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NCT00790400 · OUTCOME

Duration of Angiomyolipoma Response - Only Everolimus Patients With Angiomyolipoma Response

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
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
From date of randomization until the earliest date of first documented AML progression, date of further anti-AML medication (including open-label Everolimus)/surgery or up to about 5.7 years

What was measured

Duration of angiomyolipoma response was defined as the time from the date of the first documented angiomyolipoma response until the date of the first documented angiomyolipoma progression . Angiomyolipoma response was defined as the combination of the following criteria: reduction in angiomyolipoma volume of ≥ 50% relative to baseline, where angiomyolipoma volume was sum of volumes of all target lesions identified at baseline, and with a confirmatory scan performed approximately 12 weeks later (no sooner than 8 weeks later); no new angiomyolipoma lesions ≥ 1.0 cm in longest diameter were identified; there were no kidney increases in volume \> 20% from nadir. The patient did not have any angiomyolipoma-related bleeding of ≥ grade 2.

Analysis population: The analysis was performed on the Full analysis Set for patients in Everolimus arm and who experienced an angiomyolipoma response.

Groups in this outcome

Everolimus Randomized (Core Period)

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

Everolimus (Core and/or Extension Period)

Patients initially randomized in everolimus and patients initially randomized in placebo but who crossed-over to everolimus during extension.

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)33
Everolimus (Core and/or Extension Period)65

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Everolimus Randomized (Core Period)NANot reportedNANAN/A = Median not reached since no patients progressed
Everolimus (Core and/or Extension Period)NANot reportedNANAN/A = Median not reached since too few no of patients with progressions (n=2)
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        N/A = Median not reached since no patients progressed
        group Id
        OG000
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      2. comment
        N/A = Median not reached since too few no of patients with progressions (n=2)
        group Id
        OG001
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      33
    2. group Id
      OG001
      value
      65
    units
    Participants
description
Duration of angiomyolipoma response was defined as the time from the date of the first documented angiomyolipoma response until the date of the first documented angiomyolipoma progression . Angiomyolipoma response was defined as the combination of the following criteria: reduction in angiomyolipoma volume of ≥ 50% relative to baseline, where angiomyolipoma volume was sum of volumes of all target lesions identified at baseline, and with a confirmatory scan performed approximately 12 weeks later (no sooner than 8 weeks later); no new angiomyolipoma lesions ≥ 1.0 cm in longest diameter were identified; there were no kidney increases in volume \> 20% from nadir. The patient did not have any angiomyolipoma-related bleeding of ≥ grade 2.
dispersion Type
95% Confidence Interval
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
    Patients initially randomized in everolimus and patients initially randomized in placebo but who crossed-over to everolimus during extension.
    id
    OG001
    title
    Everolimus (Core and/or Extension Period)
param Type
MEDIAN
population Description
The analysis was performed on the Full analysis Set for patients in Everolimus arm and who experienced an angiomyolipoma response.
reporting Status
POSTED
time Frame
From date of randomization until the earliest date of first documented AML progression, date of further anti-AML medication (including open-label Everolimus)/surgery or up to about 5.7 years
title
Duration of Angiomyolipoma Response - Only Everolimus Patients With Angiomyolipoma Response
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice