{"classes":[{"categories":[{"measurements":[{"groupId":"OG003","value":"0"}]}],"title":"Completed suicide"},{"categories":[{"measurements":[{"groupId":"OG003","value":"1"}]}],"title":"Suicidal attempt"},{"categories":[{"measurements":[{"groupId":"OG003","value":"2"}]}],"title":"Prep. actions toward imminent suicidal behavior"},{"categories":[{"measurements":[{"groupId":"OG003","value":"7"}]}],"title":"Suicidal ideation"},{"categories":[{"measurements":[{"groupId":"OG003","value":"1"}]}],"title":"Self-injurious behavior without suicide intent"}],"denoms":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"361"}],"units":"Participants"}],"description":"The C-SSRS was completed at each visit. The table below presents the number of patients who reported at least one completed suicide, one suicide attempt, one preparatory action toward imminent suicidal behavior, one suicidal ideation and one self-injurious behavior without suicidal intent at any time point after starting everolimus.","groups":[{"description":"Participants were randomized to receive everolimus dispersible tablets for oral suspension with titration to a low trough (LT) range of 3 to 7 ng/mL","id":"OG000","title":"Everolimus LT Target of 3 to 7 ng/mL"},{"description":"Participants were randomized to receive everolimus dispersible tablets for oral suspension with titration to a high trough (HT) range of 9 to 15 ng/mL","id":"OG001","title":"Everolimus HT Target of 9 to 15 ng/mL"},{"description":"Participants were randomized to receive placebo dispersible tablets for oral suspension.","id":"OG002","title":"Placebo"},{"description":"Participants who were treated with everolimus either in the Core or Extension phases of the study and were evaluated for longer term safety and efficacy.","id":"OG003","title":"Everolimus Long Term Evaluation (LTE)"}],"paramType":"NUMBER","populationDescription":"The LTE Efficacy Set included 361 patients who received at least one dose of everolimus in Core and Extension phase and had at least one valid post-baseline efficacy evaluation.","reportingStatus":"POSTED","timeFrame":"During everolimus treatment from start of everolimus up to permanent discontinuation of everolimus, an average of 2.3 years","title":"Long Term Evaluation: Incidence of Suicide Attempt, Suicidal Ideation or Behavior During Core Phase Per Columbia Suicide Severity Rating Scale (C-SSRS) Outcomes","type":"SECONDARY","unitOfMeasure":"Participants"}