{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"31.6","upperLimit":"86.1","value":"61.5"},{"groupId":"OG001","lowerLimit":"2.5","upperLimit":"100","value":"100"},{"comment":"The 95% CI was not estimable due to insufficient number of participants with events.","groupId":"OG002","lowerLimit":"NA","upperLimit":"NA","value":"0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"13"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"1"}],"units":"Participants"}],"description":"CBR=percentage of participants with CR/PR/SD which has been lasting at least 16 weeks (i.e. 4 cycles if 28 days are in 1 cycle) from first dose date. CR=disappearance of all target CNS/brain lesion, including lesions in brain stem \\&/ cerebellum identified at baseline\\&disappearance of all non-target CNS/brain lesion at baseline \\& no identification of new CNS/brain lesion. PR=at least a 30% decrease in SOD of any CNS/brain lesion, identified as target lesions at baseline \\& if in absence of unequivocal progression of any non-target CNS/brain lesion at baseline, or identification of new CNS/brain lesion. SD=neither sufficient shrinkage for PR nor sufficient increase for PD for target/non-target CNS/brain lesion, taking as reference smallest SOD while on study. PD=either at least 20% increase in SOD of target CNS/brain lesion, taking as reference smallest sum on study. Unequivocal progression of any CNS/brain lesion nontarget lesions at baseline, or identification of new CNS/brain lesion.","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"}],"paramType":"NUMBER","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 and sufficient evidence of a RET alteration. As specified in the SAP, CBR was to be assessed in RET-fusion CNS metastases sub-population (participants with CNS metastases) only. Hence only NSCLC arms are presented here. Phase 1 participants treated at 400 mg QD are pooled with Phase 2 participants for efficacy analysis.","reportingStatus":"POSTED","timeFrame":"Up to approximately 79.8 months","title":"Phase 2: Intracranial CBR in RET-fusion Positive NSCLC CNS Metastases Participants","type":"SECONDARY","unitOfMeasure":"percentage of participants"}