{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"19"},{"groupId":"OG001","value":"10"}]}],"title":"ADA positive at any visit"},{"categories":[{"measurements":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"5"}]}],"title":"ADA positive post-baseline only"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}],"title":"Treatment-boosted ADA positive"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"2"}]}],"title":"ADA positive at baseline and post-baseline"},{"categories":[{"measurements":[{"groupId":"OG000","value":"9"},{"groupId":"OG001","value":"3"}]}],"title":"ADA positive at baseline only"},{"categories":[{"measurements":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"5"}]}],"title":"ADA persistently positive"},{"categories":[{"measurements":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"2"}]}],"title":"ADA transient positive"},{"categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"0"}]}],"title":"Neutralizing antibodies positive at any visit"}],"denoms":[{"counts":[{"groupId":"OG000","value":"416"},{"groupId":"OG001","value":"204"}],"units":"Participants"}],"description":"ADA positive post-baseline only was also referred to as treatment-induced ADA positive. Treatment-boosted ADA was defined as baseline positive ADA titer that was boosted by ≥4-fold following drug administration. Persistently positive was defined as positive at ≥2 post-baseline assessments (with ≥16 weeks between first and last positive) or positive at last post-baseline assessment. Transiently positive was defined as having at least 1 post-baseline ADA positive assessment and not fulfilling the conditions of persistently positive. Confirmed ADA positive samples were subsequently tested in a neutralizing antibody assay.","groups":[{"description":"Patients in the durvalumab (MEDI4736) monotherapy group were to receive durvalumab 10 mg/kg Q2W via intravenous infusion for up to 12 months.","id":"OG000","title":"Durvalumab (MEDI4736)"},{"description":"Patients in the placebo group were to receive matching placebo for intravenous infusion Q2W for up to 12 months.","id":"OG001","title":"Placebo"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"ADA evaluable population included patients who had non-missing baseline ADA and at least 1 non-missing post-baseline ADA results.","reportingStatus":"POSTED","timeFrame":"Samples were collected pre-dose on Day 1 (Week 0), Week 8, Week 24 and Week 48. Analysis performed at 22 Mar 2018 DCO.","title":"Number of Patients With Anti-Drug Antibody (ADA) Response to Durvalumab","type":"SECONDARY","unitOfMeasure":"Participants"}