{"classes":[{"categories":[{"measurements":[{"comment":"The 95% confidence interval (CI) was not estimable due to insufficient number of participants with events.","groupId":"OG000","lowerLimit":"NA","upperLimit":"NA","value":"0"},{"groupId":"OG001","lowerLimit":"11.8","upperLimit":"88.2","value":"50.0"},{"groupId":"OG002","lowerLimit":"5.3","upperLimit":"85.3","value":"40.0"},{"groupId":"OG003","lowerLimit":"13.9","upperLimit":"68.4","value":"38.5"},{"groupId":"OG004","lowerLimit":"16.7","upperLimit":"76.6","value":"45.5"},{"groupId":"OG005","lowerLimit":"15.2","upperLimit":"72.3","value":"41.7"},{"groupId":"OG006","lowerLimit":"0.99","upperLimit":"80.6","value":"25.0"},{"groupId":"OG007","lowerLimit":"28.4","upperLimit":"99.5","value":"80.0"},{"groupId":"OG008","lowerLimit":"19.4","upperLimit":"99.4","value":"75.0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"6"},{"groupId":"OG002","value":"5"},{"groupId":"OG003","value":"13"},{"groupId":"OG004","value":"11"},{"groupId":"OG005","value":"12"},{"groupId":"OG006","value":"4"},{"groupId":"OG007","value":"5"},{"groupId":"OG008","value":"4"}],"units":"Participants"}],"description":"ORR was defined as the percentage of participants with a confirmed CR or PR for at least two assessments with at least 28 days apart and no PD in between. Per RECIST v1.1, CR was defined as the disappearance of all target lesions or any pathological lymph nodes (whether target or non-target) having a reduction in the short axis to \\<10 mm. PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR. PD was defined as at least a 20% increase in SOD of target lesions, taking as reference the smallest SOD on study (including baseline). ORR and its two-sided 95% CI, based on the exact binomial distribution (Clopper-Pearson), was presented.","dispersionType":"95% Confidence Interval","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":"NUMBER","populationDescription":"Efficacy population included all participants who have been exposed to at least one dose of the study drug on or prior to 11 July 2019.","reportingStatus":"POSTED","timeFrame":"Up to approximately 28 months","title":"Phase 1: ORR","type":"SECONDARY","unitOfMeasure":"percentage of participants"}