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NCT00789828 · OUTCOME

Everolimus Trough Concentrations (Cmin) at 24 Hours After Last Dose

Efficacy and Safety of Everolimus (RAD001) in Patients of All Ages With Subependymal Giant Cell Astrocytoma Associated With Tuberous Sclerosis Complex (TSC)(EXIST-1) · Source last updated 2016-02-03

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEAN
Unit
ng/mL
Interval / dispersion
Standard Deviation
Time frame
24 hours post dose on Week 6, Week 24, Week 48, Week 72, Week 96, Week 144, and Week 240

What was measured

The participants were assessed for everolimus trough concentration (Cmin) at 24 hours time point after previous dose administration, at a steady state following 5 days of consistent dosing, if the participant did not vomit within 4 hours of previous dose. Tandem liquid chromatography-mass spectrometry method was used for evaluation. Cmin values were categorized as \<5 ng/mL, 5-10 ng/mL, and \>10 ng/mL, concentrations below the lower limit of quantification were entered as 0 ng/mL.

Analysis population: The analysis was performed in the Safety Set population. The 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.

Groups in this outcome

Everolimus (Core Period)

Participants received oral dose of everolimus 4.5 mg/m\^2 daily as an initial starting dose to attain the whole blood trough concentrations in range of 5-15 ng/mL. Dose adjustments were permitted based on safety and whole blood trough concentrations.

Everolimus (Extension Period)

Participants received oral dose of everolimus 4.5 mg/m\^2 daily as an initial starting dose to attain blood trough concentrations in range of 5-15 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
Everolimus (Core Period)78
Everolimus (Extension Period)111

Reported measurements

Week 6 (n= 64, 94)
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Everolimus (Core Period)5.83.68Not reportedNot reportedNot reported
Everolimus (Extension Period)6.093.708Not reportedNot reportedNot reported
Week 24 (n= 64, 89)
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Everolimus (Core Period)6.593.43Not reportedNot reportedNot reported
Everolimus (Extension Period)6.863.504Not reportedNot reportedNot reported
Week 48 (n= 23, 86)
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Everolimus (Core Period)7.283.11Not reportedNot reportedNot reported
Everolimus (Extension Period)7.073.214Not reportedNot reportedNot reported
Week 72 (n= 4, 92)
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Everolimus (Core Period)6.082.19Not reportedNot reportedNot reported
Everolimus (Extension Period)7.253.66Not reportedNot reportedNot reported
Week 96 (n= 0, 83)
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Everolimus (Core Period)NANANot reportedNot reportedNo participant was evaluable, so value was not available.
Everolimus (Extension Period)7.093.697Not reportedNot reportedNot reported
Week 144 (n= 0, 69)
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Everolimus (Core Period)NANANot reportedNot reportedNo participant was evaluable, so value was not available.
Everolimus (Extension Period)7.283.35Not reportedNot reportedNot reported
Week 240 (n= 0, 13)
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Everolimus (Core Period)NANANot reportedNot reportedNo participant was evaluable, so value was not available.
Everolimus (Extension Period)5.852.507Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        3.68
        value
        5.8
      2. group Id
        OG001
        spread
        3.708
        value
        6.09
    title
    Week 6 (n= 64, 94)
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        3.43
        value
        6.59
      2. group Id
        OG001
        spread
        3.504
        value
        6.86
    title
    Week 24 (n= 64, 89)
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        3.11
        value
        7.28
      2. group Id
        OG001
        spread
        3.214
        value
        7.07
    title
    Week 48 (n= 23, 86)
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        2.19
        value
        6.08
      2. group Id
        OG001
        spread
        3.66
        value
        7.25
    title
    Week 72 (n= 4, 92)
  5. categories
    1. measurements
      1. comment
        No participant was evaluable, so value was not available.
        group Id
        OG000
        spread
        NA
        value
        NA
      2. group Id
        OG001
        spread
        3.697
        value
        7.09
    title
    Week 96 (n= 0, 83)
  6. categories
    1. measurements
      1. comment
        No participant was evaluable, so value was not available.
        group Id
        OG000
        spread
        NA
        value
        NA
      2. group Id
        OG001
        spread
        3.35
        value
        7.28
    title
    Week 144 (n= 0, 69)
  7. categories
    1. measurements
      1. comment
        No participant was evaluable, so value was not available.
        group Id
        OG000
        spread
        NA
        value
        NA
      2. group Id
        OG001
        spread
        2.507
        value
        5.85
    title
    Week 240 (n= 0, 13)
denoms
  1. counts
    1. group Id
      OG000
      value
      78
    2. group Id
      OG001
      value
      111
    units
    Participants
description
The participants were assessed for everolimus trough concentration (Cmin) at 24 hours time point after previous dose administration, at a steady state following 5 days of consistent dosing, if the participant did not vomit within 4 hours of previous dose. Tandem liquid chromatography-mass spectrometry method was used for evaluation. Cmin values were categorized as \<5 ng/mL, 5-10 ng/mL, and \>10 ng/mL, concentrations below the lower limit of quantification were entered as 0 ng/mL.
dispersion Type
Standard Deviation
groups
  1. description
    Participants received oral dose of everolimus 4.5 mg/m\^2 daily as an initial starting dose to attain the whole blood trough concentrations in range of 5-15 ng/mL. Dose adjustments were permitted based on safety and whole blood trough concentrations.
    id
    OG000
    title
    Everolimus (Core Period)
  2. description
    Participants received oral dose of everolimus 4.5 mg/m\^2 daily as an initial starting dose to attain blood trough concentrations in range of 5-15 ng/mL.
    id
    OG001
    title
    Everolimus (Extension Period)
param Type
MEAN
population Description
The analysis was performed in the Safety Set population. The 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.
reporting Status
POSTED
time Frame
24 hours post dose on Week 6, Week 24, Week 48, Week 72, Week 96, Week 144, and Week 240
title
Everolimus Trough Concentrations (Cmin) at 24 Hours After Last Dose
type
SECONDARY
unit Of Measure
ng/mL

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Preserved source evidence · Not medical advice