{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"208"},{"groupId":"OG001","value":"146"}]}],"title":"Clinically notable AE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"162"},{"groupId":"OG001","value":"109"}]}],"title":"Grade 3-4 Adverse Events"},{"categories":[{"measurements":[{"groupId":"OG000","value":"19"},{"groupId":"OG001","value":"11"}]}],"title":"On treatment death"},{"categories":[{"measurements":[{"groupId":"OG000","value":"126"},{"groupId":"OG001","value":"74"}]}],"title":"Serious adverse events"}],"denoms":[{"counts":[{"groupId":"OG000","value":"215"},{"groupId":"OG001","value":"211"}],"units":"Participants"}],"description":"AEs are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. SAEs are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.","groups":[{"description":"Everolimus was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity. Each treatment cycle lasted 28 days. Patients received their first dose of everolimus at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1, Day 1.","id":"OG000","title":"Octreotide+ Everolimus"},{"description":"Matching placebo was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity; Each treatment cycle lasted 28 days. Patients received their first dose of matching placebo at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1 Day 1.","id":"OG001","title":"Octreotide+ Placebo"}],"paramType":"NUMBER","populationDescription":"The Safety Set consists of all patients who received at least one dose of study drug and who had at least one valid post-baseline safety assessment.","reportingStatus":"POSTED","timeFrame":"From first day of treatment up to 28 days after last day of treatment in double blind","title":"Number of Patients With Adverse Events (AEs), Clinically Notable AE, Death, Serious Adverse Events (SAEs) (Double-Blind Phase)","type":"SECONDARY","unitOfMeasure":"Patients"}