{"classes":[{"categories":[{"measurements":[{"comment":"Upper Limit was not applicable or computable as median was just reached.","groupId":"OG000","lowerLimit":"13.93","upperLimit":"NA","value":"21.75"},{"groupId":"OG001","lowerLimit":"8.71","upperLimit":"22.44","value":"13.90"}]}],"title":"5-HIAA <=median (n=93,96)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"10.61","upperLimit":"18.63","value":"13.83"},{"groupId":"OG001","lowerLimit":"8.08","upperLimit":"11.33","value":"8.41"}]}],"title":"5-HIAA > median (n=94,95)"}],"denoms":[{"counts":[{"groupId":"OG000","value":"187"},{"groupId":"OG001","value":"191"}],"units":"Participants"}],"description":"5-HIAA levels in urine are frequently elevated in patients with advanced carcinoid tumors. Baseline levels of 5-HIAA in urine were defined as 'High' if they exceeded the median value, and 'Low' if they were lower than or equal to the median.","dispersionType":"95% Confidence Interval","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":"MEDIAN","populationDescription":"The Full Analysis Set (FAS; Intent-to-treat Population) consists of all randomized patients. This analysis includes PFS patients with non missing baseline 5-HIAA data.","reportingStatus":"POSTED","timeFrame":"If elevated at baseline, evaluated every cycle visit (28 days/cycle) reported between day of first patient randomised, 10 January 2007, until cut-off date 02 April 2010","title":"Progression Free Survival (PFS) as Per Adjudicated Central Review by Baseline 5-hydroxyindoleacetic Acid (5-HIAA) Level","type":"SECONDARY","unitOfMeasure":"Months"}