{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"95"},{"groupId":"OG001","value":"100"},{"groupId":"OG002","value":"85.7"},{"groupId":"OG003","value":"95.2"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"20"},{"groupId":"OG001","value":"8"},{"groupId":"OG002","value":"7"},{"groupId":"OG003","value":"21"}],"units":"Participants"}],"description":"An AE is defined as any untoward medical occurrence in a participants administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not it is related to the medicinal product. TEAEs grades were evaluated as per NCI CTCAE, Version 5.0. Grade 1 scaled as mild; Grade 2 scaled as moderate; Grade 3 scaled as severe or medically significant but not immediately life-threatening; Grade 4 scaled as life-threatening consequences; and Grade 5 scaled as death related to AE. 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"}],"paramType":"NUMBER","populationDescription":"The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573.","reportingStatus":"POSTED","timeFrame":"Up to 54.3 months in Part 1","title":"Part 1: Percentage of Participants Reporting One or More Grade 3 or Higher TEAEs","type":"PRIMARY","unitOfMeasure":"percentage of participants"}