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NCT01713946 · OUTCOME

Seizure Free Rates by Time Window

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
Percentage of seizure-free participants
Interval / dispersion
95% Confidence Interval
Time frame
Weeks 18, 30, 42, 54, 66, 78, 90 & 102

What was measured

Percentage of seizure-free participants for each 12-week time window.

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

GroupSource count
Everolimus LT Target of 3 to 7 ng/mL0
Everolimus HT Target of 9 to 15 ng/mL0
Placebo0
Everolimus Long Term Evaluation (LTE)361

Reported measurements

Week 18

Analysis denominator · Participants

GroupSource count
Everolimus LT Target of 3 to 7 ng/mL0
Everolimus HT Target of 9 to 15 ng/mL0
Placebo0
Everolimus Long Term Evaluation (LTE)352
Values in Percentage of seizure-free participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Everolimus Long Term Evaluation (LTE)3.98Not reported2.26.6Not reported
Week 30

Analysis denominator · Participants

GroupSource count
Everolimus LT Target of 3 to 7 ng/mL0
Everolimus HT Target of 9 to 15 ng/mL0
Placebo0
Everolimus Long Term Evaluation (LTE)335
Values in Percentage of seizure-free participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Everolimus Long Term Evaluation (LTE)6.87Not reported4.410.1Not reported
Week 42

Analysis denominator · Participants

GroupSource count
Everolimus LT Target of 3 to 7 ng/mL0
Everolimus HT Target of 9 to 15 ng/mL0
Placebo0
Everolimus Long Term Evaluation (LTE)320
Values in Percentage of seizure-free participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Everolimus Long Term Evaluation (LTE)8.44Not reported5.612.0Not reported
Week 54

Analysis denominator · Participants

GroupSource count
Everolimus LT Target of 3 to 7 ng/mL0
Everolimus HT Target of 9 to 15 ng/mL0
Placebo0
Everolimus Long Term Evaluation (LTE)299
Values in Percentage of seizure-free participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Everolimus Long Term Evaluation (LTE)8.70Not reported5.812.5Not reported
Week 66

Analysis denominator · Participants

GroupSource count
Everolimus LT Target of 3 to 7 ng/mL0
Everolimus HT Target of 9 to 15 ng/mL0
Placebo0
Everolimus Long Term Evaluation (LTE)282
Values in Percentage of seizure-free participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Everolimus Long Term Evaluation (LTE)10.99Not reported7.615.2Not reported
Week 78

Analysis denominator · Participants

GroupSource count
Everolimus LT Target of 3 to 7 ng/mL0
Everolimus HT Target of 9 to 15 ng/mL0
Placebo0
Everolimus Long Term Evaluation (LTE)252
Values in Percentage of seizure-free participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Everolimus Long Term Evaluation (LTE)13.49Not reported9.518.3Not reported
Week 90

Analysis denominator · Participants

GroupSource count
Everolimus LT Target of 3 to 7 ng/mL0
Everolimus HT Target of 9 to 15 ng/mL0
Placebo0
Everolimus Long Term Evaluation (LTE)222
Values in Percentage of seizure-free participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Everolimus Long Term Evaluation (LTE)14.86Not reported10.520.2Not reported
Week 102

Analysis denominator · Participants

GroupSource count
Everolimus LT Target of 3 to 7 ng/mL0
Everolimus HT Target of 9 to 15 ng/mL0
Placebo0
Everolimus Long Term Evaluation (LTE)191
Values in Percentage of seizure-free participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Everolimus Long Term Evaluation (LTE)15.18Not reported10.421.1Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG003
        lower Limit
        2.2
        upper Limit
        6.6
        value
        3.98
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        352
      units
      Participants
    title
    Week 18
  2. categories
    1. measurements
      1. group Id
        OG003
        lower Limit
        4.4
        upper Limit
        10.1
        value
        6.87
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        335
      units
      Participants
    title
    Week 30
  3. categories
    1. measurements
      1. group Id
        OG003
        lower Limit
        5.6
        upper Limit
        12.0
        value
        8.44
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        320
      units
      Participants
    title
    Week 42
  4. categories
    1. measurements
      1. group Id
        OG003
        lower Limit
        5.8
        upper Limit
        12.5
        value
        8.70
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        299
      units
      Participants
    title
    Week 54
  5. categories
    1. measurements
      1. group Id
        OG003
        lower Limit
        7.6
        upper Limit
        15.2
        value
        10.99
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        282
      units
      Participants
    title
    Week 66
  6. categories
    1. measurements
      1. group Id
        OG003
        lower Limit
        9.5
        upper Limit
        18.3
        value
        13.49
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        252
      units
      Participants
    title
    Week 78
  7. categories
    1. measurements
      1. group Id
        OG003
        lower Limit
        10.5
        upper Limit
        20.2
        value
        14.86
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        222
      units
      Participants
    title
    Week 90
  8. categories
    1. measurements
      1. group Id
        OG003
        lower Limit
        10.4
        upper Limit
        21.1
        value
        15.18
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        191
      units
      Participants
    title
    Week 102
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    2. group Id
      OG001
      value
      0
    3. group Id
      OG002
      value
      0
    4. group Id
      OG003
      value
      361
    units
    Participants
description
Percentage of seizure-free participants for each 12-week time window.
dispersion Type
95% Confidence Interval
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
  4. 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
Weeks 18, 30, 42, 54, 66, 78, 90 & 102
title
Seizure Free Rates by Time Window
type
SECONDARY
unit Of Measure
Percentage of seizure-free participants

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

Preserved source evidence · Not medical advice