{"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.0001","statisticalMethod":"One-sided unstratified log-rank"},{"groupIds":["OG002","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.0001","statisticalMethod":"One-sided unstratified log-rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"7.6","upperLimit":"12.7","value":"8.4"},{"groupId":"OG001","lowerLimit":"3.0","upperLimit":"5.7","value":"3.9"},{"groupId":"OG002","lowerLimit":"9.2","upperLimit":"18.5","value":"13.8"},{"groupId":"OG003","lowerLimit":"3.0","upperLimit":"5.9","value":"4.4"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"134"},{"groupId":"OG001","value":"69"},{"groupId":"OG002","value":"64"},{"groupId":"OG003","value":"31"}],"units":"Participants"}],"description":"Will be assessed per Response Evaluation Criteria in Solid Tumors 1.1 determined by retrospective independent central review. Will be compared between treatment arms using the stratified log rank test at one-sided level 0.025. The stratification factors will be used for the analysis. The hazard ratio (HR) for PFS will be estimated using a stratified Cox proportional hazards model, and the 95% confidence interval (CI) for the HR will be provided. Results from an unstratified analysis will also be provided. Kaplan-Meier methodology will be used to estimate the median PFS for each treatment arm, and Kaplan-Meier curves will be produced. Brookmeyer Crowley methodology will be used to construct the 95% CI for the median PFS for each treatment arm.","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":"36 months","title":"Progression-free Survival (PFS)","type":"PRIMARY","unitOfMeasure":"months"}