{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"292"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"340"}],"units":"Participants"}],"title":"ADA evaluable patients"},{"categories":[{"measurements":[{"groupId":"OG000","value":"64"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"292"}],"units":"Participants"}],"title":"ADA positive at any visit (ADA Prevalence)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"54"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"292"}],"units":"Participants"}],"title":"Treatment-emergent ADA positive (ADA Incidence)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"292"}],"units":"Participants"}],"title":"Treatment-boosted ADA"},{"categories":[{"measurements":[{"groupId":"OG000","value":"53"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"292"}],"units":"Participants"}],"title":"Treatment-induced ADA (Positive Post-baseline only)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"8"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"292"}],"units":"Participants"}],"title":"ADA Positive at Baseline only"},{"categories":[{"measurements":[{"groupId":"OG000","value":"3"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"292"}],"units":"Participants"}],"title":"ADA Positive Post-baseline and Positive at Baseline"},{"categories":[{"measurements":[{"groupId":"OG000","value":"31"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"292"}],"units":"Participants"}],"title":"Persistently Positive"},{"categories":[{"measurements":[{"groupId":"OG000","value":"25"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"292"}],"units":"Participants"}],"title":"Transiently Positive"},{"categories":[{"measurements":[{"groupId":"OG000","value":"50"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"292"}],"units":"Participants"}],"title":"nAb Positive at any visit"}],"denoms":[{"counts":[{"groupId":"OG000","value":"340"}],"units":"Participants"}],"description":"Serum Samples will be measured for the presence of ADAs and ADA-neutralizing antibodies for Tremelimumab using validated assays. Tiered analysis will be performed to include screening, confirmatory, and titer assay components, and positive-negative cut points previously statistically determined from drug-naïve validation samples will be used. Persistently positive is defined as having at least 2 post-baseline ADA positive measurements with at least 16 weeks (112 days) between the first and last positive measurements, or an ADA positive result at the last available assessment. Transiently positive is defined as having at least one post-baseline ADA positive measurement and not fulfilling the conditions for persistently positive. The category may include patients meeting these criteria who are ADA positive at baseline.","groups":[{"description":"MEDI4736 (Durvalumab) + Tremelimumab","id":"OG000","title":"Combination Therapy"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"ADA evaluable patients is defined as patients in the safety analysis set who have a non-missing baseline ADA and at least one non-missing post-baseline result","reportingStatus":"POSTED","timeFrame":"At week 0, 4, 12 and at follow-up Month 3.","title":"Number of Participants With Anti-Drug Antibody (ADA) Response to Tremelimumab, Safety Analysis Set - ADA Evaluable Patients","type":"SECONDARY","unitOfMeasure":"Participants"}