NCT01713946 · OUTCOME

Long Term Evaluation: Incidence of Suicide Attempt, Suicidal Ideation or Behavior During Core Phase Per Columbia Suicide Severity Rating Scale (C-SSRS) Outcomes

A Placebo-controlled Study of Efficacy & Safety of 2 Trough-ranges of Everolimus as Adjunctive Therapy in Patients With Tuberous Sclerosis Complex (TSC) & Refractory Partial-onset Seizures · Source last updated 2018-11-07

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: During everolimus treatment from start of everolimus up to permanent discontinuation of everolimus, an average of 2.3 years

What was measured

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.

Analysis population: 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.

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.

Everolimus Long Term Evaluation (LTE)

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.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

Group	Source count
Everolimus LT Target of 3 to 7 ng/mL	0
Everolimus HT Target of 9 to 15 ng/mL	0
Placebo	0
Everolimus Long Term Evaluation (LTE)	361

Reported measurements

Completed suicide

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Everolimus Long Term Evaluation (LTE)	0	Not reported	Not reported	Not reported	Not reported

Suicidal attempt

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Everolimus Long Term Evaluation (LTE)	1	Not reported	Not reported	Not reported	Not reported

Prep. actions toward imminent suicidal behavior

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Everolimus Long Term Evaluation (LTE)	2	Not reported	Not reported	Not reported	Not reported

Suicidal ideation

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Everolimus Long Term Evaluation (LTE)	7	Not reported	Not reported	Not reported	Not reported

Self-injurious behavior without suicide intent

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Everolimus Long Term Evaluation (LTE)	1	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG003
value
0
title
Completed suicide
categories
measurements
group Id
OG003
value
1
title
Suicidal attempt
categories
measurements
group Id
OG003
value
2
title
Prep. actions toward imminent suicidal behavior
categories
measurements
group Id
OG003
value
7
title
Suicidal ideation
categories
measurements
group Id
OG003
value
1
title
Self-injurious behavior without suicide intent

denoms

counts
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
361
units
Participants

description

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)

param Type

NUMBER

population Description

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.

reporting Status

POSTED

time Frame

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

unit Of Measure

Participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice