{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"40"},{"groupId":"OG001","value":"75"},{"groupId":"OG002","value":"28.6"},{"groupId":"OG003","value":"61.9"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"20"},{"groupId":"OG001","value":"8"},{"groupId":"OG002","value":"7"},{"groupId":"OG003","value":"21"}],"units":"Participants"}],"description":"AE: any untoward medical occurrence in participants administered a pharmaceutical product; untoward medical occurrence does not necessarily have causal relationship with this treatment. AE can therefore be any unfavorable \\& unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of medicinal (investigational) product whether or not it is related to medicinal product. TEAE: any AE either reported for first time or worsening of pre-existing event after first dose of study drug \\& within 30 days of last administration of study drug. Serious TEAEs: any untoward medical occurrence that: 1)results in death, 2) is life-threatening, 3) requires inpatient hospitalization or prolongation of existing hospitalization, 4) results in persistent or significant disability/incapacity, 5) leads to a congenital anomaly/birth defect in the offspring of the participant or 6) is medically important event. Percentages were rounded off to 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 approximately 54.3 months in Part 1","title":"Part 1: Percentage of Participants Reporting One or More Serious Treatment-emergent Adverse Events (Serious TEAEs)","type":"PRIMARY","unitOfMeasure":"percentage of participants"}