{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"37"},{"groupId":"OG001","value":"540"},{"groupId":"OG002","value":"9"},{"groupId":"OG003","value":"590"}]}],"title":"AEs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"26"},{"groupId":"OG001","value":"381"},{"groupId":"OG002","value":"7"},{"groupId":"OG003","value":"416"}]}],"title":"SAEs"}],"denoms":[{"counts":[{"groupId":"OG000","value":"37"},{"groupId":"OG001","value":"540"},{"groupId":"OG002","value":"9"},{"groupId":"OG003","value":"590"}],"units":"Participants"}],"description":"An AE was any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE can be any unfavorable and unintended sign (e.g., an abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, without any judgment about causality. A SAE is any significant hazard, contraindication, side effect that is fatal or life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is medically significant or requires intervention to prevent one or other of the outcomes listed above.","groups":[{"description":"Participants received pralsetinib, 300 mg or less, orally, QD until discontinuation due to toxicity, disease progression, or other reasons.","id":"OG000","title":"Pralsetinib ≤ 300 mg QD"},{"description":"Participants received pralsetinib, 400 mg, orally, QD until discontinuation due to toxicity, disease progression, or other reasons.","id":"OG001","title":"Pralsetinib 400 mg QD"},{"description":"Participants received pralsetinib, 100 mg, orally, BID or 200 mg in the morning and then 100 mg in the evening, orally, until discontinuation due to toxicity, disease progression, or other reasons.","id":"OG002","title":"Pralsetinib BID Dosing Schedule"},{"description":"Participants received pralsetinib at varying doses at the QD and BID schedule until discontinuation due to toxicity, disease progression, or other reasons.","id":"OG003","title":"Pralsetinib All Doses"}],"paramType":"NUMBER","populationDescription":"Safety Population included all participants who have received at least 1 dose of the study drug regardless of starting dose levels. As pre-specified in the SAP, safety data was to be analyzed and reported as per the pre-planned grouped dose level II (SAP section 3.6.5.2). Hence, per dose safety data is not presented for this study.","reportingStatus":"POSTED","timeFrame":"From Cycle 1 Day 1 up to 30 days after the final dose of study drug (up to approximately 6.7 years)","title":"Phase 1 and Phase 2: Number of Participants With AEs and Serious AEs (SAEs)","type":"PRIMARY","unitOfMeasure":"percentage of participants"}