{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"10"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"9.5"},{"groupId":"OG004","value":"12.5"},{"groupId":"OG005","value":"66.7"},{"groupId":"OG006","value":"24"},{"groupId":"OG007","value":"25"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"20"},{"groupId":"OG001","value":"8"},{"groupId":"OG002","value":"7"},{"groupId":"OG003","value":"21"},{"groupId":"OG004","value":"8"},{"groupId":"OG005","value":"3"},{"groupId":"OG006","value":"25"},{"groupId":"OG007","value":"8"}],"units":"Participants"}],"description":"Percentage of participants with TEAEs meeting DLT definition were reported. Toxicity was evaluated as per the NCI CTCAE, Version 5.0. The hematologic TEAEs of Grade ≥3 clearly unrelated to the underlying disease and occur during the first cycle that are considered DLTs: Grade ≥3 hemolysis; Grade 4 neutropenia for \\>7 consecutive days; Grade 4 thrombocytopenia for \\>14 consecutive days; Grade 3 thrombocytopenia with clinically significant bleeding; Any other Grade ≥4 hematologic toxicity except for Grade 4 lymphopenia. An incomplete recovery from treatment-related toxicity causing \\>2-week delay in the next scheduled infusion before the initiation of Cycle 2 were considered a DLT. Percentages were rounded off to the nearest decimal.","groups":[{"description":"Participants received modakafusp alfa 0.001 up to 0.75 mg/kg, infusion, IV, Q1W on Days 1, 8, 15 and 22 of each 28-day treatment cycle up to 2 cycles, followed by Q2W on Days 1 and 15 of each 28-day treatment cycle up to 4 cycles, followed by Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.","id":"OG000","title":"Part 1 (Dose Escalation) Schedule A"},{"description":"Participants received modakafusp alfa 0.20 up to 0.30 mg/kg, infusion, IV, Q2W on Days 1 and 15 of each 28-day treatment cycle until treatment discontinuation.","id":"OG001","title":"Part 1 (Dose Escalation) Schedule B"},{"description":"Participants received modakafusp alfa 0.40 up to 0.75 mg/kg, infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.","id":"OG002","title":"Part 1 (Dose Escalation) Schedule C"},{"description":"Participants received modakafusp alfa 1.5 up to 6.0 mg/kg, infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.","id":"OG003","title":"Part 1 (Dose Escalation) Schedule D"},{"description":"Participants received modakafusp alfa 0.400 mg/kg infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.","id":"OG004","title":"Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa"},{"description":"Participants received modakafusp alfa 0.400 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.","id":"OG005","title":"Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa + Dexamethasone"},{"description":"Participants received modakafusp alfa 1.500 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.","id":"OG006","title":"Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa"},{"description":"Participants received modakafusp alfa 1.500 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.","id":"OG007","title":"Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa + Dexamethasone"}],"paramType":"NUMBER","populationDescription":"The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. Overall number of participants analyzed is the number of participants with data available for analysis.","reportingStatus":"POSTED","timeFrame":"Up to 54.3 months in Part 1; Up to 34.7 months in Part 2","title":"Parts 1 and 2: Percentage of Participants With Dose-limiting Toxicities (DLTs)- Like Events","type":"SECONDARY","unitOfMeasure":"percentage of participants"}