{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"11.4","upperLimit":"23.5","value":"16.4"},{"groupId":"OG001","lowerLimit":"9.3","upperLimit":"35.1","value":"13.0"},{"groupId":"OG002","lowerLimit":"9.2","upperLimit":"16.6","value":"12.1"},{"groupId":"OG003","lowerLimit":"19.9","upperLimit":"35.0","value":"24.9"},{"comment":"The upper limit of 95% CI was not estimable due to insufficient number of participants with events.","groupId":"OG004","lowerLimit":"37.2","upperLimit":"NA","value":"55.3"},{"comment":"The median and upper limit of 95% CI was not estimable due to insufficient number of participants with events.","groupId":"OG005","lowerLimit":"14.7","upperLimit":"NA","value":"NA"},{"groupId":"OG006","lowerLimit":"3.9","upperLimit":"12.8","value":"7.0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"141"},{"groupId":"OG001","value":"24"},{"groupId":"OG002","value":"116"},{"groupId":"OG003","value":"67"},{"groupId":"OG004","value":"78"},{"groupId":"OG005","value":"31"},{"groupId":"OG006","value":"28"}],"units":"Participants"}],"description":"PFS was defined as the time from the first dose of pralsetinib to the date of first documented PD or death due to any cause, whichever occurred first. PD was defined as at least a 20% increase in SOD of target lesions, taking as reference the smallest SOD on study (including baseline). PFS was analyzed using KM methods.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants who had RET-fusion positive NSCLC previously treated with platinum-based chemotherapies received pralsetinib, 400 mg orally, QD until discontinuation due to toxicity, disease progression, or other reasons.","id":"OG000","title":"RET- Fusion Positive NSCLC With Prior Platinum Treatment"},{"description":"Participants who had RET-fusion positive NSCLC previously treated with non-platinum or systemic therapies received pralsetinib, 400 mg orally, QD until discontinuation due to toxicity, disease progression, or other reasons.","id":"OG001","title":"RET-fusion Positive NSCLC With Non-platinum Systemic Treatment"},{"description":"Participants who had RET-fusion positive NSCLC not previously treated with systemic or platinum-based chemotherapies received pralsetinib, 400 mg orally, QD until discontinuation due to toxicity, disease progression, or other reasons.","id":"OG002","title":"RET-fusion Positive NSCLC With No Prior Systemic or Platinum Treatment"},{"description":"Participants who had RET- mutation positive MTC previously treated with either cabozantinib and/or vandetanib therapies received pralsetinib, 400 mg orally, QD until discontinuation due to toxicity, disease progression, or other reasons.","id":"OG003","title":"RET-mutation MTC With Prior Cabozantinib and/or Vandetanib Treatment"},{"description":"Participants who had RET- mutation positive MTC not previously treated with cabozantinib or vandetanib therapies received pralsetinib, 400 mg orally, QD until discontinuation due to toxicity, disease progression, or other reasons.","id":"OG004","title":"RET-mutation MTC With No Prior Cabozantinib or Vandetanib Treatment"},{"description":"Participants who had RET-fusion positive TC received pralsetinib, 400 mg, orally, QD until discontinuation due to toxicity, disease progression, or other reasons.","id":"OG005","title":"RET-fusion Positive TC"},{"description":"Participants who had other RET-positive solid tumors other than NSCLC and TC received pralsetinib, 400 mg, orally, QD until discontinuation due to toxicity, disease progression, or other reasons.","id":"OG006","title":"RET-fusion Positive Solid Tumors Other Than NSCLC and TC"}],"paramType":"MEDIAN","populationDescription":"Efficacy population included all participants who have been exposed to at least one dose of the study drug at the RP2D. As pre-specified in the SAP, PFS was to be assessed in participants with RET-fusion positive NSCLC, RET-mutation MTC, RET-fusion TC, and RET-fusion solid tumors other than NSCLC and TC. Hence, only the data for these arms is presented here. Overall number analyzed is the number of participants with data available for analysis.","reportingStatus":"POSTED","timeFrame":"Up to approximately 7 years","title":"Phase 2: Progression-free Survival (PFS)","type":"SECONDARY","unitOfMeasure":"months"}