51","value":"-2.7"},{"groupId":"OG002","spread":"1.65","value":"-10.1"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"129"},{"groupId":"OG001","value":"131"},{"groupId":"OG002","value":"119"}],"units":"Participants"}],"title":"FACT-BL Total score (Average overall visits)"}],"denoms":[{"counts":[{"groupId":"OG000","value":"205"},{"groupId":"OG001","value":"209"},{"groupId":"OG002","value":"207"}],"units":"Participants"}],"description":"the change from baseline in the following total/index scores will be evaluated as secondary endpoints: FACT-BL TOI (refer to as TOI), FACT-BL Total score, and NFBlSI-18 score.\n\nAll the 5 subscales (PWB (0-28), FWB (0-28), EWB (0-24), SWB (0-28), and BlCS(0-48)) are summed as the FACT-BL total score (range 0-156), while the sum of PWB, FWB and BICS constitutes the FACT-BL TOI (range 0-104).\n\nNFBlSI-18 (range 0-72) is based on the scores of 16 items (GP4, C2, BL1, GP3, GE6, GE1, C6, BL5, GF5, GP2, GP1, GP6, C3, GP5, GF3, GF7) and 2 extra items \"I feel weak all overall\" and \"I feel light-headed (dizzy)\". The range of each item is 0-4.\n\nHigher score represent worse","dispersionType":"Standard Error","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":"MEAN","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":"Change From Baseline in FACT-BL (Derived NFBlSI-18 Score, FACT-BL TOI, and FACT-BL Total Score) by MMRM Analysis, PD-L1-High Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Mono Therapy vs SoC","type":"SECONDARY","unitOfMeasure":"Scores on a scale"}