{"analyses":[{"ciLowerLimit":"-4.35","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.69","groupDescription":"NFBLSI- 18 score (Average overall visits)","groupIds":["OG000","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"0.3865","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":"-1.3","statisticalMethod":"Mixed Models Analysis"},{"ciLowerLimit":"-5.05","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.49","groupDescription":"NFBLSI- 18 score (Average overall visits)","groupIds":["OG001","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"0.2840","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":"-1.8","statisticalMethod":"Mixed Models Analysis"},{"ciLowerLimit":"-5.41","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.66","groupDescription":"FACT-BL TOI (Average overall visits)","groupIds":["OG000","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"0.2970","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":"-5.85","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.83","groupDescription":"FACT-BL TOI (Average overall visits)","groupIds":["OG001","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"0.3026","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":"-2.0","statisticalMethod":"Mixed Models Analysis"},{"ciLowerLimit":"-7.29","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"2.38","groupDescription":"FACT-BL Total score (Average overall visits)","groupIds":["OG000","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"0.3168","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":"-2.5","statisticalMethod":"Mixed Models Analysis"},{"ciLowerLimit":"-8.51","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.96","groupDescription":"FACT-BL Total score (Average overall visits)","groupIds":["OG001","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"0.2179","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":"-3.3","statisticalMethod":"Mixed Models Analysis"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"1.01","value":"-3.4"},{"groupId":"OG001","spread":"1.18","value":"-3.8"},{"groupId":"OG002","spread":"1.16","value":"-2.0"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"91"},{"groupId":"OG001","value":"73"},{"groupId":"OG002","value":"69"}],"units":"Participants"}],"title":"NFBLSI - 18 Score (Average overall visits)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"1.18","value":"-4.9"},{"groupId":"OG001","spread":"1.39","value":"-5.0"},{"groupId":"OG002","spread":"1.36","value":"-3.0"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"91"},{"groupId":"OG001","value":"73"},{"groupId":"OG002","value":"69"}],"units":"Participants"}],"title":"FACT-BL TOI (Average overall visits)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"1.62","value":"-5.7"},{"groupId":"OG001","spread":"1.90","value":"-6.5"},{"groupId":"OG002","spread":"1.86","value":"-3.2"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"91"},{"groupId":"OG001","value":"73"},{"groupId":"OG002","value":"69"}],"units":"Participants"}],"title":"FACT-BL Total score (Average overall visits)"}],"denoms":[{"counts":[{"groupId":"OG000","value":"137"},{"groupId":"OG001","value":"137"},{"groupId":"OG002","value":"137"}],"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-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":"Change From Baseline in FACT-BL (Derived NFBlSI-18 Score, FACT-BL TOI, and FACT-BL Total Score) by MMRM Analysis, PD-L1-Low/Negative Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Mono Therapy vs SoC","type":"SECONDARY","unitOfMeasure":"Scores on a scale"}