{"analyses":[{"ciLowerLimit":"-0.6","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"3.59","groupDescription":"NFBLSI- 18 score (Average overall visits)","groupIds":["OG000","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"0.1617","pValueComment":"MMRM model included patient, treatment, cisplatin eligibility, PD-L1 status 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":"1.5","statisticalMethod":"Mixed Models Analysis"},{"ciLowerLimit":"-0.07","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"4.29","groupDescription":"NFBLSI- 18 score (Average overall visits)","groupIds":["OG001","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0578","pValueComment":"MMRM model included patient, treatment, cisplatin eligibility, PD-L1 status 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":"-0.91","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"4.32","groupDescription":"FACT-BL TOI (Average overall visits)","groupIds":["OG000","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"0.2003","pValueComment":"MMRM model included patient, treatment, cisplatin eligibility, PD-L1 status 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":"1.7","statisticalMethod":"Mixed Models Analysis"},{"ciLowerLimit":"0.57","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"6.00","groupDescription":"FACT-BL TOI (Average overall visits)","groupIds":["OG001","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0178","pValueComment":"MMRM model included patient, treatment, cisplatin eligibility, PD-L1 status 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"},{"ciLowerLimit":"-1.96","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"5.17","groupDescription":"FACT-BL Total score (Average overall visits)","groupIds":["OG000","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"0.3765","pValueComment":"MMRM model included patient, treatment, cisplatin eligibility, PD-L1 status 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":"1.6","statisticalMethod":"Mixed Models Analysis"},{"ciLowerLimit":"0.40","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"7.81","groupDescription":"FACT-BL Total score (Average overall visits)","groupIds":["OG001","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0300","pValueComment":"MMRM model included patient, treatment, cisplatin eligibility, PD-L1 status 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":"4.1","statisticalMethod":"Mixed Models Analysis"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.70","value":"-3.7"},{"groupId":"OG001","spread":"0.76","value":"-3.1"},{"groupId":"OG002","spread":"0.82","value":"-5.2"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"220"},{"groupId":"OG001","value":"204"},{"groupId":"OG002","value":"189"}],"units":"Participants"}],"title":"NFBLSI - 18 Score (Average overall visits)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.87","value":"-5.5"},{"groupId":"OG001","spread":"0.95","value":"-3.9"},{"groupId":"OG002","spread":"1.02","value":"-7.2"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"220"},{"groupId":"OG001","value":"204"},{"groupId":"OG002","value":"189"}],"units":"Participants"}],"title":"FACT-BL TOI (Average overall visits)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"1.19","value":"-7.2"},{"groupId":"OG001","spread":"1.30","value":"-4.7"},{"groupId":"OG002","spread":"1.39","value":"-8.8"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"220"},{"groupId":"OG001","value":"204"},{"groupId":"OG002","value":"189"}],"units":"Participants"}],"title":"FACT-BL Total score (Average overall visits)"}],"denoms":[{"counts":[{"groupId":"OG000","value":"342"},{"groupId":"OG001","value":"346"},{"groupId":"OG002","value":"344"}],"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 outcome.","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":"Full analysis set (FAS) included all randomized participants analyzed on an intent-to-treat (ITT) basis.","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, Full Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Mono Therapy vs SoC","type":"SECONDARY","unitOfMeasure":"Scores on a scale"}