{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"8.54","upperLimit":"16.49","value":"11.17"},{"groupId":"OG001","lowerLimit":"2.99","upperLimit":"5.55","value":"4.90"}]}],"title":"CgA Levels at baseline: CgA <= 2x ULN (n:121, 97)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"7.69","upperLimit":"13.80","value":"8.54"},{"groupId":"OG001","lowerLimit":"2.86","upperLimit":"5.39","value":"4.34"}]}],"title":"CgA levels at baseline: CgA > 2x ULN (n:84, 103)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"7.56","upperLimit":"14.00","value":"8.54"},{"groupId":"OG001","lowerLimit":"3.19","upperLimit":"8.54","value":"5.70"}]}],"title":"Early CgA response: Response (n: 48, 22)"},{"categories":[{"measurements":[{"comment":"Upper boundary of the 95% Confidence Interval (CI) was not be computable","groupId":"OG000","lowerLimit":"6.90","upperLimit":"NA","value":"11.14"},{"groupId":"OG001","lowerLimit":"2.83","upperLimit":"5.36","value":"3.19"}]}],"title":"Early CgA response: Non-Response (n:40, 82)"}],"denoms":[{"counts":[{"groupId":"OG000","value":"207"},{"groupId":"OG001","value":"203"}],"units":"Participants"}],"description":"Baseline levels of serum CgA SE were characterized towards progression free survival (PFS) as per local investigator assessment, relative to the upper limited of normal (ULN). CgA levels exceeding 2 x ULN were considered to be 'Elevated' otherwise considered as \"Non-elevated\". An 'early response' (applicable to only those patients with elevated levels at baseline) was defined as a decrease of greater than or equal to 30% from baseline to Cycle 2 Day 1 or normalization by Cycle 2 Day 1. CgA is widely expressed in well-differentiated pancreatic NET. CgA is present in the secretory granules of neuroendocrine cells. Pancreatic NET patients often present with elevated circulating levels of CgA in their blood. Baseline levels of these biomarkers are considered as prognostic factors.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants received 10 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).","id":"OG000","title":"Everolimus 10 mg/Day"},{"description":"Participants received matching placebo to everolimus daily plus best supportive care. Patients received their first dose of matching placebo at Visit 2 (Cycle 1 Day 1).","id":"OG001","title":"Placebo"}],"paramType":"MEDIAN","populationDescription":"The Full Analysis Set (FAS) consisted of all patients who were randomized.","reportingStatus":"POSTED","timeFrame":"Time from randomisation to dates of disease progression, death from any cause or last tumor assessment, reported between day of first patient randomised, 17 August 2007, until cut-off date 28 February 2010","title":"Progression Free Survival According to Chromogramin A Tumor Marker (CgA) Baseline Level and According to CgA Early Response","type":"SECONDARY","unitOfMeasure":"Months"}