{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.81","value":"4.3"},{"groupId":"OG001","spread":"1.00","value":"5.1"},{"groupId":"OG002","spread":"2.63","value":"3.9"},{"groupId":"OG003","spread":"2.11","value":"5.7"},{"groupId":"OG004","spread":"4.14","value":"6.1"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"6"},{"groupId":"OG003","value":"2"},{"groupId":"OG004","value":"5"}],"units":"Participants"}],"title":"Cycle 1 Day 1: 1 hour post-dose"},{"categories":[{"measurements":[{"comment":"Standard Deviation could not be estimated due to insufficient number of participants available for analysis.","groupId":"OG001","spread":"NA","value":"4.3"},{"groupId":"OG002","spread":"1.47","value":"3.7"},{"groupId":"OG003","spread":"0.14","value":"4.0"},{"groupId":"OG004","spread":"1.06","value":"4.1"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"5"},{"groupId":"OG003","value":"2"},{"groupId":"OG004","value":"4"}],"units":"Participants"}],"title":"Cycle 1 Day 1: 4 hour post-dose"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"1.12","value":"2.4"},{"groupId":"OG001","spread":"0.65","value":"3.8"},{"groupId":"OG002","spread":"0.62","value":"2.2"},{"comment":"Standard Deviation could not be estimated due to insufficient number of participants available for analysis.","groupId":"OG003","spread":"NA","value":"3.5"},{"groupId":"OG004","spread":"1.60","value":"4.4"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"4"},{"groupId":"OG003","value":"1"},{"groupId":"OG004","value":"5"}],"units":"Participants"}],"title":"Cycle 1 Day 1: 24 hour post-dose"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.01","value":"1.6"},{"groupId":"OG001","spread":"0.30","value":"2.5"},{"groupId":"OG002","spread":"0.78","value":"1.8"},{"groupId":"OG003","spread":"0.07","value":"2.4"},{"groupId":"OG004","spread":"0.39","value":"2.2"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"5"},{"groupId":"OG003","value":"2"},{"groupId":"OG004","value":"3"}],"units":"Participants"}],"title":"Cycle 1 Day 8: Pre-dose"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.03","value":"3.5"},{"groupId":"OG001","spread":"1.18","value":"4.0"},{"groupId":"OG002","spread":"2.83","value":"6.0"},{"groupId":"OG003","spread":"0.35","value":"4.1"},{"groupId":"OG004","spread":"1.12","value":"5.6"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"6"},{"groupId":"OG003","value":"2"},{"groupId":"OG004","value":"3"}],"units":"Participants"}],"title":"Cycle 1 Day 8: 1 hour post-dose"},{"categories":[{"measurements":[{"groupId":"OG002","spread":"0.61","value":"1.4"},{"comment":"Standard Deviation could not be estimated due to insufficient number of participants available for analysis.","groupId":"OG003","spread":"NA","value":"2.8"},{"groupId":"OG004","spread":"0.89","value":"2.3"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"4"},{"groupId":"OG003","value":"1"},{"groupId":"OG004","value":"4"}],"units":"Participants"}],"title":"Cycle 1 Day 15: Pre-dose"}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"6"},{"groupId":"OG003","value":"2"},{"groupId":"OG004","value":"5"}],"units":"Participants"}],"description":"Blood samples were collected to assess TAK-981-SUMO adduct formation. TAK-981-SUMO adduct formation in peripheral blood lymphocytes was tested by flow cytometry with an antibody recognizing the TAK-981-SUMO adduct formation during the inhibition of the SUMO-activating enzyme by TAK-981.","dispersionType":"Standard Deviation","groups":[{"description":"Participants received TAK-981 60 mg, infusion, intravenously, twice weekly on Days 1, 4, 8, 11 and 15, and mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15 and 22 during Cycles 1 and 2, then once every 2 weeks during Cycles 3 through 6, further once every 4 weeks, until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.","id":"OG000","title":"Phase 1b, Part 1: TAK-981 60 mg BIW + Mezagitamab 600 mg"},{"description":"Participants received TAK-981 90 mg, infusion, intravenously, twice weekly on Days 1, 4, 8, 11 and 15, and mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15 and 22 during Cycles 1 and 2, then once every 2 weeks during Cycles 3 through 6, further once every 4 weeks, until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.","id":"OG001","title":"Phase 1b, Part 1: TAK-981 90 mg BIW + Mezagitamab 600 mg"},{"description":"Participants received TAK-981 90 mg, infusion, intravenously, in combination with mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15, 22 during Cycles 1 and 2, then every 2 weeks during Cycles 3 through 6, further once every 4 weeks until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.","id":"OG002","title":"Phase 1b, Part 1: TAK-981 90 mg QW + Mezagitamab 600 mg"},{"description":"Participants received TAK-981 120 mg, infusion, intravenously, twice weekly on Days 1, 4, 8, 11 and 15, and mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15 and 22 during Cycles 1 and 2, then once every 2 weeks during Cycles 3 through 6, further once every 4 weeks, until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.","id":"OG003","title":"Phase 1b, Part 1: TAK-981 120 mg BIW + Mezagitamab 600 mg"},{"description":"Participants received TAK-981 120 mg, infusion, intravenously, in combination with mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15, 22 during Cycles 1 and 2, then every 2 weeks during Cycles 3 through 6, further once every 4 weeks until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.","id":"OG004","title":"Phase 1b, Part 1: TAK-981 120 mg QW + Mezagitamab 600 mg"}],"paramType":"MEAN","populationDescription":"Pharmacodynamic analysis set included participants who provided evaluable blood samples (Cycle 1 Day 1 predose sample and at least 1 postdose sample). Here \"overall number of participants analyzed\" signifies participants who were evaluable for this outcome measure and here, \"number analyzed\" signifies participants evaluable at specified time-points.","reportingStatus":"POSTED","timeFrame":"Cycle 1 Day 1: 1, 4, and 24 hours post-dose; Cycle 1 Day 8: Pre-dose, and 1 hour post-dose; Cycle 1 Day 15: Pre-dose (Cycle length = 28 days)","title":"Phases 1b, Part 1: Fold Change From Baseline in Level of TAK-981-Small Ubiquitin-like Modifier (TAK-981-SUMO) Adduct Formation in Peripheral Blood Lymphocytes","type":"SECONDARY","unitOfMeasure":"fold change"}