{"analyses":[{"ciLowerLimit":"0.8","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"2.6","estimateComment":"The OR and confidence interval (CI) were calculated using logistic regression, adjusting for PD-L1 status, 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":"0.2419","pValueComment":"P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status.","paramType":"Odds Ratio (OR)","paramValue":"1.4","statisticalMethod":"Regression, Logistic"},{"ciLowerLimit":"0.9","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"2.8","estimateComment":"The OR and confidence interval (CI) were calculated using logistic regression, adjusting for PD-L1 status, 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":"0.1553","pValueComment":"P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status.","paramType":"Odds Ratio (OR)","paramValue":"1.5","statisticalMethod":"Regression, Logistic"},{"ciLowerLimit":"1.4","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"2.8","estimateComment":"The OR and confidence interval (CI) were calculated using logistic regression, adjusting for PD-L1 status, 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":"0.0003","pValueComment":"P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status.","paramType":"Odds Ratio (OR)","paramValue":"2","statisticalMethod":"Regression, Logistic"},{"ciLowerLimit":"1.1","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"2.3","estimateComment":"The OR and confidence interval (CI) were calculated using logistic regression, adjusting for PD-L1 status, 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":"0.0148","pValueComment":"P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status.","paramType":"Odds Ratio (OR)","paramValue":"1.6","statisticalMethod":"Regression, Logistic"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"38"},{"groupId":"OG001","value":"37"},{"groupId":"OG002","value":"24"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"141"},{"groupId":"OG001","value":"129"},{"groupId":"OG002","value":"115"}],"units":"Participants"}],"title":"Patients with improvement in fatigue"},{"categories":[{"measurements":[{"groupId":"OG000","value":"142"},{"groupId":"OG001","value":"130"},{"groupId":"OG002","value":"83"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"265"},{"groupId":"OG001","value":"270"},{"groupId":"OG002","value":"226"}],"units":"Participants"}],"title":"Patient with deterioration in pain"}],"denoms":[{"counts":[{"groupId":"OG000","value":"342"},{"groupId":"OG001","value":"346"},{"groupId":"OG002","value":"344"}],"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":"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":"Improvement in Fatigue and Deterioration in Pain Per FACT-BL, Full Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Mono Therapy vs SoC","type":"SECONDARY","unitOfMeasure":"Participants"}