{"analyses":[{"ciLowerLimit":"0.153","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.423","estimateComment":"Stratified by RET mutation type (M918T vs. Others) and intended treatment if randomized to Arm B (Vandetanib vs. Cabozantinib).","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.0001","paramType":"Hazard Ratio (HR)","paramValue":"0.254","statisticalComment":"Stratified by RET mutation type (M918T vs. Others) and intended treatment if randomized to Arm B (Vandetanib vs. Cabozantinib).","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"comment":"Data not available due to high censoring.","groupId":"OG000","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"groupId":"OG001","lowerLimit":"11.27","upperLimit":"25.10","value":"13.93"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"193"},{"groupId":"OG001","value":"98"}],"units":"Participants"}],"description":"TFFS by BICR is defined as the time from randomization to the first occurrence of:\n\n* documented radiographic disease progression per RECIST 1.1 as assessed by BICR; or\n* unacceptable toxicity leading to treatment discontinuation as assessed by the investigator.\n\nProgressive Disease (PD) was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions.\n\nTo qualify as an event, the toxicity must be from an intolerable AE (defined as any study drug-related AE that meets protocol guidance for treatment discontinuation, with the exception of alopecia); or death (due to any cause).","dispersionType":"95% Confidence Interval","groups":[{"description":"160 milligrams Selpercatinib administered orally (PO) twice daily (BID).\n\nAdolescent Dose: 92 mg/m2 BID (not to exceed 160 mg BID).","id":"OG000","title":"Selpercatinib (TRT A)"},{"description":"140 mg Cabozantinib administered orally daily (QD) or 300 mg Vandetanib administered orally QD per physician choice.\n\nCabozantinib Adolescent Dose: 40 mg/m2.\n\nVandetanib Adolescent Dose:\n\n* 0.7 - \\<0.9 - 100 mg every other day (QOD)\n* 0.9 - \\<1.2 - 100 mg QD\n* 1.2 - \\<1.6 - 7-day schedule 100 mg - 200 mg - 100 mg - 200 mg - 100 mg - 200 mg - 100 mg\n* ≥1.6 - 200 QD","id":"OG001","title":"Cabozantinib or Vandetanib (TRT B)"}],"paramType":"MEDIAN","populationDescription":"All randomized participants, even if a participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol. Censored participants: Selpercatinib - 166; Cabozantinib or Vandetanib - 61","reportingStatus":"POSTED","timeFrame":"Baseline to Progressive Disease, Unacceptable Toxicity or Death from Any Cause Up to 39 Months","title":"Treatment Failure-Free Survival (TFFS) by Blinded Independent Committee Review (BICR)","type":"SECONDARY","unitOfMeasure":"Months"}