{"classes":[{"categories":[{"measurements":[{"comment":"Since data was available only for 1 participant geometric co-efficient of variation was not evaluable.","groupId":"OG000","spread":"NA","value":"1.04"},{"groupId":"OG001","spread":"27.6","value":"1.25"},{"groupId":"OG002","spread":"114","value":"3.20"},{"groupId":"OG003","spread":"110","value":"1.17"},{"groupId":"OG004","spread":"40.5","value":"1.87"},{"groupId":"OG005","spread":"102","value":"1.62"},{"comment":"Values were LTR for 1 participant. Since data was evaluable only for 1 participant geometric co-efficient of variation was not evaluable.","groupId":"OG006","spread":"NA","value":"2.97"},{"groupId":"OG007","spread":"40.7","value":"1.91"},{"comment":"Since data was available only for 1 participant geometric co-efficient of variation was not evaluable.","groupId":"OG008","spread":"NA","value":"1.41"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"6"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"12"},{"groupId":"OG004","value":"9"},{"groupId":"OG005","value":"10"},{"groupId":"OG006","value":"2"},{"groupId":"OG007","value":"4"},{"groupId":"OG008","value":"1"}],"units":"Participants"}],"description":"Number of participants in each arm of this OM is based on the actual treatment received. 1 participant originally assigned to the 200/100 mg arm received the 100/100 mg treatment and hence, was counted under the 100/100 mg arm for this OM.","dispersionType":"Geometric Coefficient of Variation","groups":[{"description":"Participants received pralsetinib 30 mg, orally, QD until discontinuation due to toxicity, disease progression, or other reasons.","id":"OG000","title":"Phase I: Pralsetinib 30 mg"},{"description":"Participants received pralsetinib 60 mg orally, QD until discontinuation due to toxicity, disease progression, or other reasons.","id":"OG001","title":"Phase I: Pralsetinib 60 mg"},{"description":"Participants received pralsetinib 100 mg orally, QD until discontinuation due to toxicity, disease progression, or other reasons.","id":"OG002","title":"Phase I: Pralsetinib 100 mg"},{"description":"Participants received pralsetinib 200 mg, orally, QD until discontinuation due to toxicity, disease progression, or other reasons.","id":"OG003","title":"Phase I: Pralsetinib 200 mg"},{"description":"Participants received pralsetinib 300 mg, orally, QD until discontinuation due to toxicity, disease progression, or other reasons.","id":"OG004","title":"Phase I: Pralsetinib 300 mg"},{"description":"Participants received pralsetinib 400 mg, orally, QD until discontinuation due to toxicity, disease progression, or other reasons.","id":"OG005","title":"Phase I: Pralsetinib 400 mg"},{"description":"Participants received pralsetinib 600 mg, orally, QD until discontinuation due to toxicity, disease progression, or other reasons.","id":"OG006","title":"Phase I: Pralsetinib 600 mg"},{"description":"Participants received pralsetinib 100 mg, orally, BID until discontinuation due to toxicity, disease progression, or other reasons.","id":"OG007","title":"Phase I: Pralsetinib 100/100 mg"},{"description":"Participants received pralsetinib 200 mg in the morning and then 100 mg in the evening orally until discontinuation due to toxicity, disease progression, or other reasons.","id":"OG008","title":"Phase I: Pralsetinib 200/100 mg"}],"paramType":"GEOMETRIC_MEAN","populationDescription":"PK evaluable population included all participants who received at least one dose of pralsetinib and from whom at least one post dose PK sample was collected. Overall number analyzed is the number of participants with data available for analysis.","reportingStatus":"POSTED","timeFrame":"24 hours postdose on Day 15 of Cycle 1 (1 cycle = 28 days)","title":"Phase 1: Accumulation Ratio for Cmax (RCmax)","type":"SECONDARY","unitOfMeasure":"ratio"}