{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"37"}]}],"title":"ADA positive at any visit (ADA prevalence)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"8"}]}],"title":"Treatment-emergent ADA positive (ADA Incidence)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}],"title":"Treatment-boosted ADA"},{"categories":[{"measurements":[{"groupId":"OG000","value":"7"}]}],"title":"Treatment-induced ADA (Positive Post-baseline only)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"29"}]}],"title":"ADA Positive at Baseline only"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}],"title":"ADA Positive Post-baseline and Positive at Baseline"},{"categories":[{"measurements":[{"groupId":"OG000","value":"4"}]}],"title":"Persistently Positive"},{"categories":[{"measurements":[{"groupId":"OG000","value":"4"}]}],"title":"Transiently Positive"},{"categories":[{"measurements":[{"groupId":"OG000","value":"6"}]}],"title":"nAb Positive at any visit"}],"denoms":[{"counts":[{"groupId":"OG000","value":"453"}],"units":"Participants"}],"description":"Whole blood samples for assessing ADA for durvalumab in serum were collected from patients undergoing durvalumab treatment, following the specified assessment schedule. ADA prevalence is the proportion of patients with a positive ADA result at any time, baseline or post-baseline. Treatment-emergent ADA includes both treatment-induced and treatment-boosted ADA. Its incidence is the proportion of patients with treatment-emergent ADA positivity. Treatment-boosted ADA refers to a baseline-positive ADA titer that increased ≥4-fold during the study. Persistently positive patients have at least two post-baseline ADA-positive readings, with at least 16 weeks between the first and last, or an ADA-positive result at the final assessment. This includes baseline-positive patients meeting these criteria. Transiently positive is defined by at least one post-baseline ADA-positive reading without being persistently positive, including baseline-positive patients meeting these terms.","groups":[{"description":"Treatments and dosing regimens: Durvalumab 1500 mg IV q3w (neoadjuvant) 1500 mg IV q4w (adjuvant post-radical cystectomy) Day 1 and Day 8 (gemcitabine 1000 mg/m2 IV) of each 21-day cycle (neoadjuvant) Day 1 and Day 8 (cisplatin 35mg/m2 IV) or Day 1 (cisplatin 70 mg/m2 IV) each 21-day cycle (neoadjuvant) Dosing will be adjusted based on renal function","id":"OG000","title":"Durvalumab + Gemcitabine + Cisplatin"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"The ADA analysis set includes all participants who had non-missing baseline ADA and at least one non-missing post-baseline ADA result.","reportingStatus":"POSTED","timeFrame":"Up to 12 months","title":"Immunogenicity of Durvalumab When Used in Combination With Gemcitabine/Cisplatin as Measured by Presence of Antidrug Antibodies (ADA)","type":"SECONDARY","unitOfMeasure":"Participants"}