{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}],"title":"Completed suicide"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}],"title":"Suicide attempt"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}],"title":"Prep actions toward imminent suicidal behavior"},{"categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"0"}]}],"title":"Suicidal ideation"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}],"title":"Self-injurious behavior without suicide intent"}],"denoms":[{"counts":[{"groupId":"OG000","value":"117"},{"groupId":"OG001","value":"130"},{"groupId":"OG002","value":"119"}],"units":"Participants"}],"description":"Comparison of suicidality using the C-SSRS in the everolimus low-trough treatment arm (3-7 ng/mL), high-trough treatment arm (9-15 ng/mL) and placebo arm. The Columbia-Suicide Severity Rating Scale (C-SSRS) is a questionnaire used for suicide assessment developed by multiple institutions, including Columbia University, with NIMH support. The scale is evidence-supported and is part of a national and international public health initiative involving the assessment of suicidality. There are different scoring systems depending on the population. The important elements to note are that the higher the scores on the individual items and the more \"yes\" items, the higher the suicide risk.","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"}],"paramType":"NUMBER","populationDescription":"The Safety Set comprised all patients who received at least one dose of study treatment and had at least one post-Baseline safety assessment in the Core phase (where the statement that a patient had no AE constitutes a safety assessment).","reportingStatus":"POSTED","timeFrame":"Baseline, Week 18","title":"Core Phase: Incidence of Suicide Attempt, Suicidal Ideation or Behavior During Core Phase Per Columbia Suicide Severity Rating Scale (C-SSRS) Outcomes","type":"SECONDARY","unitOfMeasure":"Participants"}