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NCT01713946 · OUTCOME

Core Phase: Response Rate 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 of responders
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

Comparison of response rate in seizure frequency for 5 categories of time-normalized minimum concentration (Cmin, TN) (\< 3 ng/mL; 3-7 ng/mL; \>7-\<9 ng/mL; 9-15 ng/mL; \>15 ng/mL). Response rate is the percentage of patients with ≥ 50% reduction from baseline in average weekly partial-onset seizure frequency during the maintenance period of the Core phase.

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 of responders · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
<3 ng/mL14.3Not reported1.842.8Not reported
3-7 ng/mL29.9Not reported22.738.0Not reported
>7-<9 ng/mL44.2Not reported30.558.7Not reported
9-15 ng/mL50.0Not reported31.368.7Not reported
>15 ng/mL50.0Not reported1.398.7Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.8
        upper Limit
        42.8
        value
        14.3
      2. group Id
        OG001
        lower Limit
        22.7
        upper Limit
        38.0
        value
        29.9
      3. group Id
        OG002
        lower Limit
        30.5
        upper Limit
        58.7
        value
        44.2
      4. group Id
        OG003
        lower Limit
        31.3
        upper Limit
        68.7
        value
        50.0
      5. group Id
        OG004
        lower Limit
        1.3
        upper Limit
        98.7
        value
        50.0
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
Comparison of response rate in seizure frequency for 5 categories of time-normalized minimum concentration (Cmin, TN) (\< 3 ng/mL; 3-7 ng/mL; \>7-\<9 ng/mL; 9-15 ng/mL; \>15 ng/mL). Response rate is the percentage of patients with ≥ 50% reduction from baseline in average weekly partial-onset seizure frequency during the maintenance period of the Core phase.
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: Response Rate in Seizure Frequency by Time Normalized Minimum Concentration
type
SECONDARY
unit Of Measure
Percentage of responders

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

Preserved source evidence · Not medical advice