{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}],"title":"Positive ADA predose"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}],"title":"Positive ADA post dose"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}],"title":"Positive ADA at any time"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}],"title":"Positive ADA before and after dose"}],"denoms":[{"counts":[{"groupId":"OG000","value":"78"}],"units":"Participants"}],"description":"ADA testing included number of participants with positive pre-dose ADA response, number of participants with post-dose ADA response only, and number of participants with positive ADA response at any time. Collection of ADA was stopped if ADCT-301 administration was discontinued. For participants treated with ADCT-301 in combination with pembrolizumab, unless there was a penultimate observation of positive ADA response, no other collection of ADA data was necessary if ADCT-301 administration was discontinued.\n\nUpon consultation with the Sponsor, ADA samples were not collected anymore if ADCT-301 was permanently discontinued and pembrolizumab continues as single agent.","groups":[{"description":"Participants received 20, 30, 45, 60, 80, 100, 125 and 150 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.\n\nPembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion)","id":"OG000","title":"Overall Study"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Pharmacodynamic Analysis Set: The pharmacodynamic analysis set consisted of all participants who received study drug and had at least 1 valid pharmacodynamics/biomarker assessment. The data was pooled overall as pre-specified in protocol.\n\nIncludes participants with available data at each timepoint.","reportingStatus":"POSTED","timeFrame":"C1D1, from Pre-dose to 336 hr post dose.","title":"Number of Participants With Anti-drug Antibody (ADA) Response in Serum","type":"SECONDARY","unitOfMeasure":"Participants"}