{"classes":[{"categories":[{"measurements":[{"comment":"Upper Limit was not applicable or computable as median was just reached.","groupId":"OG000","lowerLimit":"19.32","upperLimit":"NA","value":"31.31"},{"comment":"Upper Limit was not applicable or computable as median was just reached.","groupId":"OG001","lowerLimit":"13.04","upperLimit":"NA","value":"20.07"}]}],"title":"CgA<=2x ULN (n=60,78)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"11.30","upperLimit":"17.08","value":"13.93"},{"groupId":"OG001","lowerLimit":"7.72","upperLimit":"11.14","value":"8.41"}]}],"title":"CgA>2x ULN (n=152,130)"}],"denoms":[{"counts":[{"groupId":"OG000","value":"212"},{"groupId":"OG001","value":"208"}],"units":"Participants"}],"description":"Serum CgA levels in urine are frequently elevated in patients with advanced carcinoid tumors. Baseline levels of serum CgA were characterized relative to the upper limited of normal (ULN). CgA levels exceeding 2 x ULN were considered to be 'Elevated'; otherwise considered as \"Non-elevated\".","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 CgA 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 Chromogranin A (CgA)","type":"SECONDARY","unitOfMeasure":"Months"}