{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"400"}]}],"title":"MTD"},{"categories":[{"measurements":[{"groupId":"OG000","value":"400"}]}],"title":"RP2D"}],"denoms":[{"counts":[{"groupId":"OG000","value":"51"}],"units":"Participants"}],"description":"MTD was defined as the highest tolerated dose of pralsetinib without causing dose limiting toxicities (DLTs). DLT was defined as any Grade ≥3 adverse event (AE) occurring during Cycle 1 during Phase 1 (dose escalation) that is not clearly caused by something other than pralsetinib. RP2D was defined as the highest dose with acceptable toxicity as determined from dose-escalation phase.","groups":[{"description":"Participants received pralsetinib at varying doses at a QD schedule until discontinuation due to toxicity, disease progression, or other reasons.","id":"OG000","title":"Phase 1: All Participants QD"}],"paramType":"NUMBER","populationDescription":"Dose-determining population included all participants in the dose-escalation part who have received ≥75% (21 days) of the study drug and completed safety evaluations through Cycle 1 Day 28 or experienced a DLT.","reportingStatus":"POSTED","timeFrame":"Up to approximately 30.8 months","title":"Phase 1 : Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of Pralsetinib","type":"PRIMARY","unitOfMeasure":"mg"}