{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"46.2"},{"groupId":"OG001","value":"0.0"},{"groupId":"OG002","value":"0.0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"13"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"5"}],"units":"Participants"}],"description":"The primary efficacy endpoint was defined as the percentage of responders at Month 6 among pooled PNET patients (insulinoma, gastrinoma, VIPoma, and glucagonoma). A responder was defined as a patient who either attained normalization or had a greater than 50% reduction from baseline of the level of the primary biochemical tumor marker at Month 6 (M6). Four insulinoma pts were excluded from analysis because of unavailability of normal ranges for the associated primary biochemical tumor marker (insulin-to-glucose ratio). One patient with VIPoma with a normal baseline was also excluded. As a result, only 20 out of 25 patients with PNET were included in the assessment of the primary endpoint, which was less than the planned sample size of 34. Therefore, the primary objective could not be assessed with sufficient power. Patients with missing Month 6 assessment were considered as non-responders. Responder analyses are reported only for indications with minimum of 6 patients.","groups":[{"description":"One of the 10 types of PNETs analyzed","id":"OG000","title":"Gastrinoma"},{"description":"One of the 10 types of PNETs analyzed.","id":"OG001","title":"VIpoma"},{"description":"One of the 10 types of PNETs analyzed.","id":"OG002","title":"Glucagonoma"}],"paramType":"NUMBER","populationDescription":"The efficacy analyzable set included all enrolled patients who received at least one dose of pasireotide LAR and had indication-specific baseline primary biochemical tumor marker levels \\>ULN. Patients with baseline primary biochemical tumor marker levels either missing at baseline or missing ULN or baseline value ≤ ULN were excluded.","reportingStatus":"POSTED","timeFrame":"6 months","title":"Percentage of Responders at Month 6 - Pooled Pancreatic NETs (PNETs)","type":"PRIMARY","unitOfMeasure":"percentage of participants"}