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NCT01713946 · OUTCOME

Core Phase: Median Percentage Change From Baseline in Seizure Frequency by Time Normalized Minimum Concentration

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
Percentage change
Interval / dispersion
95% Confidence Interval
Time frame
Baseline (8-week period before randomization), Week 7 to 18 (12-week maintenance period of the core phase)

What was measured

Percentage change from baseline in average weekly seizure frequency during the maintenance period of the Core phase is calculated as follow: (SFcfb) = 100 × (SFB - SFM) ÷ SFB where SFB is the average weekly seizure frequency in the Baseline phase and SFM is the average weekly seizure frequency in the maintenance period of the Core phase. A positive percentage change from baseline (SFcfb) means a reduction in seizure frequency whereas a negative percentage change from baseline (SFcfb) means an increase in seizure frequency.

Analysis population: Confirmed PK Sample Set from all everolimus-treated patients in the Safety Set was defined as: Cmin collected prior to dose administration on the same treatment day and 20-28 hours after the previous dose, at steady state, and with no evidence of vomiting within 4 hours of the previous dose.

Groups in this outcome

<3 ng/mL

Observed TN-Cmin concentration during the maintenance of the core phase: \<3 ng/mL

3-7 ng/mL

Observed TN-Cmin concentration during the maintenance of the core phase:3 - 7 ng/mL

>7-<9 ng/mL

Observed TN-Cmin concentration during the maintenance of the core phase: \>7 - \<9 ng/mL

9-15 ng/mL

Observed TN-Cmin concentration during the maintenance of the core phase: 9 - 15 ng/mL

>15 ng/mL

Observed TN-Cmin concentration during the maintenance of the core phase: \>15 ng/mL

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

Analysis denominator · Participants

GroupSource count
<3 ng/mL14
3-7 ng/mL147
>7-<9 ng/mL52
9-15 ng/mL30
>15 ng/mL2

Reported measurements

Source class 1
Values in Percentage change · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
<3 ng/mL20.55Not reported-8.4535.39Not reported
3-7 ng/mL35.56Not reported24.4341.88Not reported
>7-<9 ng/mL39.72Not reported28.0262.79Not reported
9-15 ng/mL47.69Not reported36.4666.32Not reported
>15 ng/mL61.56Not reported42.7380.38Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -8.45
        upper Limit
        35.39
        value
        20.55
      2. group Id
        OG001
        lower Limit
        24.43
        upper Limit
        41.88
        value
        35.56
      3. group Id
        OG002
        lower Limit
        28.02
        upper Limit
        62.79
        value
        39.72
      4. group Id
        OG003
        lower Limit
        36.46
        upper Limit
        66.32
        value
        47.69
      5. group Id
        OG004
        lower Limit
        42.73
        upper Limit
        80.38
        value
        61.56
denoms
  1. counts
    1. group Id
      OG000
      value
      14
    2. group Id
      OG001
      value
      147
    3. group Id
      OG002
      value
      52
    4. group Id
      OG003
      value
      30
    5. group Id
      OG004
      value
      2
    units
    Participants
description
Percentage change from baseline in average weekly seizure frequency during the maintenance period of the Core phase is calculated as follow: (SFcfb) = 100 × (SFB - SFM) ÷ SFB where SFB is the average weekly seizure frequency in the Baseline phase and SFM is the average weekly seizure frequency in the maintenance period of the Core phase. A positive percentage change from baseline (SFcfb) means a reduction in seizure frequency whereas a negative percentage change from baseline (SFcfb) means an increase in seizure frequency.
dispersion Type
95% Confidence Interval
groups
  1. description
    Observed TN-Cmin concentration during the maintenance of the core phase: \<3 ng/mL
    id
    OG000
    title
    <3 ng/mL
  2. description
    Observed TN-Cmin concentration during the maintenance of the core phase:3 - 7 ng/mL
    id
    OG001
    title
    3-7 ng/mL
  3. description
    Observed TN-Cmin concentration during the maintenance of the core phase: \>7 - \<9 ng/mL
    id
    OG002
    title
    >7-<9 ng/mL
  4. description
    Observed TN-Cmin concentration during the maintenance of the core phase: 9 - 15 ng/mL
    id
    OG003
    title
    9-15 ng/mL
  5. description
    Observed TN-Cmin concentration during the maintenance of the core phase: \>15 ng/mL
    id
    OG004
    title
    >15 ng/mL
param Type
MEDIAN
population Description
Confirmed PK Sample Set from all everolimus-treated patients in the Safety Set was defined as: Cmin collected prior to dose administration on the same treatment day and 20-28 hours after the previous dose, at steady state, and with no evidence of vomiting within 4 hours of the previous dose.
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: Median Percentage Change From Baseline in Seizure Frequency by Time Normalized Minimum Concentration
type
SECONDARY
unit Of Measure
Percentage change

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

Preserved source evidence · Not medical advice