{"classes":[{"categories":[{"measurements":[{"comment":"The median and upper limit of 95% CI was not estimable due to insufficient number of participants with events.","groupId":"OG000","lowerLimit":"11.2","upperLimit":"NA","value":"NA"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"14"}],"units":"Participants"}],"title":"CCDC6"},{"categories":[{"measurements":[{"comment":"The upper limit of 95% CI was not estimable due to insufficient number of participants with events.","groupId":"OG000","lowerLimit":"6.9","upperLimit":"NA","value":"15.2"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"6"}],"units":"Participants"}],"title":"NCOA4"},{"categories":[{"measurements":[{"comment":"The median and upper limit of 95% CI was not estimable due to insufficient number of participants with events.","groupId":"OG000","lowerLimit":"23.6","upperLimit":"NA","value":"NA"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"}],"units":"Participants"}],"title":"Other"}],"denoms":[{"counts":[{"groupId":"OG000","value":"23"}],"units":"Participants"}],"description":"Oncogenic RET activation has been implicated as a driver in MTC. These rearrangements typically produce chimeric transcripts that encode a fusion protein consisting of the RET kinase domain coupled to a protein with a dimerization domain (e.g., KIF5B, CCDC6, NCOA4). RET genotypes were determined by local testing and/or central analysis of ctDNA. DOR was assessed in participants having specific RET rearrangements. DOR=time from first documented CR/PR to date of first documented PD or death due to any cause, whichever occurs first. Per RECIST, CR= disappearance of all target lesions or any pathological lymph nodes (target or non-target) having a reduction in the short axis to \\<10 mm. PR=at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in absence of CR. PD=as at least a 20% increase in SOD of target lesions, taking as reference smallest SOD on study (including baseline). DOR was analyzed using the KM method.","dispersionType":"95% Confidence Interval","groups":[{"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":"OG000","title":"RET-fusion Positive TC"}],"paramType":"MEDIAN","populationDescription":"RET-altered measurable disease population included participants in the efficacy population who have measurable (target) disease per RECIST v1.1, at baseline according to BICR \\& sufficient evidence of a RET alteration. As prespecified in SAP, Phase 1 participants treated at 400 mg QD are pooled with Phase 2 participants for efficacy analysis. Participants who had a response of CR/PR were analyzed in this outcome measure. Number analyzed is the number of participants with the specified mutation.","reportingStatus":"POSTED","timeFrame":"Up to approximately 79.8 months","title":"Phase 1 and Phase 2: DOR in RET-fusion Positive TC Participants With Specific RET Gene Status","type":"SECONDARY","unitOfMeasure":"months"}