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NCT00789828 · OUTCOME

Everolimus Blood Concentration (C2h) at 2 Hours Post 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
2 hours post dose on Week 6, Week 24, Week 48, Week 96, Week 144, and Week 240

What was measured

The participants were assessed for everolimus blood concentration at 2 hours time point after dose administration on the same day, if the participant did not vomit between previous dose and blood sample collection. Tandem liquid chromatography-mass spectrometry method was used for evaluation. C2h values were categorized as \< 20 ng/mL, 20-50 ng/mL, and \> 50 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 (Only evaluable PK Samples), defined as participants who received at least one dose of the double-blind study drug, with a valid post baseline assessment. 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= 37, 47)
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Everolimus (Core Period)27.5215.24Not reportedNot reportedNot reported
Everolimus (Extension Period)27.7416.202Not reportedNot reportedNot reported
Week 24 (n= 11, 13)
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Everolimus (Core Period)38.715.76Not reportedNot reportedNot reported
Everolimus (Extension Period)39.2514.662Not reportedNot reportedNot reported
Week 48 (n= 1, 3)
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Everolimus (Core Period)23.2NANot reportedNot reportedOnly one participant was evaluable, so value was not available.
Everolimus (Extension Period)49.7328.884Not reportedNot reportedNot reported
Week 96 (n= 0, 6)
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)31.6321.902Not reportedNot reportedNot reported
Week 144 (n= 0, 6)
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)26.3311.908Not reportedNot reportedNot reported
Week 240 (n= 0, 0)
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)NANANot reportedNot reportedNo participant was evaluable, so value was not available.
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        15.24
        value
        27.52
      2. group Id
        OG001
        spread
        16.202
        value
        27.74
    title
    Week 6 (n= 37, 47)
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        15.76
        value
        38.7
      2. group Id
        OG001
        spread
        14.662
        value
        39.25
    title
    Week 24 (n= 11, 13)
  3. categories
    1. measurements
      1. comment
        Only one participant was evaluable, so value was not available.
        group Id
        OG000
        spread
        NA
        value
        23.2
      2. group Id
        OG001
        spread
        28.884
        value
        49.73
    title
    Week 48 (n= 1, 3)
  4. 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
        21.902
        value
        31.63
    title
    Week 96 (n= 0, 6)
  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
        11.908
        value
        26.33
    title
    Week 144 (n= 0, 6)
  6. categories
    1. measurements
      1. comment
        No participant was evaluable, so value was not available.
        group Id
        OG000
        spread
        NA
        value
        NA
      2. comment
        No participant was evaluable, so value was not available.
        group Id
        OG001
        spread
        NA
        value
        NA
    title
    Week 240 (n= 0, 0)
denoms
  1. counts
    1. group Id
      OG000
      value
      78
    2. group Id
      OG001
      value
      111
    units
    Participants
description
The participants were assessed for everolimus blood concentration at 2 hours time point after dose administration on the same day, if the participant did not vomit between previous dose and blood sample collection. Tandem liquid chromatography-mass spectrometry method was used for evaluation. C2h values were categorized as \< 20 ng/mL, 20-50 ng/mL, and \> 50 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 (Only evaluable PK Samples), defined as participants who received at least one dose of the double-blind study drug, with a valid post baseline assessment. The 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.
reporting Status
POSTED
time Frame
2 hours post dose on Week 6, Week 24, Week 48, Week 96, Week 144, and Week 240
title
Everolimus Blood Concentration (C2h) at 2 Hours Post Dose
type
SECONDARY
unit Of Measure
ng/mL

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Preserved source evidence · Not medical advice