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NCT01713946 · OUTCOME

Core Phase: Changes From Baseline in Number of Seizure-free Days

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
MEDIAN
Unit
Number of seizure-free days -per 28 days
Interval / dispersion
Full Range
Time frame
Baseline (8-week period before randomization), Week 7 to 18 (12-week maintenance period of the core phase)

What was measured

Comparison of seizure-free days relative to baseline in the everolimus low-trough treatment arm (3-7 ng/mL), high-trough treatment arm (9-15 ng/mL) and placebo arm during maintenance period of the core phase

Analysis population: The Full Analysis Set (FAS) comprised all patients to whom study treatment was assigned by randomization

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

Analysis denominator · Participants

GroupSource count
Everolimus LT Target of 3 to 7 ng/mL117
Everolimus HT Target of 9 to 15 ng/mL130
Placebo119

Reported measurements

Source class 1
Values in Number of seizure-free days -per 28 days · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Everolimus LT Target of 3 to 7 ng/mL2.00Not reported-23.127.7Not reported
Everolimus HT Target of 9 to 15 ng/mL4.01Not reported-10.027.5Not reported
Placebo0.47Not reported-13.421.8Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    -0.4
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    3.1
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY
    param Type
    Mean Difference (Final Values)
    param Value
    1.4
  2. ci Lower Limit
    2.5
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    5.9
    group Ids
    1. OG001
    2. OG002
    non Inferiority Type
    SUPERIORITY
    param Type
    Mean Difference (Final Values)
    param Value
    4.2
Complete source fields
analyses
  1. ci Lower Limit
    -0.4
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    3.1
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY
    param Type
    Mean Difference (Final Values)
    param Value
    1.4
  2. ci Lower Limit
    2.5
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    5.9
    group Ids
    1. OG001
    2. OG002
    non Inferiority Type
    SUPERIORITY
    param Type
    Mean Difference (Final Values)
    param Value
    4.2
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -23.1
        upper Limit
        27.7
        value
        2.00
      2. group Id
        OG001
        lower Limit
        -10.0
        upper Limit
        27.5
        value
        4.01
      3. group Id
        OG002
        lower Limit
        -13.4
        upper Limit
        21.8
        value
        0.47
denoms
  1. counts
    1. group Id
      OG000
      value
      117
    2. group Id
      OG001
      value
      130
    3. group Id
      OG002
      value
      119
    units
    Participants
description
Comparison of seizure-free days relative to baseline in the everolimus low-trough treatment arm (3-7 ng/mL), high-trough treatment arm (9-15 ng/mL) and placebo arm during maintenance period of the core phase
dispersion Type
Full Range
groups
  1. 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
  2. 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
  3. description
    Participants were randomized to receive placebo dispersible tablets for oral suspension.
    id
    OG002
    title
    Placebo
param Type
MEDIAN
population Description
The Full Analysis Set (FAS) comprised all patients to whom study treatment was assigned by randomization
reporting Status
POSTED
time Frame
Baseline (8-week period before randomization), Week 7 to 18 (12-week maintenance period of the core phase)
title
Core Phase: Changes From Baseline in Number of Seizure-free Days
type
SECONDARY
unit Of Measure
Number of seizure-free days -per 28 days

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

Preserved source evidence · Not medical advice