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NCT00790400 · OUTCOME

Time to Angiomyolipoma Progression as Per Central Radiology Review

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

Time to angiomyolipoma progression (TTAP) is defined as time from date of randomization to date of first documented angiomyolipoma progression. Angiomyolipoma progression was defined as one or more of the following: Increase from nadir of ≥ 25% in angiomyolipoma volume to value greater than baseline; the appearance of a new angiomyolipoma ≥ 1.0 cm in longest diameter; an increase from nadir of 20% or more in the volume of either kidney to a value greater than baseline; angiomyolipoma-related bleeding grade ≥ 2. For the everolimus (core/extension periods) treatment group, the time to angiomyolipoma progression is defined starting from the start of everolimus. The baseline means the latest value on or before starting everolimus.

Analysis population: The Full Analysis Set (FAS) is defined according to the Intention-to-Treat principle and consists of all randomized patients.

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.

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)79
Placebo Randomized (Core Period)39
Everolimus (Core and/or Extension Period)112

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Everolimus Randomized (Core Period)NANot reportedNANAMedian not reached since too few number of patients with progressions (n=3).
Placebo Randomized (Core Period)11.37Not reported11.07NAUpper limit not estimable due to few number of patients at this time point.
Everolimus (Core and/or Extension Period)NANot reportedNANAMedian not reached since too few number of patients with progressions (n=16)
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Median not reached since too few number of patients with progressions (n=3).
        group Id
        OG000
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      2. comment
        Upper limit not estimable due to few number of patients at this time point.
        group Id
        OG001
        lower Limit
        11.07
        upper Limit
        NA
        value
        11.37
      3. comment
        Median not reached since too few number of patients with progressions (n=16)
        group Id
        OG002
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      79
    2. group Id
      OG001
      value
      39
    3. group Id
      OG002
      value
      112
    units
    Participants
description
Time to angiomyolipoma progression (TTAP) is defined as time from date of randomization to date of first documented angiomyolipoma progression. Angiomyolipoma progression was defined as one or more of the following: Increase from nadir of ≥ 25% in angiomyolipoma volume to value greater than baseline; the appearance of a new angiomyolipoma ≥ 1.0 cm in longest diameter; an increase from nadir of 20% or more in the volume of either kidney to a value greater than baseline; angiomyolipoma-related bleeding grade ≥ 2. For the everolimus (core/extension periods) treatment group, the time to angiomyolipoma progression is defined starting from the start of everolimus. The baseline means the latest value on or before starting everolimus.
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
    Placebo was given by continuous oral daily dosing of two 5 mg tablets.
    id
    OG001
    title
    Placebo Randomized (Core Period)
  3. description
    Patients initially randomized in everolimus and patients initially randomized in placebo but who crossed-over to everolimus during extension.
    id
    OG002
    title
    Everolimus (Core and/or Extension Period)
param Type
MEDIAN
population Description
The Full Analysis Set (FAS) is defined according to the Intention-to-Treat principle and consists of all randomized patients.
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
Time to Angiomyolipoma Progression as Per Central Radiology Review
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice