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NCT00790400 · OUTCOME

Change From Baseline in Plasma Angiogenic Molecules - Vascular Endothelial Growth Factor (VEGF) Marker

Efficacy and Safety of RAD001 in Patients Aged 18 and Over With Angiomyolipoma Associated With Either Tuberous Sclerosis Complex (TSC) or Sporadic Lymphangioleiomyomatosis (LAM) · Source last updated 2017-02-17

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

Measure
MEAN
Unit
pg/mL
Interval / dispersion
Standard Deviation
Time frame
4 weeks, 12 weeks, 24 weeks, 36 weeks 48 weeks, 60 weeks, 72 weeks

What was measured

Blood samples for biomarker assessment were collected immediately prior to study administration. On-treatment samples was compared to baseline samples with the change from baseline.

Analysis population: The Full Analysis Set (FAS) is defined according to the Intention-to-Treat principle and consists of all randomized patients. The 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.

Groups in this outcome

Everolimus Randomized (Core Period)

Study drug was given by continuous oral daily dosing of two 5 mg tablets.

Placebo Randomized (Core Period)

Placebo was given by continuous oral daily dosing of two 5 mg tablets.

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 Randomized (Core Period)79
Placebo Randomized (Core Period)39

Reported measurements

Week 4 (n:56, 28)
Values in pg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Everolimus Randomized (Core Period)38.7141.89Not reportedNot reportedNot reported
Placebo Randomized (Core Period)17.657.51Not reportedNot reportedNot reported
Week 12 (n:56, 29)
Values in pg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Everolimus Randomized (Core Period)43.460.62Not reportedNot reportedNot reported
Placebo Randomized (Core Period)-6.146.28Not reportedNot reportedNot reported
Week 24 (n:53, 29)
Values in pg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Everolimus Randomized (Core Period)31.175.83Not reportedNot reportedNot reported
Placebo Randomized (Core Period)-4.344.76Not reportedNot reportedNot reported
Week 36 (n:26, 18)
Values in pg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Everolimus Randomized (Core Period)18.045.07Not reportedNot reportedNot reported
Placebo Randomized (Core Period)5.424.01Not reportedNot reportedNot reported
Week 48 (n:16, 8)
Values in pg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Everolimus Randomized (Core Period)55.380.31Not reportedNot reportedNot reported
Placebo Randomized (Core Period)3.134.55Not reportedNot reportedNot reported
Week 60 (n:0, 1)
Values in pg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Everolimus Randomized (Core Period)NANANot reportedNot reportedN/A = No patient was included at this time point, so no mean, no standard deviation (SD) could be calculated.
Placebo Randomized (Core Period)-4.12NANot reportedNot reportedN/A = only 1 patient was included, so no SD could be calculated
Week 72 (n:0, 1)
Values in pg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Everolimus Randomized (Core Period)NANANot reportedNot reportedN/A = No patient was included at this time point, so no mean, no SD could be calculated.
Placebo Randomized (Core Period)-6.1NANot reportedNot reportedN/A = only 1 patient was included, so no SD could be calculated
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        141.89
        value
        38.7
      2. group Id
        OG001
        spread
        57.51
        value
        17.6
    title
    Week 4 (n:56, 28)
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        60.62
        value
        43.4
      2. group Id
        OG001
        spread
        46.28
        value
        -6.1
    title
    Week 12 (n:56, 29)
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        75.83
        value
        31.1
      2. group Id
        OG001
        spread
        44.76
        value
        -4.3
    title
    Week 24 (n:53, 29)
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        45.07
        value
        18.0
      2. group Id
        OG001
        spread
        24.01
        value
        5.4
    title
    Week 36 (n:26, 18)
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        80.31
        value
        55.3
      2. group Id
        OG001
        spread
        34.55
        value
        3.1
    title
    Week 48 (n:16, 8)
  6. categories
    1. measurements
      1. comment
        N/A = No patient was included at this time point, so no mean, no standard deviation (SD) could be calculated.
        group Id
        OG000
        spread
        NA
        value
        NA
      2. comment
        N/A = only 1 patient was included, so no SD could be calculated
        group Id
        OG001
        spread
        NA
        value
        -4.12
    title
    Week 60 (n:0, 1)
  7. categories
    1. measurements
      1. comment
        N/A = No patient was included at this time point, so no mean, no SD could be calculated.
        group Id
        OG000
        spread
        NA
        value
        NA
      2. comment
        N/A = only 1 patient was included, so no SD could be calculated
        group Id
        OG001
        spread
        NA
        value
        -6.1
    title
    Week 72 (n:0, 1)
denoms
  1. counts
    1. group Id
      OG000
      value
      79
    2. group Id
      OG001
      value
      39
    units
    Participants
description
Blood samples for biomarker assessment were collected immediately prior to study administration. On-treatment samples was compared to baseline samples with the change from baseline.
dispersion Type
Standard Deviation
groups
  1. description
    Study drug was given by continuous oral daily dosing of two 5 mg tablets.
    id
    OG000
    title
    Everolimus Randomized (Core Period)
  2. description
    Placebo was given by continuous oral daily dosing of two 5 mg tablets.
    id
    OG001
    title
    Placebo Randomized (Core Period)
param Type
MEAN
population Description
The Full Analysis Set (FAS) is defined according to the Intention-to-Treat principle and consists of all randomized patients. The 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.
reporting Status
POSTED
time Frame
4 weeks, 12 weeks, 24 weeks, 36 weeks 48 weeks, 60 weeks, 72 weeks
title
Change From Baseline in Plasma Angiogenic Molecules - Vascular Endothelial Growth Factor (VEGF) Marker
type
SECONDARY
unit Of Measure
pg/mL

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Preserved source evidence · Not medical advice