{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"19.0","value":"29.5"},{"groupId":"OG001","spread":"111.6","value":"550"},{"groupId":"OG002","spread":"67.9","value":"30100"},{"groupId":"OG003","spread":"83.2","value":"208000"},{"groupId":"OG004","spread":"263.7","value":"7090"},{"groupId":"OG005","spread":"98.0","value":"10600"},{"groupId":"OG006","spread":"106.8","value":"17900"},{"groupId":"OG007","spread":"44.5","value":"287000"},{"groupId":"OG008","spread":"83.9","value":"197000"},{"groupId":"OG009","spread":"107.7","value":"229000"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"6"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"3"},{"groupId":"OG004","value":"4"},{"groupId":"OG005","value":"4"},{"groupId":"OG006","value":"4"},{"groupId":"OG007","value":"2"},{"groupId":"OG008","value":"6"},{"groupId":"OG009","value":"3"}],"units":"Participants"}],"title":"Cycle 1 Day 1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"34.8","value":"76.3"},{"groupId":"OG001","spread":"88.4","value":"1270"},{"groupId":"OG002","spread":"38.2","value":"23900"},{"groupId":"OG003","spread":"66.1","value":"285000"},{"groupId":"OG004","spread":"514.0","value":"8710"},{"groupId":"OG005","spread":"17.0","value":"19200"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"4"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"2"},{"groupId":"OG004","value":"3"},{"groupId":"OG005","value":"3"},{"groupId":"OG006","value":"0"},{"groupId":"OG007","value":"0"},{"groupId":"OG008","value":"0"},{"groupId":"OG009","value":"0"}],"units":"Participants"}],"title":"Cycle 1 Day 15"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"113.1","value":"128"},{"comment":"Geometric coefficient of variation was not estimable for a single participant.","groupId":"OG001","spread":"NA","value":"584"},{"groupId":"OG002","spread":"48.5","value":"27700"},{"comment":"Geometric coefficient of variation was not estimable for a single participant.","groupId":"OG005","spread":"NA","value":"6020"},{"groupId":"OG006","spread":"225.4","value":"15600"},{"groupId":"OG007","spread":"54.0","value":"332000"},{"groupId":"OG008","spread":"77.5","value":"190000"},{"groupId":"OG009","spread":"250.5","value":"582000"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"2"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"1"},{"groupId":"OG006","value":"3"},{"groupId":"OG007","value":"2"},{"groupId":"OG008","value":"5"},{"groupId":"OG009","value":"2"}],"units":"Participants"}],"title":"Cycle 2 Day 1"},{"categories":[{"measurements":[{"comment":"Geometric coefficient of variation was not estimable for a single participant.","groupId":"OG004","spread":"NA","value":"22200"},{"comment":"Geometric coefficient of variation was not estimable for a single participant.","groupId":"OG005","spread":"NA","value":"5090"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"1"},{"groupId":"OG005","value":"1"},{"groupId":"OG006","value":"0"},{"groupId":"OG007","value":"0"},{"groupId":"OG008","value":"0"},{"groupId":"OG009","value":"0"}],"units":"Participants"}],"title":"Cycle 2 Day 15"}],"denoms":[{"counts":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"6"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"3"},{"groupId":"OG004","value":"4"},{"groupId":"OG005","value":"4"},{"groupId":"OG006","value":"4"},{"groupId":"OG007","value":"2"},{"groupId":"OG008","value":"6"},{"groupId":"OG009","value":"3"}],"units":"Participants"}],"description":"As per planned analysis, data for this outcome measure was collected and reported dose-wise for each treatment schedule.","dispersionType":"Geometric Coefficient of Variation","groups":[{"description":"Participants received modakafusp alfa 0.01 mg/kg, infusion, IV, Q1W on Days 1, 8, 15 and 22 of each 28-day treatment cycle up to 2 cycles, followed by once on Days 1 and 15 of each 28-day treatment cycle up to 4 cycles, followed by once on Day 1 of each 28-day treatment cycle until treatment discontinuation.","id":"OG000","title":"Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.01 mg/kg"},{"description":"Participants received modakafusp alfa 0.1 mg/kg, infusion, IV, Q1W on Days 1, 8, 15 and 22 of each 28-day treatment cycle up to 2 cycles, followed by once on Days 1 and 15 of each 28-day treatment cycle up to 4 cycles, followed by once on Day 1 of each 28-day treatment cycle until treatment discontinuation.","id":"OG001","title":"Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.1 mg/kg"},{"description":"Participants received modakafusp alfa 0.4 mg/kg, infusion, IV, Q1W on Days 1, 8, 15 and 22 of each 28-day treatment cycle up to 2 cycles, followed by once on Days 1 and 15 of each 28-day treatment cycle up to 4 cycles, followed by once on Day 1 of each 28-day treatment cycle until treatment discontinuation.","id":"OG002","title":"Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.4 mg/kg"},{"description":"Participants received modakafusp alfa 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 once on Days 1 and 15 of each 28-day treatment cycle up to 4 cycles, followed by once on Day 1 of each 28-day treatment cycle until treatment discontinuation.","id":"OG003","title":"Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.75 mg/kg"},{"description":"Participants received modakafusp alfa 0.2 mg/kg, infusion, IV, Q2W on Days 1 and 15 of each 28-day treatment cycle until treatment discontinuation.","id":"OG004","title":"Part 1 (Dose Escalation) Schedule B: Modakafusp Alfa 0.2 mg/kg"},{"description":"Participants received modakafusp alfa 0.3 mg/kg, infusion, IV, Q2W on Days 1 and 15 of each 28-day treatment cycle until treatment discontinuation.","id":"OG005","title":"Part 1 (Dose Escalation) Schedule B: Modakafusp Alfa 0.3 mg/kg"},{"description":"Participants received modakafusp alfa 0.4 mg/kg, infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.","id":"OG006","title":"Part 1 (Dose Escalation) Schedule C: Modakafusp Alfa 0.4 mg/kg"},{"description":"Participants received modakafusp alfa 0.75 mg/kg, infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.","id":"OG007","title":"Part 1 (Dose Escalation) Schedule C: Modakafusp Alfa 0.75 mg/kg"},{"description":"Participants received modakafusp alfa 0.75 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.","id":"OG008","title":"Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 0.75 mg/kg"},{"description":"Participants received modakafusp alfa 1.5 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.","id":"OG009","title":"Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 1.5 mg/kg"}],"paramType":"GEOMETRIC_MEAN","populationDescription":"The PK Analysis Set included participants from the SAS who had sufficient data to calculate at least 1 PK parameter for modakafusp alfa. Overall number of participants analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis during the specified time-point.","reportingStatus":"POSTED","timeFrame":"Part1:Schedule A:Day 1 in Cycles1&2&Day15 in Cycle1;Schedule B: Day1&15 in Cycle 1;Schedule C:Day1 in Cycles1&2; Schedule D:Day 1 in Cycles1&2: Pre-infusion&at multiple times post-infusion (cycle length= 28 days for Schedule A, B&D;21 days for Schedule C)","title":"Part 1: AUClast: Area Under the Serum Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Modakafusp Alfa","type":"SECONDARY","unitOfMeasure":"h*ng/mL"}