{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"25.1","upperLimit":"80.8","value":"53.8"},{"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":"ORR=percentage of participants with CR or PR for at least 2 assessments with at least 28 days apart \\& no PD in between. CR=disappearance of all target CNS/brain lesion, including lesions in brain stem \\&/or 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 the SOD of any CNS/brain lesion, identified as RECIST 1.1 target lesions at baseline \\& if in the absence of unequivocal progression of any non-target CNS/brain lesion at baseline, or the identification of new CNS/brain lesion. PD=either at least 20% increase in the SOD of target CNS/brain lesion, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm or unequivocal progression of any CNS/brain lesion identified as RECIST 1.1 nontarget lesions at baseline, or the 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, ORR 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 ORR in RET-fusion Positive NSCLC Central Nervous System (CNS) Metastases Participants","type":"SECONDARY","unitOfMeasure":"percentage of participants"}