TriangleNCT01713946 · OUTCOME
Core Phase: Incidence of Suicide Attempt, Suicidal Ideation or Behavior During Core Phase Per Columbia Suicide Severity Rating Scale (C-SSRS) Outcomes
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- Baseline, Week 18
What was measured
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.
Analysis population: 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).
Groups in this outcome
Everolimus LT Target of 3 to 7 ng/mL
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
Everolimus HT Target of 9 to 15 ng/mL
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
Placebo
Participants were randomized to receive placebo dispersible tablets for oral suspension.
| Group | Source count |
|---|---|
| Everolimus LT Target of 3 to 7 ng/mL | 117 |
| Everolimus HT Target of 9 to 15 ng/mL | 130 |
| Placebo | 119 |
Reported measurements
Completed suicide
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Everolimus LT Target of 3 to 7 ng/mL | 0 | Not reported | Not reported | Not reported | Not reported |
| Everolimus HT Target of 9 to 15 ng/mL | 0 | Not reported | Not reported | Not reported | Not reported |
| Placebo | 0 | Not reported | Not reported | Not reported | Not reported |
Suicide attempt
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Everolimus LT Target of 3 to 7 ng/mL | 1 | Not reported | Not reported | Not reported | Not reported |
| Everolimus HT Target of 9 to 15 ng/mL | 0 | Not reported | Not reported | Not reported | Not reported |
| Placebo | 0 | Not reported | Not reported | Not reported | Not reported |
Prep actions toward imminent suicidal behavior
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Everolimus LT Target of 3 to 7 ng/mL | 2 | Not reported | Not reported | Not reported | Not reported |
| Everolimus HT Target of 9 to 15 ng/mL | 0 | Not reported | Not reported | Not reported | Not reported |
| Placebo | 0 | Not reported | Not reported | Not reported | Not reported |
Suicidal ideation
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Everolimus LT Target of 3 to 7 ng/mL | 3 | Not reported | Not reported | Not reported | Not reported |
| Everolimus HT Target of 9 to 15 ng/mL | 1 | Not reported | Not reported | Not reported | Not reported |
| Placebo | 0 | Not reported | Not reported | Not reported | Not reported |
Self-injurious behavior without suicide intent
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Everolimus LT Target of 3 to 7 ng/mL | 0 | Not reported | Not reported | Not reported | Not reported |
| Everolimus HT Target of 9 to 15 ng/mL | 0 | Not reported | Not reported | Not reported | Not reported |
| Placebo | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- title
- Completed suicide
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- title
- Suicide attempt
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- title
- Prep actions toward imminent suicidal behavior
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 0
- title
- Suicidal ideation
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- title
- Self-injurious behavior without suicide intent
- denoms
- counts
- group Id
- OG000
- value
- 117
- group Id
- OG001
- value
- 130
- group Id
- 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
- param Type
- NUMBER
- population Description
- 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).
- reporting Status
- POSTED
- time Frame
- 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
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice