{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"7250","value":"23000"},{"groupId":"OG001","spread":"6450","value":"21100"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"10"},{"groupId":"OG001","value":"29"}],"units":"Participants"}],"description":"AUC1week was defined as the area under the plasma concentration versus time curve from time 0 to 1 week post dose calculated using the trapezoidal method over the dosing interval after the first administration in Cycle 1.","dispersionType":"Standard Deviation","groups":[{"description":"Participants received isatuximab 10 mg/kg IV infusion QWx4 followed by Q2W (on Days 1, 8, 15 and 22 in Cycle 1, and on Days 1 and 15 in Cycle 2 and beyond of a 28-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or any other reason.","id":"OG000","title":"Phase 2: Isatuximab"},{"description":"All participants who received isatuximab in combination with cemiplimab were included in this arm.","id":"OG001","title":"Phase 1 and 2: Combination Arm: Isatuximab + Cemiplimab"}],"paramType":"MEAN","populationDescription":"Analysis was performed on the PK population. \"Isatuximab + Cemiplimab\" arm includes 3 and 27 participants from phase 1 and phase 2, respectively. Same dose of isatuximab was administered to all participants in phase 1 and phase 2 part of study in Isatuximab + Cemiplimab Q2W and Q4W arms. Hence PK analysis was combined for phase 1 and phase 2 Isatuximab + Cemiplimab Q2W and Q4W arms. Only those participants with data available were analyzed.","reportingStatus":"POSTED","timeFrame":"At SOI, EOI, EOI+4 hours, 72 hours and 168 hours on Day 1 of Cycle 1","title":"Phase 1 and 2: AUC From Time 0 to Week 1 (AUC1week) of Isatuximab Alone and in Combination With Cemiplimab","type":"SECONDARY","unitOfMeasure":"(mcg*hour)/mL"}