{"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.2438","statisticalMethod":"One-sided stratified log-rank"},{"groupIds":["OG002","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"0.4426","statisticalMethod":"One-sided stratified log-rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"18.8","upperLimit":"30.4","value":"21.9"},{"groupId":"OG001","lowerLimit":"14.2","upperLimit":"30.0","value":"19.7"},{"comment":"Upper end of the confidence interval is not able to be estimated due to a low number of events","groupId":"OG002","lowerLimit":"31.3","upperLimit":"NA","value":"40.0"},{"comment":"Upper end of the confidence interval is not able to be estimated due to a low number of events","groupId":"OG003","lowerLimit":"23.4","upperLimit":"NA","value":"31.1"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"134"},{"groupId":"OG001","value":"69"},{"groupId":"OG002","value":"64"},{"groupId":"OG003","value":"31"}],"units":"Participants"}],"description":"The analyses for OS will follow intent-to-treat (ITT) principle and will be conducted separately within each cohort (pancreatic neuroendocrine tumor \\[NET\\] and carcinoid tumor). The distribution of OS will be estimated using the method of Kaplan-Meier. The median OS, along with the 95% CI, will be estimated by the two treatment groups. Overall survival will be compared between treatment arms using the stratified log-rank test at a one-sided cumulative 2.5% level of significance. The stratified Cox regression will be used to estimate the HR of OS, along with the 95% CI. A hierarchical approach will be used to control for family-wise type-I error rate, therefore OS will be formally statistically tested only if the primary efficacy endpoint, PFS, is statistically significantly different between the two treatment groups.","dispersionType":"95% Confidence Interval","groups":[{"description":"Patients receive cabozantinib S-malate PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, MRI, and/or x-ray imaging during screening and on study.\n\n\\>\n\n\\> Cabozantinib S-malate: Given PO\n\n\\>\n\n\\> Computed Tomography: Undergo CT\n\n\\>\n\n\\> Magnetic Resonance Imaging: Undergo MRI\n\n\\>\n\n\\> Quality-of-Life Assessment: Ancillary studies\n\n\\>\n\n\\> X-Ray Imaging: Undergo x-ray","id":"OG000","title":"Arm Ia (Cabozantinib S-malate, Extra-pancreatic NET Cohort [epNET])"},{"description":"Patients receive placebo PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, MRI, and/or x-ray imaging during screening and on study. Patients may crossover to receive cabozantinib S-malate at the time of disease progression.\n\n\\>\n\n\\> Computed Tomography: Undergo CT\n\n\\>\n\n\\> Magnetic Resonance Imaging: Undergo MRI\n\n\\>\n\n\\> Placebo Administration: Given PO\n\n\\>\n\n\\> Quality-of-Life Assessment: Ancillary studies\n\n\\>\n\n\\> X-Ray Imaging: Undergo x-ray","id":"OG001","title":"Arm IIa (Placebo, Extra-pancreatic NET Cohort [epNET])"},{"description":"Patients receive cabozantinib S-malate PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, MRI, and/or x-ray imaging during screening and on study.\n\n\\>\n\n\\> Cabozantinib S-malate: Given PO\n\n\\>\n\n\\> Computed Tomography: Undergo CT\n\n\\>\n\n\\> Magnetic Resonance Imaging: Undergo MRI\n\n\\>\n\n\\> Quality-of-Life Assessment: Ancillary studies\n\n\\>\n\n\\> X-Ray Imaging: Undergo x-ray","id":"OG002","title":"Arm Ib (Cabozantinib S-malate, Pancreatic NET Cohort [pNET])"},{"description":"Patients receive placebo PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, MRI, and/or x-ray imaging during screening and on study. Patients may crossover to receive cabozantinib S-malate at the time of disease progression.\n\n\\>\n\n\\> Computed Tomography: Undergo CT\n\n\\>\n\n\\> Magnetic Resonance Imaging: Undergo MRI\n\n\\>\n\n\\> Placebo Administration: Given PO\n\n\\>\n\n\\> Quality-of-Life Assessment: Ancillary studies\n\n\\>\n\n\\> X-Ray Imaging: Undergo x-ray","id":"OG003","title":"Arm IIb (Placebo, Pancreatic NET Cohort [pNET])"}],"paramType":"MEDIAN","reportingStatus":"POSTED","timeFrame":"60 months","title":"Overall Survival (OS)","type":"SECONDARY","unitOfMeasure":"months"}