{"analyses":[{"ciLowerLimit":"-0.23","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"-0.10","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.0001","pValueComment":"Stratified by RET mutation type (M918T vs. Others) and intended treatment if randomized to Arm B (Vandetanib vs. Cabozantinib).","paramType":"Mean Difference (Final Values)","paramValue":"-0.16","statisticalMethod":"Wilcoxon (Mann-Whitney)"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.169","value":"0.08"},{"groupId":"OG001","spread":"0.304","value":"0.24"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"145"},{"groupId":"OG001","value":"77"}],"units":"Participants"}],"description":"Comparative tolerability defined as a comparison of the proportion of time on treatment with high side effect bother as assessed by the FACT-GP5. The FACT-GP5 is a single question used to assess the overall bother of the treatment side effects. It is scored using a 5-point rating scale (0 = not at all; 1 = a little bit; 2 = somewhat; 3 = quite a bit; and 4 = very much), where lower scores reflect less bother from treatment side effects.\n\nTime with high side effect bother (i.e.) score of 3 or 4 is reported here and was derived as follows: cumulative amount of time, in weeks, during which a participant reports high side effect bother divided by the total duration of therapy (weeks), derived as (date of last study treatment dose - date of first study treatment dose + 1) divided by 7.","dispersionType":"Standard Deviation","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":"MEAN","populationDescription":"All participants who received the first dose of study treatment prior to the interim efficacy analysis and at least 6 months prior to the data cutoff date. Analysis of tolerability will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive (\"as treated\").","reportingStatus":"POSTED","timeFrame":"Baseline to Progressive Disease, Unacceptable Toxicity or Death from Any Cause Up to 39 Months","title":"Comparative Tolerability: Number of Weeks With High Side Effect Bother Based Score of 3 or 4 on the Functional Assessment of Cancer Therapy Item GP5 (FACT-GP5)","type":"SECONDARY","unitOfMeasure":"Weeks"}